Flo-Gard Model 6201 Operators Manual Rev D 1999

Table of Contents Introduction ...1 Physical Description...3 Operating Instructions ...10 Precautions ...10 Loading the Pump ...11 Starting a Primary Infusion ...14 Starting a Secondary Infusion ...17 Using Volume-Time Programming ...18 Changing the Flow Rate While the Pump Is Running ...20 The OPTIONS Key ...21 Using the Manual Programmed Delivery Profile ...21 Using the Ramp Programmed Delivery Profile ...24 Computer Control...29 Computer Monitoring...30 Locking the Front Panel...30 Battery Powered Operation ...31 FLOW CHECK Information Display...31 Cleaning and Storage ...32 Alerts and Alarms ...33 Technical Specifications ...38 Configurable Options ...40 Warranty and Service Information ...45 Warranty ...45 Service Information ...46

Change record 7-19-01-602 Original issue: 4/92 Rev. A: 6/92 Rev. B: 4/93 Rev. C: 11/94 Rev. D: 3/99 Page

Revision

Front cover i ii 1 2–11 12 13–14 15–38 39 40–46 Back cover

0 B D B 0 B 0 B C B D

A zero in the “Revision” column indicates original issue.

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Rev. D

Introduction The Flo-Gard® 6201 Volumetric Infusion Pump from Baxter can deliver a wide variety of fluids over a broad range of infusion rates. Its features include: •

Uses only standard Baxter solution administration sets.

•

Configurable settings allow the pump to be customtailored to best suit the hospital's needs.

•

Computer control capability allows remote control or monitoring of the Flo-Gard® 6201 pump via a standard RS232-C interface.

•

Pumps a wide variety of fluids, including blood and fat emulsions.

•

Suitable for use in epidural administration.

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Safety clamp automatically occludes the tubing when the pump door is opened.

•

Occlusion sensors detect both upstream and downstream restrictions. Sensitivity of the downstream occlusion sensor is selectable through the pump's configuration.

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Flow check display shows resistance to flow.

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Ultrasonic air-in-line detector. Sensitivity of the air detector is selectable through the pump's configuration.

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The Programmed Delivery Profile (PDP) enables manual programming or ramped calculation of up to 10 sequential infusion programs for situations where multiple flow rates are indicated.

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Slide clamp loading option provides flow shutoff when I.V. set is removed from the pump.

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Locking control panel helps prevent patient tampering.

Rev.B 1

2

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An independent secondary medication program. The pump automatically switches over to the primary program upon completion.

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Volume-Time programming automatically calculates flow rate.

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Automatic self-test routine checks for proper function before use.

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Five-hour memory retains infusion data after power-off.

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Easily replaceable fuse, battery, and power cord.

Physical Description All front panel items are shown in Figure 1.

Front Panel ITEM

FUNCTION

1. Message display

Shows all alarm and alert messages.

2. BACK LIGHT key

Backlights the displays when pressed. Pressing the key again turns the backlight off. If the pump is running on battery power, the backlight remains on for 60 seconds each time the BACK LIGHT key is pressed.

3. SILENCE key

Temporarily silences an audible alarm or alert for two minutes, unless another alarm occurs within the two minute silence period. All messages remain displayed until the cause of the alarm or alert is alleviated.

4. NEXT legend

Lights when the TOT VOL/STATUS key is functioning as the NEXT key.

5. TOT VOL/STATUS key

Displays total volume delivered when pressed. The key is also used to advance to the next step when programming a delivery profile. (See NEXT legend, item 4 above.)

6. CLEAR TOT VOL key

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

7. TIME key

Enters the time over which an infusion is to take place during Volume-Time programming.

8. STOP key

Stops the pump until further instructions are given. The message STOPPED appears when the key is pressed. An alert will sound if the pump is stopped for more than two minutes. Clears all programming alerts while pump is running.

9. Door latch

Opens and closes pump door for I.V. set loading and removal.

10. ON-OFF/CHARGE key

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

11. Battery icon

Lights when the pump is operating on battery power.

