Globus Genesy 3000 User manual
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DEAR CUSTOMER
THANK YOU FOR CHOOSING A GLOBUS PRODUCT. WE REMAIN AT
YOUR DISPOSAL FOR ANY ASSISTANCE OR ADVICE YOU MAY NEED
DOMINOs.r.l.
Via Vittorio Veneto 52
31013 - Codognè - TV - Italy
Tel. (+39) 0438.7933
Fax. (+39) 0438.793363
www.globuscorporation.com
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Table of contents
TECHNICAL FEATURES ..........................................................................................................6
Device ...............................................................................................................................6
Disposal of the device .....................................................................................................8
Declaration of conformity...............................................................................................8
INTENDED USE .......................................................................................................................8
The risk class of the device is IIb.........................................................................................8
EQUIPMENT ...........................................................................................................................9
LABELLING AND SYMBOLS.................................................................................................11
Panel and keyboard .........................................................................................................15
Display and interface........................................................................................................16
PREPARATION TO THE USE OF THE DEVICE ......................................................................16
Warnings before the use ...............................................................................................17
How to connect the cables..........................................................................................18
Connection of the electrodes......................................................................................18
Battery..............................................................................................................................19
Safety precautions .........................................................................................................19
Contraindications...........................................................................................................20
Side effects......................................................................................................................21
USER GUIDE OF THE DEVICE ..............................................................................................22
For a correct use of the device, proceed as follows:..................................................22
Program List menu..........................................................................................................22
“Last 10” Menu ...............................................................................................................24
“Treatments” Menu........................................................................................................25
“Programming” Menu ...................................................................................................26
Advanced Menu............................................................................................................27
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PROGRAM LIST....................................................................................................................32
GENERAL NOTES ON ELECTRODE POSITIONING .............................................................39
ACTION PRINCIPLES ...........................................................................................................48
Muscular electrostimulation..........................................................................................48
Stimulation intensity........................................................................................................49
MAINTENANCE AND CLEANING.......................................................................................54
Device .............................................................................................................................54
Battery..............................................................................................................................54
Accessories .....................................................................................................................54
WARRANTY..........................................................................................................................56
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TECHNICAL FEATURES
Device
Size: 220x170x60 mm
Weight: 790 g.
Case: ABS
Protection level: IP 20
Use Conditions
Temperature: From 0°C to 35°C
Max. relative humidity: from 15% to 93%
Atmospheric pressure: from 700 hPa to 1060 hPa
Storage and transport conditions
Temperature: From -10°C to 45°C
Max. relative humidity: 30% - 75%
The values represent the limits allowed if the product or the accessories are not in
their original package.
Technical features of EMS and TENS currents:
Channels available: Channels 1-2-3-4
Constant current: Yes
Intensity: 0-120 mA with 1000 Ohms load
Waveform: rectangular, biphasic, symmetrical, compensated
Work frequency: 0.3-150 Hz
Recovery frequency: 0.3-150 Hz
Pulse amplitude: 50-450 µs
Working time: from 1 to 30 seconds
Working time: from 0 to 1 minute
Frequency modulation range: Cont. variation from 1 to 150 Hz
Minimum modulation time: 3 seconds
Period modulation range: Continuous variation from 50 to 450 µs
Microcurrents
Channels available: Channels 1-3
Constant current: Yes
Minimum frequency: 5 Hz
Maximum frequency: 200 Hz
Min. intensity: 0 µA/1000 Ohm Step 10 µA
Max. Intensity: 800 µA/1000 Ohm
Period value: included between 1 and 250 µ seconds
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Interferentials:
Channels available: Channels 1-3
Max. Intensity: - 60 mA
Carrier frequency: 2500 Hz 4000 Hz
10000 Hz
Frequency modulation: 0 - 200 Hz
Type of oscillation: Variable in duration and period
Russ:
Channels available: Channels 13
Max. Intensity: 60 mA
Carrier frequency: 1250 - 2500 Hz
Mod. wave: 6, -12, -25, -100 Hz
Denervated muscles:
Channels available: Channels 1-3
Max. Intensity: 60 mA
Pulses: Triangular 1000 ms,
Rectangular/trapezoidal 500 ms
Ionophoresis:
Available outputs: Channel 1
Constant current: Yes
Min. intensity: 0 mA/1000 Ohm
Max. Intensity: 10 mA/1000 Ohm step 0.1 mA/1000
Ohm
Min. time: 1 minute
Max. time: 99 minutes
Power supply unit:
Brand: GlobTek
model: GTM4160-2512
PRI: 100‐240V 50‐60Hz0.6Amax
SEC: 12V 2.08A
Polarity:
Battery
Battery pack: Ni-MH 7.2V 1 Ah
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Disposal of the device
Do not throw the device or parts of it into the fire; dispose of the product in the
specialized centers and respecting the regulations in force in your Country. When
the product has to be disposed of, the user can give it back to the retailer when
purchasing a new device.
