Technical Data; Symbols On The Product - Ottobock 12K42 ErgoArm plus Instrucciones De Uso

Safety instructions
ist will pass the prosthesis on to the Ottobock Myo-Service.
• Take special care when lifting heavy loads! Be careful when
unlocking the lock under such conditions due to the possibil-
ity of injury.
• Ensure that neither solid particles nor liquids can penetrate
the ErgoArm.
• The ErgoArm should not be subjected to intense smoke, dust,
mechanical vibrations or shocks, or extreme heat.
• Inform the patient that the ErgoArm is to be cleaned with a damp
cloth and mild soap only. Do not use solvents such as acetone
or benzene as these can make the plastic brittle.
• The electronic components may malfunction in the vicinity of
high-tension power lines, transmitters, transformers or other
sources of strong electromagnetic radiation (such as security
systems for goods in department stores). To reduce this risk,
the electrodes should be set to as low a sensitivity as possible.
• In case of malfunction, which could endanger the patient´s
safety, the system should be turned off by removing the bat-
tery. The ErgoArm ElectronicPlus can be locked and unlocked
when it is turned off by pulling the control cable mechanically.
• The ErgoArm as well as damaged components of the ErgoArm
may be opened or repaired only by the certified Ottobock
Myo-Service.
• Should the malfunction persist, please contact the certified
Ottobock Myo-Service.
• Risk of pinching where the elbow joint bends. Ensure that
fingers and other body parts are not in this area when
bending the elbow joint.
These products may not be disposed of with household
waste in some jurisdictions. Disposal that is not in accord-
ance with the regulations of your country may have a det-
rimental impact on health and the environment. Please ob-
serve the information provided by the responsible authorities
in your country regarding return and collection processes.
Attention!
Car driving capability
The question of the ability of the amputee with an upper
limb prosthesis to drive a car does not have a simple
answer: It depends on the type of prosthetic fitting (am-
putation height, uni- or bilateral, residual limb conditions,
prosthesis type) as well as the individual capabilities of the
upper limb prosthesis user. All persons are required to ob-
serve their country's national and state driving laws when
operating vehicles. For insurance purposes, drivers should
have their driving ability examined and approved by an
authorized test center. In general, Ottobock recommends
that the vehicle is adapted by a specialist-manufacturer
to fit specific needs of the user (e.g. palm grip) so as to
ensure risk-free driving. It is indispensable to ensure that
the driver is able to operate the vehicle without any risk.
Caution!
Before an ErgoArm with a quick-disconnect wrist can be
used, the terminal device must be positioned in such a
way that a slight turn of it cannot disconnect the terminal
device from the prosthesis!
Notice
Distance to communication devices. If the distance to HF
communication devices (e.g. mobile phones, Bluetooth devices,
WiFi devices) is too small, interference with internal data com-
munications can result in unexpected prosthesis behaviour.
28 | Ottobock
The battery can be located either in the forearm socket (connected
to the forearm cable) or in the humeral socket (connection via Easy
Plug). It is forbidden to use both connection options simultaneously
due to safety reasons.

5 Technical data

Maximum load capacity:
Maximum flexion angle:
Storage temperature:
Operating temperature
Storage and transport tempe-
rature in packaging:
Storage and transport tempe-
rature without packaging:
Service life of the elbow joint:

6 Symbols on the product

7 Liability
Otto Bock Healthcare Products GmbH, hereafter referred to as
manufacturer, assumes liability only if the user complies with the
processing, operating and maintenance instructions as well as the
service intervals. The manufacturer explicitly states that this product
may only be used in combination with components that were author-
ized by the manufacturer (see instructions for use and catalogs).
The manufacturer does not assume liability for damage caused by
component combinations which it did not authorize.
The product may only be opened and repaired by authorized Ot-
tobock technicians.
8 CE Conformity
This product meets the requirements of the 93/42/EWG guidelines
for medical products. This product has been classified as a class I
product according to the classification criteria outlined in appendix IX
of the guidelines. The declaration of conformity was therefore cre-
ated by Ottobock with sole responsibility according to appendix VII
of the guidelines.
12K42 ErgoArm plus, 12K44 ErgoArm Hybrid plus, 12K50 ErgoArm Electronic plus
Therefore, keeping the following minimum distances to these
HF communication devices is recommended:
• Mobile phone GSM 850/GSM 900: 0.99 m
• Mobile phone GSM 1800/GSM 1900/UMTS: 0.7 m
• DECT cordless phones incl. base station: 0.35 m
• WiFi (routers, access points,...): 0.22 m
• Bluetooth devices (third-party products not approved by
Ottobock): 0.22 m
Notice
When operating the product in the immediate vicinity of active,
implantable systems (e.g. pacemakers, defibrillators, etc.), en-
sure that the minimum distances stipulated by the manufacturer
of the implant are observed. Interference with active, implant-
able systems may occur due to the electromagnetic radiation
emitted by the product. Furthermore, make sure to observe any
operating conditions and safety instructions stipulated by the
manufacturer of the implant.
12K44 12K50
ErgoArm Electronic plus
ErgoArm Hybrid plus
Declaration of conformity according to the European Directive
for Medical Devices 93/42/EEC and 1999/5/EC.
Approx. 60 N
Approx. 15° – 145°
-10° – 60°C
5° – 40°C
-25 ° – +70 °C
-25 ° – +70 °C
5 years