IFU00021vH
10
10.2 Operating and Storage Conditions
* If the system is stored at a temperature outside the operating temperature range, allow the system to
stabilize at room temperature for a minimum of 1 hour before use.
11. Glossary of Terms
12. Graphic Symbols Contained in Device Labeling
Symbol
Description
Reference
Symbol
Description
Reference
Refer to instruction
manual/booklet
IEC 60601-
1:2005
ISO 7010-
M002
Temperature
limit
ISO 15223-
1:2012, 5.3.7
Separate collection
for electrical and
electronic equipment
WEEE
Directive
2012/19/EU,
Annex IX
Atmospheric
pressure
limitation
ISO 15223-
1:2012, 5.3.9
Keep Dry
ISO 15223-
1:2012, 5.3.4
IP21
International
Protection Code
against ingress
of solid foreign
objects
≥
12.5mm
diameter and
vertically falling
water drops
when enclosure
tilted up to 15°
IEC 60601-
1:2005
IEC 60529, 4.2
Caution: Federal law
restricts this device
to sale by or on
the order of a
(licensed healthcare
practitioner)
FDA Final
Rule 81 FR
38911
Serial number
ISO 15223-
1:2012,5.1.7
Operating
Conditions
5°C- 40°C
15-93% humidity
700 – 1060 hPa
Storage
Conditions and
Temperature
Limit*
-20ºC to 55ºC
Maximum relative humidity of
93% non-condensing.
Use conditions
Avoid high temperatures
and sustained exposure to
direct sunlight.
Frequency
range
100Hz to 10,000Hz
TM
Tympanic Membrane
Lens
Tympanic Lens
ELF
Earlens Fitting Software
EAS
Electronic Article Surveillance
AE
Adverse Event
