hydrosun®750 Instructions for Use - Eisenhut-Vet AG
hydrosun®750 Instructions for Use - Eisenhut-Vet AG
hydrosun®750 Instructions for Use - Eisenhut-Vet AG
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<strong>hydrosun®750</strong> <strong>Instructions</strong> <strong>for</strong> <strong>Use</strong><br />
DIRECTIONS FOR USE AND MAINTENANCE – <strong>hydrosun®750</strong><br />
1) GENERAL INFORMATION.................................................................................................................... 2<br />
2) COMPONENTS..................................................................................................................................... 2<br />
3) EXPLANATION OF SYMBOLS ON THE DEVICE.................................................................................... 3<br />
4) IMPORTANT! SAFETY INFORMATION ................................................................................................. 3<br />
5) CONTRAINDICATIONS ......................................................................................................................... 6<br />
6) INSTALLATION..................................................................................................................................... 7<br />
7) OPERATING HYDROSUN®750 ............................................................................................................. 7<br />
8) OPERATING THE TIMER ...................................................................................................................... 7<br />
9) DURATION OF TREATMENT ................................................................................................................ 8<br />
10) MAINTENANCE ................................................................................................................................. 8<br />
SAFETY INSPECTION .....................................................................................................................................8<br />
INSPECTION OF THE FILTER CUVETTE..............................................................................................................8<br />
11) CLEANSING ....................................................................................................................................... 9<br />
12) STOR<strong>AG</strong>E........................................................................................................................................... 9<br />
13) ENVIRONMENTAL PROTECTION........................................................................................................ 9<br />
14) REPLACEMENTS AND REPAIR ........................................................................................................ 10<br />
REPLACING THE FILTER CUVETTE .................................................................................................................10<br />
REPLACING THE LAMP, REMOVING VENTILATOR WITH HOUSING .....................................................................10<br />
REPLACING THE FUSES ...............................................................................................................................11<br />
15) WARRANTY AND SERVICE TO THE CUSTOMER ............................................................................. 11<br />
16) TROUBLE SHOOTING....................................................................................................................... 12<br />
17) ELECTROM<strong>AG</strong>NETIC COMPATIBILITY (EMC)................................................................................... 13<br />
TABLE 1: ELECTROM<strong>AG</strong>NETIC EMISSIONS.....................................................................................................14<br />
TABLE 2: RECOMMENDED SAFETY DISTANCES..............................................................................................14<br />
TABLE 3: ELECTROM<strong>AG</strong>NETIC STABILITY (INTERFERENCE RESISTANCE)............................................................15<br />
18) TECHNICAL SPECIFICATION............................................................................................................ 16<br />
<strong>hydrosun®750</strong>, HZG GB 10.08 1
<strong>hydrosun®750</strong> <strong>Instructions</strong> <strong>for</strong> <strong>Use</strong><br />
1) General in<strong>for</strong>mation<br />
Congratulations on your purchase of <strong>hydrosun®750</strong>! With its wide spectrum of application it can soon<br />
become an indispensable aid <strong>for</strong> you.<br />
This manual is an integral part of the device. Close observance of the in<strong>for</strong>mations given in the<br />
manual is a prerequisite <strong>for</strong> the intended use and <strong>for</strong> safe operation. Please unfold the photos at the<br />
end of this manual so that you can always easily have a look at them.<br />
The parts of the product described in this manual including accessories, which get in contact with the<br />
patient according to the instructions, are designed in a way that they fulfill the requirements of<br />
biocompatibility of the applicable standard if applied according to the instructions. This manual is in<br />
con<strong>for</strong>mity with the device specifications and the safety standards valid at the time of printing. All rights<br />
are reserved <strong>for</strong> devices, circuits, techniques, software programs and names appearing in the manual. No<br />
part of this manual may be reproduced without written permission from Hydrosun Medizintechnik<br />
GmbH. Subject to change! In case of any questions, please contact Hydrosun Medizintechnik GmbH or<br />
