New Age MAGNETO BIOLIFE User manual

MAGNETO BIOLIFE
Portable, wearable magnetotherapy
MANUAL
Instructions for use
New Age Italia srl
Via De’ Brozzi, 3 -48022 Lugo (RA)
Tel.:[phone] - Telefax: +39-0545.369028
Web: www.newageitalia.it - E-mail: [e-mail]
This document is the property of New Age Italia srl. All rights reserved. It is forbidden to copy and reproduce it
through any means, including total or partial photocopying of the content, without the written authorisation of New
Age Italia srl.

Rev. 01 on 06/05/16
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Rev. 01 on 06/05/16
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Rev. 01 on 06/05/16
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CONTENT
Cap.1 –PRESENTATION......................................................................6
1.1 –What is MAGNETO BIOLIFE................................................6
1.2–Why use MAGNETO BIOLIFE ..............................................6
1.3 –Who should use MAGNETO BIOLIFE...................................6
Cap.2 –INSTRUCTIONS AND CONTRAINDICATIONS....................7
2.1 –Instructions..............................................................................7
2.2 –Contraindications ....................................................................7
Cap.3 –OPERATION.............................................................................8
3.1 –Connection and application .....................................................8
3.2 –Power supply for use................................................................9
3.3 –Switching on the device............................................................9
3.4 –Select the program...................................................................9
3.5 –Starting stimulation.................................................................9
3.6 –Timer Adjustment ...................................................................9
3.7 –Stop/terminate therapy............................................................9
3.8 –Switch off device ....................................................................10
3.9 –Symbols on the display...........................................................10
Cap.4 –APPLICATIONS.....................................................................10
4.1 –Therapy sessions....................................................................10
4.2 –Position to maintain during the sessions ................................10
Cap.5 –POWER SUPPLY....................................................................12
5.1 –Charge indications.................................................................12
5.2 –Charge ...................................................................................12
5.3 –Battery maintenance..............................................................12
5.4 –Replacing the battery.............................................................13
5.5 –Precautions for use.................................................................13
Cap.6 –MAINTENANCE.....................................................................14
6.1 –Multi-use applicator...............................................................14
6.2 –Device and power supply unit................................................14
6.3 –Replacing the power supply unit............................................14
6.4 –Immediate maintenance:........................................................14

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Cap.7 –WARNINGS ............................................................................15
Cap.8 –TECHNICAL FEATURES......................................................16
8.1 –Power supply .........................................................................16
8.2 –Output features......................................................................16
8.3 –Other features........................................................................16
Cap.9 –SYMBOLS...............................................................................17
Cap.10 –STANDARD EQUIPMENT AND ACCESSORIES .....17
10.1 –Standard equipment ............................................................17
10.2 –Accessories and consumable material..................................17
Cap.11 - ELECTROMAGNETIC COMPATIBILITY ...............................18
Cap.12 –BIBLIOGRAPHY..................................................................21

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Ca p.1 –PRESENTATION
MAGNETO BIOLIFE is part of the new line of portable electromedical devices for
physiotherapy. Compact size, easy use and versatility are the main features of this
innovative line of products.
1 . 1 –What is MAGNETO BIOLIFE
Constant research in the medical devices sector led to the creation of the new
magnetotherapy system composed of the MAGNETO BIOLIFE generator, compact
in size yet with professional features. The innovative software enables generation of
magnetic fields for therapeutic purposes to treat common pathologies (cuts, injuries,
illnesses) by using preset programs ready for use. Technological innovation and easy
use makes the product extremely innovative in the electromedical devices sector.
1 . 2 –Why use MAGNETO BIOLIFE
MAGNETO BIOLIFE enables application of magnetic fields with beneficial effects
on the reconstruction of bone tissue and, in general, regeneration of damaged tissue,
as well as obtaining analgesic, anti-inflammatory and anti-edemigenous action.
1 . 3 –Who should use MAGNETO BIOLIFE
MAGNETO BIOLIFE is most suited for home use to avail of its full potential. The
compact size also ensures it is easily transported and the rechargeable battery allows
its use while travelling and in any location where application is needed; do not use
the device in very hot or humid environments (see WARNINGS chapter).
ATTENTION: for home use, follow the instructions given by the doctor who
prescribed magnetotherapy.
READ THE MANUAL CAREFULLY BEFORE USE

