20
21
Authorized Component
Please use the included IC
Sciences authorized
adaptor
Complied Standards List
Contact Information
AUTHORIZED COMPONENT
For more information about our products
and
assistance
, please
contact
www.icsciences.com for
customer service
.
Manufactured
for
:
IC Sciences
Company:
Informed Clinical Sciences Corporation
Address:
1 Joy Street
Boston, MA USA 02108
FCC Statement
UE08WCP-060100SPA
100-240V 50-60Hz,400mA
6V 1A
Adaptor
Type:
Input:
Output:
(Conforms to UL Certification)
ISO 14971:2007
EN 980:2008
EN 1041:2008
Risk Management
Labeling
User Manual
Generl Requirements
for Safety
Performance and
Clinical
Requirements
Electromagnetic
Compatibility
IEC 60601-1:2005/A1:2012
ANSI/AAMI/IEC 80601-2-30:2009
ANSI/AAMI/ISO 81060-2:2009
IEC 60601-1-2:2007
Note:
POTENTIAL FOR RADIO/TELEVISION INTERFERENCE (for U.S.A. only)
This product has been tested and found to comply with the limits for a Class B digital
device, pursuant to Part 15 of FCC Rules. These limits are designed to provide
reasonable protection against harmful interference in a residential installation.
The product generates, uses, and can radiate radio frequency energy and, if not installed and
used in accordance with the instructions, may cause harmful interference to radio
communications. However, there is no guarantee that interference will not occur in a
particular installation. If the product does cause harmful interference to radio or television
reception, which can be determined by turning the product on / off, the user is encouraged to
try to correct the interference by one or more of the following measures:
- Reorient or relocate the receiving antenna.
- Increase the separation between the product and the receiver.
- Connect the product into an outlet on a circuit which is different from what the receiver is
connected to.
- Consult the dealer or an experienced radio / TV technician for help.
EMC guidance
Table 1 – Guidance and
MANUFACTURER
’
S
declaration –
ELECTROMAGNETIC EMISSIONS
–
for all
ME EQUIPMENT
and
ME SYSTEMS
Guidance and manufacturer’s declaration – electromagnetic emissions
Emissions test
Compliance
Electromagnetic environment
–
guidance
RF emissions
CISPR 11
Group 2
RF emissions
CISPR 11
Class B
Harmonic emissions
IEC 61000-3-2
Not applicable
Not applicable
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
The device is intended for use in the electromagnetic environment specified below.
The customer or the user of the device should assure that it is used in such an
environment.
The device must emit electromagnetic
energy in order to perform its intended
function. Nearby electronic equipment may be affected.
EMC GUIDANCE
Software life-cycle
processes
IEC 62304:2006
Caution: The user is cautioned that changes or modifications not
expressly approved by the party responsible for compliance could void the
user's authority to operate the equipment.