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Intelect® Shortwave 400

SAFETy iNSTruCTiONS

GENErAL iNFOrmATiON

The Intelect Shortwave 400 therapy unit and the accompanying components and individual elements fulfill individually and as

a unit, the currently valid safety standards and comply with the stipulations of IEC 601 and the medical products regulations.

The unit and its external components (accessory elements) are safe if used properly and in compliance with the explanations

and instructions provided in this documentation.

Nevertheless, the unit or its external components can pose dangers.

Therefore, we urgently recommend that anyone operating the shortwave therapy unit become aware of the potential dangers

of the unit and its external components before beginning work.

Please read and observe all safety instructions in this operating manual.

Содержание Intelect Shortwave 400 3813

Страница 1: ...15V 3814 230V OptionalEquipment 020 453218 Capacitive Plate Electrodes 020 453216 Capacitive Plate Electrodes 020 453267 Soft Rubber Electrode 020 453267 Soft Rubber Electrode 020 969553 Diplode with Cable Coil Field Electrode 020 453263 Diplode Coil Field Electrode Electromagnetic Compatibility EMC Tables ...

Страница 2: ...nit 20 Inspection upon Receipt 20 NOMENCLATURE 21 24 Operator Side 21 Patient Side 22 Accessories 23 specifications 25 36 Unit Specifications 25 Description of Functions 26 Shortwave Therapy in the Capacitive Dielectric Field 27 Shortwave Therapy in the Inductive Field 28 Program Description 29 Display and Control Element 29 Main Menu 30 Indications Menu 32 Programming Menu 35 Basic Settings Menu ...

Страница 3: ...gram Menu 43 Basic Operations 44 Beginning the Treatment 44 Interrupting Ending Treatment 45 Changing the Basic Settings 46 maintenance 47 52 Maintenance and Repairs 47 Routine Maintenance 47 Cleaning and Disinfection 47 Safety Inspection 49 Visual Inspection 49 Functional Test 49 Electrical Tests 50 Error Messages 51 Operator Errors 51 Internal Errors 51 Repairs 52 Service 52 Accessories 53 Warra...

Страница 4: ...ontained in this manual for each mode of treatment available as well as the indications contraindications warnings and precautions Consult other resources for additional information regarding the application of shortwave therapy Product Description The Intelect Shortwave 400 system utilizes both inductive and capacitive electrodes to administer electromagnetic energy to the patient s body at short...

Страница 5: ... regulations The unit and its external components accessory elements are safe if used properly and in compliance with the explanations and instructions provided in this documentation Nevertheless the unit or its external components can pose dangers Therefore we urgently recommend that anyone operating the shortwave therapy unit become aware of the potential dangers of the unit and its external com...

Страница 6: ...presence of flammable anesthetics NOTE Throughout this manual NOTE may be found These Notes are helpful information to aid in the particular area or function being described Precautionary Definitions Caution Warning Explosion Hazard Text with a DANGER indicator will explain possible safety infractions that are imminently hazardous situations that would result in death or serious injury Danger Text...

Страница 7: ...e Inappropriate handling of the accessories may adversely affect their characteristics Inspect cables and associated connectors before each use Remove hearing aids prior to treatment Treatment should not be given through clothing although it is permissible to administer treatment through a dressing or plaster in pulsed modes External conductive material should be removed from the immediate treatme...

Страница 8: ...rapy system may result in malfunctions of this unit or other devices Do not store or operate the unit in a dusty environment Care must be taken when operating this equipment around other equipment Potential electromagnetic or other interference could occur to this or to the other equipment Try to minimize this interference by not using other equipment in conjunction with it Keep all electrodes acc...

Страница 9: ...ings on the unit e g the connecting sockets of the electrode cables Therefore do not use cleaning or disinfectant sprays The unit electrodes and cables may not be sterilized using steam or gas Never clean the unit with abrasives disinfectants or solvents that could scratch the housing or damage the unit In order to prevent excessive warming of tissue the effective output power as summarized in the...

