Kangaroo ePump Operating Manual

en Thank you for purchasing the Kangaroo™ ePump™ Enteral Feed and Flush Pump with Pole Clamp. With proper care, this device will provide you with years of precision service.

Table of Contents Page

Section I - General Information... 1 Section II - Safety and Warnings... 3 Section III - Icon Identification ... 6 Section IV - Initial Setup Attaching the A/C Power Adapter ... 7 Battery Setup... 7 Attaching Pole Clamp... 7

Section V - Instructions for Use

Quick Start... 8 General Startup Placement/Mounting... 9 A/C Power Operation... 9 Battery Power Operation ... 9 Power On/Off... 9 Language Selection, First Power Up... 9 Keep or Clear Prior Pump Settings... 9 Loading Pump Sets... 10 Prime Pump... 11 Auto Priming... 11 Hold-To-Prime... 11 Feed-Only Pump Sets... 11 Feed & Flush Pump Sets... 12 Re-priming after Bag Empty... 12 Selecting Feed Mode... 12 EZMODE Option... 12 Selecting EZMODE ... 13 Kangaroo™ ePump™ Enteral Feed and Flush Pump with Pole Clamp

Table of Contents Selecting Continuous or Intermittent Feed Mode ... 13 Continuous Mode (Adjust Feed) Continuous Mode Feeding... 14 Continuous Mode Flushing... 14 Intermittent Mode (Adjust Bolus) Intermittent Mode Feeding... 15 Intermittent Mode Feeding - Bolus Max... 15 Intermittent Mode Flushing... 16 Run... 16 Keep Tube Open (KTO)... 17 Lock Screen Feature... 17 Hold... 17 Clear Volume Fed... 18 Adjust Settings... 18 Resume In __ Min... 18 Run Mode... 18 View History... 18 Flush Now... 19 More Options ... 19 Buzzer Alarm Volume... 19 History... 19 Language Selection... 19 Continuous/Intermittent Mode... 19 BioTech Menu... 20 Accessing the BioTech Screen... 20 BioTech Screen Data... 20 BioTech Options... 20 Lock Settings Feature (Program Locked)... 20 EZMode... 20 Communication ... 20

Section VI - Performance Evaluation System Performance Tests... 21 Certifying the Accuracy of Pump Flow Rate ... 21

Section VII - Cleaning... 22 Kangaroo™ ePump™ Enteral Feed and Flush Pump with Pole Clamp

Table of Contents Section VIII - Battery Replacement... 24 Section IX - Error/Warning/Informational Screens and Troubleshooting

System Error... 26 Hold Error... 28 Rotor Error... 28 Feed Error... 28 Flush Error... 29 Flow Error ... 29 Pump Set Dislodged Error... 30 Battery Low... 30 Feeding Complete... 30 Pump Set Use >24 Hours Warning... 30 LED Array... 30

Section X - Specifications and Symbols Specifications... 31 Symbols on Pump and Accessories... 33

Section XI - Customer Service... 34 Section XII - Maintenance Side Door Enclosing Pump Set Loading Area ... 34 Battery Pack ... 35 Battery Door ... 35 A/C Power Adapter... 35 Pole Clamp ... 35

Section XIII - Service Part Numbers ... 35 Section XIV - Warranty... 37 Section XV - Electromagnetic Conformity Declaration... 38

This product contains software solely owned by Covidien. Covidien grants the user a non-exclusive, limited license to use the software according to the operating instructions. A copy of the license can be obtained from Covidien.

Kangaroo™ ePump™ Enteral Feed and Flush Pump with Pole Clamp

Section I – General Information The Kangaroo™ ePump™ enteral feed and flush pump with pole clamp is a simple-to-use, precision enteral feeding pump. It is easily programmed to provide patients with either continuous or intermittent feeding, and can provide automatic flushing capability when used with Kangaroo™ ePump™ feed & flush sets.

Intended use: Intended for use in patients with any condition requiring enteral feeding and/or enteral hydration, which can be accomplished by means of an enteral feeding pump and pump set. The pump and feeding sets are intended to be used in alternate and acute care settings by clinicians. The purpose of this device is to deliver enteral nutrition at a controlled rate to a patient’s gastrointestinal system.

