Fresenius Kabi Amika User manual

Amika
Enteral feeding pump
Version 2.3 / i
Instructions For Use

Symbol descriptions
Unique Device IdentifierMedical Device
CE markingRefer to the Instructions For Use
Mass; weightClass II equipment
Product serial numberProduct reference
Name and address of the manufacturing
facility
Manufacturer
Defibrillation-proof type CF applied partBattery characteristics
Alternating Current (AC)Direct Current (DC)
Electrical inputElectrical output
This way upFragile, handle with care
Temperature limitationKeep away from rain
Atmospheric pressure limitationHumidity limitation
Forest Stewardship Council symbol
Batteries, accumulators and battery packs
for separate collection
Product reference and
product serial number
Production order
(01) Product identifier GTIN
(21) Product serial number
(11) Date of manufacture under form YYMMDD
(240) Product Reference
Holder: IP32-Index of protection against solid foreign objects (> 2.5 mm) and dripping liquids
Pump: IP35-Index of protection against solid foreign objects (> 2.5 mm) and water jets from
any direction
IP32
IP35
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.
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INFORMATION
Please refer to the Use environment section for additional information on
temperature, pressure and humidity limitations.
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Table of contents
1 Introduction 7
1.1 Scope....................................................................................................................7
1.2 Principles of operations.........................................................................................7
1.3 Intended purpose...................................................................................................7
1.4 Intended use..........................................................................................................7
1.4.1 Indications..................................................................................................7
1.4.2 Contraindications........................................................................................7
1.4.3 Intended users............................................................................................8
1.4.4 Intended patients........................................................................................8
1.4.5 Use environment........................................................................................8
1.5 Clinical benefits.....................................................................................................9
1.6 Side-effects............................................................................................................9
1.7 Risks for patients...................................................................................................9
2 Description 10
2.1 System definition.................................................................................................10
2.2 Packaging content...............................................................................................10
2.3 General description.............................................................................................10
2.4 Detailed description.............................................................................................11
2.5 Display description..............................................................................................13
3 Installation and removal 14
3.1 Installation...........................................................................................................14
3.1.1 Global installation.....................................................................................14
3.1.2 Using the pole clamp................................................................................15
3.1.3 Positioning the holder on a rail, pole, bed or wheelchair..........................15
3.1.4 Positioning the holder on a table..............................................................15
3.1.5 Positioning the pump................................................................................16
3.1.6 Electrical connection.................................................................................16
3.2 Removal..............................................................................................................17
3.2.1 Removing the pump from the pump holder..............................................17
3.2.2 Removing the pump holder......................................................................17
3.2.3 Electrical disconnection............................................................................17
3.2.4 Attaching / Removing the Quick Guide.....................................................18
4 Operations 19
4.1 Use of internal battery.........................................................................................19
4.1.1 Battery precautions...................................................................................19
4.1.2 Battery operating mode............................................................................19
4.2 Basic operations..................................................................................................20
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4.2.1 Switch-on..................................................................................................20
4.2.2 Installing the giving set.............................................................................20
4.2.3 Priming the giving set...............................................................................23
4.2.4 Change feeding setting.............................................................................25
4.2.5 Start feeding.............................................................................................26
4.2.6 Terminate feeding.....................................................................................26
4.2.7 Switch off pump........................................................................................27
4.2.8 Removing/Changing the giving set from the pump..................................28
4.2.9 Keypad lock..............................................................................................29
4.2.10 Mute alarm..............................................................................................29
5 Pump menu 31
5.1 Access menus.....................................................................................................31
5.2 Feeding mode......................................................................................................32
5.3 Night mode..........................................................................................................33
5.4 Sound..................................................................................................................33
5.5 Settings lock........................................................................................................34
5.6 Cumulative feeding volume counter....................................................................35
5.7 Alarm history........................................................................................................35
5.8 Feeding history....................................................................................................36
5.9 Contrast / Brightness...........................................................................................37
5.10 Set time between two alarm sounds..................................................................37
5.11 Set time for target volume almost reached message........................................38
5.12 Technical information.........................................................................................38
