Mantis MR991 Manual

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MANTIS s.r.l. - Via Artigianale Croce n.13 - 42035 Castelnovo ne’ Monti (RE) - ITALY
Tel. [phone] - Tel. [phone]
www.mantisitalia.it - [e-mail]
Operating and maintenance instructions
Electro-medical device for endomassage
and magnetic field application
MR991
1370
The manual must be kept in a safe place for the entire life of the device. Carefully read the entire manual
before operating the device.

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TABLE OF CONTENTS
CERTIFICATE OF CONFORMITY
1
GENERAL INFORMATION
1.1
Description of the EM device
1.2
Definitions and symbols used in the manual
2
SCOPE
2.1
Intended use
2.2
Reasonably foreseeable misuse
3
TECHNICAL DATA
4
DESCRIPTION OF THE EM DEVICE
4.1
EM Device
4.2
Handpieces - applied parts
5
GENERAL SAFETY PRECAUTIONS
5.1
Warnings
5.2
Safety devices
5.3
Pictograms
6
TRANSPORT AND INSTALLATION
6.1
Description of the packaging and storage
6.2
Removing the packaging and checking the contents
6.3
Transport
6.4
Installation
6.4.1
Positioning
6.4.2
Assembly
6.4.3
Power connection
6.4.4
Connection for tele-assistance (if available)
7
COMMISSIONING
7.1
Functions of the EM device
7.1.1
MAXI d.e.s. handpiece
7.1.2
MINI d.e.s. handpiece
7.1.3
MAXENERGY handpiece
7.1.4
VIXO handpiece
7.2
Switching on and preparation of the EM device
7.3
Starting a cycle of treatments
7.3.1
Background information
7.3.2
First cycle
7.3.3
d.e.s. technology treatments
7.3.4
Controls and warnings on the handpieces –applied parts
7.4
Repeat a cycle of treatments
7.5
Changing the handpiece during treatment, if applicable (MAXI d.e.s. - MINI d.e.s.)
7.6
Stopping ongoing treatment
7.7
Stopping the EM device in an emergency
7.8
Restoring the device in an emergency
7.9
Restoring the device in case of a power cut

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7.10
Saving and using data on a USB stick
7.10.1
Saving the first time
7.10.2
7.10.2 Previously saved customer
7.11
7.11 Operational test
8
EM DEVICE MAINTENANCE
8.1
Routine maintenance
8.1.1
Cleaning and disinfecting the handpieces
8.1.2
Cleaning the EM device and the touch-screen
8.1.3
Cleaning the suction filters and replacing the cartridges
8.1.4
Remote Assistance
8.1.5
Enabling MAXENERGY from the touch-screen
8.1.6
Troubleshooting
9
ACCESSORIES AND OPTIONAL EXTRAS
9.1
Accessories
9.2
Using accessories
9.2.1
Treatment gown
10
DECOMMISSIONING THE EM DEVICE
11
SPARE PARTS
12
RETURNING THE EM DEVICE
13
GENERAL WARRANTY TERMS AND CONDITIONS

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1
GENERAL INFORMATION
1.1
Desc
riptio
n of
the
EM
devi
ce
DESCRIPTION OF THE EM DEVICE
MR991 is an EM device that combines the following three technologies, which can be
easily programmed by the operator:
MRM - mechanical manipulation with motorised rollers - for effective endomassage with
mechanical rollers and micro-suction.
PMFS SYSTEM -pulsed magnetic fields with stochastic resonance- the use of which has
shown that treated areas, based on tests carried out, have a greater blood supply than
usual, thus leading to greater oxygen exchange with the tissues and at the same time
draining all toxic and unwanted substances towards the organs of detoxification and
excretion.
Thanks to this detoxifying action, which drains the stagnant liquid in the tissues, the
PMFS system is ideal to treat lymphoedema and E.F.P.
PMF, using high energy magnetic fields, has a specific effect on ions, macromolecules
and membranal proteins.
1.2
DEFINITIONS AND SYMBOLS USED IN THE MANUAL
The manual defines some figures authorised to operate on the EM device in different
manners:
Manufacturer: the producer of the EM device who affixes their own mark on the EM
device itself (MANTIS s.r.l.).
Operator: personnel who use the EM device, who has working knowledge of its operation
following a course with subsequent authorisation granted by the manufacturer. The
operator is also in charge of cleaning and routine maintenance.
Customer: the person who avails of the treatment or who requests it. Technical
assistance: personnel in charge of special maintenance and repairs of the EM device,
specifically assigned by the manufacturer.
The following symbols are used in the manual:
Important requirements concerning safety and operation of the
device

