Elamed ALMAG-03, Operating Manual

Page 1: ...iagnosis has been established ATTENTION No special training or skills are required to carry out the procedures by the patient at home To ensure efficient use of device please carefully study this Operating Manual This Operating Manual is a document identifying the basic technical characteristics and parameters of the device indications for its use and the treatment procedures certified by the Manu...

Page 2: ...elated to safety and effective operation The housing is protected with reinforced insulation No safety grounding is required Read the Operating Manual carefully Applied part type BF Emitter is protected with reinforced insulation Operating ambient temperature from 10 ºC to 35 ºС THE LIST OF STANDARDS USED EN ISO 10993 1 2009 Cor 1 2010 EN 60601 1 2006 AC 2010 DIN EN ISO 15223 1 2013 EN 60601 1 8 2...

Page 3: ...Make sure to do visual examination of the device prior to start ing the treatment procedure Using the device if its housing emitters or cables are damaged is PROHIBITED Please store and use the control unit and emitters only in dry places Avoid penetration of moisture inside the control unit and emit ters while treating their surfaces with disinfectant solution Pro tect the device from dampness sh...

Page 4: ...tal protection Dispose of the device upon termination of its service life as electronic waste at specialized recycling points Exclusion of liability the Manufacturer shall not be held liable for damages resulting from non observance of the above in structions ...

Page 5: ...on doctor s advice Device operation does not require any special training The device consists of a control unit Fig 1 and a headband type emitter Fig 2 The headband emitter consists of two flexible emit ting lines Each of the lines contains 6 individual induc tors emitters The working surface of the emitters is designated with an N la bel north The unit generates two types of pulsed magnetic field...

Page 6: ...ront panel of the control unit has the following controls and dis displays Fig 4 1 The LED displaying depend ing on the operating mode either the program number or the mag neto action as a moving luminous circle segment or the E error symbol 2 The PROGRAM button is used to select the exposure pro gram number 3 The START STOP button is used to switch on off the magneto action EXPOSURE INITIATION Ex...

Page 7: ...Item Quantity Control unit Flexible emitting line Elastic band Operating Manual Magnetic field indicator 1 2 2 1 1 INDICATIONS After effects of a cerebrovascular accident Transient ischemic attack Chronic cerebral ischemia Migraine hemicrania migraine neuralgia Osteochondrosis of the cervical spine with symptoms of cephalgia cranialgia Chronic iridocyclitis Further areas of application Parkinson s...

Page 8: ...ressure Changes in blood oxygen saturation indicating activation of metabolic processes Normalization of blood coagulation Restoration of sensitivity Anesthesia Normalization of muscle tone Reduction of the level of anxiety fear of death irritability Restoration of sleep The treatment of Parkinson s disease patients demonstrated an improvement of their general health due to normalization of the ca...

Page 9: ... odorless and belongs to a class of low hazard substances The solution can be prepared in any dish by mixing it with water The interval between the wipings should be at least 15 minutes Make sure to squeeze the cloth out in order to avoid leakage of the solution inside the unit and emitter lines during disinfection of the surfaces Then wipe the surfaces with a napkin moistened with water and squee...

Page 10: ...l elastic bands To do this place the flexible emitting lines against one another as shown in Figure 5 Pull one elastic band through the front line buckles Fig 6 and the other elastic band in the same way through the rear buckles Place the emitter on the patient s head as described below see Fig 7 for an example For a tighter fit of the emitters around the patient s head pull the loose ends of the ...

Page 11: ...ment of the emitters for treatment of brain diseases Note In order to enhance bio safety while per forming the procedures and to prevent emit ters contact with the patient s skin and hair it is recommended to use disposable materials such as a non woven cloth or a medical cap Press the START STOP button to initiate generation of a preset magneto action while the LED display will be showing the tim...

Page 12: ...et sec 7 Field density mT 10 Exposure time min 20 Program 2 Type of pulsed magnetic field travelling Exposure mode continuous Action mode by single pulses Pulse frequency sec 7 Field density mT 10 Exposure time min 20 Program 3 Type of pulsed magnetic field travelling Exposure mode continuous Action mode by pulse packets Repetition frequency of pulse packets sec 5 15 Pulse frequency within the pac...

