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Safety

Instructions for use • LED Headlight KS70 • MVZ182_EN_V1.0_03-2021_IFU_CE-MDR

8

Do not operate the product in explosive atmospheres.

Do not operate the product in environments with combustible gases such as inhalation
anesthetics and mixtures thereof. Observe the hazard zones:

Only connect or disconnect the power plug to or from the power supply outside explosive
atmospheres.

Combustible and flammable gases must be allowed to escape, be extracted, or be
displaced with CO2 before use.

Combustible and flammable liquids must be allowed to vaporize or be extracted before
use.

Only start the application when combustible or flammable gases and liquids are no longer
present.

3.6 Hot components

The high level of light intensity produced by the light source may cause the distal end, the light
connections, and adjacent components to heat up. This can cause burns to patients, users,
and third parties.

Set the light source output to a level that is just high enough to ensure optimal illumination
of the operating area.

Avoid contact with the distal end and light connections.

3.7 High light intensity

The high level of light intensity produced by the light source may lead to permanent eye
damage or blindness, and may cause tissue and items facing the light output to heat up.

Do not look into the light output.

Set the light source output to a level that is just high enough to ensure optimal illumination
of the operating area.

Make sure the light output is sufficiently far away from tissue and operating accessories.

3.8 Failure of products

The product may fail during use.

Have a replacement product ready for each application or plan for an alternative surgical
technique.

3.9 Electromagnetic interference

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.

Содержание 078770

Страница 1: ...Instructions for use LED Headlight KS70 en...

Страница 2: ...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 ri...

Страница 3: ...the packaging 12 5 Preparation 13 5 1 Unpacking the product 13 5 2 Inspecting the product 13 5 3 Assembling the product 13 6 Application 15 6 1 Using the product 15 6 2 Monitoring the battery charge s...

Страница 4: ...and warnings 1 3 Scope These instructions for use are valid for Product name Item number Headband for LED headlight KS70 078770 LED headlight KS70 white light 094203 LED headlight KS70 yellowish ligh...

Страница 5: ...eral information Instructions for use LED Headlight KS70 MVZ182_EN_V1 0_03 2021_IFU_CE MDR 5 NOTICE ATTENTION Designates a possibly harmful situation If this is not avoided the products could be damag...

Страница 6: ...adband is non invasive and is designed for short term use in non surgically invasive procedures and surgical procedures 2 2 Indications The use of the headlight is indicated if it is indicated in the...

Страница 7: ...t is not handled correctly patients users and third parties may be injured Only persons with the necessary medical qualification and who are acquainted with the application of the product may work wit...

Страница 8: ...and third parties Set the light source output to a level that is just high enough to ensure optimal illumination of the operating area Avoid contact with the distal end and light connections 3 7 High...

Страница 9: ...2 Rotating ring for setting the diame ter of the illuminated field 3 Control unit incl button on off brightness intensity see 8 and con nection socket for charging the bat tery pack 4 Forehead cushion...

Страница 10: ...ved with the smallest spot High setting 3 approx 29 kLux Mid setting 2 approx 19 kLux Low setting 1 approx 11 kLux Operating conditions Temperature 0 C 45 C rel humidity 30 70 air pressure 700 hPa 1 0...

Страница 11: ...over charging Protected by protective circuit Battery temperature range Storage 20 C 45 C charging 0 C 45 C operation 20 C 60 C Air pressure Operation 700 hPa 1 060 hPa storage 500 hPa 1 060 hPa Weig...

Страница 12: ...h code Medical device Unique Device Identifier Fragile handle with care Keep dry Unsterile Consult the printed or electronic instructions for use Federal USA law restricts this device to sale by or on...

Страница 13: ...sible contamination Do not use contaminated products 2 Inspect the products for the following characteristics Good working order Functionality Correct assembly of the components Completeness Inspect t...

Страница 14: ...1_IFU_CE MDR 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...

Страница 15: ...status LEDs which light up for approx 3 seconds 1 LED luminous intensity 1 2 LEDs luminous intensity 2 3 LEDs luminous intensity 3 The LEDs then change back to green to indicate the battery s chargin...

Страница 16: ...the batteries during operation Only the 094229 USB power supply unit or the KARL STORZ 11301DL charging station may be used for charging The LED headlight is switched off Insert the battery charger pl...

Страница 17: ...witch off the LED headlight using the pushbutton on the control unit 2 Remove the batteries from the control unit and from the battery box 3 Open the press fasteners on the forehead cushion and remove...

Страница 18: ...ion manual are exempt from this rule Please contact your local KARL STORZ subsidiary or authorized dealer see the list of subsidiaries Contaminated devices may not be shipped To prevent contact infect...

Страница 19: ...9 1 Spare parts list Spare parts for LED headlight 094220 094230 Item Order number LED headlight KS70 white light for 094220 094203 LED headlight KS70 yellowish light for 094230 094204 Control unit 09...

Страница 20: ...this can result in incorrect operation If such use is necessary this and the other devices should be observed to ensure that they are operating correctly WARNING Reduced immunity Risk of injury The u...

Страница 21: ...315 phase angles Voltage interruption 100 for 250 300 cy cles The power supply qual ity should be that of a typical commercial or hospital environment If the user of the product requires continued op...

Страница 22: ...M 1900 DECT LTE band 1 3 4 25 UMTS Pulse modula tion 217 Hz 28 28 1 845 1 970 2 450 2 400 2 570 Bluetooth WLAN 802 11 b g n RFID 2450 LTE band 7 Pulse modula tion 217 Hz 28 28 5 240 5 100 5 800 WLAN 8...

Страница 23: ...00 MHz to 2 5 GHz Interferences may occur in the vicinity of equipment marked with the following symbol Note At 80 MHz and 800 MHz the higher frequency range applies Note These guidelines may not appl...

Страница 24: ...ation distances between portable and mobile HF communications equipment and the product The product is intended for use in an electromagnetic environment in which HF disturbances are controlled The cu...

Страница 25: ...STORZ Endoscopy Suomi OY Taivaltie 5 01610 Vantaa Finland Phone 358 0 96824774 Fax 358 0 968247755 Email asiakaspalvelu karlstorz fi KARL STORZ SE Co KG Representation Office K stu io st 59 Lenktoji s...

Страница 26: ...ilding B 18F Beijing IFC No 8 Jianguomenwai Street Chaoyang District 100022 Beijing People s Republic of China Phone 86 10 5638188 Fax 86 10 5638199 Email info karlstorz com cn KARL STORZ Endoscopy Sh...

Страница 27: ...Subsidiaries Instructions for use LED Headlight KS70 MVZ182_EN_V1 0_03 2021_IFU_CE MDR 27...

Страница 28: ...RZ SE Co KG Dr Karl Storz Stra e 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 MVZ182 EN V1 0 03 2021 IF...

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