Baxter Flo-Gard 6301 Service manual

07-I g-Al -729

.-.

Service Manual

Flo-GardQ 6301

Dual Channel Volumetric Infusion Pump

Product Code: 2M8064

Baxter Healthcare Corporation
Deerfield, IL 60015, USA

0 Copyright 1993, 1995, Baxter Healthcare Corporation. All rights reserved

Change Record Page
Specification number: 7- 19-O l-729
Original issue: 04/93

Rev A: 05/95

Page Revision

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7-19-Al-729

Table of Contents

General Description

1.1 Introduction

1.2 Device Overview

1.2.1 Principal Features

1.2.2 Nurse Call

1.3 Technical Specifications

1.4 Controls and Indicators

1.5 Configuration Option Feature

1.5.1 Reviewing the Configuration Option Settings

1.5.2 Modifying the Configuration Option Settings

1.6Alarms.

1.7Alerts

Hospital Service Procedures

2.1 Replacement Of Main Power Fuse

2.2 Cleaning

2.3 Battery Charging

2.4 Preventive Maintenance
Problem Checklist
Theory of Operation

4.1 CPU System

4.1.1CPUs

4.1.2 Programmable Timer Module (PTM)

4.1.3 Watchdog Function

4.1.4 I/O Controllers

4.1.5 Multiplexer

4.1.6 Universal Pulse Processor

4.1.7 Communication Controller

4.1.8 Air Sensor Circuit

4.1.9 Occlusion Sensors

4.1.10 Tube Misloading Detectors

4.1.11 Slide Clamp Detectors

4.1.12 Battery Low Alert/Alarm Detector

4.1.13 Interlock Switches

4.1.14 Panel Lock Circuit

4.1.15 Keypad

4.1.16 Displays

4.1.17MotorDriver

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111

4.1.18 Motor Rotation Detectors .................. 4-7

4.2 DC Power Supply and Power Control Circuit

.............. 4-7

Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . .

5.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . .

5.2 Failure Identification Codes . . . . . . . . . . . . . . . . . . . . . 5-l

5.3 Automatic Test Modes . . . . . . . . . . . . . . . . . . . . . . . 5-2

5.3.1 Automatic Test Mode 1: Calibration Mode 1 . . . . . . . . . . . 5-2

5.3.2 Automatic Test Mode 2: Calibration Mode 2 . . . . . . .

5.3.3 Automatic Test Mode 3: Manufacturing Test Mode . . . . . . . .

5.3.4 Automatic Test Mode 4: Aging Mode . . . . . . . . . . . . . . 5-5

5.3.5 Automatic Test Mode 5: Display Check Mode . . . . . . . . . . 5-6

5.3.6 Automatic Test Mode 6: Time Information Display Mode . . . . . . 5-6

5.3.7 Automatic Test Mode 7: Pumping Sensor Monitoring Mode .

5.3.8 Automatic Test Mode 8: Air Sensor Test Mode . . . . . .

5.3.9 Automatic Test Mode 9: Elapsed Time Test Mode . . . . . . . . . 5-7

5.3.10 Automatic Test Mode 0: Downstream Occlusion Test Mode . . . . 5-7

5.4 Failure Identification Code Troubleshooting Table . . . . . . . .

5.5 Troubleshooting Chart . . . . . . . . . . . . . . . . . . . . . .

Disassembly and Calibration ....................

6.1 Introduction .......................

6.2 Preparation for Maintenance ................

6.2.1 Tools and Test Equipment .............

6.2.2 Recording the Configuration Option Settings ......

6.3 Disassembly/Reassembly .................

6.3.1 Separation of Front and Rear Housings ........

6.3.2 Separation of Printed Circuit Boards .........

6.3.3 Replacement of Front Panel Film ..........

6.3.4 Replacement of Pump Door Cover ..........

6.3.5 Replacement of Pump Door Latch ..........

6.3.6 Replacement of Pump Door or Pump Door Assembly . .

6.3.7 Replacement of Door Latch Pin ...........

6.3.8 Replacement of Pump Head Assembly ........

6.3.9 Replacement of Upstream Occlusion Sensor ......

6.3.10 Replacement of Downstream Occlusion Sensor Assembly

6.3.11 Installation of Air Sensor Assembly .........

6.3.12 Replacement of Force Sensing Resistor* (FSR**)

Devices for Tube Misloading Sensors ........

6.3.13 Replacement of Pump Motor ............

6.3.14 Replacement of Safety/Slide Clamp Assembly .....

6.3.15 Spring Retainer Removal .............

6.3.16 Spring Retainer Installation ............

6.3.17 Replacement of Back Plate ............

6.3.18 Replacement of Battery .............

* Interlink Electronics
**Interlink Electronics

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5-l

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5-4

5-5

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5-6
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6-7

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6-10
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6-12

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6.3.19 Replacement of Power Supply Board

6.3.20 Replacement of CPU/Display Board

6.3.2 1 Replacement of Audible Alarm/Alert Board ..........

6.3.22 Replacement of Backup Audible Alarm/Alert Board ...... 6-22

6.3.23 Replacement of Terminal Board

6.3.24 Replacement of Power Transformer

6.3.25 Replacement of the PANEL LOCK Switch ..........

6.3.26 Replacement of Lithium Backup Battery

6.3.27 Tube Guide Shim Installation

6.3.28 LCD Cushion Installation .................

6.3.29 Software Installation ...................

6.4 Calibration

6.4.1 DC Line Voltages

6.4.2 Air Sensor Calibration ...................

6.4.3 Downstream Occlusion Sensor Calibration

6.4.4 Upstream Occlusion Sensor Calibration ............

6.4.5 Slide Clamp Sensor Calibration

6.4.6 Slide Shaft Sensor Calibration ................

6.4.7 A/D Convertor Reference Voltage Calibration

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.................... 6-29

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6-21

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6-23

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6-26
6-27
6-29

6-32

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6-35

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6-37

......... 6-38

Checkout

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7.1 Introduction

............................

