KLC FLEX-MATE K500 User manual

USER’S MANUAL
P/N 1.07080 Revision G 1 of 8
4038 Weaver Court East
Hilliard, OH 43026
Ph: [phone]
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Toll Free: [phone]
®

P/N 1.07080 Revision G 2 of 8
IMPORTANT SAFEGUARDS
When using electrical products, especially when children are present, basic safety precautions should always be followed, including the following:
READ ALL INSTRUCTIONS AND WARNINGS PRIOR TO OPERATION.
DANGER: TO REDUCE THE RISK OF ELECTROCUTION:
Always unplug this product immediately after using.
Do not use while bathing.
Do not place or store product where it can fall or be pulled into a tub or sink.
Do not place in or drop into water or other liquid.
Do not reach for a product that has fallen into water. Unplug immediately.
WARNING: TO REDUCE THE RISK OF BURNS, ELECTROCUTION, FIRE, OR INJURY TO PERSONS:
A product should never be left unattended when plugged in.
Close supervision is necessary when this product is used by, on, or near children or invalids.
Use this product only for its intended use as described in this manual. Do not use attachments not recommended by the manufacturer.
Never operate this product if it has a damaged cord or plug. If it is not working properly, if it has been dropped or damaged, or dropped into water.
Return this product to a service center for examination and repair.
Keep the cord away from heated surfaces.
Never use while sleeping or drowsy.
Never drop or insert any object into any opening,
Do not use outdoors or operate where aerosol (spray) products are being used or where oxygen is being administered.
Connect this product to a properly grounded outlet only. See grounding instructions.
CAUTION: This equipment may cause electromagnetic or other interference between other devices. If this occurs, move the device away from the affected
equipment.
CAUTION: Federal law restricts this device to sale by or on the order of a licensed health care practitioner.
CAUTION: Work in a range of motion as instructed by your healthcare practitioner.
CAUTION: If you experience increased pain, swelling, or any adverse reactions while using this product, immediately consult your health care practitioner.
WARNING: Set up and use of this equipment should be in a low traffic location and away from children and pets.
WARNING: Pinch points exist during assembly; use caution and assemble pursuant to the instructions.
WARNING: Make sure the hand control is accessible to the operator before starting this equipment. The stop button on the hand control is the only way of
stopping the motion for disabled patients or children using the unit.
WARNING: Maximum rated load is 45 lbs.
CONTRAINDICATIONS:
USE OF CPM THERAPY IN GENERAL SHOULD BE AVOIDED OR DISCONTINUED, AT LEAST TEMPORARILY, IF SIGNS OF HYPERTHERMIA,
IRRITATION, SWELLING, BLEEDING, OR INCREASED OR PERSISTENT PAIN ARE OBSERVED. ACUTE INFLAMMATORY CONDITIONS, SUCH AS
ACUTE ARTHRITIS, OR DESTRUCTIVE BONE OR JOINT DISEASES, SHOULD NOT BE TREATED WITH CPM. PRODUCT IS LATEX FREE.
CAUTION: It is important to install and use this equipment in accordance with the instructions, to prevent harmful interference to other devices in the
vicinity. If this equipment does cause harmful interference to other devices, which can be determined by turning the equipment off and on, the
user is encouraged to try to correct the interference by one or more of the following measures:
 •Reorientorrelocatetheotherdevice(s).
 •Increasetheseparationbetweentheequipment.
 •Connectthisequipmentintoanoutletonacircuitdifferentfromthattowhichtheotherdevice(s)areconnected.
 •Consultthemanufactureroreldservicetechnicianforhelp.
SAVE THESE INSTRUCTIONS
USER’S MANUAL