12. Plug icon

Always lit when pump is plugged in and battery is charging.

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1

3

2

4

5

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26 8 25

BACK LIGHT ALARM

PUMPING

ALERT

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SILENCE

NEXT TOT VOL STATUS

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9

CLEAR TOT VOL

22 21 20 19

PRI RATE

PRI VTBI

PRI START

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8 5 2

9 6 3

0

CLR

SEC RATE

SEC VTBI

SEC START

OPTIONS

P U S H

TIME

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STOP

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ON OFF CHARGE

COMPUTER CONTROL

MONITOR

Flo-Gard® 6201 VOLUMETRIC INFUSION PUMP

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Figure 1. Front View

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10

Front Panel ITEM

FUNCTION

13. MONITOR legend

Lights when the pump is being monitored by a computer.

14. COMPUTER CONTROL legend

Lights when the pump is being controlled by a computer.

15. SEC START key

Starts the delivery of the secondary solution.

16. SEC VTBI key

Allows programming of the secondary VTBI.

17. OPTIONS key

Allows a computer to control the pump and permits use of the Programmed Delivery Profile (PDP). If Computer Control and/or PDP are available, the OPTIONS key is lit.

18. SEC RATE key

Allows programming of the secondary infusion rate.

19. CLR key

Clears any programming values currently being entered.

20. Numerical keypad

Programming values and decimal point are entered with these keys.

21. PRI VTBI key

Allows programming of the primary VTBI.

22. PRI RATE key

Allows programming of the primary infusion rate.

23. PRI START key

Starts the primary infusion.

24. Main display

Shows rate, volume to be infused (VTBI) and total volume infused for primary and secondary infusion programs. The decimal point is displayed as an underscore (example: 99_9).

25. ALARM LED

Red LED that blinks during an alarm, accompanied by a message display and a repeated sequence of three tones. An alarm indicates that the pump requires immediate attention.

26. PUMPING LED

Green LED which is constantly lit during pumping.

27. ALERT LED

Yellow LED illuminates during alert conditions, accompanied by a message display and a repeated single tone. An alert indicates that the pump needs timely attention.

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The pump head features are shown in Figure 2.

Pump Head Features ITEM

6

FUNCTION

1. Upstream occlusion sensor

Detects a complete tubing restriction upstream of the pump.

2. Pumping fingers

The linear peristaltic pump mechanism consists of cam-driven pumping fingers which successively manipulate the tubing against the backplate, resulting in fluid movement in a downward direction.

3. Downstream occlusion sensor

Detects tubing restrictions downstream of the pump. The sensitivity level can be adjusted to suit the needs of the hospital through the pump's configuration.

4. Air sensor

Detects air bubbles in the tubing. The sensitivity is adjustable via the pump's configuration.

5. Safety clamp

Prevents accidental fluid flow by automatically occluding the tubing whenever the pump door is opened.

6. Slide clamp slot

When the slide clamp loading option is enabled, the I.V. set's slide clamp must be inserted into this slot. The operator must push the slide clamp into the slot to occlude the tubing before the I.V. set can be removed from the pump. The slide clamp loading option is selectable through the configuration.

7. Slide clamp spring retainer

If your hospital has not selected the slide clamp loading option, this spring retainer will be inserted into the slide clamp slot, preventing the insertion of the slide clamp into the slot.

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2

3

4

5 6 7

Figure 2. Pump Head Features

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The following items are located on the rear of the pump and are shown in Figure 3.

Rear Panel Features ITEM

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FUNCTION

1. I.V. pole clamp

Secures the pump to the I.V. pole.

2. Power cord strap

Stores the power cord.

3. Audio speakers

For generation of alarm and alert tones.

4. Battery compartment

Allows access to the battery by authorized service personnel only.

5. VOLUME knob

Adjusts volume of alert and alarm tones. The alarm and alert tones cannot be turned completely off.

6. PANEL LOCK switch

Disables all front panel keys except BACK LIGHT and TOT VOL/STATUS when pressed.

7. Power cord

Supplies AC power to the pump when plugged into hospital-grade earth-grounded outlet. Removable by authorized service personnel only.

