Kangaroo Connect Operator Manual with Wireless Comms Hub March 2014

Thank you for purchasing the Kangaroo™ Connect Enteral Feeding Pump system. With proper care, this system will provide you with years of precision service.

Table of Contents Section 1 Section 2 Section 3 Section 4 Section 5

Pump Overview...3 Safety and Warnings...4 User Interface...6 Symbols...7 System Setup Attaching the Power Adapter ...8 Installing the Wireless Communications Hub (WCH) ...9

Section 6

User Screens Preparing for a feed... 11 Cassette loading sequence... 11 Priming the pump... 12 Entering feed rate settings... 12 More options... 13 Adjusting Dose... 13 Entering BIOTECH MODE... 14 Adjusting Bolus... 14 Adjusting KTO... 15 Lock settings... 15 Language & Power Save settings... 16 How to Lock/Unlock the input screen... 16

Section 7

Certification of Performance Manual Certification... 17

Section 8 Section 9

Cleaning... 18 Alarms and Troubleshooting Feed set usage... 19 Setting Locked... 19 Feed Complete... 20 Feed Incomplete... 20 Communication Lost... 20 Pump Inactive... 20 Low Battery... 21 Feed Bag Empty... 21 Rotor Stuck... 21 Patient Tube Blocked... 21 Supply Tube Blocked... 22 Cassette Dislodged... 22 Cassette Error... 22 Dead Battery... 23 System Error... 23

Section 10 Section 11 Section 12

Specifications... 25 Customer Service... 27 Maintenance Wireless Communications Hub... 28 Power Adapter... 28 Pole Clamp Metal Clip Kit... 28 Cassette Metal Clip Kit... 28

Section 13 Section 14 Section 15 Section 16

Service Part Numbers... 29 Warranty... 30 Electromagnetic Conformity Declaration... 31 Glossary of Terms... 35 Appendix A... 36 Appendix B - Explanation of Alarms... 38

Section 1 – Pump Overview The Kangaroo™ connect enteral feeding pump is a portable rotary peristaltic enteral feeding pump, intended to provide enteral nutrition to a patient. It can be programmed to provide patients with continuous, dose, or bolus feeding when used with Kangaroo™ connect feeding sets. The pump may also be used with a Kangaroo™ connect wireless communications hub (hereafter called the WCH), which allows for new communication options. The Kangaroo connect enteral feeding pump is intended for hospital and acute care settings, as well as for long term and home care use. It is intended to be used in both stationary and ambulatory conditions. The Kangaroo connect pump can be used for both adult and pediatric patients, provided the patient can tolerate the flow rates and accuracy level of the pump.

User Interface:

Features:

• Large, color LCD display • Step-by-step prompts and animated illustrations to guide pump operation • “Stoplight” LED array visually indicates pump status in a bright or darkened room • The WCH provides wireless link capabilities • The WCH also charges the pump battery when the pump is docked

Ergonomics: • Quiet pump operation • Compact, lightweight design • Tabletop, bed rail or IV pole mounting • Simple, one-handed loading of pump cassette • Pump is designed for cleaning under running water • Rubberized casing for better grip • Pole clamp can detach from either pump or WCH without removing from IV pole 1. Soft Keys Press a key to select the option that appears next to it on the screen. 2. Flow Indicator (Droplet) Moving droplet flowing down the screen shows that the pump is running.

• Magnetic feeding set identification system to ensure a match between the pump’s user interface and feeding set type • State of the art STOP (Safety Threshold Overflow Protection) valve automatically prevents free flow conditions, even when feeding set is unloaded from the pump • Audible alarm to indicate errors or feeding set loading conditions • Pump orientation-independent design eliminates need for drip chamber on feeding set • Sensor technology detects both upstream and downstream flow conditions • Continuous feed and dose feed capability • Auto-prime feature reduces the need for time-consuming manual priming • “Keep Tube Open” (KTO) feature • View previous 72 hours of feeding history • 17 Languages • ~24 hour battery life at 125 mL/hr (using Power Saver Mode and Airplane Mode) • Unique wireless technology allows for: -- Remote troubleshooting for better user support -- Future software upgrades and new features -- Long term historical trending to better meet patient needs

7

2

3. Power Button Press once to power on. Press and hold to power off. 4. Power Source Shines a green light when the pump is connected to AC power. 5. Pump Rotor The circular black wheel that drives fluid through the feeding set.

6 1

6. Pump Status ● = Warning Alarm ● = Notice or Caution Alarm ● = Standby or Feeding 7. Cassette The feeding set component that attaches to the pump. 

