KaWe HiLight LED H-800 Headlamp User Manual

June 12, 2024
KaWe

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KaWe HiLight LED H-800 Headlamp

KaWe-HiLight-LED H-800-Headlamp-PRODUCT

Product Information

The Kopfleuchte KaWe HiLight LED H-800 is a headlamp used for medical examinations. It provides optimal illumination of the area under examination and can be equipped with a binocular loupe for magnification. The headlamp is classified as a medical device of class 1 and complies with Regulation EU 2017/745 (European Regulation on Medical Devices).

Technical Data:

  • Weight (without battery): Not specified
  • Battery Operating Time (Headband): Approximately 4 hours*
  • Battery Life: Minimum of 500 charge cycles
  • LED Life: Approximately 50,000 hours
  • Relative Humidity: 10% to 75%
  • Storage Temperature: Not specified
  • Atmospheric Pressure: 700 to 1060 hPa
  • Protection Rating: IP X0

*The actual battery operating time may vary.

Product Usage Instructions

Important Note: The Kopfleuchte KaWe HiLight LED H-800 should only be operated by authorized qualified personnel.

Charging of Batteries

  1. Use the included special power unit with an integrated plug to charge the headlamp batteries.
  2. When the green LED on the power unit is on, it indicates that the connected battery is charging. The LED indicators on the battery remain dark during charging.
  3. The green LED on the power unit turns off when the battery is fully charged.
  4. Do not operate the headlamp while it is charging. The battery should not be switched on during charging.

Binocular Loupe Attachment

The headlamp can be equipped with a binocular loupe for magnification. Follow these steps to attach the binocular loupe:

  1. Loosen the fastening screw on the joint of the binocular loupe.
  2. Insert the binocular loupe into the holder on the back of the headlamp.
  3. Adjust the position of the binocular loupes by slightly loosening them and then tightening the fastening screw to secure them in the desired position.

Please refer to the user manual for more detailed instructions and maintenance recommendations.

KaWe-HiLight-LED H-800-Headlamp-FIG-1

Dear buyer, we are grateful to you for choosing KaWe products Our products are of high quality and long-lasting. This KaWe device complies with the provisions of Regulation EU 2017/745 (European Regulation on Medical Devices), whereby it is classified as a medical device of class 1.

Please, read this user’s manual attentively and carefully and pay attention to the maintenance recommendations prior to use.

Please, carefully read the operating instructions prior to use.

Application

Headlamp KaWe HiLight LED H-800 shall be operated only by authorized qualified personnel.

Intended use

Headlamp KaWe HiLight LED H-800 is used as an illuminating device for medical examinations. The headlamp is put on the head during operation in order to provide for optimal illumination of the area under examination. Additionally, the headlamp may be equipped with a binocular loupe to examine the region under magnification. The following parameters can be selected (magnification x operating di-stance): 2.5 x 340 mm, 2.5 x 420 мм, 3.5 x 340 mm, 3.5 x 420 mm.

Assembly/Disassembly

Headlamp KaWe HiLight LED H-800 shall be connected to the KaWe lithium-ion battery. There is a cable for this on the right, which is directly connected to the battery for the head rim or to the battery cable for belt fastening. When the headlamp is used with the battery for the head rim, it shall be fastened of its backside. For this purpose, insert the clamping elements of the battery body to the grooves on the back side of the head rim and clamp it with a light move-ment. In order to disconnect the clamping elements, move them together again to the opposite direction.

The binocular loupe can be fastened on the back in a holder under the lamp body. For this purpose, loosen the fastening screw on the joint of the binocular loupe. After insertion into the holder, fix the fastening screw in the threaded hole on the front side. To regulate the position of binocular loupes, slightly loosen them. Then tighten the fastening screw to reliably fix the binocular loupes in the required position.

Improper use of the device/contraindications for use

Any other use of use outside the above indication shall be considered improper. The manufacturer is not responsible for damage resulting from such use. Only the use is responsible for the risk. For power supply, use only the battery in the delivery package or the original battery by KaWe.

