Alaris IVAC 710x, IVAC 720x Service manual

IVAC® MODEL

710

720

SERIES

Signature Edition

Volumetric Pump

TECHNICAL

SERVICE

MANUAL

EDICAL SYSTEMS

™

EDICAL S YSTEM S

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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.

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

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http://www.alarismed.com

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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Signature Edition™ Technical Service Manual

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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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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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

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? PRI SEC KVO

•

1 2 3 4 hrs

1-2 IVAC

Signature Edition™ Technical Service Manual

GENERAL INFORMATION

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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

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

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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.

IVAC®Signature Edition™ Technical Service Manual 1-15

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

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

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— 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)

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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141345 FAA Page of 146

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

141345 FAA Page of 146

EDICAL SYSTEMS

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2-2 IVAC

Signature Edition™ Technical Service Manual

CHECKOUT AND CONFIGURATION

+ 110 hidden pages

Alaris IVAC 710x, IVAC 720x Service manual

Specifications and Main Features

Frequently Asked Questions

User Manual

Phone Numbers for Reference

WARRANTY

TABLE OF CONTENTS