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17B203=* E-MAG Active
Page 1: ...17B203 E MAG Active Instructions for use qualified personnel 3...
Page 2: ...2 17B203 E MAG Active...
Page 3: ...nds the lamination resin or prepreg technique 1 3 Area of application Max body weight kg Without medial support 85 With 17B206 medial support 100 1 4 Indication INFORMATION For further information on...
Page 4: ...on 1 6 Function and design 1 6 1 Function The E MAG Active is a knee joint system with stance phase control which offers the user a free swing phase and locks the knee joint for a secure stance phase...
Page 5: ...lam ination resin or prepreg technique steel or titanium length 130 mm width 16 mm thickness 6 mm bottom and 3 mm top 17B206 medial support identical for left and right steel lamination joint bars for...
Page 6: ...risks of accident or injury NOTICE Warning regarding possible technical damage 2 2 General safety instructions INFORMATION Certification certificate of competence for the E MAG Active is mandatory Wi...
Page 7: ...tivated or manipulated CAUTION Risk of injury during trial fitting We recommend fabricating a trial orthosis in order to verify the functionality and fit of the orthosis before the final orthosis is c...
Page 8: ...ocked orthosis joint Fully extend the knee prior to heel strike NOTICE Risk of damage to electronic components due to installation errors or improper use Incorrect handling of the electronics can caus...
Page 9: ...actory The risk of alignment problems is minimised by this approach Alignment problems can result in failure of the E MAG knee joint system to extend fully so that it cannot be opened and or closed 3...
Page 10: ...lly sand down and smoothen fissures and ridges of the lamination joint bars before laminating the orthosis NOTICE Risk of damage due to improper installation When setting ensure that the bending radiu...
Page 11: ...Casing This section describes how to fabricate a casing for the protection and retention of cables and electronic compon ents First cut the knee joint dummy free see fig 14 14 INFORMATION The marked c...
Page 12: ...oint to the electronics From the electronics to the battery Fasten the dummies of the battery with receptacle and the electronics with receptacle with Plastilin moulding dough Fill the edges between t...
Page 13: ...lectronics with receptacle until the edges are free see fig 21 21 CAUTION Risk of pinching Overlapping sockets may cause the patient to suffer painful contusions when bending the knee The E MAG Act iv...
Page 14: ...mount of hardener Do not add too much hardener since this could cause the resin to form bubbles during hardening and make the connection brittle Bond the receptacle to the casing In order to do so let...
Page 15: ...ttery cable in the battery plug section Leave approximately 5 cm additional cable length to allow for installa tion of the locking unit see fig 30 Ensure proper polarities see fig 31 see fig 32 plus c...
Page 16: ...requent bending can destroy the cables between the joint and electronics and between the battery and electronics If possible do not bend or crease the electronics cable until it is ready to be fastene...
Page 17: ...r for tightening and secure with Loctite 241 NOTICE Risk of damage to electronic components Dust moisture and heat may destroy the electronics Always seal the electronics on the E MAG knee joint befor...
Page 18: ...ocks the joint prior to toe off Prior to heel strike at the end of the swing phase the orthosis knee joint is locked in the extended position so the patient can step down safely In order to determine...
Page 19: ...ntinuous sound Remove and then reinsert the battery 4 1 2 Initial walking in test mode Initial walking attempts see fig 43 should definitely be made between parallel bars or at least with the help of...
Page 20: ...e patient to easily switch the orthosis functions from the inside of the trouser pock et 4 1 4 Positioning of the electronics max 2cm 60 40 compromise pivot point according to Nietert 44 4 1 5 Auto ca...
Page 21: ...points were correctly adjusted during calibration Due to an incorrect patient movement or if the orthosis alignment is not yet optimised the switching points may deviate In acoustic mode an audible t...
Page 22: ...NFORMATION The battery should always be removed when the orthosis is not in use INFORMATION Failure to unlock the knee joint for more than one hour automatically causes the control electronics to swit...
Page 23: ...t not waterproof Use the maintenance schedule see Page 26 as a template for making copies Retain completed maintenance schedules as part of your documentation and advise the customer of the need for r...
Page 24: ...th a short cut off cannula facilitates controlling the dosage INFORMATION The magnet G and the electronics H must not be removed CAUTION Risk of malfunction due to disassembly The actuating bolt I mus...
Page 25: ...fail to start the electronics are defective Check the cable system and contacts Reinsert the battery If the system still does not start replace the electronics with a service set 5 2 2 Lock does not...
Page 26: ...oint 2 Medial support Play in the joint when unlocked Noise Tight connection between bars joint 3 Electronics Cable connections tight and undamaged Plug connections clean and free of oxidisa tion Cont...
Page 27: ...assume liability for damage caused by disregarding the information in this document particularly due to improper use or unauthorised modification of the product 7 2 CE Conformity This product meets t...
Page 28: ...e Version SB_2016 10 21 FM483 SB_210x297 Ottobock SE Co KGaA Max N der Stra e 15 37115 Duderstadt Germany T 49 5527 848 0 F 49 5527 72330 healthcare ottobock de www ottobock com Ottobock 647G1165 en 0...