their representative.<br />
<strong>hydrosun®750</strong> is a medical radiation device which works with visible light (VIS) and waterfiltered<br />
infrared-A (WIRA). It can be used in the treatment of adults and children.<br />
<strong>hydrosun®750</strong> has been developed over years of thorough research and development and is particularly<br />
characterized by homogenous irradiation and high efficiency.<br />
WIRA® means water-filtered infrared-A. An aqueous solution which is hermetically sealed in a cuvette<br />
absorbs the skin-irritating wavelengths of the infrared radiation. Thus WIRA enables therapeutic heating<br />
of deeper tissue layers over longer periods of time without overheating of the superficial skin layers.<br />
Therapeutic use of the simultaneous visible light (VIS) is equally possible, e.g. therapy of acne or<br />
photodynamic therapy.<br />
2) Components (illustration 1)<br />
Different versions of <strong>hydrosun®750</strong> are available.<br />
On a table stand (illustration 1), on a mobile stand*, on a wall or a ceiling mount<br />
1. Timer<br />
2. Body with optics<br />
3. Water filter<br />
4. Deepening with colour filter<br />
5. Set screw (<strong>for</strong> tightening - prepared ready <strong>for</strong> use by the manufacturer)<br />
6. Housing of the ventilator<br />
7. Distance rod <strong>for</strong> keeping the safty distance, 32 cm (illustration 2)<br />
8. Support<br />
9. Combined plug element: connector plug, main switch off/on, box with fuses (also illustration 3)<br />
10. Table stand or adapter <strong>for</strong> attachment to the mobile stand<br />
11. Power cord<br />
*Vertical adjustment by pressing the button at the top of the stand while moving the device upward or<br />
downward! Illustration, see Instruction <strong>for</strong> Assembling hydrosun Mobile Stand 750.<br />
<strong>hydrosun®750</strong>, HZG GB 10.08 2
<strong>hydrosun®750</strong> <strong>Instructions</strong> <strong>for</strong> <strong>Use</strong><br />
3) Explanation of symbols on the device<br />
Caution, refer to accompanying documents<br />
Protective earth connection<br />
Fuse<br />
4) Important! Safety in<strong>for</strong>mation<br />
Please wear IR-eye protection when irradiating facial areas<br />
Separate collection of electrical and electronic devices<br />
In case of non-observance of the safety advice there is danger of life!<br />
The requirements of the directive MDD93/42/EEC are satisfied. The devices correspond to the guideline<br />
EN 60601-1-2:2006-10 <strong>for</strong> electromagnetic compatibility.<br />
• This manual ist an integral part of the device. It should always be kept near the device. Read the<br />
manual once in its entirety because in<strong>for</strong>mation pertinent to several chapters is given only once.<br />
• The use of the <strong>hydrosun®750</strong> is only permittet with a valid approval certificate <strong>for</strong> medical devices of<br />
the country where it is located.<br />
• There are no unfavourable influences on other device or from other devices known. In case of a<br />
common application of the Irradiator with other devices (e.g. measuring instruments) the<br />
functioning of these appliances should be checked be<strong>for</strong>e the application.<br />
• Portable and mobile HF-communication appliances (e.g. mobile phones) can influence medical<br />
electrical devices (see chapter 17).<br />
• Be<strong>for</strong>e using the Irradiator, the operator must ascertain that it is in correct working order and<br />
operating condition (inclusive visual control of the cuvette, see chapter 10).<br />
• Be<strong>for</strong>e initial operation please check if the indication of voltage on the device corresponds to the<br />
mains voltage.<br />
• Attention: In order to avoid the risk of an electric shock this device may only be connected to a<br />
mains power supply with a protective conductor.<br />
• Defective or damaged mains cable is to be replaced only by the manufacturer or an authorised<br />
person.<br />
• The power cord must be routed such that it cannot be damaged and that the device cannot move or<br />
overturn should someone inadvertently pull on the cord.<br />
• Do not use the connecting cable when it is convoluted (prevention of induction heating)!<br />
• Please avoid heavy vibrations of the device!<br />
• It is not allowed to operate the hydrosun®- Irradiator in a humid environment (e.g. bathroom, near a<br />
shower or a swimming pool)!<br />
<strong>hydrosun®750</strong>, HZG GB 10.08 3
<strong>hydrosun®750</strong> <strong>Instructions</strong> <strong>for</strong> <strong>Use</strong><br />
Continuance of safety in<strong>for</strong>mation<br />
• It is important to dry off thoroughly be<strong>for</strong>e a hydrosun®-treatment (e.g. after swimming, bathing or<br />
taking a shower).<br />
• Liquids must not be allowed to enter the Irradiator. If a liquid has entered the device, it must be<br />
checked by a service technician be<strong>for</strong>e being reused.<br />
• A defective <strong>hydrosun®750</strong> is to be repaired only by the manufacturer or an authorised person.<br />
• After any repair a savety inspection (chapter 10) is obligatory. Exception: the maintenance and<br />
replacement works described in this manual.<br />
• Do not operate the hydrosun®-irradiator unattended!!<br />
• Do not fall asleep when treating yourself!<br />
• After use or power failure switch off the device at the main switch(illustration 1, N o 10, and 3 N o 3)<br />
• Keep the hydrosun®-irradiator out of reach of children. While treating the special heat regulation<br />
system of infants must be considered.<br />
• The Hydrosun®750 must be placed on a solid, even base!<br />
