h/p/cosmos airwalk ap Service manual

h/p/cosmos sports & medical gmbh Am Sportplatz 8 DE 83365 Nussdorf-Traunstein / Germany
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IMPORTANT! READ CAREFULLY AND KEEP AVAILABLE!
original instructions for use
airwalk®ap / airwalk®lt
unweighting device
body weight support device (BWS)
with optional fall prevention
h/p/cosmos®medical device
product family: body weight support device
model: airwalk®ap
article number: [cos30028]
model: airwalk®lt
article number: [cos30028-lt]
The copyright of this document, media, design, software and intellectual property is owned by
h/p/cosmos sports & medical gmbh, except where explicitly stated differently. Warning: All rights
reserved. Unauthorized copying, reproduction, hiring, lending, public performance and
broadcasting prohibited.
development, production, sales &service
h/p/cosmos sports &medical gmbh
Am Sportplatz 8
DE 83365 Nussdorf-Traunstein
Germany
phone +49 86 69 86 42 0
fax +49 86 69 86 42 49
www.hpcosmos.com
h/p/cosmos EUDAMED ID:
Economic Actor Manufacturer
SRN: DE-MF-000006147
version of instructions for use
version 1.2, revision 28.06.2021
order-no.: [cos101676-en]

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These instructions for use are valid for the original configuration of all devices mentioned above.
Changes of the original configurations of your device (updates, retrofitting of accessories, etc.) may result in invalidity of these
instructions for use.
In this case, always consider the last version of these instructions for use as well as the instructions for use of the retrofitted
accessories (e.g unweighting vests, shorts and harnesses) and/or combined products, such as for example an h/p/cosmos
treadmill.
The latest version of these instructions for use is always available on the h/p/cosmos website:
https://www.hpcosmos.com/en/contact-support/media-downloads/manuals
NIt is strictly forbidden to perform any amendments of the technical design, technical specifications, labelling
and configurations of this device and the accessories connected to it.
NAny amendments, unauthorized, poor or lack of service / maintenance will result in loss of manufacturer’s
liability and warranty.
Latest field safety notes FSN and safety warnings are available on the h/p/cosmos website:
https://www.hpcosmos.com/en/safety
Basic-UDI: 4050588004064
UDI-DI airwalk ap: 4050588002305
UDI-DI airwalk ap lt: 4050588002312

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Dear customer,
We would like to express our gratitude for putting your trust in us, in deciding for this top of the range device.
Since 1988 h/p/cosmos®has been developing and manufacturing running machines and accessories for applications in sports,
rehabilitation, medicine, diagnostics and science. When it comes to technology, ergonomics, design and safety, we have set
extremely high standards for ourselves.
h/p/cosmos’devices are designed for the challenging applications of therapy, diagnostics and training in the medical field and
competitive sports. Our declared goal is the improvement of health and performance of your patients and customers.
In order to reach this goal we developed this high-performance device, which naturally bears certain risks due to its power.
The compliance with the safety regulations reduces these risks to a minimum. For that reason, it is very important to read the
instructions for use in full before taking the device into operation and pay special attention to the mentioned safety regulations.
Although our devices are very robust and service reduced some maintenance and monitoring has to be performed regularly in
order to keep the device in a safe and reliable condition.
The instructions for use describe all the maintenance and monitoring that has to performed by you.
The attached instructions for installation and maintenance describe the processes of installation, detailed maintenance and
repair work that must only be performed by trained and authorized technicians who have been certified by h/p/cosmos.
We recommend calling our competent service team or entering into a maintenance contract for a routine service at an interval
of 6 or 12 months for standard machines and standard applications. A form for registration of your institution and device is
included in the delivery. In order to be able to supply you with the latest technical information and service, it is important for
you to fill out the form for registration immediately and send it back via fax, email or mail.
These instructions for use as a firm part of the delivery have to be accessible to the user at any time. They have been written
with great care. Should you, however, still find any details that do not correspond with your device, please notify us so that we
can correct any mistakes as soon as possible.
Since these instructions for use are subject to alterations without prior notice always refer to the latest version on our website.
E & OE. Errors and omissions excepted.
We wish you a lot of fun and success while exercising and working with this h/p/cosmos device.
h
Franz Harrer
President & CEO
h/p/cosmos sports & medical gmbh

