Chattanooga Group OPTIFLEX3 2090 Скачать руководство пользователя страница 11 | Manualshive

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OptiFlex® 3 Continuous Passive Motion (CPM) Therapy Unit

4.2 DESCRIPTION OF DEVICE MARKINGS

The markings on the OptiFlex3 CPM unit are your assurance of its conformity to the highest applicable standards
of medical equipment safety and electromagnetic compatibility. One or more of the following markings may
appear on the device:

9700675

Meets Directive 93 /42 /EEC
IEC/UL/EN 60601-1, 60601-1-2

Listed by Intertek Testing Services NA Inc.

Conforms to UL Standard 60601-1

Certified to CAN/CSA Standard C22.2 No.
601.1-M90 w/A2

Refer to Instruction Manual/Booklet

Type B Equipment

Protected Earth

Emergency Stop

Standby Power ON

Standby Power OFF

Start

This product complies with WEEE
Directive 2002/96/EG (waste electrical
and electronic equipment). Separate
collection for electrical and electronic
equipment.

4.3 ADDITIONAL DEVICE MARKINGS

4 SPECIFICATIONS

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Содержание OPTIFLEX3 2090

Страница 1: ...Model 2090 Applies to Serial numbers 1000 and above SERVICEMANUAL ISO 13485 CERTIFIED ...

Страница 2: ...ION ANGLE AND CALIBRATION TEST 13 5 8 TRAVEL SPEED TEST 15 5 9 EMERGENCY START STOP FUNCTION TEST 15 5 10 PENDANT DISCONNECT TEST 15 6 REMOVAL REPLACEMENT 16 31 6 1 UNIT COVERS 16 6 2 MANUAL MOVEMENT OF THE CARRIAGE 17 6 3 MOTOR CONTROL BOARD 18 6 4 DRIVE BELT 19 6 5 MOTOR ASSEMBLY 20 6 6 POWER SUPPLY 21 6 7 POTENTIOMETER KNEE POT 22 6 8 ACME SCREW BALL SCREW 24 6 9 PENDANT RECEPTACLE CABLE 26 6 1...

Страница 3: ...were in effect at the time of the publication However owing to Chattanooga Group s policy of continuous improvement changes to these specifications may be made at any time without obligation on the part of Chattanooga Group Chattanooga Group requires all Field Technicians stay informed and trained on all changes pertaining to the OptiFlex3 CPM Therapy Unit As significant changes occur to the OptiF...

Страница 4: ...otor and Gearbox Assembly Universal Power Supply Motor Control PC Board Adjustable Foot Plate Adjustable Femur Bar and User Interface Pendant The unit is designed for patient use only with the Patient Softgoods Kit Part Number 20533 This single patient use softgoods kit is designed specifically for the OptiFlex3 CPM unit and provides proper installation and support to the patient during therapy If...

Страница 5: ...injury and equipment damage Text with a DANGER indicator will explain possible safety infractions that are imminently hazardous situations that would result in death or serious injury Text with a Dangerous Voltage indicator serves to inform the technician of possible hazards resulting in the electrical charge disbursement from certain components if handled or serviced improperly Throughout this ma...

Страница 6: ...lacement of the OptiFlex3 All hardware bolts nuts and screws used to assemble the OptiFlex3 are SAE Standard Due to the size of these components no metric equivalent is available Therefore it will be necessary to obtain the proper size tools for removal and replacement of certain components Federal law restricts this device to sale by or on the order of a physician or licensed practitioner Make ce...

Страница 7: ...the working mechanism of the OptiFlex3 to help prevent damage to the OptiFlex3 and any other modality used with it Unconscious patients or patients under heavy influence of medication must be constantly attended and monitored while the OptiFlex3 is in use The OptiFlex3 must be completely visible at all times during use Never cover the unit with bedding or any other means of concealment while in op...

Страница 8: ... 2 3 4 6 7 8 9 10 11 12 13 14 15 16 3 NOMENCLATURE 3 1 OPTIFLEX3 5 Adjustable Foot Plate Foot Rest Pivot Adjustment Tibial Adjustment Knob Angle Potentiometer Knee Pot Femur Bar Adjustment Scale Femur Bar Adjustment Knob Frame Base Pendant User Interface Refer to Page 7 Carrying and Storage Handle 1 2 3 4 5 6 7 8 9 Rear Access Cover On Off Switch Mains Power Cord Universal Power Supply Motor and G...