• Do not expose the hydrosun®-irradiator to temperatures below zero (°C)! Permitted range of<br />
application 10 °C and 35 °C.<br />
• Application only in an environment without air draught!<br />
• A simultaneous cooling of the skin is only allowed in case of a suitable control (e.g. restriction of<br />
irradiance to
<strong>hydrosun®750</strong> <strong>Instructions</strong> <strong>for</strong> <strong>Use</strong><br />
Continuance of safety in<strong>for</strong>mation<br />
• If sensations of excess heating or stinging are experienced in an irradiated area, the Irradiator must<br />
be switched off immediately and the filter cuvette controlled (see chapter 10)<br />
• Avoid looking directly into the lamp when it is on, even if you are not blinded by the light. If parts of<br />
the face around the eyes are to be irradiated, undamaged and original hydrosun® infrared protective<br />
goggles must be worn. In order to make the googles more com<strong>for</strong>table comercially available cotton<br />
pads can be moistened and placed on the eyes under the googles.<br />
• During use, the device must be placed at a minimum distance of 35 cm from walls or from any<br />
inflammable or heat-sensitive objects. Objects in the irradiation area may become warm and catch<br />
fire.<br />
• Only original hydrosun® accessories are allowed to use with the hydrosun® Irradiator<br />
• The front of <strong>hydrosun®750</strong> gets rather hot during use. Do not touch the front part!<br />
• Wait <strong>for</strong> at least 15 minutes be<strong>for</strong>e service interventions, to allow the device to cool down.<br />
• The power cord must not come into contact with the hot filter at the front side of the device!<br />
• Be<strong>for</strong>e opening the <strong>hydrosun®750</strong> (e.g. <strong>for</strong> cleansing or replacing the lamp) the device must be<br />
disconnected from the electrical outlet.<br />
• Do not use damaged devices, disconnect them from the mains supply. In no case reconnect them!<br />
• Let treated areas of body cool down slowly, or even cover them. Do not cool them down too<br />
intensely.<br />
• Analgesics reduce the heat sensitivity of skin. When using analgesics do not simultaneously apply<br />
the hydrosun®-Irradiator without medical consultation!<br />
• If medications or other substances are applied to the irradiated area during or immediately<br />
temporally near to the treatment, their effect is likely to be considerably increased. Side effects, such<br />
as allergic reactions, may be increased or noticed <strong>for</strong> the first time in rare cases. Topical use of<br />
substances stimulating the blood flow should be avoided, since these substances will, as a general<br />
rule, have excessive and painful effects.<br />
• For home use, patients are required to consult their GP, a physician or a specialised therapist. This is<br />
imperative in particular when the device is used <strong>for</strong> wound healing or <strong>for</strong> adjuvant treatment of<br />
tumours (hyperthermia).<br />
• In case of hypersensitivity to infrared light be careful with the application of the hydrosun®-<br />
Irradiator! In case of doubt look <strong>for</strong> expert advice!<br />
• Areas showing swelling or inflammation with swelling or exertion of pressure should not be<br />
irradiated – the troubles may intensify by the heat. In case of doubt ask <strong>for</strong> competent advice!<br />
• Persons who cannot provide feedback or persons with malfunctioning sensorium (e.g. diabetic<br />
neuropathy) must be kept under surveillance closely while treated. The same is necessary at<br />
treatment of areas with inferior blood perfusion or thin subcutaneous tissue (as <strong>for</strong> example at the<br />
shinbone). The control of the filter cuvette (see chapter 10) is always necessary be<strong>for</strong>e treatment of<br />
these patients! Possibly increase the irradiation distance!<br />
• The use of <strong>hydrosun®750</strong> at the same time as other devices supplying energy to the patient (e.g.<br />
ultrasound or electrotherapie devices) is only allowed after consulting the manufacturer.<br />
Other joint applications with processes supplying energy or material to the patient are not allowed<br />
due to lacking experience. In case of a well-founded interest in such combinatioons, please consult<br />
the manufacturer.<br />
• The inner screws of the water filter (illustration. 7, No. 2), must never be opened nor removed :<br />
otherwise the water filtering can be destroyed resulting in a strong risk of burns!<br />
• This particular Irradiator is not suitable <strong>for</strong> neonatology.<br />
• The Irradiator must not be operated with trans<strong>for</strong>mer or with different supply voltage or supply<br />
frequency (see chapter 18).<br />
<strong>hydrosun®750</strong>, HZG GB 10.08 5
<strong>hydrosun®750</strong> <strong>Instructions</strong> <strong>for</strong> <strong>Use</strong><br />
5) Contraindications<br />
General contraindications <strong>for</strong> local IR-A-irradiation<br />
• elevated photosensitivity: therapy with photosensitizing medicaments (e.g. porphyrins, tetracyclines,<br />
sulphonamides, psoralenes, phenothiazines)<br />
• porphyria (inborn photosensitivity)<br />
• contact with photosensitizing plants (e.g. St. John's wort - "Hypericum per<strong>for</strong>atum“)<br />
• thermo urticaria<br />
• fresh haematoma (bruise), apart from that can be assumed that an increased resorption of wound<br />
seroma and wound haematoma by WIRA irradiation is achievable<br />
Contraindications <strong>for</strong> local hyperthermia at the extremities<br />
