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DEVICE
FOR COMBINED PHOTO-MAGNETICINFRARED LASER THERAPY
Revision
2/2010
Operating Manual
CONTENTS
1.
INTRODUCTION .......................................................................... 4
2.
GENERAL INFORMATION .......................................................... 5
3.
SAFETY PRECAUTIONS ............................................................ 6
4.
INTENDED USE ........................................................................... 8
5.
TECHNICAL CHARACTERISTICS .............................................. 10
6.
DELIVERY SET ............................................................................ 11
7.
THE DEVICE DESIGN ................................................................. 13
8.
THE DEVICE SETUP ................................................................... 16
9.
THE DEVICE OPERATION .......................................................... 17
10. MAINTENANCE ........................................................................... 22
11. TROUBLESHOOTING ................................................................. 23
12. PACKING, STORAGE AND TRANSPORTATION ....................... 24
13. MANUFACTURER'S WARRANTY............................................... 25
14. ACCEPTANCE CERTIFICATE .................................................... 26
WARRANTY CARD ................................................................................ 27
RIKTA-ESMIL(2A)
Operating Manual
1.
1.1.
INTRODUCTION
We can hardly meet somebody who never had pain. Pain is a symptom or sign of something wrong in an organism. And pain is a signal
of incipient disease or a disease in progress. Medicine has contrived
variety of methods to defeat pain but, unfortunately, these methods
don't delete a disease as if concealing a disease inside an organism.
Owing to long-term investigations of big group of scientists, physicians, engineers, geneticists, biophysicists and clinicians of Russia
there has been designed the first-in-the-world medical device of new
type called RIKTA-ESMIL (hereinafter referred to as "the Device"). The Device not only eliminates acute and chronic pain but also allows treating the disease which provokes the pain.
1.2.
All rights for the Device are protected by a series of patents. The
trademark is reserved in many countries of the world.
1.3.
The Device is produced by JSC MILTA-PKP GIT which quality system is certified according to the International standard ISO
13485:2003.
1.4.
1.5.
1252
1.6.
1.7.
The Device meets the requirements of Medical Device Directive 93/42 EEC annex II.
RIKTA-ESMIL(2A)
Operating Manual
2.
GENERAL INFORMATION
2.1.
2.2.
2.3.
The Manual shall be kept during all the Device service life.
2.4.
RIKTA-ESMIL(2A)
Operating Manual
3.
SAFETY PRECAUTIONS
3.1.
The person(s) who will operate the Device must thoroughly learn the
Operating Manual and the applied Methodical Recommendations before undertaking any operation.
3.2.
3.3.
3.4.
3.5.
3.6.
Switch off immediately the Device and unplug the AC/DC adapter if a
smoke or unusual smell emanates from the Device.
3.7.
Don't pull out the battery from a battery's box in the Device body.
Please approach the Seller or Manufacturer if you need to replace
the battery.
3.8.
3.9
While treating the apex cardiac beat zone or other cardiac projection,
laser radiation of 5 Hz frequency is only permitted to be used.
3.10 Do not get treated or apply treatments to another person if you have
a pacemaker.
RIKTA-ESMIL(2A)
Operating Manual
3.11. After completion of a treatment procedure wipe the Device with a wet
gauze napkin. Use for this purpose a special cleanser for disinfecting
of medical devices. Prevent falling of the cleanser into the Device.
The Device cleaning and disinfecting shall be only provided AFTER
THE DEVICE IS SWITCHED OFF, and AC/DC adapter is unplugged.
3.12. Keep the Device away from children.
3.13
Keep the Device far from the open flame and heat sources and protect it against direct sun light.
3.14
3.15
The Device disposal shall meet the conventional standards and local regulations for the environment protection.
RIKTA-ESMIL(2A)
Operating Manual
4.
4.1.
INTENDED USE
The Device is designed to provide pain relief and also painless, noninvasive, non-pharmacological treatment of diverse diseases of human being.
The Device can be also used in combination with pharmacological
methods.
4.2.
4.3.
The treatment using the Device in mode 1 can be carried out either
by a contact method when the Device is put directly on painful zones
of D SDWLHQWV ERG\ DFFRUGLQJ WR WKH Methodical Recommendations,
or by non-contact method when the Device is at a distance of 0.5-2
cm over wounds, burns, ulcers, etc. of a body surface. In case of
wide injury surface a treatment shall be carried out using scanning
method when the Device is smoothly moved over all the affected area overlapping 2-4 cm of healthy skin along the edges.
