Abbott Freego - Operating Manual 522q3n

Abbott FreeGo Enteral Feeding Pump

Operator Manual For Enteral Use Only Not For IV Use

TABLE OF CONTENTS INDICATIONS FOR USE ............................................................................................................................. 1 PUMP CHARACTERISTICS ......................................................................................................................... 1 WARNINGS .............................................................................................................................................. 2 PRECAUTIONS ......................................................................................................................................... 2 FRONT AND BACK S ....................................................................................................................... 3 LCD DISPLAYS ............................................................................................................................... 4 FEEDING SETS .......................................................................................................................................... 5 INSTRUCTIONS FOR USE .......................................................................................................................... 6 ALARM AND WARNING MESSAGES .......................................................................................................... 8 PUMP DIAL AND BUTTON REFERENCE ................................................................................................... 11 CLEANING ............................................................................................................................................. 14 PUMP ACCURACY TESTING .................................................................................................................... 15 ACCESSORY INFORMATION ................................................................................................................... 16 SERVICE INFORMATION ......................................................................................................................... 17 WARRANTY INFORMATION ................................................................................................................... 17 SPECIFICATIONS .................................................................................................................................... 18 SYMBOLS ............................................................................................................................................... 19

INDICATIONS FOR 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.

PUMP CHARACTERISTICS The Abbott FreeGo enteral feeding pump is a microprocessor (computer)-controlled rotary peristaltic pump that provides for accurate, controlled enteral feeding in a safe, -friendly system. It has a large, easy-toread display and simple controls. The pump uses specially designed Abbott FreeGo feeding sets, each of which includes a bolus-prevention 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. -friendly controls 11. Simple setup o Pump memory has automatic and indefinite retention of the following values until reprogrammed or cleared:  ACCUMULATED VOLUME FED/DELIVERED  RATE  DOSE

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WARNINGS NOT FOR INTRAVENOUS (IV) USE Possible explosion hazard if used in the presence of flammable anaesthetics.

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. 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. 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. 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. 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, 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. should 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.

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FRONT AND BACK S FRONT

LCD Display

AC/Mains LED Indicator

Up and Down Arrow Buttons

Door Latch Pump Dial

Prime Button Audio/Backlight Adjuster Button

BACK

Audio Speaker

AC/Mains Power Input Battery Door Pole Clamp Receptacle

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LCD DISPLAYS

Unit of Measure Indicator

Primary Display

Secondary Display

Battery Life Indicator

Feeding Indicator

Audio Level Indicator AC/Mains Operation 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 . 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 Life 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.

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FEEDING SETS Ready-to-Hang (RTH) pre-filled container with Feedcap or Spike feeding set (to be attached by )

Top-fill enteral nutrition bag with pre-attached feeding set Lilac Prime Tab

To attach Spike set: Pump Insert Lilac Cassette

Stopcock

Feeding Adaptor Feedcap Adaptor 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.

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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 either the Spike or 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. 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. 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 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, should that all segments on the LCD display activate and deactivate, and then display the pump’s software version and serial number (for example, V1:00 AF11001000). Simultaneously, that the audio beeps at high volume, then low, then high again. 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. Page |6

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 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. OFF”.

To deactivate the lock-out feature, repeat the step (1) above. The display will read “OFF LOCK

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ALARM AND WARNING MESSAGES PRIMARY SECONDARY DISPLAYS OCCL INTO PUMP

OCCL OUT OF PUMP

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

EXPLANATION OR CORRECTIVE ACTION Turn dial to HOLD Clear obstruction; check for kinked tubing or empty container 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

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

ATTN PUMP ON HOLD

Hold time has elapsed.

Turn dial to RUN to begin feeding

BATT LOW BATTERY

Pump battery is nearly empty. Approximately 30 minutes of battery operation remain.

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

NO CASSETTE

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

Turn dial to HOLD Insert cassette and close door Turn dial to RUN to begin feeding, or attempt to prime the feeding set again

ER## SYSTEM FAIL

Pump malfunction.

Remove pump from patient immediately and your local Abbott Nutrition representative Turn dial to OFF/CHRG

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PRIMARY SECONDARY DISPLAYS

CONDITION OR PROBLEM

EXPLANATION OR CORRECTIVE ACTION

__ HOLD MINUTES

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 PUMP LOCKED

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

FEED EMPTY

Air is detected in the feeding set.

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). Or… If there is more food to deliver: 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

DOSE DONE

The pump has completed delivering the programmed dose.

If you are done feeding: 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: 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

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PRIMARY SECONDARY DISPLAYS DIAL NOT SET

CONDITION OR PROBLEM

EXPLANATION OR CORRECTIVE ACTION

Pump dial is between two dial positions.

