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63

EN

7.11. Electromagnetic Immunity

Immunity Test

Test

Level

Compliance

Level

Guidance electromag-

netic Environment

Electrostatic 

Discharge 

(ESD)

IEC 61000-4-2

±6kV 

contact

±8kV air

±4kV 

contact

±8kV air

Floors should be wood, 

concrete, or ceramic 

tile. If Floors are covered 

with synthetic material, 

the relative humidity 

should be at least 40%. 

Explanation and training 

of stuff in ESD-precau-

tionary procedures.

Power fre-

quency

Magnetic fields

IEC 61000-4-8

3A/m

3A/m

Power frequency mag-

netic fields should be 

at levels characteristic 

of a typical location in 

a typical commercial or 

hospital environment.

Содержание diaDENS-CARDIO

Страница 1: ...der of Treatment 50 4 Technical Maintenance 53 5 Order of Replacing the Power Source 54 6 Troubleshooting List 55 7 Specifications 57 8 Safety Measures 65 9 Guarantees of the Manufacturer 69 10 Special EMC information 72 Certificate of Acceptance 75 Coupon for Warranty Repair 77 ...

Страница 2: ...abile form of the arterial hypertension and patients with a lasting increase of the ar terial blood pressure essential hypertension as an addi tional treatment on the background of drugs taken The DiaDENS CARDIO apparatus combines frequency 9 2 Hz which is traditionally applied for treatment of hyper tension and a specially developed mode 77 10 intended for producing a general sedative effect Elec...

Страница 3: ...roves The DiaDENS CARDIO apparatus is intended for course treatment of patients with arterial hypertension as an additional treatment on the background of basic drug therapy Even in cases of situational single seldom increase of the arterial blood pressure a course treatment of not less than 10 procedures is necessary 1 2 procedures daily Meanwhile in the beginning of treatment a temporary destabi...

Страница 4: ...ed repeated reg ular treatment courses minimum once a month for instance from the first to the 15th day of each month Attention There is no need to control AP after the pro cedure In compliance with international recommendations it is recommended for patients with essential hypertension to keep a journal of AP and measure arterial blood pressure three time a day at one time morning afternoon eveni...

Страница 5: ...ter having a stable hypotensive effect registered in the jour nal of AP regimes and doses of drug treatment may be changed by the attending doctor Patients with seldom periodical and slight increase of the arterial blood pressure not higher than 150 mmHg labile arterial hypertension can apply the DiaDENS CARDIO apparatus as monotherapy Such an approach can retard and prevent the disease from conve...

Страница 6: ... indices before the procedure With a stable form of arterial hypertension repeat the courses monthly Recommendations for one time application of the DiaDENS CARDIO apparatus for persons with sus ceptibility to AP increase under ill being take a hypo tensive medicine recommended by your attending doctor and additionally carry out treatment procedures with the DiaDENS CARDIO apparatus every 1 1 5 ho...

Страница 7: ... break During first treatment course AP can fluctuate a little that s why the patient shall continue taking the hypotensive medicines prescribed by the doctor Recommendations for application of the DiaDENS CARDIO apparatus for patients with malignant hy pertension malignant hypertension is a stable high arte rial blood pressure more than 180 mmHg that cannot be treated with drug correction under c...

Страница 8: ...ms of any etiology and localization acute febrility of unclear etiology vein thrombosis condition of acute psychic excitement alcoholic or drug intoxication Attention On the background of application of the Dia DENS CARDIO apparatus taking the drugs prescribed by the doctor is obligatory Changing the regimes of medical treatment and reduction of doses of the drug to be taken is allowed after stabl...

Страница 9: ...47 EN 2 COMPLETE SET AND APPARATUS ARRANGEMENT Apparatus body Display Cover of the power source compartment ON OFF button Cuff Case Batteries LR6 AA 1 5 V type Operations Manual ...

Страница 10: ...ls of the display Contact with skin surface stable End of the procedure blinking Replace the power source blinking the batteries are partly discharged stable replace the pow er source urgently The apparatus is ON ...

