FIOR & GENTZ Locked System Knee Joints User manual

EN
Instructions for Use for Patients
Locked System Knee Joints

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You can find these instructions for use in the download section on our website at www.fior-gentz.com/downloads.

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Instructions for Use for Patients
Locked System Knee Joints 3
1. Safety Instructions 3
1.1 Classification of the Safety Instructions 3
1.2 All Instructions for Your Safety 3
2. Intended Use 4
3. Using the Orthosis 5
3.1 Locking the System Joint 5
3.2 Unlocking the System Joint 5
3.3 Adjusting the Permanent Unlock Function 6
3.4 Releasing the Permanent Unlock Function 6
4. Cleaning the Orthosis 6
5. Maintenance of the Orthosis 6
6. Disposal of the Orthosis 7
7. Signs and Symbols 7
8. CE Conformity 7
9. Legal Information 7
10. Handing Over the Orthosis 8

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Dear Patient,
You have received an individually produced orthosis with a high quality FIOR & GENTZ locked system knee joint
from your orthotist or a qualified/trained expert.
1. Safety Instructions
1.1 Classification of the Safety Instructions
DANGER Important information about a possible dangerous situation which, if not avoided,
leads to death or irreversible injuries.
WARNING Important information about a possible dangerous situation which, if not avoided,
leads to reversible injuries that need medical treatment.
CAUTION Important information about a possible dangerous situation which, if not avoided,
leads to light injuries that do not need medical treatment.
NOTICE Important information about a possible situation which, if not avoided, leads to
damage of the product.
All serious incidents according to Regulation (EU) 2017/745 which are related to the product have to be
reported to the manufacturer and to the competent authority of the Member State in which the orthotist or
qualified/trained expert and/or the patient is established.
1.2 All Instructions for Your Safety
DANGER
Potential Trac Accident Due to Limited Driving Ability
Gather information about all issues concerning safety and security and potential dangers before driving a
motor vehicle with orthosis.
WARNING
Risk of Falling Due to Loosely Attached Cover Plate
Do not secure screws for the system joint on your own. Consult your orthotist or a qualified/trained expert
about the maintenance intervals to be respected.
Instructions for Use for Patients
Locked System Knee Joints
EN

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WARNING
Risk of Falling Due to Improper Handling
Have your orthotist or a qualified/trained expert inform you about the correct use of the system joint and
potential dangers. Avoid contact with moisture and water.
WARNING
Risk of Falling Due to Improper Shoe/Wrong Shoe Pitch
Wear a shoe to which your orthosis is adjusted in order to avoid joint dysfunction.
WARNING
Risk of Falling Due to Orthosis Adjustments
If you notice any changes on the orthosis (e.g. loosely attached joint components or changed spring forces),
immediately contact your orthotist or a qualified/trained expert.
WARNING
Risk of Falling Due to Improper Cleaning
In order to avoid a failure of the lock function, clean the orthosis and the system joint as described in these
instructions for use. Do not grease the system joint on your own. If necessary, consult your orthotist or a
qualified/trained expert.
WARNING
Risk of Falling Due to Improper Handling of the Lock Function
Have your orthotist or a qualified/trained expert inform you about the correct use of the lock function and
potential dangers.
- Avoid an unintentional unlocking of the system joint through external influences (e.g. a fall) and a
(forceful) unlocking under flexion load.
- Disable the permanent unlock function if you no longer wish to use it.
- Avoid unintentional locking of the system joint by activating the lock lever when the permanent lock
function is used.
2. Intended Use
The FIOR &GENTZ locked system knee joints are exclusively for use for orthotic fittings of the lower extrem-
ity. They must be handled by an orthotist or qualified/trained expert. All FIOR & GENTZ system joints were
developed for everyday life activities such as standing and walking. Extreme loads connected to activities like
running, climbing and parachuting are excluded.
The following locked system knee joints are part of the FIOR &GENTZ product range:
NEURO LOCK
NEUROLOCK MAX
NEURO FLEX MAX lock function
NEURO FLEX MAX step lock function

