ato form Starlight Flex User manual

User manual
Head protection
Starlight®Flex
Body protection
edition 37/21

Page 3/24 (37/21)
Dear Customer!
We would like to thank you for your trust
extended to us and for purchasing our
product.
The head protection Starlight®Flex
distinguishes itself by its quality, security,
easy operation and modern design.
For optimal use of this aid, we ask you and
possible other users to carefully read this
operating manual.
Foreword
Please read through these instructions
carefully before first use and handle
equipment appropriately!

Page 4/24 (37/21)
2 Table of contents
Table of contents
Topic Page
1 Foreword ……………………………………… 3
2 Table of contents ……………………………… 4
3 Safety instructions …………………………… 5
4 Warranty and product liability ……………… 9
5 CE sign and position ………………………… 9
6 Indications and prophylaxis ………………… 10
7 Purpose of use ………………………………… 10
8 Product overview ……………………………… 11
8.1 Basic model ……………………………… 11
8.2 Accessories / Options……………………… 12
9 Initial operation ……………………………… 13
10 Assembly and adjustment …………………… 14
10.1 Basic model ……………………………… 14
10.2 Accessories / Options……………………… 17
11 Types and accessories ………………………… 18
11.1 Basic model ……………………………… 18
11.2 Accessories / options ……………………… 18
12 Technical details ……………………………… 19
13 Cleaning and disinfection …………………… 20
14 Maintenance and overhaul …………………… 20
15 Operation life and Re-use …………………… 21
16 Faults, repairs, spare parts …………………… 21
17 Storage ………………………………………… 21

Page 5/24 (37/21)
3 Safety instructions
Safety instructions
The head protection series Starlight®Flex
is CE-marked and fulfils the requirements
of the latest directive. It was developed in
line with most recent findings. Production is
subject to an on-going quality control.
Please read this user manual carefully
before operating the head protection.
In case of loss, request a new copy or
download directly from our download area
on our homepage www.ato-form.com.
Please keep the user manual in a safe place,
accessible to care and maintenance staff.
The user manual does not replace the
experience of supervisory staff with the
experience and knowledge of operators,
which they gained from (for example)
training courses.
In the event of specific or difficult
applications, the user manual represents a
guide to the most important handling.
Ensure all users of this aid understand its
handling and the meaning of the symbols
attached to the device.
Accidents can be prevented when technical
instructions according to the EWG
guidelines are followed.
Protective coverings, labels and warning
notices may not be removed.
Regular monitoring at your specialist
dealer (at least once a year) lengthens
the life time of the head protection and
gives you security.
Please also see section: maintenance
and overhaul.

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• Before mounting or using the head
protection series Starlight®Flex carefully
read all instructions of this user manual,
as these have been drawn up for your
safety and as a guideline for the correct
use and maintenance of this product.
This operating manual is an indispensable
component of the delivery and should be
stored carefully for further use.
• The operating manual is intended for
retailers and users of the head protection
series Starlight®Flex, (or their carers),
it contains the required information to
secure the correct use of the product, it
cannot, however replace the necessary
experience of the user or assistant in
handling the device.
• The reseller has the duty to deliver the
device ready for operation and to explain
precisely the functions and technical
data of the device, as well as provide the
necessary support and briefing needed
for a correct and efficient use of the
device.
• The given instructions of the operating
manual, refers to the point in time of
the device being placed on the market.
The manufacturer reserves the right to
introduce any modifications which prove
necessary to the device and associated
operating manual, without being
bound to change previous devices and
associated operating manuals.
• Use of the rehabilitation aid and its
accessories, must be administered under
medical supervision.
• The head protection should be worn by
only one user.
• Adjust the head protection correctly
before use!
• ATO FORM head protection is equipped
with an adjustable chin strap. Adjust the
straps to ensure a good fit of the head
protection, however not too tight. This
also applies to the chin protection, which
is accessorily available.
• Please ensure that the straps are firmly
locked!
• The head protection is designed to absorb
shocks and falls of the user. It is not a
helmet that provides protection against
falling objects.
• The ATO FORM head protection may
only be used for the provided indication
and must not be used for any other
purposes (sports and alike)!
• The head protection should preferably
be stored in the same place and close
to the user, when not wearing the head
protection. Ensure the head protection
is always handy, so that it can be put on
quickly and properly.
• The head protection series Starlight®Flex
may only be operated by persons or their
carers who have familiarized themselves
with the standards and rules of the
present operating manual.
• Do not use the rehab aid before ensuring
a complete and correct fitting of the chin
strap.
Safety instructions
3 Safety instructions

