MEDICAL DEVICE FOR SLEEP DISORDER CORRECTION
“MORPHOTRON”
TU 9444-001-34013480-2005
Operations manual ОР МТ.00РЭ
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Contents
1. Application of the device
1.1 General information
1.2 Indications for application
1.3 Contraindications, side-effects
2 Technical specifications
3 Completeness of the set
4 Design and operation principle
4.1 Physiological mechanism of sleep disorder correction
4.2 Internal design of the device
4.3 Marking
4.4 Operation modes of the device
5 Safety measures
6 Using the device according to its purpose
6.1 Preparation for use
6.2 Start-up and individual set-up
6.3 Operating an adjusted device
6.4 Instructional guidelines
7 Maintenance support and service
8 Storage, transportation and utilization
9 Acceptance certificate
10 Certification data
11 Manufacturer’s guarantee
Coupon of warranty repair
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Dear Customer,
You have bought “Medical device for sleep disorder correction
Morphotron” (hereinafter referred to as device), that is produced by the
Russian manufacturer “Obyedinenye Rodina Ltd” (Ioshkar Ola).
The device is included in the list of the devices which are
permitted to use in medical practice. Registration certificate number is
FC 02012005/1745-05. The safety of the device is confirmed by the
conformity certificate of directive MDD 93/42 EEC (CE marking).
Before using the device, you should carefully study the rules and
requirements described in the service manual. Observance of rules
provides long and safe service of the device. Violating the operation
rules can cause malfunction of the device.
Operations manual is the document specifying basic features and
technical characteristics of the device that are guaranteed by the
manufacturer.
When buying the device you should check the completeness of set,
check the body of the device for visible defects and mechanical
damages, make sure that the stamp of the trading company, the date of
buying, the signature of the seller are written in the talon of warranty.
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1.
1.1
Application of the device
General information
1.1.1
This apparatus is a medical device, meant for treatment,
code 94 4490 according All Russia Classifier of Products OK 005-93.
1.1.2
The device exercises physiotherapeutic effect on psycho
physiological activity of human brain during the period of physiological
night sleep for the complex treatment of illness and sickness, connected
with psycho emotional sphere disorder.
1.1.3
Sleep disorder correction is carried out by using
energetically weak sound and light stimulation effect on sight and
hearing receptors in the stages of REM and NREM sleep corresponding
to the sensor perception.
1.1.4
The device is certified for use in conditions of medical
institutions, sanatoriums and home use. Treatment method shall be
carried out by the recommendation of the physician.
1.1.5
The device is intended for use in dry, heated space in
normal climate conditions according to GOST 15150-69 (atmospheric
temperature is from 10ºC to 35°C, maximum relative air humidity
80%).
1.1.6
Concerning electrical safety the device is designed in
accordance with class II, type V, GOST 30324.0-95/GOST R 50267.092 and GOST 20790-93/GOST R 50444-92.
1.1.7
The device falls into the group of C class according to the
possible consequences of failure during the usage – GOST 20790-93/
GOST R 50444-92 (the failure while usage reduces the effectiveness of
the treatment without creating an emergency situation).
1.1.8
The device falls into the second group according to the
classification of mechanical effect resistance – GOST 20790-93/GOST
R 50444-92 (it is a portable device; it is not intended for use while
carrying).
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1.2
Indications for application
1.2.1
Diseases and states of body, concerned with sleep
disorder
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Neurosis of different etiology, showing itself in psycho
emotional lability and acrimony
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Vexatious depressive disorders, panic disorders, mood disorders
Mental and physical defatigation
Headaches coming from sleep disorder
Cardiophyshoneurosis and vegetative-vascular dystonia
I-II stage of idiopathic hypertensia
Spasmodic asthma connected with sleep;
Gastritis and peptic ulcer;
Nerodermits, dermatosis
Secondary immunodefficient disease;
Logoneurosis;
Alcoholism;
1.2.2
Physiological sleep disorder
1.2.2.1 Endogenic and exogenic dyssomnia
Psychophysiological insomnia;
Essential insomnia;
Narcolepsy
Occasional hypersomnia;
Non-specified endogenic sleep disorder;
Sleep disorder resulting from poor sleep hygiene;
Sleep disorder connected with environmental factors;
Subnormal sleep syndrome;
Syndrome of short sleep;
Night food/drink syndrome;
1.2.2.2 Sleep disorder coming from circadian rhythms
abnormality
 Time zone changing syndrome;
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 Sleep disorder caused by shift working
 Irregular sleep-awakening regime
 Sleep disorder connected with non 24 hours cycle of sleep-
awakening regime
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1.2.2.3 Parasomnies
Confused physical state while awakening
Sleepwalking
Nightmares
Sleep-awakening transfer disorder
Sleeptalking
Erection disorder caused by bad sleep
1.2.2.4 Suppositional sleep diseases
Sleep loss
Oversleep
Syndrome of non complete awakening
Sleep disorder caused by menstrual cycle
Sleep disorder caused by pregnancy
Horrifying hypnogogic hallucinations
1.3
1.3.1
Contraindications and side effects
Contraindications:
 serious psychic disease;
 epilepsy and the state of pre-existing epileptic status;
 cerebrovascular accident
1.3.2
No side-effects have been found.
2 Technical specifications
2.1 The device consists of one base block (BB) and one remote
control unit (RCU)
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2.2 The weight of the base block is about 2 kg, the mass of RCU is
about 0.2 kg
2.3 Overall size of BB is 210*180*80 mm maximum; the overall
size of RCU is 150*60*30 mm max.
