W2 Wrist CPM Owner`s Manual
Contents
1. CAUTION This feature should only be used as prescribed by the physician or therapist To Power On the Device Slide the power button one click to the right to power the device on The force setting is LOW in this position Pushing the power button one more click to the right puts the device in the FULL force setting To Power the Device Off Slide the power button all the way to the left to power off the device 11 For Customer Service 1 888 430 1625 W2 Instructions for Use 4 0 Maintenance Information needed for service personnel can be found in the Technical Service Manual WARNING Battery only replaceable by service technician WARNING If this equipment is modified appropriate inspection and testing must be conducted to ensure continued safe use of the equipment Expected Service Life The device s expected service life is 5 years which is limited to the life of the motor With proper maintenance the device can last longer Maintenance Between Patients 12 Softgoods for the device are for single patient use only and cannot be washed for reuse 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 Ensure that all knobs and or levers are usable and in place Ensure that all moving components move freely as required Check all displays and electronic contr2. Power On Class Il Equipment Danger Electric Shock Service by qualified individual only High Load Setting Use specified power Attention Consult T supply only K Low Load Setting e gt e ACCOMPANYING DOCUMENTS This bd Way Up T Fragile Caution FDA Policy Federal U S Law vw Danger Explosive Risk lf used with flammable anaesthetic Right Hand Flexion Keep Dry restricts this device to sale by or on the order of a licensed healthcare practitioner D AD Left Hand Flexion y Figure 2 Upon opening the device packaging there will be one of each of the following items W2 100U W2 CPM Device W2 101 Disposable Softgoods W2 103 Carrying Case GE 102 2 Power Supply 14157 Power Cord Shipping Damage Your new CPM is shipped complete in one carton or two boxes where necessary Upon receipt please inspect the carton and the unit for visible and hidden damage If any damage is discovered hold all shipping materials including the carton and call the shipping agent who delivered the unit The carton in which your new CPM was received is specially designed to protect the unit during shipping Please retain all shipping materials in the event that you will need to return your unit for servicing NOTE All repairs must be performed by the manufacturer or an authorized service facility 3 For Customer Service 1 888 430 1625 W2 Instructions for Use 1 0 Intended Use 1
3. 1 25A Battery Part number EABBC 7 2V 2 8 AH Battery Life up to 100 hours Device Classification Class II Degree of Electric Shock Protection Type B 7 For Customer Service 1 888 430 1625 W2 Instructions for Use 2 2 Technical Data cont Environmental Storage and 10 to 35 C 14 to 95 F temperature Transportation Conditions 90 maximum humidity 15 minimum ATM pressure 750 to 1250 hPa pressure The device must remain in the operational environment a minimum of one hour prior to USE 2 3 Ordering Information W2 100U W2 Wrist CPM device complete with softgoods carrying case and rechargeable battery pack W2 101 Patient Kit complete disposable Upon opening the device packaging there will be one of the following items W2 100U W2 CPM Device W2 101 Disposable Softgoods W2 103 Carrying Case GE 102 2 Power Supply 14157 Power Cord 8 For Customer Service 1 888 430 1625 W2 Instructions for Use 3 0 Using the W2 For assistance in set up use or maintenance or to report unexpected operations call QAL Medical LLC contact info included in this document or your distributor 3 1 Setting Up the W2 Install the forearm softgoods by first sliding the large pocket over the forearm support Fit into place and slide the small pocket over the front end of the forearm support With buckle side down wrap the hand softgoods around the hand support Optional Softgoods The MP Block is fixed t
