Globus Elite User manual

Rev.02.15

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Rev.10.15

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Rev.10.15
DEAR CUSTOMER
THANK YOU FOR CHOOSING A GLOBUS PRODUCT. WE REMAIN AT YOUR
ENTIRE DISPOSAL FOR ANY ASSISTENCE OR ADVICE YOU MAY NEED
The electrostimulators A1R (Elite) are manufactured by:
SAVIA L.t.d. - 4nd Industrial District, Feng Huang
Village (Shenzen) - Made in PRC - [email protected]
and distributed by:
DOMINO s.r.l.
via Vittorio Veneto 52
31013 - Codognè - TV - Italy
Tel. [phone]
Fax. [phone]
E-Mail: [e-mail]
www.globuscorporation.com
This product has been manufactured according to the technical regulations in
force and is certified according to Directive 93/42/EEC updated by 2007/47
directive for medical devices, by Notified Body n. 0197.
ELITE

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Rev.10.15
Table of contents
Device ............................................................................................................................................................ 6
Conditions of use......................................................................................................................................... 6
Technical features of the currents.......................................................................................................... 6
EQUIPMENT.......................................................................................................................................................... 7
INTENDED USE...................................................................................................................................................... 8
CONNECTIONS ...................................................................................................................................................... 9
How to connect the cables ..................................................................................................................... 9
Electrode application ................................................................................................................................ 9
Battery: how to charge the batteries.................................................................................................. 10
LABELLING AND SYMBOLS..................................................................................................................................11
Device .......................................................................................................................................................... 12
PANEL AND KEYBOARD....................................................................................................................................... 14
Display and interface............................................................................................................................... 15
ALARMS .............................................................................................................................................................. 15
Compliance................................................................................................................................................ 15
WARNINGS AND CONTRAINDICATIONS ............................................................................................................. 16
Mandatory behavior ................................................................................................................................ 16
Warnings before use................................................................................................................................. 16
Warnings during use ................................................................................................................................. 17
Side effects.................................................................................................................................................. 18
Contraindications...................................................................................................................................... 18
MAINTENANCE AND CLEANING......................................................................................................................... 19
Device .......................................................................................................................................................... 19
Battery .......................................................................................................................................................... 19
Accessories ................................................................................................................................................. 20
Disposal of the device ............................................................................................................................. 20
INSTRUCTIONS FOR USE ..................................................................................................................................... 21

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Rev.10.15
“Program List” menu................................................................................................................................. 21
“Last 10” menu........................................................................................................................................... 23
ACTION PRINCIPLES ............................................................................................................................................ 25
Muscular electrostimulation ................................................................................................................... 25
Stimulation intensity .................................................................................................................................. 26
Tens........................................................................................................................................................ 27
PROGRAM LIST................................................................................................................................................ 29
WARRANTY ......................................................................................................................................................... 37

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Rev.10.15
TECHNICAL FEATURES
Device
Size: 160x99x35.4 mm
Weight: 404 g
Case: in Food Grade ABS
Protection level: IP 22
Storage and transportation temperature: from -10°C to 45°C
Max. relative humidity: 30% - 75%
The values indicate the allowable limits if the product or its accessories are not in the
original package.
Conditions of use
Temperature: from 0°C to 35°C
Max. relative humidity: from 15% to 93%
Atmospheric pressure: from 700 hPa to 1060 hPa
Technical features of the currents
EMS and TENS:
compensated
Working frequency: 0.3-150 Hz
Recovery frequency: 0.3-150 Hz
Pulse amplitude: 50-450 µs
Working time: from 1 to 30 seconds
Recovery time: from 0 to 1 minute
Frequency mod. range: continuous variation from 1 to 150 Hz
Min. modulation time: 3 seconds
Amplitude modulation range: continuous variation from 50 to
450 µseconds
Charger
Brand: FLO
model: DKT-088-0200-EU
Input: 100-240V~ 50-60Hz 0, 2A
Output: 8,8 Vd.c. 0.2A
Polarity:
Channels available: Channels 1-2-3-4
Constant current: Yes
Intensity: 0-100 mA with 1000 Ohm load
Wave form: Rectangular, biphasic, symmetrical,