Table of Contents

3

4

5

Kangaroo™ Connect Enteral Feeding Pump with Wireless Communications Hub | 3

Section 2 - Safety and Warnings Note to healthcare personnel who provide training to lay operators or lay responsible organizations:

or tubing in a pathway where a person could trip on them and sustain an injury.

Be sure to include all of the Warnings below when providing training to lay operators, especially in a Home Care Environment. Lay users should be instructed to contact Customer Service if there is a change in the performance of the pump or the WCH. Additionally, Lay Operators should be instructed on proper cleaning procedures to avoid hazards such as electric shock. Lay users should also be trained on inappropriate environments for use (e.g. bathtub) of the pump and WCH. For guidance on training, please contact Customer Service.

11 Caution: Do not store the pump, WCH, or power adapter at temperatures >50ºC (122ºF). This can damage the equipment sensors, which will prevent the pump from operating under normal conditions.

General warnings 1. Caution: Read this booklet thoroughly before using the pump and WCH. 2. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. 3. Danger: Strangulation Hazard. Avoid leaving power adapter cord, 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. 4. Danger: Explosion Hazard. Do not use the pump or WCH device in the presence of flammable anesthetics. Flammable anesthetics can ignite due to a spark within the unit, which could result in fire or explosion. 5. Danger: The pump, WCH, 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. 6. Use only Kangaroo connect feeding sets with this device. This pump is designed to be incompatible with other feeding sets. Danger: 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. 7. 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. 8. 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. 9. 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. 10. Caution: The power adapter cord, feeding set tubing, and pump accessories may cause a tripping hazard. Avoid leaving wires, cords,



Table of Contents

12. Caution: Avoid using accessories, detachable parts and materials with the pump and WCH that are not recommended in this manual. Use only approved Kangaroo connect accessories with the pump and WCH. 13. Caution: Use the pump and WCH 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 and WCH. 14. Caution: Always disconnect power adapter before cleaning or servicing. Failure to do this could result in electric shock to the user performing the cleaning function. In some cases, electric shock can be fatal. 15. 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 a critical alarm. 16. Caution: This pump and WCH are 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 and WCH contain metal components which could cause unintended movement. This unexpected movement could cause harm due to falling objects or collisions. 17. 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 18. Use only the supplied power adapter to charge your feeding pump or WCH from an A/C power source. See Section 13 - Service Part Numbers for replacement of power adapter and the associated part number.

Kangaroo™ Connect Enteral Feeding Pump with Wireless Communications Hub | 4

Section 2 - Safety and Warnings 19. For pump certification, see Section 7 Certification of Performance. For other integrity checks, consult with a qualified Biomedical Technician or contact the manufacturer (Section 11 - Customer Service).

31. Used feeding sets should be disposed of in accordance with current hospital procedure or local disposal guidelines. For disposal of the pump or WCH, be sure to contact local authorities to determine the proper method of disposal of these items, keeping in mind that the pump contains a rechargeable Lithium-Ion battery.

20. For service or for technical information, please contact Customer Service (Section 11).

32. The pump and WCH are 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/WCH devices.

21. Do not open the main pump or WCH housings, as there are no user-serviceable parts inside. Opening may affect function of device and voids the warranty. 22. Cleaning frequency and practices must be consistent with institutional policy for cleaning of non-sterile devices. See Section 8 - Cleaning, for instructions on cleaning the pump and WCH. 23. See icon descriptions in Section 3 - User Interface and Section 4 - Symbols for additional safety information. 24. This device is designed and tested 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. 25. Do not use feeding solutions or formula other than that prescribed by a qualified physician, nurse, registered dietician, or other licensed practitioner. 26. For optimal accuracy, the top of the starting volume of formula should be 10 inches above the top of the pump. Do not reuse feeding sets. 27. Should feeding sets require rinsing, it is recommended that the feeding sets be rinsed while they are loaded in the pump. 28. The feeding set should 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. 29. Do not clean the pump, the WCH, or the accessories while these items are plugged into an electrical outlet. Clean only as recommended in this manual. Failure to clean in accordance with this manual could result in damage or failure of the pumping system.

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 and/ or WCH to cause the IV pole to tip over. This could result in injury to a patient or operator. When attaching the pump and/or WCH 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 606011 safety standards. For clarification purposes, the feeding set is considered an Applied Part and has been tested and evaluated accordingly.