4. 1 Introduction The W2 Continuous Passive Motion CPM system is designed for the rehabilitation of the wrist The W2 CPM offers the following features e Full range of motion in flexion extension ulnar and radial deviation or a combination of the two e Anatomical free linkage movement with floating hand support which eliminates compression and distraction of radial carpal joint Easy setup and alignment Two operating force settings No reassembly required to change from flexion to deviation Durable compact and fully portable Lightweight and comfortable Reverse on load safety feature Rechargeable battery operation 1 2 Application Continuous Passive Motion CPM is best applied immediately post operative and continued uninterrupted for up to six weeks as per physicians prescriptions 1 3 Clinical Advantages e Maintenance of a good range of motion e Reduction of post operative pain e Prevention of negative effects on immobilization 1 4 Indications Distal radius fractures stable Open Carpal Tunnel procedures Ganglionectomy rheumatoidal neurological or after burn stiffness synovectomy RSD Reflex Sympathetic Dystrophy following arthrotomy and drainage of acute septic arthritis providing infection is controlled 1 5 Contraindications Do not use the device if any of the following are present 4 For Customer Service 1 888 430 1625 W2 Instructions for Use e Septictenosynovitis until infection is con
5. Does not reverse at stop Drive belt slipping Replace drive belt Pushbutton travel too small Pushbutton installed Loosen screws and adjust to adjust stop position improperly pushbuttons 14 For Customer Service 1 888 430 1625 W2 Instructions for Use 6 0 Warranty New Product Limited Warranty To obtain warranty service the product must be returned freight prepaid to the Company or the selling distributor with a clear indication as to the defect Upon receipt of a product returned under warranty the Company will inspect the product and will notify the buyer of the extent of repair or replacement which the Company will perform under warranty If the product is received incomplete missing parts will automatically be replaced at the buyer s expense The Company also reserves the right at its sole election and own cost to upgrade or replace parts or subassemblies to the latest production standards The Company will normally perform the repair and return the product or provide a replacement within 30 days from the day of receipt freight collect QAL Medical LLC a Division of Quality Assembly and Logistics LLC the Company warrants the product for a period of 2 years for all major components motor power transmission parts and circuit boards and for a period of 90 days for all housing parts knobs hardware and sub assemblies excluding disposables The warranty takes effect from the date of the original purchase from QAL Medical
6. Woleske Road Marinette Wisconsin 54143 USA Tel 1 715 735 4727 Fax 1 715 735 6402 Website www qalmedical com Note Please enclose the following information when returning the device Return Authorization Number Ship to Address Purchase order for non warranty repairs Name and phone number of a person to contact Brief description of the problem Disposal of Device For proper disposal of the device contact your distributor or the listed manufacturer 16 For Customer Service 1 888 430 1625 W2 Instructions for Use QAL Medical LLC 3000 Woleske Road Marinette Wisconsin 54143 USA Tel 1 888 430 1625 Fax 1 715 732 6402 Russell Square Quality Representatives Ltd Ludgate House 107 111 Fleet Street London EC4A 2AB euar rsqa co uk www rsqa co uk QAL Medical is registered to ISO 13485 for Quality Assurance 17 For Customer Service 1 888 430 1625
7. or its Authorized Distributor or the original activation date into the QAL Medical rental pool and provided the product is new and unused THE COMPANY IS NOT RESPONSIBLE FOR LOSS OF USE LOST PROFITS OR SPECIAL INCIDENTAL OR CONSEQUENTIAL DAMAGES RESULTING FROM THE BREACH OF THIS WARRANTY THE FAILURE OF ANY PRODUCT OR THE NEGLIGENCE BY THE COMPANY IN THE PERFORMANCE OF ANY SERVICE INCLUDING DAMAGES FOR PERSONAL INJURY THE WARRANTY CONTAINED HEREIN IS IN LIEU OF ALL WARRANTIES EXPRESSED OR IMPLIED INCLUDING IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE NO STATEMENT OF ANY REPRESENTATIVE SHALL EXTEND THE COMPANY S LIABILITY AS HEREIN ESTABLISHED OR LIMITED THIS WARRANTY IS PROVIDED TO THE ORIGINAL PURCHASER OF THE PRODUCT AND IS NON TRANSFERRABLE 15 For Customer Service 1 888 430 1625 W2 Instructions for Use Returning the Device for Service Should the device require warranty repair buyer must contact either the Customer Service department or the authorized distributor from which the device was purchased for return instructions If any warranted product is found by the Company for have a defect covered by this warranty the Company shall at its option either repair the defective item or install a replacement If the device needs to be returned for any repair pack the components in the original shipping container and contact Customer Service QAL Medical LLC Attn Customer Service 3000