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Ca p.2 –INSTRUCTIONS AND CONTRAINDICATIONS
2 . 1 –Instructions
The most common pathologies treated with magnetotherapy are bone and joint
related. In particular, magnetic fields are indicated to treat:
recent fractures, delayed union;
osteoporosis, bone atrophy;
pseudoarthrosis, arthrosis, arthritis;
inflammatory and degenerative arthropathies;
oedema;
algodystrophy;
tendinitis;
You are advised to consult a doctor for diagnosis and control of the therapy.
2 . 2 –Contraindications
Magnetic fields have certain common contraindications with other physical media
which react with endogenous heat production.
presence of metal fragments;
cancer (tumours);
tuberculosis;
acute inflammatory processes;
skin lesions;
changes in sensitivity.
pace-maker
pregnancy.

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Ca p.3 –OPERATION
1 –LCD display
2 –ON/OFF START/STOP:
3 –(+) AND (-) KEYS
4 –Output socket for applicator
5 –Input socket for power supply unit
NOTE: check the contraindications before applying magnetotherapy; follow the
instructions carefully of the doctor prescribing magnetotherapy.
3 . 1 –Connection and application
Connect the cable of the applicator to the device output. Position the applicator on the
zone to treat (also over stockings or clothing) fastening it so it fits with the elastic
strap (see colour photo in the APPLICATIONS chapter).
1
2
3
4
5

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3 . 2 –Pow er supply for use
MAGNETO BIOLIFE can be battery operated or use 230V, connecting the power
supply unit to the device and a normal electricity socket.
3 . 3 –Switching on the device
To switch on MAGNETO BIOLIFE Keep the (I) ON/OFF key pressed. The display
shows the name of the device followed by the program.
3 . 4 –Select the program
Choose the desired program with the +/- keys (see Programs Table);
Programs Table
PROGRAMS
No.
FREQ (Hz)
DURATION
INTENS. G
STIM
1
75
4h
15
KNEE/ELBOW
2
70
1.5h
20
SHOULDER
3
65
2h
20
BUNION
4
75
4h
15
ANKLE
5
70
1.5h
20
WRIST
6
80
1h
15
3 . 5 –Starting stimulation
When the desired program appears on the display, press the START button. Once the
program is activated on thedisplay, the TIMER appears to indicate the remaining time
and at the bottom of the display this signal will appear to indicate treatment has
started.
3 . 6 –Timer Adjustment
You can increase the duration of the program (Timer) to prolong therapy by some
hours or for night applications, up to a maximum of eight hours. To adjust the timer
when a program is in progress, use the + and - keys
ATTENTION: for the duration of the sessions, follow the instructions of the doctor
who prescribed magnetotherapy, in particular for applications from 4 to 8 hours.
3 . 7 –Stop/terminate therapy
If you want to stop therapy before the end, press the STOP key: once to pause (to
continue press START).

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3 . 8 –Switch off device
To switch off the device, keep the (I) ON/OFF key pressed for a few seconds.
3 . 9 –Symbols on the display
- BATTERY STATUS: battery power supply and load level
Ca p.4 –APPLICATIONS
4 . 1 –Therapy sessions
Apply magnetotherapy according to medical prescription.Applications can be
carried out every day, with the most suitable program for the patient's pathology, until
the problem is healed or significantly reduced; if necessary, 2-3 applications can be
carried out daily a few hours apart, without exceeding the 8 hours per day of therapy.
If the problem persists, consult your doctor.
4 . 2 –Position to maintain during the sessions
MAGNETO BIOLIFE allows you to have therapy sessions while going about
everyday activities.

