Kangaroo Connect Operator Manual

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...6 User Interface...7 Symbols...9 System Setup Attaching the Power Adapter ... 10 Using the Pole Clamp tube support guide... 11 Installing the Wireless Communications Hub (WCH) ... 11 Installing a WiFi/Ethernet Module (WiFi module)... 12

Section 6

User Screens Preparing for a feed... 13 Cassette loading sequence... 13 Priming the pump... 14 Entering feed rate settings... 14 More options... 15 How to Lock/Unlock the input screen... 15

Section 7

Certification of Performance/Calibration Manual Certification... 16

Section 8 Section 9

Cleaning... 17 Alarms and Troubleshooting Feed Set Usage... 18 Setting Locked... 18 Feed Complete... 19 Feed Incomplete... 19 Pump Inactive... 19 Low Battery... 19 Feed Bag Empty... 20 Rotor Stuck... 20 Patient Tube Blocked... 20 Supply Tube Blocked... 20 Cassette Dislodged... 21 Cassette Error... 21 Dead Battery... 21 System Error... 21

Section 10 Section 11 Section 12

Specifications... 22 Customer Service... 24 Maintenance Wireless Charging Hub Button... 25 Power Adapter... 25 Pole Clamp Latch Clip Kit... 25 Cassette Latch Clip Kit... 25

Section 13 Section 14 Section 15 Section 16 Appendix A Appendix B Appendix C

Service Part Numbers... 26 Warranty... 27 Electromagnetic Conformity Declaration... 28 Glossary of Terms... 32 Accuracy Graphs... 33 Explanation of Alarms... 38 Fluid/Occlusion Detection Overview... 39

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 feeding pump and its standard accessories (the AC power adapter, feeding set and pole clamp) are considered medical electrical equipment. The pump may also be used with additional optional accessories like the Kangaroo Connect car charger and either a Kangaroo Connect wireless communication hub (WCH) or a Kangaroo Connect WiFi/Ethernet communications module (WiFi module). The pump used in conjunction with one or more of these optional accessories comprises the medical electrical equipment system. All components in the system are suitable for use within the patient environment. 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, age infant and above, provided the patient can tolerate the flow rates and accuracy level of the pump. Not for use with neonates. Use only commercially available pre-packed or commercially prepared feeding solutions prescribed by a licensed health care provider, dietician or nutritionist. Do not use homemade blenderized or liquidized foods or other non-prescribed, noncommercially available feeding solutions.

User Interface: • 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

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.

Features: • 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 Save and Airplane Mode) • If enabled, unique wireless technology allows for: -- Remote troubleshooting for 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. 1 5. Pump Rotor The circular black wheel that drives fluid through the feeding set.

6

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



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5

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Wireless Features The wireless feature of the Kangaroo Connect pump is initially disabled unless activated by a specific type of feeding set. Through the use of a wireless enabled Kangaroo Connect pump and a communications hub, clinicians will be provided with the ability to acquire and display nutritional delivery data from the pump within a website called the Kangaroo Connect Portal.

Wireless Safety

The wireless technology used within the Kangaroo Connect pump and communications hub is built on the IEEE 802.15.4 standard which transmits in the ISM band (2.4GHz). A patented combination of short range and long range wireless provides seamless wireless capability for the pump.

1. The pump only provides alarms directly from the pump to a user/ clinician. The pump does not provide real time communication of alarms though the wireless communications feature, but rather logs historical alarm events. This prevents confusion as to how the pump alarms (only through the pump itself ) and prevents the condition where loss of wireless connection could cause a missed alarm.

The following are required in order to utilize the wireless capability of the Kangaroo Connect Pump: 1. Kangaroo Connect pump with short range wireless chip (located in but initially disabled in ALL Kangaroo Connect pumps) 2. Either a: • Kangaroo Connect wireless communication hub (WCH) with 3G wireless capability, or • Kangaroo Connect WiFi/Ethernet communications module (WiFi module) with WiFi/Ethernet capability 3. Kangaroo Connect ENtelliSet Feeding Set (designed to enable the short range wireless chip in the pump when loaded in the pump) 4. Internet access

