JACE K100-A Knee CPM Operating Manual
Contents
1. STEP 2 APPLYING SOFTGOODS 1 Each set of softgoods includes A Calf Support Pad B Thigh Support Pad C Ankle Boot D Knee Extension Straps 2 2 Attach the Thigh Support Pad B and Ankle boot C as shown in photo on page 7 Velcro strips have been provided on the Thigh Support Plate and Foot Plate to keep soft goods securely in place 3 Fitthe Calf Support Pad A by wrapping the Velcro straps around the K100 A carriage as shown by simply fastening to the underside of the pad 4 The optional Knee Extension Straps D include an elastic strap with a Velcro closure This helps to maintain proper knee alignment CARE CLEANING Softgoods are made of a washable synthetic fleece material for easy care and patient com fort NOTE Each softgoods kit is in tended for use by one patient only NOTE Softgoods International are applied in the same way Softgoods must be washed and disinfected in between patient use STEP 3 PATIENT FITTING L Ankle Angle Adjustment Knob s C Foot Plate J Calf Leg length Pivot Knob s K Thigh Length Adjustment Knob s 1 Prior to fitting patient position the carriage approximately at 30 of flexion IMPORTANT If the K100 A isn t in this position advance to Step 75 Section B Setting Parameters With Carriage in Motion see page 11 to reposition carriage 7 Tighten all adjustment knobs securely 8 The K100 A features a non skid base which is designed to ope2. DESIGNED TO MEET ALL 60601 SAFETY REQUIREMENTS FOR USE ONLY WITH JACE HAND HELD CONTROLLER USE ONLY WITH JACE SUPPLIED POWER CORD TO AVOID INJURY USE ONLY AS PRESCRIBED BY YOUR PHYSICIAN CORD MAKE SURE THE VOLTAGE SELECTION IS SET TO THE CORRECT VOLTAGE FOR YOUR COUNTRY N BEFORE CONNECTING THE POWER STEP 1 UNPACKING THE UNIT 1 After unpacking the K100 A check for the following components JACE K100 A Base Unit e Hand Held Controller Patient Override Switch One set of Softgoods Power Cord User Manual Accessory Bag NOTE These items can be stored in the accessory bag SAVE ALL PACKING MATERIAL FOR FUTURE SHIPPING REQUIREMENTS 2 Power switch located on the side of the Base Unit with the handle should be in the OFF position 3 Connect the controller to the Base Unit by plugging into the compartment as shown in the photo above Tighten thumb screws on either side of plug 4 Connect the power Cord to the Base Unit before closing lid carefully align cords to match up to exit slots molded into compartment lid 5 OPTIONAL To use PATIENT OVERRIDE SWITCH plug into receptacle See photo on page 2 6 Plug Power Cord into a standard grounded AC wall outlet 7 Slide the SET RUN switch on the Hand Held Controller to the SET Position REFER TO ALL SAFETY PRECAUTIONS PRIOR TO USE 8 Unit is ready for operation Set Power Switch to ON position S NOILIVHidoO
3. zZ Universal CPM K100 A TM e e AP o u u n za px Ss T E NT For Additional Information Call PONE 1 800 800 4CPM SUPERIOR BY DESIGN i T i 856 669 6600 Fax 800 236 2308 International Fax 001 1 856 669 6606 5 Rockhill Road Suite 2 uu Cherry Hill New Jersey 08003 Copyright 2011 JACE SYSTEMS 94MA0306 Rev A p OPERATING MANUAL We SUPERIOR BY DESIGN SUPERIOR BY DESIGN JACE Universal Reference Description CPM K100 A IEC 60417 5032 AC IEC 60417 5021 Earth Ground IEC 60417 5008 Off Power COMPONENTS 2 TROUBLESHOOTING 12 IEC 60417 5010 On Power PRODUCT DESCRIPTION 4 CARE AND CLEANING 13 OPERATIONS 5 REPLACEMENT PARTS 13 IEC 60417 5840 Type B Applied Part Step 1 Unpacking the Unit 5 Step 2 Applying Softgoods 6 LIMITED WARRANTY 13 f Step 3 Patient Fitting 6 SPECIFICATIONS 14 ISO 7010 W001 General Warning Sign Step 4 Controller Operations 8 Step 5 Setting Parameters 10 PRECAUTIONS 15 ISO 7000 1641 Follow Operating Instructions NOTES 16 or Consult instructions for use S IN INOO BASE UNIT onmo ou gt KNEE PIVOT FOOT PLATE FOOT PLATE PIVOT THIGH SUPPORT PLATE POWER SWITCH ON OF
