Fresenius Kabi Ambix activ Instructions For Use Manual
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Fresenius Kabi Ambix activ Instructions For Use Manual

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Applicable to software version 2.3
INSTRUCTIONS FOR USE

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Summary of Contents for Fresenius Kabi Ambix activ

  • Page 1 Applicable to software version 2.3 INSTRUCTIONS FOR USE...
  • Page 2 Description of the symbols used on the device and its packaging Warning Power plug-in connector (Refer to the Instructions for Use) Refer to the Instructions for Use Serial interface REF/SN Product reference / part number CE marking 0 1 2 3 E-Code Input terminal - connector Features Code of equipment...
  • Page 3 Local Contacts for Servicing Write your contact here:...

  • Page 4: Table Of Contents

    Table of contents INTRODUCTION 1.1 I ..................6 NTENDED USE 1.2 I ....................6 NDICATIONS 1.3 I ...............6 NTENDED PATIENT POPULATION 1.4 I .................6 NTENDED USER PROFILE 1.5 I ..............7 NTENDED CONDITIONS OF USE 1.6 A ................7 DMINISTRATION OUTES 1.7 C ................7 ONTRAINDICATIONS 1.8 E .............7...
  • Page 5 GUIDANCE AND MANUFACTURER'S DECLARATION ON EMC 8.1 EMC .............49 AND ESSENTIAL PERFORMANCE 8.2 E ..50 LECTROMAGNETIC COMPATIBILITY AND INTERFERENCE GUIDANCE WARRANTY, INSPECTION AND REPAIR 9.1 W ...................51 ARRANTY 9.2 M ...............51 AINTENANCE REQUIREMENTS 10 CLEANING AND DISINFECTING 10.1 C ...............53 LEANING NSTRUCTIONS 10.2 D...

  • Page 6: Introduction

    Ambix activ is not designed for infusion of Insulin and critical life-sustaining drugs. The Ambix activ is intended for children and adults. It is not suitable for neonatal use. Operators must be nurses or trained adults (patients or relatives) able to read the on-screen instructions and able to hear auditory alarms signals.

  • Page 7: Intended Conditions Of Use

    (homecare, nursing home). The Ambix activ is made for long term use as well as over-night use. The Ambix activ is intented to be used in a backpack as an option (See Section 11, page 55).

  • Page 8: Important Notes

    Please check the compatibility with prescriptions, the characteristics of trumpet curves and occlusion alarm settings in relation to the programmed flow rate. Warning  Do not operate the Ambix activ in areas with a risk of explosion.
  • Page 9 Section 7.2, page 43.  Use of ASV (Anti Siphoning Valve): - Ambix activ may be used with any ASV with a triggering pressure lower or equal than 0.2 bar. - ASV will affect the flow rate with a negative bias...

  • Page 10: Overview

    Overview The Ambix activ infusion pump provides the following four programmable modes: Continuous: Fluid is administered continuously at the selected rate. Setting of target volume is optional. Volume over time: Fluid is administered continuously at the calculated rate. The rate is calculated by the pump from the values for target volume and the required administration time.
  • Page 11 Contacting prongs for connecting to Door lever pump holder * The identification labels on the AMBIX Activ pump and on the Activ holder are readable at a distance of 20 cm. 2.1.2 Pump holder and pump The pump can be attached...
  • Page 12 2.1.3 Nurse call and data interface Socket Data interface and nurse call connection 2.1.4 Attaching the pump to the pump holder Depress button to release pump 2.1.5 User interface Keypad lock Alarm silence Pump priming Enter parameter menu Change mode Reset pump to factory settings Set flow rate Set time thresholds...
  • Page 13 Display Symbol Meaning Further details Indicates the volume of the alarm Auditory alarm silent, low, medium, high volume level (see parameter setting menu Section 3.6.1, page 28). Keypad locked Keypad lock is active. Wrench flashing: Maintenance Pumped volume > 1000 litres. requested KVO function is activated and target volume selected;...
  • Page 14 Cable references are accessible on the Technical Manual. Warning  Use only original Fresenius Kabi cables. For additional information about Data communication, please refer to Data communication, page 34. Use of the Nurse call does not replace permanent patient observation.

  • Page 15: The Ambix Activ

    Ambix activ pump sets The activ sets are specially designed for the Ambix activ. Every set includes a sophisticated particle/air filter which, in conjunction with the air alarm sensor of the Ambix activ, prevents air administration. Downstream kink protection is also integrated to reduce the risk of kink especially in ambulatory use.

  • Page 16: Backpack For Adults And For Children

    The activ Rucksack for adults is suitable for carrying up to 5 litres of infusion fluids along with the pump.  The Ambix activ pump is located in the main compartment and for easy access. It can be operated from outside through the front window.

  • Page 17: Operating Instructions

    Operating instructions Packaging Content: Ambix activ activ holder Power cord Instructions for use Packaging weight: Approximately 1600 g. Packaging consists of: Recycling cardboard. Power supply Warning  Before using the pump, the internal battery should be charged for at least 6 hours. The battery is charged during operation when the pump is mounted on the activ holder and connected to the wall outlet.

  • Page 18: Loading The Set

    Loading the set (patient not connected) 3.3.1 Installing the set in the pump 1. Open the door with the lever. 2. Insert the activ clamp into the intended cavity of the pump. Position and lock the green section of the set into the green slot in the pump. 3.

  • Page 19: Operating Thea

    5. If it is required to restart the pump, repeat the installation procedure described above in Section 3.3.1, page 18. Operating the Ambix activ 3.4.1 Switch pump on Press the On/Off button for more than one second to switch the pump on.
  • Page 20 3.4.3 Priming the set using the pump (recommended)  Close the activ clamp.  Connect the container to the set and hang up. Do not remove the stop flow cap at this stage.  After having installed the set in the pump (see Section 3.3.1, page 18), press and hold the prime button.
  • Page 21 3.4.6 Start pumping Press the Start button to start administration. Warning For sets with a drip chamber, please check that the roller clamp is opened and that liquid is flowing into the drip chamber. 3.4.7 Stop pumping Press the Stop/Esc button to stop administration. Information ...
  • Page 22 3.4.11 Keypad lock Lock the keypad of the pump prevents unintentional change of infusion settings of the pump. Press the Lock button once. A key symbol will flash in the display for 5 seconds. If the OK button is pressed during this time, the keypad will be locked and the key symbol will remain in the display.
  • Page 23 3.4.14 Parameter menu Press the Lock button and the Alarm silence button simultaneously to enter the parameter menu, see Section 3.6, page 28. Exit the menu by pressing the Lock button and the Alarm silence button simultaneously again. 3.4.15 Mode lock Press the Lock button and the Alarm silence button simultaneously to enter the parameter menu.

