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Summary of Contents for I-Tech ORTHOMAG
- Page 1 USER MANUAL Magnetotherapy model MA5032 ORTHOMAG...
- Page 3 Summary SUMMARY ..................II TECHNICAL SPECIFICATIONS ............4 .................. 4 ANUFACTURER ..............4 UTHORISED REPRESENTATIVE ................... 4 MPORTER ..............4 ECLARATION OF CONFORMITY ................... 5 LASSIFICATIONS ................5 URPOSE AND SCOPE ..............6 ECHNICAL SPECIFICATIONS ............7 EVICE DESCRIPTION AND CONTROLS ...................
- Page 5 Xilixiaobaimang 518108 Nanshan District, Shenzhen P.R. China herewith declares under its own responsibility, that the product Model: MA5032 Name: ORTHOMAG has been designed and manufactured according to the European Medical Device Directive 93/42/EEC (transposed in Italy by the D.Lgs. 46/97), as modified by the Directive 2007/47/EC (D.Lgs.37/2010) and further...
- Page 6 Directive 93/42/EEC. Classifications From now on, for the sake of simplicity, in this user manual, reference will be made to the device ORTHOMAG meaning the device model MA5032, name ORTHOMAG. ORTHOMAG has the following specifications: Class IIa equipment (Directive 93/42/CEE, Annexed IX, rule 9 and •...
- Page 7 • tendinitis ORTHOMAG is particularly suitable for the treatment and the care of the osteoporosis and all the pathologies on bony tissues. ORTHOMAG device is indicated both for professional (physiotherapists, medics etc.) and for domestic user. In case of home therapy we recommend using the device exclusively on medical/therapist suggestion.
- Page 8 Feature Specification Relative humidity From 30% to 85% Atmospheric From 700 to 1060hPa pressure Ambient From -5° to +40°C temperature Transport and storage Relative humidity From 10% to 93% conditions Atmospheric From 700 to 1060hPa pressure Useful life of the device: 3 years. Device description and controls Label (back) Power on/off key...
- Page 9 Labelling The label on the side is placed the back of the device. Symbol Description Importer logo Product certification issued by notified body No. 0197. Manufacturer's Data. Authorised representative Importer Manufacturing date Follow the instructions for use. WEEE directive for the disposal of electronic and electrical waste.
- Page 10 15° from normal operating position). Power supply (DC12V/1A) Package content ORTHOMAG kit: • N°1 ORTHOMAG device; • N°1 wall mount charger (cable 1.5 m); • N°1 user and maintenance manual; • N°1 universal flexible applicator (cable 1.5 m);...
- Page 11 (Gauss) generated by the device allows treatments in presence of braces or plaster bandage. Thanks to its innovative universal applicator, light and flexible, and to the portability guarantee by a lithium rechargeable battery, ORTHOMAG represents an extremely powerful, easy-to-use device to be used everywhere. Contraindications Pregnant women, patients with tuberculosis, juvenile diabetes, viral •...
- Page 12 Do not place the applicator on the chest, it could increase the risk of cardiac • fibrillation. • Do not use the device when connected to other medical devices, especially high frequency surgical devices. Danger of burns in the treatment area and damage to the device.
- Page 13 • not expose the device to dust, dirt, direct sunlight and water; avoid electric shocks to the device; • • not drop or allow the device to fall; not open the device, in case of problems contact IACER Srl; • not use the device in case of faults or malfunctions;...
- Page 14 • The electrical system of the environment in which ORTHOMAG is inserted complies with national laws. • The device is used in strict compliance with the instructions given in this manual.
- Page 15 The following image provides some of the possible applications for the most common conditions treatable with magnetotherapy such as cervical and/or elbow/knee joint arthritis, scapula/humeral arthritis, lumbar pain, fractures, sprains. Position it in the most comfortable way on the area to be treated, fixing it in position using the elastic straps provided.
- Page 16 MNPG566-00...
- Page 17 Place the applicator onto the part of the body to be treated (see • picture at page 16) and fix it with the elastic strap supplied. • Connect the power supply adapter to Orthomag (the POWER LED starts blinking green). • Switch on the Orthomag by pressing the middle button.
