Kinetec Prima XL User Manual
Kinetec Prima XL™
467896317 – 03/2015
Série 2
Notice Originale
User manual
Before use, please read this document.
Kinetec SAS reserves the right to effect technical modifications.
EN
Kinetec Prima XL™ EN 1/11
USER MANUAL
Summary
Page
• Definition _____________________________________________________________________ 2
• Warning and safety instructions ________________________________________________ 2
• Compliance __________________________________________________________________ 3
• Unpacking and packing ______________________________________________________ 3
• Installing the device __________________________________________________________ 3
• Description ___________________________________________________________________ 4
• Electrical connection _________________________________________________________ 4
• Procedure to start the machine ________________________________________________ 4
• START/STOP/REVERSE function __________________________________________________ 5
• Procedure to stop the machine ________________________________________________ 5
• Setting the FLEXION and EXTENSION limits ______________________________________ 5
• Setting the SPEED _____________________________________________________________ 5
• Using the Plastic Comfort Case kit ______________________________________________ 6
• Using the Kinetec Patient Pad kit _______________________________________________ 6
• Setting up the patient _________________________________________________________ 7
• Options ______________________________________________________________________ 7
• Product information
- Maintenance ______________________________________________________________ 8
- Troubleshooting guide ______________________________________________________ 8
- Cleaning ___________________________________________________________________ 8
- Disposal and recycling ______________________________________________________ 8
- Technical specifications ____________________________________________________ 9
- Symbols used _______________________________________________________________ 9
- Warranty ___________________________________________________________________ 9
- Guidance and manufacturer’s declaration __________________________________ 10-11
Kinetec Prima XL™ EN 2/11
Definition
The device Kinetec Prima XL™ is a PASSIVE KNEE mobilization device enabling extension and flexion
movements from -5° to 115°.
Indications
• Arthroplasties of the knee and hip joints.
• Osteosynthesised femoral or tibial fractures.
• Patellar fractures.
• Arthrolysis and palliative surgery (cartilage lesions,
removal of osteomas, etc.).
• Osteotomies of the pelvis or femur.
• Ligament repairs (LCI, LCE, LLI, LLE).
• Freeing the knee extensor mechanism (Judet's
operation).
• Synovectomies, Meniscectomies, Patellectomies,
Arthroscopies.
Clinical Benefits
• Breaks the cycle of trauma, inflammation and the loss
of range of motion.
• Prevents joint stiffness.
• Speeds the recovery of post-operative range of motion.
• Maintains the quality of the joint surface.
• Reduces pain and oedema.
• Promotes joint cartilage healing.
• Reduces hospitalization time
• Reduces the need for pain medication.
• Provides immediate post-operative continuous passive
motion
.
Contraindications
Rheumatoid arthritis in the inflammatory phase, gout, algodystrophy in the inflammatory phase (hyper painful), para-
osteo-arthroplasty, unhealed infected wounds, established phlebitis, bone cancer, myositis ossificans of the quadriceps,
arthrodesis of the hip, infectious arthritis, deformed joint surfaces, paralysed limbs (atonic or spastic), non-stabilised
fractures.
The machine is not adapted for patient’s height more 1.95 m (6'7") or under 1,50m (4'7") and for patient’s less than 135kg
(300Lbs) and more than 227Kg (500Lbs).
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 5.
WARNING: To avoid the parameters being accidentally changed, you are recommended to close the
protective cover on the control panel.
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 4.
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: 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 d between these devices and
the machine. See the table on page 11.
Kinetec Prima XL™
EN 3/11
Compliance:
The device Kinetec Prima XL™ complies with the standards of Directive 93/42/EEC, and bears the EC
mark.
The device Kinetec Prima XL™ complies with the standards in force (IEC 60601-1-2) concerning the
electromagnetic compatibility of medical devices and IEC 60601-1 concerning electrical safety.
The device Kinetec Prima XL™ meets the requirements of the Machinery Directive No. 2006/42/EC.
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.
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.
Before using your machine you must move the foot plate into
its working position. (See page 7).
Your machine is ready to be connected to the power supply.
(See page 4).
Packing
To prevent any problems when the machine is
transported, only pack it using its original packaging.
- Set the leg support to 42cm
- Stop the unit at 5° of flexion.
- Move the foot plate back into its packing position.
Installing the device
The device Kinetec Prima XL™ machine is designed to be used in hospitals, clinics, doctors' offices or in
private homes (rental).
The machine must be installed on a flat surface that is wide enough to accommodate the entire device
plus the other leg.
We recommend using the machine with a physiotherapy table, a healthcare bed, a bed or a bench.
We do not recommend the use of an air mattress.
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