Wireless Quality of Service The wireless communication feature of the Kangaroo Connect pump was designed to add multiple features and benefits without compromising pump safety. In the event of an intermittent or failed wireless connection, the pump feeding operation is designed to work independently of any wireless connection and will continue to operate normally and safely. Therefore, the patient can be confident their pump will continue to work properly even if there is a wireless delay, loss of signal, or wireless failure. The communication system is designed to take advantage of the time when a connection is available and wait for a connection to be restored when it is not. The pump will store data for up to 30 days, for upload when a connection is available. As the pump is designed to be ambulatory, loss of wireless capability is expected to be a common occurrence. The Kangaroo Connect pump wireless system has an acceptable latency of 25 seconds for message exchanges. (Typical latency is approximately 5 seconds.) However, this latency is not a concern because the data is not being used in real time. Since the pump confirms that all transmitted data is received by the Kangaroo Connect Portal before it is deleted, any data not acknowledged will be resent at a later time within the 30 day window. Considering the acceptable latency and a low signal priority on the network, the following table shows the network access time required by the pump to prevent any loss of stored data based on the probability of network data loss: Probability of Network Data Loss Network Access Time Required (Hours)



Probability of Network Data Loss

Network Access Time Required (Hours)

0%

6.3

10%

6.9

20%

7.8

30%

8.9

40%

10.4

50%

12.5

60%

15.6

70%

20.8

80%

31.3

90%

62.5

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The following pump features were specifically designed to ensure patient safety related to use of the wireless communication feature:

2. The pump is designed to operate independently of any wireless communications, allowing it to continue to provide safe and effective enteral nutrition to a patient. Therefore, the patient can be confident their pump will continue to work properly even if there is a wireless delay, loss of signal or wireless failure. 3. The wireless data communicated by the pump is encrypted for patient security and protection. No confidential patient information is communicated from the pump to internet, so privacy remains intact and secure. 4. With medical device hacking being a heightened concern, this pump has been designed from the ground up to prevent wireless intrusions seen on older medical devices. This pump was tested to the latest standard of penetration testing to help safeguard against possible intrusions.

System Configuration / Operation No additional system configuration is required to operate the wireless communication feature. Refer to Section 5 – System Setup for instructions on how to install the WCH or WiFi module.

Operating Distances and Ranges For the wireless capability to work properly, the pump must be within 300 feet of the WCH or WiFi module with direct line of sight. Obstructions such as walls and doors will reduce this range. Strength of the wireless signal between the pump and WCH or WiFi module can be determined by looking at the wireless icon on the pump screen.

Wireless Coexistence Wireless coexistence testing has been performed on the wireless communication feature of the Kangaroo Connect pump. Testing established on the intended environment included multiple sources of possible interference such as Wi-Fi connections, Bluetooth devices, cellular connections, cordless phones, and microwaves, with no degradation of signal noted. Should a coexistence issue be suspected, turn off or relocate any other electronic devices located near the pump or WCH or WiFi module which might generate interference.

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Wireless Features Wireless Communication Delay In the event of an unexpected wireless disruption: 1. Move the pump closer to the WCH or WiFi module 2. Reduce or remove obstructions between the pump and WCH or WiFi module. Having direct line of sight between the pump and WCH or WiFi module is important to a good wireless signal. The pump will store its data waiting for the system to come back online for a maximum of 30 days while the pump is disconnected from the communication system. Data older than 30 days will be deleted from the pump to conserve data storage resources on the pump. Once communication is restored, the pump will send the backlogged data (up to 30 days) to the Kangaroo Connect Portal.

Wireless Security The wireless communications of the pump are designed to utilize a multitude of methods to protect data in every stage of the communication pathway. In addition to the use of a proprietary communications data protocol, the serial number assigned to each pump is encoded both at rest and while in transit. Pump data is encrypted at the pump before transmission to the WCH or WiFi module. At the WCH or WiFi module, the data is decrypted and then re-encrypted via AES before transmission to the Kangaroo Connect Portal.



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Section 2 - Safety and Warnings Note to healthcare personnel who provide training to lay operators or lay responsible organizations: 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, WCH or WiFi module. 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, WCH or WiFi module. For guidance on training, please contact Customer Service.

General warnings 1. Caution: Read this booklet thoroughly before using the pump. 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, WCH or WiFi module 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 or WiFi module, 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 freeflow 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. Neonates 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.



