I-Tech MAG700 User manual

USER MANUAL
Magnetotherapy model
MAG700

III
INDEX
INDEX III
TECHNICAL SPECIFICATIONS 4
MANUFACTURER 4
DECLARATION OF CONFORMITY 4
CLASSIFICATIONS 5
PURPOSE AND SCOPE 5
TECHNICAL FEATURES 6
DEVICE AND COMMANDS DESCRIPTION 7
LABELLING 8
Package content 10
HOW TO USE 11
INTRODUCTION TO TECHNOLOGY 11
CONTRAINDICATIONS AND SIDE EFFECTS 11
WARNINGS 11
PATIENT PREPARATION:POSITIONING OF THE THERAPEUTIC BELT,MAIN APPLICATIONS AND
SUGGESTIONS 14
SETUP AND PROGRAMS INSTRUCTIONS 14
Connections and power on 14
Main menu 15
Program selection 16
Language selection 19
CARE OF THE DEVICE 20
MAINTANCE 20
DISPOSAL 21
WARRANTY 22
Assistance 23
Spare parts 24
INTERFERENCE AND ELCTROMAGNETIC COMPATIBILITY TABLES 24

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Technicalspecifications
Manufacturer
I.A.C.E.R. S.r.l.
Via Enzo Ferrari, 2 • 30037 Scorzè (VE)
Tel. [phone] • Fax [phone]
IACER Srl is an Italian medical devices manufacturer (CE certificate
n°0068/QCO-DM/230-2020 issued by MTIC InterCert S.r.l. notified body
n°0068).
Declaration of conformity
I.A.C.E.R. S.r.l
Via Enzo Ferrari, 2 –30037 Scorzè (Ve), Italia
herewith declares under its own responsibility, that the family product
MAG2000
which includes the following models
MAG700, MAG2000, MAG2000 Premium and MAG2000 PLUS
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
modifications/integrations.
The products have been assigned to class IIa, according to Annex IX, rule 9
of the Directive 93/42/EEC (and further modifications/integrations) and
bear the mark
Compliance of the concerned products with the Directive 93/42/EEC has
been assessed and certified by the notified body:
0068 –MTIC InterCert S.r.l.
Via G. Leopardi 14, Milano (MI) 20123
Certified number: 0068/QCO-DM/230-2020
following the certification procedure according to Annex II (excluding point
4) of the Directive 93/42/EEC.
________________ _____________________
Place, date Legal Representative
MASSIMO MARCON
Scorzè, 31/01/2022

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Classifications
MAG700 has the following specifications:
•class IIa equipment (Directive 93/42/CEE, Annexed IX, rule 9 and
following modifications);
•class II applied part type BF (Classif. EN 60601-1);
•IP21 protection equipment against solids, dust and liquids penetration;
•equipment and accessories not subjected to sterilization;
•use of the equipment is prohibited close to flammable substances when
mixed with air, with nitrous oxide or when mixed with any flammable
agents and in environments with high concentrations of oxygen;
•continuous operating mode equipment;
•equipment not suited to be used in external.
Purpose and scope
Clinical Purpose: Therapeutic
Scope of Use: Ambulatory/Hospital and domestic
MAG700 is indicated for the treatment, rehabilitation and functional
recovery of the following pathologies:
•wrist, hand, shoulder, foot, ankle and knee articulation
•skeletal motor apparatus
•arthrosis
•atrophies and muscular dystrophy
•bursitis
•bruises
•degeneration of locomotor apparatus
•sprains
•periarthritis
•benign lesions and muscular tears
•tendinitis
MAG700 is particularly recommended for the treatment and care of
osteoporosis and all pathologies borne by bone tissues. Thanks to the high
intensity of the magnetic field that can generate, MAG700 is particularly
indicated in the treatment of bone fractures even in the presence of rigid
bandages or plaster.

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MAG700 is a device intended for both the professional user (physician,
therapist, etc.) and the patient at home. In case of home therapy, the use
of the device is recommended only on indication of the
physician/therapist.
The patient population intended for magnetotherapy treatment using the
MAG700 device includes patients of both sexes, men and women, of age
(unless otherwise indicated by medical doctors). For further details, please
refer to the Contraindications section.
Technical features
Characteristics
Specification
Power supply
GJ24WA-1500120V, output 15V DC, 1.2A
Max. absorbed current
0,8A
Isolation class (EN 60601-1)
II
Applied part (EN 60601-1)
BF
Dimensions (length x width
x height)
179x107x50 mm
Field intensity
Adjustable on increasing level up to 70
Gauss
Squared wave frequency
Adjustable 5-100Hz
Therapy time
Adjustable by the user (max 12
consecutive hours)
Environmental conditions of
operation
Temperature
From +5 to + 28 °C
Relative humidity
From 15 to 93%
Pressure
From 700 to
1060hPa
ATTENTION! The device delivers current above 10mA.
Maximum magnetic field intensity is 70 Gauss with elastic
therapeutic band. Intensity, frequency and time values are given with
±20% of accuracy.
Expected life of the device and its accessories: 2 years.

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Device and commands description
Power button and return to the program choice menu.
OK
OK key, confirmation button.
Selection/increment key.
Selection/decrement key.
During the therapy a green light will turn on.
Label
(retro)

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Labelling
The label on the side is
placed on the back of
the device
1. ON/OFF button
2. Power supply
entrance DC
15V/1.2A
3. CH1 connector 1
2
1
3

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Symbol
Description
Manufacturer logo
Certification of the product issued by the notified
body N° 0068.
Manufacturer
Manufacturing date (YYYY-MM)
Attention, consult operating instructions.
Product subject to WEEE regulations concerning
separate waste collection of electronic equipment.
Class II equipment.
Applied part type BF.
Admission temperature (storage, packaging).
Relative humidity (storage, packaging).
IP20
IP01
Protection level against solids, dusts and liquids
entrance (device protected against solid foreign
objects ≥ 12,5 mm and greater and vertically falling
The label is placed on
the protective
envelope.

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Symbol
Description
water drops). The case of the device guarantees the
IP20 level protection. The envelope guarantees the
IP01 level protection. The IP21 protection is
guaranteed only when using the device inside the
envelope.
Only domestic usage.
Not protected against liquid entrance, keep dry.
Power supply symbol.
Generic warning symbol: pay attention to the danger
indicated
Package content
The MAG700 package contains:
•N°1 MAG700 device;
•N°1 power supply (cable approx. 1.5m);
•N°1 elastic therapeutic belt with 2 solenoids (not inspectionable,
cable approx. 1.5m);
•N°1 operating and belt position manual;
•N°1 magnet tester;
•N°1 carrying bag;
•N°1 protective envelope.