  • Page 24: Programming The 3.6 Advanced Functions

    Programming the Ambix activ 3.5.1 Continuous Mode Button Action Switch pump on ON/OFF Change to continuous mode MODE Set rate +/– Start pumping START Information  Press the + and – buttons in the lowest row simultaneously to activate the target volume.
  • Page 25 Button Action Middle row +/– Set dose time, interval time and delay start Set dose volume and number of intervals Lower row +/– START Start pumping Information  To abort the program, switch pump off.  By pressing the i-button the flow rate, the total volume and the total time of the programmed protocol will be shown in the display.
  • Page 26 A: dose duration D: number of doses B: dose volume E: delay start C: interval Rate Time 3.5.4 Ramp Mode Button Action ON/OFF Switch pump on MODE Change to Ramp mode Switch between the screens: total time and volume (ttl), Upper row +/–...
  • Page 27 Warning Taking into account the accuracy range of ± 5%, in order to prevent an interruption of the ramp down, please make sure to program a target volume 5% lower than the volume in the container or to have 5% more nutrition in the container than the programmed target volume.
  • Page 28 Advanced functions 3.6.1 The parameter setting menu See Section 3.4.14, page 23. The parameter setting menu allows the following parameters to be modified: Function Button Mode locking Password KVO rate Pressure sensitivity Sound volume level Backlight status End volume pre-alarm Alarm, interval time (for alarm level medium or low) Max.
  • Page 29 3.6.4 KVO rate The Ambix activ can perform a Keep Vein Open (KVO) function. This function will continue the infusion at a low rate after the target volume is reached in order to keep the vascular access device and vein open. The KVO function is available in all modes except continuous mode with deactivated target volume.
  • Page 30 Button Action Upper +/– Select 2 from the menu to enable KVO rate change Change to the desired value (between 0 and 10 ml/h, Lower +/– increments of 1 ml/h, preset 2 ml/h) i/OK Confirm the adjusted value Information  A setting of 0 will deactivate the KVO ...
  • Page 31 3.6.7 Backlight status The backlight function of the Ambix activ depends on whether the pump is running on battery or connected to the wall outlet. If the pump is running on battery, the backlight is off. Only when a key is pressed will the backlight come on for 10 seconds.
  • Page 32 Information  The volume for the pre-alarm is silent without any further reminder by pressing the Alarm silence button.  In Volume over Time, Intermittent and Ramp modes, the target volume feature is automatically switched on.  The alarm will sound 30 minutes before the end of the target volume even if the programmed percentage threshold is not reached.
  • Page 33 3.6.10 Maximum flow rate The physical maximum flow rate of the Ambix activ is 600 ml/h. To avoid harm to the patient, this maximum flow rate can be limited to a value between 100 and 600 ml/h in increments of 5 ml/h.

  • Page 34: Data Communication

    The Ambix activ includes an internal time keeper. Every event (command, alarm etc.) is recorded with the time and date in the pump’s memory. The date of the internal time keeper of the Ambix activ will be retained for 3 months following the last switch-off, provided the battery was fully charged at switch-off.

  • Page 35: Alarms & Safety Features

    Alarms & safety features Ambix activ has an intelligent alarm management system (with auditory and visual alarms). This system can discriminate different level of alarm in the aim to show to the operator the most important one to be solved.
  • Page 36 Blinking Alarm Pumping Operating Meanings Type Symbols Priority stop conditions/Actions Upstream occlusion , detection when infusing only Flow obstruction above the pump Remove kink Tube is bent between container and pump Open roller clamp High alarm If applicable, roller clamp closed Check bag and spike Blockage in bag or spike...
  • Page 37 Contact your Fresenius Kabi sales representative or the local High alarm distributor. *If alarm persist, please contact your Fresenius Kabi sales representative or the local distributor. Ambix activ Pump intelligent alarm management system uses the following prioritization rules: Highest Priority 1...

  • Page 38: Troubleshooting

    Troubleshooting Issue description Recommended action  Pump is not stable when Check that the clamp handle of the holder is fastened mounted  Remove the holder power cord Pump is damaged, noisy,  Do not use the device smoking or with an ...

  • Page 39: Safety Features

    Safety features 5.3.1 Air infusion The Ambix activ has an integrated air sensor that stops the infusion if an air bubble higher than 0.75 ml is detected. In addition every activ set has a particulate and air filter. Warning High-lipid-containing solutions could impair the air removal function of the filter! 5.3.2...

  • Page 40: User Test And Alarms Checking

    The following tests allow the user to check if the device is functioning correctly. Fresenius Kabi recommends that these tests are performed before attaching the Ambix activ to a patient. Auditory alarm can be checked during Downstream Occlusion detection function test.
  • Page 41 In case of test failure or any doubt regarding the integrity of the pump, please do not use the device.  If one or more checks do not comply with the right pump behaviour, please contact the appropriate department or Fresenius Kabi After-Sales Service for additional verification.