A correct separate waste collection or the compliance with the above-mentioned
prescriptions contribute to avoiding possible negative effects on the environment
and the health and promote the reuse and/or recycle of the materials of which
the device is composed. The illegal disposal of the product entails the application
of administrative fines according to applicable regulations.
Declaration of conformity
The device has been manufactured in compliance with applicable technical
standards and has been certified, in compliance with Directive 93/42/EEC as
amended by directive 2007/47 on medical devices, by the Notified Body Kiwa
Cermet Italia, Via Cadriano 23, 40057 Granarolo Dell’Emilia (BO) Italy (n. 0476), in
order to ensure product safety.
INTENDED USE
The estimated usable life of the product is 5 years. It is advisable to return the
device to the producer and/or authorized center to perform security and
maintenance checks every 2 years. The number of treatments depends on the
battery charge.
The risk class of the device is IIb.
The device is intended for:
- Antalgic electrotherapy through peripheral nervous system stimulation;
- Muscular electrostimulation in order to reduce atrophy, spasticity and to increase
the muscular power.
E3K (Genesy 3000) devices are not intended for domestic purposes and are
designed to be used in the following operating environments:
- clinics;
- physiotherapy centers;
- rehabilitation in general;
- general pain treatments (medical treatments);
The use of the device is permitted to doctors and physiotherapists.
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EQUIPMENT
The electrostimulation device is supplied with all the necessary cables and
electrodes; therefore, when you open the package, check that the basic
equipment is complete. If some elements are missing, contact your authorized
retailer immediately.
A. 4 coloured cables for electrode connection(per for EMS,TENS,DENERVATED,
INTERFERENTIALS, RUSSIAN) and 2 gray cables for electrode connection (for
MICROCURRENTS and IONOPHORESIS treatments)
B. 4 self-adhesive, re-usable electrodes (50 x 50 mm)
C. self-adhesive, re-usable electrodes (50 x 90 mm)
D. Battery charger (see technical features)
E. Unity
F. User Manual
G. Carrying case
H. Ionophoresis kit
Equipment description
REF G0464 - Electrodes Myotrode Plus (50x50 mm). Package with 4 adhesive
electrodes. Electrodes can be used multiple times on the same patient. We
recommend the use of these electrodes for small surfaces such as upper limbs,
calves, cervical area...
REF G0464 - Electrodes Myotrode Plus (50x50 mm). Package with 4 adhesive
electrodes. Electrodes can be used multiple times on the same patient. We
recommend the use of these electrodes for large surfaces such as thighs,
abdomen, gluteus...
AB‐CDEFG
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Accessories that are not included in the equipment (to be purchased separately)
The device can be combined with optionals some accessories(see the technical
features on our websitewww.globuscorporation.comwww.globuscorporation.com
). To purchase these accessories, please contact your dealer.
REF Name Description
G1188 VAGINAL PROBE Probe for the treatment of incontinence and for the
reinforcement of the pelvic floor.
G0757 Anal probe Probe for the treatment of incontinence and for the
reinforcement/relaxation of the pelvic floor.
