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CONTENTS
1. Function..................................................................40
3. Order of Treatment...................................................50
4. Technical Maintenance.............................................53
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
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Summary of Contents for Diadens diaDENS-CARDIO

  • Page 1: Table Of Contents

    CONTENTS 1. Function..............40 2. Complete Set and Apparatus Arrangement....47 3. Order 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...
  • Page 2: Function

    1. FUNCTION The DiaDENS-CARDIO apparatus is intended for thera- peutic non-invasive (without damaging the skin surface) course treatment of biologically active zones of the wrist by the method of dynamic electrostimulation for correction of the arterial blood pressure (AP) and normalization of the general state of health.
  • Page 3 — the risk of complications of the essential hypertension is reduced; — quality of the patient’s life improves. 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.
  • Page 4 Apparatus treatment has an effect of “accumulation” that is AP becomes stable by the end of the treatment course. Application: DENS procedure is to be carried out 1-2 times daily, bet- ter in one and the same time of the day regardless of the AP level before the procedure.
  • Page 5 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 converting into a stable form.
  • Page 6 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 hours until the complaint is eliminated. In case of long-lasting high arterial blood pressure, address the doctor.
  • Page 7 Recommendations for application of the “DiaDENS- CARDIO” apparatus for patients older than 70 years of age: in the advanced age a slower rate of AP reduction. For this a recommended order of treatment with the “Dia- DENS-CARDIO” is once a day. Treatment course – not more than 7-8 procedures.
  • Page 8 Contraindications to Application: Absolute: — individual intolerance to the electric current; — implanted cardiostimulator; Relative — in these cases it is recommended to use the electrostimulator only after consulting your attending doc- tor: — epileptic seizure; — neoplasms of any etiology and localization; —...
  • Page 9: Complete Set And Apparatus Arrangement

    2. COMPLETE SET AND APPARATUS ARRANGEMENT Apparatus body Display Cover of the power source compartment ON/OFF button Cuff Batteries LR6/AA, Operations Manual Case 1.5 V type...
  • Page 10 Symbols of the display: Replace the power source Contact with skin surface (stable) (blinking – the batteries / End of the procedure (blinking) are partly discharged / stable – replace the pow- er source urgently) The apparatus is ON.
  • Page 11 Attention! To avoid breaking the case, fold the cuff of 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...
  • Page 12: Order Of Treatment

    After the treatment procedure, the patient should relax for 20-30 minutes. Attention! It is forbidden to carry out procedures with the “DiaDENS-CARDIO” apparatus in a standing position! 1. From the left wrist take off watches or bracelets, fold the sleeve back.
  • Page 13 4. Turn the apparatus on by pressing the button – the ap- paratus will turn on and produce a sound signal and the display will show the following symbols which indicate the contact of electrodes with skin surface and beginning of the treatment procedure.
  • Page 14 The duration of the procedure is determined by the pro- gramme and is approximately 5-6 minutes. 6. Take the apparatus off. 7. Turn the apparatus 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.
  • Page 15: Technical Maintenance

    4. TECHNICAL MAINTENANCE 4.1. Daily technical maintenance should include the fol- lowing: — external examination of the apparatus; — disinfection of electrodes. Use standard 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.
  • Page 16: Order Of Replacing The Power Source

    5. ORDER OF REPLACING THE POWER SOURCE When the symbol appears on the display (blinking – power source is partly discharged, on – replace power sources urgently) or if the apparatus does not turn on (the power sources are discharged), you need to replace the power sources.
  • Page 17: Troubleshooting List

    6. TROUBLESHOOTING LIST Trouble Method of eradication The apparatus turns off, Power sources does not turn on or the discharged – replace power display shows the sign sources (part 5) Remove power sources, let The apparatus does no turn the apparatus stay during 2 on after replacement of minutes without them and power sources...
  • Page 18 The display shows the symbol The electrodes are dirty (heart) when there is no – wipe the electrodes contact with skin surface (item 4.1) Attention! Other troubles must be eradicated by the manufacturer or at the service centers of the manufactur-...
  • Page 19: Specifications

