The PrimeSight UNITY 9000 Video Processor User Manual
1 - Symbols and Terms
2
SYMBOL
SYMBOL TITLE
[REFERENCE NUMBER]
DESCRIPTION OF SYMBOL
Authorized Representative in
the European Community
[5.1.2]
1
Indicates the device’s Authorized representative within
the European Community
Temperature Limit
[5.3.7]
1
Indicates the temperature limits to which the medical
device can be safely exposed
Humidity Limitation
[5.3.8]
1
Indicates the range of humidity to which the medical
device can be safely exposed
Fragile, Handle with Care
[5.3.1]
1
Indicates the medical device can be broken or damaged
by not handling carefully
Keep Dry
[5.3.4]
1
Indicates the medical device needs to be protected
from moisture
This way up
[0623]
5
Indicates the direction which the box should remain
oriented (stored or shipped) to avoid potential damage
to the device
Stacking limit by number
[2403]
5
Indicates the devices shall not be vertically stacked
beyond the specified number (4) due to the nature of
the devices
CE Mark
Denotes this equipment has been designed, tested and
certified as essentially compliant with all applicable
European Union (EU) regulations and recommendations
For Prescription Only
Indicates this device is restricted to sale by or on the
order of a physician.
5013356
MEE
Medical Electrical
Equipment Mark
The presence of this safety mark shows that the device
is Medical Electrical Equipment which has been
evaluated with respect to electrical shock, fire and
mechanical hazards. Safety assessment only applies to
the UNITY 9000 Video Processor and videoscopes.
Conforms to AAMI STD ES60601-1:2005 +A1, IEC
60601-1-6:2010 Ed.3+A1, IEC 60601-2-18:2009
Ed.3.
Certified to CSA C22.2#60601-1:2014 Ed.3.
Waste Electrical and
Electronic Equipment
(WEEE)
Do not dispose of this device as household waste. This
product is designated for separate collection at an
appropriate collection facility in accordance to the WEEE
directive
Restriction of Hazardous
Substances (RoHS)
The presence of this symbol on the product or
packaging indicates that this device is RoHS compliant,
in accordance with the RoHS2 Directive
20%
85%
-20°C
60°C
1. ISO 15223-1:2016 – Medical Devices – Symbols to be used with medical device labels, labeling, and information to be supplied – Part 1: General requirements
5. ISO 7000:2014 – Graphical symbols for use on equipment – Registered symbols