• acute phlebothrombosis<br />
• varicosis (varicose vein complaint)<br />
• serious arterial occlusive disease (stages III and IV)<br />
• lymphatic vessel illness (lymph oedema, lymphangitis, and others)<br />
• arterial ulcer<br />
• neuropathic ulcer<br />
• open injury<br />
• acute unclarified skin disease<br />
• acute rheumatoid arthritis<br />
• acute attack of gout<br />
• diabetic neuropathy<br />
Contraindications <strong>for</strong> extensive hyperthermia at the body trunk<br />
• serious febrile illness<br />
• serious cardiac insufficiency<br />
• serious hypertonia<br />
• serious arterial vessel lesions<br />
• serious vegetative distonia<br />
• serious respiratory insufficiency<br />
• consuming system illness<br />
• hyperthyreosis<br />
• taking of betablockers<br />
• pregnancy<br />
• cardiac pace maker<br />
Contraindications <strong>for</strong> IR-A-irradiations in the area of the head<br />
• acute otitis media<br />
• acute parotitis<br />
• cataract<br />
• glaucoma<br />
• epilepsy<br />
<strong>hydrosun®750</strong>, HZG GB 10.08 6
<strong>hydrosun®750</strong> <strong>Instructions</strong> <strong>for</strong> <strong>Use</strong><br />
6) Installation<br />
Table device: Take the hydrosun® Irradiator and the table stand out of the shipping box, unpack, and<br />
mount the table stand on the device according to its separate instruction. Then place it, with the food of<br />
the stand on a solid surface.<br />
Mobile stand: If you have acquired an Irradiator with a mobile stand or wall mount, please assemble the<br />
device as described in the separate instructions.<br />
7) Operating <strong>hydrosun®750</strong><br />
- Using the power cord connect the device at first to the connector plug (illustration 1, N o 9; illustration<br />
3, N o 1) and afterwards to a properly installed wall outlet of the mains network.<br />
- Turn the device on by setting the main switch to “ I “ (illustration 1, N o 9; illustration 3, N o 3). The<br />
display and the relay of the timer will energize you can set the desired amount of minutes required<br />
(chapter 8) and start the treatment. The light beam will make it easier <strong>for</strong> you to direct <strong>hydrosun®750</strong><br />
to the area to be treated.<br />
- In order to keep the minimum distance, the distance rod must be observed (illustration 1, N o 7). It must<br />
be guaranteed during treatment that the distance does not fall below the minimum distance (e.g.<br />
through movements during the period of irradiation).<br />
- For persons with particularly sensitive skin, a greater distance may be required to ensure that they feel<br />
com<strong>for</strong>table during treatment. In certain cases a greater distance is imperative (e.g. wound treatment).<br />
However, it should be taken into account that in case of a larger distance the treated area of body is<br />
extended whereas the intensity of the irradiation decreases.<br />
- In case of a longer period of non-use or after a day of use the device is to be switched off completely<br />
at the main switch (illustration 1, N o 10; illustration 3, N o 3).<br />
8) Operating the timer (illustration 1, N o 1; illustration 4)<br />
Key functions<br />
[PROG] Select between hours, minutes and seconds.<br />
[+] Increments the selected time range.<br />
[–] Decrements the selected time range<br />
[RESET] Resets to start time<br />
[START/STOP] Starts and stops the countdown<br />
Setting the time: Press the [PROG] button once. This will cause the hour digit to flash. Using the [+] [–]<br />
keys to set the desired amount of hours required. When keeping keys [+] or [–] depressed, the fashing<br />
digit will change upwards or downwards. Repeat the process to set minutes and seconds. Pressing<br />
[ PROG ] again returns the timer from the programming mode to the chronometry mode. Please note:<br />
After starting the countdown, the key [PROG] is without functions until counting is finished.<br />
Operation: Press the [START/STOP] button to start the device and the set time begins to count down in<br />
one second steps. If the [START/STOP] button is pressed during the countdown period, the device will<br />
deenergize and time remaining is shown on the display. Pressing [ START/STOP ] again restarts the<br />
device, the countdown continues. When the set time reaches zero the unit emits an audible signal, the<br />
device deenergizes and the set time is indicated on the display.<br />
<strong>hydrosun®750</strong>, HZG GB 10.08 7
<strong>hydrosun®750</strong> <strong>Instructions</strong> <strong>for</strong> <strong>Use</strong><br />
Resetting to the time: If the device is stopped with [START/STOP] during the countdown period<br />
optionally the [RESET] button will set the time back to the start time.<br />
Total reset: Press and hold down all three buttons <strong>for</strong> approx four seconds. > 0:00,oo < will appear on<br />
the display.<br />
Operating without time setting: If [START/STOP] is pressed and the display shows > 0:00,oo -:-- < to indicate loss of power.<br />
When power is resumed the remaining time will be shown and the timer will need to be restarted..<br />
9) Duration of treatment<br />
The maximum application period of 60 minutes per session must not be exeeded unless after consulting<br />
a physician and under medical care.<br />
10) Maintenance<br />
Safety inspection<br />
- The Irradiator must be checked yearly <strong>for</strong> its safety. The standard DIN EN 60 601-1 <strong>for</strong> electrical<br />
medical devices has to be applied <strong>for</strong> the inspection.<br />
Possible regulations of professional associations and worker´s compensation boards typical <strong>for</strong> the<br />
