Residual Risk; Reference Standards; Life Span - Promeba PS-190 User Manual

USER GUIDE // EVACUATION CHAIR WITH TRACKS PS-190
Review 2021/09
34. Brakes are used only to prevent the empty chair from moving when unsupervised, and as an aid during
patient transfer. The brakes cannot provide enough resistance to keep the chair fully braked on all surfaces
or with a load on the chair.
35. Never use the brake on a chair with badly worn wheels, as it could affect the locking ability of the brakes,
and therefore cause possible injury to the patient, operator or equipment.
01.11 Residual risks
The residual risks listed below have been identified only with reference to the intended use of the device:
1. Use by untrained personnel may result in injury to patient, operator, or third parties.
2. Inappropriate disinfection procedures can create a risk of cross infection.
3. If the device is not locked in the fixation system or is not positioned correctly, it could result in sudden and
dangerous movements, which could cause injury to the patient and the operators. Always make sure that
the locking system is properly anchored.
4. Failure to comply with the warnings for operators can create risks.
5. Failure to read and understand the product instructions can result in injury to the patient and operators.

01.12 Reference standards

REFERENCE
TITLE OF DOCUMENT
Patient handling equipment used in road ambulances. Part 1. General stretcher
UNI EN ISO 1865-1
systems and patient handling equipment
UNI EN 1789 Medical vehicles and their equipment. Road ambulances
As a distributor or end user of the products manufactured and/or distributed by Promeba,
S.L., you are strictly obliged to know the legal provisions in force in the country of destination
of the goods, applicable to the devices to be supplied (including the regulations relating to
technical specifications and/or safety requirements) and, therefore, understand the necessary
requirements to ensure compliance of the products themselves with all the legal requirements
of the territory.

01.13 Life span

If used as described in the following instructions, this device has a useful life of 10 years from the date
of purchase.
This useful life can be extended with annual reviews carried out by the manufacturer, which uses speciali-
zed and authorized internal and external technicians.
In case these annual checks are not carried out, the device must be disposed of according to the informa-
tion in paragraph 01.4 and the manufacturer must be notified.
Only the manufacturer or an authorized center can extend the life of the device, if it meets the safety requi-
rements.
Promeba, S.L. will not accept any responsibility for malfunction or damage caused by the use of devices
that have not been checked by the manufacturer or authorized center, or that have exceeded the maximum
allowed useful life.
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