Fresenius Kabi APPLIX SMART User manual

GB INSTRUCTIONS FOR USE
Enteral Feeding Pump

Information
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Information 4
Intended purpose 4
Indication 4
Contraindications 4
Complications 4
Important notes 5
Description 6
Illustration of the pump 6
Pump holder and pump 7
Attaching the pump to the pump holder 8
Nurse call 9
Giving set 10
Priming of the giving set 10
Installing the giving set in the pump 12
Keypad 13
Starting up the pump 18
Mains operation 18
Battery operation 18
Switch on 18
Insert giving set 19
Automatic priming using the pump 19
Start 19
Stop 19
Switch off 19
Operating instructions for APPLIX Smart
Please read the following instructions before using the pump.

Information
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Administration programme 20
Continuous programme 20
Alarms 22
Cleaning the pump 29
Pump and pump holder 29
Pump door 29
Pump mechanism and sensor area 30
Technical information 31
Technical data 31
Operating conditions 33
Warranty 35
Inspection 35
Repair 35
Contact 36
Explanation of symbols 37
Guidance and manufacturer’s declaration 38
Ordering information 42
Valid for software version 5.1.

Information
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INFORMATION
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.
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.

Information
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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.

Description
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DESCRIPTION
Illustration of the pump
Giving set
View from the front View from the rear
Giving set
Guide rail
Door lever
Pump door
Serial number label
(Unit number)
Contact pins
for connecting
to pump holder

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
Screw to lock
the clamping
device
Clamping device
Pump Pump holder
Insert point for the pole
stand to suspend the
administration system
The clamping
device can be
rotated 180°

Description
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Attaching the pump to the pump holder
Depress button to
release pump

Description
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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.
Nurse call
The pump holder provides the opportunity of connecting to a nurse call system.
Cable fixing
Mains socket
Nurse call connection

Giving set
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GIVING SET
Priming of the giving set
for example: APPLIX Smart Pump Set VarioLine
1. Close tube clamp.
2. Connect food container to giving set and hang
up.
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“).
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.
Verify the flow by checking the liquid flow
in the drip chamber after starting the pump.
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).
Tube clamp
T-piece
EasyBag connector
VarioLine adaptor

Giving set
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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.

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
mechanism
Clamp lever
Pump door
Lower
tube guide
(Sensor area)
Door lever
Giving set
correctly installed
Giving set
incorrectly installed

Keypad
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KEYPAD
Keys Symbol Operation Function
On/Off Press key for at least
1second
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 Press keys
simultaneously
Pump returns to original factory
settings of continuous feeding at
a rate of 100 ml/h.

Keypad
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Keys Symbol Operation Function
Keypad lockout 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 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.

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.

Keypad
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Keys Symbol Operation Function
To reset
Information
display
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

Keypad
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Keys Symbol Operation Function
Target volume
countdown option
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.
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.
Select "on" using
bottom set of arrow
keys
Press key again
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.

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!
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.
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.
Battery is full
Battery is empty
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.

Starting up the pump
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(*) 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).
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.

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
234 5 6 7 9 1018
30
20
50
10
40
(ml/h) Rate
Time (h)