HEINE OMEGA 500, 500 UNPLUGGED with LED and XHL Illumination Instructions for Use Aug 2008

HEINE OMEGA® 500 HEINE OMEGA® 500 UNPLUGGED with LED and XHL Illumination

DEUTSCH

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ENGLISH

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FRANÇAIS

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ESPAÑOL

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ITALIANO

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SVENSKA

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NEDERLANDS

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SUOMI

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PORTUGUÊS

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ENGLISH

HEINE OMEGA® 500 HEINE OMEGA® 500 UNPLUGGED with LED and XHL Illumination Please read and follow the instructions for use of HEINE OMEGA® 500 and keep them for future reference. General Conditions of Warranty Instead of the statutory warranty time period of 2 years, HEINE will grant a guarantee of 5 years from the date of the consignment of the goods ex works, concerning its equipment (excluding disposables, e.g. bulbs, single-use articles, and rechargeable batteries). The guarantee covers irreproachable workmanship, on condition of the proper use of the equipment and the observation of the operating instructions. During the warranty- and guarantee time period, errors and deficiencies arising on the equipment will be rectified free of charge, in so far as such are evidenced by defective materials, processing and/or constructional errors. Should buyer complain of a material deficiency during the warranty time period, then the onus of proof is always to be on the orderer, that the product was defective already upon receipt of the goods. The statutory warranty and the guarantee do not apply to loss or damage caused by wear and tear, negligent use, the non-employment of original HEINE components and/or spares (in particular bulbs, as these have been especially developed for HEINE instruments in accordance with the following criterions: colour temperature, useful service life, safety, optical quality and performance. The statutory warranty and the guarantee do not apply to interventions by persons not authorised by HEINE or when the operating instructions are not observed by the customer. Any modification of a HEINE product with parts or additional parts which do not conform to the original HEINE specification will invalidate the warranty for the correct function of the product and further invalidate any warranty claims which result from such a change or modification. Further claims, in particular claims for replacement of loss or damage, which are experienced otherwise than directly on the HEINE product itself, are hereby excluded. For U.S. only: Federal law restricts this device to sale by or on the order of a Physician or Practitioner. Warnings and Safety Information Caution! Indicates potential hazardous situations. Ignoring the corresponding instructions may lead to dangerous situations of mild to moderate extent. (Background color yellow, foreground color black.) Note! Note indicates valuable advice in terms of installation, operation, maintenance or repair. Notes are important, but not related to hazardous situations. Intended Use The indirect Ophthalmoscope HEINE OMEGA® 500 is an AC-powered or battery powered device for medical professionals, containing illumination and viewing optics intended to examine the media, cornea, aqueous, lens, vitreous and the retina of the eye.

Product overview 1 Headband height adjustment knob 2 Adjustment knob 3 Optics unit 4 Optics overband 5 Position control 6 Filter Control 7 Aperture Control 8 Control Locks 9 Rotary knob 10 Mount for Teaching Mirror 11 Operating lever 12 Bulb cover 13 Lamp 14 Brightness control HC 50 L 15 Guide pin 16 Hole for guide pin 17 Pin 18 Release 19 Detent plate 20 Guide pin 21 Cable guide 22 Headband size adjustment knob 23 Segment cover 24 HC 50 L connecting cable with UNPLUGGED socket Setting up the HEINE OMEGA® 500 HEINE OMEGA® 500 can be used with HEINE LED or 5 Watt XHL bulbs. Operation with the HEINE® mPack or EN50: To operate the HEINE OMEGA® 500 with the HEINE® mPack or HEINE® EN50, connect the short cable (24) from the HC 50 L brightness control (14) to the connecting cable (Cinch) and secure it in the cable guide (21). Connect the connecting cable (Cinch) to the HEINE® mPack or the HEINE® EN50 and set the brightness on the instrument with the HC 50 L brightness control (14), (Fig. 1). Operation with the mPack UNPLUGGED: To operate the HEINE OMEGA® 500 with the HEINE® mPack UNPLUGGED, first remove the cover from the rear segment (23) on the headband. To do this, slide the segment cover from the headband in the direction of the arrow (Fig. 2). Next, fit the HEINE® mPack UNPLUGGED to the headband. To do this, hold the headband with your left hand and using your right thumb, slide the HEINE® mPack UNPLUGGED to the left until it latches audibly. Connect the short cable (24) from the HC 50 L brightness control (14) to the HEINE® mPack UNPLUGGED. Switching on and adjustment of brightness are carried out by means of the rotary knob on the HC 50 L brightness controller (14), (Fig. 3). Operation with Power supply for HC 50 L brightness controller: To operate the HEINE OMEGA® 500 with power supply, please connect the short cable (24) of the brightness controller HC 50 L (14) with the connection cable (UNPLUGGED connector) secure it in the cable guide (21). Connect the connecting cable (Cinch plug) with the power supply and set the brightness using the brightness controller HC 50 L (14) on the instrument (Fig. 1).

