Fresenius Kabi Ambix nova Instructions For Use Manual
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Fresenius Kabi Ambix nova Instructions For Use Manual

Ambulatory infusion pump
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Ambix nova
Ambulatory Infusion Pump
Version V1.0
Instructions For Use

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Summary of Contents for Fresenius Kabi Ambix nova

  • Page 1 Ambix nova Ambulatory Infusion Pump Version V1.0 Instructions For Use...
  • Page 2 Symbol descriptions Medical Device Unique Device Identifier Refer to the Instructions For Use CE mark 0123 Protection against electric shock: Medical electrical system weight (kg) class II Product reference / part number Product serial number Name and address of the manufacturing Name and address of the manufacturer facility Battery specification...
  • Page 3 INFORMATION ■ Please refer to the Use environment section for additional information on temperature, pressure and humidity limitations. ■ These Instructions For Use (IFU) are also available online. For further information, check IFU for Ambix nova (ref.: DHF-0279) on https://key2.fresenius-kabi.com.

  • Page 4: Table Of Contents

    1.4.3 Intended user profile...................9 1.4.4 Intended patient population................9 1.4.5 Use environment..................9 1.5 Clinical benefits....................10 1.6 Side-effects......................10 1.7 Risks for patients....................10 2 Ambix nova infusion system 3 Description 3.1 Packaging content....................13 3.2 General description.....................13 3.3 Detailed description.....................14 3.3.1 Pump .......................14 3.3.2 Smart Holder Power (Pump holder)............14 3.3.3 Front panel (keypad) ................15...
  • Page 5 5 Operations 5.1 Power management....................24 5.1.1 Connect to the mains................24 5.1.2 Battery operating mode................24 5.1.3 Battery precautions...................25 5.2 Switch on......................26 5.3 Preparing the set....................27 5.3.1 Description of the pinch clamp..............27 5.4 Loading the set....................27 5.5 Priming the set with the pump (recommended)...........29 5.5.1 Access priming interface................29 5.5.2 Automatic priming..................30 5.5.3 Semi-automatic priming................31...
  • Page 6 6.6.4 KVO (Keep Vein Open)................66 6.6.5 Maximum flow rate ..................68 6.6.6 Reset manufacturing ................68 6.7 History.........................69 6.7.1 Infusion history..................70 6.7.2 Cumulative counter menu.................71 6.7.3 Alarm history.....................71 6.8 Information......................72 7 Cleaning and disinfection 7.1 Recommended cleaning and disinfection agents..........74 7.2 Prohibited cleaning or disinfection agents............74 7.3 Cleaning instructions...................74 7.4 Disinfection instructions..................75 8 Quick check protocol...
  • Page 7 11.2.7 Compliance with standards..............93 12 Transport, storage and recycling conditions 12.1 Storage and transport conditions...............95 12.1.1 Storage....................95 12.2 Recycling and disposal..................96 13 Guidance and manufacturer’s declaration on EMC 13.1 Electromagnetic compatibility and interference guidance.........97 13.2 Guidance and manufacturer’s declaration - Electromagnetic immunity....98 13.3 Recommended separation distances between portable and mobile RF communication equipment and pump................98 14 Services...

  • Page 8: Introduction

    - ramp mode - continuous mode - intermittent mode Ambix nova is intended for use on only one patient at a time. It can be reused indefinitely on multiple patients throughout its lifetime. 1.3 Intended purpose Ambulatory infusion pump and accessories for IV administration of specific fluids.

  • Page 9: Contraindications

    ■ The pump should be used under specified operational conditions listed below to ensure pump performance. Ambix nova is an ambulatory infusion system intended to be used in a home environment (homecare and nursing home) and in ambulatory care environment.

  • Page 10: Clinical Benefits

    EN/IEC 60601-1-8). 1.6 Side-effects There is no side-effect directly related to the use of Ambix nova. 1.7 Risks for patients Failure to follow all instructions described in this document or loss or degradation of essential...

  • Page 11: Ambix Nova Infusion System

    Amika and Ambix Maintenance Software nova Partner Software designed to maintain, configure, test and calibrate the Ambix nova and Amika pumps. Smart Holder Power Holder The holder can be positioned on authorized support such as a pole, rail, bed, wheelchair, table and table stand. It allows the pump to be attached to it to ensure the pump is securely positioned.
  • Page 12 For ordering information, check Accessories on page 102. Administration sets Disposables Ambix nova Sets Administration sets dedicated to Ambix nova pump. For ordering information, check Administration sets on page 102.