8. Fuse

Fuse compartment is located behind power cord retention strain relief plate.

9. COMMUNICATIONS PORT

Standard RS-232C port that allows the pump to communicate with a computer.

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4 9 COMMUNICATIONS PORT

VOLUME

PANEL LOCK (PUSH)

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8

5

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Figure 3. Rear of Pump

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Operating Instructions

Precautions General

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•

DANGER-Possible explosion hazard if used in the presence of flammable anesthetics.

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Operate pump from 115 V, 60 Hz, hospital-grade earth-grounded outlet only.

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Though the factory-supplied configuration settings are suitable for most therapies, the operator and hospital professionals should verify that the pump's settings are appropriate for their clinical applications.

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Use only with standard Baxter soft tubing administration sets with an “s” designation.

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Read and understand this manual before using the Flo-Gard® 6201 pump.

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When infusing fluid through a central line catheter, Baxter recommends that sets with a Luer lock adapter be used.

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If using a filter set, use only filters which are suitable for use with infusion pumps. Read and follow instructions of the filter to be used.

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To use the automatic piggyback function, use only Continu-Flo® sets from Baxter as the primary line with a compatible secondary set for the secondary line.

Epidural Administration • Epidural administration of anesthetics is limited to short-term infusion (not to exceed 96 hours) with indwelling catheters specifically indicated for shortterm anesthetic epidural drug delivery. •

Epidural administration of analgesics is limited to use with indwelling catheters specifically indicated for either short-term or long-term analgesic epidural drug delivery.

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To prevent infusion of drugs that are not indicated for epidural use, do not use administration sets that incorporate injection sites during epidural delivery.

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It is strongly recommended that pumps used for epidural drug delivery be clearly differentiated from pumps used for other routes of administration.

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WARNING-Epidural administration of drugs other than those indicated for epidural use could result in serious injury to the patient.

Loading the Pump 1. Plug the pump in.

Plug power cord into a 115 V, 60Hz grounded outlet, unless temporary battery power is required. The plug icon lights whenever the pump is plugged in. When the pump is not plugged in and is battery-powered, the battery icon will light.

2. Prepare solution.

Prepare fluid container and administration set according to the directions accompanying the products. Prime the set. Ensure all air is expelled from the set.

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3. Close set regulating clamp. 4. Open pump door.

Raise pump door latch to horizontal position and pull door open.

5. Load the set.

a. Press SAFETY CLAMP to open position. b. If your hospital has enabled the slide clamp loading feature, insert the slide clamp on the I.V. set fully into the slot, so that it is flush with the pump housing. (See Figure 4.) If the slide clamp loading feature is not enabled, a black spring retainer occupies the slide clamp slot and the slide clamp cannot be inserted. Proceed to step c.

Note:

During an emergency, in the alert mode, the pump will operate without inserting the slide clamp. An alert tone will sound until the slide clamp is inserted or the SILENCE key is pressed. In the alarm mode (software versions later than 1.08), the pump will NOT start and an alarm tone will sound if the slide clamp is not loaded.) c. Load the tubing through the guide channel from bottom to top as shown in Figure 4. d. Ensure that the tubing is loaded straight through the pump mechanism tubing guides and safety clamp. e. Ensure that the tubing is touching the pumping fingers before closing the pump door.

Slide clamp in slot Figure 4. I.V. Set Loading

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Rev.B

6. Close pump door.

If resistance is felt when closing the door, check for misloaded I.V. set.

7. Open set regulating clamp completely.

a. Verify that no drops are falling in drip chamber. If flow is observed, close regulating clamp, recheck I.V. set loading and verify that the proper administration set is being used. b. If flow is again observed, do not use the pump. Have it inspected by service personnel.

Note:

Always close the administration set regulating clamp(s) before opening pump door and removing set.

