FreeGo Operating Manual Rev P Sept 2020

INDICATIONS OF USE The Abbott FreeGo enteral feeding pump is intended for hospital, acute care, long-term care, and home use. It is designed for both stationary use and ambulatory use. The pump is also designed to function safely on a commercial aeroplane. The Abbott FreeGo pump can be used for adult and paediatric patients, provided the patients can tolerate a feeding range within the pump operational specifications. •

The flow rate range is 1 to 400 mL/hr, in 1 mL/hr increments.

•

The flow rate accuracy is +/- 5%, under recommended head height (see PUMP ACCURACY TESTING).

•

Pump operates against 103 kPa to 124 kPa nominal back pressure before occlusion alarm. If these specifications are not appropriate for a given patient, the Abbott FreeGo pump should not be used.

Page 2

44772 Rev. P

PUMP CHARACTERISTICS The Abbott FreeGo enteral feeding pump is a microprocessor (computer)-controlled rotary peristaltic pump that provides accurate, controlled enteral feeding in a safe, user-friendly system. It has a large, easy-to-read display and simple controls. The pump uses specially designed Abbott FreeGo feeding sets, each of which includes a bolusprevention feature to provide safe, accurate control of enteral feeding. The Abbott FreeGo pump offers these features: 1.

Alarm features (see ALARMS AND WARNINGS)

2.

Flow-rate selection from 1 to 400 mL/hr, in 1 mL/hr increments

3.

Accuracy to ± 5% (see PUMP ACCURACY TESTING)

4.

Dose setting

5.

Volume-fed accumulation

6.

24-hour battery operation at 125 mL/hr, when fully charged

7.

Programmable HOLD timer

8.

Lock-out feature

9.

System self-check

10. User-friendly controls 11. Simple setup »

Pump memory has automatic and indefinite retention of the following values until reprogrammed or cleared: •

ACCUMULATED VOLUME FED/DELIVERED

•

RATE

•

DOSE

44772 Rev. P

Page 3

WARNINGS •

NOT FOR INTRAVENOUS (IV) USE.

•

Possible explosion hazard if used in the presence of flammable anaesthetics.

•

No modification of this equipment is allowed.

PRECAUTIONS •

The Abbott FreeGo pump is designed to deliver liquid enteral feeding products only (standard liquid products, infant formulas, or reconstituted powder products that have been thoroughly mixed into solution).

•

Exposure to magnetic fields, electrical external influences, and electro static discharges may affect the operation of any electronic medical device, including enteral feeding pumps.

•

All enteral feeding pumps have the potential to bolus-feed or over-deliver, which is an important consideration in feeding volume-sensitive patients. In these patients, a volume of product no greater than four (4) times the hourly feeding rate should be in the feed container.

NOTE: Do not rely on the pump’s alarms as a criterion for use with volume sensitive patients. •

Confirm proper placement and function of patient’s enteral feeding tube. Failure to do so may result in vomiting and/or aspiration. Verify the following before initiating a feeding: 1. Only an Abbott FreeGo feeding set is being used. 2. Abbott FreeGo feeding set pump insert is lightly stretched counterclockwise around rotor and lilac cassette is secured to the pump. Also ensure that the pump insert is correctly seated around the rotor. Use caution as over stretching can lead to delivery accuracy issues. 3. If the Abbott FreeGo feeding set is damaged in any way (e.g. broken, cut, torn, parts separated), replace the set immediately. 4. Flow rate is set at the prescribed mL/hr.

•

Abbott FreeGo feeding set and container should be replaced as needed, or at least every 24 hours, to avoid contamination problems.

•

Abbott FreeGo feeding sets are for single-patient use only.

•

The FreeGo occlusion alarm is triggered by the accumulation of pressure in the feeding system. At very low rates (below 40 ml/hr) it may take up to 10 minutes for the FreeGo pump to detect an occlusion.

Page 4

44772 Rev. P

•

Do not use excessive force when manually priming the Abbott FreeGo feeding set. Doing so could alter feeding accuracy.

•

If the pump is dropped it should be checked by Abbott Nutrition-authorised technical personnel prior to use on a patient. Studies have shown that dropping from any angle from a height of 1 metre (3 Feet) should not damage pump operation.