User Interface: • Intuitive user interface • Large, backlit LCD display • Step-by-step prompts to guide programming and operation • “Stoplight” LED array visually indicates pump status in a bright or darkened room

Ergonomics: • Quiet operation • Compact, aesthetic design • Tabletop usage or IV pole mounting • Simple loading of pump sets • Transparent side door to protect pump set • Integrated handle for easy transport

Features: • MISTIC (Magnetic Intelligent Set Type Identification Connector) Feed-Only vs. Feed & Flush Set identification system to ensure match between the pump’s user interface and pump set type • Automatic Anti-Free-Flow (AFF) System • Audible alarm to indicate errors or pump set loading conditions • Attitude-independent design eliminates need for drip chamber on pump set • Sensor technology detects both upstream and downstream flow conditions • Continuous feed, intermittent feed, and flush capability • Auto-prime feature reduces the need for time-consuming manual priming • Hold feature with restart and Keep Tube Open (KTO) feature • Stores previous 72 hours of feeding and flushing history

Service: • Serial I/O port for data retrieval • Uses replaceable, rechargeable NiMH Battery Pack for 15 hours of backup power • Removable A/C Power Adapter Kangaroo™ ePump™ Enteral Feed and Flush Pump with Pole Clamp

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Status Line

Menu Selections

Status LEDs

Input Settings Menu Selection Buttons

Output Totals Power Button

Graphic Display

Front

Battery Status

Integrated Handle Feeding Set Cap Storage Area Pole Clamp Attachment Point

A/C Adapter Port

Serial I/O Port Door

Battery Compartment

Back Figure 1A. Kangaroo™ ePump™ features, front and rear views.

Kangaroo™ ePump™ Enteral Feed and Flush Pump with Pole Clamp

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Feeding Set Capture

Pole Clamp

Feeding Set Loading Area Figure 1B. Kangaroo™ ePump™ pump set loading area.

Section II - Safety and Warnings Caution: U.S. federal law restricts the sale of this device to physicians or to their direct representatives. 1. Read this booklet thoroughly before using the Kangaroo™ ePump™ enteral feed and flush pump. 2. Do not use this device near flammable anesthetics. 3. Disconnect power supply before cleaning or servicing. 4. Use only Kangaroo™ ePump™ Enteral Feed and Flush Pump A/C Power Adapter with pump. See Section XIII - Service Part Numbers for replacement of power adapter. Use of an alternate consumer style A/C power adapter may cause damage to the charging circuit and battery of the Kangaroo™ ePump™ feeding pump. 5. Danger: Use only Kangaroo™ ePump™ enteral feed or feed with flush pump sets with this device. Pump is not compatible with other pump sets. Use of other feeding sets with this pump can create hazardous situations, including free-flow conditions that can result in overfeeding, underfeeding, formula in the lungs, and death to a patient. 6. For performance tests, see Section VI - Performance Tests. For other integrity checks, consult with a qualified biomedical technician or contact the manufacturer (Section XI - Customer Service). 7. For service or for technical information, please contact Customer Service (Section XI). 8. Do not open the main housing, as there are no user-serviceable parts inside. Opening may affect function of device and voids the warranty. To replace battery, see Section VIII. 9. Dispose of old battery-powered electronic equipment in a manner consistent with institutional policy for expired equipment disposal. 10. Cleaning frequency and practices must be consistent with institutional policy for cleaning of non-sterile devices. See Section VII - Cleaning, for instructions on cleaning the Kangaroo™ ePump™ enteral feed and flush pump. Kangaroo™ ePump™ Enteral Feed and Flush Pump with Pole Clamp

