Medical Quant Handy Cure S' User manual

User Manual

Introduction
Introduction…………………………………………………………………2
Technical Information ………………………………………………………3
Operating Instructions ……………………………………………………4
Guidance for treatment with Handy Cure s’ ………………………………5
Method of treatment ………………………………………………………5
Treatment Area ……………………………………………………………6
Laser Safety precautions…………………………………………………….7
General Safety…………………………………………………………….…8
Care and Cleaning …………………………………………………………8
Packing List …………………………………………………………………8
Troubleshooting ……………………………………………………………9
Declarations…………………………………………………………………9
Warnings …………………………………………………………………13
FAQ ………………………………………………………………………13
Warranty…………………………………………………………………14
Symbols………………………………………………………………15
Handy Cure S’ is a low-level laser therapy (LLLT) home use device which
combines low-level pulse laser radiation, pulsating infrared radiation,
visible red light, and static magnetic fields. Together these radiances
provide synergistic therapeutic effects. Incorporating all these radiances in
one device has proven to achieve rapid and efficient clinical effects within
a relatively short time.
The Handy Cure S’ is an Over-The-Counter hand-held device heating
lamps intended for pain management with applications that include
temporary relief of minor muscle and joint pain, arthritis and muscle
spasm, relieving stiffness, promoting relaxation of muscle tissue, and to
temporarily increase local blood circulation where heat is indicated.
Handy Cure S’ is particularly effective in situations where cell tissue has
become inflamed. Cell tissue inflammation is caused from reduced
micro-circulation. The reduction changes the quantity of blood supply to
the cells, resulting in ischemic injury. By reducing the ischemic period,
Handy Cure S’ reduces the disease duration and accompanying pain.
Handy Cure S’ speeds up recovery and relief when used alone or together
with other medical therapeutic modalities. It reduces the need for
analgesic and anti-inflammatory medication. Treatment with Handy Cure
S’ accelerates inflamed tissue recovery, generates cells renewal and
improves micro-circulation
2
Table of Contents

Average power: Total radiation: 60-90 mW
Laser radiation: 0.4-6.25 mW
Infrared radiation: 30-90 mW
Red LEDs: 2-10 mW
Permanent magnet induction: 25-45 mT
Wavelength of: Laser radiation: 905nm
Infrared radiation: 875 nm
Red radiation: 635 nm
Maximum pulsating laser power: 25W
Class II equipment, Applied Part type BF
Laser class I (IEC 60825-1)
Supply ratings: 5 VDC, Max 1.8A
AC/DC battery charger-in: 100-240Vac, 50-60 Hz.
ENG
3
Technical Information
• Non-invasive treatment
• Safe to use
• Painless
• Easy to use
• No side effects
• Compact

4
Operating Instructions
*Important: Handy Cure S’ is programmed to run a self-test every 8 hours.
1. Press the Start/Stop button to power the device. Handy Cure S’ will run a
self-test* (3 lights will blink).When 2 lights will turn green Handy Cure S’
is ready for use.
2. Press the Mode button to select treatment program as indicated in the
guidelines.
3. Press the Start/Stop button to begin treatment. The treatment light will
begin to blink. Hold the device over the area being treated for the
duration of the treatment.
4. In conclusion of the treatment, the treatment light will stop blinking and
a short beep will be heard.
Press the Start/Stop button to repeat the treatment.
It is possible to stop a treatment at any time by pressing the Start/Stop
button.
5. Turn of Handy Cure S’ by pressing on the Start/Stop button for 3 seconds.
Variable
Start/Stop Button
50 Hz
5 Hz
Mode Button
Battery Light
Treatment
Light

