Steeper Espire Elbow Pro & Hybrid Instruction Manual Download Page 65

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Espire Elleboog Pro & Hybrid van Steeper Group, distributeur Loth Fabenim B.V.

Espire

Elbow Pro & Hybrid Instruction Manual - For Prosthetists

Intended Use and Safety

Definitions of symbols used in this device and its packaging

Symbol

Definition

Source

Consult instructions for use.

BS EN ISO 15223-1:

2012 Reference no. 5.4.3

Keep dry.

BS EN ISO 15223-1:

2012 Reference no. 5.3.4

This product contains electrical and

electronic components that may contain

materials which, if disposed with general

waste, could be damaging to the

environment. Residents of the European

Union must follow specific disposal or

recycling instructions for this product.

Residents outside the European Union

must dispose or recycle this product in

accordance with local laws or regulations

that apply.

IS EN 50419:2006

Reference no. Fig. 1

Caution: Federal (USA) law restricts

this device to sale by or on the order

of a physician.

USA Code of Federal

Regulations

21 CFR Part 801 §

801.109(b)(1)

Refer to instruction manual/booklet.

IEC TR 60878 Ed.

3.0 b:2015

The requirements for accreditation

and market surveillance relating to

the marketing of products; Medical

Device Directive.

765/2008/EC

768/2008/EC

MDD 93/42/EEC

Articles 4,11,12,17,

Annex II )

Type BF applied part.

IEC 60601-1

IEC 60878

ISO 9687:2015

Reference no. 5334

Temperature limit.

ISO 15223-1

Reference no. 5.3.7

Storage humidity range.

ISO 15223-1

Reference no. 5.3.8

Summary of Contents for Espire Elbow Pro & Hybrid

Page 1: ...EspireTM Elbow Pro Hybrid Instruction Manual for Prosthetist Distributeur Distributeur ...

Page 2: ......

Page 3: ...eedback Motor 20 3 5 Connecting Cables to the Input Board 20 3 6 Strain Relief Disc 21 4 AC Myo Elektrodes with TruSignalTM Technology 23 4 1 Electrode Overview 23 4 2 Electrode Kits 24 4 3 Electrode Placement 25 4 4 Electrode Installation Instructions 27 5 Pattern Recognition 28 5 1 Pattern Recognition Overview 28 5 2 Coapt COMPLETE CONTROL System Gen2 28 5 3 Infinite Biomedical Technologies IBT ...

Page 4: ...9 The Lmanination Collar and Clamp Ring 46 9 1 Orientation of the Lamination Collar and Clamp Ring 46 9 2 Internal External Rotation 47 9 3 Attaching the Lamination Collar to the Elbow 47 9 4 Determining Proper Orientation on Test Socket 48 9 5 Final Adjustment with the User 48 10 Forearm Cable Lift Kit Hybrid 49 10 1 Cable Mounting Overview 49 10 2 Setting Up the Cable Mounting 49 10 3 Terminal E...

Page 5: ...ication to maintenance and care of the Espire Elbow system Read these instructions carefully and educate the end user on all functions of this product before final delivery If you have any questions concerns or comments please contact us at 31 30 27 32 506 or by email sales lothfabenim nl The Espire Elbow is a state of the art internally powered myoelectric elbow prosthesis The Espire Pro uses ele...

Page 6: ...eboog Pro Hybrid Instruction Manual For Prosthetists 6 System Overview 1 1 2 Anatomy Strain Relief Disc Lamination Collar Drive Unit Input Connector Board LED Indicator Forearm Haptic Feedback Motor Forearm Cable Lift Kit Hybrid Only optional Battery Battery Cover Lamination Clamp Clamp Ring ...

Page 7: ...r with Adapter Forearm Cable Lift Kit Hybrid only optional extra Instruction Manuals Espire Elbow Quick Setup Guide Espire Elbow Technical Manual Espire Elbow User Manual Hardware Espire Elbow Fabrication Instructions Espire Elbow Hub App Instructions Note All manuals are available at lothfabenim nl Powering on the Espire Elbow Power Button MEDIAL LOCATION The power button is located on the medial...

Page 8: ... Espire Elbow will emit a Bluetooth signal for 2 minutes after the battery is installed and the elbow is powered on during which time it can be paired with the Hub App software Bluetooth signal is ONLY sent when the elbow is power cycled the battery is removed and re installed Once a Bluetooth connection is established the LED indicator will display a blue light while paired Note For information o...

