ARTROMOT-F Operating Instructions REV 03/04 Jan 2017

1. How to use the motion device

The ARTROMOT®-F is a motorized motion device used for Continuous Passive Motion (CPM) of the hand and finger joints. Its use is an important contribution to medical-therapeutic treatment both in clinics/doctors’ offices and in rental services.

– Prothetic replacement of MP and PIP joints

1.2 Objectives of therapy

– Hand or digit reattachment

CPM therapy with the ARTROMOT®-F mainly serves to prevent the negative impact of immobilization, regain painless movement of the joints quickly, and ensure a faster healing process with a positive functional result.

– Burn injuries

– Stable fractures – Crush injuries of hand without fractures or dislocations

English

– Flexor and extensor tendon synovectomies, following arthrotomy and drainage of acute septic arthritis

1.1 Possible applications

– Dupytren’s Contracture Release

– Reflex Sympathy Dystrophy (RSD)

The ARTROMOT®-F should not be used with:

Other objectives of the therapy include:

– Untreated or uncontrolled infections

– Prevention of joint stiffness (arthrofibrosis)

– Unstable fractures – Hemorrhage

– Better joint metabolism

m PRECAUTION!

– Support for the healing of cartilage areas and damaged ligaments

 OTE: Upon using the device, if signs of N infection such as hyperthermia, fever, redness, irritation, warmth, swelling, bleeding and/or increased persistent pain are present, discontinue operation of the device and contact the pa­tient’s physician. Do not proceed with treatment until the physician has approved continued use of the device.

– Faster haematoma resorption – Better lymph and blood circulation – Prevention of thrombosis and embolism – Reduction of post-operative pain

1.3 Indications The motion device is indicated in the treatment of most injuries, postoperative states, and diseases of the hand and finger joints, for example: – Capsulotomy, arthrolysis and tenolysis for post-traumatic stiffness of MCP and PIP joints – Open reduction and rigid internal fixation of intraarticular, diaphyseal and metaphyseal fracture of the phalanges and metacarpals – Flexor and extensor tendon tenolysis 23

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2. ARTROMOT®-F description The CPM device allows for the following motions of the finger/hand joints:

19 Coil Cord 20 Philips screwdriver

Extension/flexion MCP: 0°–90° (MCP or MP – Metacarpophalangeal joint)

Symbol-Erklärung

Extension/flexion PIP: 0°–110° (PIP – Proximal interphalangeal joint) Extension/flexion DIP: 0°–70° (DIP – Distale interphalangeal joint) The ARTROMOT®-F features the following: – Anatomically correct adjustments

Extension

Speed

Battery Stop

Flexion

Increase

Low Battery

Start/Stop

Decrease

Lock-Out

Setting

Force

Warm-Up

Pause

Type B Applied Part

– Physiological movement processes – The greatest possible range of motion – Hand-held programming unit for precise adjustments of all treatment values – Easy-to-transport design

Explanation of the device parts Note: Fold out page 2! 1

Actuator housing

2

Remote Stop Switch

3

Splint Clamp

4 Right Bridge Arm 5

Left Bridge Arm

Use specified power supply only Attention, Consult,

6 Drive Bar 7

Finger Actuator (large)

8

Finger Actuator (small)

ACCOMPANYING DOCUMENTS

9 “V”-clamps Danger Explosive Risk, If used

10 Large hinge

with flammable anaesthetic

11 Actuator

Caution: FFDA Policy. Federal Law r

12 Splint

estricts this device to sale by or on the order of a (licensed healthcare practitioner)

13 Velcro straps 14 Velcro straps hand 15 Mounting bracket

This Way Up

16 Finger Clips 17 VHB Pad

Fragile

Keep Dry

18 Finger Strip 24

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3. Safety instructions

Please read before starting the device!

– The doctor or therapist must decide on a case-to-case basis whether the device can be used with the particular patient.

– Turn the power off before unplugging. Unplug the power supply by grasping the plug, not the cord.

– Make sure that the characteristic values of your power supply correspond to the voltage and frequency data indicated on the ID plate.

– Use the ARTROMOT®-F only in accordance with the Physician prescription and Setup and Operation Manual. Failure to do so may result in damage to the device and/or personal injury.

English

as paralyzed persons or those who have had operations on both shoulders, specialists must constantly supervise treatment.

m PRECAUTION!