•

Whenever priming air from the Abbott FreeGo feeding set, make certain that the feeding set is not connected to the enteral feeding tube.

•

Prior to pump startup, user should: 1. Clean the pump (see CLEANING). 2. Inspect the pump and AC adapter charger, and should not use the system if there is evidence of damage or tampering.

•

User should verify that, during the pump startup, the pump’s LCD display and audio both operate according to the Self-Check Procedure (see the first NOTE under TO START PUMP in the INSTRUCTIONS FOR USE). Do not use if the pump’s operation is not exactly as described.

•

Only use approved Abbott FreeGo AC Adapter Charger to operate the FreeGo pump.

•

The AC Charger has an interchangeable adapter that is designed for specific country wall power outlets. Please ensure that the adapter is properly fitted to the AC/Main charger block to avoid risk of disconnection when removing from the wall power outlet or causing an electrical fire related to an electrical short.

•

The FreeGo pump battery may be fully discharged when received and may require approximately 2 minutes of power prior to illumination of the AC/Mains LED indicator.

•

Keep mains electrical cables, plugs and open sockets clear of feeding system to avoid risk of fire in the event of leakage of enteral feed.

•

There is a potential risk for entanglement with the tubing from a pump set in some patient populations such as children. These patients should be monitored during feeding as deemed necessary by their Health Care Professional.

44772 Rev. P

Page 5

FRONT AND BACK PANELS Front Panel

LCD Display

Up and Down Arrow Buttons

AC/Mains LED Indicator

Door Latch Prime Button

Pump Dial

Options Button

Refrain from using sharp instruments when using the front face buttons to avoid damage.

Back Panel

Audio Speaker

AC/Mains Power Input Battery Door

Page 6

Pole Clamp Receptacle

44772 Rev. P

LCD PANEL DISPLAYS Primary Display

Unit of Measure Indicator

Secondary Display Battery Charge Indicator

AC/Mains LED Indicator

Feeding Indicator

Audio Level Indicator

Primary Display: This 4-character display shows the value of the selected dial parameter. This would include the rate, the dose, or the volume fed, depending on the pump’s dial position. Abbreviated alarm messages will also show here. Secondary Display: This 12-character display is used to provide additional information to the user. Unit of Measure Indicator: This display indicates the unit of measure (mL, hr, mL/hr) corresponding to the value displayed in the Primary Display. Battery Charge Indicator: The battery charge status is indicated by battery icon located on the lower left side of the display. When operating on batteries the number of bars showing in the battery indicates the amount of battery charge remaining. When charging the battery bars scroll. AC/Mains Operation Indicator: AC/Mains-powered operation is indicated by a plug icon located to the right of the battery icon, as well as an LED light above the dial. Audio Level Indicator: The audio volume level setting is indicated by this icon. If the setting is at HIGH, there will be two bars . If the setting at LOW, the there will be one bar . Feeding Indicator: Four drop icons will scroll in the lower right hand corner of the display during feeding, incremental priming, or auto priming. Otherwise, the drops are not present.

44772 Rev. P

Page 7

FEEDING SETS Ready-to-Hang (RTH) pre-filled container with Feedcap

Top-fill enteral nutrition bag with pre-attached feeding set

NOTE: not shown, 220 mL RPB (reclosable plastic bottle) and Flexitainer

PRECAUTIONS: •

The Abbott FreeGo feeding set and container should be replaced as needed, or at least every 24 hours, to avoid contamination problems.

•

For single-patient use only.

•

Do not store for prolonged periods at extreme temperatures.

•

Only Abbott FreeGo sets can be used with the Abbott FreeGo enteral feeding pump.

Page 8

44772 Rev. P

INSTRUCTIONS FOR USE TO PREPARE FEED CONTAINER: 1. Depending on your feed container, complete ONE of the following (A, B, or C): A. If feeding from a Ready-to-Hang (RTH) container, attach the Feedcap feeding set securely onto the pre-filled enteral nutrition container. B. If feeding from a RPB (reclosable plastic bottle), attach the Feedcap feeding set securely onto the pre-filled enteral nutrition container. C. If feeding from a bag set, unscrew the cap on the bag set, pour in the feeding solution, and be sure to securely re-screw the cap onto the bag set to prevent accidental fluid spilling. 2.