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11. See icon descriptions in Section III - Icon Identification and Section X - Specifications and Symbols for additional safety information. 12. This device is designed to minimize the effects of uncontrolled electromagnetic interference and other types of interference from external sources. Avoid use of other equipment that may cause erratic operation or degradation in the performance of this device. 13. Warning: The serial I/O port (see Figure 1A) is intended only for use with the approved communication cable (Part Number 382499). Any other equipment that can be connected to the DB9 Serial I/O port may lead to a reduced level of safety of the pump. • The Covidien approved Communication Cable (Part Number 382499) is specifically approved as complying with the safety requirements for accessories used with the pump, whereas the safety approval of the accessory has been performed in accordance to the appropriate IEC 60601-1 and/or IEC 60601-1-1 harmonized standard. • Connection of the pump to other equipment could result in previously unidentified risks. Before connecting to other equipment, the risks of using the pump with this equipment should be identified, analyzed, evaluated, and controlled prior to use. 14. Caution: This enteral feeding pump should only be used for patients who can tolerate the flow rates and accuracy levels delivered by the pump. Premature infants may require higher accuracy rates than specified for this enteral feeding pump. 15. Do not attempt to rotate the valve stem inside the feeding set valve assembly. Rotation of the valve stem can only be done by the pump while the valve assembly is properly loaded into the pump. 16. Should feeding sets require rinsing, it is recommended that the feeding sets be rinsed while they are loaded in the pump. 17. Used feeding sets should be disposed of in accordance with current hospital procedure or local disposal guidelines. 18. Caution: Ensure buzzer hole is unobstructed during normal operation so as to allow clear recognition of alarm. Inability to hear the alarms could pose a serious risk to the patient, since the operator may not hear an alarm. 19. Caution: The battery cells used in this device may present a fire or chemical hazard if mistreated. Do not disassemble, heat above 100°C (212°F), or incinerate. 20. Danger: Strangulation Hazard. Avoid leaving power adapter wires, feeding set tubing or other choking hazards where infants or young children can become caught. If these objects get wrapped around a child’s neck, strangulation and death can occur. 21. Danger: The pump and disposable feeding set all contain small parts which could become detached and pose a choking hazard. Some of these components could be inhaled or swallowed by a small child, toddler, or infant, which could result in suffocation and death. Keep all small components out of reach of small children. 22. Danger: Explosion Hazard. Do not use the pump in the presence of flammable anesthetics. Flammable anesthetics can ignite due to a spark within the unit, which could result in fire or explosion. 23. Danger: Do not power the pump while plugged into a power outlet above 2000m altitude, especially while on an airplane or other air vehicle. Do not attempt to charge the pump battery above 2000m altitude. Failure to comply could result in overheating, fire, or explosion of the internal rechargeable battery pack. Run the pump only using the internal pump battery power in these situations. 24. Caution: Do not store the pump or power adapter at temperatures >50°C (122°F). This can damage the equipment sensors, which will prevent the pump from operating under normal conditions. 25. Warning: Do not modify this equipment without authorization of the manufacturer. Modification of any devices or accessories can result in physical hazards including delayed therapy, over delivery, under delivery, electrocution, and fire. These hazards could result in patient injury or death. 26. Caution: The power adapter wires, feeding set tubing, and pump accessories may cause a tripping hazard. Avoid leaving wires, cords, or tubing in a pathway where a person could trip on them and sustain an injury.

Kangaroo™ ePump™ Enteral Feed and Flush Pump with Pole Clamp

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27. Caution: Avoid using accessories, detachable parts and materials with the pump that are not recommended in this manual. Use only approved Kangaroo™ ePump™ accessories with the pump. 28. Caution: Use the pump only as directed in this user manual. Do not interconnect this device with other devices or modify the equipment in any way outside of the recommendations in this manual. Failure to comply could result in incorrect delivery of formula to the patient and could result in damage to the pump. 29. Caution: This pump is not intended to be used in MRI environments or in the presence of strong magnetic fields. Do not use these devices in any areas with strong magnetic fields. The pump contains metal components which could cause unintended movement. This unexpected movement could cause harm due to falling objects or collisions. 30. Caution: There are significant hazards associated with accidental misconnections with other infusion devices, which could lead to patient harm or death. For more information about hazards and risk reduction strategies associated with misconnections, see the following: The Joint Commission Sentinel Event Alert Issue 36 - April 13, 2006. 31. Do not use the pump for delivery of any fluids or substances that are not enteral solutions prescribed by qualified medical personnel. 32. The pump is designed to be used outdoors for short periods of time (no more than 24 hours). Leaving the pump outdoors for extended periods of time (exceeding 24 hours) can result in damage and/or fading of the pump devices. 33. This device is designed for use on a conventional IV pole. As with any medical device, it is possible for the weight of the pump to cause the IV pole to tip over. This could result in injury to a patient or operator. When attaching the pump to the IV pole, take precautions to ensure the IV pole remains stable while in use. 34. This enteral feeding system was designed to meet IEC 60601-1 safety standards. For clarification, purposes, the feeding set is considered an Applied Part and has been tested and evaluated accordingly. 35. Warning: Not for intravenous use. Do not use for intravenous infusion into a patient. Intravenous infusion of enteral fluids can result in serious complications up to and including death. 36. Warning: This enteral feeding pump should only be used for patients who can tolerate the flow rates and accuracy levels delivered by the pump. Premature infants may require higher accuracy rates than specified for this enteral feeding pump. Delivery of fluid to patients who cannot tolerate the pump accuracy can result in over or under delivery with the possibility of aspiration. 37. Use only commercially available pre-packed or commercially prepared feeding solutions prescribed by a licensed health care provider, dietitian or nutritionist. Do not use homemade blenderized or liquidised foods or other non-prescribed, noncommercially available feeding solutions.

Kangaroo™ ePump™ Enteral Feed and Flush Pump with Pole Clamp

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Section III – Icon Identification Run Mode

Vertically-moving droplet in RUNNING screen indicates Run mode.

Battery Symbols • Full charge • 2/3 or less charge • 1/3 or less charge • Very low battery (30 minutes max.)

Auto Priming Indicator When auto priming, the bar will progress to show auto prime feature is active.

Volume Setting Indicates alarm volume setting.

Error Indicator Pump operations are stopped until the error is resolved.

Information Indicator This indicates information only, and does not require any immediate action.

