Prima Advance S1 User Manual Oct 2005

USER MANUAL INDICATIONS

CLINICAL BENEFITS

• Knee replacement surgery. • Fractures (patellar, tibia plateau, femoral,...). • Arthrolysis. • Hip surgery, including hip replacement, hip pinning, osteotomy,...). • Ligament repairs. • Arthroscopic surgery (menisectomies, patellectomies,...) • Burns, joints sepsis,...

• 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 Bone Cancer, Warped joint surfaces, Spastic paralyses, unstable fractures, Uncontrolled infection. The machine is not adapted for patient’s height more 2 m (6'7") or under 1,40m (4'7").

1 • DESCRIPTION KINETEC Prima Advance is a Knee PASSIVE mobilization device enabling the extension and flexion movement from -5° to 115°. A - Lower limb support B - Thigh support C - Foot support D - Control panel E – Hand control

A

C

B D

E 2 • ELECTRICAL CONNECTION: SAFETY FIRST. KINETEC Prima Advance is a type B class I device. Plug the power cord (1) on the KINETEC Prima Advance unit into a receptacle (Voltage between 100 to 240 Vac 50/60 Hz). IMPORTANT: Before use: Check that the electrical socket is in good condition and is suitable for the splint power supply cord. The latter complies with current standards and has a grounding socket. The plug may be connected to any standard socket. The socket must however have a grounded pin. 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.

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Fuse change Warning: Replace the fuse with one of the same type and value: - on main socket, 2 fuses T 500 mA 250V (6.3x32) - on power supply PCB, 1 fuse F 2 A 250V (5x20) - on PCB, 1 fuse T1.25 A (5x20))

3 • SAFETY The physician defines the protocol and ensures that it is correctly implemented (adjustments, session duration and frequency of use). The patient must know the start/stop/reverse function on the control handle. Hand control must be accessible to patient at all times. (See page 2). KINETEC Prima Advance complies with Directive 93/42/CEE. EXPLOSION HAZARD: KINETEC Prima Advance is not designed for use in the presence of flammable anesthetics. In case of electromagnetic interference with other devices move the device. KINETEC Prima Advance is in compliance with standards in force (IEC 601.1.2), electromagnetic compatibility standard for medical devices. Please, do not touch the moving parts while the unit is running, pinching risk.

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4 • STARTING THE UNIT

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Turn on the power switch (2). The yellow light (3) on the control panel is on.

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START / STOP / REVERSE function The KINETEC Prima Advance is fitted with a START/STOP/REVERSE function. First, press the hand control switch; the machine stops. Press the hand control switch again; the mobilization reverses. IMPORTANT: for maximum safety, the hand control should always be given to the patient.

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Adjusting the FLEXION and EXTENSION limits

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Select the extension and flexion angles via button (4) for flexion and button (5) for extension. Modification of the extension or flexion limit can be done while the machine is running or stationary.

Adjusting the SPEED The SPEED is set by turning button (6). At maximum speed, the machine moves at 145° per minute (for medium femur length). At minimum speed, the machine moves at 40° per minute (for medium femur length). Modification of the speed can be done while the machine is running or stationary.

5 • USE OF THE KINETEC PATIENT PAD KIT The KINETEC Patient Pad Kit is designed for rapid fitting, optimal hygiene and maximum patient comfort. For optimal hygiene, a new set of pads should be used for each patient. - For using and positioning the straps, please refer to here under. CLEANING: Disinfecting of the pads: Washing at 30°C with use of a disinfecting solution during the rising cycle. Example of product that can be used: Solution " Baclinge" at 0.125 % or "Souplanios" at 0,125% from ANIOS Laboratory. Part number to order the complete set: - Set of 4 straps: 4650001107 - Foot support: 4650001131

6 • SETTING UP THE PATIENT - Place the KINETEC Prima Advance machine in a position that will be comfortable for the patient. - Measure in cm or inches the length of the patient’s femur; adjust the thigh support to this measurement using knobs (7). - To install the patient on the KINETEC Prima Advance machine. - Push the foot plate (C) up to the patient and tighten the knobs (8). IMPORTANT Adjust the axis of the patient’s hip with the axis rotation of the KINETEC Prima Advance machine, and the axis of the patient’s knee with the axis rotation of the KINETEC Prima Advance machine.