Battery pack warnings 1. Caution: The battery cells used in this device may present a fire or chemical hazard if mistreated. Do not disassemble, heat above 60ºC (140ºF), or incinerate. Avoid exposing the battery pack to heat or fire since a fire or explosion hazard could result. 2. The pump and WCH utilizes a two prong, medical grade power supply adapter specifically designed for use only with this pump’s Lithium-Ion battery charging circuit. Caution: Use of an alternate consumer style power adapter or DC car adapter may cause damage to the charging circuit and battery of the pump or the WCH. 3. The pump contains a rechargeable lithium-ion battery. When disposing of the pump unit, be sure to discard this equipment in a manner consistent with institutional policy for expired battery operated equipment. 4. The stated battery life is approximate. Performance of the battery may degrade due to excessive temperatures, frequent recharging, and other factors. 5. Avoid using battery packs from other providers. Only Covidien pump battery packs are approved for use in this pumping system. 6. After extended periods of storage, it may be necessary to charge and discharge the cells or batteries several times to obtain optimum performance.

30. Do not use the pump for delivery of any fluids or substances that are not enteral solutions prescribed by qualified medical personnel.



Table of Contents

Kangaroo™ Connect Enteral Feeding Pump with Wireless Communications Hub | 5

Section 3 - User Interface 1 2

1

1. Title Bar The Title Bar tells current running status of the pump. 2. Moving Droplet Vertically moving droplet shows the pump is delivering fluid and is working normally.

2 3

4

1. Set Usage > 24 Hrs Indicator shows if the feeding set has been in use for more than the recommended 24 hrs.

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

2. Lock Settings Shows if the pump settings have been locked out to prevent tampering. 3. Airplane Mode When Airplane Mode symbol is showing, indicates that the wireless function is disabled. 4. Battery Charge Status Shows the percentage of charge remaining on the pump battery.

1.

2.

3. Brightness Level Indicator Indicates the brightness level for the pump’s LCD color screen’s backlighting. The brightness setting can be adjusted using the + or - buttons.



Table of Contents

1. Alarm Acknowledged Indicator Pressing this button will temporarily silence the alarm. 2. Pressing this button reactivates a previously acknowledged alarm. 3. Wireless Signal Strength

Kangaroo™ Connect Enteral Feeding Pump with Wireless Communications Hub | 6

Section 4 - Symbols

Symbol

Definition

Symbol

122°F 50°C -13°F -25°C



Definition

Keep away from sunlight

Non-sterile

Keep Dry

Identification of a substance that is not contained or present within the product or packaging.

This product does not contain natural rubber latex.

China RoHS (reduction of hazardous substances)

Authorized representative in the European Community

Federal (USA) law restricts this device to sale by or on the order of a physician

Dispose of as Electrical and Electronic Waste

Catalog number

DEHP free

Ul recognized component certification symbol

Manufacturer

Do not use if package is opened or damaged

32°F 0°C

Symbol

Sterile using ethylene oxide

XX12345

122°F 50°C

Definition

Lithium Ion Battery Li-ion

0123

Use by

CE Mark

Use by or expiration date

Consult instructions for use

Caution for indoor use only

Batch code

Caution, consult accompanying documents

Type BF applied part

Serial Number

Follow instructions for use. Symbol appears blue on device.

Class II Equipment

Date of manufacture

MR unsafe (magnetic resonance)

21

Protection against fluid ingress: Drip-proof

Power Symbol

Feed

25

Water Jet resistant

Network Connection

Do not use for greater than 24 hours

0

Not water resistant

ZigBee™* wireless

Temperature limitations

Non-ionizing electromagnetic radiation

3G Signal Strength

Avoid temperature extremes

NRTL Mark

Table of Contents

Kangaroo™ Connect Enteral Feeding Pump with Wireless Communications Hub | 7

Section 5 - System Setup

Fig. 1

Important Note: The pump and WCH equipment, along with feeding sets and accessories need to be installed and put into service in accordance with the information provided by this manual and accompanying documents.

Attaching the power adapter The pump and WCH were designed to allow two different charging modes for the pump: 1. The pump can be directly charged using the power adapter. Simply: a.

Plug the power adapter into the power adapter port located on the left side of the pump (Fig. 1) plug the other (two prong) end of the power adapter into a nearby A/C outlet.

b.

Check to see that the A/C Indicator Light is on to confirm that the pump is receiving power from the wall outlet.

c.

Since the pump batteries are shipped with less than full charge, be sure to charge the pump for a minimum of 7 hours before initial use.

Fig. 2

2. The WCH is designed to serve as a docking station to re-charge the pump batteries. Quick disconnection is facilitated with the clearly visible eject button. Note: The WCH uses the same power adapter that is provided with the pump. To re-charge the pump in this configuration, simply:

Fig. 3

1. Place the WCH on a tabletop surface or attach to pole clamp.

5.

2. Plug the pump power adapter into the port on the back of the WCH (Fig. 2). 3. Slide the pump from right to left into the WCH until you hear a click (Fig 3). The WCH is designed to automatically latch the pump to the base when the pump is fully seated in the base. 4. Check to see that the Power Indicator Light is on to confirm that the pump is receiving power from the wall outlet. See page 3, number 4, to find the location of the A/C Indicator Light. 