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Rev.10.15
Battery
Battery pack: Ni-MH 7,2 V 1,8 Ah
EQUIPMENT
The electrostimulator is supplied complete of cables and electrodes: therefore,
please check that the package contains the complete equipment. If some
elements are not contained in the package, please contact immediately the
authorized retailer where you purchased the product.
Control the integrity of the device and its electrodes carefully.
A. 4 colored electrode connection cables (for EMS and TENS treatments)
B. A bag containing 4 reusable self-adhesive electrodes (50 x 50 mm)
(for small areas such as upper limbs, calves, cervical area…)
C. A bag containing 4 reusable self-adhesive electrodes (50 x 90 mm)
(for large areas such as thighs, abdomen and gluteal muscles...)
D. Charger (See technical features)
E. A1R Unit
F. User manual
Warranty
G. Carrying bag
All the supplied information can be modified without prior notice.
The device can be used with some optional accessories (for further info, visit the
website www.globuscorporation.com ).
If you are interested in buying these accessories, please contact the retailer.
Accessories not included (available on charge)
- Motor point pen
- Kit of 8 elastic bands for legs and thighs
A B-C D E F G

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Rev.10.15
- Kit of 4 elastic bands for thighs
- Face electrodes
- Kit Y cables
INTENDED USE
The service life of the product is estimated at 5 years. It is advisable to return the
product for maintenance and security checks every two years. The number of
treatments depends on the battery charge. The duration of the battery is 6 months;
thereafter its replacement is recommended.
The electrostimulators are intended for use in the following operating environments:
- domestic environment;
- clinics;
- physiotherapy centers;
- rehabilitation centers;
- general pain treatments;
- beauty and sport purposes;
The device can be used by patients (appropriately informed about the conditions
of use) and the medical staff only.

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Rev.10.15
CONNECTIONS
Cable connection outlets and power supply
Attention:
If the package, the cable or the connector of the charger show signs of wear or
damage, replace them instantly.
How to connect the cables
Plug the connectors in the slots in the upper part of the unit to connect the diffusers
to the device (see pic.). When plugging in the cable, the grooves of the cable have
to be oriented downwards. The inlets are placed exactly under the corresponding
channels.
ATTENTION: the images are for illustrative purposes only to show the correct insertion
of the connectors into the appropriate slots. It is recommended to unplug the
connectors grabbing the final part with the grooves and not pulling them taking the
cable in the middle.
NOTE: For EMS and TENS currents, the 4 channels with colored cables can be used
indifferently.
Electrode application
Remove the electrodes from the original package; all new electrodes have a seal
on the package. Ensure that the device is off. First, connect the two cable plugs to
the electrodes, then disconnect the electrodes from their position and apply them
on the skin. See the pictures included in this manual to place the electrodes
correctly.
After use, place the electrodes in their original position again.

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Rev.10.15
ATTENTION: Do not unplug the electrodes if the unit is working.
Battery: how to charge the batteries
The device is supplied with a set of rechargeable nickel-metal hydrate batteries
(7.2V, 1.5Ah).
Recharge the batteries when the battery indicator on the display indicates ¼.
To charge the batteries, turn off the electrostimulator and disconnect the
electrodes, then connect the electrostimulator to the charger provided by plugging
it in the appropriate inlet (see picture above).
Use the charger contained in the package only. Contact the authorized service
center to replace the batteries.

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Rev.10.15
LABELLING AND SYMBOLS
It refers to the manufacturer
Warning
This symbol on your device indicates that it complies with
the directives on medical devices (93/42/EEC
47/2007/EEC.
It indicates that this is a II class device.
It indicates that this device has type BF parts.
WEEE symbol (Waste of Electrical and Electronic
Equipment). Recycling symbol. The WEEE symbol used for
this product indicates that the device may not be
disposed of as a household product. Properly dispose of
the product to help protect the environment. For more
information on recycling this product, contact the local
competent department, the household waste
management company or the store in which the
product was purchased.
It indicates that the product has been produced
respecting the directive 2011/65/EEC.
It indicates the optimal temperatures for the storage and
transportation of the product.
It informs the operator that before using the device he
must read the manual.
IP22
It indicates the water protection degree
It informs the operator of a compulsory conduct
It refers to the pressure of the storage and transport
environment where the device and its accessories are
used

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Rev.10.15
It refers to the humidity of the storage and transport
environment where the device and its accessories are
used.
Output Power
It indicates the output power of the device
Input
Input: it indicates the value of the mains voltage for the
power supply unit
Output
Output:
- it indicates the power supply unit outbound voltage
- it indicates the maximum power value of the magnetic
field emitted by the device
- it indicates the range of frequencies of the magnetic
field emitted by the device"
Type
It indicates the device type
Power
It indicates the power supply unit model of the device
Battery
It indicates the battery pack inside the device
It refers to the expiry date
It refers to the production lot
It refers to the manufacturing date
Polythene symbol
Device

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Rev.10.15
Electrodes
The supplied electrodes can be used on a single patient. They are self-adhesive,
reusable and pregelled. The electrode cable is female. The electrodes are labeled
"CE" in compliance with Directive 93/42/EEC for medical devices. All the supplied
information can be modified without prior notice.

