General; Information About The User Manual; Symbols In This User Manual; Warranty - Invacare Aquatec ORCA Manuel D'utilisation

Aquatec® ORCA / ORCA F / ORCA XL

1 General

1.1 Information about the user manual

This user manual contains important information about the handling
of the product. In order to ensure safety when using the product,
read the user manual carefully and follow the safety instructions.
The position specifications (A, B, C, etc.) in the handling instructions
always refer to the preceding figure.

1.2 Symbols in this user manual

In this user manual, warnings are marked with symbols. The title next
to the warning symbol indicates the level of danger.
WARNING
Indicates a dangerous situation which could lead to
death or serious injury if not avoided.
CAUTION
Indicates a dangerous situation which could lead to
minor injuries if not avoided.
IMPORTANT
Indicates a dangerous situation which could lead to
damage if not avoided.
Useful tips, recommendations and information to
ensure efficient and smooth operation.
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
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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.
Covers and suction cups are excluded from this.

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 EN ISO
14971 (Medical devices - Application of risk management to
medical devices), DIN EN ISO 10535 (Hoists for the transfer of
disabled persons - Requirements and test methods), IEC 60601-1
(Medical electrical equipment - Part 1: General requirements for
basic safety and essential performance). IEC 60601-1-2 (Medical
electrical equipment - Part 1-2: General requirements for basic safety
and essential performance - Collateral standard: Electromagnetic
disturbances - Requirements and tests) and DIN EN ISO 10993–1
(Biological evaluation of medical devices - Part 1: Evaluation and
testing within a risk management system).
It has a lift capacity greater than 1.5 times the nominal load.
Invacare® is continuously working towards ensuring that the
company's impact on the environment, locally and globally, is reduced
to a minimum.
•
We comply with the current environmental legislation (e.g.
WEEE and RoHS directives).
•
We only use REACH compliant materials and components.
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