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Important requirements concerning the use and maintenance of the
EM device
1.3
USING THE MANUAL
The “Operating and maintenance instructions” manual is intended for the operator (see
“definitions and symbols used in the manual”) and must be read and understood in its
entirety before commissioning the EM MR991 device.
This manual must be kept in a safe place for the entire life of the device.
Please read the entire manual carefully before operating any part of
the device.
For the replacement of some spare parts, contact the technical
assistance centre. The technical assistance centre is in possession of
the “Manual reserved for Technical Assistance”, which contains the
wiring diagrams and instructions to dismantle the device.
This manual is strictly reserved for MANTIS technicians.
The manual cannot be handed over to personnel who are not
specialised and approved by MANTIS.
2
SCOPE
2.1
INTENDED USE
MR991 is an EM device designed for face and body treatment, which is carried out with special
handpieces driven by software that also guides the operator throughout the entire treatment.
An “optional” check-Up sheet indicating the Customer's overall health condition is first compiled
in order to assess any risk factors and consequently exclude certain phases of the treatment.
Each handpiece is specific for a type of treatment and is briefly described as:
-
MAXI d.e.s. “MRM + PMFS SYSTEM”
Suitable for body treatment on the recommended areas and following the specified procedures.
-
MINI d.e.s. “MRM + PMFS SYSTEM”
Suitable for body treatment on the recommended areas and following the specified procedures.
-
MAXENERGY “PMF SYSTEM magnetic field treatment”
Suitable for body treatment on the recommended areas and following the specified procedures.
-
VIXÒ “programmable PMFS SYSTEM”
Suitable for face treatment on the recommended areas and following the specified
procedures.

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2.2
REASONABLY FORESEEABLE MISUSE
Using MR991 in any of its modes is forbidden in the following cases:
- On individuals with implanted devices (Pacemakers, Internal
defibrillators, and any other device that is not applicable to the
treatment).
- Treatment on open wounds, eyes, intracavitary regions, nipples,
testicles and soft areas.
Using the MR991 in MRM mode
-mechanical manipulation with motorised rollers-
is forbidden in the following cases:
- Thrombophlebitis
- Cardiovascular insufficiency
- Phlebitis
- Dermatological infections
- Hypertension
- Varicose veins
- Skin cancer (malignancy)
- Tuberculosis
- Pregnancy if treating the abdomen
Using the MR991 in PMFS and PMF mode
-pulsed magnetic fields in stochastic resonance-
is forbidden in the following cases:
- In the presence of metal implants e.g. screws, staples, nails, clips.
- Heart rhythm disorders
- Dermatitis
- Epilepsy
- Diseases in the autonomic nervous system
- Nerve disorders
- Pregnancy
- Menstruation with a heavy flow
- Open haemorrhoids and vascular lesions in general
- Individuals with intrauterine devices, such as catheters.
- Localised fungal infections
- Fever or thermoregulation disorders.
With the exception of the above-mentioned cases and in the following cases, MR991
must be used carefully in any of its modes and only with the doctor’s approval:
- Pregnancy
- Asthma

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- Cancer (malignancy)
- Vascular malformations
- Lymphadenopathy
- Mesotherapy
- Psoriasis
- Multiple sclerosis
- Scleroderma
Before starting the treatment, inform the Customer about the
contraindications of the treatment itself, without any omission. Fill in
every section of the “Check-Up” form, including the date and
signature for acceptance by the Customer undergoing treatment.
Make sure that no changes in the Customer's health conditions occur
during the cycle of sessions, which may constitute contraindications
with the continuation of the cycle
Prepare a privacy policy form for the destination country of the
device.
Under no circumstances are individuals with implanted devices
(Pacemakers, internal defibrillators or other devices) to receive
treatment.
Under no circumstances is treatment to be performed on open
wounds, eyes, intracavitary regions, nipples, testicles and soft areas.
The Manufacturer assumes no liability if the Customer is not given a
correct diagnosis and if maintenance is not performed in accordance
with the indicated methods and frequency (see par. 8).
Nor if the device is used improperly or not in compliance with the
instructions set forth herein.
ATTENTION: do not alter the device in any way. The Manufacturer
assumes no liability in the event of any tampering or modifications
made to the EM device.
It is mandatory to wear the “optional” gown for treatments using the
MAXI d.e.s. / MINI d.e.s. mechanical handpiece
Never apply the handpiece in suction mode; in the presence of
creams, oils or directly in contact with the skin (MINI d.e.s. MAXI d.e.s.)
unless preventively cleansed and dry (VIXO).

