Caldera Benesta CAL-TR1511 Manual de instrucciones - Página 2
Navegue en línea o descargue pdf Manual de instrucciones para Equipamiento médico Caldera Benesta CAL-TR1511. Caldera Benesta CAL-TR1511 7 páginas. Tissue removal device
Imprimir páginaThe following is an explanation of symbols that may be used on Caldera Medical's products and packaging:
Symbol
Title/ Meaning/ Referent
Manufacturer
EU Authorized Representative
Date of Manufacture
Use by Date
Batch Code
Catalogue number
Sterilized Using Ethylene Oxide
Do Not Re-sterilize
Do Not Use If Package Is Damaged
Non-sterile
Keep Dry
Temperature Limit
Humidity Limitation
Do Not Re-use
Consult Instructions for Use
Consult Instructions for Use, or
For Instructions for Use Refer to
[IFU URL]
Follow Instructions for Use
Caution
General Warning
Type BF Applied Part
Ingress Rating
IPX2
Non-Ionizing Electromagnetic
Radiation
NRTL Certification
Packaging Unit
Prescription Only
Symbol Glossary
Function/ Description
Manufacture
Indicates the medical device manufacturer.
Indicates the authorized representative in the European community.
Indicates the date when the medical device was manufactured.
Indicates the date after which the medical device is not to be used.
Indicates the manufacturer's batch code so that the batch or lot can be
identified.
Indicates the manufacturer's catalogue number so that the medical device can
be identified.
Sterility
Indicates a medical device that has been sterilized using ethylene oxide.
Indicates a medical device that is not to be re-sterilized.
Indicates a medical device that should not be used if the package has been
damaged or opened.
Indicates a medical device that has not been subjected to a sterilization process.
Storage
Indicates a medical device that needs to be protected from moisture.
Indicates the temperature limits to which the medical device can be safely
exposed
Indicates the range of humidity to which the medical device can be safely
exposed
Safe Use
Indicates a medical device that is intended for one use, or for use on a single
patient during a single procedure.
Indicates the need for the user to consult the instructions for use.
Indicates the need for the user to consult the instructions for use and where the
electronic instructions for use (eIFU) and symbols glossary can be found.
Refer to Instruction manual/booklet; on medical electrical equipment, Follow
Instructions for Use
Indicates the need for the user to consult the instructions for use for important
cautionary information such as warnings and precautions that cannot, for a
variety of reasons, be presented on the medical device itself.
General Warning Sign
Signifies Applied Part Type
Signifies that the device is rated to level 2 for water ingress protection, and that
water splashing against the enclosure from any direction shall have no harmful
effect.
Indicates generally elevated, potentially hazardous levels of non-ionizing
radiation, or to indicates equipment or systems e.g. in the medical electrical area
that include RF transmitters or that intentionally apply RF electromagnetic
energy for diagnosis or treatment.
Signifies that the device meets regulatory and performance requirements
verified by NRTL
Other
Indicates the number of pieces in the package.
Requires prescription in the United States of America.
2
ISO 7000
ISO 15223-
Reg. no.
1 or Other
3082
5.1.1
N/A
5.1.2
2497
5.1.3
2607
5.1.4
2492
5.1.5
2493
5.1.6
2501
5.2.3
2608
5.2.6
2606
5.2.8
2609
5.2.7
0626
5.3.4
0632
5.3.7
2620
5.3.8
1051
5.4.2
1641
5.4.3
1641
5.4.3
ISO 7010-
N/A
M002
0434A
5.4.4
ISO 7010-
N/A
W012
IEC 60517-
N/A
5840
N/A
N/A
IEC 60417-
N/A
5140
N/A
N/A
2794
N/A
21 CFR
N/A
801.109