Product Manual

Operating Environment
• Temperature: -4°F to 104°F (-20°C ~ 40°C)
• Humidity: 20 to 95% Relative humidity
• Atmospheric Pressure 101.325 kPa (760mmHg)
Storage Environment
• Temperature: -4°F to 122°F (-20°C ~ 50°C)
• Humidity: 20 to 95% Relative humidity
Regulatory Standards
EN 606011: 2005 + CORR. 1:2006 + CORR. 2:2007 + AM1:2012
EN 60601-1-2:2007+AC: 2010
Guidance and Manufacturer’s Declaration
Warning: Electrical m
edical equipment may require special precautions in relation to EMC and this
device must be put into service in accordance with the EMC precautions provided further in these in-
structions for use.
Warning: Portable and mobile RF communications equipment can affect medical electrical equipment.
Care should be taken when using this device near active RF equipment. Follow the guidelines outlined
below for further information.
Warning: T
his equipment is supplied with a USB cable. When using an AC adapter to charge this
device (not supplied), use only adapters with OUTPUT VOLTAGE: 5~9VOUTPUT CURRENT: 1A~3A.
Use of accessories or cables other than those specified above and the use of unapproved replacement
components may result in increased emissions or decreased immunity of this device.
Warning: This d
evice should not be used adjacent to or stacked with other equipment unless such
use has been verified to function normally within the configuration in which it will be used.
Warning: Accessories and cables provided with this device have not been tested or verified for use
with other medical electrical equipment and should not be considered interchangeable.
Guidance and manufacturer’s declaration - electromagnetic emissions - for all MEDICAL
ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS
Table 1:Guidance and manufacturer’s declaration – electromagnetic emissions
The 658 is intended for use in the electromagnetic environment specified below.
The customer or the user of the 658 should assure that it is used in such an environment.
Emissions test Compliance E
lectromagnetic environment - guidance
RF emissions
CISPR 11
RF emissions
CISPR 11
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations/
Flicker emissions
IEC 61000-3-3
Group 1
Class B
A
Complies
The 658 uses RF energy only for its internal function.
Therefore, its RF emissions are very low and are not
likely to cause any interference in nearby electronic
equipment.
The 658 is suitable for use in all establishments, in-
cluding domestic establishments
and those directly
connected to the public low-voltage power supply net-
work that supplies buildings used for domestic pur-
poses.