Flo-Gard Model 6301 Operators Manual Rev B May 1993

Table of Contents Introduction... 1 Physical Description ... 3 Operating Instructions ... 10 Precautions ... 10 Loading the Pumps ... 11 Starting a Primary Infusion ... 15 Starting a Secondary Infusion... 18 Using Volume-Time Programming... 19 Changing the Flow Rate While the Pump Is Running... 21 The OPTIONS Key ... 22 Using the Programmed Delivery Profile Feature... 22 Computer Control ... 25 Computer Monitoring... 26 Locking the Front Panel ... 26 Battery Powered Operation ... 27 FLOW CHECK Information Display ... 27 Cleaning and Storage ... 28 Alerts and Alarms ... 29 Technical Specifications ... 34 Configurable Options... 36 Warranty and Service Information ... 41 Warranty ... 41 Service Information ... 42

7-19-B1-564

i

Change record 7-19-01-564 Original issue: 7/92 Rev. A: 9/92 Rev. B: 05/93 Page

Revision

Front cover i ii 1–4 5 6–8 9 10–14 15 16–17 18-30 31–32 33 34 35–38 39–42 Back cover

0 B B 0 A 0 A B 0 B 0 B 0 A 0 B B

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

ii

7-19-B1-564

Introduction The Flo-Gard® 6301 Dual Channel Volumetric Infusion Pump from Baxter can deliver a wide variety of fluids over a broad range of infusion rates. The device's features include:

7-19-B1-564

•

Uses only standard Baxter® solution administration sets.

•

Two separate pump channels allow it to do the work of two conventional pumps, resulting in space savings.

•

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

•

Computer control capability allows remote control or monitoring of the device via a standard RS-232C interface.

•

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

•

Suitable for use in epidural administration.

•

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 device's configuration.

•

Flow check display shows resistance to flow.

•

Ultrasonic air-in-line detectors. Sensitivity of the air detectors is selectable through the device's configuration.

•

Each pump channel features a Programmed Delivery Profile that enables programming of up to 10 sequential infusion programs for situations where ramping of medications are indicated.

1

2

•

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

•

Locking control panel helps prevent patient tampering.

•

Each pump channel features an independent secondary medication program. The channel automatically switches over to the primary program upon completion.

•

Volume-Time programming automatically calculates flow rate.

•

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

•

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

•

Easily replaceable fuse, battery, and power cord.

•

Access to test points and internal program simplifies servicing and software upgrades.

•

Device can be configured to display a hospital area designator, such as “ONCOLOGY” or “CARDIAC ICU,” upon power-up.

7-19-B1-564

Physical Description Items 1 through 9 are associated with Pump 1 and are described below. The controls associated with Pump 2 are identical and function in exactly the same manner. Items 10 through 28 are common to the operation of both pumps. All front panel items are shown in Figure 1.

Front Panel ITEM

FUNCTION

1. Pump 1 ONOFF/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

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

3. Pump 1 STOP key

Stops Pump 1 until further instructions are given. The message STOPPED appears when the key is pressed. An alert sounds if Pump 1 is stopped for more than two minutes. Clears all programming alerts while pump is running.

4. PUMP 1 key and indicator

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

5. Pump 1 main display

Shows rate, volume to be infused (VTBI), and total volume infused for Pump 1 primary and secondary infusion programs. The decimal point is displayed as an underscore (example: 99_9).

6. Pump 1 message display

Shows all Pump 1 messages and messages that apply to the device as a whole.

7. Pump 1 ALARM LED

Red LED that blinks on and off during a Pump 1 or general alarm, accompanied by a message display and a repeated sequence of three tones. An alarm indicates that Pump 1 or the device as a whole requires immediate attention.

8. Pump 1 PUMPING LED

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

9. Pump 1 ALERT LED

Yellow LED which lights during Pump 1 and general alerts, accompanied by a message display and a repeated single tone. An alert indicates that Pump 1 or the device as a whole needs timely attention.