8 C

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7 • POSITIONING THE FOOT PLATE The articulated foot plate allows the positioning of the foot from 40° of PLANTAR FLEXION to 30° of DORSIFLEXION. - The knob (9) allows positioning the foot in plantar flexion or dorsiflexion.

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8 • MAINTENANCE After 2,000 hours of operation, KINETEC Spectra requires a few lubrication and maintenance operations (lubrication of the joints, pointer stops and ball screws). When the machine is switched on the yellow light blinks 5 times to indicate that the service interval has been reached. Despite that warning, you can continue to use your KINETEC Prima Advance by pressing START, but you should contact your nearest KINETEC technician to have the maintenance operations conducted as soon as possible.

9 • CLEANING Before conducting any cleaning operation, SWITCH the unit OFF and disconnect the power supply. In order to ensure optimal hygiene, you are advised to clean the machine for each new patient. Use a DISINFECTANT (PROPANOL/ISOPROPANOL or ALDEHYDE-based solution). Spray the disinfectant on the SURFACES (plastic shells and metal components). To clean the KINETEC hygienic pads, please refer to paragraph 5.

10 • ELIMINATION AND RECYCLING a • Packing: Packing must be separated from the components plastic and paper/cardboard and given to the specific sites from recycling. b • KINETEC PATIENT PAD KIT: To clean with a product of disinfection then to give it to the specific sites of recycling. c • Prima Advance unit: It contains electronic components, cables, aluminum, steel and plastic parts. When the splint is not operational any more, to dismount and separate in groups from materials and to give them to correct unit of recycling or to turn over the machine to Kinetec for destruction.

11 • TROUBLESHOOTING A spare parts list and technical catalog are available to you on request from your KINETEC distributor. If, after connecting the power supply cable to the power supply and switching on KINETEC Prima Advance: • The light is off: - Check that the electrical socket is live using another device. - Replace the fuse(s) of the connector (2) with fuses of the same type and caliber: 2 fuses T 500 mA 250V (6.3 x 32). - If the led still does off, contact your nearest KINETEC technician. 2 • If the machine fails to operate but the yellow light remains on, - Press the START/STOP switch 1 more times. Your KINETEC Prima Advance still does not function: Contact your nearest KINETEC technician. Your KINETEC Prima Advance does not function and the led indicates: The LED blinks 1 time Æ angle measurement function failure The LED blinks 2 times Æ no movement The LED blinks 3 times Æ abnormal consumption The LED blinks 4 times Æ the motor PCB provides the energy but motor consumption is null. The LED blinks 5 times Æ Service Time ≥ 2000h The LED blinks 6 times Æ not enough power The LED blinks 7 times Æ START/STOP switch failure. Contact your nearest KINETEC technician.

12 • TECHNICAL SPECIFICATIONS Product Weight: 11,8 Kg Splint dimensions: 94 cm (37 in) x 33 cm (13 in) x 33cm (13 in) Angular limits: -5 to 115° Speed: from 40 to 145° per minute. Patient height: from 1.5 m (4,92 ft) to 1.95 m (6,40 ft)

Electricity Power supply: 100-240 V~ Frequency: 50-60Hz Power consumption: 50VA Device of type B class I IP 20.

Environment - Storage/transport conditions: Temperature: -40 to 70°C / -40 to 160°F Relative humidity: up to 90% - Operating conditions: Room temperature: 10 to 40°C/50 to 105°F Relative humidity: up to 80%

13 • SYMBOLS USED Caution (consult the accompanying documents

PCB is powered (12Vdc)

FLEXION limit

TYPE B device (protection against electric shocks)

Service

EXTENSION limit

STOP (power off)

Minimum SPEED

ON (power on)

Maximum SPEED

Contains electric and electronic components; not to throw in the dustbins of household refuse

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14 • WARRANTY The KINETEC warranty is strictly limited to the replacement free of charge or repair in the plant of the component or components found to be defective. KINETEC guarantees its joint passive mobilization systems for 2 years against all defects of manufacture from the date of purchase by the consumer. KINETEC is the only organization able to assess the application of the warranty to its systems. The warranty will be considered null and void if the device has been used abnormally or under conditions of use other than those indicated in the user's manual. The warranty will also be considered null and void in the event of deterioration or an accident due to negligence, inappropriate surveillance or inappropriate maintenance, or due to transformation of the equipment or an attempt to repair the equipment.