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Remove any cream or oil at the end of the VIXO treatment (step2)
before switching the device off or restarting it.
3
TECHNICAL DATA
Characteristic
U.O.M.
VALUE
Width
mm
600
Depth
mm
600
Height
mm
1950
Weight
Kg
100
Available working perimeter around the
device
mm
900
Length of the power cable
mm
2500
Handpiece pipe available working length
mm
2000
Insulation rating
IP20
Protection rating against direct and
indirect contact
BF type
Insulation class
1
Power supply
V
230 1ph+N+T
Frequency
Hz
50
Max Vacuum
kPa
70
Circuit breaker switch
A
10
Maximum absorbed power
VA
1400
Operating
environment
Temperature range
°C
10 ÷35
Humidity range
RH
10 ÷70%
Minimum atmospheric
pressure
hPa
800
Maximum altitude
m.a.s.l.
2000
Storage
environment
Temperature range
°C
-20 ÷55
Humidity range
RH
10 ÷ 98%
Type of source used
Altair LED model LS572-W
Dominant wavelength
451 nm
Type of emission
Continuous
Power
5100 lumens

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Classification
EN 60825-1: 1994 + A1: 2002 + A2:
2001
Characteristic
U.O.M.
Value
Width
mm
730
Depth
mm
850
Height
mm
1560
Weight (tare)
Kg
17.5
4
DESCRIPTION OF THE EM DEVICE
4.1
EM DEVICE
-FRONT-
1
Touch-screen control panel
2
Vixò handpiece
3
MAXI d.e.s. handpiece
4
MINI d.e.s. handpiece
5
MAXENERGY handpiece
6
Start keyswitch
7
Emergency stop
8
USB port
9
Wheels with brake
10
Pull-out lifting handles
8
2
3
1
10
6
5
4
5
7
10
9
9
9
H
L
P

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-REAR-
2
Vixò handpiece
3
MAXI d.e.s. handpiece
4
MINI d.e.s. handpiece
5
MAXENERGY handpiece
21
Transparent handpiece support
22
Cable guide casing
23
Handpiece connector cover
24
Ethernet connection*
25
Master switch
24
Remote assistance connection
26
MAXENERGY connection
27
Power supply
28
MINI d.e.s. connection
29
MAXI d.e.s. connection
30
Vixò connections
31
Filters
(24)
* The Ethernet connection is reserved for the
internet connection for remote tele-assistance
(if available).
Connections for other purposes are not
permitted.
3
4
25
24
27
26
23
2
5
21
22
28
23
29
30
31
23

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4.2
HANDPIECES –APPLIED PARTS-
A
MINI d.e.s. HANDPIECE
A1
Start / Pause / invert roller rotation
A2
Enabled handpiece LED
B
MAXI d.e.s. HANDPIECE
B1
Start / Pause
B2
Selected mode value increase
B3
Roller drive inversion
B4
Mode menu scroll
B5
Selected mode value reduction
B6
Mode display
C
VIXO HANDPIECE
C1
Start / Pause
C2
PMF mode LED
D
MAXENERGY HANDPIECE
D1
Start / Pause
C
C1
C2
D2
D1
D1
D
B2
B5
B6
3
B1
B4
A2
A1
A1
B
B3
B3
A

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D2
PMF mode LED
5
GENERAL SAFETY PRECAUTIONS
5.1
WARNINGS
ATTENTION: Stop treatment immediately if symptoms, such as chest
pain, difficulty breathing, profuse sweating, cognitive impairment, loss
of consciousness or abnormal skin irritation arise during treatment
Before carrying out any operation on the EM device, read this entire
manual carefully.
The operator must be able to use the EM device safely, have a suitable
psychological and physical profile, not be under the influence of drugs
or alcohol and be perfectly informed on how the EM device works.
The EM device must be kept out of the reach of children
The EM device must be used by a single operator to prevent functions
that are not required from being activated unexpectedly.
The EM device is designed for the uses described in paragraph “2.1 Intended use”,
according to the instructions in the chapters "COMMISSIONING" and "MAINTENANCE".
Any other use is strictly forbidden. Before connecting the EM device to the power supply
system, make sure that the power supply is suitable for that required by the device (Volt
V–frequency HZ –Absorption VA), stated on the data plate.
Also make sure that the electrical system conforms to the standards for the intended use
of the device and the regulations in the country of destination and installation.
Disconnect the EM device also during brief periods of inactivity, by extracting the switch-
on key and storing it in a safe place.
Do not leave the EM device unattended during operation; disconnect it from the power
supply during inactivity, even if brief.
In case of maintenance, disconnect the power supply by removing the plug from the back
of the EM device.
Before cleaning or performing maintenance, such as connecting the handpieces or
cleaning the filters, always disconnect the power supply by removing the plug.
Never alter or tamper with the safety systems of the EM device. Do not install the EM
device near magnetic media, such as cash cards, credit cards, badges, mobile phones or
any other device that could be affected. Install the EM device away from static and
dynamic sources of heat (radiators, convection heaters) or particularly dusty

