Alaris IVAC 710x, IVAC 720x Service manual

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IVAC® MODEL

710

720

SERIES

Signature Edition

Volumetric Pump

TECHNICAL

SERVICE

MANUAL

EDICAL SYSTEMS

™

Page 2

EDICAL S YSTEM S

™

ii IVAC

Signature Edition™ Technical Service Manual

U. S. AND FOREIGN PATENTS ISSUED AND PENDING.

PATENTED: UNITED STATES: Patent 4,534,756; 5,096,385; 4,898,576, 5,534,691; 5,542,826; 5,537,853; 5,563,347; 5,568,912; 5,575,632; 5,601,420; 5,603,613; 5,609,576; D367,527; D367,528; D371,144;D371,194; CANADA: Patented/Brevete 1,219,497;1,279,800; 78,377; 78,376 and 78,378. FRANCE: Brevet No. 0,121,931; 0,431,310; 0,248,632; 951,426; 951,427 and 951,428. GERMANY: D.P.B. No. EP P3482620.3; P3778211.8-08; M9501997.9; M9,501,997.0; M9501995.2; and M9501996.0. GREAT BRITAIN: Patent No. EP 0,121,931; 0,431,310; 0,248,63; 2,045,812; 2,045,814; 2,045,813; JAPAN: 1,743,342. SWITZERLAND: +EP 0,121,931; 0,328,163; 0,328,162; 0,248,632; 122,210; 122,211and 122,212. Other U.S. and foreign patents issued and pending.

This document contains proprietary information of ALARIS Medical Systems, and its receipt or possession does not convey any rights to reproduce its contents, or to manufacture or sell any product described. Reproduction, disclosure, or use other than for the intended purpose without specific written authorization of ALARIS Medical Systems is strictly forbidden.

This Technical Service Manual is subject to change without notification. For current technical information, please call Technical Support at (800) 854-7128 ext. 6003, or write ALARIS Medical Systems, 10221 Wateridge Circle, San Diego, CA 92121-1579, Attention: Technical Support.

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IVAC®Signature Edition™ Technical Service Manual 1

Phone Numbers for Reference

USA Only

CUSTOMER SERVICE

(800) 482-4822

For placing an order for parts, accessories, etc., and

checking status of an order.

TECHNICAL SUPPORT

(619) 458-6003

(800) 854-7128, EXT. 6003

For technical, troubleshooting and preventive main-

tenance information.

QUALITY ASSURANCE

(800) 854-7128 EXT. 7812

For product complaints.

CANADA Only

CUSTOMER SERVICE

(800)513-2254

For Western Canada to place orders.

For all of Canada to place complaints.

CUSTOMER SERVICE

(800) 268-4457

For Eastern Canada to place orders.

EDICAL SYSTEMS

™

http://www.alarismed.com

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iv IVAC

Signature Edition™ Technical Service Manual

WARRANTY

ALARIS Medical Systems, Inc., (hereinafter referred to as “ALARIS Medical Systems”) warrants that:

A. Each new IVAC

Signature Edition™Pump, excluding the battery, is free from defects in material and workmanship under normal use and service, for the period stated in the Directions For Use, from the date of delivery by ALARIS Medical Systems to the original purchaser.

B. The battery and each new accessory are free from defects in material and workmanship

under normal use and service for a period of ninety (90) days from the date of delivery by ALARIS Medical Systems to the original purchaser.

If any product requires service during the applicable warranty period, the purchaser should communicate directly with ALARIS Medical Systems headquarters (San Diego, CA) to determine the appropriate repair facility. Except as provided otherwise in this warranty, repair or replacement will be carried out at ALARIS Medical Systems’s expense. The product requiring service should be returned promptly, properly packaged and postage prepaid by purchaser. Loss or damage in return shipment to the repair facility shall be at purchaser’s risk.

In no event shall ALARIS Medical Systems be liable for any incidental, indirect or consequential damages in connection with the purchase or use of any ALARIS Medical Systems product. This warranty shall apply solely to the original purchaser. This warranty shall not apply to any subsequent owner or holder of the product. Furthermore, this warranty shall not apply to, and ALARIS Medical Systems shall not be responsible for, any loss or damage arising in connection with the purchase or use of any

ALARIS Medical

Systems

product which has been:

(a) repaired by anyone other than an authorized ALARIS Medical Systems service

representative;

(b) altered in any way so as to affect, in ALARIS Medical Systems judgment, the

product’s stability or reliability;

lot number altered, effaced or removed;

(d) improperly maintained or used in any manner other than in accordance with the

written instructions furnished by ALARIS Medical Systems.

This warranty is in lieu of all other warranties, express or implied, and of all other obligations or liabilities of ALARIS Medical Systems, and ALARIS Medical Systems does not give or grant, directly or indirectly, the authority to any representative or other person to assume on behalf of

ALARIS Medical Systems

any other liability in connection with the sale or

use of ALARIS Medical Systems products.

ALARIS MEDICAL SYSTEMS, INC., DISCLAIMS ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING ANY WARRANTY OF MERCHANTABILITY OR OF FITNESS FOR A PARTICULAR PURPOSE OR APPLICATION.

See packing inserts for international warranty, if applicable.

EDICAL SYSTEMS

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IVAC®Signature Edition™ Technical Service Manual v

Chapter 1 General Information

1.1 Introduction .......................................................................................................................................1-1

1.2 Expanded Pump Specifications ...........................................................................................................1-3

1.3 Battery Management System .............................................................................................................1-5

1.3.1 Fan ....................................................................................................................................................1-5

1.3.2 Battery and Charging Process ............................................................................................................1-5

1.3.3 Refresh Cycle .....................................................................................................................................1-6

1.3.4 Battery Gauge ...................................................................................................................................1-6

1.3.5 Power On/Off ....................................................................................................................................1-7

1.3.6 Lower LCD Display .............................................................................................................................1-7

1.3.7 Clock .................................................................................................................................................1-7

1.3.8 Battery Maintenance .........................................................................................................................1-7

1.4 NiCd Battery Capacity Information .....................................................................................................1-8

1.5 Dynamic Monitoring™ System ...........................................................................................................1-9

1.6 Data Communications Function .......................................................................................................1-11

1.7 Accessories ......................................................................................................................................1-11

1.7.1 Nurse Call ........................................................................................................................................1-11

1.7.2 Learn/Teach RS-232 Cable ...............................................................................................................1-11

1.8 Summary of Precautions ..................................................................................................................1-11

1.8.1 Notes ..............................................................................................................................................1-11

1.8.2 Cautions ..........................................................................................................................................1-14

1.8.3 Warnings .........................................................................................................................................1-14

1.9 Compliance to Standards..................................................................................................................1-16

1.9.1 710X/720X ......................................................................................................................................1-16

1.9.2 Declaration of Conformity ...............................................................................................................1-17

Chapter 2 Checkout and Configuration

2.1 Introduction ......................................................................................................................................2-1

2.2 New Instrument Checkout .................................................................................................................2-1

2.3 Start-Up Defaults ...............................................................................................................................2-3

2.4 Configuration Procedure ...................................................................................................................2-3

2.4.1 Entering Configuration Mode ............................................................................................................2-4

2.4.2 Setting to Defaults .............................................................................................................................2-4

2.4.3 Setting Language ..............................................................................................................................2-5

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2.4.4 Setting Air-in-Line Threshold ..............................................................................................................2-5

2.4.5 Setting Dose Rate Drugs ....................................................................................................................2-6

2.4.6 Setting Maximum Rate ......................................................................................................................2-8

2.4.7 Setting Computer Link .......................................................................................................................2-8

2.4.8 Setting Optional Modes .....................................................................................................................2-9

2.4.9 Setting Optional Features ................................................................................................................2-10

2.4.10 Setting KVO Rate .............................................................................................................................2-12

2.4.11 Setting Dynamic Monitoring™ Options ...........................................................................................2-13

2.4.12 Setting Audio Volume .....................................................................................................................2-14

2.4.13 Setting Configuration Name ............................................................................................................2-14

2.5 Transferring Settings to Another Pump ............................................................................................2-15

2.5.1 Teacher/Learner Pump Procedure .....................................................................................................2-16

2.5.2 Pop-Up Displays ...............................................................................................................................2-16

Chapter 3 Preventive Maintenance

3.1 Introduction ......................................................................................................................................3-1

3.2 Storage and Cleaning ........................................................................................................................3-1

3.2.1 Storage .............................................................................................................................................3-1

3.2.2 Cleaning ............................................................................................................................................3-2

3.3 Preventive Maintenance Inspections ...................................................................................................3-3

3.3.1 Regular Inspection .............................................................................................................................3-3

3.3.2 Functional Test ..................................................................................................................................3-3

3.3.3 Flow Stop Test....................................................................................................................................3-4

3.3.4 Rate Accuracy Verification Test ..........................................................................................................3-4

3.3.5 Pressure Calibration............................................................................................................................3-5

3.3.6 Ground Current Leakage Test ............................................................................................................3-6

3.3.7 Ground Resistance Test ......................................................................................................................3-6

3.3.8 Battery Refresh Cycle..........................................................................................................................3-6

3.3.9 Reset Time..........................................................................................................................................3-6

3.3.10 Reset PM Due.....................................................................................................................................3-6

Chapter 4 Functional Description

4.1 Introduction ......................................................................................................................................4-1

4.2 Principle of Operation ........................................................................................................................4-1

4.3 Overview ...........................................................................................................................................4-2

4.4 Main PCB ..........................................................................................................................................4-4

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IVAC®Signature Edition™ Technical Service Manual vii

4.4.1 Processor Kernel ................................................................................................................................4-4

4.4.2 COMBO IC ........................................................................................................................................4-4

4.4.3 EEPROM ............................................................................................................................................4-4

4.4.4 RAM ..................................................................................................................................................4-4

4.4.5 EPROM ..............................................................................................................................................4-5

4.4.6 RS-232 Interface ................................................................................................................................4-5

4.4.7 RS-232 Interface (7101/7201 only) ....................................................................................................4-5

4.5 Power System ....................................................................................................................................4-6

4.5.1 Battery Manager ................................................................................................................................4-6

4.5.2 AC Off Line Switcher .........................................................................................................................4-7

4.5.3 Battery Charge Regulator ..................................................................................................................4-7

4.5.4 Refresh Cycle Load ............................................................................................................................4-8

4.5.5 VAO Shutdown .................................................................................................................................4-8

4.5.6 AC Line Sense ...................................................................................................................................4-8

4.5.7 System Power Source Select ..............................................................................................................4-8

4.5.8 Battery Voltage Monitor ....................................................................................................................4-9

4.5.9 VMEAS ..............................................................................................................................................4-9

4.5.10 Voltage Reference 4.1V .....................................................................................................................4-9

4.5.11 System Current Monitor ....................................................................................................................4-9

4.5.12 Always On Supply (+5VAO) .............................................................................................................4-10

4.5.13 System Switching Supplies ...............................................................................................................4-10

4.5.14 VRAM Supply ..................................................................................................................................4-10

4.5.15 VPOS Supply ....................................................................................................................................4-10

4.5.16 Battery Temperature Sensor .............................................................................................................4-10

4.5.17 System Watchdog ............................................................................................................................4-12

4.5.18 Power Switch ..................................................................................................................................4-13

4.5.19 System Reset/Power On ....................................................................................................................4-13

4.5.20 Lower LCD Display Backlight Drive....................................................................................................4-13

4.6 Motor Drive/ Sensors .......................................................................................................................4-14

4.6.1 Motor Drive .....................................................................................................................................4-14

4.6.2 Air-in-line Sensor .............................................................................................................................4-17

4.6.3 Transducer ......................................................................................................................................4-17

4.7 User Interface ..................................................................................................................................4-18

4.7.1 Main Speaker Driver ........................................................................................................................4-19

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Signature Edition™ Technical Service Manual

4.7.2 Backup Audio Buzzer and Test Circuit ..............................................................................................4-19

4.8 LED Module .....................................................................................................................................4-20

4.9 Lower LCD Display ...........................................................................................................................4-21

4.10 Main LCD Module ...........................................................................................................................4-21

4.10.1 Main LCD Back Light .......................................................................................................................4-21

4.10.2 Graphic LCD Contrast ......................................................................................................................4-21

4.11 Nurse Call Circuit .............................................................................................................................4-21

4.12 Panel Lock Switch ............................................................................................................................4-21

4.13 ECD Board .......................................................................................................................................4-21

4.13.1 ECD Board Option for 7100/7200 ....................................................................................................4-21

4.13.2 ECD Board Option for 7101/7201.....................................................................................................4-21

Chapter 5 Corrective Maintenance

5.1 Introduction ......................................................................................................................................5-1

5.2 Repair or Replacement .......................................................................................................................5-2

5.3 Replacing Battery ...............................................................................................................................5-2

5.4 Disassembling Pump ..........................................................................................................................5-4

5.4.1 Disassembly of Rear Case ..................................................................................................................5-7

5.4.2 Disassembly Procedure for Cable Routing .........................................................................................5-10

5.4.3 Disassembly of Front Case ................................................................................................................5-12

5.4.4 Reassembly Procedure for Cable Routing ..........................................................................................5-18

5.5 Assembling Pump ............................................................................................................................5-20

5.6 Test and Calibration ........................................................................................................................5-21

5.6.1 Power-On Self-Test ..........................................................................................................................5-21

5.6.2 Mechanism Visual Check .................................................................................................................5-21

5.6.3 Mechanical Leak Test .......................................................................................................................5-21

5.6.4 Pressure Verification and Calibration Test ........................................................................................5-21

5.6.5 Set Sensor Check..............................................................................................................................5-21

5.6.6 Test Run Mode .................................................................................................................................5-22

5.6.7 Hard Pressure Cal Procedure.............................................................................................................5-23

5.6.8 Checking Pressure Calibration ..........................................................................................................5-23

5.6.9 Rate Calibration Procedure ...............................................................................................................5-24

5.7 Level of Testing Guidelines ..............................................................................................................5-25

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IVAC®Signature Edition™ Technical Service Manual ix

Chapter 6 Troubleshooting

6.1 Introduction ......................................................................................................................................6-1

6.2 Technical Troubleshooting Guide .......................................................................................................6-1

6.3 Error Messages ..................................................................................................................................6-4

6.4 Diagnostics Mode ..............................................................................................................................6-9

6.4.1 Entering Diagnostics Mode ................................................................................................................6-9

6.4.2 Setting Preventive Maintenance Interval ...........................................................................................6-10

6.4.3 Viewing Alarm or Error History ........................................................................................................6-11

6.4.4 Clearing Diagnostic History ..............................................................................................................6-12

6.4.5 Viewing Battery Status .....................................................................................................................6-13

6.4.6 Changing Rated Capacity of Battery ................................................................................................6-13

6.4.7 Viewing DC Voltages .......................................................................................................................6-14

6.4.8 Setting ID Number ...........................................................................................................................6-14

6.4.9 Viewing Battery and Total Run Times ...............................................................................................6-15

6.4.10 Setting Self-Check Timer .................................................................................................................6-15

6.4.11 Viewing Channel Sensors ................................................................................................................6-16

6.4.12 Viewing Rate Calibration Information ..............................................................................................6-17

6.4.13 Testing Main LCD ............................................................................................................................6-17

6.4.14 Testing Aux (Lower) LCD .................................................................................................................6-18

6.4.15 Testing Switches ..............................................................................................................................6-18

6.4.16 Changing Main LCD Contrast ..........................................................................................................6-19

6.4.17 Calibrating Channel Pressure ............................................................................................................6-19

6.4.18 Viewing Temperature Calibration Information ..................................................................................6-21

6.4.19 Configuring Pressure System Auto Zero ............................................................................................6-23

Chapter 7 Illustrated Parts Breakdown

7.1 Introduction ......................................................................................................................................7-1

7.2 Illustrations ........................................................................................................................................7-1

7.3 Parts List ............................................................................................................................................7-1

7.4 Ordering Parts ...................................................................................................................................7-1

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Signature Edition™ Technical Service Manual

List of Figures

Figure 1-1 Lower LCD Display Layout ...........................................................................................................1-7

Figure 1-2 Resistance Graph ......................................................................................................................1-10

Figure 1-3 Pressure and Resistance Graph ..................................................................................................1-10

Figure 2-1 Map of Configuration Screens ...................................................................................................2-19

Figure 3-1 Cleaning the Mechanism Area ....................................................................................................3-2

Figure 3-2 Setup for Rate Verification Test ...................................................................................................3-5

Figure 3-3 Pressure Test Setup .....................................................................................................................3-6

Figure 4-1 Main Block Diagram ...................................................................................................................4-2

Figure 4-2 COMBO IC Block Diagram ..........................................................................................................4-5

Figure 4-3 Electrical Partitioning ..................................................................................................................4-6

Figure 4-4 Battery Manager Block Diagram ..................................................................................................4-7

Figure 4-5 Battery Monitor ........................................................................................................................4-11

Figure 4-6 Main Power Supply ...................................................................................................................4-11

Figure 4-7 System Watchdog .....................................................................................................................4-12

Figure 4-8 System Reset/Power On ............................................................................................................4-13

Figure 4-9 Motor Drive Circuit, Phase 1 (A) ................................................................................................4-16

Figure 4-10 Motor and Mechanism Sensors Block Diagram ..........................................................................4-16

Figure 4-11 Air-in-line Detector Block Diagram ............................................................................................4-17

Figure 4-12 Pressure Sensor Interface Block Diagram ...................................................................................4-17

Figure 4-13 User Interface Block Diagram ....................................................................................................4-18

Figure 4-14 Main Speaker ...........................................................................................................................4-19

Figure 4-15 Backup Audio ...........................................................................................................................4-20

Figure 4-16 Lower LCD Display Layout .........................................................................................................4-21

Figure 4-17 Flow Sensor Interface Block Diagram ........................................................................................4-23

Figure 5-1 Instrument Assembly Organization ..............................................................................................5-4

Figure 5-2 Leak Test Setup ........................................................................................................................5-22

Figure 6-1 Map of Diagnostics Screens .......................................................................................................6-25

Figure 7-1 Case Assembly SINGLE CHANNEL or DUAL CHANNEL................................................................7-5

Figure 7-2 Front Case Assembly SINGLE CHANNEL or DUAL CHANNEL......................................................7-11

Figure 7-3 Rear Case Assembly SINGLE CHANNEL or DUAL CHANNEL.......................................................7-17

Figure 7-4 Label/Literature Assembly .........................................................................................................7-23

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IVAC®Signature Edition™ Technical Service Manual xi

List of Tables

Table 1-1 Battery Trip Points .......................................................................................................................1-6

Table 1-2 Common Abbreviations ............................................................................................................1-15

Table 1-3 Reference Designators ..............................................................................................................1-16

Table 1-4 Symbol Definition .....................................................................................................................1-16

Table 2-1 Configuration Options and Defaults ............................................................................................2-2

Table 2-2 Drug List .....................................................................................................................................2-7

Table 2-3 Record of Configured Instruments ............................................................................................2-17

Table 3-1 PM Inspections ...........................................................................................................................3-7

Table 4-1 Definition of Terms .....................................................................................................................4-3

Table 4-2 Battery Trip Points .......................................................................................................................4-8

Table 4-3 Motor Control Signals ...............................................................................................................4-15

Table 5-1 Test Equipment ...........................................................................................................................5-1

Table 5-2 Level of Testing Guidelines ........................................................................................................5-25

Table 6-1 Technical Troubleshooting Guide ................................................................................................6-2

Table 6-2 Error Messages ...........................................................................................................................6-4

Table 6-3 Battery Manager Error Codes ......................................................................................................6-8

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Page 12

IVAC®Signature Edition™ Technical Service Manual 1-1

NOTE: The changes from 7100F/7200F to 7100G and 7200G are software only — added event log, auto zero enable/disable and real time software clock.

NOTE: The 7101/7201 Keypad uses symbols instead of words.

NOTE: Refer to the ALARIS Medical Systems Warranty before servicing the pump. Any attempt to service an ALARIS Medical Systems instrument by anyone other than an authorized ALARIS Medical Systems service representative may invalidate the ALARIS Medical Systems Warranty. ALARIS Medical Systems offers a variety of repair agreements for post-warranty service. Call toll-free (800) 482-4822 (ALARIS Medical Systems) for information.

1.1 INTRODUCTION

This manual covers Signature Edition versions with software 2.44 and higher and is the initial release of the 7101A/7201 version. Series includes 7100F, 7200F, 7100G, 7200G, 7101A and 7201A. 710X means 7100 and 7101 iterations.

There are two specific model groups — 7100G/7200G and 7101A/7201A. The key differences are:

HARDWARE — The 7101A/7201A Series is labeled for 220V with two power cord options and has isolated RS232 Board, potential equalization (PE) connector, drop sensor board installed. There is no Nurse Call option. The keypad has symbols instead of words.

SOFTWARE — The 7101/7201 Series has no drug list (Drug ? only), some defaults are different in configuration mode and there are seven (7) languages to choose from.

The IVAC Signature Edition system includes the SE I — Model 710X, and SE II — Model 720X Volumetric Infusion Pumps and AccuSlide

™

administration sets. Refer to the Directions for Use manual for complete

information regarding the setup and operation of the pump.

The Model 7100/7200 Series pump is a 100-240 VAC, 50/60 Hz instrument family that supports both single and dual channel fluid delivery. Each instrument carries identification labels designating its model and serial number.

The pump features user-interactive software. It displays prompts, alarms and alert messages, and troubleshooting information on the main LCD display of the instrument. The pump can be configured to your specific operational requirements and allows upgrades for future product enhancements. The pump has been designed to interface with accessory equipment including nurse call system and/or computer monitoring system.

This manual contains instructions for maintenance, repair, and configuration of the instrument. The maintenance and repair sections of the manual are written for personnel experienced in the analysis, troubleshooting, and repair of analog and digital microprocessor-based electronic equipment.

Chapter 1 — GENERAL INFORMATION

EDICAL SYSTEMS

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SEC

PRI

™

? PRI SEC KVO

•

1 2 3 4 hrs

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1-2 IVAC

Signature Edition™ Technical Service Manual

GENERAL INFORMATION

EDICAL SYSTEMS

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Specifications

RATE RANGE:

VOLUME TO BE INFUSED RANGE:

VOLUME INFUSED RANGE:

KVO RANGE:

SYSTEM ACCURACY

ALARMS:

DIMENSIONS:

CASE:

ADMINISTRATION SETS:

POWER REQUIREMENTS:

MODE OF OPERATION

GROUND CURRENT LEAKAGE:

BATTERY:

MAXIMUM BOLUS VOLUME (ml)

MAXIMUM TIME TO ALARM (ml)

MAXIMUM INFUSION PRESSURE

OCCLUSION ALARM PRESSURE

CRITICAL VOLUME:

ENVIRONMENTAL CONDITIONS:

Testing performed per proposed standard IEC 601-2-24 using IVAC IV sets

0.1 to 999.9 ml/hr in 0.1 ml/hr increments (primary)

0.1 to 270.0 ml/hr in 0.1 ml/hr increments (secondary)

0.1 to 9999.9 ml in 0.1 ml increments (primary)

0.1 to 999.9 ml in 0.1 ml increments (secondary)

0.0 to 9999.9 ml in 0.1 ml increments

0.1 to 20.0 ml/hr in 0.1 ml/hr increments

±5%*

• Air In Line

• Battery Depleted

• Channel Malfunction

• Computer Link Failure

• Flow Sensor Unplugged

7100/7101 7200/7201

Width 7.6 in/19.3 cm 10.5 in/26.7 cm Height 8.6 in/21.8 cm 8.6 in/21.8 cm Depth

5.0 in/12.7 cm 5.0 in/12.7 cm

Weight

§§

6.6 lbs./2.9 kg 8.4 lbs/3.7 kg

Power Cord 10ft/3 m 10ft/3 m

without pole clamp§§without power cord

Impact resistant plastic Use only IVAC 72 series administration sets. All disposable IV set and IV set accessory

models are defined on a separate card included with this Directions for Use. 100-240V ~, 50/60 Hz, 0.6A ~, 72VA max — 3-wire grounded system. Class 1 with

Internal Power Source. Continuous Risk Current (normal/single fault condition)

Ground (enclosure) leakage current: less than 100/500 µA (normal/single fault) Patient leakage current: less than 10/50 µA (normal/single fault)

Rechargeable nickel cadmium. Use only IVAC Nickel Cadmium or Nickel Metal Hydride, 12V, 1.8AHr (minimum) batteries.With a new, fully charged battery, the pump will operate for 4 hours nominal at 100 ml/hr for a two channel instrument operating on both channels simultaneously.

