Amblyopia Therapeutic Device with Semiconductor Laser 
【Name of product】
semiconductor laser Amblyopia therapeutic device
【Manufacturing license No.】
E FDA Manufacturing license No. 20040271
【Registration number】
E FDA Certified No. (2005) 2260968
【Scope of application】
1) About amblyopia
Amblyopia refers to that distant vision is less than 0.9 and corrected visual acuity can not reach the normal standards caused by functional factors without the change of organic diseases and the structural defect of eyes, or refers to deterioration of sight which can not be corrected and does not conform to the pathological changes with the change of organic diseases and ametropia.
According to the degree, amblyopia can be divided into
Mild amblyopia （vision 0.8-0.6）
Moderate amblyopia （vision 0.5-0.2）
Severe amblyopia （vision 0.5-0.2）
Disease rate of amblyopia: 2-4% in china; 2-2.5% overseas
The development of vision under 5 is the most important stage for children and will last until 6-8 years old. If there is vision disorder due to some reasons in this stage and the visual cell can not be stimulated normally by light, the vision development will cease and amblyopia appear .if watch by only one eye and the other eye develop slowly , it will lead to single eye amblyopia. Amblyopia may occur in any time during the vision development stage, especially in 1/2 years old. The early it appears, the more serious the degree will be.
2) Characteristic
a) Stimulating the retinal cone cell in ocular fundus yellow spot area by the laser with certain power and specific wave length which is sensitive to retinal cone, stimulate the retinal cone cell positively and activate the function of retinal cone then achieve the effective goal to cure amblyopia .
b) This product adds the assistant training functions including the multi-spectral function, red light twinkle, afterimage, etc, which is the therapeutic device with multi-function truly.
c) This product attaches the amblyopia training softerware and the picture books which avoid the boredom during the treatment process and improve the pleasure of treatment. The children will be more likely to accept the treatment.
3) Purpose and Scope of Application
The HN-300C amblyopia therapeutic device with semiconductor laser researched by our company mainly applies to the treatment of amblyopia for child, which is portable, safe and reliable with convenient operation, especially suitable for the family use.
【Cautions】
1) Before using, the conventional inspection should be made by the oculist. The diagnosis should be definitely the non-organic disease.
2) During the treatment period, pay attention to the heath of using eye and avoid using eye excessively.
3) Inspection of ocular fundus should be made regularly during the treatment period (at intervals of two week or three week). Report the therapeutic situation to the oculist in due time.
4) It is suggested that the consumer using the battery should replace the battery after consecutive using for 8 times to eliminate the impact due to the shortage of electric quantity.
5) Do not adjust or repair the device except the professional in our company ,or it will influence the effect of treatment.
6) Do not eat drug or food which is photosensitive during the treatment period, or it will influence the effect of treatment. (Such as acheomycin, seafood , spinach, pakchoi，carrot ,etc)
Generally, persist using the laser function once everyday. For the patient with severe degree, use two times everyday.
Then carry out the assistant treatments: red light twinkle training, multi-spectral training afterimage training, software training. It is better to use different function for two successive days.
A month is a course of treatment, 3-5 days’ rest after a course of treatment is viable according to the situation. Then carry out the next course. Treatment for about 1-2 month to consolidate the effect is viable after the vision reaches 1.0. (During the period of consolidation, please use the red light twinkle training or multi-spectral training).
[Side effects forecast and the measures that should be taken]
Possible side effects:
Photophobia, with tears in his eyes, slight hurt, black nuts, glare and photosensitive etc reaction, eyes closed and rest a few minutes to ease their own symptoms, no need to fear.
Hypersensitivity may occur on individual patients, specific treatment should be given: the use of dexamethasone and disodiumcromoglicate etc drug treatments.
[Performance and structure of products]
1) Outside view of the therapeutic equipment
Picture 1
2) Component principle of the therapeutic equipment
Picture 2 Block picture of component principle
Function selection
Power
Control unit
Timing
Laser
Afterimage
Multi-spectrum
Red flash
3) Panel
Panel layout, as Picture 3 shows.
Picture 3 Panel layout picture
4) The side power jack picture
Picture 4
5) Membrane replacement picture
Picture 5
6) Picture of pupil distance adjustment
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Picture 6
7) Main technical indexes ClassⅡ-B
1) Wavelength of laser 入=650nm;
2) Input power ≤100VA;
3) Laser irradiation time is 3 minutes;
4) Power: AC220V±22V 50HZ±1Hz or 4 AA batteries;
5) Afterimage high brightness duration T=30 seconds;
6) Afterimage low-light level flicker frequency: 40 times/minute；
7) Afterimage low-light level flicker duration: T=180 seconds;
8) Red flash frequency: 40 times/minute；
9) Red flash duration: T=300 seconds;
10) Multi-spectrum flicker frequency: 40 times/minute；
11) Multi-spectrum flicker duration: T=180 seconds;
[Installation directions]
This therapeutic equipment is used by the installation on the horizontal table-top, two power input schemes-external power and four AA batteries are provided for the equipment. If using external power, please use alternating current adapter provided by us, connect the input side of direct current of alternating current adapter to pedestal of the equipment (see picture 4) and the input side of alternating current of alternating current adapter to the socket of alternating current, then turn on the power switch, namely the equipment can be used; if you want to use the battery, please use four AA batteries, turn over the equipment to let the bottom upturned then the battery cover at the soleplate can be seen, twist-off the battery cover according to the battery installation illustration of the soleplate, correctly install the battery at the soleplate, after the installation of the battery, screw on the battery cover, namely the battery installation is finished, at this time, turn on the power switch, namely the equipment can be used.
