Spectra Essential
Contents
1. together with its accessories for destruction A motor running time counter is available Simultaneously press keys and the displays shows RESET TIME 215H this is an example this counter can be reset by pressing the key 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 the KINETEC Spectra Essential The display does not indicate any information Check that the electrical socket is live using another device Replace the fuse s 25 of the connector with fuses of the same type and calibre 2 fuses T 750 mA 250V 6 3 x 32 KINETEC order 4610007434 If the display still does not indicate any information contact your nearest KINETEC technician Your KINETEC Spectra does not work and the display indicates 50 STOP 25 115 Press START again Your KINETEC Spectra Essential still does not function Contact your nearest KINETEC technician Your KINETEC Spectra Essential does not function and the display indicates SERVICE D1 angle measurement function failure or SERVICE D2 no movement or SERVICE D3 abnormal consumption or SERVICE D4 power failure or disconnected motor Contact your nearest KINETEC technician if the same message is displayed after having switched the device off then on and started it by pressing START Cleaning Before conducting any cleaning oper2. 1876 Single strap Part number to order a complete kit fastening with clips 4670024345 fastening without clips 4670023701 if your machine is not fitted with clips Use of the Kinetec Patient Pad Kit The KINETEC Patient Pad Kit is designed for rapid fitting optimal hygiene and maximum patient comfort For using and positioning the straps please refer to here under Make sure that the self adhesive parts 19 are visible Place the sponge side next to the skin FOR OPTIMAL HYGIENE A NEW SET OF PADS SHOULD BE USED FOR EACH PATIENT Each cover is provided with a label to record the patient s name CLEANING Sterilization of the pads if necessary Sterilized at 134 C during 18 minutes Disinfecting of the pads Washing at 30 C with use of a disinfecting solution during the rising cycle Example of products that can be used Solution Baclinge at 0 125 or Souplanios at 0 125 from ANIOS Laboratory A complete list of distributors in your country is available on request The KINETEC Spectra is delivered with a complete set Components 4 straps 4650001107 foot support 4650001420 1 cover 4650001090 Part number to order the complete set 4650001868 Spectra Essential ES 5 9 Setting up the patient Place the KINETEC Spectra Essential machine in a position that will be comfortable for the patient Measure in cm or inches the length of the patient s femur L adjust the thigh support to this measu
3. Before use please read this document User manual P Kinetec reserves the right to effect technical modifications EN 467896340 12 2009 Serie 1 2 Spectra Essential Xkinetec BY MONS RESTI molyan Sammons Preston Rolyan A Patterson Medical Company 4 Sammons Court Bolingbrook IL 60440 4989 800 228 3693 extension 8774 P ATIERSON FAX 262 387 8748 MEDICAL Definition The KINETEC Spectra Essential is a PASSIVE Knee mobilisation device enabling the extension and flexion movement from 10 to 120 Indications Knee replacement surgery e Fractures patellar tibia plateau femoral Arthrolysis Hip surgery including hip replacement hip pinning osteotomy Ligament repairs Arthroscopic surgery menisectomies patellectomies e Burns joints sepsis 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 Digital ROM readout on the patient hand control for positive reinforcement Maintains desired positions for stretching and muscular rest Contraindications Bone Cancer warped joint surfaces spastic paralysies unst
4. able fractures uncontrolled infection The machine is not suitable for patients over 2 m 6 7 or under 1 40m 4 7 Warning and Safety instructions Warning The physician physiotherapist defines the protocol and ensures that it is correctly A implemented adjustments session time 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 3 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 To avoid all risks of electric shock the machine should only be connected to a power supply that has protective earthing 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 Pleas
5. ange will flash Press re or e buttons to modify the setting the new setting will flash To confirm the new setting press another function button or wait approximately 5 seconds for automatic confirmation Movement parameters can be set either when the machine is stopped or when it is in operation NB pressing the button repeatedly allows you to select pausing at the extension or flexion limit Possible values for each parameter Possible values Default setting Extension limit 10 to 115 Flexion limit 5 to 120 Speed 1 to 5 from 45 to 155 per minute Extension pause O to 900 seconds 15minutes Flexion pause O to 900 seconds 15minutes Spectra Essential ES 4 9 Using the Plastic Comfort Case kit Specially designed to improve comfort and hygiene for the patient Plastic Comfort Cases come with clips fixed directly on the tubes of the machine s thigh and lower limb support segments and straps with protection stops to precisely and quickly adjust to the patient s leg dimensions CLEANING To ensure optimal hygiene clean the supports after each patient use To clean spray the surfaces with disinfectant use a propanol isopropanol or aldehyde based solution Replacement parts a 4670024048 Complete foot support b 4635010561 Foot support strap kit c 4635010157 Tibia case only d 4670024329 Tibia case with straps e 4635010165 Femur case only f 4670024337 Femur case with straps g 465000
