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Fresenius Kabi Amika Instructions For Use Manual Download Page 8

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

Pages de 5800-12_Master_ifu_Amika_eng-V7.pdf 1 08/08/2017 16:33:40

Figure 1:

Pump + Pump  AC/DC a 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

Summary of Contents for Amika

Page 1: ...Amika Enteral feeding pump Version 2 2 i INSTRUCTIONS FOR USE ...

Page 2: ...neral 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 pot...

Page 3: ...TION 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 Se...

Page 4: ...rage 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 Maint...

Page 5: ...rs 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 healt...

Page 6: ...ids 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 ...

Page 7: ...ating 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 ...

Page 8: ... respective accompanying documents 2 2 Packaging content MEDICAL DEVICES Amika Enteral feeding pump Software version 2 2 INSTRUCTIONS FOR USE Pages de 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 desc...

Page 9: ...be 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 ...

Page 10: ...l keypad description Legend 1 2 3 4 5 6 7 8 9 10 11 12 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 S...

Page 11: ...umping 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 ...

Page 12: ... 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 installation Figure 2 Recommended installation The container can be placed down to 0 5 m be neath the pump Place the container above the pump D...

Page 13: ...ent 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 ...

Page 14: ...necting 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 ...

Page 15: ...pter 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 15 ...

Page 16: ...ction 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 minute...

Page 17: ...reen 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 compa...

Page 18: ...pen 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 dir...

Page 19: ...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 ...

Page 20: ...eep 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...

Page 21: ...etting screen WARNING At the end of priming check that the set is correctly primed 4 2 3 2 Priming without the pump Manual priming 1 Remove the giving set from the pump see Removing Changing the giving set from the pump on page 24 2 Close Pinch clamp 3 Connect food container to giving set and hang up 4 Fill drip chamber half full by pressing gently 5 Open Pinch clamp and prime to the end of the gi...

Page 22: ...ndividually to the patient Regular checks are required Adjust feeding rate mL h Press or key to set the feeding rate Adjust target volume mL Press or key to set the target volume WARNING Make sure feeding parameters are checked before starting feeding programming error can lead to overfeeding underfeeding or delay of therapy 22 ...

Page 23: ... before starting feeding 3 Check power supply before starting feeding Green light indicator if supplied by mains or Battery icon filled up if supplied by the battery 4 2 6 Terminate feeding Stop feeding When feeding is stopped flow rate and target volume parameters can be adjusted Then feeding can resume Reset the progress bar 23 ...

Page 24: ... mode sound level key beep activation deactivation contrast and brightness feeding and Alarm history settings lock activation deactivation time between 2 alarm sounds time for target volume almost reached message technical information This information is saved even if the battery is disconnected with no time limit 4 2 8 Removing Changing the giving set from the pump The mechanical properties of th...

Page 25: ... the lever to unlock the door 2 Open the door 3 Remove giving set Install a new giving set in the pump see Installing the giving set on page 17 4 2 9 Keypad lock Keypad lock prevents from unintentional tampering of pump settings When keypad is locked is displayed in the status bar is the only active key If other keys are depressed the forbidden key beep 2 beeps is triggered no action is undertaken...

Page 26: ...the alarm symbol is displayed and the yellow LED keeps flashing until a corrective action is performed the alarm sound is off for 2 minutes When a low priority alarm is muted the mute icon is displayed in the status bar the alarm symbol is displayed and the yellow LED is lit the alarm sound is off and an information signal sound 2 beeps is emitted every 30 minutes For further information about ala...

Page 27: ...ust sound level Sound Deactivate activate key beep Deactivate activate settings lock Settings lock Display cumulative feeding volume Cumulative feeding volume counter Clear cumulative feeding volume Consult the last 250 alarm events Alarm history Consult the last 250 feeding events Feeding history Contrast setting Contrast Brightness Brightness setting Consult time between 2 alarm sounds Time betw...

Page 28: ...arget volume with respectively different flow rates the respective flow rates are saved Press to select target volume mode Press or to deactivate activate target volume mode defaut setting activated Press to validate INFORMATION When target volume mode is deactivated the target volume and the progress bar disappear from the display If the settings lock is activated the access code is required to a...

Page 29: ... INFORMATION When night mode is activated display backlight and power LED are set to minimum level In case of alarm the backlight turns back to normal Night mode is automatically deactivated after switching OFF the pump 5 4 Sound The pump is set by default to the highest sound level It can be reduced to a lower sound level Press to select the sound level and key beep sound 29 ...