4. Suitable for continuous operation User Profile Health Care Professional JACE Repre sentative end user patient The age of the patient ranges from children to adults of all ages The patient may use the JACE K100 A Knee CPM at a hospital doctors office related health care facility or home under the prescription of a physician A WARNING Use of the K100 A may cause the following e Bleeding of Wound Opening of Stitches e Chafing of Leg e Discomfort as range of motion is increased Contact you physician if any of these conditions occur MODIFICATIONS A WARNING DO NOT modify this equipment without authorization from JACE Systems The replacement parts listed are the only user replaceable parts All other parts MUST be replaced by JACE personnel ONLY Modification other than the replacement parts listed could cause damage to the equipment and Will void the warranty J N WARNING e Read understand and practice the precau tionary and operating instructions found in this manual before operating or using the unit Know the limitations and hazards asso ciated with using the K100 A Continuous Passive Motion CPM Therapy Unit Observe any and all precautionary and operational decals placed on the unit Only use the K100 A on firm flat level surfaces Extreme caution should be taken when in use with or around children Use the K100 A only for its intended purpose as described in this
5. UP DOWN Used to reset a displayed parameter Depress the UP button to increase or DOWN button to decrease a selected parameter Constant or intermittent pressure on the button will vary the speed of change e FORCE Allows the force of the K100 A to be customized for each patient Different forces can be set for flexion and extension Minimum Force is setting 1 Maximum Forces is setting 10 e PAUSE Allows K100 A to stop at the end of the flexion and extension cycle Pause can be different for flexion and extension Minimum Pause is 0 00 Maximum Pause is 9 59 e TIME RESET The accumu lated run time is displayed in minutes This can be used to monitor patient compliance To Reset Time see Setting Parameters as described in Step 5 Section A 15 RUN MODE FUNCTION BUTTONS e SPEED Used with UP DOWN button s Controls the speed of the K100 A e GO STOP BUTTON Pressing this button will start or stop operation of the K100 A Pressing button a second time in succession reverses the direction of travel e PATIENT OVERRIDE SWITCH The PATIENT OVERRIDE SWITCH performs the same function as the GO STOP button IMPORTANT BUILT IN SAFETY FEATURE During the first two cycles of operation the K100 A records actual patient force profiles for every 16 through flexion and extension Any deviation caused by a freign obstacle in the path of the carriage or significant patient resistance during operation
6. UP time 18 To bypass the WARM UP feature position the SET RUN button to the SET position Press the PAUSE and TIME RESET buttons simultaneously Release the TIME RESET button first then the PAUSE button Press the DN or UP button until WARM UP TIME displays zero NOTE If any parameters are changed during WARM UP treatment WARM UP will reset to the beginning NOTE Pause and Muscle Stimulation will not operate during WARM UP period B Setting Parameters With Carriage in Motion This mode is preferred for fitting patients who are experiencing extreme pain or anxiety 1 Press either EXT or FLEX button 2 Once the window displays the respective message Or Press and HOLD the FLEX OR EXT button S NOIILIVHidoO 11 NO TROUBLE SHOOTING 3 Then use the UP DOWN button s to move the K100 A carriage to the desired position NOTE While setting parameters with Carriage in Motion the previous limit value on the display will jump to the current angular position as the UP DOWN button s is pressed IMPORTANT When setting parame ters with carriage in motion DO NOT at tempt any fine tuning with patient in device RUN MODE To start or restart the K100 A use the RUN MODE Once the RUN MODE is selected all pre set parameters are stored in memory even after the K100 A has been turned off unplugged or in the event of a power failure 1 Position the SET RUN button
7. select the following operations e SET MODE Allows selection and adjustment of all operation parameters e RUN MODE Locks in preset parameters for required operation of the K100 A F PLUG IN Plug In for external device such as a Neuromuscular Electrical Stimulator NMES At the end of travel for each parameter FLEX EXT the K100 A has a pause function which is designed to interface with compatible external devices The pause can be set for up to ten minutes The Time indicator on the LCD display window switches to a countdown configuration during the pause AN PLUG INS ARE FOR NMES ONLY IMPORTANT Once the RUN MODE is selected all pre set parameters are stored in memory even when the K100 A has been turned off un plugged or in the event of a power failure SET MODE FUNCTION BUTTONS e FLEX Displays the pre set angle for maximum UP DOWN button s allows a new parameter limit to be set e EXT Displays the pre set angle for maximum Extension Limit Used with the UP DOWN button s allows a new parameter limit to be set NOTE These functions are normally set without carriage in motion An alternate mode permits setting with motion as described in Step 5 Section B Setting Parameters With Carriage in Motion see page 11 e SPEED Used with the UP DOWN button s to set the desired speed that the K100 A performs each cycle Speed is directly related to range of motion e