  • Page 13: Description

    ■ 1 Smart Holder Power (referred to as pump holder) ■ 1 Power cable ■ User documents Packaging consists of: recycled cardboard. Check the integrity of the content before use. Symbols used on Ambix nova packaging are described in Symbol descriptions on page 2. 3.2 General description Legend...

  • Page 14: Detailed Description

    3.3 Detailed description 3.3.1 Pump Legend Pinch clamp slot Tube guides Pumping mechanism Front panel (keypad) Status light indicator Door lever Pump door Contact pins for pump to holder connection Pump door identification label Pump identification label Rails for installation on pump holder Speaker 3.3.2 Smart Holder Power (Pump holder) Legend...

  • Page 15: Front Panel (Keypad)

    3.3.3 Front panel (keypad) Legend Alarm beep mute Keypad lock / unlock Menu & Information Mains supply light indicator ON / OFF key Scroll up in Menu / Select previous field Increase value / Active function Decrease value / Deactive function Scroll down in Menu / Select next field Prime...

  • Page 16: Display Description

    3.4 Display description 3.4.1 Infusion screens Infusion programming screen layout Legend Status bar Infusion parameters KVO (keep vein open) status indicator Detailed information are described in KVO (Keep Vein Open) on page 66 Remaining time Progress bar Delayed start Detailed information are described in Delayed start page 55...
  • Page 17 Pumping status indicator Pumping is in progress Infusion start but no pumping (pause status during intermittent mode with KVO deactivated) Infusion is stopped Infusion start but in delayed start period (no pumping if KVO is deactivated) Progress bar On the left side of the progress bar "75 mL" indicate infused volume and on the right side "150 mL"...

  • Page 18: Menu Screen

    3.4.2 Menu screen Menu screen layout Legend Status bar Menu list Soft key bar Status bar Sound level icons Alarm icons Battery icons (check Muted alarm icon details in Battery operating mode on page Keypad locked icon Nurse settings lock icon Soft key bar Semi-automatic Prime Automatic Prime...

  • Page 19: Installation And Removal

    ■ Check that the power cable is connected and the device is operational after movement of the pump. Figure 1: Recommended installation Fresenius Kabi recommends placing the container 50 cm (± 5 cm) above the pump...

  • Page 20: Using The Pole Clamp

    4.1.2 Using the pole clamp The holder can be attached universally, vertically and horizontally. Turn the pole clamp to the suitable position. 4.1.3 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).

  • Page 21: Electrical Connection

    Slide the pump down until the grey locking lever locks the position (be sure to hear the "Click" sound). 4.1.6 Electrical connection Ensure power cable is not damaged. To charge battery or to use the pump on the mains power supply: 1.

  • Page 22: Removal

    4.2 Removal 4.2.1 Removing the pump from the pump holder 1. Push the grey locking lever. 2. Pull the pump up. 4.2.2 Removing the pump holder 4.2.3 Electrical disconnection 1. Remove power cable from the mains socket. ■ A beep is emitted by the pump when the power cable is disconnected. ■...

  • Page 23: Attaching / Removing The Quick Guide

    4.2.4 Attaching / Removing the Quick Guide A quick guide can be easily attached and removed from the pump holder.

  • Page 24: Operations

    ■ The power outlet must remain accessible at all times to allow emergency power supply disconnection. ■ The pump and its accessories can only be connected to the mains power supply with the power cable supplied by Fresenius Kabi. For connection, described in Electrical connection on page 21.

  • Page 25: Battery Precautions

    80) (in red) INFORMATION ■ 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.

  • Page 26: Switch On

    ■ Do not use a battery that is severely scratched or damaged. ■ Do not short the terminals. ■ Do not expose to high temperatures or very low temperatures: refer to the operating conditions for use, and the storage and transport conditions.

  • Page 27: Preparing The Set

    5.3 Preparing the set In order to protect user health from infection, please follow aseptic handling procedures for container, set and infusion tube. Only Fresenius Kabi infusion sets can guarantee pump reliability (Ordering information page 102) WARNING ■...
  • Page 28 1. Open the pump door by lifting the door lever ; 2. Align the set along with the tube guide of the pump with the right flow direction (the arrow mark on the pump indicates the direction of the flow). 3.