EZMODE Indicator Indicates that EZMODE feature is turned on.

Communication Indicator Indicates that communication feature is turned on.

Volume to be Delivered Indicator Indicates that VTBD feature is turned on.

Keep Tube Open Indicates that Keep Tube Open feature is turned on.

Kangaroo™ ePump™ Enteral Feed and Flush Pump with Pole Clamp

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Section IV - Initial Setup Attaching the A/C Power Adapter

A/C Adapter Port

A/C Adapter Plug

Plug the A/C Power Adapter (Part Number 382491) into the A/C adapter port on the back of the pump. See Figure 1A to locate port on pump. Make note of the location of the pins and tab on the plug to properly orient the plug. The connector, which attaches to the back of the pump, has a spring-loaded locking sleeve that locks into the pump, thus helping to prevent the connector from being accidentally unplugged from the pump. To remove the connector, grasp the outer sliding sleeve member and pull. Do not detach the connector by pulling on the cord only.

Use care aligning adapter with pump connector Figure 2. Alignment of A/C adapter plug with pump’s adapter port.

Battery Setup

The battery pack is fully charged before shipping, and is left unconnected to optimally preserve battery life. Warning: The battery should be connected before using the pump. It is also recommended that the battery charge be “topped off” before battery-only operation is utilized. The battery pack will charge continuously whenever the pump is plugged into a wall outlet, including during normal use of the pump with A/C power. Eight hours of charging is required to fully recharge the battery pack. A new battery pack will provide approximately 15 hours of service before needing to be recharged.

Attaching Pole Clamp The Kangaroo™ ePump™ enteral feed and flush pump can be attached to a vertical pole using the pole clamp, included with the pump. The pole clamp provides the ability to retain the power cord to prevent accidental cord removal or cord loss. Simply place the A/C adapter power cord into the U-shaped groove located on the back of the pole clamp as shown in Figure 3 and attach the pole clamp to the Kangaroo™ ePump™ enteral feed and flush pump. Be sure not to pinch the cord of the A/C power adapter or damage the cord insulation when installing. To attach the pole clamp to the Kangaroo™ ePump™ enteral feed and flush pump, align the hole on the pole clamp with the mounting hole on the back of the pump. Use a 3/8” - 16 bolt to fasten together, as shown in Figure 3. If cord restraint is preferred but use of the pole clamp is not desired, a cord restraint clip is provided with the Kangaroo™ ePump™ enteral feed and flush pump. Using the pole clamp mounting bolt, follow the pole clamp assembly instruction to attach the cord clip (Refer to Fig. 3).

Figure 3. Attaching and using the pole clamp or cord clip.

Kangaroo™ ePump™ Enteral Feed and Flush Pump with Pole Clamp

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Section V - Instructions For Use Quick Start 1. Press

POWER on lower, right-hand corner of control panel.

2. Open blue door enclosing pump set loading area. 3. To load pump set , refer to Figure 4: • Grasp finger tab on valve and insert into left pocket (1). • Grasp black ring retainer and gently stretch tubing around rotor (2). Pull up on retainer and insert into right pocket (3). • Press down on finger tab to ensure that valve is fully seated. Finger tab should align with locating rib. • Close blue door. (Note: display status line should read SET LOADED). 4. To automatically prime the pump, press4PRIME PUMP and4AUTO PRIME. For Kangaroo™ ePump™ feed & flush sets, auto priming will prime both lines. 5. To directly control pump priming, press4PRIME PUMP and then press and hold the HOLD TO PRIME button(s)4. If a feed & flush set is used, remember to first press4HOLD TO PRIME FLUSH until the flushing fluid has reached the valve, and then press4HOLD TO PRIME FEED until the feeding fluid has reached past the valve and down to the distal end connector. 6. Use buttons4on left side of LCD to set the feeding parameters. Set flushing parameters if a feed & flush set is loaded. The continuous or intermittent feed mode selection is made under the MORE options menu. 7. Press4RUN when ready to start. The screen will display RUNNING. 8. To stop, press4HOLD or press and hold the

POWER button.

Black Ring Retainer (MISTIC)

Finger Tab

1

3

Valve

2 Rotor Figure 4. Installation of pump set.

Kangaroo™ ePump™ Enteral Feed and Flush Pump with Pole Clamp

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General Startup Placement/Mounting There are two recommended placement methods for the Kangaroo™ ePump™ enteral feed and flush pump. • Attached to a vertical IV pole via the pole clamp peripheral device, included with the pump. • Placed feet down on any horizontal surface.

A/C Power Operation Plug the Kangaroo™ ePump™ enteral feed and flush pump into an A/C power outlet for normal operation. When the pump is not plugged in, or if A/C power is interrupted, a built-in rechargeable battery will run the pump.