7-19-B1-564

3

Front Panel

4

ITEM

FUNCTION

10. BACK LIGHT key

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

11. SILENCE key

Temporarily silences an audible alarm or alert for two minutes, unless another alarm or alert occurs on either pump within the two-minute silence period. All messages remain displayed.

12. NEXT legend

Lights when theTOT VOL STATUS key is functioning as the NEXT key.

13. TOT VOL/STATUS key

Displays total volume delivered for each pump. The key is also used to advance to the next step when programming a delivery profile. (See NEXT legend, item 12 above.)

14. CLEAR TOT VOL key

Resets the total volume delivered by the selected pump to zero if pressed when the pump is stopped.

15. TIME key

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

16. PRI RATE key

Allows programming of the primary infusion rate for the selected pump.

17. PRI VTBI key

Allows programming of the primary VTBI for the selected pump.

18. PRI START key

Starts the primary infusion for the selected pump.

19. Plug icon

Always lit while the device is plugged in and the battery is charging.

20. MONITOR legend

Lights when the device is being queried by the computer during computer monitoring.

21. Battery icon

Lights when the device is operating on battery power.

22. COMPUTER CONTROL legend

Lights when the device is being controlled by a remote computer.

23. CLR key

Clears any programming values currently being entered.

24. SEC START key

Starts the delivery of the secondary infusion for the selected pump.

7-19-B1-564

8

7

11 12 13

9 10

14

15

6

16

5

BACK LIGHT

ALARM

PUMPING

SILENCE

ALERT

ALERT

PUMPING

17

ALARM

NEXT

4

TOT VOL STATUS

CLEAR TOT VOL

3

18

TIME

2

PU MP

P U S H

1

PUMP

1

PRI RATE

PRI VTBI

PRI START

STOP

7

8 5

9 6

4 ON OFF CHARGE

1

2

3

.

0

CLR

SEC VTBI

SEC START

2 P U S H

STOP

ON OFF CHARGE

19

OPTIONS

SEC RATE

COMPUTER CONTROL

®

28

MONITOR

20

Flo-Gard® 6301 DUAL CHANNEL VOLUMETRIC INFUSION PUMP

27

26

25

24

23

22

21

Figure 1. Front View

Front Panel ITEM

FUNCTION

25. SEC VTBI key

Allows programming of the secondary VTBI for the selected pump.

26. SEC RATE key

Allows programming of the secondary infusion rate for the selected pump.

27. Numerical keypad

Programming values and decimal point are entered with these keys.

28. OPTIONS key

Allows the device to enter an enabled optional mode. These may include the Programmed Delivery Profile (PDP) or Computer Control modes. If Programmed Delivery Profile and/or Computer control is available, the OPTIONS key is lit.

7-19-B1-564 Rev. A

5

Figure 2 shows Pump 2 only. Pump 1 has identical features, which function in the same manner.

Pump Head Features ITEM

6

FUNCTION

1. Upstream occlusion sensor

Detects a 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 device's configuration.

4. Air sensor

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

5. Safety clamp

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

6. Slide clamp slot

The slide clamp loading option is selectable through the configuration. 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.

7. Slide clamp spring retainer

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

7-19-B1-564

1

2

3

4

5 6 7

Figure 2. Pump 2 With Door Open

7-19-B1-564

7

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

Rear Panel Features ITEM

8

FUNCTION

1. I.V. pole clamp

Secures the device 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 easy access to the battery. (For use by authorized service personnel only.)

5. Fuse

Fuse compartment is located behind the power cord cover.

6. Power cord

Supplies AC power when plugged into a hospital-grade earth-grounded outlet. Removable by authorized service personel only.

7. PANEL LOCK switch

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

8. COMMUNICATIONS PORT

Standard RS-232C port that allows the device to communicate with a computer and provides the nurse call signal when enabled.

9. VOLUME knob

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

7-19-B1-564

2 3

1

9 COMMUNICATIONS PORT

VOLUME

8

PANEL LOCK (PUSH)

7

5 4

6

Figure 3. Rear View

7-19-B1-564 Rev. A

9

Operating Instructions

Precautions General

10

•

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

•

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

•

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

•

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

•

Read and understand this manual before using this device.

