Fresenius Kabi Amika User manual

Amika
Enteral feeding pump
Version 2.2 / i
INSTRUCTIONS FOR USE

Symbol descriptions
CE mark
0123
Warning (Refer to the Instructions For
Use)
Medical electrical system weight (kg)Refer to the Instructions For Use
Product serial numberProduct reference / part number
Name and address of the manufacturing
facility
Name and address of the manufacturer
/ Date of manufacture
Protection against leakage current; de-
fibrillation-proof type CF applied part
Battery specification
Alternating Current (AC)Direct Current (DC)
Input terminal - connectorOutput terminal - connector
This way upFragile, handle with care
Temperature limitationKeep away from rain
Atmospheric pressure limitationHumidity limitation
Eco packaging symbolGeneral symbol for recyclable material
Holder: IP32-Index of protection against solid foreign objects (> 2.5 mm) and dripping li-
quids
Pump: IP35-Index of protection against solid foreign objects (> 2.5 mm) and water jets
from any direction
AC/DC Adapter: IP41-Index of protection against solid foreign objects (> 1 mm) and
dripping liquids
IP32
IP35
IP41
Part included in a recycling process
Warning: warning of a potential hazard that could result in serious personal injury and/or
product damage if the written instructions are not followed.
Caution: warning of a potential hazard that could result in minor personal injury and/or
product damage if the written instructions are not followed.
Information: recommendations to be followed.
INFORMATION
Please refer to the Use environment section for additional information on
temperature, pressure and humidity limitations.
2

Table of Contents
1 INTRODUCTION 5
1.1 Scope...................................................................................................................5
1.2 Intended use.........................................................................................................5
1.3 Intended user population......................................................................................5
1.4 Intended patient population..................................................................................5
1.5 Principles of Operation.........................................................................................6
1.6 Contraindications..................................................................................................6
1.7 Use environment..................................................................................................6
2 DESCRIPTION 8
2.1 System definition..................................................................................................8
2.2 Packaging content................................................................................................8
2.3 General description..............................................................................................8
2.4 Detailed description..............................................................................................9
2.5 Display description.............................................................................................10
3 INSTALLATION AND REMOVAL 12
3.1 Installation..........................................................................................................12
3.2 Removal.............................................................................................................14
4 OPERATIONS 16
4.1 Use of internal battery........................................................................................16
4.2 Basic operations.................................................................................................17
5 PUMP MENU 27
5.1 Access menus....................................................................................................27
5.2 Target volume mode...........................................................................................28
5.3 Night mode.........................................................................................................29
5.4 Sound.................................................................................................................29
5.5 Settings lock.......................................................................................................30
5.6 Cumulative feeding volume counter...................................................................31
5.7 Alarm history.......................................................................................................31
5.8 Feeding history...................................................................................................32
5.9 Contrast / Brightness..........................................................................................33
5.10 Set time between two alarm sounds.................................................................33
5.11 Set time for target volume almost reached message.......................................34
5.12 Technical information........................................................................................34
6 CLEANING AND DISINFECTION 36
6.1 Prohibited cleaning or disinfection agents..........................................................36
3

6.2 Precautions.........................................................................................................36
6.3 Recommended cleaning and disinfection agents...............................................36
6.4 Cleaning and disinfection guidelines and protocol.............................................36
7 QUICK CHECK PROTOCOL 39
8 ALARMS AND SAFETY FEATURES 41
8.1 Alarms / Actions..................................................................................................41
8.2 Troubleshooting..................................................................................................46
9 TECHNICAL INFORMATION 48
9.1 Performance.......................................................................................................48
9.2 Technical characteristics.....................................................................................50
10 TRANSPORT, STORAGE AND RECYCLING CONDITIONS 57
10.1 Storage and transport conditions......................................................................57
10.2 Storage.............................................................................................................57
10.3 Recycling and disposal.....................................................................................58
11 GUIDANCE AND MANUFACTURER’S DECLARATION ON EMC 59
11.1 Electromagnetic compatibility and interference guidance.................................59
11.2 Guidance and manufacturer’s declaration - Electromagnetic immunity...........60
11.3 Recommended separation distances between portable and mobile RF
communication equipment and pump........................................................................60
12 SERVICES 61
12.1 Warranty...........................................................................................................61
12.2 Quality control...................................................................................................61
12.3 Maintenance requirements...............................................................................62
12.4 Service policy and rules....................................................................................62
13 ORDERING INFORMATION 63
13.1 Instructions for use...........................................................................................63
13.2 Giving sets........................................................................................................63
13.3 Accessories......................................................................................................63
14 GLOSSARY OF TERMS 65
LOCAL CONTACTS FOR SERVICING 67
4