Battery Power Operation If A/C power is not available to the pump, or if A/C power is interrupted, the pump will automatically operate on backup battery power. The built-in battery recharges any time the pump is plugged into an outlet. A fully-charged, new battery will supply 15 hours of backup power at 125 mL/hr before requiring recharging. Contact Customer Service, Section XI, to replace the battery pack if battery life degrades.

Power On/Off To power up the pump, press the POWER button on the lower right of the front panel. To power down the pump, press and hold the POWER button. A countdown will begin on the display; when the countdown reaches 0, immediately release the POWER button. Note: The display backlight and Status LED array will remain on for a short period after releasing the POWER button while the pump completes its internal power down process and will then extinguish.

Language Selection, First Power Up Immediately after powering up the pump for the first time, the language option screen will appear. Select the language using the (  ) or (  ) buttons. When the language is selected, push the fifth button (  ) to enter the language selection. After the language is selected the first time the pump is powered up, the language selection screen will not appear during future power up operations. Should the language need to be changed after the initial power up, it can be changed through the “MORE OPTIONS” menu (see Figure 10A).

Keep or Clear Prior Pump Settings Immediately after powering up the pump, if the prior feed or flush settings were not cleared and the settings are not locked in the BioTech Screen, the pump will give the following two options:

KEEP SETTINGS - Select this option to start with the same settings that were most recently programmed into the pump. Any of the previously-programmed settings can be modified, if needed. The feed volume totals, “mL FED” (Continuous Feed Mode) or “BOLUSES FED” (Intermittent Feed Mode) and “mL FLUSH” are also maintained.

CLEAR SETTINGS - Select this option to reset all input feeding settings and the output feed totals to zero. It will then be necessary to program all settings before running the pump. The BioTech options settings will not change.

The status line of the pump will then show LOAD A SET (Figure 5), or, if the pump set is already loaded, it will show SET LOADED (Figure 7).

Kangaroo™ ePump™ Enteral Feed and Flush Pump with Pole Clamp

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Note: The output feed totals (“mL FED,” “BOLUSES FED,” “mL FLUSH”) can be cleared at any time, and without clearing the input settings, by doing the following: • Start the pump RUNNING • Press4HOLD • Press4CLEAR VOLUME

Loading Pump Sets The Kangaroo™ ePump™ enteral feed and flush pump will indicate LOAD A SET in the screen’s status line if a pump set is not installed. A blinking icon of a pump set will also appear in the upper left corner of the screen. Figure 5A shows the screen for continuous feeding mode and Figure 5B shows the screen for intermittent feeding mode (intermittent feeding mode not available in EZMODE). To load a pump set, follow the steps below:

Figure 5A. LOAD A SET opening menu screen for Continuous Feeding mode (EZMODE not activated).

1. Open the blue transparent door that encloses the rotor and pump set loading area. 2. Load the pump set by holding the finger tab on the valve, and inserting the valve down into the slot on the left. (Figure 6A) 3. Grasp the MISTIC retainer end (black ring retainer) and wrap the tubing counterclockwise around the rotor. Avoid overstretching the silicone tubing. (Figure 6B) 4. Carefully pull the MISTIC retainer end upwards to position it over the slot on the right, and then lower the retainer into the slot. (Figure 6B) 5. Press down on the valve’s finger tab to ensure proper seating.

Figure 5B. LOAD A SET opening menu screen for Intermittent Feeding mode (EZMODE not activated).

6. Close blue transparent door. 7. The bottom of the feed bag should be 18 inches from the top of the pump.

Pump Set

Set Loading Door

Finger Tab Valve

MISTIC Retainer End Power Button

Figure 6A.

Figure 6B.

Kangaroo™ ePump™ Enteral Feed and Flush Pump with Pole Clamp

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The display should read SET LOADED and will show one of the following opening menus, depending on the type of pump set detected, and whether continuous or intermittent feeding mode has been selected.

Figure 7A. Opening menu for Continuous Feed mode with a feed-only set.

Figure 7B. Opening menu for Continuous Feed mode with a feed & flush set.

Figure 7C. Opening menu for Intermittent Feed mode with a feed-only set.

Figure 7D. Opening menu for Intermittent Feed mode with a feed & flush set.

Prime Pump The Kangaroo™ ePump™ enteral feed and flush pump may be primed automatically with a single button push, including the flushing line if a feed & flush set is loaded. The pump can also be primed in a more interactive method using the hold-to-prime feature. The flow rate for priming, whether Auto Prime or Hold-to-Prime, is 1960 ml/hr (32.7 mL/minute). Note: During priming the Flow Error alarm is disabled. After a pump set has been loaded and the status line shows SET LOADED, press4PRIME PUMP in the opening menu (Figures 7A-7D) to get one of the PRIME PUMP menus shown in Figures 8A-8B.