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airwalk ap [cos30028] stand alone device with external air compressor
airwalk ap [cos30028] in combination with an h/p/cosmos treadmill and robowalk expander
airwalk lt [cos30028-lt] floor mounted pillar with possible installation example via ceiling mounted pulleys

h/p/cosmos sports & medical gmbh Am Sportplatz 8 DE 83365 Nussdorf-Traunstein / Germany
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1. Symbols used ................................................................................................................................................................. 6
2. Description...................................................................................................................................................................... 7
3. Intended use ................................................................................................................................................................... 8
4. Residual risk / Side effects (med)............................................................................................................................... 10
5. Forbidden Use / reasonably foreseeable misuse...................................................................................................... 10
6. General safety requirements....................................................................................................................................... 11
7. Emergency dismount / emergency release ............................................................................................................... 12
8. Application body weight support................................................................................................................................ 13
9. Application fall prevention and safety stop (optional).............................................................................................. 21
10. Trouble shooting .......................................................................................................................................................... 23
11. Name plate .................................................................................................................................................................... 24
12. Technical data .............................................................................................................................................................. 24
13. Spare parts and consumables .................................................................................................................................... 28
14. Intended / expected lifetime ........................................................................................................................................ 28
15. Disposal ........................................................................................................................................................................ 28
16. Installation .................................................................................................................................................................... 29
17. Pneumatic wiring.......................................................................................................................................................... 33
18. Options.......................................................................................................................................................................... 36
19. Labelling........................................................................................................................................................................ 39
20. Packing.......................................................................................................................................................................... 41
21. Maintenance.................................................................................................................................................................. 42
22. Contact .......................................................................................................................................................................... 43

h/p/cosmos sports & medical gmbh Am Sportplatz 8 DE 83365 Nussdorf-Traunstein / Germany
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1. Symbols used
General
c
CE sign, proof for meeting the essential requirements according to medical device directive
93/42/EEC (MDD), replaced by medical device regulation (EU) 2017/745 (MDR) since May 26,
2021.
Danger –hazard with high risk! (acc. to ISO 3864-2)
In case this hazard is not prevented, it will lead to death or severe injury.
Warning –hazard with medium risk! (acc. to ISO 3864-2)
In case this hazard is not prevented, it might lead to death or severe injury.
Caution –hazard with low risk! (acc. to ISO 3864-2)
In case this hazard is not prevented, it might lead to minor or slight injury.
Manufacturer (acc. to ISO 15223-1)
2020-09-30
Manufacturing date (acc. to ISO 15223-1)
Follow instructions for use (acc. to ISO7010-M002)
Potential equalization (IEC 60445)
Transport
Fragile, Handle with care (acc. to ISO7000-0621)
This way up (acc. to ISO7000-0623)
Keep dry (acc. to ISO7000-0626)
Centre of gravity (acc. to ISO7000-0627)
Do not stack (acc. to ISO7000-2402)
Temperature limitations (acc. to ISO7000-0632)

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2. Description
2.1. Design
The h/p/cosmos airwalk ap is an unweighting, also called “body weight support” (BWS), device for partial body weight support
(relief) with optional safety stop for fall prevention.
The airwalk ap is made of powder coated steel. The component box is the connection between the rails and the two vertical
adapters, which carry the two arches. The two arches carry the cable guide. Like a crane, the device is overlapping the treadmill
in a height of approximately 2.75 m.
The unweighting unit is integrated into one of the vertical adapters. A pneumatic cylinder is performing the weight support. The
unweighting force is transferred via a static rope to the unweighting bar. The subject is wearing a special vest (harness,
optionally chest belt and/or unweighting pants/shorts, which is fixed to the unweighting bar.
In order to support the subject, the unweighting vest is similar to a climbing harness with a high degree of comfort.
(1) Component box
(2) 2x adapter
(3) 2x arch
(4) Cable guide
(5) Roller + cover
(6) Rope
(7) Adjustable stop
(8) 2x rail
(9) Unweighting bar
2.2. Application
In neurological and also in orthopedic rehabilitation it is important for the patient to start exercising as early as possible.
Therefore an individual and optimal unweighting system is crucial for the patient. Further applications are gait training, balance
training and functional training under unweighted and/or safe conditions without risk of falling. The h/p/cosmos airwalk
unweighting system supports a natural gait pattern. The single-point suspension allows dynamic vertical movement when
walking and at the same time allows freedom in movement and body rotations where wanted. Additional fixation straps for
further stabilization may be utilized if desired and if recommended for the patient. The unweighting, depending on the progress
of therapy, can be adjusted via a hand unit.

