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11 Legal information

11.1 Liability

The manufacturer will only assume liability if the product is used in accordance with the descriptions and instruc­
tions 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 unauthorised modification of the product.

11.2 Trademarks

All  product  names  mentioned  in  this  document  are  subject  without  restriction  to  the  respective  applicable  trade­
mark 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 justify the conclusion
that the denotation in question is free of third-party rights.

11.3 CE conformity

This product meets the requirements of the European Directive 93/42/EEC for medical devices. This product has
been classified as a class I device according to the classification criteria outlined in Annex IX of the directive. The
declaration of conformity was therefore created by the manufacturer with sole responsibility according to Annex VII
of the directive.
Hereby,  Ottobock  Healthcare  Products  GmbH  declares  that  the  product  is  in  compliance  with  Directive
2014/53/EU.  The  full  text  of  the  EU  declaration  of  conformity  is  available  at  the  following  internet  address:
www.ottobock.com/conformity
The product meets the requirements under the RoHS Directive 2011/65/EU of the European Parliament and of the
Council  of  8  June  2011  on  the  restriction  of  the  use  of  certain  hazardous  substances  in  electrical  and  electronic
equipment.

11.4 Local Legal Information

Legal information 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 is subject to the following two conditions:
1) This device may not cause harmful interference, and
2) This device must accept any interference received, including interference that may cause undesired operation.
This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part
15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a
residential installation. This equipment generates uses and can radiate radio frequency energy and, if not installed
and used in accordance with the instructions, may cause harmful interference to radio communications. However,
there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harm­
ful interference to radio or television reception, which can be determined by turning the equipment off and on, the
user is encouraged to try to correct the interference by one or more of the following measures:
—Reorient or relocate the receiving antenna.
—Increase the separation between the equipment and receiver.
—Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.
—Consult the dealer or an experienced radio/ TV technician for help.
Any changes or modifications not expressly approved by the party responsible for compliance could void the user’s
authority to operate the equipment.

Caution: Exposure to Radio Frequency Radiation.

This device must not be co-located or operating in conjunction with any other antenna or transmitter.
Responsible party:
Otto Bock Health Care, LP
3820 West Great Lakes Drive
Salt Lake City, Utah 84120-7205 USA
Phone + 1-801-956-2400
Fax + 1-801-956-2401

26

Legal information

DynamicArm 12K100N

Содержание DynamicArm 12K100N

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 30: ...30 DynamicArm 12K100N...

Страница 31: ...31 DynamicArm 12K100N...

Страница 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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