Страница 10: ...t implanted after the implant is removed This unit generates non ionizing radiation Patients with implanted electronic devices such as cardiac pacemakers and defibrillators cochlear implants bone growth stimulators deep brain stimulators spinal cord stimulators and other nerve stimulators must not be treated even if the device has been turned off The function of certain implanted devices e g pacem...

Страница 11: ...e standing and the patient is not in direct contact with metal objects such as heating radiators metal beds or other equipment The insulation of the RF output jack and electrode connection cables is not damaged The electrode connection cable is connected properly and is not cross routed which may cause capacitive short circuits Only accessories cables electrodes approved by the manufacturer are co...

Страница 12: ...ioning properly for moisture development perspiration in the area of the electrodes and whether the patient feels well After the treatment ask the patient about his tolerance of the treatment and visit the treatment environment Licensed Practitioner The affected parts of the body should be unclothed during treatment since accumulation of moisture on the skin or in folds can cause local overheating...

Страница 13: ...ons of this unit or other devices Observe the following instructions in order to prevent malfunctions In order to prevent electromagnetic disturbances place the unit at least 6 meters from any other devices Also make sure that there is sufficient distance between the unit and Mains Power Supply or data cables in walls ceilings and floors since the electromagnetic radiation from the unit can pass t...

Страница 14: ...Supply until these requirements have been fulfilled Before putting the unit into operation check to make sure that the electrode connection cable and the electrodes are undamaged and have been connected correctly to the unit Never operate the unit with open outputs i e without electrodes Do not operate the unit for an extended period with no load without a patient especially in coil induction fiel...

Страница 15: ...Chronic polyarthritis of the hip and shoulder Joints Definition Inflammation of more than one joint Goal of treatment Pain relief lessening of inflammation General C Achillodynia Definition Irritation of the Achilles tendon Goal of treatment Stimulation of perfusion elimination of functionally impaired contractures analgesia trophic improvement D Bechterew s disease Definition Inflammatory stiffen...

Страница 16: ...ne Possible causes of this are nerve root compressions and acute blockages in the area of the kinetic elements or the joint faces of the vertebral bodies Goal of treatment Pain relief K Ischialgia Definition Pain in ending of nervus ischiadicus always radicular usually caused by damaged intervertebral disc Goal of treatment Analgesia tone reduction hyperaemisation of the affected muscles L Contrac...

Страница 17: ...tis Goal of treatment Pain relief inflammation stop R Raynaud s disease Definition Acute arterial blood supply in the fingers angiospasms Goal of treatment Reduction of the frequency intensity and duration of the attacks S Spondylosis osteochondrosis Definition Arthrosis of the vertebral bodies Degeneration of the intervertebral discs Goal of treatment Freedom from affliction retardation of degene...

Страница 18: ...of treatment Pain relief stimulation of perfusion specific relaxation and stretching of tense muscle groups Heat perception Treatment Dosage 1 2 3 4 None Low Medium Strong NOTE Always begin the treatment with an intially low dosage After the treatment has been in progress for 1 2 minutes make the final setting based on the subjective response of the patient Dosage Levels according to Schliephake D...

Страница 19: ...by heat Patients with tuberculosis Patients with hemorrhages or risk of hemorrhage Patients with septic conditions and empyemas Patients with malignant tumors and tumors that are not yet identified According to Schneider in Elektromedizin 7 62 Tissue and organ sections with inflammations necroses pus formation and abscesses In such cases the therapist must choose between the application of cold or...

Страница 20: ...nce irradiation of the abdomen could cause teratogenous damage due to alterations of blood circulation and diffusion During the menstrual cycle Sudeck s syndrome stage I and II Basedow s disease irradiation could cause serious states of agitation Varicose veins irradiation could cause congestive pain The higher conductivity of metals causes concentration of the field producing a high temperature i...

Страница 21: ...ldren particular care is obviously required due to the low body weight Very careful dosing and constant observation manual checks of the skin temperature while the unit is switched off are necessary Since the effects of high frequency fields on unborn life have not yet been sufficiently researched we recommend that operators who are pregnant do not remain in the immediate vicinity of the applicato...

Страница 22: ...ters Please note that the radiation can easily pass walls ceilings and floors The room and the installation location must be large enough so that the unit can be operated from the front even if the electrodes are positioned inconveniently Transport of the Unit Measures concerning the transport of the unit from the manufacturer to the operator are based on the individual circumstances and are defin...