2.4 Power source of BB is electric network of 220 ±10% voltage
and frequency of 50 Hz. The power source of RCU is a set of 3±0.5 V
batteries.
2.5 Wattage of BB is no more than 15.
2.6 Continuous work time of the device – no less than 15 hours
per day.
2.7 Continuous work time of RCU using one set of batteries – no
less than 3 months.
2.8 The device provides sound effects in the form of specially
designed music compositions; there are no less than 30 compositions on
the removable flash card of the device. The device plays the music
compositions of 250-10000 Hz frequency range without unwanted
sounds and blasting, herewith electric wattage output of the speaker of
the device is no less than10 mW A.
2.9 The device provides light effect in the form of red light flashes
of approximately 0.85 Hz frequency.
2.10 The device provides the following operation algorithm in the
mode of preprogrammed automatic sound-and-light effect (mode of
exposure):
 Sound-and-light effects start after 0, 30, 60 or 90 minute delay
depending on patient’s choice;
 one cycle of effect lasts for about 30 minutes;
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 cycle repertory: period of effect can 10 minutes, the rest 20 minutes it
pauses;
 one chosen music composition is played during each cycle, if a
number of compositions is chosen they change sequentially from cycle
to cycle;
 There are 24 cycles, after the end of the last cycle the operation mode
switches off automatically.
2.11 “Morphotron” provides voice prompts for the patient while
preset programming of the operation mode (setup mode).
2.12 BB and RCU controls make it possible to preprogram the
operation mode (setup mode) by means of:
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Switching to the setup mode
Setting the desired delay time before switching to operation
mode
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Setting the desired time for the operation mode
Setting one of three types of amplitude modulation,(the change
of sound effects volume and light effects brightness levels from cycle to
cycle): “decrease”, “increase”, “zero variation”;
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Switching to the music compositions playing mode (audition
mode);
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Smooth adjustment of the volume level while listening;
Choosing of the desired music compositions for the operation
mode;
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Setting the sound level for operation mode;
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Setting the brightness level of light effects for operation mode;
Switching to the operation mode.
2.13 The surfaces of the base block case and remote control unit
are resistant to disinfection with 3 % of peroxide.
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2.14 The device is operable in dry heated interiors, with
permissible temperature ranging from 10,00°C (50,00°F) to 35°C
(95,00°F)and maximum relative air humidity up to 80%.
2.15 The average error-free running time of the device is no less
than 1500 hours.
2.16 The average life span of the device is no less than 3 years.
End of life span means a critical state of the device in which the
reconditioning operation is economically inadvisable.
3 Completeness of the set
Complete set of the device is shown the table 1.
Table 1 Complete set of the device
Name of constituent
part
The complete set of the
device for sleep disorder
correction “Morphotron”
includes:
Marking
Quantity,
pcs
Basic block
Remote control unit
OP MT. 01
OP MT. 02*
1
1
Flash card
Operations manual
OP MT. 01.07
OP MT. 00OM
1
1
Package
OP MT. 03
1
OP MT. 00
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*The device can be equipped with an RCU by other manufacturers,
in this case there are markings of the specific control elements and
other particularities of their constructions in the special insert card
of the operations manual.
ATTENTION!
The power source for the RCU is not included in the set. The
following batteries are permitted to be used in the RCU: CR2032,
BR2032, DL2032, EA2032C, ECR2032, L14, L2032, LF1/2V, SBT15.
4 Design and operation principle
4.1 Physiological mechanism of somnological correction
4.1.1. Sound and light effects used in the device are highly
informative, productive for people and have low intensity (subliminal and liminal level), and therefore is harmless.
4.1.2. From the wide range of special sound compositions
available, the patient should choose the ones, which he feels shall
create positive emotional associations in his mind. When affecting
the patient, these compositions create pleasant calming associative
visions in his dreams. Productive dreams are usually presented in
fragmentary visions, and visions connected by a plotline.
4.1.3. Light flashes are used for photic stimulation. Their
frequency (0.8-0.9 Hz) matches the phase of a sleeping brain
biorhythm range (delta rhythms). The red colour of the flashes is
used because the sensibility of person’s photoreceptors in this
spectral subrange is maximum.
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The specialties of photic stimulation mentioned above and its
simultaneous use with sound stimulation make it a kind of “rhythm
operator” and additional physical and physiological factor of brain
structure activation, based on resonant phenomena.
4.1.4 Multiple sessions of light-and-sound therapy contribute
to better sleep quality (deep sleep, pleasant dreams, easy awakening
with a feeling of proper rest and vivacity), that leads to:
- alteration and stabilization of different organs and systems
functioning, recovery from diseases;
- renewing body strength in sleep;
- nervous and emotional stress relief;
- effective digestion of information received during the day;
- as the result, life tonus and workability of a patient are improved.
4.1.5 Further characteristics of the hardware software and
methodical implementation of physiological mechanism of
somnological correction give “Morphotron” advantages over other
known devices of psycho-physical light-and-sound correction:
- “Morphotron” is used during the physiological sleep of a patient,
it does not affect his wakefulness with treatment process;
- The frequency of photic stimulation performed by “Morphotron”
matches in phase with brain delta rhythms range, that provides
higher efficiency of low-energy sound stimulation with the
guaranteed preservation of dormant state;
- The patient can adjust the parameters of photic-and-sound
stimulation according to his own psycho-physiological condition. It
can be done before or during the process of treatment.