G1156 Motor point pen It helps finding the best positioning of the electrodes
G1309 G-trode Handpiece Bipolar G-PULSE head
G0479 Kit conductive elastic
bands for thighs
Kit conductive elastic bands for thighs Bands can be used
instead of electrodes, and are recommended for
aesthetic and beauty treatments.
G0480
Kit conductive elastic
bands for thighs and
arms Fitness Top
Kit conductive elastic bands for thighs and arms Bands
can be used instead of electrodes, and are
recommended for aesthetic and beauty treatments.
G0487 Fast Band Abdominal band for treatment on abdomen, gluteus and
back - 98 cm
G0489 Fast Pad Special reusable electrodes, specifically suitable for
aesthetic treatments on thighs and gluteus.
G0890 Medium ionophoresis
electrode Carbon electrode + pouch 50x50 mm
G0885 Big ionophoresis
electrode Carbon electrode + pouch 60x85 mm
G0488 Fast body kit fast band + fast pad
G0439 Kit 2 splitting cables This accessory is used to split the cables in order to use
more electrodes at the same time.
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LABELLING AND SYMBOLS
It refers to the manufacturer
Warning
The device emits current values over 10 mA or10V
Keep the device dry
This symbol indicates that the device complies with the
directives on medical devices (93/42/EEC 47/2007/EEC).
The number of the notified body is 0476.
It indicates that this is a class II device.
It indicates that this device has BF-type applied parts.
WEEE symbol (Waste of Electrical and Electronic
Equipment). Recycling symbol.
The WEEE symbol used for this product indicates that it
cannot be treated as a household waste. The proper
disposal of the product will contribute to protecting the
environment. For further information on the recycling of
this product, please contact the concerned office of
your local body, the household waste management
company or the store where the product was
purchased.
Itindicatesthattheproducthasbeendesignedincompliancewiththe
directive 2011/65/EEC
It informs the operator that s/he must read the manual
before using the device.
It informs the client of the compulsory conduct
It indicates the ideal temperature for the storage and
transportation of the product.
IP20 It indicates water protection
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Model Indicates the battery charger model
PRI Input electric features of the battery charger
SEC Output electric features of the power supply
Nerve and Muscle
stimulator It indicates the device type
Input power Input electric features of the device for battery
charging
Input battery Features of the electric power supply from internal
battery
Output Output, indicates the maximum value of current
emitted by the device
SN It indicates the serial number of the device.
Internal battery Indicates the features of the battery pack inside the
device
It refers to the expiry date of the product
It refers to the production lot
It refers to the manufacturing date.
It indicates the pressure of the environment in which the
device and the accessories are transported and stored.
It indicates the humidity of the environment where the
device and its accessories are used and stored
RH It indicates the percentage of storage humidity
Symbol for polythene
Device
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GLOBTEK
Model: GTM91099-6024-6.0-T2
PRI: 100-240V 50-60Hz 1.5A max
SEC: 18V 3.33A
Nerve and Muscle stimulator: GENESY 3000
Input power: 18V 1.65A IP20
Battery power: 12V 1.58A
Output: 120mA (1000Ω)
SN: E3KR381900001
Internal battery: 12V NiMH 2000mAh
*TYPEWWYYXXXXX
*
Accessories
Electrodes
Clean and degrease the skin.
Do not apply the electrode on wounds or injured skin.
Connect the cable connector to the electrode connector.
Remove the electrode.
It indicates the dimensions of the electrode
It indicates the number of electrodes contained in the package
It indicates the product code
It refers to product certification and indicates that it complies
with directive 2001/95/EC updated as 2014/357/EU
It indicates the storage temperature of the electrodes
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Apply on the skin.
Start the program.
At the end, turn off and put the electrode back in the package.
Electrodes are for personal use.
Do not remove the electrode by grabbing the connector.
Electrodes should not touch each other.
Do not apply the electrodes on the temples, the neck and in a transthoracic way.
Do not leave the electrodes in the car.
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Panel and keyboard
NOTE: when the 3" message appears, it means that by holding the button down for
3 seconds the function is activated.
ON/OFF/OK
BUTTON
It confirms the selection. It pauses the running program.