Страница 9: ...REEN Displays settings and status of therapy session RESET Clear previous treatment settings and completed cycles UP ARROW Allows user to increase treatment parameters DOWN ARROW Allows user to decrease treatment parameters COMFORT ZONE Temporarily decreases the flexion ROM when discomfort is experienced 1 2 3 4 5 6 7 EMERGENCY START STOP Start or stop treatment EXTENSION FLEXION DELAY Allows user...

Страница 10: ...on Speed 30 per minute to 150 per minute Maximum Patient Weight 350 pounds 159 kg Lower Leg Length Range 10 23 5 25 4 59 7 cm Center of knee to sole of heel Thigh Length Range 12 19 30 5 48 3 cm Hip joint to center of knee TRANSPORTATION AND STORAGE REQUIREMENTS Unit should be transported and stored under the following conditions Temperature 0 F to 140 F 18 C to 60 C Humidity 0 to 75 Relative Humi...

Страница 11: ...evice 9700675 Meets Directive 93 42 EEC IEC UL EN 60601 1 60601 1 2 Listed by Intertek Testing Services NA Inc Conforms to UL Standard 60601 1 Certified to CAN CSA Standard C22 2 No 601 1 M90 w A2 Refer to Instruction Manual Booklet Type B Equipment Protected Earth Emergency Stop Standby Power ON Standby Power OFF Start This product complies with WEEE Directive 2002 96 EG waste electrical and elec...

Страница 12: ...low Replace Battery or Pendant 6 A general error on the Motor PCB has occurred Motor Control Board Failure Replace the Motor Control Board 7 The Angle Potentiometer sensor is out of range Carriage angle below 10 limit Loosen the Femur Adjustment Knobs Raise the carriage to above zero and tighten the Femur Adjustment Knobs Turn the unit oﬀ and back on with the power switch 8 The Angle Potentiometer...

Страница 13: ...s trained and certified by Chattanooga Group C Equipment Required 1 Digital Multimeter 2 Fine Edged Tool for removing decals 3 Tape Measure or Ruler 4 Required SAE Tools 1 Phillips Screwdriver 2 Phillips Screwdriver Preset and calibrated 5 inch pound T Handle Torque Wrench with 1 4 square drive and 5 64 straight hex key socket Preset and calibrated 10 inch pound T Handle Torque Wrench with 1 4 squ...

Страница 14: ...nd on page 15 Clears all settings by activating the Reset 5 5 ELECTRICAL SAFETY The OptiFlex3 has been tested to UL 60601 1 Standard for Safety for Medical Equipment NOTE The device complies with current leakage ground continuity and dielectric withstand Hi Pot limits as prescribed by IEC EN UL 60601 1 and C22 2 No 601 1 M90 w A2 Medical Electrical Part 1 General Requirements for Safety Facility l...

Страница 15: ... the Down Arrow button until 0 is displayed on the Pendant Refer to Figure 5 2 5 Press and hold the Time and Extension buttons While holding the Time and Extension buttons press the Up or Down Arrow button until 5 Sec is displayed on the Pendant Refer to Figure 5 3 6 Press and hold the Time and Flexion buttons While holding the Time and Flexion buttons press the Up or Down Arrow button until 5 Sec...

Страница 16: ... continuing to hold the Speed Button press the Emergency Start Stop button on the Pendant When movement of the unit stops press the Emergency Start Stop button Verify the display reads 90 Min 10 Using the Inclinometer or Protractor measure the angle of the flexion of the unit Refer to Figure 5 7 NOTE In Figure 5 7 a Digital Inclinometer is used to measure each side and the two numbers are added to...

Страница 17: ...upon pushing button A Equipment Required OptiFlex3 with Pendant B Test 1 Place unit on a level work surface 2 Plug unit power cord into grounded wall outlet with appropriate voltage See Specifications on page 8 3 Connect Pendant to unit and turn unit power ON 4 Press the Emergency Start Stop button to start and stop the unit Repeat several times 5 If unit fails test troubleshoot the following comp...