Page 9: ...trol 5 135 Speed preset control 135 sec Max Cable Length AC Electrode Cable 609 mm Mode of Operation Continuous Connections Inputs 12 Outputs 4 Device Operation Internally Powered Battery Removable Smart Li Ion 10 8 V 3 000 mAh 32 WI Time to Full Charge 3 5 hours Voltage Elbow 11 1 V nominal Voltage Hand 7 4 V regulated Charger 100 250 VAC 24 V 2 5A DC Wireless Connection Bluetooth 4 2 Maximum Spe...

Page 10: ... for 15 minutes before using IP Rating IP22 Protected from touch by fingers and objects greater than 12 millimetres Protected from water spray less than 15 degrees from vertical Manufacturer Product Steeper Group All Steeper Myoelectric Hands Ossur iLimb hands OttoBock Bebionic hand Electric Greifer Electronic Wrist Rotator SensorHand Speed Other Ottobock Myoelectric Hands Taska Prosthetics Taska ...

Page 11: ...and the frequency of use The batteries are shipped with a partial charge up to 30 We recommend charging both batteries to 100 upon receipt of the Espire Elbow system based on average use during an 8 hour period Caution Use only the Steeper Group manufactured Espire Elbow battery pack and the provided battery charger with the Espire Pro and Hybrid systems Always follow the manufacturer s instructio...

Page 12: ...y Installation and Removal Batteries can be removed and replaced as necessary To remove the battery simply push the battery cover clip and gently lift it off the elbow Use the pull tab to remove the battery Installing a battery is the reverse process Insert the battery into the elbow ensuring that the pull tab is accessible for future removal Then apply the battery cover The battery cover clip wil...

Page 13: ...urrent battery The Espire must be powered on to use this feature Press the power button for one second to activate the LED indicator light on the forearm The number of blinks indicates the state of the charge Feature Description Power Button Press and hold for 1 second to indicate the battery status Elbow LED Indications Battery Colour Indicator Battery Status 4 Green Blinks 100 Charged 3 Green Bl...

Page 14: ...harger is recommended for daily use and will assure that the battery will receive a full charge and provide maximum running time There are two charger types single bay or dual bay and three power adapter options US UK or European to match the needs of different regions There is also a car charger available Caution Using a different AC adapter than the one provided with the battery charger may caus...

Page 15: ... using the cable supplied 2 If the battery you wish to charge is inside of the Espire Elbow it must first be removed from the battery compartment Remove the battery cover via the clip and remove the battery by using the pull tab 3 Place the battery into the battery bay ensuring that the 5 way connector is fully seated The LEDs in the status window will provide status information and the charger wi...

Page 16: ...y see section 4 Linear Transducers Touch Pads DC Cased Electrodes requires Espire input cable Note Input components from other manufacturers will require a unique wire harness and must be installed and tested by Steeper Group prior to delivery Other Manufacturers Switches Single State Dual State Bump etc requires Espire input cable Remote Power Switches Items Not Listed Contact Steeper Group for c...

Page 17: ...ewed in the Espire Hub App under the diagnostics tab Espire Hub App System Settings Diagnostics Connections The table adjacent lists the location the type of connection that can be used and its setup type Note The image below is shown with the TruSignal circuit board installed which includes connections A D for use with TruSignal AC electrodes This board is only factory installed when specified du...

Page 18: ...11 13 12 2 3 4 9 10 6 5 8 7 Input Connector Board Inputs 3 Board Location Input Option Setup Type TruSignal AC Electrodes 1 site or 2 sites TruSignal AC Electrodes w TMR 4 sites TruSignal AC Electrodes w TMR 6 sites DC Electrodes DC Electrodes w TMR Linear Transducer Touch Pads Switches Any combination up to 9 inputs Remote Power Switch 1 input Shoulder Lock Unlock 1 input Auxiliary Port Haptic Fe...

Page 19: ...res during the order fulfillment process to identify the input type and its location on the input board Board Location Input Type Colour AC Pair 1 Red AC Pair 2 Orange AC Pair 3 Yellow AC Pair 4 Green AC Pair 5 Blue AC Pair 6 Purple AC Grounds White Linear Transducer Purple Touchpads Yellow Green Stripe DC Electrodes Blue Remote Power Switch Black Shoulder Lock Output Grey Haptic Feedback Output B...

Page 20: ...ptic feedback motor plug the cable to the input board port 13 like any other connector 3 5 Connecting Cables to the Input Board 1 Apply silicone grease to the plug connectors before inserting into the board 2 When attaching cables note the proper orientation The connectors are keyed or asymmetrical to assure proper alignment The connector should plug in easily and is held in place with friction 3 ...