– Unless using the device, turn the device off and unplug the power supply.

– Position the device in a comfortable and secure position. Ensure that the device is stable through its full range of motion.

– Only use brand-name batteries. Do not use rechargeable batteries. – Only authorized staff may perform repairs and maintenance as the manufacturer’s warranty and liability would otherwise be invalidated.

– The device should not be used in the presence of flammable anesthetics. Do not use the device near exposed flames, while smoking or near extensive heat. Make sure that the device is not exposed to water or extreme temperatures.

– Check all of the components at least once per year to see if there is any damage or loose connections. – Before cleaning and repairs, make sure the mains plug has been dis­connected.

m PRECAUTION!

–  Do not pour cleaning liquids directly onto the device. This may allow fluids to enter the device and cause electrical problems, or wash lubricants away from running components, reducing the life span of the device

Allow the device to reach room temperature for a minimum of one hour prior to use.

– When in doubt regarding the correct setting and programming, interrupt the therapy immediately. Check the device and contact Customer service at ORMED GmbH if necessary.

– Select the location for the device and device components (controller, straps, cables and power supply) to prevent a tripping hazard during use or storage.

– Movement must always be free of pain and irritation.

– Keep hair, loose clothing, fingers and all parts of the body away from moving components of the device.

– The patient must be fully conscious when being instructed and using the device.

– Following accessories are for single patient use only:

– To prevent potential physical injury, such as strangulation and choking hazards, keep the device away from children or individuals with mental or physical conditions that preclude the safe use of the device.

– glove – silipos digital cap – splint

– If the patients cannot operate the hand-held programming unit, such 25

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4. Adjusting the device – Loosen the splint clamp (3) underneath the actuator housing (1) by turning it several times.

4.1 Adjusting the device for the finger treatment

– Slide the CPM actuator onto the splint’s mounting bracket (15) and adjust the CPM actuator distally or proximally along the mounting bracket.

† Attaching the Splint

– Correctly position the actuator so that the center of large round hinge (10) aligns with the center of the MP joints. – To accommodate various patient size, the CPM actuator (11) adjusts proximally and distally, and laterally and medially.

Å Attaching finger clips (16) and finger actuators (7/8)

– Place the splint (12) on the forearm with the distale end of the splint extending to the middle of the MP joints.

– First, apply the fully-adhesive side of the VHB Pad (17) to the underside of the finger clip (16).

– Form the sides of the splint (12) to adapt them to the contours of the forearm and hand.

– Next, peel the label off the adhesive portion of the VHB Pad and place the adhesive portion onto the finger nail.

– Tighten the splint (12) onto the forearm and hand with the Velcro straps (13/14).

– Pay attention that the finger clip (16) aligns with the end of the finger. – Peel and wrap a finger strip (18) around the finger and finger clip (16) to complete the attachment. (fig.1) – The finger actuators are easily designed to clip in and out of the finger clips (16). – To attach the finger actuators (7/8), pinch together the “V”-clamps (9) at the end of the finger actuators and roll into the finger clips. (fig.2)

ΠAttaching and positioning

– Make sure, you hear it engage and the “V”-clamps are secure.

the CPM actuator

To detach the finger actuator, pinch together the lock for finger clip and laterally slide the lock for finger clip out of the finger clip.

m PRECAUTION!  ttaching the finger actuators to the A finger clips is best done after the CPM actuator is attached to the splint and positioned correctly. 26

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4.2 Adjusting the device for the thumb treatment

m PRECAUTION!

– Apply finger clip to the thumb.

m PRECAUTION!

Figure 10 shows the device in flexion. The axis is on the PIP and the fingers are flexed at the DIP and PIP only. Make sure you adjust the flexion ROM on the controller to match this limited arc of motion.

The center of the clip should straddle the DIP of the thumb as shown, since this position allows for more opposition motion to occur. (fig.4)

This setup can be accomplished by using all clip attachment methods including the silipos digital cap (fig.11) or to the preferences of the clinician, patient or you. (see “Features”, page 28)

– Apply the motor (11) to the splint (12) aligning the device with the CMC joint. (fig.5) – Depending on the size of the hand different sizes of actuators can be used. The blue actuator (8) provides good motion to the average sized thumb.

