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This device complies with RSS 210 of Industry Canada. 
Operation is subject to the following two conditions: 
(1) this device may not cause interference, and 
(2)  this  device  must  accept  any  interference,  including  interference  that  may  cause  undesired  operation  of  this
device. 

L’ utilisation de ce dispositif est autorisée seulement aux conditions suivantes: 
(1) il ne doit pas produire d’interference et 
(2) l’ utilisateur du dispositif doit étre prêt à accepter toute interference radioélectrique reçu, même si celle-ci est
susceptible de compromettre le fonctionnement du dispositif.

Caution: Exposure to Radio Frequency Radiation.

The installer of this radio equipment must ensure that the antenna is located or pointed such that it does not emit
RF  field  in  excess  of  Health  Canada  limits  for  the  general  population;  consult  Safety  Code  6,  obtainable  from
Health Canada’s website
http://www.hc-sc.gc.ca/rpb.
Responsible party:
Otto Bock Healthcare Canada Ltd.
5470 Harvester Road
L7L 5N5 Burlington, Ontario
Canada
Phone + 1-800-665-3327

Caution: Federal law (USA) restricts this device to sale by or on the order of a practitioner licensed by law of the
State in which he/she practices to use or order the use of the device.

12 Technical data

Ambient conditions

Storage (with and without packaging)

-25 °C/-13 °F to +70 °C/+158 °F
Max. 93% relative humidity, non-condensing

Transport (with and without packaging)

-20 °C/-4 °F to +40 °C/+104 °F
Max. 93% relative humidity, non-condensing

Charging temperature

0 °C/-32 °F to +45 °C/+113 °F

Operation

+5 °C/+41 °F to +40 °C/+104 °F
Max. 93% relative humidity, non-condensing

General information

Reference number

12K100N=*

Weight (dependent on forearm length)

approx. 1000 g

Max. lifting force

50 N

Flexion angle

Approx. 15°–145°

Service life

5 years

Battery of the product

Battery type

Li-Ion

Output voltage

approx. 3.7 V

Charging voltage

approx. 4.2 V

Capacity 

1,880 mAh

Dimensions of battery cells

33.8 x 48.8 x 10.5 mm

Charging  cycles  (charging  and  discharging  cycles)
after which at least 80% of the original battery capacity
remains available

500

Weight

38.5 g (battery without options)

Charging time until battery is fully charged

3.0 h

27

DynamicArm 12K100N

Technical data

Summary of Contents for DynamicArm 12K100N

Page 1: ...DynamicArm 12K100N Instructions for use qualified personnel 3...

Page 2: ...PT INFORMA O Adicionalmente ao manual de utiliza o impresso encontra se inclu do um CD com mais idiomas consultar a contracapa A pedido poss vel encomendar gratuitamente um exemplar impresso do manual...

Page 3: ...ally controlled elbow joint driven by an electric motor It helps the wearer perform everyday tasks in combination with other prosthetic components see Page 5 A Li Ion battery integrated into the produ...

Page 4: ...shes the electrical connection between the product electric wrist rotator and System Electric Hand or System Electric Greifer On delivery the forearm cable is rolled up in the forearm of the elbow joi...

Page 5: ...anatomical replacement for the elbow joint and forearm 3 2 Conditions of use The product is suitable for patients with unilateral or bilateral upper arm amputations The product is intended exclusively...

Page 6: ...WARNING Use of the product while operating a vehicle or machinery Risk of accident due to unexpected behaviour of the product Risk of injury due to faulty control or malfunction of the product Applica...

Page 7: ...Improper use Injury due to loss of product functionality Instruct the patient in the proper use of the product CAUTION Manual unlocking of elbow lock under load Injury by release of elbow lock under...

Page 8: ...erminal device before use so that a slight turn cannot disconnect the terminal device from the prosthesis CAUTION Incorrect donning and doffing of the product Injuries The product should always be fle...

Page 9: ...152 instructions for use qualified per sonnel 1 pc 646D229 instructions for use user 1 pc 646T333 instructions for use qualified per sonnel 1 pc 646D644 service pass Accessories 1 pc strap clamp for U...