Страница 18: ... of the Rivet Refer to Figure 6 1 2 Lift up and rotate the Rear Acess Cover toward the Carrying Handle of the unit Slide the cover over the Carrying Handle to completely remove from the unit 3 To install the Rear AcessCover reverse the above steps D Front Access Cover Removal and Replacement NOTE Miniature Diagonal Cutter are used only to remove the Rivets They are not intended to cut the Rivets O...

Страница 19: ...es to prevent electrical shock A Part Number None B Tools and Equipment Required NOTE Refer to Section B of each sections referenced below for additional tools needed C Manual Carriage Adjustment 1 Refer to Section 6 1 part C Rear Cover Removal and Replacement to remove the rivets from the Rear Cover of the unit 2 Lift the bottom of the Rear Cover just enough to be able to manipulate the Pulley Ro...

Страница 20: ...r to Figure 6 2 FIGURE 6 2 4 Replace in reverse order NOTE When connecting harnesses each harness will connect only to their respective locations on the board 5 After Motor Control Board replacement perform the following in the order listed 7 1 Angle Potentiometer Position Calibration 5 7 Flexion Angle and Calibration Test 7 2 Force Reversal Calibration 5 4 Functional Inspection FIGURE 6 3 MOUNTIN...

Страница 21: ...r of the unit 2 Using a 9 64 Allen wrench loosen the three Motor Mounting screws Refer to Figure 6 4 3 Rotate the Motor to remove the old Belt from the Pulleys 4 Replace Drive Belt in reverse order NOTE When replacing the Drive Belt rotate Motor by hand applying tension to the Belt Make certain the Belt is seated into the Pulley teeth Torque Motor Mounting screws using the Preset 10 inch pound T H...

Страница 22: ...unting screws using the 9 64 Allen wrench and remove Motor from unit Refer to Figure 6 6 7 Install the Motor with ribbon cable up Install the three Motor Mounting screws and Nylon Lock nuts Do not completely tighten 8 Position the Pulley onto the Motor shaft Make certain the set screw hole is aligned with the flat area of the shaft 9 Push the Pulley onto the shaft until the face of the Pulley coll...

Страница 23: ... Connection is not easily located turn the unit over There are four mounting slots on the bottom of the unit The two Pin Connection can be pull out of one of the top inner slots and separated FIGURE 6 7 GROUND CONNECTOR 2 PIN CONNECTOR 3 Using Needle Nose pliers disconnect the ground wire Refer to Figure 6 7 4 Using Needle Nose pliers disconnect the red wire from the Rocker Switch and the blue wir...

Страница 24: ...ectrical shock POTENTIOMETER DECAL COVER SCREWS 3 Use a 2 Phillips screwdriver to remove the 3 screws securing the Potentiometer Cover and remove the Cover NOTE When installing the Potentiometer Cover part number J6105 hand tighten the three screws until snug Overtightening the screws will crack the Cover 4 Using a 3 32 Allen wrench remove the two cleat screws Refer to Figure 6 10 5 Using a Heyco ...

Страница 25: ... and detach 8 Turn the unit over and using a Heyco Tool remove the Heyco securing the Potentiometer Cable to the Base Slide the cable wire through the Base to release 9 Install the replacement Potentiometer by reversing steps 4 8 When step 8 is complete refer to section 7 1 Angle Potentiometer Position Calibration Perform the calibration Once the calibration is done complete the installation by re...

Страница 26: ...amage to the Pulley 5 Remove the 2 washers and the bearing from the end of the Ball Screw Refer to Figure 6 12 7 Using a 5 16 Socket Driver remove the 4 nuts and washers securing the Base Plate at the end of the Frame Base Refer to Figure 6 14 6 Using a 2 Phillips screwdriver remove the screw on each side of the Frame Base to release the Base Refer to Figure 6 13 SCREW SECURING BASE TO THE FRAME B...

Страница 27: ...2 Remove the steel washer and the bearing by using a Phillips screwdriver to push the shaft of the Ball Screw through the Front Plate NOTE Observe the locations of the washers and bearings for installation Insert A on page 38 details proper installation 13 Slide the Carriage to the front end of the Frame Base FIGURE 6 17 COTTER PIN SNAP RING SNAP RING HOUSING 14 Using Snap Ring pliers remove the s...