Note: for the battery, it is advised to use the same model and use at the same time, no allowance for different models of batteries or mixed use of batteries used for different time.
If regard the battery as power, it is advised to change the battery after continuous use of this equipment for 8 years. Otherwise the service effect of this equipment will be affected.
[Direction for use]
Preparations before use:Pupil distance adjustment: (If only one eye of the child needs amblyopia therapy, please skip to next step.)
The patients’ eyes need to be close to the viewing port of the equipment, turn on the equipment according to the steps of installation indirections, then depress the laser key, at this moment, the emission of two-beam lasers will appear, it is all right to strike the adjustable knob in picture 6 to make two-beam lasers completely shone on the child’s eyes.
Four methods for HN-300C amblyopia therapeutic equipment: laser therapy, afterimage training, red flash training and multi-spectral training etc.
1) Laser therapy
a. Put through power in accordance with installation instructions
b. Turn on the power switch, and the power light is on
c. Eyes of the patient close to observing window
d. Depress the laser key (pressing the laser key once will turn on the left laser and treat the left eye, pressing the laser key for two times will turn on the right laser and treat the right eye, pressing the laser key for three times will simultaneously turn on both the left and right lasers and treat both eyes simultaneously, when pressing for the fourth time, the laser goes out.) when the laser lamp is on, and treatment starts.
e. Amblyopia eye of the patient watches the high light of the laser emission until the laser goes out.
Remarks: The laser therapy time is 180 seconds. If a single eye is to be treated, another eye is required to be closed or be covered by an eye sticker. After therapy, open the unaffected eye or take off the eye sticker.
2) Multispectral Training
a. Put through power in accordance with installation instructions
b. Turn on the power switch, and the power light is on
c. Eyes of the patient close to observing window
d. Press multispectral button (Pressing multispectral button once will turn on the left multispectral twinkle and treat the left eye. Pressing multispectral button twice will turn on the right multispectral twinkle and treat the right eye. Pressing multispectral button three times will simultaneously turn on both the left and right multispectral twinkle and simultaneously treat both eyes. Pressing multispectral button the forth time, the multispectral twinkle goes out.) The multispectral light is on, and treatment starts.
Remark: When Multispectral Training, red, blue and green light twinkles and the training time is 180 seconds. If a single eye is to be treated, another eye is required to be closed or be covered by an eye sticker. After therapy, open the unaffected eye or take off the eye sticker.
3) Afterimage Training
a. Insert an insert plate as shown in Picture 7 according to Picture 5;
b. A patient observes the window and stares at the insert plate center with a single affected eye through left side；
c. Press “Afterimage” button；
d. The afterimage light is on. When the afterimage light turn dark, replace the insert plate as showed in Picture 8; The patient distinguishes animal pictures in the insert plate till the afterimage light goes out.
Remark: The training time with persistent high brightness is 30 seconds. When shifting to low brightness twinkle, the training time is 180 seconds.
Notice: One eye training every time. Another eye is required to be closed or be covered by an eye sticker. After therapy, open the eye or take off the eye sticker.
The insert plate with high brightness is as Picture 7.
The insert plate when twinkling with low brightness is as Picture 8
4) Red Light Twinkle Training
a. Put through power in accordance with installation instructions;
b. Turn on the power switch, and the power light is on;
c. Inset a red plate as showed in Picture 5;
d. Eyes of the patient close to observing window;
e. Press “Red Twinkle” button.
f. The patient stares at insert plate center till the twinkle light goes out.
Remark: Red ray filter permeates red light. The training time is 300 seconds. If a single eye is to be treated, another eye is required to be closed or be covered by an eye sticker. After therapy, open the unaffected eye or take off the eye sticker.
【Condition and Method for Transportation and Storage】
Indoor Storage with temperature of -10℃—50℃, less than 80%RH, no vibration, no caustic gas and proper ventilation. Not placed in the open air.
【Items Loading List】
a)Instructions for use 1；
b)Inspection certificate 1；
c)Training software 1 set；
d)Training picture book 2；
e)Access to Internet（quality goods validation）card 1;
f) After service card 1;
g) Laser Amblyopia device 1;
Insert plate 3
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