Страница 23: ... the safety bands from the transport packaging Remove the transport packaging upward Remove the remaining foam material Lift at least two persons the unit from the lower packaging element Inspection Upon Receipt Verify the delivery documents to make sure that the delivery is complete Immediately after unpacking the unit check the external components and accessories for possible damage due to trans...

Страница 24: ...ode connection cable with sponge rubber covering 3 Self locking plastic electrode arm extractable 4 Cable clamp for electrode connection cable 5 Control panel with graphic display 6 Metal housing 7 Locking castor 8 Power switch Figure 1 Front View of Intelect Shortwave 400 operator side ...

Страница 25: ...electrode connection cable 3 Electrical Safety Protection fuses 4 High load non heating Appliance Plug Power Cord 5 Serial Decal 6 Female end of the electrode connection cable 7 Adjusting element for Electrode Skin Distance 8 Locking screw on electrode arm 9 RF output jacks Figure 2 Back view of Intelect Shortwave 400 9 ...

Страница 26: ...m extenders Electrodes or their cords in contact with each other during treatment could result in improper stimulation or skin burns Figure 3 Capacitive Plate Electrodes Dielectric Field 1 Capacitive Plate Electrode Ø 165 mm 2 Capacitive Plate Electrode Ø120 mm Standard accessory 3 Capacitive Plate Electrode Ø 80 mm 4 Electrode connecting cable with sponge rubber covering WARNING ...

Страница 27: ... 120 mm 3 Felt layer with linen bag for 1 and 2 4 Perforated rubber band with 2 buttons Figure 4 Soft Rubber Electrodes Dielectric Field Figure 5 Plastic Eddy Current Electrodes Coil Induction Field 1 Eddy current Electrode diplode with cable 2 Eddy current Electrode diode with cable Accessories continued ...

Страница 28: ...wer Pulse Duration 200 600 µs Pulse Frequencies 10 300 Hz Treatment Duration 1 60 minutes Fuses T16A 115V T8 A 230V Electrical Class CLASS I Electrical Type TYPE BF Regulatory Risk Class IIa according to MDD 93 42 EEC Transport and Storage Conditions Ambient temperature 40 C to 70 C 40 F to 158 F Relative Humidity 10 to 100 Air Pressure 500 hPa to 1060 hPa Regulatory Compliance The Intelect Shortw...

Страница 29: ...hods in continuous or pulsed mode The application of high frequency energy in heat therapy has the advantage of greater depth penetration as opposed to simpler methods such as packs baths infrared light and heat cushions The endogenous heat that is formed triggers a series of physiological processes producing a spasmolytic effect on muscles tendons and other structures containing connective tissue...

Страница 30: ... the electrodes together form a capacitor This causes heat to be generated in the entire treatment field located between the electrodes With the capacitive method fat tissue is warmed more effectively than muscle tissue Rigid electrodes capacitive plate electrodes and soft rubber electrodes are used for the capacitive method An adjusting device on the plate electrodes or layers of felt with the So...

Страница 31: ...issue with better conductivity such as muscles and inner organs are warmed more than fat tissue The danger of excessive heating of the outer layers of tissue is therefore significantly reduced while effective warming down into the muscles is primary Two different Eddy current Electrodes are available as induction field electrodes Diode for treatment of mid sized areas Three part diplode for treatm...

Страница 32: ...400 operating element 2 Graphic display 3 Multi function keys 4 Stop key power output shut off 5 Important Read operating instructions 6 Multi function rotary switch with push button function Enter NOTE Device of type BF insulated non earthed application element Figure 8 Intelect Shortwave 400 Operating Element ...

Страница 33: ...entifying the key functions 12 Text output display field 13 Matching display field 14 Effective power display field patient effective power Parameters can be set in three ways 1 Direct input of parameter with the function keys 5 through 8 2 Selection of a disorder in the indications menu 9 3 Selection of a program saved in the programming menu 10 The treatment is always started by turning up the o...