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Filter Control: The filter control (6) can be used to select an interference red-free filter, a blue or a yellow filter which can be introduced into the illumination beam. Synchronized adjustment of Convergence and Parallax: This feature ensures the best possible stereopsis and image quality for any pupil size by simultaneous adjustment of the observation and illumination beams. For a dilated pupil, move the control (11) underneath the instrument to the large circle position. For a small pupil, move the control to the small circle position. The control (11) can be positioned anywhere between these two settings to select the optimum parallax and stereopsis (convergence) for any pupil size. The illumination beam can be adjusted vertically by the control (9). Teaching Mirror: The optional teaching mirror can be slid onto the fixture (10) of the optics. Changing the bulb (does not apply to OMEGA 500 LED): First allow the instrument to cool down.

HEINE OMEGA® 500 operation Basic Adjustments: Switch the instrument on by means of the rotary knob (brightness control) on the HC 50 L brightness controller. Aperture wheel (7) and filter wheel (6) should be rotated upwards to select the large aperture with white light. Control (11) should be in the middle position. The beam control (9) should be in the mid-position. Slide the eyepieces into position to match your P.D. or select the mid-position on the scale. Setting the brightness: If you use OMEGA 500 with LED, please adjust a slightly higher brightness initially and reduce the brightness afterwards. Control Locks: The aperture and filter controls can be locked into position by means of the lock (8) to avoid unintentional operation. Aperture Control: 3 different aperture sizes and a diffuser aperture can be selected by means of the aperture control (7). The choice of aperture depends mainly on the size of the patient’s pupil. The diffuser is useful for photophobic patients and the examination of the periphery.

