Baxter Flo-Gard 6201 User manual

DIVISION OR FUNCTION: MEDICATION DELIVERY DOCUMENT NO: 07-19-01-905 REV. C

OWNING GROUP: IS ENGINEERING CHANGE NO: CP0190218

DOCUMENT TYPE: DIRECTION SHEET ISSUE DATE: 09/21/2007

FOR APPROVALS: 1143067 OWNER CODE: HD1 PAGE: 1 of 12

2M8063 FLO-GARD 6201 INFUSION PUMP REPAIR SPEC, JCAHO CERTIFICATION, PREVENTIVE MAINTENANCE CHECK LIST

________________________________________________________________________

1.0 Purpose

This is a recommended procedure for customers to verify proper

operation of a 2M8063, FLO-GARD 6201 Infusion Pump after repair. This procedure is also for customers and Baxter field service personnel for preventive maintenance checks. This may also be used to comply with JCAHO recommendation of safety and performance testing.

If any failures are found during this inspection, the device

should be repaired prior to placing it back into service.

2.0 Equipment

- Hemostat (Optional)

- Stopwatch or timer calibrated to range of 0-15 min. with a resolution of at least 1 second

- Balance or scale with resolution of 0.1 g calibrated to at least a range of 0 to 500 g.

- ASTM Class A 25 mL graduated cylinder with increments of 0.2 mL tc (to contain)

- Baxter standard S-Suffix set such as 2C5545s with the new (dark blue) slide clamp design

- Occlusion calibration thickness gauge (Part No. UKOG1013.B)

- Safety analyzer which can accurately measure ground resistance of 0.5 ohm and current leakage of 50 microamps

- Gas Tight Syringe (Part No. S9662-81)

- 20 gauge needle (Part No. S9670-1) or catheter

- Old style (light blue) slide clamp (Part No. 020416132)

- E-ring remover

- New style (dark blue) slide clamp (Part No. 030216490)

3.0 Calibration Verification and Display Tests

3.1 Calibration Verifications In Mode 1

With the device powered OFF, press and hold both CLEAR TOT VOL and

"1" keys simultaneously, then press the ON/OFF CHARGE key (both CLEAR TOT VOL and "1" keys must remain pressed for at least 3 seconds). Place the occlusion calibration thickness gauge (Part No. UKOG1013.B) alternately in the upstream and downstream occlusion sensors of the pump with the device connected to AC power. (Multiple gauges can be used at the same time.)

1. Upstream Occlusion

Verify the value displayed in the PRI RATE location (upper

left of pump's main display). Value must be 3242 to 3314. Record value and check PASS or FAIL on the data sheet.

BAXTER and FLO-GARD are registered trademarks of Baxter International Inc.

DIVISION OR FUNCTION: MEDICATION DELIVERY DOCUMENT NO: 07-19-01-905 REV. C

OWNING GROUP: IS ENGINEERING CHANGE NO: CP0190218

DOCUMENT TYPE: DIRECTION SHEET ISSUE DATE: 09/21/2007

FOR APPROVALS: 1143067 OWNER CODE: HD1 PAGE: 2 of 12

2M8063 FLO-GARD 6201 INFUSION PUMP REPAIR SPEC, JCAHO CERTIFICATION, PREVENTIVE MAINTENANCE CHECK LIST

________________________________________________________________________

2. Downstream Occlusion

Verify the value displayed in the PRI VTBI location (lower

left of pump's main display). Value must be 2967 to 3039. Record value and check PASS or FAIL on the data sheet.

3. Main Battery

Verify the value displayed in the SEC RATE location (upper

right of pump's main display). Value must be 688 to 714. Record value and check PASS or FAIL on the data sheet.

4. Backup Battery

Verify the value displayed in the SEC VTBI location (lower

right of pump's main display). Value must be 574 to 737. Record value and check PASS or FAIL on the data sheet.

3.2 Calibration Verifications In Mode 2

With the device powered OFF and connected to AC power, press and

hold both CLEAR TOT VOL and "2" keys simultaneously, then press the ON/OFF CHARGE key to access Test Mode 2. (Both CLEAR TOT VOL and "2" keys must remain pressed for at least 3 seconds).

1. NORM and MIN Air Sensor Calibrations With Primed Tubing:

Load a primed tubing segment such as 2C5545s, spliced into the

middle of an S-suffix set, into the pump head and close the door. Open and close the pump head door two more times and wait 2 minutes for the readings to stabilize. View the NORM value displayed in the PRI RATE location (upper left of pump's main display). Next, view the MIN value displayed in the PRI VTBI location (lower left of pump's main display). Both values must be 330 to 565. Record values and check PASS or FAIL on the data sheet.