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3. Intended use
3.1. Intended use
NBody weight support of a subject (during treadmill therapy / training)
NFall protection of a subject (during treadmill therapy / training)
NEmergency stop in case of falling during treadmill therapy / training
NBalance training under unweighted and/or secured conditions
NFunctional movement and gait training under unweighted and/or secured conditions
NOverspeed / hyperspeed and excess frequency training in athletics (only for sports applications)
Prescribed fall prevention device for any application where falling might cause an unacceptable risk (e.g. high speed or
special applications, applications with subjects not able to support their weight properly, physically impaired, newly
operated hip patients, invasive probes, osteoporosis, etc.)
3.2. Intended operator
NMedical staff only
Nthat has been carefully trained according to these instructions for use
Nthat is working according to the prescription of the medical doctor, where applicable and necessary
NThe subject is not the intended operator.
But the intended operator is authorized to allow the subject to control the device according to the instructions of the intended
operator and under the permanent observation of the intended operator.
This means the operation of the device remains the responsibility of the intended operator at all times, taking the physical
and mental condition of the subject into account.
The intended operator has to be within reach of at least one emergency stop / off at all times
3.3. Intended location
NMedical facilities only
NNo use at home or in home healthcare environments (acc. to IEC 60601-1-11)
NNo outdoor use
NNo direct sunlight
NSufficiently lighted for proper readability of warning, labels, displays and operation elements
NProper environmental conditions (see “Technical Data”)
NStationary training equipment: Not moved during use
3.4. Intended duration
NDepending on the prescription of the medical doctor
3.5. Contraindications
Absolute contraindications
(have to be excluded before the treadmill is used)
NAcute myocardial infarction (within 2 days)
NInstable angina pectoris
NCardiac arrhythmia pathology and/or limited hemodynamics
NSymptomatic massive aortic stenosis
NUncompensated / uncontrolled heart insufficiency
NAcute pulmonary embolism or pulmonary infarction

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NAcute endocarditis, myocarditis, pericarditis
NAcute aortic dissection
NAcute coronary syndrome
NAcute phlebothrombosis of the lower extremities
NFebrile infections
NPregnancy
NAcute thrombosis
NFresh wounds e.g. after surgery
NAcute fracture
NDamaged disc or traumatic disease of the spine
NEpilepsy
NInflammations
NAcute migraine
Relative contraindications
(The application may be started if the possible benefits exceed the risks.
The decision has to be made by the medical doctor before the treadmill is used)
NLeft main coronary stenosis
NMain artery disease
NCardiac valve disease of moderate severity
NKnown electrolyte imbalance
NArterial hypertonia (RR > 200 mm Hg syst. > 110 mm Hg diast.)
NTachyarrhythmia or bradyarrhythmia
NHypertrophic cardiomyopathy and other forms of outflow tract obstruction
NHigher degree atrioventricular AV-blocking
NAnemia
NPhysical and/or mental disabilities leading to inability to exercise adequately
NPartially invasive medical devices (probes, infusions, catheters, external fixators, etc.)
NCardiac pacemaker
NVisual impairment (vision < 30% acc. to WHO)
Further contraindications may occur. This has to be evaluated by the medical doctor.
In case of relative contraindications permanent observation of the subject by medical staff is obligatory.
Sources:
http://leitlinien.dgk.org (German Cardiac Society)
www.acc.org (American College of Cardiology Foundation)
www.americanheart.org (American Heart Association)
http://my.americanheart.org/idc/groups/ahaecc-internal/@wcm/@sop/documents/downloadable/ucm_423807.pdf
The above list does not claim to be exhaustive. The decision as to whether a subject is suitable for treatment always comes
under the remit of the physician in charge, who has sole medical responsibility for the treatment. As part of this, he must
evaluate in particular, in each individual case, possible risks and side-effects of the treatment against the benefit gained from
it. In addition, the subject’s individual situation plays just as important a role as the basic risk assessment for specific patient
groups.
Being a scientific discipline, medicine is subject to constant change in response to new knowledge and progress. It is therefore
the task of the physician in charge to continually keep his knowledge up to date by reading the latest scientific literature and to
acquire new knowledge during the course of treatment.