With a fully charged, new battery at 25ºC, volatile memory configuration information will be retained for at least 6 months. Interrupted secondary or advanced operating modes retain special program settings up to six hours. Additionally, Resistance Trending information is retained for 6 hours.

At 1.0 ml/hr: 0.5 ml;* At 25 ml/hr: 0.5 ml* At 1.0 ml/hr: 60 min*.; At 25 ml/hr: 2 min*. 16 psi* 12 psi ±4psi, not adjustable*

Maximum incremental volume in case of single point failure will not exceed 1.0 ml @

999.9 ml/hr.

Operating Storage/Transport

Temperature Range: 10ºC to 40ºC -40ºC to 60ºC

(50ºF to 104ºF) (-40ºF to 140ºF)

Relative Humidity: 15 to 90% 5 to 95%

Non-condensing Non-condensing

Atmospheric Pressure: 631 to 1031 mbar 631 to 1031 mbar

• Hold Time Exceeded

• Instrument Malfunction

• Key Stuck

• Latch Open

• No U

pstream Flow Detected

•

Occlusion Downstream

•

Occlusion Upstream

•

Primary Flow Detected During

Secondary

• Set Up Time Exceeded

•

Set Out

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IVAC®Signature Edition™ Technical Service Manual 1-3

GENERAL INFORMATION

EDICAL SYSTEMS

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1.2 Expanded Pump Specifications

Administration Set: Use only IVAC 72 Series administration sets.

When used for Max. Gravity Flow Rate: gravity infusion: >4200 ml/hr with 16 gauge catheter x 2.25” Teflon

Air-in-Line Accuracy:

Altitude: Operating Altitude: -500 ft.(-150M) to 7,500 ft. (2285M)

Battery: 500 charge/discharge cycles, minimum under nominal charging conditions

Recharge time while instrument is running, is 4 hours to 95% capacity +50%, -0% battery gauge accuracy

Case: Impact resistant plastic, flame retardant

Fluid Ingress Rating: Drip proof IPX1

Ground Current Leakage: (7100/7200) <100 µAmps.120Vrms

Tested to UL Standard 544 and CSA C22.2 No.125 for medical and dental equipment.

Parts per ml: 1150 steps to deliver 1 ml (Rate cal #191)

Programmable Features: Air-in-line alarm threshold: 50, 100, 200, or 500 µl (Configuration) Air-in-line reset feature: On/Off

Audio: Hi/Med/Lo levels accessible

These features can be customized Communications: Baud Rate, Parity by qualified service personnel. Computer control: Control, Monitor, Off

Configuration is not lost when Configuration Name: 4 bit alpha-numeric code disconnected from AC power Display language: Choice of two or seven and/or battery power. Dose Rate Calculation: On/Off

Drug? Access: On/Off Drug Specific Access: Short/Extended/Off (7100X/7200X only) Dynamic Monitoring™

Configured Threshold Air Volume Detections Range

50µL 15µL - 85µL 100µL 35µL - 140µL 200µL 100µL - 235µL 500µL 275µL - 565µL

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GENERAL INFORMATION

EDICAL SYSTEMS

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Mode: Hi Resistance/Resistance/Pressure Only Alert: On/Off Restarts: 0 (Off), 1-9 Resistance Display: On/Off

Resistance Trend Graph: On/Off Instrument ID: 9 digits KVO rate: 0.1 - 20.0 ml/hr Loading Dose: On/Off Panel lock: On/Off Preventive maintenance interval 1-52 weeks Preventive maintenance reminder: On/Off Maximum rate: 0.1- 999.9 ml/hr Multi-Dose Alert: On/Off Multi-Dose Mode: On/Off Multi-Step Mode: On/Off Transition tone: On/Off VTBI: ON/OFF (7101/7201 or flow sensor modification)

Rate Accuracy: ±5% typical at 30” delivery container head height

RFI: Tolerate > 10 V/m across frequency range

Temperature: Operating above 30°C, for extended periods, will reduce battery life.

Volume to Be Infused Range: 0.1 to 9999.9 ml in 0.1 ml increments (primary)

0.1 to 999.9 ml in 0.1 ml increments (secondary)

0.1 to 999.9 ml in 0.1 ml increments (loading dose)

0.1 to 9999.9 ml in 0.1 ml increments (dose rate)

0.1 to 999.9 ml per step in 0.1 ml increments (multi-step)

0.1 to 999.9 ml per dose in 0.1 ml increments (multi-dose)

Warnings: • Battery Low • Multi-Step Complete

• Checking Line • Resistance Alert

• Computer Control Released • Secondary Complete

• Dose Complete • VTBI = 0

• Load Dose Complete

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1.3 Battery Management System

This section contains general information on the battery management system. Included is information on how the Battery Manager monitors and maintains the battery, controls the power on/off for the rest of the instrument, and provides support functions for the main processor. Refer to Chapter 4 for more detailed functional descriptions.

The battery management system consists of the Battery Manager IC and various sensors and signal processing circuits. The Battery Manager IC (Rev.

3.06) is a custom programmed microcontroller that performs the following functions:

• Controls the battery charger

• Provides a battery status “battery gauge“

• Monitors voltage and temperature of battery

• Controls the instrument power source (on/off

function)

• Drives the Lower LCD Display (See Figure 1-1)

• Includes a relative-time clock

The Battery Manager communicates with the main processor via a serial data channel. The main processor issues commands to the Battery Manager which then responds with status information and data using this channel.

1.3.1 Fan

The internal fan is used for cooling, mainly to help prolong battery life. It is a ball bearing, brushless DC fan.

The fan is always on when battery is charging with “Fast” or “Top-up” charge. The fan will go on any time battery temperature is over 22°C.

1.3.2 Battery and Charging Process

The battery is a ten cell (1.2V per cell), high capacity nickel-cadmium type rated at 12 volts and 1.8 amphours (with a minimum of 500 charge/discharge cycles).

The battery pack (10 to 18V) has a built-in temperature sensor which allows the Battery Manager to monitor the temperature of the battery. The pack also includes a temperature limiting thermostat which opens the circuit if the battery temperature gets too hot and closes again when the temperature returns to normal.

The battery charge circuit charges the battery with a constant current of 1 ampere whenever the Battery Manager turns the charger on. The Battery Manager regulates average charge current by turning the charger on and off with the appropriate duty ratio. The battery charge cycle consists of four modes; fast charge, top-up charge, float charge, and hot charge.

a. Fast Charge: Fast charge is initiated whenever the

battery is less than 36ºC, and has been discharged by more than 200 Ampere-seconds through actual use or self discharge. Leaving the instrument unplugged for a day would cause about 200 Ampere-seconds of self discharge. The charge current is a continuous 1 Ampere. The end of a fast charge is detected when the temperature of the battery rises 7ºC above its temperature at start of charge and is at least 30ºC, or when the battery voltage declines by 192mV below its peak value, or total charge time exceeds 3.2 hours. Also refer to Battery Charge Regulator section (4.5.3) for further details.

b. Top-Up Charge: The top-up charge phase begins

at the end of the fast charge phase and finishes adding the last few percent of charge to the battery and balances individual cell charges. This phase charges at an average rate of 180 mA (1A for 0.9 seconds every 5 seconds) for 180 minutes. At that time,the instrument will go into float charge mode. The charger will suspend top-up if the battery temperature exceeds 37ºC. The time spent to cool down to below 37ºC is in addition to the 180 minutes top-up charge time. If top-up cool down time exceeds 5 1/2 hours, the instrument will go into float charge mode.

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c. Float Charge:

The float charge phase begins at the end of the top-up phase and helps maintain a fully charged battery. This phase charges at an average rate of 40 mA (1 A for 0.2 seconds every 5 seconds). The fan remains on or turns on when battery temperature exceeds 22ºC.

d. Hot Charge: The Hot Charge Mode occurs when

the instrument determines that the battery is >36°C (normally due to ambient temperature being >27°C) to allow a charge after waiting 3 hours for it to cool down. Hot Charge Mode charges at an average rate of 180 mA (1A for 0.9 seconds every 5 seconds) for a total charge time of 18 hours. If the battery temperature exceeds 43°C, the charging is turned off until the temperature falls below 43°C. Note that the cool down time is in addition to the 18 hour charge time. The float charge cycle begins at the end of the hot charge cycle.

Table 1-1 Battery Trip Points

Battery Voltage Instrument Response

12.0V (Single) • 15 minutes left on gauge

12.1V (Dual) • Unit continues to function

• Warning tone activated

• Low battery warning

11.45V • Unit does not pump

• Constant alarm

• Low battery alarm (Depletion)

10.25V • 1 min or longer (nominal 5 min.) after low batt alarm

• Backup speaker activated

• Instrument shutdown (5 min. after

alarm)

9.75V • No AC power applied

• Battery disconnected from circuit by shutdown signal

1.3.3 Refresh Cycle

A battery refresh cycle performs a full charge, discharge, and recharge to condition and measure the capacity of the battery. This refresh results in a new “Measured Capacity” in the battery diagnostics and can be used to judge the condition of the battery. The refresh cycle must be initiated manually, either by disconnecting/reconnecting the battery or by loading 0.0 A-H as the rated capacity in the battery diagnostics page. After the zero rated

capacity is loaded and the OK button is pressed, the original rated capacity must be reloaded to preserve the battery gauge. The empty “E” icon will flash during the discharge part of the refresh cycle. The AC power must remain connected and uninterrupted during the discharge cycle. If the AC power is removed during this cycle, the discharge cycle will be terminated and another refresh cycle will have to be initiated. The time for complete refresh is dependent upon battery temperature and takes an average of 20 hours to complete.

Two ways to initiate a manual refresh cycle are:

1. Disconnect from AC, unplug the battery, then press the power switch. The lower LCD will go blank. Reconnect the battery then plug the pump into AC.

2. Enter Diagnostics Mode, go to page D2, and enter

0.0 Ah for battery rated capacity. Press Enter and

ok. Turn pump off and back on, then plug the

pump into AC. Once the fan turns on (indicating the start of a refresh cycle), return to page D2 and reset the battery rated capacity to 1.3 Ah (with battery manager software 3.01 and higher).

1.3.4 Battery Gauge

The battery gauge provides an indication to the user of the approximate amount of time the instrument will run on battery power. It will usually indicate less run time than the user will actually get on a new battery. This is displayed in a bar graph format on the lower LCD Display and is active as long as the battery is connected to the instrument. The display indicates up to 4 hours in 15 minute increments. (See Figure 1-1, Lower LCD Display Layout)

The battery gauge circuitry measures the current flow into and out of the battery and maintains a record of the state of charge of the battery. This record is reset each time the pump completes a full refresh cycle. The battery gauge uses this record, together with a measurement of the present power requirements of the instrument, to estimate the time available on battery power at the current infusion rate.

NOTE: When the instrument is turned off, the gauge will indicate approximate run time for infusions of 125 ml/hr.

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1.3.5 Power On/Off

The Battery Manager provides the interface between power on/off switch(es) and the main processor. When the instrument is off, the Battery Manager interprets either power switch as a turn on command and applies power to the rest of the instrument, informing the main processor which switch was pressed. Once power is on, further presses of a power switch are passed on to the main processor which determines the appropriate response under the existing conditions. If the response is to turn the power off, the main processor requests that the Battery Manager remove power from the rest of the instrument.

If an error has been detected which causes the watchdog to be in alarm, a push of either power switch will immediately cause the power to be turned off, without intervention by the Battery Manager.

1.3.6 Lower LCD Display

The Battery Manager also contains the driver for the Lower LCD Display. In addition to the battery gauge, this display contains a four character alphanumeric “configuration” display and several icons. The information for these other displays is controlled by the main processor and is communicated to the Battery Manager through the serial channel. The Battery Manager also uses the four character display to indicate errors detected in the Battery Manager system itself.

Figure 1-1 Lower LCD Display Layout

1.3.7 Clock

The Battery Manager provides a “relative

time”

clock which the main processor can set and read. This clock consists of a 32 bit counter which is incremented once a second under all conditions. The main processor uses this counter as a means of determining elapsed time even when power has been turned off. The clock is used to determine when a battery refresh cycle is required as well as compensating for normal battery capacity degradation over time.

1.3.8 Battery Maintenance

CAUTION: Use only ALARIS

™

Medical approved batteries due to Battery Manager requirements and the thermostat contained in the battery assembly.

Connect pump to AC before turning pump on if it has been in storage. Usually one refresh cycle is sufficient to restore battery capacity. If necessary, repeat the procedure at 24 hour intervals, 2 or 3 times, to increase capacity.

Several features have been included in the Battery Manager to help properly maintain the battery.

• A measurement of the capacity of the battery is available in the diagnostic mode.

• A special circuit removes all load from the battery when the voltage falls too low, preventing damage from over discharge due to long term storage.

NiCd batteries can be stored indefinitely with no load but will self-discharge from a charged state in about 100 days. This does not damage the battery as it would if it were a lead acid type battery. Connect instrument to AC to recharge batteries.

NOTE: If under load (inside instrument), the maximum storage time would be about 130 days before electrolyte extrusion occurs past the battery seal.

If the battery exhibits short run times, a reconditioning procedure can be used. Disconnect battery and AC, press the On/Off switch and verify

CTRL

MNTR

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lower LCD goes blank. Reconnect the battery. Plug instrument into AC. A refresh cycle will be initiated. Repeat this procedure at 24 hour intervals, 2 or 3 times to increase capacity or use a battery conditioner.

CAUTION: Dispose of or recycle battery following

hospital protocol. Refer to your institution’s operating procedures, your state’s EPA guidelines for disposal of battery or contact Rechargeable Battery Recycling Corporation (RBRC) at 1-800-822-8837.

1.4 Nicd Battery Capacity Information

All batteries have specific conditions under which they are guaranteed to meet their published specifications. Deviations from these conditions typically result in a reduction of available capacity. Manufacturers of nicd batteries rate capacities, usually expressed in Ah (Ampere-Hours), based on a specified “ideal“ charge and discharge condition as well as the use of a “new” battery. Battery Manufacturer’s date codes start on 9/1 of the upcoming year (e.g. date code 9611 = first week of November 1995).

An ideal charge cycle starts with a fully discharged battery charged at C/10 (C is the rated capacity in Ah) constant current for 15 hours while at room temperature. For instance, a 1.8Ah battery would be charged for 15 hours at 180mA constant current with a room temperature of 23°C.

The ideal discharge starts with a fully charged battery under a C/5 constant current load at room temperature discharging to a cell voltage of 0.9V. The rated capacity is then calculated as the time to discharge divided by 5. Again, a 1.8Ah cell would be discharged at 360mA constant current and not reach

0.9V for at least 5 hours. Note that a given battery type has different capacities based on the load. For instance, a battery rated at 1.8Ah at a 360mA load may have only 1.6Ah at a 1600mA load.

As can be seen from the preceding ideal conditions, there are many conditions which can affect the battery capacity. The following conditions have the

most practical impact on battery capacity delivered in this instrument.

a. TEMPERATURE DURING CHARGE - As the effective

ambient temperature of the battery increases, the amount of charge that the battery will accept is decreased. At an ambient temperature of 35°C, an enclosed battery will temporarily accept only about 90% of the charge it would otherwise accept at 23°C. Since the batteries are internal to the instrument case, they will be exposed to temperatures above room temperature since the instrument itself generates heat. Some of the ways the instrument limits the temperatures that the battery sees include forcing air across it (an internal fan) and turning off the charger when the battery temperature gets too high.

b. CYCLE LIFE AND AGING - As batteries get older

and go through many charge/discharge cycles, batteries “wear out” in that the chemicals and materials used to construct the cell break down. The way the instrument deals with this is to assume that a battery will continually reduce capacity at a rate equivalent to 30% over 4 years and continually reduce capacity at a rate equivalent to 30% per 200 full discharge/charge cycles. These calculated values are used to reduce the runtime displayed on the battery gauge.

c. PARTIAL DISCHARGE/RECHARGE - When a battery

is partially discharged, then charged for less than the full time, differences between individual cell capacities result in cells completing charge at different times. If the full charge sequence is not then completed, the cell “mismatch“ becomes progressively greater. This is viewed by the user as low apparent runtimes and premature low battery warning and alarms. The problem is cumulative in that the mismatch increases for every partial cycle. The lowered capacity is not permanent, but may require 2-3 full discharge/charge cycles to recover. The way the instrument deals with this is to reduce the runtime displayed based on a limited history of partial cycles.

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d. CHARGE RATE - The ideal charge rate requires 15

hours to get to full charge, which is undesirable from the user’s perspective. The instrument provides a multiphase charge cycle which results in about 80% capacity in the first 2 hours after Fast charge. The next charge phase, Top-up, is designed to finish the charge and to bring all individual cells to the fully charged state, essentially rematching them. Refer to Section

1.3.2 for Fast Charge and Top-up Charge information. If the Top-up charge is not completed, then the cell mismatch is not reduced and the cumulative capacity reduction occurs. Top-up is a 3 hour charge, but the elapsed time to complete it may be over 5 hours as the charger is turned on and off to keep the battery cool during that time.

e. BATTERY ALARM VOLTAGE - The battery alarm

voltage is the voltage at which the instrument stops operating and generates an alarm to tell the user to plug it into AC line. As noted in the ideal discharge condition, the end of discharge is determined by 0.9V/cell. Under perfect conditions, a battery of 10 cells connected in series would reach the end of discharge at 9.0V. However, cells are not perfectly matched so some will reach 0.9V before others. The problem occurs when a cell in series with other cells can go below 0.9V and actually can go into cell reversal, which permanently damages the particular cell. On the other hand, increasing the alarm voltage to compensate for imperfectly matched cells results in reduced runtimes with available capacity. The user sees this as premature low battery warnings and alarms. The way the instrument deals with this is to increase the alarm voltage to guarantee the battery is not damaged and reduce the assumed capacity to below that printed on the battery. The battery gauge is intended to show the minimum run time left on the battery taking all these factors into account.

NOTE: In the future, ALARIS Medical Systems may provide different battery packs. The replacement battery may have a different rated capacity. Therefore, the Battery Manager of the instrument needs to know that a new battery has been added and the rated capacity has changed. Refer to Section

5.3 “Replacing Battery” and Section 6.4.6, Changing Rated Capacity of Battery.

1.5 Dynamic System Monitoring™ (DSM)

The following is general information regarding the Dynamic Monitoring™ system as it relates to the Signature Edition instrument.

In order for fluid to move through the administration set, a pressure difference (gradient) must exist. In a gravity setup, this is done by head height. In a pump, the instrument will develop pressure to overcome downstream effects on fluid flow.

The fundamental concept behind the Dynamic Monitoring™ system is that the resistance to fluid flow from the mechanism to the patient’s infusion site can be measured. This is done by intentionally varying the flow rate while monitoring the resulting changes in fluid pressure. Refer to Figure 1-2 “Resistance Graph”. Signal processing of the pressure and flow data can then produce the fluid impedance value. Such measurements can be made continuously at short intervals and be independent of the selected rate. Head height and resulting pressure variations, likewise, will not affect the measurement.

When a complete occlusion occurs, the resistive part of the fluid impedance is very large (theoretically infinite). Elevated resistances due to clotting, clogged filters, partial occlusions or infiltrations can be measured.

The Dynamic Monitoring™ system provides a means to measure the mechanical properties of the downstream flow path.

Pressure = Effect when a force is against a restriction. Resistance = Cause when impediment to fluid flow occurs. Resistance = C

hange in Pressure (∆P) Change in Flow (∆F)

Refer to Figure 1-3 “Pressure and Resistance Graph”.

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Features include:

• Alarm setting is based on dynamic system impedance (pressure changes, not absolute pressure).

• Detection of complete occlusions.

• Reduced nuisance alarms by minimizing artifact

effects such as head height and patient movement.

• Faster time to alarm at low rates.

• The AutoRestartPlus™ feature allows the pump to

automatically continue operation if an occlusion is cleared within the self-check period (40 seconds). A warning tone and “Checking Line” message will occur for up to 40 seconds. The feature can be turned off (set the restarts to zero), or the number of restarts may be set from 1 to 9.

NOTE: The restart counter is reset whenever the clinician presses Run/Hold, if the pump or channel is turned off, or if an alarm occurs.

NOTE: When infusion is started, the resistance may be other than 0%, depending on solution viscosity, catheter/tubing size and filters.

• Resistance Alert, provides an early warning of slow or gradual changes in the resistance of the IV line/site. The Resistance Alert marker can be set from 5 to 100%. It allows the nurse to monitor resistance and will provide a tone every 30 seconds if the percent resistance exceeds the resistance alert mark.

• The resistance display may be turned off. If off, the system will continue to monitor downstream resistance and alarm appropriately.

Figure 1-2 Resistance Graph

Figure 1-3 Pressure and Resistance Graph

Pressure rise is quite small with site complication, especially with low flow rates.

Resistance rises dramatically with site complication.

≈

100%

75%

50%

600

300

100

PRESSURE mmHg

300

200

100

FLUID OHMS

mmHg/Liter/Hr

OCCLUSION

∆ IN PRESSURE

TIME

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1.6 Data Communications Function

The instrument has built-in remote monitoring capability. This allows features and their data to be monitored by a computer, providing a means to create advanced clinical systems. A separate manual on data communications is available and organized to support technical personnel with a wide range of experience and needs. The separate manual includes:

• General Information: Includes the phone number for technical support.

• Operation: The instrument’s communications modes, controls, indicators, and procedures from the user’s point of view.

• Instrument Setup: How to set the baud rate, enable or disable computer control, and other parameters.

• Electrical Interfacing: RS-232 background information, connectors and recommended wiring for common computers.

• Communications Protocol: Inquiry, response, and command codes, data formats, message sequences, and error detection.

1.7 Accessories

Accessory items are available for use with the instrument. These items are described in the following paragraphs.

1.7.1 Nurse Call (7100/7200 only)

All instruments are equipped with the nurse call feature. Alarms and some alerts from the pump will be relayed to the hospital’s existing nurse call system. No operating features of the pump are changed. The pump will alarm with or without the nurse call. The only additional item needed is a cable with a 9 pin to mono phone jack (P/N 136111).

NOTE: This option is not available on 7101/7201 pumps.

