Spectra Essential - PremierMedicalProducts
Contents
1. Changing the display language 5 START STOP REVERSE function 5 Procequre to stop the machine 5 6 6 6 Locking Unlocking the hand control setting Setting the movement parameters Possible values for each parameter e Using the Plastic Comfort Case kit 7 e Using the Kinetec Patient Pad kit 7 Setting up the patient 8 Options 8 Product information Maintenance 9 Troubleshooting guide 9 Cleaning 9 Disposal and recycling 9 Technical specifications 10 Symbols used 10 Warranty 10 Guidance and manufacturer s declaration 1 Spectra Essential EN 1 12 Definition The KINETEC Spectra Essential is a PASSIVE KNEE mobilisation device enabling extension and flexion movements from 10 to 120 Indications Clinical Benefits e Arthroplasties of the knee and hip joints e Effectively breaks the vicious circle trauma immobility Osteosynthesised femoral or tibial fractures effusion and atrophy e Patellar fractures e Prevents joint stiffness of the knee and hip e Arthrolysis and palliative surgery cartilage lesions e Speeds the recovery of post operative range of motion removal of osteomas etc e Maintains the quality of the joint surface e Osteotomies of the pelvis or femur Promotes joint cartilage healing e Ligament repairs LCI LCE LLI LLE Prevents venous thrombosis e Freeing the knee extensor mechanism Judet s e Provides imme2. The display comes on the machine carries out a self test and then the display shows 30 STOP 15 70 Your KINETEC Spectra Essential is ready to be used Changing the display language KINETEC Check if the hand control is not 40 STOP 50 110 locked See page 6 LANGUAGE The display indicates the language ENGLISH selected LANGUAGE The French language is selected Available languages English French German Italian and Spanish Switch the unit ON Press simultaneously on the 2 keys To change the language FRENCH Switch the machine off OK and then on again SWITCH ON OFF to apply the changed display language To confirm the new language START STOP REVERSE function As with all KINETEC systems KINETEC Spectra Essential machines are equipped with a START STOP REVERSE function Press the y 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 oe key To switch the unit off press the ON OFF switch 9 see page 5 Spectra Essential EN 5 12 Locking the hand control setting The hand control allows the patient to control the machine as appropriate Simultaneously press the amp and keys to lock the hand control The display reads LOCK you can
3. emissions CISPR 11 Class B The KINETEC SPECTRA Essential is suitable for use in all establishments including Harmonic emissions IEC 61000 3 2 Class A domestic establishments and those directly connected to the public low Voltage fluctuations Flicker emissions IEC Complies voltage power supply network that supplies buildings used for domestic Guidance and manufacturer s declaration Electromagnetic immunity use in the electromagnetic environment specified below The customer or the user of the it is used in such an environment ESD Immunity test EE Compliance level Electromagnetic environment guidance 2 kV 4 kV 6 kV 2 kV 4 kV 6 kV Electrostatic discharge contact contact Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity 0 5kV 1 kV 2 kV between line and earth between line and earth IEC 61000 4 2 2 kV 4 kV 8 kV 2 kV 4 kV 8 kV should be at least 30 air air ee RENNER 2 kV 2 kV Mains power quality should be that of a typical IEC 61000 4 4 for power supply lines for power supply lines commercial or hospital environment 40 5 KV 1 kV ONE KV between ines between lines Surge Mains power quality should be that of a typical IEC 61000 4 5 0 5 kV 1 kV 2kV commercial or hospital environment Voltage interruptions IEC 61000 4 11 lt 5 Ur gt 95 dip in Ur for 5 seconds lt 5 Ur gt 95 dip in U
4. free or lt 5 alcohol solution in spray In order to ensure optimal hygiene you are advised to clean the covers for each new patient All the consumables enable hazard free disposal Disposal and recycling a Packaging The packaging must be separated into plastic and paper cardboard components and taken to special recycling sites b Kinetec patient pad kit Clean with a disinfectant product then take it to special recycling sites Ce Unit It contains electronic components cables aluminium steel and plastic parts When the machine is no longer operational disassemble it separate it into different types of material and take these to authorised recycling centres or return the machine to Kinetec for destruction Or contact the local authorities to determine the appropriate method of disposal for parts and accessories that are potentially hazardous to the environment Spectra Essential EN 9 12 Technical specifications Product Lifespan of the machine Weight Splint dimensions Angular limits Speeds Patient sizes Maximum weight of the user Acoustic pressure Electricity Power supply Frequency Power consumption Class Protection classification Fuse Environment Storage transport conditions Operating conditions Symbols used 12 years 12Kg 26 pounds 95cm 37 inches x 33cm 13 inches x 33cm 13 inches 10 to 120 from 45 to 155 per minute Full leg 71 to 99 cm 28 to 39 in