Table of Contents

Since the pump batteries are shipped with less than full charge, be sure to charge the pump for a minimum of 7 hours before initial use.

6. Since the WCH also provides wireless capability to the pump, check that the wireless module is activated by looking through the window on the back of the wireless communications hub (WCH). Confirm that the Power icon in the window is lit up.

Kangaroo™ Connect Enteral Feeding Pump with Wireless Communications Hub | 8

Section 5 - System Setup The Kangaroo connect enteral feeding pump and WCH can be attached to a vertical pole using the pole clamp which is included with the pump. The pole clamp can easily retain either the pump or the WCH. This can be done using the “slide and click” attachment feature located on the back of the pump and the WCH (Fig. 4). To attach the pole clamp to an IV pole, place the inside elbow of the clamp against the IV pole. Turn the knob to tighten the pole clamp against the IV pole. Turn the knob hard enough so the pole clamp does not slide down the pole. Next, rotate the plastic latch plate of the pole clamp so that the “slide and click” feature looks like an upside down letter “U”. Once this step is complete, you are ready to attach the pump or WCH to the pole clamp. Fig. 4

Hold the pump and place the back face of the pump against the flat portion of the pole clamp latch plate. Slide the pump to the right until the pump hits the latch plate guide. Keeping contact with the guide, slide the pump downward until you hear a positive “click”. This indicates that the pump has been properly seated. To remove the pump, gently pull upward on the pump until it “pops” upward off the latch plate (Fig 5). Follow the same procedure as above for attachment of the WCH to the pole clamp. The pole clamp is designed to work universally with either the pump or the WCH (Fig. 5 and Fig. 6). Note: The plastic retention plate is designed to be rotated in 90 degree increments to allow attachment to a horizontal tabletop surface or a horizontal bed rail. If assistance is needed in setting up, using, or maintaining the pump, please contact Customer Service for additional support.

Installing the Wireless Communications Hub (WCH)

Fig. 5

The WCH is designed to work with two accessories that come with the pump: the Kangaroo™ connect power cord with adapter and Kangaroo™ connect pole clamp. If it is desired to have the WCH powered or attached independent from the pump, contact Customer Support to order additional accessories. To Install the WCH, complete the following steps: 1. Remove packaging materials from the WCH. 2. Place the WCH on a tabletop surface or affix to the pole clamp. 3. Plug in the pump power adapter into a wall outlet. 4. Plug the keyed end of the power adapter into the WCH. 5. Look through the transparent window on the back of the WCH. The Power symbol should be lit up to indicate that power is being supplied to the WCH. 6. Looking through the same window, confirm that the ZigBee™* wireless icon is steadily lit with a green color. If the wireless icon is not lit or is flashing irregularly, relocate the pump closer to the WCH.

Fig. 6



Table of Contents

7. Finally, when looking through the window, confirm the network connection icon is also lit green. This symbol indicates whether the WCH has a good network connection. If this symbol is not green, reposition the WCH until a green light is achieved. Kangaroo™ Connect Enteral Feeding Pump with Wireless Communications Hub | 9

Section 5 - System Setup For additional instruction on how to use the software features for the Covidien wireless communication system, please visit: www.covidien.com/kangarooconnect. For troubleshooting the activation of the wireless communications hub, please see the table below. The chart below shows what each indicator light seen through the WCH back window means. For additional support, please contact Customer Service. Indicator Light Power Light

ZigBee™* Light

Network Light

Light Symbol

Indicator Light Status

WCH State

Off

WCH does not have power

Solid Green

WCH is receiving power

Off

Radio Disabled

Blinking Green (Slow)

Searching for other ZigBee™* devices on the network

Blinking Green (Fast)

Establishing a connection to the pump

Solid Green

Connected to a pump

Off

Powered Off

Blinking Yellow (slow)

Powered ON, no network link

Blinking Yellow (fast)

Network link, no IP address

Solid Yellow

IP address assigned

Blinking Green (slow)

Attempting a connection to the server

Blinking Green (fast)

Server found, authenticating

Solid Green

Connected to the server

If assistance is needed in setting up, using, or maintaining the wireless communications hub (WCH), please contact Customer Service for additional support.



Table of Contents

Kangaroo™ Connect Enteral Feeding Pump with Wireless Communications Hub | 10

Section 6 - User Screen Preparing for a feed STEP 1: Press the Power button to power up the pump.

Step 2 If you have used the pump previously, your last settings were automatically retained for you. Press Keep Settings to keep the settings from the last feeding, otherwise, press Clear Settings.