1.7.2 Learn/Teach RS-232 Cable

This is a standard commercially available 9-pin Null Modem RS-232 cable (also ALARIS P/N 133450). The Learn/Teach RS-232 cable is used to connect two instruments for the purpose of transferring (downloading) configuration data from/to another instrument.

1.7.3 Flow Sensor

Flow sensor capability is available with an upgrade kit on 7100/7200. For 7101/7201 all that is needed is the drop sensors.

The flow sensor attaches to the administration set’s drip chamber. It detects an empty solution container and verifies fluid flow. When installed, it will allow VTBI to be turned off. The Flow Sensor will not see drops falling if drip chamber is tilted more than 24º.

1.8 Summary of Precautions

The following is a consolidation of NOTES, CAUTIONS, and WARNINGS found throughout this manual. Each is repeated in context with its related subject matter.

A NOTE is information that is of particular importance to the reader.

A CAUTION is a precaution that, if not taken, can result in damage to equipment.

A WARNING is a precaution that, if not taken, can result in personal or patient injury.

1.8.1 Notes

NOTE: If under load (inside instrument), the maximum storage time would be about 130 days before electrolyte extrusion occurs past the battery seal.

NOTE: This option is not available on 7101/7201 pumps.

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NOTE: When the instrument is turned off, the gauge will indicate approximate run time for infusions of 125 ml/hr.

5.3 “Replacing Battery” and Section 6.4.6, Changing Rated Capacity of Battery.

NOTE: The restart counter is reset whenever the clinician presses Run/Hold, if the pump or channel is turned off, or if an alarm occurs.

NOTE: When infusion is started, the resistance may be other than 0%, depending on solution viscosity, catheter/tubing size and filters.

NOTE: The instrument’s configuration information is not lost when disconnected from AC power and battery power. However, error history and infusion program settings may be lost. If you want to save this information be sure to record before disconnecting power.

NOTE: It is strongly recommended that you review Table 2-1 for a complete list of defaults before selecting factory defaults.

NOTE: Setting the Maximum Rate below the preset KVO Rate will lower the KVO Rate. The KVO rate will not exceed the Maximum Rate.

NOTE: The maximum rate setting applies to all infusion modes.

NOTE: The KVO rate will not exceed the present Maximum Rate.

NOTE: If Display is off then the alert feature will automatically be turned off.

NOTE: Resistance trend graph data is lost when:

1) Clear is pressed, 2) Pump is off for more than 6 hours.

NOTE: Resistance measurement is restarted at 0% when: 1) Run/Hold is pressed to put on hold and again to start, 2) Dose ends in Multi-Dose mode, 3) Checking line message appears.

NOTE: Checking line alert applies to pressure, resistance and upstream occlusion with one tone at the beginning and a flashing popup display (on for 4 seconds, off for 6 seconds). No nurse call activation.

NOTE: Resistance alert will give an alarm tone every thirty seconds, with a popup display (on for 4 seconds, off for 6 seconds). Nurse call activated. This occurs when the resistance measurement is above the alert threshold or at 100% even when checking line.

NOTE: You will see a 4 digit alpha/numeric code next to the configuration name upon entering configuration mode. Refer to Section 2.4.1 “Entering Configuration Mode” . This code is only a hexadecimal reflection of your instrument’s configuration name.

NOTE: If you have changed the configuration but not the name, the pump will display the option to rename before turning off or proceeding to the teach mode. Refer to Section 2.5.2 “Pop-Up Displays” for further explanation.

NOTE: Must have 4 characters in configuration name, use space (-) symbol to fill in any open character.

NOTE: Only the configuration settings will be transferred. The instrument ID number and the periodic maintenance settings from the diagnostics mode will not be transferred through LEARN/TEACH.

NOTE: Repeat allows you to re-attempt or teach the next pump.

NOTE: The Learn/Teach function will not work if revision level is not the same on both pumps or if the pumps are not the same model (ie 710x/720x to 7000A).

NOTE: Do not use 70RCS more than 40 times.

NOTE: Due to the Dynamic Monitoring feature, the rate is varied during operation. For this reason, ALARIS MEDICAL SYSTEMS does not recommend using automatic testers to check rate accuracy. Generally, these devices collect small samples and may cause the results to be incorrect even though the instrument is accurate.

NOTE: The main PCB board can only be replaced in pumps with main software Rev. 2.02 or higher.

NOTE: Do not use 70RCS more than 40 times.

NOTE: X’s appear once pressure calibration is started or if pressure calibration is required.

NOTE: The main PCB board can only be replaced in pumps with main software Rev. 2.02 or higher.

NOTE: The alarm history is not stored in the EEPROM.

NOTE: Refer to Figure 4-5 “Battery Monitor” and Figure 4-6 “Main Power Supply” when following Sections 4.5.2 through 4.5.17.

NOTE: The charger will turn off if the battery gets too hot (>37º C) to let the battery cool down. Cool down time is not included in the 180 minute charge time.

NOTE: The instrument’s operation, when the battery is disconnected, is the same as the Battery Manager generating the SHUT-DOWN* signal and requires the instrument to be plugged into AC after the battery has been reconnected.

NOTE: The tests to be performed on a just-repaired instrument depend on the level of repairs made to the pump.

NOTE: Instrument configuration will not be lost when disconnecting power. However, history and infusion program settings may be lost. If you want to save event log, record before proceeding.

NOTE: The instrument will not run with battery disconnected.

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NOTE: The instrument will attempt to refresh the battery when it is first installed. This refresh may take in excess of 24 hours if the instrument is turned on.

NOTE: If replacing battery, ensure battery run time is cleared in Diagnostic Mode.

NOTE: Do not remove cover from back of power supply board. If it’s loose, reinstall with RTV.

NOTE: Single channel pump routing is similar to Channel B (ChB).

NOTE: Exercise caution when removing connectors. Pulling on wires can break them. Wires and connectors must be replaced as part of an assembly. They cannot be repaired separately.

NOTE: When removing flex cables, carefully lift locking bar to remove cable from connector.

NOTE: Pay particular attention to wire routing. Wires should be routed back to initial scheme and similar to the example shown. This will prevent them from getting pinched and jamming the mechanism.

NOTE: The large capacitor for the backup speaker may be discharged before removing the board. Jumper across terminals of capacitor C-146 (C- 179) for one minute. See Troubleshooting Section for more information.

NOTE: Pay close attention to cable routing when disassembling the instrument. The cables are specifically routed to ensure they are not pinched or stressed when reassembled.

NOTE: Keypad pictures are for reference only and may not match your instrument.

NOTE: Cable routing may change over time to ensure wires are not pinched and ease of assembly and disassembly is maintained. When the pump was opened, if the cable routing was different, follow that cable routing scheme..

NOTE: Calibration coefficients for the transducer are stored in the EEPROM on the main board assembly. Once they have been calibrated, the Signature Edition mechanism and board assemblies become a matched set. Replacement of either requires pressure and rate calibration.

NOTE: Pay close attention to cable routing when disassembling the instrument. The cables are specifically routed to ensure they are not pinched or stressed when reassembled.

NOTE: No fluid in set for mechanical leak test.

NOTE: Ensure clamp is in the closed position.

NOTE: When air pressure is first applied a few bubbles are acceptable during mechanical leak check.

NOTE: Care should be taken to avoid applying too much tamper seal so it does not effect the transducer.

NOTE: There is one case screw inside battery compartment.

NOTE: If, as a result of the following calculation, the new rate cal value falls outside the range of 182 to 214, return the instrument to ALARIS Medical Systems or replace the mechanism.

NOTE: The disposable set (70RCS) cannot be used for more than 40 rate accuracy verification runs (20 rate cal number changes).

NOTE: If unit operation is at all doubtful, perform a complete PM procedure. This table provides minimum test requirements.

NOTE: Steps listed are in order of actions to take to correct problem/fault.

NOTE: Mechanism and boards can only be replaced in 7100E/7200E (or later) instruments.

NOTE: Record alarm history using the Alarm or History Error mode described in Section 6.4.3 “Viewing Alarm or Error History” before disconnecting the battery, disassembling, troubleshooting, or testing the pump.

NOTE: Pressing undo or cancel will undo any edits made to that page, and stay on the page. Pressing ok will accept all information on the page, and progress to another page in Diagnostic Mode.

NOTE: PM Due decrements with calendar time and is displayed to the nearest week.

NOTE: Pressing the Reset PM Due soft key resets the PM Due to the displayed PM Interval.

NOTE: If AC and battery power are disconnected from the instrument, alarm and error history may be lost.

NOTE: The only situation that the clock will not run is on loss of power. When viewing the alarms, the time will not be updated until exiting this page.

NOTE: Battery voltage will flash when updated by software.

NOTES: See Chapter 3 for specific rate accuracy verification testing. If the rate verification fails, see chapter 5 for rate calibration procedure with software 2.02 and higher.

NOTE: Battery is rated at 1.8 Ah under ideal conditions. 1.3 Ah will be entered here to help compensate for uneven cell capacity and ensure getting a “low battery alarm” with 30 minutes or more use on battery.

NOTE: The ID Number can be up to 9 digits.

NOTE: When the ON/OFF key is pressed while pump is on, it will display “Press and hold key to turn off”.

NOTE: The hard cal procedure is in Chapter 5.

NOTE: Perform TEMP CAL message means TC=/0.0 in Adjust Tc Section. This may occur when main board is replaced.

NOTE: Measured Tc may be all dashes or show a number. Selected Tc must be 0.0 if software is 2.02 and higher.

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NOTE: Selected Tc=0.0 with software is 2.02 or higher. If not, will get Perform Temp Cal message when in pressure calibration (soft).

NOTE: As a result of continuing product development, the part number you receive may not match the one you requested, but will be interchangeable, unless otherwise noted.

1.8.2 Cautions

CAUTION: Use only ALARIS Medical approved

batteries due to Battery Manager requirements and the thermostat contained in the battery assembly.

CAUTION: Dispose of or recycle battery following

CAUTION: Keep latch closed when instrument is

not in use.

CAUTION: When there is no AC power available,

do not replace dead battery for the purpose of re-powering the instrument. The instrument will not operate unless it is first connected to AC power after battery replacement.

CAUTION: Alcohol will cause the key pad to crack

over time.

CAUTION: Do not connect ground resistance

probe to pressure transducer.

CAUTION: To avoid serious damage to the board

assemblies, use extreme care and always use proper static grounding techniques.

CAUTION: Do not mix mechanisms in dual

channel or with other instruments. When a mechanism is removed, it must go back in the original position or the pump will need hard and soft pressure calibration as well as rate calibration.

CAUTION: Use only ALARIS Medical approved

batteries due to Battery Manager requirements and the thermostat contained in the battery assembly

1.8.3 Warnings

WARNING: When an instrument’s configuration

is changed, the configuration name should also be changed to document the new parameter settings. The intent of the configuration name is to have only one set of parameters for each alpha-numeric code. Refer to Section 2.5.2 “Pop-Up Displays”

WARNING: Powering down in configuration

mode during an alarm or error will not save any configuration changes.

WARNING: Failure to perform regular and

preventive maintenance inspections may result in improper instrument operation.

WARNING: Turn the instrument off and unplug

the power cord from the AC wall outlet before cleaning. Do not steam autoclave, EtO sterilize, immerse the pump, or allow fluids to enter the pump case.

WARNING: Disconnect pump from AC power

before disassembling. Hazardous voltages are present when AC power is connected regardless of the setting of the ON/OFF switch.

WARNING: Always perform a rate accuracy

verification after mechanism and board have been removed and reinstalled or cables have been disconnected and reconnected.

WARNING: Use extreme caution in servicing the

instrument when connected to AC power Hazardous voltages are present when AC power is connected regardless of the setting of the power switch.

Page 26

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GENERAL INFORMATION

EDICAL SYSTEMS

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Table 1-2 Common Abbreviations

* “active Low” logic signal A ampere A/D analog to digital converter A/R as required AC alternating current Ah ampere-hour AIL air-in-line cm centimeter cmH2O centimeters of Water CMOS complimentary symmetry metal oxide

semiconductor COML commercial °C degrees celsius D/A digital to analog DC direct current die diameter DIP dual in-line package EEPROM electrically erasable programmable read-only

memory ELECT electrolytic capacitor EMI electromagnetic interference EPROM erasable programmable read-only memory ESD electrostatic discharge EtO ethylene-oxide gas °F degrees fahrenheit FET field-effect transistor ft foot H hexadecimal Hex hexagonal Hg mercury hr hour Hz hertz IC integrated circuit ID inside diameter in inch I/0 input/output IV intravenous Js jack kg kilogram kHz kiloHertz kV kilovolt KVO keep vein open kΩ kilohm kW kilowatt lb pound

LCD liquid crystal display LED light emitting diode lg long MHz megahertz µA microamp µF microfarad µsec microsecond mA milliampere min minute ml milliliter mm millimeter mmHg millimeters of mercury MOS metal oxide semiconductor ms millisecond MUX digital multiplexer N/A not applicable NPN negative-positive-negative no.; nos. number or numbers NU not used OD outside diameter Ω Ohm P/N part number PCB printed circuit board pF picofarad PNP positive-negative-positive PR power regulator psi pounds per square inch psig psi-gauge PWB printed wiring board r m s root mean square R/R remove/replace RAM random access memory RFI radio frequency interference ROM read-only memory SCR silicon controlled rectifier sec second SIP single in-line package SMD surface mount device S/N serial number SSD static sensitive device TANT tantalum capacitor thk thick TTL transistor-transistor logic V volt VAC volts alternating current

Page 27

1-16 IVAC

Signature Edition™ Technical Service Manual

Table 3 Reference Designators

C capacitor CR diode/zener diode DS display F fuse FB ferrite bead J connector, terminal header L inductor P plug connector Q transistor/FET R resistor RESN ceramic resonator S switch SPKR speaker T transformer TH thermistor U integrated circuit XU socket for IC Y crystal

ground

1.9 Compliance To Standards

The standards used as guidelines (at current revision level of public availability) in the design and development of the pump are as follows:

1.9.1 710X/720X

UL 544, “Standard for Medical and Dental

Equipment”

CSA C.22.2 No. 125, “Safety Standards for Electro-

medical Equipment”

AAMI ID26, “Standards for Infusion Devices”.

FDA MDS 201-0004, “Electromagnetic Compatibility

Standard for Medical Devices”.

CISCR 11, “Limits and Methods of Measurement of

Electromagnetic Disturbance Characteristics of Industrial, Scientific, and Medical (ISM) Radio Frequency Equipment”.

IEC 529, 1989, “Classification of Degrees of

Protection Provided by Enclosures”.

Table 4 Symbol Definition

Attention, consult accompanying documents.

RS-232 Connector

Nurse Call

IEC 801-2, “Electromagnetic Compatibility for

Industrial Process Measurement and Control Equipment, Part 2: Electrostatic Discharge Requirements”.

IEC 801-3, Electromagnetic Compatibility for

Industrial Process Measurement and Control Equipment, Part 3: Susceptibility to Radiated Electromagnetic Energy.

IEC 801-4, Electromagnetic Compatibility for

Industrial Process Measurement and Control Equipment, Part 4: Electrical Fast Transient/Burst Requirements”.

IEC 801-5, Electromagnetic Compatibility for

Industrial Process Measurement and Control Equipment, Part 5: Voltage Surge Immunity Requirements”.

FCC Docket 20780 Part 15 (Class A) Accessories with

Information on Sets and Set Materials.

NAFTA 99, “Standards for Health Care Facilities.

RS 232

GENERAL INFORMATION

EDICAL SYSTEMS

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IVAC®Signature Edition™ Technical Service Manual 1-17

GENERAL INFORMATION

EDICAL SYSTEMS

™

— DECLARATION OF CONFORMITY —

MEDICAL DEVICES DIRECTIVE 93/42/EEC

Manufacturer: ALARIS Medical Systems, Inc. Address: 10221 Wateridge Circle Drive

San Diego, CA 92121-2733

Device: Model 710X/720X Family Infusion Pumps and associated

sterile IV administration sets.

Device Options: Model 180 Flow Sensor w/Flow Sensor Handle Cap

We herewith declare that the above mentioned device(s) and accessories comply with the requirements of the EC Directive 93/42/EEC, that the conformity assessment procedures are completed, and the device(s) is designed, manufactured, and tested in accordance with the information contained within the Technical File.

This declaration is based on:

Annex II of EC Directive 93/42/EEC, EC Declaration of Conformity Certification of Quality System Certification Number: 0526 Issued By: British Standards Institution Date: 27 June 1995

Device Technical File

Completed By: Quality Engineering Initial Release Date: 1 July 1997

Supplementary Information

The product herewith has additionally been assessed and complies with the following specifications and standards:

Safety: • IEC 601-1:1988/BS 5724:Part 1: 1989 “Safety of Medical

Electrical Equipment”

• Draft IEC 601-2-24: Part 2 “Particular Requirements for Safety of Infusion Pumps and Controllers”

EMC: • EN 55011: 1991

• EN 60601-1-1: 1993

• Draft IEC 60601-2-24 “Applicable EMC Limits”

Authorized EU Representative: Issued by:

ALARIS Medical Systems, Inc. V.P. Quality and Regulatory, Tony Thorne, Manager, International QA/RA ALARIS Medical Systems, Inc. Intec 2 Wade Road San Diego, California U.S.A. Basingstoke, UK Hants RG24 8NE

1.9.2 Declaration of Conformity (7101/7201)

Page 29

IVAC®Signature Edition™ Technical Service Manual 2-1

CAUTION: Keep latch closed when instrument is

not in use.

2.1 Introduction

This chapter describes the initial setup and configuration of the instrument. Included in this chapter is a reproducible form (Record of Configured Instruments, Table 2-3) available for recording and tracking configurations for instruments located in different areas. For your reference, a fold-out map of all the configuration screens is provided at the end of this chapter.

2.2 New Instrument Checkout

Refer to the instrument's Directions For Use (DFU) manual for instructions regarding unpacking and setting up the instrument for the first time.

When turning on the instrument, verify that the instrument beeps and that all display LED segments flash. This confirms that the pump has performed its self test, and is operating correctly. During operation, the pump continually performs a self test, and will alarm and display a message if it detects an internal malfunction.

Service is required if the pump fails to satisfactorily pass the start-up sequence. Refer the instrument to qualified service personnel if the instrument shows physical damage, is out of calibration, fails to complete the self test, or continues to alarm. Information about instrument alarms is found in Chapter 6 of this manual and in the Directions For Use.

For new instrument checkout, the minimum checks are:

• Functional Test (Chapter 3)

• Ground Current Leakage Test (Chapter 3)

• Flow Stop Test (Chapter 3)

• Instrument Configuration (Chapter 2)

• Rate Verification (Chapter 3)

• Pressure Verification (Chapter 3)

• Set Sensor Check (Chapter 3)

Chapter 2 — CHECKOUT AND CONFIGURATION

EDICAL SYSTEMS

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Page 30

Table 2-1. Configuration Options and Defaults**

FEATURES OPTIONS FACTORY DEFAULTS

7100/7200 7101/7201 7100/7200 7101/7201

Air-in-Line:

Threshold 50, 100, 200, or 500 µl 50, 100, 200, or 500 µl 100 µl 100 µl

Reset On/Off On/Off Off Off

Audio:

Volumes Low/Med/Hi, Med/Hi, Hi Low/Med/Hi, Med/Hi, Hi Low/Med/H Low/Med/Hii

Transition Tone On/Off On/Off On On

AUTO ZERO: On/Off On/Off Off Off

(Set in Diagnostics Mode)

Computer Link:

Mode Ctrl/Mntr/Off, Mntr/Off, Off Ctrl/Mntr/Off, Mntr/Off, Off Off Off

Baud Rate

300/600/1200/1800/2400/4800/9600 300/600/1200/1800/2400/4800/9600

9600 9600

Parity Even/Odd/None Even/Odd/None None None

Dose Rate Drugs:

Extended List Access Short/Extended/Off Off

Drug ? Short/Extended/Of Drug ? (only) Short Drug ? (only)

Drug Specific Access* Short/Extended/Off Off

Dynamic Monitoring:

Mode Hi Resist./Resist/Pressure Hi Resist./Resist/Pressure Pressure Resistance

Display On/Off On/Off On On

Restarts 0 (Off), 1 to 9 0 (Off), 1 to 9 3 3

Alert(%) On/Off (% in 5% increments) On/Off (% in 5% increments) Off Off

Instrument ID: 9 digits 9 digits Serial Number Serial Number

(Set in Diagnostics Mode) (Factory Set) (Factory Set)

Config Name: 4 alpha-numeric characters 4 alpha-numeric characters IVAC IVAC

KVO Rate: 0.1 to 20.0 ml/h 0.1 to 20.0 ml/hr 5.0 ml/hrr 5.0 ml/hr Languages: English, Canadian French English, French, German, Dutch, English. English

Italian, Swedish, Spanish

LCD Contrast: 1 to 256 1 to 256 127 127

(Set in Diagnostics Mode)

Maximum Rate: 0.1 to 999.9 ml/hr 0.1 to 999.9 ml/hr 999.9 ml/hr 999.9 ml/hr Optional Features:

Panel Lock On/Off On/Off On On

VTBI On/Off

(requires optional flow sensor) On/Off (requires optional flow sensor) On On***

Resistance Trend

(Graph) On/Off On/Off On On

Multi-Dose Alert On/Off On/Off Off Off

Optional Modes:

Loading Dose On/Off On/Off On On

Dose Rate On/Off On/Off On On

Multi-Step On/Off On/Off Off Off

Multi-Dose On/Off On/Off Off Off

Periodic Maintenance:

(Set in Diagnostics Reminder On/Off On/Off On On

Mode)

Interval 1 to 52 weeks 1 to 52 weeks 52 weeks 52 weeks

Self-Check Timer: 1 to 52 weeks 1 to 52 weeks 12 weeks 12 weeks

(Set in Diagnostics Mode)

Set Time: MO/YR/HR/MIN MO/YR/HR/MIN

JAN 1, 1970 00:00 JAN 1, 1970 00:00

(Set in Diagnostics Mode)

* SEE TABLE 2-2

** Revision 2.44 Software and above.

*** Has Flow Sensor Board

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CHECKOUT AND CONFIGURATION

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2.3 Start-Up Defaults

A hospital biomedical technician has the capability to set all configuration parameters to their startup defaults in a single operation. The terms “configuration parameters” and “programmable features” are interchangeable and have the same meaning. Refer to Table 2-1. “Configuration Options and Defaults” for the instrument's options and initial factory start-up defaults.

2.4 Configuration Procedure

The configuration procedure is for use by qualified service personnel only. The configuration mode is intended for programming the technical and clinical features in accordance with your institution's current procedures and practices. Default values are listed in Table 2-1. “Configuration Options and Defaults”.

Record the instrument configuration settings using Table 2-3. “Record of Configured Instruments”.

A fold-out map of all the configuration screens is located at the end of this chapter (Figure 2-1).

Pressing a soft key at the side of the main display the first time selects it for editing. Some features are edited by subsequent presses of the soft key to cycle through available options. Other features are edited by means of the numeric keyboard entry.

Pressing

undo will undo any edits made to that

page, and stay on the page. Pressing

ok will

accept all information on the page, and return to menu page.

Pressing POWER switch after editing a configurable item will evoke an invalid key tone and a message to “

ok entry”. You must OK

your edit before you can power off instrument.

NOTE: The instrument's configuration information is not lost when disconnected from AC power and battery power. However, error history and infusion program settings may be lost. If you want to save this information be sure to record before disconnecting power.