particular country where the device is runmust be followed.<br />
- Thermal inspection: The device must switch off within 240 s when the ventilator is blocked. For this<br />
inspection the irradiator must have room temperature (24° C ±2° C) at the beginning of the<br />
measurement. The ventilator is blocked, then the device is switched on and the time stopped. Within<br />
240 s the halogen lamp must switch off. The unblocked ventilator keeps on running. The inspection is<br />
successful. Please also effect the following: Visual and function control <strong>for</strong> damage of the<br />
mechanical components, especially of the load-bearing parts. In case of doubt exchange them!<br />
Inspection of the Filter Cuvette<br />
- First, remove the optical filters (chapter 14)! Align the irradiator horizontally, turn it on and briefly look<br />
into the Irradior at an angle (Never look straight into the Irradiator at the incandescent filament<br />
danger of dazzle!).<br />
- If liquid level is visible behind the first window pane (illustration 5), the cuvette is exhausted and must<br />
be replaced (chapter 14).<br />
- If no liquid level is visile the filter is OK. Particles floating in the water do not impair the effectiveness<br />
of the filter. If a black filter is fitted, the filter cuvette must be removed be<strong>for</strong>e the inspection (Kap.<br />
14). Then look straight into the filter cuvette from the back to check the liquid level.<br />
- This easy visual inspection is recomended every time you put the Irradiator into operation. It must be<br />
carried out approximately after 3.000 h or after one year at the latest. Effect this inspection at least<br />
quarterly.<br />
<strong>hydrosun®750</strong>, HZG GB 10.08 8
<strong>hydrosun®750</strong> <strong>Instructions</strong> <strong>for</strong> <strong>Use</strong><br />
11) Cleansing<br />
Please cool the device down and disconnect it from the mains supply be<strong>for</strong>e all cleansing works! Due to<br />
the air cooling of the waterfilter, on the rear glass of the filter intercepts dust of the surrounding area.<br />
Remove dust when necessary (approx. every 3 months).<br />
The filter cuvette and the housing of the ventilator must be removed <strong>for</strong> cleansing (chapter 14):<br />
- Wipe the reflector (illustration 6a) and the funnel-shaped heat shield (illustration 6b) carefully with a<br />
dry, lint-free cloth.<br />
- Clean the rear glass of the filter with a dry, lint-free cloth. Should the glass be very dirty, you can add<br />
a standard commercial dishwashing liquid. Subsequently, wipe the glass clean with a lint-free cloth<br />
without detergent. Do not use abrasive cleansing agents!<br />
- Reinstall the cuvette by reversing the above operating steps (chapter 14).<br />
Usually it will be sufficient to clean the external surfaces of the Irradiator with a dry dust cloth. If<br />
necessary, use a moist cloth and a mild household detergent to remove dirt from the Irradiator.<br />
12) Storage<br />
Store the Hydrosun®750 in a cooled-off state and with the mains plug disconnected at a dry, normally<br />
tempered place.<br />
13) Environmental Protection<br />
At the end of their service life, the Irradiator and its accessories must be disposed in compliance with the<br />
applicable local waste control regulations. The Irradiator only contains non-hazardous substances. At the<br />
end of the durability do not throw the device into the normal domestic waste. Please bring it <strong>for</strong><br />
recycling to an official collection point. That way you help to preserve the environment. For disposal, the<br />
Irradiator can be returned to Hydrosun Medizintechnik GmbH carriage paid. Consignments which are not<br />
delivered freight paid will not be accepted and will be returned at the expense of the sender.<br />
<strong>hydrosun®750</strong>, HZG GB 10.08 9
<strong>hydrosun®750</strong> <strong>Instructions</strong> <strong>for</strong> <strong>Use</strong><br />
14) Replacements and repair<br />
Only original accessories of the manufacturer Hydrosun are allowed to be used with <strong>hydrosun®750</strong>!<br />
This is also valid <strong>for</strong> the mains cable!<br />
In case of non-observance there may be danger of life <strong>for</strong> user and patients!<br />
Replacing the Filter Cuvette (illustration 7)<br />
Demounting of the filter cuvette (because liquid level is visible, or <strong>for</strong> cleansing): Swivel the cooled of<br />
and from mains disconnected device into a vertical position with the filter at the top. Loosen the three<br />
outer screws (illustration 7, N o 1) on the front side of the cuvette with an Allan key (N o 3) and remove<br />
the screws. Now you can remove the filter cuvette. The inner screws of the water filter (illustration. 7,<br />
N o 2), must never be opened nor removed: otherwise the water filtering can be destroyed resulting in a<br />
strong risk of burns!<br />
Reinstall the cuvette or the replacement cuvette by reversing the above operating steps. First of all turn<br />
all screws loosely in until all of them are locked in place. Only then tighten all of them firmly.<br />
After receiving your order, the Hydrosun Customer Service will send you a new filter as soon as possible.<br />
When you receive the new filter, please return the defective one in the special shipping box. Please find<br />
the address and telephone number of the Hydrosun customer service in chapter 15.<br />
Replacing the lamp, removing ventilator with housing (illustration 8)<br />
The lamps have a service life of approx. 1,500 operating hours. <strong>Use</strong> only the lamp types indicated in the<br />