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4. Residual risk / Side effects (med)
After risk reduction most risks are "acceptable". Only a few risks remain "widely acceptable".
In case fall prevention is not applied or not applied correctly, there are residual risks, such as falling of a person resulting
in skin abrasions, bruises, fractures or in worst case even death.
These risks may occur during use as well as when entering or leaving the device.
Furthermore there is residual risk such as unintended overload of the subject caused by wrong operation, wrong
assessment, or wrong application of the operator.
The residual risk of trapping of clothes / shoes / fingers / hair or other body parts in moving parts can not be excluded as
well. These risks are reduced by safety information within the IFU.
It cannot be excluded that unintended or forbidden use might cause further not yet regarded risks and that already
regarded risks might have been estimated incorrectly. It can also not be excluded that the daily use of the medical product
might show further risks.
For medical applications such as parallel bar gait training there are alternatives such as overground gait training secured
only by the therapist.
However, the benefit of parallel bar gait training contrast to these alternatives is clearly outweighing the residual risk of
falling or overload with the known consequences utilizing this medical device.
In this risk analysis the "present state" of the device has been evaluated.
Having carried out the evaluation and validation of the product, the risk of appearance of a not acceptable risk is very low.
The device (it´s construction, it´s function as well as the intended application) does - under normal conditions - not
represent any unjustifiable risk for the subject, the user, the operator or third persons.
However, the risk of injury or even death due to a malfunction of this medical device is very low.
In over 30 years of history and with many medical devices on the worldwide market, there has never been such a reported
incident.
5. Forbidden Use / reasonably foreseeable misuse
NDo not modify the system and do not connect to other equipment which is not explicitly declared as compatible by
all involved manufactures.
NThe system must not be used without carefully trained specialist staff and without the staff having been instructed
on the safety regulations.
NThe subject must interrupt the training immediately if he/she starts feeling sick or dizzy and should see a doctor.
NSubjects with cardiac pacemakers or any kind of physical restriction must see a doctor before using the system and
ask for permission.
NIn the event of any detected and/or assumed malfunctions and/or defects or unreadable safety warning labels, the
device has to be taken out of operation, clearly marked as such and disabled. The supplier and authorized service
personnel have to be informed in writing.
NUnder no circumstances should a subject/patient or other user be overloaded or overstressed.
NAll prohibitions in the chapter “General safety requirements”.
NOther use than the explicitly mentioned intended use.