Page 21: ...ie Cut excess zip tie material ensuring no sharp edges remain This is necessary to prevent accidental wire disconnection figure 1 figure 2 figure 3 S I L I C O N E R T V Figure 4 Sealing the Input Board 1 Apply a small amount of silicone grease at the perimeter seal between the disc and the ring 2 Line up the fastener holes on the disc to the mounting threads on the input board then gently press t...

Page 22: ...bbon through the slotted hole of the disc then attach the connector to the board 2 Insert the EMG Interface Cable connector through the matching shape on the disc then attach to the board 3 Fasten the wires to the strain relief disc using the two provided zip ties This is necessary 4 to prevent accidental wire disconnection twisting and damage 5 Use two M2 x 5mm fasteners and washers to secure the...

Page 23: ... technology a unique process for buffering a signal immediately sending it to the microprocessor and then amplifying it The benefit of amplifying the signal later in the process is that it results in a cleaner and clearer signal than other electrode options The result is better slow speed control of the elbow and its accessories How it Works 1 TruSignal board located directly at the electrode clea...

Page 24: ...tes 1 site 2 site 4 site 6 site wire length 6 in 12 in 24 in and dome size paediatric medium large TruSignal AC Electrode Kit Part Numbers PART ID MYO SITES WIRE LENGTH DOME SIZE CP TLE 1 2 4 6 06 12 24 P M L Example Part Number CPE TLE 212 M TruSignal AC Electrode Kit 2 Site 12 in Medium Dome The remote metal electrodes are Cavity Backed for use with the electrode kits and snap onto the TruSignal...

Page 25: ...ric applications Large Medium Paediatric AC MYO Electrodes with TruSignalTM Technology 4 4 3 Electrode Placement Since the electrodes are independent the clinician can place these where they want in the socket Each site has two active electrodes In general each pair of electrodes should lie along the longitudinal axis of the muscle with an edge to edge spacing of not more than 1cm An additional pa...

Page 26: ...des with TruSignalTM Technology 4 Example 2 Site Myo Placement Transhumeral Electrode Type Location AC Pair 1 Bicep AC Pair 2 Tricep AC Grounds Away from muscle signal Electrode Type Location AC Pair 1 Pectoralis Major AC Pair 2 AC Pair 3 AC Pair 4 AC Pair 5 Example 6 Site Myo Placement TMR Shoulder Disarticulation AC Pair 6 AC Grounds Away from muscle signal ...

Page 27: ...post of the electrode dome through the inside of the socket The dome should be inside of the socket where it will contact the residual limb 3 Place the nut snap onto the post of the electrode dome and hand tighten Use the provided hex driver CP HXD to tighten snugly 4 Use a pair of wire snips to trim the post The post should not protrude beyond the snap when secured in place 5 Snap the electrode b...

Page 28: ...COMPLETE CONTROL System Gen2 Kit Types for COMPLETE CONTROL System Gen2 Espire Pro with standard grip Espire Pro with advanced grip Espire Hybrid with standard grip Espire Hybrid with advanced grip The COMPLETE CONTROL Gen2 must be ordered directly from Coapt but will ship from Steeper Group The Coapt circuit board will be pre installed to the Espire Elbow input connector board and the systems wil...

Page 29: ...ection that can be used and its setup type 8 5 6 7 11 12 13 3 2 1 10 9 4 B A INPUT CONNECTOR BOARD WITH COAPT CIRCUIT BOARD Board Location Input Option Setup Type EMG Interface cable 8 sites COMPLETE CALIBRATE Button 1 input Touch Pads Switches Any combination up to 9 inputs Remote Power Switch 1 input Shoulder Lock Unlock 1 output Advanced Grip Control 1 output Haptic Feedback 1 output A B 1 9 10...

Page 30: ...d shipped directly from IBT The IBT circuit board will be pre installed to the Espire Elbow input connector board and the systems will be tested together before delivery to the customer The circuit board is designed to fit the Sense Controller Cable and advanced grip control cable if specified IBT Circuit Board for Espire Pro and Hybrid Espire Elbow will be shipped with the configuration specified...

Page 31: ... the location the connection that can be used and its setup type 8 5 6 7 11 12 13 3 2 1 10 9 4 A INPUT CONNECTOR BOARD WITH IBT CIRCUIT BOARD Board Location Input Option Setup Type Sense Controller 8 sites Touch Pads Switches Any combination up to 9 inputs Remote Power Switch 1 input Shoulder Lock Unlock 1 output Advanced Grip Control 1 output Haptic Feedback 1 output A 1 9 10 11 12 13 ...