Page 10: ...esis should be approx 1 cm shorter than the sound arm 2 Cut the forearm using a vibrating saw 3 Sand all sides of the cut edge at a right angle Smooth inner and outer sanded edges Round the inside edg...

Page 11: ...efully and proceed exactly in the order described INFORMATION Read the relevant material safety data sheets before processing the 636K18 Orthocryl sealing resin compact adhesive and the 617H14 hardene...

Page 12: ...m length For forearm lengths from 225 mm to 213 mm with 10S17 electric wrist rotator Make sure the 10S17 electric wrist rotator dummy is pushed over the cable protector cap This ensures correct axial...

Page 13: ...et head screw 3 Or pull out the lamination ring cover on its own 4 Remove the cable protector cap using the hook 5 The cables are rolled up inside the cable protector cap When removing the cable prote...

Page 14: ...electric wrist rotator Proceed as described above to cut to length and glue in the lamination ring INFORMATION If the foam disc has been glued into place the cables can be pulled out carefully throug...

Page 15: ...de housing with the connected cables into the greased lamination ring It has to engage completely 2 The circuit board and the edge of the lamination ring must be parallel to each other 3 The electrode...

Page 16: ...socket Make sure the friction adjustment screw and lamin ation ring thread recess are applied opposite to each other 3 Set the AFB dial to minimum compensation force 4 Extend the elbow and lock it wit...

Page 17: ...into neutral position no outward or inward rotation 2 Affix the cable guide to the socket with cap screws centred in relation to the strap clamp and approx 30 mm away from the lamination ring CAUTION...

Page 18: ...er arm section of the prosthesis while testing the joint function 4 Position 1 Low compensation that allows natural free swing of the arm while walking Position 2 Compensation increases progressively...

Page 19: ...the three pole connectors is marked with a coloured dot 5 If the two three pole connectors are interchanged when connecting them to the two contacts no func tion of the System Electric Hand or System...

Page 20: ...requency range of 50 60 Hz INFORMATION Please note the corresponding instructions for use of the battery charger 7 1 1 Charging process WARNING Charging the prosthesis without taking it off Risk of el...

Page 21: ...arging the battery We recommend charging the product once a day when used by the patient on a daily basis The battery should be charged for at least 3 hours prior to initial use Note the permissible t...

Page 22: ...s Risk of injury due to sudden flexion of the prosthesis Switch off the prosthesis before donning or doffing The prosthesis must always be flexed for donning and doffing 7 4 Switching modes 7 4 1 Swit...

Page 23: ...stem Electric Gre ifer Control Two electrodes and 4 stage control element Indication For patients with two strong muscle signals Control type Proportional Switching between the components takes place...

Page 24: ...with co contraction Switching to the hand Switching to the elbow joint Switching back Automatically switching back to the hand component takes place five seconds after relaxing the muscles DynamicArm...

Page 25: ...s controlled by the linear control element Switching to the elbow joint Flexion Pull on the linear control element Extension Release of the linear control element 8 Cleaning and Care 1 Clean the produ...

Page 26: ...mation that applies exclusively to specific countries is written in the official language of the respective country of use in this chapter This device complies with part 15 of the FCC Rules Operation...

Page 27: ...ngton Ontario Canada Phone 1 800 665 3327 Caution Federal law USA restricts this device to sale by or on the order of a practitioner licensed by law of the State in which he she practices to use or or...

Page 28: ...Disposal that is not in accordance with the regulations of your country may have a detri mental impact on health and the environment Please observe the instructions of your national authority pertain...

Page 29: ...is present Function is present Very high high low very low Decreasing bat tery charge level No function Function is present Function is present 6 x low Battery charger was connected during opera tion...

Page 30: ...30 DynamicArm 12K100N...

Page 31: ...31 DynamicArm 12K100N...

Page 32: ...ersion SB_2016 10 21 FM483 SB_210x297 Otto Bock Healthcare Products GmbH Brehmstra e 16 1110 Wien Austria T 43 1 523 37 86 F 43 1 523 22 64 info austria ottobock com www ottobock com Ottobock 647G152...

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