ottobock 8S7, 8S8, 8S9 Passive Inner Hand Instruction Manual

ottobock 8S7, 8S8, 8S9 Passive Inner Hand

INFORMATION

Last update: 2021-05-21

• 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 problems.
• Report each serious incident in connection with the product, in particular a worsening of the state of health, to the manufacturer and to the relevant authority in your country.
• Please keep this document for your records.

Expalantion of symbols

WARNING **** Warnings regarding possible risks of severe accident or injury.

CAUTION Warnings regarding possible risks of accident or injury.
NOTICE Warnings regarding possible technical damage.
INFORMATION ** Additional information on the fitting / use.
INFORMATION**

Please read the Instructions for Use carefully. Pay special attention to the safety instructions!

The scope of delivery is shown on the front page.

Single components

• 8S7=* Inner hand for men
• 8S8=* Inner hand for women
• 8S9=* Inner hand for children
• 8S7=*T Inner hand for partial hand prosthesis for men
• 8S8=*T Inner hand for partial hand prosthesis for women
• 8S9=*T Inner hand for partial hand prosthesis for children

For available sizes refer to the catalogue

Accessories

• 646M3 Colour Pattern Set (for colour determination of the prosthetic glove in case of standard gloves)

• 646M47 Colour Pattern Set (for colour determination of the prosthetic glove in case of Skin Natural gloves)

• 8S4()= Prosthetic Glove

• 8S5()= Prosthetic Glove

• 8S6()= Prosthetic Glove
  Connecting elements for prosthesis hands:

• 10A40 Wrist Connector of Wood

• 10A41 Threaded Stud

• 10R1 Adapter

• 10R4=* Knurled Plate

The accessories are not included. They must be ordered separately.

 Description

Indications for use

The passive prosthesis hands are to be used solely for the exoprosthetic
fitting of the upper extremities in combination with Ottobock arm components.

Field of application

The passive prosthesis hands can be used for any residual limb length from wrist disarticulation and higher amputation level. Inner hand for partial hand prosthesis is to be used for fitting of partial hand amputations.
Thanks to their natural appearance the passive prosthesis hands are preferably used for arm prostheses where the user puts greater emphasis on the outer appearance

Safety instructions

Please forward the following safety instructions to your patients

WARNING

Risk of accident when driving a motor vehicle. The ability of prosthesis users to drive a vehicle is determined on a case-by-case basis. Factors include the type of fitting (amputation level, unilateral or bilateral, residual limb conditions, design of the prosthesis) and the amputee‘s abilities.
All persons are required to observe their country’s national and state driving laws when operating motor vehicles. For insurance purposes, drivers should have their driving ability examined and approved by an authorized test center.
For maximum safety and convenience, Ottobock recommends that, at the very least, a specialist evaluate the need for any adaptations to the car (such as by installing a steering fork, automatic shift). Risk-free driving should be ensured even when the prosthesis is not functioning

CAUTION
Risk of injury as a result of excessive strain. The Ottobock prosthetic components described here have been developed for activities of daily living and must not be used for unusual activities such as extreme sports (free climbing, paragliding etc.).
Careful handling of the prosthesis and its components not only increases their service life but, above all, ensures the patient‘s safety.
Should prosthetic components be subjected to unusual stresses (such as a fall), immediately contact your prosthetist and have the components inspected for any damage. If necessary, the responsible prosthetist will pass the prosthesis on to the Ottobock Service.

NOTICE
Damage due to incorrect environmental conditions. Prosthetic components must not be subjected to intense smoke, dust, vibrations, shocks or high temperatures. Do not allow debris or liquids to get into the prosthesis and its components. Failure to follow these instructions can lead
to malfunctioning and damage of the prosthesis

NOTICE
Damage caused by improper cleaning agents. Do not use any aggresive cleaning agents since they could cause damage to bearings, seals and plastic parts

NOTICE
Limitation of function. Do not use silicone spray when putting on the prosthetic glove on the inner hand or prosthesis! The silicone oil film cannot not dry which would result in instability of the glove on the inner hand, subsequent finger twisting, poor fitting and limited functionality
of the prosthesis.

NOTICE
Damage caused by contact with dyeing materials. Avoid any contact with substances that strongly dye such as print colors, carbon copy paper, ballpoint pen ink etc. Before wearing any new clothes that dye, wash them once or several times according to the manufacturer’s recommendations to prevent from discoloring.

NOTICE
Damage due to contamination. Protect the prosthesis with a protective glove while carrying out household, garden or other activities that cause dirt and dust.

Function

The inner hands are parts of functional components of passive prosthesis hands. They consists of an inner hand and a prosthesis glove of appropriate size. The standard inner hands are fabricated of molded foam. It provides a high stability at low weight. The steel wire reinforcement in the inner hands for adults allow for correction of the finger position to a limited extent. As for inner hands for children, this function is only available in larger hands.
The passive prosthesis hand are universally applicable thanks to various
attachment options
Actual measurements of all inner hands differ from those shown, as they are reduced by the wall thickness of the cosmetic glove. If the inner hand is to be used for a partial hand replacement a „T“ must be added to the article number for ordering (e.g. 8S8=165x72LT).

Handling

Inner hand/Prosthetic glove selection

The size of the prosthetic glove is determining for inner hand selection. The inner hand with the prosthetic glove of the corresponding size form functional unit of the passive prosthesis hand

Example: The prosthetic glove such as 8S5 of the certain size can only be combined with an 8S8 Inner Hand of the size of the selected glove. In case of changing the prosthetic glove size, the inner hand size must also be changed accordingly.
The inner hands for partial hand prosthesis are fabricated without steel wire reinforcement. Therefore, they are individually adaptable.
The inner hands for children with metacarpal circumference <150 mm are fabricated without steel wire reinforcement. However, as standard inner hands have different material properties than inner hands for partial hand prosthesis, the inner hand for partial hand prosthesis must always be used for the fitting of the partial hand amputations

Assembly

The application of the moderate layer of 633S2 Procom fort Gel on the inner hand facilitates the donning of the prosthetic glove on the inner hand. Do not use silicone spray (see notice in Section 2.3) or coloured substances (such as disinfectants). The colour pigments may migrate into the glove or inner hand and cause discoloration
To avoid damaging, use the 711M1 Hand Holding Tool while pulling on the glove. The 711M2 Mounting Plate is used for attaching the Hand Holding
Tool to a workbench. For more information about the assembly of the prosthetic glove please refer the instructions for use of the particular glove type.
Use the 10A40 Wrist Connector of wood for attaching the inner hand to the forearm shell. Use the 10A41 Threaded Stud for attaching the inner hand to wrist units without ratchet.

Care

No special care or maintenance are required for the inner hands for passive prosthetic hand.
For information on cleaning the prosthetic glove please refer to the instructions for care enclosed with the glove.

Legal information

All legal conditions are subject to the respective national laws of the country of use and may vary accordingly.

Liability

The manufacturer will only assume liability if the product is used in accordance with the descriptions and instructions provided in this document. The manufacturer will not assume liability for damage caused by disregard of this document, particularly due to improper use or unauthorised modification of the product.

CE conformity

The product meets the requirements of Regulation (EU) 2017/745on medical devices. The CE declaration of conformity can be downloaded from the manufacturer‘s website

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