7.2 Maintenance Flowchart

7.3 Operational Checkout

........................ 7-3

7.3.1 Administration Set Placement

7.3.2 Functional Testing .....................

7.3.3 Door Open Alarm Testing ..................

7.3.4 Air Alarm Testing

7.3.5 Drive Defect Test/Occlusion Check

7.3.6 Downstream Occlusion Testing

7.3.7 Upstream Occlusion Testing ................. 7-8

7.3.8 Battery Check ....................... 7-9

7.3.9 Panel Lock Test

7.3.10 Safety Clamp Test

7.3.11 AlarmVolume .....................

7.3.12 Slide Clamp Test .................... 7-l 1

7.3.13 Electrical Safety Tests

7.3.14 Accuracy Tests ..................... 7-13

Illustrated Parts Breakdown

.........................

Warranty and Service Information

9.1 Warranty Information

9.2 Service Information

9.3 General Information

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7-1

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7-3

7-5

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7-11

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8-l

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V

Diagrams

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Data Sheet, Flo-Gard@ 6301
Volumetric Infusion Pump (2M8064)

....................

10-l

A-l

Multiple Key Combinations

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B-l

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7-19-Al-729

List of Illustrations

Figure 1- 1. Front View of Pump .......................

Figure l-2. Pump with Door Open ......................

Figure l-3. Rear View of Pump .......................

Figure 6- 1. Adhesive Application ....................... 6-25

Figure 6-2. Pressure Application Points

Figure 6-3. LCD Cushion Placement .....................

Figure 6-4. Calibration Equipment Setup ....................

Figure 7- 1. Maintenance Flowchart ...................... . 7-2

Figure 8-1. Front Housing Assembly - External

Figure 8-2. Front Housing Assembly - Internal .................

Figure 8-3. Rear Housing Assembly - Internal .................. . 8-7

Figure 8-4. Rear Housing Assembly - External ................. 8-9

Figure 8-5. Pump Head Door Assembly
Figure 8-6. Pump 1 Base Plate Assembly with FSRs

Figure 8-7. Pump 1 Base Plate Assembly-Rear .................

Figure 8-8. Pump 1 Base Plate Assembly with Pump Mechanism .......... 8-19

Figure 8-9. Safety/Slide Clamp Assembly 1 .................. 8-23

Figure 8-10. Pump Head 2 Door Assembly
Figure 8-l 1. Pump 2 Base Plate Assembly with FSRs

Figure 8-12. Pump 2 Base Plate Assembly - Rear ................

Figure 8-13. Pump 2 Base Plate Assembly with Pump Mechanism ......... 8-31

Figure 8- 14. Safety/Slide Clamp Assembly 2
Figure 8-15. Power Supply Board Component and Solder Sides
Figure 8-16. Display PCB - Component Side

Figure 8-16. Display PCB - Solder Side ....................

Figure 8-17. CPU PCB - Component Side ................... 8-42

Figure 8-17. CPU PCB - Solder Side .....................

Figure 8- 18. Terminal PCB .........................

Figure 8-19. Backup Buzzer Board ......................

Figure 8-20. Audible Alarm PCB ....................... 8-46

Figure 10-l. System Block Diagram ..................... 10-3

Figure 10-2. Rear Housing Wiring Diagram

Figure 10-3. Front Housing Wiring Diagram ..................

Figure 10-4. CPU Board Block Diagram ....................

Figure 10-5. Power Supply Section ......................

Figure 10-6. DC Power Supply ........................

Figure 10-7. Power Supply Control ......................

Figure 10-8. Power Supply Control - Hybrid Circuit ...............

Figure 10-9. Master CPU Block Diagram ...................

.................... 6-25

................. . 8-3

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............... 8-15

................... 8-25

............... 8-27

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. l-5
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l-10

6-27
6-30

. 8-5

8-17

8-29

8-40
8-43

8-44
8-45

10-5
10-6
10-7
10-8

10-9
10-10
10-11

Figure 10-10. Master CPU Schematic .....................

Figure 10-l 1. UPP, RTC and SRAM Block (P/O CPU Board) ...........

Figure lo- 12. Alarm Control Circuit

.....................

Figure lo- 13. Address Decoder .......................

10-12

10-13
10-14

10-15

Figure lo- 14. Serial Communication Block ................... lo-16

Figure 10-15. Slave CPU Block Diagram ................... 10-17

Figure lo- 16. Slave CPU Schematic ..................... 10-18

Figure lo- 17. Slave RAM and Programmable Timer Module (PTM)

......... 10-19

Figure 10-18. Motor Driver Circuit - Pump 1 .................. 10-20

Figure 10-19. Motor Driver Circuit - Pump 2 .................. 10-21

Figure 10-20. CPU PCB (Sensor Block)

.................... 10-22

Figure 10-21. PPI Block #1 ......................... 1 O-23

Figure 10-22. PPI Block #2 .........................

lo-24

Figure 10-23. Occlusion Sensing Block .................... lo-25

Figure 10-24. Air Sensing Block ....................... lo-26

Figure 10-25. Misload and Slide Clamp Sensors
Figure 10-26. Display PCB

......................... 10-28

................. lo-27

Figure 10-27. LCD Drivers for Pump 1 .................... lo-29

Figure 10-28. LCD Drivers for Pump 2 .................... 10-30

Figure 10-29. LCDs for Pump 1 ....................... 10-31

Figure 10-30. LCDs for Pump 2
Figure 10-3 1. LED Lamps

....................... lo-32

......................... 10-33

Figure 10-32. Audible Alarm PCB ...................... 10-34

Figure 10-33. Backup Buzzer PCB ...................... 10-35

Figure 10-34. Terminal PCB

Figure 10-35. Accessories ..........................