12. Caution: The power adapter cord, 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. 13. Caution: Do not store the pump, WCH, WiFi module, power adapter or car charger at temperatures >50ºC (122ºF). This can damage the equipment sensors, which will prevent the pump from operating under normal conditions. 14. Caution: Avoid using accessories, detachable parts and materials with the pump, WCH and WiFi module that are not recommended in this manual. Use only approved Kangaroo Connect accessories with the pump, WCH and WiFi module. Failure to use Covidien accessories could result in damage to the pump or physical injury. 15. Caution: Use the pump, WCH and WiFi module 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, WCH and WiFi module. 16. Caution: Always disconnect the 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. 17. 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. 18. Caution: This pump, WCH and WiFi module is not intended to be used in MRI environments or in the presence of strong magnetic fields. Do not use this device in any areas with strong magnetic fields. The pump, WCH and WiFi module contain metal components which could cause unintended movement. This unexpected movement could cause harm due to falling objects or collisions. 19. 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

10. Warning: The use of non-commercially prepared or other non-prescribed feeding formulas is not appropriate for use with the Connect Pump. Formulas made in blender present variability of unknown ingredients and inconsistency regarding the degree of mixing. Therefore these homemade formulas cannot be adequately tested to validate their usage with this enteral feeding pump. Use ONLY commercially available pre-packed or commercially prepared feeding solutions prescribed by a licensed health care provider, dietician or nutritionist. DO NOT USE HOMEMADE BLENDERIZED OR LIQUIDIZED FOODS OR OTHER NON-PRESCRIBED, NON-COMMERCIALLY AVAILABLE FEEDING SOLUTIONS.

20. Use only the supplied power adapter to charge your feeding pump, WCH or WiFi module. See Section 13 – Service Part Numbers for replacement of power adapter and the associated part number.

11. Warning: The pump, WCH and WiFi module should not be used with additional multiple socket-outlets or extension cords. The use of multiple socket-outlets or extension cords will compromise electrical safety and/or increase the risk of electrical shock.

21. 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).

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Section 2 - Safety and Warnings 22. For service or for technical information, please contact Customer Service (Section 11). 23. Do not open the pump, WCH or WiFi module, as there are no user-serviceable parts inside. Opening may affect function of device and voids the warranty. 24. 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. 25. See icon descriptions in Section 3 - User Interface and Section 4 - Symbols for additional safety information. 26. 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. Electromagnetic interference could make the display unreadable or prevent the pump from being able to feed. 27. Do not use feeding solutions or formula other than that prescribed by a qualified physician, nurse, registered dietician, or other licensed practitioner.

35. 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. 36. 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. 37. The rear label is intended to provide tamper protection and liquid ingress protection. Do not use the pump if the rear label contains puncture marks or looks like it has been removed and replaced. Pump functionality cannot be guaranteed. 38. The Kangaroo Connect WCH and WiFi/Ethernet Module are not intended to be ambulatory.

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.

28. 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.

2. The pump and WCH utilize a 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.

29. Should feeding sets require rinsing, it is recommended that the feeding sets be rinsed while they are loaded in the pump.

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.

30. 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.

4. The stated battery life is approximate. Performance of the battery may degrade due to excessive temperatures, frequent recharging, and other factors.

31. Do not clean the pump, WCH, WiFi module, 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.

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.

32. Do not use the pump for delivery of any fluids or substances that are not enteral solutions prescribed by qualified medical personnel. 33. Used feeding sets should be disposed of in accordance with current hospital procedure or local disposal guidelines. For disposal of the pump, WCH, WiFi module, 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 LithiumIon battery. 34. The pump and WCH is designed to be used outdoors for short periods of time (no more than 24 hours). Leaving these devices outdoors for extended periods of time (exceeding 24 hours) can result in damage and/or fading of the pump and WCH.



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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.

