Skanlab NG Pro™ OPERATING INSTRUCTIONS
Contents
1. Software life cycle processes EN ISO 14971 2007 Medical devices Application of risk management to medical devices EN ISO 10993 2009 Biological evaluation of medical devices Part 1 Evaluation and testing within a risk management process 20 Manufacturing Standards EN ISO 13485 2012 Medical devices Quality management systems Requirements for regulatory purposes SYMBOLS and ABBREVIATIONS oa ee Serial number including manufacturing date Refer to Operating Instructions a Do not dispose with your general waste Type BF Applied Part Temperature transport conditions CE 0470 The Device Complies with Medical Device Directive 93 42 EEC A Safety Alert Refer to Operating Instructions Operating Instructions Skanlab NG Pro ver 03 20152. 5 2 APPLICATION OF PROBE AND ELECTRODE We recommend to never start treatment at level 7 10 this may cause discomfort to the patient It is recommended to start treatment at power level 3 7 and then adjust based on patients feedback 1 Uncover the skin in the area to be treated 2 Apply the Skanlab Electrode gel on the area to be treated 3 Apply the floating ground electrode to the opposite side of the treatment 4 Use the screen menu or manual protocol to administer the treatment After treatment disconnect the electrode and probe cables and clean the probe and electrodes with an alcohol based swab Apply the Skanlab Electrode gel on the floating ground electrode Apply Skanlab Electrode when using metal rod gel onto the electrode before treatment starts before attachment Operating Instructions Skanlab NG Pro ver 03 2015 Hamba 17 6 0 CHAPTER MAINTENANCE 6 1 TECHNICAL MAINTENANCE Check the electrode cables regularly for damage and or bad electrical contact We also advise that you keep an extra set of treatment cables in stock We recommend that the unit is serviced annually This may be done by your supplier or by another agent authorised by the manufacturer It is also recommended that a record of the service history is kept for all activities relating to service and maintenance In some countries this is even obligatory Maintenance and all repairs should only be carried out by an authorised ag
3. ISKANLAB N GI j Skanlab NG Pro OPERATING INSTRUCTIONS Skanlab AS Norge ver 03 2015 Made in Norway CE 0470 SKANLAB AS Org nr 976079027 Phone 47 69 35 20 80 P O Box 166 e mail info skanlab no NO 1650 Sellebakk www skanlab no INDEX 1 0 Introduction 1 1 Approvals and certificates 2 0 Safety Overview 2 1 Preliminary notes 2 2 General 2 3 Exclusions 2 4 Electromagnetic interference 2 5 Product liability 2 5 1 Limitations of liability 2 5 2 Service 3 0 Contraindications 3 1 Important Warnings 4 0 Installation 4 1 Connection 4 2 Switching on and self test 4 3 Disconnecting from the mains 5 0 Operation 5 1 Treatment start 5 1 1 Skanlab NG Pro The Capacitor Field method 5 1 2 Controls 5 1 3 Starting and Selecting Treatment 5 1 3 1 Menu Driven Treatment 5132 Manually Selected Treatment 5 2 Actions in relation to treatment 5 3 Treatment manual 6 0 Maintenance 6 1 Technical maintenance 6 2 Cleaning the Control Unit 6 3 Cleaning the Electrodes and Cables 6 4 Main Power Fuses 6 4 1 Treatment electrodes 6 4 2 Electrode cables 6 4 3 Main power fuses 7 0 Standard Equipment 7 1 Accessories 7 1 1 Applied Parts Electrodes 7 1 2 Cables Connectors and Electrode Gel 8 0 Specification 8 1 Technical specification 8 2 Unit 8 3 Environment Conditions for Transport and Storage 8 4 Environment Conditions for Normal Use 8 5 Classifications and Standards 8 6 Symbols and Abbreviations Patent No 179348 US Pat
4. the nature of injury or strain Operating Instructions Skanlab NG Pro ver 03 2015 Hamba 9 MM SK ANLASB N ON 9 1 2 CONTROLS Hand held probe handle w treatment electrode to adjust Energy remote ON OFF Operating Instructions Skanlab NG Pro ver 03 2015 Hamba 10 Floating ground electrode black electrode cable Power on off switch Hand held probe handle to adjust Energy Treatment electrode remote 9 1 3 STARTING AND SELECTING TREATMENT On turning on the system goes through the following 2 screens automatically Operating Instructions Skanlab NG Pro ver 03 2015 There are 4 language versions currently offered Once the language has been selected by pressing the touch screen symbol the following screen is shown CONTRAINDICATIONS Do not treat patients with a pacemaker Do not treat patients with infusion pump Do not treat patients who are pregnant acceptable after 6months Do not treat patients who have cancer Do not treat patients with general loss of sensitivity Do not treat patients with phlebitis clot Hearing aids should be removed Do not treat patients whose skin sensitivity is reduced in the treatment area unless the patients doctor recommends the treatment If treatment test the energy level on the opposite healthy body part Important Apply Skanlab Electrode cream onto the floating ground electrode before attachment The floating