4.2 Internal design of the device
4.2.1 The BB of the device has a plastic case, with printed
circuit board of electric circuits inside it (with the power supply
unit), a sound speaker, light emitter and remote control receiver.
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Control elements and power supply cord are on the rear panel of
BB, the speaker is on the bottom panel, the removable flash
memory stick hatch is on the side panel, light emitter and receiver
are on the front panel.
4.2.2. RCU of the device has a plastic case with a printed
circuit board of electric circuits inside it. Control elements are on
the upper panel of the RCU, battery hatch is on the bottom panel.
4.2.3. The BB provides:
- playing recorded sound compositions from the memory stick;
- decoding the imported data with further transformation into analog
signal and power amplification for playback through the speaker;
- adjusting sound and photic stimulation parameters;
- performing sound stimulation through the speaker in accordance
with previously set parameters;
- photic stimulation through the emitter in accordance with
previously set parameters;
- switching between operation modes of the device;
- receiving and handling RCU signals.
4.2.4 RCU provides generation and transference of the
command signals in infra-red band to the BB.
4.2.5 Control elements are presented in 7 buttons with symbols
-◄, ►, ▲, ▼, ■, # (the RCU), and power switch and six buttons with
symbols -◄, ►, ▲, => , # on the base block’s control panel.
In order to minimize the quantity of buttons six of them are multifunctional, that means that in different modes they provide different
commands. The button # always provides reset of the BB’s electric
circuit (in every mode and in any moment) into standby mode.
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WARNING!
To prevent accidental reset, # button on the RCU (unlike
on BB) responses only when pressed three times with an
approximately 0.5 second delay!
4.3
4.3.1
Marking
BB case is marked with the following marks:
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manufacturer’s trademark;
the device marking;
serial number;
month (two numbers) and year (two numbers) of manufacture;
electrical safety classification symbols;
working voltage (V) and electrical frequency (Hz);
wattage (V-A)
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4.3.2 RCU case is marked with the following marks:
manufacturer’s trademark;
the remote control marking;
serial number;
month (two numbers) and year (two numbers) of manufacture.
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4.3.3 Consumer packaging should be marked with:
trademark and manufacturer’s name;
the device marking;
month and year of packaging;
“Fragile. Caution.” mark
4.4 Operation modes of the device
4.4.1 Standby mode
The device enters the standby mode automatically after connection to
electrical supply, after the end of the operation mode, and after pressing
button # (once on BB or thrice on RCU). Start of the standby mode is
supported by a triple low-pitched sound signal.
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In standby mode the patient is given prompts what to do to switch into
one of the modes. In the standby mode the red light indicators of the BB shine
without flickering.
The prompts are recorded with a female voice. Standby mode voice
prompt: “Hello. You are in the standby mode. To set the device by yourself
press the button “Left”, to start your settings press the button “Right”, to start
the standard settings press the button “Enter”.” If the patient doesn’t operate
on the setups during the prompt and 4 seconds after it, the voice message is
repeated.
You can quit the standby mode and switch the device into setup mode
(by pressing button◄), into operation mode (by pressing the button►, the
voice prompt: “Loading your settings. Good night”) or into the base setup
mode (by pressing the button =>, the voice prompt: “Start of the standard
settings. Sweet dreams.”)
There are no voice prompts red light indicators of the BB shine without
flickering, indicating switching on the power of the BB, after you quit the
operation mode. You can switch the device into standby mode by pressing
any button on the RCU or the BB (except #)
4.4.2 Setup mode
A patient enters the setup mode to program the settings for the operation
mode. Start of the setup mode is confirmed by a single low-pitched
sound signal.
In the setup mode the device “prompts” the patient what to do to set up
the time needed to fall asleep.
Setup voice prompt: “Set up the time you need to fall asleep, after which
the device starts working. To increase time delay press the button “Left”, to
decrease time delay press the button “Right”, to confirm, press the button
“Enter”. Time delay now is zero minutes.” If the patient doesn’t operate on the
setups during the prompt and 4 seconds after it, the voice message is repeated.
You can quit the setup mode after selecting and fixing chosen
parameters and enter the mode of exposure pressing button =>.
In setup mode all commands are made through buttons ◄, ►, ▲, ▼, ■,
=>.
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4.4.3 Audition mode (sound compositions selecting mode)
Audition mode is a part of setup mode. It allows a patient to listen
to sound compositions with returns and repetitions, with selected
loudness, fixing chosen compositions.
On one hand it contributes to thoughtful selection of an
individual set of compositions for the oncoming operation mode.
In the audition mode the device “prompts” the patient what to do to
choose the melody for the operation mode.
Audition mode voice prompt: “You are in the mode of playing and choosing
melodies which arouse your pleasant dreams. To increase the volume level
press the button “Left”, to decrease the volume level press the button “Right”,
to advance to the next composition press the button “Up”, to return to the
previous one press the button “Down”. You can select the desired melody by
pressing the button “Square”. To confirm press the button “Enter”.
On the other side it gives the additional possibility to use the
device as an audio player for relax-sessions.
4.4.4. Amplitude modulation mode.
Amplitude modulation mode is a part of the setup mode. It allows the
patient to set the device according to his dream peculiarities (“deep”, “light”).