........................ lo-36

10-37

Figure 10-36. Sensors on Pumphead 1 ..................... lo-38

Figure 10-37. Sensors on Pumphead 2 ..................... 10-39

Figure 10-38. Front Panel Key Assignments .................. 1 O-40

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7-19-Al-729

Section

1

General Description

1 .I Introduction

This manual provides service information for the Flo-Gard@ 6301 Dual Channel Volumetric In­fusion Pump (product code 2M8064) for qualified hospital biomedical engineers and Product
Service personnel. See the device’s Operator’s Manual for detailed operating instructions.

1.2 Device Overview

1.21 Principal Features

The Flo-Gard@ 6301 Dual Channel Volumetric Infusion Pump is an electromechanical device
used for the intravenous infusion of liquids at user-selected rates. The device contains two linear
peristaltic pump heads, allowing it to simultaneously infuse two different solutions. Each pump
head is independently programmable and permits infusion of primary and secondary medication
programs. The secondary program automatically switches over to the primary program when
secondary infusion is complete (automatic piggybacking).

The device operates on standard 115 VAC 60 Hz electrical power, or on its self-contained re­chargeable battery. It is portable and has a panel lock-out feature to prevent patient tampering. It
is designed for use with Baxter’s standard administration sets which contain an “s” as the last
character of the code number, for example, 2C5537s. When infusing solutions through a central
line catheter, sets with Luer lock adapter should be used. Sets with a Flashball@ device are not

recommended in these applications.
The primary rate of infusion is selectable from 1 to 1,999 mL in 1 mL/hr increments’and 1 .O to

99.9 mL/hr in 0.1 mL/hr increments. The secondary rate is selectable from 1 to 999 mL in 1

mL/hr increments and 1 .O to 99.9 mL/hr in 0.1 mL/hr increments. The volume to be infused

(VTBI) is also selectable from 1 to 9,999 mL in 1 mL increments and 1 .O to 99.9 mL in 0.1 mL

increments.
The total volumes infused from primary and secondary programs are added together and accu-

mulated and can be displayed on demand. The primary and secondary VTBIs are independently
decremented and displayed. Upon completion of the primary VTBI, the pump automatically
switches to a keep vein open (KVO) rate. If the pump is started on a secondary rate and VTBI,
the pump will change to the primary rate when the secondary program is completed. Either
pump may be stopped at any time by depressing the STOP key unless the device is in the lock­out mode.

07-19-Al-729

l-l

General Description

1.2.2 Nurse Call

The Nurse Call feature is enabled by installing a jumper wire to the Terminal Printed Circuit
Board at the location labeled R421 on the board. When the jumper is connected, the Nurse Call
relay will be energized only during an alarm condition and when the ALARM LED is lit. The re­lay contact points (normally closed, normally open, and common) are accessible from the COM­MUNICATIONS PORT on the rear of the device (pins 1,4, and 9, respectively). The Nurse Call
feature may be used when the device is connected to a computer, however, provisions must be
made at the communications port to connect both options simultaneously. Specifications for the
9-pin D connector are listed under Technical Specifications.

1-2 07-19-Al-729

1.3 Technical Specifications

Item

Catalog Code Number
Description
Administration Set
Keep Vein Open (KVO) rate
Battery
Battery Life

Battery Recharge

AC Power Requirements

Power Cord
Leakage Current

Power Consumption

Weight

Dimensions

Flow Rate Range

VT81 Range

Air-in-Line Detection

Fuse
Nurse Call

-

Characteristic

2M8064

Dual channel linear peristaltic volumetric infusion pump
Baxter’s standard administration set with “s” suffix

5 mL/hr or programmed rate, whichever is less

12 Volt, 3.2 Ah sealed lead acid

- Approximately 6 hours with one pump running
1400 mUhr using a fully charged battery

- Approximately 4 hours with
1400 mL/hr using a fully charged battery

8 hours for 80% recharge

11 O/f20V, 60 Hz

2.75 m (9.0 ft.) long, with Hospital Grade plug

Typically less than 50 microamps
(using UL-544 specified test methods)

50 watts

8.2 kg (18 Ibs)

33cmWx13cmDx29cmH
(13” W x 5.1” D x 11.4” H)

Primary program: 1 - 1,999 mL/hr in 1 mL/hr increments and 1 .O -

99.9 mUhr in 0.1 mUhr increments. Upper limit can be reduced by

authorized service personnel.
Secondary program: 1 - 999 mUhr in 1 mUhr increments and 1 .O -

99.9 mUhr in 0.1 mUhr increments.

I - 9,999 mL in 1 mL increments and 1 .O - 99.9 in 0.1 mL increments
for both primary and secondary. Upper limit can be reduced by
authorized service personnel.

Factory set to NORM which causes the device to alarm on air
bubbles approximately 75pL or larger. The MIN setting causes the
device to alarm on bubbles approximately 50 PL or larger.