WARNING: When an instrument's configuration

WARNING: Powering down in configuration

mode during an alarm or error will not save any configuration changes.

IVAC®Signature Edition™ Technical Service Manual 2-3

CHECKOUT AND CONFIGURATION

SEC

RUN

HOLD

OPTIONS

3 6 9

Clear

Enter

POWER

OPT PRI HLD SEC KVO

PRI

1 4

•

™

2 5

8 0

1 2 3 4 hrs

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2-4 IVAC

Signature Edition™ Technical Service Manual

CHECKOUT AND CONFIGURATION

2.4.1 Entering Configuration Mode

The instrument must be off (both channels must be off for Model 7200 instruments).

The procedure for the single and dual channel pump is the same. Any configuration in the dual channel pump sets the same value for both channels.

1. Press and hold the left-bottom display soft key.

2. Press and release POWER switch. Continue to press the display soft key until the configuration mode display appears, then release.

3. Page C1 (notice C1 in the upper right corner of the display) of the configuration mode is displayed. This is a read only display. Press

page-> to advance to the page you want to

configure.

NOTE: FOR 7101X/7201X the default code will be 5B44 for instruments set to factory defaults (instead of 2098)

2.4.2 Setting to Defaults

The Set To Defaults Mode programs all configuration items to their default values.

NOTE: It is strongly recommended that you review Table 2-1 for a complete list of defaults before using this feature.

1. Advance to the C2 page (notice C2 in the upper right corner of the display).

2. Press

Set to Defaults soft key.

3. Press

ok to accept the change and return to the

beginning of the C2 page. Pressing

Cancel

will leave all items set to their previous values and return to the beginning of the C2 page.

OPTIONS

A B

CONFIGURATION MODE C ID No. : 001234567

SW Rev.: 2.44 Config.: 2098 IVAC

page

OPTIONS

A B

Set To Defaults C Language

Air In Line Dose Rate Drugs

<–

page

OPTIONS

A B

Set All C

configuration

items to their default values

cancel ok

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IVAC®Signature Edition™ Technical Service Manual 2-5

CHECKOUT AND CONFIGURATION

2.4.3 Setting Language

The language choices are English and Canadian French. All operating displays will be in the language selected. Diagnostic and configuration modes, however, will remain in English.

1. From the C2 page, press the

Language soft

key.

2. Press and release the soft key to select for editing. Press again to cycle between English and Canadian French for Models 7100/7200. For Models 7101/7201 the language choices are English, French, German, Dutch, ltalian, Swedish and Spanish.

3. Press

ok to accept the change and return to the

beginning of the C2 page.

2.4.4 Setting Air-in-Line Threshold

The air-in-line threshold sets the bubble size sensitivity. The air-in-line reset allows the clinician to respond to an air-in-line alarm, assess the clinical significance of the air, and choose whether or not to continue the infusion without removing the air. The reset feature only allows the current bubble to proceed without tripping an alarm. The air-in-line threshold value choices are: 50, 100, 200, and 500 microliters.

NOTE: Use 50 microliter setting on microbore tubing. Other settings may be used on macrobore tubing.

1. From the C2 page, press the Air-in-Line soft key.

2. Press and release the

Threshold soft key to

select for editing. Press again to cycle through 50 µl, 100 µl, 200 µl, and 500 µl.

3. Press and release the

Reset soft key to select

for editing. Press again to cycle between

and Off.

4. Press

ok to accept the change and return to the

beginning of the C2 page.

OPTIONS

A B

Set To Defaults C Language

Air In Line Dose Rate Drugs

<–

page

OPTIONS

A B

Language= ”C English

undo ok

OPTIONS

A B

OPTIONS

A B

Set To Defaults C Language

Air In Line Dose Rate Drugs

<–

page

Air In Line C

Threshold= 100 mc1

Reset= Off

undo ok

Page 34

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2-6 IVAC

Signature Edition™ Technical Service Manual

CHECKOUT AND CONFIGURATION

2.4.5 Setting Dose Rate Drugs

NOTE: In Models 7101/7201, Drug? is used instead of a drug list option. There is no tick mark next to Dose Rate.

The Dose Rate Drugs feature allows the selection of a drug name to program a dose rate calculated infusion while in normal mode.

1. From the C2 page, press the

Dose Rate

Drugs soft key.

2. The introduction screen appears next. The introduction screen displays the legend used when selecting a drug. It is from this screen that you page forward to select a drug or select

done to go to the Summary Page.

Use the short list symbol “s” to select drugs that will appear in the short list. This is a convenient way to display frequently used drugs immediately in the normal drug selection process (startup mode, press options key).

Use the extended list symbol “e” when selecting drugs to appear on the extended list. The extended list, if configured, provides a secondary list of drug names not normally used.

Press

done at any time to display the Summary

Page. Press

page->to advance to the next

page.

3. Press and release the

Extended List soft

key to cycle between “s” and “blank”. If “blank” is selected the Extended List will not be

available.

4. Press and release the

Drug? soft key to cycle

between “s”, “e”, and “blank”. Use “s” for commonly used drugs.

5. Press and release a soft key next to a drug to cycle between “s”, “e”, and “blank”. Press

page-> to continue viewing the drug list. Refer

to Table 2-2 “Drug List” to view full list of drugs.

6. Press

done to display the Summary Page.

7. Press

review to return to the introduction

screen or press

ok to accept the selections and

return to the C2 page.

OPTIONS

A B

Set To Defaults C Language

Air In Line Dose Rate Drugs

<–

page

OPTIONS

A B

-EXTENDED LIST C

s-Drug?

-Alfentanil

-Alprostadil

done

<–

page

OPTIONS

A B

Dose Rate Drugs C

(s) = short list

(e) = extended list ( ) = not displayed

done page

OPTIONS

A B

Summary C

14 Drugs Selected

EXT D LIST Selected Drug? Selected

review ok

Page 35

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IVAC®Signature Edition™ Technical Service Manual 2-7

CHECKOUT AND CONFIGURATION

Alfentanil (Alfent®)

Alprostadil(Prostin®)2(PGE-1)

Alteplase (Activase

)

Aminophylline

Amrinone (Inocar

)

Atracurium (Tracrium®)

Bretylium (Bretylol®)

Cimetidine (Tagamet®)

Diltiazem (Cardizem®)

Dobutamine (Dobutrex®)

Dopamine (Intropin®)

Esmolol (Brevibloc®)

Heparin

Isoproterenol (Isuprel

)

Labetalol(Normodyne®)11(Trandate®)

Lidocaine (Xylocaine®)

Magnesium Sulfate

Methylprednisolone

Milrinone

Morphine

Nitroglycerin (Tridil

)

Nitroprusside (Nipride®)

Norepinephrine (Levophed®)

Oxytocin

Phenylephrine (Neo-Synephrine

)

Potassium Chlor

Procainamide

Propofol (Diprivan

)

Ranitidine (Zantac®)

Streptokinase (Streptase®)

Succinylcholine (Anectine®)

Theophylline

Urokinase (Abbokinase

)

Vecuronium (Norcuron®)

Janssen Parmaceutica Inc., 1125 Trenton-Harbourton Road, P.O. Box 200, Titusville, NJ 08560-0200

The Upjohn Company, Kalamazoo, MI 49001

Genentech, Inc., 460 Point San Bruno Blvd., South San Francisco, CA 94080-4990

Sanofi Winthrop Parmaceuticals, 90 Park Avenue, New York, NY 10016

Burroughs Wellcome Co., 3030 Cornwallis Road, Research Triangle Park, NC 27709

Du Pont Multi-Source Products, The Du Pont Merck Pharmaceutical Company, 1000 Stewart Avenue, Garden City, NY 11530

SmithKline Beecham Consumer Brands, L.P., Unit of SmithKline Beecham Inc., P.O. Box 1467, Pittsburgh, Pa 15230

Marion Merrell Dow Inc., 9300 Ward Parkway, P.O. Box 8480, Kansas City, MO 64114-0480

Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN 46285

Anaquest Inc., 110 Allen Road, Box 804, LIberty Corner, NJ 07938-0804

Schering Corporation, a wholly-owned subsidiary of Schering-Plough Corporation, Galloping Hill Road, Kenilworth, NJ 07033

Allen & Hansbury, Division of Glaxo Inc., Five Moore Drive, Research Triangle Park, NC 27709

Astra USA, Inc., 50 Otis Street, Westboro, MA 01581-4500

Elkins-Sinn, Inc., 2 Esterbrook Lane, Cherry Hill, NJ 08003-4099

Stuart Pharmaceuticals, A business unit of Zeneca Inc., Wilmington, DE 19897 USA

Glaxo Pharmaceuticals, Division of Glaxo Inc., Five Moore Drive, Research Triangle Park, NC 27709

Abbott Laboratories, Pharmaceutical Products Division, North Chicago, IL 60064, U.S.A.

Ohmeda Inc., Pharmaceutical Products Division, 110 Allen Road, Box 804, Liberty Corner, NJ 07938-0804

Table 2-2. Drug List (7100/7200 only)

Page 36

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2-8 IVAC

Signature Edition™ Technical Service Manual

CHECKOUT AND CONFIGURATION

2.4.6 Setting Maximum Rate

This sets the maximum rate selectable by the clinician. The range for Maximum Rate is 0.1 to

999.9 ml/hr.

1. Advance to the C3 page.

2. Press

Maximum Rate soft key.

3. Press and release soft key to select for editing.

4. Use the numeric keypad to enter the maximum rate. Press ENTER.

5. Press

okto accept the change and return to the

beginning of the C3 page.

NOTE: Setting the Maximum Rate below the preset KVO Rate will lower the KVO Rate. The KVO rate will not exceed the Maximum Rate.

NOTE: The maximum rate setting applies to all infusion modes.

2.4.7 Setting Computer Link

The Computer Link feature allows a hospital computer to interact with the pump and programs the level of computer control available to the clinician. The computer cannot start or stop the pump, set the rate, or make any change in status. If the feature is off, the computer cannot communicate with the pump.

a. Contr

ol Mode:

allows the computer to send

information to the pump's display.

b. Monitor Mode:

allows the computer to only

receive information from the pump.

c. Of

f Mode: does not allow any communication

between the pump and a computer.

OPTIONS

A B

Maximum Rate= C

999.9 ml/hr

OPTIONS

A B

Maximum Rate C Computer Link

Optional Modes Optional Features

page

Page 37

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IVAC®Signature Edition™ Technical Service Manual 2-9

CHECKOUT AND CONFIGURATION

Enabling of the monitoring and control modes will automatically place them in the user's options menu.

1. On the C3 page, press the

Computer Link

soft key.

2. Press and release

Mode soft key to select for

editing. Press again to cycle through

Off,

Mntr Off, and Ctrl Mntr Off.

3. Press the Baud Rate soft key to select for editing. Press again to cycle through choices (

300, 600, 1200, 1800, 2400, 4800 and

9600).

4. Press the

Parity soft key to select for editing.

Press again to cycle through

Even, Odd, and

None.

5. Press

ok to accept the changes and return to

the beginning of the C3 page.

2.4.8 Setting Optional Modes

The Optional Modes feature allows the clinician to configure how the options menu will appear in normal mode. Enabling of these modes will automatically place them in the user's option menu.

When Loading Dose, Multi-Step, and Multi-Dose are on, they appear in the menu when the options key is pressed in normal mode.

For Dose Rate to appear in the options menu, it must be turned on as well as something programmed in the drug short list. If anything is programmed for the drug short list, then the appearance of the Dose Rate in the options menu only requires that the Dose Rate feature be on.

1. On the C3 page, press the

Optional Modes

OPTIONS

A B

Maximum Rate C Computer Link

Optional Modes Optional Features

page

OPTIONS

A B

Maximum Rate C Computer Link

Optional Modes Optional Features

page

OPTIONS

A B

Mode= Off C Baud Rate= 9600

Parity = None

undo ok

Page 38

2-10 IVAC

Signature Edition™ Technical Service Manual

2. Press and release Loading Dose soft key to select for editing. Press again to cycle between

On and Off. This feature allows the clinician to

set up an initial infusion rate for a specific volume, automatically followed by a maintenance rate from the same container.

3. Press and release

Dose Rate soft key to select

for editing. Press again to cycle between

On and

Off. This feature allows the clinician to

program dose parameters and the instrument calculates the volumetric rate.

4. Press and release

Multi-Step soft key to

select for editing. Press again to cycle between

On and Off. This feature allows a sequential

program to deliver up to nine steps; fluid volumes and delivery rates may be programmed for each step.

5. Press and release

Multi-Dose soft key to

select for editing. Press again to cycle between

On and Off. This feature allows the clinician to

pre-program multiple infusions over a period of up to 24 hours; the fluid volume and delivery rate is repeated for each delivery.

6. Press

ok to accept the changes and return to

the beginning of the C3 page.

2.4.9 Setting Optional Features

The Panel Lock feature allows the clinician to lock and unlock the front panel to help prevent tampering.

When VTBI (Volume To Be Infused) is on, the clinician must always enter a volume to be infused, otherwise the last remaining VTBI or last entered VTBI will be in effect depending on the channel's last usage. When VTBI is off there is no VTBI line capability to the user.

CHECKOUT AND CONFIGURATION

EDICAL SYSTEMS

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141345 FAA Page of 146

OPTIONS

A B

Loading Dose On C Dose Rate= On

Multi-Step= Off Multi-Dose= Off

undo ok

Page 39

Accessible only if ECD option is installed.

IVAC®Signature Edition™ Technical Service Manual 2-11

When the Resistance Trend feature is on, a graph is displayed on main LCD via Options Menu.

When the Multi-Dose Alert feature is on, the clinician will get the option to set an alert at the end of every dose when in Multi-Dose Mode.

1. On the C3 page, press the

Optional

Features soft key.

2. Press and release

Panel Lock soft key to

select for editing. Press again to cycle between

On or Off.

3. Verify

VTBI is on (need flow sensor option

installed to be able to turn off).

4. Press and release the

Resistance Trend

soft key to select for editing. Press again to cycle between

On or Off.

a. In Pressure Only mode, the graph still displays

Hi Resistance data.

b. Trend data is lost when:

- User clears graph information

- Unit is off for more than 6 hours

- Resistance Mode is changed

- Resistance Mode is changed to Pressure Only Mode.

c. Trend data is maintained when:

- Pressure Only Mode is changed to/from Hi Resistance Mode.

- Rate is changed

- Unit is off for less than 6 hours.

5. Press and release the

Multi-Dose Alert

soft key to select for editing. Press again to cycle between

On or Off.

6. Press

ok to accept the changes and return to

the beginning of the C3 page.

CHECKOUT AND CONFIGURATION

EDICAL SYSTEMS

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141345 FAA Page of 146

OPTIONS

A B

Maximum Rate C Computer Link

Optional Modes Optional Features

page

OPTIONS

A B

Panel Lock= On C VTBI= On

Resistance Trend=On Multi-Dose Alert=Off

undo ok

Page 40

2-12 IVAC

Signature Edition™ Technical Service Manual

2.4.10 Setting KVO Rate

The pump will automatically operate at the KVO rate (or the current rate, whichever is less) once the primary VTBI has counted down to zero. The KVO rate range is 0.1 to 20.0 ml/hr.

1. Advance to the C4 page.

2. Press

KVO Rate soft key.

3. Press soft key next to rate value once to select for editing.

4. Use the numeric pad to enter the KVO rate. Press ENTER.

5. Press

ok to accept the change and return to the

beginning of the C4 page.

NOTE: The KVO rate will not exceed the present Maximum Rate.

CHECKOUT AND CONFIGURATION

EDICAL SYSTEMS

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141345 FAA Page of 146

OPTIONS

A B

KVO Rate C Monitoring Options

Audio Configuration Name

page

OPTIONS

A B

KVO Rate= C

5.0 ml/hr 4

undo ok

OPTIONS

A B

KVO Rate= C

1.0 ml/hr 4

undo ok

•

Clear

Enter

Page 41

NOTE: Resistance trend graph data is lost when:

1) Clear is pressed, 2) Pump is off for more than 6 hours.

NOTE: Resistance measurement is restarted at 0% when: 1) Run/Hold is pressed to put on hold and again to start, 2) Dose ends in Multi-Dose mode, 3) Checking line message appears.

IVAC®Signature Edition™ Technical Service Manual 2-13

2.4.11 Setting Monitoring Options

The graphical resistance display (appearing in the Main LCD) may be turned on or off. Turning the display off will also turn the resistance alert feature off.

The AutoRestartPlus

feature allows the pump to automatically continue an infusion if a downstream occlusion is cleared during the “re-check” period (40 seconds). A warning tone and display message will appear for 40 seconds. The feature can be turned off (set the restarts to zero), or the number of restarts may be set from 1 to 9.

NOTE: The restart counter is reset whenever the clinician presses Run/Hold, if the pump or channel is turned off, or if an alarm occurs.

A resistance alert feature may be turned on or off. If on, the hospital can set the desired alert level. The default alert level can be set from 5 to 100% in 5% increments. This is the initial value presented to the clinician; the clinician may reset the value to meet specific application needs.

1. On the C4 page, press the

Monitoring

Options soft key.

2. Press and release the

Mode soft key to select for

editing. Press again to cycle between

Resist., Resistance and Pressure Only.

3. Press and release the

Display soft key to

select for editing. Press again to cycle between

On and Off.

NOTE: If display is off, the alert feature will automatically be turned off.

4. Press and release the Restarts soft key. Use

the numeric keypad to enter the number of restarts from 0 (which turns the feature off) to 9, then press ENTER.

5. Press the

Alert soft key. Press again to cycle

between

On and Off. If on, use the numeric

keypad to enter the desired alert %. Press ENTER. The value will round to the nearest 5%.

6. Press

ok to accept the changes and return to

the beginning of the C4 page.

CHECKOUT AND CONFIGURATION

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141345 FAA Page of 146

OPTIONS

A B

Mode= Pressure C Display= On

Restarts= 3 Alert=Off

KVO Rate C Monitoring Options

Audio Configuration Name

page

A B

OPTIONS

•

Clear

Enter

Page 42

2-14 IVAC

Signature Edition™ Technical Service Manual

2.4.12 Setting Audio Volume

The volume settings determine which range of audio volume is available to the clinician. For example; “Low” may be too low for your institution, therefore you would choose “Med Hi”. A transition tone, if enabled, will sound upon completion of a secondary VTBI, step in multi-step mode, dose beginning and ending in multi-dose mode, and completion of a loading dose in loading-dose mode. The speaker volumes are approximately: Low = 65 dB, Med = 70 dB, and Hi = 75 dB.

1. On the C4 menu, press the

Audio soft key.

2. Press and release the

Volumes soft key to

select for editing. Press again to cycle between

Low/Med/Hi, Med/Hi, or Hi.

3. Press the

Trans. Tone soft key to select for

editing. Press again to cycle between

On and

Off.

4. Press

ok to accept the changes and return to

the beginning of the C4 page.

2.4.13 Setting Configuration Name (Instrument ID Label)

The characters entered here will be shown in the lower LCD display. This electronic label is normally displayed, even when the pump is off.

The configuration name can be used to uniquely identify the instrument's configuration, hospital location, or reference number. It is a 4 character alpha/numeric name, examples are: PICU (Pediatric Intensive Care Unit), ICU (Intensive Care Unit), or

2400.

CHECKOUT AND CONFIGURATION

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141345 FAA Page of 146

OPTIONS

A B

KVO Rate C Monitoring Options

Audio Configuration Name

page

OPTIONS

A B

Audio C

Volumes= Low Med Hi

Trans. Tones= On

undo ok

Page 43

OPTIONS

A B

1. On the C4 menu, press the Configuration

Name soft key.

2. Press and release

Config.Name soft key to

position the highlight on the character to be changed.

3. Press and release the character soft keys aligned with the rows A to M, N to Z, or 0 to _ to highlight the character you want.

4. Press

enter. Up to four characters can be

programmed in this way. Repeat steps 2,3,4 as necessary.

5. Press

okto accept the changes and return to

the beginning of the C4 page.

NOTE: Must have 4 characters in configuration name, use space (-) symbol to fill in any open character.

2.5 Transferring Settings to Another Pump

Once a pump has been programmed to meet technical and clinical needs, the settings can be transferred to other pumps. The programmed pump is referred to as the “Teacher” and the other pump is referred to as the “Learner”.

NOTE: Only the configuration settings will be transferred. The instrument ID number and the periodic maintenance settings from the diagnostics mode will not be transferred.

Connect a standard 9-pin Null Modem RS-232 cable (also available from ALARIS Medical Systems, P/N 133450) to the RS-232 ports on the pumps.

IVAC®Signature Edition™ Technical Service Manual 2-15

CHECKOUT AND CONFIGURATION

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141345 FAA Page of 146

OPTIONS

A B

KVO Rate C Monitoring Options

Audio Configuration Name

page ->

Config. Name= IVAC C A B C D E F G H I J K L M

N O P Q R S T U V W X Y Z 0 1 2 3 4 5 6 7 8 9 _

undo enter ok

Page 44

141345 FAA Page of 146

EDICAL SYSTEMS

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2-16 IVAC

Signature Edition™ Technical Service Manual

CHECKOUT AND CONFIGURATION

2.5.1 Teacher/Learner Pump Procedure

1. Access the Configuration Mode for both “teacher” and “learner” instruments and advance to page C5.

2. Press and release the

Teach soft key of the

“Teacher” instrument and press and release the

Learn soft key of “Learner” instrument.

3. Press and release the

start soft key of the

“Teacher” instrument.

The pumps will display

Downloading

until the transfer is complete, then they will indicate if the transfer was successful or unsuccessful.

NOTE: Repeat allows you to re-attempt or teach the next pump.

NOTE: The Learn/Teach function will not work if revision level is not the same on both pumps or if the pumps are not the same model (ie., 710x/720x to 7000A).

2.5.2 Pop-Up Displays

The pop-up screens appear when the user attempts to turn off the instrument or execute the teach mode after changing the configuration (or accessing a configured item) but not changing the configuration name. If you change the instrument's configuration and not the configuration name, you may have similarly named instruments but with different configurations. The pop-up menus ask you if you want to rename the configuration.

OPTIONS

A B

Learn: Rev. 00.06 C Teach: Rev. 00.06

<–

page

OPTIONS

A B

Teach Status C

Awaiting Start

2098 IVAC

cancel start

OPTIONS

A B

Configuration has C

been changed.

Press POWER key

to keep name IVAC.

cancel rename

OPTIONS

A B

Configuration has C

been changed.

Press teach key

to keep name IVAC.

cancel teach rename

Page 45

IVAC®Signature Edition™ Technical Service Manual 2-17

CHECKOUT AND CONFIGURATION

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141345 FAA Page of 146

Duplicate the following table for additional entries.