Hang the feed container (i.e. from a drip stand, from Abbott FreeGo table drip stand, or inside Abbott FreeGo backpack).

TO PRIME AND LOAD THE FEEDING SET: 1.

Complete ONE of the following (Option A or Option B):

Option A »

MANUALLY PRIME THE SET: Gently push the lilac prime tab on the feeding set cassette against tubing until fluid flows. Completely prime the set by allowing fluid to expel air from the tubing.

»

LOAD THE SET INTO THE PUMP: Open the door on the pump. Grasp the lilac cassette body on the feeding set and loop the pump insert around rotor stretching lightly. Gently pull down and then seat the lilac cassette into the pump. Firmly press the tubing to ensure it is fully seated in slots below the cassette. Close the door firmly.

Or… Option B »

LOAD THE SET INTO THE PUMP: Open the door on the pump. Grasp the lilac cassette body on the feeding set and loop the pump insert around rotor stretching lightly. Gently pull down and then seat the lilac cassette into the pump. Firmly press the tubing to ensure it is fully seated in slots below the cassette. Close the door firmly.

» AUTO PRIME THE SET: Turn pump dial to SET RATE or SET DOSE. Press and hold the Prime Button for two (2) seconds then release. “PRIMING” will be displayed. Auto priming will stop when the priming

44772 Rev. P

Page 9

volume has been reached. To stop this process prior to its completion, press and release the Prime button.

» INCREMENTALLY PRIME THE SET: There may still be a small section of air in the feeding set. Press and hold the Prime Button. Priming will begin after two (2) seconds. Release Prime Button when fluid has reached desired level. NOTE: See in PUMP DIAL AND BUTTON REFERENCE for more information on priming.

TO START PUMP: 1. Turn pump dial to SET RATE. Then select your prescribed flow rate by pressing the Up and Down Arrow Buttons while observing the entry on the display. Keeping an Arrow Button depressed will cause the scroll rate to increase. NOTE: Any time the dial is turned from OFF/CHRG to any other dial position (i.e. the pump is turned on), the pump will initiate system Self-Check Procedure. During this procedure, user should verify that all segments on the LCD display activate and deactivate, then the pump’s software version and serial number (for example, V1:00 AF11001000) are displayed. Simultaneously, verify that the audio beeps at high volume, then low, then high again. If the pump has a software version later than V1:01, then the pump will also display either NC ENABLED or DATA ENABLED, at the end of the sequence described above. Do not use the pump if the operation is not exactly as described above.. 2. Turn the dial to SET DOSE and programme your prescribed dose using the Up and Down Arrow Buttons. Keeping an Arrow Button depressed will cause the scroll rate to increase. NOTE: Pump can be programmed to feed until the container is empty (SET DOSE at INF DOSE; see PUMP DIAL AND BUTTON REFERENCE). In this case, feeding will continue until the pump’s sensors detect air in the feeding set. At that time, the pump will stop and the display will read “FEED EMPTY”. NOTE: Be sure that the feeding volume has been cleared from the pump’s memory prior to beginning a new feeding (for instruction, see CLEAR VOL at step 6, below). 3. Connect the Abbott FreeGo feeding set securely to the enteral feeding tube. 4. Turn dial to RUN to start feeding. NOTE: If alarm sounds, turn pump dial to HOLD. Correct alarm condition that has been indicated on the LCD display, then return dial to RUN to

Page 10

44772 Rev. P

restart feeding. For Alarm and Warning information, see ALARM AND WARNING MESSAGES. 5. To view the accumulated feeding volume delivered, turn dial to VOL FED. 6. To clear the accumulated feeding volume delivered, turn dial to CLEAR VOL (the volume will clear after a five (5) second countdown.) 7. When feeding is complete, turn the pump dial to OFF/CHRG. 8. Detach the feeding set from the enteral feeding tube.