Step 3 Upon power up, you will see the Load Set screen. Press More Options to adjust pump preferences -OR- Press Adjust Rate to input feeding settings prior to loading the set -ORLoad a feeding set on the pump to continue.

Step 4 To load the cassette portion of the feeding set onto the pump, follow the animated instructions on the screen.

10” (25.4 cm)

Step 5 Hang the feeding set bag or fluid container so the starting volume of fluid is 10” (25.4 cm) above the top of the pump as shown.

Cassette Loading Sequence



1

2

3

4

Table of Contents

Step 6 The Set Loaded screen will confirm that pump has correctly identified the feeding set. You will now be ready to prime the feeding set. Press the Prime button to continue. Kangaroo™ Connect Enteral Feeding Pump with Wireless Communications Hub | 11

Section 6 - User Screen Priming the pump

Step 7 Once you press the Prime button, you will see the screen above. Note the warning on the screen, fill the feeding container/bag with feeding solution, then press Auto Prime. Auto Prime will automatically prime the feeding set. If desired, Hold to Prime can be used instead for a manual prime.

Step 8 The pump will show an animated timing sequence indicating the prime is in process. Wait for the priming to complete.

Step 9 Once the Auto Prime is complete, the feeding solution will stop short of the feeding set connector. To “top off”, press and hold the Hold to Prime button. To continue with pump set-up, press Done.

Step 11 Press the + OR – buttons to increase or decrease the rate. Push and hold on either button to accelerate the numbers. Press OK when finished.

Step 12 The screen should now say Ready to Feed. Press the Start button to begin feeding. Once started, you must press the Pause button to change the feed rate.

Note: When using Hold to Prime feature; Feed Bag Empty, Patient Tube Block and Supply Tube Blocked alarms are disabled.

Entering feed rate settings

Step 10 Upon completion of the prime, the Ready to Feed screen will appear. Press Adjust Rate to enter the feeding rate.



Table of Contents

Kangaroo™ Connect Enteral Feeding Pump with Wireless Communications Hub | 12

Section 6 - User Screen More Options (Clear Amount Fed, History, Airplane Mode, Brightness) To access the features of Clear Amount Fed, Airplane Mode, View History, Adjust Brightness, or Prime Pump, press the More Options button. Use the arrow keys to highlight the feature you want to activate. Once highlighted, press the Select button to activate the highlighted feature. Hit the Back button to resume feeding. The following is a summary of each feature: •

Clear Amount Fed = Resets the feeding counter to zero for starting a new patient or a new feeding

•

View History = Allows the user to retrieve the last 72 hours of pump history

•

Airplane Mode = Allows the user to disable the wireless connectivity of the pump

•

Adjust Brightness = Allows the user to configure the brightness of the display backlight

Entering BIOTECH MODE The BIOTECH MODE is a menu location for certain pump settings that are generally only changed by the caregiver or clinician. Since the features stored in the BIOTECH MODE affect critical functionality of the pump, it is stored in a more secure location to avoid accidental changes made by the user or clinician. To access BIOTECH MODE: 1. Turn off the pump. 2. Turn on the pump. 3. While the animation is moving, press and release the upper left button. The BIOTECH MODE above should be visible. Press the View Options button to enter the feature selection screen. Use the arrow keys to highlight the feature you want to activate. Note: Press the View Info button to see the lastest software version of the pump



Table of Contents

Once highlighted, press the Select button to activate the highlighted feature. A checkmark should appear next to the activated feature. To lock in the setting, press the Power button to shut off the unit. The new setting will be retained upon powering the pump.

Kangaroo™ Connect Enteral Feeding Pump with Wireless Communications Hub | 13

Section 6 - User Screen Adjusting Dose The Dose feature on the pump is used to establish a fixed volume of formula to be delivered to the patient. Once the Dose limit is reached, the pump will stop operation with feeding complete. Note: To avoid Feed Bag Empty alarms at the end of each feeding, it is recommended that you use the Dose feature. When using the Dose feature, the Bag Empty Alarm will not sound when the feeding is complete. This is a useful feature for night time feedings to avoid waking the patient.

To enable the Dose Feature, follow the instructions above to enter BIOTECH MODE (see Entering BIOTECH MODE). After pressing View Options, highlight and select Bolus from the OPTIONS menu.

Use the arrow keys to highlight the Dose feature. Once highlighted, press the Select button to activate the Dose feature. A checkmark should appear in the Dose checkbox. Press the Back button to resume feeding.

Now that the Dose feature has been enabled, the Adjust Dose button will appear below the Adjust Rate button. Press the Adjust Dose button to set the maximum amount of feeding solution to be delivered.

