Fresenius Kabi Amika Instructions For Use Manual
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Fresenius Kabi Amika Instructions For Use Manual

Enteral feeding pump
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Amika
Enteral feeding pump
Version 2.2 / i
INSTRUCTIONS FOR USE

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Summary of Contents for Fresenius Kabi Amika

  • Page 1 Amika Enteral feeding pump Version 2.2 / i INSTRUCTIONS FOR USE...
  • Page 2 Symbol descriptions Warning (Refer to the Instructions For CE mark 0123 Use) Refer to the Instructions For Use Medical electrical system weight (kg) Product reference / part number Product serial number Name and address of the manufacturer Name and address of the manufacturing / Date of manufacture facility Battery specification...

  • Page 3: Table Of Contents

    Table of Contents 1 INTRODUCTION 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 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 3.1 Installation......................12...
  • Page 4 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 8 ALARMS AND SAFETY FEATURES 8.1 Alarms / Actions....................41 8.2 Troubleshooting....................46 9 TECHNICAL INFORMATION 9.1 Performance.......................48 9.2 Technical characteristics..................50 10 TRANSPORT, STORAGE AND RECYCLING CONDITIONS 10.1 Storage and transport conditions..............57 10.2 Storage......................57 10.3 Recycling and disposal..................58...

  • Page 5: 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.

  • Page 6: Principles Of Operation

    ■ 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 ■ 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.

  • Page 8: Description

    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.

  • Page 9: Detailed Description

    2.4 Detailed description Pump description Legend Tube guides Pinch clamp slot Pumping mechanism Status light indicator Front panel (keypad) Door lever Pump door Pump identification label Speaker Rails for installation on pump holder Contact pins for pump to holder connection Pump door identification label...

  • Page 10: Display Description

    Pump holder description Legend AC/DC adapter’s connector Clamp handle Pole clamp Grey locking lever Contact pins for pump to holder connection (Power supply) Holder identification labels Near the power cable inlet of the holder, description in Power supply specifications on page 50 Front panel (keypad) description Legend Display (description next page)
  • Page 11 Setting screen layout Legend Pumping status indicator: Pumping is stopped Pumping is in progress Status bar Flow rate Target volume Progress bar showing volume delivered Menu display layout Legend Menu list Menu access Scroll bar Back...

  • Page 12: Installation And Removal

    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.
  • Page 13 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 Ø...

  • Page 14: Removal

    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 Push the grey locking lever.
  • Page 15 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.

  • Page 16: Operations

    ( 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...

  • Page 17: Basic Operations

    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...
  • Page 18 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 open Pinch clamp is closed 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"...
  • Page 19 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...
  • Page 20 ■ 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.
  • Page 21 At the end of automatic priming, it is possible to continue the priming using the semi-automatic priming function as defined below. Semi-automatic priming Press key to access to the priming modes. Press key to launch the priming. Keep it depressed during priming. Release it once priming is complete. Press to go back to setting screen.
  • Page 22 4.2.4 Change feeding setting INFORMATION ■ A longer keypress provides faster scrolling. ■ The flow rate of delivery must be adapted individually to the patient. Regular checks are required. ■ Adjust feeding rate (mL/h) Press key to set the feeding rate. ■...
  • Page 23 4.2.5 Start feeding 1. Connect the giving set to the patient's enteral feeding tube. 2. Make sure that priming is correctly completed before starting feeding. 3. Check power supply before starting feeding. ■ Green light indicator if supplied by mains, or ■...
  • Page 24 When the pump is stopped, progress bar can be reset by depressing the key for 2 seconds. 4.2.7 Switch off pump Feeding shall be stopped before switching off the pump. INFORMATION ■ When feeding is on-going, the key is inactive: the forbidden key beep is triggered but feeding continues.
  • Page 25 Administration sets are supplied sterile and are indicated for single use. WARNING ■ The use of the same set for more than 24 hours can lead to therapeutic issues, such as infection, and uncontrolled flow. ■ For patients requiring special attention, another giving set must always be available.
  • Page 26 Unlocking the keypad is required to stop feeding, change feeding settings and enter the menu. 4.2.10 Mute alarm To temporarily release alarm sound, press When a medium priority alarm is muted: ■ the mute icon is displayed in the status bar; ■...

  • Page 27: Pump Menu

    5 Pump menu INFORMATION ■ The menu is accessible when feeding is stopped. ■ A beep sound is triggered when a forbidden key (not active in specific screens) is depressed. ■ During a procedure, press ) to validate the choice and go back to the setting screen.

  • Page 28: Target Volume Mode

    Menu navigation Press then press to scroll up / down between submenus. Press to enter the submenu. 5.2 Target volume mode On this screen, target volume mode is activated . If you programme a feeding with no target volume and a feeding with target volume with respectively different flow rates, the respective flow rates are saved.