5. ground electrode should be attached to the patient Explain that the patient should feel a comfortable heat Maintain verbal contact with the patient throughout the treatment Whatever the type of treatment be sure to take a common sense approach If you are at all unsure then do not start without consulting the patients doctor with experience of the injury in question OK This screen is a reminder of the contraindications and warnings listed in the instructions for use The operating modes cannot be accessed without pressing the OK button Once the OK button has been pressed the following appears Operating Instructions Skanlab NG Pro ver 03 2015 Hamba 12 BNN S KANLAB NGO D The i symbol gives access to a screen below where screen brightness can be modified depending on environmental conditions and user preferences This option also gives access to the service menu only accessible by authorized service personnel not by user code access required In order to promote the best possible treatment with Skanlab NG Pro we have endeavoured to set out the advice and experience of our own and other therapists using the method and incorporate these into a range of treatment menus These are accessed Operating Instructions Skanlab NG Pro ver 03 2015 Hamba by pressing the anatomical locations on the above screen Alternatively a fully manual protocol can be used by selecting the MAN button on the touch scr
6. has become effective in many countries This Product Liability laws implies amongst other things that once a period of 10 years has elapsed after the product has been brought into circulation the manufacturer can no longer be held responsible for possible shortages of the product 2 5 1 LIMITATIONS OF LIABILITY To the maximum extent permitted by applicable law in no event will Skanlab AS or its suppliers or resellers be liable for any indirect special incidental or inability to use the product including without limitation damages for loss of goodwill work and productivity computer failure or malfunction or any and all other commercial damages or losses even if advised of the possibility thereof and regardless of legal or equitable theory contract tort or otherwise upon which the claim is based In any case Skanlab AS s entire liability under any provision of this agreement shall not exceed in the aggregate the sum of the fees paid for this product received by Skanlab AS under a separate support agreement if any with the exception of death or personal injury caused by the negligence of Skanlab AS to the extent applicable law prohibits the limitation of damages in such cases Skanlab AS cannot be held liable for any consequence resulting from incorrect information provided by its personnel or errors incorporated in this manual and or other accompanying documentation including commercial documentation The opposing party produc
7. 1 Skanlab NG Pro THE CAPACITOR FIELD METHOD Applied parts the floating ground electrode and treatment electrodes are placed on opposing sides of the body area to be treated The surface of the treatment electrode is non conducting and the conductive part is separated from the skin by an insulating material The treatment electrode is mounted on the treatment probe or handle There are currently 2 diameter electrodes 23 and 30 mm suitable for treatment of smaller or larger areas The ground electrode is conducting and is non insulating The treatment electrode and ground electrode act as the plates of a capacitor while the patient s tissue together with the insulated treatment electrode surface material form the dielectric When current is applied rapidly alternating charges are induced in the treatment electrodes and give rise to a rapidly alternating electric field between them The electric field influences the materials which lie within it The Capacitor field method is dependent on e The dimension of the capacitor plate of the treatment electrode 023 and 30 mm e The distance between the two electrodes e The materials between the electrodes including tissue insulation electrode gel It is therefore important to have the smallest possible distance between the area being treated by the probe and the floating ground electrode during the treatment There are currently 2 different sizes of treatment electrodes and the choice depends on
8. MMMM S KANLAB NGO D The selected indication from the touch screen loads the recommended treatment parameters The time is given in minutes Treatment is started by pressing START 05 00 gt START BNN P Once start is pressed the treatment proceeds as indicated by this screen Operating Instructions Skanlab NG Pro ver 03 2015 Hamba O4 405 00 gt Epicondylitter latteralt og medialt lt 1 c Treatment can be stopped anytime by pressing the STOP button The clock counts down to zero until treatment is finished shown by 405 00 gt FERDIG Once started the treatment time cannot be extended by using the and symbols in the time bar on the touch screen Power can be adjusted by Use of the probe power adjustment button e Pressing the or buttons on the power scale Sliding the power bar button on the power scale left or right 5 1 3 2 MANUALLY SELECTED TREATMENT Selection of the Manual mode gives the following screen and no anatomical location is given Operating Instructions Skanlab NG Pro ver 03 2015 05 00 gt ae START ee ad ST The time and power level 1 10 are selected manually and the START button pressed to initiate the selected treatment Please note that Skanlab recommends never starting treatment above level 7 This can be adjusted upwards once feedback on comfort is obtained from the patient Once complete a FINISHED screen is shown