  • Page 29: Priming The Set With The Pump (Recommended)

    5.5 Priming the set with the pump (recommended) WARNING ■ Patient must not be connected to the set when priming is performed. ■ Check the air absence in the infusion set at the end of priming. INFORMATION ■ To proceed to infusion set priming, fill drip chamber 2/3 full by pressing gently if applicable.

  • Page 30: Automatic Priming

    Under priming interface, Ambix nova pump enables two ways of priming: ■ Automatic priming: Pump automatically fills in the infusion set at maximum rate once ) key is pressed; ■ Semi-automatic priming: Pump fills in the infusion set at maximum rate while user press and HOLD the ) key.

  • Page 31: Semi-Automatic Priming

    3. Check the administration set to make sure there is no air in the line. 4. If necessary, press and hold ) key to perform semi-automatic priming (see Semi-automatic priming on page 31) until no air can be found in the line. 5.

  • Page 32: Programming The Infusion Settings

    2. Check the administration set to make sure there is no air in the line. 3. If necessary, repeat step 1 to restart priming to make sure no air can be found in the infusion line. 4. Press ) key to confirm. Pump automatically goes back to the infusion programming screen.

  • Page 33: Start Infusion

    1. Press on the keypad to select the parameter needs to be adjusted and press to adjust the value of the selected parameter (the selected parameter appears in a dark blue background). 2. Repeat step 1 until all parameters are set. Incompatible values When a new infusion is programmed with incompatible values: ■...

  • Page 34: Keypad Lock

    3. Confirm that the administration set is correctly installed in the pump. 4. Open the roller clamp (for stationary set only). 5. Connect the administration set to the patient's IV access device. 6. Check the infusion settings prior to start the infusion. 7.
  • Page 35 To activate the keypad lock: 1. Press for 3 seconds to activate the keypad lock. NOTE: A beep sound can be heard when keypad lock is activated. 2. Check the symbol is displayed in the status bar to confirm the keypad has been locked.

  • Page 36: Mute Alarm

    Keypad can be unlocked by pressing again the keypad lock key for 3 seconds. 5.9 Mute alarm To temporarily release alarm sound, press When a high priority alarm is muted: ■ the mute icon is displayed and blinks in the status bar; ■...

  • Page 37: Reset Infusion Progress

    When infusion is stopped, infusion parameters can be adjusted. Then, infusion can be resumed by press key. 5.10.2 Reset infusion progress To reset infusion progress during pumping: 1. Press key to stop infusion. 2. Press key for 3 seconds to reset the infusion progress. This action will reset the progress bar, remaining time and delayed start time (if delayed start is activated).

  • Page 38: Switch Off Pump

    ■ At the end of infusion (with or without KVO activate), press key or switch off the pump can reset infusion progress. 5.11 Switch off pump Infusion shall be stopped before switching off the pump. Keep pressing for more than 3 seconds to switch the pump off. The display will count down, 3-2-1, and the pump will then shut down.
  • Page 39 1. Push up the lever to unlock the door. 2. Open the door. 3. Remove the set by pull out the blue antikink from the slot first, then push the green connector out towards position Install a new set in the pump (see Loading the set on page 27).

  • Page 40: Pump Menu

    6 Pump menu INFORMATION ■ Menu is only accessible when infusion is stopped. ■ A beep sound is triggered when a forbidden key (not active in specific screens) is pressed. ■ In menu screen, if no action is taken after 1 minute, the display automatically returns to the main screen (infusion programming screen).

  • Page 41: Menus Description

    6.2 Menus description 1st level menu 2nd level menu Programming screen / Configuring screen Program the flow rate Program delayed start duration (setting range is 1 min to 24 h when Flow rate only mode Infusion mode activated) menu Program the flow rate, the volume and the infusion duration Program delayed start duration Continuous mode...
  • Page 42 1st level menu 2nd level menu Programming screen / Configuring screen Select occlusion pressure level between high and low Set single bubble volume detection Occlusion pressure / Air detection Advanced (range: 0.125 mL to 0.75 mL) settings menu Set cumulated bubbles volume (access code detection (volume range: 0.25 mL to required)

  • Page 43: Menu Navigation

    1st level menu 2nd level menu Programming screen / Configuring screen Serial number Information Software version Production date Last maintenance date Next maintenance date Total infused volume Total running time 6.3 Menu navigation In a function configuring screen, when all the settings are customized, press ) to validate the choice, the screen automatically goes back to the infusion programming screen.

