compliant concept AMS User manual

compliant concept AG •Jurastrasse 58 •5430 Wettingen •Switzerland •www.compliant-concept.ch
AMS –Active Mobilisation System
Operating Manual
Release Date: 31.08.2023
M-000002.en –2.8.2

AMS –Active Mobilisation System • Operating Manual
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compliant concept AG 2/ 52 M-000002.en –2.8.2
Imprint
Active Mobilisation System (AMS)
Operating Instructions
Document ID: M-000002.en
Revision: August 2023
Version: 2.8.2
compliant concept AG
Jurastrasse 58
5430 Wettingen
SWITZERLAND
Telephone: [phone]
E-mail: [email protected]
Internet: www.compliant-concept.ch
All rights reserved. We reserve the right to make changes due
to technical developments. The contents of this document are
subject to change without prior notice.
© compliant concept AG

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compliant concept AG 3 / 52 M-000002.en –2.8.2
Table of Contents
1. General Information..................................................................................................................................6
1.1. About this manual............................................................................................................................................................... 6
1.2. Limitation of liability........................................................................................................................................................... 6
1.3. AMS features ......................................................................................................................................................................... 7
1.4. Scope of delivery ................................................................................................................................................................. 7
2. Purpose ......................................................................................................................................................8
2.1. Intended use.......................................................................................................................................................................... 8
2.2. Operating principle of the AMS..................................................................................................................................... 8
2.3. Structure and essential functions of the AMS.......................................................................................................... 8
2.4. Indication ................................................................................................................................................................................ 9
2.5. Contraindication................................................................................................................................................................... 9
2.6. Side effects...........................................................................................................................................................................10
2.7. Clinical benefit ....................................................................................................................................................................10
2.8. When used by lay persons trained on the AMS....................................................................................................10
3. Safety....................................................................................................................................................... 11
3.1. Symbols .................................................................................................................................................................................11
3.2. General warnings...............................................................................................................................................................11
4. Overview ................................................................................................................................................. 13
4.1. AMS components..............................................................................................................................................................13
Active Mattress System (MS) ....................................................................................................................13
4.2. Connections.........................................................................................................................................................................14
4.3. Type plate Control Unit (CU).........................................................................................................................................15
4.4. Type plate Moving System (MS)..................................................................................................................................15
5. AMS Installation ..................................................................................................................................... 16
5.1. Commissioning...................................................................................................................................................................16
5.2. Positioning the Active Modules...................................................................................................................................19
6. Function of the AMS .............................................................................................................................. 21
6.1. Overview of programmes...............................................................................................................................................22
6.2. Programme 1 –Rotation with pressure relief to the left and right ...............................................................23
6.3. Programme 2 –Rotation to the right with pressure relief on the left..........................................................23
6.4. Programme 3 –Rotation to the left with pressure relief on the right ...........................................................24
6.5. Programme 4 –Stimulation ..........................................................................................................................................24
6.6. Pressure redistribution for heels..................................................................................................................................25
7. Operating the AMS ................................................................................................................................ 26
7.1. General information and default settings................................................................................................................26
7.2. User interface –Overview...............................................................................................................................................27
7.3. Turning the AMS on / off ...............................................................................................................................................27
7.4. Key lock ........................................................................................................................................................................28
7.5. Starting the device ................................................................................................................................................28
7.6. Stopping the device..............................................................................................................................................28
7.7. Selecting the programme ................................................................................................................29

