KaWe QM-1-176I Eurolight Ophthalmoscopes User Manual

KaWe QM-1-176I Eurolight Ophthalmoscopes

Please read this User‘s Manual thoroughly and carefully before attempting to use this product and heed the given care instructions.

We would like to thank our valued customers for their decision to purchase a KaWe product. Our ophthalmoscopes are characterized by high quality and durability. KaWe ophthalmos-copes meet the requirements of Regulation (EC) 2017/745 (European Regulation on Medical Devices) and are classified as medical devices class I.

Please read this manual carefully, adhere to it strictly, and keep it for future reference if necessary. Before using the product, carefully study operation rules, especially care requirements. If you have any questions concerning the device’s operation, please contact the service department (the manufacturer’s address is indicated on the back).

Icon

• Slit aperture
• large spot
• large spot
• Semi-circle
• Red-free/green large spot
• Fixation target
• Slit aperture
• large spot
• small spot
• Cobalt blue large spot
• Red-free/green large spot
• Fixation target

KaWe ophthalmoscopes are available in two models:

• EUROLIGHT: Models with metal handles and plastic button
• PICCOLIGHT: Models with plastic handles and button

Images are shown on the cover of this application manual. The difference between the two models are described in this appli-cation manual. Other options (battery operation, light sources, etc.) are not discussed in detail, as they do not have significant differences in service.

Symbols used in the application manual and on the packaging

• ATTENTION!
• Please follow this User’s Manual
• Item No.
• Manufacturer’s number, lot number
• Manufacturer
• Store in dry conditions
• Temperature range limits
• Separate collection of electrical/electronic equipment and rechargeable batteries
• CE conformity mark
• GOST-R certification of goods imported into Russia
• Medical product

Purpose and intended use

KaWe ophthalmoscopes are diagnostic instruments and are primarily used for optical examination of the fundus by direct ophthalmoscopy. In this method, the central elements of the visual organ, such as the optic disc, the vascular bundle, macula (Makula lutea) are examined. The ophthalmoscope allows examinations without the use of mydriatics. However, in this case, the patient‘s field of vision is limited.

• Target patient groups: Patients of all ages and genders who require visual examination.
• The product must only be used by authorized specialized personnel!

Intended use is compliance with all instructions in this application manual as well as basic rules and directives. The manufacturer does not accept any liability for damage resulting from any other use.

Safety rules/contraindications

• Before each use, please check whether the ophthalmoscope is operating properly. Do not use the device in case any damage is detected.

• Ensure the ophthalmoscope is protected from moisture.

• Avoid direct contact of the ophthalmoscope with the visual organ.

• If the light is on for a long time, the areas around the lamp may become hot.

• KaWe ophthalmoscopes are not intended for use during surgery.

• Use only the KaWe MedCentether 5000 wall-mounted station for the power supply of the KaWe EUROLIGHT E25 head.

• Do not use the device in areas subject to strong magnetic fields (MRI systems).

• When handling ophthalmoscopes – as with all
  energy-consuming diagnostic devices – special electromagnetic compatibility (EMC) precautions must be observed.

• The performance of ophthalmoscopes can be affected by mobile high-frequency communication devices.

• Only original spare parts and accessories from KaWe may be used.

In case of a malfunction, a large amount of heat can be generated, resulting in an increased risk of fire. In case of strong heat, turn off the handle.

Installation and maintenance

When handling the instrument, it is necessary to take into account that the examiner must bring his eye as close as possible to the instrument. Due to the lateral illumination of the patient‘s fundus area and the approach to a maximum distance of 2-3 cm, diagnostics can be carried out without drugs.

Duration of operation
The devices are not intended for continuous operation, the maximum duration of one use is 1 minute with a 10 minutes pause between uses.

KaWe EUROLIGHT E10/ E15/ E16

1. Light outlet (dustproof)
2. Blend wheel (except E10 model)
3. Inspection window
4. Correction lens wheel with 18 lenses (± 20 diopters)
5. Correction value indication (+) black; (-) red
6. Plug connector
7. Light regulator on/off
8. Handle with battery
9. End cover

• Place the ophthalmoscope head on the handle with the battery (8) and secure it with the screw. Consider the location of the holes on the head for securing the screw.
• Insert batteries or accumulators into the handle. Observe the polarity and the lamp voltage (2.5 or 3.5 V)! For detailed information see Section 8: Maintenance and Service.
• Switching on is carried out by pressing the white switch fixing the on position and moving the light regulator to the left (7). To switch it off, move the light regulator to the initial position 0 (until it clicks!). Brightness can be adjusted smoothly.