Table 2-3. Record of Configured Instruments

Serial # Serial # Serial # Serial # Serial #

*Instrument ID #

Config Name (Instr Label)

Location

Language

Air-in-Line:

Threshold µl µl µl µl µl

Reset

Maximum Rateml/hr ml/hr ml/hr ml/hr ml/hr ml/hr

Computer Link:

Mode

Baud Rate

Parity

Optional Modes:

Loading Dose

Dose Rate

Multi-Step

Multi-Dose

Optional Features:

Panel Lock Resistance Trend Multi-Dose Alert

KVO Rate ml/hr ml/hr ml/hr ml/hr ml/hr ml/hr

Monitoring Options:

Mode

Display

Restarts

Alert

Audio:

Volume

Trans. Tone

*PM Reminder

*PM Interval

*Accessed through Diagnostic Mode. Refer to Section 6.4.1 “Entering Diagnostics Mode”

Page 46

141345 FAA Page of 146

EDICAL SYSTEMS

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2-18 IVAC

Signature Edition™ Technical Service Manual

CHECKOUT AND CONFIGURATION

RECORD OF CONFIGURED ALARIS Medical Systems SE INSTRUMENTS

Hospital:

Unit:

DRUG NAME/OPTION TRADE NAME NOT SELECTED SHORT LIST EXTENDED LIST Extended List Access DRUG? Alfentanil Alfenta

Alprostadil Prostin®(PGE-1) Alteplase Activase

Aminophylline Amrinone Inocar

Atracurium Tracrium

Bretylium Bretylol

Cimetidine Tagamet

Diltiazem Cardizem

Dobutamine Dobutrex

Dopamine Intropin

Esmolol Brevibloc

Heparin Isoproterenol Isuprel

Labetalol Normodyne®/Trandate

Lidocaine Xylocaine

Magnesium Sulfate Methylprednisolone Milrinone Morphine Nitroglycerin Tridil

Nitroprusside Nipride

Norepinephrine Levophed

Oxytocin Phenylephrine Neo-Synephrine

Potassium Chlor Procainamide Propofol Diprivan

Ranitidine Zantac

Streptokinase Streptase

Succinylcholine Anectine

Theophylline Urokinase Abbokinase

Vecuronium Norcuron

Page 47

OPTIONS

A B

CONFIGURATION MODE C ID No. : 001234567

SW Rev.: 2.44 Config.: 2098 IVAC

page

IVAC®Signature Edition™ Technical Service Manual 2-19

CHECKOUT AND CONFIGURATION

Map of Configuration Screens

EDICAL SYSTEMS

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141345 FAA Page 50 of 146

OPTIONS

A B

Set To Defaults

Language

Air In Line Dose Rate Drugs

<–

page

OPTIONS

A B

Set A

configuration

items to their default values

cancel

OPTIONS

A B

Language=

English

undo ok

OPTIONS

A B

Air In Line

Threshold= 100 mc1

Reset= On

undo ok

OPTIONS

A B

Dose Rate Drugs C

(s) = short list

(e) = extended list ( ) = not displayed

done page

OPTIONS

A B

Maximum Rate= C

999.9 ml/hr 3

OPTIONS

A B

Maximum Rate

Computer Link

Optional Modes Optional Features

page

OPTIONS

A B

Mode=Ctrl Mntr Off

Baud Rate= 9600

Parity = Even

undo ok

OPTIONS

A B

Loading Dose= On

Dose Rate= On

Multi-Step= Off Multi-Dose= Off

undo ok

OPTIONS

A B

Panel Lock= On C VTBI= On

Resistance Trend=On Multi-Dose Alert=Off

undo ok

OPTIONS

A B

KVO Rate

Monitoring Options

Audio Configuration Name

page

OPTIONS

A B

KVO Rate= C

5.0 ml/hr 4

undo ok

OPTIONS

A B

Mode= Pressure

Display= On

Restarts= 3 Alert=On 100%

OPTIONS

A B

Audio

Volumes= Low Med Hi

Trans. Tones= On

undo ok

OPTIONS

A B

Config. Name=

PICU C

A B C D E F G H I J K L M

N O

P Q R S T U V W X Y Z

0 1 2 3 4 5 6 7 8 9 _

undo enter

OPTIONS

A B

Learn: Rev. 00.06

Teach: Rev. 00.06

<–

page

OPTIONS

A B

Teach Status

Awaiting Start

2098 IVAC

cancel start

OPTIONS

A B

Learn Status

Awaiting Download

cancel

Page 48

IVAC®Signature Edition™ Technical Service Manual 3-1

WARNING: Failure to perform regular and

preventive maintenance inspections may result in improper instrument operation.

3.1 Introduction

To ensure the pump remains in good operating condition, regular and preventive maintenance inspections are required. Regular inspections are not covered under any contract or agreement offered by ALARIS Medical Systems and must be performed before each use of the instrument by the user.

Use Table 3-1 “PM Inspections” to record the completion of preventive maintenance inspections. These inspections should be performed yearly or as indicated by qualified technician or biomedical engineer.

The preventive maintenance inspections listed are recommended at a one year interval and should be performed in accordance with ALARIS Medical Systems requirements and guidelines. A maintenance reminder will occur after 52 weeks, unless the feature has been changed to select a different time interval or has been disabled. These inspections are also intended to complement the intent of JCAHO requirements, and are not covered by the ALARIS Medical Systems warranty.

In the United States, a service agreement may be obtained from ALARIS Medical Systems for the performance of all required preventive maintenance inspections.

3.2 Storage and Cleaning

3.2.1 Storage

The pump may be stored without connection to AC power. It will automatically disconnect the battery when the voltage gets too low. To reuse the pump after storage, connect it to AC power for a minimum of three (3) hours before placing it back into service. When temporarily taking instrument out of service, connect it to AC power to ensure a fully charged battery when needed.

Chapter 3 — PREVENTIVE MAINTENANCE

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141345 FAA Page of 146

Page 49

3-2 IVAC

Signature Edition™ Technical Service Manual

3.2.2 Cleaning

It is good practice to routinely clean the pump, especially if spillage has occurred.

Do not use solutions containing phosphoric acid (Foamy Q&A1) or aromatic solvents (naphtha, paint thinner, etc.), chlorinated solvents* (Trichloroethane, MEK, Toluene, etc.) or alcohol.

CAUTION: Alcohol may cause the key pad to

crack over time.

Do not use hard or pointed objects to clean any part of the pump.

Do not steam autoclave, EtO sterilize, or immerse the pump.

WARNING: Turn the instrument off and unplug

the power cord from the AC wall outlet before cleaning. Do not steam autoclave, EtO sterilize, immerse the pump, or allow fluids to enter the pump case.

Acceptable cleaning solutions are (Use per manufacturer’s instructions):

Warm Water Vesphene

llse

CompuBlend™II

Virex*II 256

Manu-Klenz

(cleaning only)

10% Bleach Solution (1 part bleach to 9 parts water)

a. Place instrument on drain board or other surface

above sink. Keep instrument upright and do not allow any part of the instrument to become submersed in water during the cleaning operation.

b. Use a soft cloth dampened with warm water and a

mild non-abrasive cleaning solution to clean all exposed surfaces. For sanitizing or anti-bacterial treatment, use 10% bleach solution and water.

• A soft-bristled brush may be used to clean hard to reach and narrow areas.

• Use light pressure when cleaning the pressure transducer and air-in-line detector areas of the pumping channels. Refer to “Cleaning the Mechanism Area”.

• Move latch to open and closed positions as required to clean behind latch and air-in-line arm.

c. No additional lubrication should be necessary.

Figure 3-1 Cleaning the Mechanism Area

Clean in and around the latch.

Clean the flow control actuator.

Clean in and around the clamp arms and pumping mechanism.

Use light pressure when cleaning the pressure transducer.

Use light pressure when cleaning the airin-line detector.

Clean in and around the air-in-line arm.

* excluding 10% bleach solution in water.

Calgon Vestal Laboratories, Division of Calgon Corporation, Subsidiary of Merck & Co., Inc.

3M Healthcare, Subsidiary Building Service & Cleaning Products, a Division of 3M.

This is a trademark of Building Service & Cleaning Products, a Division of 3M.

PREVENTIVE MAINTENANCE

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141345 FAA Page of 146

latch

flow control actuator

air-inline arm

transducer

clamp arms

Page 50

IVAC®Signature Edition™ Technical Service Manual 3-3

3.3 Preventive Maintenance Inspections

A message can be set through the diagnostics mode which automatically reminds the user when preventive maintenance inspections are due. Refer to Section 6.4.2 “Setting Preventive Maintenance Interval” for setting the inspection interval.

3.3.1 Regular Inspection

Regular inspections consist of a visual inspection for damage and cleanliness, and performing the procedure described in the Start Up Sequence Section of the Directions For Use manual before each usage of the instrument. Regular inspections are not covered under any contract or agreement offered by ALARIS Medical Systems and must be performed by the user.

Case

Examine the unit for overall condition. The case should be clean and free from IV solution residue, especially near moving parts. Also check for dried solution deposits on accessible areas of air-in-line sensor, pressure transducer, and latch mechanism. Check that labels and markings are legible.

Mounting Bracket

Pole mounting bracket should be secure and functioning. If the instrument is mounted on a pole or stand, examine the condition of the mount. Also, examine the pole and stand.

Power Cord Assembly

Examine the power cord assembly for:

a. Signs of damage, cuts or deformities in the cord. If

damaged, replace the entire cord.

b. Integrity of hospital grade power plug. Attempt to

wiggle the blades to determine that they are secure. If any damage is suspected, replace the entire cord.

c. Appropriate tension and connection if the IV pole

has electrical receptacles for accessories.

d. Strain reliefs. Examine the strain reliefs at both ends

of the line cord. Be sure they hold the cord securely.

Keypad

Check membrane switches for damage; e.g., from fingernails and pens. During the course of the inspection, be sure to check that each switch performs its proper function. Refer to Section 6.4.15 “Testing Switches”.

Mechanism

Clean any surfaces where solution or obstructions have accumulated. Verify that:

a. The mechanism seal is not torn or worn.

b. The cam followers are not broken or cracked and

are free of foreign matter.

c. Proper operation of latching mechanism. Cam

followers should retract and extend smoothly.

d. Air-in-line arm moves smoothly from opened to

closed position.

e. Fluid Control Actuator rotates 180˚.

3.3.2 Functional Test

a. Turn instrument on without set installed. Verify

that it “beeps” and red alarm light flashes.

b. Set infusion rate to 460 ml/hr and VTBI to 100 ml.

c. Press the RUN/HOLD switch with the latch closed,

and rate and VTBI ≠ 0 to cause a “set out” and “air in line” messages.

d. Open the latch.

e. Install primed administration set with latch open.

f. Verify the pump displays “air in line” and “latch

open” messages.

g. Close the latch and verify the display returns to

the setup page.

h. Perform upstream occlusion test as follows:

1. Verify the infusion rate is set to 460 ml/hr.

2. With the pump on hold, or at start-up, verify the primary VTBI is set to 100.

3. Press the RUN/HOLD switch to begin the infusion.

PREVENTIVE MAINTENANCE

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Page 51

141345 FAA Page of 146

EDICAL SYSTEMS

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4. Clamp off IV line just above pump to simulate an upstream occlusion. Verify the pump stops running, alarms, and displays OCCLUSION UPSTREAM within 60 seconds.

5. Press the RUN/HOLD switch to silence the alarm and put the pump on hold.

6. Remove or open the clamp on the line.

7. Press the RUN/HOLD switch to resume infusion. The alarm should not reoccur.

i. Perform downstream occlusion test as follows:

1. Continue pumping from above step.

2. Verify rate is set to 460 ml/hr. Clamp off the set just below the pump.

3. Allow pump to run until it alarms OCCLUSION DOWNSTREAM within 60 seconds.

4. Press the RUN/HOLD switch to silence the alarm and put the pump on hold.

5. Release or open clamp.

6. Press the RUN/HOLD switch to resume infusion. The alarm should not reoccur.

3.3.3 Flow Stop Test

a. Turn the power off with the administration set

primed and loaded in the instrument.

b. With all tubing clamps open and the fluid

container two or more feet above the device, verify that no fluid flows out of the set.

c. Remove set. Verify that no fluid flows out of the

set.

3.3.4 Rate Accuracy Verification Test

Refer to Figure 3-2 “Setup for Rate Verification Test”.

NOTE: Due to the Dynamic Monitoring feature, the rate is varied during operation. For this reason, ALARIS Medical Systems does not recommend using automatic testers to check rate accuracy. Generally, these devices collect small samples and may cause the results to be incorrect even though the instrument is accurate.

NOTE: Do not use 70RCS more than 40 times.

a. Fill the solution container with clean tap water.

Take a 70 RCS rate calibration set and close the AccuSlide™ clamp, then insert the spike into the solution container.

b. Open AccuSlide clamp and prime set. Pay

particular attention to ensure that all air is expelled from the set. Close the AccuSlide clamp.

c. Connect the output of the set to one side of the

three-way stopcock.

d. Load the set.

e. Verify that there is no fluid flow or drops falling in

the drip chamber.

f. Plug the instrument into a properly grounded AC

outlet.

g. Set stopcock to output to a Class A or B burette.

h. Press channel’s POWER switch to turn channel on.

i. Set the primary infusion rate to 400 ml/hr. Set the

VTBI to 20 ml.

j. Press the channel’s RUN/HOLD to start the primary

infusion. Run infusion for one minute, or until tubing and burette are fully primed.

k. Press the channel’s RUN/HOLD to stop infusion.

l. Adjust the height of the instrument and/or fluid

container as necessary to attain head height of 30” between the middle of the pump mechanism and the fluid level in the container (bag or vented bottle with unvented administration set) or the drip chamber (unvented bottle with vented administration set).

NOTE: You may need to run instrument to prime line to “0” level of burette.

m. Adjust the fluid level so the meniscus is level with

the zero mark on the burette.

n. Verify primary infusion rate is 400 ml/hr. Reset the

VTBI to 40 ml.

3-4 IVAC

Signature Edition™ Technical Service Manual

PREVENTIVE MAINTENANCE

Page 52

Water Source

Instrument Stand

Three-Way Stopcock

Used Fluid Receptacle

Tubing

IV Tubing

Burette

Burette Clamp

Equipment Stand

30 ±2 inches

Table or Bench

IVAC®Signature Edition™ Technical Service Manual 3-5

o. Press the channel’s RUN/HOLD to start the primary

infusion.

p. The pump will run approximately 360 seconds to

deliver 40 ml, then go into KVO mode. Stop the pump within 1 second of KVO operation.

q. Verify the volume collected is 40.0 ml ± 2.0 ml

(5%).

r. If rate accuracy verification fails:

1. Ensure 70RCS Rate Cal Set has not been used for more than 40 runs. Refer to Chapter 5 for rate calibration procedure or call ALARIS Medical SystemsTechnical Support.

2. Set stopcock to drain into receptacle.

Figure 3-2 Setup for Rate Verification Test

3.3.5 Pressure Calibration

a. Place instrument on bench or other flat surface

and connect to AC power.

b. Connect pressure meter, hand pump, and

reservoir to pressure calibration set. Refer to Figure 3-3 “Pressure Test Setup”.

c. Install a pressure cal set (70ISS) into the

instrument.

d. Enter Diagnostics Mode by pressing and holding

top soft key, then turn instrument on and release soft key when diagnostics display appears. Refer to Section 6.4.1 “Entering Diagnostics Mode”.

e. Advance to D6 screen by pressing page soft key

five times.

PREVENTIVE MAINTENANCE

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141345 FAA Page of 146

(50 ml)

70RCS Rate Cal Set

OPTIONS

SEC

PRI

™

POWER

RUN

HOLD

Clear

Enter

PRI SEC HLD

OPT KVO

HLD PRI SECKVO OPT

•

POWER

RUN HOLD

1 2 3 4 hrs

A B

Page 53

3-6 IVAC

Signature Edition™ Technical Service Manual

f. Select Cal Pressure (A or B for dual channel).

g. Allow 1 hour warmup.

h. Perform soft pressure calibration:

1. With no pressure applied, press the 0 mmHg soft key.

2. Apply 500 mmHg (±1 mmHg ) of pressure.

3. Press the 500 mmHg soft key.

4. Remove set and pressure from pump.

j. Set sensor check/calibration verification:

- Verify both 0 mmHg and 500 mmHg readings say “pass”.

- Install set and close latch. Verify reading over

170.

- Verify sensor reading is in the -30 to +80 mmHg range without set installed.. If the pump will not “soft cal,” see the hard pressure calibration procedure in Chapter 5.

3.3.6 Ground Current Leakage Test

Use a BIO-TEK®*Model 260 or equivalent to measure the ground leakage current. Refer to the electrical safety tester’s operation manual for the proper measurement technique. Leakage current must be ≤ 100 µA for normal and reversed line polarity.

Figure 3-3 Pressure Test Setup

3.3.7 Ground Resistance Test

Use a BIO-TEK Model 260 (or equivalent ground resistance testing equipment) to measure resistance from the the AC power plug ground pin to the screw for the power cord strap or the screw for the battery cover on the chassis. Refer to the test equipment operation manuals for proper setup and measurement technique. The resistance measured must be ≤ 0.10Ω. For Models 7101/7201, measure resistance from AC power plug ground pin to PEC connector must be ≤ 0.10Ω.

CAUTION: Do not connect ground resistance

probe to pressure transducer.

3.3.8 Battery Refresh Cycle

a. Initiate a battery refresh cycle by:

1. Disconnecting the battery, pressing ON/OFF switch for 5 seconds and reconnect battery.

2. If software is 2.02 or higher, enter 0.0 AH in the rated capacity for battery (in Diagnostics Mode). Once “ok” is pressed, cycle will start. Set rated cap back to 1.3 AH.

b. Leave connected to AC for 24 hours to complete

cycle.

3.3.9 Reset Time

a. Enter Diagnostic Mode and advance to D2 page.

b. Reset hours and minutes as needed from time reference. (See Setting Time in Diagnostics section)

NOTE: Clock will lose about 3 minutes per month since it is not a true real time clock. Once reset, the previous loop will not be affectted or adjusted.

3.3.10 Reset PM Due

Enter Diagnostic Mode and go to D2 page. Access PM Setup and reset PM Due by pressing lower left soft key.

* BIO-TEK® Instruments, Inc.

PREVENTIVE MAINTENANCE

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141345 FAA Page of 146

RUN

POWER

HOLD

PRI SEC HLD

HLD PRI SECKVO OPT

OPT KVO

PRI

SEC

OPTIONS

A B

Clear

Enter

•

™

N O

I T I

D E

1 2 3 4 hrs

Instrument Stand

Pressure

Gauge

mmHg

72 Series Set

Air

Pressure Source

0-500 mmHg

775

psi

Reservoir

Page 54

141345 FAA Page of 146

EDICAL SYSTEMS

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IVAC®Signature Edition™ Technical Service Manual 3-7

PREVENTIVE MAINTENANCE

Table 3-1. PM Inspections

I.D Number_________________________ Instrument Serial Number____________

Ref. Date Date

Section Frequency Completed Completed

Regular Inspection (record every 12 months) 3.3.1 Every Use

Functional Test 3.3.2 12 Months Flow Stop Test 3.3.3 12 Months Rate Accuracy Verification Test 3.3.4 12 Months Pressure Calibration 3.3.5 12 Months Ground Current Leakage Test 3.3.6 12 Months Ground Resistance Test 3.3.7 12 Months Battery Refresh Cycle 3.3.8 12 Months Reset Time 3.3.9 12 Months

I.D Number_________________________ Instrument Serial Number____________

Ref. Date Date

Section Frequency Completed Completed

Regular Inspection (record every 12 months) 3.3.1 Every Use

I.D Number_________________________ Instrument Serial Number____________

Ref. Date Date

Section Frequency Completed Completed

Regular Inspection (record every 12 months) 3.3.1 Every Use

Page 55

IVAC®Signature Edition™ Technical Service Manual 4-1

4.1 Introduction

This chapter describes the mechanical and electrical systems that comprise the instrument.

The Main PCB for both the single and dual channel instrument is a double sided multi-layered Surface Mount Technology (SMT) board. If a board is determined to have failed, it can be replaced or the unit can be returned to ALARIS Medical Systems for repair. ALARIS Medical Systems does not provide replacement components for repair of SMT boards nor does ALARIS Medical Systems recommend attempting field service of the instrument’s SMT circuit boards.

Full Schematics are not included with this service manual.

NOTE: The main PCB board can only be replaced in pumps with main software Rev. 2.02 or higher.

The AC Off Line Switcher and RS-232 boards are replaced as an assembly. If a board is determined to have failed, it is replaced with a new board (see Chapter 7 for part numbers). ALARIS Medical Systems does not provide replacement components for repair of these boards.

Both single and dual channel pumps function in the same manner. However, they use two different Main PCBs. Therefore, the component reference designations are different for each board. To help distinguish between the one and two channel pump reference designations in this chapter, the two channel pump will be represented in parenthesis and italicized; e.g., (U13).

4.2 Principle of Operation

The pump contains a peristaltic pumping mechanism and support circuitry to ensure controlled flow. The peristaltic mechanism consists of a linear array of 12 cam followers which travel perpendicular to the administration set. These cam followers act like “fingers” kneading the membrane. When the fluidfilled disposable is placed against the array of cam followers, the coordinated, sinusoidal motion of the cams causes a peristaltic wave of fluid displacement in the pumping segment of the disposable.

Chapter 4 — FUNCTIONAL DESCRIPTION

EDICAL SYSTEMS

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141345 FAA Page of 146

Page 56

4-2 IVAC

Signature Edition™ Technical Service Manual

The pump will alarm at signs of internal problems and at preset thresholds for external problems (for example, when battery charge falls below a critical level, or pump output pressure exceeds a programmed limit). All alarms provide visual and auditory signals to alert the operator.

Accuracy of fluid delivery is a function of the microprocessor-controlled rotation cycle of the camshaft, and the administration set section compressed by the cam followers.

4.3 Overview

The instrument contains one Main PCB and several modules that interface to it. The interfacing modules are as follows:

• LED module

• Graphic LCD module (MAIN)

• Lower LCD module

• Battery

• AC Off Line Switcher

• Keypad

• Nurse Call/RS-232 board

• Motor

• Air-in-line sensors

• Pressure module

• Motor rotation sensor and the mechanism

latch detector (optocouplers).

• ECD board The instrument power is supplied through the AC Off Line Switcher module and the battery.

The Main PCB contains all the control circuitry

required for the instrument. The board can be broken down into four main sections; kernel, power system, motor drive and sensor control, and user interface circuitry.

a. The microprocessor, RAM, ROM, data

communication, and COMBO IC make up the heart of the system. These are collectively referred to as the kernel. The kernel is responsible for controlling the motor actuation, sensing and responding to user input, monitoring various system sensors, and performing start-up and ongoing system operational testing.

b. The power system is responsible for charging the

battery, generating the DC power supplies, notifying the user of the number of hours of battery life remaining on the battery and performing watchdog (clock sync checks) functions. The power system includes the Battery Manager custom IC.

c. The motor drive and sensor control circuitry drives

the motors, the air-in-line sensors, the mechanism latch detectors, and the rotation detectors. The circuit is also responsible for monitoring the pressure sensors, the power supply voltages, the motor current, and the air-in-line sensor outputs.

d. The user interface circuitry connects to the key-

pad, LED modules, and LCD modules to the kernel circuitry for monitoring and control. This circuitry also contains the audio interface, and audio test.

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Figure 4-1 Main Block Diagram

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Table 4-1. Definition of Terms

80C188 Microprocessor that controls all instrument operations. A/D (A2D) Analog to digital converter. Battery Temperature

Sensor Monitors the temperature inside battery to ensure optimum battery capacity. Battery Assembly Contains battery, battery temperature sensor, and thermal cutout.

Channel A Refers to left mechanism, sensors, and LED module. Channel B Refers to the right mechanism, sensors, and LED module. COMBO IC A custom integrated circuit with many I/O functions. DIP Dual Inline Package. A form of electronic part packaging which mounts on pins extending

through a printed circuit board.