9. able for floating ground electrode 21 3600 17 Main power cable 21 3600 6 Skanlab Electrode gel mk ee ee ee 7 1 ACCESSORIES 7 1 1 Electrodes 61 4 Treatment electrode 030mm 62 4 Treatment electrode 23mm 70 3 Hand held probe handle w remote 11 4 Floating ground electrode massive 7 1 2 Cables connectors and electrode gel 21 3600 4 Cable for floating ground electrodes 21 3600 6 Skanlab Electrode gel 1 It 21 3600 13 Skanlab Electrode gel 5 It 21 3600 11 Hand pump 21 3600 17 Main power cable 2 Main power fuses 2xT 2 5A H 250V Operating Instructions Skanlab NG Pro ver 03 2015 Hamba 19 8 0 CHAPTER SPECIFICATION The anticipated in use life of Skanlab 25 NG pro is 10 years from first use Probes and electrodes are subject to accidental damage due to storage or impact and should be checked prior to use for visible damage 8 1 TECHNICAL SPECIFICATION Mains voltage 100 240 VAC Frequency 60 50 Hz AC Output current 1 2 0 6 Amp Maximum output power 24 W Output frequency 500 kHz 8 2 UNIT Medical device classification lla according to MDD 93 42 EEC Safety class tyoe BF according to IEC 60601 1 Patient leakage current better than IEC reqg IEC lt 100 pA Safety tests Medical Electrical Equipment Part 1 General requirements for safety Dimensions 302x300x126 5mm Ixwxh Weight 4 3 kg 8 3 ENVIRONMENT CONDITIONS FOR TRANSPORT AND STORAGE Environment temperature 10 till 40C Relative humidi
10. by increased heat and blood flow to treated areas Care should be taken with patients taking anti thrombotic medication such as warfarin and aspirin Whatever the type of treatment be sure to take a common sense approach If you are at all unsure then do not start without consulting a physician colleague manufacturer or distributor with experience of the injury in question Skanlab NG Pro is for treatment of external tissues only It should never be used internally in any body orifice Only touch the patient with the treatment probe during treatment Do not touch the patient with your other hand as this could result in a change in electrical potential between patient and Skanlab NG Pro device This may cause an electric shock to you or the patient Do not use in a critical care environment Electromagnetic radiation may impact critical care equipment Do not use in hydrotherapy rooms Avoid contact of the electrodes and control unit with water during use Skanlab NG Pro therapy should not be applied to patients through clothing Conductive material should be excluded from the treatment area The patient should not be allowed to come into contact with conductive parts which are earthed or which have an appreciable capacitance to earth which may provide unwanted pathways for the radiofrequency current in particular beds or chairs having metal frames should not be used Avoid having the applicator cables coming in contact with t
11. dications and warnings see chapter 3 0 Do not touch the patient during treatment Never leave the patient unattended during treatment The apparatus may not be used in close proximity i e less than 2 meters to other equipment 5 The apparatus may not be used in so called wet rooms hydrotherapy rooms PONS The manufacturer cannot be held responsible for the results of using this apparatus for any purpose other than described in these operating instructions 2 2 GENERAL When the unit is switched on all functions are controlled via a microprocessor During the functioning of the unit the actual output of the current is measured continuously Operating Instructions Skanlab NG Pro ver 03 2015 Hamba and compared to the requested output If a fault is detected the unit will switch off the current immediately 4 2 3 EXCLUSIONS Skanlab NG Pro is for treatment of soft and hard skeletal tissues only such as articulating joints including the spine and skeletal muscle It is not intended for treatment of any other internal tissues or organs Please refer to Contraindications and Warnings in Chapter 3 2 4 ELECTROMAGNETIC INTERFERENCE Simultaneous connection of a patent to High Frequency Therapy equipment and an electrical stimulator must not be done this may result in burns at the site of the stimulator electrodes Therefore simultaneous connection is not allowed 2 5 PRODUCT LIABILITY A law on Product liability
12. een 13 Remember that all treatment is individual so try to create your own approach to therapy Some rules have to be followed of course and we have sought to describe them here Additional points to consider e Floating ground electrode Choose the type of floating ground electrode that is most popular for the type of injury concerned massive or disposable adhesive floating ground electrode In most cases the patient will be lying down during treatment In this case the massive can be placed under the patient e Treatment time time Usually treatment will be minimum 4 minutes depending on the size of the injured area and the state of the injury e Intensity energy The energy may vary from 1 10 Only seldom does the therapist use energy 1 2 or 7 10 Work fairly slowly and always and work down until the patient feels comfortable heat e Treatment electrode The choice of the large or small treatment electrode is determined by the size of the injury Back injuries require the larger electrode finger injuries a smaller electrode Remember that a large electrode needs more energy and that a small area requires less Both the speed and the technique applied will determine how much energy to apply 5 1 3 1 Menu Driven Treatment An anatomical location from the listed 10 sites is selected by the touch screen The screens for all 10 locations are shown below Operating Instructions Skanlab NG Pro ver 03 2015 Hamba