  • Page 44: Infusion Mode

    NOTE: In a configuring screen, when the function is activated, the related settings can be selected. The selected value is displayed in blue background. 6.4 Infusion mode Ambix nova pump propose 4 infusion modes: ■ Flow rate only mode (symbol: ■ Continuous mode (symbol: ■...
  • Page 45 3. Press to select the applicable infusion mode (the selected infusion mode is in light blue background). 4. Press ) to confirm the selection and enter infusion programming screen.

  • Page 46: Flow Rate Only Mode

    6.4.2 Flow rate only mode INFORMATION ■ Under flow rate only mode, the end of infusion pre-alarm cannot be triggered. ■ Under flow rate only mode, KVO is only functional when delayed start is activated. Flow rate only mode enables continuous infusion at an adjustable flow rate. 1.

  • Page 47: Continuous Mode

    Accessing to information screen is described in Start infusion on page 33. 6.4.3 Continuous mode INFORMATION The target duration can be set from 1 min. to 96 h with a default value of 15 h. Continuous mode enables continuous infusion at an adjustable flow rate, volume and time. 1.

  • Page 48: Ramp Mode

    4. Press to start the infusion. Accessing to information screen is described in Start infusion on page 33. 6.4.4 Ramp mode INFORMATION ■ The flow rate can not be set and will be calculated automatically and displayed. ■ The flow rate displayed on the infusion screen is a rounded value (rounded to the nearest integer).
  • Page 49 ■ Ramp down phase with a gradual flow rate decrease 1. Select the ramp mode and press ) to enter. For mode selection, see Select the infusion mode on page 44. 2. Press to select the parameter, then adjust the value by pressing 3.

  • Page 50: Intermittent Mode

    4. Press to start the infusion. Accessing to information screen is described in Start infusion on page 33. 6.4.5 Intermittent mode INFORMATION ■ The target volume of one cycle can be set from 1 mL to 9999 mL with a default value of 50 mL.

  • Page 51: Basic Settings Menu

    2. Press to select the parameter, then adjust the value by pressing 3. Repeat step 2 until all parameters are set. NOTE: Flow rate , volume per cycle , number of infusion cycle duration of one cycle are programmable. 4. Press to start the infusion.

  • Page 52: Night Mode

    6.5.1 Night mode This function enables to manage pump luminosity at night. When the night mode is active: The display backlight and power LED are set to minimum level when the pump is working. In case of alarm, the backlight turns back to normal. 1.

  • Page 53: Date And Time

    3. Once the night mode is activated, it is automatically for 24 hours mode (the programmable start time and end time are not activated). To choose programmable time mode , press to go down, then press to select programmable time mode . 4.
  • Page 54 1. Under basic settings menu screen (see Basic settings menu on page 51 to access), select the date and time menu and press ) to enter. 2. Press to select the day, month or year that need to be set, press to adjust the value of the selected one.

  • Page 55: Delayed Start

    4. Press to go down to set the time: press to switch from one parameter to another and press to adjust the value of the selected parameter. 5. Press ) to validate the settings. Pump returns to the infusion programming screen. NOTE: If 12 h format is selected, AM or PM choice must be done.
  • Page 56 2. Press to activate the delayed start (deactivated by default). 3. Press to go down to program the duration: press to switch from one parameter to another and press to adjust the value of the selected parameter. 4. Press ) to validate the settings. Pump returns to the infusion programming screen. If the delayed start function is activated on the menu configuring screen, the duration of delayed start can also be adjusted from the infusion programming screen (the selected area...

  • Page 57: Sound

    in the figure below). When delayed start is launched, the symbol and the time before start of infusion are displayed on the monitoring screen. On this screen, the infusion will start 30 minutes later. 6.5.4 Sound This function enables to customize sound of alarms and beep. 1.
  • Page 58 NOTE: The volume adjustment has 3 levels - low, medium, high level. The sound level is high by default. 3. Press to select the time between 2 alarm sounds setting, then press to adjust the value. NOTE: Time between 2 alarm sounds can be adjusted from 3 seconds to 15 seconds with step of 1 second .

  • Page 59: Light

    5. Press ) to validate all the settings. Pump returns to the infusion programming screen. WARNING Alarm sound level is adjustable. Proper set depends on the use environment, make sure that you can hear and recognize the alarms, especially when the pump is used on battery.