6. ass IP 20 full leg 71 to 99 cm 28 to 39 inches Tibia 38 to 53 cm 15 to 23 inches Femur 33 to 46 cm 13 to 18 inches Fuse T 750mA 250V 6 3x32mm KINETEC order 4610007434 Environment Storage transport conditions Operating conditions Symbols used Temperature 40 to 70 C 40 to 160 F Relative humidity up to 9076 Room temperature 10 to 40 C 50 to 105 F Relative humidity up to 8076 TYPE B device instructions storage or transport Alternative current Right way up when box is stored Fragile Keep dry during storage or transport protection against electric e Speed o Flexion limit shocks Warning or CAUTION check accompanying Pause e Extension limit documentation STOP power off e ncrease Start movement ON power on amp Decrease e Stop movement iia Refer to the operating emperature Limit during MG zu gt OO gt Contains electric and electronic components not to throw in the dustbins of household refuse 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 syst
7. ation 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 Cleaning should be carried out in the environmental conditions specified in the Technical Specifications section below Use a DISINFECTANT PROPANOL ISOPROPANOL or ALDEHYDE based solution Spray the disinfectant on the SURFACES plastic shells and metal components In order to ensure optimal hygiene you are advised to clean the covers for each new patient All the consumables enable hazard free disposal Elimination and recycling ae Packing Packing must be separated from the components plastic and paper cardboard and given to the specific sites for recycling b KINETEC PATIENT PAD KIT Clean with disinfectant then to give it to the specific sites for recycling c Unit It contains electronic components cables aluminium 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 return the machine to Kinetec for destruction Spectra Essential ES 7 9 Technical specifications Product Weight 12Kg 24 pounds Splint dimensions 95cm 37 inches x 33cm 13 inches x 33cm 13 inches Angular limits 10 to 120 Speed from 45 to 155 per minute Patient height Electricity Power supply 100 240 V Frequency 50 60 Hz Power consumption 50 VA Device of type B cl
8. e do not touch the moving parts while the unit is running pinching risk Warning Modifying the machine in any way is strictly forbidden Spectra Essential EH 1 9 Compliance KINETEC Spectra Essential complies with the standards of Directive 93 42 EEC and bears the CE mark KINETEC Spectra Essential complies with the standards in force IEC 601 1 2 concerning the electromagnetic compatibility of medical devices Kinetec Spectra Essential complies with the standards of Directives Machine n 2006 42 CE Description The KINETEC Spectra Essential machine consists of the following components 1 Lower limb support 2 Thigh support 3 Foot support and hand control location f transport 4 Hand control 5 Thigh support setting lock 6 Lower limb support setting lock 7 Foot support positioning setting lock 8 Transport handle 9 ON OFF switch and fuses 10 Liquid crystal display 2 lines of 16 characters 11 Increase decrease keys 12 EXTENSION setting key 13 FLEXION setting key 14 STOP key 15 START key 16 PAUSE key 17 SPEED key Display Details A 16 character line used to display various messages when starting up the machine then the display does not change while the machine is being used Be 16 character line used to display various messages when starting up the machine then it displays the operational parameters C 3 character area showing the extensio
9. ems 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 Spectra Essential 8 9 GUIDANCE AND MANUFACTURER S DECLARATION Electromagnetic emissions The KINETEC Spectra Essential is intended for use in the electromagnetic environment specified below The customer or the user of the KINETEC Spectra Essential should ensure that it is used in such an environment Emissions test Compliance Electromagnetic environment guidance The KINETEC Spectra Essential uses RF energy only for its internal Radio electric Frequency emissions 27 CISPR 11 Group 1 function 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 The KINETEC Spectra Essential is suitable for use in all Harmonic emissions Class A establishments including domestic establishments and those directly IEC 61000 3 2 connected to the public low voltage power supply network that Voltage fluctuations Flicker emissions Gormpli s supplies buildings used for domestic purp
10. n limit D 4 character area showing various messages RUN STOP EXT FLEX E 3 character area showing the real time angle of the knee this value changes in line with the movement Fe 3 character area showing the flexion limit Spectra Essential EH 2 9 Electrical connection SAFETY FIRST The KINETEC Spectra Essential Machine is a type B class device I Before connecting the device to the power supply check that the mains voltage matches that shown on the identification plate 100 240 V 50 60Hz Connect the hand control 4 Connect the power supply cable 18 IMPORTANT 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 Check that the machine is not damaged in particular the protective housings Starting the unit Switch on the unit 9 The display comes on the machine carries out a self test and then the display shows Your KINETEC Spectra Essential is ready to be used Changing the display language Press the following buttons simultaneously o and 4 followed by or to change the display language Press the button to co