Страница 11: ... the apparatus in a correct way Step 1 Pass the end of the cuff through the loop Step 2 Fold the cuff around the apparatus body that the lock ele ment of cuff be on the side of the cover of the power source compart ment Step 3 Place the apparatus into the case ...

Страница 12: ...res with the DiaDENS CARDIO apparatus in a standing position 1 From the left wrist take off watches or bracelets fold the sleeve back Skin should be dry and clean 2 Hold your hand with your palm up place the apparatus on your wrist with the display up 1 cm from the wrist joint 3 Tighten the cuff and fix it as there is no free space between the cuff and your wrist the apparatus electrodes touching ...

Страница 13: ...f electrodes with skin surface and beginning of the treatment procedure 5 Carry out the treatment procedure The procedure con sists of three stages which are different in frequency time and amplitude of treatment After the end of stage the apparatus pro duces a short sound signal After the end of the procedure the ap paratus produces a long sound signal and the symbol will start blinking ...

Страница 14: ...paratus off by pressing the button hold ing it during 1 3 seconds or with absence of contact with skin surface the apparatus will turn off automatically after 3 minutes Attention Treat the apparatus electrodes with a stand ard disinfection solution for instance alcoholic solution after each procedure Keep the apparatus with dry elec trodes ...

Страница 15: ...tandard disinfection means and soft napless nap kins to clean the electrodes 4 2 Check of service ability of the apparatus in accord ance with instructions in Part 3 4 3 If the apparatus is supposed not to be used for a long period remove the power source from its compart ment Part 5 4 4 Having noticed the symbol on the indicator re place the power source part 5 ...

Страница 16: ...replace the power sources For this open the power source compartment remove the power sources let the apparatus stay without power sources dur ing 2 3 minutes install new power sources taking into the po larity install only that power sources which are intended for this de vice type LR6 AA rated voltage 1 5 V When replacing the power sources it is recommended to use power elements of the same type...

Страница 17: ...e discharged replace power sources part 5 The apparatus does no turn on after replacement of power sources Remove power sources let the apparatus stay during 2 minutes without them and install power sources again part 5 The display does not show the symbol heart with contact with the skin surface The skin surface is dry wipe it with a wet tampon ...

Страница 18: ... the symbol heart when there is no contact with skin surface The electrodes are dirty wipe the electrodes item 4 1 Attention Other troubles must be eradicated by the manufacturer or at the service centers of the manufactur er ...

Страница 19: ...57 EN 7 SPECIFICATIONS 7 1 Dependence of Shape and impulse parameters on load resistance Load resist ance Shape Voltage peak peak Free Output 210 V 20 ...

Страница 20: ...58 EN 200 Ohm 8 V 20 500 Ohm 19 V 20 ...

Страница 21: ...59 EN 1 kOhm 24 V 20 2 kOhm 37 V 20 ...

Страница 22: ...60 EN 10 kOhm 99 V 20 20 kOhm 116 V 20 ...

Страница 23: ... Power supply battery type LR6 AA 2 pcs voltage V 1 5 0 45 7 7 The apparatus automatically switches off not later than in 3 min after the last contact of the electrodes to the patient s skin or after pressing and holding the button 7 8 The apparatus generates the following frequencies of impulses 9 2 0 2 Hz during phases I and II 77 7 Hz and 10 0 5 Hz modulated by frequency 2 0 5 Hz 7710 mode phas...

Страница 24: ...11 Class B The Portable electrostimulator DiaDENS CARDIO is suitable for use in all establishments including domestic establishments 7 10 RF Immunity Immunity test IEC 60601 1 2 Test Level Compliance Level Conducted RF IEC 61000 4 6 3 Vrms 150 kHz to 80 MHz 3 Vrms Radiated RF IEC 61000 4 3 3V m 80 MHz to 2 5 GHz 3V m ...