The user can choose between 3 programs which have been pre-set to treat
different pain conditions.
A program is selected by pushing the mode button.
Each program uses different pulse frequencies, as displayed in the table
below. Pulse frequencies
variations alter the laser light's depth of penetration.
• The treatment series spans across 3 weeks (21 days)
• During the first week, treatment needs to proceed with the variable
program. The treatment will continue with the 5Hz/50 Hz program
based on the table on page 6
• For chronic pains, it is recommended to perform the treatment twice a
day during the first week of treatment
• Pain relief is experienced after two weeks. In severe cases, more
treatment may be needed for pain relief
• After completing a treatment series (21 days), another series can be
taken following a 3-day break
• Treatment can be terminated as soon as you experience relief. Even so, it
is recommended to complete a full series
Program Variable 50 Hz 5 Hz
Treatment Initial treatment Acute pain Chronic pain
Pulse frequency 1000-2500 Hz 50 Hz 5 Hz
Program duration 5 minutes 5 minutes 5 minutes
Laser Depth
5
Guidance for treatment with Handy Cure s’
Method of treatment

6
14
3
9
12
2
11
4
8
6
10
13
7
5
1
• Where possible, treatment should be
provided over bare skin.
• During treatment, the device should be
held in a hovering state over the area
where the pain is felt.
• If the treatment area is wider, the device
should be moved (scanned) around the
treatment area.
• If required, treatment can be provided
over clothing or over wound dressing.
Treatment area and number of treatments
Program
week 1
Program
weeks 2 and 3
1Achilles’ tendon - 2 scanning sessions
Ankle - 2 sessions, front and back
Elbow joint (Tennis Elbow; Golf Elbow) -
2 sessions, front and back
Fingers (Non-deforming arthritis;
post-traumatic processes) - 2 sessions, front and back
Foot, toes - 3 sessions, both sides of ankle and scanning top of foot
Heel (Calcaneal spur) - 2 sessions, back of ankle and under heel
Lower Back Pain (disci intervertebrales problems, Ischialgia) -
2 sessions scanning lower back, 1 session scanning back of thigh
Migraines, headaches - 2 sessions scanning back of neck
Shin - 2 scanning sessions
Spine
(Vertebral Column Osteochondrosis) - 4 sessions scanning affected area
Wrist (Writing Syndrome, Radiocarpal Articulation)-2 sessions, front and back
Knee - 4 sessions around knee
Hip joint - 4 scanning sessions
Shoulder
– 2 sessions scanning front and 2 sessions scanning back of shoulder
Arthritis, ligament or tendon injury, cartilage abrasion – treatment in the pain area as indicated in the table.
For chronic pains, including; muscle, tendon pain and other injuries not mentioned in the above table,
we recommend performing 2 treatment sessions with the Variable program for two weeks or until you
experience relief.
Variable 50 Hz
2Variable 50 Hz
3Variable 50 Hz
4Variable 50 Hz
5Variable 50 Hz
6Variable 50 Hz
7Variable 50 Hz
8Variable 50 Hz
9Variable 50 Hz
10 Variable 50 Hz
11 Variable 50 Hz
12 Variable 50 Hz
13 Variable 5 Hz
14
*
*
Variable 5 Hz
Treatment Area

1. Laser beam parameters:
The product contains a class 3B near IR laser having following beam
specifications.
Wavelength - 905 nm
Pulse energy - 3 µW
Pulse width - 100 ns
Average power - Max 15 mW
Beam Diameter - 1.3x3.1 mm
Beam divergence - > 100 mR
2. Laser Hazard Class: The emerging laser beam from the product is
assigned Class 1.
3. Compliance Statement: The product is designed and built to comply
with the EN/IEC 60825-1: 2007-03, and with CDRH Title 21 CFR 1040.10
requirements as a Class 1 laser product. Class 1 laser beam is safe
during use, including long-term direct intrabeam viewing, even when
exposure occurs while using optical viewing instruments.
4. Implemented Safety Means: The product includes the following
safety means required by the laser safety standards:
4.1 Protective housing: The product is built with protective housing that
prevents laser exposure in excess of class 1 level.
4.2 Marking Plate: The product carries a marking plate containing the
required information of the product.
4.3 Warning label: The product carries a warning label for non-inter-
locked panel.
ENG
CAUTION
CLASS 3B Invisible Radiation
When Open
AVOID Exposure the Beam
7
Laser Safety precautions