TO PAUSE FEEDING: In order to temporarily pause feeding, turn the dial to HOLD. The pump’s hold timer will start its countdown from 5 minutes, by default. The hold time can be manually changed in one-minute increments, from 1 to 90 minutes, by using the Up and Down Arrow Buttons. The pump’s hold time resets back to this default value every time the dial is switched away from HOLD. At the end of the countdown, an alarm will sound, but the PUMP WILL NOT AUTOMATICALLY RESTART. The dial must be returned to RUN for the pump to begin feeding again. The hold timer is only meant as an audio reminder that the feeding was paused. NOTE: Since feeding only occurs in RUN mode, feeding may be temporarily paused by switching the dial from RUN to any of the other dial settings. HOWEVER, there is the possibility of changing the feeding parameters (in SET RATE or SET DOSE dial mode) or clearing the accumulated delivered volume (in CLEAR VOL dial mode). Therefore, it is advised to only use the HOLD function to temporarily pause a feeding.

TO LOCK THE PUMP: In order to prevent an unintentional altering of the current numerical values in SET RATE, SET DOSE and VOL FED (via CLEAR VOL), the pump has a lock-out feature. NOTE: The HOLD timer can still be adjusted while the lock-out feature is activated. NOTE: The pump will not prime the feeding set while the lock-out feature is activated. 1. To activate the lock-out feature, simultaneously press both the Up and Down Arrow Buttons while the dial is in either SET RATE or SET DOSE dial modes. The display will read “ON LOCK ON”. 2. To deactivate the lock-out feature, repeat the step (1) above. The display will read “OFF LOCK OFF”.

44772 Rev. P

Page 11

USING THE DATA DOWNLOAD ACCESSORY CABLE (S412): CAUTION: The pump COMM (communication output) setting must be configured to DATA (for Data Download Accessory Cable). NOTE: Pumps with software version V1:01 are not configured for use with the Data Download Accessory Cable (S412). To check the software version of your pump, from the OFF/CHRG position, turn the pump dial to SET RATE. During the system SelfCheck Procedure the pump display will show the software version. If your pump has software version V1:01, contact your local Abbott representative to have the pump upgraded. To configure your pump for use with the Data Download Accessory Cable:

Press the Options Button until COMM is displayed on the pump display. Then use the Up and Down Arrow Buttons until DATA is displayed. Pump must be plugged into live AC/Mains power in order for Data Download Accessory Cable to work. Refer to the drawing below for cable and charger connections.

To verify functionality of the Data Download Accessory Cable (S412), turn the pump dial to RUN. Then open the pump door, which will trigger a DOOR OPEN alarm. Verify the alarm is transmitted from the Data Download Accessory Cable.

Page 12

44772 Rev. P

TROUBLESHOOTING: If the DATA function is not working properly: •

Check to see that all ends of the accessory cable and charger are securely connected.

•

Check the accessory cable for damage.

•

If the cable is properly connected and not damaged, return the pump and cable for service.

USING THE NURSE CALL ACCESSORY CABLE (S468): CAUTION: The pump COMM (communication output) setting must be configured to NC (for “Nurse Call”, Nurse Call Accessory Cable). NOTE: Pumps with software version V1:01 are not configured for use with the Nurse Call Accessory Cable (S468). To check the software version of your pump, from the OFF/CHRG position, turn the pump dial to SET RATE. During the system Self-Check Procedure the pump display will show the software version. If your pump has software version V1:01, contact your local Abbott representative to have the pump upgraded. To configure your pump for use with the Nurse Call Accessory Cable:

Press the Options Button until COMM is displayed on the pump display. Then use the Up and Down Arrow Buttons until NC is displayed. Pump must be plugged into live AC/Mains power in order for Nurse Call Accessory Cable to work. Refer to the drawing below for cable and charger connections.

44772 Rev. P

Page 13

CAUTION: Be certain to verify functionality at the nurse call station prior to connecting the feeding set to the patient. To verify functionality of the Nurse Call Accessory Cable (S468), turn the pump dial to RUN. Then open the pump door, which will trigger a DOOR OPEN alarm. Verify the nurse station is receiving this alarm. Press the nurse call button and verify the nurse station is receiving this alarm. CAUTION: The Nurse Call Accessory Cable functionality should be verified periodically. TROUBLESHOOTING: If the NC function is not working properly: •

Check to see that all ends of the accessory cable and charger are securely connected.

•

Check the accessory cable for damage.

•

If the cable is properly connected and not damaged, return the pump and cable for service.