KaWe EUROLIGHT E30/ E36

1. Light outlet (dustproof)
2. Blend wheel (except E30 model)
3. Inspection window
4. Correction lens wheel with 18 lenses (± 20 diopters)
5. Correction value indication (+) black; (-) red
6. Clic connector
7. Light regulator on/off
8. Handle with battery
9. End cover

• Place the ophthalmoscope head on the handle with battery (8) and secure it until it clicks. Observe the position of the cutout.
• Insert batteries or accumulators into the handle. Observe the polarity and the lamp voltage (2.5 or 3.5 V)! For detailed information see Section 8: Maintenance and Service
• Switching on is carried out by pressing the white switch with fixing the on position and moving the light regulator to the left (7). To switch off, move the light regulator to the initial position 0 (until it clicks!). Brightness can be adjusted smoothly.

KaWe EUROLIGHT E25/E35

1. Closing blend
2. Blend wheel
3. Filter 4000 K (F)
4. Filter arm
5. Polarizing filter for lighting (P)
6. Attachment lens wheel
7. Correction value indication (+) green; (-) red
8. Correction lens wheel 71 Lenses (-36 to +35 diopters)
9. Inspection window
10. Polarizing filter for inspection window

Attention:
When the ophthalmoscope is not operated, close the inspection window (9) with a blend (1) to prevent dust from entering the head!

E35 head installation
see KaWe EUROLIGHT E30/E36

E25 head: KaWe MedCenter 5000 installation
The KaWe EUROLIGHT E25 head can only be used with the KaWe MedCenter 5000 wall station.

• Insert the E25 head into the handle of the KaWe MedCenter 5000 device.
• Note that the centering hole must be lined up with the support on the retaining screw.
• Tighten the retaining screw lightly.
• To remove the head, unscrew the retaining screw and carefully pull out the head.

Observe the KaWe MedCenter 5000 manual instructions.

KaWe PICCOLIGHT E50/ E56

1. Light outlet (dustproof)
2. Blend wheel (except E50 model)
3. Inspection window
4. Correction lens wheel with 18 lenses (± 20 diopters)
5. Correction value indication (+) black; (-) red
6. Thread
7. On/off slide switch

• Install batteries into the handle (2 pcs. AA 1.5V minion). Observe the polarity. For detailed information see Section 8: Maintenance and Service
• Screw the head onto the handle (6).
• Move the slide switch (7) to turn the lamp on and off.
• Battery and lamp replacement is possible after unscrewing the head. For detailed information see Section 8: Maintenance and Service.

Preparing for operation

• Periodically check that all parts are in good condition -replace defective parts.
• Check the smooth running of moving parts (e.g. correction lens /blend wheel, plug connector).
• Keep all electrical contacts clean.
• Check the batteries charge.

After a successful inspection, the ophthalmoscope is ready for use.

Hygienic preparation
Keep the ophthalmoscope in its packaging to protect it from dirt and dust.

Manual cleaning/disinfection

Protect the device from moisture!
Do not place the ophthalmoscope in liquids, make sure that no liquid gets into the casing.

Clean the outside of the ophthalmoscope with a damp, soft, lint-free cloth. If necessary, wipe the light outlet glass with a cotton swab slightly moistened with alcohol.

• Do not press on the glass.
• Verwenden Sie keine scheuernden Reinigungsmittel!

Do not use abrasive cleaning agents. For disinfection, the ophthalmoscope can be wiped with an alcohol-based surface disinfectant. Use a slightly damp cloth.

Automatic cleaning

• Not applied.

Sterilization
Not applied.