3” = Turn On/Off
LEFT/BACK Button To scroll the selection left.
To go back to the previous selection.
3” = It returns to the previous phase while the program is
running.
P+ Button It moves the selection upwards.
It increases the intensity of the 4 channels simultaneously,
while a program is running
P- Button It moves the selection downwards.
It increases the intensity of the 4 channels simultaneously,
while a program is running
RIGHT/USER button: It moves the selection to the right.
3” = It moves to the next phase, while a program is running
* Button It starts and stops the contraction while "Action Now"
programs are running (where "Action Now" programs are
included).
Increase/decrease
intensitybutton
Function
Back/Left
P‐Button
ON/OFF/OKBUTTON
Right/User
P+Button
*Button
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Fn (Runtime) button If pressed together with other buttons, it permits the user to
modify their function. Moreover, it selects Runtime mode
(editing time, frequency and amplitude)
Intensity button It increases/decreases the stimulation intensity of the
corresponding channel.
Display and interface
-On/off indicator
-PAUSE indicator (during the treatment)
-General error indicator. If the led turns on, check the connections
between the cables and the electrodes. If the light is still on,
contact the customer care.
CH1-4 - Active channel indicator
PREPARATION TO THE USE OF THE DEVICE
Name of the program
Time indicators
Battery level
indicator
Rest or work time
Stimulation
intensity
Current type,
number of phases
and running
phase
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For maximum safety, the device must be used following the rules and the
limitations of the user manual.
The manufacturer declines all responsibility with reference to a different use from
what is indicated in this manual.
The full or partial reproduction in any form and by any electronic or mechanical
means of the texts and/or pictures contained in this manual without the written
authorization of the manufacturer is forbidden.
Treatments should not be performed on skin lesions.
If the package, the cable or the connector of the power supply show signs of
wear or damage, replace it instantly.
The device should be connected to the mains by its power supply. Before starting
the treatment, make sure that the power system specifications comply with the
directives in force in your country. Make sure that the power supply will be easily
unplugged.
The use of muscle stimulation programs referred to the treatment of urinary
incontinence can be used exclusively for the treatment of urge, stress and mixed
incontinence.
Warnings before the use
Do not use this device simultaneously with other electronic devices, especially if
they maintain vital functions. Incaseitisnecessarytousethedevicenearbyoronotherdevices,
makesureitworksproperly,pleaserefertothechapterEMCaccompanyingdocuments.
- It is recommended to read carefully the entire operating manual before using the
unit; keep carefully this operating manual.
- The device is capable of delivering current values exceeding 10mArms.
- Before each use always check the integrity of the device. This is a fundamental
requirement for carrying out the therapy; do not use the device if the buttons or
the cables are defective or malfunctioning.
- It should not be used for purposes other than transcutaneous neurostimulation.
- The device must be used with the transcutaneous neurostimulation electrodes
suitable for this use.
- The device must be kept out of the reach of children.
- With its current, it can disturb ECG monitoring devices.
- It must not be used in a transthoracic mode as it could cause cardiac arrhythmia
by superimposing its frequency to that of the heart. (Do not perform the treatment
on the chest and the back simultaneously)
- A simultaneous connection of a patient to a high frequency electrosurgical
device can cause burns near the electrodes of the stimulator and therefore the
stimulator may be damaged.
- Once you have turned the device on, make sure the display shows the software
version and the device model: it means that the device is working and ready to
be used;
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If it doesn't, or the display does not show all the segments, turn it off and on again.
If the problem persists, contact the service center and do not use the device.
- The sudden shutdown shortly after the starting indicates a low battery level.
Recharge as reported in the section "HOW TO CHARGE THE BATTERIES".
How to connect the cables
In order to connect the cables to the device, plug the connectors into the
intended inlets on the top of the unit (see picture). Cables should be inserted with
grooves downwards. The inlets are placed exactly under the corresponding
channels.
NOTE: for EMS and TENS currents use indifferently the 4 channels with
colored cables.
NOTE: for Microcurrent programs use only channels 1 and 3 with
gray cables.