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Rev.10.15
PANEL AND KEYBOARD
Keyboard
NOTE: When the 3” message appears, it means that pressing the button for 3
seconds the function is activated.
ON/OFF/OK Button
It confirms the selection. While a program is running, it
activates the pause.
3” = ON/OFF.
Left/BACK Button
It moves the selection to the left.
It returns to the previous selection.
3” = While a program is running, it returns to the previous
phase.
P+ Button
It moves the selection upwards.
While a program is running, it increases the intensity of the
4 channels simultaneously.
P- Button
It moves the selection downwards.
While a program is running, it decreases the intensity of
the 4 channels simultaneously.
Right/USER Button
It moves the selection to the right.
3” = While a program is running, it moves to the next
phase.
Increase/Decrease intensity button
Function button
Left/Back button
P- button
ON/OFF/OK button
Right/User button
P+ button
*button

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Rev.10.15
* Button
Service button disabled.
fn button
If pressed together with other buttons, it modifies their
function; if pressed singularly during the stimulation, it
permits the access to the Runtime function (to modify time,
frequency and amplitude).
Intensity button
It increases/decreases the stimulation intensity of the
corresponding channel.
Display and interface
ALARMS
Compliance
Certifications: CE MDD certificate.
The sound and acoustic signals are in compliance with directive 60601-1-8.
Meaning of the “Electrode error” alarm
If one or more cables are not connected to the mains, the message "Electrode
error" will appear on the display.
Program name
Time indicators
Battery indicator
Time of the work
phase and of the
rest phase
Stimulation
intensity
Type of currents
and indicator of
the phase
number and of
the phase in
progress

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Rev.10.15
WARNINGS AND CONTRAINDICATIONS
Mandatory behavior
For safety reasons, the device must be used exclusively as indicated in the present
manual.
Do not perform the treatment in case of skin lesions.
If the package, the cable or the charger connector show signs of wear or damage,
replace them instantly.
The unit has to be connected to the mains by its power supply unit. Before starting
the treatment, ensure that the building wires comply with the directives in force in
your country. Ensure that the power supply unit is in a comfortable position and can
be easily unplugged.
The producer declines all responsibility related to any misuse or mishandling of the
device.
Electronic or manual reproduction of part or all of the contents of the present
manual is strictly forbidden without producer's prior permission.
Warnings before use
Do not use Elite combined with other electronic devices, especially if they maintain
vital functions. Read the tables at the end of the present manual for a correct use
of Elite. If the device is used nearby or on other electromedical equipment, ensure
that Elite works properly.
- Read the present manual carefully before using the device. Keep the present
manual in a safe place;
- The current emitted by the device is higher than 10mArms.
- Checking the integrity of the device before each use is a fundamental
requirement to perform the therapy correctly. The device must not be used if the
buttons or cables are defective or malfunctioning.
The device:
- has to be used for neuromuscular stimulation only and as described in this manual;
- has to be used for transcutaneous neuromuscular stimulation only.
- has to be used according to the indications in the present manual and under the
physician’s or physiotherapist’s supervision;
- has to be used with the electrodes included in the package and specifically
intended for transcutaneous neuromuscular stimulation;
- has to be kept out of the reach of children;
- ECG monitoring devices may not operate properly when electrostimulation is
working.
- has not to be used in transthoracic modality because it may cause cardiac
arrhythmia, interfering with the heart frequency. Do not stimulate the pectoral and
dorsal muscles simultaneously;
- in case of health problems, consult the doctor before use;

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Rev.10.15
- the simultaneous use of high-frequency electrosurgery device may sear the skin
near the electrodes and damage the electrostimulator;
- Check whether the software version and the device model appear during start-
up, which means that the device is working correctly.
Otherwise, if all the segments do not appear on the monitor, shut down the device
and restart it. If the problem persists, contact the customer care and do not use the
device.
- If the device switches off unexpectedly, the battery is likely to be out of charge
and has to be recharged according to the instructions in the section HOW TO
CHARGE THE BATTERIES.
Warnings during use
While using the electrostimulator, please comply with the following indications:
- damaged cables have to be replaced with original, brand-new parts;
- use only Globus electrodes;
- pay particular attention when the current density for every electrode is above
2mA/cm2(effective value);
- keep the device out of the reach of any pet which could damage it and
contaminate the electrodes and its accessories with parasites;
- the cables must never be wound up around the neck, since it may lead to
strangulation and suffocation;
- mobile and fixed radio-communication devices may affect the functioning of Elite;
read the tables in the present manual for more info.
Preventative measures for incontinence treatments.
- Do not use the device on patients with extra-urethral incontinence.
- Do not use the device on patients suffering from excessive incontinence owing to
evacuation disorders.
- Do not use the device on patients with severe urinary retention to the upper
urinary passages.
- Do not use the device on patients with total peripheral denervation of the pelvic
floor.
- Patients suffering from a total/subtotal prolapse of the uterus/vagina have to be
stimulated with extreme care.
- Patients with infections to the urinary passages should be treated for these
symptoms first, before starting the stimulation treatment.
- Before removing or touching the probe, it is necessary to turn off the stimulator or
to regulate the intensity of both channels to 0.0 mA.
- Since the treatment is a personalized medical prescription, do not lend the
stimulator to non-authorized persons.

