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22

Electromagnetic Compatibility

Like other electrical medical equipment, the X8000 requires special precautions 
to ensure electromagnetic compatibility with other electrical medical devices. To 
ensure electromagnetic compatibility (EMC), the X8000 must be installed and 
operated according to the EMC information provided in this manual. 

Note

The X8000 has been designed and tested to comply with IEC 
60601-1-2 requirements for EMC with other devices.

Caution

Portable equipment may affect the normal function of the 
X8000.

W

ARNING

D

O

 

NOT

 

USE

 

CABLES

 

OR

 

ACCESSORIES

 

OTHER

 

THAN

 

THOSE

 

PROVIDED

 

WITH

 

THE

 X8000, 

AS

 

THIS

 

MAY

 

RESULT

 

IN

 

INCREASED

 

ELECTROMAGNETIC

 

EMISSIONS

 

OR

 

DECREASED

 

IMMUNITY

 

TO

 

SUCH

 

EMISSIONS

.

W

ARNING

I

F

 

THE

 X8000 

IS

 

USED

 

ADJACENT

 

TO

 

OR

 

STACKED

 

WITH

 

OTHER

 

EQUIPMENT

, 

OBSERVE

 

AND

 

VERIFY

 

NORMAL

 

OPERATION

 

OF

 

THE

 

X8000 

IN

 

THE

 

CONFIGURATION

 

IN

 

WHICH

 

IT

 

WILL

 

BE

 

USED

 

PRIOR

 

TO

 

USING

 

IT

 

IN

 

A

 

SURGICAL

 

PROCEDURE

. C

ONSULT

 

THE

 

TABLES

 

BELOW

 

FOR

 

GUIDANCE

 

IN

 

PLACING

 

THE

 X8000.

Guidance and Manufacturer's Declaration: Electromagnetic Emissions

X8000 is intended for use in the electromagnetic environment specified below. The customer or the 

user of X8000 should ensure that it is used in such an environment.

Emissions test

Compliance 

Electromagnetic Environment - guidance

RF emissions CISPR

11

Class B

X8000 is suitable for use in all establishments, 

including domestic establishments and those 

directly connected to the public low-voltage 

power supply network that supplies buildings 

used for domestic purposes.

Harmonic emissions

IEC61000-3-2

Class A

Voltage Fluctuations/

flicker emissions

IEC61000-3-3

Complies

Содержание X8000

Страница 1: ...X8000 Light Source 220 200 000 ...

Страница 2: ......

Страница 3: ...ode 11 Adjusting the Brightness 11 Visual Display 12 Language Selection 13 Safety Shutoff 13 Checking the ESST Feature 14 Using the X8000 with a Voice Controlled System Interface 15 Using the SFB Serial Interface 15 Troubleshooting 16 Cleaning and Maintenance 18 Cleaning the X8000 18 Caring for the Bulb Module 18 Replacing the Bulb Module 18 Replacing the Fuses 20 Disposing of the X8000 20 Technic...

Страница 4: ...EN USING THIS DEVICE WITH A LIGHT SOURCE FIRE AND OR SEVERE INJURY MAY RESULT TO THE PATIENT USER OR INANIMATE OBJECTS IF THE INSTRUCTIONS IN THIS MANUAL ARE NOT FOLLOWED ALL LIGHT SOURCES INCLUDING THE X8000 CAN GENERATE SIGNIFICANT AMOUNTS OF HEAT EXCEEDING 41 C 106 F AT THE SCOPE TIP THE SCOPE LIGHT POST THE LIGHT CABLE TIP AND OR NEAR THE LIGHT CABLE ADAPTER HIGHER LEVELS OF BRIGHTNESS FROM TH...

Страница 5: ...s unit was fully tested at the factory before shipment 5 Attempt no internal repairs or adjustments that are not specifically detailed in the Troubleshooting Cleaning and Maintenance sections of this operating manual 6 Never sterilize any part of the X8000 console 7 Disconnect the X8000 from the electrical outlet when inspecting the fuses 8 No modification of this equipment is allowed 9 To avoid r...

Страница 6: ...rately Please contact the manufacturer or other authorized disposal company to decommission your equipment Caution Surface may be hot The user must read the provided instructions to safely operate the device Disregarding the information could result in serious injury to the patient or user Consult instructions for use Caution consult instructions for use Power on off alternates when button is push...

Страница 7: ...ensing Technology ESST a special safety feature that helps prevent accidental burns caused by a light cable that is not connected to the scope For more information refer to the section Checking the ESST Feature When operated with an ESST light cable the X8000 senses when the scope and the light cable are separated and places the light source in Standby mode In Standby mode the X8000 will reduce li...

Страница 8: ...b module spare or replacement bulb modules can be purchased separately as P N 220 201 000 The features of the X8000 console are described below see Figures 1 and 2 Figure 1 Front panel of the X8000 console 1 Power Button Powers the unit on and off 2 Standby LED Illuminates when the unit is operating in the Standby mode In Standby mode light output is reduced to a minimum level 3 Mode Button Select...

Страница 9: ...ors Enables FireWire connection with Stryker FireWire devices Provides connection for remote diagnoses and future software upgrades 12 AC Inlet Connects to the provided power cord for AC power supply 13 Fuse Holder Contains two T 5 0 AH 250 V fuses 14 Equipotentiality Plug Provides a grounding post for common grounding with other equipment Connects to a potential equalization conductor The resulti...

Страница 10: ...owing connections Connect the AC power cable Connect the light cable Connecting the AC Power Cable 1 Plug in the AC power cord to the AC Inlet on the rear console panel 2 Plug in the other end of the AC cord to a hospital grade outlet WARNING WHEN THE X8000 IS INTERCONNECTED WITH OTHER MEDICAL ELECTRICAL EQUIPMENT LEAKAGE CURRENTS MAY BE ADDITIVE TO MINIMIZE LEAKAGE CURRENT THAT MAY TRAVEL TO THE ...

Страница 11: ...DO NOT LOOK DIRECTLY INTO THE CABLE PORT THE HIGH INTENSITY LIGHT MAY CAUSE DAMAGE TO THE EYES 2 Insert a clean dry fiberoptic cable into the cable port until the jaw latch releases and the jaw clamps the cable in place see Figure 4 Pull gently on the fiberoptic cable to test that it is securely seated in the cable port Figure 4 Inserting the light cable into the cable port 3 Connect an endoscope ...

Страница 12: ... off Failure to do so can cause the bulb to rapidly darken and fail To power on the X8000 1 Confirm that the X8000 contains a properly installed bulb The bulb handle must be turned all the way to the left to ensure proper latching If no bulb is installed follow the instructions in the Replacing the Bulb section of this manual before proceeding 2 Press the power switch on the front panel The Standb...

Страница 13: ...ODE AND THEREFORE MAY STILL RESULT IN FIRE AND OR BURNS TO THE PATIENT USER OR INANIMATE OBJECTS IF NOT USED PROPERLY DO NOT PLACE THE SCOPE OR THE LIGHT CABLE ON THE PATIENT ON THE DRAPES OR OTHER FLAMMABLE MATERIAL EVEN WHEN THE DEVICE IS IN STANDBY MODE Adjusting the Brightness The X8000 has up and down buttons for adjusting the bulb brightness Press the up arrow to increase brightness and pres...

Страница 14: ...hows how many total hours the bulb has operated For example if the LCD shows 250 the bulb has operated 250 total hours The bulb hours will flash after 500 hours and the LCD will display Replace Bulb after 1000 hours The LCD also displays warning and error codes The table below lists and defines the warning and error codes displayed Code Definition Recommended Action E 1 All conditions are met for ...

Страница 15: ...WER WILL RESUME TO THE BULB AND THE UNIT WILL RESTART IN STANDBY MODE TO PREVENT FIRES AND ACCIDENTAL BURNS TO THE PATIENT USER OR INANIMATE OBJECTS ALWAYS PLACE THE SCOPES AND OR FIBEROPTIC CABLES IN A SAFE PLACE AND NOT ON THE PATIENT DRAPES OR OTHER FLAMMABLE MATERIAL TO ENSURE SAFE RESUMPTION OF LIGHT OUTPUT IF THE X8000 LIGHT SOURCE EXPERIENCES A TEMPORARY SHUTDOWN IT IS RECOMMENDED THAT THE ...

Страница 16: ...om the ESST scope adapter The X8000 should return to Standby mode indicating that the ESST feature is functioning properly WARNING ALWAYS CHECK TO ENSURE THAT THE UNIT HAS SWITCHED INTO STANDBY MODE BEFORE ASSUMING ESST SAFETY PROTECTION IF THE UNIT FAILS TO RETURN TO STANDBY MODE THERE MAY BE A FAULT WITH THE ESST FEATURE IN THIS CASE DO NOT ASSUME ESST SAFETY PROTECTION AND RETURN THE UNIT FOR S...

Страница 17: ...nance Manual P N 1000 400 653 Using the SFB Serial Interface The SFB serial connection on the rear panel of the X8000 enables FireWire connection to the Stryker Endoscopy Software Management site Connecting to this site enables remote diagnostics and software updates Note This system feature is not necessary for regular light source operation Note This system feature requires an additional device ...

Страница 18: ...ed all the way to the left within the light source Ensure the bulb is in operating condition Replace the bulb if necessary Ensure the light cable is correctly engaged with the cable port As a safety feature the X8000 will provide no light output unless a fiberoptic light cable is properly seated in the cable port Ensure the bulb access door is completely shut Check for error codes E 1 E 2 E 3 E 4 ...