8. Attach set to I.V. access site. 9. Turn pump on by pressing the ON/OFF CHARGE key. Verify that the pump performs the following self-test:

a. All segments of both displays appear momentarily.

b. Three separate audible tones sound. c. If a Hospital Area Designator (HAD) has been programmed into the pump, it appears for 3 seconds. d. The occlusion detection level is momentarily displayed in the message display (LEVEL 1, 2, or 3), followed by AUDIBLE SWITCHOVER if the Audible Switchover option is enabled. e. If Auto Restart and Flow Check are both enabled, the message AUTO RESTART appears for one second following the occlusion detection level display.

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f.

If the pump is plugged into an AC outlet, the plug icon is lit. If the pump is running on battery power, the battery icon is lit.

g. If the message INSERT SLIDE CLAMP appears when you close the door, the slide clamp loading option is enabled. Close the I.V. set's regulating clamp, open the door, and insert the I.V. set's slide clamp fully into the slide clamp slot located below the safety clamp. Close the door and open the regulating clamp. 10. Set VOLUME knob on the rear of the pump to the desired level.

Starting a Primary Infusion 1. Set primary flow rate as follows:

a. Press PRI RATE. b. Program desired flow rate (in mL/hr) on keyboard. Zero cannot be entered as the first digit. c. A selected flow rate higher than the allowable maximum results in the message Hi appearing in the PRI RATE display. To correct a mistake, press CLR or PRI RATE again and reenter correct rate. The flow rate is displayed in the main display.

2. Set primary volume to be infused.

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a. Press PRI VTBI.

b. Program desired VTBI (in mL) on keyboard. Set VTBI equal to the amount of fluid in the container or less if desired. c. To correct a mistake, press CLR or PRI VTBI again and re-enter the correct VTBI. The VTBI is displayed in the main display. 3. If necessary, reset the volume previously infused to zero.

Note:

Press the CLEAR TOT VOL key.

Always verify programmed information prior to starting the pump.

4. Start the pump.

a. Press PRI START. The green PUMPING LED lights and a moving bar appears next to the flow rate setting. b. If the alarm (software versions later than 1.08) or the alert tone sounds with the message INSERT SLIDE CLAMP when you press PRI START, the slide clamp loading option is enabled and the slide clamp has not been loaded into the slide clamp slot. Close the I.V. set's regulating clamp, open the door, and insert the I.V. set's slide clamp fully into the slide clamp slot located below the safety clamp. Close the door and open the regulating clamp. c. Confirm flow by checking for drops in the I.V. set drip chamber.

5. To stop an infusion before it is complete:

Rev.B

a. Press the STOP key.

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b. The PUMPING LED goes out and STOPPED appears in the message display. c. If the pump is not restarted within two minutes, an audible alert sounds. 6. To restart an infusion, press the PRI START key. 7. When the infusion completes:

When the pump has delivered the selected volume, it sounds an alert tone and switches to a KVO (Keep Vein Open) rate of 5 mL/hr or the current rate setting, whichever is lower.

8. Remove set from pump as follows:

a. Press the STOP key. b. Close administration set regulating clamp. c. Open pump door. d. If the slide clamp loading option is enabled, press the slide clamp fully into its slot. e. Press the SAFETY CLAMP to the open position. f.

Check that no fluid is flowing in set, then remove set from pump.

g. To turn the pump off, press the ONOFF/CHARGE key.

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Rev.B

Starting a Secondary Infusion 1. Prepare secondary fluid container and administration set.

a. To perform automatic piggybacking, a Continu-Flo® set from Baxter must be used as the primary set. b. Follow directions accompanying the products. c. Ensure all air is expelled from the secondary set.

2. Attach the secondary set to the injection site of the primary set above the pump. 3. Lower primary container with the hanger accompanying the secondary set. 4. Set secondary flow rate as follows:

a. Press SEC RATE key. The right-hand side of the main display now shows secondary infusion data. b. Enter desired flow rate (in mL/hr) for the secondary solution. c. To correct a mistake, press CLR or SEC RATE again and re-enter the correct value.

5. Set secondary volume to be infused as follows:

a. Press the SEC VTBI key. b. Enter the desired fluid amount (in mL) on the keyboard. Set VTBI equal to the volume of fluid in the container.

Rev.B

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