  • Page 60: Advanced Settings Menu

    3. Press to select pumping LED activation (activated by default). 4. When pumping LED is activated (to deactivate, press ), press to select the pumping LED blinking frequency (6 sec. by default, range 01~60 sec.), and press to adjust the value. 5.

  • Page 61: Occlusion Pressure / Air Detection

    , then press ) to validate and access to advanced settings menu. INFORMATION ■ To get the access code, contact your Fresenius Kabi sales representative. ■ If the code is wrong, is displayed on the screen for 3 seconds, then the pump goes back to the access code screen in order to enter a new code.
  • Page 62 2. For level of occlusion pressure setting, press to select the low level or press select the high level of occlusion pressure (high by default). NOTE: Low level = an occlusion alarm will be triggered for a pressure value of 487.5 mmHg ± 187.5 mmHg in the administration set;...

  • Page 63: End Of Infusion Pre-Alarm

    6.6.2 End of infusion pre-alarm This function enables to customize alarm to notify approaching end of infusion. Ambix nova enables pre-alarm before the end of infusion for Continuous mode, Intermittent mode and Ramp mode. 1. Under advanced settings menu (see...
  • Page 64 2. Once the pre-alarm is activated, press to go down to choose the mode to trigger the pre-alarm. Press to select remaining volume before end of infusion or press to select remaining time before end of infusion (activated by default). 3.

  • Page 65: Nurse Settings Lock

    INFORMATION ■ By default, end of infusion pre-alarm is activated and will be triggered when remaining time is 5 min. before end of infusion. ■ Time before end of infusion setting range is 1 ~ 59 min. (preset is 5 min.). ■...

  • Page 66: Kvo (Keep Vein Open)

    3. Press ) to validate. Pump returns to the infusion programming screen. displayed in the status bar. All keys are accessible except keys in infusion programming screen. 6.6.4 KVO (Keep Vein Open) This function enables to customize the KVO. KVO is a low flow rate to keep vein open during all infusion interruptions (delayed start, end of infusion and pause period of an intermittent cycle).
  • Page 67 3. Press to select the KVO flow rate value and adjust it by pressing (the parameter can only be selected when KVO is activated). NOTE: KVO rate setting range is from 1 mL/h to 10 mL/h, the default value is 2 mL/h. 4.

  • Page 68: Maximum Flow Rate

    This function enables to customize a pump flow rate value to not exceed. The maximum flow rate of the Ambix nova is 600 mL/h, this maximum flow rate can be limited to a value between 1 and 600 mL/h with increment of 1 mL/h, the preset is 600 mL/h.

  • Page 69: History

    1. Under advanced settings menu (see Advanced settings menu on page 60 to access), select reset manufacturing menu and press ) to enter. 2. Press to activate reset manufacturing settings. 3. Press ) to confirm. Once reset is confirmed, the reset symbol displays and rotates for 3 seconds, the pump returns to the menu screen.

  • Page 70: Infusion History

    6.7.1 Infusion history This menu enables to consult information of previous infusion events. 1. Under history menu screen (see History on page 69 to access), select the infusion history menu and press ) to enter. 2. Press to switch from one infusion event to another. For each infusion event, the infusion history indicates: ■...

  • Page 71: Cumulative Counter Menu

    6.7.2 Cumulative counter menu This menu enables to consult the cumulative volume infused during a selected period of days. 1. Under history menu screen (see History on page 69 to access), select the cumulated counter menu and press ) to enter. 2.

  • Page 72: Information

    1. Under history menu screen (see History on page 69 to access), select the alarm history menu and press ) to enter. 2. To review the alarm events, press to switch from one alarm event to another. INFORMATION ■ Each event is characterized by an alarm symbol and its time and date of occurrence.
  • Page 73 1. Under main menu screen (see Access menu on page 40), select the information menu and press ) to access. 2. Press to check the information. NOTE: the information menu displays: Serial number Software version Production date (dd/mm/yyyy) Last maintenance date (dd/mm/yyyy) Next maintenance date (dd/mm/yyyy) Total infused volume Total running time...

  • Page 74: Cleaning And Disinfection

    ■ Do not exchange pumps’ doors, miss match between the door and the pump can lead to false alarm or system failure. ■ The Ambix nova backpack must be cleaned before inserting the pump. Please refer to its specific accompanying documents.