8. the customer s use of parts fittings or accessories not specified by JACE Systems or from service or modification performed by unauthorized personnel JACE Systems shall not be liable for incidental or consequential damages including loss or use property damage or to the extent allowed by law personal injury which results from breach of warranty This warranty is in lieu of all other warranties expressed or implied including warranties or merchantability and fitness for particular purpose PREVENTATIVE MAINTENANCE Preventative Maintenance includ ing calibration lubrication and electrical safety checks should be performed yearly by JACE Authorized Personnel ONLY Please contact JACE Systems to schedule maintenance DISPOSAL There are no risks associated with disposal of the JACE K100 A or any accessories at the end of the service life of the equipment 10 years 13 ee N Uu Designation Medical Devices SPECIFICATION Model K100 A Intended Use The JACE K100 A is a CPM Continuous Passive Motion device intended for use in a hospital doctors office related health care facility or home under the prescription of a physician for physical rehabilitation of the lower extremity Classification JACE Systems K100 A complies with the following Safety Standards UL 60601 1 IEC EN 60601 1 IEC EN 60601 1 2 Meets MDD 93 42 EEC CE 1984 Electrical Safety Class Type B Applied Parts Class
9. will be instantly detected and the K100 A will automatically reverse direction The amount of force required to cause detection is controlled by the FORCE setting NOTE The unit MUST run 2 complete cycles before the force profile will be set NOTE Storage and Transport Temperature 22 F to 160 F 30 to 70 C Running Temperature 0 to 160 F 18 to 70 C Running Environment Temperature 50 to 104 F 10 to 40 C Min Max Voltage 100V or 120V Service 90 VAC to 135 VAC 50 60Hz 220V Service 185 VAC to 260 VAC 50 60Hz Maximum Power 30 Watts S NOIILIVHidoO 10 STEP 5 SETTING PARAMETERS SET MODE All adjustments to the Range of Motion Limits must be made in the SET MODE 1 Position the SET RUN button to the SET position 2 Turn Power Switch located on base unit to ON The following message will appear on the display Followed by Select Parameters NOTE The FLEX Limit Setting must be set one degree greater than the EXT Limit A Setting Parameters Without Carriage in Motion 1 Press the EXT button to display the current setting The display will show the extension range of motion Limit from 3 to 129 2 Press the UP DOWN button s to set the desired Extension Limit 3 To set the Extension Pause while in the Extension Mode depress the Pause Button to display the current setting 4 Press the UP DOWN button s to set the desired Extens
10. 16 Any deviation caused by a foreign obstacle in the path of the carriage or any significant patient resistance during operation will be instantly detected and the K100 A will automatically reverse direction The speed of the carriage is con tinuously adjusted to maintain a Con stant Angular Velocity This insures maximum patient comfort and prevents the possibility of Free fall or sudden hyperextension The K100 A features a Hand held Controller which allows the operator patient to remotely control all K100 A operations The Controller is used to set execute and monitor angle param eters for flexion and extension within a 1 2 tolerance It also controls the speed of the K100 A which can be adjusted up or down The K100 A is designed to easily interface with external devices such as neuromuscular electrical stimulators These plug directly into the base of the Controller An optional PATIENT OVERRIDE SWITCH is included This performs the same functions as the GO STOP Button when plugged into the K100 A SAFETY PRECAUTIONS THE JACE K100 A IS INTENDED FOR PHYSI CIAN PRESCRIBED USE ONLY BEFORE ACTUAL USE READ OPERATING MANUAL KEEP OVERRIDE SWITCH OR HAND CONTROLLER WITHIN PATIENT S REACH ONLY USE IN THE RECOMMENDED RUNNING TEMPERATURE ENVIRONMENT CONTACT JACE SYSTEMS REPRESENTATIVE FOR REQUIRED SERVICE OR MAINTENANCE DO NOT OPERATE THE JACE UNIVERSAL K100 A IN THE PRESENCE OF FLAMMABLE ANESTHETICS
