APPLIX SMART Instructions for Use Dec 2014

Information

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Operating instructions for APPLIX Smart Please read the following instructions before using the pump.

Information Intended purpose Indication Contraindications Complications Important notes

Description Illustration of the pump Pump holder and pump Attaching the pump to the pump holder Nurse call

Giving set Priming of the giving set Installing the giving set in the pump

4 4 4 4 4 5

6 6 7 8 9

10 10 12

Keypad

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Starting up the pump

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Mains operation Battery operation Switch on Insert giving set Automatic priming using the pump Start Stop Switch off 2

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Administration programme Continuous programme

Information 20 20

Alarms

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Cleaning the pump

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Pump and pump holder Pump door Pump mechanism and sensor area

Technical information Technical data Operating conditions Warranty Inspection Repair Contact Explanation of symbols Guidance and manufacturer’s declaration

Ordering information

29 29 30

31 31 33 35 35 35 36 37 38

42

Valid for software version 5.1.

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Information

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INFORMATION Intended purpose The APPLIX Smart is intended exclusively for enteral feeding. The APPLIX Smart pump is a peristaltic pump delivering enteral nutrition and hydration to the patient through a feeding tube. It can be used with both home patients and hospital patients and is a very simple pump to operate. The APPLIX Smart has a continuous feeding administration programme and several functions for patient safety.

Indication  Only suitable for enteral feeding.  The user should refer to the operating conditions (see p. 33), in order to check that the use of the APPLIX pump is compatible with the clinical condition of the patient, particularly on infants and neonates.  Due to the diversity of the use conditions with a wide range of solution characteristics (density, viscosity, quantity of dissolved gasses, rheology, particles, temperature, individualized nutrition preparation, ...), the performance of the occlusion detection may not be granted under all circumstances. Therefore Fresenius Kabi recommends not using the Applix device without a timely and regular surveillance especially when an interruption of the nutrition delivery may lead to a patient hazard (e.g. comatose situation).  The pump must only be used by trained users both on using and cleaning the pump.  Keep the pump, sets and wall plug away from unsupervised children (and animals).

Contraindications  Do not use for the intravenous administration of infusions.  Do not use if enteral feeding is contraindicated (e.g. ileus, uncontrolled diarrhoea, severe acute pancreatitis or intestinal atony) or the patient needs to be fed parenterally.

Complications  Even with pump assisted feeding, problems such as diarrhoea or a bloated feeling may arise. The speed of administration must be adapted individually to the patient. Regular checks are required. 4

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Information

Important notes  The APPLIX Smart is intended solely for enteral feeding.  When using the pump, please note the operating conditions (see p. 33).  The function of the pump is guaranteed only if it is operated with the appropriate Fresenius Kabi giving sets, (see ordering information on p. 42), and if the giving set is correctly installed (see installing the giving set in the pump p. 12). Otherwise patients may be put at risk under certain circumstances. The giving sets should be single use only for no longer than 24 hours as depicted by Bristish Standard EN 1615.  The feeding tube should be flushed through before and after every administration of feed and before, between and after the administration of individual drugs.  The APPLIX Smart may not be operated in areas where there is a risk of explosion.  The feeding pump has a BF-classification. To conform with CF requirements in a cardiac environment where the patient has direct cardiac access, keep the pump attached on its holder.  When changing the nutrition bag/bottle/container without changing the giving set, it is recommended to open the door of the pump and check the right position of the set before starting the pump again.  In case of prolonged storage of the device, check the general aspect of this one in order to make sure it is in good condition.

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Description

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DESCRIPTION Illustration of the pump

Giving set

Giving set

Serial number label (Unit number)

Pump door

Guide rail

Door lever

View from the front

6

Contact pins for connecting to pump holder

View from the rear

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Description

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Pump holder and pump The pump can be attached universally, vertically and horizontally to both round and square rails. E.g.:  drip stands  wheelchairs  hospital beds  table-top pump stand

Pump

Pump holder

Insert point for the pole stand to suspend the administration system

The clamping device can be rotated 180°

Screw to lock the clamping device

Clamping device

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Description

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Attaching the pump to the pump holder

Depress button to release pump

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Description

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Nurse call The pump holder provides the opportunity of connecting to a nurse call system.  The function is available if the pump is properly engaged in the holder and the holder is connected to the mains.  Plug the connecting cable for the nurse call function into the connector on the holder and guide through the lateral cable fixing. Then connect to the nurse call system.  Before using the pump, check that the transfer line for the nurse call system is working properly by initiating an alarm (e.g. start without giving set) at the pump.