Page 30: ...re Settings lock Press key to enter the access code Enter the access code by adjusting each digit 0 to 9 using and keys and validate each digit by pressing If you enter the wrong code it is reset to 0 0 0 Press to activate settings lock function When settings lock is activated is displayed in the status bar target volume and flow rate cannot be changed Accessible keys are with restrictions INFORMA...

Page 31: ... volume counter Press to display the cumulative feeding volume The total feeding volume since last reset is displayed If needed press then to clear the cumulative feeding volume default setting 5 7 Alarm history Alarm events are automatically saved in the pump memory Press to display the alarm events 31 ...

Page 32: ...d 9 days 15 hours and 22 minutes ago 5 8 Feeding history Press to display the feeding events Press to switch from one feeding event to another INFORMATION Feeding history indicates the delivered volumes their associated flow rate and the time elapsed since their delivery Example a volume of 1500 mL was administered at a flow rate of 125 mL h 13 days 2 hours and 25 minutes ago 32 ...

Page 33: ...nds Press Press to set the time between two alarm sounds Press to validate INFORMATION The access code is required to set time between two alarm sounds WARNING Time between 2 alarms can be adjusted from 2 5 to 30 seconds with steps of 0 5 seconds This adjustment can modify the perception of an alarm Default value 2 5 seconds 33 ...

Page 34: ...ached message and target volume reached alarm can be adjusted from 0 to 59 min with steps of 1 min default setting 5 min Access code is required to set time for target volume almost reached message 5 12 Technical information Press to access the technical information NOTE the technical information menu displays Pump serial number Software version Hardware version Production date mm dd yyyy 34 ...

Page 35: ...Last maintenance date mm dd yyyy Total delivered volume Total functioning time 35 ...

Page 36: ...t may damage the pump The Amika is a non sterile medical device The Amika backpack must be cleaned before inserting the pump Please refer to its specific accompanying documents Make sure to use the original door when replacing it on the pump check the serial number on the pump is the same as on the door A door switch between pumps can lead to major pumping errors 6 3 Recommended cleaning and disin...

Page 37: ...all exposed surfaces housing keypad screw area holder connection area etc of the pump from top to bottom Gently wipe down the pump exposed mechanism and sensor area tube guide purple insert A minimum cleaning of 1 minute is recommended allow to remain visibly wet for 1 minute until all organic matter is dissolved and removed Do not allow liquids to run leak or drip into the pump housing Use cotton...

Page 38: ...not turn the pump over to avoid liquid leak in the battery door 3 Use a ready to use wipe to wipe down all exposed surfaces of the pump holder and pump door as described in cleaning protocol making sure to cover all cracks crevices and hard to reach areas Do not allow liquids to run leak or drip into the pump housing 4 Using a fresh ready to use wipe repeat steps 3 Ensure that the minimum contact ...

Page 39: ...ns 5 Switch on the pump 6 Check the autotest sequence LCD display intact speaker LED and the back light Do not use with damaged screens 7 Check the mains LED lights up 8 Remove the Amika from the holder and check the battery symbol on the display 9 Install the Amika pump on the holder 10 Check that the pump and its holder are securely attached or positionned 11 Check that all menu settings are ada...

Page 40: ...ages symbol on the display beep sound blinking status light indicator 1 Set installation alarm 2 Door alarm 3 Upstream occlusion alarm 4 Downstream occlusion alarm 5 Empty bag Air in Line alarm 6 Target volume almost reached message 7 Battery nearly empty message 8 Check the flow rate by measuring the delivered volume 40 ...

Page 41: ...ironment The alarm sound level measures are Pump inside a backpack Pump on its holder Settings 45 dB A 50 dB A Low Level High me dium low priority alarms 50 dB A 60 dB A High Level NOTE dB A is the Level average pressure mesured following ISO 3744 8 1 1 The different types of information signal or alarm Feeding continues Information signal Information signal sound 2 beeps Feeding continues Informa...

Page 42: ...ding using the key WARNING Identify displays symbols and status in the table below to understand the meaning and conduct the appropriate action 8 1 2 Alarm descriptions Line control Actions Meanings Symbol Medium priority Yellow LEDs are flashing Check position of giving set above and below the pump mechanism and insert correctly if necessary Check that the proper set is used Amika giving sets onl...