English

As the force of the motor needs to be concentrated on the PIP joints, not on the MP joints, move the motor so that the axis point is aligned with the PIP joints. (fig.9)

– Rotate splint from the dorsal forearm to the radial side as shown. (fig.3)

– To avoid an ulnar deviation as the thumb flexes, the patient should place their hand on a flat surface such as a table, couch arm or other comfortable surface. – Figure 6 shows the device in full opposition/flexion.

m PRECAUTION! It is important that the actuator bar does not hit the index finger when it reaches this position as it could cause irritation to the patients skin.

4.3 Adjusting the device for MP Block treatment – Apply ARTROMOT®-F as usual. – Extend splint (12) by pulling on distal and proximal ends, so that the splint is positioned in-between the MP and PIP joints. (fig.7) – Apply the volar block by placing it under the fingers and attaching the long black Velcro straps (14) to the splint. (fig.8) – The MP joints are now blocked from both extension and flexion.

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5. Programming the ARTROMOT®-F 3. To program extension press EXT button. The LCD will display the extension icon and the currently programmed extension setting.

Before programming Ensure the device is completely assembled prior to operation 1. Attach the cable (19) from the hand-held programming unit to the CPM actuator.

4. To program the desired amount of extension, press the + and – buttons to increase or decrease the range.

2. Install batteries, or plug the AC adapter into the hand-held programming unit and a grounded wall outlet.

5. To program flexion press the FLEX button. The flexion icon will appear in the LCD display. 6. To program the desired amount of flexion, press the + or – buttons to adjust the demanded range.

3. Turn the device on and off from the POWER ON/OFF button on the handheld programming unit. The LCD displays shows the current range of motion position of the device.

7. Once programming is complete, press the SET button again to store the settings in the hand-held-programming unit (yellow light will go off ). Or, continue setting other operating features.

4. Before programming ARTROMOT®-F, ensure the device is not running. If it is, stop the device by pressing START/STOP button on the hand-held programming unit. Extension

8. To start the treatment press START/ STOP button on the hand controller.

LCD-Display

Programming Speed Flexion

Speed

1. With power on, press the SET button. The yellow light will appear indicating that the controller is ready to receive new programming. The LCD will flash all system icons.

START/STOPkey

SET-key

„–“ key

Pause

„+“ key

2. Press the SPEED button. The LCD now only displays the SPEED icon and the currently programmed speed setting. There are 4 speed settings: 1 is the lowest, indicated by a tortoise, and 4 is the fastest, indicated by a hare.

5.1 Programming steps Programming Range of Motion

3. To increase or decrease speed, press the + or – buttons.

1. Turn the device on by pressing the POWER ON/OFF button on the hand controller. The hand-held programming unit momentarily flashes all the system icons and then permanently displays the present range of motion.

4. W hen programming is complete, press the SET button again to store the setting in the hand controller (yellow light will go off ). Or do not press the SET button but continue setting other operating features.

2. Press the SET button (system icons flash). The yellow SET light will appear indicating that the hand controller is ready to receive new programming.

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Programming Pause

5.2 Programming the special functions

1. With power on, press the SET button. The yellow light will appear indicating that the controller is ready to receive new programming. The LCD will flash all the system icons.

m PRECAUTION! Reverse-on-load, Lock-Out and Timer are features to be set by the medical care giver only. Use by the patient could result in injury.

2. Press the PAUSE button. The LCD will only display the pause icon (hourglass) and the two EXT and FLEX hand icons. 3. Select flexion or extension by depressing either the FLEX or EXT button. Press + or – buttons to change the pause setting from 0 to 30 seconds. Pause may be set independently in flexion and/or extension.

Reverse-on-load

English

The following are NOT for patient use.

The Reverse-on-load setting is programmed by the medical care giver to meet the treatment requirements for each patient. This feature is hidden from the patient for reason and safety.

4. W hen programming is complete, press the SET button again to store the settings in the hand-held programming unit (yellow light will go off ). Or, press the SET button continue setting other operating features.

1.  Turn power off from the POWER ON/ OFF switch. 2. Simultaneously press and hold the SPEED button and POWER ON switch. The force icon will be displayed and the flexion and extension icons will blink (-1 is lowest force setting, 5 is highest force setting).