1 Introduction
Amika is an enteral feeding pump with a holder power and disposables dedicated to enteral
feeding and hydration. The intended use of Amika pump and sets is to deliver nutrition and
hydration fluids to the patient through a feeding tube, in a safe, instinctive and convenient
manner.
1.1 Scope
These Instructions for Use (IFU) are applicable to the Amika pump referred to as pump with
software and hardware versions 2.2 / i.
WARNING
■Check that these IFU are applicable to the current Amika software version.
■ The software and hardware versions of the pump are displayed in the
technical information menu described in Technical information on page
34.
■ The user must follow the instructions specified in this IFU. Failure to
observe these instructions may result in damage to the equipment, injury
to patients or injury to users. Specific texts are highlighted using the
symbols described in Symbol descriptions on page 2.
1.2 Intended use
Amika enteral feeding pump is intended for use on adults and pediatrics to deliver nutrition
and hydration fluids to the patient through an enteral route of administration using a feeding
tube.
It is intended for use by both qualified and trained healthcare professionals in clinical
healthcare facilities, in ambulatory use with an Amika Backpack and in pre-hospital medical
ground transportation and home users in homecare.
1.3 Intended user population
WARNING
Keep the pump, sets and AC/DC adapter away from unsupervised children
(and animals).
The pump must only be used and cleaned by trained healthcare professionals, patients or
patient relatives.
It is recommended that users attend a single training session of about 40 minutes (For
training, contact your Fresenius Kabi sales representative).
1.4 Intended patient population
The pump can be used on one patient at a time and on multiple patients during its lifetime.
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The pump can be used on patients requiring enteral feeding and enteral hydration.
The intended patient population includes patients who get enteral nutrition parallel to IV
insulin administration. Those patients require special attention during the feeding process.
1.5 Principles of Operation
The device is a peristaltic pump dedicated to enteral feeding.
The pump is used to administer to patient (humans only) a volume of nutrition at a
programmed flow rate.
The pump is designed to administer fluids through trans-nasal or percutaneous feeding
tube.
The pump is designed to administer any kind of enteral nutrition fluids, including drinking
water (still and sparkling), tea, soda, fresh water and the whole product range of ready
nutrition from Fresenius Kabi.
1.6 Contraindications
DO NOT USE:
■ for the intravenous administration of infusion fluids;
■ if enteral feeding is contraindicated by medical prescription;
■ with premature (born < 37 weeks of pregnancy) and neonates (<1 month);
■ in Magnetic Resonance Imaging (MRI) environments;
■ in ambulances, helicopters, aircrafts and hyperbaric chambers;
■ in areas where there is a risk of explosion.
1.7 Use environment
The Amika AC/DC adapter is not meant to be used outdoors (such as in the garden, on the
patio).
WARNING
■ Keep away from heat sources, dust, fluff, direct and prolonged light
exposure.
■ The pump should be used under specified operational, storage and
transport conditions listed below to ensure pump performance.
■ At the limit of the operating temperature range, physical properties of
set’s tube may change; in such condition, alarms are more likely to
happen.
■ Temperature operating range: 10°C to 40°C
■ Storage and transport temperature: -20°C to +45°C
■ Pressure operating range: 700 hPa to 1060 hPa
■ Storage and transport pressure: 500 hPa to 1060 hPa
■ Humidity operating range: 30% to 85%, no condensation
■ Storage and transport humidity: 10% to 90%, no condensation
6

■ Altitude: maximum 3000 m.
In case of refrigerated products, allow the product to reach the operating temperature range
before use.
When the pump is stored at extreme temperature (-20°C and +45°C), wait for 2 hours to
allow the product to reach the operating temperature range before using the pump. An
intempestive alarm can be triggered if the pump/giving set temperature is too low or too
high.
7

2 Description
2.1 System definition
The Amika system is composed of the following components:
■ Amika pump: enteral feeding pump with pump holder and AC/DC adapter.
■ Amika disposable (applied part): giving sets.
■ Amika accessories.
For more information on accessories, refer to their respective accompanying documents.
2.2 Packaging content
MEDICAL DEVICES
Amika
Enteral feeding pump
Software version 2.2
INSTRUCTIONS FOR USE
Pagesde 5800-12_Master_ifu_Amika_eng-V7.pdf 1 08/08/2017 16:33:40
Figure 1: Pump + Pump holder + AC/DC adapter + User documents
Packaging consists of: recycled cardboard.
Symbols used on Amika packaging are described in Symbol descriptions on page 2.
2.3 General description
Legend
2
1
3
Pump
1
Giving set (sold separately)
2
Pump holder
3
8

