Fresenius Kabi Ambix activ User manual

INSTRUCTIONS FOR USE
Applicable to software version 2.3

23325-10_ifu_Ambix_Activ_INT
Description of the symbols used on the device and its packaging
Warning
(Refer to the Instructions for Use) Power plug-in connector
Refer to the Instructions for Use Serial interface
REF/SN Product reference / part number CE marking
Input terminal - connector E-Code Features Code of equipment
Output terminal - connector Name and address of the
manufacturer / Date of manufacture
Alternating Current (AC) Name and address of the
manufacturing facility
Direct Current (DC) Fragile, handle with care
Protection against electric shock:
class II This way up
IP34
IP33 Splash-protected Keep away from rain
Part included in a recycling process Temperature limitation
Degree of protection against
electric shock: type CF applied part Humidity limitation
Nurse call Atmospheric pressure limitation
Battery General symbol for recyclable material
Eco packaging symbol
Warning of a potential hazard that
could result in serious personal
injury and/or product damage if the
written instructions are not followed.
Recommendations to be followed.
0123

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Local Contacts for Servicing
Write your contact here:

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Table of contents
1 INTRODUCTION 6
1.1 I NTENDED USE .........................................................................................6
1.2 I
NDICATIONS ............................................................................................6
1.3 I
NTENDED PATIENT POPULATION ...............................................................6
1.4 I
NTENDED USER PROFILE .........................................................................6
1.5 I
NTENDED CONDITIONS OF USE .................................................................7
1.6 A
DMINISTRATION R OUTES ........................................................................7
1.7 C
ONTRAINDICATIONS ...............................................................................7
1.8 E
NVIRONMENT C ONSIDERATIONS .............................................................7
1.9 I
MPORTANT NOTES ...................................................................................8
2 OVERVIEW 10
2.1 T HE A MBIX ACTIV - ILLUSTRATIONS .........................................................11
2.2 D
ATA INTERFACE AND N URSE CALL CONNECTION ....................................14
2.3 A
MBIX ACTIV PUMP SETS ........................................................................15
2.4 B
ACKPACK FOR ADULTS AND FOR CHILDREN ...........................................16
3 OPERATING INSTRUCTIONS 17
3.1 P ACKAGING ...........................................................................................17
3.2 P
OWER SUPPLY .....................................................................................17
3.3 L
OADING THE SET ( PATIENT NOT CONNECTED ) ........................................18
3.4 O
PERATING THE A MBIX ACTIV ................................................................19
3.5 P
ROGRAMMING THE A MBIX ACTIV ...........................................................24
3.6 A
DVANCED FUNCTIONS ..........................................................................28
4 DATA COMMUNICATION 34
4.1 I NTERNAL DATA MANAGEMENT ................................................................34
4.2
History file .............................................................................................34
5 ALARMS & SAFETY FEATURES 35
5.1 A LARMS ...............................................................................................35
5.2 T
ROUBLESHOOTING ..............................................................................38
5.3 S
AFETY FEATURES .................................................................................39
6 USER TEST AND ALARMS CHECKING 40
7 TECHNICAL INFORMATION 42
7.1 P ERFORMANCE .....................................................................................42
7.2 O
CCLUSION ALARM ................................................................................43
7.3 F
LOW RATE TRUMPET AND START UP CURVES .........................................44
7.4 A
CCURACY ............................................................................................48

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8 GUIDANCE AND MANUFACTURER'S DECLARATION ON EMC 49
8.1 EMC AND ESSENTIAL PERFORMANCE .....................................................49
8.2 E
LECTROMAGNETIC COMPATIBILITY AND INTERFERENCE GUIDANCE ..........50
9 WARRANTY, INSPECTION AND REPAIR 51
9.1 W ARRANTY ...........................................................................................51
9.2 M
AINTENANCE REQUIREMENTS ...............................................................51
10 CLEANING AND DISINFECTING 53
10.1 C LEANING I NSTRUCTIONS .......................................................................53
10.2 D
ISINFECTION INSTRUCTIONS .................................................................54
11 ORDER INFORMATION 55

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1Introduction
1.1 Intended use
1.2 Indications
1.3 Intended patient population
1.4 Intended user profile
The Ambix activ is designed for parenteral nutrition and antibiotic
therapy in homecare environment. 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.
The Ambix activ is made for long term use as well as over-night use.
Suitable for parenteral nutrition and antibiotic therapy.
The Ambix activ pump is a mobile, portable, stationary, reusable
device. the pump ensures fluid delivery in:
Continuous
Volume over time
Intermittent mode
Ramp mode
It uses a pumping and clamping fingers mechanism for advancing the
liquid to the patient through a dedicated set.
Ambix activ is intended for children and adults that require parenteral
nutrition. It is not suitable for neonatal (< 1 month) use.
Operators must be nurses or trained adults (patients or relatives) able to
read the on-screen instructions and pumps alarms.
Warning
The pump must only be used by trained users both on using and
cleaning the pump and able to understand and solve the pump
alarm conditions.
Typical initial training duration: 1 hour.
It is recommended that users attend a refresher training session of about
20 minutes every year.
For training, contact your Fresenius Kabi sales representative.

