MEDICAL DEVICE FOR SLEEP DISORDER CORRECTION
“MORPHOTRON”
TU 9444-001-34013480-2005
Operations manual ОР МТ.00РЭ
Contents
1. Application of the device / 51.1 General information / 5
1.2 Indications for application / 6
1.3 Contraindications, side-effects / 7
2 Technical specifications / 7
3 Completeness of the set / 10
4 Design and operation principle / 11
4.1 Physiological mechanism of sleep disorder correction / 11
4.2 Internal design of the device / 12
4.3 Marking / 14
4.4 Operation modes of the device / 14
5 Safety measures / 17
6 Using the device according to its purpose / 18
6.1 Preparation for use / 18
6.2 Start-up and individual set-up / 18
6.3 Operating an adjusted device / 24
6.4 Instructional guidelines / 28
7 Maintenance support and service / 33
8 Storage, transportation and utilization / 33
9 Acceptance certificate / 34
10 Certification data / 35
11 Manufacturer’s guarantee / 35
Coupon of warranty repair / 37
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.
1. Application of the device
1.1 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 50267.0-92 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).
1.2 Indications for application
1.2.1 Diseases and states of body, concerned with sleep disorder
§ Neurosis of different etiology, showing itself in psycho emotional lability and acrimony
§ 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;
§ Sleep disorder caused by shift working
§ Irregular sleep-awakening regime
§ Sleep disorder connected with non 24 hours cycle of sleep- awakening regime
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 Contraindications and side effects
1.3.1 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)
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;
§ 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:
§ Switching to the setup mode
§ Setting the desired delay time before switching to operation mode
§ 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”;
§ Switching to the music compositions playing mode (audition mode);
§ Smooth adjustment of the volume level while listening;
§ Choosing of the desired music compositions for the operation mode;
§ Setting the sound level for operation mode;
§ 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.
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 / Marking / Quantity, pcsThe complete set of the device for sleep disorder correction “Morphotron” includes: / OP MT. 00
Basic block / OP MT. 01 / 1
Remote control unit / OP MT. 02* / 1
Flash card / OP MT. 01.07 / 1
Operations manual / OP MT. 00OM / 1
Package / OP MT. 03 / 1
*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, SB-T15.
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 (sub-liminal 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.
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. 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 multi-functional, 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.
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 Marking
4.3.1 BB case is marked with the following marks:
- 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)
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.
4.3.3 Consumer packaging should be marked with:
- trademark and manufacturer’s name;