ottobock 4P862 C-Leg Guard Instructions
- June 5, 2024
- ottobock
Table of Contents
4P862 C-Leg Guard Instructions
4P862
Instructions for use (qualified personnel)
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Foreword
INFORMATION
Date of last update: 2021-09-30
► Please read this document carefully before using the product and observe the
safety notices.
► Instruct the user in the safe use of the product.
► Please contact the manufacturer if you have questions about the product or
in case of prob lems.
► Report each serious incident related to the product to the manufacturer and
to the relevant authority in your country. This is particularly important when
there is a decline in the health state.
► Please keep this document for your records. The “4P862 C-Leg Guard” will
hereon be referred to as the guard/product. These instructions for use provide
you with important information on the use, adaptation, and handling of the
product. Only put the product into use in accordance with the information
contained in the accompanying documents supplied.
Product description
2.1 Function
The guard functionally and visually sheaths the C-Leg electronic knee joint.
In the covered area, the guard protects the housing of the knee joint against
external influences such as scratching and surface contamination. The guard is
open on the front. The guard is not required for the prop er and safe
functioning of the joint. To fully sheathe the knee joint, the 4P863=* shield
insert has to be used at the front.
2.2 Combination possibilities
Prosthetic components that are suited for combination with the product are
listed below.
Knee Joint Combination Possibilities
| Designation | Reference number |
|---|---|
| C-Leg | 3C98-3/3C88-3 |
INFORMATION
The product is not compatible with the charger extension cable – 4X156 ankle,
charger exten sion cable – 4X157 knee head, and charger extension cable –
4X158* ankle, long.
Intended use
3.1 Indications for use
The product is to be used solely for lower limb endoprosthetic fittings.
3.2 Conditions of use
The product was developed for everyday use and must not be used for unusual
activities such as extreme sports (free climbing, paragliding, etc.).
3.3 Contraindications
• All conditions which contradict or go beyond the specifications listed in
the section on “Safety” and “Indications for use”.
Safety
4.1 Explanation of warning symbols
CAUTION Warning regarding possible risks of accident or injury.
NOTICE Warning regarding possible technical damage.
4.2 Structure of the safety instructions
CAUTION
The heading describes the source and/or the type of hazard The introduction
describes the consequences in case of failure to observe the safety instruc
tions. Consequences are presented as follows if more than one consequence is
possible: > E.g.: Consequence 1 in case of failure to observe the hazard
E.g.: Consequence 2 in case of failure to observe the hazard
► This symbol identifies activities/actions that must be observed/carried out in order to avert the hazard.
4.3 General safety instructions
CAUTION
Non-observance of safety instructions
Personal injury/damage to the product due to using the product in certain
situations.
► Observe the safety instructions and the stated precautions in this
accompanying document.
CAUTION
Improper disassembly, assembly and handling of the product
Injury due to pinching of body parts.
Possible injury in case of parts with sharp edges.
► Use increased caution during disassembly/assembly and handling of the product.
CAUTION
Changes or modifications to the product made independently
Injury due to faulty operation or malfunction of the product.
► Have any changes or modifications to the product been carried out only by
authorized, qualified Ottobock personnel.
NOTICE
Mechanical damage to the product
Change in or loss of functionality due to damage.
► Use caution when working with the product.
► If the product is damaged, check it for proper function and readiness for
use.
► Take any necessary measures (e.g. repair, replacement, inspection by the
manufacturer’s customer service, etc.).
Scope of Delivery and Accessories
5.1 Scope of delivery
- 1 pc. 4P862 C-Leg Guard
- 1 pc. Instructions for use (qualified personnel)
5.2 Accessories
The following components can be ordered separately as needed:
- 1 pc. 4P863=* shield insert
Use
-
Open the closures on the guard.
-
Spread open the guard.
-
Put the guard over the knee joint from the front (see fig. 1).
-
Squeeze the guard together with both hands (see fig. 2).
