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15140-101 Rev. C

Warnings & Cautions

Reichert Technologies

®

 (Reichert) is not responsible for the safety and reliability of this instrument when:

• 

Assembly, disassembly, repair, or modification is made by unauthorized dealers or persons.

•  Instrument is not used in accordance with this User’s Guide. 

WARNING:   AN INSTRUCTION THAT DRAWS ATTENTION TO RISK OF INJURY OR DEATH.

 WARNING: 

UNITED STATES FEDERAL LAW AND EUROPEAN REGULATIONS REQUIRE THAT THIS 

DEVICE BE PURCHASED ONLY BY A PHYSICIAN OR A PERSON ACTING ON BEHALF OF A PHYSICIAN. 

 WARNING: 

THIS INSTRUMENT SHOULD BE USED IN STRICT ACCORDANCE WITH THE 

INSTRUCTIONS OUTLINED IN THIS USER’S GUIDE.  THE SAFETY OF THE OPERATOR AND THE 

PERFORMANCE OF THE INSTRUMENT CANNOT BE GUARANTEED IF USED IN A MANNER NOT 

SPECIFIED BY REICHERT TECHNOLOGIES.

 WARNING: 

DO NOT REPAIR OR SERVICE THIS INSTRUMENT WITHOUT AUTHORIZATION FROM 

THE MANUFACTURER.  ANY REPAIR OR SERVICE TO THIS INSTRUMENT MUST BE PERFORMED BY 

EXPERIENCED PERSONNEL OR DEALERS WHO ARE TRAINED BY REICHERT OR SERIOUS INJURY 

TO THE OPERATOR OR PATIENT MAY OCCUR.

 WARNING: 

MODIFICATIONS TO THIS INSTRUMENT ARE NOT ALLOWED.  ANY MODIFICATION TO 

THIS UNIT MUST BE AUTHORIZED BY REICHERT OR SERIOUS INJURY TO THE OPERATOR OR 

PATIENT MAY OCCUR.

 WARNING: 

IF THIS INSTRUMENT IS MODIFIED, APPROPRIATE INSPECTION AND TESTING MUST BE 

CONDUCTED TO ENSURE CONTINUED SAFE USE OF THIS INSTRUMENT.

 

 WARNING: 

TO AVOID RISK OF ELECTRIC SHOCK, THIS EQUIPMENT MUST ONLY BE CONNECTED TO 

A SUPPLY MAINS WITH PROTECTIVE EARTH OR DAMAGE TO THIS INSTRUMENT AND/OR INJURY TO 

THE OPERATOR OR PATIENT MAY OCCUR.

 WARNING: 

ENSURE THAT THE VOLTAGE APPLIED TO THE UNIT IS THE SAME AS THE VOLTAGE THAT 

IS INDICATED ON THE DATA PLATE OR DAMAGE TO THE UNIT MAY OCCUR. 

 WARNING: 

THIS INSTRUMENT MUST BE PLUGGED INTO AN OUTLET WITH AN EARTH GROUND.  DO 

NOT REMOVE OR DEFEAT THE EARTH GROUND CONNECTION ON POWER INPUT CONNECTOR 

OR THE UNIT’S POWER CORD OF THIS INSTRUMENT OR DAMAGE TO IT  AND/OR INJURY TO THE 

OPERATOR OR PATIENT MAY OCCUR.

 WARNING:

 THE EQUIPMENT OR SYSTEM SHOULD NOT BE USED ADJACENT TO OR STACKED WITH 

OTHER EQUIPMENT AND THAT IF ADJACENT OR STACKED USE IS NECESSARY, THE EQUIPMENT 

OR SYSTEM SHOULD BE OBSERVED TO VERIFY NORMAL OPERATION IN THE CONFIGURATION IN 

WHICH IT WILL BE USED.

 WARNING: 

THIS INSTRUMENT IS NOT SUITABLE FOR USE IN THE PRESENCE OF FLAMMABLE 

ANESTHETIC MIXTURES, SUCH AS OXYGEN OR NITROUS OXIDE.

 WARNING: 

BECAUSE PROLONGED INTENSE LIGHT EXPOSURE CAN DAMAGE THE RETINA, THE 

USE OF THE DEVICE FOR OCULAR EXAMINATION SHOULD NOT BE UNNECESSARILY PROLONGED, 

AND THE BRIGHTNESS SETTING SHOULD NOT EXCEED WHAT IS NEEDED TO PROVIDE CLEAR 

VISUALIZATION OF THE TARGET STRUCTURES. THIS DEVICE SHOULD BE USED WITH THE 

INTEGRATED FILTERS WHICH PROTECT AGAINST UV RADIATION.

 WARNING:

 THE USE OF ACCESSORIES OR CABLES OTHER THAN THOSE SPECIFIED, WITH THE 

EXCEPTION OF THOSE SOLD BY THE MANUFACTURER AS REPLACEMENT PARTS FOR THE 

INTERNAL COMPONENTS, MAY RESULT IN INCREASED EMISSIONS OR DECREASED IMMUNITY OF 

THE EQUIPMENT OR SYSTEM. 

 

Содержание XCEL 455

Страница 1: ...XCEL 455 Slit Lamp User s Guide...

Страница 2: ...nges in the product described in this manual without notice and without incorporating those changes in any products already sold ISO 9001 13485 Certified Reichert products are designed and manufacture...

Страница 3: ...3 Filters 13 Slit Rotation 14 Illumination Inclination 14 Slit Centration 14 Cleaning Maintenance 15 Cleaning 15 External Cleaning 15 Forehead Chinrest Cleaning Disinfection 15 Cleaning the Glide Plat...