Page 32: ... connects to the input board 6 2 Routing Cables Through the Exoskeletal Shoulder Joint In the exoskeletal version both input and output wires are routed through a channel between the yoke plate and the humeral plate Lock output wire To electrodes switches etc To input board 1 A hole entering the socket must be provided for the Axis output wire 2 Input wires travel from the input control electrodes...

Page 33: ...er joint down outside of pylon to elbow input board 3 Fasten cables to pylon with tape 4 Insert cables through one of two openings on the endo adapter 5 Attach cables to input board In the endoskeletal version both input and output wires are routed through the centre of the shoulder joint To electrodes switches etc Lock output wire To input board Axis Shoulder Joint Side View Info For more informa...

Page 34: ...ow A removable sticker is applied to the forearm to reference the maximum cut area MAX CUT AREA 3 2 8 7 1 4 5 6 MAX SNIJGEBIED Dimension Measured From Small Standard Diameter Wrist 45 mm 50 mm Diameter Upper Arm Connection 70 mm 70 mm Minimum Build Height Residual Limb to Elbow Centre 48 mm 48 mm Overall Length Elbow Centre 248 mm 273 mm Minimum Length w rotator Elbow Centre 222 mm 225 mm Minimum ...

Page 35: ... board Measuring and Cutting Forearm 7 Note Foam insert must be in place prior to cutting the forearm and completing wrist fabrication Failure to use the insert will damage the Espire Elbow 7 3 Cutting the Forearm to Length 1 Measure the desired length of the forearm 2 Cut the forearm preferably with a band saw 3 Continue with wrist fabrication section 8 Note It is important to avoid subjecting th...

Page 36: ... wrist options The wrist type must be specified at the time of ordering Non Powered Wrists Type Manufacturer Small Elbow Standard Elbow Quick Disconnect Wrist Steeper Group QD Wrists from other manufacturers also compatible 45 mm wrist 50 mm wrist Powered Wrists Type Manufacturer Small Elbow Standard Elbow Standard Electronic Wrist Rotator Motion Control n a 50 mm wrist 10S17 Electronic Wrist Rota...

Page 37: ...ard of the Espire Elbow They can easily be retrieved from inside of the forearm and connected to the desired device The wires will be colour coded and simply need to be plugged into the appropriate terminal device Wires that are not needed can be tucked away into the forearm See section 8 6 for output wires with pattern recognition systems Colour Output Type Orange Hand Open Green Hand Close Grey ...

Page 38: ...er s instructions for more detailed fabrication and assembly information Wiring Connector Orientation The curve of the socket connectors should face inward toward the centre of the wrist 1 Insert the orange hand open cable into the left pins labeled 2 2 Insert the green hand close cable into the right pins labeled 2 3 Insert the red power cable into the pins labeled 1 1 2 2 Caution Do not insert t...

Page 39: ...1 mounting screw Verify the rotator does not contact the distal end of the Espire control board 2 Remove and separate the rotator from the lamination collar 3 Bond the lamination collar into the forearm of the Espire Elbow before installing the electronic wrist rotator Refer to the manufacturer s instructions for more detailed fabrication and assembly information Note The Motion Control Standard E...

Page 40: ...rt the orange handopen cable into the left pins labeled CH A 2 Insert the green hand close cable into the right pins labeled CH B 3 Insert the grey wrist cable into the pins labeled wrist 4 Insert the red power cable into the pins labeled hand Caution Do not insert the 2 socket connectors wrist or power into the wrong pin receptacles This may damage the hand or Espire system Note If the 3 socket c...

Page 41: ... inward toward the centre of the wrist however the 2 socket wrist connector is reversible 1 Insert the orange handopen cable into the left pins labeled 2 2 Insert the green hand close cable into the right pins labeled 2 3 Insert the factory provided motor connection into the left pins labeled 3 4 Insert the grey wrist cable into the right pins labeled 3 5 Insert the red power cable into the left p...

Page 42: ...anced grip control If advanced grip control is not being used wires that are not needed will be tucked away into the forearm The wires provided vary by grip option and hand choice Wiring Option 1 No Advanced Grip All Hands Colour Output Type Orange Hand Open Green Hand Close Grey Wrist Red Power Blue Bus Communication Not Used Black Not Used Wiring Option 2 Hands with Advanced Grip and 4 Band Coax...