  • Page 29: Night Mode

    5.3 Night mode On this screen, night mode is activated Press to select Night or Day Mode. Press to activate Day Mode or activate Night Mode. Press to validate Night or Day Mode. INFORMATION ■ When night mode is activated, display backlight and power LED are set to minimum level.

  • Page 30: Settings Lock

    ■ target volume and flow rate cannot be changed; ■ Accessible keys are: with restrictions. INFORMATION ■ To get the access code, contact your Fresenius Kabi sales representative. ■ Settings lock activation / deactivation isn’t modified after switching OFF the pump.

  • Page 31: Cumulative Feeding Volume Counter

    ■ When settings lock is activated, keypad lock can still be activated / deactivated. 5.6 Cumulative feeding 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.

  • Page 32: Feeding History

    Press to switch from one alarm event to another. INFORMATION Alarm history indicates the type of alarm and the time elapsed since the event happened. Example: a battery alarm occurred 9 days, 15 hours and 22 minutes ago. 5.8 Feeding history Press to display the feeding events.

  • Page 33: Contrast / Brightness

    5.9 Contrast / Brightness Press . Press to set the contrast or the brightness. Press to validate. 5.10 Set time between two alarm sounds 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.

  • Page 34: Set Time For Target Volume Almost Reached Message

    5.11 Set time for target volume almost reached message Press . Press to set the time for target volume almost reached message. Press to validate. INFORMATION ■ Time between target volume almost reached message and target volume reached alarm can be adjusted from 0 to 59 min., with steps of 1 min (default setting 5 min.).
  • Page 35 Last maintenance date (mm/dd/yyyy) Total delivered volume Total functioning time...

  • Page 36: Cleaning And Disinfection

    ■ The pump is not intended to be sterilized, it 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).
  • Page 37 6.4.1 Cleaning Instructions Prerequisites ■ The pump is switched off. ■ The power cord and all other cables are unplugged. ■ The pump is disconnected from the holder. ■ The air is at room temperature (20 to 25 °C). ■ The operator is wearing suitable protective equipment. Protocol 1.
  • Page 38 9. 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). 6.4.2 Disinfection instructions Prerequisites ■ The cleaning protocol has been performed. ■ The pump is switched off. ■...

  • Page 39: Quick Check Protocol

    Action Before use 1 - Check if the Amika pump, holder and AC/DC adapter are not damaged in any way 2 - Check the general status of the display 3 - Install the Amika pump on the holder...
  • Page 40 Action 3 - Check the membrane of Amika pump is intact (no cracks, no wear) Once a year Check the following alarms and messages (symbol on the display, beep sound, blinking status light indicator) 1 - Set installation alarm 2 - Door alarm...

  • Page 41: Alarms And Safety Features

    8.1 Alarms / Actions The Amika pump has a continuous inspection system that operates as soon as it is in use. It is recommended that the user should be in front of the Amika pump, for best visibility of alarm display.
  • Page 42 ■ Check that the proper set is used (Amika giving sets only). ▷ See Installing the giving set on page Area where Pinch clamp is inserted is ■...
  • Page 43 Symbol Meanings Actions Door open Pump door not properly closed at start. ■ Close pump door. ▷ See Installing the giving set on page Pump door opened after start. ■ Close pump door. ▷ See Installing the giving set on page Pump door removed from its anchor- ■...
  • Page 44 Symbol Meanings Actions Target volume Target volume will be reached. The time of message before target almost reached volume is reached can be set in the menu. ▷ See Set time for target volume al- most reached message on page 34. ■...
  • Page 45 Symbol Meanings Actions Battery empty Alarm medium This alarm appears 10 min. before Minimum battery voltage is not avail- battery is fully discharged. able. ■ Connect the pump to the mains via the pump holder. Recharge battery to resume pump operation. flashing Medium priority - Yellow LEDs are flashing Empty bag / Air...

  • Page 46: Troubleshooting

    Symbol Meanings Actions Battery technical The last battery technical alarm that ■ Note the technical Error code (Err alarm occurred before switch OFF is re- xyz). minded at the next switch ON. ■ Contact your biomedical depart- ment. Fail safe technic- Pump stops immediately.
  • Page 47 Remove AC/DC adapter smoking or with an abnor- ■ Do not use the device mally hot part. ■ Contact your biomedical department or Fresenius Kabi sales rep- Pump screen, Holder resentative immediately power or Holder COM are damaged Pump has been dropped ■...