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EXAMPLES OF APPLICATIONS
SHOULDER APPLICATION
ELBOW APPLICATION
KNEE APPLICATION
ANKLE APPLICATION
FOOT APPLICATION
WRIST APPLICATION

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Ca p.5 –POWER SUPPLY
MAGNETO BIOLIFE can be powered by the electrical mains using the power supply
unit provided or an internal rechargeable Ni-Mh 8.4V –900mAh battery, which, in
normal use conditions, has an autonomy of a few hours. Guaranteed autonomy varies
based on the type of emission used, the intensity set and the application time.
To correctly identify the battery and the power supply unit provided as standard,
consult the "Technical features" chapter. The power supply nor the battery must be
replaced by inexpert staff and in particular using equipment differing from that
supplied by the manufacturer.
5 . 1 –Charge indications
When MAGNETO BIOLIFE is powered by the internal battery, the symbols bar on
the display shows the BATTERY " " symbol.
Legend: - Battery charged indication - Battery flat indication
The intermediate charge levels are indicated by a partial blackening of the BATTERY
symbol .
When the flat battery status is signalled, proceed with the recharge cycle. To safeguard
the battery, MAGNETO BIOLIFE is equipped with an auto-power off system.
5 . 2 –Charge
To charge the MAGNETO BIOLIFE battery:
1- switch off the device;
2- connect the power supply unit to the electricity mains and to MAGNETO
BIOLIFE;
3- leave the device charging (the display shows the outline of the battery symbol
flashing as it charges) until the battery symbol is full (a complete recharge cycle
lasts approx. 7 hours); every now and then, you are advised to leave it charging
for 8-10 hours or all night);
4- Disconnect the power supply unit from the electricity mains and from
MAGNETO BIOLIFE;
5 . 3 –Battery maintenance
The life of a rechargeable battery is linked to the number of charge/discharge cycles
it is subjected to and the way these cycles are executed.
If you do not frequently use MAGNETO BIOLIFE, we suggest you charge the
battery on a monthly basis. To prolong the life of the battery, you are advised to
discharge it as much as possible (see flat battery symbol) and every 3 weeks
completely recharge for 8-10 hours (e.g. all night).

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5 . 4 –Replacing the battery
An indicator of battery exhaustion is the duration of the battery after normal recharge.
When you note the duration of the battery is considerably less than that of a new
battery, you need to replace it. To replace the battery, contact NEW AGE ITALIA
SRL.
Never invert the poles of the battery connections, which would destroy the
electronic circuits.
5 . 5 –Precautions for u se
(1) Do not throw the old battery in ordinary waste, but give it to authorised staff for
its disposal.
(2) Do not open or throw the battery on the fire.
(3) Do not short circuit the terminals.
(4) Avoid causing sparks, or flames, over or around the battery.
(5) If material leaks from the battery and comes in contact with the skin, or with
clothing, immediately wash with water. If it comes in contact with your eyes,
wash with plenty of water and immediately seek medical advice.

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Ca p.6 –MAINTENANCE
6 . 1 –Multi -use applicator
Periodically check the connection cable to check for any cracks, a possible cause of
dispersion of magnetic fields; clean the applicator periodically with a damp cloth.
6 . 2 –Device and power supply unit
Use a damp cloth to clean the power supply unit and the device. Never use liquids
for any reason, because they are not protected against liquid entering (IP20).
6 . 3 –Replacing the p ow er supply unit
Check the isolations (casing and cables) on the power supply unit for wear, before
connecting it to the mains. If damaged, even if partially, replace the power supply unit
immediately.
6 . 4 –Immediate maintenance:
Immediate maintenance in New Age Italia or authorised staff if:
the device was subjected to external mechanical stress (e.g. serious fall);
the device was subjected to strong overheating (e.g. if left near intense heat
sources);
if you doubt liquids can penetrate inside;
the power supply unit, the casing and other parts of the device are damaged,
broken or missing;
device functionality appears altered.
For safety purposes, you are advised not to work with accessories (e.g. knobs and
power supply unit) other than those provided as standard equipment.
The frequency for maintenance, functionality testing and correspondence
checking with safety standards EN60601-1 for medical devices should be carried out
annually using a safety tester. The operation lifespan of the device is guaranteed
by the manufacturer only if maintenance is carried out regularly.
NOTE: you are advised to only have the device tested by New Age Italia. The unit
can be sent directly to the company support lab or handed to the dealer that sold the
device.
Support centre:
New Age Italia srl - De’ Brozzi, 3 – 48022 Lugo (RA)
Tel:[phone] - Telefax: +39.0545.369028 - [e-mail]