Cable fixing

Mains socket

Nurse call connection

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Giving set

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GIVING SET Priming of the giving set for example: APPLIX Smart Pump Set VarioLine

APPLIX Smart - Pump Set VarioLine (product number 7751691) WARNING! Operate the pump only with the appropriate Fresenius Kabi APPLIX giving sets (see Ordering information on p. 42). Otherwise administration problems cannot be ruled out. CAUTION: The fluid in the giving set and the bag/bottle must be within normal temperature conditions: +13°/+40°C. DANGER! Respect the appropriate positions between patient, pump, giving set and container. Check the stability of the whole system. If the container is positioned lower than 0.5 meter beneath the pump, this can lead to flow rate deviation. WARNING! Give particular attention to the risk of strangulation with cables and sets. NOTE: When opening the pump door, the tube clamp is closed automatically (free-flow prevention device). 1. Close tube clamp. 2. Connect food container to giving set and hang up.

VarioLine adaptor

3. Fill drip chamber half full by pressing gently. 4. Use preferably the automated priming process: Ensure that the set is correctly installed in the pump prior to closing the door, (see page 12 "Installing the giving set in the pump“).

EasyBag connector T-piece

5. Close the door by pushing firmly on the grey door-lever. 6. Press the automated priming key: keep the priming key depressed. Prime to the end of the giving set. 7. Release the key once priming is completed.

Tube clamp

Verify the flow by checking the liquid flow in the drip chamber after starting the pump.

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Giving set

NOTE: When priming the set manually, the steps following step n° 3 above are: 4. Open tube clamp. Prime to the end of the giving set. 5. Close tube clamp. 6. Install the set in the pump to start nutrition administration (see "Installing the giving set in the pump“, page 12 and “starting up the pump”, page 18). Verify the flow by checking the liquid flow in the drip chamber after starting the pump. NOTE: For giving sets without drip chamber, use only the automatic priming.

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Giving set

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Installing the giving set in the pump 1. Unlock and open the pump door with the door lever. 2. Insert the tube clamp on the giving set into the pump in accordance with the arrow marking, with the clamp lever pointing upwards. 3. Guide the giving set over the pump mechanism and fix it in the lower tube guide ensuring that it is in a straight line and slightly stretched but not elongated. 4. Push the pump door shut and ensure that it engages properly.

Pump door

Clamp lever

Door lever Giving set correctly installed

Pump mechanism

Lower tube guide (Sensor area)

Giving set incorrectly installed

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Keypad

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KEYPAD Keys

Symbol

Operation

Function

On/Off

Press key for at least 1 second

Pump switches on (self-test) or pump switches off.

Automatic priming

Keep key depressed

Initially fill giving set with feed (600 ml/h). Release key once priming is complete.

Set rate

Press keys

Up arrow key increases. Down arrow key decreases.

Target volume On/Off

Press keys simultaneously

Activates target volume function or switches off target volume function.

Press keys individually Sets target volume. Start/Stop

Press key

Starts administration or stops administration: STOP appears in the bottom display cell for 3 seconds. (During which time parameters cannot be changed). The following functions are available only if the pump is stopped:

Reset

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Press keys simultaneously

Pump returns to original factory settings of continuous feeding at a rate of 100 ml/h.

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Keypad

Keys

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Symbol

Operation

Keypad lockout

Function All key functions except ON/OFF and START/STOP can be locked or released.

Press key

Key symbol in display flashes.

Set code 7 using top set of arrow keys Press key again

Key symbol in display:  appears: keypad is locked  disappears: keypad is released

Alarm volume

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Press key (repeatedly to alter alarm volume)

Set at different volumes. The selected setting can be both seen and heard.

In alarm mode: Press key (once to snooze the alarm)

The alarm remains silent for 2 minutes. The Backlight and the error message keep on flashing on the display.

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Keypad

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Keys

Symbol

Operation

Function

Information display

Press key briefly

The following information is automatically displayed if the information key is actuated in the sequence described.

 when option Target volume countdown is not activated

When administering feed

1. Volume  of feed administered since the pump was last reset. 2. Remaining volume - of feed to be delivered before the target volume is reached (if target volume is activated).

When pump is stopped 1. Volume  of feed administered since the pump was last reset. 2. The icons corresponding to the last alarm triggered are shown on the display.  when option Target volume countdown is activated

When administering feed

1. Volume  of feed administered since the pump was last reset. 2. Programed target volume  to be delivered for this application (if target volume is activated).