  • Page 48: Technical Information

    9 Technical information 9.1 Performance 9.1.1 Essential performance Essential pump performance is defined as follows in standard operating conditions: ■ flow rate accuracy (± 7% at 50 mL/h with medical water); ■ occlusion detection time (< 6 min at 50 mL/h with medical water); ■...
  • Page 49 Occlusion detection time Flow rate Downstream occlusion (1 m after the Upstream occlusion (5 cm before the pump) pump) 1 mL/h 5 hours 1 hour 40 min. 25 mL/h 9 min. 4 min. NOTE: Maximum occlusion pressure for the pump is 1875 mmHg, ± 150 mmHg. 9.1.5 Volume Accuracy Accuracy Limit to detect...

  • Page 50: Technical Characteristics

    9.2 Technical characteristics 9.2.1 Operation mode The Amika pump is a reusable device. The pump ensures fluid delivery in a continuous feeding mode, using pumping and clamping fingers to push the liquid to the patient. 9.2.2 Power supply specifications The AC/DC adapter must be connected directly to the mains power socket.
  • Page 51 The curves can be helpful in determining the suitability of feeding parameters for specific nutrition programmes. Giving set used: Amika Varioline 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...
  • Page 52 Instantaneous 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...
  • Page 53 Instantaneous flow rate (1 mL/h, over set change interval 24 hours) Trumpet 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)
  • 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)
  • Page 55 Trumpet curves for 2, 5, 11, 19, 31 minute observation windows (25 mL/h, over last hour of the set change interval, 24 hours) Sampling time: 15 minutes Instantaneous flow rate (25 mL/h, over set change interval 24 hours) Trumpet curves for 15, 60, 150, 330, 570, 930 minute observation windows (25 mL/h, over set change interval, 24 hours) 9.2.7 Compliance with standards General requirements for basic safety and essential...
  • Page 56 General requirements, tests and guidance for alarm Conform to IEC 60601-1-8 systems in medical electrical equipment and medical electrical systems Requirements for medical electrical equipment and Conform to IEC 60601-1-11 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.

  • Page 57: Transport, Storage And Recycling Conditions

    10 Transport, storage and recycling conditions 10.1 Storage and transport conditions During transport, the Amika pump shall not be removed from its pole or rail when carrying feeding devices, especially when feeding is running. Check that the AC/DC adapter is connected and operational after transport of the pump.

  • Page 58: Recycling And Disposal

    (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.

  • Page 59: Guidance And Manufacturer's Declaration On Emc

    11 Guidance and manufacturer’s declaration on The Amika pump is intended to be used in the electromagnetic environment specified below. The customer or the user of the Amika pump should ensure that it is used in such an environment. Excluding the cases described in this manual, the pump operation must systematically be checked by a qualified operator, should the pump be installed in the vicinity of other electrical devices.

  • Page 60: Guidance And Manufacturer's Declaration - Electromagnetic Immunity

    UPS circuit (uninterruptible power supply); ■ increase the separation between the Amika and patient or disruptive equipment; ■ connect the Amika into an outlet on a different circuit from that to which the patient or disruptive equipment is connected; ■ in any case, whatever the context, the user should conduct interoperability testing in a real situation to find the right setup and good location.

  • Page 61: Services

    Please contact your Fresenius Kabi sales representative for additional information. 12.2 Quality control Upon request by the hospital, a quality control check can be performed on the Amika every 12 months. A regular quality control (not included in the guarantee) consists of various inspection operations listed in the technical manual.

  • Page 62: Maintenance Requirements

    ■ 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 rules For further information concerning device servicing or use, please contact our sales representative or our Customer service.

  • Page 63: Ordering Information

    Fresenius Kabi sales representative for orders. 13.2 Giving sets Do not use Amika giving sets to deliver liquids using gravity method, except the Amika set Varioline Comfort that can be used either for feeding by pump or by gravity.
  • Page 64 Amika AC Adapter / Charger Z200651** *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.

  • Page 65: Glossary Of Terms

    14 Glossary of terms Term Description °C Celsius Degree Amper Alternating Current Ampere hours Amika Enteral feeding and hydratation pump manufactured by Fresenius Kabi CE mark European Conformity Mark CISPR Special International Committee on Radio Interference Centimeters Decibel DECT Digital Enhanced Cordless Telecommunications...
  • Page 66 Term Description Milliliter mL/h Milliliter per hour Millimeters Magnetic Resonance Imaging NiMH Nickel-Metal Hydride Nuclear Magnetic Resonance Radio Frequency RFID Radio Frequency Identification Seconds Uninterruptable Power Supply Volt Volt Alternating Current Volt Direct Current Watt...

  • Page 67: Local Contacts For Servicing

    Local contacts for servicing Write your contacts here:...
  • Page 68 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.

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