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Otto Bock 8E2 Series Instructions For Use Manual
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Otto Bock 8E2 Series Instructions For Use Manual

Otto Bock 8E2 Series Instructions For Use Manual

Speed.hand, wrist.flex, wrist.eqd, wrist.short, wrist.transcarpal
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8E2=* speed.hand, 10V61=1 wrist.flex, 10V62=1
wrist.eqd, 10V63=1 wrist.short, 10V64=1 wrist.trans­
carpal
Instructions for use (qualified personnel) ...........................................................................
3

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Summary of Contents for Otto Bock 8E2 Series

  • Page 1 8E2=* speed.hand, 10V61=1 wrist.flex, 10V62=1 wrist.eqd, 10V63=1 wrist.short, 10V64=1 wrist.trans­ carpal Instructions for use (qualified personnel) ................
  • Page 3 Table of contents General ..........................Product description ....................... Function ......................2.1.1 Wrist joint versions ....................Design ........................ Product combinations ................... Intended use ........................Indications for use ....................Conditions of use ....................Environmental conditions ..................Indications ......................Contraindications ....................Qualification ......................Safety-related information ....................
  • Page 4 Locking/unlocking the wrist (10V61=1) ..............Opening the terminal device manually ..............Relaxed hand position ..................Activating/deactivating the thumb sensor (AutoGrasp, FlexiGrip) ......8.6.1 Operation without control unit ................8.6.2 Operation with control unit ................... Storage .......................... Cleaning ........................Maintenance and repair ....................
  • Page 5 1 General INFORMATION Date of last update: 2025-02-06 Please read this document carefully before using the product and observe the safety ► notices. Instruct the user in the safe use of the product. ► Please contact the manufacturer if you have questions about the product or in case of prob­ ►...
  • Page 6 10V62=1 Wrist with EQD The quick-disconnect wrist (EQD) makes it easy to disconnect the terminal device from the prosthetic socket. The terminal device can be quickly removed if necessary and replaced with another terminal device with the same closure. To change the terminal device, see the section “Changing the terminal device”...
  • Page 7 2.2 Design 1. Fingers 2. Thumb sensor (for variant 8E2=*-1) 3. Thumb 4. ON/OFF button (switching on/off) 5. For 10V61=*: Slider (locking/unlocking the wrist) 6. Wrist Structure of the article numbers Article number Side Size Thumb sensor Description 8E2=* speed.hand Left hand Right hand Size extra small...
  • Page 8 Lamination rings • Lamination ring 10S1=* (for 10V61=1, 10V62=1) • 9S110=50 Lamination ring (included in the scope of delivery for 10V63=1) • 9S110=54 Lamination ring (can be optionally ordered) Active rotation • 10S17 Electric wrist rotator • MyoRotronic 13E205 (for prostheses without control unit) Passive rotation •...
  • Page 9 • Interthoracascapular amputation • Dysmelia with characteristics similar to that of an amputation mentioned • The user must be able to understand usage instructions and safety notices and put them into practice. • The user must fulfil the physical and mental requirements for perceiving optical/acoustic sig­ nals and/or mechanical vibrations 3.5 Contraindications •...
  • Page 10 ► Avoid proximity to sources of strong magnetic or electrical interference (e.g. theft prevention systems, metal detectors). CAUTION! Risk of injury due to malfunction of the product or interference with other electronic devices ► Do not operate the product in the immediate vicinity of other electronic devices. ►...
  • Page 11 7.1.1 Assembling the wrist 7.1.1.1 Preparation 1) Clamp the mounting plate in the vice at the marked surface. 2) Push the system inner hand behind the base plate. 3) Slide the hand into the mounting plate with the square. 4) Set the hook wrench onto the torque wrench so the pin lies against the torque wrench.