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



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Section 4 - Symbols

Symbol

Definition

Symbol

122°F 50°C -13°F -25°C

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

Lithium Ion Battery Li-ion

Use by

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

26

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

Cellular Signal Strength

Avoid temperature extremes

NRTL Mark

Keep away from sunlight



Definition

Keep Dry

Do not use if package is opened or damaged

32°F 0°C

Symbol

Non-sterile

XX12345

122°F 50°C

Definition

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0123

CE Mark

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Section 5 - System Setup Important Note: The basic Kangaroo Connect enteral feeding setup consists of the pump, AC power adapter, feeding set and pole clamp. If necessary, the car charger may be used to supplement the AC power adapter. The pump can provide remote communications if one of the wireless accessories (either the WCH or WiFi module) is installed along with the pump, and a Kangaroo Connect ENtelliSet Feeding Set is being used. The pump and WCH or WiFi module, 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 may be charged directly or through use of the WCH. 1. The pump can be charged directly. a.

Plug the power adapter into the power adapter port located on the left side of the pump (Fig. 1). Plug the other end of the power adapter into a nearby A/C outlet. Or if using the car charger power adapter, plug the cylindrical connector into the car charger port.

b.

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

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.

2. T he 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 located on the left side of the WCH. Note: The WCH uses the same power adapter that is provided with the pump. To re-charge the pump in this configuration, simply:

Fig. 1

1. Place the WCH on a tabletop surface or attach to pole clamp. 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. 5. 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. Reference Section 5 for icon descriptions and pictures.

Fig. 2

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 the pump or the WCH. This can be done using the “slide and click” attachment feature located on the back of the pump (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. 3



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Section 5 - System Setup 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. This rotation is done by grasping the latch plate and twisting until the latch plate “pops” into the next angled position.

Fig. 4

If assistance is needed in setting up, using, or maintaining the pump, please contact Customer Service for additional support.

Using the Pole Clamp tube support guide The Pole Clamp tube guide is designed as an additional support for the tubing. To install the tube into the tube guide, complete the following steps: 1. Ensure the Cassette is properly loaded. 2. Select the tube that goes to the patient (tube exiting the right side of the cassette). 3. Press the tubing into the tube guide creating a loop above the pump (see fig. 6). 4. Ensure that the loop has sufficient length to make a gradual curve.

Fig. 5

Installing a Wireless Communications Hub (WCH) The WCH is designed to work with the Kangaroo Connect pole clamp and Kangaroo Connect power adapter that are packaged with the pump. The WCH may also be powered using the Kangaroo Connect car charger. If it is desired to have the WCH powered or attached independent from the pump, contact Customer Support to order additional accessories. Note: The Kangaroo Connect WCH is not intended to be ambulatory. 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 power adapter into wall outlet.

Fig. 6

4. Plug the keyed end of the power adapter into the back of the WCH. 5. Look through the transparent window on the back of the WCH to confirm its operating status. Reference the table in this section for icon descriptions and pictures.



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a.

The power indicator should be lit up to indicate that power is being supplied to the WCH.

b.

The signal strength indicator should be yellow or green to indicate presence of a cellular signal. If the signal strength indicator is not lit, reposition the WCH to a location with a better cellular signal.

c.

The Zigbee indicator should be flashing green. If the Zigbee indicator is not green, relocate the pump closer to the WCH.

d.

The network indicator should be solid green. This light indicates when the WCH has a good network connection. If this light is not green, reposition the WCH until a green light is achieved.

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Section 5 - System Setup Installing a WiFi/Ethernet Module The WiFi/Ethernet module shall be packaged with its own AC power adapter, CAT5 cable and Gateway quick start guide. Follow the directions provided in the quick start guide to connect and configure the WiFi module for use. Note: The Kangaroo Connect WCH is not intended to be ambulatory. Indicator Light

Light Symbol

Power Light

ZigBee™* Light

Cellular Signal Strength Solid Yellow

Adequate signal

Solid Green

Good signal

Network Light

Indicator Light Status

WCH State

Off

WCH does not have power

Solid Green

WCH is receiving power

Off

Radio Disabled

Blinking Green (Slow)

Ready to connect to pump

Off

No Signal

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

Alternating between Green and Yellow

Cannot connect to server

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



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Section 6 - User Screen The pump comes with the following default setting:

Default Settings

Settings

Continuous (Rate) Mode

On

Screen Brightness

Level 3 of 4

Feed Rate

0 mL/hr

Preparing for a feed Step 1: Ensure the cassette portion of the feeding set is not loaded on the pump. Step 2: Press the Power button to power up the pump. Step 3:

Step 6: 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.

10” (25.4 cm)

Step 4:

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.

Step 7: 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.