Page 13: ...gional or primary vascular care facilities while in the sub acute and residual effects periods it is done in rehabilitation departments or at home Transcranial magnetic treatment is applied as part of the rehabilita tion complex for cerebral stroke after patient s transfer from the in tensive care unit to the unit for patients with acute stroke starting on the 5th 7th day from the time of disease ...

Page 14: ...evice has not been applied in a healthcare facility in the acute phase of stroke it is necessary to consult a physiotherapist or a local physician After the consultation the patient can conduct the procedure ei ther by him her self or with the relatives assistance making sure to check the blood pressure before the procedure and 20 30 minutes after it This is done to evaluate the patient s level of...

Page 15: ...n the following 3 days exposure duration is 7 minutes once or twice a day In the remaining days of treatment under Program 1 the duration should be 20 minutes During the subsequent 7 10 days the treatment procedures are conducted by the method of Program 2 The procedures are to be per formed the same way once or twice a day Migraine migraine neuralgia ATTENTION With migraine patients you must alwa...

Page 16: ...th can be reduced A repeated treatment course is carried out as follows Program 1 proce dure for the first three days followed by 5 7 days of Program 2 proce dure Procedure length 20 minutes Chronic iridocyclitis Treatment method The emitters are placed on the patient s head with the N north side towards the head so that the No 1 emitters of each line are over the occipital region then the emittin...

Page 17: ...an Repeated treatment courses if necessary are carried out in 1 5 2 months Sleep disorders Treatment method The emitters are placed on the patient s head with the N north side towards the head in such a way that the No 1 emitters of each line are over the occipital region while the No 6 ones are over the frontal part Treatment is performed just before bedtime as set out in Program 1 The duration o...

Page 18: ...st once a year For this purpose do the following arrange the flexible emitting lines in a way to provide access to all the emitters plug the device into the mains select one of the four exposure programs activate the magneto action using the magnetic field indicator check the presence of magnetic field in each of the emitters stop the action unplug the device from the mains A preventive maintenanc...

Page 19: ...lses sec programs No 1 No 4 from 5 to 15 pulses sec program No 3 Relative deviation of the frequency rate extremes is within 10 d the time during which the repetition frequency of pulse packets changes from maximal to minimal value and back is 126 10 sec for program No 3 and 612 30 sec for programs 1 and 4 e pulse frequency within each packet 30 pulses sec program No 3 7 pulses sec programs No 1 N...

Page 20: ...indications program number exposure time presence of magneto action 4 11 The duration of the device continuous operation is at least 8 hours in an intermittent cycle 20 minutes of magneto action are fol lowed by a 5 minute break 4 12 The mean lifetime of the device is at least 5 years 4 13 The exterior surfaces of the device components are resistant to disinfection with any chemical solution appro...

Page 21: ... customer or the user of the device should assure that the device is used in such an environment Emissions test Compliance Electromagnetic environment guid ance RF emissions CISPR 11 Group 1 The device uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions CISPR 11 Class B The de...

Page 22: ...4 4 2 kV for pow er supply lines 1 kV for in put output lines Complies Mains power quality should be that of a typi cal commercial or hos pital environment Surge IEC 61000 4 1 kV differen tial mode 2 kV common mode Complies Mains power quality should be that of a typi cal commercial or hos pital environment Voltage dips short interruptions and voltage varia tions on power supply input lines IEC 61...

Page 23: ...ts W according to the transmit ter manufacturer and d is the recommended separa tion distance in metres m Field strengths from fixed RF transmitters as de termined by an electro magnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equip ment marked with the fol lowing symbol Radiated RF IEC 61000 4 3 3 V m 80 MHz to 2 5...

Page 24: ...isturbances are controlled The customer or the user of the device can help prevent electromagnetic interference by maintaining a minimum dis tance between portable and mobile RF communications equipment transmitters and the device as recommended below according to the maximum output power of the communications equipment Rated maximum output power of transmitter W Separation distance according to f...

Page 25: ...ation GIKS 941519 106 and is hereby vali dated as ready for service Date of production _____________________Stamp ______________________________________________ signature of a person responsible for acceptance DIAMAG magnetotherapy device is packed according to the re quirements specified in the design documentation Date of packing _____________________ Packed by _____________________ Stamp ...

Page 26: ...y does not cover the following cases if the device bears traces of outside interference or repair attempts by non authorized servicing companies if unauthorized changes into the design or construction of the de vice have been detected if the device has mechanical damages if the device has been damaged as a result of penetration of for eign objects substances or liquids if the device has been damag...

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