0.5 A Slo-610

g-pin D connector, Pin 1: N/C (normally closed), Pin 4: N/O (normally

open), Pin 9: Common

Contact rating: 0.4A at 30 VAC, 2A at 30 VDC resistive load (internal

connection required)

both

pumps running

at a

rate from 1 to

at a

rate from 1 to
b

07-19-Al-729 1-3

General Descridon

1.4 Controls and Indicators

All controls and indicators are shown in Figures l-l, 1-2, and l-3. Service personnel should be

familiar with the pump’s features and operation before servicing the device. Items 1 through 9 in
Figure I- 1 are associated with Pump 1. The controls associated with Pump 2 are identical and
function in exactly the same manner. Items 10 through 27, Figure l-l are common to the opera­tion of both pumps. When the word “device” is used in this manual, reference is being made to
the entire Flo-GardB 6301 Dual Channel Volumetric Infusion Pump. Generally, the word

“pump” is used to refer to either Pump 1 or Pump 2.
Each device’s serial number is recorded on a label on the back of the device.

ITEM FUNCTION

1. Pump 1 ON-OFF/CHARGE Key Turns Pump 1 on and off. The internal battery charger re­mains on regardless of the ON-OFF/CHARGE key-as long
as the device is plugged in.

2. Pump 1 Door Latch

3. Pump 1 STOP Key

4. PUMP 1 Key and Indicator

5. Pump 1 Main Display

6. Pump 1 Message Display

7. Pump 1 ALARM LED

Opens and closes pump door.

Stops Pump 1. The message

STOPPED

appears when the
key is pressed. An alert will sound if Pump 1 is stopped for
more than two minutes. Clears all programming alerts
while pump is running.

Allows the device to accept keystrokes and other controls
common to both pumps for Pump 1 programming. Yellow
LED lights to indicate that Pump 1 is selected.

Shows rate, volume to be infused (VTBI) and total volume
infused for Pump 1 primary and secondary infusion pro­grams.

Shows all Pump 1 messages.

Red LED that blinks on and off during a Pump 1 alarm, ac­companied by a visual message display and a repeated se-

quence of three beeps. An alarm indicates that Pump 1
requires immediate attention.

8. Pump 1 PUMPING LED

l-4

Green LED which is constantly lit while Pump 1 is pump­ing.

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6,

!j\

4\

3\

General Description

8 9 IO 11

hhi3 14

45

A6

A-17

\

*b

l-

27'

Figure l-l. Front View

”

3

P
:

-18

07-19-Al-729

l-5

General Description

9. Pump 1 ALERT LED

10. BACKLIGHT key

11. SILENCE Key

12. TOT VOWSTATUS Key

Yellow LED which lights during Pump 1 alerts, accompa­nied by a message display and a repeated single beep. An
alert indicates that Pump 1 needs routine attention.

Provides backlighting of the displays when the device is
used in darkened areas. The key toggles the backlighting
on and off. If the device is operating on battery power, the
backlight remains on for 60 seconds and turns off automat­ically to conserve battery power.

Temporarily silences an audible alarm or alert for two min­utes. All visual alarm or alert information remains dis­played.

Dual-function key. During operation, this key causes total
volume delivered and current settings to display when
pressed. It is also used to select a next step in Review Con­figuration, Modify Configuration and Programmed Deliv­ery Profile modes. The word “NEXT” above the key is
illuminated when the key is functioning as a NEXT key.

13. CLEAR TOT VOL Key

14. TIME Key

15. PRI RATE Key

16. PRI VTBI Key

17. PRI START Key

18. PLUG Icon

19. MONITOR Legend

Resets the total volume delivered to zero when the pump is
stopped.

Enters desired time interval for an infusion during Volume-

Time or Rate-Time programming.

Allows programming of the primary infusion rate.

Allows programming of the primary VTBI.

Starts the primary infusion.

Green LED, always lit while the device is plugged in and
the battery is charging.

Yellow LED which lights for at least 2 seconds each time
the host computer communicates with the device when the
device is in monitor mode.

20. BATTERY Icon

1-6

Yellow LED, always lit while the device is operating on
battery power.

07-19-Al-729

2 1. COMPUTER CONTROL

Legend

Yellow LED which flashes when the device is initiating
communications with a host computer to enter the com­puter control mode. It is constantly illuminated when the
device is in computer control mode.

22. CLR Key Clears any locked in values and programming values cur­rently being entered.

23. SEC START Key Starts the delivery of the secondary solution.

24. SEC VTBI Key Allows programming of the secondary VTBI.

25. SEC RATE Key

26. Numerical Keyboard

Allows programming of the secondary infusion rate.

The numerical values for rate, VTBI and time are entered
with these keys.

27. OPTIONS Key/Legend Enables the device to operate in special modes.

07-19-Al-729

1-7

General Descridion

See Figure l-2 for the location of the following items. Note that this figure shows Pump 2 only.
Pump 1 has identical features which function in the same manner.

1. Upstream Occlusion Sensor

2. Pump Mechanism

3. Tube Misloading Sensor

Detects a complete tubing restriction upstream of the pump.

Linear peristaltic pump mechanism.

Detects misloaded tubing out of the channel guide slot.

2

l-8

3

4

8

7

Figure 1-2. Pump With Door Open

07-19-Al-729

General Description

4. Downstream Occlusion Sensor Detects complete tubing restrictions downstream of the
pump.

5. Air Sensor Detects air bubbles in the IV set.

6. Safety Clamp

prevents accidental fluid flow when the IV set is properly
loaded and the pump door is opened.