  • Page 75: Disinfection Instructions

    2. During cleaning, do not turn the pump upside-down to avoid liquid leak into the pump. 3. Use a ready-to-use wipe to remove any major grime. 4. Thoroughly wipe down 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, blue insert).
  • Page 76 ■ The air is at room temperature (20 to 25 °C). ■ The operator is wearing suitable protective equipment. Protocol 1. Place the previously cleaned pump and holder on a cleaned surface or disposable underlay. The door can be removed from the pump to facilitate the disinfection. 2.

  • Page 77: Quick Check Protocol

    Fresenius Kabi sales representative for additional verification. Action Before use 1 - Check if the Ambix nova pump, holder and power cable are not damaged in any 2 - Check the general status of the display 3 - Install the Ambix nova pump on the holder...
  • Page 78 Action 3 - Check the membrane of Ambix nova 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 - Missing set alarm...

  • Page 79: Alarms And Safety Features

    The Ambix nova pump has a continuous inspection system that operates as soon as it is in use, but it cannot replace the users present at the bedside. It is recommended that the user should be in front of the Ambix nova pump, for best visibility of alarm display.

  • Page 80: Alarm Description

    Wrong set installed. ■ Replace the wrong set with compatible Ambix nova set. Area where set clamp is ■ Remove dirt with cloth and inserted is contaminated. soapy water or as directed by healthcare facility or healthcare provider policy.
  • Page 81 Symbol Pumping Alarm condition Actions status Pump door not properly ■ Close pump door. Door open Pumping stops closed at start. Loading the set on page 27. Pump door opened after ■ Close pump door. start. Loading the set on page 27. Pump door removed from ■...
  • Page 82 Symbol Pumping Alarm condition Actions status Downstream Pumping stops Downstream flowpath is ■ Open the door, check that the occlusion blocked after the pump, at set is installed properly, close the patient side. the door. Loading the set on page 27. ■...
  • Page 83 Symbol Pumping Alarm condition Actions status The target volume is ■ Stop infusion or restart a new End of infusion Pumping stops reached. (Complete one. if KVO progress bar) deactivated or pumping continues with KVO flow rate Empty battery Pumping stops Minimum battery voltage ■...
  • Page 84 Symbol Pumping Alarm condition Actions status Empty battery Pumping Minimum battery voltage ■ Connect the pump to the pre-alarm continues is not available. Appears mains via the pump holder. at least 30 min. before the empty battery alarm. NOTE: The battery icon becomes Yellow.

  • Page 85: Reacting To Alarms

    ■ If the alarm persist when the pump is powered on again, do not use the device on a patient, and contact your biomedical department or your Fresenius Kabi sales representative. ■ Battery technical alarm that occurred before switch off the pump will be reminded at the next switch on.

  • Page 86: Alarm Settings

    INFORMATION ■ When two alarms occur at the same time, the higher priority alarm is displayed. ■ When two alarms with the same priority level are triggered at the same time, the pump software assigns them a priority. 9.6 Alarm settings The following alarm settings are available: ■...

  • Page 87: Troubleshooting

    Remove the holder power cable Power is damaged, noisy, ■ Do not use the device smoking or with an ■ Contact your biomedical department or Fresenius Kabi sales abnormally hot part. Pump representative immediately screen is damaged. Pump has been dropped ■...

  • Page 88: Technical Information

    11 Technical information 11.1 Performance 11.1.1 Essential performance Essential pump performance is defined as follows in standard operating conditions: ■ flow rate accuracy (see Flow rate accuracy on page 88); ■ occlusion detection time (< 4 min. at 25 mL/h with medical water); ■...

  • Page 89: Volume To Be Infused (Vtbi) Range

    * the values in this mode refer to the flow rate of plateau phase, which is automatically calculated and cannot be programmed. 11.1.4 Volume to be infused (VTBI) Range Range Default value Increments Continues mode From 1 mL to 9999 mL 1500 mL 1 mL from 1 mL to 9999 mL Ramp mode...

  • Page 90: Empty Bag / Air In Line Detection Time At Different Flow Rates

    61. 11.2 Technical characteristics 11.2.1 Operation mode The Ambix nova pump is a reusable device. The pump ensures fluid delivery in 4 kinds of infusion mode (for Infusion mode on page 44), using pumping and clamping fingers to push the liquid to the patient.