Страница 28: ... counterclockwise Continue to unscrew to release Refer to Figure 6 18 FIGURE 6 18 Disconnect the pendant from the unit before attempting any removal or replacement procedures to prevent electrical shock 3 Hold the nut inside of the unit Frame securing the Receptacle Cable Using a pair of adjustable pliers turn the housing on the outside of the unit counterclockwise to release Continue to unscrew a...

Страница 29: ...Disconnect the pendant from the unit before attempting any removal or replacement procedures to prevent electrical shock FIGURE 6 21 NOTE The part number for the screws securing the back of the pendant is J1120 The O ring is part number J1121 3 Fold the Rubber Gasket on the handle of the Pendant and lift the back Cover off to remove SCREWS FOLD BACK THIS GASKET 4 Detach the 5 pin connector from th...

Страница 30: ...e from the Control Board Refer to Figure 6 23 FIGURE 6 23 LCD RIBBON CABLE PLASTIC BAR SECURING RIBBON CABLE 3 Disconnect the 2 Pin connector harness from the Display attached to the Control Board Refer to Figure 6 24 FIGURE 6 24 2 PIN CONNECTOR HARNESS SCREWS SECURING CONTROL BOARD 22TOTAL BATTERY 4 Using a 1 Phillip screwdriver remove the 22 screw securing the Control Board to the Pendant Base R...

Страница 31: ...endant Cable Removal and Replacement to open the Pendant and remove the Cable 2 Hold the sides of the Battery While holding touch one of the solder points securing the Battery to the Control Board and lift to detach that side of the Battery from the Control Board Refer to Figure 6 25 3 Repeat this process on the second solder point 4 To install the Battery use a soldering iron and solder to place ...

Страница 32: ... J6100 Lower Keymat J6101 B Tools and Equipment Required 1 Phillips Screwdriver NOTE Refer to Section B of the section referenced below for additional tools needed C Upper and Lower Keymat Pendant Removal Replacement 1 Refer to Section 6 11 part C Control Board Removal and Replacement to open the Pendant remove the Cable and remove the Control Board 2 Lift to remove the Keymat Refer to Figure 6 26...

Страница 33: ...r NOTE Refer to Section B of the section referenced below for additional tools needed C Pendant Receptacle Cable Removal Replacement 1 Refer to Section 6 11 part C Control Board Removal and Replacement to open the Pendant remove the Cable and remove the Control Board 2 Using a 1 Phillips screwdriver remove the 4 screws securing the Pendant Display to the Upper case of the Pendant Refer to Figure 6...

Страница 34: ...d tool carefully remove the Decal from the Potentiometer Cover Refer to Figure 7 1 FIGURE 7 1 Using the 2 Phillips Screwdriver remove the three Potentiometer cover mounting screws Refer to Figure 7 2 FIGURE 7 2 C Initial Position Calibration Procedure 1 Enter the Calibration Mode of the Pendant by pressing and holding the Comfort Zone button 2 While holding down the Comfort Zone button press the f...

Страница 35: ...cess if the Carriage is moved too far an Error Message may be displayed It will then be necessary to manually move the Carriage by loosening the Femur Bar and raising it until the Carriage Guide Bar is approximately at 0º to cancel the Error Once the Guide Bar is zeroed turn the unit off to clear the error message If the Carriage is required to be manually moved then it will be necessary to re sta...

Страница 36: ...he sequence listed 1 Progressive ROM 2 Fast Back 3 Oscillation Zone 4 Mode 5 Release the Speed button STAND BACK Unit Self Calibrating should be displayed at the bottom of the Pendant display and a Timer should begin counting down from approximately 30 sec Refer to Figure 7 10 FIGURE 7 10 6 After all movement of the unit has stopped the Display will prompt the technician to turn the unit off and b...

Страница 37: ...ction should be performed by a person qualified to recognize any signs of wear or tear looseness of bolts parts or inconsistencies in function 8 3 FACTORY SERVICE When the OptiFlex3 CPM unit requires factory service contact the dealer or Chattanooga Group Service Department WARRANTY REPAIR OUT OF WARRANTY REPAIR 1 Written statement containing the following information RA Number Obtain from Factory...

Страница 38: ...36 OptiFlex 3 Continuous Passive Motion CPM Therapy Unit MAINTENANCE 8 4 MAINTENANCE RECORDS ...