Figure 8A. PRIME PUMP menu for feed-only set.

Figure 8B. PRIME PUMP menu for feed & flush set.

Auto Priming The AUTO PRIME option will be available if the pump senses that the currently installed pump set was not previously primed, and that there is no fluid in the line near the rotor. If auto-priming is desired, press and release4AUTO PRIME to automatically prime the line(s). For feed & flush pump sets, the auto prime feature will automatically prime both lines, starting with the flush line. Press4STOP to cancel AUTO PRIME. When auto-priming is completed, the status line will show AUTO PRIME COMPLETE and will no longer show the AUTO PRIME option. Be sure that the line(s) are fully primed. If not, use the hold-to-prime option(s) to complete the priming, as described below.

Hold-to-Prime The hold-to-prime options allow for precise interactive control of the priming process.

Feed-Only Pump Sets For feed-only pump sets, the screen will appear as in Figure 8A. Press and hold4HOLD TO PRIME FEED until the feed line has been primed down to the stepped end connector at the end of the pump set. Kangaroo™ ePump™ Enteral Feed and Flush Pump with Pole Clamp

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Feed & Flush Pump Sets For feed & flush pump sets, the display will appear as in Figure 8B. First press and hold4HOLD TO PRIME FLUSH to prime the flushing line, and then press and hold4HOLD TO PRIME FEED to prime the feed line down to the stepped end connector at the end of the pump set. If a feed & flush pump set is used, remember to first press4HOLD TO PRIME FLUSH until the flushing fluid has reached the valve, and then press4HOLD TO PRIME FEED until the feeding fluid has reached past the valve and down to the stepped end connector. If the feeding line is primed first, subsequent priming of the flushing line will force the air between the flush solution bag and valve into the main line, which already has been primed with enteral formula.

Re-priming after Bag Empty A pump set bag that has been emptied will trigger the FEED ERROR screen. In this condition the pump set bag can be refilled to continue the feeding, but only after the pump set has been re-primed. To re-prime the pump set, do the following: • Disconnect the feeding line from the patient • Refill the bag • Press4CONTINUE to begin the pump RUNNING • Press4HOLD • Press4ADJUST SETTINGS • Press4PRIME PUMP • Press4HOLD TO PRIME to prime the line(s) Pump sets should not be reused after 24 hours of initial usage. The feeding set should also be replaced after 24 hours from initiation of feeding. This ensures that the system is operating within specified parameters and prevents bacterial growth that could be a hazard to the patient.

Selecting Feed Mode EZMODE Option The EZMODE option is a limited, CONTINUOUS MODE only setting of ePump™. It feeds non-stop (no VTBD option) at a rate 0-400mL/hr as defined by the user until manually stopped. It has no BOLUS, FLUSHING, RUN MODE SCREEN LOCK, or AUTORESUME capability and displays no HISTORY information. Turning on EZMODE will automatically force the unit out of the INTERMITTENT (BOLUS FEED) mode if set. Although the Continuous Mode feed VTBD will be set to 0 while EZMODE is enabled, the previous value of the Feed VTBD will be stored in flash memory and recalled when “EZMODE” is deselected. The user can change the Feed Rate by normal means. All other user settings, including those not compatible with the EZMODE (BOLUS VTBD, NUMBER OF BOLUSES, SUPER BOLUS, etc), that were set before the pump was put into the EZMODE will be ignored and invisible while in EZMODE but remain stored in the flash memory for when EZMODE is deselected. EZMode essentially has no effect on CLEAR SETTINGS; pressing CLEAR SETTINGS while EZMODE is enabled will clear all feed and flush settings and totalizers as normal, not just those that apply to EZMODE. Selecting the CLEAR SETTINGS option on power up will not clear Biotech Options such as EZMODE or LOCK SETTINGS. If the user selects the ADJUST FEED option from either the LOAD A SET or SET LOADED screens, control will pass directly to and from the Enter Feed Rate screen and bypass the ADJUST FEED screen since without the ability to adjust VTBD in EZMode, the Adjust Feed screen is redundant. Kangaroo™ ePump™ Enteral Feed and Flush Pump with Pole Clamp

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Selecting EZMODE EZMODE may be selected through the Biotech Options button which may be accessed on the Biotech screen (see page 19). The EZMODE setting will be stored in the flash memory and saved when the unit is shut off. Note: If the user inserts a feed/flush set while the EZMODE is enabled, EZMODE will be cancelled and the unit will immediately revert back to the normal mode. If EZMODE is desired, the user must then re-enable EZMODE through the Biotech Options screen. When enabled and not in CERTIFICATION MODE, a small EZ icon will be visible on the bottom of the screen near the battery icon. However, it will not appear in the POWER DOWN, SYSTEM ERROR, or LOW BATTERY SCREENS.