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1.5 Intended conditions of use
1.6 Administration Routes
1.7 Contraindications
1.8 Environment Considerations
The Ambix activ is an ambulatory infusion system intended to be used
in a home environment (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).
The nurse call function is available through the use of Ambix holder as
an option.
Outdoor use is not prohibited but temperature and humidity conditions
of use to be respected are defined:
Temperature: Operating: +13 to +40°C
Relative humidity: Operating: 20 to 85%, no condensation
Atmospheric pressure: Operating: 700 to 1060 hPa
Altitude maximum: 3000 m
The pumps administers products through intravenous (IV) access.
Not for use with life-sustaining critical application drugs, or drugs
with short half-life.
Not designed for infusion of insulin.
Not for use at flow rates below 10 ml/h.
Not suitable for neonates.
Warning
Keep the pump, sets, holder and cables away from unsupervised
children (and animals).
Consider the following operational conditions to ensure proper device
performance:
Do not expose to sun light, keep in dry place, at room
temperature, normal pressure.
Keep in clean environment.
Keep away from objects which can potentially damage the
device.
Keep away from any noise disturbance which could prevent
patient or relatives from hearing the pump alarms.
Keep away from heat source, dust, fluff, direct and prolonged
light exposure
Keep away from animals, pests or children.
Do not share an outlet with another electrical device.

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1.9 Important notes
Warning
Before using the Ambix activ, read the operating conditions
carefully and check the good condition of the pump according to
Section 6, page 40.
Do not use the Ambix activ without a timely and regular
surveillance of patient and system, especially when an
interruption of the nutrition delivery may lead to a patient hazard
(e.g. comatose situation).
Before using the Ambix activ, check the battery level indicator.
Full charge of the battery is obtained after 6 hours.
The pump and holder shall be cleaned/disinfected before
operation with a new patient.
Give particular attention to the risk of strangulation with cables
and sets, and with the small parts that could be swallowed or
inhaled.
In stationary mode, pump and holder shall be installed as close
as possible to the patient with cable and set arranged so to
minimize the risk of accidental disconnection by the operator or a
person in vicinity of patient. The operator should be located in a
position to be able to see the pump display and have access to
pump keypad for alarm condition clearance.
In order to ensure that all safety features are activated, switch
pump ON before being connected with a patient.
Warning
The pump is designed to operate only with the appropriate
Fresenius Kabi activ sets.
The activ sets are single use only with a maximum set
replacement interval of 24 hours, to avoid risk of underdose.
The physiological effects of drugs can be influenced by the
characteristics of the device and the associated disposables.
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.

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In case of refrigerated products, allow the product to reach the
operating temperature range before use.
When the device is stored at the minimum temperature of -20°C,
wait for 2 hours to allow the product to reach the operating
temperature range before using the pump. False occlusion alarm
can be triggered if the pump/set temperature is too low.
When the device is stored at the maximum temperature of
+45°C, it is ready to be used at ambient temperature.
Warning
This device can be affected by environmental pressure or
pressure variations, mechanical shocks, heat ignition sources,
radio-frequency interference (RFI) or electromagnetic radiation.
The pump should only be connected to the wall outlet with the
power cord supplied by the manufacturer.
Check that the line power voltage corresponds with the value
indicated on the device label.
Do not exceed the permitted voltage on the external connections.
A non-medical electric device connected to the device must
conform to the suitable IEC/EN standard (e.g. IEC/EN 60950 and
IEC/EN 60601-1).
Fresenius Kabi accepts no liability for use of any interface
communication between the Ambix activ and computer
systems.
The pump should be used under specified operational, storage
and transport conditions, see 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 ≤3%.