Technical Specifications chapter. Using lamps with other specifications will cause damage to the<br />
Irradiator or impair its functionality. Lamps can be obtained through the hydrosun® Customer Service<br />
(see chapter 15).<br />
- Using the supplied Allan key (N o 3), loosen and remove the four fastening screws on the back of the<br />
cooled of and disconnected device (illustration 8a).<br />
- Remove the faceplate (illustration 8b).<br />
- Now you can take out the housing of the ventilator (illustration 8c and d).<br />
- Spread the two retaining clips (illustration 8e, N o 1).<br />
- Hold the cooling element of the halogen lamp with the fingers and pull the lamp out of the base<br />
(illustration 8f).<br />
- Caution, Lamp Damage: Never touch the glass bulb of the lamp. Hold it by the protective cover or the<br />
lamp base cooling element. Otherwise, sweat, oil or grease will cause the glass to break when the lamp<br />
warms up. If the glass is accidentally touched with bare fingers, it must be cleaned with a cloth<br />
moistened with alcohol be<strong>for</strong>e use.<br />
- Be<strong>for</strong>e putting in the new halogen lamp please adjust the retaining clips again (illustration 8f, N o 1), so<br />
that after the assembly the retaining clip snaps in into the lamp base on each side.<br />
- When mounting the ventilator housing the halogen lamp must be carefully inserted into the borehole<br />
of the reflector (illustration 8g, N o 2) (borehole is always visible through the big rectangular opening in<br />
the housing), so that the lamp is not damaged.<br />
- Now fix the ventilator housing after attaching the ring facing (with the fixing screws). First of all turn<br />
all screws loosely in until all are fixed. Only then tighten all of them firmly.<br />
<strong>hydrosun®750</strong>, HZG GB 10.08 10
<strong>hydrosun®750</strong> <strong>Instructions</strong> <strong>for</strong> <strong>Use</strong><br />
Replacing the fuses (illustration 3)<br />
- Cooled off and disconnected device: Bend the two safety clips inwards (illustration 3, N o 2 and 4) e.g.<br />
with a small screwdriver (put the screwdriver into the outermost, narrow slots, illustration. 3, N o 4) and<br />
take the safety box out of the connector universal element (illustration 3, N o 5).<br />
- Then pull out the fuses out of the box and put in the new ones.<br />
- Now insert the box carefully into the connector universal element and press it in until you hear the<br />
snaping of the safety clips.<br />
15) Warranty and service to the customer<br />
The manufacture warrants all parts, excluding lamps (illuminants), to be free from defects <strong>for</strong> a period of<br />
2 years from the date of delivery. During this warranty period we will correct any defects, if the defect is<br />
due to faulty material or workmanship. Not covered by the warranty is, if applicable <strong>for</strong> the respective<br />
product,<br />
- damage resulting from incorrect or improper use (e.g. connecting the device to the wrong voltage or<br />
current or to an unsuitable power source, damage of the illuminant),<br />
- damage resulting from improper operation or resort to violence,<br />
- usual wear and tear,<br />
- damage that only insignificantly affects the value or usefulness of the device.<br />
- The halogen lamp (illuminant) is generally excluded from the warranty.<br />
The warranty and the manufacturer´s third part liability becomes null and void if any unauthorised<br />
person tampers with the device or if spare parts are used other than original and identified hydrosun®<br />
parts.<br />
If you have got any questions, feel free to contact Hydrosun or our partner in your country (see back<br />
cover <strong>for</strong> address and telephone number). Our address:<br />
Hydrosun Medizintechnik GmbH Tel. +49- (0) 7631 / 3 66 32 – 0<br />
Mauchener Str. 14 Fax: +49- (0) 7631 / 3 66 32 – 9<br />
D-79379 Muellheim, Germany info@hydrosun.de / www.hydrosun.eu<br />
<strong>hydrosun®750</strong>, HZG GB 10.08 11
<strong>hydrosun®750</strong> <strong>Instructions</strong> <strong>for</strong> <strong>Use</strong><br />
16) Trouble shooting<br />
If <strong>hydrosun®750</strong> does not function as desired, first have a look at the following list. If your problem is<br />
not included in the list, the device has a defect.<br />
In this case please contact your representative or directly Hydrosun Medizintechnik GmbH.<br />
Problem Cause Solution<br />
The irradiated area feels hot on the<br />
skin despite a regular distance of<br />
32 cm (distance rod completely<br />
extended), or patients complain<br />
about excess heating or stinging<br />
sensations.<br />
The filtering effect of the patented<br />
filter cuvette is partly or<br />
completely missing. This may<br />
happen after several years making<br />
use of hydrosun and if the<br />
indications <strong>for</strong> use have not been<br />
observed (see chapter 10)<br />
A futher possibility is that the filter<br />
cuvette is damaged e.g. through<br />
transport, although this rarely<br />
occurs. Please check the cuvette<br />
(chapter 10).<br />
Irradiator does not illuminate Main switch/timer has turned off<br />
No connection to power line<br />
Irradiator switches repeatedly off<br />
and on again, fan continues to run<br />
Irradiator switches unintentionally<br />
off, fan continues to run<br />
Fan not running although Irradiator<br />
is illuminated<br />
Irradiator´s fuses are defect<br />
Lamp defect<br />
No power<br />
Safety cut-out has turned off the<br />
device<br />
Safety cut-out has turned off the<br />
device because the ventilation is<br />
impaired, e.g. air vents are covered<br />
and / or<br />