7. Slide Clamp Feature Provides an additional means of preventing accidental
gravity fluid flow by occluding the tubing in the admini­stration set with the slide clamp before the set can be re­moved from the pump. The use of this feature is optional;
when used, the slide clamp must be loaded in the slide
clamp slot. The feature is selectable through the pump’s
configuration options. If alert mode is enabled, the pump
will operate without the slide clamp inserted and the

INSERT SLIDE CLAMP

message displayed. An alert tone

will sound to notify the user that the slide clamp should be

inserted. If the alarm mode is enabled (software versions

1.09 or later), the pump will NOT start and an alarm tone

will sound if the slide clamp is not loaded.

8. Spring Retainer Insert

The pump is shipped from the factory with this plastic in-

sert in the slide clamp slot. It prevents damage to the

mechanism during shipment and maintains the proper

spring tension. If your hospital does not plan on using the
slide clamp feature, Baxter recommends that this plastic in­sert remain in place during use. See Section 6.3.16.

9. Channel Guide Ridges

07-19-Al-729

Function as a guide to keep the tubing properly aligned
over the pumping fingers.

1-9

General Description

8-

Figure 1-3. Rear View

l-10

07-19-Al-729

The following items are located on the rear of the device and are shown in Figure l-3.

1. IV Pole Clamp

Secures the device to the IV pole.

2. Power Cord Strap

3. Audio Speakers

4. Battery Compartment

5. Fuse Compartment

6. Power Cord

7. PANEL LOCK Switch

8. COMMUNICATIONS PORT

Stores power cord during battery operation and device stor­age.

For generation of audible alarm and alert tones.

Allows authorized service personnel easy access to the bat­tery, EPROMS, and battery fuse.

The power cord cover must be removed to access the fuses.

Removable only by authorized service personnel.

Disables all front panel keys, except BACKLIGHT and
TOT VOWSTATUS, while the pump is running without

alerts.

The communications port contains wiring for a nurse call

jack as well as RS-232 serial communications. See the

Technical Specifications listed previously in this section.

9. VOLUME Knob

Adjusts loudness of audible alarm and alert tones. The

audible alarm cannot be turned completely off.

07-19-Al-729

l-11

General Description

1.5 Configuration Option Feature

This section describes the configuration option feature of the device, which allows qualified per-

sonnel to inspect and/or modify certain device operating parameters to suit customer require-

ments.
These parameters and their setting options are shown in Table l- 1. The factory settings made at

the time of manufacture are also shown in the table.

Note:

1.5.1 Reviewing the Configuration Option Settings

Although the configuration option data is stored in battery backed-up
RAM, it may be lost if the main battery connector (CN302) is discon­nected from the CPU board without turning off the device. The con­figuration option data is also lost if the lithium backup battery
connector (CN304) is disconnected while the main battery is discon­nected. Therefore, we advise that the configuration options be re­corded before beginning repair procedures and reset when repairs
are complete.

To view the configuration option settings, both pumps must be on and stopped. Press TIME and
TOT VOWSTATUS simultaneously for one second. The message REVlEW COW/G will be dis­played in the Pump 1 Message Display. The option description will be displayed in the first line
of the Pump 2 Message Display when the NEXT or SEC START key is pressed, beginning with

OCCLUSION.

The current setting will be displayed on the second line.

To view the next setting, press the NEXT or SEC START key. Each press of the NEXT or SEC
START key will cause the device to advance to the next setting, in the order shown in Table l-

1, starting with Occlusion Alarm Level. To exit the inspection mode, press and hold the STOP

key and the TIME key, while pressing the TOT VOWSTATUS.

1-12 07-19-Al-729

General Description

1.52 Modifying the Configuration Option Settings

1. Turn off the device.

2. Press and hold either STOP key and the PANEL LOCK switch while pressing either ON­OFF/CHARGE key. The following will occur:

a. The

Note: If the message

MODIFY CONFIG

LOCKED

message appears in the Pump 1 Message Display.

OUTis displayed, the configuration option set­tings can be changed only via computer control. See the Program­mer’s Manual for additional information.

b. The parameter descriptor appears in the first line of the Pump 2 Message Display

when the NEXT or SEC START key is pressed.

c. The current parameter setting appears in the second line of the Pump 2 Message

Display.

d. The programming displays are blank.

3. Press the NEXT or SEC START key to advance to the desired parameter. The parame­ters appear in the order shown in Table 1- 1.

4. To change the settings, enter the desired value on the front panel. The selected numeric
value will be displayed in the Pump 2 Primary Rate display until the value is locked in
by the PRI START key, or the next parameter is displayed by pressing the NEXT or

SEC START key.

Note:

The alarm log for each pump can be cleared via the configuration op­tion. See Table l-l.

5. To lock in the selected value, press the PRI START key. The selected value will then be
displayed in the Pump 2 Message Display. To move on to the next parameter, press the
NEXT key or SEC START key.

6. To exit, press the ON-OFF/CHARGE key pressed in step 2.

07-19-Al-729 1-13

General Description

Table l-l. Cod

Parameter Description

1. Alarm Log

Clear alarm/failure codes of Pump 1 or Pump 2.
Select 1 or 2 to clear the corresponding pump’s

alarm log.

2. Occlusion Alarm Level

The increase in pressure required to trigger a
downstream occlusion alarm.

3. Audible Switchover

Determines whether or not an audible alert tone will
be generated when either pump switches from the

secondary program to the primary program.