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environments.
Use only original spare parts supplied by the manufacturer which bear the
manufacturer's mark.
Do not insert objects through the suction grilles; do not obstruct the side and rear suction
grilles on the device base in any way.
Do not use corrosive chemicals to clean the EM device.
Do not use sharp or abrasive objects on the Touch-screen control panel or on the
handpiece support.
Do not use the EM device near devices that spray water or sources of high humidity,
such as saunas, showers, hydromassage tubs, etc.
Do not expose the EM device to direct sunlight.
The EM device is designed to operate in safety and is equipped with safety devices
which must not be tampered with under any circumstances.
Special maintenance and repairs must only be performed by skilled
personnel appointed by MANTIS (skilled technical assistance).
Any tampering with the EM device by non-specialised technicians will
invalidate any warranty to relieve the manufacturer of any liability.
5.2
SAFETY DEVICES
The EM device is provided with a number of protective and safety devices which must not
be tampered with in any way.
Contact the Technical Assistance Centre in case of faults or
malfunctions.
- Switch with key selector to protect unauthorised intervention.
- Emergency stop button (red push-button).
- Power supply isolation devices.
- Power cable.
- Thermal control device of pulsed magnetic fields.
- EM device compartment overtemperature control device.
- Handpiece overtemperature control device.
- Connected handpiece automatic recognition.
- Magnetic field shielding device.

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DRAFT
- Vacuum electronic sensors.
- Temperature control with ventilation grids and forced ventilation.
- Audio and visual alarms to detect malfunctions.
- Roller anti-locking device.
- Mechanical handpiece connector locking device.
- Braking system on the wheels.
5.3
PICTOGRAMS
A few pictograms are affixed on the EM device, near the main switch and on the
handpiece support, indicating the safety requirements as well as the CE marking. If the
stickers become illegible they must be replaced.

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-LABELS AFFIXED TO THE DEVICE-
Attention –Dangerous voltage (IEC EN 60601-1) - On the device
Generic warning symbol (IEC EN 60601-1) On the label of the device
Appliance emits non-ionising radiation (IEC EN 60601-1-2) On the
label of the device
Follow the user instructions (IEC EN 60601-1) On the label of the
device
Electrostatic discharge sensitivity label –On the device
Symbol conforming to Directive 2012/19/EC. On the label of the
device
Type BF applied part (IEC EN 60601-1) On the label of the device
1370
CE marking and notified body number On the label of the device
Year of manufacture Manufacturer (UNI EN ISO 15223)1 On the label
of the device
Do not use on pacemaker wearers On the device
Name of the device model (UNI EN ISO 15223) On the label of the
device
Device serial number (UNI EN ISO 15223) On the label of the device

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-LABELS AFFIXED TO THE DEVICE PACKAGING-
Correct storage position:
indicates the direction of the package.
Fragile, handle with caution.
Do not use lifting hooks.
Do not turn over and do not swing
sideways while handling.
Humidity range permitted during storage:
min. 10% max. 98% RH
Store away from sources of humidity.
Do not compact the side and top walls of the package.
Do not stack.
Temperature range permitted during storage.
Min. -20 C° Max. +55 C°
6
TRANSPORT AND INSTALLATION
6.1
DESCRIPTION OF THE PACKAGING AND STORAGE
MR991 and the accessories are supplied in a single
package secured on a pallet.
Store in a dry place that conforms to the environmental
characteristics indicated in the “Technical data” table,
away from the weather and direct sunlight. Upon delivery,
check that the package is intact, including the EM device
and the accessories therein.
If not, immediately notify the manufacturer or dealer.
-1
Remove the supporting straps that block the first
package, while being careful not to damage the