We strongly recommend you use the device in strict compliance with the safety
pre-cautions and operating instructions in this manual.
Handy Cure S’ should be maintained and serviced by Medical Quant Limited
personnel or other qualified personnel approved in writing by Medical Quant
Limited.
Please review the manual before initial use. It is important to keep this manual
handy.
• Direct or reflected laser radiation should be prevented from direct eye
contact
• Pregnant women should not apply the device in the vicinity of the
womb
• Do not use Handy Cure S’ in the vicinity of a pacemaker
• Treatment is not recommended in cancer cases
• Keep the Handy Cure S’ away from children
• Children under the age of 18 should be treated under the supervision of
an adult
It is possible to clean the Handy Cure S’ with a moistened cloth.
Do not expose Handy Cure S’ to extreme temperatures, humidity or direct
sunlight.
Store the device at room temperature.
Product/Accessory
Handy Cure S’ device
Charger
Device silver bag
Carton Packing
1
1
1
1
Protective Glasses 1 Optional
Device Holder 1 Optional
Quantity Remarks
8
General Safety
Care and Cleaning
The device is supplied with all the needed accessories and cables, DO NOT use
other accessories and cables
Packing list

RF emissions
CISPR 11
Group1 Class
B
Harmonic
emissions IEC
61000-3-2
Voltage Fluctuations
And Flicker
IEC 61000-3-3:2013
Class A
Complies
Declaration – electromagnetic emissions
Emissions test Compliance Electromagnetic environment – guidance
The Handy Cure S’ is suitable for use in all
establishments other than domestic, and may
be used in domestic establishments and those
directly connected to the public low-voltage
power supply network that supplies buildings
used for domestic purposes, provided the
following warning is heeded: Warning:
This equipment/system is intended for use by
healthcare professionals only. This equipment/
system may cause radio interference or may
disrupt the operation of nearby equipment.
It may be necessary to take mitigation
measures, such as re-orienting or relocating
the Handy Cure S’ or shielding the location.
The Handy Cure S’ uses RF energy only for
its internal function. Therefore, its RF
emissions are very low and are not likely to
cause any interference in nearby electronic
equipment.
Note:
When in operation, only the red light is visible to the eye.
If no red-light lights on, contact the dealer.
9
Falut
Battery light is red
All 3 program
light are showing
Wrong mode of device
operation
Power the device as specified
in operating instructions
Technical fault Contact the dealer
Handy Cure S’
rechargeable battery
has run out of power
Connect Handy Cure S’ to
the electricity until the battery
light turns green
Handy Cure S’ can’t be
operated while recharging
Possible cause Solution
Troubleshooting
Declarations

Electrostatic
discharge (ESD)
IEC 61000-4-2
8 kV contact
2, 4, 8, 15kV
air
8 kV contact
2, 4, 8, 15kV
air
Floors should be wood, concrete
or ceramic tile. If floors are
covered with synthetic material,
the relative humidity should be
at least 30 %.
Electrical fast
transient/burst
IEC 61000-4-4
2 kV for
power supply
lines
1 kV for
input/output
lines
Evaluated
during AC/DC
adaptor
approval N/A
Mains power quality should be
that of a typical commercial or
hospital environment.
Surge
IEC 61000-4-5
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
NOTE UT is the a.c. mains voltage prior to
application of the test level.
30 (A/m) 30 (A/m)
Power frequency magnetic fields
should be at levels characteristic of a
typical location in a typical
commercial or hospital environment.
0% UT;
0.5 cycle at 0°,
45°, 90°, 135°,
180°, 225°,
270° and 315°
0% UT; 1cycle
and 70% UT;
25/30 cycles
Single phase
at 0° 0% UT;
250/300 cycle
Evaluated
during AC/DC
adaptor
approval
0% UT; 1cycle
and 70% UT;
25/30 cycles
Single phase
at 0° 0% UT;
250/300 cycle
1 kV line(s)
to line(s)
2 kV line(s)
to earth
2 kV Signal
input/output)
to earth
Evaluated
during AC/DC
adaptor
approval
N/A
N/A
Mains power quality should be
that of a typical commercial or
hospital environment.
Mains power quality should be
that of a typical commercial or
hospital environment. If the user
of the Handy Cure S’ requires
continued operation during
power mains interruptions, it is
recommended that the Handy
Cure S’ be powered from an
uninterruptible power supply or
a battery.
Declaration – electromagnetic immunity
IMMUNITY test IEC 60601
test level
Compliance
level
Electromagnetic environment
guidance
10