5.13 Reset manufacturing settings............................................................................39
6 Cleaning and disinfection 40
6.1 Prohibited cleaning or disinfection agents...........................................................40
6.2 Precautions..........................................................................................................40
6.3 Recommended cleaning and disinfection agents................................................40
6.4 Cleaning and disinfection guidelines and protocol..............................................40
6.4.1 Cleaning Instructions................................................................................41
6.4.2 Disinfection instructions............................................................................42
7 Alarms and safety features 43
7.1 Alarms / Actions...................................................................................................43
7.1.1 The different types of information signal or alarm....................................43
7.1.2 Alarm descriptions....................................................................................44
7.1.3 Maximum alarm raising delay...................................................................48
7.2 Troubleshooting...................................................................................................48
8 Technical information 50
8.1 Performance........................................................................................................50
8.1.1 Essential performance..............................................................................50
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8.1.2 Flow Rate range.......................................................................................50
8.1.3 Volume range...........................................................................................50
8.1.4 Upstream and downstream occlusions.....................................................50
8.1.5 Volume Accuracy......................................................................................51
8.1.6 Empty bag / Air in Line alarm response time at different flow rates.........51
8.1.7 Giving set alarm response time at different flow rates.............................51
8.2 Technical characteristics......................................................................................51
8.2.1 Operation mode........................................................................................51
8.2.2 Power supply specifications.....................................................................52
8.2.3 Battery specifications................................................................................52
8.2.4 Power consumption..................................................................................52
8.2.5 Dimensions - Weight................................................................................52
8.2.6 Trumpet curves.........................................................................................52
8.2.7 Compliance with standards......................................................................57
9 Transport, storage and recycling conditions 59
9.1 Storage and transport conditions.........................................................................59
9.2 Storage................................................................................................................59
9.2.1 Prepare the device for storage.................................................................59
9.2.2 Install the device after storage..................................................................60
9.3 Recycling and disposal........................................................................................60
10 Guidance and manufacturer’s declaration on EMC 61
10.1 Electromagnetic compatibility and interference guidance.................................61
10.2 Guidance and manufacturer’s declaration - Electromagnetic immunity............62
10.3 Recommended separation distances between portable and mobile RF
communication equipment and pump........................................................................62
11 Services 63
11.1 Warranty............................................................................................................63
11.1.1 General conditions of warranty...............................................................63
11.1.2 Limited warranty.....................................................................................63
11.1.3 Warranty conditions for battery and accessories....................................63
11.2 Quality control....................................................................................................63
11.3 Maintenance requirements................................................................................64
11.4 Service policy and rules.....................................................................................64
11.5 Notification of serious incident...........................................................................64
12 Ordering information 66
12.1 Instructions for use............................................................................................66
12.2 Giving sets.........................................................................................................66
12.3 Accessories.......................................................................................................66
13 Glossary of terms 68
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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
The Instructions for Use (IFU) is applicable to the Amika pump referred to as pump with
software and hardware versions 2.3 / i.
WARNING
■ Check that the IFU is 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 38.
■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 Principles of operations
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.
1.3 Intended purpose
Enteral feeding pump and accessories for administration through an enteral route (using a
feeding tube) of nutrition and hydration fluids.
1.4 Intended use
1.4.1 Indications
The pump is indicated to administer products through clinically accepted routes. These
products include: water, tea, soda and ready-to-use nutrition bags.
Administration routes:
The pump allows administration via the following tubes and associated access routes:
■ Trans-nasal tubes
■ Percutaneous feeding tubes
1.4.2 Contraindications
DO NOT USE:
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■ 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.
1.4.3 Intended users
WARNING
Keep the pump, sets and power cable away from unsupervised children (and
animals).
The pump must only be used and cleaned by qualified and 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).
INFORMATION
For Thailand, Amika pump is dedicated for qualified and trained healthcare
professionals use.
1.4.4 Intended patients
The pump is intended for use on adults and pediatrics.
The pump can be used on one patient at a time and on multiple patients during its lifetime.
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.
1.4.5 Use environment
It is intended to be used in clinical healthcare facilities, in ambulatory use with an Amika
Backpack, in pre-hospital medical ground transportation and in homecare.
INFORMATION
For Thailand, homecare is not the claimed use environment for Amika pump.
The Amika power cable 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.
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■ 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
■ Altitude: less than 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.