Transportation and storage

| ****

Temperature

| Relative humidity| Air pressure
---|---|---|---
Operation| +10°C to

+35°C

| 30% to 90%| 800 GPa to

1060 GPa

Storage| ****

-10°C bis

+55°C

| ****

10% to 95%

| 700 GPa to

1060 GPa

Trans- portation| 500 GPa to

1060 GPa

Maintenance and Service

The end of the useful life is usually determined by wear and tear. Damaged parts are to be sorted out and replaced immediately. If the light intensity decreases, check for the following possible causes:

1. Battery charge; replace or recharge if necessary.
2. Clean or replace the lamp.

If the above reasons are excluded, repair or replacement may be required. In this case, please, contact a specialized dealer.

Battery replacement
Check the batteries charge regularly. Low battery voltage (depending on consumption) leads to a light intensity decrease and the possible appearance of LED lamps flashing. In both cases, it’s necessary to replace the batteries. When replacing, use only new, high-quality alkaline batteries (or fully charged batteries).

Besides, observe the manuals’ requirements for use of the batteries.

• Installation of batteries for KaWe EUROLIGHT, 2 pcs. medium size 1.5V (type C)
• Installation of batteries for KaWe EUROLIGHT
• Installation of batteries for KaWe PICCOLIGHT, 2 pcs. minion type 1.5V (type AA)

Lamp replacement
The correct performance of the ophthalmoscope with original light quality is only ensured when using original KaWe replacement lamps.

KaWe EUROLIGHT E10

1. Unscrew the retaining screw on the handle and remove the ophthalmoscope head from the handle.
2. Unscrew the cap ring (1).
3. Pull out the lamp holder (2) on the bottom of the head and replace the lamp.
4. Clean the glass bulb (3) of the new lamp with alcohol. The glass bulb must be clean and free from fingerprints (grease-free).
5. Install the lamp holder and lamp back into the head.
6. Screw the cap ring.

KaWe EUROLIGHT E15/ E16/ E25/ E30/ E35/ E36

1. Remove the ophthalmoscope head from the handle.

2. Models E15/E16:
   Unscrew the retaining screw on the handle. 1.2. Models E25/E30/E35/E36:

3. Push down on the wickered sleeve.

4. Remove the lamp at the bottom of the head.

5. Clean the glass bulb of the new lamp with alcohol. The glass bulb must be clean and free from fingerprints (grease-free).

6. Insert the lamp into the head until it stops.

KaWe PICCOLIGHT E50/ E56

1. Unscrew the ophthalmoscope head from the handle.
2. Remove the lamp at the bottom of the head.
3. Clean the glass bulb of the new lamp with alcohol. The glass bulb must be clean and free from fingerprints (grease-free).
4. Insert the lamp into the head until it stops.

Accessories and Spare parts
Accessories and spare parts can be found in the general catalog of our company at https://www.kawemed.com/download/broschueren/ or can also be viewed at your specialist dealer.

Disposal
The product is to be disposed of in accordance with local environmental regulations. Disposal instructions are also shown on the pictograms on the device or packaging.

Defective and/or recyclable electrical/electronic devices and rechargeable batteries must be transferred to a designated waste collection point for recycling.

Instructions for service personnel and patients
In case of problems during the device use, it is necessary to immediately contact the manu-facturer and the competent authorities of the re-levant member state of the Union, in which the service personnel or the patient are located.

Annex

Warranty & Guarantee

In case of proper handling and adherence to the rules laid down in this application manual, as well as the use of original KaWe spare parts, the statutory warranty period of two years from the date of sale is valid (excluding lighting equipment, batteries, and accumulators). LED lamps are warranted for five years from the date of sale.

For other questions and if repair is required, contact your specialized dealer.

Contact information
Please contact your specialist dealer or directly the manu-facturer (see back for address).

Basic UDI-DI
4030155KaWe0102YT

KIRCHNER & WILHELM GmbH + Co. KG
Eberhardstraße 56 71679 Asperg, Germany
Phone: +49 7141 68188-0
Fax: +49 7141 68188-11
e-mail: [email protected]
www.kawemed.com

All information is without guarantee and subject to change.

References

• Broschüren – KaWe Medizintechnik
• KaWe Medizintechnik - Kompetenz und Qualität seit 1890
• Broschüren – KaWe Medizintechnik
• KaWe Medizintechnik - Kompetenz und Qualität seit 1890
• Download – KaWe Medizintechnik
• Broschüren – KaWe Medizintechnik

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