11
Conducted
RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3V, 6V
3V/m
3V from 0.15
to 80MHz;
6V from 0.15
to 80MHz and
80% AM at
1kHz
3Vrms, 6V
3V/m
Portable and mobile RF
communications equipment
should be used no closer to any
part of the Handy Cure S’,
including cables, than the
recommended separation
distance calculated from the
equation applicable to the
frequency of the transmitter.
Recommended separation
distance
where P is the maximum output
power rating of the transmitter in
watts (W) according to the
transmitter manufacturer and d is
the recommended separation
distance in metres (m).
Field strengths from fixed RF
transmitters, as determined by an
electromagnetic site survey, should
be less than the compliance level in
each frequency range.
D Interference may occur in the
vicinity of equipment marked with
the following symbol:
10V/m from
80MHz
to 2.7GHz
10V/m from
80MHz
to 2.7GHz
3V from 0.15
to 80MHz;
6V from 0.15
to 80MHz and
80% AM
at 1kHz
Declaration – electromagnetic immunity
IMMUNITY test IEC 60601
test level
Compliance
level
Electromagnetic environment
guidance

Recommended separation distances between
portable and mobile RF communications equipment and the Handy Cure S’
Rated maximum
output power of
transmitter
W
Separation distance according to frequency of transmitter m
150 kHz to 80 MHz
outside ISM
bands
0.01
0.1
1
10
100
0.12
0.37
1.17
3.7
11.7
0.2
0.64
2
6.4
20
0.4
1.3
4
13
40
1
2.6
8
26
80
150 kHz to 80 MHz
in ISM bands
80 MHz to 800 MHz 800 MHz to 2,5 GHz
12
Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment
Test
frequency
(MHz)
Band a)
(MHz)
Service a) Modulationb) Maximum
power
(W)
Distance
(m)
IMMUNITY
TEST
LEVEL
(V/m)
Compliance
level
(V/m)
385 380 –390 TETRA 400 Pulse
modulationb)
18 Hz
1.8 0.3 27 27
450 430 – 470 GMRS 460,
FRS 460
FM c)
± 5 kHz deviation
1 kHz sine
2 0.3 28 28
710 704 – 787 LTE Band 13,
17
Pulse
modulationb)
217 Hz
0.2 0.3 9 9
745
780
810 800 – 960 GSM 800/900,
TETRA 800,
iDEN 820,
CDMA 850,
LTE Band 5
Pulse
modulationb)
18 Hz
2 0.3 28 28
870
930
1720 1 700 –1 990 GSM 1800;
CDMA 1900;
GSM 1900;
DECT;
LTE Band 1, 3,
4, 25; UMTS
Pulse
modulationb)
217 Hz
2 0.3 28 28
1845
1970
2450 2 400 –2 570 Bluetooth,
WLAN,
802.11 b/g/n,
RFID 2450,
LTE Band 7
Pulse
modulationb)
217 Hz
2 0.3 28 28
5240 5 100 –5 800 WLAN 802.11
a/n
Pulse
modulationb)
217 Hz
0.2 0.3 9 9
5500
5785
NOTE: If necessary to achieve the IMMUNITY TEST LEVEL, the distance between the transmitting antenna and the ME
EQUIPMENT or ME SYSTEM may be reduced to 1 m. The 1 m test distance is permitted by IEC 61000-4-3.
a) For some services, only the uplink frequencies are included.
b) The carrier shall be modulated using a 50 % duty cycle square wave signal.
c) As an alternative to FM modulation, 50 % pulse modulation at 18 Hz may be used because while it does not represent
actual modulation, it would be worst case.