EZ Mode icon Figure 9.

Selecting Continuous or Intermittent Feed Mode The Kangaroo™ ePump™ enteral feed and flush pump can be programmed to feed continuously or intermittently. The continuous feeding mode will deliver the enteral nutrition at a steady rate, either until the programmed volume has been delivered or until the supply has been exhausted. The Intermittent feeding mode delivers boluses of enteral nutrition at programmed time intervals. The bolus volume and feed rate are also programmed. To select continuous feed mode or intermittent feed mode, press4MORE on the opening menu, shown in Figures 5A-5B or Figures 7A-7D, to access the MORE OPTIONS menu, Figure 10A. The MORE option is available either before a pump set has been loaded (Figures 5A-5B) or after the pump set is loaded (Figures 7A-7D). See subsection “More Options” for information on the other options in the MORE OPTIONS menu. Select4CONTINUOUS/INTERMITTENT under the MORE OPTIONS menu, Figure 10A. Then press 4CONTINUOUS MODE or4INTERMITTENT MODE from the SELECT MODE menu, Figure 10B. Press4DONE to exit.

Figure 10A. MORE OPTIONS menu.

Figure 10B. SELECT MODE menu for continuous or intermittent mode selection.

Kangaroo™ ePump™ Enteral Feed and Flush Pump with Pole Clamp

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Continuous Mode - Adjust Feed Continuous Mode Feeding For CONTINUOUS feeding mode, the ADJUST FEED option is available in the opening menus (Figure 7A for feed-only sets or Figure 7B for feed & flush sets). Select this option to program the feeding parameters from the ADJUST FEED screen, Figure 11A. Press4FEED RATE in Figure 11A to define the rate of delivery. Press the4buttons in Figure 11B to program the rate from 1 to 400 in increments of 1 mL/hr. Press4ENTER (top button) to exit the menu. Press4FEED VTBD in Figure 11A to define the Volume To Be Delivered. Press the4buttons in Figure 11C to program the volume from 1 to 3000 mL in increments of 1 mL. Press4ENTER (top button) to exit the menu. If the FEED VTBD is set to zero, the pump will run until the supply is exhausted. Note: When a FEED VTBD is set, the remaining volume to be delivered (remaining VTBD) will be displayed next to the v icon on the lower right-hand portion of the screen (Figure 11A). If the FEED VTBD is reprogrammed during a feeding, from HOLDING mode, the pump will restart the feeding and deliver the entire volume of the new VTBD setting.

VTBD symbol Figure 11A. ADJUST FEED menu.

Figure 11B. Setting the Feed Rate.

Figure 11C. Setting the Feed Volume to be Delivered.

Continuous Mode Flushing (Not Available in EZMODE) For CONTINUOUS feeding mode with a feed & flush set loaded, the opening menu will appear as shown in Figure 7B. Press4ADJUST FLUSH in Figure 7B to program the flushing parameters from the ADJUST FLUSH screen, shown in Figure 12A. Press4FLUSH VOLUME in Figure 12A to define the volume per flush occurrence. Press the4buttons in Figure 12B to program the flush volume from 10 to 500 in increments of 1 mL. Press4ENTER (top button) to exit the menu. Press4FLUSH INTERVAL in Figure 12A to define the time interval between starts of flushing. Press the4buttons in Figure 12C to program the time interval from 1 to 24 hours in increments of 1 hour. Press4ENTER (top button) to exit the menu. The pump will automatically limit flushing settings which exceed pump capabilities to deliver. Caution: The Kangaroo™ ePump™ enteral feed and flush pump flushes at a rate of 1960 mL/hr (32.7 mL/minute). Use care when programming the flush volume so that it matches the patient’s need. Note: The pump will automatically flush an additional 25 mL of water after completing the programmed delivery of formula, as long as at least one flush had occurred during formula delivery.

Figure 12A. ADJUST FLUSH menu, continuous mode.

Figure 12B. Setting the Flush Volume.

Kangaroo™ ePump™ Enteral Feed and Flush Pump with Pole Clamp

Figure 12C. Setting the Flush Time Interval.

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Intermittent Mode - Adjust Bolus (Not Available in EZMODE) Intermittent Mode Feeding For INTERMITTENT feeding mode, the ADJUST BOLUS option is available in the opening menus (Figure 7C for a feed-only set or Figure 7D for a feed & flush set). Select this option to program the feeding parameters from the ADJUST BOLUS screen, Figure 13A. Press4BOLUS RATE in Figure 13A to define the rate of delivery. Press the4buttons in Figure 13B to program the delivery rate from 1 to 400 in increments of 1 mL/hr. Press4ENTER (top button) to exit the menu.