  • Page 12 7.1.1.2 Assembling the wrist flexion, EQD (10V61=1, 10V62=1) 1) Set the wrist onto the hand. For flexion: Align the axis between +10 ° and +20 °. Note the alignment of the slider depending on the desired actuating direction. INFORMATION: The specified values are guidelines and do not have to be observed exactly.
  • Page 13 8) For EQD, short: Slide on the foam ring. INFORMATION: The foam ring is included in the scope of delivery in 2 sizes (11S115=49, 11S115=54). It is used to create a harmonious transition between the socket and the hand. For eqd: The size of the foam ring depends on the socket design and hand size.
  • Page 14 The disconnect piece can be rotated by 60° in either direction to insert it into the lamination ring. Marking on the wrist wrist.short When inserting the disconnect piece, align the marking of the disconnect piece with the mark­ ing of the wrist. Arranging the O-ring, starting disc, sliding disc (1) O-ring...
  • Page 15 Overall orientation of the system Align the ulna /radius /(1) axis with the plane of the palm. Align the radius with the thumb as you do so. Align the mark on the disconnect piece (2) with the mark on the wrist (2). INFORMATION: The wrist itself has no specif­...
  • Page 16 4) Apply special grease paste to the sliding disc. 5) Insert the washers into the black sliding washer and press them in. 6) Apply special grease paste to the O-ring. 7) Place the O-ring on the washers. 8) Slide the black sliding washer onto the wrist so the teeth interlock.
  • Page 17 10) Remove the plug cover. 11) A: Connect the cable from the opening contact to the hand cable (1). 12) B: Connect the cable from the closing con­ tact to the hand cable (2). INFORMATION: When using a control unit, the cable from the closing contact is marked with a blue dot.
  • Page 18 19) Hold the socket with your hand. 20) Manually tighten the black friction ring. NOTICE! Damage to the cables and thread → Make sure you do nottwist the socket during tightening. → When tightening by hand, ensure that the threads interlock precisely. →...
  • Page 19 2) A: Connect the cable from the opening contact to the hand cable (1). 3) B: Connect the cable from the closing con­ tact to the hand cable (2). INFORMATION: When using a control unit, the cable from the closing contact is marked with a blue dot.
  • Page 20 7.1.2 Disassembling the wrist (all variants) 1) Clamp the mounting plate in the vice at the marked surface. 2) For wrist 10V61=1: Pull off the flexion guard. 3) For wrist 10V62=1, 10V63=1: Pull off the foam ring. 4) Pull off the prosthetic glove. 5) Slide the hand into the mounting plate with the square.
  • Page 21 6) Set the hook wrench onto the torque wrench so the pin lies against the torque wrench. 7) Loosen the union nut using the torque wrench. 7.2 Assembling the coaxial plug Insert the coaxial plug 9E176 into the coupling crown with the lug facing the recess. Secure the coaxial plug with the lock ring 9E170.
  • Page 22 Article number Designation Contains the following parts 9E169 Coaxial plug • Coaxial plug piece 9E176 • Lock ring 9E170 • Cup screw 501Z49=M4x6 10S4 Coupling piece • Clutch crown • Lock ring 9E170 7.3 Positioning the electrodes The ideal position of the electrodes is determined with the adjustment app and the 757M20-2=* cuff;...
  • Page 23 Attaching the MyoRotronic Left hand Disconnect the motor cable from the electric wrist rotator. Attach the MyoRotronic to the electric wrist rotator so that the no. 1 contacts remain free.  Connect the motor cable to the MyoRotron­ Right hand Disconnect the motor cable from the electric wrist rotator.
  • Page 24 Right hand  Connect the 3-pin cable from the opening contact to the right contact no. 2.  Connect the 3-pin cable from the closing contact to the right contact no. 1. INFORMATION: For the ErgoArm, the cable from the closing contact is marked with a blue dot.
  • Page 25 7.4.3 Overview of connections without control unit Transradial Transhumeral ErgoArm DynamicArm Coaxial plug Electric wrist rotator – – without MyoRotronic Left hand Electric wrist rotator with MyoRotronic Right hand Electric wrist rotator with MyoRotronic Hand cable (for wrist 10V63=1, 10V64=1) 7.5 Operation with control unit The optional control device with a control unit (e.g.
