Kinetec KINETEC CEM User manual

KINETEC CEM™
Manuel d'utilisation Avant toute utilisation lire ce document.
Kinetec se réserve le droit de toutes modifications techniques. FR
User manual Before use, please read this document.
Kinetec reserves the right to effect technical modifications. EN
Bedienungsanleitung Vor Benutzung unbedingt dieses Dokument lesen.
Kinetec behält sich das Recht vor, jegliche technische Änderung
durchzuführen. DE
467896366 – 12/2014
Série 1-2
Notice Originale

KINETEC CEM™ 1/22 EN
Contents
Page
DESCRIPTION ....................................................................................................................................................................................................2
1. Definition...........................................................................................................................................................................................2
2. Indications ........................................................................................................................................................................................2
3. Clinical Benefits................................................................................................................................................................................2
4. Contraindications..............................................................................................................................................................................2
5. Warning and safety instructions .......................................................................................................................................................3
6. Compliance:......................................................................................................................................................................................3
7. Unpacking and packing ....................................................................................................................................................................4
8. Installing the device ..........................................................................................................................................................................4
9. Basic assembly.................................................................................................................................................................................5
10. Assembling the components of the KINETEC CEM™ .....................................................................................................................5
11. Transporting the device ....................................................................................................................................................................6
12. Description........................................................................................................................................................................................6
USING THE HAND CONTROL............................................................................................................................................................................8
1. Electrical connection: safety first ......................................................................................................................................................8
2. Starting the unit ................................................................................................................................................................................8
3. Changing the display language ........................................................................................................................................................9
4. Locking-Unlocking the hand control setting......................................................................................................................................9
5. START/STOP/REVERSE function ...................................................................................................................................................9
6. Procedure to stop the machine.........................................................................................................................................................9
7. Session Time..................................................................................................................................................................................10
8. Quick Start......................................................................................................................................................................................10
9. Possible values for each parameter ...............................................................................................................................................10
10. To set the parameters for a single movement................................................................................................................................11
11. PROGRAM MODE: To enter a program ........................................................................................................................................12
12. Using Programs..............................................................................................................................................................................14
13. Reading the values of a program: e.g. SPEED ..............................................................................................................................14
14. To use the WARM UP key..............................................................................................................................................................15
15. To define the patient tolerance • At the start of a session ..............................................................................................................16
16. To define the patient tolerance • During the session......................................................................................................................16
17. Session Time..................................................................................................................................................................................16
USING THE KINETEC PATIENT PAD KIT........................................................................................................................................................17
SETTING UP THE PATIENT.............................................................................................................................................................................18
PRODUCT INFORMATION...............................................................................................................................................................................19
1. Maintenance...................................................................................................................................................................................19
2. Trouble shooting.............................................................................................................................................................................19
3. Cleaning .........................................................................................................................................................................................19
4. Disposal and recycling....................................................................................................................................................................19
5. Technical specifications..................................................................................................................................................................20
6. Symbols used.................................................................................................................................................................................20
7. Warranty.........................................................................................................................................................................................20
8. Guidance and manufacturer’s declaration......................................................................................................................................21

KINETEC CEM™ 2/22 EN
DESCRIPTION
1. Definition
The device KINETEC CEM™ is a PASSIVE mobilisation device allowing Extension/Flexion
movements of the ELBOW from -10° to 135° with fixed prono-supination, in all abduction planes of
the shoulder.
It is available as a complete device with chair or as an add-on module that can be used on Series 2
or higher KINETEC CENTURA™ devices.
2. Indications
- Intra-articular fractures of the elbow
- Metaphyseal fractures, osteosynthesised in the elbow area
- Arthrolysis for post-traumatic stiffness with limitation of elbow movement
- Elbow prostheses
- Synovectomies
3. Clinical Benefits
- Effectively breaks the vicious circle of: trauma immobility effusion atrophy.
- Improves the nutrition of joint surfaces.
- Speeds the recovery of post-operative range of motion.
- Speedy recovery of the motor pattern for the limb operated on.
- Promotes joint cartilage healing.
- Provides immediate post-operative continuous passive motion.
- Reduces hospitalization time.
- Reduces the need for pain medication.
- Visual feedback for users.
- Realization of postures (resting, stretching muscles).
4. Contraindications
Rheumatoid arthritis in the inflammatory phase, algodystrophy in the inflammatory phase (hyper
painful), para-osteo-arthroplasty, unhealed infected wounds, bone cancer, infectious arthritis,
deformed joint surfaces, paralysed limbs (atonic or spastic), non-stabilised fractures.