    7. SPECIFICATIONS 7.1. Dependence of Shape and impulse parameters on load resistance Load resist- Voltage Shape ance peak-peak ≈210 V ± Free Output...
  • Page 20 ≈8 V ± 20% 200 Ohm ≈19 V ± 500 Ohm...
  • Page 21 ≈24 V ± 1 kOhm ≈37 V ± 2 kOhm...
  • Page 22 ≈99 V ± 10 kOhm ≈116 V ± 20 kOhm...
  • Page 23 7.2. Dimensions of the apparatus, mm, not more than.........120x110x110 7.3. Weight, kg, not more than.........0.3 7.4. Consumable current, mA, not more than.....10 7.5. Voltage of the electrostimulator power supply, V...........3±0.6 7.6. Power supply: battery type LR6/AA, 2 pcs, voltage, V..........1.5±0.45 7.7.
  • Page 24: Electromagnetic Emissions

    7.9. Electromagnetic Emissions Guidance electromagnetic Emission Test Compliance Environment The Portable electrostimulator RF emissions DiaDENS-CARDIO is suitable for Class B CISPR 11 use in all establishments including domestic establishments 7.10. RF Immunity Immunity test IEC 60601-1-2 Test Level Compliance Level...
  • Page 25 7.11. Electromagnetic Immunity Test Compliance Guidance electromag- Immunity Test Level Level netic Environment Floors should be wood, concrete, or ceramic tile. If Floors are covered Electrostatic ±6kV ±4kV with synthetic material, Discharge contact contact the relative humidity (ESD) ±8kV air ±8kV air should be at least 40%.
  • Page 26 7.12. Recommended Separation Distances (d) between Portable and Mobile RF Communication Equipment and Portable electrostimulator DiaDENS-CARDIO. Frequency of 150kHz to 150kHz to 800MHz to Transmitter 80MHz 800MHz 2,5GHz Equation d= 1,2 √ P d= 1,2 √ P d= 2,3 √ P...
  • Page 27: Safety Measures

    8. SAFETY MEASURES Read all the information in the present manual care- fully! The manual contains important information of your safety as well as recommendations of correct usage and unit care. The apparatus is not electrically dangerous 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-...
  • Page 28 During stimulation the patient must not be con- nected to any high-frequency electric device, si- multaneous application of the apparatus and an- other electric device can result in 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.
  • Page 29 Conditions of transportation: temperature from – 50 to + 50°C, relative air humidity from 30 to 93%, at- mospheric pressure from 70 to 106 kPa Conditions of storage: temperature 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 C to 35...
  • Page 30 Recycling: All the package materials are environmental-friend- ly and can be reused. Separate 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).
  • Page 31: Guarantees Of The Manufacturer

    9. GUARANTEES OF THE MANUFACTURER 9.1. manufacturer guarantees compli- ance of the apparatus to the technical conditions TU 9444-005-44148620-2006 on condition the conditions of operation, transportation and storage are observed. 9.2. The operation lifetime is 5 years. Observation of op- eration regulations can considerably increase the lifetime set by the manufacturer officially.
  • Page 32 4) force-majeure. 9.5. Guarantee obligations do not apply to products with broken manufacturer’s seals. 9.6. In case of unit breakdown or malfunction 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’...
  • Page 33 Manufacturer’s address: LLC “RC ART” 620146 Russia, Ekaterinburg Akademika Postovskogo Str., 15 Phone: +7 (343) 267-23-30 http://www.denascorp.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.
  • Page 34: Special Emc-Information

    10.2. Electromagnetic Environment guidance The Portable electrostimulator DiaDENS-CARDIO is suit- able for use in the specified electromagnetic environment. The customer and/or the user of the DiaDENS-CARDIO...
  • Page 35 40%. Conducted and radiated RF: Portable and mobile RF communications equipment should be used no closer to any part of the DiaDENS-CARDIO including cables, than the recommended separation distance calculated from the equation appropriate for the frequency of the transmitter: Recommended Separation distance d= 2,3 √...
  • Page 36 Electrostatic discharge (ESD): A recommendation that all stuff involved receive an explanation and training in ESD precautionary procedures. Stuff must be made aware to precautionary procedures: — User shouldn’t use 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%.

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