  • Page 26 • Access to further product information 7.5.1 Adjustment app The qualified personnel can carry out the basic product settings using the adjust­ ment app after a successful login in “qualified personnel mode”. These basic set­ tings are part of treatment and can only be adjusted or deleted by qualified per­ sonnel.
  • Page 27 2) For an interchangeable battery system (757B20, 757B21): Remove the battery. 3) Rotate the terminal device once or twice around its own axis until a slight resistance is felt. 4) Overcome this resistance and pull the terminal device off the socket. Attaching the terminal device to the socket 1) Insert the quick-disconnect wrist unit into the lamination ring and press it in firmly.
  • Page 28 2) At the same time, apply some pressure to the thumb sensor (see fig. 1, (1)), e.g. by pressing on the edge of a table. → 2 vibration signals: thumb sensor activated → 1 vibration signal: thumb sensor deactivated 8.6.2 Operation with control unit The thumb sensor can only be activated/deactivated with the adjustment app.
  • Page 29 1) Mount the hand on the assembly tool. 2) Pull off the system inner hand and remove 3) Apply and distribute special grease paste on the inner diameter of the new system inner hand. 4) Pull on the system inner hand. 5) Engage the groove of the system inner hand in the base plate.
  • Page 30 6) Secure the system inner hand with string. 11.2 Replacing the ball bearing retainer Required tools • FSV 765 White special grease paste 633F100=* Spare parts • 509Y1=3 Bearing ball • 11S9 Ball bearing retainer 1) Pry off and remove the ball bearing retain­ 2) Remove the balls.
  • Page 31 5) Snap on the new ball bearing retainer. 6) Use a flat object to press the balls into the ball bearing retainer. 7) Twist the ball bearing retainer several times to distribute the special grease paste. 11.3 For short, transcarpal: Replacing the electronics with cable Required tools •...
  • Page 32 12.3 CE conformity Otto Bock Healthcare Products GmbH hereby declares that the product is in compliance with applicable European requirements for medical devices. The product meets the requirements of the RoHS Directive 2011/65/EU on the restriction of the use of certain hazardous substances in electrical and electronic devices.
  • Page 33 Hand size Weight Length to base plate Length to under­ (with system side of thread inner hand) 368 g 103 mm 111 mm 376 g 107 mm 115 mm 392 g 107 mm 115 mm 425 g 109 mm 117 mm Maximum load on the hand (with wrist) Strength When carrying objects protruding from the hand (e.g. tray: size 120 N 100 x 100 mm) On the fingers from the outside with the hand closed (e.g.
  • Page 34 Recharge­ 757B20 757B21 757B35 =1 757B35 =3 757B35=4 757B35 =5 able bat­ tery refer­ ence num­ Approved 757L20 757L35 battery chargers See labeling on battery Wrists 10V61=1 10V62=1 10V63=1 10V64=1 wrist.flex wrist.eqd wrist.short wrist.tran­ scarpal Weight 115 g 60 g 50 g 40 g Overall installa­...
  • Page 35 observe the instructions of your nation­ WW – week of manufacture al authority pertaining to return and NNN – sequential number collection procedures. Medical device Manufacturer UDI number (Unique Device Identifier) Type BF applied part Article number The product is classified as a type BF applied part from an electrical point of Global Trade Item Number view only.
  • Page 36 Phenomenon EMC basic standard Interference immunity test level test procedure IEC 61000-4-8 Magnetic fields with 30 A/m rated power frequen­ 50 Hz or 60 Hz cies Electrical fast transi­ IEC 61000-4-4 ± 2 kV ents/bursts 100 kHz repetition rate IEC 61000-4-5 Surges ± 0.5 kV, ± 1 kV Line against line IEC 61000-4-6 Conducted interfer­...
  • Page 37 Test fre­ Frequency Radio ser­ Modulation Maximum Distance Interfer­ quency band vice power [W] ence [MHz] [MHz] immunity test level [V/m] 1,720 1,700 to GSM 1800; Pulse modu­ 1,990 CDMA 1900; lation 1,845 GSM 1900; 217 Hz 1,970 DECT; LTE band 1, 3, 4, 25; UMTS 2,450 2,400 to...
  • Page 40 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. Otto Bock Healthcare Products GmbH Brehmstraße 16 · 1110 Wien · Austria T +43-1 523 37 86 ·...

This manual is also suitable for:

10v62 110v61 110v63 110v64 1