Amplitude modulation mode voice prompt: “Amplitude modulation mode. If
your dream becomes lighter by the morning, press the button “Right”, if your
dream becomes deeper, press the button “Left”, if your dream doesn’t change
during the night, press the button “Enter” to confirm the previous settings and
switch to the operation mode.” If the patient doesn’t operate on the setups
during the prompt and 4 seconds after it, the voice message is repeated.
4.4.5 Operation mode
Operation mode provides performance of the light-and-sound
stimulation program with previously customized settings.
Start of the operation mode is confirmed by a complete the switch to the
operation mode is confirmed with a voice prompt: “You are in the sound and
light mode. Good night”, by a complete extinction of the light indicator and a
triple low-pitched sound signal.
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You can quit the operation mode and switch the device into:
1)
Standby mode. It switches on automatically after the end of 24
cycles of sound and photic simulation, or forcibly (if the # button is
pressed)
2)
The “Express” mode (p. 6.3.6). It can be switched on by
pressing button ■ on the BB’s control panel.
4.4.6 Test modes
Test modes are used for operation monitoring of some BB
characteristics in the process of manufacturing and exploitation.
They can be switched on only from BB’s control panel. The user
may choose one of the test modes (“Express”) according to p. 6.3.6
for a quick verification of accuracy of his actions during setup. The
user will not enter unwanted test modes, provided that he operates
correctly with the control elements.
The unwanted test mode may reveal itself in the device’s
generation of continuous sounds of different mood or in inadequate
reaction of the device to setup operation. In this case press button #
to return to standby mode.
5 Safety Precautions
5.1 For safety provisions you should:
- use the device in accordance with operation’s manual and doctor’s
instructions;
- use only local electrical supply with voltage and frequency according
to p. 2.4 and properly functioning outlets;
- use the device in places providing convenient conditions for
connecting power cord plugs of the BB to wall outlets, eliminating the
possibility of cord tension;
- unplug the BB from an electric socket when the device is unused for
long periods of time. When pulling the plug from the outlet, make sure
to hold the plug, not the cord;
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- protect the device from dampness, strikes, shaking, protect from
ingress of moisture inside the case of the device during disinfection;
- do not use the device if BB case and cord are damaged;
- do not use the device in
“Contraindications, side effects”;
cases,
stated
in
paragraph
- after the device was kept in temperatures lower than 10°С (50,00°F)
for a long period of time, keep it in a room with normal climatic
conditions (p. 2.13) for no less than four hours.
6 Application of the device
6.1
Preparation for use
6.1.1 Before the first use, wipe all the surfaces of the BB and
RCU with dry cloth. If the device has dirty signs, perform the
disinfection as described in p. 7.1.
6.1.2 Place BB on the bedside stand following recommendations
of p. 6.4.14. The surface of the stand should not interfere sound
emission from the speaker located on the bottom panel of the BB.
6.2.
Start-up on and individual setup.
6.2.1 Connect the plug of the BB cable to an electric socket.
Pressing the power switch make sure that electrical supply reaches the
electric circuit of the BB (red lights start to glow without flickering, a
triple low pitched sound signal is emitted and the device starts to prompt
the patient the actions for further settings). It is the standby mode.
If the flash memory stick of the device is defective, is inserted
inaccurately into the connector or is absent, a triple high pitched sound
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signal is emitted. Disconnect the BB from electrical supply, unscrew
two bolts of the memory stick hatch and open the hatch, and insert an
operable memory stick.
WARNING!
You should press the control buttons of the BB and the RCU
accurately and only once (except reset button # on the remote
control, which should be pressed three times)! Feel the light
mechanical click of the button, after that release the button at once.
Monitor the actuation of the generated command according to the
Operation’s Manual (light and sound signals). If the location of the
button (the BB or RCU) is not specified, press it where it is more
convenient for you in current situation, voice prompts.
6.2.2 After pressing buttons ◄ and # on RCU, whose radiating
sight is directed to BB, you should hear a single low pitched sound
signal and after that - a triple low pitched sound signal. After that BB
enters the standby mode.
If the RCU does not operate, check the batteries and if needed
replace the batteries with new ones.
WARNING!
Before starting the individual setup, we recommend you to
read carefully the following explanations in order to understand
the meaning of every aspect of photic and sound stimulation
♦♦♦ Sound stimulation:
The device reproduces pleasant sound compositions (songs,
music, natural sounds) very softly, without awakening you. You
choose them yourself during setup, fixing from 1 to 24
compositions from several dozens of given variants. The loudness
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of the sound is minimal, but such that in a quiet bedroom before
falling asleep you catch the meaning or leitmotif of the composition
slightly straining your hearing.
♦♦♦ Photic stimulation:
The device irradiates your face with thin flashes of red light
during your sleep without awakening you. These flashes reach your
brain through the closed eyes, which perceives them positively,
because the frequency of flashes and rhythms of brain functioning
coincide during sleep. Flashes improve the efficiency of your
brain’s perception of sound compositions. The brightness of this
influence is minimum, but such that in a dark bedroom before
falling asleep you feel it through closed eyelids.
♦♦♦ Delay time:
The device does not start light-and-sound stimulation right
after you have customized all the settings. It “waits” 0, 30, 60 or 90
minutes, allowing you fall asleep. Set the delay time in accordance
with the time you usually need to fall asleep after you go to bed and
switch of the light.
♦♦♦ Stimulation time:
The device operates cyclically, turning on light and sound
every half hour only for 10 minutes. The rest 20 minutes it pauses.
The device automatically sets 24 cycles of stimulation, which
means a 12 hours’ sleep. If the patient awakes earlier, he can stop
the stimulation by pressing button #.
