User Manual
24 Pages
Preview
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User’s Manual: med.lux / Cliplight LED / KaWe DIALIGHT XL / Diagnostic light, white
Operation:
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 product of class 1.
med.lux: Before the first use, remove the plastic battery insulator between the battery and the contact surface. Switch the light on and off by pressing the push-button switch at the end of the clip. Unscrew the metal lamp bracket to replace the batteries.
Please carefully consider this instruction and read all the provisions prior to use. Follow the maintenance recommendations. Prior to use, please carefully consider the maintenance procedure. Keep the User’s manual, so you can refer to it again in the future, and pass it on to the next user of the device.
Type: AAA
Cliplight LED: Switch on by pressing the clamp until contact occurs with the metal ring on the pin. Unscrew the metal lamp bracket to replace the batteries.
Application: Only qualified medical professionals can use the diagnostic light.
Type: AAA
Group of patients with indications for use: All
Intended use:
Diagnostic Lamp KaWe DIALIGHT XL: Switch on and off by moving the slider switch. Unscrew the upper part from the handle to replace the lamp or batteries.
A diagnostic tool for illuminating the studied areas, for example, the oral cavity and the skin surface. The Cliplight LED and med.lux models have been tested according to the EN 62471 standard, and are also suitable for eye examination.
Type: AA
Diagnostic light, white: Switch the light on and off by pressing the black push-button switch at the end of the clip. Unscrew the upper part of the clamp to replace the lamp or batteries. Type: AAA
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Time of application: The models DIALIGHT XL and the “diagnostic light, white” are designed for intermittent use. The maximum operation time totals 1 minute. There shall be 10-minute pauses between the applications.
Transportation and storage:
Improper use of the device/contraindications for use:
Ambient temperature:
Keep the tool away from dust, humidity and contamination during storage and transportation.
Operation: from +10 °C to +35 °C Storage: -10 °C to +45 °C Transportation: -20 °C to +50 °C
Any other use of use outside the above intended use shall be considered improper. The manufacturer is not responsible for damage resulting from such use. DIALIGHT XL and the „diagnostic lamp, white“ can not be used for eye examination!
Relative air humidity: 30 % to 75 %
Warnings:
Cleaning:
• If the diagnostic light is visibly damaged, it should be removed from clinical use. • If the light falls, it may break. • Never immerse diagnostic lights in liquid. • Avoid direct contact of the diagnostic lights with the tongue or mucosa. • The device should not be used in strong magnetic fields (MRI). • Do not use the device in flammable or explosive environment (for example, oxygen or anesthetics). • Diagnostic lights, like any electrical diagnostic devices,are subject to special precautions regarding electromagnetic compatibility. • Use only original KaWe accessories and spare parts.
Clean the light surface with a damp or wet cloth.
Disinfection: The light surface can be disinfected with an alcohol-soaked cloth.
Sterilization: Sterilization is not possible.
Control and functional check: Before each use, check the diagnostic light for faultless operation. Do not use the device if damage is found. Make sure the moving parts are firmly fixed.
An error may cause extensive heat posing a threat of burn injury. In case of strong heating, immediately turn off the device and do not use it again.
Disposal: The product should be disposed of at a separate collection point for electrical appliances and electronics.
Secondary treatment limitations: No special requirements. The service life of the product is usually defined based on the degree of wear and use-related damage. Prompt secondary processing of the tool is recommended after its application.
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General accessories:
Warranty:
To find out more about the products, visit our homepage: www.kawemed.com.
The warranty for the device totals two years from the date of purchase with proper handling and following the operation manual (the warranty does not cover lamps/ rechargeable batteries). If you have any additional questions or need repair, please, contact your dealer.
Manufacturer: KIRCHNER & WILHELM GmbH + Co. KG Eberhardstrasse 56 | Germany, 71679 Asperg
Symbols:
Manufacturer’s contact details: Dealer’s address or phone number: +49 7141 68188-0.
Safety instructions or warnings
Basic UDI-DI:
Article number
4030155KaWe1202Z7
Factory number, batch Manufacturer Please follow the User’s manual Store in a dry place CE conformity mark GOST-R certification of export goods imported into Russia Electric/electronic devices and used batteries shall be disposed separately
Medical device
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.
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KIRCHNER & WILHELM GmbH + Co. KG Eberhardstraße 56 71679 Asperg, Germany Phone: +49 7141 68188-0 Fax: +49 7141 68188-11 e-mail: [email protected]
QM-1-124O / B-24600 / 2021-07
www.kawemed.com
DE - Alle Angaben ohne Gewähr – Änderungen vorbehalten. | EN - All information is without guarantee and subject to change. | FR - Informations sous toutes réserves – Sous réserve de modifications | IT - Tutte le informazioni sono fornite senza alcuna garanzia e possono essere modificate. | ES - Toda la información sin compromiso. Nos reservamos el derecho de realizar cambios. | PT - Todas as indicações entendem-se sem compromisso – Sujeito a alterações sem aviso prévio. | RU - Информация представлена без гарантий любого рода – оставляем за собой право вносить изменения.