Introducing the.. Flex-Mate

Transcription

1 Introducing the.. Flex-Mate

2 Product Description The purpose of the Flex-Mate K500 is to provide continuous passive motion to the knee or hip joint to increase range of motion (ROM), circulation, and to prevent scarring in the joint. The Flex-Mate K500 is an anatomically aligned CPM which mirrors the path of the knee as it goes through its range of motion from full or hyperextension through full flexion.

3 Safety Precautions Use only manufacturer approved parts and maintenance procedures to service the unit. Refer to the Flex-Mate K500 Service Manual. Read and adhere to all warnings and instructions listed on the Flex-Mate K500 and in the Users Manual. If you suspect the Flex-Mate K500 is not working properly, unplug the unit and refer to the Service Manual. If you detect a flaw of any type in the power cord, immediately unplug the transformer from the wall. Use only the external power supply provided with the Flex- Mate K500 in order to meet the requirement of UL

4 Selected Specifications Weight Range of Motion Safety Pause Approximately 26 lbs. -10 extension to 120 flexion UL/C-UL ; UL , UL 1431 CSA C22.2 / No seconds at maximum extension/flexion Standard Configuration Pediatric Configuration Limb Length in. (77 107cm)

5 Physical and Electrical Specifications Size Setup for Use: Length 39 Width 13 Height 22 Weight: Without accessories 26 lbs With accessories 27 lbs Fully packaged 34 lbs Electrical Specifications: Input 120 VAC 60Hz 25W Standards Compliance: Designed to conform to applicable requirements of: UL , UL 1431 CSA C22.2 / No

6 Flex-Mate K500 - Overview Please familiarize yourself with all the components and the operation of the Flex-Mate K500 device prior to setting up a patient or beginning therapy. Flex-Mate K500 Knee CPM

7 Package Contents: 1 Flex-Mate K500 CPM 1 Users Manual 1 Service Manual 1 Package of soft goods (4- pieces) 1 Tape measure 1 Small bottle of lubricating oil

8 Flex-Mate K500 - Overview Features: Programmable R.O.M. (-10 Full ext Full flex) Anatomical motion Lightweight design (26 lbs.) Easy patient set-up User friendly controls Patient Lock-out feature Integrated carrying handle Universal left / right design High quality soft goods that are easy to attach TKR / ACL / adult / pediatric / sports medicine applicable Adult / pediatric foot cradle conversion Ideal for home & hospital settings

9 Product Overview Foot Plate Power On/Off Switch (on back of unit) Foot Pad Tibial Pad Thigh Strap (not shown) Tibial Carriage Femur Pad Hand-held Controller Carrying Handle Femoral Carriage Femur Scale

10 Product Overview Potentiometer Foot Plate Adjustment Knob Tibial Cradle Adjustment Knob Thigh Cradle Adjustment Knob

11 Set Up Instructions 1. Open the shipping container and set aside the soft goods bag. Lift the Flex- Mate K500 from the box and place it where it is to be used. Top Side

12 Set Up Instructions 2. Plug the wall transformer into a grounded 110/120 volt AC wall outlet close to the machine. Grounded Wall Outlet Note: (Use of an extension cord is not recommended) 3. Locate the power switch (at the back of unit) and press to the On position. Transformer On/Off Switch

13 Set Up Instructions 4. Upon turning the unit On you should hear and audible beep and the LCD Display should light up on the Control Pendant LCD Display

14 Set Up Instructions 5. Using the hand-held controller, press the Start/Stop button. Bring the machine to between 45 and 90 of flexion. (See Handheld Controller Operating instructions. This allows the soft goods to be applied easier. Control Pendant (45-90 ) Flexion Start/Stop Button

15 Flex-Mate Soft Good Kit 6. Open the bag containing the soft good kit and identify the different pieces that make up the kit. Note: There are (3) Velcro straps on the Tibial pad and (2) on the Femoral pad. (Back Side) Boot Tibial Pad Auxiliary Strap (Wraps around Thigh) Femoral Pad Pillow

16 Set Up Instructions 7. Secure the patient pads to the machine. The foot pad has a pocket that slips over the Foot Plate. The Tibia and Femoral pads have Velcro straps that fit around the corresponding cradle and secure to the back side of the pad itself. Pocket Velcro Straps Femur Pad Foot Pad (Boot) Tibial Pad

17 Set Up Instructions 8. Next (using the tape measure provided) measure the patient s involved leg. Measure in centimeters from the hip joint to the midline of the knee joint. (Hip Joint) (Joint line of Knee) This measurement will be transferred to the femoral carriage of the device.