♦♦♦ Amplitude modulation
The initial operation mode level settings for brightness and
volume will not change during the whole sleep period, if the “zero
variation” mode of amplitude modulation is set to “on”.
The device also has an “increasing” mode of amplitude modulation (the
initial level settings for brightness and volume will smoothly increase
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from cycle to cycle) and “decreasing” mode (the initial level settings for
brightness and volume will smoothly decrease from cycle to cycle)
Enter the setting mode:
6.2.3 Switch the device to the delay setting mode by pressing ◄
(a single low-pitched sound signal and minimum brightness of the
indicators). 0 minutes delay will be set automatically. The voice prompt:
“Time delay is zero minutes.”
By pressing ◄ you can increase the delay time (30 minutes – a
single low pitched sound signal, the voice prompt: “Time delay is thirty
minutes”, 60 minutes - a single medium pitched signal and medium brightness
of the indicator, the voice prompt: “Time delay is sixty minutes”, 90 minutes a single high-pitched signal and the and the high brightness of the indicator,
the voice prompt: “Time delay is ninety minutes”).. By pressing ► you can
decrease the delay time.
Save the chosen delay time by pressing => (a triple low-pitched
sound signal), the device will automatically switch to the next step of
the setting mode.
6.2.4 In the operating time setting mode a 10 minute operating
time is set automatically. By pressing ► you can decrease the time to 5
minutes (a single low-pitched sound signal and minimal brightness of
the indicators). By pressing ◄ you can increase the time by 5 minutes
(a single high-pitched sound signal and maximum brightness of the
indicators).
Save the chosen operating time by pressing => (a triple lowpitched sound signal), the device will automatically switch to the next
step of the setting mode.
6.2.5 In the music composition selection mode the device
sequentially plays all music compositions stored in its memory. In this
mode, the indicators glow permanently on (medium brightness).
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This is the audition mode. By pressing ◄ you can increase, and by
pressing ► you can decrease the sound volume by one grade. A double
high-pitched sound signal notifies of reaching maximum or minimum
volume level.
You can advance to the next music composition at any moment by
pressing ▲ on the remote control device (a single low-pitched sound
signal).
You can return to the previous music composition at any moment
by pressing ▼ on the remote control device (a single low-pitched sound
signal).
You can select the desired music composition by pressing ■ (a
double high-pitched signal voice prompt: “The melody was added to the
list.”), and the next music composition will start playing automatically.
If there are no selected music compositions, the device
automatically starts playing the music compositions from the beginning.
Also, you can force the device to start playing music compositions from
the beginning at any moment by pressing => (a triple high-pitched
sound signal).
All settings will be saved when you advance to the next step of the
setting mode. The device advances to the next step of the setting mode
at the exhaustion of melodies, or you can do it at any moment by
pressing =>. A triple high-pitched sound signal notifies of advancing
to the next step of the setting mode.
ATTENTION!
At the next step of the setting mode you MUST set volume and
brightness levels in COMPLETE silence and darkness while lying
in bed in your usual sleeping position. You should use the remote
control for the setting, so that volume and brightness levels would
be as close to reality as possible.
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6.2.6 In the initial brightness and volume levels setting mode
the device sequentially plays the music compositions you had
previously chosen and flashes its indicators.
By pressing ◄ you can increase, and by pressing ► you can
decrease the sound volume by one grade. A double high-pitched sound
signal notifies of reaching maximum or minimum volume level. You
can advance to the next music compositiony at any moment by pressing
■ on the remote control device (you will be notified with a single lowpitched sound signal). Set the volume level that allows you to
understand the tune of the melody with some hearing effort.
You can increase the brightness of the indicators by one grade by
pressing ▲, and decrease the brightness of the indicators by one grade
by pressing ▼. Exceeding maximum (minimum) brightness by pressing
the same button will automatically set the brightness to minimum
(maximum). By pressing ▲ and ▼ set the minimum brightness level
that allows you to see the flashes of light through your eyelids (the
eyelids should be closed without effort).
Save the chosen volume and brightness levels by pressing => (a
triple low-pitched sound signal), the device will automatically switch to
the last step of the setting mode.
6.2.7 On the step of the setting of volume and brightness
modulation mode, “zero variation” mode is set automatically, the
indicators glow permanently, melodies are not being played.
If it is known that patient’s sleep becomes deeper at night, set the
“increasing” mode by pressing ◄ (a single high-pitched sound signal
and maximum brightness of the indicators, voice prompt: “Increasing of
the amplitude modulation”). If patient’s sleep becomes more light at night,
set the “decreasing” mode by pressing ► (a single low-pitched sound
signal and minimum brightness of the indicators, voice prompt:
“Decreasing of the amplitude modulation”). You can return to “zero
variation” mode by pressing ◄ or ► (a single medium-pitched sound
signal and medium brightness of the indicators, voice prompt: “Without
changes”).
Save the chosen modulation mode by pressing => (a triple lowpitched sound signal), the setting is finished, the device will
23
automatically switch to the operating mode. (Voice prompt: You are in the
light and sound mode, good night”)
6.3 Operating the adjusted device
6.3.1 In the operating mode the device works off the chosen delay
time, giving the patient the time to fall asleep in complete silence and
darkness. Sound and light effects are off in this mode. The patient can
cancel the delay time by pressing =>.