Page 7/24 (37/21)
Safety instructions
• Check all adjustable parts are locked,
before every use of the aid.
• Please note the individual and overall
safety relevant information when using
several rehabilitation aids simultaneously.
• Do not use the aid, if parts of it are
damaged or missing. Missing parts are
only to be replaced with original spare
parts.
• Do not carry out any interferences or
measurements if you are unsure of their
effects; for your own safety contact the
nearest service centre or contact the
dealer directly.
• In case of accidents or malfunctions,
contact the dealer or manufacturer from
whom you purchased the device.
• The manufacturer is not liable for damage
to persons, objects or animals resulting
from false usage of the equipment by the
user or third parties, through incorrect
mounting of parts and accessories, by
neglect or poor maintenance, neglect,
through unauthorized alterations and
modifications, usage of non-original
spare parts or accessories, through
unpredictable and exceptional events
resulting from non-compliance of the
regulations in the presented operating
manual.
• Any serious incidents occurring in
connection with the product must be
reported to the manufacturer (ATO
FORM GmbH) and the competent
authority of the country in which the user
is resident.
• Clean the head protection series
Starlight®Flex accordance with the
instructions given in the chapter
„c le an ing”.
• Please ensure before use the product
is cleaned according to the cleaning
instructions and if indicated also
disinfected.
Warning!
The head protection should not be
used by children when climbing or
doing other activities where there is
a risk of strangulation/hanging if the
child becomes entangled with the head
protection.
We constantly develop new aids and
improve existing products. We are happy
to receive your suggestions of every
description.
The head protection is a hygiene
product and is to be worn by only one
user.

Page 8/24 (37/21)
ATO FORM grants the required by law
warranty of your country against defects in
workmanship and materials.
The warranty would be adversely affected
if the customer’s responsibility of servicing
and/or daily maintenance is not carried out
according to the guidelines and intervals
prescribed by the supplier and/ or stated in
the manual.
For further information, we refer to the
ATO FORM homepage/download www.
ato-form.com.
The warranty can only be sustained if the
ATO FORM product is in use in the same
country where it was purchased and if
the product can be identified by the serial
number. The warranty does not cover
accidental damage, including damage
caused by misuse or neglect.
The manufacturer‘s obligations transfer
then to the person carrying out the
modifications.
The warranty does not extend to non-
durable parts, which are subject to
normal wear and tear and need periodic
replacement.
The warranty is null and void if non-original
ATO FORM parts/accessories are used, or if
the product is repaired or altered by anyone
other than an authorized ATO FORM
representative or by trained personnel
officially recognized by ATO FORM for
repair and maintenance of ATO FORM
products.
ATO FORM reserves the right to inspect the
product being claimed for and the relevant
documentation before agreeing to the
warranty claim and to decide upon whether
to replace or repair the defective product. It
is the customer’s responsibility to return the
item being claimed for under warranty to
the address of purchase.
The warranty is given by ATO FORM or,
subsequently, an ATO FORM dealer.
Warranty and product liability
4 Warranty and product liability
The CE-Label with details of the serial
number, the manufacturer and the washing
instructions is sewn into the inner lining of
the head protection.
6 CE-sign and position

Page 9/24 (37/21)
The shape of the head can change due to
illness, growth or surgery - for a variety of
reasons.
Thanks to its innovative design, the Star-
light®Flex can be adjusted in many places
and can thus be ideally adapted to the
user‘s individual requirements.
You can rightly expect us - Europe‘s largest
manufacturer of medical head protection
- to consistently dispense with potentially
dangerous metal parts, screws or the like
that could cause head injuries to the user in
the event of a fall, without compromising
wearing comfort, multi-adjustability or the
required protective effect!
The device must be prescribed by a medical
specialist, who has tested beforehand and
determined if the Starlight®Flex is suitable
for the individual therapeutic goal of the
patient. Furthermore, the medical special-
ist has determined the aid to be suitable
according to measurements, weight and
willingness of the patient to use the aid.
The aid is delivered via an authorised tech-
nician in compliance with the requirements
of the country where it is being used and in
strict accordance with the information and
instructions in this manual for adjustments
of the aid according to the measurements of
the user. Only compliance of the regulations
and instructions can lead to positive ergo-
nomically effects.
We wish you every success when using the
head protection Starlight®Flex.
• Safety during independent movements
and activities, for cerebral paretics, epilep-
tics and others at risk of falling.
• Protection against increased injury poten-
tial in autoaggressive patients.
• Protection against head injuries in the
case of uncontrolled falling movements or
movement sequences.
• Protection against fall hazards with
increased potential of injury.
• Models with the top closed offers
patients special protection, who for
example have part of their skull cap
missing.
The only contraindications to be mentioned
here are possible skin intolerances to the
materials used.
We use selected materials for the processing
of the head protection models that meet the
highest quality standards.
Indications and prophylaxis
Purpose of use
6 Indications and prophylaxis
7 Purpose of use