18 Set Up Instructions 9. Loosen the femoral knobs on each side of the device. Femoral Knob Adjust the femoral cradle so the measurement of the patients leg (centimeters) matches that on the femur scale. (both sides) Femur Scale Retighten the femoral knobs. Femur Scale in centimeters

19 Set Up Instructions 10. Next - Loosen the adjustment knobs on the tibial cradle. Tibial Adjustment Knob Slide the foot plate out to a length greater than the patient s lower leg. Note: You can either eye-ball or actually measure the patient s affected limb from the joint line of the knee to the heel of the foot. (Joint line of Knee) (Base of Heel)

20 Set Up Instructions 11. Prior to starting the machine, follow the Hand-held Controller Operating instructions to set the flexion, extension, speed and pause duration to the doctors prescribed settings. Without the patient in the device, Start the unit and run a complete cycle to ensure that it functions properly. Users Manual Run a complete cycle

21 Set Up Instructions 12. When ready to place the patient s leg into the CPM carriage, press Start/Stop on the control pendant. Allow the device to run until it reaches 0 of extension or until the leg carriage is straight. This makes putting the patient s leg into the carriage easier and typically is more comfortable for the patient, as well. 0 or Straight Start/Stop

22 Hand-held Controller Operation 1. Set Range of Motion Hold down FLEX or EXT button and simultaneously press the UP or DOWN arrow button to set the limits. Upon releasing the UP or DOWN arrows this becomes the end parameter setting. Full range is from -10 extension to 120 flexion. EXT and UP or DOWN (Simultaneously) FLEX and UP or DOWN (Simultaneously)

23 Hand-held Controller Operation 2. Set Speed Hold down SPEED and simultaneously press the UP or DOWN arrow to set speed. Upon releasing the UP or DOWN arrows this becomes the end parameter setting. Depress Simultaneously Speed can be adjusted in 10 degree increments ranging from 30 (slow) per minute to 150 (fast) per minute. SPEED and UP or DOWN

24 Hand-held Controller Operation 3. Set Pause Hold down DELAY and simultaneously press the UP or DOWN arrow to set the length of time the unit will pause at the flexion and extension limits. (It will pause at both limits) Depress Simultaneously Upon releasing the UP or DOWN arrows this becomes the end parameter setting. SPEED and UP or DOWN Delay range is from 0 seconds to 30 seconds.

25 Hand-held Controller Operation 4. Begin Motion Press START/STOP to begin motion. Press START/STOP again to stop motion. Note: Upon restarting the unit it will move in the opposite direction than prior to stopping. Press START/STOP to begin or stop motion

26 Hand-held Controller Operation 5. Set Lock-out Press both the UP and DOWN arrows at the same time to lock the settings, and again to unlock. Lock out Dot Depress Simultaneously When locked, a dot will show in the lower right corner of the display. Note: Lock-out mode is retained even when power is turned off. Press START/STOP to begin or stop motion

27 Hand-held Controller Operation 6. Simplified Instructions Are located on the backside of the control pendant for easy reference. Instructions for setting Flexion, Extension, Speed, Pause, and Start/Stop are listed.

28 Set Up Instructions (Positioning the Patient) 1. The machine is now ready to be fit to the patient and to begin rehabilitation. With the patient lying on the bed, couch or floor - support and then lift the patients affected leg. Slide the unit under the patients affected limb and then place into the carriage of the device. Note: This is easier to do with two people helping.

29 Set Up Instructions (Positioning the Patient) 2. Upon placing the patients leg in the machine, make sure the patients knee is aligned with the joint or center axis of the machine. Knee Axis Align patients knee axis to center axis of device

30 Set Up Instructions 3. Adjust the length of the tibial carriage so the footplate meets the sole of the patient s foot. You should be able to place your fingers between the bottom of the patient s foot and the footplate. (Positioning the Patient) Fingers width between footplate and patients foot Tighten Knobs Tighten the Tibial Carriage adjustment knobs. Tibial carriage length adjustment

31 Foot Plate Adjustment (For Plantar / Dorsi-flexion) 1. The foot plate can be adjusted for plantar/ dori-flexion so it s comfortable for the patient. Normally in a straight (90 ) or slightly Plantar flexed position as when lying down. Footplate - Straight Footplate Plantar Flexed

32 Foot Plate Adjustment A. Plantar / Dorsi-flexion (For Plantar / Dorsi-flexion) Loosen the adjustment knobs on each side of the foot plate. Adjust the foot plate to the desired degree of plantar or dorsi-flexion. Plantar Flexed Adjustment Knob Dorsi-Flexed Retighten knobs. Adjustment Knob