The treatment in mode 2 is carried out by a contact method when the
Device is put directly on painful zones according to the Methodical
Recommendations.
RIKTA-ESMIL(2A)
Operating Manual
4.4.
4.5.
RIKTA-ESMIL(2A)
Operating Manual
5.
TECHNICAL CHARACTERISTICS *
10
RIKTA-ESMIL(2A)
Operating Manual
6.
6.1
DELIVERY SET
Description
RIKTA-ESMIL(2A) device with built-in battery
Protective optical cap
AC/DC adapter 10VAC/13 VDC 1.3 A
Device case
Packing box
Operating Manual
Methodical Recommendations
Qty.
1
1
1
1
1
1
1
OPTIONS
RIKTA-ESMIL(2A)
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Operating Manual
Operating Manual
Methodical Recommendations
Device case and Device
with protective optical cap
AC/DC adapter
12
RIKTA-ESMIL(2A)
Operating Manual
7.
7.1
7.2.
7.3.
7.4.
The controls and appropriate light indicators are on the front panel
of the Device.
7.5.
7.6.
Laser and infrared diodes, red LEDs and permanent magnet are
mounted inside the Device.
Attention! During the Device operation a human eye is capable to
discern radiation of only red LEDs four ruby spots.
DON'T DIRECT radiation to the eyes!
7.7.
(2A)
13V 1.3A
8
7
1 0DQXIDFWXUHUVWUDGHPDUN AC/DC adapter output voltage and current; 3 the Device serial No. and year of manufacture; 4 identification
number of EC certification body 5 symbol of electrical safety, protection
class II; 6 symbol of electrical safety, type BF; 7 - Manufacturer's name;
8 - laser hazard, class 1; 9 - symbol of laser emission availability
RIKTA-ESMIL(2A)
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Operating Manual
10
7
11
6
12
13
3
14
2
15
14
RIKTA-ESMIL(2A)
Operating Manual
Legend on Fig. 2:
1.
2.
3.
4
5
4.
6
7
8
9
10
5.
11
12
13
14
15
RIKTA-ESMIL(2A)
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Operating Manual
8.
8.1.
Take out the Device and accessories from the package. After
transportation at low temperature the Device shall be kept at a
room temperature of during at least 2 hours.
8.2.
Note
If after switching on the Device or during its operation (including treatment
procedure) LED "Battery/TENS" (7) begins blinking red, this means that the
battery is discharged and must be recharged to provide the Device operation (see item 9.4).
8.3.
16
put the Device with an aperture (12) down against any flat light
surface (e.g. sheet of white paper or a palm);
shortly press and release "Start/Stop" button (3). You will hear
DVKRUWEHHSDQGthree indicators (9) "100", "50" and "5" will
be blinking in turn;
if after the test completion all LED indicators (6), (9) are blinking and you hear intermittent sound signal, it means that the
Device is failed. In this case unplug the adapter and approach
to the Seller that sold you the Device or the Manufacturer.
RIKTA-ESMIL(2A)
Operating Manual
9.
After the Device is switched on use button "Time" (5) to set the required treatment time (1 min, 2 min or 5 min) in accordance with
the "Methodical Recommendations" or physician's prescription.
Appropriate LED indicator (6) will turn on (in case if 5 min is selected LED indicators "1" and "2" (6) will turn on simultaneously).
Then use "Frequency" button to set the required pulse repetition
frequency" 5 Hz or 50 Hz or 1000 Hz or Var (variable). Appropriate
LED indicator will turn on. (In case if "Var" frequency is selected
LED indicators "50" and "1000" (9) will light up simultaneously).
Note
OFF - to use TENS mode, press in series "Frequency" button (10) until no
one of LED indicators (9) lights up.
9.1.2.
9.1.3.
17
Operating Manual
On the termination of treatment time you will hear "beep" again,
light emission is turned off and one of indicators (6) corresponding
to the preset treatment time will steadily light.
9.1.4.
9.1.5.
To switch off the Device, press "Start/Stop" button (3) and hold it
during 2-3 seconds; you will hear "beep", all LED indicators will go
out and the Device will be switched off.
Note
If switch-on Device is not used during 40 seconds (no one of buttons is
pressed and treatment procedure is not carried out), then "beep" sounds
and the Device is automatically switched off.
9.2.
9.2.1.