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3. Using the Orthosis
3.1 Locking the System Joint
You can lock the system knee joint by stretching the knee completely.
The permanent unlock function must not be set. Check the correct
locking of the system knee joint. If your orthosis has two system joints
in the knee area, you have to make sure that both system joints always
lock at the same time.
Acoustic Check
You must hear a “clack” when the system joint locks.
Visual Check
No opening must be seen at the front side of the system joint (fig. 1).
If the system joint cannot be locked actively and reliably, it must be
locked passively. To do this, push the knee back with the hand (fig.2).
Alternatively, another person can assist in locking the system joint
when you are seated or lying down (fig. 3).
3.2 Unlocking the System Joint
To unlock the system knee joint, press the locking pawl against the
joint's upper part by using the lever extension (lock lever) or a
pulling cable. For low eort and minimal wear of the system com-
ponents you have to:
-take the body weight off the orthosis and
-apply a slight extension moment (fig. 2–4).
Sit on the edge of the chair. The heel should touch the ground
(fig.4).
Your first walking and standing attempts with the orthosis
should only be carried out under the supervision of an
instructed person.
= "Clack"
fig. 1
fig. 3fig. 2
fig. 4

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3.3 Adjusting the Permanent Unlock Function
With the permanent unlock function you can disable the system joint's lock func-
tion.
1 Press the locking pawl against the joint’s upper part and hold it in this position.
2 Push the locating pin against the spring force until it snaps into the joint’s upper
part (fig. 5).
3.4 Releasing the Permanent Unlock Function
1 Stretch your knee.
2 Press the locking pawl against the joint’s upper part again. By doing so, the locating pin is automatically
pushed out.
You can use the system joint with the lock function again.
4. Cleaning the Orthosis
Clean the orthosis regularly. Do not immerse an orthosis with metal system joints in water or other liquids.
Instead, clean the orthosis with a damp cloth. Leave out the area around the system joint and clean it only
superficially with a dry cloth. Remove visible dust and lint from the mechanics by using tweezers. Check the
orthosis in straight and flexed position. Mind in particular the locking and unlocking parts.
5. Maintenance of the Orthosis
Ask your orthotist or a qualified/trained expert to check the system joint of your orthosis every 6 months.
Bring these instructions for use to each follow-up and let your orthotist or a qualified/trained expert enter
the next appointment in the table on the back. Never carry out maintenance work or other adjustments and
repairs yourself. In the case of children and people with cognitive impairments, we would like to point out to
you as parents or care team that you must regularly check the orthosis and the system joint for signs of wear.
If you notice any changes, immediately contact your orthotist or a qualified/trained expert.
fig. 5

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6. Disposal of the Orthosis
If you no longer need the orthosis, please return it to your orthotist or a qualified/trained
expert. The product must not be disposed of with the residual waste (fig.7).
7. Signs and Symbols
Symbols on the Packaging
medical device
8. CE Conformity
We declare that our medical devices as well as our accessories for medical devices are in conformity with the
requirements of Regulation (EU) 2017/745. Therefore, the FIOR & GENTZ products bear the CE marking.
9. Legal Information
With the purchase of this product, our General Terms and Conditions of Business Transactions, Sales, Delivery
and Payment will apply. The warranty expires, for example, if the product is mounted several times. Please note
that the product is not supposed to be combined with other components or materials than with those recom-
mended according to the configuration result from the FIOR & GENTZ Orthosis Configurator. The combination
of the product with products from other manufacturers is not permitted.
The information in these instructions for use is valid at the date of printing. The contained product information
serve as guidelines. Subject to technical modifications.
All rights, particularly the distribution, copy and translation of this manual or any part of it, in paper or as
electronic document, must be authorised in writing by FIOR & GENTZ Gesellschaft für Entwicklung und Vertrieb
von orthopädietechnischen Systemen mbH. Reprints, copies and any other electronic reproduction, even par-
tial, must be authorised in writing by FIOR & GENTZ Gesellschaft für Entwicklung und Vertrieb von orthopädie-
technischen Systemen mbH.
fig. 6

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When handing over the orthosis to the patient by the orthotist or qualified/trained expert, they also received the instructions
for use for patients. The functions and handling of the orthosis were explained in detail by means of these instructions for use.
Place, Date Signature Orthotist or Qualified/Trained Expert
10. Handing Over the Orthosis

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Gesellschaft für Entwicklung und Vertrieb
von orthopädietechnischen Systemen mbH
Dorette-von-Stern-Straße 5
21337 Lüneburg (Germany)
info@fior-gentz.de
www.fior-gentz.com
[phone]
[phone]
PB2400-PI-2020-07
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DIN EN ISO
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ORTHOSIS SERVICE PASSPORT
Have you not yet received an orthosis service passport? Ask your orthotist or a qualified/trained expert!