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2Overview
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. These parameters are input by the user. The
calculated rate is shown in the display.
-Intermittent mode:
A defined dose of fluid (volume over time) is administered continuously at
a calculated rate. After the dose is administered the pump returns to the
KVO rate for a defined period. The dose is administered as often as
defined. All parameters are input by the user. The calculated rate will be
displayed by pressing the i button.
- Ramp mode:
Fluid is administered continuously, but with an increasing flow rate at the
beginning and a decreasing flow rate at the end. Programmable ramping
up and down times are entered by the user.
Information
Calculation rule: When a Volume over time mode is programmed, the
rate is calculated according to the following rule: R=V/T
R: Rate; V: Volume to Be Infused; T: AdministrationTime
Features:
Rate range: 10 to 600 ml/h
- Increments of 1ml/h from 10 to 100 ml/h
- Increments of 5 ml/h from 100 to 600 ml/h.
Volume to be infused range: 1 to 9999 ml
- Increments of 1 ml from 1 to 200 ml,
- Increments of 10 ml from 200 to 9999 ml.
Typical Accuracy of ± 5% at 22.5°C ± 2.5°C, pressure < 0.1 bar.
Dedicated pumping segment with integral anti-free-flow activ clamp and
bend protection.
Upstream and downstream occlusion detection when infusing.
Small, light and compact:
- H/W/D 132 x 120 x 45 mm, 550 g (pump).
- H/W/D 146 x 162 x 115 mm, 500 g (holder).
Dedicated activ sets with built-in safety features (anti-free-flow clamp,
flow stop cap, bend protection, DEHP free, ...).
Virtually silent operation.
40 h battery life (at 125 ml/h), 15h battery life (at maximum rate of 600
ml/h).
Dedicated activ Rucksack.

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2.1 The Ambix activ - illustrations
2.1.1 View of the pump
* 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 AMBIX Activ pump shall be installed at a height between 50cm and 150cm on the rolling stand.
Serial number label
(Unit number)*
Pump door
Door lever
Contacting prongs
for connecting to
pump holder
Guide rail
IV set
Pump Pump holder
Insert point for the pole
stand to suspend the
administration system
Clamping device
Screw to lock the
clamping device
The clamping
device can be
rotated 180°
The pump can be attached
universally, vertically and
horizontally to both round
and square rails.
E.g.:
• IV poles
• medical wheelchairs
• beds
• table-top pump
stand
• rolling stand**

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2.1.3 Nurse call and data interface
2.1.4 Attaching the pump to the pump holder
2.1.5 User interface
Socket
Data interface and
nurse call connection
Depress button
to release pump
Keypad lock
Information and OK/reset given volume/dose/time last dose
Start pumping
Stop pumping or escape
Activate target volume
Set target volume
Set time thresholds
Set flow rate
Change mode
Enter parameter menu
Alarm silence
Pump priming
Reset pump to factory settings
Switch pump on/off

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Display Symbol Meaning Further details
Auditory alarm
volume level
Indicates the volume of the alarm
silent, low, medium, high
(see parameter setting menu Section 3.6.1, page 28).
Keypad locked Keypad lock is active.
Wrench flashing:
Maintenance
requested
Pumped volume > 1000 litres.
Keep Vein Open
mode
KVO function is activated and target volume selected; if
this symbol is flashing, KVO is running (see parameter
setting menu Section 3.6.1, page 28).
Continuous mode Continuous mode is active.
Volume/Time mode Volume/Time mode is active.
Ramp mode Ramp mode is active.
Intermittent mode Intermittent mode is active.
Active ramping
phase Active phase of the ramping procedure will flash.
Priming mode Pump is priming.
Battery charging
status
Charging status of the internal battery pack
( empty battery, nearly empty battery, partially
charged battery, fully charged battery).
Information mode Mode-dependent information will be displayed.
Volume remaining
to infuse Remaining volume will be displayed.
or Time threshold Time thresholds should be programmed.
Pressure indication Current pressure. If the arrow reaches the black area of the
circle, occlusion alarm will be triggered.

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2.2 Data interface and Nurse call connection
Power indication Activ holder is connected to mains.
Volume remaining
to be administered
Volume remaining to be administered
75%, 50%, 25%, 0%.
Run indicator The movement of drops and bars indicates that the pump
is running.
The pump holder includes a data interface and nurse call connection
port.
This port enables the pump to be connected either to a computer or to a
nurse call system.
The type of cable connected to this port determines the function used.
Data interface:
- Only used for maintenance.
- The pump must not be connected to a patient.
This feature is available when the pump is properly engaged in the
holder and the holder is connected to the AC wall outlet.
Further information about connectivity is available from the technical
service department. 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.
Display Symbol Meaning Further details

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2.3 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. Free flow protection is provided by the
activ clamp, an advanced second generation pinch clamp. This clamp
automatically closes when the pump door is opened, thereby preventing
free-flow. An integrated flow cap facilitates priming proceedings.
Information
Fresenius Kabi recommends placing the container 50 cm
(± 10 cm) above the pump.
For further information about activ sets, please refer to the related
labelling on the activ sets.
Warning
In case of use of ASV (Anti syphoning valve), the pressure level may be
changed, see warning Section 1.9, page 8.
When set is out of the pump, ensure that the clamp is closed especially
when the container is placed above the injection site or that the set is
disconnected from the patient.
The Ambix activ is designed to operate exclusively with the
appropriate Fresenius Kabi activ sets including the patented activ
clamp (see ordering information Section 11, page 55). The use of other
sets is prohibited and may endanger patient safety either through the
risk of air infusion, reduced flow rate accuracy or free-flow conditions.
For ordering information see Section 11, page 55.
Pumping segment
with kink protection Roller
clamp
Drip chamber with
integrated spike
Combined
particle/air filter
Figure: activ set ambulatory SF Figure: activ set stationary SF
opened closing being opened 1 being opened 2
Rotatable luerlock
Spike
Ambix
clamp
Rotatable luerlock with Stop
Flow cap and backcheck valve
Combined
particle/air filter