5. 4640001927 4670023777 Spectra Essential EN 8 12 Maintenance After 2 000 hours of operation or once a year 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 MOTEUR when the system is switched on Despite this indication you can continue to use your machine by pressing START but you should contact your nearest KINETEC technician to have the maintenance operations carried out as soon as possible An after sales service inspection sheet and the technical catalogue are available on request from your KINETEC distributor 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 When the machine is no longer in working condition please return it to us together with its accessories for destruction A motor running time counter is available by simultaneously pressing keys and amp the displays shows RESET TIME 215H this is an example This counter can be reset by pressing the key Troubleshooting guide A spare parts list a
6. Immunity test Test level according to Compliance Electromagnetic environment Radiated RF interference from 80 MHz to 2 5 GHz EIC 60601 level guidance Mobile and portable RF communication devices should not be used closer to any part of the KINETEC SPECTRA Essential machine including its cables than the recommended separation distance calculated based on the equation applicable to the emitter s frequency Recommended separation distance Conducted RF interference fom a 80 MHz ST d 12VP IEC 61000 4 6 3 V m 3 V m d 1 24 P from 80 MHz to 800 MHz IEC 61000 4 3 d 23 VP from 800 MHz to 2 5 GHz where P is the emitter s maximum output power characteristic in watts W according to the emitter s manufacturer and d is the recommended separation distance in metres m The field intensities of fixed RF emitters determined by an on site electromagnetic investigations should be below the compliance level in each frequency ranget There may be interference near appliances bearing the following symbol a NOTE 1 At 80 and 800 MHz the highest frequency range is applicable NOTE 2 These directives cannot be applied in every situation Electromagnetic propagation is affected by absorption and reflection by structures objects and people a The field intensity of fixed emitters such as base stations for radio telephones cellular cordless and land mobile radios amateur radio AM FM radio broadcasts and TV broadcasts cannot
7. Spectra Essential Avant toute utilisation lire ce document FR 1 Ant Manuel d utilisation Kinetec se r serve le droit de toutes modifications techniques Before use please read this document User manual Kinetec reserves the right to effect technical modifications EN Vor Benutzung unbedingt dieses Dokument lesen E Bedienungsanleitung Kinetec beh lt sich das Recht vor jegliche technische Anderung DE durchzuf hren Prima di mettere in funzione l apparecchio leggere con attenzione il Istruzioni per l uso presente documento IT La Kinetec si riserva il diritto di apportare modifiche tecniche Antes de cualquier utilizaci n lea este documento ES Kinetec se reserva el derecho a cualquier modificaci n t cnica Manual de empleo Lees voor ieder gebruik dit document door Gebruikershandleiding Kinetec behouden zich het recht voor technische wijzigingen aan te NL brengen 467896360 06 2014 S rie 1 2 3 4 0459 Notice Originale kinetec Kinetec SAS Zone Industrielle de Tournes Rue Maurice P rin F 08090 Tournes France 33 0 3 24 29 85 05 LA 33 0 3 24 33 51 05 Gd Ka contact kinetec fr bi www kinetec fr USER MANUAL Summary Page e Definition 2 e Warning and safety instructions 2 e Compliance 3 e Unpacking and packing 3 e Installing the device 3 e Description 4 Electrical connection 5 e Procedure to start the machine 5 e Using the hand control
8. be predicted exactly in theory To evaluate the electromagnetic environment due to fixed RF emitters an on site electromagnetic investigation should be considered If the field intensity measured where the KINETEC SPECTRA Essential machine is used exceeds the aforementioned applicable RF compliance level the KINETEC SPECTRA Essential machine should be monitored to check that it is working normally If abnormal results are observed additional measures may be necessary such as reorienting or repositioning the KINETEC SPECTRA Essential b Over the frequency range 150 kHz to 80MH7 field intensities should be less than 3V m Recommended separation distances between mobile and portable RF communication devices and the KINETEC SPECTRA Essential machine The KINETEC SPECTRA Essential machine is designed to be used in an electromagnetic environment in which radiated RF interference is controlled The customer or user of the KINETEC SPECTRA Essential machine can help prevent electromagnetic interference by maintaining a minimum distance between mobile and portable RF communication devices emitters and the KINETEC SPECTRA Essential machine as recommended below according to the communication device s maximum output power NOTE 1 NOTE 2 watts W according to the latter s manufacturer At 80 and 800 MHz the separation distance for the highest frequency range is applicable These dire