11. F FRAME ANGLE INDICATOR JACK FOR PATIENT OVERRIDE SWITCH CARRYING HANDLE CARRIAGE FRAME CALF LEG LENGTH ADJUSTMENT KNOB S THIGH LENGTH ADJUSTMENT KNOB S ANKLE ANGLE ADJUSTMENT KNOB S ACCESSORIES A POWER CORD B PATIENT OVERRIDE SWITCH C ACCESSORY BAG SOFTGOODS USA A B C D CALF SUPPORT PAD THIGH SUPPORT PAD ANKLE BOOT KNEE EXTENSION STRAPS 2 SOFTGOODS International A CALF SUPPORT PAD B THIGH SUPPORT PAD C ANKLE BOOT CONTROLLER A mO OU LCD LIQUID CRYSTAL DISPLAY WINDOW CONTROL BUTTONS GO START BUTTON SET RUN SWITCH EXTERNAL DEVICE JACKS 2 FOR NEUROMUSCULAR ELECTRICAL STIMULATOR S LN3NOdMWO Oo N PRODUCT DESCRIPTION JACE Universal CPM K100 A THE JACE UNIVERSAL K100 A is a lower extremity CPM Continuous Passive Motion system for rehabilita tion therapy The K100 A integrates a 4 bar link hinge system that extends the Flexion ROM to 130 degrees The 4 bar link system also provides a more anatomical ROM that mimics a more natural movement The K100 A is engineered for in bed use featuring the most advanced technology for safe and reliable patient operation It provides an adjustable range of motion from 3 hyperexten sion to 130 of flexion The K100 A has been engineered for ultimate patient comfort and safety During the first two cycles of operation the K100 A records the force exerted by each individual patient s leg for every
12. ection indicates the proper AC voltage Check Parameters or Select Parameters If this appears e Switch to the SET MODE and select parameters as usual CARE CLEANING CAUTION Disconnect unit from power when cleaning Do not immerse the unit Avoid spilling liquids or other contami nants into the moving parts or electrical components of the K100 A The surfaces of the K100 A may be wiped with a soft cloth or sponge dampened with a mild soap solution A 10 1 part bleach to 10 parts water solution of household bleach Sodium Hypochlorite and water may be used as a disinfecting wipe Dry all sur faces with a clean soft cloth after applying any cleaning solutions REPLACEMENT PARTS Description Part No Softgood Kit USA MS9916 Softgood Kit International 93KA0801 Hand held Controller 11CA01 User manual 94MA0306 Rev A Power Cord 55AA1301 Patient Override Switch 55AA1101 Anti Slip Pads 93RA0101 LIMITED WARRANTY The JACE Model K100 A CPM is warranted against defects in material and workmanship for one 1 year from date of initial purchase During the warranty period parts will be repaired or replaced by JACE Systems at no charge to the customer when such defective parts have been properly packaged and returned prepaid to JACE Systems This warranty is rendered void if damage to the unit is a result of mishan dling misuse or abuse Furthermore no warranty will apply to damage result ing from
13. ence of medication must be constantly attended and monitored while the K100 A is in use The K100 A unit must be completely visible at all times during use Never cover the unit with bedding or any other means of concealment while in operation SNOILN V OJ Ud d 15 SALON TY
14. ion Pause 5 To set the Extension Force while in the Extension Mode depress the Force Button to display the current setting 6 Press the UP DOWN button s to set the desired Extension Force 7 Press the FLEX button to display the current setting The display will show the flexion range of motion limit from 2 to 130 8 Press the UP DOWN button s to set the desired Flexion Limit 9 To set the Flexion Pause while in the Flexion Mode depress the Pause Button to display the current setting 10 Press the UP DOWN button s to set the desired Flexion pause 11 To set the Flexion Force while in the Flexion Mode depress the Force Button to display the current setting 12 Press the UP DOWN button s to set the desired Flexion Force 13 Press SPEED button to display the current setting 14 Press the UP DOWN button s to set the desired speed 15 To reset the Run Time press the Time Reset Button followed by either the UP DOWN button s Time will automatically reset to zero on the controller display 16 WARM UP consists of 1 to 255 minutes of CPM at 50 of programmed Range of Motion This will increase to 100 of the programmed Range of Motion ROM during selected WARM UP session 17 To program WARM UP time position the SET RUN button to the SET position Press the PAUSE and TIME RESET buttons simultaneously Release the TIME RESET button first then the PAUSE button Program the desired WARM