6.3.2 The device starts making programmed sound and light
effects when the delay time gets cancelled or runs out. After the last
(24th) cycle the device makes a triple low-pitched sound signal and
automatically switches to standby mode (by pressing any button the device
switches to the standby mode).
If the patient wakes up in less than 12 hours, he can switch the
device to standby mode by pressing #
.6.3.3 If the patient plans to use the previously set sound and
volume parameters for the next session, he should do the actions
described in 6.2.1 – 6.2.2, and press ►. The device switches to
operating mode.
6.3.4 In order to change the setting for the operation mode you
should repeat all the steps of the setting mode.
6.3.5 If you want to occasionally use the device as an audio player
with a chambered volume level you should enter the standby mode and
press ◄, =>, => with a 2-3 seconds delay. The music compositions will
start playing in a few seconds (audition mode).
By pressing ◄ you can increase, and by pressing ► you can
decrease the sound volume by one grade. A double high-pitched sound
signal notifies of reaching maximum or minimum volume level.
You can advance to the next music composition at any moment by
pressing ▲ on the remote control device (a single low-pitched sound
signal).
You can return to the previous music composition at any moment
by pressing ▼ on the remote control device (a single low-pitched sound
signal).
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You can replace the flash card with a one with a different set of
music compositions, but ONLY when the device is switched off
completely.
You can end playing the music compositions by pressing #. If you
want to use the device for sleep disorder correction after listening the
music compositions you should go through all the setting steps
mentioned above.
6.3.6 While getting familiar with the setting of the device the user
can quickly estimate the effect of the setting with a chronometer. In
order to do that, you should enter the “Express” testing mode by
pressing ■ on device’s control panel (a single low-pitched sound signal)
after switching the device into the operation mode.
In this mode all delays set in minutes will be scaled to seconds – a
90-minute delay will pass in 90 seconds, 5 minute operating time will
pass in 5 seconds, etc. In fact, the “Express” mode is identical to
operating mode, but 60 times advanced.
After the device exits the “Express” mode (you can press => to
force the device, or the device will do it automatically) it is ready again
to execute the program for the operating mode in real time. The
“Express” mode can be successfully used for the pre-purchase
demonstration of the device.
6.3.7 Operating modes and setting methods are shown in table 2.
№
0
Mode description
Standby mode:
(after power is
switched on, after
“#” is pressed, after
ending of mode 6)
Button «▲ »
Button
«►»
Switching to
mode 1
Switching to mode
6 (previously
chosen settings)
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1
Setting mode:
Setting the delay
time before
switching on the
operation mode
(0min/30min / 60min
/ 90min)
2
Increase delay
time
Decrease delay
time
Setting mode:
Melody selection
(audition mode)
Increase volume
level
Decrease
volume level
3
Setting mode:
Initial volume and
brightness level
settings
Increase
volume/brightness
level
Decrease
volume/brightne
ss level
4
Setting mode:
Setting
volume and
brightness
modulation
mode
Increase
modulation value
Decrease
modulation
value
5
Light and
sound effects
setting mode
Not used
Not used
6
«Express» mode
Not used
Not used
Important: to switch to the audition mode (mode 3) from the standby
mode you must press ◄, => ,=> with a 2-3 seconds delay
Button «▲»
Button «▼» Button «■»
Button «=>» Button «#»
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Not used
Not used
Not used
Not used
Advance to
next music
composition
Advance to
next music
composition
Increase
indicator
brightness
Not used
Not used
Not used
switch to
mode 5
Confirm the
chosen
value and
switch to
mode 2the
Confirm
chosen play
Switch
list and
switch to device to
mode 4 standby mode
(mode 0)
Advance to Confirm the (from remote
chosen list control you need
next music
to press 3 times
composition and switch
Decrease
within 3
to mode 5
indicator
seconds)
Confirm the
brightness
chosen list
Not used
Not used
and switch
to mode 6
Not used
Not used
Not used
Not used
Store
melody to
play list
Switch to
Disable
mode 6
delay time
(“Express”
mode)
(device’s
Disable
Notcontrol
used
delay time
panel only)
6.4 Practical policies
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6.4.1 If the device is used at home, the patient should set the device on
his own, according to his feelings and these instructions, he also should
consult a doctor in difficult cases.
6.4.2 If the device is used at hospital, the attending doctor should
organize the whole process of treatment: personal light and sound effects
setting (this can be done by the patient or the medical attendants), or decide to
stop using the device because of acquiring the aim of the treatment or of
specific patient’s irrelevance to the device.
6.4.3 The attending medical doctor should explain to the patient the
point of somnological correction method, application conditions, peculiarities
of associative choice and melody selection, explain how to describe their
feelings before and after somnological correction sessions, how to monitor the
changes in their psychophysiological state and when to decide to continue or
stop using the device or to revise the program for the somnological correction
sessions.
The doctor should perform initial quantative estimation of patient’s
psychoemotional sphere and further revisions of the estimation as the
treatment progresses.
6.4.4 The device should be used for treating one patient only, as it is
difficult to choose a single program of somnological correction for two or
more patients. Also, it is nearly impossible to monitor and revise the programs
for two or more patients simultaneously.
6.4.5 The device is not going to make any positive effect if:
- patient’s sleep is disturbed (he wakes up) by manifestations of his disease:
intense permanent pains, itching, violent cough, high body temperature,
deliration, hallucinations, etc.
- patient is affected by alcohol and other narcotic drugs
- patient snores heavily and continuously when sleeping
- patient has bad sense of sight or hearing (not nearsightedness or
farsightedness)
- patient uses personal means of sound and light protection (masks, earplugs,
etc.)