1.5 Clinical benefits
The therapeutic benefit of Amika enteral feeding pump for the patient is enabling controlled
and safe enteral feeding in a clinical and outpatient setting as well as mobile. The objective
of enteral nutrition is prevention and treatment of malnutrition to improve outcome.
1.6 Side-effects
There is no side-effect directly associated to the use of Amika.
1.7 Risks for patients
Failure to follow all instructions described in this document or loss or degradation of essential
performance (see Essential performance on page 50) may result in: underfeeding,
overfeeding, delay of therapy, air embolism, trauma, incorrect therapy, electric shock, toxicity
or infection.
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2 Description
2.1 System definition
The Amika system is composed of the following components:
■ Amika pump: enteral feeding pump with pump holder and power cable.
■ Amika disposable (applied part): giving sets.
■ Amika accessories.
For more information on accessories, refer to their respective accompanying documents.
2.2 Packaging content
The Amika packaging contains the following elements:
■ 1 Amika pump
■ 1 pump holder
■ 1 power cable
■ 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
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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
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Pump holder description
Legend
Clamp handle
1
Contact pins for pump to holder
connection
2
Slot
3
Grey locking lever
4
Mains supply light indicator
5
Pole clamp
6
Holder identification labels
7
Power cable inlet
8
Mains supply light indicator, on the
front panel of the holder
Near the power cable inlet of the
holder, description in Power supply
specifications on page 52
AC~
Front panel (keypad) description
Legend
1
234
5
6
7
8
9
10
1112
13
Display
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
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2.5 Display description
Status Bar icons
Alarm iconSound level icons
Muted alarm iconBattery icon
Settings lock iconKeypad locked icon
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
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3 Installation and removal
Installation and removal must only be done when the patient is not connected.
Check that the Amika pump, holder and power cable are not damaged in any way at the
beginning of installation and at the end of removal.
WARNING
If the Amika pump, holder or power cable is damaged, please do not use and
contact the appropriate department or Fresenius Kabi sales representative for
maintenance.
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 2: Possible installationFigure 1: Recommended installation
The container can be placed down to 0.5 m
beneath 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.
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3.1.2 Using the pole clamp
The holder can be attached universally, vertically and horizontally.
Turn the pole clamp to the suitable position.
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 minimum = 10 mm
X, Y maximum = 35 mm
Ø minimum = 8 mm
Ø maximum = 40 mm
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.
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3.1.5 Positioning the pump
Slide the pump down until the grey
locking lever locks the position.
3.1.6 Electrical connection
Ensure power cable is not damaged.
To charge battery or to use the pump on the mains power supply:
1. Connect power cable to the holder.
2. Plug the power cable to the mains socket.
When connecting to the mains, ensure that the power cable and the power socket are
easily accessible.
The mains power supply is indicated by a green light on the pump's front panel (keypad).
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3.2 Removal
3.2.1 Removing the pump from the pump holder
1. Push the grey locking lever.
2. Pull the pump up.
3.2.2 Removing the pump holder
3.2.3 Electrical disconnection
1. Remove power cable from power socket.
■ A beep is emitted by the pump with mains supply light indicator turned off when the
power cable is disconnected.
■ To store the pump, see Storage on page 59.
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2. Remove power cable from holder.
3.2.4 Attaching / Removing the Quick Guide
A quick guide can be easily attached and removed
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.
Minimum 24 hours 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 16)
► Battery charges automatically, also during operation
(green)
When the pump is disconnected from the mains (see Electrical disconnection
on page 17)
► 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 43).
When battery is empty (less than 10 minutes left), an alarm is triggered (see
Alarms / Actions on page 43.)
(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.
■ Under normal condition of use, battery life might be reduced from 24 hours
to 20 hours by the end of the third year of use.
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4.2 Basic operations
Before using the pump, please check it is not damaged in any way to ensure the integrity
of the pump appearance.
WARNING
If there is any damage found with the pump, please do not use it and contact
the appropriate department or Fresenius Kabi sales representative for
maintenance.
4.2.1 Switch-on
When using a pump on patient requiring special attention, ensure that a backup pump or
giving 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 14.
Figure 3: 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 66) and compatible
nutrition fluids (see Intended use on page 7). The use of unsuitable giving
sets may cause patient harm such as overfeeding, underfeeding.
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