Invacare Matrx, Руководство пользователя

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1.2 Symbols in this user manual
In this User Manual warnings are indicated by symbols. The warning
symbols are accompanied by a heading that indicates the severity of
the danger.
WARNING
Indicates a potentially hazardous situation which if not
avoided could result in death or serious injury.
CAUTION
Indicates a potentially hazardous situation which if not
avoided could result in product damage, minor injury
or both.
IMPORTANT
Indicates a hazardous situation which if not avoided
could result in damage to the product.
Gives useful tips, recommendations and information
for efficient, trouble-free use.
This product complies with the directive 93/42/EEC
for medical products. The launch date for this product
is specified in the CE declaration of conformity.
Manufacturer
1.3 Warranty
We provide a manufacturer’s warranty for the product in accordance
with our General Terms and Conditions of Business in the respective
countries. Warranty claims can only be made through the provider
from whom the appliance was obtained.
1.4 Standards and regulations
Quality is of the utmost importance for our company; all processes
are based on the ISO 9001 and ISO 13485 standards.
This product features the CE mark, in compliance with the Medical
Device Directive 93/42/EEC Class 1.
The product meets the requirements of the standards DIN EN 12182
(Technical aids for disabled persons - general requirements and test
methods), DIN EN ISO 14971 (Medical devices - Application of risk
management to medical devices) and DIN EN ISO 10993–1 (Biological
evaluation of medical devices - Part 1: Evaluation and testing within a
risk management system).
Invacare® is continuously working towards ensuring that the
company’s impact on the environment, locally and globally, is reduced
to a minimum. We only use REACH compliant materials and
components.
For further information please contact Invacare® in your country (for
addresses, see back page of this manual).
1.5 Intended use
The Matrx® Elan headrest hardware and headrest pads are designed
to offer comfort and posterior head support. It will provide simple,
comfortable and effective support helping to maximise function and
seating tolerance.
1.6 Scope of delivery
The following components are included in the scope of delivery:
•
Matrx® Elan Hardware (MEHW, post length 356 mm) or
Matrx® Elan Mini Hardware (MEMH, post length 254 mm)
(see Fig. 1)
•
Headrest pad (see Fig. 2 and following table for options)
Option Designation
A
Elan Standard Pad 150 mm x 90 mm – SMALL
B
Elan Standard Pad 250 mm x 130 mm – MEDIUM
C
Elan Standard Pad 360 mm x 130 mm – LARGE
D
Elan Occipital Pad 230 mm x 180 mm
E
Elan Occipital Pad 300 mm x 200 mm
F
Elan 4–Point Pad 280 mm x 260 mm
•
User manual
1.7 Service life
The expected service life of this product is three years when used in
accordance with safety instructions and intended use, stated in this
manual. The effective service life can vary depending on frequency
and intensity of use.
2 Setup and usage
2.1 Installing the mounting hardware / headrest
pads (Fig. 1)
WARNING!
Risk of serious injury
Injury may occur during use of the wheelchair if a
headrest is wrongly adjusted or not installed correctly.
The users neck may become hyperextended in the event
of a collision, or when the system is tilted or reclined.
–
This item must be fitted by an experienced clinician
or technician.
– Before each use, check that all screws are securely
fastened.
WARNING!
Risk of severe injury when transporting the client
within a wheelchair fitted with an Invacare®
Matrx® ELAN headrest in a motor vehicle.
– Wherever practicable Invacare recommends that the
client is transferred out of the wheelchair into a vehicle
seat using a lap and diagonal seat belt or an appropriate
child safety seat.
– Invacare® Matrx® ELAN headrests may only be used
in conjunction with wheelchairs that comply with the
performance requirements of RESNA WC19 or ISO
7176–19.
–
For safe transportation of a client within a wheelchair
in a motor vehicle, refer to the user manuals of the
wheelchair and the tie-down and occupant restraint
system (WTORS).
1. Remove the headrest assembly and components from the
packaging.
WARNING!
Risk of injury
–
Inspect the headrest hardware to ensure that there are
no missing or damaged parts.
WARNING!
Risk of injury
– Before drilling or modifying any back shell, always
contact the back manufacturer to ensure the back is
recommended for a headrest application.
Tools: Allen keys 2.5 mm / 4 mm / 5 mm (provided)
Hacksaw, Power drill, 6 mm drill bit
1603314-A 3