Use Instructions

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Symbol
Meaning
Designation Number and Title of the Standard
Title of the Symbol in the
Standard
protect
the
device
package from sunlight
ISO 15223-1 clause 5.3.2 Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied
Indicates the device is
compliant with the RoHS
regulation found in the
European Union Directive 2002/95/EC
transport
and
storage
temperature limit
ISO 14708-1 clause 9.11 Temperature limit
transport and storage humidity limit ISO 7000-
2620
ISO 14708-1 clause 9.11 Humidity limitation
transport and storage
atmospheric limit ISO
7000-2621
ISO 14708-1 clause 9.11
Atmospheric pressure
limitation
Directs the user not to
use
the device if the package has been opened or damaged
ISO 15223-1 clause 5.2.8 ISO 11607-1 clause 10
Do not use if package is
damaged
defibrillation
-
proof
type
CF applied part and IEC 60417-5336 symbol
IEC 60601-1 clause 8.5.5.1
Defibrillation
-
Proof Type CF
Applied Part
Physician Instructions for Use
DRAFT