When pump is stopped 1. Volume  of feed administered since the pump was last reset. 2. Programed target volume  to be delivered for this application (if target volume is activated). 3. The icons corresponding to the last alarm triggered are shown on the display.

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Keypad

Keys

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Symbol

To reset Information display

Operation

Function

Keep key depressed for 3 seconds

Reset volume display.

Time set up between 2 alarm signals

The user can select the time between two alarm signals (except for reminder and battery pre-alarm). Press key

Key symbol in display flashes.

Set code 15 using top set of arrow keys Set time (from 5 to 300 seconds) using bottom set of arrow keys

Time in display appears. Note: This option is only available if there is no administration in progress. To cancel administration, press the 'i' key 3 seconds.

Press key again

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Keypad

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Keys

Symbol

Operation

Target volume countdown option

Function When programing the administration with a target volume, the user can choose to display the countdown of the programed target volume during the administration, instead of displaying the target volume programed.

Press key

Key symbol in display flashes.

Set code 26 using top set of arrow keys

Symbol "-" appears in display, before the target volume to be administered.

Select "on" using bottom set of arrow keys Press key again

In this option, there is no automatic reset of the volume infused if the administration has been interrupted and/or the pump has been switched off (to reset the remaining volume to be infused, press the 'i' button during 3 seconds. A reset of the volume will also occur in case of reset to return to original factory settings). To select the displaying of the target volume instead of the countdown, repeat the operation and select "off" with the bottom set of arrow keys. Please note that the pumps are delivered with the configuration displaying the target volume programed per default. Note: This option is only available if there is no administration in progress. To cancel administration, press the 'i' key 3 seconds.

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Starting up the pump

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STARTING UP THE PUMP Mains operation With pump holder and mains lead

1. Push the pump onto the guide rail of the holder until it clicks. 2. Plug the mains lead into the mains connector on the holder. (see page 9). 3. Connect the mains lead to the mains (the green "Mains" indicator on the holder comes on). The "Plug" symbol appears in the display.

Battery operation Battery life: 24 hrs Rate: 125 ml ⁄ h

Before starting for the first time, charge the batteries for approx. 5 hours!

Battery is full

If the pump is connected to the mains, the batteries also charge during operation. When the pump is disconnected from the mains, it automatically switches to battery mode.

Battery is empty

The maximum life of the batteries is only achieved after several charge/discharge cycles. In the event of frequent mains operation, battery life may be less. Battery indicator shows 3 bars when fully charged. The "battery pre-alarm" will be activated when there is at least 30 minutes of battery life (or charge) remaining. If the pump is not connected to an electrical power source to recharge during the pre-alarm, the pump will stand by and the "battery alarm" will activate for 10 minutes. If at this time the battery is not recharged, it will shut off.

Switch on Press key for approx 1 second

An acoustic signal sounds. The pump performs a self-test. The numbers 1-4 and then all the display symbols appear. The user should have a look at the display during the self test, in order to detect potential failures. The last feeding program activated including settings is displayed.

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Starting up the pump

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Insert giving set (See page 12)

Automatic priming using the pump Keep key depressed

Prime to the end of the giving set (Release key once priming is complete).

Start Press key

Flashing bars and drops indicate the start of feed/fluid administration (*).

Stop Press key

STOP appears in the display.

Switch off Keep depressed for approx. 1 second

In mains mode, the "Plug" symbol is visible in the display. The pump retains all information when switched off. This information is saved for 1 month provided the battery was fully charged at switch off.

(*) In order to detect an upstream occlusion occurred before starting the pump, the APPLIX Smart delivers a small initial volume at a higher rate, right after START, if the door has been previously opened or an upstream occlusion alarm has been triggered (see Operating conditions p. 33).

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Administration programme

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ADMINISTRATION PROGRAMME Continuous programme Continuous

Administering feed at a continuous speed (with activated target volume if appropriate).

Parameter

Definition of term

Setting range

Increments

Rate:

Speed of administration

1… 600 ml/h

1 or 5 ml/h

Target volume if appropriate:

Total volume of feed selected. An alarm sounds when the target volume is reached.

1… 5000 ml

1 or 10 ml

Example settings

Pump calculations

Target volume

Rate

Duration of administration

1. 1500 ml

150 ml/h

10 h

2. 500 ml

50 ml/h

10 h

Example 2 (ml/h) Rate

50 40 30 20 10 Time (h)

1

20

2

3

4

5

6

7

8

9

10

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