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6. General safety requirements
Danger
NThe device has to be inaccessible for unsupervised children (<12 years).
NIncorrect or excessive training may result in injuries to health.
NAlways make sure the device is installed on a stable and levelled base.
from standard EN 20957-1
NFor any application where falling might cause an unacceptable risk (e.g. newly operated hip patients, invasive
probes, osteoporosis, etc.), the chest-belt safety harness cos14903-04-xxx has to be applied additionally.
NBefore adjusting the unweighting force always make sure, the rope is not slung around any part of the subject’s
body.
NThe unweighting bar is freely movable; always make sure it does not hit the subject (e.g. the subject’s head).
NBefore connecting the device to a compressed air supply make sure the hand unit valve is closed, otherwise the
unweighting bar will flip up immediately. Therefore unlock turning knob and turn counter-clockwise until stop.
NDisconnect device from compressed air supply for maintenance or cleaning in order to avoid unintended
movements.
NDevice must only be used by carefully trained, authorized and professional staff.
NRegard limits for max subject weight (see technical data / name plate).
NRegard the instructions for regular disinfection of the unweighting vest / safety harness after every training session
(see “application”).
NDo not use the device in combination with other than the intended devices (see technical data).
NDo not use the device in case any of the contraindications applies (see list of contraindications).
NUnauthorized modifications, service or maintenance is forbidden and will result in loss of any liability and warranty.
NDo not use the device in environmental conditions other than described in the chapter “technical data”.
NIn case of unconsciousness the subject has to be released immediately in order to avoid a suspension trauma.
NIn case of any wear and tear the device has to be set out of order immediately
NIn case of any detected or assumed malfunction, defect or unreadable safety label, the device is to be disengaged,
marked and secured against operation immediately. Authorized service personnel has to be informed in writing.
NUse of the device is only allowed for persons correctly secured by the chest belt / unweighting vest. The estimation
has to be performed by the therapist or medical doctor.
NConnection to pressurized air supply has to be accessible for any user at any time!
NAlways check correct position of the slide with the subject! Subjects’ knees must not touch running surface while
suspended in vest / harness.
NBefore deactivation of air cushion / fall stop mode, make sure the system is not under pressure.
NThe intended location must provide a suitable potential equalization condition (e.g. PE-bolt).
NRope has to be replaced by an authorized h/p/cosmos technician at least every 12 months or earlier in case of any
visible or assumed damage.
from risk management
Any serious incident that has occurred in relation to the device should be reported to the manufacturer and the competent
authority of the EU Member State in which the user and/or patient is established.
See also EUDAMED database: https://ec.europa.eu/tools/eudamed/#/screen/home
h/p/cosmos EUDAMED ID Economic Actor Manufacturer: SRN: DE-MF-000006147

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7. Emergency dismount / emergency release
Danger!
General precaution and warning for emergency dismount and /or emergency release:
In case there is a risk of a subject to become unconscious, there have to be sufficient professional staff available within the
treatment room to handle the subject for emergency dismount.
The pull knob and slide in order to adjust the position of the fall stop cannot be re-adjusted in case the subject is unconscious.
Thus a lowering of a subject with the help of the air pressure control valve may not work until a subject can reach a wheelchair
position.
7.1. Device in working condition / subject unconscious
NStop the treadmill if unweighting has been used together with a treadmill.
NCall a doctor.
NCall third person (or sufficient persons to handle and support the body-weight of the subject) in order to stabilize
the subject.
NLower the subject as described in the chapter “Application”.
NRender first aid.
7.2. Device in error condition (subject cannot be lowered by hand unit valve) / subject conscious
NStop the treadmill if unweighting has been used together with a treadmill.
NInstruct subject that you will open the pneumatic circuit and the unweighting will be reduced immediately.
NTell subject to hold handrails and call third person (or sufficient persons to handle and support the body-weight of
the subject) in order to stabilize subject.
NDisconnect device from pressurized air supply.
NUnweighting will be reduced immediately!
NHelp subject to open the vest and exit the treadmill.
7.3. Device in error condition (subject cannot be lowered by hand unit valve) / subject unconscious
NStop the treadmill.
NCall a doctor.
NCall third person (or sufficient persons to handle and support the body-weight of the subject) in order to stabilize
the subject.
NInstruct the third person that you will open the pneumatic circuit and the unweighting will be reduced immediately.
NDisconnect device from pressurized air supply.
NUnweighting will be reduced immediately!
NOpen the vest and carry subject down from treadmill.
NRender first aid
Danger!
Connection to pressurized air supply has to be accessible for any user at any time!

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8. Application body weight support
8.1. General functions
step
picture
description
1.
Increase unweighting force
Turn control knob clockwise
(pull knob if it is locked).
2.
Decrease unweighting force
Turn control knob counter-clockwise
(pull knob if it is locked).

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3.
Setting of fall stop
Pull knob and move slide up or down in order to
adjust the position of the fall stop.
Caution!
Always check correct position with subject!
Subjects’ knees should not touch running surface
while suspended in vest / harness.
Warning!
The pull knob and slide in order to adjust the
position of the fall stop cannot be re-adjusted in
case the subject is unconscious.
Thus a lowering of a subject with the help of the air
pressure control valve may not work until a subject
can reach a wheelchair position.
In case there is a risk of a subject to become
unconscious, there have to be sufficient
professional staff available within the treatment
room to handle the subject for emergency dismount.
4.
Air cushion / fall stop mode (optional)
Air cushion mode: no continuous air supply
necessary (reduces noise / energy consumption).
Deactivated: knob in horizontal position
Activated: knob in vertical position
Warning!
Before deactivation of air cushion / fall stop mode,
make sure the system is not under pressure. Hand
unit valve turned counter-clockwise
completely!
deactivated
activated