ENGENG
13
WARNINGS
1. “WARNING: Use of this equipment adjacent to or stacked with other
equipment should be avoided because it could result in improper operation. If
such use is necessary, this equipment and the other equipment should be
observed to verify that they are operating normally.”
2. “WARNING: Use of accessories, transducers and cables other than those
specified or provided by the manufacturer of this equipment could result in
increased electromagnetic emissions or decreased electromagnetic immunity
of this equipment and result in improper operation.”
3. “WARNING: Portable RF communications equipment (including peripherals
such as antenna cables and external antennas) should be used no closer than
30 cm (12 inches) to any part of the Handy Cure S’, including cables specified by
the manufacturer. Otherwise, degradation of the performance of this
equipment could result.”
4. accuracy of laser power output is essential for safe use of the device.
excessive electromagnetic disturbances can cause loss of accuracy.
Frequently Asked Questions (FAQ)
What will I feel during a treatment session?
Some people might feel a slight warming effect but usually people feel
nothing, which is good.
Even though you may not feel anything during treatment session, the laser
light penetrates the tissue and does the work.
How many treatments will I need?
This depends on the severity of your condition. The average treatment ranges
between 10 and 14 sessions.
Many patients will experience some relief of symptoms after 3 - 4 treatments and
after several more they will feel a significant improvement. It is important to
remember that everyone's body is different, so keep treating until you feel relief.
Could my pain increase?
For a small number of people, due to increased blood flow, the pain may
increase after a few treatments. If so, stop and take a 3 day break and then
return to daily treatment. After a few treatments you will feel relief.
Can the laser burn me?
No. Handy Cure S’ is a class 1 laser device
• Specifications are subject to change without early notice

14
ENG
Serial No. : __________________________________________________
Distributor Details
Distributor: _________________________________________________
Date of Purchase: ____________________________________________
Signature and distributor stamp: _______________________________
Client Detals
First Name: _________________________________________________
Last Name: _________________________________________________
Handy Cure S’ Warranty
Medical Quant Limited guarantees that Handy Cure S’ will operate in the
manner described in this manual for a period of 24 months from the date of
purchase, when used and maintained in accordance with the instructions
herein. Defects or damage due to misuse or abuse are not covered by this
warranty.
Please bring this warranty with the Handy Cure S’ in the event of a complaint
Medical Quant Limited shall not be liable in any manner in respect of bodily
injury and / or property damage arising from the use of Handy Cure S’ where
such use is not in strict compliance with the instructions and safety precautions
contained in the Handy Cure S’ Operating Manual, including all supplements
there-to, in all product labels, and according to the terms of warranty and
safety of this equipment, nor if any changes unauthorized by Medical Quant
Limited are made to Handy Cure S’.

ENG
#
1.
Symbol Symbol meaning Phrase
Manufacturer Medical Quant Ltd, 14
Hata'as St. Kfar- Saba,
Israel 4442514, Israel
2.
Authorized Representative in the
European Community
Obelis S.A.- Av. De
Tervueren 34 bte 44,
B-1040 Brussels, Belgium
3.
Symbol for "Caution, consult
accompanying documents" or
"Attention, see instructions for use."
N/A
4.
non-ionizing radiation N/A
5.
Class II equipment (Double isolation) N/A
6.
Symbol for "Shock protection type
(BF)."
N/A
7.
Symbol used to indicate that the
product should be kept dry.
N/A
8.
Temperature limitation N/A
9.
Keep away from sunlight N/A
10.
1023
CE Mark - conformity with the essential
health and safety requirements set out in
European Directives accompanied by a
four-digit identification number of the
notified body
N/A
ENG
15
Symbols

UM300720-EN.HC version Nov/2018
MADE IN ISRAEL
European Representative
“Obelis S.A”
Av. De Tervueren 34
BTE 44, B-1040 Brussels
Belgium
1023
Manufactured by Medical Quant Ltd.
14 Hataash St., Kfar-Saba 4425144, Israel
[email protected]
ENG