Page 43: ...per Group or a Coapt representative for which option Wiring Option 2 or Wiring Option 3 will be correct for the type of hand they are planning Note Not all multiarticulating hands have advanced grip control capabilities verify with the manufacturer Wiring Option 1 No Advanced Grip All Hands If no advanced grip is being used refer to the regular wrist installation instructions see sections 8 3 8 4 ...

Page 44: ...ards the centre of the wrist 1 Insert the orange hand open cable into the left pins labeled 2 2 Insert the green hand close cable into the right pins labeled 2 3 Insert the red power cable into the pins labeled 1 4 Remove the cover from receptacle A then insert the purple pass through cable into the pins labeled A 1 A 2 2 Caution Do not insert the 2 socket connectors power or pass through into the...

Page 45: ...connector is reversible 1 Insert the orange hand open cable into the left pins labeled CH A 2 Insert the green hand close cable into the right pins labeled CH B 3 Insert the grey wrist cable into the pins labeled wrist 4 Insert the red power cable into the pins labeled hand 5 Insert the purple passthrough cable into the bottom 2 pin receptacle Caution Do not insert the 2 socket connectors wrist po...

Page 46: ...perly relative to the patient socket to allow for correct internal external humeral rotation and to protect the wiring of the Espire Elbow Colours for representation only Line indicates posterior Anti rotation stop pin located internally on the underside of the lamination collar The clamp ring left below is a two piece assembly that is uniquely shaped to fit the profile of the Espire Elbow When as...

Page 47: ...f motion is 30 externally and 135 internally 9 3 Attaching the Lamination Collar to the Elbow 1 Disassemble the clamp ring by removing the fasteners 2 Place the lamination collar or socket with attached collar near top of the elbow 3 Plug appropriate cables into the input board if applicable see section 3 2 4 With the lamination collar in place insert Clamp Ring A around both the anterior end of t...

Page 48: ...residue from the collar surface at the elbow attachment point 4 Re attach the elbow to the lamination collar and test socket Rotate the forearm clockwise and anti clockwise and verify the stop positions at 100 from centre see section 6 2 Rotate the collar accordingly to adjust the amount of internal or external rotation 5 Temporarily fit the arm to the user verify that the position carry angle and...

Page 49: ...re Pro Three indentations on the surface of the forearm indicate where a hole may be drilled to attach the cable loop The recommended starting point is the first hole closest to elbow centre The closer to the joint the bracket is located the more force is required to flex the elbow 10 2 Setting Up the Cable Mounting Drill Mounting Hole A 17 64in or 6 75mm drill bit and collar are provided to contr...

Page 50: ...ded options include Single Cable Control to raise the forearm The lift cable is attached to a cosmetic arm terminal and then to the forearm Allows for changing from hook to passive hand or powered terminal device Dual Cable Control to raise the forearm and control the terminal device The lift cable is attached to a ball terminal and then connected to the terminal device For use with most hands Ter...

Page 51: ...ism is not removable or field serviceable Do not attempt to disassemble or modify the unit Adjustment Dial Location The counterbalance dial can be installed on either the medial or lateral side of the elbow and should be specified at the time of ordering Medial placement is the typical location Counterbalance Dial Note Adjustments are easier to make when the forearm is flexed Caution Be aware that...

Page 52: ...nnot be over adjusted In this direction it will simply reach maximum flexion Supports more load on the elbow Turn the dial anteriorly to decrease the counterbalance weight Note Elbow will spring back into flexion according to how much spring lift assist is put into the system if it exceeds the minimum adjustment Supports less load on the elbow Note The direction of adjustment would be opposite if ...

Page 53: ...ow should never be serviced while connected to the end user Ensure that the device is disconnected and powered off before any service or maintenance is performed This device should never be serviced while in use Never let children handle this device unsupervised Take caution when using this device around pets that may cause damage to the device Caution Powering the elbow on before donning or leavi...

Page 54: ... cloth including the electrodes The inside of the socket may also be cleaned with mild soap and a damp cloth or isopropyl alcohol Ensure that all visible wire connections are secure and no wires have become entangled or frayed Make sure the battery has sufficient charge If the battery is too low swap it with an extra fully charged battery Ensure that the battery is fully inserted into the Espire E...

Page 55: ...bow system is only to be purchased configured and fit by a qualified prosthetist 13 2 Indications and Contraindications Indications for use of the Espire Pro or Hybrid elbow system include the following Adequate limb length to allow for appropriate socket fit at a level above the elbow This would include elbow disarticulation transhumeral shoulder disarticulation and forequarter Adequate muscle ac...