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2.4 Backpack for adults and for children
Both backpacks have a main compartment incorporating a universal
fastening system for infusion bags and the pump. A second large
compartment at the front is provided for accessories and personal items.
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.
The activ Rucksack can be carried using the top handle, the
shoulder straps, or worn on the back.
The activ Rucksack mini is suitable for carrying up to 1.5 litres
with the pump.
The activ Rucksack mini can be carried using the top handle or
the shoulder straps. It also has a hanging strap from hang from a
baby carriage.
When the activ Rucksack is used, the pump display and keypad
are not immediately accessible for alarm condition clearance. In
such a use, the auditory alarm level shall be set to high.
Detailed instructions for use are available for the activ Rucksack. For
ordering information see Section 11, page 55.
activ Rucksack activ Rucksack mini

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3Operating instructions
3.1 Packaging
3.2 Power supply
Content:
Ambix activ
activ holder
Power cord
Instructions for use
Packaging weight: Approximately 1600 g.
Packaging consists of: Recycling cardboard.
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. When the pump is disconnected from the outlet, it
automatically switches to battery mode. The maximum battery
life is achieved after several charge/discharge cycles.
When the pump is used in stationary, connect the pump/holder to
the mains supply.
The battery should be fully charged before every ambulatory use
and check the battery is fully charged.
The power outlet on activ holder is the disconnecting device
from mains and must remain accessible at anytimes to allow
emergency disconnection. For switching OFF the pump, please
refer to Section 3.4.2, page 19.

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3.3 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. Place the upper ring of the blue kink protector in the blue coloured
notch. Take care that the pumping segment of the tubing is in front
of the pump mechanism.
4. Close the pump door and push the lever down. The activ clamp will
open automatically. Flow will be prevented by the pumping
mechanism until administration is started.
5. If applicable, open roller clamp after set installation, before starting
infusion.
Pump
mechanism
Lower tube guide
(Sensor area)

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3.3.2 Removing the set
3.4 Operating the Ambix activ
3.4.1 Switch pump on
3.4.2 Switch pump off
If the pump is running, stop the infusion by pressing the STOP/ESC
button.
1. Switch the pump OFF by holding the On/Off button down for more
than 3 seconds.
2. Ensure that backflow from the patient access system is prevented, if
present, close the roller clamp, and disconnect the set from the
patient.
3. Open the pump door – the activ clamp will be automatically closed.
Remove the set starting with the green adapter.
4. Dispose of the set following appropriate legislation and local
procedures.
5. If it is required to restart the pump, repeat the installation procedure
described above in Section 3.3.1, page 18.
Press the On/Off button for more than one second to switch the pump
on. The pump will boot and will perform a self test. The most recent
parameters and program will be shown in the display.
Press the On/Off button for more than three seconds to switch the pump
off. The display will count down, 3-2-1-off, and the pump will then shut
down. Parameters from the most recent infusion will be retained in the
pump’s memory. This information is saved for 1 month following the last
switch-off, provided the battery was fully charged at switch off.
This operation is possible when the pump is not running (for example,
after the end of infusion programmed or at stopping of the infusion by
pressing the STOP/ESC button).

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3.4.3 Priming the set using the pump (recommended)
3.4.4 Select application mode
3.4.5 Change parameters
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.
For the correct priming procedure, refer to the Instructions for
Use included in each set box or on each individual set package.
Release the priming button when the set is fully primed.
Warning
The container should be placed 50 cm±10cm above the pump or
place the container in its dedicated location of the activ
rucksack.
The pump primes the line at 600 ml/h. During priming the empty bag
alarm is deactivated and a short beep sounds every 2 seconds.
Warning
Never prime the set with a patient connected.
Information
Check the integrity of the set prior to connecting the patient.
The empty bag alarm is disabled while the pump is priming.
Warning
When priming stationary sets, do not forget to open the roller
clamp.
After priming, make sure there is no air in the infusion line.
Pressing the Mode button changes the mode of delivery. There are 4
modes: continuous, volume over time, intermittent and ramp mode.
Displayed parameters are changed using the +/– buttons in the adjacent
row. The + button will increase the value whereas the – button
decreases it. All buttons have an auto acceleration push button mode. If
the button is kept depressed, the rate of change of the value
accelerates.