I-Tech ORTHOMAG User manual

USER MANUAL
Magnetotherapy model
ORTHOMAG

ii
Summary
SUMMARY ...................................................................................... II
TECHNICAL SPECIFICATIONS........................................................... 4
MANUFACTURER .................................................................................. 4
DECLARATION OF CONFORMITY................................................................ 4
CLASSIFICATIONS .................................................................................. 5
PURPOSE AND SCOPE ............................................................................. 5
TECHNICAL SPECIFICATIONS..................................................................... 6
DEVICE DESCRIPTION AND CONTROLS ........................................................ 7
LABELLING ........................................................................................... 8
Package content ........................................................................... 9
HOW TO USE................................................................................. 10
INTRODUCTION TO TECHNOLOGY............................................................ 10
CONTRAINDICATIONS........................................................................... 10
Side effects.................................................................................. 11
WARNINGS........................................................................................ 11
PREPARING THE PATIENT:MAIN POSITIONS OF THE APPLICATOR.................... 14
HOW TO USE THE DEVICE...................................................................... 16
CARE OF THE DEVICE..................................................................... 19
MAINTANCE ...................................................................................... 19
TROUBLESHOOTING............................................................................. 20
Battery recharge ......................................................................... 20
Battery replacement ................................................................... 21
DISPOSAL .......................................................................................... 21
WARRANTY ....................................................................................... 22
Assistance ................................................................................... 23
Spare parts.................................................................................. 23
INTERFERENCE AND ELECTROMAGNETIC COMPATIBILITY TABLES.................... 23

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IACER Srl 4 MNPG207-03
Technical specifications
Manufacturer
I.A.C.E.R. S.r.l.
Via S. Pertini, 24/a • 30030 Martellago (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 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
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
Martellago, 19/06/2020

IACER Srl 5 MNPG207-03
Classifications
ORTHOMAG 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. CEI EN 60601-1).
•IP22 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
Use: Clinic/Hospital and domestic use
ORTHOMAG 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
•degeneration of locomotor apparatus
•sprains
•periarthritis
•muscular tears
•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.
According to medical devices directives, the fabricant suggests a device
control to check its efficiency and safety every 2 years.

IACER Srl 6 MNPG207-03
Technical specifications
Feature
Specification
Power supply Lithium polymer batteries, 3.7V 900mAh
Battery charger model AK12G-1200100V
input 100-240V, 50/60Hz, 0.5A; output 12V, 1A
Max. current consumption
≤300mA (in therapy)
Insulation (EN 60601-1)
II
Applied parts (EN 60601-1)
BF
Field strength
20 Gauss ± 30%
Square wave frequency
50Hz (L program)
75Hz (H program)
Pulse width
16ms (L program),
10.66ms (H program)
Duty cycle
80%
Therapy duration
Preset to 4 hours
Dimensions
(Length x Width x Height)
97.9x71.8x30mm
Weight
88g
Usage conditions
Ambient
temperature
From +5° to +40°C
Relative humidity
From 30% to 85%
Atmospheric
pressure
From 700 to 1060hPa
Transport and storage
conditions
Ambient
temperature
From -5° to +40°C
Relative humidity
From 10% to 93%
Atmospheric
pressure
From 700 to 1060hPa
Useful life of the device: 3 years.

IACER Srl 7 MNPG207-03
Device description and controls
Power on/off key
L
L Program key (50Hz)
H
H Program key (75Hz)
Label (back)

IACER Srl 8 MNPG207-03
Labelling
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.
Type BF applied part
Allowed temperatures (storage and use temperatures,
on the packaging and on the device body).
Relative humidity (relative humidity for storage and use,
on the packaging and on the device body).
IP22
Protection rating against ingress of solids, dusts and
liquids (device protected against solid foreign objects of
diameter ≥ 12.5 mm and against vertical drops of water
when the device is kept at 15° from normal operating
The label
on the side
is placed on
the back of
the device.

IACER Srl 9 MNPG207-03
Symbol
Description
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);
•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.