Page 10/24 (37/21)
Product overview
8 Product overview
1. Outer ring, adjustable to the head cir-
cumference
2. Ratchet closure for adjustment
3. Ear straps, padded, adjustable in length
and inclination
4. Upper side, anatomically shaped,
adjustable
5. Back head plate with Velcro tab for top
attachment.
6. Padding-Inlet, soft, flexible, firmly con-
nected to the back head plate and the
rear outer ring
8.1 Basic model
5
2
4

Page 11/24 (37/21)
Product overview
The Starlight®Flex is with following options
available:
1. Closed top
2. Ear protection
3. Forehead protection
4. Chin protection
5. Sunshild
6. Alternative upper side, head circumfer-
ence adjustable with velcro
7. Different fasteners
(without image)
8.2 Accessories / options
For a complete overview of our extensive
range of accessories for the Starlight®Flex
see item 11.2 Types and accessories on
page 18.

Page 12/24 (37/21)
Initial operation
9 Initial operation
The reseller is to unpack the unit, ensure
that the components and accessories listed
in the scope of delivery are all present and
undamaged, and give the buyer the initial
instructions on use of the aid. Above all the
reseller should read through the complete
present user manual carefully, in order to
then explain it to the customer in detail.
This way, with help of the reseller, the user
as well as the attendant must become famil-
iar with the correct operation of the aid.
Once the demonstration has been complet-
ed, the reseller must ensure the user and/or
the assistant have fully understood the basic
functions of the equipment. This is the only
way to prevent the user from dangerous
situations.
The above mentioned requirements must be
observed for first use and also for reuse.
The seller must give instruction for use, as
well as explain the basic functions of the
device according to MPG (medical products
law) to qualified staff.

Page 13/24 (37/21)
Assembly and adjustments
10 Assembly and adjustments
10.1 Basic model
The Starlight®Flex head protection is de-
signed in such a way that it can be adjusted
to the individual dimensions of the user at
different points.
The following basic adjustment options are
available:
• Length of the ear straps
• Inclination of the ear straps
• Head circumference
• Upper side
The head protection is stabilised and held in
its shape by the connection of the outer ring
with the padding-inlet.
To adjust your head protection, the pad-
ding-inlet must be loosen in the front area
of the outer ring first for all adjustment
options.
Setting the length of the ear straps
and the ear cut-out
To adjust the length of the ear straps (3),
detach them from the Velcro connection
with the outer ring (1). Stagger the ear
straps according to the required length
according following steps.
1. First fix the position of the straps at the
inner side of the outer ring and...
2. and then fix this position on the outside
with the Velcro.
Inclination
You can adjust the inclination of the head
protection or the ear straps via the ear
straps as described above by only adjusting
the straps slightly at the front or back.
1.
2.
1
3
Fig. 2: Picture shows setting with standard ear
straps

Page 14/24 (37/21)
Assembly and adjustments
Adjusting the head circumference on
the outer ring
You have the option of adjusting the head
protection to a range of approx. 4 cm on
each side by means of the ratchet closure.
Do not adjust the head circumference too
tightly, after completing the settings the
head circumference can be adjusted slightly
using the ratchet closure.
2
Fig. 4
2
3
1 4
Fig. 3
After completing all adjustments, fix the
padding-inlet to stabilise the settings as
described on page 17.

Page 15/24 (37/21)
Assembly and adjustments
Adjusting the height of the top
The height of the top (4) can be adjusted by
max. 1 cm at the front, back and sides.
To do this, loosen the Velcro fasteners inside
the outer ring (2) at the front and/or sides
and move them accordingly.
To adjust the height of the top in the rear
area, open the Velcro connection (6) on the
back of the head (5) and replace the top (4)
according to the desired settings.
After completing all adjustments, fix the
padding-inlet to stabilise the settings as
described on page 17.
Fig. 5: Front side inner
5
4
Fig. 6: Back side with back head plate (5) and
Velcro connection (6) to the top side (4)
5
4
6

