Intended Use; Definition Of Terms; General - Ottobock 12K42 ErgoArm plus Instrucciones De Uso

Intended use
Date of the last update: 2015-01-16
• Please read this document carefully.
• Follow the safety instructions and the precautions specified in
this accompanying document.
• If assistance is required during the start-up, use or maintenance
of the product, as well as in the event of unexpected operating
behaviour or circumstances, contact the manufacturer (see manu-
facturer's address on the back of this accompanying document).
Contents
General .................................................................................. 26
Scope of delivery ..................................................................... 29
Laminating the humeral segment ............................................. 29
Sealing with 633F30 special grease and 633F11 Silicone
Grease .................................................................................... 34
Modifying and servicing the forearm ........................................ 36
Removing the elbow joint ......................................................... 36
Removing the AFB ................................................................... 37
Shortening the forearm, positioning the battery box .................. 38
Inserting the AFB ..................................................................... 39
Changing the right-to-left cable orientation ............................. 39
Shortening the control cable ................................................... 41
Inserting the elbow joint ........................................................... 41
Adjustment of preflexion ........................................................... 43
Control harness cable attachment ........................................... 45
Function of the AFB ................................................................. 46
AFB compensation adjustment ................................................ 46
Functional range ...................................................................... 47
Humeral rotation feature .......................................................... 47
12K50 - ErgoArm Electronic Plus ............................................. 48
Annex ....................................................................................... 49
Failure to follow the safety instructions given below can
lead to damage to or malfunction of the product. Follow
the safety instructions and the precautions specified in
this accompanying document.
Only put the product into use in accordance with the information
contained in the accompanying documents supplied. Instruct the
patient in the proper use and care of the product. The product may
not be transferred to the patient without prior instruction.

1 Intended use

1.1 Medical purpose
The ErgoArm 12K42/12K44/12K50 models of elbow-forearm as-
sembly are solely intended for use in upper limb prostheses.
1.2 Application
The ErgoArm 12K42/12K44/12K50 models of elbow-forearm as-
sembly can be used for unilateral or bilateral transfemoral amputees.
The ErgoArm models are solely intended for adults.
1.3 Application conditions
The ErgoArm 12K42/12K44/12K50 models of elbow-forearm
assembly have been developed for everyday life activities and
26 | Ottobock

General

must not be used for unusual activities such as extreme sports (free
climbing, paragliding, etc.).
1.4 Prosthetist qualification
The fitting of patients with the ErgoArm 12K42 / 12K44 / 12K50
models of elbow-forearm assembly may only be carried out by an
authorized prosthetist.

2 Definition of terms

AFB (Automatic Forearm Balance):
Page
When the prosthetic arm is extended, the AFB stores the energy
generated to make flexion easier later on. The complex mechanism
of the AFB controls the dynamic movement of the prosthetic fore-
arm, counterbalancing the weight of the forearm, wrist, and terminal
device via compensation gears. The force that the patient must
generate to flex the elbow is dramatically reduced. The amount of
compensation can be easily adjusted by the patient whenever neces-
sary according to the prosthetic forearm weight and clothing type.
Easy plug:
1 Battery connection
2 CLOSE electrode
3 OPEN electrode
The Easy Plug feature makes it simple to wire externally powered
hybrid prostheses. The electrode, switch, and battery cables are
plugged into the internal elbow cover. Since there are no external
cables, this enhances both the durability and cosmetic appearance
of the ErgoArm.
12K42 ErgoArm plus, 12K44 ErgoArm Hybrid plus, 12K50 ErgoArm Electronic plus
12K42 12K44
ErgoArm Plus ErgoArm Hybrid Plus
12K44 12K50
ErgoArm Hybrid Plus ErgoArm Electronic Plus
2
1
4 Switch
5 Electronics housing
12K50
ErgoArm Electronic Plus
3
4
5