- Page 18 POWER LED flashing alternating green/red: battery half charged (emission of magnetic field is guaranteed but not sufficient to start a complete new cycle of therapy). POWER LED red steadily lit: battery is low. The magnetic field is still emitted until the device is switched off. MNPG566-00...
- Page 19 LIST OF PROGRAMS Therapeutic indications (average time of therapy 2/4 hours per day) Program L (50 Hz) Program H (75 Hz) Algodystrophy Scar adherence Gonarthrosis Arthritis Cartilage degeneration Arthrosis Fractures Bursitis Cartilage injuries Brachialgy Osteoarthrosis Capsulitis Osteonecrosis Cervical pain Osteoporosis Whiplash Delayed calcification Chondropathy...
- Page 20 WARNING: in the case of equipment supplied for hire, ORTHOMAG can be locked in the L or H program in order not to allow the program to be changed by the end user (this is in order to strictly follow the instructions given by medical personnel).This function can only be...
- Page 21 Care of the device Maintance If used in accordance with the information reported herein, this device requires no particular routine maintenance operations. In the event of malfunction, first follow these simple steps: make sure that the power outlet to which the device is connected is •...
- Page 22 CARRIAGE AND STORAGE Carriage precautions ORTHOMAG is a portable device, so it does not need any particular carriage precautions. However we recommend to put away ORTHOMAG and its accessories in their own bag after every treatment.
- Page 23 Before use it please finish a charge clip. Disposal The ORTHOMAG magnetotherapy apparatus, compatibly with the operating and safety requirements, has been designed and built to have a minimum negative impact on the environment, following the provisions of the European Directive 2012/19/EU on the disposal of waste electrical and electronic equipment.
- Page 24 Warranty IACER Srl guarantees a warranty period from the purchasing date for ORTHOMAG device, unless information contained in this manual regarding installation, use and maintenance is strictly adhered. The wearing parts (applicators’ fabric as well as elastic velcro closure of the same) are not included in the warranty, unless of visible manufacturing defects.
- Page 25 IACER Srl (also consult the Warnings paragraph). Interference and electromagnetic compatibility tables The ORTHOMAG equipment has been designed and manufactured according to the TECHNICAL STANDARD on ELECTROMAGNETIC COMPATIBILITY legislation EN 60601-1-2:2015 with the aim of providing adequate protection from harmful interference when installed in homes and health establishments.
- Page 26 medical device and it’s recommended a separation distance “d” calculated from the fabricant in table “R.f. immunity aspects”, column 800MHz-2,5GHz, paragraph EMC tables. Example: for a mobile phone with 2W maximum output power the separation distance d is 3,3 m in order to obtain an immunity level of 3V/m or a separation distance d=0,5m for an immunity level of 20V/m.
- Page 27 Guidance and manufacturer's declaration – ELECTROMAGNETIC EMISSIONS – FOR ALL DEVICES AND SYSTEMS ORTHOMAG is expected to operate in the electromagnetic environment below specified. The customer or user of the ORTHOMAG must ensure that it is used in such environment. Electromagnetic environment –...
- Page 28 Guidance and manufacturer's declaration – ELECTROMAGNETIC IMMUNITY FOR DEVICES AND SYSTEMS THAT ARE NOT OF VIABLE FUNCTION The ORTHOMAG is expected to operate in the electromagnetic environment below specified. The user or operator of the ORTHOMAG must ensure that it is used in this environment. MNPG566-00...
- Page 29 AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the ORTHOMAG is used MNPG566-00...
- Page 30 ORTHOMAG that are not life-supporting ORTHOMAG is intended for the use in an electromagnetic environment in which radiated RF disturbances are controlled. The user or the operator of ORTHOMAG can help prevent electromagnetic interferences by maintaining a minimum distance...
- Page 31 ORTHOMAG. All rights reserved. ORTHOMAG logos are owned by IACER Srl and are registered. Edition: MNPG545-00 of the 27/03/2024 MNPG566-00...
- Page 32 Imported and distributed exclusively by :...
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