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7.8. Interval / Speed settings ..................................................................................................................30
7.9. Intensity setting ....................................................................................................................................30
7.10. Indicators ..............................................................................................................................................................................31
Back Rest Incline..................................................................................................................................31
Error Indicator Light ...........................................................................................................................32
Acoustic Alert/Alarm Off ...................................................................................................................32
Power Light.............................................................................................................................................33
7.11. CPR –CardioPulmonary Resuscitation......................................................................................................................33
7.12. Special functions................................................................................................................................................................34
Deactivation of back rest incline sensor...............................................................................................34
Test mode.........................................................................................................................................................34
8. Cleaning Instructions ............................................................................................................................. 35
8.1. Responsibilities...................................................................................................................................................................35
8.2. Instruction for cleaning and disinfection .................................................................................................................35
8.3. Approved disinfectants ...................................................................................................................................................36
8.4. Mattress cover ....................................................................................................................................................................36
8.5. Active modules (AM) and tubing ................................................................................................................................37
8.6. Carrier cover ........................................................................................................................................................................37
8.7. Control Unit (CU) ...............................................................................................................................................................37
9. Cleaning and Disinfecting for Private Households.............................................................................. 38
9.1. Please note...........................................................................................................................................................................38
9.2. Cleaning of surfaces .........................................................................................................................................................38
9.3. Disinfecting of surfaces...................................................................................................................................................39
9.4. Cleaning and disinfecting the mattress cover........................................................................................................39
9.5. Cleaning and disinfecting the mattress ....................................................................................................................39
9.6. Cleaning and disinfecting the Active Modules and the piping/cables ........................................................39
9.7. Cleaning and disinfecting the carrier cover ............................................................................................................39
9.8. Cleaning and disinfecting the Control Unit (CU) ..................................................................................................39
9.9. Recommissioning the AMS............................................................................................................................................40
10. Servicing and Maintenance ................................................................................................................... 41
10.1. Servicing................................................................................................................................................................................41
10.2. Storage...................................................................................................................................................................................41
10.3. Replacement parts ............................................................................................................................................................41
11. Errors and Troubleshooting................................................................................................................... 42
12. Technical Specifications......................................................................................................................... 43
12.1. Emission.................................................................................................................................................................................44
12.2. Immunity...............................................................................................................................................................................45
12.3. Recommended safety distances..................................................................................................................................47
13. Warranty Conditions .............................................................................................................................. 48
13.1. General information .........................................................................................................................................................48
13.2. Scope......................................................................................................................................................................................48
13.3. Exclusion................................................................................................................................................................................48
14. Disposal Instructions.............................................................................................................................. 48

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15. Revision History...................................................................................................................................... 49
16. How to Contact Us ................................................................................................................................. 50
16.1. Ensuring conformity in the EU......................................................................................................................................50
17. Declaration of Conformity..................................................................................................................... 51

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1. General Information
1.1. About this manual
This manual is part of the AMS (Active Mobilisation System) by compliant concept AG and provides
important instructions for commissioning, safety, intended use and care of the appliance.
All pictures and drawings in this manual are for general illustration only and are not binding for its
construction details.
The operating instructions must always be available; their best location is in the vicinity of the device.
It should be read by every person and be applied by all who are tasked with:
•Commissioning,
•Operation,
•Cleaning,
•Maintenance,
•Troubleshooting
of the AMS.
1.2. Limitation of liability
All technical information, data and installation, operation and care instructions included in this manual
reflect the latest status at the time of printing and are based on our previous experience and knowledge
to the best of our knowledge.
No claims can be derived from the details, illustrations, and descriptions in this manual.
The manufacturer assumes no liability for damages due to:
•Not adhering to the manual
•Improper use
•Improper repairs
•Technical changes
•Use of unauthorized replacement parts
•Unauthorized conversions and changes
Translations are carried out in good faith. We do not assume any liability for translation errors, even if
the translation was carried out by us or on our behalf. The original German text is the solely binding
version.

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1.3. AMS features
The following features distinguish the AMS:
•Continuous repositioning/side positioning with additional, intermittent pressure relief on the
patient’s body
•Extremely low noise and low vibration
•Very easy to use
•Good transfer properties for entering and exiting
•When the back rest is raised too high (>30° or optionally >50°), the AMS stops its movements
•The adjustment options of the bed remain: the knee and foot section should not be adjusted while
the AMS is running. The back rest can however be raised to a maximum of 30° (or optionally 50°).
•CPR function (Cardiopulmonary resuscitation)
•Tapered heel zone for additional pressure relief
1.4. Scope of delivery
The Active Mobilisation System comprises:
•Protective carrying bag
•Control unit (CU)
•Active mattress (MS - Moving System), consisting of:
Carrier cover, Foam mattress, Active modules, Mattress protection cover, and Tube connector
•Power cable
•Operating manual and Quick guide

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2. Purpose
The AMS is a hybrid, dynamic mattress that combines continuous lateral repositioning with additional
intermittent pressure relief to support the prevention and treatment of pressure injuries.
2.1. Intended use
Scope for use: hospital, long term care, home care, the private sector within the EU and EFTA
Users: health care workers, people with medical training, any trained individuals
2.2. Operating principle of the AMS
The operating principle of the AMS combines lateral repositioning with intermittent pressure relief.
The device mobilises or turns the patient at periodic intervals into a slight left and/or right lateral
position, depending on the user's choice and the needs of the patient. In the lateral position, the
patient experiences additional, intermittent pressure relief in the shoulders, upper back, hips/sacrum
and thighs. The rotations and reliefs are intended for patients in the supine position.
2.3. Structure and essential functions of the AMS
The upper part of the mattress consists of a high specification reactive pressure injury prevention
foam surface with a reinforced edge zone and a bevelled foot part for heel relief . The lower part ,
the mobilising part, consists of four transverse mounted lamellae , which deform in a wave-like
manner and thus reposition the patient from one side to the other, and additionally provide
intermittent relief at critical pressure points and body parts . The on/off and programme selection
are done via push buttons on the control unit , which is mounted at the foot end of the bed by
means of the hooks supplied.








