HEINE OMEGA 600 Indirect Ophthalmoscope Instruction Manual

HEINE OMEGA 600 Indirect Ophthalmoscope

Specifications:

• Product Name: HEINE OMEGA 600
• Model: HEINE OMEGA 600 wired V-200.00.328
• Intended Use: Binocular indirect ophthalmoscope for examining posterior segments of the eyes
• Power Source: AC-powered or battery-powered
• Usage: Qualified medical professionals in medical healthcare facilities

Product Overview:
The HEINE OMEGA 600 and HEINE OMEGA 600 wired binocular indirect ophthalmoscope is designed with various features:

1. Width adjustment
2. Height adjustment
3. Padding for comfort
4. Brightness control socket
5. Adjustment lever
6. Brightness control
7. Charge status indicator
8. Battery compartment
9. USB-C socket for charging
10. Rechargeable battery CB1
11. Power indicator
12. Power supply connection
13. Optics unit for viewing
14. Aperture selection lever
15. Illumination height adjustment
16. Dust cover
17. Stereoscopic adjustment lever
18. Filter selection lever
19. Eyepieces for viewing

Setting Up:
HEINE OMEGA 600 (Battery-Powered):

1. Insert the CB1 battery into the battery compartment and ensure it clicks into place.
2. Charge the battery fully before the first use.

HEINE OMEGA 600 wired (AC-Powered):

1. Connect the power supply unit to a mains plug using the appropriate adapter.
2. Check and match the mains voltage indicated on the identification plate.
3. Mount the power supply for easy unplugging.

Charging:
Charging the OMEGA 600:
Charge the device outside the patient environment, at least 1.5 meters away from the patient.

Charging via USB:
Connect the USB power supply unit to the USB-C socket of the device for charging. The LED lighting will switch off during charging.

FAQ:

1. Q: Can the HEINE OMEGA 600 be used without medical expertise?
   A: No, the product must only be used by qualified medical professionals in healthcare facilities.

2. Q: How should I store the device when not in use?
   A: Store the device in a clean, dry place away from direct sunlight and moisture.

3. Q: What should I do if the device malfunctions?
   A: Immediately stop using the device and contact HEINE customer support for assistance.

HEINE Optotechnik GmbH & Co. KG Dornierstr. 6 · 82205 Gilching · Germany
E-Mail: info@heine.com · www.heine.com
MED 234766 2022-01-20
Please read and follow these instructions for use and keep them for future reference.

Intended use
The HEINE OMEGA 600 and HEINE OMEGA 600 wired binocular indirect ophthalmoscope is a head worn AC-powered or battery powered device for transient use, containing illumination and viewing optics intended to examine posterior segments of the eyes.
The product must only be used by qualified medical professionals and in medical healthcare facilities.

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! This symbol 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! This symbol indicates valuable advice. Notes are important, but not related to hazardous situations.

Product overview

1. Width adjustment
2. Height adjustment
3. Padding
4. Socket for brightness control
5. Adjustment lever
6. Brightness control
7. Charge status indicator
8. Battery compartment
9. USB-C socket
10. Rechargeable battery CB1
11. Power indicator
12. Power supply connection
13. Optics unit
14. Aperture selection lever
15. Illumination height adjustment
16. Dust cover
17. Stereoscopic adjustment lever
18. Filter selection lever
19. Eyepieces

Setting up

To put the OMEGA 600 into operation, insert the CB1 battery (10) into the instrument’s battery compartment (8) by quickly pressing it in so that it audibly clicks into place. We recommend to charge the battery CB1 (10) of the device fully before first use.
To put the OMEGA 600 wired into operation, connect the power supply unit to a mains plug using the appropriate country-specific primary adapter. Fig. 5 and Fig. 6 describe the approach for changing the plug.

Connect the power supply unit to the mains after checking the mains voltage indicated on the identification plate.
Mount the power supply in such a position where it can be easily unplugged. The LED indicates the operational readiness of the power supply. The power indicator (11) is automatically activated when the device is switched on.
To put the power supply out of operation just disconnect the power supply from the mains supply.
Do not pull the cable to disconnect the power adapter from the mains.

Charging of the OMEGA 600
Charge the device outside of the patient environment (at least 1.5 metres from the patient or patient support pursuant to IEC 60601-1, see Fig. 7).