INFORMATION: The retainers (detail, see fig. 2) of the guard have to engage on the frame element of the knee joint. -
Fasten the two closures (see fig. 3).
If the optional shield insert is used, the following steps must also be completed:
► Slide the shield insert into the recess of the guard from the front and let
it engage (see fig. 4).
NOTICE
Loss of stability due to inadequately installed retainers No hold of the guard
on the knee joint.
► Ensure that all retainers and closures are properly engaged and/or fastened.
6.1 Customising the shield insert
CAUTION
Painting the shield insert
Falling due to unexpected product behavior caused by changed damping behavior.
► Only use paints that do not contain any electrically conductive particles
and cannot be mag need. This includes paints that are free of metallic
additives (pure synthetic paints).
► In case of doubt, ask your specialist dealer whether the paint contains
additives.
► Ensure that the paints being used have no negative influence on people and
their environ ment.
► Some paints contain solvents that release harmful vapors during processing.
Observe the information provided by the manufacturer.
► The paint is safe after it has dried.
- Clean and degrease the 4P863=4 customizable shield insert (e.g. with Hesse-Signal NV 395).
- Pre-treat the outer surface of the shield insert with a bonding agent for polycarbonates (e.g. Hesse-Signal TG 5250 adhesive primer) according to the processing instructions for the bonding agent.
The bonding agent being used specifies which paint can be used for painting.
INFORMATION: Follow the processing instructions for the chosen paint to obtain optimal painting results.
6.2 Functional Test
INFORMATION
All of the points described in this section must be completed exclusively by
qualified personnel.
After assembly, the following points have to be checked:
- Is the distance between the socket and guard at least 5 mm?
- Is the function of the rotation adapter impaired?
Material may be removed from the guard to improve the functionality.
INFORMATION: If material is removed, the stability/flexibility of the guard on the knee joint may be impaired.
Maintenance
► During the standard inspection of the prosthesis components, also inspect
the product.
7.1 Cleaning and Care
NOTICE
Improper product care
Damage to the product due to the use of incorrect cleaning agents.
► Only clean the product with a damp cloth and mild soap (e.g. 453H10=1-N
Ottobock Der Maclean).
- Clean the product with a damp, soft cloth.
- Dry the product with a soft cloth.
- Allow to air dry in order to remove residual moisture.
Legal information
8.1 Liability
The manufacturer will only assume liability if the product is used in
accordance with the descrip tions and instructions provided in this document.
The manufacturer will not assume liability for damage caused by disregarding
the information in this document, particularly due to improper use or
unauthorized modification of the product.
8.2 CE conformity
Otto Bock Healthcare Products GmbH hereby declares that the product is in
compliance with applicable European requirements for medical devices.
The full text of the regulations and requirements is available at the
following Internet address: http://www.ottobock.com/conformity
8.3 Trademarks
All product names mentioned in this document are subject without restriction
to the respectively applicable trademark laws and are the property of the
respective owners.
All brands, trade names, or company names may be registered trademarks and are
the property of the respective owners.
Should trademarks used in this document fail to be explicitly identified as
such, this does not justi fy the conclusion that the denotation in question
is free of third-party rights.
Technical data
Environmental conditions|
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Storage and transport in original packaging| -25 °C/-13 °F to +70 °C/+158 °F
Storage and transport without packaging| -25 °C/-13 °F to +70 °C/+158 °F
Max. 93 % relative humidity, non-condensing
Operation| -10 °C/+14 °F to +60 °C/+140 °F
Max. 93 % relative humidity, non-condensing
General information|
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Reference number| 4P862
Product service life| Wear part subject to normal wear and tear
Guard weight| 225 g
Appendices
10.1 Symbols Used
Manufacturer
Declaration of conformity according to the applicable European directives
Lot number (PPPP YYYY WW)
PPPP – plant
YYYY – year of manufacture
WW – week of manufacture
References
Read User Manual Online (PDF format)
Read User Manual Online (PDF format) >>