13. ent The manufacturer will not be held responsible for the results of maintenance or repairs by unauthorised person The service and or maintenance must be carried out conform the procedure described in the service manual for the unit Opening of the equipment by unauthorised agencies is not allowed and will terminate any claim to warranty 6 2 CLEANING THE CONTROL UNIT Switch off the unit and disconnect it from the mains supply Clean the apparatus using a cloth moistened with soap and water 6 3 CLEANING THE ELECTRODES AND CABLES Clean the electrodes and probes by wiping the surface with a standard alcohol based swab Wipe with a tissue to dry or allow to air dry The electrodes and probes should be cleaned both before and after use The disposable adhesive electrode is for single use only and should be disposed of after single use 6 3 MAIN POWER FUSES In case of power failure the main power fuses should be checked and changed by the owner Pull out the main power cable Pull out the fuse holder and change both fuses Fuses 2xT 2 5A H 250V Replace the fuse holder and plug in the main power cable Turn on the machine and check the ON indicator If it still doesn t work contact your dealer oi ol Operating Instructions Skanlab NG Pro ver 03 2015 Hamba 18 7 0 STANDARD EQUIPMENT 61 4 Treatment electrode 030mm 70 3 Hand held probe handle w remote 11 4 Floating ground electrode massive 21 3600 4 C
14. ent No 5 579 202 Trade Mark No 178941 Operating Instructions Skanlab NG Pro ver 03 2015 Hamba Page UJ o MOONNAUAA A A AW W Hamba 1 0 INTRODUCTION Skanlab NG Pro is a medical device indicated for the treatment of soft and hard skeletal tissue disorders resulting from injury or degenerative processes It was developed in Norway and was introduced to the market in 1988 under the brand SKANLAB 25 BODYWAVE The instrument uses a 500 kHz high frequency AC current where the patients own tissue is part of the capacitor a diathermy treatment known as the Capacitor Field Method lt is intended for use by clinicians and practitioners who have been professionally trained in diathermy such as physical therapists and chiropractors It should only be used by trained professional personnel Please contact your local Skanlab representative or distributor who will arrange a product demonstration and training in the use of the Skanlab NG Pro 1 1 APPROVAL AND CERTIFICATES CE 0470 The equipment complies with all requirements of the Medical Device Directive 93 42 EEC 2 0 CHAPTER SAFETY OVERVIEW 2 1 PRELIMINARY NOTES lt is important that you read these operating instructions carefully before using Skanlab NG Pro Please make sure that these instructions are available to all personnel who operate the equipment Pay attention to the following before using the Skanlab NG Pro Study the full list of contrain
15. he patient the therapist or any conductive or energy absorbent materials Only use the applicators and their cables as directed Look after the insulation on probes and probe cables being careful to avoid damage Do not use damaged cables or probes Only use Skanlab NG Pro electrode gel as advised during the treatment Operating Instructions Skanlab NG Pro ver 03 2015 Hamba During treatment explain that the patient should feel a comfortable heat Avoid excessive manual pressure which could be uncomfortable 7 Maintain verbal contact with the patient throughout the treatment Do not leave the patient alone and seek feedback on how they are feeling during treatment Other equipment connected to patient must be removed before the treatment starts Local skin conditions may become irritated by the application of the probes for example eczema or psoriasis If this happens do not directly treat the area Avoid treating a patient who has just come in from the cold Wait until the patient has returned to his or her natural body temperature in the area to be treated Care should be taken in treatment of menstruating women The effects on blood flow if any are unknown When using to treat the spine care should be taken to avoid the cervical occipital joint which would require treatment of the head The apparatus may not be used in close proximity i e less than 2 meters to other equipment Do not install the unit i
