I-Tech ORTHOMAG User Manual

I-Tech ORTHOMAG User Manual

Magnetotherapy model
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USER MANUAL
Magnetotherapy model
ORTHOMAG

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Summary of Contents for I-Tech ORTHOMAG

  • Page 1 USER MANUAL Magnetotherapy model ORTHOMAG...
  • Page 3: Table Of Contents

    Summary SUMMARY ..................II TECHNICAL SPECIFICATIONS ............4 .................. 4 ANUFACTURER ..............4 ECLARATION OF CONFORMITY .................. 5 LASSIFICATIONS ................5 URPOSE AND SCOPE ..............6 ECHNICAL SPECIFICATIONS ............7 EVICE DESCRIPTION AND CONTROLS ................... 8 ABELLING Package content ................9 HOW TO USE .................
  • Page 5: Technical Specifications

    I.A.C.E.R. S.r.l Via S.Pertini 24/A – 30030 Martellago (Ve), Italia herewith declares under its own responsibility, that the product ORTHOMAG UMDNS Code: 12415 has been designed and manufactured according to the European Medical Device Directive 93/4/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: Classifications

    • 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 7: Technical Specifications

    Technical specifications Feature Specification Power supply Lithium polymer batteries, 3.7V 900mAh model AK12G-1200100V Battery charger input 100-240V, 50/60Hz, 0.5A; output 12V, 1A Max. current consumption ≤300mA (in therapy) Insulation (EN 60601-1) Applied parts (EN 60601-1) Field strength 20 Gauss ± 30% 50Hz (L program) Square wave frequency 75Hz (H program)
  • Page 8: Device Description And Controls

    Device description and controls Label (back) Power on/off key L Program key (50Hz) H Program key (75Hz) IACER Srl MNPG207-03...
  • Page 9: Labelling

    Labelling label on the side is placed on the back of the device. Symbol Description Manufacturer's logo. Product certification issued by notified body No. 0068. Manufacturer's Data. Date of manufacture (YYYY-MM). Follow the instructions for use. WEEE directive for the disposal of electronic and electrical waste.
  • Page 10: Package Content

    • N°1 universal flexible applicator (cable 1.5 m); • N°1 carriage bag; • N°1 test emissions magnet; • N°2 elastic bands (S and L size); • N°1 car charger (optional). Visit website www.orthomag.eu to obtain more information. IACER Srl MNPG207-03...
  • Page 11: How To Use

    (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 •...
  • Page 12: Side Effects

    • Avoid rapid/sudden movements that could cause the device to malfunction. • 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.
  • Page 13 • use and store the device in a clean and dry place; 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; • •...
  • Page 14 The electrical system of the environment in which ORTHOMAG is • inserted complies with national laws.
  • Page 15: Preparing The Patient: Main Positions Of The Applicator

    Preparing the patient: main positions of the applicator The flexible applicator guarantees a comfortable fit and wearability, adapting effectively to different parts of the body. It is also very light and compact. 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.
  • Page 16 IACER Srl MNPG207-03...
  • Page 17: How To Use The Device

    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 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 19 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 enabled via software/PC by authorised personnel.
  • Page 20: Care Of The Device

    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 21: Troubleshooting

    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 22: Battery Replacement

    Put back the belt. 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 23: Warranty

    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 24: Assistance

    (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...
  • Page 25 from harmful interference when installed in homes and health establishments. Use the device at least 3 metres away from televisions, monitors, mobile phones, WIFI routers or any other electronic device as they may affect its functioning. In particular portable communication equipment as WIFI devices, mobile phones, cordless phones and their base stations, walkie-talkie, can affect the medical device and it’s recommended a separation distance “d”...
  • Page 26 Il cliente o l’utilizzatore dovrebbe assicurarsi che esso venga usato in tale ambiente. ORTHOMAG is intended for use in the electromagnetic environment specified below. The customer or the user of ORTHOMAG should assure that is used in such environment. Ambiente elettromagnetico – Guida Prova di emissione Conformità...
  • Page 27 Il cliente o l’utilizzatore dovrebbe assicurarsi che esso venga usato in tale ambiente ORTHOMAG is intended for use in the electromagnetic environment specified below. The customer or the user of ORTHOMAG should assure that is used in such environment. Prova di immunità...
  • Page 28 Il cliente o l’utilizzatore dovrebbe assicurarsi che esso venga usato in tale ambiente ORTHOMAG is intended for use in the electromagnetic environment specified below. The customer or the user of ORTHOMAG should assure that is used in such environment. Prova di immunità...
  • Page 29 Il cliente o l’utilizzatore dovrebbe assicurarsi che esso venga usato in tale ambiente ORTHOMAG is intended for use in the electromagnetic environment specified below. The customer or the user of ORTHOMAG should assure that is used in such environment. Prova di immunità...
  • Page 30 Il cliente o l’utilizzatore dovrebbe assicurarsi che esso venga usato in tale ambiente ORTHOMAG is intended for use in the electromagnetic environment specified below. The customer or the user of ORTHOMAG should assure that is used in such environment. Prova di immunità...
  • Page 31 Il cliente o l’utilizzatore dovrebbe assicurarsi che esso venga usato in tale ambiente ORTHOMAG is intended for use in the electromagnetic environment specified below. The customer or the user of ORTHOMAG should assure that is used in such environment. Prova di immunità...
  • Page 32 Il cliente o l’utilizzatore dovrebbe assicurarsi che esso venga usato in tale ambiente ORTHOMAG is intended for use in the electromagnetic environment specified below. The customer or the user of ORTHOMAG should assure that is used in such environment. Prova di immunità...
  • Page 33 ORTHOMAG is intended for the use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of ORTHOMAG can help prevent electromagnetic interferences by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and ORTHOMAG as recommended below, according to the maximum output power of the communication equipment.
  • Page 34 ORTHOMAG. All rights reserved. ORTHOMAG logos are owned by IACER and are registered. Edition: MNPG 207-03 of the 13/11/2020 IACER Srl MNPG207-03...

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