8. W23 Instructions for Use 2014 QAL Medical MMW2TM2 rev 7 2014 W2 Instructions for Use Table of Contents Metan gate rataraterehe E ee ee ee eres A 2 4 Supplementary Information Ne 3 TO Intended USC LS 4 ARTNR 4 TENNESSEE 4 EE Ge ENE AG ES serea 4 EA aol are ON DE EEE NA 4 do COM thal Cl Call OM EEE REE 4 5 16 Safety CONTE IN 5 6 POON DOIN NCS NN 7 GE NE ER uae 7 2 2 TECHNICA Dal desica en a ONE 7 8 2S Oderin IOMa ON REE EE EE 8 SONNE 9 3 1 Preparing the Device for the Patient nmenenenonensvsnsesrsrsrsrsrserersrsrsesesesesesesenenenenenes 9 3 2 SENG the Plane On MOTION sorses ITOO 9 10 3 3 Device Application and Alignment nemerenenenenenenenenenenenenenenenenenenenenenenenenenenene 10 11 34 SENG CHE Range TF MOON rv 11 TEEN 11 3 6 Range of Motion Options uussanarasnemansaseasmunadadaannnanandndmn 11 40 Maintenance Ls sca oss oc cscs i E E este ae 12 5 0 TOUDICSNOOUING sossa aaa 13 0 0 Warranty eee te no pr re Opp e noiai a Ov rat Ope neat EE 14 1 For Customer Service 1 888 430 1625 W2 Instructions for Use FOREARM SUPPORT AND SOFTGOOD HAND SUPPORT 2 RING Er HAND SUPPORT AND SOFTGOOD ALIGNMENT INDICATOR cP ACTUATOR C RING ACTUATOR 7 A BUTTON THUMB SCREW POWER BATTERY SWITCH LIGHT Tuk BAR DRIVE DISK CONTROLLER MIT ETOP POWER SUPPLY Figure 1 2 For Customer Service 1 888 430 1625 W2 Instructions for Use Power Off Deviation Type B Applied Part
9. al conditions that preclude the safe use of the device e Potential for allergic reaction to accessible materials used in equipement 5 For Customer Service 1 888 430 1625 W2 Instructions for Use e Caution As with all portable objects please store the device in a location when not in use to avoid a potential tripping hazard e Caution Ensure placement of the device allows plug to be disconnected from power Source e Caution Equipment not suitable for use in the presence of flammable anaesthetic mixture with air or nitrous oxide Biocompatibility The patient s skin is not intended to come in contact with the device Clothing or medical gauze is intended to be between the patient and the device in addition to the disposable patient kit provided 6 For Customer Service 1 888 430 1625 W2 Instructions for Use 2 0 Components 2 1 Overview 1 Instructions for Use Manual 2 W2 Device with Motion Controller Power Supply and Power Cord 3 Patient Kit 2 2 Technical Data Weight of Device approx 1 0 kg 2 2 Ibs including softgoods Dimensions 31 0 x 11 0 x 14 0 cm of Device 12 0 x 4 5 x 5 5 Dimensions of 9 6 x 18 0 x 3 7 cm Motion Controller 3 75 x 7 0 x 1 5 Range of Motion Flexion 0 to 90 Extension 0 to 90 Full Ulnar and Radial Deviation up to 90 Rate of Speed 180 per minute Force Settings Low 2 8 Nm 25 in lbs High 4 0 Nm 35 in Ibs Power Supply Input 100 240Vac 47 63Hz 40VA Output 12Vdc
10. ition the Actuator at any of the stop points along the Actuator Ring Loosen the thumb screw and rotate the hand support ring to a horizontal position Secure the thumb screw Turn the Motion Controller on and allow the device to move into a 0 position on the goniometer 3 3 Device Application and Alignment Note The Wrist Alignment indicator is located on the Drive Disk Open the hand and forearm softgoods Slide the Hand Support to the end of the drive bar Place the forearm in the Forearm Support and align the center of the wrist with the Alignment Indicator 10 For Customer Service 1 888 430 1625 W2 Instructions for Use Slide the Hand support into the palm of the patient s hand Secure the softgoods 3 4 Setting Range of Motion pe To set the range of motion in any of the three Plan vand of Motion options UT Depress and rotate the limit stops to the prescribed range of motion on the goniometer 3 5 Initiate Treatment The Motion Controller is equipped with two mar ER Operating Force Settings as indicated by the large T and small graphics at the Power Switch Small graphic indicates low force setting large graphic indicates high force setting FULL FORCE LOW FORCE 3 6 Range of Motion Options Dynamic Traction Mode To use the W2 in a dynamic traction mode Place the Limit Stops just outside the patients range Select the LOW force setting on the Motion Controller
11. o the hand support ring across the digits to maintain MP Flexion throughout the range of motion The sling is used to support the device in portable applications 3 2 Selecting the Plane of Motion Three Setup Options 1 Single Axis Flexion Extension 2 Single Axis Ulnar Radial Deviation 3 Combined Axis Motion Option 1 Flexion Extension To position the device for Flexion Extension Depress the Actuator Button to move the Actuator to align with the Left or Right Hand Flexion graphics at the top side of the Actuator Ring Note Place the Actuator on the ulnar side of the wrist to avoid possible thumb obstruction 9 For Customer Service 1 888 430 1625 W2 Instructions for Use Loosen the thumb screw and rotate the hand support ring to the top end Secure the thumb screw Turn the Motion Controller on and allow the device to move into a 0 position on the goniometer Option 2 Ulnar Radial Deviation To position the device for ulnar radial deviation Depress the Actuator Button to move the Actuator to align with the deviation graphics located on the center of the Actuator Ring Loosen the thumb screw and rotate the hand support ring to a horizontal position Secure the thumb screw Turn the Motion Controller on and allow the device to move into a 0 position on the goniometer Option 3 Combined Axes Motion To position the device for combined axes motion Depress the Actuator Button to pos