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

Cassette Loading Sequence

1



2

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4

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Section 6 - User Screen Priming the pump

Step 8 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 9 The pump will show an animated timing sequence indicating the prime is in process. Wait for the priming to complete.

Step 10 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.

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

Note: Due to the head pressure of the formula within the feeding set bag, the tube may fill with fluid up to and including the cassette. In this case, the Auto Prime feature will not function and Manual Prime will have to be used to prime the set.

Entering feed rate settings

Step 11 Upon completion of the prime, the Ready to Feed screen will appear. Press Adjust Rate to enter the feeding rate.



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Step 12 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 13 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.

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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 • Prime Pump = Allows the user to prime the pump after initial setup.

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.



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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.

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Section 7 - Certification of Performance/Calibration The pump does not require periodic calibration. It is recommended to conduct a performance test every 2 years, or as recommended by facility protocol. The certification procedure requires access to the Biomed Menu and should be performed by appropriate personnel.



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Section 8 - Cleaning Caution: The pump, WCH, WiFi module and power adapters are not designed to be immersed underwater. Do not immerse the pump, WCH, WiFi module or power adapters 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, WCH and WiFi module to avoid electrical shock hazard, fire hazard, or damage to electrical components. Caution: Disconnect pump, WCH and WiFi module from A/C power source before cleaning. After cleaning, do not connect to an A/C power source until thoroughly dry. If any of the following events occur, do not use the pump, WCH and WiFi module until it has been properly cleaned and dried. For assistance, please contact Customer Service: • Wetting of the power adapter • Leakage into the pump interior • Leakage into the WCH Interior • Leakage into the WiFi module interior

General cleaning directions Cleaning Chemicals: A mild, common dish washing liquid detergent should be used for general cleaning. This detergent should be used with a 20:1 ratio water to detergent mixture. Wipe down the pump with a paper towel moistened with the cleaning solution, removing all visible soil. Use a brush to remove soil from hard to reach crevices. Caution: The use of cleaners and disinfectants other than the ones described in the instructions for use may cause significant damage to the pump, WCH or WiFi module and may void warranty. Cleaning Frequency: It is recommended that the pump and WCH be cleaned after each feeding set use for a minimum duration of 30 seconds, 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. 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. Directions for Cleaning pump Housing • Refer to General Cleaning Directions before starting. • Clean outside surface with a damp cloth or sponge using a mild detergent. • 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.



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Directions for Cleaning Power Adapter and WiFi Module • Refer to General Cleaning Directions before starting. • Unless soiling is observed, the power adapter and WiFi Module should not be cleaned. • If cleaning of the power adapter or WiFi Module is necessary, unplug and wipe the exterior surfaces with a cloth dampened with isopropyl alcohol. • Allow excess moisture to evaporate prior to use. • Caution: Washing the power adapter or WiFi module with a wet cloth, under running water, or through submersion will result in damage to the unit! The power adapter and WiFi module are rated IPX0, which means they are not water resistant. Caution: Avoid exposing the power adapter or WiFi module 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. 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.

General disinfection directions Disinfection chemicals: The pump and the WCH can be disinfected by wetting their surfaces with a 10:1 water and chlorine bleach mixture. To wet the devices, use at least two bleach wetted lint-free wipes and wipe as necessary to maintain visual wetness. Visual wetness should be maintained for a minimum duration of 10 minutes for the pump, and a minimum duration of 1 minute for the WCH. Repeated disinfection with this solution can damage the plastic housings. Disinfection frequency: It is necessary to clean and 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.

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Section 9 - Alarms and Troubleshooting LED Indicator Lights

How to temporarily silence/clear the alarm

The pump status LED Indicator lights on the upper right of the pump provides a quick visual indication of the pump status, especially in darkened rooms.

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.

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. 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, please report any findings to Customer Service.

Feeding Set Usage > 24 Hours Condition 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.

Caregiver Alarm Notification 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:

The SETTINGS LOCKED screen will appear if the Lock Settings feature has been activated in the Biotech Mode. 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.

1. Load a new feeding set onto the pump 2. Leave the feeding set empty! 3. Run Auto Prime 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.



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Section 9 - Alarms and Troubleshooting FEED COMPLETE Notification

PUMP INACTIVE Alarm

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.