2.4 Detailed description
Pump description
1
1
2
3
4
56
7
8
9
10
11
12
Legend
Tube guides
1
Pinch clamp slot
2
Pumping mechanism
3
Status light indicator
4
Front panel (keypad)
5
Door lever
6
Pump door
7
Pump identification label
8
Speaker
9
Rails for installation on pump holder
10
Contact pins for pump to holder connection
11
Pump door identification label
12
9

Pump holder description
Legend
6
5
4
3
2
1
AC/DC adapter’s connector
1
Clamp handle
2
Pole clamp
3
Grey locking lever
4
Contact pins for pump to holder
connection (Power supply)
5
Holder identification labels
6
Near the power cable inlet of the
holder, description in Power supply
specifications on page 50
Front panel (keypad) description
Legend
1
234
5
6
7
8
9
10
1112
13
Display (description next page)
1
Mute (alarm silence) key
2
Keypad lock key
3
Menu key
4
Mains supply light indicator
5
Power ON/OFF key
6
Flow rate Up
7
Flow rate Down / Scroll up in Menu
8
Target volume Up
9
Target volume Down / Scroll down
in Menu
10
Priming function key
11
Stop / Cancel / Back key
12
Start / Enter / OK key
13
2.5 Display description
Status Bar icons
Alarm iconSound level icons
Muted alarm iconBattery icon
Settings lock iconKeypad locked icon
10

Setting screen layout
Legend
Pumping status indicator:
Pumping is stopped
Pumping is in progress
1
Status bar
2
Flow rate
3
Target volume
4
Progress bar showing volume
delivered
5
Menu display layout
Legend
1
2
3
4
Menu list
1
Menu access
2
Scroll bar
3
Back
4
11

3 Installation and removal
Installation and removal must only be done when the patient is not connected.
3.1 Installation
3.1.1 Global installation
Ensure that the appropriate positions between patient, pump, giving set and container are
maintained.
WARNING
■ Do not vary the pump height while a patient is connected to it. This may
lead to false alarms and will alter flow rate accuracy.
■ Check the stability of the whole system. If the container is positioned
lower than 0.5 m beneath the pump, this can lead to flow rate deviation.
■ Give particular attention to the risk of strangulation with cables and sets,
and with the small parts that could be swallowed or inhaled.
Figure 3: Possible installationFigure 2: Recommended installation
The container can be placed down to 0.5 m be-
neath the pump
Place the container above the pump
Do not place the pump below the patient or more than 1.3 meter above the patient.
3.1.2 Using the pole clamp
The holder can be attached universally, vertically and horizont-
ally. Turn the pole clamp to the suitable position.
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3.1.3 Positioning the holder on a rail, pole, bed or wheelchair
Ensure the holder is positioned so that the display is at the suitable height to ensure good
visibility and orientation in the reading direction (the contact pins are at the bottom).
X, Y min = 10 mm
X, Y max = 35 mm
Ø min = 8 mm
Ø max = 40 mm
X
Y
Ø
1. Fasten pole clamp firmly on the pole or rail to avoid any movement of the pump.
2. Ensure that the pump is securely attached and positioned.
3.1.4 Positioning the holder on a table
The holder can be placed on a flat and horizontal
table as indicated in the figure.
Ensure the pump is positioned away from table
edges to avoid being accidentally pushed off the
table.
3.1.5 Positioning the pump
Slide the pump down until the grey locking lever
locks the position.
3.1.6 Electrical connection
Ensure AC/DC adapter is not damaged and is compatible with local voltage range.
To charge battery or to use the pump on the mains power supply:
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1. Connect AC/DC adapter to the holder.
2. Plug the AC/DC adapter to the mains socket.
When connecting to the mains, ensure that the AC/DC adapter and the power socket
are easily accessible.
The mains power supply is indicated by a green light on the pump's front panel (keypad).
3.2 Removal
3.2.1 Removing the pump from the pump holder
2
1
1. Push the grey locking lever.
2. Pull the pump up.
14