16. ker Do not treat patients with infusion pump Do not treat patients who are pregnant acceptable after 6months Do not treat patients who have cancer Do not treat patients with general loss of sensitivity Do not treat patients with phlebitis clot Hearing aids should be removed Do not treat patients whose skin sensitivity is reduced in the treatment area unless the patients doctor recommends the treatment If treatment test the energy level on the opposite healthy body part Important Apply Skanlab Electrode cream onto the floating ground electrode before attachment The floating ground electrode should be attached to the patient Explain that the patient should feel a comfortable heat Maintain verbal contact with the patient throughout the treatment Whatever the type of treatment be sure to take a common sense approach If you are at all unsure then do not start without consulting the patients doctor with experience of the injury in question Operating Instructions Skanlab NG Pro ver 03 2015 Hamba 3 1 IMPORTANT WARNINGS To avoid the risk of electric shock this equipment must only be connected to a supply mains with protective earth Prior to treatment patients should be asked about their general health and screened against the list of contraindications in Section 3 0 and any co morbidities such as clotting disorders Clots may become dislodged due to local thermal effects Bleeding disorders may be impacted
17. n a location near to a heat source such as a radiator Avoid exposure to sunlight water and rain excessive dust dampness mechanical vibration and shocks Should water enter into the control unit disconnect from the wall socket and have it checked by an authorized agent 4 0 CHAPTER INSTALLATION 4 1 CONNECTION e Mains supply connections must comply with the national requirements regarding medical rooms e Be sure to place the device for easily reach of main switch ON OFF on rear side e Prior to connection of this apparatus to the mains supply check that the voltage and frequency stated on the type plate correspond with the available mains supply e Only the manufacturers approved mains cable is allowed for use e Only the manufacturers approved electrode cable and probe cable are allowed for use e Only use the Applied parts supported by Skanlab NG Pro defined as the floating ground electrode and treatment electrodes Operating Instructions Skanlab NG Pro ver 03 2015 8 4 2 SWITCHING ON AND SELF TEST e Connect the mains cable to the connector and to the wall socket e Switch on the unit using the on off switch on the rear side of the unit e Immediately after switching on the unit carries out a self test indicated on the screen 4 3 DISCONNECTING FROM THE MAINS e Switch the device off using the on off switch e Remove the mains cable from the wall socket 5 0 CHAPTER OPERATION 5 1 TREATMENT START 5 1
18. t s user or its representative shall disclaim Skanlab AS from all claims arising from third parties whatever nature or whatever relationship to the opposing party 2 5 2 Service Skanlab AS will Authorize Service persons and provide them with Servicemanual that connents circuit diagrams component part lists descriptions calibration instructions Operating Instructions Skanlab NG Pro ver 03 2015 Hamba 5 3 0 CHAPTER CONTRAINDICATIONS Do not treat patients with a pacemaker Do not treat patients with an infusion pump eg insulin pump Do not treat patients who are pregnant acceptable after first 6 months but not directly over foetus Hearing aids should be removed Do not use in patient with cochlear implants Do not treat patients who have cancer Do no treat patients with acute tuberculosis Do not treat patients with phlebitis clots Deep Vein Thrombosis Do not treat patients with general loss of sensitivity or whose skin sensitivity is reduced in the treatment area unless the patients doctor recommends the treatment If treatment is indicated test the energy level on the opposite healthy body part where local insensitivity is a concern Haemorrhaging areas that is skin with open cuts or partially healed wounds are contraindicated This contraindication information is visible in the display and must be accepted before treatment can commence CONTRAINDICATIONS Do not treat patients with a pacema
19. ty 10 till 90 Atmospheric pressure 500 till 1060 hPa 8 4 ENVIRONMENT CONDITIONS NORMAL USE Environment temperature 10 till 40C Relative humidity 10 till 90 Atmospheric pressure 800 till 1060 hPa 8 5 CLASSIFICATION AND STANDARDS Classification of Skanlab 25 NG Pro Class lla according to the Medical Devices Directive MDD 93 42 Software Class A according to EN ISO 62304 2006 Software Safety Classification Implemented Safety Standards IEC 60601 1 2005 A1 2012 Medical Electrical Equipment Part 1 General requirements for safety IEC 60601 1 2 2007 Medical electrical equipment Part 1 General requirements for basic safety and essential performance Section 2 Collateral standard Electromagnetic disturbances Requirements and tests Operating Instructions Skanlab NG Pro ver 03 2015 Hamba IEC 60601 1 4 2002 Medical electrical equipment Part 1 4 General requirements for safety Collateral standard Programmable electrical medical systems IEC 60601 1 6 2010 Medical Electrical Equipment Part 1 General requirements for safety Section 6 Collateral standard Usability IEC 60601 1 11 2010 Medical electrical equipment Part 1 General requirements for basic safety and essential performance Section 11 Collateral standard Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment EN ISO 62304 2006 Medical device software
Download Pdf Manuals
Related Search