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Prima Advance USER MANUAL

1. 9 e 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 EIMINATION 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 PATIENTPAD 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
2. USER MANUAL INDICATIONS C UNICAL BENERTS Knee replacement surgery Breaks the cycle of trauma e Fractures patellar tibia plateau femordl 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 e Arthrolysis e Hip surgery including hip replacement hip pinning osteotomy e Ligament repairs e Arthroscopic surgery menisectomies patellectomies e Burns joints sepsis 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 A a KINETEC Prima Advance is a Knee PASSIVE mobilization C B device enabling the extension and flexion movement eT from 5 to 115 7 A va A Lower limb support D s eZ B Thigh support C Foot support D Control panel E Hand control eis 2 ELEC TRICAL CONNECTION SAFETY ARST KINETEC Prima Advance is a type B class 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
3. 12Vdc FLEXION limit e TYPE B device shocks protection against electric Service O STOP power off a aD EXTENSION limit Minimum SPEED Contains electric and electronic components not to throw in the dustbins of ON power on Maximum SPEED household refuse Prima Advance 3 4 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 e OPTIONS 15 1 4665003297 Trolley 15 2 e 4655001053 Cart 15 3 4650001090 Mattress 1 15 5 e 4650001123 Leg strap 15 6 467000xxxx Plastic support kit GUIDANCE AND MANUFACTURER S DECLARATION 5 4 e 4650001868 Patient pad Kit 4 straps foot support 1 mat
4. 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 7 POSMONING THE FOOTPLATE 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 24 Prima Advance 8 e 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
5. be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 If the movement stops push the start button the movement starts again If the yellow LED is lighting switch off then on the 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 Voltage interruptions CEI 61000 4 11 gt 5 dip in Uj for 5 seconds gt 95 dip in Ur for 5 seconds P lines 2IkKV fof power sUppIy Iines commercial or hospital environment 1 kV between lines 1 kV between lines Surge Mains power quality should be that of a typical IEC 61000 4 5 2 kV between line and 2 kV between line and commercial or hospital environment earth earth lt 5 Ur lt 5 Ur At the interruption there is a reset of the KINETEC PRIMA Advance After turning on push START to begin the session lt 5 Ur gt 95 dip in Ur for 0 5 cycle Voltage dips and voltage variations on power supply ee ae Uy input lines for 5 ee CEI 61000 4 11 70 Ur 30 dip in Ur for 25 cycles lt 5 Ur gt 95 dip in Ur for 0 5 cycle 40 Ur 60 dip in Un for 5 cycles 70 Ur 30 dip in Ur for 25 cycles Mains power quality should be that of a typical commercial or hospital environment If the user of the KINETEC PRIMA Advance requires continued operation du
6. led still does off contact your nearest KINETEC technician 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 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 13 SYMBOLS USED The LED blinks 1 time gt angle measurement function failure The LED blinks 2 times gt no movement The LED blinks 3 times gt abnormal consumption The LED blinks 4 times gt the motor PCB provides the energy but motor consumption is null The LED blinks 5 times gt Service Time 2 2000h The LED blinks 6 times gt not enough power The LED blinks 7 times gt START STOP switch failure Contact your nearest KINETEC technician 12 TECHNICAL SPECIRCATIONS Electricity Environment Power supply 100 240 V Frequency 50 60Hz Power consumption SOVA Device of type B class IP 20 2 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 Caution consult the accompanying documents PCB is powered
7. IT Turn on the power switch 2 The yellow light 3 on the control panel is on 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 contol should always be given to the patient Adjusting the FLEXION and EXTENSION limits 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 o USE OF THE KINETEC PATIENTPAD 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
8. ring power supply interruptions it is recommended that the KINETEC PRIMA Advance be powered from an uninterruptible power supply or a battery Power frequency 50 60 Hz magnetic field 3A m IEC _61000 4 8 3A m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment NOTE Uris the a c mains voltage prior to a lication of the test level aja Prima Advance
9. tress Hectromagnetic 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 ee he KINETEC Prima Advance uses RF energy only for its internal Radio electric Frequency emissions g y A CISPR 11 Group 1 unction Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment Radio electric Frequency emissions Class B CISPR 11 he KINETEC Prima Advance is suitable for use in all establishments Harmonic emissions Class A including domestic establishments and those directly connected to IEC 61000 3 2 he public low voltage power supply network that supplies buildings Voltage fluctuations Flicker emissions Complies used for domestic purposes 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 2 kV 4 kV 6 kV Electrostatic discharge ESD contact EC Oe 2 kV 4 kV 8 kV air 2 kV t4 kV 6 kV contact 2 kV 4 kV 8 kV air Immunity test Immunity test Immunity test Immunity test Floors should
10. 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 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 SAFEIY 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 Prima Advance 1 4 4 STARTING THE UN

Prima Advance USER MANUAL

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