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8.2. Preventive maintenance
step
picture
description
1.
Check rope for wear and tear.
Check rollers for free motion.
Check accessible tubes and vest for wear and tear.
Warning!
In case of any wear and tear or malfunction the
device has to be set out of order until the worn
component is replaced.
Warning!
Rope has to be replaced by an authorized
h/p/cosmos technician at least every 12 months or
earlier in case of any visible or assumed damage.

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8.3. Putting on unweighting vest, shorts and chest belt
step
picture
description
1.
The vest supports from the waist.
Before putting on vest, extend all straps.
Tight and nonslip cloths reduce riding up.
Tight fit provides greater support and is more
comfortable.
http://ergolet.gofiqr.com/ERDyFQ
Always read instructions and warnings also of all
accessories used!
Warning!
For any application where falling might cause an
unacceptable risk, the chest-belt safety harness
cos14903-04-xx has to be applied additionally.
2.
Optionally to the vest, different size neoprene
tights/shorts can be utilized for moderate
unweighting:
cos10095-neo-S
cos10095-neo-M
cos10095-neo-L
Always read instructions and warnings also of all
accessories used!
Warning!
For any application where falling might cause an
unacceptable risk, the chest-belt safety harness
cos14903-04-xx has to be applied additionally.

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3.
Put on chest belt cos14903-04-xx
Put on the chest belt so that the h/p/cosmos logo is
at the front. In order to attach the carabiner, put the
vertical belt (1) below the shoulder belts (2), facing
the body, thereby unloading the seam at the joint
(3).
Warning!
If the chest belt is put on differently, it may loosen
and it may not prevent from falling.
Always read instructions and warnings also of all
accessories used!

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8.4. Treatment / Unweighting
step
picture
description
1.
Deactivate air cushion mode.
Turn knob in horizontal position.
Warning!
Turn knob slowly and make sure the system is not
under pressure
2.
Connect device to active compressed air supply.
Warning!
Before connection to active compressed air supply,
make sure the system is not under pressure. Hand
unit valve turned counter-clockwise
completely!
3.
Connect unweighting vest to unweighting bar
Use the supplied karabiners for connection, in case
of small subjects elongate with extensions.
4.
Warning!
Safety harness chest belt cos14903-04-xx
For any application where falling might cause an
unacceptable risk, the safety harness has to be
applied additionally.
5.
Lift subject (from wheelchair)
Turn control knob clockwise carefully, if possible
ask the subject to support the process. The less
force needed to lift the subject, the less the vest
rides up.

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6.
Set emergency stop position
When subject stands upright, pull knob and move
slide down to one step before lowest possible
position.
Now the subjects’ vertical movement is limited.
Warning!
The pull knob and slide in order to adjust the
position of the fall stop cannot be re-adjusted in
case the subject is unconscious.
Thus a lowering of a subject with the help of the air
pressure control valve may not work until a subject
can reach a wheelchair position.
7.
Set unweighting force
Adjust the unweighting force by turning the control
knob until the desired value is reached by the
pointer.
Start exercise.
Warning!
Keep subject under permanent supervision.
8.
Set back emergency stop position
Instruct subject to stand on the feet and hold tight
to the treadmill handrails.
Pull knob und push slide upwards completely.
Now the subjects’ vertical movement is free.
9.
Lower subject (back to wheelchair)
After exercise, turn control knob counter-clockwise
carefully to reduce unweighting completely.
If possible, ask the subject to support the process.

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10.
Release subject from unweighting bar
Make sure the subject either can stand stabile and
firm or the subject is sitting in the wheelchair.
Unlock karabiners.
Remove vest and/or chest belt and/or neoprene
tights/shorts.
11.
Cleansing
The manufacturer of the unweighting vest
recommends cleansing with a diluted disinfectant.
The device itself should be cleaned according to
the regulations of your institution. h/p/cosmos
recommends
Bacillol AF, order number [cos12179-01].
This manual suits for next models
1
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