iRhythm Technologies Inc. AT18G ユーザーズマニュアル
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SYMBOL
STANDARD
REFERENCE
REFERENCE
STANDARD TITLE
SYMBOL TITLE
DESCRIPTION/EXPLANITORY TEXT
ISO 15223-1 Clause 5.4.2
Medical devices — Symbols to be used with
medical device labels, labelling and
information to be supplied
medical device labels, labelling and
information to be supplied
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.
for use on a single patient during a single procedure.
ISO 7000-1051
Graphical symbols for use on equipment
ISO 15223-1 Clause 5.4.3
Medical devices — Symbols to be used with
medical device labels, labelling and
information to be supplied
medical device labels, labelling and
information to be supplied
Consult instructions for use
Indicates the need for the user to consult the instructions
for use.
for use.
ISO 7000-1641
Graphical symbols for use on equipment
IEC 60601-1 Table D.1,
Symbol 11
Symbol 11
Medical electrical equipment — Part 1: General
requirements for basic safety and essential
performance
requirements for basic safety and essential
performance
ISO 15223-1 Clause 5.4.4
Medical devices — Symbols to be used with
medical device labels, labelling and informa-
tion to be supplied
medical device labels, labelling and informa-
tion to be supplied
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.
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.
ISO 7000-0434
Graphical symbols for use on equipment
IEC 60601-1 Table D.1,
Symbol 10
Symbol 10
Medical electrical equipment — Part 1: General
requirements for basic safety and essential
performance
requirements for basic safety and essential
performance
ISO 15223-1 Clause 5.7.1
Medical devices — Symbols to be used with
medical device labels, labelling and
information to be supplied
medical device labels, labelling and
information to be supplied
Patient number
Indicates a unique number associated with an individual
patient.
patient.
IEC 60417-5140
Graphical symbols for use on equipment
Non-ionizing electromagnetic
radiation
radiation
To indicate generally elevated, potentially hazardous,
levels of nonionizing radiation, or to indicate equipment or
systems e.g. in the medical electrical area that include RF
transmitters or that intentionally apply RF electromagnet-
ic energy for diagnosis or treatment.
levels of nonionizing radiation, or to indicate equipment or
systems e.g. in the medical electrical area that include RF
transmitters or that intentionally apply RF electromagnet-
ic energy for diagnosis or treatment.
IEC 60601-1-2:2007,
Clause 5.1.1
Clause 5.1.1
Medical electrical equipment — Part 1-2:
General requirements for basic safety and
essential performance — Collateral standard:
Electromagnetic compatibility — Requirements
and tests
General requirements for basic safety and
essential performance — Collateral standard:
Electromagnetic compatibility — Requirements
and tests
IEC/TR 60878-5140
Graphical symbols for electrical equipment in
medical practice
medical practice
IEC 60417-5333
Graphical symbols for use on equipment
Type BF Applied Part
To identify a type BF applied part complying with IEC
60601-1.
60601-1.
IEC 60601-1, Table D.1,
Symbol 20
Symbol 20
Medical electrical equipment — Part 1: General
requirements for basic safety and essential
performance
requirements for basic safety and essential
performance
ASTM F2503-13
Standard Practice for Marking Medical Devices
and Other Items for Safety in the Magnetic
Resonance Environment
and Other Items for Safety in the Magnetic
Resonance Environment
Magnetic Resonance (MR)
unsafe
unsafe
Keep away from magnetic resonance imaging (MRI)
equipment.
equipment.
Symbols Glossary (cont’d)