Warm up feature The Warm up feature starts the patient off with 50% less range of motion than programmed and gradually works up to the full range of motion over several cycles (i.e. if programmed range is 0° to 120° treatment would begin at half the range, 30° to 90°, and gradually work up to the full range.) The device needs 10 cycles to the full range of motion.

3. Select which range you wish to set force in by choosing flexion or extension. Force may be set independently in both flexion or extension. 4. W ith the + or – buttons increase or decrease force setting.

m PRECAUTION!

5. Press the SET button to program the new force setting.

While Warm Up feature is on, all settings on the hand-held programming unit are locked.

Lock-Out

1.  Turn off the power from the POWER ON/OFF switch on the hand controller.

The lock out feature allows the medical Care giver to effectively lock out setting to prevent a patient from making adjustments. If any of the features are locked out, the Lock-Out icon is displayed at all times.

2. Place the Warm Up feature switch in the ON position and then turn the power on from the POWER ON/OFF switch again. The thermometer Warmup feature icon will appear in the LCD display.

1.  Turn power off from POWER ON/ OFF switch. 2. Simultaneously press the SET button and the POWER ON switch. The Lockout icon will flash.

3. W hen ready, start the device from the START/STOP button.

3. Select and press the button of the operating features you wish to lock 29

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out. The icon of each feature you lock out will appear. You may lock out one or all features.

3. W ith the bar detached, slide the finger actuators off the bar and replace or rearrange them for left or right hand set up.

4. Press the SET button when finished to set lock outs.

4. W hen changing from right to left hand, or vice versa, remove the finger actuators and rearrange them so that the short finger actuator (blue) is always in position to attachment to the smallest finger.

Unlocking the Lock-Outs: Repeat Steps 1 and 2 on how to set the Lock Out feature. Select the operating features you wish to unlock and press the corresponding unlock and press the corresponding button. The feature’s icon will disappear from the LCD. Press the SET button when finished.

7. Maintenance – Always unplug the device before cleaning.

Timer The timer is used to monitor the number of treatment hours a patient receives.

– The ARTROMOT®-F can be wiped clean with disinfectant and thus fulfills the hygienic requirements for medical equipment.

1. Turn power off from the POWER ON/OFF switch.

– Only wipe the motion device itself with a moist cloth.

2. Press and hold the PAUSE button and the POWER ON switch simultaneously.

m PRECAUTION!  o fluids may be allowed to N enter the casing or the hand-held programming unit.

3. T he display represents the number of hours the device has been used (to the closest hour). 4. To reset the timer to 0 hours for the next patient, press and hold the – button until 0 hours is displayed. The device will now begin counting usage hours from 0.

– Protect the motion device from intensive UV light (sunlight)

The timer counts to a maximum of 999 hours after which is must be reset.

Complying with the following in­structions will help reduce unnec­essary wear and damage to the ARTROMOT®-F.

6. Conversion

1. ALWAYS use the hand-held programming unit to run the device to adjust the position of the Drive Bar and Finger Actuators.

ATTENTION WARNING

Replacing/Changing Finger Actuators

2. DO NOT force the actuators to move by hand by pushing on the Drive Bar. This action breaks the gear in transmission and requires the gear motor to be replaced. This action also breaks the Arm Drive Gear Support Pins and requires that each damaged Bridge Arm assembly be replaced. (fig.23/24)

The ARTROMOT®-F can be converted easily: 1. There are 3 medium finger actuators (black) and one small finger actuator (blue). Additional finger actuators in small, medium or large size may be ordered separately. See the Ordering Information chart for details. 2. To replace finger actuators, detach the black bar (6) containing the finger actuators by removing both fastening screws with a Phillips screwdriver (20). 30

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– Ensure that are labels are present. – Replace the patient softgoods kit.

– For Range of Motion (ROM) settings verify device calibration by observing the ROM of the device while taking a visual reading using a geniometer at the device’s anatomic pivot points. Compare the ROM settings of the device with the geniometer readings. ROM readings should be within +/- 5° of the set parameters. If the readings do not fall within the set parameters, the device needs to be checked and recalibrated by a properly trained Service Technician.

Maintenance Important! Check all of the components at least once a year for damage and loose connections. Damaged or worn out parts must be exchanged for original spare parts immediately by authorized experts.

English

– Verify that the device operates to its set limits over several complete cycles.

