C-Leg Prosthetic System
Instructions for Use (Qualified Personnel)
Page 1: ...C Leg Prosthetic System Instructions for Use Qualified Personnel...
Page 2: ...b ock 4X77 D 03 11 11 2R82 Standard Justierbereich 2R81 Torsionseinheit Justierbereich Rohradapter 75 kg Stop 100 kg Stop 136 kg Stop max 100 kg proximale Systemh he 23 mm distale Systemh he 191 mm to...
Page 3: ...13 2 4 Charging the C Leg Prosthesis System 13 2 6 BionicLink Optional Serial Data Cable 15 2 7 C Soft 15 2 8 Optional Parameter Settings with Foam Cover and C Soft 15 2 9 C Leg Modes 16 2 9 1 1st Mo...
Page 4: ...em 2 9 C Leg Modes 2 12 Important User Instructions 3 1 Service Intervals 3 3 Technical Informa tion 3 6 Liability 1 1 Medical Purpose The 3C98 2 and 3C88 2 C Leg knee joints are to be used exclusivel...
Page 5: ...angle and angular velocity of the knee joint These measured variables are transmitted to the microprocessor which then calculates the necessary movement resistance Ser vomotors correspondingly open an...
Page 6: ...t its use The opening and repairing of the joint may only be performed by authorized Ottobock technicians and the handling of the battery may only be carried out by Ottobock Service Centres exchanges...
Page 7: ...se the patient to fall Avoid areas with extreme temperatures see Section 3 3 Technical Information CAUTION Mechanical overloading Exterior mechanical impact or stress such as shocks and vibrations can...
Page 8: ...You may resume your activities once the vibration signals stop If activities are continued despite the vibration signals the hydraulic element may overheat and in extreme cases lead to a damage to th...
Page 9: ...ng a motor vehicle The ability of leg prosthesis users to drive a motor vehicle is determined on a case by case basis Criteria include the type of fitting amputation level unilateral or bilateral resi...
Page 10: ...N Error during alignment of the prosthesis Errors during the alignment of the prosthesis can lead to malfunction of the joint up to loss of function due to structural failure This can cause the patien...
Page 11: ...A This applies to all feet that are recommended for use with the C Leg independently of the specifications in the instruction manuals of those feet Add 5 mm to the required heel height Set correct out...
Page 12: ...fter Bench Alignment 3 mm 1 8 5 CAUTION Error during alignment of the prosthesis Errors during the alignment of the prosthesis can dam age the hydraulic unit of the joint A defective hydraulic unit ca...
Page 13: ...is System INFORMATION Advise your patients of the information in this section 1 2 3 4 CAUTION Incorrect behaviour while charging the joint If the patient walks while the battery charger is connected t...
Page 14: ...charger Battery is being charged Battery capacity is lower than 50 Battery is being charged Battery capacity is above 50 Battery is fully charged or connection with C Leg is interrupted 4 Close plug...
Page 15: ...ly for right side fittings to the C Leg 2 7 C Soft INFORMATION Prior to the parameter adjustment with 4X180 C Soft V2 4 and higher read the corresponding 647G268 Instructions for Use INFORMATION Ottob...
Page 16: ...control The remote control is not waterproof If water penetrates the remote control the device may become damaged guaranty will become void This can lead to malfunction of the remote control result in...
Page 17: ...ep it pressed Fig 1 until the joint confirms the activation with a vibration signal 2 Activation of the 2nd mode Within 3 seconds after activation of the remote control press key 2 and keep it pressed...
Page 18: ...to 2nd mode Activation of the 1st mode 1 short beep signal joint changes from 2nd mode to 1st mode Switching between 1st and 3rd modes without the remote control 2 1 1 2 3 1 second 3 in 1 second 1 Wh...
Page 19: ...driving must be ensured even when the leg prosthesis is not functioning Before operating a motor vehicle make sure to turn off the standing mode feature using the remote control unit The standing mod...
Page 20: ...standing angle can be selected at any time by repeating steps 2a 2b 1st mode remains active Explanation of arrow symbols Flexion Extension Very slow extension Slow extension Quick extension Turning t...
Page 21: ...when getting used to the prosthesis or for a changed gait pattern For safety purposes the damping behaviour can only be slightly changed with the remote control Optimization of the damping behaviour 1...
Page 22: ...g procedures with the remote control have been determined Performing the pairing matching the C Leg to the remote control 1 1 Distance between the remote control and C Leg Hold the remote control at a...
Page 23: ...ctivated there is the risk that the patient will fall If the C Leg does not switch to the safety mode e g because of a short circuit due to water penetration the amputee must actively stabilize the C...
Page 24: ...ary muscular and cognitive abilities to control a freely moving knee joint without stance phase locking If an empty battery was the reason for entering the empty battery mode then the operating mode 1...
Page 25: ...Tube Adapters approx 178 g to 256 g Weight of the 2R81 Tube Adapters approx 438 g to 482 g Max flexion angle approx 125 Operating voltage of the battery charger 100 V to 260 V AC Operating frequency o...
Page 26: ...nufacturer is not liable for damage caused by component combinations that were not authorized by the manufacturer 3 7 CE Conformity The electronic 3C88 2 3C98 2 C Leg Prosthesis System meets the requi...
Page 27: ...C Leg Prosthetic System Ottobock 27...
Page 28: ...ency Radiation This device must not be co located or operating in conjunction with any other antenna or transmitter Responsible party Otto Bock Health Care Two Carlson Parkway North Suite 100 55447 Mi...