•

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

•

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.

•

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.

•

As with all medical electronic equipment, care must be exercised to avoid exposing this device to powerful sources of electromagnetic interference. This device design has been tested to the requirements of

7-19-B1-564

MDS–201–004, and applicable portions of MIL–STD–461C, which are voluntary test guidelines for electromagnetic susceptibility and emissions. This device was not found to be adversely affected by the susceptibility tests in these specifications, and will perform safely. The device's emissions were also found to be acceptable.

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.

•

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

•

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

•

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

Loading the Pumps 1. Plug the device in.

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

7-19-B1-564

11

Note:

The procedure for preparing and loading the administration set (steps 2 through 9) is the same for Pump 1 and Pump 2.

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.

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

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

5. Load the I.V. 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 can be operated without inserting the slide clamp. An alert tone sounds until the slide clamp is inserted or SILENCE 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.

Figure 4. I.V. Set Loading Diagram

12

Slide clamp in slot

7-19-B1-564

c. Load the tubing through the guide channel from bottom to top as shown in Figure 4. d. Ensure that the I.V. 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. 6. Close pump door.

If resistance is felt when closing the door, check for a 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(s) on by pressing appropriate ON/OFF CHARGE key(s). Verify that the following self-test occurs when you turn on the first pump:

a. All segments of the Pump 1 and Pump 2 message displays appear momentarily. All segments of the main display of the powered-on pump appear momentarily. b. Three separate audible tones sound.

7-19-B1-564

13

c. If a Hospital Area Designator (HAD) has been programmed into the device, it is displayed for three seconds in the Pump 1 message display. d. The occlusion detection level is momentarily displayed in the Pump 1 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, AUTO RESTART appears for one second in the Pump 1 message display. f.

If the device is plugged into an AC outlet, the plug icon is lit. If the device is operating 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 compatible 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 device to the desired level.

14

7-19-B1-564

Starting a Primary Infusion Note:

The procedures for programming Pump 1 and Pump 2 are identical.

1. Select the pump you wish to program.

Press PUMP 1 or PUMP 2 as appropriate. The yellow LED on the PUMP key lights to indicate that the pump is selected.

2. Set primary flow rate.

a. Press PRI RATE. b. Program desired flow rate (in mL/hr) on keypad. 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 of the selected pump.

3. Set primary volume to be infused.

a. Press PRI VTBI. b. Program desired VTBI (in mL) on keypad. 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 of the selected pump.

4. Review infusion settings and/or read total volume infused.

7-19-B1-564

Press TOT VOL/STATUS key. VOLUME INFUSED is displayed first, followed by RATE and VTBI.

15

5. If necessary, reset the volume previously infused on the selected pump to zero.

Note:

Press the CLEAR TOT VOL key.

Always verify programmed information prior to starting the selected pump.

6. Start the pump.

a. Press PRI START. The green PUMPING LED lights and a moving bar appears next to the appropriate 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 into the slide clamp slot located below the safety clamp. Close the door, then open the regulating clamp. c. Confirm flow by checking for drops in the I.V. set drip chamber. d. If Auto Restart is enabled and Flow Check is not enabled, AUTO RESTART is displayed in the Pump 1 message display. e. If you wish to program the other pump, press its ON-OFF/CHARGE key and repeat steps 1 through 6.

7. To stop an infusion before it is complete:

16

a. Press the appropriate STOP key.

7-19-B1-564

b. The selected pump's PUMPING LED goes out and STOPPED appears in the message display. c. If the pump is not restarted or powered off within two minutes, an audible alert sounds. 8. To restart an infusion:

a. Press the PUMP 1 or PUMP 2 key as appropriate. b. Press the appropriate START key.

9. When the infusion completes:

When a 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.

10. Remove set(s) from pump(s) as follows:

a. Press the appropriate STOP key. b. Close administration set regulating clamp. c. Open appropriate 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 a pump off, press the appropriate ON-OFF/CHARGE key.

7-19-B1-564

17