2. NORM and MIN Air Sensor Calibrations With Air Filled Tubing:

Remove the primed tubing and load an unprimed calibration

tubing segment and close the door. Open and close the pump head door two times and wait 2 minutes. View the NORM and MIN air sensor values. Both values must be less than 11. Record values and check PASS or FAIL on the data sheet.

3. NORM and MIN No Tube Air Sensor Values

Remove the empty tubing and close the door. View the NORM and

MIN air sensor values. Both values must be less than 40. Record values and check PASS or FAIL

on the data sheet.

BAXTER and FLO-GARD are registered trademarks of Baxter International Inc.

DIVISION OR FUNCTION: MEDICATION DELIVERY DOCUMENT NO: 07-19-01-905 REV. C

OWNING GROUP: IS ENGINEERING CHANGE NO: CP0190218

DOCUMENT TYPE: DIRECTION SHEET ISSUE DATE: 09/21/2007

FOR APPROVALS: 1143067 OWNER CODE: HD1 PAGE: 3 of 12

2M8063 FLO-GARD 6201 INFUSION PUMP REPAIR SPEC, JCAHO CERTIFICATION, PREVENTIVE MAINTENANCE CHECK LIST

________________________________________________________________________

4. Right and Left Force Sensing Resistor (FSR) Voltage

View the value displayed in the SEC RATE location (upper right

of pump's main display). View the value displayed in the SEC VTBI location (lower right of pump's main display). Both values must be 500 to 820. Record values and check PASS or FAIL on the data sheet.

3.3 Display Check In Mode 5

With the device powered OFF, press and hold both CLEAR TOT VOL and

"5" keys simultaneously, then press the ON/OFF CHARGE key (both CLEAR TOT VOL and "5" keys must remain pressed for at least 3 seconds). Verify that all segments appear. Check PASS or FAIL on the data sheet.

Note: All the LCD segments, LEDs and icons turn on sequentially

for a visual check each time the STOP key is pressed. At any point in the sequence the SEC START key may be pressed to return to the beginning of the sequence.

4.0 Standard Functional Tests

4.1 Software Version

With the pump powered OFF, press and hold the SILENCE key, then

press the ON/OFF CHARGE key.

Record the software version number displayed in the secondary VTBI

display on the data sheet.

4.2 Self Test

With the device disconnected from AC power and the device powered OFF, press the ON/OFF CHARGE key to power it ON. Then verify that:

1. AT BEGINNING OF SELF TEST:

- All LEDs turn on. All segments of the message display and all segments of the main display must turn on. All backlighted icons are turned on except for the plug icon.

- The main buzzer will turn on and change tone while all segments of the displays are on.

- The backup buzzer will turn on after the main buzzer turns off.

- When the backup buzzer turns off, all LEDs will turn off.

BAXTER and FLO-GARD are registered trademarks of Baxter International Inc.

DIVISION OR FUNCTION: MEDICATION DELIVERY DOCUMENT NO: 07-19-01-905 REV. C

OWNING GROUP: IS ENGINEERING CHANGE NO: CP0190218

DOCUMENT TYPE: DIRECTION SHEET ISSUE DATE: 09/21/2007

FOR APPROVALS: 1143067 OWNER CODE: HD1 PAGE: 4 of 12

2M8063 FLO-GARD 6201 INFUSION PUMP REPAIR SPEC, JCAHO CERTIFICATION, PREVENTIVE MAINTENANCE CHECK LIST

________________________________________________________________________

2. DURING SELF TEST:

- The main display remains off until the end of self test.

- The message display sequence is as follows:

Hospital Area Designator - if device is configured with

options 1-9),

OCCLUSION LEVEL 1, 2, or 3 AUDIBLE SWITCHOVER if configured ON, and then AUTO RESTART if configured with options 1-9, and FLOW

CHECK if configured ON.

Note: Options configured in the pump will determine what may

appear on the display during self test.

3. AT THE END OF SELF TEST:

- The main display should show the following:

PRI RATE (ML/HR) 0 PRI VOLUME (ML) TO BE INFUSED 0

Non zero PRI and/or SEC rates and VTBIs may appear if still

retained in the five hour memory.

- The message display should show the following:

STOPPED

- BATTERY LOW alarm must not be activated.

- Battery icon must be lit.

- Reconnect the device to AC power. Verify that the plug icon is lit and that the battery icon is OFF.

Leave the device connected to AC power whenever possible.

Check PASS or FAIL

on the data sheet.

4.3 Record the Configuration

Enter the Review Configuration mode.

1. Power ON the device.

2. Press the TIME and TOT VOL STATUS keys simultaneously and hold for 1 second.

3. The Message display should show "REVIEW CONFIG".

4. If the device does not show the above message, repeat step 2 above.

BAXTER and FLO-GARD are registered trademarks of Baxter International Inc.

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