11. nfirm then switch the machine off and then on again to apply the changed display language Available languages English French German Italian and Spanish START STOP REVERSE function As with all KINETEC systems KINETEC Spectra is equipped with a START STOP REVERSE function When the unit is running the display reads RUN FLEX EXT 30 STOP 15 70 Press the e key of the hand control The movement stops Press the key of the hand control The movement starts in the opposite direction Caution For optimum safety always give the hand control to the patient before starting the system Procedure to stop the machine To stop the machine s movement Press the button To switch power off press the ON OFF switch 9 Locking the hand control setting The hand control allows the patient to control the machine as appropriate Simultaneously press the e and keys to lock the hand control The display reads LOCK you cannot change the parameters if you try the display reads LOCK SOFT To unlock the hand control simultaneously press the same keys The display reads UNLOCK 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 Spectra Essential E 3 9 Setting the movement parameters Select the parameter to be set Extension limit or flexion limit e or speed or pouse at the extension or flexion limit the setting to ch
12. oses IEC 61000 3 3 Electromagnetic immunity The KINETEC Spectra Essential is intended for use in the electromagnetic environment specified below The customer or the user of the KINETEC Spectra Essential should ensure that it is used in such an environment field IEC 61000 4 8 IEC 60601 Compliance Immunity test Electromagnetic environment guidance Test level level Floors should be wood concrete or ceramic tile If floors are 2 kV 4 kV 6 KV Complies covered with synthetic material the relative humidity should be Electrostatic discharge contact at least 3076 ESD If the movement stops push the start button the movement IEC 61000 4 2 22 kV 4 kV 8 kV Conia starts again ar p If the yellow LED is lighting switch off then on the apparatus and push the start button the movement starts again s TAST Ud 2 kV for power Complies Mains power quality should be that of a typical commercial or ly li i i IEC 61000 4 4 supply lines hospital environment 1 kV between lines Surge Complis Mains power quality should be that of a typical commercial or IEC 61000 4 5 2 kV between line p hospital environment and earth Voltage interruptions Y s UA Complies At the interruption there is a reset of the KINETEC Spectra CEI 61000 4 11 for FU P Essential After turning on push START to begin the session lt 5 Ur gt 95 dip in Un C omolies Voltage osand for 0 5 cycle Pas Mains
13. power quality should be that of a typical commercial or g pam hospital environment If the user of the KINETEC Spectra voltage variations on 40 Ur e oWwer subpvBUt 60 dip in Ui Complies Essential requires continued operation during power supply x as for 5 REA P interruptions it is recommended that the KINETEC Spectra Essential be powered from an uninterruptible power supply or a CEI 61000 4 11 ant battery o UT i 20 dpinuy C9mPlies for 25 cycles Power frequency Power frequency magnetic fields should be at levels 50 60 Hz magnetic T NER 3A m Complies characteristic of a typical location in a typical commercial or hospital environment NOTE Ur is the a c mains voltage prior to application of the test level Spectra Essential 9 9 Xkinetec nT BY MONS Pet Folyan Sammons Preston Rolyan A Patterson Medical Company 4 Sammons Court Bolingbrook IL 60440 4989 800 228 3693 extension 8774 FAX 262 387 8748
14. rement using knobs 5 To install the patient on the KINETEC Spectra Essential machine Push the foot plate 3 up to the patient and tighten the knobs Adjust the plantar flexion 40 or the dorsal flexion 30 of the foot with the knobs 7 Adjust the internal 30 or external 30 flexion of the foot with the knob 20 IMPORTANT Adjust the axis of the patient s hip 21 with the axis rotation 22 of the KINETEC Spectra Essential machine and the axis of the patient s knee 23 with the axis rotation 24 of the KINETEC Spectra Essential machine Trolley for all CPM Part number to order 4655001053 Transport box Part number to order 4640001927 Spectra Essential 23 Cart for bed use Seat Adaptor Part number to order Part number to order 4665003297 4670024098 Paediatric foot plate Part number to order 4670023777 E 6 9 Maintenance After 2 000 hours of operation the KINETEC Spectra Essential requires lubrication and maintenance operations lubrication of the joints pointer stops and ball screws The need for maintenance is indicated by display of the message SERV MOTOR when the system is switched on Despite that warning you can continue to use your KINETEC Spectra Essential by pressing START but you should contact your nearest KINETEC technician to have the maintenance operations conducted as soon as possible When the machine is no longer in working condition please return it to us
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