EEPROM Electrically Erasable Programmable Read Only Memory. Memory whose data can change

under CPU control. Data is not lost if power is removed. EMI Electromagnetic Interference. EMC Electromagnetic Compatibility. The ability of the instrument to operate in the presence of

other electrical devices. EPROM Erasable Programmable Read Only Memory. Memory whose data is fixed and does not

change. Data is not lost if power is removed. ESD Electrostatic Discharge. Kernel Circuit consisting of CPU, program memory (EPROM), data memory (RAM), associated I/O,

and time bases. Keypad Membrane switch panel. LCD Module Liquid crystal display (LCD) for alpha-numeric display (128 x 64) of prompts, status, and setup

information. LED Module A custom light emitting diode (LED) module that contains numeric LED's, annunciator blocks,

status indicators, and a custom integrated circuit. Mechanism

Latch Detector Optical switch to detect the status of the latch on the mechanism. Motor

Rotation Detector Optical switch used with a decoder disk. PLCC Plastic Leaded Chip Carrier. A form of electronic part packaging which mounts on the surface

of a printed circuit board. Battery Manager Custom programmed microcontroller, used for battery management, control of the Lower

LCD Display, power on and watchdog functions. PQFP Plastic Quad Flat Package. A surface mountable electronic package. RAM Random Access Memory. Memory whose data can change under CPU control. Data is lost if

power is removed. System Watchdog A circuit which monitors the proper operation of the 80C188 microprocessor and clocks. UART Universal Asynchronous Receiver Transmitter. A logic device which formats data as a serial bit

stream for remote communications. Ultrasonic AIL

Transducer A sensor used to detect air in the tubing. Passes high frequency sound through fluid filled set. VCO Voltage controlled oscillator. An oscillator where output frequency can be varied through a

control voltage.

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4.4 Main PCB

4.4.1 Processor Kernel

The processor kernel is responsible for controlling the motor actuation, sensing and responding to user input, monitoring various system sensors, and performing start-up and on-going system operational testing. The kernel is based on a 16 bit 80C188 microprocessor U11 (U15), 512K Bytes of EPROM program storage, and 64K Bytes of battery backed up RAM data storage. In addition, the kernel has 2K bits of EEPROM memory and a 9600 baud serial communications interface.

The COMBO IC U10 (U14) is a custom ASIC (Application Specific Integrated Circuit) which incorporates timing, address decoding, digital I/O, and other system “glue” functions. The Combo IC has a 16 bit CRC generator which is used to periodically test the EPROM data. The COMBO IC also contains the local serial interface control logic used to interface to serially accessed peripherals such as the A/D, EEPROM, LED Module(s), and Battery Manager. Additional information can be found in Section 4.4.2 "COMBO IC".

The kernel data communications function supports RS-232 level serial communications up to 9600 baud. The UART function is embedded in the COMBO IC, while the RS-232 interface is based on an industry standard RS-232 level converter chip. The communications channel is EMI filtered and ESD protected to 10 kV with components on the RS232/Nurse Call board and is not electrically isolated. The interface supports two signals (TxD and RxD) along with ground.

4.4.2 COMBO IC

The COMBO IC, U10 (U14), is a 160 pin PQFP device which supports a variety of kernel functions, primary audio support, digital I/O and other functions. The COMBO latches the address bus and outputs the latched addresses as A19-A16, and A7-A0. The COMBO IC has a 16 bit CRC generator which is used to periodically test the EPROM data. The RAMTEST

circuit provides redundant storage and error detection of RAM data. The local serial interface control logic is used to interface with serial accessed peripherals such as the A/D converter, EEPROM, LED Module(s), and Battery Manager. The device also generates the Main LCD interface control signals. The UART (Intel 8251 equivalent) and three 16 bit counters (Intel 8254 equivalent) are also provided inside the COMBO chip. Six pulse width modulators for motor control and LCD backlight and contrast are also within the custom IC.

4.4.3 EEPROM

The EEPROM is used to store all configuration and diagnostic settings. The EEPROM, U9 (U11) is accessed using the serial control unit within the COMBO IC. Data is written and read back from the device through the serial data registers within the COMBO chip.

This device holds 128, sixteen bit words. It is used to store data that will not be destroyed if power is lost to the instrument. The EEPROM will store configuration mode, calibration (LCD contrast) settings, and certain diagnostic information e.g., instrument ID number, PM interval, PM on/off, battery run time, and total instrument run time.

NOTE: The event log is not stored in the EEPROM.

4.4.4 RAM

The RAM is used to store user set parameters, e.g., Volume To Be Infused (VTBI), mode, rate, and PRI/SEC, as well as the event log. The instrument provides read/write memory integrity by using redundant storage and automatic comparison. Data written to RAM is stored in both of the RAM devices, main RAM, U8 (U9) and phantom RAM, U4 (U5). The processor reads data directly from the main RAM. The phantom RAM data only goes to the COMBO IC. The COMBO IC compares the data from the two RAMs on each read. If the data does not match, a bit will be set in a register within the COMBO IC.

When the pump is off the VRAM supply is still on,

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preserving the contents of the RAMs. The second chip select line, CS2, of the RAMs is tied to RST_CPU*, so that the RAMs can not be selected during power down sequence.

4.4.5 EPROM

The EPROM (CMOS), U3 (U4), contains 512K bytes (x8) of program memory. The EPROM is held in a socket. To change the EPROM the instrument must be opened. Turn the instrument off and disconnect from AC power before opening the case to replace the EPROM.

4.4.6 RS-232 Interface (7100/7200 only)

The RS-232 serial communications is supported by a UART (Universal Asynchronous Receiver/Transmitter) which is located inside the COMBO IC. The UART is equivalent to an Intel 8251. The UART's outputs drive interface U22 (U45), which converts the logic

level signals to RS232 levels. The system can support up to 9600 baud rate.

4.4.7 RS-232 Interface (7101/7201 only)

The isolated RS-232 Interface provides 500VAC electrical isolation between the RS-232 signals on the RS-232 connector and the rest of the instrument as well as connections for the speaker, tamper switch, and flow sensor interface option. The isolation is created using optical isolators U3 and U4 for the signals and an isolation power transformer T1 for isolated circuit power. Voltage level conversions are generated by the MAX250/25 1 chip set U1 and U2 to generate the appropriate signal conditioning. Limit resistor R1 converts the RS-232 signal levels, nominally ±6V, to match the input signal range required by U1.

NOTE: The RS-232 board in the International version is isolated and hence cannot have trhe Nurse Call option.

Figure 4-2-a COMBO IC Block Diagram

Figure 4-2-b COMBO IC Block Diagram

Isolation

Transformer

Optical Isolator

Isolated

Interface

Nonisolated

Interface

Rxd Txd

Iso Rxd Iso Txd

Iso Rxd Pwr

Audio Tone Generator

Main CPU

Background

Irp Timer

Kernel

Bus

Interface

Motor Timer

Chan A

Motor Timer

Chan B

Motor PWM

Chan A

Motor PWM

Chan B

LCD PWM

DataCRC

Generator

LCD Bus

Interface

RAM Test

Circuit

Output

Ports

Input Ports

UART

Audio Tone Generator

OSC

AMP3-0

BKGND-IRPT

TIMER1_OUT

TIMER0_OUT

DMARQ0

TXD

PD7 - 0 PH_EN RAMCS

OUT - 27 - 20 OUT - 36 - 34

LCD - D7 - 0 LCD - CS1 - 0 LCD - RS LCD - EN LCD - WR

PWM1, PWM1_OUT6-5

PWM0, PWM0_OUT6-5

PWM3, PWM3_OUT6-5

PWM2, PWM2_OUT6-5

PWM5 (LCD Contrast)

PWM4 (LCD Backlight)

A19 - 16 A191 - 161 A7 - 0 AD7 - 0

IN - 07 - 00 IN - 17 - 10 IN - 33 - 30

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4.5 Power System

4.5.1 Battery Manager

For general information, also refer to Chapter 1.

The Battery Manager, U34 (U40), is a custom programmed microcontroller with 4K of ROM and 1K of RAM memory. The Battery Manager has two system time bases, a 32 kHz crystal, Y2, and a 4 MHz ceramic resonator, RESN1. In normal operation the Battery Manager operates at 4 MHz. Under low power condition (instrument is off and AC is unplugged) the Battery Manager switches to the lower frequency to save power. The battery manager is turned on for three seconds every minute when the pump is off and connected to AC power.

The Battery Manager has the following functions:

• Instrument on/off

• Battery charge control

• Battery gauge

• Battery warning and alarm

• Relative time clock

• Displays configuration name

• Instrument icon display

• Inter-processor communications

• Processor self test

• Error detection (battery, temperature input,

current integrator, power on/off, and watchdog faults)

• In-circuit test.

RS232 PCB

Figure 4-3 Electrical Partitioning

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4.5.2 AC Off Line Switcher

NOTE: Refer to Figure 4-5 "Battery Monitor" and Figure 4-6 "Main Power Supply" when following Sections 4.5.2 through 4.5.17.

The AC Off Line Switcher is an AC to DC power converter capable of running the instrument and supplying 22-24V @ 1.5A to the battery charging circuit from an input of 85-264VAC 50/60 Hz. The module has foldback current limiting to protect against output shorts. It contains two input fuses which are designed for worst case hospital line transients and they will only blow if there is a fault in the module. There are no user adjustments in the module.

4.5.3 Battery Charge Regulator

The battery charger circuit is a step-down (buck type) switching regulator, U20 (U28), configured to provide a constant current of 1A through the battery whenever the charge control signal, CHARGE*, is low. The input to the battery charger regulator is DC_INPUT, which is generated by the off line switcher between 22-24V.

The circuit measures the battery charge current through a 0.1 ohm resistor, R29 (R43), between the battery and “P” ground. This voltage is amplified

and sent to the feedback input of the switching regulator U20 (U28). The regulator will keep the voltage at the feedback pin at 1.23V by adjusting its output pulse width. The gain of the amplifier is set so that an average current of 1A through the 0.1 ohm sense resistor will result in the 1.23V feedback voltage.

The Battery Manager controls the average current into the battery by varying the duty cycle of the charge control. There are four possible phases for the average current charge cycle.

a. Fast charge phase charges at 1 amp within limits

on the ambient temperature. The Battery Manager charges with this phase until one of the following charge criteria are met.

• Battery voltage drops at least 192mV below the peak value.

• Battery temperature is more than 7˚C above starting temperature and at least 30ºC.

• Total charge time exceeds 3.2 hours.

b. Top-up charge phase starts after fast charge if the

battery temperature is less than 37ºC, at an average of 180mA for 180 minutes. This average current is produced by charging at 1 Ampere for

0.9 seconds every 5 seconds.

Figure 4-4 Battery Manager Block Diagram

AC SUPPLY

CHARGER

VOLTAGE CURRENT

TEMPERATURE

AC POWER

SENSOR

ON/OFF SWITCH

ANALOG

CIRCUITS

ON/OFF

CONTROL

BATTERY

MANAGER

DC-DC

CONVERTER

LOWER LCD

DISPLAY

WATCHDOG

MAIN CPU

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NOTE: The charger will turn off if the battery gets too hot (>37º C) to let the battery cool down. Cool down time is not included in the 180 minute charge time.

c. Float charge phase charges at an average current

of 40mA in a fully charged battery. This average current is produced by charging at 1A for 0.2 second every 5 seconds.

d. Hot charge phase charges at a rate of 180 mA for

a total time of 18 hours if battery temperature is more than 36ºC. Charge stops above 43º C and starts below 43º C, the cool down time is in addition to the 18 hour charge time.

Table 4-2 Battery Trip Points

Battery Voltage Instrument Response

12.0V (Single) • 15 minutes left on gauge

12.1V (Dual) • Unit continues to function

• Warning tone activated

• Low battery warning

11.45V • Unit does not pump

• Constant alarm

• Low battery alarm (Depletion)

10.25V • 5 min after low batt alarm

• Backup speaker activated

• Instrument shutdown (5 min.

after alarm)

9.75V • No AC power applied

• Battery disconnected from circuit by shutdown signal.

4.5.4 Refresh Cycle Load

The battery refresh feature uses the refresh cycle load circuit to add an additional resistive load across the battery to accelerate the discharge when the instrument is plugged into AC and the instrument is either on or off.

The signal DUMP_RES, generated by the Battery Manager, is used to turn on the FET transistor, Q9 (Q34), to apply the 47 ohm, 7 Watt, R273 (R353) load to the battery.

4.5.5 VAO Shutdown

VAO_SOURCE is used to supply power to the Battery Manager, its supporting circuitry and the RAMs. When the instrument is turned off, these supplies remain active. If AC is unplugged, and the battery

has decreased to approximately 9.75V, the Battery Manager has the ability to remove these supplies from the battery load. This circuit is designed to protect the battery by preventing the battery from getting fully discharged. The Battery Manager generates the signal SHUT_DOWN* to remove the VAO_SOURCE from the battery load. When the SHUT_DOWN* command has been given the Battery Manager will lose power as well as the RAMs and Lower LCD display. This power will only be restored when AC power is connected.

NOTE: The instrument’s operation, after the battery is disconnected, is the same as the Battery Manager generating the SHUT—DOWN* signal and requires the instrument to be plugged into AC after the battery has been reconnected.

When the SHUT_DOWN* signal is asserted low, Q37 (Q39) will turn off, which opens the path from the battery to VAO_SOURCE.

4.5.6 AC Line Sense

The AC power sense circuit detects the presence of AC power and notifies the user and the Battery Manager of its status. The DC_INPUT is the output of the AC Off Line Switcher and should be between 22 to 24V. When the input voltage, DC_INPUT, reaches at least 15V, the circuit will recognize that AC has been plugged in. When AC power is detected, the AC LED on the LED module is lit and a status input to the Battery Manager, AC_PWR, is asserted high. The circuit is designed to switch off the LED quickly when AC power is removed.

When DC_INPUT is at least 15V, the voltage through the sense circuit is high enough to turn on the AC led within the LED module. The AC_LED signal will be about 1.5 to 2.4V when the LED is on.

4.5.7 System Power Source Select

The system power source, DC_DC_SOURCE, is used to drive three switching power supplies. It is controlled by the Battery Manager through the signal PWR_ON. When the instrument is on, the DC_DC_SOURCE is normally supplied by either the battery or the AC off line switcher if the instrument

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is plugged into AC. The Battery Manager disconnects the AC source during the battery refresh cycle.

When the Battery Manager asserts PWR_ON high, Q24 (Q41) will turn on. If PWR_AC is high, Q7 (Q25) will turn on, and DC_DC_SOURCE will be supplied by the DC_INPUT.

If PWR_AC is high, Q8 (Q21) is on and DC_DC_SOURCE will be supplied by the battery.

4.5.8 Battery Voltage Monitor

The battery voltage can range from 10 to 18V. The Battery Manager monitors the battery voltage through its internal A/D converter. The valid input range of the A/D converter is 0 to 4.1V. The battery voltage must be reduced to meet the input requirements. The 4.1V reference and the voltage subtracter-multiplier amplifier circuit U29-5 (U37-5) scale the battery voltage and maintain an accuracy of ±15 counts (1 count = 1mV).

The Battery Manager uses the battery voltage for its charging, battery gauge, error detection, and battery alarm and warning features.

When MEASURE is low Q27 (Q43) will open and remove BATT_PLUS from input to U29 (U37). Also MEASURE being low will open Q26 (Q45) so that VMEAS is removed as well.

4.5.9 VMEAS

VMEAS is the supply used to power the REF 4.1V reference circuit, the voltage monitor circuit, and the current monitor circuit. The Battery Manager turns VMEAS off by setting the MEASURE signal low when the instrument is off and AC is unplugged to reduce the load on the battery. In this condition, the Battery Manager turns VMEAS on once a minute to check the battery's voltage and temperature.

The 12V Zener CR31 (CR41) is placed between the gate and source of the FET, Q26 (Q45), to limit the gate to source voltage. The FET can see up to 24V but the Vgs (Voltage gate to source) of the FET is only rated to 20V.

4.5.10 Voltage Reference 4.1V

The 4.1V reference is used in the voltage monitor circuit, the battery temperature sensor circuit, the ambient temperature sensor circuit, and is the reference voltage for the A/D converter in the Battery Manager. The reference voltage is 4.096V ±2%. VMEAS, which can be between 7.7 to 24V, turns on the precision reference Zener U27 (U47).

4.5.11 System Current Monitor

The circuit to measure the supply current uses a 0.1 ohm resistor, R32 (R86), to generate a voltage drop. The resistor is placed between “P” ground, the ground from the AC Off Line Switcher, and “L” ground, the ground to the rest of the instrument (The battery charger circuit is tied to “P” ground so that the battery charge current is not measured as system load current). The amplifier, U29-7, (U37-7) is designed as an integrator. Since the “P” ground voltage will be less than the “L” ground voltage a current will be generated in a resistor tied to the operational amp's negative input, to maintain equal voltage levels at the operational amp inputs. This current charges the feedback capacitor, C52 (C56), thereby integrating the current as long as the feedback transistor, Q30 (Q48) is off.

The Battery Manager integrates the current for 100 ms, 1 ms before resetting the integrator by pulsing the signal RESET_I high for 1 ms. Forcing RESET_I high will turn on Q30 (Q48) thereby placing a short across the feedback capacitor, C52 (C56). The resulting output voltage, I_MON, is fed to an A/D input of the Battery Manager. At a 1A load current the output voltage is about 2.7V. The Battery Manager samples I_MON once before the RESET_I signal is pulsed high and once after. The difference between the two samples becomes the current measurement. The Battery Manager uses the current measured for: charging, to monitor current in and out of battery, battery gauge, updates gauge under present power requirements, and error detection functions.

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4.5.12 Always On Supply (+5VAO)

The always on supply, U39 (U43), is used to power devices that remain powered when the instrument is off e.g., Battery Manager circuitry and VRAM. The supply is regulated at 5V ±5%.

4.5.13 System Switching Supplies

The system switching supplies provide regulated +5V, +29V, and -15V power to the logic, display, motor, and sensor circuits. Each of the supplies uses an integrated switching regulator IC which provides thermal overload protection, internal oscillator, internal reference, and current limit functionality. The DC_DC_SOURCE voltage is applied to three switching power supplies:

a. The +5V supply U17 (U31) is a step down

(“buck”) configuration switching regulator which provides a lower output voltage (5V ±5%) than input voltage (10V-24V). The supply can provide in excess of 1A peak. Output clamp Zener diodes limit circuit damage in the event of regulation failure. The regulator has an internal pass element which turns on current to the output inductor until the output voltage, as sensed through the sense resistors, reaches the internal 1.23V reference voltage. It then turns off and the inductive flyback voltage created is clamped by a catch diode.

b. The VMOTOR supply U21 (U26) is a step up

(“boost”) supply which provides a higher output voltage (29V ±1.5V) than the input supply (9V24V). The supply can provide up to 1A peak and has a soft start feature to limit inrush current upon starting. The internal pass element shorts the output side of the power inductor to ground, then releases it, generating about 29V at the cathode of a diode. This voltage is sensed by a resistor pair and the loop controlled to generate a 1.23V reference signal level.

c. The VNEG supply U16 (U30) is a buck-boost supply

which generates a negative supply (-15V ±1V)

from a positive supply (9V-24V). The supply can provide about 100mA. The IC ground pin is bootstrapped to the negative output voltage. Then, referencing the feedback signal to ground potential allows the chip to sense the negative voltage and therefore regulate it. In operation, the internal pass element provides current through the inductor while on. When the pass element turns off, the flyback action of the inductor generates a negative voltage spike which is captured across a capacitor though a steering diode.

4.5.14 VRAM Supply

The VRAM supply is a 4.8V supply generated for the RAMs to keep them active when the instrument is turned off. When the instrument is off, VRAM is sourced by +5VAO through a diode. When the instrument is on, VRAM is sourced by +5V through a diode.

4.5.15 VPOS Supply

A linear regulator, U2 (U1), from a DC-DC Source provides a 6V supply for the pressure transducer and A/D circuits. The output voltage is dependent on the voltage gain of the amplifier, approximately 1.5 times the input reference voltage. The power is supplied by the DC_DC_ SOURCE while the reference is ADVREF_RAW. The transistor Q1 (Q1) is used as a pass transistor to boost the current supplied by the amplifier.

4.5.16 Battery Temperature Sensor

The battery temperature sense circuit measures the temperature in the battery pack through a nominal 10 kilohm @ 25˚C thermistor. The thermistor is the same type as used in the ambient temperature sense circuit. The sensor will measure, with a 2.5˚C accuracy, over the temperature range 0˚ to 65˚C. The circuit is a voltage divider between a resistor and the thermistor with a 4.1V reference voltage used as the input voltage. The output BATT_TEMP drives an A/D input to the Battery Manager.

The Battery Manager uses the battery temperature in its error detection and charging functions.

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Figure 4-5 Battery Monitor

Figure 4-6 Main Power Supply

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4.5.17 System Watchdog

The system watchdog provides a monitor on the operation of the main processor and the Battery Manager. It also provides an independent clock signal to the main processor for continuous comparison with the main time base. The Battery Manager controls an output signal (10 Hz) that performs multiple functions.

The 10 Hz* has three states; continuous high, continuous low, or oscillating at 10 Hz. 10 Hz* is continuously low when the instrument is off or a watchdog error has been caused by the main processor. 10 Hz* is continuously high whenever the Battery Manager detects an error within the Battery Manager itself. 10 Hz* oscillates at 10 Hz when the instrument is on and no watchdog errors have occurred.

When the 10 Hz signal begins to oscillate the watchdog outputs, WD_OUT, and WD_OUT* will be deactivated. The one shot, U36-9 (U46-13), keeps its output Q high as long as the falling edges of the signal (10 Hz*) are faster than the pulse width of the pulse generated by R245 (R323) and C49 (C67) which is 105 to 220 ms. The Q* output of the one shot, U36-12 (U46-4) disables the second one shot U36-13 (U46-5). The second one shot is only enabled when the watchdog is in alarm.

When 10 Hz* is not oscillating, the one shot, U36-5 (U46-13), will not trigger, therefore, output Q is low and Q* is high. The watchdog outputs, WD_OUT* and WD_OUT, are activated until the Battery Manager releases them, by generating the 10 Hz* output. The NCALL_WD* signal is also brought low because WD_OUT turns on Q35 (Q49). Whenever the 10 Hz* stops oscillating and is high, a watchdog error has occurred within the Battery Manager itself. The 10 Hz* signal being high, prevents clock pulses to U36-9 (U46-1) and the one shot to time-out so the output Q (WD_OUT*) goes to zero and Q*(WD_OUT) goes to a high. Once WD_OUT is high the second one shot, U36-13 (U46-5) is enabled. If the user presses either on/off switch, U29-10 (U42-

10) output will go high sending a 4 to 11 ms pulse to the Battery Manager reset input. This allows the user to reset the Battery Manager through hardware when the Battery Manager is stuck in a watchdog error. The system power is also turned off at this time because the pulse resets the power latch,U40-9 (U39-9) bringing PWR_ON low.

The 10 Hz* signal also goes to an interrupt input of the main processor. It is used to compare the time base of the main processor with the time base of the Battery Manager. Nominally, the timebase is 100 ms ±1 ms from falling edge to falling edge.

