Labeling - Gemini 810 DIODE LASER Manual Del Usuario

SYMBOLS
UNIT LABEL
AZENA MEDICAL, LLC
3021 Citrus Circle - Suite 180
Walnut Creek, CA
94598 - USA
2797
1 (800)466-5273
Manufactured by
ULTRADENT PRODUCTS, INC
EMERGO EUROPE
505 West 10200 South EC REP
Prinsessegracht 20
South Jordan, UT
2514 AP The Hague
84095 - USA
The Netherlands
1 (888) 230-1420 EUROPEAN REP
Distributed by
Manufacture Date
PN BARCODE LABEL
REF
Part Number
SN
Serial Number
COMPLIES WITH: IEC 60601-2-22:2007 / IEC 60825-1:2007
AS WELL AS TO US FEDERAL REGULATIONS FOR LASER PERFORMANCE
STANDARDS SET OUT IN 21CFR 1040.10 AND 1040.11
EXCEPT FOR DEVIATIONS PURSUANT TO LASER NOTICE 50 DATED JUNE 24, 2007
THIS PRODUCT COMPLIES WITH FDA
Power Input: 13V - 3.5A
PERFORMANCE STANDARDS FOR LASER
Model: GEMINI 810+980 DIODE LASER
PRODUCTS EXCEPT FOR DEVIATIONS
PURSUANT TO LASER NOTICE 50 DATE Connect only to provided power supply.
JUNE 24, 2007
ID:
IC:
DANGER. Visible and/or The applied part is not Refer to Non-ionozing
Radiation
invisible laser radiation conductive to the patient User's Manual
DESCRIPTION
MANUFACTURER
INDICATES WHICH COMPANY MANUFACTURES
DATE OF MANUFACTURE
INDICATES THE DATE AND YEAR OF MANUFACTURE
CATALOG PART NUMBER
INDICATES THE MANUFACTURER PART NUMBER.
SERIAL NUMBER
INDICATES SERIAL NUMBER FOR THE PRODUCT
PART
PRESCRIPTION STATEMENT
FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY
OR ON THE ORDER OF A DENTIST OR PHYSICIAN
OR OTHER LICENSED MEDICAL PRACTITIONER
LASER WARNING
INDICATES THE SYSTEM CONTAINS A LASER
WARNING
INDICATES POSSIBLE EXPOSURE TO BOTH RED
AND INFRARED LASER RADIATION
LASER APERTURE
INDICATES WHERE LASER ENERGY COMES OUT
PEDAL LABEL
AZENA MEDICAL, LLC
ULTRADENT PRODUCTS, INC
3021 Citrus Circle - Suite 180 505 West 10200 South
EMERGO EUROPE
Prinsessegracht 20
Walnut Creek, CA South Jordan, UT
2514 AP The Hague
94598 - USA 84095 - USA The Netherlands
EUROPEAN REP
1 (800)466-5273 1 (888) 230-1420
Manufactured by Distributed by
Model:
Gemini
810+980
Manufacture Date
Diode Laser
PN
BARCODE LABEL
REF
Part Number
SN Power Input:
AA Batteries
Serial Number
COMPLIES WITH: IEC 60601-2-22:2007 / IEC 60825-1:2007
AS WELL AS TO US FEDERAL REGULATIONS FOR LASER
PERFORMANCE STANDARDS SET OUT IN 21CFR 1040.10
AND 1040.11 EXCEPT FOR DEVIATIONS PURSUANT
TO LASER NOTICE 50 DATED JUNE 24, 2007 2797
THIS DEVICE COMPLIES WITH PART 15 OF FCC RULES.
OPERATION IS SUBJECT TO THE FOLLOWING TWO
CONDITIONS:
1) THIS DEVICE MAY NOT CAUSE HARMFUL INTERFERENCE
2) THIS DEVICE MUST ACCEPT ANY INTERFERENCE RECEIVED
Refer to Non-ionozing
INCLUDING INTERFERENCE THAT MAY CAUSE UNDESIRABLE
User's Manual Radiation
INTERFERENCE
KEEP DRY
SHIP VERTICAL, WITH ARROWS
POINTED UPWARD
FRAGILE - HANDLE WITH CARE
DO NOT USE IF PACKAGE IS DAMAGED
40°C
104°F
RECOMMENDED STORAGE TEMPERATURE
0°C
32°F
106kPa
ATMOSPHERIC PRESSURE LIMITATION
70kPa
95%
RELATIVE HUMIDITY RANGE
10%
KEEP AWAY FROM HEAT/SUNLIGHT
SYMBOLS
THE APPLIED PART IS NOT CONDUCTIVE TO
EMERGENCY SWITCH TO STOP LASER OUT-
DESCRIPTION
TYPE B APPLIED PART
THE PATIENT
REFER TO USER'S MANUAL
LASER STOP
PUT POWER
NON-IONIZING RADIATION
WESTERN EUROPE ELECTRONIC AND
ELECTRICAL DISPOSAL STANDARD (WEEE)
15