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

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

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No action can be taken. Pump will be available for use when the display indicates "PUMP READY TO USE"

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 OFF/ CHRG

SET RATE

SET DOSE

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Function 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, should that all segments on LCD display activate and deactivate, and then display the pump’s software version and serial number (for example, V1:00 AF11001000). Simultaneously, that the audio beeps at high volume, then low, then high again. 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. 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”. Primary purpose is to set the dose (to limit the total amount of fluid volume) delivered during an entire feeding. 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”.

Dial/ Button RUN

HOLD

VOL FED

CLEAR VOL

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Function 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: o The volume delivered equals the programmed dose volume (when VOL FED equals SET DOSE), or… o An alarm condition has been detected. 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 life, and does not affect the accuracy of the pump. Primary purpose is to remind patient that the pump is temporarily paused. Pump will not automatically restart the feeding after the hold time has elapsed. To restart the feeding, must turn dial back to RUN. To programme hold time, use Up and Down Arrow Buttons. Keeping an Arrow Button depressed will make the numerals scroll. Display will read “HOLD TIME”, along with the current remaining hold time (from 1 to 90 minutes). Default is 5 minutes, and the pump’s hold time resets back to this default value every time the dial is switched away from HOLD. Primary purpose is to display the accumulated volume of feeding solution that has been delivered. When this number matches the SET DOSE, feeding will stop and an audio alarm will sound along with a visual display alarm (reading “DOSE DONE”). Once upper limit (9999 mL) has been reached, the display will show “- - - “ and is not accompanied by alarm. Therefore, it is critical to perform CLEAR VOL function (below) prior to beginning feeding. Display will read “VOLUME FED”, along with the current accumulated fluid volume that has been delivered (from 1 to 9999 mL). Primary purpose is to allow the to clear the accumulated volume of feeding solution that has been delivered and been stored in the pump’s memory (shown at dial position VOL FED). If lock-out feature is not set, the display will read “CLEAR IN n SEC”, where n represents the number of seconds before the accumulated volume delivered is set back to 0 mL. This is a countdown from 5 seconds, and each second is accompanied by a beep. When the volume has been cleared, a beep will sound for 2 seconds. If you do not wish to clear the accumulated volume delivered, turn the dial away from CLEAR VOL before the 5 seconds has elapsed. If lock-out feature is set, the display will read “PUMP LOCKED”.

Dial/ Button

Function The Up and Down Arrow Buttons are used for increasing or decreasing values, respectively. They also serve to toggle between different settings (see below). The Prime Button is used to remove air from the feeding set. This button is functional only in the SET RATE and SET DOSE dial positions. While priming, be absolutely certain that the feeding set is not connected to your enteral feeding tube. See INSTRUCTIONS FOR USE. The pump will begin auto priming if this button is depressed when the pump’s sensors detect air in the feeding set and the pump dial has not yet been set to RUN after one of the following has occurred: the door has opened and closed, or the pump dial is turned from OFF/CHRG to any other position. Otherwise, the pump will begin incremental priming when this button is depressed. The Audio/Backlight Adjuster Button is used to change the audio volume of the alarms, as well as the brightness and timing of the LCD display. Press the button until the option you wish to change is displayed, then use the Up and Down Arrow Buttons to choose your preference: AUDIO LEVEL - LOW - HIGH BRIGHTNESS - LOW - MED - HIGH LITE (controls when display is on) - 10 SEC ON - ALWAYS ON NOTE: “ALWAYS ON” option is only available when pump is plugged in to live AC/Mains, in order to conserve battery charge.

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CLEANING For trouble-free operation, check the pump daily and clean immediately after spills occur. Before cleaning, be sure that pump is turned OFF and UNPLUGGED. HOUSING Do not submerge, autoclave, heat, steam, ETO or radiation sterilize the pump. Clean outside surface only (do not spray water or cleaning solution into pump). For general cleaning, use soft cloth and warm soapy water. Rinse and dry thoroughly. Do not remove the rotor.  After cleaning the rotor, that all rollers (on rotor) turn freely. For general disinfecting, use: o 10% solution of 5.25% sodium hypochlorite (household bleach) o 40% solution of ethyl alcohol o 10% solution of phosphoric acid NOTE: These recommendations are not substitutes for official procedures that may differ among institutions.