  • Page 91: Dimensions - Weight

    The curves can be helpful in determining the suitability of infusion parameters for specific nutrition or medication programmes. The curves presented below are drawn from the test data of the same pump. Administration set used: Ambix nova stationary set Fluid used: distilled water 11.2.6.1 Minimum flow rate: 1 mL/h...
  • Page 92 Trumpet curves for 2, 5, 11, 19, 31 minute observation windows (1 mL/h, during second hour of the set change interval, 24 hours) Trumpet curves for 2, 5, 11, 19, 31 minute observation windows (1 mL/h, during last hour of the set change interval, 24 hours) 11.2.6.2 Intermediate flow rate: 25 mL/h Sampling time: 30 seconds Start up and instantaneous at intermediate flow rate (25 mL/h, during first 2hours of the set...

  • Page 93: Compliance With Standards

    Trumpet curves for 2, 5, 11, 19, 31 minute observation windows (25 mL/h, during second hour of the set change interval, 24 hours) Trumpet curves for 2, 5, 11, 19, 31 minute observation windows (25 mL/h, during last hour of the set change interval, 24 hours) 11.2.7 Compliance with standards General requirements for basic safety and essential Conform to IEC 60601-1...
  • Page 94 Conform to the 93/42/EEC Medical Directive 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.

  • Page 95: Transport, Storage And Recycling Conditions

    INFORMATION ■ The storage area must be clean, organized and compliant with the storing conditions mentioned above. ■ The Ambix nova pump must be handled with care during storage. 12.1.1.1 Prepare the device for storage WARNING Remove the battery and store it as per storage conditions above in case of a prolonged storage period.

  • Page 96: Recycling And Disposal

    They must be collected separately and disposed of according to local regulations. Before disposal, make sure that a qualified technician removes the battery from the device according to the procedure described in the Technical Manual. For information on waste processing regulations and dismantling, please contact your Fresenius Kabi sales representative.

  • Page 97: Guidance And Manufacturer's Declaration On Emc

    The Ambix nova pump is intended to be used in the electromagnetic environment specified below. The customer or the user of the Ambix nova 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 98: Guidance And Manufacturer's Declaration - Electromagnetic Immunity

    The Ambix nova pump is intended to be used in the electromagnetic environment specified in the Ambix nova Technical Manual. The customer or the user of the Ambix nova pump should ensure that it is used in such an environment.

  • Page 99: Services

    Fresenius Kabi, the following conditions must be respected: ■ Fresenius Kabi is not liable for loss or damage to the device during transport. ■ the device must have been used according to the instructions described in this user guide and other accompanying documents;...

  • Page 100: 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 Ambix nova pump: 10 years provided that the maintenance is properly performed as described above. 14.4 Service policy and rules If the device must be sent for servicing, proceed as follows: 1.
  • Page 101 http://www.fresenius-kabi.com...

  • Page 102: Ordering Information

    15 Ordering information Ambix nova pump is available in several countries, contact your Fresenius Kabi sales representative for orders. 15.1 Instructions for use Several 'Instructions for use' documents translated into local languages are available. Please contact your Fresenius Kabi sales representative for orders.

  • Page 103: Glossary Of Terms

    16 Glossary of terms Term Description °C Celsius Degree Amper Alternating Current Ampere hours Ambix nova Infusion pump manufactured by Fresenius Kabi Approx. Approximately CE mark European Conformity Mark CISPR Special International Committee on Radio Interference Centimeters Days Decibel DECT...
  • Page 104 Term Description Maximum MegaHertz Minumum min. Minutes Milliliter mL/h Milliliter per hour Millimeters Magnetic Resonance Imaging Nuclear Magnetic Resonance Radio Frequency RFID Radio Frequency Identification Seconds Uninterruptable Power Supply Volt Volt Alternating Current Volt Direct Current Watt...
  • Page 105 This document may not be reproduced in whole or in part without the written consent of Fresenius Kabi. Made in China Revision date: November 2020 Reference: DHF-0279-10_Master_IFU_Ambixnova_eng http://www.fresenius-kabi.com...
  • Page 106 Local contacts for servicing Fresenius Kabi AG Fresenius Kabi 61346 Bad Homburg (Nanchang) CO., Ltd. Germany Qin Lan Road, Nanchang Tel.: +49 (0) 61 72/6 86-0 Economic & Technological Development Zone, 330013 Nanchang, Jiangxi Province PEOPLE'S REPUBLIC OF CHINA...

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