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- patient has a fixed habit to cover his head with something when sleeping
- the sleeping room is not dark enough during sleeping period
- the sleeping room is insulated poorly from external industrial and
neighborhood noise
- the patient is not alone in the sleeping room
- there is a strong smell in the sleeping room (fresh paint, medicine,
chemicals, etc.)
- the conditions in the sleeping room are not comfortable for sleeping for the
specific patient (temperature and humidity)
- patient’s bed is situated in Earth’s geopathology zone
- patient is disturbed by insects
6.4.6 The care is delivered in the form of recurrent somnological
correction sessions every night.
6.4.7 The course of treatment lasts from two to four weeks depending on
patient’s well-being, a 1-2 week pause before the next course of treatment is
needed.
6.4.8 It is possible to select the structure of the somnological correction
sessions and the optimum light and sound effects program in 3-5 night
sessions. The session should be started in patient’s habitual sleeping time (the
device should be all set beforehand). The patient should pass on to the
dormition phase right after the setting. When awaken, the patient should
immediately write down his feelings about the session.
6.4.9 Let us consider a typical variant of the structure of somnological
correction sessions and light and sound effects program, developed for a
patient not having serious sleeping problems.
For an example, the patient usually falls asleep no later than 23-00,
falling asleep takes no more than half an hour, he wakes up at the alarm clock
at 6-00, and his sleep becomes deeper at night. So, the patient has to finish the
setting of the device before 22-30 and switch it to the operation mode. Set the
delay time to 60 minutes, operating time 10 minutes, “increasing” modulation
mode. If there are no noticed positive effects after 2-3 sessions, the patient
should try changing the following settings:
- change the selected melodies
- increase the initial indicator brightness level
- increase the initial sound effects volume level
- decrease the delay time to 30 minutes
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If the patient wakes up from first stimulation cycles he should
consequently do the following actions:
- increase delay time up to 90 minutes;
- decrease action time to 5 minutes;
- set modulation option “zero variation” or “decrease”;
- decrease initial volume level (if a patient has a feeling that he woke up from
a sound) or brightness (if a patient has a feeling that he woke up from a flash
of light).
If the patient wakes up from later stimulation cycles he should
consequently do the following actions:
- set modulation option “zero variation”;
- decrease initial volume level (if a patient has a feeling that he woke up from
a sound) or brightness (if a patient has a feeling that he woke up from a flash
of light).
6.4.10. Let us consider an example of a session for a patient with sleep
disorder
For an example, a patient falls asleep only after 11 p.m. and the period
of falling asleep lasts up to 1,5 hours. The patient wakes up on his own no later
than 6.00 a.m. Sleep is getting more light during the night. So he should finish
setting or resetting of the device before 9.30 p.m. and switch the device to
operation mode. The device should be set as follows: delay time - 90 minutes,
operation time - 5 minutes, modulation option “zero variation”. If there is no
positive effect after 2-3 sessions consequently do following actions:
- change chosen music compositions;
- increase initial flash brightness level;
- increase initial volume level;
- decrease delay time to 60 or 30 minutes.
30
If the patient wakes up from first stimulation cycles he should
consequently perform the following actions:
- change chosen music compositions;
- decrease initial volume level (if a patient has a feeling that he woke up from
a sound) or brightness (if a patient has a feeling that he woke up from a flash
of light).
If the patient wakes up from later stimulation cycles he should consequently
perform the following actions:
- set modulation option “decrease”;
- decrease initial volume level (if a patient has a feeling that he woke up from
a sound) or brightness (if a patient has a feeling that he woke up from a flash
of light).
Besides, it is could be useful for this patient to listen audio compositions
more carefully when setting up the device. Do it laying in complete darkness
and silence, ready to sleep. When setting, use the remote control only. Try
listening audio compositions not containing words, the ones that are
monotonous, slow and unirritating from the beginning to the end, try replaying
them and not paying attention to time, until you are completely relaxed and
have the intension of falling asleep. After that it is necessary to complete other
steps of setting, switch the device to the operation mode, take away the remote
control WITHOUT standing up (to the floor, under the pillow) and try to fall
asleep.
6.4.11. The device is allowed for use for prevention measures of sleep
disorder when even there are no complaints on sleep quality and health.
6.4.12. It is allowed to perform sessions of daytime stimulation only by
using sound stimulation - by using the device in audition mode as an audio
player. Listening specific audio compositions by a wakeful patient has
efficient relaxation effect on him.
6.4.13. The first device setting may take more than an hour. It is useful to
practice in order to keep on the customary sleep schedule. It is not difficult to
memorize setting steps, practice finding by the feel special buttons on the
remote control in complete darkness, satisfy the requirements to precision of
31
pressing of buttons (see the reminder to paragraph 6.2.1.), distinguish aurally
high, medium and low pitched signals and single, double and triple signals
during 5-10 attempts of setting. During practice a patient gets acquainted with
suggested audio compositions and chooses more suitable of them for positive
effect.
6.4.14. Set the base block on a bed-side table, a table or a shelf, located
near the foot of the bed, so that the patient could see it from laying position
and not needing to lift up his head to do it. This guarantees unhampered
capture of sound-and-light stimulus of the device by patient’s sensor organs.