33 Foot Plate Adjustment (For Internal / External rotation) 1. The foot plate can also be rotated internally or externally for patient comfort or to help the leg from rotating in the carriage. This allows the device to track the axis of the patients knee more accurately. Ultimately this provides a truer therapy. Inverted Adjustment Knob Adjustment Knob Everted

34 Foot Plate Adjustment (For Internal / External rotation) A. Internal / External Rotation Everted Loosen the adjustment knob on the foot plate. Adjust the foot plate to the prescribed degree of internal/external rotation. Retighten knob. Inverted Adjustment Knob Adjustment Knob

35 Foot Plate Adjustment (For Pediatric or Small Adult tibial length) Note: In situations where you are fitting a small adult or pediatric patient then you might need to convert the foot cradle for this type of application. This will allow you to more accurately fit the patient and provide a better overall therapy. Adult Set Up Pediatric Set Up

36 Foot Plate Adjustment (For Pediatric or Small Adult tibial length) Remove Footplate 1. Remove the adjustment knob on the bottom (back) of the foot plate. Remove Knob Next, remove the foot plate itself. Footplate Removed

37 Foot Plate Adjustment (For Pediatric or Small Adult tibial length) 2. Rotate the foot plate bracket inward 180 as shown.

38 Foot Plate Adjustment (For Pediatric or Small Adult tibial length) 3. Reattach the foot plate to the foot plate bracket. Adjust for plantar/dorsiflexion and internal/external rotation as needed. To convert back to the adult configuration just reverse the steps you completed.

39 Set Up Instructions Wrap the Auxiliary (thigh) strap around the patients thigh and the femoral carriage of the device. This helps secure the patient s leg in the carriage of the Flex- Mate K500 and keep the knee axis in line with the axis of the machine. Auxiliary Strap Apply strap around patients thigh and femoral cradle

40 Set Up Instructions With the patient set-up in the device properly, push the Start/Stop button and watch it run through a complete cycle at the prescribed settings. If the knee joint does not mirror the movement of the machine axis (joint), adjust the femur or tibial carriage and/or Foot cradle to keep the knee in the proper alignment. Knee Axis Axis of Machine

41 Optional Accessories 1. Hospital Bed Fixture The Flex-Mate K500 Hospital Bed Fixture may be purchased optionally to attach the K500 to a hospital bed utilizing a standard hospital traction clamp. The Hospital Bed Fixture is used to provide additional stability of the unit while used in a bed. Hospital Bed Mount

42 Optional Accessories 2. Hospital Bed Fixture Attach the Hospital Bed Fixture to the K500 by sliding the fixture into the tubes located at the end of the K500 as shown. Knobs Tighten Knobs Fixture Tubes Hospital Bed Fixture Insert and tighten the knobs included with the fixture as shown. Slide Fixture into Tubes

43 Optional Accessories 3. Hospital Bed Fixture Position the K500 on the bed in the appropriate position and attach to a bed mounted traction bar using standard traction fittings. Note: Do not carry the K500 by the Hospital Bed Fixture.

44 Cleaning and Maintenance With unit unplugged clean housing and leg carriage with a mild soap solution and dry thoroughly. Refer to the Service Manual for recommended maintenance. CAUTION: Avoid getting water inside the housing as it may damage the electrical components.

45 Routine Maintenance Monthly Inspect general condition of unit. (frayed cords, housing integrity, Velcro, belt wear) replace as necessary. Oiling Instruction Label Apply 3 drops of oil (provided in box of new unit) to the oiling felt located in the nut housing. Clean housing & leg carriage with a mild soap solution and dry. Location of oiling felt in nut housing

46 Basic Troubleshooting (During Warranty Period) No pendant display. Pendant displays Err. Pendant adjustments inoperative, but display on. Unit will not start, or it starts then stops Cannot change pendant settings. Check that the wall outlet has power. Check power switch-on. Turn power off, wait 5 seconds, and turn power back on. Check all connections at the P.C. Board. Check pendant settings. Check belts. Refer to User s Manual regarding locking feature. NOTE: If the above solutions do not work or for other problems not listed, call KLC Services, Inc. Any actions other than those listed above will void the warranty.

47 Contact Information KLC Services, Inc. Corporate Head Quarters 4038 Weaver Court East Hilliard, OH USA (866) (Free) (614) (Ph) (614) (Fx) Mark Reep Kay Reep CPM Sales Mgr. Office Mgr. Website:

48 Strength Through Motion Flex-Mate