3UHVV DQG KROG 6WDUW6WRS EXWWRQ WR VZLWFK RQ WKH Device as
has been described in item 8.2.
9.2.2.
9.2.3.
Then use "Time" button (5) to set the required treatment time (see
item 9.1.1).
9.2.4.
9.2.5.
18
RIKTA-ESMIL(2A)
Operating Manual
9.2.6.
9.2.7.
9.2.8.
9.2.9.
RIKTA-ESMIL(2A)
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Operating Manual
9.3.
9.3.1.
9.3.2.
9.3.3.
9.3.4.
9.3.5.
Note
As in TENS mode (mode 2), in case of failure of a contact between the
electrodes and skin, a "beep" sounds and "Battery/TENS" indicator (7) begins blinking in turn red and green. To continue the procedure, it is necessary to provide contact with skin.
20
RIKTA-ESMIL(2A)
Operating Manual
9.4.
9.4.1.
The battery is in a battery's box (15) in the Device body. The battery charge is automatically checked after the Device is switched
on and during the Device operation.
The battery can be charged in any state of the Device. To charge
the battery, the Device shall be connected to main power through
AC/DC adapter.
To charge the battery:
connect AC/DC adapter connection cable to the socket (1) of
the Device;
plug AC/DC adapter in a wall outlet. Approximate time of the
battery charging - no more than 3 hours (depending on the
battery condition). After the charging process is completed (indicator "Battery/TENS" will light green), unplug AC/DC adaptor
from wall outlet and disconnect the adapter connection cable
from the Device socket. The Device is ready to work stand
alone.
Please remember that light indicator "Battery/TENS" (7) has two
functions:
x
before beginning treatment procedure (before pressing
"Start/Stop" button (3)) this indicator is used for indication of
the battery charge condition;
x
during the treatment (after pressing "Start/Stop" button (3)) this
indicator is used for indication of normal operation in TENS
mode.
If the battery voltage is normal, the "Battery/TENS" indicator is off.
This means that the battery is charged and the Device is ready to
work.
If the battery voltage is less than the minimum allowable level, the
"Battery/TENS" indicator will be blinking red. This means that the
battery charge is only enough for the Device operation during approximately 10 minutes. In case of continuation of the Device operation the battery will be yet more discharged, the Device will generate a short intermittent signal and then will be switched off. All indicators will be out. Therefore, it is necessary to charge the battery to
provide the Device normal work.
9.4.2.
9.4.3.
9.4.4.
9.4.5.
RIKTA-ESMIL(2A)
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Operating Manual
10.
MAINTENANCE
10.1.
10.2.
10.3.
If during the maintenance you will find out that the Device doesn't
meet any technical requirements stated in Table 2, further operation of the Device is prohibited and it is subject to repair.
Table 2
Periodicity
Work description
Technical requirements
Before
each
treatment
Absence of mechanical
defects on the Device
and AC/DC adapter
22
1. Battery
charge
using
"Battery/TENS" (7) indicator.
"Battery/TENS" indicator
(7) shall not light up.
2. Availability of radiations.
RIKTA-ESMIL(2A)
Operating Manual
11. TROUBLESHOOTING
11.1.
Possible failures of the Device, their causes and appropriate corrective measures are listed in Table 3.
3
Failure
Possible causes
Corrective measures
RIKTA-ESMIL(2A)
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Operating Manual
12.1.
12.2.
12.3.
24
RIKTA-ESMIL(2A)
Operating Manual
13.2.
13.3.
13.4.
13.5.
13.6.
RIKTA-ESMIL(2A)
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Operating Manual
14.1
Date of manufacture___________________________________
Stamp
26
RIKTA-ESMIL(2A)
Operating Manual
WARRANTY CARD
Device
RIKTA-ESMIL(2A)
Serial No.
Warranty period
Date of sale
Seller's Name
Seller's Address
Seller's stamp
Manufacturer:
151 Liublinskaya St. 109341 Moscow, Russia
JSC "MILTA Humanitarian-Information
Technologies Design & Production Company"
(MILTA PKP GIT)
Tel.: +7(495)228-1433
Fax: +7(495) 346-9247
Web site: www.quantnmed.ru
EU-Representative: gasteiger science GmbH
Dietmar Schaffarczyk
Gollierstrasse 19, D-80339 Mnchen, Germany
Phone: +49 (0) 160 780 96 28
Fax: +49 (0) 3212 36 99 590
Mail: zyk@gasteiger-science.com
RIKTA-ESMIL(2A)
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