15 • OPTIONS 15.1 • 4665003297 • Trolley 15.2 • 4655001053 • Cart 15.3 • 4650001090 • Mattress 15.4 • 4650001868 • Patient pad Kit (4 straps + foot support + 1 mattress) 15.5 • 4650001123 • Leg strap 15.6 • 4670023701 • Plastic support kit

GUIDANCE AND MANUFACTURER’S DECLARATION Electromagnetic emissions The « KINETEC Prima Advance » is intended for use in the electromagnetic environment specified below. The customer or the user of the « KINETEC Prima Advance » should assure that it is used in such an environment. Emissions test Emissions test Emissions test The « KINETEC Prima Advance » uses RF energy only for its internal Radio electric-Frequency emissions Group 1 function. Therefore, its RF emissions are very low and are not likely to CISPR 11 cause any interference in nearby electronic equipment. Radio electric-Frequency emissions Class B CISPR 11 The « KINETEC Prima Advance » is suitable for use in all establishments including domestic establishments and those directly connected to Harmonic emissions Class A the public low-voltage power supply network that supplies buildings IEC 61000-3-2 used for domestic purposes. Voltage fluctuations / Flicker emissions Complies IEC 61000-3-3 Electromagnetic immunity The « KINETEC PRIMA Advance » is intended for use in the electromagnetic environment specified below. The customer or the user of the « KINETEC PRIMA Advance » should assure that it is used in such an environment. Immunity test Immunity test Immunity test Immunity test Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity ±2 kV, ±4 kV, ±6 kV ±2 kV, ±4 kV, ±6 kV should be at least 30%. contact contact Electrostatic discharge (ESD) If the movement stops, push the start button, the IEC 61000-4-2 movement starts again. ±2 kV, ±4 kV, ±8 kV ±2 kV, ±4 kV, ±8 kV If the yellow LED is lighting, switch off then on the air air apparatus and push the start button, the movement starts again. Electrical fast transient / ±2 kV for power supply Mains power quality should be that of a typical burst ±2 kV for power supply lines lines commercial or hospital environment. IEC 61000-4-4 ±1 kV between lines ±1 kV between lines Surge Mains power quality should be that of a typical IEC 61000-4-5 commercial or hospital environment. ±2 kV between line and ±2 kV between line and earth earth < 5% UT < 5% UT At the interruption, there is a reset of the « KINETEC PRIMA Voltage interruptions (>95% dip in UT) (>95% dip in UT) Advance ». After turning on, push START to begin the CEI 61000-4-11 for 5 seconds for 5 seconds session. < 5% UT < 5% UT (>95% dip in UT) (>95% dip in UT) for 0,5 cycle for 0,5 cycle Mains power quality should be that of a typical commercial or hospital environment. If the user of the Voltage dips and voltage 40% UT 40% UT « KINETEC PRIMA Advance » requires continued operation variations on power supply (60% dip in UT) (60% dip in UT) during power supply interruptions, it is recommended that input lines for 5 cycles for 5 cycles CEI 61000-4-11 the « KINETEC PRIMA Advance » be powered from an uninterruptible power supply or a battery. 70% UT 70% UT (30% dip in UT) (30% dip in UT) for 25 cycles for 25 cycles Power frequency (50/60 Hz) Power frequency magnetic fields should be at levels magnetic field 3A/m 3A/m characteristic of a typical location in a typical commercial IEC 61000-4-8 or hospital environment. NOTE : UT is the a.c. mains voltage prior to application of the test level.

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