Страница 25: ... Floors should be wood concrete or ceramic tile If Floors are covered with synthetic material the relative humidity should be at least 40 Explanation and training of stuff in ESD precau tionary procedures Power fre quency Magnetic fields IEC 61000 4 8 3A m 3A m Power frequency mag netic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment ...

Страница 26: ...DiaDENS CARDIO Frequency of Transmitter 150kHz to 80MHz 150kHz to 800MHz 800MHz to 2 5GHz Equation d 1 2 P d 1 2 P d 2 3 P Rated maximum output power of Transmitter w Separation dis tance m Separation distance m Separation dis tance m 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 device of BF type ...

Страница 27: ...erous for the patient due to its built in low voltage electric power source isolated from the operational part of the apparatus device of BF type The apparatus must not be used for treating pa tients with implanted electronic devices for exam ple cardiostimulator and for treating patients with individual electric current intolerance The apparatus must not be used in the area of direct projection o...

Страница 28: ...burns and pos sible damage of the apparatus Operation in the close proximity to shortwave or mi crowave equipment may produce instability in the stimulator output The apparatus contain fragile elements Keep it from blows and drops The apparatus is not waterproof Protect it from wa ter All the repair works for the apparatus shall be car ried by qualified personnel of the manufacturer ...

Страница 29: ...perature from 50 to 40 C relative air humidity from 30 to 93 atmos pheric pressure from 70 to 106 kPa Operation conditions ambient air temperature from 100 C to 350 C relative air humidity from 30 to 93 at mospheric pressure from 70 to 106 kPa If the apparatus is stored at the temperature below 100 C keep it under normal conditions at least for two hours before use ...

Страница 30: ...assemblage of electric and electronic equipment The old apparatus is not useless garbage It contains val uable materials which can be recycled in compliance with rules on environmental protection Hand them to specially assigned centers for collection and recycling consult your district authorities ...

Страница 31: ...he lifetime set by the manufacturer officially 9 3 The guarantee period of operation is 24 months from the date of sale 9 4 The seller manufacturer or organization carrying out the functions of the seller manufacturer on a contrac tual basis is not responsible for the defaults should they oc cur after the disposal of the apparatus as a result of 1 a failure on the part of the consumer to comply wi...

Страница 32: ...nction within the warranty period as well as in case of incomplete shipping is found the owner must send the following documents to the manufacturer s address or manufacturers representative claim for repair exchange with name address telephone number defects list with brief description of the malfunc tion date and conditions of its appearance ...

Страница 33: ... ru e mail corp denascorp ru Official Representative in the European Union DENAS Deutschland GmbH Deutschland 64347 Griesheim Im Leuschnerpark 3 06155 66 57 73 Representative in the European Union DENAS CZ s r o Chech Republik 360 01 Karlovy Vary SHOPPING CENTER atrium Karla IV 505 1 office 209 phone 420 353 549 285 fax 420 359 019 209 ...

Страница 34: ...shments including domestic estab lishments The Portable electrostimulator DiaDENS CARDIO should not be used adjacent to or stacked with other equip ment and that if adjacent or stacked use is necessary the DiaDENS CARDIO and the other equipment should be observed to verify normal operation in the configuration in which it will be used 10 2 Electromagnetic Environment guidance The Portable electros...

Страница 35: ... including cables than the recommended separation distance calculated from the equation appropriate for the frequency of the transmitter Recommended Separation distance d 2 3 P 800 MHz to 2 5 GHz The Factor 2 3 is a function of frequency P is the maximum output power rating of the transmitter in Watts W according to the transmitter manufacturer Power frequency magnetic field It should be at levels...

Страница 36: ...se synthetic clothing Floors should be wood concrete or ceramic tile If Floors are covered with synthetic material the relative hu midity should be at least 40 Explanation and training of stuff in ESD precautionary procedures Radiated RF User should keep a separation distance of minimal ap prox 3 meter with portable communication devices such as cellular cordless telephones with a maximum output p...

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