Before Use; Intended Use; General Safety Instructions - Vermeiren Neoflex Neo 00 User Manual

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2

Before use

2.1

Intended use

In this paragraph a brief description of the intended use of your product is given. Additionally,
relevant warnings are added to the instructions in the other paragraphs. In this way we would like
to make you aware of the possible misuse that may appear.
• Indications and contraindications: the Neoflex stabilisation belts are intended for people who
require external support while sitting in order to maintain a correct position, or for those who
want to stop the process of pathological positioning of the trunk, pelvis or lower limbs.
The system should only be used by people with healthy skin, normal breathing, no mental
disabilities, and no fractured bones in places where the Neoflex belts are touching the body.
Body parts in contact with Neoflex should be covered by clothing. It should not be used for
pregnant women.
The stabilisation belts are intended be used on wheelchairs or other seating systems. They
should NOT be used as a restraint or as a seat belt in a moving vehicle.
• Please read all technical details and limits of your Neoflex system in chapter 5.
• The warranty on this product is based on normal use and maintenance as described in this
manual. Damage to your product caused by improper use or lack of maintenance will cause
the warranty to lapse.
2.2

General safety instructions

CAUTION
• Please read and follow the instructions in this manual. Otherwise you may get injured or your
product may get damaged.
• This product should only be installed and fitted to the user by a qualified person.
• Neoflex upper body support should always be combined with Neoflex pelvic support.
• Neoflex lower body support should always be combined with Neoflex pelvic support.
Keep the following general warnings in mind during use:
• Only use the attachment systems provided by Vermeiren. Do not structurally modify the device
to which Neoflex is attached.
• Before each use, check the product and attachments to the wheelchair/chair to make sure they
are undamaged and well secured.
• Only use the Neoflex system over clothing.
• After each use, check the user's skin in the places of contact. Increasing redness and irritation
can evolve into more serious injuries such as pressure ulcers.
• In case of damage, do not attempt to repair the product yourself. Contact your specialist dealer.
• Do not modify your product in any way.
• Accidental unfastening of the Neoflex system may cause the user to fall. For users with a
cognitive or motion disorder that may lead to accidental release, an attendant or caregiver
should be present when using the Neoflex system.
Any serious incident [MDR (EU) 2017/745 §2 (65)] that has occurred in relation to the device
should be reported to the manufacturer and the competent authority of the Member State in which
the user and/or patient is established.
For future communication, make sure to keep the LOT number from the packaging.
Risk of injuries and/or damage
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Neoflex : Neo 00
2023-10
Before use