NOTE: For programs with currents for DENERVATED muscles (rectangular,
and trapezoidal currents), use only channels 1 and 3 with colored cables.
NOTE: for programs with interferential currents use only
channels 1 and 3 with colored cables.
NOTE: for programs with ionophoresis currents use only channel
1 with gray cables.
Connection of the electrodes
Take the electrodes from the original packaging; all new electrodes have a sealed
packaging. Ensure that the device is off. To start, connect the two plugs of the
cables to the electrodes, then remove the electrodes from their place and put
them on the skin. To place the electrodes correctly, see the images at the end of
this manual.
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After the use, place the electrodes back in their specific place.
WARNING: do not unplug the electrodes if the device is operating.
Battery
The device works both connected to the mains and with the use of rechargeable
batteries.
The device is supplied with a set of rechargeable nickel-metal hydrate batteries
(12V, 2Ah) with high performances and no memory effect.
The battery has an estimated life of 6 months in case it is not used. The number of
cycles (discharge and recharge) depend on the type of stimulation and on the
frequency treatments are executed. The device is supplied with charge indicator;
it is advisable to recharge when it indicates ¼. In case after recharge the number
of executable treatments is reduced, the battery must be replaced.
How to charge the batteries
Turn the electrostimulator off and disconnect the electrodes, then connect the
elctrostimulator to the power supply by inserting the plug in the appropriate inlet
(see picture above). Do not use a power supply different from the one provided
with the device. Contact an authorized service center to replace the set of
batteries.
Safety precautions
While using the electrosimulator, some warnings should be followed:
- In the case of damaged cables, they must be replaced with original parts and
not used anymore.
- Only use Globus marked electrodes.
- Great attention has to be paid when current densities exceed 2mA/cm²
(effective value) for each electrode.
The device must be kept out of the reach of pets, as they could damage the
device and contaminate the electrodes and other accessories with parasites.
- The cables of the electrostimulator should not be wrapped around people's neck
to avoid any risk of strangulation and suffocation.
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- Keep out of the reach of children who may accidentally swallow small
detachable parts of the device (for example the support feet).
‐Mobileandfixedradiocommunicationdevicesmightaffectthefunctioningoftheelectromedicaldevice:
seethetablesattachedtothismanual.PleaserefertothechapterEMCaccompanyingdocuments.
Contraindications
The device should not be used in the following cases:
--Stimulation of the urogenital apparatus, in case of extra-ureteral incontinence;
--Stimulation of the urogenital apparatus, in case of incontinence due to
evacuation disorders;
--Stimulation of the urogenital apparatus, in case of chronic urinary retention, in
the upper urinary tract
--Stimulation of the pelvic floor in presence of a complete peripheral
denervation;
--In case of actual or alleged tumour formation, consult the oncologist
--Pains with unknown etiology.
--Stimulation on areas with sores and dermatological diseases.
--Stimulation on areas with acute traumas
--Pregnancy;
--Presence of severe cognitive deficiencies that do not permit the patient to
communicate or perceive pain or discomfort;
--People whose sensitivity to heath and/or pain is diminished due to surgery
interventions, anesthesia, ionizing radiations treatments, diabetes, etc.;
--Presence of severe pathologies on main organs
--Presence of neurological diseases.
-Do not use the device on the following parts pf the body:
--Eyes zone;
-Stimulation of the anterior neck (carotid sinus).
--Brain region
-- Near body areas with metallic implants or infra-tissue metals (e.g. prostheses,
osteosynthetic devices, coils, screws, plates), when using monophasic currents
such as interferential and continuous currents (ionophoresis).
--In presence of pacemaker and active implantable medical devices.
-Patients suffering from a total/subtotal prolapsed uterus/vagina must be
evaluated by a doctor and stimulated with extreme caution.
Patients with urinary tract infections should be treated for these symptoms before
starting use the electrostimulator.
It is also recommended to use the device with caution in case of capillary fragility,
as excessive stimulation may cause a further break of capillaries.
For those programs that consist in anal or vaginal stimulation, in addition to the
general warnings, the following contraindications have to be considered:
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