Fresenius Kabi Ambix nova User manual

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

Symbol descriptions
Unique Device IdentifierMedical Device
CE mark
0123
Refer to the Instructions For Use
Medical electrical system weight (kg)
Protection against electric shock:
class II
Product serial numberProduct reference / part number
Name and address of the manufacturing
facility
Name and address of the manufacturer
Protection against leakage current;
defibrillation-proof type CF applied part
Battery specification
Alternating Current (AC)Direct Current (DC)
Input terminal - connectorOutput terminal - connector
This way upFragile, handle with care
Temperature limitationKeep away from rain
Atmospheric pressure limitationHumidity limitation
Part included in a recycling processGeneral symbol for recyclable material
Accompanying documents
(01) Product identifier GTIN
(21) Product serial number
(11) Date of manufacture
(240) Product Reference
Smart Holder Power: IP32-Index of protection against solid foreign objects (> 2.5 mm) and
dripping liquids
IP32
Pump: IP35-Index of protection against solid foreign objects (> 2.5 mm) and water jets from
any direction
IP35
Warning: warning of a potential hazard that could result in serious personal injury and/or
product damage if the written instructions are not followed.
Information: recommendations to be followed.
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INFORMATION
■ Please refer to the Use environment section for additional information on
temperature, pressure and humidity limitations.
■ 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.
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Table of contents
1 Introduction 8
1.1 Scope....................................................................................................................8
1.2 Principle of operation.............................................................................................8
1.3 Intended purpose...................................................................................................8
1.4 Intended use..........................................................................................................8
1.4.1 Indications..................................................................................................8
1.4.2 Contraindications........................................................................................9
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 11
3 Description 13
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
3.4 Display description..............................................................................................16
3.4.1 Infusion screens.......................................................................................16
3.4.2 Menu screen ............................................................................................18
4 Installation and removal 19
4.1 Installation...........................................................................................................19
4.1.1 Recommended installation.......................................................................19
4.1.2 Using the pole clamp................................................................................20
4.1.3 Positioning the holder on a rail, pole, bed or wheelchair..........................20
4.1.4 Positioning the holder on a table..............................................................20
4.1.5 Positioning the pump................................................................................20
4.1.6 Electrical connection.................................................................................21
4.2 Removal..............................................................................................................22
4.2.1 Removing the pump from the pump holder..............................................22
4.2.2 Removing the pump holder......................................................................22
4.2.3 Electrical disconnection............................................................................22
4.2.4 Attaching / Removing the Quick Guide.....................................................23
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5 Operations 24
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
5.6 Programming the infusion settings......................................................................32
5.7 Start infusion........................................................................................................33
5.8 Keypad lock.........................................................................................................34
5.9 Mute alarm...........................................................................................................36
5.10 Terminate infusion.............................................................................................36
5.10.1 Stop infusion...........................................................................................36
5.10.2 Reset infusion progress..........................................................................37
5.11 Switch off pump.................................................................................................38
5.12 Removing/Changing the set from the pump......................................................38
6 Pump menu 40
6.1 Access menu.......................................................................................................40
6.2 Menus description...............................................................................................41
6.3 Menu navigation..................................................................................................43
6.4 Infusion mode......................................................................................................44
6.4.1 Select the infusion mode..........................................................................44
6.4.2 Flow rate only mode.................................................................................46
6.4.3 Continuous mode.....................................................................................47
6.4.4 Ramp mode..............................................................................................48
6.4.5 Intermittent mode......................................................................................50
6.5 Basic settings menu............................................................................................51
6.5.1 Night mode...............................................................................................52
6.5.2 Date and time...........................................................................................53
6.5.3 Delayed start............................................................................................55
6.5.4 Sound.......................................................................................................57
6.5.5 Light .........................................................................................................59
6.6 Advanced settings menu.....................................................................................60
6.6.1 Occlusion pressure / Air detection............................................................61
6.6.2 End of infusion pre-alarm ........................................................................63
6.6.3 Nurse settings lock...................................................................................65
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