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Summary of Contents for Storz KS70
- Page 1 Instructions for use LED Headlight KS70...
- Page 2 03-2021 Copyright © All product illustrations, product descriptions, and texts are the intellectual property of KARL STORZ SE & Co. KG. Their use and reproduction by third parties require the express approval of KARL STORZ SE & Co. KG. All rights reserved.
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Page 3: Table Of Contents
10.4 Table 3 – Test levels for radiated and conducted immunity tests ............ 22 10.5 Table 4 – Emission class and group ....................... 24 10.6 Table 5 – Recommended separation distances between portable and mobile HF communications equipment and the product ........................ 24 11 Subsidiaries.............................. 25 Instructions for use • LED Headlight KS70 • MVZ182_EN_V1.0_03-2021_IFU_CE-MDR... -
Page 4: General Information
Designates a possible imminent risk. If this is not avoided, it could lead to death or serious injuries. CAUTION CAUTION Designates a possible imminent risk. If this is not avoided, it could lead to minor injuries. Instructions for use • LED Headlight KS70 • MVZ182_EN_V1.0_03-2021_IFU_CE-MDR... - Page 5 General information NOTICE ATTENTION Designates a possibly harmful situation. If this is not avoided, the products could be damaged. Instructions for use • LED Headlight KS70 • MVZ182_EN_V1.0_03-2021_IFU_CE-MDR...
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Page 6: Normal Use
The medical device may only be used by doctors and medical assistants with a relevant specialist qualification. 2.5 Patient population There are no restrictions in terms of patient groups for this product. Instructions for use • LED Headlight KS70 • MVZ182_EN_V1.0_03-2021_IFU_CE-MDR... -
Page 7: Safety
The product can generate sparks, which cause combustible or flammable gases and liquids to ignite or explode. This may cause injuries to patients, users, and third parties. The product must not be operated in oxygenated environments. Instructions for use • LED Headlight KS70 • MVZ182_EN_V1.0_03-2021_IFU_CE-MDR... -
Page 8: Hot Components
The product creates an electromagnetic field. This can impair or damage other electronic devices and active implants (such as pacemakers). Observe the information on electromagnetic compatibility. In case of uncertainties, seek expert advice from KARL STORZ. Instructions for use • LED Headlight KS70 • MVZ182_EN_V1.0_03-2021_IFU_CE-MDR... -
Page 9: Product Description
Battery box Rotary knob for size adjustment Status LEDs Button (on/off/brightness intensity) Battery pack for LED headlight Power supply unit KS70 Various power supply unit adaptors Instructions for use • LED Headlight KS70 • MVZ182_EN_V1.0_03-2021_IFU_CE-MDR... -
Page 10: Technical Data
No significant warming during charging and when in operation Weight Approx. 22 g each Battery type Lithium-ion battery 3.7 V, 2,600 mAh, with protective circuit and overcurrent protection Power supply Nominal 3.7 V, max. 4.2 V, min. 2.75 V Instructions for use • LED Headlight KS70 • MVZ182_EN_V1.0_03-2021_IFU_CE-MDR... - Page 11 2.0 A Connecting cable 1.8 m with Micro-B USB plug Operating conditions Temperature: 0°C ... +45°C; rel. humidity: 30% ... 70%; air pressure: 700 hPa ... 1,060 hPa Storage conditions Temperature: -20°C ... +45°C; rel. humidity: 10% ... 85%; air pressure: 500 hPa ... 1,060 hPa Weight Approx. 130 g Instructions for use • LED Headlight KS70 • MVZ182_EN_V1.0_03-2021_IFU_CE-MDR...
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Page 12: Symbols On The Packaging
CE conformity mark With this mark, the manufacturer declares the compliance of the prod- ucts with the applicable regulation (EU) 2017/745. A code number after the CE mark indicates the responsible notified body. Instructions for use • LED Headlight KS70 • MVZ182_EN_V1.0_03-2021_IFU_CE-MDR... -
Page 13: Preparation
Adjust the size and fit of the headband using both rotary knobs. Set the orientation of the LED light and the diameter of the illuminated field using the rotating ring on the lamp head. Instructions for use • LED Headlight KS70 • MVZ182_EN_V1.0_03-2021_IFU_CE-MDR... - Page 14 The LED headlight does not offer any electric insulation against radio frequency (RF) voltages. Protection against RF voltage must be ensured through the use of correct RF instruments. For this please follow the instructions for use of the RF applied part used. Instructions for use • LED Headlight KS70 • MVZ182_EN_V1.0_03-2021_IFU_CE-MDR...