6.4.15. Select audio compositions for the stimulation mode using the
following criteria:
- they should cause pleasant memoirs, restful visual imagery and the
desire of listening them again and again;
- cause fluent flying, drowsing and the condition of absence of thoughts;
- do not cause the desire to sing and do synchronous movements such as
dancing or marching.
7. Repair and maintenance
7.1 The device maintenance is performed by its owner or the staff using
this device and consists of weekly exterior check for any mechanical damages
of the base block and the remote control cases, monthly cleaning from dust
and impurities and the disinfection of the base block and the remote control
surfaces contacting with a human body if necessary.
Disinfection is performed by wiping the surface with a soft clean napkin
wetted in a three-percent solution of hydric dioxide and then thoroughly
squeezed out. Adding a weak disinfection liquid is possible. Don’t wet the
napkin much and do not allow leaks to appear.
32
7.2 When the batteries in the RCU are discharged completely it is
necessary to replace them with batteries of the similar size, voltage and
capacity (see section 3). Open the cover of the remote control battery
compartment, accurately take out used batteries, remove battery acid leaks
from the battery compartment with a dry wiper if necessary, insert new
batteries, close the compartment cover and check working ability of the remote
control (see paragraphs 6.2.1 and 6.2.2)
7.3 The repair of the device is performed by the manufacturer or by
specialized work shops of repair agencies, addresses of which are indicated by
selling.
If the device is equipped with the remote control by other manufacturers,
its repair is not performed by the manufacturer of the device.
8. Storage, transportation
and utilization
8.1. Packed devices should be transported by any enclosed transport
upon condition of providing cargo safety and in accordance with transportation
rules, applied to each kind of transport. The protection against direct effect of
atmospheric condensation and mechanical damages should be provided.
8.2. The storage of packed devices is performed in the following
conditions:
- air temperature range is from -50°С up to +40°С;
- relative air humidity is up to 98% by temperature 25°С;
- atmospheric pressure is from 84 up to 106,7 kPa (630-800 mm hg);
- the absence of vapors of acids, bases and other aggressive impurities in the
air of the storage.
8.3 The transportation of packed devices is performed in the following
conditions:
- air temperature range is from -50°С up to +50°С;
- relative air humidity is up to 100% by temperature 25°С;
- atmospheric pressure range is from 84 up to 106,7 kPa (630-800 mm hg).
33
8.4 After transportation in conditions of subzero weather the device
should be left in transportation packing in normal weather conditions not less
than 12 hours.
8.5 The devices should not be subjected to sharp blows during cargohandling operations and transportation. Devices in sectional package are
allowed to be put in 4 tiers during the transportation.
8.6 The device is not dangerous for human life, health and environment
after operating life expiry, and special measures of its utilization are not
required.
9. Test certificate
Device for sleep disorder correction “Morphotron” ОР МТ.ОО
ТУ 9444-001-34013480-2005 serial number ________________ produced
and accepted in accordance with requirements of state standards and
effective technical documentation is qualified for operation.
Quality control department representative
LS
personal signature clarification of signature
date, month, year
10. Certification data
Device for sleep disorder correction “Morphotron” ОР МТ.00 ТУ
9444-001-34013480-2005 is certified in certification system GOST R of State
Standard of Russia.
34
Conformity Certificate # is РОСС
01.08.2005.
RU.HM02.B13039 dated
11. Manufacturer’s warranty
11.1 The manufacturer guarantees conformity of the device quality to
operation manual requirements when conditions and instructions of storage,
transportation and operation are observed by the customer. Guaranteed
operating life is 12 months from the day of sale, but no more than 18 months
from the date of shipment by the manufacturer.
Warranty doesn’t cover the remote control (if the device is equipped
with the remote control by other manufacturers) and the electric power supply
of the remote control.
11.2. Warranty is valid only with a guarantee bond filled correctly and
clearly with indication of the date of sale and the clear stamp of a trading
organization.
11.3 Warranty doesn’t cover the following:
- if there were attempts of outside interference on the device or repair in
unauthorized service center;
- if unauthorized modifications of the device design and scheme are
found;
- if the device has mechanical damages;
- if there are damages caused by ingress inside of foreign items, substances
and liquids;
- if there are damages caused by unconformity
of power line parameters to state standards requirements.
35
A notification of nonworking of device “Morphtron” is to be sent to the
following address:
Obyedinenye Rodina Ltd.,
46, Krylova str., Ioshkar-Ola, the Republic of Mari-El, Russia, 424007
36
Cut line
Valid after filling
Coupon for warranty repair
filled by the manufacturer:
Date of manufacture
Representative of Quality control department
QC department stamp
Address of coupon return to the
manufacturer:
Obyedinenye Rodina Ltd.,
46, Krylova str., Ioshkar-Ola, the Republic of
Mari-El, Russia, 424007
Filled by a trade enterprise
date, month in words, year
Seller
Date of sale
Signature, stamp
Address and stamp of a trade
enterprise
Продавец
Counterfoil of a coupon for warranty repair is taken «______»________200 __
Radio repair specialist __________________________
Surname, signature
Device for sleep disorder correction
“Morphotron” ОР МТ.00 ТУ 9444-001-340134802005 serial number ________________________
37
Filled by a repair agency:
Warranty number of device “Morphotron”
__________________________
Cause of repair, name of a replaced detail or a unit :
___________________________________________
___________________________________________
___________________________________________
Repair date_________________________________
date, month in words, year
Surname and signature of a person performing
repair _____________________________________
___________________________________________
Stamp of a repair agency
with indication of a city
38
39