4. Number of Automatic Restarts

Determines whether or not the pump will
automatically restart after a downstream occlusion,
and if so, how many restarts can occur before the

pump will remain in alarm. If this parameter is set
to anything other than 0, it is enabled. The selected

number corresponds to the number of automatic

restarts. If set to 0, the feature is disabled.

5. Door Open Required

Determines if the pump door must be opened after
a downstream occlusion alarm. If the door is not
opened and the pump is started within two minutes
of the alarm, the pump uses the pressure at which
the alarm occurred as the baseline for the next
alarm. You may wish to set this option to force the

user to open the pump door. This action resets the

baseline and encourages the user to relieve the
downstream pressure, thereby lowering the alarm
threshold.

Example:

approximately 1 p.s.i. and the occlusion alarm is
set to LEVEL 1 or approximately 7 p.s.i. The first

alarm will occur at approximately 1+7 or 8 p.s.i.
This value represents the baseline pressure that
will be used to calculate the next alarm unless the
door is opened, the downstream pressure is

relieved, and a new baseline is set.

6. Air Bubble Alarm Size

Determines the air bubble size which will cause an
AIR alarm.

7. Alarm Off Interval

Sets the number of seconds between each
occurrence of the three-beep alarm tone.

Suppose the initial pressure is

guration Options

Setting Options

1: LEVEL
2: LEVEL

3: LEVEL

1: OFF

2: ON

o-9

1:

OFF

2: ON

1:

MIN (average 50 pL)

2: NORM (average 75 uL)

l-7 1

1 (approx. 7 psi)
2 (approx. 12 psi)
3 (approx. 17 psi)

.

Factory
Settings

WA

-EVEL 1

3FF

3

3FF

-

VORM

-

1-14

07-19-Al-729

Table l-l. Configuration Options

Parameter Description Setting Options ,

8. Alert Off Interval

Sets the number of seconds between each
occurrence of the one-beep alert tone.

9. Maximum Rate of Infusion

Sets the maximum programmable primary infusion
rate of both pumps. When the maximum primary
rate is 999 or higher, the maximum secondary rate
is 999. At values below 999, the maximum
secondary rate matches the value of the maximum
primary rate.

10. Maximum VTBI

The maximum volume that either pump can be
programmed to infuse.

11. Flow Check Display

Determines whether the flow check display will
appear during pump operation, or only when the
decimal point key and TOT VOUSTATUS keys are
pressed simultaneously.

12. Baud Rate

Determines the baud rate for normal 2: 1200
communications between the device and a 3: 2400
computer. The baud rate is 9600 when the device 4: 4800
is in modify configuration mode. 5: 9600

13. Computer Control

Determines the type of computer control option
available at power up. The pump will drop out of remote

14. Hospital Area Designator

Determines the hospital area designator to be 1: NICU
displayed upon power ON for 3 seconds. These

messages

communications feature.

can be redefined using the computer

15. Close C/amp Message

Determines whether or not the CLOSE CLAMP
message appears with the DOOR OPEN message.

1-7

1 - 1999 mUhr 1999 mUhr

1 - 9999 mL 9999 mL

1: OFF

2: ON

1: 300

1:

Disabled

2: Off with Alarm

control when an alarm occurs.

3: On with Alarm

The pump will remain in remote

control when an alarm occurs. See

the Programmer’s Manual for

additional information.
0: HAD (no message) no message

2: PICU

3: MED/SURGICAL
4: TRAUMA/BURN UNIT
5: OPER ROOM
6: CARDIAC/ICU
7: SURGICAUICU
8: ICU
9: ONCOLOGY

1: OFF ON
2: ON

Factory
Settings

7

OFF

9600

Disabled

07-19-Al-729

1-15

General Description

Table l-l. Conf

~ Parameter Description

~~ 16. insert Clamp Message
Ii

Determines whether or not the slide clamp loading

feature is enabled. The spring retainer must be re­,~ moved when this feature is enabled. See Sections
;~6.3.14 and 6.3.15.
1 Note: The alarm option is available only on
‘! pumps running software versions 1.09 or later.

17. Programmed Delivery Profile

i Determines the memory to store the programmed

delivery profile.

/I

18. Time Setting

Set the real time clock in hours and minutes.

r

,‘(military time 0O:OO - 23:59)

19. Date Setting

1 Set the date usina the MonthlDav/Year format.

guration Options

Setting Options

4

1: OFF (The spring retainer should
be installed.)
2: ON for software versions earlier

than 1.09 or ALERT for 1.09 or

later (An audible alert occurs and

the message INSERT SLIDE

CLAMP is displayed. The pump
continues pumping.
3: ALARM (An audible alarm
occurs and the message INSERT
SLIDE CLAMP is displayed. The
pump will not operate.)

1: Disabled
2: 5 hour memory
3: Semi-permanent memory
4: Permanent memory

Factory
Settings

OFF

­l

Iisabled

t

(

Zentral

!

standard
Time - CST

(

Current date -

(

XT

I

-

1-16

07-19-Al-729

General Description

1.6 Alarms

The device has a number of built-in safety features. Should a situation occur which requires op­erator attention or intervention, the pump stops infusing and sounds an audible alarm. The fol­lowing are brief descriptions of these alarms.

AIR

An ultrasonic sensor in each pump head detects air in the administration set. Detection of an

air bubble stops the infusion and illuminates the red ALARM LED.

propriate Message Display and the audible alarm is activated.

AIR

is displayed in the ap-

OCCLUSION

The downstream occlusion sensor senses an increase in back-pressure between the
patient and the pump, indicating an occlusion or closed clamp. When an occlusion is sensed, the
pump stops,

OCCLUSloN

is displayed in the appropriate Message Display, the red ALARM

LED is illuminated and the audible alarm is activated.

