General Information - Invacare Octave User Manual

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1. General information

This manual must be given to the user of the product. Before using this product, read this manual and save for
future reference.
Please note that there may be sections in this User Manual, which are not relevant for your bed.
All indications of right and left are based on a patient lying on his back in the bed.
Metal side rails and U-profile bed ends may be disassembled without the use of any tools.
1.1 Intended use
The bed is designed for use especially for home care.
The bed is designed for patients over the age of 12 years. 150 cm and longer.
The bed is a nursing bed with modular structure.
Max patient weight: 350 kg (provided the equipment - bed ends, side rails, support handles, lifting pole and
mattress have a total weight of max 35 kg).
Safe Working Load: Max 385 kg (Patient + accessories).
The Ocatve™ bed is defined to be used according to;
Application environment 3; Long-term care in a medical area where medical supervision is required and
monitoring is provided if necessary and medical electrical equipment used in medical procedures may be pro-
vided to help maintain or improve the condition of the patient.
Application environment 4; Care provided in a domestic area where medical electrical equipment is used to
alleviate or compensate for an injury, disability or disease.
In order to optimise the patient's comfort Invacare® recommends using a 15 cm mattress.
(see order numbers in section 6 "Part numbers for accessories").
1.2 Certification
TM
Octave
is marked in accordance with directive 93/42/EEC concerning Medical
Devices.
Octave
TM
is tested and approved in accordance with EN 60601-2-52 of TÜV
Product Service in Germany.
TM
Octave
has undergone a risk analysis according to EN 14971.
The motors and control unit of the bed are approved according to IEC 60601-1:2005 3:rd edition.
The hand control, control unit and motors are protected according to IPX6 or IPX4.
A lock cam must be used on the control unit - if not, Invacare®can not guarantee the IP protection.
All service work described in chapter 7 may only be performed by personnel who have been trained or instructed
by Invacare® service course.
If the functions of the bed change, please send the bed for a check-up according to the maintenance chart in
chapter 7.
Invacare® is certified according to EN ISO 9001 and ISO 13485 and ensures compliance by 3:rd party.
Throughout the entire production process our materials/products are quality controlled by the operators.
Additionally, a final test is carried out prior to packaging and shipping.
The operator carrying out the final test, which includes a check of all moveable
parts, motors and castors, issues a QA number on the product thereby confirming
its quality.
If the product does not correspond to the quality demands of Invacare®, it will be discarded.
If, contrary to our expectations, a problem should arise in connection with the delivered product, please contact
your Invacare® supplier. An address list is shown on the back of this manual.
3
QA XXX

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