file: n:\article\cos101676-en\20210629_cos101676-en_hpcosmos_airwalk_ap_unweighting_ifu_iim_manual.docx
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6.
General safety requirements
Danger
N
The device has to be inaccessible for unsupervised children (<12 years).
N
Incorrect or excessive training may result in injuries to health.
N
Always make sure the device is installed on a stable and levelled base.
from standard EN 20957-1
N
For 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.
N
Before adjusting the unweighting force always make sure, the rope is not slung around any part of the subject’s
body.
N
The unweighting bar is freely movable; always make sure it does not hit the subject (e.g. the subject’s head).
N
Before 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.
N
Disconnect device from compressed air supply for maintenance or cleaning in order to avoid unintended
movements.
N
Device must only be used by carefully trained, authorized and professional staff.
N
Regard limits for max subject weight (see technical data / name plate).
N
Regard the instructions for regular disinfection of the unweighting vest / safety harness after every training session
(see “application”).
N
Do not use the device in combination with other than the intended devices (see technical data).
N
Do not use the device in case any of the contraindications applies (see list of contraindications).
N
Unauthorized modifications, service or maintenance is forbidden and will result in loss of any liability and warranty.
N
Do not use the device in environmental conditions other than described in the chapter “technical data”.
N
In case of unconsciousness the subject has to be released immediately in order to avoid a suspension trauma.
N
In case of any wear and tear the device has to be set out of order immediately
N
In 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.
N
Use 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.
N
Connection to pressurized air supply has to be accessible for any user at any time!
N
Always check correct position of the slide with the subject! Subjects’ knees must not touch running surface while
suspended in vest / harness.
N
Before deactivation of air cushion / fall stop mode, make sure the system is not under pressure.
N
The intended location must provide a suitable potential equalization condition (e.g. PE-bolt).
N
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.
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: