background image

Electromagnetic compatibility

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

23

Interference immunity
tests

EN/IEC 60601 test
level

Compliance

level

Electromagnetic envi-

ronment – guidelines

Radiated HF distur-
bances acc. to IEC
61000-4-3

3 V/m

80 MHz to 2.5 GHz

3 V/m

product, including cables,
than the recommended
separation distance calcu-
lated from the equation
applicable to the fre-
quency of the transmitter.

Recommended separation
distances:

d = 1.2 √P

Where P is the rated
power of the transmitter in
watts [W] according to the
information provided by
the transmitter manufac-
turer and d is the recom-
mended separation dis-
tance in meters [m].

Field strengths from fixed
HF transmitters as deter-
mined by an electromag-
netic site survey 

a

 should

be less than the compli-
ance level in each fre-
quency range 

b

.

d = 1.2 √P

80 MHz to 800 MHz

d = 2.3 √P

800 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 apply in all situations. The propagation of electromagnetic
waves is affected by absorptions and reflections of buildings, objects, and people.

a

 Field strengths from fixed transmitters, e.g., base stations for radio (cellular/cordless) tele-

phones and land mobile radios, amateur radio, AM and FM radio broadcast, and TV broad-
cast cannot be predicted theoretically with accuracy. To assess the electromagnetic environ-
ment due to fixed transmitters, an electromagnetic site survey should be considered. If the
measured field strength at the location where the device is used exceeds the above compli-
ance levels, the device should be monitored to ensure proper function. If abnormal perfor-
mance is observed, additional measures may be necessary, such as re-orienting or relocating
the product.

b

 Over the frequency range from 150 kHz to 80 MHz, field strengths should be less than 3 V/

m.

Summary of Contents for 078770

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

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

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

Page 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...

Reviews: