FONA CDRelite System User Guide
B1057003 Rev. 3
41
A-3. Summary of Specifications
FONA CDRelite USB Interface Module is ETL-certified and
complies with EMC, safety, and quality standards listed below.
Table 7. Specifications
Item
Value
EMC/Safety
IEC60601-1:2005
+CORR.1(2006)
+CORR.2(2007)
Medical Electrical Equipment – Part 1: General
Requirements for basic safety and essential performance
IEC60601-1-
2:2007
Medical Electrical Equipment – Part 1-2: General
requirements for basic safety and essential performance -
Collateral standard: Electromagnetic compatibility
Requirements and tests
UL60601-1
UL Standard for Safety Medical Electrical Equipment –
Part 1: General Requirements for Safety – Edition 1,
Issued 2003/04/25
Quality
AAMI
TIR12:2004
Designing, testing and labeling reusable medical devices
for reprocessing in health care facilities: A guide for
device manufacturers
CAN/CSA C22.2
No. 60601.1:08
Medical Electrical Equipment – Part 1: General
Requirements for Basic Safety and Essential Performance
93/42/EEC
Council Directive of 14/6/ 1993 concerning medical
devices amended by directives 98/79/EC (27/10/98);
2000/70/EC(16/10/2000); 2001/104/EC(7/12/2001);
2007/47/EC(5/9/2007)
Classification
Class II, Type BF equipment
Not Category AP Equipment
Not Category APG Equipment
Mode of Operation
Equipment is intended for continuous use
Additional Notes
Equipment is not suitable for use in the presence of a Flammable Anesthetic
Mixture with Air or with Oxygen or Nitrous Oxide.
Supply Voltage
+5V DC (derived for PC USB port)
Supply Current
250 mA
Power Consumption
1.25W
Dimensions
3.25 x 2.3 x 0.9 in. (1.28 x 0.91 x 0.35 cm)
Weight
1.8 oz. (50g)
Transport and Storage
Conditions
Ambient temperature range: -40
F (-40
C) to 158
F (+70
C)
Relative humidity range: 10 to 100%, including condensation
Atmospheric pressure range: 500 hPa to 1060 hPa
Operating Conditions
Ambient temperature range: 50
F (+10
C) to 104
F (+40
C)
Relative humidity range: less than 75%
Atmospheric pressure range: 700 hPa to 1060 hPa
Restricted service
statement
Unless otherwise specified, this unit should be serviced only by the
manufacturer. It contains no user-serviceable parts.
External power supply
None (power supplied via USB)
Maximum cable length
5 m (5.5 yds)