LOW BATTERY Alarm 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 top shows a completed Dose. The screen on the bottom 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. If a sound indication is desired, you can enable feed complete audio in the More Options menu. Press Done to clear the notification.

FEED INCOMPLETE Notification LED Indicator: blinking green

LED Indicator: solid yellow

The LOW BATTERY screen appears and the alarm beeps continuously when the battery needs to be recharged. There is approximately 30 minutes of battery life remaining when this screen appears Plug the power adapter in to a wall outlet to begin charging. The pump will automatically return to the screen that was active prior to the error. The battery will charge continuously whenever the pump is plugged into a wall outlet. The pump will continue to operate normally while the battery in the pump is recharging. 7 hours of charging is required to fully recharge the battery pack. If this screen appears while the power adapter is plugged in to the pump, check to make sure the power adapter plug is pushed all the way in so it fully inserted into the side of the pump. If this screen appears while the pump is attached to the WCH, check to make sure the power adapter plug is pushed all the way in so is fully inserted into the back of the WCH and ensure that the pump is fully seated into the base to resume charging the pump.

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 top shows an Incomplete Dose. The screen on the bottom shows an Incomplete Bolus.

Detection of this alarm condition may take up to 30 minutes to occur under normal operating conditions.

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.



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Section 9 - Alarms and Troubleshooting FEED BAG EMPTY Alarm

PATIENT TUBE BLOCKED Alarm

LED Indicator: blinking yellow

LED Indicator: blinking yellow

The FEED BAG EMPTY screen appears when the enteral formula is no longer being delivered because the bag is empty. Large amounts of foam or bubbles in the feeding solution can also be a cause for this alarm. Check the bag to see if it is empty and re-fill the bag as required. If the bag still contains feeding solution, remove cassette and check the bag side tubing for excessive foam or bubbles. Clear bubbles from line and reload the feeding set or replace with a new feeding set.

The PATIENT TUBE BLOCKED error screen appears when the feeding solution is no longer being delivered because of a clog between the pump and the patient. If the error cannot be resolved, remove the cassette from the pump. Check the line to find and clear the blockage. While the cassette is removed, clean and dry the sensor pocket on the right side of the pump. Re-load the feeding set onto the pump, which could clear the error. If the error still cannot be resolved, load a new pump set, prime it, and press Continue to restart the feeding.

Detection of this alarm condition may take up to 130 minutes to occur at 1 mL/hr.

Detection of this alarm condition may take up to 3 minutes to occur at flow rates greater than 50 mL/hr.

Detection of this alarm condition may take up to 5 minutes to occur at flow rates greater than 50 mL/hr.

If the error still cannot be resolved, press the Power button to stop operation of the pump and put a different pump into service.

If the error still cannot be resolved, press the Power button to stop operation of the pump and put a different pump into service.

SUPPLY TUBE BLOCKED Alarm

Detection of this alarm condition may take up to 95 minutes to occur at 1 mL/hr.

LED Indicator: blinking yellow

ROTOR STUCK Alarm LED Indicator: blinking yellow

The ROTOR STUCK error screen appears when the pump detects an unusual amount of resistance to the rotation of the rotor. (The rotor is the black circular wheel attached to the motor that rotates to move fluid through the feeding set). This error is typically attributed to formula or contaminant build-up on the rotor shaft, which can be corrected by cleaning the rotor. In rare circumstances, this problem could be due to a faulty motor/gearbox assembly. Detection of this alarm condition may take up to 31 minutes to occur at 1 mL/hr.

The SUPPLY TUBE BLOCKED screen will appear if there is a blockage, obstruction, or kinked tubing between the feeding bag and the pump. Check the tubing between the bag and the pump to see if cause of the blockage can be located and cleared. If the error cannot be fixed, remove the blocked pump set and load a new pump set onto the pump. Detection of this alarm condition may take up to 350 minutes to occur at 1 mL/ hr.  etection of this alarm condition may take up to 9 minutes to occur at flow rates D greater than 50 mL/hr. If the error still cannot be resolved, press the Power button to stop operation of the pump and put a different pump into service.

Detection of this alarm condition may take up to 1 minute to occur at flow rates greater than 50 mL/hr. If cleaning of the rotor and rotor shaft does not resolve this error, press Power Off to stop operation of the pump and put a different pump into service.



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