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Figure 4-7 System Watchdog

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4.5.18 Power Switch

The power on/off switch(es) are located on the keypad. The switch(es) are not included in the standard keypad matrix. One (Two) output(s) is generated, PWR_SW* (PWR_SW_A/B*), one for each channel. The signals are pulled up to 5V, by VBKUP supply, through two pull-up resistors. (VBKUP is the supply for the backup audio.) These signals are decoupled from the signals that drive the Battery Manager logic, PWR_SW* (PWR_SW_A/B*), through two 100K resistors. The PWR_SW* (PWR_SW_A/B*), signals drive interrupt inputs in the Battery Manager, U34 (U40), and are used by the error reset and power on circuits. Upon recognition of the power switch, the Battery Manager controls when the main processor and the rest of the circuit will receive power.

4.5.19 System Reset/Power On

System Reset is controlled by the Battery Manager. Either the lack of a reset inactive signal from the

Battery Manager, U34 (U40) signal R61 or the lack of the PWR_ON signal being asserted will initiate a RST_CPU*.

Power on is also controlled by the Battery Manager. Under normal conditions the Battery Manager uses its output R62 to toggle the power latch, U40-9 (U39-9), to turn the instrument on/off. The Battery Manager turns PWR_ON high when the instrument is on and turns PWR_ON low when the instrument is off.

If the instrument is on and a watchdog error is active, WD_OUT* is asserted low. The second one shot, U36-13 (U46-5), will be enabled. When the power switch is pressed an 8 ms pulse is generated at the Q output of U36-13 (U46-5). The pulse resets the power latch, U40-9 (U39-9), System Reset is controlled by the Battery Manager. Either the lack of a reset inactive signal from the Battery Manager, U34 (U40) signal R61 or the lack of the PWR_ON signal being asserted will initiate a RST_CPU*.

Figure 4-8 System Reset/Power On

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4.5.20 Lower LCD Display Backlight Drive

The backlight for the Lower LCD display contains 6 LEDs in series. The signal AOD_BKLT is tied to the anode of the first LED in the series. Each led has about a 2V forward drop. So AOD_BKLT will be about 12-13V when the LEDs are turned on.

The Lower LCD display backlight drive circuit controls the amount of current supplied to the LEDs. The circuit contains two current sources “or'd” together. One current source is powered from DC_INPUT, the voltage supply from the AC off line switcher. The second source is powered from VMOTOR which is generated when the instrument is on.

The circuit has four modes of operation:

a. First, if the instrument is off and unplugged, the

backlight driver is off. The two power supplies that drive the circuit are both off.

b. In the second mode, the instrument is off but

plugged into AC. The current to the LEDs is limited by a resistor under these conditions. VMOTOR will not be on, therefore only the DC_INPUT path will generate the current for the LEDs. The current in the LEDs will be about 4 mA.

c. Under the third situation, the instrument is on and

plugged into AC. Now both current sources are on, driving the LEDs for maximum brightness. The current to the LEDs should be around 6 mA.

d. And lastly, the instrument is on and not plugged

into AC. Now only VMOTOR is on, so the driver generates the current to turn on the LED. The current should be around 2 mA.

4.6 Motor Drive/Sensors

4.6.1 Motor Drive

The stepper motor drive circuit consists of a dual H bridge to provide voltage to each winding of the hybrid stepper motor, and a voltage comparator to control the duration that voltage is applied to each motor winding.

The sequence of operation for a single phase [Phase 1 (A)] of the motor is as follows:

a. Phase A, MTR_PH_1 (MTRA_PH_1) is active, which

causes the high side switch and low side switch (diagonally opposite the high side switch), to close. This presents the motor supply voltage across the motor winding. The signals MTR_1A (MTRA_lA) and MTR_1B (MTRA_1B) are used to drive the motor.

b. Current will begin to increase at a rate determined

by the ratio of the motor voltage to the inductance of the motor; e.g., about 0.5 amps/millisecond, and flow in the direction indicated by the arrow shown. The current will increase in the sense resistor at the same rate and result in a voltage sensed by the comparator.

c. Once the sense resistor voltage MTR_I1 (MTR

A/B_I_1) rises above the reference voltage at the comparator inputs, U14 (U27), the comparator output, U14-1 (U27-7) will switch low forcing the high side switch to open. The low side switch will always remain closed until a phase change occurs. With the supply voltage now removed from the coil, the coil current and the sense resistor current will decay. Once the sense resistor voltage drops below the reference voltage, the comparator will turn the high side switch back on. The comparator circuit has been designed with a fixed turn on delay of 50 microseconds. This is a result of the RC network on the output of the sense comparator stage. A second comparator stage will sense when the output of the first stage rises above 3.3 volts. The turn on delay results in a maximum chopping frequency of 20 kHz. The lowest chopping frequency is a function of the motor current, at a maximum motor current of 240 milliampere, the chopping frequency is 14 kHz. Inserted between the sense resistor and the comparator input is an RC network needed for filtering of the short circuit current caused by the distributed capacitance of the motor winding.

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d.The chopping action results in a steady state

current in the winding for a given phase duration. When the phase is reversed the opposite high side and low side switch will turn on. This forces current to flow in the opposite direction. The reference, MTR_I1 (MTRA_I_1), is controlled to ramp the motor current exponentially, this minimizes step oscillation, reducing mechanical noise.

The following table illustrates the phase sequence and the respective power, high side and low side switches that are enabled. Refer to schematic for signal references.

Table 4-3. Motor Control Signals

Control Signal Logic Active Winding

Logic State Switches Effected

MTR_EN_1 H Q4-6, Q3-1 MTR_PH_1 L (Q17-6), (Q19-3) MTR_1A/B MTR_EN_2 H Q6-6, Q5-3 MTR_PH_2 L (Q8-6), (Q10-3) MTR_2A/B MTR_EN_1 H Q4-7, Q3-3 MTR_PH_1 H (Q17-7), (Q19-1) MTR_1A/B MTR_EN_2 H Q6-5, Q5-1 MTR_PH_2 H (Q8-7), (Q10-1) MTR_2A/B

To assist the down stream pressure algorithm and reduce mechanical noise the motor is stepped in packets, a series of motor steps followed by a short resting period.

e. The efficiency of the motor driver is determined by

the low on resistance in the Mosfet switches, and the speed at which they are switched on and off. Since only the high side switches are involved in

regulating the motor current, a bipolar network has been designed around these switches to keep switching times below a microsecond. An example of a switching sequence is described as follows.

To activate the following circuit requires MTR_PH_1 (MTRA_PH_1), MTR_EN_1 (MTRA_EN_1), and WD_OUT* to be at a logic high. When the second comparator output U14-7 (U27-1) switches low, this turns on transistor Q18 (Q23), which turns off Q4 (Q1 7) immediately, thereby removing the motor voltage away from the motor winding. When U14-7 (U27-1) switches high, this causes the output of comparator U13-7 (U25-1) to switch low and transistor Q18 (Q23) to turn off, this quickly turns on Q4 (Q17). A 1000 pF capacitor is in series with the output of U13-7 (U25-1) to speed up the switching time of Q4 (Q17) when the comparator output goes low.

Two motor current sense comparators are included in the motor drive circuit to provide a means for the instrument to detect that an instrument malfunction that results in a “watchdog” alarm will shut off current to the motor. The signal WD_OUT* when at a logic low is the indicator for a “watchdog” alarm. When motor current of approximately 20 milliampere or greater flows through either motor winding the motor current sense comparator output MTR_SNS* U12-7/U12-1 (U17- 1/U17-7) will be at a logic low. Both motor windings would have to have a motor current of less than 100 milliampere for the motor current sense comparator output to go to a logic high.

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Figure 4-9 Motor Drive Circuit, Phase 1(A)

Figure 4-10 Motor and Mechanism Sensors Block Diagram

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4.6.2 Air-In-line Sensor

The Air-in-Line (AIL) Detector System consists of a:

• Transmitter arm that also loads the set in position to monitor for air.

• Receiver which is mounted in the mechanism.

• Voltage control oscillator (VCO).

• COMBO IC and associated circuits.

The voltage control oscillator will sweep a frequency range of 1 to 4 MHz and serve as the excitation for the ultrasonic AIL transducer. This frequency sweep is necessary to ensure that the piezoceramic elements will achieve resonance over assembly and temperature variances. The AIL Gate signal will initiate the VCO to sweep. The detector is scanned at a 10 msec rate (40 msec to check bubble) and once a second to test the AIL hardware.On the receiver side, the signal envelop will be seen if fluid is in the set. This signal is then returned to the COMBO IC and eventually to the processor to determine if air is present (no signal) and to compute the size of the air bubble. The instrument will consider air bubbles separated by less than 70 microliters of fluid as one bubble and alarm accordingly.The instrument will also alarm if 10% to 15% of downstream tubing is filled with air (varies with alarm set point).

4.6.3 Transducer

The transducer assembly is a silicon based resistor bridge producing a linear output. The sensing area is in the front of the assembly and directly in contact with the tubing (no gel). It is used to measure stress not absolute pressure. A film over the transducer provides a means to protect the sensor from electrostatic discharge. At least 1 hour is required for the transducer to stabilize to room temperature.

The transducer is used to sense upstream and downstream occlusions as well as sensing if the set is installed or removed. To accomplish these tasks the transducer is calibrated with a special set. The pressure calibration set has a hole drilled into the dome of the AccuSlide. This enables the pressure to be applied directly to the transducer for calibration (0 and 500 mmHg). Temperature compensation (factory set) of the pressure reading is also done and stored in a section of the diagnostic mode.

After pressure calibration, the reading shown in the diagnostic mode for the sensor is corrected for any offset /stress from loading the set outside of the pressure sensing area.

When the set is installed, with dome intact, the instrument looks for an increase in stress (greater than 55 mmHg with auto zero enabled, >90 mmHg

Figure 4-11 Air-in-line Detector Block Diagram

Figure 4-12 Pressure Sensor Interface Block Diagram

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with auto zero disabled). Drift is checked periodically to ensure the transducer is accurate. If not, a “Cal Reqd” message will appear. This is done by asking the operator to remove the set before powering down the instrument. The time period of this test is selectable in the diagnostic mode under the Self Check timer.

PRES_TST_A/B is used to take the transducer out of balance by inducing a known positive offset. This is the means by which the transducer is tested.

The “Cal Reqd” message will appear if transducer shifts more than 170 counts positive or 200 counts negative from last “0” cal level.

4.7 User Interface

The user input interface consists of a keyboard organized as a 5x8 matrix which is scanned and controlled through the LED Module on a single channel pump and the Channel A LED Module on

the dual channel pump. The keyboard is scanned approximately every 10 ms and key data updated when there is a change due to any key or keys being pressed or released. Note that the panel lock is scanned as part of the scan sequence even though it is located on the back of the pump. Switches are scanned every 10 msec., two cycles are required to be a true switch actuation. This provides a debounce function to eliminate mechanical noise and EMI/RFI interference. The power switch(es) are sensed separately by the Battery Manager. During normal operation, the power switch(es) are monitored like the other keys so that inadvertent pump turnoff can be avoided. In a system alarm state (i.e., watchdog alarm active), the keys directly control turning power off to the pump.

The user output interface consists of three display modules. The LED Module(s) provide rate data visible from a distance, along with operating mode annunciators, AC/Battery operation notice, and visual

Figure 4-13 User Interface Block Diagram

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alarm indication. The Graphic LCD Module provides user information on a 128x64 dot matrix display with LED back light. The Lower LCD display shows the current battery run time along with the current audio level selected, communications interface status, panel lock status, and battery refresh status.

4.7.1 Main Speaker Driver

The main speaker driver is based on an LM386 low voltage speaker drive chip, U32 (U29) driven by an exponentially weighted 4 bit control signal (AMP 0 to

3) modulated at the desired frequency (200 Hz - 4 kHz) by the COMBO IC U10 (U14). The speaker is pulsed at 3 to 50 mA with a 50% duty cycle (max. 100 mA). The driver has a fixed 26dB gain which provides up to 3Vpp AC coupled into an 8Ω speaker. The speaker is tested by monitoring the speaker current with a 0.511Ω resistor.

The voltage across the resistor is amplified, rectified, and compared to low and high threshold values by a

window comparator, U38 (U16). The speaker is tested when an alarm or error occurs, while the test circuit is verified at power up. The speaker audio volume settings are approximately: Low= min 45 dB, Med= 65 dB, and Hi= approx. 70 dB.

4.7.2 Backup Audio Buzzer and Test Circuit

A backup audio generation capability is provided to allow the instrument to generate an audible alarm in the event that the main speaker is unable to do so. It is supplied through VBKUP, a 1.0 Farad “supercap” C146 (C179) energy storage device charged by a 5V linear regulator, U32 (U44) on the VAO_SOURCE supply. The buzzer is a self oscillating audio generator and speaker module which produces a 3 to 4 kHz tone when energized. A logic circuit, U30 (U41) powered by VBKUP arms the circuit using the BKUP_ALARM_ARM signal once the instrument has powered up so that the watchdog WD_OUT* signal will not generate an alarm if the unit is turned on or

Figure 4-14 Main Speaker

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off properly. Additional logic is provided to allow the power switch(es) to turn off the backup audio if the main CPU or battery processor no longer have control over the instrument.

The circuit has two test functions. The VBKUP supply is tested at power up to verify that the supercap can drive the buzzer when the regulator is disabled through VBKUP_SRC_EN signal. The buzzer operation is tested by sensing the oscillating current waveform generated by a normally operating buzzer. The buzzer current is sampled by a sense resistor, whose voltage is amplified. The DC level is compared to VTHRES Hi by a comparator, U33 (U33), whose

output (BKUP_SPKR_TST*) drives a digital input on the COMBO IC.

4.8 LED Module

The LED Module(s) provide rate data, along with operating mode annunciators, AC/Battery operation notice, and visual alarm indication. The modules have 58 individual LEDs controlled by a custom IC. The IC performs LED scanning and test functions along with keyboard scanning circuits and interfaces to the main CPU through the local serial interface. The LED intensity is controlled by the main processor to limit power use while running on battery.

Figure 4-15 Backup Audio

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4.9 Lower LCD Display

The Lower LCD Display is visible whether the pump is on or off, AC or battery operation. It shows the current battery run time available along with the current audio level selected, communications interface status, panel lock status, and battery refresh status. It is driven by the Battery Manager and is back lit when the pump is on or plugged into AC.

Figure 4-16 Lower LCD Display Layout

4.10 Main LCD Module

The Main LCD Module provides user information on a 128x64 dot matrix display with LED back light. The main processor generates all text and symbols in bit mapped form, then compares data read back from the display memory to that which was generated to find and avoid problems. Screen updates occur every 100 mSec. The back light intensity is controlled by the main processor to limit power use while running on battery. The LCD contrast is controlled by the main CPU and can be adjusted from factory default through the diagnostics mode. Refer to Section

6.4.16 “Changing Main LCD Contrast”.

4.10.1 Main LCD Back Light

The graphic LCD backlight is an array of LEDs driven by an adjustable constant current source controlled by a PWM signal from the COMBO IC. The LED current can be adjusted stepwise linearly over a 0200 mA range. The current source consists of a low on resistance FET, 0.511Ω sense resistor, and op amp to set the sense resistor voltage based on the

filtered PWM input voltage BKLT_LED. The backlight intensity is not user adjustable.

4.10.2 Graphic LCD Contrast

The graphic LCD contrast is controlled by varying the Vneg supply to the module over a -7V to -11V range. The drive circuit inverts and scales the filtered PWM LCD_CONT signal from the COMBO IC to cover this range. Nominally, the contrast voltage is -9V, but can be adjusted through Configuration Mode in software.

4.11 Nurse Call Circuit (7100/7200 only)

An optional nurse call circuit is located on the RS232/Nurse Call board and provides a 35V @ 1A rated relay contact on system alarms through pins 6 and 9 of the RS-232 connector.

4.12 Panel Lock Switch

The pump can be protected from unauthorized changes with the Panel Lock Switch. A lock symbol is shown in the Lower LCD Display whenever the feature is active. When activated, access to all front panel keys is restricted (except channel select and split screen viewing key).

4.13 ECD Board

4.13.1 ECD Board Option for 7100/7200

The ECD board (sold in a separate kit) provides empty container detection using standard IVAC Model 180 Drop Sensors. The board contains two independent drop sensor control circuits and drop detection circuits as well as timing control logic. The circuitry can detect whether a drop sensor is installed and generates a ~20 ms pulse for each drop detected. Note that, for SE I use, the second channel is not used.

4.13.2 ECD Board Option for 7101/7201

a. Overview The flow sensor interface is a separate

PC board which drives a standard IVAC 180 optical flow sensor, performs ambient light rejection on the resulting signals, and provides digital output signals for a detected drop and sensor attached detection. The board consists of 2 separate ambient light discriminator loops and

hrs

CTRL

MNTR

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drop detectors for independent Model 180 flow sensors along with common timing and control logic. The board assembly is common to both single and dual channel instruments, where the “B” channel is not available externally and is ignored in the software of the single channel instruments. Note that the “A” channel is used for both the “A” channel in the dual channel instrument as well as the single channel instrument, even though the mechanisms are on opposite sides of the case.

b. Common Timing Logic The common timing and

control logic generates the necessary discriminator timing signals to drive the flow sensor LED and sample signals representing room ambient light and LED driven light outputs from the flow sensor. The main system CLK_32KHz is used as the timebase and decade counter U3 that generates non-overlapping “A” and “B” channel drive and sense signals. This reduces the peak LED current load and flow sensor crosstalk during normal operation. Transistors Q5 and Q6 provide logically inverted control signals for the LED drive circuits.

c. Ambient Light Discriminator Loop The flow

sensor drive current is set to maintain a 2.8V level normally at DROP_A/B. This level is determined by the difference in input signal from a 180 drop sensor when the emitter is undriven and driven. Analog multiplexor U4 normally grounds the output of the sense capacitor C18/23 so that room ambient light signal voltage is set across it. When the LED drive is turned on, the output of the sense capacitor, representing the driven signal voltage less the ambient signal voltage, is transferred to sample cap C28/C26. This signal is amplified by U8/U7 with a gain of about 23 and is the DROP_A/B signal.

The DROP_A/B signal is sensed by integrator U1/U6 and C9/C10 to generate an appropriate LED drive level to maintain DROP_A/B at about

2.8V. The integrator output signal is controlled by drive enable FET Q1/Q2 to drive the LED constant current sink U1/Q4 and related components. The constant current source generates a 0-200mA sink current with a 0V-1V input signal.

To prevent a drop even from skewing the LED drive signal, a long time constant filter, consisting of CR1/CR2, R31/R13, and C9/C10, is enabled on a negative going output signal DROP_A/B.

d. Drop Detector The drop detector circuit

generates a digital pulse when a valid drop event is detected. A drop event occurs when a fluid drop passes between the emitter and detector of the Model 180 drop sensor and appears as a generally negative going short duration pulse on the DROP_A/B signal. Detector comparators U8B/U7B generate a 0 to 5V pulse when a drop “signature” of appropriate length and duration occurs. One shots U9A/B generate a nominal 20 ms pulse which indicates a valid drop (ECD-SIG-A/ECD-SIG-B). The main system processor processes the pulse stream and determines whether the drops are occurring properly for the current instrument rate and operating mode (i.e. primary/secondary).

EMC filtering is provided by filters C4-8 to limit energy into or out of the flow wensor connecxtion pins.

e. Option Installed and Sensor Installed Circuit

The installed option detection consists of the input signal on pin 7 of J3 tied to +5V on the board. The main processor has a pulldown resistor on the ECD_INSTALLED signal which generates a logic low signal if the option is not installed. Flow sensor installed signals are generated by monitoring the LED current sink drive transistor collector voltage. Comparator U2A/U2B monitor the voltage and generate a 5V output signal if they drop below about 1.7V. Note that, nominally, the collector voltage should not go below about

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2.2V with a flow sensor attached and driven at maximum current.

Figure 4-17 Flow Sensor Interface Block Diagram

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Integrator

Constant

Current

Sink

Timing

Logic

Drop

Detector

One

Shot

Combo IC

Model 180 Flow Sensor

Drop_A/B 2.8V

Sense Capacitor

Sample

Capacitor

ECD_INSTALLED

ECD A ACTIVE

ECD _SIG_A/B

+5 V

<28/26

<18/23

U7B/U8B

U9A/B

U7/

+5 V

U1/U6 U1/Q4

CLK_32K Hz

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Table 5-1 Test Equipment

NAME MANUFACTURER MODEL NUMBER APPLICATION

Electrical Safety Tester BIO-TEK 260* Used to test AC wiring and

pump grounding.

IV Infusion Set IVAC 70 RCS Rate accuracy test.

Nurse Call Cable IVAC 136111 Nurse call option

Pressure Cal Set IVAC 70ISS Pressure verification and

calibration.

Pressure Gauge Dresser Industries

— 203-426-3115

PTE1/901M1 Pressure calibration and

(-400 to +750mmHg) (

Heise) verification

BIO-TEK

— 802-655-4040 DPM III

Burette 50ml, 0.1 ml increment Fischer Scientific Class A or B* Rate calibration and verification.

Kymex 113 Sec A*

RS-232 (9-pin, Null Modem) IVAC 133450* Connects between 2 instruments

to download configuration.

Silicon Tubing IVAC 303109* Pressure Calibration Setup

T-Fitting IVAC 303815* Pressure Calibration Setup.

Nicd Battery Optimizer Alexander Batteries

— 800-577-2539

Model 2006* Test and condition batteries.

2003 (optional)

Permanent Ink Marker Metron

— 619-755-4477

P3* Pressure Calibration (hard)

(Orange)

* or equivalent

IVAC®Signature Edition™ Technical Service Manual 5-1

5.1 Introduction

This chapter contains procedures required to properly disassemble, repair, and replace parts as well as to test, calibrate, and reassemble an instrument if a problem is detected. Included in this chapter is a list of test equipment required to perform these functions. Table 5-1, “Test Equipment”, lists equipment required for normal checkout or maintenance of the volumetric pump. Table 5-2, “Level of Testing Guidelines”, provides tests for various levels of repair.

A thorough familiarization with the function and operation of the mechanical assemblies and electrical circuits of the pump will enable repair, replacement, and calibration to be accomplished more efficiently (refer to Chapter 4).

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Due to product changes over time, some com-

ponents/assemblies depicted in this chapter

may differ in appearance from your instrument.

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5.2 Repair or Replacement

ALARIS Medical Systems recommends that parts within the pump be replaced rather than repaired when not working properly. Boards, mechanism and display modules must be replaced as an assembly. See Chapter 7 for parts available and level of replacement possible.

NOTE: The tests to be performed on a just-repaired instrument depend on the level of repairs made to the pump. See Table 5-2, Level of Testing Guidelines.

5.3 Replacing Battery

You will need a Phillips screw driver to remove the battery.

NOTE: Instrument configuration will not be lost when disconnecting power. However, error history and infusion program settings may be lost. If you want to save error history, record before proceeding.

1. Disconnect AC power from the instrument.

2. Remove screw from Power Cord Retainer, on rear case, using a Phillips screw driver.

3. Remove Power Cord and Power Cord Retainer.

CAUTION: When there is no AC power available,

do not replace dead battery for the purpose of re-powering the instrument. The instrument will not operate unless it is first connected to AC power after battery replacement.

4. Lift and remove Battery Cover.

5. Lift cable for battery out of compartment.

6. Pull battery from compartment and disconnect.

NOTE: The instrument will not run with battery disconnected.

