Otto Bock 8E70 Series Instructions For Use Manual
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Also See for 8E70 Series:
- Instructions for use manual (388 pages) ,
- Instructions for use manual (16 pages)
Related Manuals for Otto Bock 8E70 Series
Summary of Contents for Otto Bock 8E70 Series
- Page 1 8E70=*, 8E71=*, 8E72=* Instructions for use (qualified personnel) ................
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Page 3: Product Description
Only put the product into use in accordance with the information contained in the accompanying documents supplied. According to the manufacturer (Otto Bock Healthcare Products GmbH), the patient is the operat or of the product according to the IEC 60601-1:2005/A1:2012 standard. - Page 4 2.2.1 Grips Moving the thumb from the lateral to the opposition position 1) Firmly grasp the base of the thumb with the free hand. 2) Apply controlled pressure to push the thumb inwards until it is opposite the palm. Moving the thumb from the opposition to the lateral position 1) Firmly grasp the base of the thumb with the free hand.
- Page 5 Finger adduction By spreading the fingers, a flat, thin object (< 3 mm/< 0.12 inch) can be held between the finger joints when closing the hand. Spreading the fingers is most effective with the power grip. It can also be used with the key grip and finger point. This grip cannot be selected in the adjustment software.
- Page 6 Grips with the thumb in the lateral position (the thumb is sideways to the palm) Column grip The thumb closes towards the palm, then the remaining fingers bend over the thumb. In doing so, the thumb blocks the closing movement of the index finger and lets it protrude beyond the other three fingers.
- Page 7 Relaxed hand position The thumb is in the lateral position and closes partway towards the palm. All fingers assume a slightly flexed position. When the close signal is repeated, the fingers move to form the hook grip. Application examples: this grip is recommended when the hand is not being actively used.
- Page 8 Opposed primary grips Opposed secondary grips • Default: tripod grip • Default: active index grip • Alternative: power grip • Alternative: tripod grip Lateral primary grips Lateral secondary grips • Default: key grip • Default: column grip • Alternative: finger point •...
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Page 9: Intended Use
2.2.6 Unlocking/locking the wrist joint (8E72=*) The individual flexion and extension of the wrist joint can be locked in five different positions (in 20° increments each). 1) Press the release button in the direction of the arrow. 2) Move the terminal device to the desired position while holding the release button. - Page 10 3.5 Qualification The fitting of a patient with the product may only be carried out by O&P professionals who have been authorised with the corresponding Ottobock training. 4 Safety 4.1 Explanation of warning symbols Warning regarding possible serious risks of accident or injury. WARNING Warning regarding possible risks of accident or injury.
- Page 11 WARNING Use of the product while handling a firearm. Injury due to unexpected product behaviour. ► The product may not be used for handling firearms. WARNING Skin contact with leaking lubricants due to mechanical defects Injury due to skin irritation. Avoid contact between leaking lubricants and the mouth, nose and eyes.
- Page 12 If the interference cannot be eliminated or if you do not achieve the expected results by ► adjustment or selection of the appropriate control programme, please contact the Ottobock branch responsible for your country. CAUTION Prosthesis use when battery charge level is too low Injury due to unexpected prosthesis behaviour Check the current charge level before use and charge the prosthesis if required.
- Page 13 The electrodes are to be placed on intact skin only and with as much electrode-skin contact ► as possible. In the case of strong interference from electronic devices, the position of the electrodes should be checked and changed if necessary. If the interference cannot be elim inated or if you do not achieve the expected results by adjustment or selection of the appro...
- Page 14 Check the product for visible damage before each use. ► CAUTION Improper use Injury due to faulty operation or malfunction of the product. Instruct the patient in the proper use of the product. ► CAUTION Improper product care > Injuries due to faulty control/malfunction of the product or damage to the mechanical com ponents >...
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Page 15: Scope Of Delivery And Accessories
Do not expose the product to sources of high heat (fire, stovetop, space heater, radiator ► etc.). Do not grasp or hold any red-hot objects with the product. ► CAUTION Unintentional unlocking of the terminal device Injury due to releasing the terminal device from the forearm (e.g. while carrying objects). When connecting the hand to the prosthetic socket or components, ensure that the connec... -
Page 16: Preparing The Product For Use
• 13E520=* Myo Plus TR Prosthetic glove • 8S710=* prosthetic glove • 8S711=* prosthetic glove 6 Preparing the product for use 6.1 Charging the battery The following information is found in the instructions for use of the respective batteries or elbow components: •... - Page 17 6) Mount the terminal device on the socket, turn on the energy supply and set the new contact point of the thumb with the index finger (pinch grip) and the index and middle fingers (tripod grip). 7) By closing and opening the terminal device, check the new contact point of the thumb with the index finger (pinch grip) and the index and middle fingers (tripod...
