2
Symbol Glossary
The following is an explanation of symbols that may be used on Caldera Medical’s products and packaging:
Symbol
Title/ Meaning/ Referent
Function/ Description
ISO 7000
Reg. no.
ISO 15223-
1 or Other
Manufacture
Manufacturer
Indicates the medical device manufacturer.
3082
5.1.1
EU Authorized Representative
Indicates the authorized representative in the European community.
N/A
5.1.2
Date of Manufacture
Indicates the date when the medical device was manufactured.
2497
5.1.3
Use by Date
Indicates the date after which the medical device is not to be used.
2607
5.1.4
Batch Code
Indicates the manufacturer's batch code so that the batch or lot can be
identified.
2492
5.1.5
Catalogue number
Indicates the manufacturer's catalogue number so that the medical device can
be identified.
2493
5.1.6
Sterility
Sterilized Using Ethylene Oxide
Indicates a medical device that has been sterilized using ethylene oxide.
2501
5.2.3
Do Not Re-sterilize
Indicates a medical device that is not to be re-sterilized.
2608
5.2.6
Do Not Use If Package Is Damaged
Indicates a medical device that should not be used if the package has been
damaged or opened.
2606
5.2.8
Non-sterile
Indicates a medical device that has not been subjected to a sterilization process. 2609
5.2.7
Storage
Keep Dry
Indicates a medical device that needs to be protected from moisture.
0626
5.3.4
Temperature Limit
Indicates the temperature limits to which the medical device can be safely
exposed
0632
5.3.7
Humidity Limitation
Indicates the range of humidity to which the medical device can be safely
exposed
2620
5.3.8
Safe Use
Do Not Re-use
Indicates a medical device that is intended for one use, or for use on a single
patient during a single procedure.
1051
5.4.2
Consult Instructions for Use
Indicates the need for the user to consult the instructions for use.
1641
5.4.3
[IFU URL]
Consult Instructions for Use, or
For Instructions for Use Refer to
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.
1641
5.4.3
Follow Instructions for Use
Refer to Instruction manual/booklet; on medical electrical equipment, Follow
Instructions for Use
ISO 7010-
M002
N/A
Caution
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.
0434A
5.4.4
General Warning
General Warning Sign
N/A
ISO 7010-
W012
Type BF Applied Part
Signifies Applied Part Type
N/A
IEC 60517-
5840
IPX2
Ingress Rating
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.
N/A
N/A
Non-Ionizing Electromagnetic
Radiation
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.
N/A
IEC 60417-
5140
NRTL Certification
Signifies that the device meets regulatory and performance requirements
verified by NRTL
N/A
N/A
Other
Packaging Unit
Indicates the number of pieces in the package.
2794
N/A
Prescription Only
Requires prescription in the United States of America.
N/A
21 CFR
801.109