Environmental Conditions; Medical Requirements; Field Of Application/ Target Group; Indications - Interco Simply Gebrauchsanweisung

Instruction of the customer
All functions of SIMPLY
operating instructions must be demonstrated to the
customer The operating instructions remain with the
customer All adjustments to the product that directly
affect the user may only be carried out by medical de-
vice consultants or in consultation with these
2.

Medical requirements

2.1.

Field of application/ Target group

If there is an indication for a seat shell
To accommodate the existing seat shell

2.2.

Indications

Seating aids serve to compensate for a disability with
moderate to severe bad posture and/or Postural insta-
bility� The underlying Damage as a cause of impairment
of Sitting are diverse� Mostly the interaction of Pelvis
and spine either by congenital or acquired damage to
the trunk (bony or joint structures) or by congenital or
acquired functional disorders of the musculoskeletal
system (muscular, neuronal, cerebral, injury-related)
disturbed� As exemplary clinical pictures/diseases can
be named: cerebral movement disorders, Myelodyspla-
sia, muscular dystrophy or atrophy, multiple sclerosis,
other diseases with scoliotic spinal deformities�
2.3.

Contraindications

Individuals, especially children, who, because of their
age or other physical limitations not yet or generally
3.

Product labeling

SIMPLY
®
interco Group GmbH, Im Auel 50,
Eitorf, 53783, Germany
C
74600-35 E
F
+EINT0500746000000010J
Example: Product labeling SIMPLY
Product labeling on product
which are explained in the
®
A
B
D
H
I
G
J
Max. Load 80 kg
SB25 (Art no 74600-35)
®
1.4.

Environmental conditions

The SIMPLY medical device must always be stored in
®
a dry place to prevent possible corrosion Please keep
to ambient temperatures of -10 °C to +40 °C Sand or
other dirt particles should not be allowed to penetrate
the product Use in salty water is not permissible
not take a sitting position may not be positioned in a
seat pan unless this is expressly done by one doctor
prescribed Any kind of pain when ingested a seated po-
sition can be a contraindication represent In general,
the indication should Seat shell, of a seating system
always medically and/or be accompanied therapeuti-
cally and be indexed by regulation
In addition, no other contraindications known
2.4

Intended use

When supplying individual seat shells and modular
seating systems for people with disabilities mobility
(severely limited ability to walk up to walking disabil-
ity) are chassis or bases mandatory for indoor and/
or outdoor use The chassis and undercarriages take
individual Seat shells and modular seating systems and
enable the mobility and transport of patients including
transport in motor vehicles if this is explicit allowed
A
Type designation
B
Manufacturer's data
C
Year of manufacture
D
Serial number (always indicate in case of
complaints and other questions)
E
Article number
F
UDI Code as barcode to scan
G
UDI Code in human readable form
H
Observe warnings/safety instructions
I
Read operating instructions prior to use
J
Maximum weight
The serial number and the size of the undercarriage
and/or the UDI-DI of SIMPLY
when ordering spare parts or accessories�
The serial number with all details is attached to the
lower left part of the frame (viewed in the direction of
travel) on the inside�
must always be stated
®
35
PRODUCT L ABELING