- Page 18 5) Turning the Allen key clockwise moves the thumb towards the palm (reducing the dis tance). Turning the Allen key counterclockwise moves the thumb away from the palm (increasing the distance). INFORMATION: The effect of the rota tion movement applies for both the right and left bebionic hands.
- Page 19 6.4 Donning the prosthetic glove INFORMATION Do not use silicone spray when putting on the prosthetic glove. This impairs the secure fit of the glove and can limit the functionality of the product (hand). Observe the instructions for use provided for the prosthetic glove and the process for putting it on and taking it off described in the same.
- Page 20 Attaching the terminal device to the socket 1) Insert the quick-disconnect wrist unit into the lamination ring and press it in firmly. 2) Turn the terminal device slightly to the left or right. 3) Verify proper attachment by pulling on the terminal device. INFORMATION Please see the 646T332 technical information for proper handling with the lamination ring.
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Page 21: Cleaning And Care
7.5 Switching between default and alternative grips Switching between the default and alternative grip can be carried out as follows, depending on the selected mode: • Mode 0: program switch • Modes 1 through 4: with another open signal after fully opening the hand •... -
Page 22: Maintenance And Repair
3) Dry the product with a lint-free cloth and allow it to air dry fully. INFORMATION The hand can be cleaned three times per day on average. INFORMATION When using a prosthetic glove, note the cleaning information in the instructions for use for the prosthetic glove. -
Page 23: Legal Information
8) Insert the conical fixation pin from the right side. NOTICE! The fixation pin can only be inserted from the RIGHT side (due to the conical shape of the fixation pin). 9) Use flat nose pliers to press the fixation pin into the bore. - Page 24 10.3 CE conformity Otto Bock Healthcare Products GmbH hereby declares that the product is in compliance with applicable European requirements for medical devices. This product meets the requirements of the 2014/53/EU directive.
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Page 25: Technical Data
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... - Page 26 bebionic hand EQD bebionic hand Short bebionic hand Flex General information Wrist Opening width 75 mm (between index finger and opposed thumb) – – -40° to +40° in 20° incre Extension/flexion of the ments wrist Service life 5 years Behaviour of the ter The terminal device has no function minal device during charging...
- Page 27 bebionic hand bebionic hand small medium Max. hand width 122 mm 136 mm Hand length includ 162 mm 188 mm ing fingers Finger length 75 mm 91 mm 12.2 Symbols Used Manufacturer Type BF applied part Compliance with the requirements according to "FCC Part 15" (USA) Compliance with the requirements under the "Radiocommunications Act"...
- Page 28 Serial number (YYYY WW NNN) YYYY – year of manufacture WW – week of manufacture NNN – sequential number Article number Medical device Protect from moisture 12.3 Operating states/error signals The prosthesis indicates operating states and error messages through beeps and vibration sig nals.
- Page 29 Beep signal Vibration signal When Signal can be Function deactivated 4x short 4x short After successful The configuration data exchange was transferred with the PC from the adjust ment software to the terminal device Long for Long for During product Fault, the product 3 seconds 3 seconds...
- Page 30 IEC 61000-4-8 Magnetic fields with 30 A/m rated power frequen 50 Hz or 60 Hz cies *) Tests conducted Electromagnetic interference immunity Phenomenon EMC basic standard Interference immunity test level test procedure Electrostatic dis IEC 61000-4-2 ± 8 kV contact charge ± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV air, IEC 61000-4-3 High-frequency elec...
- Page 31 Test fre Frequency Radio ser Modulation Maximum Distance Interfer quency band vice power [W] ence [MHz] [MHz] immunity test level [V/m] 704 to 787 LTE band 13, Pulse modu lation 217 Hz 800 to 960 GSM 800/90 Pulse modu lation TETRA 800, 18 Hz iDEN 820, CDMA 850, GSM 800/90...
- Page 32 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 ·...
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