Страница 34: ...tient effective power The information in the text output field varies depending on the selected program or indication and disappears after changing the parameter for these preset values The effective output power is dependent on the amplitude value of the output power the frequency setting and the pulse duration setting in the basic settings menu In continuous mode CW Mode continuous wave mode the...

Страница 35: ...ted disorder Enter alternatively the push button function of the multi function rotary switch can be used 6 Function key for calling up further information application of electrodes comments on therapy Program description continued 1 Disorder selected inverse display 2 Disorder not selected 3 Function key for return to main menu 4 Function key for calling up disorders of other medical fields index...

Страница 36: ...rtwave 400 Index Page 1 Medical field not selected 2 Medical field selected inverse display 3 Function key for confirming the selected medical field Enter alternatively the push button function of the multi function rotary switch can be used 4 Function key for return to main page Program description continued ...

Страница 37: ...y field 5 Recommended treatment dosage display field 6 Function key for return to main page 7 Function key for calling up disorders of other medical fields 8 Function key for confirming the parameters from the display field 1 alternatively the push button function of the multi function rotary switch can be used PE capactive plate electrode the number in parentheses indicates the electrode diameter...

Страница 38: ... for return to main menu 4 Function key for deleting the parameters of the selected program position 5 Function key for selecting the saved parameters of the selected program position 1 for the next treatment 6 Function key for saving the values displayed in the parameters display field in the selected program position In this case already saved parameters are overwritten Program description conti...

Страница 39: ...d 2 Transmitter volume display field 3 Service code display field 4 Language selection menu font display field 5 Graphic display brightness display field 6 Graphic display contrast display field 7 Function key for return to main menu NOTE For information regarding opening the basic settings menu refer to Changing Basic Settings Program description continued ...

Страница 40: ...ion Plug the high load connector power cord for non heating appliances into the corresponding socket on the back of the unit Check the condition of the housing and the insulation of the electrodes electrode connection cable and the power supply cable Also make sure that the cables have been routed correctly Insert the power cord plug into an earthed socket outlet Check for Operational Safety Refer...

Страница 41: ...e nearly parallel to the area being treated It is possible however to use these edge effects for therapeutic purposes NOTE If such an effect is expressly desired the dosage must be controlled very carefully Correct positioning of the electrodes for the Edge Effect allows for equal distribution of the concentrated heating effect Local overheating can occur in the electric field due to one sided app...

Страница 42: ...s of the affected body part Correct Incorrect Figure 18 Positioning of Electrodes Electrode Constriction Surface warming can be reduced by increasing the electrode distance The use of the diode is recommended for local applications It is also possible to achieve this however by using different electrode sizes and varying the positions putting the unit into operation continued ...

Страница 43: ...inal field 1 3 2 4 Figure 19 Positioning of Electrodes Normal Cases 3 Uneven irradiation by the use of different electrodes 4 Even irradiation of areas of the trunk the head or the extremities with a large Electrode Skin Distance putting the unit into operation continued Below you will find several examples for correct placement of electrodes ...

Страница 44: ...e electrodes are in contact with the patient s body by adjusting the electrode adjusting pin This adjustment changes the distance of the metal plate that is built into the electrode for determining the penetration depth of the HF field i e the distance between the metal plate and the body is increased or decreased Setting the Electrode Skin Distance 1 3 1 2 3 2 Position 1 2 3 Electrode Skin Distan...

Страница 45: ...ror code is displayed in the text output field to assist the technicians in locating the error In this case please contact your authorized dealer Setting the Parameters Parameters can be set in three ways 1 Direct input of parameters 2 Selection of a disorder in the indications menu 3 Selection of a saved program in the program menu Proceed as follows depending on the desired method for setting th...

Страница 46: ...ion by selecting the info page if applicable 5 Accept the saved parameter values for the disorder by pressing the multi function rotary switch or the Select key Selecting Parameters in the Programming Menu Set the parameters by selecting a previously saved program in the programming menu as follows 1 Select the programming menu by pressing the function key Prog in the main menu 2 Set the desired p...