7. Connect and install new battery. Note the rated capacity of the new battery.

8. Reassemble the battery cover, power cable and power cord retainer.

The replacement battery may have a different rated capacity (current battery has rated capacity of 1.8 AH, with 1.3 AH entered in Diagnostics Mode). If it does, proceed to the Diagnostics Mode (D2), select Battery Status and enter new rated capacity. Refer to Section 6.4.6 “Changing Rated Capacity of Battery”.

In the future, ALARIS Medical Systems may provide different battery packs. The battery manager needs to know if a new battery, possibly with a new rated capacity, has been installed.

9. Clear battery run time via Diagnostics Mode after installing new battery. Refer to Section 6.4.9 “Viewing Battery and Total Run Times”.

Battery replacement is now complete.

NOTE: The instrument will attempt to refresh the battery when it is first installed and connected to AC power. This refresh may take in excess of 24 hours if the instrument is turned on.

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Handle Cover

(removed to access 2 case screws)

Tamper Switch

Flow Sensor Plugs

RS232 Cover and Connector

Power Cord

Power Cord Retainer

Power Cord Retainer/Battery Cover Screw

Battery Cover

Pole Clamp

Case Screws (9)

Battery

Battery Cover

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5.4 Disassembling the Pump

Gaining access and removing various components of the pump for replacement is simple. It may not be necessary to disassemble the entire pump to replace a component. Figure 5-1, “Instrument Assembly Organization”, provides the instrument’s assembly hierarchy. Also refer to Chapter 7 for assembly drawings. A more detailed description on how to disassemble the instrument follows.

You will need a Phillips screw driver, 3/16” socket wrench, 3/8” socket wrench, and 3/32” (or 2.5 mm) allen driver to separate both case halves and disassemble the pump.

NOTE: Instrument configuration will not be lost when disconnecting power. However, history and programmed settings may be lost. If you want to save event log, record before proceeding.

Though a dual channel pump is depicted in the following procedures, both instruments disassemble in the same manner. Channel B will be the same as a single channel instrument.

Figure 5-1. Instrument Assembly Organization

WARNING: Disconnect pump from AC power

before disassembling. Hazardous voltages are present when AC power is connected regardless of the setting of the POWER switch.

CAUTION: To avoid serious damage to the board

assemblies, use extreme care and always use proper static grounding techniques.

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Lower LCD

Main PCB LED

Front Case Half

Main LCD

Mechanism (AIL, LATCH and pressure sensor included)

Main Keypad

INSTRUMENT

Pole Clamp Panel Lock Switch Speaker

Rear Case Half

Battery Fan RS-232 Board AC Line Filter

Heat sink Heat Sink Seal

AC Off Line Switcher

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1. Using a Phillips screw driver, remove screw from Power Cord Retainer on the rear case, then remove the power cord and power cord retainer.

2. Lift and remove the battery cover.

3. Pull battery from battery compartment and disconnect the battery.

NOTE: If replacing battery, ensure battery run time is cleared in Diagnostic Mode.

4. Press on cutouts to pop off cap for handle from inside (between handle and case) to access two screws to open unit. Remove the two screws using a Phillips screw driver.

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Battery compartment

Battery

Battery connection

Battery cover

Access Holes

Power cord

Power cord retainer

Power cord retainer/battery cover screw

Battery cover

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5. Remove the battery to get the hidden case screw inside the battery compartment. Remove the screw.

6. Remove remaining case screws (6 for dual, 4 for single).

7. Lay pump face down.

8. Position pole clamp knob down.

9. Lift rear case to access the inside of the pump.

Battery compartment

Hidden case screw

Case Screws

Pole clamp knob

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5.4.1 Disassembly of the Rear Case

1. Disconnect power supply board connector/battery cable. Lift up the locking bar and remove the RS232 flex cable from front case. Disconnect ground wires (1 for single channel) from under motor.

• The rear case is now completely separated from the front case. Set front case aside.

2. To replace the power supply board assembly:

remove the four screws from Heat Sink using Torx 3/32” (or 2.5mm) driver to separate power supply board from the inside of the rear case. Disconnect the cable from the power supply board.

NOTE: Do not remove cover from back of power supply board. If it’s loose, reinstall with RTV.

Locking bar

Power supply board connector/Battery cable

Ground Wires

RS-232 Flex cable

Power Supply Cable

Power Supply Cover

Screws

Pole Clamp

Screws

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3. To replace ECD board assembly (if installed):

a. Remove screw on ECD board using Phillips

screw driver, then remove the RS-232 board.

4. To replace RS-232 board assembly:

a. Pull the RS-232 cover away from the connector

then remove two hex nuts using 3/16” socket wrench.

b. Disconnect the Panel Lock Key Pad flex cable

by lifting up on locking bar.

c. Disconnect speaker and fan from RS-232

Board.

d. Remove screw on RS-232 board using Phillips

screw driver, then remove the RS-232 board.

Panel Lock Key Pad Flex Cable

Speed Nut

RS-232 Board

Screw

Fan/Speaker Connectors

Locking Bar

Fan Tab

Speaker

Speaker Tab

Fan

RS-232 Connector (Cover in place)

RS-232 Connector (Cover being removed)

RS-232 Board

Cable

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Hex nuts

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5. To replace the line filter: remove screw from

Line Filter using Phillips screw driver.

Remove two screws from exterior power connector using Phillips screw driver.

Remove exterior power connector and Line Filter assembly.

6. To replace speaker/fan assemblies: spread clips

and remove the fan or speaker.

Disconnect from RS-232 Board, if necessary.

7. To replace the Heat Sink: remove speed nuts

inside the rear case using a 3/8” socket wrench.

Remove the Heat Sink.

Disassembly of the rear case is now complete.

Fan Clip Speaker

Speaker Clip

Fan

Speed Nuts

Heat Sink

Line Filter

Line Filter Screw

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5.4.2 Disassembly Procedure for Cable Routing

Pay close attention to cable routing when disassembling the instrument. The cables are specifically routed to ensure they are not pinched or stressed when reassembled. Channel A (ChA) and Channel B (ChB) wires are routed in the opposite direction to connect to the board assembly.

NOTE: Single channel pump routing is similar to Channel B (ChB).

A. Front Case:

NOTE: Exercise caution when removing connectors. Pulling on wires can break them. Wires and connectors must be replaced as part of an assembly. They cannot be repaired separately.

1. Cut tie #1for ChB motor and AIL receiver (black).

2. Cut tie #2 for ChB motor, Latch, Rotation and AIL receiver (black).

CHANNEL B CHANNEL A

LED Flex

Latch Cable

Back 4-Bar

Tie #2

Motor Cable

Rotation Cable

XDCR Cable

Tie #3 Tie #1

AIL RCVR Cable

AIL XMTR Cable

Lower LCD

Flex Cable

RS-232 Cable

GND Wire

Batt/Power

Cable

Back 4-Bar Latch Cable

Motor Cable Tie #4

Rotation Cable

XDCR Cable Tie #5

AIL RCVR Cable

AIL XMTR Cable

Batt/Power Cable

GND Wire

TOP

BOTTOM

3. Cut tie #3 for ChB AIL transmitter (white) and ChA AIL transmitter (black).

4. Cut tie #4 for ChA motor, Latch, Rotation and AIL receiver (white).

5. Cut tie #5 for ChA motor and AIL receiver (white).

6. Disconnect ChA and ChB transducer wires (blue) from the board.

7. Disconnect ChA and ChB ground wires (black) going to the mechanism assembly.

8. Disconnect flex cables for front panel, LED modules, main LCD, RS-232 board assembly and lower LCD as needed. Lift up on locking bar before attempting to remove flex cable.

9. Continue disassembly as required.

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B. Rear Case

1. Disconnect flex cable for RS-232 board assembly. Lift up on locking bar before attempting to remove flex cable from main board assembly.

2. Disconnect power supply cable from power supply board.

3. Disconnect fan and speaker cable.

4. Disconnect battery/power cable from main board.

5. Disconnect ground wires from mechanism assembly. If needed, unhook ground wires from cable clamps (4 places on dual channel, 2 places on single channel).

6. Continue disassembly as required.

Power Supply

cable

Cable clamp

Battery/Power

cable

Tamper Switch cable

Cable clamp

Speaker Fan

Cable clamp

RS-232 Flex Connector

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5.4.3 Disassembly of Front Case

1. Disconnect all wire connections to the Main PCB.

NOTE: When removing flex cables, carefully lift locking bar to remove cable from connector.

NOTE: Pay particular attention to wire routing. Wires should be routed back to initial scheme and similar to the example shown. This will prevent them from getting pinched and jamming the mechanism.

2. To replace the main PCB on 710X/720X: remove screw from Main PCB using Phillips screw driver. Slide Main PCB to top, then lift and remove.

NOTE: The large capacitor for the backup speaker may be discharged after removing the board. Jumper across terminals of capacitor C-146 (C-179) for one minute. See Troubleshooting Section for more information.

After installing the new Main PCB , perform the following:

a. Check Tc in Diagnostic Mode. D6 screen should

have selected Tc=0.0. See Chapter 6 for proce-

dure to change, if needed for software 2.02 and higher.

b. Check Rate Cal number in Diagnostic Mode.

D4 screen should have a Rate Cal # of 182 to 214 (See Chapter 5 for Rate Calibration

Procedure, if needed). (See Chapter 6 for procedure to change)

c. Perform Soft Pressure Calibration after one

hour warm-up.

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Board Screw

CHANNEL B

CHANNEL A

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3. To replace the LED modules: Lift up on locking

bar for flex cable and disconnect. Use fingers to push back snap fittings holding the upper LEDs (only one on single channel), then lift and remove.

4. To replace the Main LCD module: Lift up on

locking bar for flex cable and disconnect. Use fingers to push back snap fittings holding the Main LCD module, then lift and remove.

5. To replace the lower LCD module: Lift up on

locking bar for flex cable and disconnect. Use fingers to push back snap fittings holding the lower LCD module, then lift and remove.

Snap Fittings

LED (Channel B)

LED (Channel A)

Snap Fittings

Main LCD

Module

Lower LCD Module

Snap Fitting

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Page 91

6. To replace the mechanism:

a. First, separate the front and rear case halves

following the procedure in Section 5.4, “Disassembling Pump”.

NOTE: Pay close attention to cable routing when disassembling the instrument. The cables are specifically routed to ensure they are not pinched or stressed when reassembled.

b. Move mechanism latch to the middle position.

This will allow the air-in-line sensor to clear the case when extracted.

c. Disconnect wiring harnesses from the Main

PCB. Note their location. They will be reconnected to the same location later in the procedure.

d. Using a flat head screw driver, unsnap the

three snap fittings (top and both sides) holding the mechanism to the front case, then remove the pumping mechanism.

e. Mark the mechanism(s) latch housing “A” or

“B” with permanent ink to ensure reinstallation in the proper location on dual channel pumps.

CAUTION: Do not mix

mechanisms in dual channel or with other instruments. When a mechanism is removed, it must go back in the original position or the pump will need hard and soft pressure calibration, as well as rate calibration.

f. Install the mechanism.

g. Perform pressure and rate calibration (see

chapters 5 and 6).

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Snap Fittings

Pumping

Mechanisms

Snap Fittings

Page 92

7. To replace the key pad assembly: remove the

Key Pad only if it is defective. Removing a good Key Pad will ruin it.

NOTE: Keypad pictures are for reference only and may not match your instrument.

a. First, separate the front and rear case halves

following the disassembly instructions in Section 5.4 “Disassembling Pump”.

b. Disconnect power supply board connector/

battery cable and RS-232 flex cable from front case.

The rear case is now completely separated from the front case. Set it aside.

c. Disconnect the Key Pad Assembly flex cables

from the Main PCB.

d. The Key Pad Assembly is removed by peeling it

off the front case. Take a corner of the Key Pad and peel it away from the front case.

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Key Pad Assembly flex cable

Front Case

Key Pad Assembly

EDICAL SYSTEMS

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e. Adhesive will remain on the surface of the

front case. Remove any remaining residue from surface before applying new Key Pad.

f. Position the front case so that it faces you. Fold

back a small portion of the protective backing along the right side of the Key Pad. Insert the Key Pad Assembly flex cables into the slot and guide them through.

g. Align the right edge of the Key Pad Assembly

and affix. If aligned, proceed to remove the remaining protective backing as you lay it into place. With your fingers, press around the perimeter of the Key Pad Assembly to assure adhesion to the front case and prevention of fluid ingress.

Alcohol may be used to remove adhesive residue.

Key Pad Assembly flex cable

Slot

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h. It may be necessary to loosen the Main PCB to

gain access to the flex cables from inside the front case. To do so, remove screw from Main PCB using Phillips screw driver. Lift and move the Main PCB to the side to gain access to the flex cables.

Pull the flex cables through and to the side of the Main PCB. Reattach the Main PCB to the front case. Connect the flex cables to the Main PCB.

i. Reconnect power supply board connector/battery

cable, and RS-232 flex cable from front case.

j. Reassemble both case halves following the instruc-

tions in Section 5.4 “ Disassembling Pump”, but in reverse sequence. See section 5.4.4 on cable routing before closing the pump.

k. Remove any protective covering from the front of

the Key Pad Assembly.

l. Turn on the instrument, verify that the instrument

beeps and that all display segments flash. This confirms that the pump has performed its selftests, and is operating correctly. The instrument configuration values remain that same as those before power was disconnected. It is not necessary to reconfigure the instrument.

m. Test the switches. Refer to Section 6.4.15

“Testing Switches” to confirm that each switch is functional.

The replacement of the Key Pad assembly is complete.

Board Screw

Flex Cables

EDICAL SYSTEMS

™

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EDICAL SYSTEMS

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5.4.4 Reassembly Procedure for Cable Routing

1. Ensure Main PCB Board and mechanism are installed in pump. Route ground wires through cable clamps, if present, and connect to the transducer.

2. Route transducer cable (blue) under motor assembly out left side for CH A (dual) and out right side for CH B (single). Bend wire up and lay along mechanism frame. Connect to the main board.

3. Route channel A air-in-line transmitter wire (white) up over motor and install tie wrap #5 with motor wires for CH A. Connect to main board assembly.

4. Route CH A ail receiver cable (black) out to left side of mechanism. Route CH B ail transmitter cable (white) to the right of mechanism. Connect both to main board. Install tie # 3 around both cables. Ensure CH B ail transmitter cable (white) and CH A ail receiver cable (black) has loop as shown.

5. Route CH A rotation sensor cable out to right side and over back 4-bar (mechanism). Connect to main board.

6. Route CH A latch sensor to left under back 4-bar. Connect to main board.

7. Connect CH A motor assembly cable to main board.

8. Install tie #4 around CH A motor, latch, rotation and ail transmitter (white) wires.

Transducer Cable

(Channel B) (Channel A)

AIL Transmitter wire

Tie wrap #5

Loop

Tie wrap #3

AIL Transmitter

(Channel B)

Receiver Cable

(Channel A)

Back 4 Bar

Latch sensor

(Channel A)

Tie wrap # 4

Rotation sensor cable

(Channel A)

Motor Assembly cable

AIL Transmitter cable

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9. Route CH B ail receiver cable (black) up over motor assembly and connect to main board. Install tie # 1 to motor cable and CH B ail receiver cable (black).

10. Route CH B rotation sensor cable out to right side and under back 4-bar (mechanism). Connect to main board.

11. Route CH B latch sensor to right under back 4-bar. Connect to main board.

12. Install tie # 2 around CH B motor, latch, rotation and ail receiver cable (black) wires.

13. Ensure locking bars are up on flex cable connectors. Install flex cables for front panel, led modules, main lcd, RS-232 board assembly and lower lcd as needed to main board.

14. Install battery/power cable to main board.

WARNING: Always perform a rate accuracy

verification after mechanism and board have been removed and reinstalled or cables have been disconnected and reconnected.

Back 4 Bar

Tie wrap #2

Rotation

AIL Receiver

Tie wrap #1

AIL Receiver

Battery/

Power Cable

EDICAL SYSTEMS

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5.5 Assembling Pump

Assemble the pump in the reverse sequence of the disassembly instructions and section 5.4.4 on cable routing before closing the pump.

When reassembling the case halves, install and tighten the case mounting screws as follows:

1. Install and snug each screw, beginning with the #1 screw and following the sequence in figure, until all screws are snug and case halves are flush.

2. Tighten each screw a 1/4 turn more beginning with the #1 screw installed and following the sequence shown.

3. Close latch when assembly is complete.

4. If ECD feature is not being used, install rubber plug in flow sensor receptacle.

Rubber Plug

Case Screws

(Dual channel)

Case Screws

(Single channel)

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Install non-check valve set (e.g. 72013) into instrument.

NOTE: No fluid in set for mechanical leak test.

2. Cut off the drip chamber of the set, if needed, to place into a fluid container filled with water.

3. Install set in the pump and close the latch.

4. Connect variable pressure air source, reservoir, and pressure meter to set at bottom of instrument.

5. Apply pressure of 15 psi +1 psi (775 mmHg +50 mmHg) for one minute.

6. Verify air bubbles do not continue to show up in the fluid container.

NOTE: When air pressure is first applied a few bubbles are acceptable during mechanical leak test.

7. If bubbles continue to show in the fluid container, return instrument to factory or replace mechanism or case as needed.

5.6.4 Pressure Verification and Calibration Test

Refer to Chapter 6 “Calibrating Channel Pressure” for soft cal procedure.

5.6.5 Set Sensor Check

1. Enter Diagnostic Mode and advance to page D6.

2. Install set and allow a 1 (one) hour warm up while in Diagnostic Mode.

3. The sensor reading with set in should be greater than 55/90 mmHg (auto-zero on/auto-zero off).

4. Remove set and close the latch. The sensor reading with set out should be -30 to +80 mmHg. If not, perform soft pressure calibration, Chapter 6.

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5.6 Test and Calibration

Additional testing and calibration may be required after certain repairs are completed. These tests are in addition to the Preventive Maintenance tests. See Table 5-3, “Level of Testing Guidelines” for more information.

5.6.1 Power-On Self Test

The power-on self test deals with determining the proper operating condition of the fully assembled pump. The pump contains extensive self-testing software. The self test is a final test.

The self test is initiated each time the instrument is turned on. The instrument continually tests itself during operation of the pump, as well. An alarm or error message will appear if there is a problem.

When turning on the instrument, verify that the instrument beeps and that all display segments and LEDs flash. This confirms that the pump has performed its self tests, and is operating correctly.

5.6.2 Mechanism Visual Check

Before the mechanism is placed back into the front case, visually check its functionality.

a. Ensure that all 12 followers are in place and

mechanism is flush to front case.

b. Rotate the latch handle and check for full, unin-

terrupted range of motion.

c. Ensure that the seal is correctly in place and

springs are not loose or damaged.

The mechanism will be further tested, when the pump is reassembled, during the self test, rate verification, and functional tests.

5.6.3 Mechanical Leak Test

1. Use a variable pressure air source (squeeze ball or equivalent), reservoir, and pressure gauge with setup as shown in Figure 5-2 “ Leak Test Setup “.

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5.6.6 Test Run Mode

The test run mode enables the instrument to run without fluid after being repaired. To run the instrument without fluid, perform the following:

1. Cut AccuSlide segment out of standard set. Leave 2 inches of tubing at the top and bottom.

2. Cut membrane on backside of AccuSlide clamp at bottom of pumping segment. Use knife or other appropriate tool and cut an ‘X’ into the membrane to relieve pressure that will build up during testing.

3. Move AccuSlide clamp up, to open position.

4. Fill lower portion of tubing with RTV. Do not let RTV enter the dome area.

5. Allow to dry (48 hours). Move AccuSlide clamp down until it “clicks” into the closed position, and install test set into the instrument.

6. Select rate and run for desired time period e.g. 100 ml/hr for 15 minutes.

7. Remove test set.

Figure 5-2 Leak Test Setup

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IVAC

2” Segment

AccuSlide Clamp

(OPEN)

AccuSlide Clamp

(CLOSED)

Place “X” cut here

(on backside)

Dome

(on backside)

2” Segment

of RTV

Instrument Stand

IVAC

7100

IVAC

RUN • HOLD

ON • OFF

ml/hr

PRI SEC

KVOOPT

HOLD

SECPRI

OPTIONS

CLR

ENTER

SILENCE

CTRL MNTR

hrs

123

Pressure

Gauge

775

psi

mmHg

Pressure Source

Air

15 psi

775 mmHg

Reservoir

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5.6.7 Hard Pressure Cal Procedure

1. Ensure warmup of two hours minimum.

2. Leave unit on and connected to AC power and battery.

3. Follow procedure to disassemble instrument.

NOTE: There is one case screw inside battery compartment.

4. Do not disconnect any cables. Adjust pole clamp so that the knob is facing downward. Lay front case on desk/bench top.

5. Locate pot under motor and on backside of the transducer.

6. Evaluate the sensor in D6 screen (see Chapter 6) as follows:

a. Compensated value is between 1000 and

1200, go to Pressure Cal screen. Verify sensor reading is between -30 and +80 mmHgS after set is removed (repeat for other channel if necessary). If not, perform soft pressure calibration.

b. Compensated value is less than 1000, or

more than 1200 then perform hard cal for this channel.

c. D6 Screen Values:

1st Value 2nd Value 3rd Value 4th Value

VBRIDGE CURRENT UNCOMP (COMPENSATED) AT LAST CAL VBRIDGE SENSOR VALUE SENSOR VALUE

ADC COUNTS ADC COUNTS

7. Adjust transducer pot for a compensated value of 1100 ±25 counts while in the D6 screen and watching the compensated sensor value.

8. Once transducer is adjusted for proper reading, press OKto accept the value.

9. Apply the tamper seal (Metron Marker or equivalent) to the transducer.

NOTE: Care should be taken to avoid applying too much tamper seal so it does not effect the transducer.

10. Close unit by setting bottom of rear case onto

front case using the case bosses for alignment. For a dual channel instrument, route the long ground wire into the corner of the case boss. Ensure that ground wires do not rub against mechanism.

11. Place rear case onto front case while watching all the cables for proper routing.

12. Close case by following pattern and tightening procedure outlined in Section 5.5.

13. Wait one hour for transducer to warmup again and check that compensated value is still in range as noted earlier.

14. Perform soft pressure cal procedure (after 1 hour warmup) as follows:

a. Install 70ISS Press Cal Set.

b. Advance to the D6 screen in the diagnostics

mode. Select Cal Pressure for channel desired.

c. Press soft key next to “0 mmHg”, verify says

pass to right and fail for “500 mmHg” and “Complete Press Cal” replaces sensor reading.

d. Attach pressure meter and squeezed ball to

end of pressure cal set. Apply 500 mmHg ± 1 mmHg.

e. Press soft key next to “500 mmHg”. Verify that

both 0 and 500 values now say pass.

f. Press ok to accept. Soft cal is now complete.

5.6.8 Checking Pressure Calibration Set

1. Go to the diagnostics mode, D6 screen, to access the Pressure Calibration section.

2. Note the sensor reading.

3. Install the pressure calibration set.

4. If the sensor reading has had a greater than ±20 count shift, or the pressure calibration set leaks, replace the set.

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Alaris IVAC 710x, IVAC 720x Service manual

Specifications and Main Features

Frequently Asked Questions

User Manual

Phone Numbers for Reference

WARRANTY

TABLE OF CONTENTS