P/N 1.07080 Revision G 3 of 8
Table 2. Physical and Electrical Specifications
Grounding Instructions:
This product should be grounded. In the event of an electrical short circuit, grounding reduces the risk of electric shock
by providing an escape wire for the electric current. This product is equipped with a cord having a grounding wire with a
grounding plug. The plug must be plugged into an outlet that is properly installed and grounded.
DANGER—Improper use of the grounding plug can result in a risk of electric shock.
Check with a qualied electrician or serviceman if the grounding instructions are not completely understood, or if in doubt as
to whether the product is properly grounded.
This product is factory equipped with a specic power supply to permit connection
to a proper electric circuit. Make sure that the product is connected to an outlet
having the same conguration as the plug. No adaptor should be used with this
product. Do not modify the plug provided—if it will not t the outlet, have the
proper outlet installed by a qualied electrician.
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 this 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 aw of any type in the power cord, immediately unplug the transformer from wall.
• Use only the external power supply provided with the FLEX-MATE®K500 in order to meet the requirement of UL 60601-1.
Package Contents:
1 FLEX-MATE®K500
1 Users Manual
1 Service Manual
1 Package of soft goods
1 Tape measure
Product Description:
The purpose of the FLEX-MATE®K500
is to provide continuous passive motion to the knee or hip joint to increase
circulation, range of motion, 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 hyper-extension through full exion.
Table 1. Symbols used on the FLEX-MATE
®K500
UL/C-UL Classication with respect to electric shock, re, and mechanical hazards only in accordance with UL
60601-1/CAN/CSA C22.2 No. 601.1. Meets UL 1431 Standards for Personal Hygiene and Healthcare Appliances.
Symbol
Direct Current
Attention: Consult User’s manual before use.
Class I, Type B, Continuous Operation.
Not suitable with flammable anesthetics.
Description
Size Setup for Use:
Length
Width
Height
Weight:
Without accessories
With accessories
Fully packaged
Electrical Specifications:
Input
Environmental Requirements:
Temperature:
Operating
Transport & Storage
Humidity:
Operating
Transport & Storage
Atmospheric Pressure:
Standards Compliance
39”
13”
22”
26 lbs.
27 lbs.
34 lbs.
120 VAC 60Hz 25 W
50oF to 95oF (10oC to 35oC)
-40oF to 158oF (-40oC to 70oC)
30 – 75% R.H.
10 – 100% R.H., non-condensing
700 hPa to 1060 hPa
Designed to conform to applicable
requirements of:
UL 60601-1, UL 1431
CSA C22.2 / No. 601.1
Grounded
Outlet
Grounded
Outlet Box
4038 Weaver Court East
Hilliard, OH 43026
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Fx: [phone]
Toll Free: [phone]

P/N 1.07080 Revision G 4 of 8
2. Plug the wall transformer into a 110/120V AC
wall outlet close to the machine. Locate the
power switch and press the “On” position.
Using the hand-held controller, bring the
machine to between 45° and 90°. See Hand-held
Controller Operation instructions.
3. Secure the patient pads to the
machine. The Foot Pad has a
pocket that slips over the Foot
Plate. The Tibia and Femur
Pads have straps that secure to
the black velcro pads.
4. Measure the patient’s involved leg in centimeters from the hip joint to the
midline of the knee joint, set the femur scale to this measurement, and retighten knobs.
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.

10. Before starting the machine, follow the Hand-held Controller Operation instructions to set exion, extension, speed and
pause duration. Run a complete cycle to ensure the knee is aligned correctly. The machine should now be tted to
begin the rehabilitation. If the knee joint does not mirror the movement of the machine joint, adjust the femur or tibia
bars to keep the knee in the proper alignment.
5. Loosen the adjustment knobs on the tibia bars and pull the foot plate out to a length greater than the patient’s lower leg.
6. Use the hand-held controller to bring the machine to the desired start position.
8. Adjust the foot plate so it just meets the patient’s
foot. Tighten the tibia bar knobs.
P/N 1.07080 Revision G 5 of 8
7. Place the patient’s leg in the machine, making sure the
patient’s knee is aligned with the joint on the machine.
9. Wrap the Pad Strap around the thigh, femur bars and
pad to secure the patient’s leg to the FLEX-MATE®K500.