Page 43: ...mp is open Flush tube if necessary Check the absence of upstream downstream occlusion in the line Upstream flowpath is blocked between the container and the pump Upstream occlu sion Open the door check the set in stallation close the door See Installing the giving set on page 17 Check that the set is not kinked Re position and verify that food flows freely after adjustment Check that the feeding t...

Page 44: ...s are flashing End feeding or proceed to the next step Alarm The target volume is reached Complete progress bar Target volume reached Function control Actions Meanings Symbol Low priority Symbol battery is fixed yellow This message appears 30 min before the empty battery alarm Connect the pump to the mains via the pump holder Recharge battery to resume pump operation Minimum battery voltage is not...

Page 45: ...giving set Open the door and remove dirt with cloth and soapy water or as directed by hospital policy see Cleaning and disinfection on page 36 Allow the pump to dry Dirt in sensor area lower tube guide Check position of giving set and insert correctly if necessary See Installing the giving set on page 17 Giving set not properly connected to the container High priority Red LEDs are flashing Alarm s...

Page 46: ... but not operated for 2 minutes 2 beeps Start reminder NOTE the maximum volume infused between the alarm condition and the technical alarms generation is 35 mL 8 1 3 Maximum alarm raising delay Time between alarm condition and alarm generation is less than 5 seconds except for Giving set Upstream and Downstream occlusions and Empty bag Air in Line alarms see Performance on page 48 INFORMATION When...

Page 47: ...her than flow rate accuracy Check the general state of the front panel keypad Check the contrast Contact your biomedical department or Fresenius Kabi sales rep resentative if problem remains Front panel problem keys LEDs Connect pump to the mains supply Check that the LED on the AC DC adapter lights If not unplug and plug it again in the mains socket Contact your biomedical department or Fresenius...

Page 48: ...eding settings 9 1 2 Flow Rate range From 1 mL h to 600 mL h default setting 50 mL h Range 1 mL h from 1 mL h to 100 mL h 5 mL h from 100 mL h to 600 mL h Increments 7 at 50 mL h 10 for the whole range of flow rates Accuracy Test initial conditions following 60601 2 24 Cumulative volume measured on a two hour period with 25 mL minimum volume Container height 50 cm 9 1 3 Volume range From 1 mL to 5...

Page 49: ...iner height 50 cm NOTE A bolus 5mL may occur during pump movement from 0 to 1 m above the patient and before occlusion release 9 1 6 Empty bag Air in Line alarm response time at different flow rates Time mentioned is applicable only if the set has been previously filled Empty bag Air in Line detection time Air volume 3 5 mL Flow rate 3 hours 30 min maximum 1 mL h 10 min maximum 25 mL h 3 min maxim...

Page 50: ...tery specifications NiMH Nickel Metal Hydride 4 8V 1 8 2 2 Ah Ni MH Characteristics Approximately 100 g Weight 6 hours Maximum charging time 9 2 4 Power consumption Consumption of the pump in standard operating conditions maximum 9 W 9 2 5 Dimensions Weight Dimensions H x W x D Weight 138 x 128 x 48 mm 610 g Pump 185 x 110 x 85 mm 350 g Holder 200 g AC DC ad apter 500 g Packaging 9 2 6 Trumpet cur...

Page 51: ...arioline Fluid used distilled water and Fresubin energy drink 1 mL h only 9 2 6 1 Minimum flow rate 1 mL h Sampling time 30 seconds Start up and instantaneous flow rate 1 mL h over first 2h of the test period Trumpet curves for 2 5 11 19 31 minute observation windows 1 ml h over second hour of the test period Sampling time 30 seconds 51 ...

Page 52: ...eous rate 1 mL h over last 2 hours of set change interval 24 hours Trumpet curves for 2 5 11 19 31 minute observation windows 1 mL h over last hour of the set change interval 24 hours Sampling time 15 minutes 52 ...

Page 53: ...rumpet curves for 15 60 150 330 570 930 minute observation windows 1 mL h over set change interval 24 hours 9 2 6 2 Intermediate flow rate 25 mL h Sampling time 30 seconds Start up and instantaneous at intermediate flow rate 25 mL h over first 2h of the test period 53 ...

Page 54: ...Trumpet curves for 2 5 11 19 31 minute observation windows 25 mL h over second hour of the test period Instantaneous rate 25 mL h over last 2 hours of set change interval 24 hours 54 ...