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PUMP ACCURACY TESTING There are many variables that can affect flow rate, such as fluid head height and fluid viscosity. The Abbott FreeGo pump system has been optimized for delivery accuracy when using Abbott Nutrition 1.0 kcal ReadyTo-Hang (RTH) feeding formulas. To check flow rate accuracy, use the following procedure: 1. Select a new Abbott FreeGo feeding set for this test. Be sure to use a graduated cylinder for volume measurement—not an enteral container or other uncalibrated vessel. 2. Use an Abbott Nutrition feeding formula in a Ready-To-Hang (RTH) container and set up pump according to INSTRUCTIONS FOR USE. 3. Suspend feed container to side or behind the pump. Recommended head height is 30 cm from the center of the rotor to the top of the fluid in feed container. 4. With the test pump connected to AC/Mains, set the rate to 84 mL/hr. 5. Run fluid into graduated cylinder for 8 hours and compare the accumulated volume in the graduated cylinder to chart below.

SET RATE 84 mL/hr

=

Amount Expected in Graduated Cylinder at 8 hours 638 mL to 706 mL

If the amount in the graduated cylinder is incorrect based on SET RATE, try a new Abbott FreeGo feeding set and repeat the procedure. The diagram below describes how variation from recommended head height affects flow rate accuracy.

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ACCESSORY INFORMATION Some accessories may not be available in all areas. Please your local Abbott Nutrition representative for more information.

Abbott FreeGo Standard Pole Clamp (S406)

Abbott FreeGo Adjustable Angle Pole Clamp (S415)

Abbott FreeGo Paediatric Backpack / Carry Bag (S404)

Abbott FreeGo Adult Backpack / Carry Bag (S405)

Abbott FreeGo Table Drip Stand (S407)

Abbott FreeGo AC Adapter Charger (S414) Abbott FreeGo 12V Automobile Charger (S413) Abbott FreeGo RS232 Adapter / Information Cable (S412) Abbott FreeGo Nurse Call Cable (S468)

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SERVICE INFORMATION In the event of a pump malfunction or the need for technical assistance or parts, please your local Abbott Nutrition representative. All servicing or adjustments should be performed by Abbott Nutrition-authorised technical personnel.

WARRANTY INFORMATION The Abbott FreeGo pump has a warranty period of 24 months. There are no routine calibrations, adjustments, or services required with the Abbott FreeGo pump.

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SPECIFICATIONS MECHANICAL Height: 140 mm Width: 120 mm Depth: 80 mm Weight: 490 g ______________________________________________________________________________ OPERATIONAL Flow Rate: 1 mL/hr to 400 mL/hr Dose: 1 mL to 9999 mL (feed until empty when SET DOSE at INF DOSE) Increments: 1 mL Priming Rate: ≥ 700 mL/hr Accuracy: ± 5%, under recommended head height (see PUMP ACCURACY TESTING) Occlusion Detection Pressure: Upstream: -34 ± 20 kPA Downstream: 103 ± 20 kPA for 30 seconds 124 ± 20 kPA for 5 seconds Head height effect: ≤ 2.5% per 30 cm (12 inches) (see PUMP ACCURACY TESTING) Operating Temperature: +5° to +40° C Operating Humidity: 10% to 95% non-condensing Atmospheric pressure: 65 kPA to 102 kPA ______________________________________________________________________________ STORAGE Storage Temperature: -20° to +65 ° C Storage Humidity: 10% to 95% non-condensing Atmospheric pressure: 50 kPA to 106 kPA ______________________________________________________________________________ POWER Voltage: Charger input 100-240 V; 50-60- Hz; output 5 V DC 2.4A ______________________________________________________________________________ BATTERY Type:

Lithium Ion, 3.7 volt

Charge Life:

≥ 24 hours, at 125 mL/hr

Charge Time:

≤ 6 hours

Note: When the message BATT LOW BATTERY appears, the battery has approximately 30 minutes of energy left for pump operation. The European Battery Directive requires collection of spent batteries, aiming to facilitate recycling and to protect the environment. This device contains a battery that is not intended to be serviced or removed by the . The battery in this product should be removed at the end of the life by Abbott Nutritionauthorised technical personnel only, and disposed in accordance with local community regulations for separate collection of spent batteries.

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SYMBOLS IEC 529 IPX5 degree of protection against water entering the enclosure. Water jets from any direction shall have no effect. EN 60601-1 Type BF degree of protection against electrical shock. No electrical connection to patient. Dropping from any angle from a height of 1 meter (3 feet) shall not damage pump operation. Not for intravenous (IV) use. Pump is designed for enteral feeding only. The European Battery Directive requires separate collection of spent batteries in accordance with local community regulations.

Abbott Logistics B.V. PO Box 365 8000 AJ Zwolle Netherlands

Manufactured By: Moog Medical Devices Group Salt Lake City, UT 84123 USA

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Manufactured For: Abbott Nutrition Abbott Laboratories Columbus, OH 43229 USA