15. manual Turn power switch off before unplugging unit from its power source Do not use the cord to unplug the power cord from the unit Grasp at the power cord base Use care when carrying transporting or storing the K100 A unit to prevent damage to the unit from dropping or improper transport and storage methods N WARNING U S Federal law restricts this device to sale by or on the order of a physician or licensed practitioner e Make certain that the unit is electrically grounded by connecting only to a grounded electrical service receptacle conforming to the applicable national and local electrical codes Keep hair loose clothing loose bedding fingers and toes away from the hinge components of the unit Do not use the K100 A outdoors or on wet surfaces Use only on firm flat stable level surfaces to ensure stability of the unit while in operation K100 A has been designed for protection against the exposure of urinary incontinence Precautionary measures should still be taken when any type of liquid comes in contact with an electrical apparatus N WARNING Exercise caution when using accessories and auxiliary devices such as muscle stimulators cold packs and other modalities Route lead wires hoses tubes etc away from the working mechanism of the K100 A to help prevent damage to the K100 A and any other modality used with it Unconscious patients or patients under heavy influ
16. rate securely for in bed applications IMPORTANT Do not attempt any fine tuning adjustments of the carriage during the Pause Mode 2 With the tape measure determine the 5 Using this distance adjust the distance between the gluteal crease position of the Foot Plate accordingly Em Space PER eadem 6 Position the patient s leg in the K100 A and make final adjustments 3 Using this distance adjust Thigh as needed for the thigh and lower Length Adjustment Knob s K leg lengths Using the Ankle Angle on both sides of the K100 A Tighten Adjustment Knob s L and the Knobs Foot Plate Pivot Knob C adjust the angle and rotation to best satisfy 4 Measure the length of the patient s i patient comfort leg from the knee to 74 beyond the bottom of the foot See diagram to the left S NOIILIVHidoO STEP 4 CONTROLLER OPERATION A TIME Displays Accumulated Run Time in Minutes Pause Countdown At the end of travel for each parameter EXT FLEX the TIME indicator switches to a pause countdown configuration The Time can be reset for each new patient B EXT Displays the pre set Extension Limit in angular degrees C ANGLE Displays the exact angle of the carriage at any given time during operation D FLEX Displays the pre set Flexion Limit in angular degrees Flashing display for EXT FLEX Indicates the current direction of travel E SET RUN SWITCH This 2 position switch allows you to
17. to the RUN position 2 When the K100 A is ready for operation the display will read Push GO to Start 3 Press the GO STOP button or PATIENT OVERRIDED SWITCH The K100 A will start carriage operation The GO STOP button or PATIENT OVERRIDE SWITCH can be pressed during operation to stop the K100 A at anytime Once the GO STOP button or PATIENT OVERRIDE SWITCH is pressed again the K100 A will restart in the opposite direction ERASING FORCE PROFILES Unplugging the unit and or switching POWER switch to OFF position will immediately erase the current force profiles The speed button s are operative during the first two cycles while the force profiles are recorded TROUBLE SHOOTING Set Orth UP This message will appear when the K100 A carriage is outside the Range of Motion Limits while in the RUN MODE e Simply press and hold the UP button This will readjust the K100 A carriage within the pre set Range of Motion and automatically stop The following will then appear in the Display Push GO to Start No Orthosis or Orthosis Dif gt If this appears after turning power on e Check to see if the Controller cable is properly connected to the Base Unit Low Power gt 10 4V ATTENTION CORRECTIVE ACTION REQUIRED This indicates the power supply is inadequate e Check all power cables and connections Have an electrician check the AC outlet e Check that the factory preset voltage sel
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