UPSTREAM OCCLUSION

blockage upstream of the pump. When sensed, the pump stops,

The upstream occlusion sensor senses a closed clamp or complete

UPSTREAM OCCLUSION

is dis­played in the Message Display, the red ALARM LED is illuminated, and the audible alarm is ac­tivated.

BATTERY LOW

tion,

BArrERY

When approximately 15 minutes of running time remains during battery opera-

LOWis

displayed in both Message Displays, the yellow ALERT LEDs are illumi-

nated, and the audible alert is activated. After approximately 15 minutes, the device stops,

BATTERY

LOWis

displayed on both Message Displays, the red ALARM LEDs are illuminated,

and the audible alarm is activated.

Table l-2 lists the alarms and the possible causes of each. In all cases, fluid infusion is halted.

See Section 5 for an explanation of how to troubleshoot the device.

07-19-Al-729 1-17

General Description

Table 1-2. Alarm Messages

Alarm Message

4/R

3CCLUSION a. Closed distal clamp, stopcock, clogged filter, kinked tubing or

YPSTREAM OCCLUSION a. Closed clamp or other blockage upstream of the pump.

3OOR OPEN

‘A/LURE with code number Turn the pump power off and back on to reset. If FAlLlJRE

COMMON FAILURE with code
lumber

3ATTERY LOWwith rapid three­beep alarm tone

:HECK SET LOADING The tubing is pinched between the pump head door and base

:OM TIMEOUT There has been no communication between the device and the

:XT COMM ERROR The controlling computer is sending multiple queries or

INSERT SLIDE CLAMP

qote: This alarm option is
available only on pumps
unning software versions 1.09
)r later.

Possible Cause

a. Air bubble at sensor.
b. Empty fluid container.
c. Improper set loading.
d. A

START

other blockage downstream of the pump.
b. Ambient and/or solution temperature is too low.

b. Pinched or kinked tube loaded in the pump.
c. Improper set loading.

Door must be fully closed with tubing properly loaded for the
pump to operate. The door latch must be pushed down

completely.

does not clear, the microprocessor has detected a pump

malfunction. After recording the code number, remove the
device from use and have it serviced. See Section 5 for more
detailed service instructions.

Turn both pumps off and back on to reset. If FAILURE does not
clear, the microprocessor has detected a device malfunction.
After recording the code number, remove the device from use
and have it serviced.

Battery power has been exhausted. Plug device into AC outlet
immediately to restore operation.

plate. Load set properly in the IV set loading path.

computer for the specified time period. Check for a
disconnected cable or computer problem. To clear this alarm,
press the OPTIONS key to return the device to computer
control, or press SILENCE or PUMP 1 or PUMP 2 to use the
pump(s) without the computer.

commands to the device without waiting for the device’s replies.
The condition has been caused by the computer, not the
device. To clear the alarm, press the

the device to computer control, or press

or

PUMP

personnel responsible for the computer. If the alarm recurs,

disconnect the cable from the communications port. Reprogram
the pump(s) for manual operation.

The slide clamp loading option is enabled and the slide clamp is

not loaded in the slide clamp slot. To clear this alarm, open the
pump door and insert the slide clamp into the slot. Close the

door.

key was pressed with no set in pump.

OPTIONS

SILENCE

2 to control the pump(s) manually. Notify the technical

key to return

or

PUMP 1

1-18

O-7-19-Al-729

General Description

1.7 Alerts

Alert messages call attention to a condition which will require operator intervention in the near
future, or indicate that a procedure has been initiated which requires that the operator complete a
sequence of keystrokes. These alerts are generally cleared by the operator taking the appropriate
action.

Table l-3 lists the various alerts and possible causes.

Table 1-3. Alert Messages

Alert Message LED

STOPPED Yellow

KVO
PRI VTBI = 0 Yellow pump has switched to 5 mL/hr KVO rate (or

NEW RA TE Green, No change PRI or SEC Primary or Secondary flow rate is being

PRI RATE = 0

BATTERY LOW Green,
with intermittent Yellow
audible alert

SEC PRO- Green,

GRAM

SEC RATE = 0

SEC VTBl= 0 Yellow

SEC COM- Yellow
PLETE

FLOW RATE Yellow

CHECK VTBI Yellow

Green, KVO rate None Primary VTBI has been delivered and the

Yellow until RATE changed while pump is running. Pump will

Yellow No flow PRI or SEC The pump cannot be started without

Yellow

Yellow

Flow Status Key

Pressed

No flow None

procedure is not exit this alert condition until the
completed appropriate START key is pressed.

START enterina a orimarv flow rate.

No change

No change

No flow

No flow

No change

No flow

No flow

None Battery needs recharging. The device will

SEC RATE
or SEC VTBI

SEC START

SEC START A secondary (piggyback) infusion cannot be

None

PRI or SEC Enter a rate within the range selected
START through the configuration option. The pump

PRI or SEC The pump cannot be started when Hi is
START displayed in a VTBI display. Enter a VTBI

Alert Condition

Either pump has been left in the STOPPED
mode for more than two minutes.

programmed rate, whichever is lower).

stop operating in approximately fifteen

minutes or longer unless it is plugged into

an AC source.
Secondary (piggyback) information is being

programmed into a pump while it is running.

Pump will not exit this alert condition until

SEC START is pressed.
A secondary (piggyback) infusion cannot be

started unless a secondary flow rate is input

started unless a secondary volume to be
infused has been input.