Page 14

44772 Rev. P

ALARM AND WARNING MESSAGES PRIMARY SECONDARY DISPLAYS

CONDITION OR PROBLEM

EXPLANATION OR CORRECTIVE ACTION

OCCL INTO PUMP

Flow has stopped due to occlusion between the formula container and the pump.

•

Turn dial to HOLD

•

Remove feeding set from pump. Clear obstruction, check for kinked tubing or empty container. Reinstall feeding set.

OCCL OUT OF PUMP

• Flow has stopped due to occlusion between the pump and the patient.

If this alarm appeared during priming, attempt to prime the feeding set again, then connect the feeding adapter to your enteral feeding tube

•

Turn dial to RUN to begin feeding

ATTN PUMP ON HOLD

Hold time has elapsed.

•

Turn dial to RUN to begin feeding

BATT LOW BATTERY

Pump Battery is nearly empty. At least 20 minutes of battery capacity remaining from time of first alarm.

•

Connect the pump to live AC/Mains power.

BATT BATT EMPTY

Pump battery is depleted. Pump has stopped feeding.

•

Connect the pump to live AC/Mains power. The display will indicate “CHRG PLEASE WAIT”

DOOR OPEN

The door is open while feeding or priming the feeding set.

•

Turn dial to HOLD

•

Close the door

•

Turn dial to RUN to begin feeding, or attempt to prime the feeding set again

•

Turn dial to HOLD

•

Insert cassette and close door

•

Turn dial to RUN to begin feeding, or attempt to prime the feeding set again

NO CASSETTE

Cassette is not installed or was installed incorrectly when user attempted to run pump or prime the feeding set.

44772 Rev. P

Page 15

PRIMARY SECONDARY DISPLAYS

CONDITION OR PROBLEM

EXPLANATION OR CORRECTIVE ACTION

ER## SYSTEM FAIL

Pump malfunction.

•

Remove pump from patient immediately and contact your local Abbott Nutrition representative

•

Turn dial to OFF/CHRG

Hold time count down. The primary display shows the remaining time.

•

Pump dial is at HOLD

•

If desired, adjust the HOLD timer to any duration (in 1-minute intervals) from 1 to 90 minutes by depressing the Up and Down Arrow Buttons

Lock-out feature disables SET RATE, SET DOSE, and CLEAR VOL dial settings, as well as the pump’s prime features.

•

Turn dial to SET RATE or SET DOSE

•

Depress both Up and Down Arrow Buttons simultaneously to deactivate lock-out feature

•

Repeat steps to activate

HOLD MINUTES

LOCK PUMP LOCKED

Page 16

44772 Rev. P

PRIMARY SECONDARY DISPLAYS

CONDITION OR PROBLEM

EXPLANATION OR CORRECTIVE ACTION

FEED EMPTY

Air is detected in the feeding set. If you are just beginning a feeding: •

Open the door. Firmly press the tubing to ensure it is fully seated in slots below the cassette. Close the door firmly.

Or… If there is more food to deliver:

This alarm condition may be caused by electromagnetic interference (reference the Guidance and Manufacturer’s Declaration - Electromagnetic immunity table in the Standards section)

44772 Rev. P

•

Turn dial to HOLD to stop the audio alarm

•

Remove feeding set adapter from your enteral feeding tube

•

Refer to INSTRUCTIONS FOR USE to prime the air out of the feeding set

•

Securely re-attach the feeding set to your enteral feeding tube

•

Turn dial to RUN to begin feeding

•

Or… If you are done feeding:

•

Turn dial to OFF/CHRG. This message is displayed because pump was programmed to feed until container is empty (SET DOSE at INF DOSE).

•

Move pump away from cellular phones, amateur radios, AM and FM radio broadcast, TV broadcast or other radio frequency (RF) transmitting devices.

Page 17

PRIMARY SECONDARY DISPLAYS

CONDITION OR PROBLEM

EXPLANATION OR CORRECTIVE ACTION

DOSE DONE

If you are done feeding: The pump has completed delivering the programmed dose. • Turn dial to OFF/CHRG, the dose has been delivered. This message is displayed because VOL FED has reached your SET DOSE Or… If there is more food to deliver:

DIAL NOT SET

Pump dial is between two dial positions. For example: the dial is stuck halfway between RUN and HOLD.