Страница 4: ...ELECTRIC SHOCK THIS EQUIPMENT MUST ONLY BE CONNECTED TO A SUPPLY MAINS WITH PROTECTIVE EARTH OR DAMAGE TO THIS INSTRUMENT AND OR INJURY TO THE OPERATOR OR PATIENT MAY OCCUR WARNING ENSURE THAT THE VOL...

Страница 5: ...NG EMC AND NEEDS TO BE INSTALLED AND PUT INTO SERVICE ACCORDING TO THE EMC INFORMATION PROVIDED IN THE ACCOMPANYING DOCUMENTS CAUTION PORTABLE AND MOBILE RF COMMUNICATIONS EQUIPMENT CAN AFFECT MEDICAL...

Страница 6: ...014 Date of Manufacture REF Catalog Number S N Serial Number Waste of Electrical and Electronic Equipment Compliance to Medical Device Directive 93 42 EEC 36FS Underwriter s Laboratories has independe...

Страница 7: ...of the anterior segment of the eye Contraindications None Phototoxicity Information Because prolonged intense light exposure can damage the retina the use of the device for ocular examination should n...

Страница 8: ...ial 13 Lamp Housing Cover 14 Fixation Light 15 Filter Lever 16 Slit Rotation Length Knob 17 Slit Rotation Scale 18 Microscope Lock Knob 19 Illumination Arm Lock Knob 20 Instrument Base Lock Knob 21 Gu...

Страница 9: ...he accessories and store them in an appropriate place so that when they are needed they will be available Refer to Figure SU 4 8 Using the 3mm Hex Wrench connect the Ground Wire from the Power Supply...

Страница 10: ...lumination Assembly and Arm Note The Illumination Assembly and Arm are con nected as one piece 14 Mount the Illumination Assembly and Arm onto the Base Assembly and secure it with the Screw using the...

Страница 11: ...NGER TO THE PATIENT WARNING POSITION THIS INSTRUMENT SO THAT IT IS NOT DIFFICULT TO OPERATE THE DISCONNECTION DEVICE PLUG 1 After the unit is in its secure location apply the correct input voltage to...

Страница 12: ...Chin Rest Assembly until the patient s canthus is in line with the Canthus Mark on the chin rest post Refer to Figures IN 2 and IN 3 7 Microscope elevation is adjusted by rotating the joystick and obs...

Страница 13: ...slit length is adjusted by rotating the Slit Length Rotation Dial The dial has five stops for adjustments They are 12 9 5 3 1 and 0 3 mm diameter and continuous length Refer to Figure IN 8 Filters Th...

Страница 14: ...mination Assembly by depressing the Inclination Latch Release and pulling the base of the Illumination Assembly toward the operator Refer to Figure IN 10 Slit Centration When the centering screw is lo...

Страница 15: ...d rest with an alcohol wipe and change the chin rest papers after each patient Cleaning the Glide Plate If the Glide Plate is dirty it may cause a rough feeling when maneuvering the base of the slit l...

Страница 16: ...Holder and Lamp Refer to Figure MM 5 5 Grip the Lamp by the Metal Disk that is attached to it and pull it out of the Lamp Holder Refer to Figure MM 6 6 Replace the Lamp with a new one and install it...

Страница 17: ...gripping the two small tabs Refer to Figures MM 8 and MM 9 3 Open the Door to the Fuse Holder by pulling it down Refer to Figure MM 9 Note The Fuses will pop up when the door is open making removal e...

Страница 18: ...ation Light Harness not plugged into the Power Supply Assembly Ensure the Fixation Light Harness is properly seated in the Power Supply Assembly Defective Power Supply Replace the Power Supply Assembl...

Страница 19: ...35 C 95 F Relative Humidity 30 to 75 Atmospheric Pressure 80 kPa 23 6 in Hg to 106 kPa 31 3 in Hg Transportation Storage Temperature 20 C 4 F to 70 C 158 F Relative Humidity 10 to 80 Atmospheric Pres...

Страница 20: ...tion Protection Class I Ingress Protection Rating IXP0 Instrument Type IEC 60601 1 B Operating Mode Continuous US FDA Class II 21 CFR 886 1850 EU Medical Device Directive Class I Rule 12 CAN CMDR Clas...

Страница 21: ...n such an environment Emissions Test Compliance Electromagnetic Environment Guidance RF Emissions CISPR 11 Group 1 Class A The Xcel 455 uses RF energy only for its internal function Therefore its RF e...

Страница 22: ...ity should be that of a typical commercial or hospital environment Surge IEC 61000 4 5 1kV Differential 2kV Common 1kV Differential 2kV Common Mains power quality should be that of a typical commercia...

Страница 23: ...distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur...

Страница 24: ...m output power of the communications equipment Max Output Pow er of Transmitter W Separation m 150kHz to 80 MHz d 3 5 V1 Sqrt P Separation m 80 to 800 MHz d 3 5 E1 Sqrt P Separation m 800MHz to 2 5GHz...

Страница 25: ...RRANTY If notified promptly in writing of any action brought against the purchaser based on a claim that the instrument infringes a U S Patent Reichert will defend such action at its expense and will...

Страница 26: ...26 15140 101 Rev C Notes...

Страница 27: ...27 15140 101 Rev C Notes...

Страница 28: ...716 686 4545 Email reichert information ametek com www reichert com AMETEK GmbH Business Unit Reichert Carl von Linde Strasse 42 85716 Unterschleissheim Munich Germany Email info reichert de ametek c...

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