Страница 47: ...e Plate Electrode Ø 80 mm 80 Watt Capacitive Plate Electrode Ø 120 mm 200 Watt Capacitive Plate Electrode Ø165 mm 400 Watt Soft Rubber Electrode 120 x 180 mm 250 Watt Soft Rubber Electrode 145 x 250 mm 400 Watt Before beginning treatment you must read and observe the safety instructions and the list of contraindications Refer to Safety Instructions Personal Safety and Contraindications for operati...

Страница 48: ...rease the output power Observe the matching display and the well being of the patient verbal response 5 Adjust the parameter setting during the treatment if necessary NOTE During active treatment it is not possible to switch directly from continuous mode CW mode to pulsed mode and vice versa Interrupting Ending Treatment Press the STOP key to interrupt the treatment or wait until the treatment dur...

Страница 49: ...tary switch The value to be changed in this line is displayed inversely Set the desired parameter value by turning the multi function rotary switch Confirm the set value by pressing the multi function rotary switch The entire line is then inverted again Change further basic parameters or switch to the main menu by pressing the function key ESC Parameter Default value Range Pulse duration 400 µs 20...

Страница 50: ...e personnel In case of defects components must be replaced by original parts In accordance with the law concerning medical products the unit must be entered in a medical products log Instruction safety inspections and repairs must be entered with the date of performance in the medical products log Cleaning and Disinfection Switch off the power switch Unplug the power plug from the socket before cl...

Страница 51: ...ities Wait until the unit is completely dry before operating it again Maintenance and repairs continued Under no circumstances may liquid penetrate the openings on the unit e g the connecting sockets of the electrode cables Therefore do not use cleaning or disinfectant sprays The unit electrodes and cables may not be sterilized using steam or gas Never clean the unit with abrasives disinfectants o...

Страница 52: ...Inspection Daily Housing not deformed Power Cable undamaged Electrode connection sockets undamaged Power switch OK Electrode Cable undamaged Capacitive Plate Electrodes Diplodes Diodes undamaged no fissures or brittle material Soft Rubber Electrodes undamaged no thin areas or holes Functional Test Daily Correct function of indicators Display of operating modes Time setting check timer for accuracy...

Страница 53: ...on Protective conductor resistance 100 mΩ NOTE It is the responsibility of the Health Care Facility to verify that the unit complies with the facility local and national Earth Leakage limits NOTE We recommend that the safety inspections be entered in a medical products log in order to document the results of the inspection If the unit is not safe for operation then it must be repaired by the autho...

Страница 54: ... as long as the tuning process is still in progress The reason for this is that if tuning takes place at a higher effective output heat can be clearly felt Internal Errors Requires authorized service personnel With the exception of temperature errors the treatment must be discontinued immediately in case of internal errors in the unit The unit can only be switched off and on again by means of the ...

Страница 55: ...s under any circumstances Service Should the unit require service warranty or repair please contact the selling dealer or your local DJO customer service This product complies with WEEE Directive 2002 96 EG waste electrical and electronic equipment Separate collection for electrical and electronic equipment DANGER ...

Страница 56: ...diameter 1 39 020453218 Capacitive Plate Electrode 165 mm diameter 1 020 453220 Shortwave electrode connection cable with cellular rubber coating 1 020 453214 Cable clamp 1 020 969553 Diplode Coil Field Electrode 18 x 39 cm with cable 1 020 453263 Diplode Coil Field Electrode 18 cm without cable 1 020 453231 Connection cable Diode 1 39 020453266 Soft Rubber Electrode 180 x 120 inclusive one Linenp...

Страница 57: ...ure in the Product caused by product misuse including but not limited to the failure to provide reasonable and necessary maintenance or any use that is inconsistent with the Product User s Manual COMPANY SHALL NOT BE LIABLE IN ANY EVENT FOR INCIDENTAL OR CONSEQUENTIAL DAMAGES Some areas do not allow the exclusion or limitation of incidental or consequential damages so the above limitation or exclu...

Страница 58: ...is an ISO 13485 Certified Company DJO France SAS Centre Européen de Fret 64990 Mouguerre France T 1 800 592 7329 USA T 1 317 406 2209 F 1 317 406 2014 chattgroup com 2012 DJO LLC All rights reserved 28256_C ...

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