Adjusting Bolus (after activation in BIOTECH MODE) The Bolus option allows you enter a fixed amount of feeding solution to be delivered to the patient, with a fixed amount repeating at a fixed interval. You must enter the BIOTECH MODE to activate this feature. Once activated, the pump must be restarted to enter Bolus parameters.

To use Bolus settings, follow the instructions above to enter BIOTECH MODE (See Entering BIOTECH MODE). After pressing View Options, highlight and select Bolus from the OPTIONS menu.



Table of Contents

The ADJUST BOLUS screen above should appear. Press each of the option buttons to input the rate, boluses, volume, and interval. After each item has received input, press Done to activate.

After pressing each of the ADJUST BOLUS options, you will enter a screen with + OR – buttons that allow you to increase or decrease the selected value. Push and hold + OR - to accelerate the numbers. Push OK to return to the ADJUST BOLUS screen.

Kangaroo™ Connect Enteral Feeding Pump with Wireless Communications Hub | 14

Section 6 - User Screen Adjusting KTO (after activation in BIOTECH MODE) KTO is the “Keep Tube Open” feature for the pump. This feature allows you to temporarily pause operation of the pump, while allowing a very small amount of formula to flow through the feeding set. This small amount of movement will work to resist clogging (and blockage) of the feeding set when the pump is paused. The flow rate for KTO is 0.065 mL/hr for KTO times less than 1 hr. For KTO times greater than 1 hr., the KTO flow rate is 0.130 mL/hr.

To use the KTO (Keep Tube Open) setting, follow instructions in the Entering BIOTECH MODE Section. The screen above will appear. Highlight and select KTO from the OPTIONS menu. To lock in these settings, press the Power button to shut off the unit. The new setting will be retained upon powering the pump.

Once enabled, you can activate the KTO feature during the feeding cycle by pressing the KTO button instead of Pause. When you press KTO, the feeding will be paused. However, it will keep a very small amount of fluid moving through the tube to prevent clogs.

As seen above, the KTO screen will show a countdown until feeding resumes.

Lock settings (after activation in BIOTECH MODE) The Lock Settings feature for the pump can be enabled through the BIOTECH MODE. This feature allows you to disable the user input of pump settings, giving the clinician better control to ensure that settings do not change. This feature is commonly used for patients who are resistant to receiving feedings or to prevent young children from tampering with the settings during ambulatory use.

To use the Lock Settings feature, follow the instructions in the Entering BIOTECH MODE section. Highlight and select Lock Settings from the Options menu. To enable this feature, press the Power button to shut off the unit. The new setting will be retained upon powering the pump.



Table of Contents

When running the pump under the new setting, a padlock symbol will be displayed on the icon bar to indicate that settings have been locked.

Once enabled, the screen above will be displayed to the user if an attempt to alter the settings has been made. The Lock Settings feature can only be disabled by entering Biotech and switching Lock Settings to Off.

Kangaroo™ Connect Enteral Feeding Pump with Wireless Communications Hub | 15

Section 6 - User Screen Language & Power Save settings (after activation in BIOTECH MODE) The Language setting allows you to change the language used on the pump screen. The Power Save feature allows you to extend the battery life by reducing the amount of time the display screen’s backlight is turned on. Both use simple check boxes to select or de-select the chosen option.

To use the Language or Power Save feature, follow the instructions in the Entering BIOTECH MODE section. Highlight and select the chosen option from the Options menu. To enable this feature, press the Power button to shut off the unit. The new setting will be retained upon powering the pump.

How to lock/unlock the input screen The pump allows the user to lock the input screen to prevent accidental button presses during portable use. This is especially helpful when transporting the pump in a backpack.

To use the Lock Screen option, press and hold the Lock Screen button for 5 seconds. A countdown will appear to show how long to hold the button.

Once activated, a Lock symbol will appear on the FEEDING screen, showing that the buttons are disabled. To disable the Lock Screen so the buttons can be re-activated, press and hold the Unlock Screen button for 5 seconds.



Table of Contents

When pressing the Unlock Screen button, a countdown will once again appear to indicate how long to hold the button. The screen should then appear as seen above. The buttons will now be re-enabled.

Kangaroo™ Connect Enteral Feeding Pump with Wireless Communications Hub | 16

Section 7 - Certification of Performance Under normal conditions, the pump will automatically certify itself using the wireless connection. If wireless connectivity is unavailable or a manual certification is desired, the following procedure can be used:

Manual Certification (after activation in BIOTECH MODE)

Test step 1 To perform a Manual Certification of the pump, follow the instructions in the Entering BIOTECH MODE Section. The screen above will appear. The TEST PUMP screen above should be visible. Load a standard feeding set filled with at least 50 mL of water.