9. ches Tibia 38 to 53 cm 15 to 21 inches Femur 33 to 46 cm 15 to 21 inches 135 kg 297 pounds lt 70dB 100 240V 50 60 Hz 50 VA Device of Type BF Class Il or Type B Class IP 20 Protected against solid objects greater than 12 5mm but not protected against liquids T 750MA 250V 6 3 x 32mm Kinetec order 4610007434 Temperature 25 to 70 C 13 to 158 F Relative humidity up to 93 without condensation Temperature 5 to 40 C 41 to 104 F Relative humidity 15 to 93 without condensation Atmospheric pressure 700 hPa to 1060 hPa Warning or CAUTION consult the accompanying documentation Speed Flexion limit STOP power off ON power on Increase Start movement Right way up when box is stored Stop movement Contains electric and electronic components do not throw away with household refuse Alternating current Temperature Limit during storage or transport Follow the instructions for use Fragile Keep dry during storage or transport Pause ES Extension limit g Follow the instructions for use Class Il device TYPE BF device gt pO OP protection against electric shocks J A TYPEB device protection against electric shocks Warranty The KINETEC warranty is strictly limited to the replacement free of charge or to factory repairs of part s recognised as defective KINETEC guarantees its
10. continuous passive motion 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 Spectra Essential 10 12 Guidance and manufacturer s declaration Guidance and manufacturer s declaration Electromagnetic emissions it is used in such an environment 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 Emissions test Compliance Electromagnetic environment guidance The KINETEC SPECTRA Essential uses RF energy only for its internal function 61000 3 3 The KINETEC SPECTRA Essential is intended for KINETEC SPECTRA Essential should ensure that purposes Radio frequency emissions CISPR 11 Group 1 Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment Radio frequency
11. ctives cannot be applied in every situation Electromagnetic propagation is affected by absorption and reflection by structures objects and people Separation distance according to the emitter s frequency Maximum assigned output power m for the emitter from 150 kHz to 80 MHz 80 MHz to 800 MHz from 800 MHz to 2 5 GHz gt d 12VP d 124P d 23VP 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 2 2 3 10 3 8 3 8 LS 100 12 12 23 For emitters whose assigned maximum emitted power is not given above the recommended separation distance d in metres m can be estimated using the equation applicable to the emitter frequency where P is the emitters maximum emission power characteristic in Spectra Essential 12 12 kinetec Kinetec SAS Zone Industrielle de Tournes Rue Maurice P rin F 08090 Tournes France 33 0 3 24 29 85 05 33 0 3 24 33 51 05 Ka contact kinetec fr bi www kinetec fr
12. d 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 Use a DISINFECTANT product alcohol free or lt 5 alcohol solution in spray plastic cases and metal components We recommend changing the cases every 500 hours of operation See the Maintenance chapter for the running time counter 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 4650001876 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 Using 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 Sterilizing the pads if necessary Sterilize at 134 C for 18 minutes Disinfecting the straps Wash at 30 C using a disinfectant solution during the rinse cycle Example of produc
13. diate post operative continuous passive operation motion e Synovectomies Meniscectomies Patellectomies e Reduces hospitalization time Arthroscopies e Reduces the need for pain medication 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 suitable for patients over 1 95 m 6 7 or under 1 45m 4 7 tall 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 CE 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 changed lock the machine s hand control befor
14. e giving it to the patient see page 6 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 5 WARNING Before using this machine always check that the electrical socket isin 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 co
15. erational parameters Ce 3 character area showing the extension limit De 4 character area showing various messages RUN STOP EXT FLEX Ee 3 character area showing the real time angle of the knee this value changes with the current movement Fe 3 character area showing the flexion limit Spectra Essential EN 4 12 Electrical connection safety first 2 versions of electrical protection are available for the KINETEC Spectra Essential machine The identification label shows which version a machine is equipped with Type BF Class Il devices Ge for home use bear the following symbols CH Type B Class I devices for use in a professional environment bear the following symbols See page 11 for the meaning of the symbols Before connecting the device to the power supply check that the mains voltage matches that shown on the identification plate 100 240V 50 60Hz Connect the hand control 4 Connect the power supply cable 18 IMPORTANT For Type B Class 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 Procedure to start the machine Press the ON OFF switch 9 EXT FLEX
16. ing 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 KINETEC Spectra Essential 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 Spectra Essential EN 3 12 Description The KINETEC Spectra Essential machine consists of the following components 1 Lower limb support 2 Thigh support 3 Articulated foot plate and hand control location for transport Ae Hand control Ae Thigh support setting lock 6 Lower limb support setting lock 7 Foot plate position setting lock 8 Transport handle 9 e ON OFF switch and fuses 10 e 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 Ae 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 op