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Ca p.7 –WARNINGS
Pay particular attention when using the solenoids to avoid compromising
treatment efficiency.
Use the device only with electrical systems complying with applicable safety
standards in force.
The device has a protection rating of IP20 (see “Technical features” chapter). Do
not use near liquids, as the device is not impermeable.
Do not use in the immediate vicinity of mobile phones (keep at least a few metres
distance).
Using close (e.g. 1 metre) to a short wave or microwave therapy device may cause
instability of the stimulator output.
Do not use in the presence of monitoring equipment for vital signs.
Do not simultaneously connect the patient to MAGNETO BIOLIFE and a HF
surgical device, as this may be hazardous for the patient and the device itself.
The device performs as specified only if surroundings are kept at a temperature
between 5 and 40° C and with humidity less than 80%. The same conditions are
required for transport and storage.
In the event of malfunctions or faults, do not use the device and send it for repair.
Do not use near inflammable substances.
Do not use gel and accessories other than those supplied as standard.
It is imperative to inform the patient in advance of the sensation experienced
during therapy, so that the session may be interrupted immediately using the
controls on the device or removing the solenoids, if the sensation is not correct.
If the output intensity setting or its subsequent adjustment causes excessive heat
or pain in the area treated, reduce the intensity of the treatment or stop the
application, if necessary.
Keep out of reach of children.

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Ca p.8 –TECHNICAL FEATURES
8 . 1 –Pow er supply
Power supply unit: Ktec KSAD1200 140W 1EU
PRI: 230V 50Hz SEC: 12V- 1.4A
Internal power supply: Rechargeable battery Ni-MH 8.4V- 900mAh
8 . 2 –Output features
Max intensity of magnetic induction (B): 20 Gauss
8 . 3 –Other featu res
Dimensions: 100x40x30h [mm]
Weight: 200 [g]
Class: IIa Type: BF
Impermeability protection rating: IP20
Safety rating for use near inflammable anaesthetic gases: AP or APG
Device operation: continuous
Manufactured in compliance with the following regulations:
EN 60601-1 (2007) –Electromedical devices: General regulations for safety
EN 60601-1-2 (2007) –Collateral regulation: Electromagnetic compatibility –
Prescriptions and tests
EN 60601-1-4 (1997) –Collateral regulation: Programmable electromedical
systems
EN 62304 (2006) –Software cycle
EN 60601-1-6 –Usability
Serial number (S.N)
Identification code of MAGNETO BIOLIFE
S.N. MG BL ZZ XXXX
Device identification number
Year of manufacture

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Ca p.9 –SYMBOLS
APPLICATOR TYPE BF
ATTENTION, CONSULT THE DOCUMENTATION ATTACHED
THIS DEVICE IS CE MARKED ACCORDING TO
0123 DIRECTIVE EEC 93/42 AMENDED BY 2007/47/EC.
WASTE DISPOSAL ACCORDING TO DIRECTIVE 2002/96/ECC
AND 2003/108EEC
Ca p.10 –STANDARD EQUIPMENT AND ACCESSORIES
1 0 . 1 –Standard equip ment
Device
Applicator
Power supply unit
No.1 elastic strap
User manual
1 0 . 2 –Accessories and consumable material
Elastic fixing strap