•

Turn dial to CLEAR VOL (after 5 seconds, volume will be cleared)

•

Turn dial to SET DOSE, and use Up and Down Arrow Buttons to set your remaining dose to be delivered

•

Turn dial to RUN to begin feeding

•

Turn the dial to the desired dial position, directly aligning the two dots (on the dial and the dial position label)

•

Continue setting up and operating pump as normal

•

No action can be taken.

•

Pump will be available for use when the display indicates “PUMP READY TO USE”

CHRG PLEASE WAIT

The battery charge is below the minimum acceptable level and the pump cannot be used until the minimum charge level is reached.

PUMP READY TO USE

The battery charge has reached • the minimum level and the pump can now be used. • •

Page 18

44772 Rev. P

Turn dial to any position to clear message Confirm all settings are accurate Turn dial to RUN to continue feeding

PUMP DIAL AND BUTTON REFERENCE DIAL / BUTTON

FUNCTION

OFF/CHRG

Primary purpose is to shut down all pump functions. •

If switched from any dial position to OFF/CHRG, the display will briefly read “PUMP SHUTDOWN”, and then enter OFF mode.

•

If switched from OFF/CHRG to any other dial position, the pump will initiate system Self-Check Procedure. During this procedure, user should verify that all segments on the LCD display activate and deactivate, then the pump’s software version and serial number (for example, V1:00 AF11001000) are displayed. Simultaneously, verify that the audio beeps at high volume, then low, then high. If the pump has a software version later than V1:01, then the pump will also display either NC ENABLED or DATA ENABLED, at the end of the sequence described above. Do not use the pump if the operation is not exactly as described above.

•

If external power supply is not connected, the display will be blank. If external power supply is connected, the display will show AC/Mains icon and battery icon.

NOTE: If external power supply is connected, pump battery will charge in any dial setting.

SET RATE

Primary purpose is to set the rate/speed (the amount of fluid volume per hour) at which feeding solution is delivered to patient. •

To program feeding rate, use Up and Down Arrow Buttons. Keeping an Arrow Button depressed will make the numerals scroll. The scrolling rate will increase (depending on length of time Arrow Button is depressed).

•

Auto Prime and Incremental Prime features are functional in this dial position.

•

To set the lock-out feature, simultaneously press both Up and Down Arrow Buttons. To deactivate lock-out feature, repeat procedure.

•

If lock-out feature is not set, the display will read “SET RATE”, along with the current rate setting (from 1 to 400 mL/hr).

•

If lock-out feature is set, the display will read “PUMP LOCKED”.

44772 Rev. P

Page 19

DIAL / BUTTON

FUNCTION

SET DOSE

Primary purpose is to set the dose (to limit the total amount of fluid volume) delivered during an entire feeding.

RUN

•

To program feeding dose, use Up and Down Arrow Buttons. Keeping an Arrow Button depressed will make the numerals scroll. The scrolling rate will increase (depending on length of time Arrow Button is depressed).

•

If you wish to feed until the container is empty, set the dose to INF DOSE (infinite dose). To do this, make sure the pump dial is in the SET DOSE position then depress the Down Arrow Button until INF DOSE appears on the display.

•

Auto Prime and Incremental Prime features are functional in this dial position.

•

To set the lock-out feature, simultaneously press both Up and Down Arrow Buttons. To deactivate lock-out feature, repeat procedure.

•

If lock-out feature is not set, the display will read “SET DOSE”, along with the current dose setting (from 1 to 9999 mL, or INF).

•

If lock-out feature is set, the display will read “PUMP LOCKED”.

Primary purpose is to initiate and continue a feeding. •

This is the only dial setting that operates a feeding.

•

As long as dial is kept in this position, feeding will continue until:

»

The volume delivered equals the programmed dose volume (when VOL FED equals SET DOSE),

»

An alarm condition has been detected.

or…

Page 20

•

Display will show the programmed rate.

•

Display will scroll 4 drops in bottom-right corner.

•

It is normal for rotor movement to be intermittent (e.g. starts, stops, starts, etc.) while in RUN mode. This intermittent movement regulates the rate of flow, conserves battery charge, and does not affect the accuracy of the pump.

44772 Rev. P