Charging via USB
For charging, connect the USB power supply unit (e.g. E4-USB) to the USB-C socket (9) of the device.
In charging mode, the LED lighting is switched off and the illumination of the device is no longer supplied with power.
Do not let the power cable become taut as this could damage the device or pose a tripping hazard.
A description of how to start up and operate the E4-USB power supply unit is provided in a separate instruction for use.

Charging via Wall Charger CW1
Use the Wall Charger CW1 to charge the battery CB1 (10) of the device. The blue LED on the Wall Charger CW1 indicates contact with the device. The charge status indicator (7) is located on the battery compartment (8) of the device.
Make sure that no foreign objects come between the device and the Wall Charger CW1. When using the Wall Charger CW1 to charge the device, make sure that Wall Charger CW1 is not contaminated in any form.
The setting up and operation of the Wall Charger CW1 is described in a separate instruction of use.

Charging via Charging Case CC1
Use the Charging Case CC1 to charge the battery CB1 (10) of the device. Turn the OMEGA 600 off. Remove the battery CB1 (10) from the battery compartment (8) and insert it into the Charging Case CC1. The charge status indicator of the Charging Case CC1 is located on the upper side of it.
Make sure that no foreign objects come between the battery CB1 (10) and the Charging Case CC1. When using the Charging Case CC1 to charge the battery CB1 (10), make sure that the Charging Case CC1 is not contaminated in any form.
The setting up and operation of Charging Case CC1 is described in a separate instruction of use.

Charge status indicator (7)
The charge status indicator (7) of the device is located on the battery compartment (8) of the device.
The charge status indicator (7) is automatically activated when the device is switched on.

• Orange/green/green: 66–100 %
• Orange/green: 33–66 %
• Orange: 10–33 %
• Orange flashing: <10 %

Operation

Initial optical set up
Remove the protective dust cover (16) and place aside for reattaching after the examination. Unlock the adjustment lever (5) so that the optics unit (13) is free to move. Place the instrument on your head and adjust the height and circumference by means of the width adjustment (1) and height adjustment (2), respectively, until a comfortable fit is achieved. The rear part of the headband can be adjusted according to personal preference. Adjust the optics unit (13) to a position as close as possible to your eyes and centred to your face, then lock it in this position using the adjustment lever (5). Adjust the eyepieces (19) horizontally to match your own personal pupillary distance. The initially mounted eyepieces (19) incorporate +2D lenses that can be exchanged with neutral lenses (0D). Switch on the light by turning the brightness control (6) clockwise. You should now see the illumination spot being centred to your view at a distance of about 40 cm and you should be able to observe a pencil-sized object sharply focused at this distance. If you cannot focus on the pencil-sized object, you may have to adjust your distance to the object. Alternatively, you may try exchanging the initially mounted eyepieces (+2D lenses) (19) with the eyepieces containing neutral lenses (0D). More details on how to interchange the eyepieces (19) can be found in the section ”Maintenance“. If the illumination spot is not centred, you can adjust it vertically by twisting the illumination height adjustment (15) and you can adjust it horizontally by simply rotating the whole instrument slightly to the desired side. If a proper alignment has not been achieved, repeat steps as above. Correct adjustment of eyepieces (19) which match your own personal pupillary distance is particularly important when examining through small pupils. Each user should adjust the setting to match their own personal pupillary distance.

Setting the brightness

Adjust the brightness by using the brightness control (6). To increase the brightness, turn the brightness control (6) clockwise. Once you reach a latch, you are operating in the highest brightness range in standard mode. If you turn the brightness control (6) further clockwise and over the latching mechanism, you switch into the visionBOOST setting. When the end stop is reached, the highest brightness range in the visionBOOST is operating.
To decrease the brightness or to turn the device off, turn the brightness control (6) counterclockwise. When the end stop is reached, the device is turned off.
It is recommended to start with the lowest possible brightness and then increase as required for the examination. The visionBOOST might be used for the examination of patients with media opacities, e.g. cataract.

Aperture selection lever (14)
Three different aperture sizes and a diffuser aperture can be selected by means of the aperture selection lever (14). The choice of aperture depends mainly on the size of the patient’s pupil. The diffuser is useful for the examination of the periphery.

Filter selection lever (18)
In addition to the unfiltered option, the filter selection lever (18) can be used to select an interference red-free filter, a blue filter or a yellow filter. These are switched into the illumination beam.
The interference red-free filter can be used to view changes of the retina (e.g. new vessels or retinal nerve fiber layer defects) and highlights whitish portions of the retina, if present.
The blue filter can be used to do fluorescein angioscopy.
The yellow filter can be used to reduce discomfort for the patient and photochemical hazard by reducing blue light.