  • Page 42: Technical Information

    For appropriate disposal, at the end of the storage between uses: device life, please contact your local Temperature:-20°C to 45°C Fresenius Kabi organisation or your local Relative humidity: 10 to 85%, no distributor.The life cycle of the pump is 5 condensation...
  • Page 43 Warning  The internal battery should be changed every 2 years. In case of a prolonged storage period (more than 4 months), it is recommended that the battery is removed.  Battery replacement must be performed by qualified and trained technical personnel in compliance with the technical manual and procedures.
  • Page 44 Flow rate trumpet and start up curves The trumpet curve shows the variation of the mean flow rate accuracy over specific observation periods. The variations are presented only as maximum and minimum deviations from the overall mean flow within the observation window.
  • Page 45 Sampling time : 30 seconds Figure 7.3: Instantenous rate (10 ml/h, over last 2h of set change interval,24h) Sampling time : 30 seconds   Figure 7.4: Trumpet curves For 2, 5, 11, 19, 31 minutes observation windows (10 ml/h, over last hour of the set change interval,24h) Sampling time : 15 minutes  ...
  • Page 46 7.3.2 Intermediate flow rate : 125 ml/h Sampling time : 30 seconds   Figure 7.7: Start-up and instantenous at intermediate flow rate (125ml/h, over first 2h of the test period) Sampling time : 30 seconds   Figure 7.8: Trumpet curves For 2, 5, 11, 19, 31 minutes observation windows (125 ml/h over second hour of the test period) Sampling time : 30 seconds  ...
  • Page 47 Sampling time : 30 seconds   Figure 7.10: Trumpet curves For 2, 5, 11, 19, 31 minutes observation windows (125 ml/h, over last hour of the set change interval,24h) Sampling time : 15 minutes   Figure 7.11: Instantenous flow rate (125ml/h, over set change interval 24h) Sampling time : 15 minutes  ...

  • Page 48: Accuracy

    Accuracy Warning Accuracy (flow rate, volume infused, pressure) can be influenced by fluid viscosity, fluid temperature and TPN product that is not fully compatible with a 1.2 micron filter on the set. Note: All tests below are in accordance with the IEC 60601-2-24 standard and tested with ISO Class III water.

  • Page 49: Guidance And Manufacturer's Declaration On Emc

    - Air and ground ambulances - Proximity with electrosurgical unit, cables and electrodes The customer or user of the Ambix activ pump must ensure that it is not used in such environments. 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 50: Electromagnetic Compatibility And Interference Guidance

    - Increase the separation between the Ambix activ pump and the disruptive equipment. - Connect the Ambix activ pump into an outlet on a different circuit from that to which the patient or disruptive equipment is connected. If the problem remains, the pump shall not be used in such environment.

  • Page 51: Warranty, Inspection And Repair

    The recommended maintenance interval for the Ambix activ and the pump holder is two years or the application of 1,000 litres (equivalent to 8,000 hours at 125 ml/h). The Ambix activ indicates the application of 1,000 litres by showing the wrench symbol permanently in the display.
  • Page 52 They must be collected separately and disposed of according to local regulations. For further information pertaining to waste processing regulation, contact your local Fresenius Kabi organisation or the local distributor.

  • Page 53: Cleaning And Disinfecting

    Cleaning and Disinfecting Warning  Do not submerge the pump in water or any liquid!  Not for use in the dishwasher. 10.1 Cleaning Instructions Didecyldimethylammonium chloride shall be used as the cleaning agent (example : WIP'ANIOS EXCEL by Anios). Prerequisites: ...

  • Page 54: Disinfection Instructions

    10.2 Disinfection instructions Didecyldimethylammonium chloride shall be used as the disinfectant agent (example : WIP'ANIOS EXCEL by Anios). Prerequisites:  The cleaning protocol has been performed.  The pump is powered off.  The power cord and all other cables are unplugged. ...

  • Page 55: Order Information

    Rucksack mini Accessories Rolling stand * Contains Ambix activ (Art. - No. 2892000), activ holder, power cable, and Instructions for use. ** Contact Fresenius Kabi for appropriate Rolling stand For any assistance, if needed, in setting up, using or reporting unexpected operation or events, please contact your homecare provider.

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