Страница 39: ...37 OptiFlex 3 Continuous Passive Motion CPM Therapy Unit MAINTENANCE 8 4 MAINTENANCE RECORDS CONTINUED ...

Страница 40: ...9 PARTS 1 2 3 4 5 3 6 5 7 6 21 8 2 9 10 12 11 13 14 15 16 17 18 19 20 7 22 23 8 24 25 26 27 8 44 SEE B 45 46 45 48 47 43 49 50 51 B 57 58 60 59 61 52 53 54 40 41 42 55 56 63 64 65 66 67 62 31 36 68 69 70 71 72 73 74 75 SEE A 76 77 78 79 80 81 1 30 28 38 37 39 34 1 35 34 33 32 29 A 60 58 59 35 57 ...

Страница 41: ...38 J6025 STOVE BOLT 2 39 J1071 PIN FOOT ROTATION 1 40 J6001 BEARING SPLIT FLANGE 2 41 J6087 PENDANT OPTIFLEX 3 KIT 1 42 89852 PENDANT RECEPTACLE CABLE 1 43 J1025 WIPER 2 44 J6103 COVER FRONT TOP 1 ITEM PART NO DESCRIPTION QTY 45 54931 PIN SPLIT 3 32 X 5 8 PLT 2 46 J1089 CLEVIS PIN 1 4 X 1 3 8 SS 2 47 J1131 WELDMENT BASE FRAME 1 48 J6000 SCREW 10 24 SELF TAP 8 49 J2003 EXTRUSION 1 50 J6104 COVER FR...

Страница 42: ...ANT CASING 1 J6100 PENDANT KEYMAT UPPER 1 J6101 PENDANT KEYMAT LOWER 1 J6106 DECAL OVERLAY PENDANT 1 J1119 SCREWS 2 X 5 16 PAN PHILLIPS 22 J1120 SCREWS 4 X 5 8 PAN PHILLIPS 7 J1121 O RING N 005 7 J6086 CABLE FOR THE PENDANT WITH RUBBER GASKET 1 J1123 PENDANT DISPLAY 1 J1124 SCREW 4 20 PLAS 3 16 PH PAN 4 89870 PENDANT BATTERY 1 J1068 VELCRO 2 BLK LOOP 1 J1102 PENDANT CONTROL BOARD 1 ...

Страница 43: ...EEN B LAC K RED WHITE ORANGE GREEN BLAC K RED WHITE 1 J1 J2 1 J 3 1 DISPLAY FLEX CIRCUIT PENDANT J1102 POT RED BLACK WHITE RED BLAC K RED BLACK POWER SUPPLY J1109 GREEN YELLOW BLU E RED RED B ROW N J6099 I E C L G N BLU E GREEN YEL LOW J6097 FERRITE FERRITE CONNECTOR POSITION D C ON OFF SWITCH FERRITE 10 1 BLOCK DIAGRAM LANDSCAPED ...

Страница 44: ...42 OptiFlex 3 Continuous Passive Motion CPM Therapy Unit 10 SCHEMATICS 10 2 CONTROL BOARD 1 LANDSCAPED ...

Страница 45: ...43 OptiFlex 3 Continuous Passive Motion CPM Therapy Unit 10 SCHEMATICS 10 2 CONTROL BOARD 2 LANDSCAPED ...

Страница 46: ...44 OptiFlex 3 Continuous Passive Motion CPM Therapy Unit 10 SCHEMATICS 10 2 PENDANT LANDSCAPED ...

Страница 47: ...e caused by labor furnished by someone other than the Company the selling dealer or a certified Company service agent Any malfunction or failure in the Product caused by product misuse including but not limited to the failure to provide reasonable and necessary maintenance or any use that is inconsistent with the Product User Manual COMPANY SHALL NOT BE LIABLE IN ANY EVENT FOR INCIDENTAL OR CONSEQ...

Страница 48: ...43 U S A 1 423 870 2281 1 800 592 7329 U S A 1 800 361 6661 CANADA 1 423 870 7200 OUTSIDE U S A 1 423 870 2046 OUTSIDE U S A FAX chattgroup com 0413 ISO 13485 CERTIFIED MDSS GMBH Schiffgraben 41 30175 Hannover Germany Telephone 49 5103 939430 Moving Rehabilitation Forward ...

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