Page 55: ...observation windows 25 mL h over set change interval 24 hours 9 2 7 Compliance with standards Conform to IEC 60601 1 General requirements for basic safety and essential performance for Medical electrical equipment Conform to IEC 60601 1 2 Electromagnetic compatibility Requirements and tests for Medical electrical equipment Conform to IEC 60601 2 24 Particular requirements for the basic safety and ...

Page 56: ...ical electrical equipment and medical electrical systems used in the home healthcare environment Conform to the 93 42 EEC Medical dir ective 0123 Notified body number TÜV SÜD Product Service GmbH Ridlerstrasse 65 80339 München Germany NOTE The full list of applicable standards is available upon request The device is protected against leakage current and does not disturb ECG or EEG devices 56 ...

Page 57: ...mp must be handled with care during storage WARNING If the device is not used for longer than 2 months remove the battery and store it as per storage conditions above If the device is stored without removing the battery charge it at least once a month by connecting it to the mains for at least 6 hours Amika must be cleaned and disinfected prior to storage see Cleaning and disinfection on page 36 1...

Page 58: ...mp an hourglass will be displayed We recommend that the Amika Quick check protocol is performed when the device is installed after transport in case of prolonged storage or before being used on a new patient 10 3 Recycling and disposal Before disposal remove battery from the device Batteries accessories and devices with this label must not be disposed of with the general waste They must be collect...

Page 59: ...atibility and interference guidance The Amika has been tested in accordance with the electromagnetic compatibility standards applicable to medical devices Its immunity is designed to ensure correct operation Limitation of the emitted radiation avoids undesirable interference with other equipment The Amika is classified as a Class B device according to CISPR 11 emitted radiation The user might be r...

Page 60: ...ed separation distances between portable and mobile RF communication equipment and pump The Amika pump is intended to be used in an electromagnetic environment in which radiated RF disturbances are controlled Users of the Amika may prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the Amika as recommended...

Page 61: ... qualified personnel the internal battery of the device must not have been replaced by a battery other than that specified by the manufacturer the serial number ID N must not have been altered changed or erased INFORMATION In case of failure to comply with these conditions Fresenius Kabi will prepare an estimate for repairs covering the parts and labour required When a return and or a repair of th...

Page 62: ...or if any malfunction occurs In this case the device must not be used Please contact your biomedical department or Fresenius Kabi When replacing components only use Fresenius Kabi spare parts When using the device on a patient no maintenance action must be performed Life cycle of Amika pump 10 years provided that the maintenance is properly performed as described above 12 4 Service policy and rule...

Page 63: ...giving set the performance of the pump is maintained ENFit ISO Sets ENPlus ENFit Transition Sets ENPlus 7751917 7752085T Amika EasyBag 7751918 7752086T Amika Easy Bag without Medication port 7751994 7752089T Amika EasyBag Two Line 7751916 7752087T Amika EasyBag mobile 7751919 7752088T Amika Varioline 7751914 7751715T Amika Bag 7751915 7752046T Amika Bag mobile 13 3 Accessories Do not use the devic...

Page 64: ...dapter Charger Several country kits are available Additional power cords AC adapter charger wall plug must be ordered separately Each Product reference includes its own appropriate wall plug depending on the country Please contact your Fresenius Kabi sales representative for orders 64 ...

Page 65: ... Interference CISPR Centimeters cm Decibel dB Digital Enhanced Cordless Telecommunications DECT Electrocardiogram ECG Electroencephalogram EEG Electromagnetic compatibility EMC Error message EXX Gram g Hours h Height Width Depth H x W x D High Frequency HF Hecto Pascal hPa Hertz Hz Serial number ID N International Electrotechnical Commission IEC Instructions for Use IFU Intravenous IV Light Emitti...

Page 66: ...ters mm Magnetic Resonance Imaging MRI Nickel Metal Hydride NiMH Nuclear Magnetic Resonance NMR Radio Frequency RF Radio Frequency Identification RFID Seconds sec Uninterruptable Power Supply UPS Volt V Volt Alternating Current Vac Volt Direct Current Vdc Watt W 66 ...

Page 67: ...Local contacts for servicing Write your contacts here 67 ...

Page 68: ...standards and of legal texts and materials the characteristics indicated in the text and images of this document are applicable only to the device with which it is included This document may not be reproduced in whole or in part without the written consent of Fresenius Kabi Amika is a registered trademark in the name of Fresenius Kabi in selected countries Made in France Revision date January 2108...

Page 69: ...6925 9_ifu_Amika_GB ...

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