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Disconnect the instrument from the power source. Unscrew the control (2) so that the optics unit (3) is free to move. Slide the bulb cover (12) upwards. Do not pull on the cord. Swivel the optics unit (3) to enable the bulb (13) to be pulled out of the bulbholder. Clean the glass dome of the new bulb carefully with a soft cloth. Insert the new bulb so that the locating pin on the bulb body fits into the guide in the bulbholder. Re-fit the bulb cover (12) into the optics unit (3) and slide the bulb cover back down into position. Handling HEINE OMEGA® 500 Headband Selecting the position of the optics overband: The overband (4) swivels and can be fixed into the following positions by means of the position lock (5) (upwards for the rest position, down for working positions 1 or 2). To release the overband, press the position lock control (5) and rotate it. Do not try to force the overband up or down. With practice a comfortable working position can be selected and, when properly adjusted, the optics unit will always return to the desired working position. Fitting the headband rheostat HC 50 L: When fitting, ensure that the guide pin (15) of the headband rheostat HC 50 L (14) locates correctly in the opening (16) of the overband (4). Locate the connecting cord between the power source and the headband rheostat in the cord clip (21) at the back of the headband. Fitting the position control: Before fitting the position control (5) ensure that the positioning plate (19) is swiveled upwards as far as possible. To do this, press the positioning plate (19) and swivel it upwards simultaneously. Ensure that the optics over-band is in the lower position and that the guide pin (20) locates in the opening (16). Now press the position control (5) on to the guide (17) until it clicks into placed. Removing the headband rheostat HC 50 L and position control: The control of the HC 50 L (14) and the position control (5) can be fitted on the right- or left-hand side of the headband according to preference. To remove, press the release (18) and pull the control off the headband. Adjusting the optics: Unscrew the control (2) so that the optics unit (3) is free to move. (The position of this control can be reversed for left-handed operation if required). Place the instrument on your head and adjust the height and circumference by means of the adjusters (22) and (1) until a comfortable fit is achieved. The rear part of the headband can be pivoted and is self-latching. Adjust the optics to a position as close as possible to your eyes and view the light spot at a distance of about 30 – 40 cm without accommodating. A small, pencilsized object should be sharply-focused (the eyepieces incorporate 2D lenses. Spectacle wearers should examine through the “far” part of the spectacle lens). Adjust the optics unit so that the light spot appears centered vertically in position of the headband or to choose an alternative working position by pressing your view and screw the adjuster knob in (2). (It may be necessary to correct the lever (5) and swiveling the optics overband into a different position. If the light spot needs horizontal adjustment, simply rotate the headband slightly to the side. Adjust and fine-tune the PD setting by closing first one then the other eye and observing an object in the middle of the light spot while adjusting the appropriate eyepiece. Repeat until the object is in the middle of the field of view, and a single image is obtained. Take off the instrument and check that the PD is symmetrically adjusted. If not, repeat the selection procedure as above. Correct adjustment of PD is particularly important when examining through a small pupil. Each user should adjust the setting to match his-own PD. Every instrument includes two plano lenses, which can be exchanged for the 2D lenses which are fitted as standard equipment. Always use the OMEGA 500 with plano or the 2D lenses. Make sure that you change the plano lenses under clean conditions to avoid that particles enter the optics. Cleaning and disinfection Before cleaning, disconnect from the power source. Use a suitable cloth only to wipe the surfaces of the instrument and the ophthalmoscopy lenses. The instrument and the loupe may be wiped clean with a damp cloth. Any cleaning agent used must be suitable for use on plastic surfaces. An alcohol-based surface disinfectant can be used to clean the instrument ophthalmoscopy lense. The use of a spray disinfectant and soaking or disinfection in a machine are