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The AMS includes the following essential functions:
•Starting and stopping of mobilisation
•Setting of the repositioning intensity
•Setting of the repositioning interval (speed)
The system does not decide when and how a patient needs to be mobilised. This is determined by the
user, who starts the system manually and stops it again and who must choose the correct intensity and
intervals. The information displayed only serves to identify which mobilisation parameters are activated.
If the mobilisation of the patient by the AMS is not possible due to a technical defect, malfunction, or
improper manipulation, this is signalled. (Always visually. Acoustic signalling can be turned off.)
The AMS by itself does not prevent pressure injuries. It can be used as a supportive measure for
preventing pressure injuries in the case of moderate, medium, and high risk, and as support for the
treatment of pressure injuries. It does not replace prophylactic / therapeutic measures, as well as
regular inspections by the nursing staff.
When the AMS is used in beds with side rails the upper edge of the side rail must be fixed at
least 22 cm above the surface of the unloaded mattress.
2.4. Indication
The AMS is suitable as a supporting device…
•for pressure injury prophylaxis in patients with a low to very high risk according to Norton or
Braden or a high immobility measured with the Mobility Monitor
•the therapy of pressure injuries of all categories according to EPUAP.
The AMS is designed for use with people with a height of 146 cm and taller and weighing between
40 and 150 kg.
With patients who may not lie on their back due to their physical condition, the mobilization
function of the AMS must be deactivated.
2.5. Contraindication
When the mobilization function of the AMS is activated, the patient is rotated in his longitudinal
axis. Thereby, the rotation angle for the upper body is greater than that for the legs.
With due consideration of the intended use, the function and mode of operation of the product, the
AMS is with the prior approval of the responsible surgeon, suitable for use following certain types of
surgery such as shoulder, back, pelvis, spinal cord, and visceral surgery in the abdomen area prior to
complete wound healing.
The AMS is not suitable for patients with the following diagnoses:
•Unstable spinal fractures
•Cervical extensions

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•Manière's disease
•Intolerance towards the product
2.6. Side effects
•The unaccustomed movements of the AMS may initially cause unease. However, this usually
disappears after a settling-in period of up to 3 days.
•The small turns of the AMS can lead to a kind of "seasickness" in patients, depending on their
pre-disposition. This "seasickness", also called travel or motion sickness (the technical term is
kinetosis from the Greek word kinein = to move), is accompanied by physical reactions such as
paleness, dizziness, headache, nausea and vomiting, caused by the unaccustomed movements.
If the patient / resident refuses or rejects the AMS, or if a decline in health can be observed, the use of
the AMS should be discontinued.
2.7. Clinical benefit
•Effective pressure relief for both the treatment of existing pressure injuries and prevention of new
pressure injuries occurring.
•Relief for the care persons by assuming the physical work of repositioning the patient.
•An improvement in quality of sleep for the patient due to lack of sleep interruptions for
repositioning.
2.8. When used by lay persons trained on the AMS
In the event that the skin condition of the patient deteriorates or in the case of uncertainty of the
suitability of the device based on the indication given, a medically trained person should be consulted
(see chapters →2.4, →2.5, →2.6).

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3. Safety
3.1. Symbols
The following information is provided for the safe use of the device, so that neither the user is
endangered, nor the product is damaged. The following warning signs are in use:
Instructions that prevent injury to personnel or the user.
Important information that will ensure proper use of the product.
→7
For more information, see the chapter number indicated (→Link).
3.2. General warnings
Please contact the manufacturer or distributor for assistance with installation and operation of
the device, or if you notice an unexpected malfunction of the device.
The device must be installed and commissioned according to the operating manual. In addition,
the user must be instructed in the operation of the device.
The pressure injury risk assessment is not performed by the device but is the responsibility of the
nursing staff.
The AMS is designed for use with people with a height of 146 cm and up and weighing between
40 and 150 kg.
The intensity of the repositioning must be adapted to the patient's weight (see chapter →7.9).
Continuing care measures: the AMS does not replace the prophylactic / therapeutic measures
nor the regular inspections by the care personnel. The AMS alone cannot prevent pressure
injuries. It can be used as a supportive measure for preventing pressure injuries in the case of
moderate, medium, and high risk.
The control unit (CU) may not be loaded with more than 5 kg (50 N).
It does not serve as shelf space.
The device is subject to special EMC precautions (See EMC declaration)
Portable and mobile RF communications equipment can affect medical electrical equipment.
The AMS may only be operated with accessories supplied by compliant concept AG.