KINETEC CEM™ 3/22 EN
DESCRIPTION
5. Warning and safety instructions
WARNING: The machine must be installed and commissioned according to the information provided in this
manual.
WARNING: If you need any assistance in the assembly, use or maintenance of the device, please contact
your KINETEC®distributor.
WARNING: The practitioner determines the protocol and ensures its proper implementation (settings, session
duration and frequency of use).
WARNING: Run a cycle with the device unloaded before installing the patient on the machine.
WARNING: For optimum safety, always give the hand control to the patient before starting the system. The
patient must know the start/stop/reverse function on the hand control (see page 9).
WARNING: To avoid the parameters being changed, lock the machine’s hand control before giving it to the
patient.
WARNING: Danger, risk of explosion: Do not use the machine with anaesthetic gas or in an environment that
is rich in oxygen.
WARNING: For Type B Class I devices, and to avoid all risks of electric shock, the machine should only be
connected to a power supply that has protective earthing, see page 8.
WARNING: Before using this machine, always check that the electrical socket is in good condition and is
suitable for the splint power supply cord. Only use the original cable supplied with the machine.
Check that the cables remain free around the device so that they do not get damaged.
WARNING: Before using this machine, always check that the machine is not damaged, in particular the
protective housings.
WARNING: In case of electromagnetic interference with other devices move the device.
WARNING: Please do not touch the fixed or moving parts while the unit is running: pinching or crushing risk.
Keep children and pets away from the machine.
WARNING: Modifying the machine in any way is strictly forbidden.
WARNING: Always check the motion parameters displayed on the hand control before starting the device.
WARNING: Only the accessories, spare parts and supplies described in this manual should be used with this
machine.
WARNING: Do not connect the device to other devices not described in this manual.
WARNING: If unforeseen events or malfunctions occur, please contact your KINETEC®distributor.
WARNING: Before each use, always check that the red knobs under the chair have been tightened (see page
5).
WARNING: Before each use, always check that the various locking knobs have been tightened (see pages 6
and 7).
WARNING: Wireless communications devices, such as domestic wireless devices in networks, mobile
phones, wireless telephones and their base stations and walkie-talkies, may affect the machine.
You are recommended to keep at least a distance dbetween these devices and the machine.
See the table on page 22.
6. Compliance:
The device KINETEC CEM™ meets the requirements of the Medical Directive No. 93/42/EEC. It bears the EC mark.
The device KINETEC CEM™ complies with the standards in force: IEC 601601-1-2 concerning the electromagnetic compatibility of
medical devices and IEC 60601-1 concerning electrical safety.
The device KINETEC CEM™ meets the requirements of the Machinery Directive No. 2006/42/EC.

KINETEC CEM™ 4/22 EN
DESCRIPTION
7. Unpacking and packing
Unpacking
When you unpack the machine, don't forget that you may need to pack it up again. We recommend that you keep the packaging
materials, boxes and plastic bags.
Your KINETEC CEM™ device is delivered in two boxes
- Box 1: Centura device (including the chair)
- Box 2: Accessories specific to the KINETEC CEM™ device
Recommendations for plastic bags: do not put them over
the head as there is a risk of suffocation, and keep them out
of the reach of children.
Be careful with small-sized pieces: they could be swallowed
by a child.
Be careful with cables and wires: risk of strangulation.
Packing
To prevent any problems when the machine is transported, only pack
it using its original packaging.
- Remove all accessories from the machine.
Box 1:
- Fold the machine into the transport position (see page 5).
- Pack each element in a plastic bag.
- Put the elements in the two boxes; do not place anything between
the boxes.
• Box A – the motor units
• Box B – the other accessories, except for the arm rest
- Place the machine in its box.
Box 2:
- Put the accessories specific to the KINETEC CEM™ in this box.
8. Installing the device
The device KINETEC CEM™ machine is designed to be used in
hospitals, clinics, doctors' offices or in private homes (rental).
The machine is delivered with its own chair. It must not be used
with another chair.
The machine must be installed on a flat surface that is wide
enough to accommodate the entire device; you should leave a
free space of 1 m (39 ins.) on each side.
Box
A
Box B
Box 1

KINETEC CEM™ 5/22 EN
1
2
4
4
3
5
DESCRIPTION
9. Basic assembly
- Place the chair (1) on the floor; we recommend that two people carry out this operation.
Take care not to trap your fingers.
- Straighten up the back of the chair (2).
The tilting axis (3) must always be in good condition. Never use the device without it.
- Lock the back of the chair by tightening the red knobs (4).
- Install the abduction motor (5) on the right or left, depending on
the limb be moved.
WARNING: Before each use, always check that the red knobs
under the chair have been tightened (see page 5).
WARNING: Before each use, always check that the various
locking knobs have been tightened (see pages 6
and 7).
Comments and special instructions:
Take care that fingers do not get pinched during handling operations or
when the chair is unfolded.
Never carry the device by the chair when it is in its working position.
10. Assembling the components of the KINETEC CEM™ Kit
Install the elbow motor support (3) Install the elbow motor (2) Install the forearm splint (6).
using the colour code as guide using the colour code as guide. It is correctly installed when you hear a click.
(Blue for left, Red for right). It is correctly installed when you hear a click.
It is correctly installed when you hear a click.
Install the arm splint (5). Install the elbow protection (4). The device KINETEC CEM™ is shown ready
It is correctly installed when you hear a click. for a right shoulder mobilisation.
3
2
6
5
4