Stereoscopic adjustment lever (17)
This feature ensures the best possible stereopsis for any pupil size and from any observation angle possible (e.g. peripheral view). When examining a dilated pupil head on, it is recommended to move the stereoscopic adjustment lever (17) into the forward position. When examining the periphery of the eye or in case of undilated pupils, it is recommended to move the stereoscopic adjustment lever (17) towards the side position (turn to your left). The stereoscopic adjustment lever (17) can be positioned anywhere between these two settings to select the optimum 3 dimensional view in any possible situation. The illumination beam can be adjusted vertically by the illumination height adjustment (15).

Use of the flip-up function
While wearing the instrument, the optics unit (13) can be folded up into the rest position. To bring the optics unit (13) back into the working position, simply fold it down again. There is no need to readjust the instrument.

Teaching mirror (TM)
The available teaching mirror can be attached to the optics unit (13) instead of the dust cover (16).
To be able to follow the examination of the main observer, the secondary observer stands next to the main observer and looks into the TM attached to the device from the side. The observation beam is split by the divider mirror, which approximately halves the brightness of the image for both the main and the secondary observer.
The TM is intended for training purposes only.

Hygienic reprocessing
The instruction is available:

• online at www.heine.com
• in a paper version which you can request from the address listed

Maintenance

There is no regular maintenance required. The following maintenance should be done outside of the patient environment (at least 1.5 metres from the patient or patient support pursuant to IEC 60601-1, see Fig. 7) and when deemed necessary.
Changing the position of the brightness control (6)
The position of the brightness control (6) can be fitted on the right or left side onto the preferred socket for brightness control (4).
To remove the brightness control (6), turn the device off and pull the dial out to gain access to the retaining screw. Remove the screw to detach the holder by using the enclosed offset screwdriver (see Fig. 8). Gently pull out the holder off the socket for brightness control (4) paying attention to the retaining clips. Remove the cover from the other socket for brightness control (4) and insert the holder by aligning the retaining clips. Insert the screw and tighten hand tight with the enclosed offset screwdriver (see Fig. 8). Reinsert the brightness control (6). Cover the spare socket for brightness control (4) with the cover. To activate the brightness control (6), remove the battery CB1 (10) from the OMEGA 600 or unplug the OMEGA 600 wired. Once power is reapplied the brightness control (6) will be fully functional.

Change of paddings (3)
To change the paddings (3), carefully pull on the corresponding padding (3), which is attached to the device via a Velcro fastening. To attach the paddings (3) to the device, press the corresponding padding (3) onto the Velcro fastener.
Change of eyepieces (19)
To remove the eyepieces (19) unscrew them counterclockwise until they detach. To attach the eyepieces (19) screw them clockwise until they are hand tight.

Service

Exchange of the battery CB1 (10)
Exchange the battery CB1 (10) outside of the patient environment (at least 1.5 metres from the patient or patient support pursuant to IEC 60601-1, see Fig. 7).
Turn the OMEGA 600 off and disconnect the USB power supply unit. Remove the battery CB1 (10) from the battery compartment (8) by gently pulling and pushing the mechanical interlock at the same time. Do not touch the contacts on the battery CB1 (10). After inserting a new battery (10) make sure that the mechanical interlock is engaged.
Removing and reinserting of the battery CB1 (10) will reset the system.
The battery CB1 (10) only needs to be replaced if it can no longer be charged to a sufficient capacity. This is usually the case when the operating time of the battery CB1 (10) is reduced.
For the rechargeable batteries (10) two-year guarantee, please tell us the serial number of both the newly installed rechargeable battery (10) and your OMEGA 600:
www.heine.com/OMEGA600/battery-change

General Notes

The warranty for the entire product is invalidated if non-genuine HEINE products or non-original parts are used and if repairs or modifications are made to the device by persons not authorized by HEINE. For more information, please visit www.heine.com.
The expected life cycle amounts with designated use and the observation of warning and safety information as well as the maintenance instructions up to 7 years. Beyond this period, the product may continue to be used if it is in a safe and good condition.

Note to the user and/or patient:
All serious incidents that occur in connection with the product must be reported to HEINE Optotechnik GmbH & Co. KG and the member state’s competent authority.
Charge your device during longer storage periods to protect the battery from discharge or store the battery and the device separate from each other.
Let the device accommodate to ambient conditions when it is cold.
Change the ocular lenses only in a clean environment in order to avoid dust to enter the indirect ophthalmoscope.
During non-use or storage of the device, cover the observation optics with the dust cover (16) to avoid dust on the exterior side of the glass.
Only use the indirect ophthalmoscope when the lenses are clean.