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The AMS may not be serviced during operation.
The maintenance intervals must be observed to ensure safe operation. See maintenance
indicator on the CU.
All modifications to the AMS are prohibited.
The battery must be replaced by trained personnel only.
Place all cables carefully to reduce the hazards from tripping or strangulation.
We urgently recommend cleaning and disinfect the system at least after each patient change.
The device is only water resistant to splashes! If dirty, the device should only be wiped with a
damp cloth. Otherwise, there is danger of electric shock.
The control unit must not be opened. Otherwise, there is danger of electric shock.
A defective device must not be used and must be professionally serviced by the manufacturer.
Otherwise, there is danger of electric shock.
In the unlikely event that someone is injured in connection with the use of the device, this should
be reported immediately to the responsible authorities and the manufacturer. For further infor-
mation on steps to be taken contact us via the contact details in chapter →16 of this manual.

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4. Overview
4.1. AMS components
Before installing, please check that all parts of the AMS are included:
•Protective carrying bag
•Control Unit (CU)
•Active mattress MS (Moving System) consisting of:
Carrier cover, Foam mattress, Active modules, Mattress protection cover, and Tube connector
•Power cable
•Operating manual and Quick guide
Active Mattress System (MS)
Control Unit (CU)
Active mattress system
(MS Moving System)
Power cable
Connection hose (Pressure and
incline sensor for back rest)
Carrying Cover/Sheath (grey)
Active Modules (yellow)
Mattress with
mattress cover
Active Base
of the MS

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4.2. Connections
On a new device plugging the connector of the inclination sensor into the control unit (CU) will
need some force. Make sure that it is inserted all the way in.
Electrical power connection
230V / 50Hz
Plug for back rest
incline sensor
cable to active mattress (MS)
Pressure port
to active mattress system (MS)
CPR
for CPR release latch (red)
and remove pressure port

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4.3. Type plate Control Unit (CU)
4.4. Type plate Moving System (MS)
MD-identification
This device is intended to be used as a medical device.
CE-label
Device fulfils the basic requirements in the EU
Please read the
Operating Manual
Serial number
Do not place in household trash →14
Name
Manufacturing date
Regulatory Repre-
sentation in the EU
Manufacturer
address
Input voltage
AC power / frequency /
amperage
Protection type (Ingress Protection)
3 = protected against foreign object from Ø2.5mm
3 = protected from falling spray water up to 60° to the vertical
Output voltage
DC power / amperage
Protection against electric shock
Protection class II
MD-identification
This device is intended to be
used as a medical device.
Protection type (Ingress Protection)
Refers to the housing and the inclination sensor inside of the MS
X = no data available / 2 = protected from dripping water up to 15° from the vertical
Serial number
Name
Do not place in
household trash →14
Manufacturing date
Regulatory Repre-
sentation in EU
Type B
component
CE-label
Device fulfils the basic requirements in the EU
Manufacturer address
Input voltage
DC /amperage

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5. AMS Installation
5.1. Commissioning
The Active Mobilisation System (AMS) must only be commissioned and adjusted for the bed by
properly instructed personnel.
We recommend that the AMS be set up in one specific bed and remain there, in particular, if
several different types of beds are in use.
The AMS is installed directly on the support surface of the bed, and thus replaces the original
mattress.
•Remove the existing mattress.
•Place the Moving System (MS) on the surface of the bed. Attach the MS using the belt loops of
the carrier cover across the corners to the back rest of the bed.
The belt loops on the carrier cover serve to secure the mattress additionally so that it is optimally
positioned on the bed and cannot slide down the bed.
Situations may arise whereby the technical characteristics of the bed do not permit the use of
the belt loops. In such cases care should be taken to secure the position of the mattress on the
bed by other means such as an elevated bed frame at the foot of the bed.
Important: Make sure that the mattress is properly oriented (labelling on the mattress oriented
correctly, logo and hose/air pipe positioned at the foot of the bed)
•Remove the mattress of the MS (large white zipper. Start in the centre of the foot end) and make
sure that the following points are adhered to:
a. The active modules are correctly positioned: (This can be checked by raising and lowering the
back rest and leg support)
1. 3rd active module in the fixed section of the bed
2. 3 visible loops distance to the modules 2 and 4
3. Module 1 approximately in the middle between module 2 and the "head" foam and at
least 1 visible loop distance to module 2
Belt loops
on carrier cover