Maintenance every 6 months – Repeat steps under “Maintenance between patients”. Maintenance every twelve months – Verify electrical ground continuity where applicable from the device frame to ground pin of the power supply, if so equipped, using a Safety Analyzer or appropriate device.

Maintenance by patients – Patients are responsible for using the device according to the Setup and Operating Manual. Do not wash softgoods. Maintenance between patients – Softgoods for the device are single patient use only and cannot be washed for reuse.

– Repeat “Maintenance between patients” procedure. Maintenance every eighteen months – A full inspection of the device by a properly trained Service Technician is recommended every 18 months.

– Check the entire device for any visible evidence of damage such as bent components, cracked or broken covers, frayed or damaged wires etc. If any signs of damage are found, the device must be repaired before use.

– Repeat steps “Maintenance every twelve months”.

– Ensure that all knobs and/or levers are usable and in place.

– Fully inspect all internal and external mechanical and drive components, and repair or replace as necessary.

– Ensure that all moving components move freely as required.

– Fully inspect all internal and external electrical components (including wire connectors and solder joints), and repair or replace as necessary.

Check all displays and electronic controls –  for proper operation. – Check all mechanical pivot and linkage points for smooth operation and secure mechanical connection. Make sure all screws, nuts, bolts, rivets, pivot pins, and other fasteners are secure.

– Perform a complete recalibration and subsequent check of electronic and mechanical safety system including Reverse-on-load function and range of motion controls.

– Gently wipe clean all exposed surfaces with a soft cloth dampened with a mild soap solution or alcohol. Do not use abrasive cleaners. To dis­infect, wipe all exposed surfaces with 10% solution of bleach and water, or other suitable disinfectants.

– Complete a final check of the device in accordance with ORMED GmbH

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Sterilization – This device does not require sterilization for use.

8. Specifications

– Exposing the device to sterilization conditions will damage the device and may result in a potential hazard. Warranty: 2 years (mechanical parts) 2 years (electronics)

Electrical connection:

Battery 6V 4AA

100-240 V,

50/60 Hz

Rated current motor:

2.5 A max.

Power consumption:

40 VA

Fuses:

1.5 A PTC

Degree of protection:

VDE

Protection class I,

Type B

Reverse-on-load: 1.6 kg low 4.3 kg high Weight: Hand-held programming unit: 0.2 kg Drive assembly with patient kit: 0.66 kg MPG:

Class 2a

CSA: IEC 60601-1

CSA 601.1-M90

UL 2601-1

Ambient conditions Ambient temperature

-40°C to +70°C

Relative air humidity

10% to 100%

Air pressure 500 hPa to 1060 hPa

Operational conditions Ambient temperature

+10°C to +40°C

Relative air humidity

30% to 75%

Air pressure 700 hPa to 1060 hPa

Subject to change without notice (09/06). 32

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Manufacturer:

DJO Global Headquarters Germany:

QAL Medical LLC. A division of Quality Assembly and Logistics, LLC 3000 Woleske Road Marinette, Wisconsin 54143 USA

DJO Global ORMED GmbH Merzhauser Strasse 112 79100 Freiburg, Germany Phone: +49 (0) 761 4566 01 Fax: +49 (0) 761 456655-01 E-mail: [email protected] Web: www.DJOglobal.de

EU Representative: RSQR Ltd. Ludgate House 107-111 Fleet Street London EC4A 2AB United Kingdom

English

9. Contact

Exclusive Sales: We would be happy to answer any questions you may have about our products and services. ARTROMOT® International: Please contact your local dealer, the DJO Global Headquarters in the USA, the DJO Global International Headquarters in England or DJO Global in Germany. DJO Global International Headquarters: DJO UK Ltd. 1a Guildford Business Park Guildford Surrey, GU2 8XG United Kingdom Phone: +44 (0)1483 459659 Fax: +44 (0)1483 459470 e-mail: [email protected] Web: www.djoglobal.eu DJO Global Headquarters DJO, LLC 1430 Decision Street 92081 Vista – California / USA Phone: +1 760 727 1280 Fax: +1 800 936 6569 e-mail: [email protected] Web: www.djoglobal.com

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Parts needed: (fig.11) A: Finger Clip

10. Technical service

B: Adhesive-backed Velcro hook

10.1 Technical hotline

C: Accessory D-Ring strap

Haben Sie technische Fragen? Benötigen Sie den technischen Service?