3.2.2 Removing the pump holder
3.2.3 Electrical disconnection
1. Remove AC/DC adapter from power socket.
■ A beep is emitted by the pump when the AC/DC adapter is disconnected.
■ To store the pump, see Storage on page 57.
2. Remove AC/DC adapter from holder.
3.2.4 Attaching / Removing the Quick Guide
A quick guide can be easily attached and re-
moved from the pump holder.
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4 Operations
4.1 Use of internal battery
4.1.1 Battery precautions
Before using the pump on battery for the first time, charge the battery until it is fully charged
(approximately 6 hours).
Keeping the pump connected to mains when not in use is recommended in order to maintain
battery charge. The battery is charging continuously ensuring its maximum capacity.
4.1.2 Battery operating mode
The icon is always displayed in the status bar. The device can be used while battery
is charging.
24 hours ± 5% until 125 mL/h and a minimum of 8 hours for flow rates
above 125 mL/h (in standard feeding conditions, at 22.5°C ± 2.5°C)
Battery life
When the pump is connected to the mains (see Electrical connection on
page 13)
► Battery charges automatically, also during operation
(green)
When the pump is disconnected from the mains (see Electrical disconnec-
tion on page 15)
► Pump switches to Battery Mode automatically
The battery is fully charged
The battery is partially charged
The battery is nearly empty.
►A visual information is triggered (see Alarms / Actions on page 41).
When battery is empty (less than 10 minutes left), an alarm is triggered
(see Alarms / Actions on page 41.)
(flashing)
INFORMATION
■ To optimize battery life, set the flow rate at 125 mL/h maximum and use
the pump in battery mode several times until battery is discharged (
flashing).
■If battery is failing, do not use the device. Return device to Fresenius Kabi
sales representative as soon as possible.
■Battery replacement must be performed by qualified and trained technical
personnel in compliance with the technical manual and procedures.
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4.2 Basic operations
Before using the pump, proceed to Quick Check Protocol (see Quick check protocol on
page 39).
4.2.1 Switch-on
When using a pump on patient requiring special attention, ensure that a backup pump or
gravity set are available for immediate use.
When switching on the pump, check that the auto test sequence is as described below.
Before switching on the pump, install holder and pump, see Installation on page 12.
Figure 4: Auto test
During the 2-second autotest:
■ red, yellow and green LEDs blink;
■beep sounds (if sound level is low, melody is playing on low, if sound level is high, melody
is on high).
4.2.2 Installing the giving set
4.2.2.1 Preparing the giving set
In order to protect user health, please follow clean aseptic handling procedures for container,
set or feeding tube disposal.
WARNING
■ Only Fresenius Kabi giving sets can guarantee pump reliability. Please
refer to the compatible giving sets (see Giving sets on page 63) and
compatible nutrition fluids (see Intended use on page 5).
■ Check the giving set's intended use regarding the feeding protocol,
especially for patients requiring special attention.
■ Check giving set and patient connection integrity before use.
17

CAUTION
The fluid in the giving set and the bag/bottle must be within normal
temperature conditions: +10°/+40°C.
4.2.2.2 Description of the Pinch clamp
Pinch clamp is closedPinch clamp is open
INFORMATION
Patient must not be connected to the set when the Pinch clamp is open.
4.2.2.3 Installing the giving set in the pump
To connect / disconnect / change the container and feeding tube to the set, refer to the
giving set "Instructions for use" on primary packaging.
WARNING
For patients requiring special attention, another giving set must always be
available.
1. Push up the lever to unlock the door . Open the door .
2. Position the Pinch clamp using the arrow marks indicating the direction of the flow .
Insert the Pinch clamp until you hear the ‘CLIC’ .
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3. On the sides of the pump, place the tube straight inside tube guides.
WARNING
Check that the giving set is correctly installed to avoid patient harm such as
overfeeding, underfeeding.
4. Close the door . Push down the lever to lock the door .
19

INFORMATION
When opening the pump door, the tube clamp is automatically closed
(free-flow prevention system).
4.2.3 Priming the giving set
WARNING
Patient must not be connected to the pump when priming is performed.
INFORMATION
■ To proceed to giving set priming, fill drip chamber half full by pressing
gently.
■ Ensure that liquid is flowing in the drip chamber after starting the pump.
■ For giving sets without drip chamber, use only automatic priming.
■ A beep sound will be heard every 30 seconds during priming.
4.2.3.1 Priming with the pump
Amika pump allows two priming modes:
■ automatic priming: Amika pump automatically fills in the giving set at maximum rate by
depressing the automatic priming key ;
■ semi-automatic priming: Amika pump fills in the giving set at maximum rate as long as
the semi-automatic priming key is kept depressed.
INFORMATION
Automatic and semi-automatic priming fill the giving set at a rate of 600 mL/h
and are stopped after 17 mL (factory settings).
Make sure that priming is correctly completed before starting feeding.
Automatic priming
Auto priming can be stopped at any time:
20