Page 16/24 (37/21)
Assembly and adjustments
Re-inserting the padding-inlet
The padding-inlet is made of slightly
stretchable or mouldable material and can
be adjusted very well to the circumference
of the head.
After completing all adjustments, fix the
padding-inlet (6) back into the outer ring
(1).
Make sure that the inlet is fixed evenly and
centrally in the outer ring.
To do this, it is advisable to first fix the inlet
in the front centre as shown in the illustra-
tion and then press it on evenly at the sides. Fig. 7: Inserting the padding-inlet
1
6
Note!
The settings on your head protection
are stabilised by the connection of the
padding-inlet to the outer ring. Check
that the padding-inlet sits at the correct
height of the outer ring all round and is
securely fastened.
The illustrations in chapter 10.1 show the
settings on the basic model. All optionally
available models are set identically as de-
scribed in chapter 10.1.
When using the forehead protection or the
sunshield, make sure that they are firmly
attached in the centre of the forehead.
10.2Accessories / options
For a complete overview of our extensive
range of accessories for the Starlight®Flex
see item 11.2 Types and accessories on
page 18.

Page 17/24 (37/21)
The correct fit of the head protection
10.3 The correct fit of the head protection
The head protection should fit the head
without tension or gaps.
The head protection is in the correct
position when the head protection ring
(1) (see illustration) sits exactly above the
eyebrows and the back of the head (the
occipital protuberance) is well covered by
the rear plate (2).
Occipital
protuberance

Page 18/24 (37/21)
Article number Model
5582-... Basic model, ear strap padded
5589-... Closed top
5584-... With ear protection
5591-... Closed top, with ear protection
Fasteners
Standard Velcro fastener (Standard)
5182-02 Fixlock fastener
5182-02-SV Fixlock fastener with safety lock
5182-02 Thorn buckle
5182-03 Magnetic fastener (incl. key)
5182-06 Strengthened thorn buckle
Types and Accessories
5555-01 Chin protection
5556-01 Fored protection, with velcro
5557-01 Sunshild, with velcro
11 Types and accessories
11.2 Accessories / options
11.1 Basic model
The most up-to-date overview of our
extensive range of accessories for head
protection and their description as well
as much more useful information can
be found on our homepage www.ato-
form.com.
For special problems, or if it seems the
accessories you require are not demon-
strated nor described, please contact us.
We may already have the right solution
for you.

Page 19/24 (37/21)
Starlight®Flex Size S Size M Size L Size XL
Forehead protection
(without accessory)
approx. 23 cm
Head circumference (cm) 48 – 52 52 – 56 56 – 60 60 – 63
Filling High-tech foam
Outer material Cowhide vegetable tanned, particularly free from
PCP, azodye, formaldehyde and chromium (VI)
compounds
Lining Roughened calf leather, skin friendly, breathable,
heat and moisture regulating
Outer material (Inlet) Spacer fabric
Filling (Inlet) High-tech foam
Product weight Basic model g approx.
340
approx.
360
approx.
380
approx.
400
Technical changes reserved!
Technical details
12 Technical details
Construction
The head protection is made of genuine
leather. Thorn buckles are nickel-free. The
rivets are made of high-quality stain-
less steel. High-quality, shock-absorbing
foams are used for all padding. The entire
construction of the Starlight®Flex is based
on the latest and most modern production
strategies for allergen-free products with
the best climate conditions.

Page 20/24 (37/21)
Cleaning the textiles:
These may be cleaned using mild soap on a
damp cloth or sponge.
Cleaning the leather:
ATO FORM leather head protection is to
be cleaned with a leather cleaning agent!
Hereby please follow given instructions.
Warning!
Strong solvents may contain substanc-
es, which can damage the head protec-
tion and thereby lead to an impairment
of its protective effect.
Do not expose the head protection to
high temperatures.
When using the cleaning agents, the
manufacturer‘s instructions for use must be
followed.
Cleaning and disinfection
Maintenance and overhaul
13 Cleaning and disinfection
14 Maintenance and overhaul
The head protection should only be
used if in a faultless condition!
Immediately contact your specialist
dealer in case of any defects!
If any repair work is required on the
Starlight®, please contact your specialist
dealer or the ATO FORM service on tel.:
[phone].
Disinfection:
We generally advise against
disinfection, as this can damage the
leather. If it is nevertheless necessary,
only use a disinfectant suitable for
natural leather.
If disinfecting is necessary, use household
disinfectants and consider the following
indications:
The assistant must wear suitable protective
clothing (for example gloves) in order to
avoid infections.
When using disinfecting agents always
follow the instructions of the manufacturer.