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If the positioning is not correct, you will find a step-by-step guide in chapter →5.2.
b. that the active modules on both sides (left and right) are hooked into the loops
c. that the hose/cable clips are closed.
Active module no. 3 in fixed area (should remain level when bed is adjusted
Distance: 3 visible loops
Module 1
approximately
centered between
Module 2 and foam
“head“ and
at least
1 visible loop distance
to Module 2
Correct
Wrong

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Before initial installation, and when changing bed type, the active modules must be properly
positioned, →5.2.
•Hang the control unit (CU) at the foot of the bed
•Connect the pressure port. Pay attention to the label on the red connector.
–Turn the red connector completely to the left (OPEN)
–Connect the pressure port of the MS.
–Turn the red connector FULLY to the right to close it (LOCK)
Important: the lock should not be left in an intermediate position!
•Plug in the backrest incline sensor cable.
Make sure that the plug is pushed all the way into the socket.
•Position the cables (connecting air pipe and power cable) so that nothing can pinch them.
Important: Check that nothing can be pinched by testing the leg and back sections in all
positions. Check also that the side rail cannot be blocked by the air pipe.
•Put the mattress of the MS on top of the carrying cover/sheath and close the zipper.
After commissioning the AMS, it is recommended to make the bed as usual with fitted sheet,
incontinence protection, etc.
Important: It is important to ensure that the sheet is not too tight or sufficiently stretchable, so
that the movements of the AMS are not hindered.
Pressure port
Back rest incline sensor plug
Lock

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5.2. Positioning the Active Modules
Step by step instructions for positioning the active modules (AM):
1. Place the MS on the surface of the bed (after the conventional mattress has been removed) for
which it should be fitted.
2. Use the belt loops to fasten the MS to the corners of the back rest. Make sure that the back rest
is still movable, and that the loops don't block anything.
3. Remove the mattress from the active base using the zipper that goes all the way around
4. Remove the active modules (AM) from the belt loops
a. Slide the AM in the belt loop to one side as much as possible
b. On the other side unhook the AM from the loops
c. Now pull the AM out of the loops on the other side also
5. Check that the carrying cover/sheath is located centrally on the bed (the same amount of
space at the top and at the bottom. It tends to slide towards the top slightly, because of the belt
loops).
6. Position the AM in the pelvic area
(3rd module) such that it is located
exactly on the fixed, i.e., non-
movable part of the bed.
a. Once the AM is in this position,
hook it into the belt loops
again.
b. Make sure that the AM is sitting
straight.
If the fixed part is narrower than the active module, please proceed as follows:
•Check if the upper leg support part retreats when lifting.
•If so, the thigh section (upper leg support) may no longer be raised.
•If not: position the active module on the fixed part with an overlap to the thigh part
(upper leg support).
7. Position the AM in the lower back
part (2nd module) so that the
distance to the 3rd module is such
that 3 are visible from above.
a. Hook in the AM
Foot
Head
Fixed
part
4 32 1
Foot
Head
3 visible loops
4 3 21

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8. Position the AM in the upper back /
shoulder area (1st module) with 1 to
3 loops distance to the 2nd module.
a. Select the distance such that
the 1st module is centred
between the 2nd module and
the foam in the head area
b. Hook the AM in
9. Position the AM in the thigh area
(4th module) with 3 loops distance
to the 3rd module
a. Hook the AM in
10. Move the back rest and leg support of the to their respective stops and check that the pipes
cannot become trapped.
11. Make sure that the foam pieces at the head and foot part are tightened and that the bands are
stowed such that they cannot interfere with the active modules.
12. Place the mattress back on top and close the zipper
Checklist before closing up the mattress:
•Is the MS attached to the back with the belt loops?
•Are the active modules positioned correctly?
•Are the active modules hooked in correctly?
•Are the tubes/hoses mounted in the guides/clips?
•Are the pipes not jammed anywhere? (Even if the bed gets adjusted)
•Are the foam pieces of the head and foot sections properly positioned and tightened and the
straps stowed such that they cannot interfere with the active modules?
Foot
Head
1 to -3 visible loops
4 3 2 1
Foot
Head
3 visible loops
43 2 1