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external wrapping
-2
Remove the tape on the upper part of the package
-3
Extract the entire casing upwards
-4
Check that parts A-B-C are inside the package and are
intact
-5
Remove the two packages A and B from the package
-6
Without using cutting tools, remove the protections and
any wrapping
-7
Unscrew the blocking handles D at the base of the
MR991 pallet
-8
Check that packages A and B contain:
E
-1 handpiece support
-4 fastening screws
F
-1 MAXI d.e.s. handpiece
-1 MINI d.e.s. handpiece
-1 MAXENERGY
handpiece
-1 VIXO handpiece
-1 Power Cable
-1 Ethernet cable
G
-2 long “MINI d.e.s. –MAXI d.e.s. handpiece” supporting antennas
-1 short “VIXO handpiece” supporting antenna
H
-1 flap extraction key
-1+1 pair of flaps for MINI d.e.s. handpiece
-1+1 pair of flaps for MAXI d.e.s. handpiece
-2 start switch keys
Dispose of the packaging in accordance with the regulations (WEEE
2002/96/EC)
C
B
A
D
D
E
H
F
G

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6.3
TRANSPORT
Before handling, always check the stability of the EM device and
make sure the area involved in the handling movements is free from
obstacles, such as objects, animals or people.
The EM device must be lifted by two people who have appropriate
physical characteristics.
Use protective gloves for transportation; remove both side
handles (11), firmly grasp them and lift the EM device while
paying attention to keep it stable.
6.4
INSTALLATION
6.4.1
POSITIONING
The EM device must be installed in premises
classified under group 1, pursuant to IEC 64-8
standards, sec. 7 10
The EM device must be placed on a flat, level surface.
Set up a work area that is large enough for all required
manoeuvres, for routine maintenance and cleaning and to
disconnect the power plug (see technical data).
The wheels facilitate brief movements, however, there should be a surrounding clearance
of at least 0.9 m diameter for the EM device to be positioned.
Consider the length of the power cable (2.5 m) and the 2 m cable lengths of the
handpieces.
Do not position the EM device near sources of water spray or high humidity, such as
saunas, showers or whirlpools.
Do not expose the EM device to direct sunlight or excessive sources of heat.
Do not position the EM device close to magnetic media (bank cards, credit cards,
badges, mobile phones - see the electromagnetic compatibility table below).
11
11
11

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Once set in position, block the wheels with the brakes (10)
Manufacturer's declaration and guide –Electromagnetic Emissions
The MR991 EM device can be used in the electromagnetic environment specified below. The customer or user
of the MR991 EM device must make sure that the appliance is used in such an environment.
Emission test
Compliance
Guide to the electromagnetic
environment
CISPR11 Radiated / Conducted
Emissions
Group 1
The MR991 EM device uses RF energy only for
its internal function. Accordingly, its RF
emissions are very low and do not cause any
interference near any electronic device
CISPR11 Radiated / Conducted
Emissions
Class (B)
The MR991 EM device is suitable for all
environments, including domestic and those
connected directly to the mains that supplies
power to environments used for domestic
purposes.
Harmonic IEC 61000-3-2
Class (A)
Voltage fluctuations/flicker IEC/EN
61000-3-3
(Complies)
Manufacturer's declaration and guide –Electromagnetic Immunity
The MR991 EM device can be used in the electromagnetic environment specified below. The customer or user of the
MR991 EM device must make sure that the appliance is used in such an environment.
Emission test
Compliance
Guide to the electromagnetic
environment
Electrostatic discharges (ESD)
IEC/EN61000-4-2
±6kV in contact
±6kV in air
The flooring must be made of
wood, concrete or ceramic. If the
floors are covered with synthetic material, the
relative humidity must be 30% at most.
Fast/burst transient IEC/EN 61000-4-4
± 2kV power
The power supply should be that typically found
in a commercial or hospital environment
Surge
IEC/EN61000-4-5
±2kV common mode
±1kV differential mode
The power supply should be that typically found
in a commercial or hospital environment
Voltage dips, short interruptions and
voltage variations IEC/EN 61000-
4-11
<5% UT for 0.5 cycle
40% UT for 05 cycle
70% UT for 25 cycle
<5% UT FOR 5 sec
The power supply should be that typically found
in a commercial or hospital environment If the
user of the MR991 EM device requires it to
operate continuously, it is recommended to use
it with a connected UPS.
Magnetic field
IEC/EN61000-4-8
3A/m
The magnetic field should be that typically found
in a commercial or hospital environment
Conducted Immunity
IEC/EN61000-4-6
3Vrms 150kHz to 80MHz (for appliances
that are not life-supporting)
-
Radiated Immunity
IEC/EN61000-4-3
3Vrms 80kHz to 2.5GHz (for appliances
that are not life-equipment)
-
NOTE: UT is the power supply voltage value
10
10