17. mmunications 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 12 Spectra Essential EN 2 12 Compliance KINETEC Spectra Essential complies with the standards of Directive 93 42 EEC and bears the EC mark The KINETEC Spectra Essential complies with the standards in force IEC 60601 1 2 concerning the electromagnetic compatibility of medical devices and IEC 60601 1 concerning electrical safety KINETEC Spectra Essential 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 cords and cables risk of strangulation Before using your machine you must move the foot plate into its working position See page 8 Your machine is ready to be connected to the power supply See page 5 Packing To prevent any problems when the machine is transported only pack it using its original packag
18. nd technical catalogue are available on request from your KINETEC distributor If after connecting the power supply cable to the power supply and switching on the machine e The display does not indicate any information Check that the electrical socket is live using another device or voltmeter 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 Check that the hand control is connected properly If the display still does not indicate any information contact your nearest KINETEC technician e Your machine does not work and the display indicates 50 STOP 25 115 Press START again If your machine still does not work contact your nearest KINETEC technician e Your machine does not work and the display indicates SERVICE D1 angle measurement function failure or SERVICE D2 no movement or SERVICE D3 abnormal consumption or PUSH STOP START power failure or disconnected motor switch the machine off then on contact your nearest KINETEC technician if the same message is displayed Cleaning Before carrying out any cleaning operation SWITCH OFF the unit 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 product alcohol
19. not change the parameters if you try the message LOCK appears To unlock the hand control simultaneously press the same keys The display will show 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 Setting the movement parameters Select the parameter to be set Extension limit or flexion limit or speed or pause at the extension or flexion limit the setting to change will flash Press the SB or v 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 Note 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 1 to 5 from 45 to 155 per e Speed minute e Extension pause O to 900 seconds 15 minutes e Flexion pause O to 900 seconds 15 minutes Spectra Essential EN 6 12 Using the Plastic Comfort Case kit Plastic Comfort Cases are specially designed to improve comfort and hygiene for the patient They have clips fixed directly on the tubes of the machine s thigh and lower limb support segments an
20. r for 5 seconds When the interruption occurs the KINETEC SPECTRA Essential is reset After turning on push START to begin the session Voltage dips and voltage variations on power supply input lines IEC 61000 4 11 lt 5 Ur gt 95 dip in Ur for 0 5 cycle 40 Ur 60 dip in Ur for 5 cycles 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 Ur 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 SPECTRA Essential requires continued operation during power supply interruptions we recommend powering the KINETEC SPECTRA Essential using an uninterruptible power supply or a battery Power frequency 50 60 Hz magnetic field EC 61000 4 8 3A m 3A m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment NOTE Ur is the AC mains voltage prior to application of the test level Spectra Essential 11 12 Guidance and manufacturer s declaration Guidance and manufacturer s declaration 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 Essentia should ensure tha it is used in such an environment
21. t that can be used Solution Bac linge at 0 125 or Souplanios at 0 125 from ANIOS Laboratories A complete list of distributors in your country is available on request The KINETEC Spectra is delivered with a complete set comprising 4 straps 4650001107 1 foot support 4650001420 1 cover 4650001090 Part number to order the complete set 4650001868 Spectra Essential 7 12 Setting up the patient See page 3 Installing the Device chapter for the positioning conditions Place the unit in a position that will be comfortable for the patient Measure the length of the patient s femur in cm or inches L adjust the thigh support to this measurement using knobs 5 Install the patient on the machine Bring the foot plate 3 into contact with the patient s foot then tighten both buttons 6 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 CAUTION Adjust the axis of the patient s hip 21 with the THEORETICAL axis of rotation 22 of the unit and the axis of the patient s knee 23 with the axis of articulation 24 of the unit 3 Trolley for all CPM Cart for bed use Seat adaptor Part number to order Part number to order Part number to order 4655001053 4665003297 4670024098 Transport box Paediatric foot plate Part number to order Part number to order
Download Pdf Manuals
Related Search