I-Tech WEPERE RESTART User Manual

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USER MANUAL

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Page 1 USER MANUAL Recover faster, anytime anywhere...
Page 3: Table Of Contents
Technical information Manufacturer Declaration of conformity Classifications Intended purpose and scope of use Technical specifications Device description and controls Labelling Pack contents How To Use Introduction to the technology Contraindications Warnings Device use Treatments Looking after the device Maintenance Troubleshooting Charging the battery Disposal Information Warranty...
Page 4: Manufacturer
Manufacturer I.A.C.E.R. S.r.l. via Enzo Ferrari 2 • 30037 Scorzè (VE) - Italy Tel. 041.5401356 • Fax 041.5402684 Declaration of conformity The manufacter I.A.C.E.R. S.r.l via Enzo Ferrari 2 - 30037 Scorzè (VE) - Italy declares under its own responsibility that the product RESTART Is conform to the dispositions of the electromagnetic compatibility Directive 2014/30/UE of the European Parliament and of the Council of the 26th February 2014, to the current...
Page 5: Classifications
Classifications The RESTART device assumes the following classifications: • class II with type BF applied part (Classif. EN 60601-1); • device with IP22 protection degree against the penetration of solids and liquids into the ma- chine body. IPX7 protection degree for the treatment head. DEVICE NOT SUITABLE FOR USE IN IMMERSION.
Page 6: Technical Specifications
Technical specification Feature Specification IN: 100-240V~, 50/60 Hz, 0.6-0.2 A Power Supply OUT: 15V 1.2A Battery Ni-MH AAA850mAh 4.8 V External dimensions 204 x 63 x 58mm (Length x Width x Height) IP22 machine body Ingress protection rating IP IPX7 head Insulation (EN 60601-1) Applied parts (EN 60601-1) Part applied to the user...
Page 7: Device Description And Controls
Device description and controls 1 Treatment time indicator 2 Time button 3 Power adjustment button 4 Treatment power indicator 5 Battery indicator 6 Device ON/OFF button 7 Emitting head 8 Power supply connector 7 USER MANUAL...
Page 8: Labelling
Labelling Model: Restart Power supply In: 100-240V~, 50/60 Hz, 0.6-0.2 A Out: 15V 1.2A Battery: Ni-MH AAA850mAh 4.8 V Ultrasound Carrier frequency of use: 1MHz ± 10%% Duty cicle: 5%, 50%, 100% (mains powered) 5%, 50%, 100% (battery powered) Maximum output power: 6.4W (mains powered) 3.2W (batter powered) RBN (max): 5,0 Actual radiant area: 4 cm²...
Page 9 Gel labelling Shenzhen Dongdixin Technology Co., Ltd. Floor 1-2, No.3 Building, Fanshen Xusheng Industrial Estate Xilixiaobaimang 518108 Nanshan District, Shenzhen P. R. China Shanghai International Holding Corp. GmbH (Europe) Eiffestraße 80, 20537 Hamburg Germany xxxx-xx 2 Anni a confezione integra / 2 years sealed condition Follow the “instructions for use”...
Page 10: Pack Contents
Pack contents The RESTART pack contains: • 1 RESTART device; • 1 medical power supply; • 1 battery charger; • 1 gel for ultrasound; • 1 carry bag; • 1 user manual. Introduction to the technology Ultrasound treatment represents a method that is based on the transfer of energy into the tissues which results in thermal and non-thermal biological effects.
Page 11: Contraindications
Contraindications It is strictly prohibited to use RESTART in users with severe arrhythmias or with pacemakers, with heart disease and severe cardiovascular problems, who suffer from epilepsy, with ongoing phle- bitis, thrombophlebitis, in feverish states, tuberculosis, malignant tumours and neoplasms, local infections, metal implants (possible after consulting a doctor), venous thrombosis, severe osteo- porosis, arteriopathies (except medical prescriptions).
Page 12: Device Use
• to use the device in hyposensitive areas, on carotid sinuses, genitals, near the uterus and ab- domen, in areas of the body where there are glands. Also avoid using the device on the neck and mouth. Finally, avoid treatment with direct exposure of the eye to the ultrasonic beam; keep the treatment head fixed in one place during treatment;...
Page 13 4. Turn on the device by moving the switch to the ON position. The ultrasound intensity indicator will display L (Low, preset), whereas the battery level indicator will indicate the battery capacity: low (L-Low preset), medium (M-Medium) and high (H-High). 5.
Page 14: Treatments
N.B. disconnect the cables before putting the device in the bag. If this is not done, the cables can be excessively bent near the connectors, which can damage the cables. WARNING: to ensure user safety, the device is equipped with a system that detects cor- rect coupling between the ultrasound head and the user’s skin.
Page 15: Troubleshooting
The device does not require sterilisation. Notes: - Never use solvents for cleaning. Cleaning agents can damage the device. - Carry out routine maintenance, in particular: • inspect the body of the device for cracks or fissures, which may allow liquids to enter; •...
Page 16: Charging The Battery
Check that you have turned The LED indicators do not light up Switch not turned ON. the switch ON. The power LED is working fine but Check and reset the desired Time and intensity set incorrectly. there is no output values.
Page 17: Warranty
Careful research into optimising machine performance guarantees a significant reduction in con- sumption, in accordance with the concept of energy saving. This symbol indicates that this product should not be disposed with other household waste. Correct disposal of obsolete equipment, accessories and especially batteries helps to prevent possible negative consequences on human health and the environment.
Page 18: Support
9) The warranty automatically expires after 2 years. In this case, any assistance operations will be performed by charging for the replaced parts, labour costs and transport costs according to the current rates. 10) Any disputes that may arise shall be settled exclusively before the court of Venice. Support The manufacturer is the only point of contact for technical support regarding the device.
Page 19 device at an appropriate distant from critical equipment for monitoring users’ vital functions and to use caution in therapeutic applications on users with pacemakers. However, it is advisable to use the device keeping a distance of at least 3 metres from televisions, monitors, mobile phones or any other electronic equipment.
Page 21 21 USER MANUAL...
Page 22: Interference And Electromagnetic Compatibility Tables
ELECTROMAGNETIC COMPATIBILITY TABLES Guidance and manufacturer’s declaration ELECTROMAGNETIC EMISSIONS – FOR ALL EQUIPMENT AND SYSTEMS The RESTART is intended for use in the electromagnetic environment specified below. The customer or the user of the RESTART should assure that it is used in such an environment. Electromagnetic environment - Emissions Test Compliance...
Page 23 Guidance and manufacturer’s declaration ELECTROMAGNETIC IMMUNITY – FOR ALL EQUIPMENT AND SYSTEMS The RESTART is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment Test level Electromagnetic Immunity test ...
Page 24 Guidance and manufacturer’s declaration – ELECTROMAGNETIC IMMUNITY – FOR EQUIPMENT AND SYSTEMS THAT ARE NOT LIFE-SUPPORTING The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment. Electromagnetic Test level Immunity test...
Page 25 Recommended separation distances between portable and mobile RF communications equipment for RESTART that are not life-supporting RESTART is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of RESTART can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and RESTART as recommended below, according to the maximum output power of the communications equipment.
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Page 28 www.wepere.com I.A.C.E.R. Srl via Enzo Ferrari 2 - 30037 Scorzè (VE) - Italy...

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