KINETEC CEM™ 6/22 EN
4
3 9
8
10
9
11
13
12
DESCRIPTION
11. Transporting the device
For easy transport of the unit, the chair has two wheels (3) and a handle
(4).
Place the arm support as close as possible to the chair to limit the overall
dimensions and help balance the unit.
Place your foot as indicated to tilt the unit.
You can adjust the height of the handle with the knobs (9).
12. Description
The device KINETEC CEM™ consists of the following
components:
1 – Chair
2 – Base
3 – Wheels
4 – Handle
5 – Arm rest knobs
6 – Arm rest
7 – Hand control support
8 – Right/left sliding motor mount bar locking knob
9 – Up/down sliding housing locking knob
10 – Chair locking knob
11 – Abduction motor locking knob
12 – Abduction motor
13 – Shoulder depth sliding lock
1
2
3
4
5
6
7

KINETEC CEM™ 7/22 EN
DESCRIPTION
Description
Composition of the KINETEC CEM™ Module:
1 • Hand control
2 • Extension – Flexion motor
3 • Elbow motor support
4 • Elbow protection
5 • Arm splint
6 • Forearm splint
7 • Forearm length setting lock
8 • Prono-Supination position setting lock
9 • Liquid-crystal display (2 lines of 16 characters)
10 • SESSION TIME display key
11 • BYPASS mode key
12 • MODULATION key
13 • WARM UP key
14 • Shoulder positioning key
15 • Upper limits setting
16 • Lower limits setting
17 • Increase / decrease keys
18 • START key
19 • STOP key
20 • FORCE key
21 • SPEED key
22 • PAUSE key
23 • TIMER key
24 • PROGRAM access key
1
4
23
6
85
7
9
10
11
12
13
14
16
17
18
21
22 23
24
20
19
15

KINETEC CEM™ 8/22 EN
1
2
3
USING THE HAND CONTROL
1. Electrical connection: safety first
2 versions of electrical protection are available for KINETEC CEM™ machines.
The identification label shows which version a machine is equipped with:
Type BF, Class II devices,
for home use, bear the following symbols:
Type B class I devices,
for use in a professional environment, bear the following symbol:
See page 20 for the meaning of the symbols.
Before connecting the device to the power supply, check that the mains voltage
matches that shown on the plate (100-240 V~ 50/60Hz).
The connectors can be plugged in any one of the sockets
(the sockets are not assigned to a specific connector).
Connect the power supply cable (1).
IMPORTANT
For Type B Class I devices, and to avoid all risks of electric shock, the
machine should only be connected to a power supply that has protective
earthing.
To connect the power supply, only use the original cable supplied with the machine.
Check that the cables remain free around the device so that they do not get damaged.
Check that the machine is not damaged, in particular the protective housings.
Watch out for the position of the motor cables. They must remain clear around the machine.
Wrong position Correct position
2. Starting the unit
Press the ON / OFF switch (2). The indicator light (3) lights up, the machine carries out an auto-diagnostic, and then the
display shows:
KINETEC
ELBOW MODULE
Then
Movement Verif.
Please Wait
Then
ELBOW MODULE
30 STOP 15 70
Your device KINETEC CEM™ is ready to be used with the parameters from the previous session
(except Timer and Warm Up mode)
Warning:Always check the motion parameters displayed on the hand control before starting the session.

KINETEC CEM™ 9/22 EN
4
USING THE HAND CONTROL
3. Changing the display language
Press the SPEED and FORCE buttons simultaneously,
then press the + or - key to change the display language.
Press to confirm, then switch the unit OFF and then ON again
to apply the changed display language.
Available languages: English, French, German, Italian and Spanish.
4. Locking-Unlocking the hand control setting
The hand control allows the patient to control the machine as
appropriate.
The switch (4) has 3 positions:
Fully locked position
In this mode the only functions available are reading the operational settings
and using the START/STOP function.
Fully unlocked position
All the operational settings can
be changed.
Half-locked position
In this mode, it is possible to switch the program and modify the upper and lower movement limits. The
START/STOP function is always accessible.
Double locking
Simultaneously press the + and - keys to lock the hand control.
The display shows "LOCK". To unlock the hand control, simultaneously press
the + and - keys; the display reads "UNLOCK".
You cannot change the parameters; if you try, the message "LOCK" will be displayed.
We recommend that you lock the hand control when you
give it to the patient.
Note: the hand control locking is preserved when you switch the unit ON/OFF.
5. START/STOP/REVERSE function
As with all KINETEC®systems, the device KINETEC CEM™ is equipped with a START/STOP/REVERSE
function.
Press this key of the hand control and the movement stops.
Press this key of the hand control and the movement starts in the opposite direction.
IMPORTANT: for optimum safety, always give the hand control
to the patient before starting the system.
6. Procedure to stop the machine
To stop the machine's movement: press the STOP key
To switch power off: press the ON / OFF switch (see page 8)