D: Silipos Digital Cap

Telefon :

– Secure the Sillipos Cap (C) on the affected finger(s) by rolling the cap back and inserting tip of finger. (fig.12)

Fax :

Directions for use:

+49-180-5-1 ormed de +49-180-5-1 67 63 33 +49-180-5-3 ormed de +49-180-5-3 67 63 33

– Remove adhesive backing from Velcro hook rectangle strip (B) and apply Velcro strip to underside of finger clip (A). (fig.13)

10.2 Shipment Für den Versand nur Originalverpackungen verwenden, um Transportschäden zu vermeiden. Versandkartons können bei DJO Global bestellt werden.

– Apply finger clip (A) with Velcro hook (B) to finger. – Use D-Ring accessory (C) to secure finger clip onto Silipos Digital Clap (D). (fig.14)

11. Features

Recommended Care: – hand wash product

11.1 Silipos Digital Cap

– air dry and lightly dust product with talcum powder after drying

A soft, comfortable and stretchable fabric fully coated with polymer gel which slowly releases a medical grade mineral oil (USP) to soften and mois­turize the skin. Product is dermatologist tested, washable and reusable.

m PRECAUTION!  emove product at least 3 to 4 hours daily R to allow skin to breathe.

Indications: – relieve pressure and friction on the affected digit

11.2 Glove

– reduce scar tissue

– Select the correct glove size for the patient.

– hammertoes, over/under lapping digits

– Attach the Velcro pad on the underside of all four clips.

– keratotic lesions

– Attach the clips to the fingertips on top of the nails and loosely secure with the Velcro strap.

– partially amputated digits – for skin or nail problems due to dryness

m PRECAUTION!

– Ensure the large end of each clip is at the tip of the finger, also ensure Velcro straps are even with the middle of each fingernail.

 o not place product on open wound. If D irritation, discomfort or poor circulation occurs, discontinue use and notify your physician immediately. KEEP OUT OF REACH OF CHILDREN.

– Slip the glove onto the patient’s hand and adjust the straps again to have the clips firmly secured. – Attach the finger clips to the glove.

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– Attach the splint on top of the glove and adjust the splint shape in order to fit the patient’s forearm before securing the Velcro straps on the splint. (fig.15/16)

12. Spare parts English

Spare parts are given in a separate spare part list. When ordering spare parts, always specify: – Position – Description – Article number – Quantity – Serial number of the device for which order is intended

m PRECAUTION! Only authorized experts may make repairs. Please note the surcharges for reduced quantities on individual spare parts.

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DECLARATION OF CONFORMITY

QAL Medical LLC. A division of Quality Assembly and Logistics, LLC Registered to ISO 13485 for Quality Assurance 3000 Woleske Road Marinette, Wisconsin 54143 USA Tel. 715.735.4700; 888.430.1625 Fax 715.732.6402 www.QALmedical.com

EC Declaration of Conformity QAL Medical LLC. declares that the following Continuous Passive Motion (CPM) medical devices have been classified as Class IIa (Annex IX Rule 9) and are in conformity with the essential requirements and provisions of Council Directive 93/42/EEC as amended by Directive 2007/47/EC:

0120

6000G – Hand CPM (Marked ORMED ARTROMOT®-F) W2G – Wrist CPM (Marked ORMED ARTROMOT®-H)

The above devices are identical to QAL Medical products 6000 and W2 respectively, except for the labeling. The EU Authorized Representative for QAL Medical LLC. is: RSQR Ltd., Ludgate House, 107-111 Fleet Street, London EC4A 2AB [email protected], www.rsqa.co.uk The devices are subject to the procedure set out in Annex II of Directive 93/42/EEC as amended by Directive 2007/47/EC under the supervision of Notified Body Number 0120, SGS United Kingdom, Ltd., Unit 202B, Worle Parkway, Weston-Super-Mare, North Somerset, BS22 6WA, United Kingdom

Marinette, Wisconsin USA October 10, 2011 Susan Johnson Regulatory Compliance

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MOT-301-REV.03/04-01/2017

Exclusive distributed by: ORMED GmbH Merzhauser Str. 112 · 79100 Freiburg · Germany Tel. +49 761 4566-01 · Fax +49 761 4566-5501 [email protected] · www.DJOglobal.de

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