KINEX KA2 Ankle CPM User Manual

KINEX KA2™ ANKLE

Ankle CPM Machine

1801 Airport Road, Suite D
Waukesha, WI 53188
Phone [phone]/Fax [phone]

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Device description

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KINEX-Ankle setup illustrations

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Contents

Description of the KINEX-Ankle System 2

KINEX-Ankle setup illustrations 3

Symbol overview 35

1. How to use the CPM device 5

1.1 Fields of application 5

1.2 Therapy objectives 5

1.3 Indications 5

1.4 Contraindications 5

2. Description of the KINEX-Ankle 6

2.1 Description of the device components 6

2.2 Description of the programming unit 7

2.3 Explanation of symbols 10

2.4 Explanation of symbols (connections and nameplate) 11

3. Safety information 12

4. Device setup 15

4.1 Connecting the device, performance check 15

4.2 Adjusting the device to the patient 16

5. Setting the treatment values 17

5.1 General information on programming KINEX-Ankle 17

5.2 Programming KINEX-Ankle 18

5.3 Treatment value details 19

6. Care, Maintenance, Transport, Conversion 26

6.1 Care 26

6.2 Maintenance (fuse replacement) 26

6.3 Transport 27

6.4 Conversion 28

7. Environmental Protection Statement 29

8. Specifications 29

9. IEC 60601-1-2:2001 30

9.1 Electromagnetic emissions 30

9.2 Electromagnetic immunity 31

9.3 Recommended Separation Distances 33

10. Contact 33

11. Technical service 34

11.1 Technical Hotline 34

11.2 Shipment 34

11.3 Spare Parts 34

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1. How to use the CPM device

The CPM device is indicated in the
treatment of most injuries and diseases
of the ankle joint as well as in the post­operative treatment after joint surgery
and in the treatment of joint diseases.
Examples:

- joint distortion and contusion

- arthrotomy and arthroscopy procedu­res in combination with synovectomy,
arthrolysis or other intra-articular in­terventions

- mobilization of joints in anesthetized
patients

- exercise-stable fractures after sur­gery, pseudoarthrosis and osteotomy

- myoplasty

- arthroplasties including implantation
of endoprostheses

Do NOT use KINEX-Ankle on
patients with:

- acute inflammatory processes in the
joints, unless on the order of a physi­cian

- spastic paralysis

- unstable osteosynthesis

1.3 Indications

1.4 Contraindications

KINEX-Ankle is a motor-operated Con-

tinuous Passive Motion (CPM) device
providing motion to the ankle joint.

Suitable for use in hospitals, clinics, ge­neral practices and rental services, it is
an important supplement to medical
and therapeutic treatment.

CPM therapy with KINEX-Ankle is
mainly used to prevent the negative ef­fects of immobilization, to allow patients
to regain painless mobility of joints at an
early stage and to promote healing and
achieve a positive functional result.

Other objectives of therapy include:

- improvement of joint metabolism

- prevention of joint stiffness

- promotion of the regeneration and he­aling of cartilage and damaged liga­ments

- faster hematoma/fluid resorption

- improved lymph and blood circulation

- thrombosis and embolism prophylaxis

1.1 Fields of application

1.2 Therapy objectives

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2. Description of the KINEX-Ankle

Note: See also page 2!

1. Clamping levers to adjust the height
of the calf support assembly

2. Calf support assembly

3. Motor A (center of rotation for dor­sal extension/plantar flexion)

4. Bracket for programming unit

5. Clamping lever to adjust the inclina­tion of the carriage

6. Aiming pin for adjustment of the ro­tational axis of the upper ankle joint

7. Footplate

8. Knurled screw for adjustment of the
footplate height

9. Knurled screw to adjust the foot­plate to the leg length

10. Motor B

11. Footplate bracket

12. Thumbscrew to secure motor B on
the moving bracket for dorsal ex­tension / plantar flexion

13. Bore hole to mount motor B to the
moving bracket for dorsal extension/
plantar flexion

14. CPM base

15. Moving bracket for dorsal extension/
plantar flexion

16. Power switch (ON/OFF)

17. Fuse cap

18. Connection for power cord

19. Locking device to adjust the height
of the carriage

20. Perforation to set the height of the
carriage

21. Programming unit

22. Nameplate

23. Connection for programming unit

2.1 Description of the
device components

The motorized CPM device provides the
following passive motion to the ankle
joint:

plantar flexion / dorsal extension
50° / 0° / 40°

inversion / eversion
40° / 0° / 20°

It can be reconfigured for use on either
side and allows patients to exercise in
bed and while sitting on a chair.

Note!

To unambiguously represent the cur­rent position of the CPM device, the
values for plantar flexion and inver­sion are marked with the symbol "-"
both on the display and in this docu­ment.

These are some of the
KINEX-Ankle features:

- anatomically correct setup

- physiological movements

- programming unit for precise
adjustment of patient-specific
therapy values

- symbols for easy operation of the
programming unit

Biocompatibility

Those parts of the KINEX-Ankle device
that come into contact with the patient
when the device is used as intended,
are designed to fulfil the biocompatibil­ity requirements of the applicable stan­dards.

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2.2 Description of the programming unit

2.2.1 Programming unit in normal mode

set angle of motor A

current position of motor A
(arrow pointing up =
dorsal extension
arrow pointing down =
plantar flexion)

set
dorsal extension value

set
plantar flexion value

motor A - selected
direction of motion

set angle of motor B

current position of motor B
(left or right - solid foot
symbol /
arrow pointing inward =
inversion
arrow pointing outward =
eversion)

therapy timer

set eversion value

set inversion value

motor B - selected
direction of motion

parameter keys

MENU key

START key“+” key

“-” key STOPkey

selected therapy
protocol

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2.2.2 Programming unit in MENU selection mode

2.2.3 Programming unit set to ROM programming

set carriage angle for
dorsal extension /
plantar flexion

current position of
motor A
(arrow pointing up =
dorsal extension
arrow pointing down
= plantar flexion)

selected MENU level

selected function

current maximum dorsal
extension value

current maximum plantar
flexion value

set carriage angle

selected parameter
(here: dorsal extension)

set carriage angle for
inversion / eversion

current position of
motor B
(left or right - solid foot
symbol /
arrow pointing inward =
inversion
arrow pointing outward
= eversion)

parameters available for
selection and correspon­ding parameter keys

selected function status of the selected

function (here: speed)

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2.2.4 Programming unit in general programming
mode

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2.3 Explanation of symbols

Also refer to symbol overview on page 36

dorsal extension

plantar flexion

inversion

eversion

pause

timer

speed

new patient

load reversal
motor A

load reversal
motor B

motor A ON/OFF

motor B ON/OFF

transport setting

synchronized/non­synchronized mode

total therapy time

service menu

warm up protocol

isolation protocol

dorsal extension /
plantar flexion therapy
documentation

inversion /
eversion therapy
documentation

stretching in
dorsal extension

stretching in
plantar flexion

stretching in
inversion

stretching in
eversion

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2.4 Explanation of symbols

(connections and nameplate)

alternating current

protective earth
connection

type B applied part

power switch OFF

power switch ON

Refer to accompanying
documents

Do not dispose of
product with unsorted
household or municipal
waste.