Table of Contents

Test step 2 Press Start. You should see the TESTING PUMP screen above while the test is commencing.

Test step 3 Wait for the circular progress indicator to stop moving, until you see the screen above. Once you have finished the testing, you will see the TEST COMPLETE screen. Contact Customer Service if you do not obtain a Test Passed result. Be sure to note the failure code on the screen.

Kangaroo™ Connect Enteral Feeding Pump with Wireless Communications Hub | 17

Section 8 - Cleaning Caution: Neither the pump nor the WCH is designed to be immersed underwater. Do not immerse the pump, WCH, or power adapter in water or other cleaning solutions. Failure to follow the cleaning procedures described herein could result in hazards to users, patients, and clinicians. As with any A/C powered electrical device, care must be taken to prevent liquid from entering the pump and WCH to avoid electrical shock hazard, fire hazard, or damage to electrical components. Caution: Disconnect pump and WCH from A/C power source before cleaning. After cleaning, do not connect to an A/C power source until pump, WCH, and power adapter are thoroughly dry. If any of the following events occur, do not use the pump or WCH until it has been properly cleaned and dried. For assistance, please contact Customer Service:

General cleaning directions Cleaning Chemicals: A mild detergent should be used for general cleaning. If necessary, the pump and WCH may be cleaned with a 10:1 water and bleach mixture, however, repeated cleaning with this solution can damage the plastic housings. Isopropyl alcohol, applied with a damp cotton swab, may be used for cleaning difficult-to-reach areas. However, it should be used sparingly because repeated cleaning may damage the device housings. Do not use strong cleaners such as Spraynine™*, Phisohex™*, Hibiclens™*, or Vesta-Syde™* because damage to the pump and WCH housing can result. Cleaning Frequency: It is recommended that the pump and WCH be cleaned after each feeding set use, to prevent bacterial contamination of the pump. Further, failure to clean the pump can interfere with the function of the pump rotor, which can increase the occurrence of errors and warning alarms. See below for methods for cleaning each component. Caution: It is necessary to clean and/or disinfect the pump and WCH after each use when these devices are used for multiple patients. This is to prevent spreading bacteria, viruses, and other germs between patients that interact with the same pump and WCH. Directions for Cleaning the WCH: • Refer to General Cleaning Directions before starting. • Clean the outside surface with a damp cloth or sponge using a mild detergent. • Caution: Washing the WCH under running water or through submersion will result in damage to the unit! The WCH is designed to a water resistance of IP21 per the IEC 60529 standard, which does not allow for submersion in water or under a running faucet.

Table of Contents

• Refer to General Cleaning Directions before starting. • Clean outside surface with a damp cloth or sponge. • For difficult to clean areas, it is permissible to wash the pump under running water. Avoid submerging the pump or washing with high pressure nozzles, which exceeds the water proof rating of the pump. The pump casing has a water proof rating of “water jet resistant”. This allows for washing under running water or wiping with a damp cloth. Directions for Cleaning Power Adapter

• Wetting of the pump’s power adapter • Leakage into the pump interior • Leakage into the WCH Interior



Directions for Cleaning pump Housing

• Refer to General Cleaning Directions before starting. • Unless soiling is observed, the power adapter should not be cleaned. • If cleaning of the power adapter is necessary, unplug from outlet and wipe the exterior surfaces of the wall plug with a cloth dampened with isopropyl alcohol. • Allow excess moisture to evaporate from the cord prior to use of power adapter. • Caution: Washing the power adapter with a wet cloth, under running water, or through submersion will result in damage to the unit! The power adapter is rated IPX0, which means it is not water resistant. Caution: Avoid exposing the power adapter to excess moisture, as this can lead to an electrical shock or fire hazard.

Preventative maintenance This pump may be periodically tested to assure proper functioning and safety. Testing may be done at the user’s Biomedical Engineering Department, an outside service, or by Covidien Factory Service. Additionally, for customer convenience, the new pump and WCH can be used together to certify the pump remotely. For instructions on Wireless Certification of the pump, see Section 7. To arrange for Covidien Factory Service in the US, call 1-800-448-0190. In Canada, call 1-877-664-8926. Outside of the US and Canada, please contact your local Customer Service for more information. If a pump malfunctions, please contact your Covidien Representative or call Customer Service for instruction.

Kangaroo™ Connect Enteral Feeding Pump with Wireless Communications Hub | 18

Section 9 - Alarms and Troubleshooting Feeding Set Usage > 24 Hours Condition

LED Indicator Lights The pump status LED indicator lights on the upper right of the pump face which gives a quick visual indication of the pump status, especially in darkened rooms. A solid green light indicates the pump is feeding. A blinking green light indicates the pump is ready for operation but not feeding. A solid yellow light indicates an informational notice. A blinking yellow light indicates a caution.