The pump has completed infusing the
secondary VTBI and has switched over to
the primary infusion settings. Pump will not
exit this alert condition until any enabled
key is pressed.

cannot be started when Hior Lo is
displayed in a rate display.

within the range selected through the
confiauration option.

07-19-Al-729

1-19

General Description

r

Alert Message LED Flow Status

INSERT SLIDE
CLAMP

COM
TIMEOUT

EXT COMM
ERROR

PGM DELIV
ENTER PGM

PGM DELIV
SEVIE W PGM

PGM DELIV
CLEAR ALL?

fellow 40 flow or

fellow lo change or

/ellow lone 40 change

fellow ‘RI or SEC

fellow Jo flow ‘RI or SEC

Yellow 10 flow

Table 1-3. Alert Messages

low if started

IO flow

Jo flow

Key

Pressed

Closed door,
‘RI or SEC
START

rlone

START

iTART

ZLR

Alert Condition

Slide clamp is not loaded into the slide
clamp slot although the set is loaded into
the pump.

Communication timeout period has elapsed.
No communication has occurred between
the device and the host computer during the
power-up default time period (60 seconds)
3r during the time period most recently
specified by the host computer (l-300
seconds). The computer and the device
must maintain periodic and successful
communication in order to avoid this
timeout alert. See the Programmer’s
Manual for further information.

The controlling or monitoring computer is
sending multiple queries or commands to
the device without waiting for the device’s
replies. The condition has been caused by
ihe computer, not the device. To clear the
alert, press OPTIONS to return the device
io computer control (if appropriate), or press
SILENCE or PUMP 1 or PUMP 2 to control
the pump(s) manually. Notify the technical
Dersonnel responsible for the computer. If
the alert recurs, disconnect the cable from
ihe communications port. Reprogram the
Dump(s) for manual operation.

4n attempt was made to start the PDP
Defore a program was entered. Enter a
xogram or press OPTIONS to leave the
PDP mode.

4n attempt was made to star-l a PDP profile
xior to reviewing all the programmed steps.

?ress NEXT until the first step is again

displayed, or press OPTIONS to leave the

PDP mode.

The CLR key was pressed after entering
the PDP mode to clear all steps. Do one of
the following: press CLR to erase the
profile; press NEXT to review the rest of the
profile; press PRI RATE or PRI VTBI to
modify this step; press OPTIONS to leave
the PDP mode.

l-20

07-19-Al-729

Section 2

Hospital Service Procedures

This section contains a table describing preventive maintenance performed on Flo-Gard@ 6301
Dual Channel Volumetric Infusion Pump in the hospital. The maintenance procedures outlined
in this section may be performed in the hospital. If an abnormal condition occurs which is not
correctable by performing the following procedures, remove the device from service and trou­bleshoot it in accordance with Section 5, or return it to Product Service for repair.

2.1 Replacement Of Main Power Fuse

1. Plug the device into an AC power outlet.

2. Check if the Plug Icon is illuminated.

3. If it is not, replace the fuse. Remove the power plug from the AC power outlet.

Remove the power cord cover on the back of the device, and unscrew the fuse caps with

4.
a small screwdriver.

5. Remove the fuses and check them for electrical continuity with an ohmmeter.

6. If necessary, replace with a new fuse of the same value, type and voltage.

7. Replace and tighten the fuse caps with a screwdriver. Over tightening the fuse caps

may cause the fuse holders to break.

8. Replace the power cord cover.

9. Perform the Electrical Safety Test to verify proper grounding impedance. See Section

7.3.13.

2.2 Cleaning

The device should be cleaned as soon as possible after each use to minimize the accumulation
and hardening of spilled solutions. The case and front panel may be cleaned with a soft cloth or
cotton swabs dampened with a properly diluted cleaning agent listed in Table 2- 1.

07-19-Al-729

2-1

Hospital Service Procedures

Be sure to follow the manufacturer’s dilution instructions for concentrated cleaners where appli­cable. Do not spray cleaning agents directly onto the inside of the pump door, the pump mecha­nism, and the front panel film. If these areas require cleaning, wipe carefully with a soft cloth,
sparingly dampened with a cleaning agent listed in Table 2-l. If solution spillage onto the pump­ing mechanism or front panel occurs, it should be cleaned immediately. If necessary, contact
Product Service at I-(800)-THE-PUMP.

Caution: Attempts to clean or disinfect internal parts, autoclaving or steriliza-

tion by ethylene oxide gas will damage the device and void the war­ranty.

Caution: The following chemicals may damage the plastic front panel and tube

misloading sensors: Acetoldehyde, Acetone, Ammonia, Benzene, Hy­droxytoluene, Methylene Chloride, n-Alkyl Dimethyl Ethyl Benzyl

Ammonium Chloride, and Ozone.

For a device that has been in an Isolation Area, select those agents from Table 2-l that both
clean and disinfect. Only external parts of the device should be disinfected. The following are
procedures for cleaning accessible areas of the device. Do not use hard instruments for clean­ing.

1. Lift the door latch to the open position. Open the door and press the safety clamp latch
until it locks in the open position.

2. Using a cotton swab dampened with one of the agents listed in Table 2- 1, clean all tub­ing guides and tubing channels from the top of the pump to the exit point below the

safety clamp. Clean all surfaces in the pump head which may contact the tubing.

3. Clean all surfaces of the air sensor located just above the safety clamp. This area must be
completely dry and free of foreign matter prior to reuse.

2-2

07-19-Al-729