the room is too hot<br />
Fan blocked<br />
Fan defect<br />
The cuvette must be replaced. See<br />
chapter 14. (In some seldom cases<br />
of quite sensible persons - despite<br />
the cuvette is O.K. - it is<br />
recommended to enlarge the<br />
distance to 35-40 cm.<br />
Caution – Skin burns!<br />
The Irradiator must not be used<br />
until a new hydrosun filter cuvette<br />
has been installed.<br />
Turn on power switch<br />
Check power connector and plug<br />
in, if applicable<br />
Check fuses, replace if necessary or<br />
Replace lamp (chapter 14)<br />
Check power supply<br />
see below under "Irradiator<br />
switches unintentionally...“, if these<br />
measures do not help, the safety<br />
cut-out must be replaced by the<br />
Customer Service or at the factory.<br />
Turn off main switch. Check that<br />
air vents at the front and back are<br />
free. Wait until safety cut-out<br />
resets with an audible click.<br />
Turn off power switch. Lower room<br />
temperature, e.g., by airing the<br />
room or installing air conditioning<br />
in the room. Wait until safety cut-<br />
out resets with an audible click.<br />
Immediately turn off device and<br />
disconnect it from power line. Open<br />
back of Irradiator, see chapter 14,<br />
illustration 8. Check whether it is<br />
possible to rotate the fan manually,<br />
remove any objects that block the<br />
rotation.<br />
If these measures did not succeed,<br />
the fan must be replaced at the<br />
factory.<br />
<strong>hydrosun®750</strong>, HZG GB 10.08 12
<strong>hydrosun®750</strong> <strong>Instructions</strong> <strong>for</strong> <strong>Use</strong><br />
Bubbles in the filter cuvette Vibration during transport,<br />
unfavourable operating conditions<br />
Single bubbles do not impair the<br />
function and safety. A large<br />
number of small bubbles may<br />
slightly reduce the filter effect.<br />
The Irradiator should be switched<br />
on, aligned horizontally and the<br />
filter is slightly knocked with hard,<br />
blunt object e.g. the handle of a<br />
screwdriver, until the bubbles leave<br />
the glas plate and move up.<br />
Particles floating in the filter liquid. Caused during production Usually the small size and number<br />
of floating particles does not affect<br />
the irradiation intensity.<br />
Milky filter glass Dust on filter Clean the filter (chapter 11)<br />
Milky layer on inside of filter glass Not yet known Tin layer at the center of the glass<br />
will not impair the irradiation<br />
intensity and does not need to be<br />
removed.<br />
Rings, irregular in shape and<br />
rainbow-coloured on the front of<br />
the filter<br />
17) Electromagnetic Compatibility (EMC)<br />
Optical phenomenon, so-called<br />
Newton´s rings: result of<br />
interference between two, almost<br />
planar surfaces that are in contact<br />
If the layer covers the entire filter<br />
glass, the filter needs to be<br />
replaced (chapter 14).<br />
This phenomenon cannot be<br />
eliminated, but it does not affect<br />
the irradiation intensity.<br />
Electromagnetic environment:<br />
<strong>hydrosun®750</strong> is suitable <strong>for</strong> the use in all stationary facilities including the living area and those which<br />
are directly connected to a public mains supply which also supplies residential buildings. Guidelines<br />
concerning installation, maintenance and repair: The installation and maintenance of <strong>hydrosun®750</strong><br />
must be effected EMC-compatible. The application of other accessories than indicated can lead to an<br />
increased emission and/or reduced immunity. Repairs that are not EMC-compatible can also lead to an<br />
increased emission and/or reduced immunity.<br />
Guidelines <strong>for</strong> operation:<br />
Electronic devices are sensitive to electrostatic discharges and high-frequency electromagnetic fields. For<br />
the prevention of operational disturbances of <strong>hydrosun®750</strong> electrostatic charging of the user should be<br />
avoided by ESD safety measures (application of antistatic materials). In order to avoid disturbances by<br />
electrostatic discharges the floors should be made of wood or concrete or be furnished with ceramic<br />
tiles. If the floor is made of synthetic material the relative humidity should at least be 40 %. In order to<br />
avoid disturbances of the timer of the <strong>hydrosun®750</strong> by HF-variable disturbances, the user should keep a<br />
minimum distance of 3 meters to portable and mobile HF-telecommunication appliances (More details<br />
<strong>for</strong> this can be found in the table 2 „Recommended safety distances “). <strong>hydrosun®750</strong> uses HF-energy<br />
exclusively <strong>for</strong> its own function. There<strong>for</strong>e the emission of high-frequency variable disturbances is<br />
extremely low and it is very unlikely that other devices operated nearby are disturbed. Nevertheless it<br />
<strong>hydrosun®750</strong>, HZG GB 10.08 13
<strong>hydrosun®750</strong> <strong>Instructions</strong> <strong>for</strong> <strong>Use</strong><br />
should be taken into consideration that a combined operation of <strong>hydrosun®750</strong> together with other<br />
appliances can lead to disturbances of Hydrosun®750 or other appliances. Thus it should be taken care<br />
that <strong>hydrosun®750</strong> may not be directly positioned next to or above another electronic device. If it is not<br />
possible to avoid a positioning of <strong>hydrosun®750</strong> directly near medical, analogue measuring devices, it<br />
must be pointed out to the user of these measuring devices that it is necessary to monitor the results of<br />