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Rev.10.15
Side effects
Isolated cases of skin irritation may occur in patients with particularly sensitive skin.
In case of an allergic reaction to the electrode gel, suspend the treatment and
contact a specialist.
If during the treatment signs of tachycardia and extrasystole appear, suspend the
treatment and contact your physician.
Contraindications
Do not use the device in the following cases:
- Stimulation of the front neck (carotid sinus);
- Pacemaker wearers;
- Patients with tumor diseases (see your oncologist);
- Stimulation of the brain region;
- Pains whose etiology is unknown;
- Ulcers and dermatological disorders;
- Severe traumas.
- Stimulation on recent scars.
- Pregnancy.
- It is strictly forbidden to use the electrostimulator on the ocular area.
- Near body areas with osteosynthesis implants (prostheses, coils, screws, orthopedic
plates), when using monophasic current, interferential or continuous current and
ionophoresis.
It is recommended to use the device carefully on people presenting with capillary
fragility, as an excessive stimulation could cause capillary rupture.

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MAINTENANCE AND CLEANING
Device
- In case of malfunctioning, do not open or tamper with the device nor try to repair
it by yourself.
- Only specialized and authorized centers can repair the device.
- Avoid violent impacts that may damage the device and cause its malfunctioning
(even if not immediately detectable).
- Use the device in a dry and open environment. Do not wrap the device.
- Clean the device and accessories only with disinfectant with sodium hypochlorite
or quaternary ammonium salt diluted with distilled water (percentage 0.2-0.3%).
After cleaning/disinfecting it, dry the device and its accessories with a clean cloth.
- It is recommended to clean/disinfect the parts after every use, unless otherwise
indicated.
- Always use the device and its accessories with clean hands.
- It is recommended to use the device in a clean room, to avoid contamination with
dust and dirt.
- It is recommended to use the device in a well-ventilated space.
Battery
Battery info
A specific menu allows the user to visualize the charge and the state of the battery.
It is recommended to access the menu only if the batteries are completely
charged.
From the main menu select "Setup" and then "Battery info".
Six codes will be visualized:
COD1 = 0 expected voltage threshold reached.
COD1 = 1 max. charge time reached.
COD2 = value of the battery voltage at the beginning of the charge.
COD3 = value of the battery voltage at the end of the charge.
COD4 = charge duration (from 1 to 840 minutes, ideal time 720 minutes).
COD5 = duration of the charger/power supply connection.
COD6 = voltage of the battery pack.
According to the above-mentioned values, it is advisable to replace the battery
when COD1 = 1 and COD3 < 7,4 volts, or when COD3-COD2 >= 2 volts and COD4
<600, or, again, when COD6 is lower than 5,8 volts.
Furthermore, it is recommended to replace the battery pack after 3 months of
inactivity. After that period, batteries generally lose their charging capacity, which
may render the recharge dangerous.

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Rev.10.15
Accessories
Use and storage of the electrodes and the cables.
Worn-out cables or electrodes have to be replaced with brand-new parts.
Skin has to be cleaned accurately before applying the electrodes.
After using the multi-purpose or single-use, single-patient electrodes, they have to
be placed in their plastic film and stored in the plastic bag.
Avoid that the electrodes touch each other or lay one over the other.
Once the package has been opened, the electrodes can be used for 25-30
applications.
The electrodes have to be always used with clean hands and replaced if they do
not adhere to the skin.
If not using self-adhesive electrodes, it is advisable to clean the surface with proper
cleansers that respect the requirements described in the manual.
The electrodes have to be stored in their bag and in an environment that respects
the requirements described in the manual.
After the end of a treatment, unplug the cables from the connectors and clean
them carefully with proper cleansers that respect the requirements described in the
manual.
After cleaning and drying the electrodes, they must be folded up and placed in the
plastic bags supplied with the cables.
Disposal of the device
Do not burn the device or part of it, but dispose of the product in the specialized
centers and respecting the directives in force in your country.
When the product has to be disposed, the user can return it to the retailer when
purchasing a new unit.
Following the previous indications and correct separate waste collection
contribute to avoiding possible negative effects on the environment and health
and promote the reuse and/or recycle of materials which the device is
composed of. The illegal disposal of the product entails the application of an
administrative fine according to the current regulations.