not permitted. Please only use disinfectants based on alcohol. The lamp can be cleaned, with a dry cloth if necessary. If touched a patients eye with the loupe you can also disinfect the loupe by Incidin® Liquid and Bacillol® plus. We recommend to use Incidin® Liquid und Bacillol® plus to disinfect the device. Cleaning and disinfection is allowed with a damp cloth only. Sterilisation of OMEGA 500 is not allowed. Maintenance OMEGA 500 Indirect Ophthalmoscopes do not require regular maintenance. Change XHL bulbs if necessary. Service OMEGA 500 Indirect Ophthalmoscopes do not require regular service. Disposal The product must be recycled as separated electrical and electronic devices. Please observe the relevant state-specific disposal regulations. Technical specification Weight: 470 g (Instrument) Environmental conditions operation: Temperature: +5 °C to +35 °C Relative humidity: 30% to 90% Air pressure: 800 hPa to 1060 hPa Environmental conditions storage: Temperature: -20 °C to +50 °C Relative humidity: 10% to 95% Air pressure: 700 hPa to 1060 hPa Environmental conditions transport: Temperature: -40 °C to +70 °C Relative humidity: 10% to 95% Air pressure: 500 hPa to 1060 hPa General Notes and Warnings The indirect opthalmoscope OMEGA 500 in its original packaging meets the requirements for transport according to ISO 15004-1. OMEGA 500 meets the requirements according to EN ISO 10943:2011. General Notes Check the correct operation of the OMEGA 500 at regular intervals. Do not use the equipment if it shows visible signs of damage. OMEGA 500 is not allowed to be entered into strong magnetic fields like MRI scanners. Use as little light as possible for the examination and ensure that the light is switched off after each examination. Please always consider your medical duty of care. Do not remove the bulb when it is hot. Please allow the bulb to cool down prior handling. Do not look into bright light sources by means of loupes. Hazard of glare. Avoid the ophthalmoscope lens to be exposed to direct sunlight. Hazard of fire. Remove mPack UNPLUGGED Battery if you do not use OMEGA 500 for a longer time. It is not allowed to modify OMEGA 500. Do not use OMEGA 500 in oxygen enriched environment. Use only original HEINE ophthalmoscope lenses. Use only original HEINE bulbs (X-004.88.111, X-008.87.200) in combination with HC 50 L. Other bulbs could influence the light and lead to an overexposure or underexposure of light, resulting in eye damages or wrong diagnoses. Use only Power sources specified by HEINE for the use of the OMEGA 500. Other power sources could influence the light and lead to an overexposure or underexposure of light, resulting in eye damages or wrong diagnoses or lead to overheating of the device. Only use the OMEGA 500 when the lenses are clean. Electric shocks or burns can be prevented by only sending the device to HEINE for repair. OMEGA 500 is a precise optical instrument. Please handle OMEGA 500 with care and store it in a clean place. Please clean the OMEGA 500 optics in regular intervals to ensure best diagnostic conditions. Let OMEGA 500 accommodate to ambient conditions when the instrument is cold. Change the ocular lens only in a clean environment in order to avoid dust to enter the OMEGA 500. We can only guarantee the performance of the instrument when fitted with original HEINE accessories and spare parts. The LED indicator of the power supply or the charge indicator on the backside of the mPack UNPLUGGED Battery are the operating indicator of the OMEGA 500.

Phototoxicity Because prolonged intense light exposure can damage the retina, the use of the device for ocular examination should not be unnecessarily prolonged, and the brightness setting should not exceed what is needed to provide clear visualization of the target structures. This device should be used with filters that eliminate UV radiation (< 400 nm) and, whenever possible, filters that eliminate short-wavelength blue light (<420 nm). The retinal exposure dose for a photochemical hazard is a product of the radiance and the exposure time. If the value of radiance were reduced in half, twice the time would be needed to reach the maximum exposure limit. While no acute optical radiation hazards have been identified for direct or indirect ophthalmoscopes, it is recommended that the intensity of light directed into the patient’s eye be limited to the minimum level which is necessary for diagnosis. Infants, aphakes and persons with diseased eyes will be at greater risk. The risk may also be increased if the person being examined has had any exposure with the same instrument or any other ophthalmic instrument using a visible light source during the previous 24 hours. This will apply particularly if the eye has been exposed to retinal photography. OMEGA® 500 Ophthalmoscope is classified as a Group 2 instrument according to EN ISO 15004-2:2007. The classification was performed together with HEINE A.R. 16D/Ø54mm Ophthalmoscopy loupe. Caution – The light emitted from this instrument is potentially hazardous. The longer the duration of exposure, the greater the risk of ocular damage. Exposure to light from this instrument when operated at maximum intensity should not exceed 21 minutes with the LED light and 15 minutes with the 5Watt XHL light. Electromagnetic Compatibility Medical electric devices are subject to special precautionary measures with regard to electromagnetic compatibility (EMC). Portable and mobile high frequency communication equipment can affect medical electric devices. The HEINE OMEGA® 500 LED is intended for use in the electromagnetic environment specified below. The user of the HEINE OMEGA® 500 LED should assure that it is used in such an environment. The ME device may not be stacked directly near or used directly beside other devices. If the ME device is to be operated in a stack or with other devices, the device should be watched to ensure it operates properly in this location. Outgoing Measurements

Compliance

Electromagnetic environment – Guidelines

RF emissions acc. to CISPR 11

Group 1

The equipment uses only RF energy for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

RF emissions acc. to CISPR 11

Class B

The ME device is suitable for use in all facilities (e.g. hospitals and medical practices), including domestic situations and those directly connected to the public low-voltage power supply network that supplies buildings for domestic purposes.