Страница 19: ...ness For details see the Adjusting the Brightness section in this manual Ensure the fiberoptic cable is transmitting light properly Hold the light source end of the cable up to an overhead room light and look into the scope end of the light cable If the pattern contains any black spots the light cable may be worn out and may require replacement Ensure the light cable is of an adequate size for the...

Страница 20: ... unevenly and fail 2 Do not power on and off the bulb in rapid succession Allow the bulb to run for at least five minutes once it has been powered on Failure to do so can cause the bulb to rapidly darken and fail 3 The X8000 has been designed to start the bulb under most conditions even when it is hot However if the bulb does not start within 10 seconds after the X8000 has powered on turn the unit...

Страница 21: ...dle to the right grasp the bulb module by the handle and remove the bulb Figure 6 Figure 6 Removing the bulb module WARNING DO NOT REACH INSIDE THE BULB DOOR FOR ANY REASON OTHER THAN REPLACING THE BULB MODULE TOUCHING PARTS OTHER THAN THE BULB MODULE MAY CAUSE BURNS OR PRODUCT DAMAGE WARNING DO NOT TOUCH ANY PART OF THE BULB MODULE EXCEPT FOR THE HANDLE THE MODULE MAY BE VERY HOT AND CAUSE BURNS ...

Страница 22: ...lacing the Fuses 1 Unplug the light source from the AC outlet and remove the power cord from the rear of the unit 2 Unlatch the fuse holder and remove the fuse s 3 Replace the fuse s with fuses of the same value and rating WARNING TO HELP AVOID THE RISK OF FIRE USE ONLY FUSES RATED AS SPECIFIED ON THE CONSOLE 4 Reinstall the fuse holder Disposing of the X8000 The device must be disposed of accordi...

Страница 23: ...lbs 7 3 kg Fiberoptic Cable Range 2 mm to 6 5 mm diameter Bulb Type 300 Watt Xenon Elliptical Life Approximately 500 hours Operating Conditions 10 to 40 C 30 to 75 Relative Humidity 700hPa to 1060hPa Transportation Storage 20 to 50 C 10 to 75 Relative Humidity 700hPa to 1060hPa Classifications Class 1 Equipment Type CF applied parts Water Ingress Protection IPX0 Ordinary Equipment Continuous Opera...

Страница 24: ...RNING IF THE X8000 IS USED ADJACENT TO OR STACKED WITH OTHER EQUIPMENT OBSERVE AND VERIFY NORMAL OPERATION OF THE X8000 IN THE CONFIGURATION IN WHICH IT WILL BE USED PRIOR TO USING IT IN A SURGICAL PROCEDURE CONSULT THE TABLES BELOW FOR GUIDANCE IN PLACING THE X8000 Guidance and Manufacturer s Declaration Electromagnetic Emissions X8000 is intended for use in the electromagnetic environment specif...

Страница 25: ...mon mode 0 5 1kV differential mode 0 5 1 2kV common mode Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC61000 4 11 5 Ut 95 dip in Ut for 0 5 cycle 40 Ut 60 dip in Ut for 5 cycles 70 Ut 30 dip in Ut for 25 cycles 5 Ut 95 dip in Ut for 5 sec 5 Ut 95 dip in Ut for 0 5 cycle 40 Ut...

Страница 26: ...E 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess th...

Страница 27: ...ce m according to frequency of transmitter 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz 0 01 0 12 0 12 0 23 0 1 0 37 0 37 0 74 1 1 17 1 17 2 33 10 3 70 3 70 7 37 100 11 70 11 70 23 30 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter where P...

Страница 28: ...Endoscopy will be issued a thirty day warranty against defects in both materials and workmanship provided the original warranty period has passed Instruments submitted due to defects in materials and workmanship during the warranty period will be repaired at no charge to the customer The warranty as set forth herein is exclusive and in lieu of all other warranties remedies obligations and liabilit...

Страница 29: ...tryker Endoscopy Customer Service Department 5900 Optical Court San Jose CA 95138 USA If service is needed either during or after the warranty period 1 Contact Stryker Endoscopy at 1 800 624 4422 or phone your local Stryker Endoscopy sales representative 2 Package all the components carefully in the original shipping container if possible 3 Ship the light source prepaid and insured to Stryker Endo...

Страница 30: ...28 ...

Страница 31: ......

Страница 32: ...800 624 4422 www stryker com 2014 01 1000 400 885 F Stryker Corporation or its divisions or other corporate affiliated entities own use or have applied for the following trademarks or service marks the Stryker logo All other trademarks are trademarks of their respective owners ...

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