General Warnings

Use only CE marked USB power supplies (5 V) from reputable manufacturers that conform to the safety requirements from IEC 60601-1 Medical electrical equipment.
Do not use power supplies where damage has been detected.
Check the correct operation of the device before use! Do not use the device if there are visible signs of damage or the light begins to flash.
Do not use the device in presence of flammable gases / liquids, or in an oxygen rich environment.
This product is not allowed to enter or be used in areas with strong magnetic fields e.g. MRI scanners.
Do not modify the device.
Use only original HEINE parts, spare parts, accessories and power sources.
Repairs shall only be carried out by qualified persons.
Do not use the device including its accessories and options outdoors.
Heating during operation is normal and harmless.
Make sure that the device is not exposed to direct sunlight.
For examination of the posterior segments of the eyes, use the indirect ophthalmoscope only in combination with ophthal-moscopy lenses.

Light exposure hazard
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. 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.

ISO 15004-2: Group 2 (LED)
Caution – The light emitted from this instrument is potentially hazardous. The longer the duration of exposure, the greater the risk of ocular damage. An exposure time with this instrument at maximum intensity of longer than (see table exposure guideline) will lead to the guideline hazard value being exceeded.

ANSI Z80.36-2016: Group 2 (LED)
Caution – The light emitted from this instrument is potentially hazardous. The longer the duration of exposure, the greater is the risk of ocular damage. Exposure to light from this instrument when operated at maximum intensity will exceed the recommended maximum exposure (RME) of 2.2 J/cm2, unless additional action is taken by the user to minimize exposure, after min (see table exposure guideline). The risk of retinal injury at an exposure of 2.2 J/cm2 is not high, but because some patients may be more susceptible than others, caution is advised if this radiant exposure value is exceeded. However, because of a significant risk of injury at exposures exceeding 10 J/cm2, the user should avoid exposures longer than min. (see table exposure guideline).

Exposure Guidelines

Data for the highest brightness setting in visionBOOST

| Working distance| Duration according to ANSI Z80.36- 2016| Duration according to EN ISO

15004-2:2007

---|---|---|---
Without ophthalmo- scopylens| 400 mm *| 30 sec| 2 min 44 sec
With ophthalmo- scopylens***| 400 mm **| 28 min| 169 min

) from instrument
) from instrument to HEINE A.R. Aspheric Ophthalmoscopy Lens (A.R. 16D), diameter: 54 mm, focal length: 16 dpt.
) HEINE A.R. Aspheric Ophthalmoscopy Lens (A.R. 16D), diameter: 54 mm, focal length: 16 dpt.

Disposal
The product must be recycled as separated electrical and electronic devices. Please observe the relevant state-specific disposal regulations.
Dispose the rechargeable battery (10) at your local collection point.

The appendix contains following tables

• Electromagnetic disturbances – Requirements and tests
• Technical specification
• Explanation of the used symbols

Electromagnetic disturbances – Requirements and tests

The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such environments.
Statement for the operational environments| Inside professional healthcare facilities except for: near active HF surgical equipment and the RF shielded room of an ME system for magnetic resonance imaging, where the intensity of EM disturbances are high.
The supply voltage quality should be that of a typical hospital environment.
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 %.
Performance features of the ME system that have been determined to be essential to the performance| None
Necessary instructions for maintaining basic safety and
essential performance with regards to electromagnetic disturbances for the expected life cycle
Warning| Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally.
Use of accessories, transducers and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation.
Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the device, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.
Note| Flickering of the LED of the OMEGA 600 wired is possible because of radiated electromagnetic fields.
Brief illumination of the LED during charging of the OMEGA 600 is possible because of electrostatic discharge.
A list of all cables, transducers and other accessories that are relevant for the EMC compliance| EMC compatibility is only ensured if original HEINE spare parts, accessories and spower sources are used as described in the chapter „Accessories“. The EMC compatibility when using power sources from other manufacturers must be evaluated by the user.
Test| Compliance
RF emissions CISPR 11| Group 1 Class B
Conducted emissions (EN 55011/CISPR 11)| Passed
Radiated emissions (EN 55011/CISPR 11)
Harmonic current emissions (IEC 61000-3-2)
Voltage changes, voltage fluctuations and flicker (IEC 61000-3-3)*
Immunity| See attached immunity test levels
Immunity test levels

Test| Test level
IEC 60601-1-2 test levels| Compliance test levels
Electrostatic Discharge (IEC 61000-4-2)| Contact Discharge: ±8 kV
Air Discharge: ±2 kV, ±4 kV, ±8 kV, ±15 kV
Radiated RF EM fields (IEC 61000-4-3)| 3 V/m
80 – 2700 MHz
80 % AM at 1kHz
Electrical fast transients / bursts (IEC 61000-4-4)| ± 2 kV
100 kHz repetition frequency
Surges
(IEC 61000-4-5)| ± 0.5 kV, ± 1 kV
Conducted disturbances induced by RF fields (IEC 61000-4-6)| 3 V
0.15 MHz – 80 MHz
6 V in ISM bands between 0.15 MHz and 80 MHz 80 % AM at 1 kHz
Proximity fields from RF wireless communications equipment
(IEC 61000-4-3)| 385 MHz; Pulse Modulation: 18 Hz; 27 V/m
450 MHz, FM: ±5 Hz deviation: 1 kHz sine; 28 V/m
710, 745, 780 MHz; Pulse Modulation: 217 Hz; 9 V/m
810, 870, 930 MHz; Pulse Modulation: 18 Hz; 28 V/m
1720, 1845, 1970 MHz; Pulse Modulation: 217 Hz; 28 V/m
2450 MHz; Pulse Modulation: 217 Hz; 28 V/m;
5240, 5500, 5785 MHz; Pulse Modulation: 217 Hz; 9 V/m
Power frequency magnetic fields (IEC 61000-4-8)| 30 A/m; 50Hz or 60 Hz| 30 A/m; 60 Hz
Voltage dips
(IEC 61000-4-11)| 0 % UT; 0.5 cycle; at 0°, 45°, 90°, 135°, 180°, 225°, 270° and 315°
0 % UT; 1 cycle and 70 % UT; 25/30 cycles Single phase: at 0°
Short interruptions (IEC 61000-4-11)*| 0 % UT; 250/300 cycles

*n/a: ”Not applicable“ in the internally powered mode

Technical Specification OMEGA 600 and OMEGA 600 wired

Environmental conditions for operation| +10 °C to +35 °C

30 % to 75 % rel. humidity 700 hPa to 1060 hPa

---|---
Environmental conditions for storage| +5 °C to +45 °C

45 % to 80 % rel. humidity 500 hPa to 1060 hPa

Environmental conditions for transport| -20 °C to +50 °C

45 % to 80 % rel. humidity 500 hPa to 1060 hPa

Classification according to EN ISO 15004-2:2007 and ANSI Z80.36-2016| Group II

The classification was performed together with a Ø54mm/16 Diopter HEINE ophthalmoscopy lens.

Technical Specification OMEGA 600

Operating: internally powered
Charging time| typ. 1.5 h
Operating time
(at maximum charge capacity)| typ. 4 h
Operating time visionBOOST)| typ. 1.5 h
Weight| 475 g incl. rechargeable battery

Technical Specification OMEGA 600 wired

Accessories

E4-USBC

(USB-C cord approx. 2 m)

| X-000.99.300

Options

Spare parts

Explanation of utilized symbols

| The CE mark indicates that the product complies with the medical device regulation (EU) 2017/745.

---|---
****| Catalogue- or order number

| Hersteller Manufacturer
****| Date of manufacture
| Product bearing this symbol may not be disposed of together with general household waste, but instead requires separate disposal according to local provisions. (European Waste Electrical and Electronic Equipment Directive, WEEE)
---|---

| Dispose the rechargeable batteries at your local collection point.
| Transport Temperature limits in °C for storage and transport
| Transport Temperature limits in °F for storage and transport
| Humidity limitation for storage and transport
| Pressure limitation for storage and transport
---|---

|  handle with care! Fragile !
| Keep dry!

|  Follow instructions for use!
(Background color: blue, foreground color: white.)
| Unique Device Identification
| Medical Device

|  Instructions for use Mode
| For indoor use only.
---|---
| The Regulatory Compliance Mark (RCM) The Regulatory Compliance Mark (RCM)

|  Class II equipment
|  Alternating current (AC)
| Direct current DC Tension continue

5V 1.2A| Charge status indicator

References

• HEINE Optotechnik - Home

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