HEINE OMEGA500, OMEGA 500 UNPLUGGED Head-worn binocular indirect ophthalmoscope Instructions for use

Instructions for use

ENGLISH

HEINE OMEGA 500® HEINE OMEGA 500® UNPLUGGED

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Please read these instructions carefully before using the HEINE OMEGA 500® and keep them in a safe place for future reference.

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

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Lamp Brightness control HC50 Guide pin Hole for guide pin Pin Release Detent plate Guide pin Cable guide Headband size adjustment knob Segment cover HC50 connecting cable with UNPLUGGED socket

Safety Range of application: The HEINE OMEGA 500® headband ophthalmoscope is designed solely for the examination of the retina. General Safety: Use as little light as possible for the examination and ensure that the light is switched off after each examination. Safety in use: • Do not use the equipment if it shows visible signs of damage. • Use only power sources, which are approved for use in medical applications. • The HEINE OMEGA 500® is compatible with existing 6 V HEINE ophthalmoscope power sources with the following exceptions: • HEINE EN15® • HEINE OMEGA 500® fitted with the HC50 headband rheostat is not compatible with the power sources HEINE E10®, Accubox II, EN20-1, EN30, E8. • We can only guarantee the performance of the instrument when fitted with original HEINE accessories and spare parts. • Do not remove the bulb when it is hot.

Symbols Observe the safety information Power supply connector (9 VDC) Instrument connector The CE marking indicates that the product conforms to the provisions of Directive 93/42/EWG concerning medical products.

Setting up the HEINE OMEGA 500® 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 HC50 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 HC50 brightness control (14), (Fig. ). 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. ). 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 HC50 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 HC50 brightness controller (14), ( Fig. ).

HEINE OMEGA 500® (C-004.33.500) Operation from other power sources (EN20, EN30, HC Converter): For operation with power sources other than mPack or mPack UNPLUGGED connect the long cable by means of the cable clip, after having clicked the cable clip into the rear segment of the headband. On/off switching and brightness control is by means of the power source (Fig. ).

HEINE OMEGA 500® operation Basic Adjustments: Switch the instrument on by means of the rotary knob (brightness control) on the HC50 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. 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. 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: • First allow the instrument to cool down. • 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.

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 HC50: When fitting, ensure that the guide pin (15) of the headband rheostat HC 50 (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 swivelled 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 HC50 and position control: The control of the HC 50 (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, pencil-sized 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 centred 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 swivelling the optics overband into a different position. If the light spot needs horizontal adjustment, simply rotate the headband slightly to the side. Adjust up 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 symmetricallyadjusted. 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.

Cleaning and maintenance • Before cleaning, disconnect from the power source. • Use only a suitable cloth to wipe the surfaces of the instrument. • The instrument 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. • The use of a spray disinfectant and soaking or disinfection in a machine are not permitted. • Check the correct operation of the HEINE OMEGA 500® at regular intervals. • Use the instrument only when you are sure that it is operating correctly.

Technical specification Power/current consumption: Duration of use with 10 W-lamp: Duration of use with 5 W-lamp: Weight:

11 W (with 10 watt lamp) 5.5 W (with 5 watt lamp) 2 h with HEINE mPack® 1 h with HEINE mPack® UNPLUGGED 4 h with HEINE mPack® 2 h with HEINE mPack® UNPLUGGED 470 g (Instrument)

Environmental conditions Normal use: Storage: Transport: Relative humidity: Air pressure:

+10 °C to +40 °C +5 °C to +45 °C –20 °C to +45 °C 10 % to 75 % 700 hPa to 1060 hPa

Applicable Standards IEC 60601-1: 1996 (Medical Electrical Equipment – General Requirements for Safety) IEC 60601-1-2 (MEDICAL ELECTRICAL EQUIPMENT – PART 1: GENERAL REQUIREMENTS FOR SAFETY 2. COLLATERAL STANDARD: ELECTROMAGNETIC COMPATIBILITY – REQUIREMENTS AND TESTS) ISO/DIS 10943 (indirect opthalmoscopes)