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Page 15: Application
10 minutes. Switch off the headlight and charge the batteries. If the LED headlight is to be used further, the batteries must be replaced. It is not possible to charge the batteries during operation. Instructions for use • LED Headlight KS70 • MVZ182_EN_V1.0_03-2021_IFU_CE-MDR... -
Page 16: Recharging The Battery
The headlight batteries can only be charged when switched off. It is not possible to charge the batteries during operation. Only the 094229 USB power supply unit or the KARL STORZ 11301DL charging station may be used for charging. ü The LED headlight is switched off. -
Page 17: Disassembly
Open the press fasteners on the forehead cushion and remove the latter. Unplug the connecting cable under the forehead cushion from the control unit. Pull the LED light upward off the headband. Instructions for use • LED Headlight KS70 • MVZ182_EN_V1.0_03-2021_IFU_CE-MDR... -
Page 18: Maintenance, Servicing, Repairs, And Disposal
8 Maintenance, servicing, repairs, and disposal 8.1 Repairing the product Repair work may only be performed by KARL STORZ or by a company authorized by KARL STORZ. The interventions described in this instruction manual are exempt from this rule. Please contact your local KARL STORZ subsidiary or authorized dealer (see the list of subsidiaries). -
Page 19: Accessories And Spare Parts
094203 LED headlight KS70, yellowish light, for 094230 094204 Control unit 094207 Battery box 094208 Battery pack 094224 USB power supply unit 094229 Headband 078770 Neoprene forehead cushion, for headband 078513 Instructions for use • LED Headlight KS70 • MVZ182_EN_V1.0_03-2021_IFU_CE-MDR... -
Page 20: Electromagnetic Compatibility
WARNING Reduced immunity! Risk of injury! The use of accessories or cables other than those specified in the KARL STORZ instructions for use may result in increased emissions or decreased immunity of the product. The cables listed have been shown to comply with the requirements of IEC 60601-1-2. - Page 21 80 MHz 80 MHz bances, induced 1 kHz 80% AM modu- 1 kHz 80% AM modu- by radio-fre- lation lation quency fields acc. 6 V in ISM band 6 V in ISM band to IEC 61000-4-6 Instructions for use • LED Headlight KS70 • MVZ182_EN_V1.0_03-2021_IFU_CE-MDR...
- Page 22 – guidelines Conducted HF distur- 3 V 3 V Portable and mobile HF bances acc. to IEC communications equip- 150 kHz to 80 MHz 61000-4-6 ment should be used no closer to any part of the Instructions for use • LED Headlight KS70 • MVZ182_EN_V1.0_03-2021_IFU_CE-MDR...
- Page 23 If abnormal perfor- mance is observed, additional measures may be necessary, such as re-orienting or relocating the product. Over the frequency range from 150 kHz to 80 MHz, field strengths should be less than 3 V/ Instructions for use • LED Headlight KS70 • MVZ182_EN_V1.0_03-2021_IFU_CE-MDR...
- Page 24 Note: At 80 MHz and 800 MHz, the separation distance for the higher frequency range ap- plies. Note: These guidelines may not apply in all situations. The propagation of electromagnetic waves is affected by absorptions and reflections of buildings, objects, and people. Instructions for use • LED Headlight KS70 • MVZ182_EN_V1.0_03-2021_IFU_CE-MDR...
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Page 25: Subsidiaries
Phone: +358 (0)96824774, Fax: +358 (0)968247755 Email: asiakaspalvelu@karlstorz.fi KARL STORZ Endoskope Greece M.E.P.E.* Patriarhou Grigoriou E’ 34, 54248 Thessaloniki, Greece Phone: +30 2310 304868, Fax: +30 2310 304862 Email: info-gr@karlstorz.com *Repair & Service Subsidiary Instructions for use • LED Headlight KS70 • MVZ182_EN_V1.0_03-2021_IFU_CE-MDR... - Page 26 No. 8 Commonwealth Lane #03-02, Singapore 149555, Singapore Phone: +65 69229150, Fax: +65 69229155 KARL STORZ ENDOSKOPE – East Mediterranean and Gulf (Offshore) S.A.L. Email: infoasia@karlstorz.com Spark Tower 1st floor Charles Helou St., Horch Tabet – Sin El Fil, Beirut,...
- Page 27 Subsidiaries Instructions for use • LED Headlight KS70 • MVZ182_EN_V1.0_03-2021_IFU_CE-MDR...
- Page 28 KARL STORZ SE & Co. KG Dr.-Karl-Storz-Straße 34 78532 Tuttlingen Postfach 230 78503 Tuttlingen Germany Phone: +49 7461 708-0 Fax: +49 7461 708-105 E-mail: info@karlstorz.com www.karlstorz.com...
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