12. ols 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 Gently wipe clean all exposed surfaces with a soft cloth dampened with a mild soap solution or alcohol Do not use abrasive cleansers To disinfect wipe all exposed surfaces with a 10 solution of bleach and water or other suitable disinfectants Ensure that all labels are present Replace the patient softgoods kit Verify that the device operates to its set limits over several complete cycles For Range of Motion ROM settings verify device calibration by observing the ROM of the device while taking a visual reading using a goniometer at the device s anatomic pivot points Compare the ROM settings of the device with the goniometer readings ROM readings should be within For Customer Service 1 888 430 1625 W2 Instructions for Use 5 of the set parameters If the readings do not fall within the set parameters the device needs to checked and recalibrated by a properly trained Service Technician Maintenance Every Six Months e Repeat steps under Maintenance Between Patients Maintenance Every Twelve Months e Repeat Maintenance Between Patients procedures Maintenance Every Eighteen Months e A fullinspection of the device by properly trained Service Technician is recommended every 18 months e Repeat
13. steps Maintenance every Twelve Months e Fully inspect all internal and external mechanical drive components and repair or replace as necessary e Perform a complete recalibration and subsequent check of electronic and mechanical safety systems including Reverse On Load function and Range of Motion controls e Complete a final check of the device in accordance with QAL Medical Final Inspection criteria These are available through QAL Medical Customer Service or your local distributor Sterilization e This device does not require sterilization for use e Exposing the device to sterilization conditions will damage the device and may result in a potential hazard 13 For Customer Service 1 888 430 1625 W2 Instructions for Use 5 0 Troubleshooting The following tables provide some common problems that may be encountered with the W2 CPM with probable causes and solutions 5 1 CPM Controller Troubleshooting Problem Probable Cause Solution Controller warm when Overcharging battery Allow more operating time charging before recharging Reduce charging time Very short run time after Replace battery charging for 8 hours 5 2 Actuator Troubleshooting Problem Probable Cause Solution Sticky pushbuttons Improper shimming at stop Add or remove shims at stop ring ring Intermittent operation Broken wires in cable Replace cable Noisy operation knocking Worn bearings in motor Replace motor mount sound mount assembly assembly
14. trolled e Unstable fractures Note If signs of infection such as hyperthermia irritation swelling bleeding or increased or persistent pain are observed CPM should be avoided or discontinued until infection is controlled 1 6 Safety Considerations Read manual before use and operating the device We recommend that all clinicians and others responsible for the operation of this device become thoroughly familiar with its capabilities and proper operation procedures prior to actual patient use Skill at measuring the patient and adjusting the device accordingly will come with experience and practice Safety Features Low Voltage The power supply delivers less than 20 volts DC to the device The W2 will tolerate electrical supply variations which may be found in the home or hospital environments Reverse On Load The device is designed to automatically reverse direction in the event that an obstruction occurs Warnings Indoor use only Do not immerse in liquid Do not reuse disposable components Do not store device above 40 C 104F Service only by a qualified technician This device will produce minimal electromagnetic fields If equipment is modified appropriate inspection and testing must be conducted to ensure continued safe use of the equipment Strangulations can occur from entanglement with cords cables e Use specified power supply only e Keep device away from children pets or individuals with mental or physic
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