the device in order to check the correct use of the device in the positioning chosen.<br />
Table 1: Electromagnetic emissions<br />
Measurements of emissions Con<strong>for</strong>mities<br />
radiation-coupled HF-emission according to CISPR 11 group 1, class B<br />
grid-bound HF-emission according to CISPR 11 class B<br />
overtones according to IEC 61000-3-2 is con<strong>for</strong>ming<br />
voltage fluctuations/patcher according to IEC 61000-3-3 is con<strong>for</strong>ming<br />
Table 2: Recommended safety distances<br />
between portable and mobile telecommunication appliances and <strong>hydrosun®750</strong>:<br />
<strong>hydrosun®750</strong> is determined <strong>for</strong> the operation in an electromagnetic environment where the HF-variable<br />
disturbances are controlled. The user of <strong>hydrosun®750</strong> can help to avoid electromagnetic disturbances by<br />
keeping the minimum distance between portable and mobile HF-telecommunication appliances (emitter)<br />
and <strong>hydrosun®750</strong> depending on the power output of the emitter.<br />
Nominal capacity of the Safety distance depending on the emission frequency<br />
emitter [W] 150 kHz-80MHz 80 MHz-800MHz 800 MHz-2,5 GHz<br />
0.01 0.12 0.12 0.23<br />
0.1 0.38 0.38 0.73<br />
2 1.7 1.7 3.25<br />
10 3.7 3.7 7.3<br />
100 12 12 23<br />
From this results a safety distance of approx. 3 m to mobile phones with D1- and E-band whose<br />
transmitting capacity is limited to approx. 2 Watt.<br />
<strong>hydrosun®750</strong>, HZG GB 10.08 14
<strong>hydrosun®750</strong> <strong>Instructions</strong> <strong>for</strong> <strong>Use</strong><br />
Table 3: Electromagnetic Stability (interference resistance)<br />
Inspections of stability IEC 60601-Inspection level Level of con<strong>for</strong>mity<br />
Discharge of static electricity<br />
(ESD) according to IEC 61000-4-<br />
2<br />
radiated HF-fields according to<br />
IEC 61000-4-3<br />
rapid transient electric variable<br />
disturbances (Burst) according<br />
to IEC 61000-4-4<br />
surge voltages (surges)<br />
according to IEC 61000-4-5<br />
conducted high frequency<br />
according to IEC 61000-4-6<br />
magnetic field at the frequency<br />
of the supply voltage according<br />
IEC 61000-4-8<br />
voltage drops, short-term breaks<br />
and fluctuations of the supply<br />
voltage according to IEC 61000-<br />
4-11<br />
+/- 6 kV contact-<br />
+/- 8 kV air discharge<br />
80 MHz-2,5 GHz: 3V/m; (not<br />
keeping alive)<br />
+/- 2 kV on power line<br />
+/- 1 kV on signal line<br />
+/- 2 kV common mode voltage.<br />
+/- 1 kV push-pull voltage<br />
3V / 150 kHz up to 80 MHz (not<br />
keeping alive)<br />
3A/m 3A/m<br />
< 5% Ur <strong>for</strong> 10 msec<br />
40% Ur <strong>for</strong> 100 msec<br />
70% Ur <strong>for</strong> 500 msec<br />
< 5% Ur <strong>for</strong> 5000 msec<br />
+/- 6 kV contact-<br />
+/- 8 kV air discharge<br />
80 MHz-2,5 GHz: 3V/m; (not<br />
keeping alive)<br />
+/- 2 kV on power line<br />
+/- 1 kV on signal line<br />
+/- 2 kV common mode voltage<br />
+/- 1 kV push-pull voltage<br />
3V / 150 kHz up to 80 MHz (not<br />
keeping alive)<br />
< 5% Ur <strong>for</strong> 10 msec<br />
40% Ur <strong>for</strong> 100 msec<br />
70% Ur <strong>for</strong> 500 msec<br />
< 5% Ur <strong>for</strong> 5000 msec (system<br />
cuts off, re-start possible)<br />
<strong>hydrosun®750</strong>, HZG GB 10.08 15
<strong>hydrosun®750</strong> <strong>Instructions</strong> <strong>for</strong> <strong>Use</strong><br />
18) Technical Specification<br />
Design: Halogen lamp as radiation source, hermetical sealed cuvette as water filter (Life of the Filter:<br />
3.000 hours ~3-4 years), radio-interference-free AC fan <strong>for</strong> convection cooling, electronic timer to<br />
determine the treatment time.<br />
Product type: hydrosun® Irradiator 750 with digital timer<br />
Irradiation Area visible at a Distance of 32 cm (distance rod): 28 cm diameter<br />
Radiation emission: WIRA® (waterfiltered infrared A) and VIS (visible light), no UV-radiation<br />
Technical data of <strong>hydrosun®750</strong> depending on rated voltage and power consumption:<br />
<strong>Use</strong> only the spare parts metioned in this chart (!):<br />
Rated Voltage Power Con- Infrared Source Average life Irradiance (distance 32 cm = distance rod)<br />
50/60 Hz sumption USHIO of source colour filter BTE31 / without colour filter<br />
230 VAC 600 W HPL 575/230X + 1,500 hours 160 mW/cm² ±10% 180 mW/cm² ±10 %<br />
230 VAC 775 W HPL 750/230X+ 1,500 hours 200 mW/cm² ±10% 225 mW/cm² ±10%<br />
Fuses (2 pieces): Type M8 A (slow blow fuse) <strong>for</strong> all voltage conditions<br />
Protection class: 1 (N o one)<br />
Safety Switch: Automatic cut-out, self-resetting when Irradiator cools down (restart)<br />
Dimensions: Length 28 cm (not including distance rod), width 27 cm, height 28 cm<br />
Weight: Approx. 7.5 kg (with table stand)<br />
Ambient Conditions: Temperature +10 °C, max. 35 °C (operation); above 0 °C, max. 50 °C (storage).<br />
Relative humidity 25% to 95% (no condensation allowed). Atmospheric pressure 600 hPa to 1060 hPa.<br />
Lifetime of Water Filter: approximately 3000 operating hours or approximately 3 years (only storing<br />
without using the water filter does not increase the lifetime substantially)<br />
Classification: Active medical device, class IIa according to 93/42/EEC European Medical<br />
Device Directive (MDD) §13, Rule 9<br />
CE Certification: In compliance with directive 93/42/EEC of June 14, 1993 (Medical Device Directive,<br />
MDD), essential requirements, and harmonised standard EN 60 601-1<br />
0535<br />
<strong>hydrosun®750</strong>, HZG GB 10.08 16