Commissioning/Handling

  1. Connect the headlamp to the battery for the head rim or belt fastening.
  2. To switch the headlamp on, press and hold the control button for approximately one second. The current charge of the battery is displayed yed by short flashing of LED indicators. If none of the LED indicators flashes, the battery is completely discharged.
  3. After switching on the brightness is at the minimum. To increase the brightness, turn the control knob clockwise. To decrease the brightness, turn the control knob counterclockwise. The brightness is indicated by LED indicators.
  4. To switch off, press and hold the control knob for approximately one second.
  5. When putting the headlamp on, make sure it fits tight.

Charging of batteries

  1. To charge the batteries of the headlamp, use only a special power unit with an integrated plug included into the delivery package.
  2. When the green LED is on at the power unit, the connected battery is charging. During charging, LED indicators on the respective battery remain dark.
  3. The green LED at the network power unit goes off, when the batte-ry is fully charged.
  4. The headlamp shall not be operated during charging. In this condi-tion, the battery shall not be switched on.

Technical data

Technical data:

Group (acc. to IEC 62471)| 2
Permissible ambient temperature| +10 °C to +40 °C
Relative humidity| 10 % to 75 %
Storage temperature| +5 °C to +60 °C
Atmospheric pressure| 700 to 1060 hPa
Protection rating| IP X0
Input voltage

(network power supply unit)

| 100-240 V alternating current, 50/60 Hz
Output voltage

(network power supply unit)

| 8.4 VDC
Capacity| Belt battery: 3 000 mAh Head rim battery: 1,500 mAh
Weight (without the battery)| about 260 g
Duration of the battery operation (head rim)| about 4 hours
Duration of the battery operation (belt fastening)| about 8.5 hours

Life span (battery)| at least 500 charging cycles
Life span (LED indicators)| about 50,000 hours

Duration of operation at the maximum brightness.  The less the brightness, the more the operating time.

Warnings:

  • The device does not need maintenance. In this connection, the body shall not be opened. Repairs shall be performed only by qualified personnel. Damaged parts shall be rejected or replaced.
  • The long operation may lead to heating of the lamp and in some cases cause discomfort at skin contact.

Do not direct the device straight to the eyes

In case of visible damages, remove the plug from the outlet immedia-tely. Avoid further operation and send the device to the repair service. Headlamp HiLight LED H-800 is not intended for operation in explosi-on hazardous premises and near powerful magnetic fields as well as in operating room (anesthesiology departments). Only KaWe compo-nents may be used. It is forbidden to modify the design of the device.

Directives

Transportation and storage
To prevent contamination and dust, store the device only in its packaging before installation.

Preparation for cleaning
No special requirements.

Manual cleaning
The headlamp or battery can be cleaned with a wet, soft, and lint-free cloth. Use soapy water or other non-corrosive products for cleaning. Binocular loupe lenses can be carefully wiped with a glass cleanser.

Automatic cleaning
Automatic cleaning is impossible/unnecessary.

Disinfection
The body can be wiped with a disinfectant for the surface. The surfaces must be wiped dry.

Control and functional check
Check the moving parts, for example, joints. Turning the product on. All products: Visually check for da-mages and wear.

Package
Delivered in a cardboard package with sections cut accor-ding to the headlamp shape.

Sterilization
Sterilization is not possible/not required.

Additional information
Follow the operation manual. If you have any additional questions, please, feel free to contact the manufacturer prior to commissioning.

Manufacturer
KIRCHNER & WILHELM GmbH + Co. KG

Manufacturer’s contact details
Dealer’s address or phone number: +49-7141-68188-0.

Additional information
The device will serve for years with proper handling and storage.

Warranty

The warranty for the device totals two years from the date of sale with proper handling and following the operation manual. If you have any additional questions or need repair, please, contact your dealer.

General accessories

To find out more about the products, visit our homepage: www.kawemed.com
Basic UDI-DI: 4030155KaWe1201Z5

SymbolsKaWe-HiLight-LED H-800-Headlamp-FIG-2

Electromagnetic compatibility of the product

This information can be found at the website www.kawemed.com

Information for users and patients

All serious incidents involving this device must be immediately reported to the manufacturer and the competent authorities of the respective Member State in which the user and/or patient is located.

competence in medical technology worldwide since 1890

All information is without guarantee and subject to change.

KIRCHNER & WILHELM GmbH + Co. KG Eberhardstr. 56 • 71679 Asperg • Germany Zentrale / Central office

References

Read User Manual Online (PDF format)

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