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16. Symbols
This chapter lists and describes the symbols and icons that may be used on the Butterfly iQ™, its accessories, and
packaging.
Symbols
lists and describes a set of symbols for medical electronic equipment that classify a con-
nection or warn of potential hazards. The symbols listed in
may be used on the Butterfly
iQ™, and on its accessories and packaging. The symbols shown in this document and on the Butterfly iQ™, and on
its accessories and packaging, are compliant with current versions of the listed standards.
Table 20. Symbols
Symbol
Standard
Refer-
ence
Title
Description
ISO 15223-1
5.4.4
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 de-
vice itself.
ASTM
F2503-1
F2503 -
13 3.1.14
MR Unsafe
Indicates an item which poses unacceptable risks to the patient,
medical staff, or other persons within the MR environment.
ISO 15223-1
5.2.8
Do not use if pack-
age is damaged
Indicates a medical device that should not be used if the package has
been damaged or opened.
ISO 15223-1
5.1.3
Date of Manufacture
Indicates the date when the medical device was manufactured.
ISO 15223-1
5.3.1
Fragile; handle with
care
Indicates a medical device that can be broken or damaged if not han-
dled carefully.
-
-
Global Medical De-
vice Nomenclature
Code
A system of internationally agreed generic descriptors used to identi-
fy all medical device products.
-
-
Globa Trade Item
Number
An identifier to look up product information in a database, often by
entering the number through a bar code scanner pointed at an actual
product.
IPX7
IEC 60529
-
Ingress protection
rating
Ingress Protection rating system showing the degrees of protection
from solid objects and liquids. The X indicates insufficient data has
been gathered to assign a protection level. The 7 indicates that the
system is protected against the effects of immersion in water to depth
between 15 cm and 1 meter.
IEC 60601-1
20
Type BF applied
part
Indicates isolated patient connection (Type BF applied part).
ISO 15223-1
5.3.4
Keep away from rain
Indicates a medical device that needs to be protected from moisture.
ISO 15223-1
5.1.1
Manufacturer
Indicates the medical device manufacturer, as defined in EU Direc-
tives 90/385/EEC, 93/42/EEC and 98/79/EC.
ISO 15223-1
5.1.5
Batch code
Identifies the manufacturer’s batch code so that the batch or lot can
be identified.
Symbols
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Symbols