Harmonic emissions acc. to IEC 61000-3-2

Class A

Illumination equipment with controls.

Voltage fluctuations/ flicker emissions acc. to IEC 61000-3-3

Fulfilled

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Table 2 Guidelines and Manufacturer’s Declaration – Electromagnetic emissions for all ME devices Guidance and manufacturer declaration - Electromagnetic emissions THE ME device is intended to be operated in an electromagnetic environment as specified below. The customer or use of the ME device must ensure that it is operated in such an environment. Noise immunity tests

IEC 60601 test level

Compliance level

Electromagnetic environment – Guidelines

Electrostatic discharge (ESD) acc. to IEC 61000-4-2

± 6 kV contact discharge ± 8 kV air discharge

± 6 kV contact discharge ± 8 kV air discharge

Floors should be wood, concrete or covered with ceramic tiles. If floors are covered with synthetic material, the relative humidity should be at least 30 %.

Electrostatic transients / bursts acc. to IEC61000-4-4

± 2 kV for mains cables ± 1 kV for input and output lines

± 2 kV for mains cables ± 1 kV for input and output lines

The supply voltage quality should be that of a typical commercial or hospital environment.

Surge voltage or surges acc. to 1EC61000-4-5

± 1 kV voltage phase – phase, ± 2 kV voltage phase – earth

± 1 kV voltage phase – phase ± 2 kV voltage phase – earth

Mains power quality should be that of a typical commercial or hospital environment.

Voltage dips, short in-terruptions and voltage variations on power supply input lines acc. to IEC 61000-4-11

< 5% UT, (>95% dip in UT) for 1/2 period 40% UT, (60% dip in UT) for 5 periods 70% UT, (30% dip in UT) for 25 periods <5% UT, (>95% dip in UT) for 5 seconds

< 5% UT, (>95% dip in UT) for 1/2 period 40% UT, (60% dip in UT) for 5 periods 70% UT, (30% dip in UT) for 25 periods <5% UT, (>95% dip in UT) for 5 seconds

Mains power quality should be that of a typical commercial or hospital environment. If the user of the ME device requires continued operation during power mains interruptions, it is recommended that the EUT be powered by a UPS (uninterruptible power supply) or a battery.

Magnetic field for the power frequency (50/60 Hz) acc. to IEC61000-4-8

3 A/m

3 A/m

Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

Comment: UT is the a.c. supply voltage prior to application of the test level.

Recommended working clearances between portable and mobile RF communication devices and the HEINE OMEGA® 500 The ME device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The user of the ME device can help to prevent electromagnetic faults by observing the minimum disturbance between portable and mobile RF communication devices (transmitters) and the ME device, as recommended in accordance with the output performance of the communication device. Rated maximum output of transmitter [W]

Working clearance according to transmission frequency [m] 150 kHz to 80 MHz d = 1,2√P

80 MHz to 800 MHz d = 1,2 √ P

800 MHz to 2,5 GHz d = 2,3 √ P

0,01

0,1

0,1

0,2

0,1

0,4

0,4

0,7

1

1,2

1,2

2,3

10

3,7

3,7

7,4

Explanation of utilized symbols The following symbols are used on the device or on the packaging: The CE marking indicates that the product conforms to the provisions of Directive 93/42/EWG concerning medical products. REF

Catalogue number

SN

Serial number Product bearing this symbol may not be disposed of together with general household waste, but instead requires separate disposal. Temperature limitation for storage and transport. Type BF equipment Maximum humidity for storage and transport. Instrument connector Power supply connector (9VDC) Please read and follow the instructions for use of and keep them for future reference. (Background color blue, foreground color white) Manufacturer

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Production date Risk of breakage Dry storage “Grüner Punkt” (country-specific)

Manufacturer: HEINE Optotechnik GmbH & Co. KG Kientalstr. 7 · 82211 Herrsching · Germany www.heine.com Patents: www.heine.com