Page 56: ...ary for operation of the terminal device s Specific environmental factors such as excessive moisture or dust or inability to charge the prosthesis Extremely rural conditions where maintenance ability is limited 13 3 Safety Legend of Symbols Note Possible technical damage Info Basic information regarding this product Caution Possible risk of accident or injury Warning Possible risk of severe accide...

Page 57: ...ce away from flammable materials if any of these signs are present In the event of battery damage immediately and carefully remove battery and please contact your certified Prosthetist regarding safe disposal and replacement In the event of contact with the skin rinse immediately and contact medical care immediately Caution Manipulation of system components Independent changes and or modifications...

Page 58: ...er use may lead to faulty control or malfunction of the Espire Elbow resulting in a risk of injury The Espire Elbow was developed for everyday use and must not be used for unusual activities These unusual activities include for example sports with excessive strain and or shocks to the wrist joint push ups downhill mountain biking etc or extreme sports free climbing para gliding etc Do not use for ...

Page 59: ...ers should have their driving ability examined and approved by an authorised test centre For maximum safety and convenience Steeper Group recommends that at the very least a specialist evaluate the need for any adaptations to the car It is indispensable to ensure that the driver can operate the vehicle without any risk with the Espire Elbow turned off Driving with the Espire Elbow turned ON may pr...

Page 60: ...ing the performance of the Espire Elbow is impaired and the full lifting force can no longer be utilised The activities must be discontinued until the drive unit has cooled After cooling the full functionality is restored Caution Risk of pinching where the elbow joint bends Ensure that fingers and other body parts are not in this area when bending the elbow joint Caution Operating the product near...

Page 61: ...rning Use Only Specified Equipment Use of accessories transducers and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation Warning Operation of Equipment in Hospitals The Espire Elbow was designed for use in residential environm...

Page 62: ...rical Equipment Part 1 6 General requirements for basic safety and essential performance Collateral standard Usability 2013 Ed 3 1 IEC 62366 1 Medical Devices Part 1 Application of Usability Engineering to Medical Devices 2015 Ed 1 IEC 60601 1 11 Medical Electrical Equipment Part 1 11 General requirements for basic safety and essential performance Collateral standard requirements for medical elect...

Page 63: ...ter the tests were completed 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 2 This device must accept any interference received including interference that may cause undesired operation This device complies with Industry Canada license exempt RSS standard s Operation is subject to the followin...

Page 64: ...nity Test IEC 61000 4 2 ed2 0 2008 12 Contact 8 kV Air 2 kV 4 kV 8 kV 15 kV The Espire Elbow is attached to the patients socket which is designed by a certified prosthetist Radiated Radio Frequency Electromagnetic Immunity IEC 61000 4 3 ed3 0 with A1 2007 A2 2010 10 V m 80 MHz 2 7 GHz Portable and mobile RF communications equipment should be used no closer to any part of the Espire Elbow including...

Page 65: ...isposal or recycling instructions for this product Residents outside the European Union must dispose or recycle this product in accordance with local laws or regulations that apply IS EN 50419 2006 Reference no Fig 1 Caution Federal USA law restricts this device to sale by or on the order of a physician USA Code of Federal Regulations 21 CFR Part 801 801 109 b 1 Refer to instruction manual booklet...

Page 66: ...anufacturer ISO 15223 1 Clause 5 1 1 21 CFR Part 15 Meets FCC requirements per 21 CFR Part 15 Federal Communications Commission Battery is recyclable follow local recycling reclaiming procedures ISO 7000 Reference no 1135 China RoHS Mark I logo Product does not contain toxic and hazardous substances or elements above the clip level in any material or application including those exempt from the req...

Page 67: ...EN Espire Elleboog Pro Hybrid van Steeper Group distributeur Loth Fabenim B V EspireTM Elbow Pro Hybrid Instruction Manual For Prosthetists 67 ...

Page 68: ...ct us if you find any page missing or disordered Contact Loth Fabenim B V De Liesbosch 14 G 3439 LC Nieuwegein THE NETHERLANDS Tel 31 30 27 32 506 Fax 31 30 27 11 045 Email sales lothfabenim nl www lothfabenim nl Manufacture Authorized representative for EU countries Emergo Europe Prinsessegracht 20 2514 AP The Hague The Netherlands Tel 31 70 345 8570 Email EmergoEurope ul com ...

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