Figure 13A. ADJUST BOLUS menu.

Press4NUMBER OF BOLUSES in Figure 13A to define the total number of boluses to be delivered. Press the4 buttons in Figure 13C to program the number of boluses, up to a maximum of 99. Press4ENTER (top button) to exit the menu. The number of boluses can be set as zero, in which case the pump will run until the supply is exhausted. Press4VOLUME PER BOLUS in Figure 13A to define the volume to be delivered in each bolus.

Figure 13B. Setting the Bolus Rate.

Press the4buttons in Figure 13D to program the volume per bolus from 1 to 3000 mL in increments of 1 mL. Press4ENTER (top button) to exit the menu. Press4BOLUS INTERVAL in Figure 13A to define the time interval between starts of bolus deliveries. Press the4buttons in Figure 13E to program the time interval between starts of bolus deliveries from 1 to 24 hours in increments of 1 hour. Press4ENTER (top button) to exit the menu.

Figure 13C. Setting the Number of Boluses.

The pump will automatically limit bolus settings which exceed pump delivery capabilities. For example, a bolus delivery volume of 200 mL cannot be made once per hour if a rate of 150 mL/ hr is already programmed. In this case, the maximum volume allowed would be 150 mL. Note: If the NUMBER OF BOLUSES is reprogrammed during a feeding (from HOLD mode), the pump will restart the bolus feeding and will deliver all the boluses as defined by the new setting.

Intermittent Mode Feeding – Bolus Max (Not Available in EZMODE) The BOLUS MAX option can be used to deliver a bolus at a high rate, similar to gravity feeding.

Figure 13D. Setting the volume per Bolus.

Press4BOLUS MAX in the BOLUS RATE menu, Figure 13B, to program the BOLUS MAX mode. The feeding rate for BOLUS MAX is 999 mL/hr.

Figure 13E. Setting the time interval between starts of bolus.

Kangaroo™ ePump™ Enteral Feed and Flush Pump with Pole Clamp

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Intermittent Mode Flushing (Feed flush set only) For INTERMITTENT feeding mode with a feed & flush set, the opening menu, shown in Figure 7D, will show the ADJUST FLUSH option. Press4ADJUST FLUSH in Figure 7D to program the flushing parameters from the ADJUST FLUSH screen, Figure 14A.

Figure 14A. ADJUST FLUSH menu, intermittent mode.

Figure 14B. Setting the Flush Volume.

Figure 14C. Setting the Flush Time Interval.

Note: The nature of two intermittent processes, periodic bolus feeding and periodic flushing, is such that occasional conflicts can arise where each process needs to be running at the same time. The flushing process is assigned precedence over the feeding process for feed & flush pump sets. “Flushing precedence” means that a flush cycle will run to its end even if a bolus delivery is scheduled to begin. It also means that a flush cycle will interrupt a bolus feeding cycle that is already in progress. The feeding cycle will pick up where it was interrupted after the flushing cycle is complete. It is therefore possible that the net feeding volume is reduced from what may be intended, over a given time period. Press4FLUSH VOLUME in Figure 14A to define the volume per flush cycle. Press the4buttons in Figure 14B to program the flush volume from 10 to 500 in increments of 1 mL. Press4ENTER (top button) to exit the menu. Press4FLUSH INTERVAL in Figure 14A to define the time interval between starts of flushing. Press the4buttons in Figure 14C to program the time interval from 1 to 24 hours in increments of 1 hour. Press4ENTER to exit the menu. The pump will automatically limit flushing settings which exceed pump capabilities to deliver. Caution: The Kangaroo™ ePump™ feed and flush pump flushes at a rate of 1960 mL/hr (32.7 mL/minute). Use care when programming the flush volume so that it matches the patient’s need. Note: The pump will automatically flush an additional 25 mL of water after completing the programmed delivery of formula, as long as at least one flush had occurred during formula delivery.

Run The Kangaroo™ ePump™ Enteral feed and flush pump will only run when a pump set is properly loaded and the necessary feeding parameters have been programmed. For a feed & flush set, the flushing parameters do not have to be set for the pump to begin operating. If flushing parameters are set as zeros, there will be no flushing. After the pump has been programmed, press4RUN to start operation. Figure 15A shows the RUNNING screen for continuous feeding with flushing. The status line will indicate RUNNING, and the droplet icon will move vertically on the screen. The green LED indicator will be illuminated to give a quick visual indication of positive status in a darkened room. The RUNNING screen shows the feed rate, amount fed, flushing data if a feed & flush pump set is used, and the remaining volume to be delivered (remaining VTBD). The remaining VTBD is shown next to the v icon.

Kangaroo™ ePump™ Enteral Feed and Flush Pump with Pole Clamp

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