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Ca p.11 - EL ECT ROM AGNE TI C CO MP ATI BILITY
Table 201-Electromagnetic emissions declaration
Guidance and manufacturer's declaration - electromagnetic emissions
The MAGNETO BIOLIFE device is intended for use in the electromagnetic
environment specified below. The user must ensure it is used in this
environment.
Emissions test
Conformity
Electromagnetic environment - guidance
RF emissions
CISPR 11
Group 2
The MAGNETO BIOLIFE device must
emit electromagnetic energy to perform the
functions for which it was created.
Electronic equipment nearby could be
affected.
RF emissions
CISPR 11
Class B
The MAGNETO BIOLIFE device is
suitable for use in all establishments,
including domestic and directly connected
to the low voltage energy supply mains that
supplies buildings used for domestic
purposes.
harmonic
emissions IEC
61000-3-2
Not applicable
Voltage
fluctuations /
emission
flicker IEC
61000-3-3
Not applicable
Table 202-Declaration – Electromagnetic immunity
Guidance and manufacturer's declaration - electromagnetic immunity
The MAGNETO BIOLIFE device is intended for use in the electromagnetic
environment specified below. The user must ensure it is used in this environment.
Immunity test
Test level
IEC 60601
Conformity
level
Electromagnetic environment -
guidance
Electrostatic
discharge
(ESD) IEC
61000-4-2
±6 kV
contact
±8 kV air
±6 kV
contact
±8 kV air
Floors should be in wood or
ceramic. If floors are covered
with synthetic material, relative
humidity should be at least 30%.
Table 204-Declaration – Electromagnetic immunity
Guidance and manufacturer's declaration - electromagnetic immunity
The MAGNETO BIOLIFE device is intended for use in the electromagnetic
environment specified below. The user must ensure it is used in this environment.
Immunity
test
Test
level
IEC
60601
Conformity
level
Electromagnetic environment - guidance
RF
3 Vrms
3Vrms
RF communications portable and mobile

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conducted
IEC
61000-4-
6
RF
radiated
IEC
61000-4-
3
150
kHz to
80
MHz
3V/m
80
MHz to
2.5
GHz
3 V/m
equipment should not be used too near any
part of the MAGNETO BIOLIFE device,
including cables, but take into account the
separation distance recommenced calculated
based on the equation applicable to
transmitter frequency.
Recommended separation distance:
Where “P” is the maximum emission power
of the transmitters calculated in watts (W)
according to the manufacturer of the
transmitter and “d” is the recommended
separation distance in metres.
Fixed RF transmitters force fields.
As determined by research on an
electromagnetic site,a it must be lower than
the conformity threshold of each frequency
range.b
Interference may manifest near devices
marked with the following symbol:
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies,
NOTE 2 These guidelines do not apply to all situations, electromagnetic
propagation is influenced by absorption and reflection of structures, objects,
people.
A Fixed transmitter force fields as radio station bases for radio (mobile/cordless
phones)
Telephones and mobile radios, amateur radios, radio transmissions, AM, FM and
TV transmissions cannot be theoretically precisely planned. To assess the
electromagnetic environment due to fixed RF transmitters, you need to consider

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an electromagnetic site. If the force of the magnetic field in the location where the
MAGNETO BIOLIFE device is used exceeds the RF conformity levels mentioned
above, the device should work normally. If you note a functional anomaly,
additional manoeuvres are necessary, such as re-positioning of MAGNETO
BIOLIFE.
b over the frequency range from 150 kHz to 80 MHz, the forces of the magnetic
field should be less than (V) V/m.
Table 206-Recommended separation distances between portable and mobile RF
telecommunication equipment and the MAGNETO BIOLIFE device
Recommended separation distances between portable and mobile RF
telecommunication equipment and the MAGNETO BIOLIFE device
The MAGNETO BIOLIFE is intended for use in an electromagnetic environment
in which RF radiated disturbance is controlled. The user must avoid
electromagnetic interference by maintaining a minimum distance between
portable and mobile telecommunications equipment and the MAGNETO
BIOLIFE device as recommended above, based on the maximum emission power
of the telecommunications equipment.
Maximum
emission power
of the
transmitters
calculated in
watts (W)
the recommended separation distance in metres based on the
transmitter frequency
√P
√P
0.01
0.12
0.12
0.23
0.1
0.38
0.38
0.73
1
1.2
1.2
2.3
10
3.8
3.8
7.3
100
12
12
23
For transmitters at maximum power not listed above, the recommended distance
“d” in metres “m” can be estimated using the equation applicable to the transmitter
frequency, where “p” is the maximum emission power of the transmitters
calculated in watts (W) according to the manufacturer of the transmitter.
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies,
NOTE 2 These guidelines do not apply to all situations, electromagnetic
propagation is influenced by absorption and reflection of structures, objects,
people.