LED indicator: Solid Green The feeding set usage indicator is a reminder that will appear on the bottom of the FEEDING screen if a Feeding Set has been used for 24 or more hours (hours actually running). It is recommended to replace feeding sets after this length of usage. This icon is only an informational message and does not require immediate action.

A blinking red light indicates a critical warning. See the information below for detailed descriptions of each warning. If an unexpected operation or event occurs while using the pump or WCH, please report any findings to Customer Service. Operator’s position All alarms are intended to be heard by operators that are within hearing range of the pump buzzer. The pump buzzer is located on the back of the pump. The pump is designed so the alarm can be heard within the patient’s room, at a minimum. The display and LED alarm indicators are intended to be seen by an operator within the room, facing the front of the pump. Since audible alarms are limited by distance, it is recommended that the operator conduct a check to determine at what distance the alarm can still be heard.

SETTINGS LOCKED Notification LED indicator: blinking green

Note: Going outside of the patient’s room may make hearing the alarms more difficult. Verifying functionality of the alarm system The best method to confirm the proper functionality of the alarm system is to run a Performance Certification cycle (See Section 7: Certification of Performance). Another quick test that can be performed to confirm audibility and function of alarms is: 1. Load a new feeding set onto the pump 2. Leave the feeding set empty! 3. Run Auto Prime

The SETTINGS LOCKED screen will appear if the Lock Settings feature has been activated in the Biotech Mode. See the Section, “Entering Biotech Mode” to access this feature. By design, no settings can be changed while the pump is in this state. To disable the Lock Settings, you must disable this feature in the Biotech mode. Follow the instructions for Entering Biotech Mode. Next, remove the check mark in the box next to the Lock Settings option.

4. Once the pump begins priming, it will detect a Feed Bag Empty condition and alarm 5. Confirm that the audible alarm, color display, and colored LEDs all properly indicate a Feed Bag Empty condition Caution: To allow proper operation of audible alarms, avoid blocking or obstructing the series of buzzer holes located in the back of the pump. How to temporarily silence/clear the alarm The alarms cannot be permanently silenced or muted. However, by pressing the Silence Alarm button, the alarm audio can be temporarily silenced for two minutes. After two minutes, the alarm audio will restart. To re-engage the audio alarm before the two minutes is up, press the Bell button. This will restart the audible alarm and end the temporary pause of the alarm. 

Table of Contents

Kangaroo™ Connect Enteral Feeding Pump with Wireless Communications Hub | 19

Section 9 - Alarms and Troubleshooting FEED COMPLETE Notification

The FEED INCOMPLETE screen will appear if a Dose or Bolus feeding is interrupted prior to completion of the allocated amount. In the pictures, you will see two different screens that may appear in this case. The screen on the bottom shows an Incomplete Dose. The screen on the top shows an Incomplete Bolus.

LED indicator: blinking green

Press Resume Dose or Resume Boluses to continue feeding from the current pump state. This often is needed if the pump was temporarily interrupted and the user wants to complete the feed that they started with. If needed, press Restart Bolus or Restart Dose if you are beginning a new, full feeding regimen.

COMMUNICATION LOST Notification LED indicator: blinking green

The FEED COMPLETE screen will appear if a Dose or Bolus feeding meets the specified amount. In the pictures above, you will see two different screens that may appear in this case. The screen on the bottom shows a completed Dose. The screen on the top shows a completed Bolus. Note that during continuous feeds (no dose, no bolus), you will not receive a feeding complete notification. Since this is only a notification and not an alarm, no beep will sound to avoid disturbing the patient.

The COMM. LOST screen will appear if the wireless connection has not been established within a 20 day period of time. This is a reminder to ensure the wireless communication with the pump is operating normally. In the event that wireless communication is lost, the pump will continue to operate normally. In all cases, it is acceptable to continue using the pump when the wireless connection is lost. Use the icons on the pump screen and the indicator lights on the back of the WCH to establish whether a proper wireless connection has been established. To troubleshoot, please contact Customer Service for support.

Press Done to clear the notification.

PUMP INACTIVE Alarm FEED INCOMPLETE Notification

LED indicator: solid yellow

LED indicator: blinking green

The pump inactive error screen will appear if the pump has been without input for more than 10 minutes. Press Continue to return to the previous screen. Detection of this alarm condition may take up to ten minutes to occur under normal operating conditions.



Table of Contents

Kangaroo™ Connect Enteral Feeding Pump with Wireless Communications Hub | 20