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Authorized European Representative:
Manufactured by:
ZHONGSHAN TRANSTEK ELECTRONICES CO.,LTD
Conpany:
ZHONGSHAN TRANSTEK ELECTRONICES CO.,LTD
Address:
Jin’an Road, Minzhong, Zhongshan,528441,Guangdong, China
Conpany:
MDSS - Medical Device Safety Service GmbH
Address:
Schiffgraben 41, 30175 Hannover, Germany
Complied European Standards list
Risk management
EN/ISO 14971:2007
Labelling
EN 980: 2008
User manual
EN 1041: 2008
General requirements
for safety
EN 60601-1:1990+A1+A2+A13
Non-invasive
sphygmomanometers
General requirements
EN 1060-1:2001/A1:2002
EN 1060-3:1997/A1:2005
EN 1060-4: 2004
Electromagnetic
compatibility
EN 60601-1-2:2001+A1
˖
2006
Table 1 Guidance and manufacture’s declaration – electromagnetic emissions-
for all EQUIPMENT and SYSTEMS
Guidance and manufacture’s declaration – electromagnetic emission
Emission test
Electromagnetic environment – guidance
RF emissions
CISPR 11
Group 1
Class B
Not applicable
Not applicable
Compliance
The TMB-1014-BT is intended for use in the electromagnetic environment
specified below. The customer of the user of the TMB-1014-BT should assure
that it is used in such and environment.
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations/
flicker emissions IEC
61000-3-3
RF emission
CISPR 11
The TMB-1014-BT 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 TMB-1014-BT is suitable for use in all
establishments other than domestic and
those directly connected to the public
low-voltage power supply network that
supplies buildings used for domestic
purposes.
1) Caution: This unit has been thoroughly tested and inspected to assure proper performance and
operation!
2) Caution: this machine should not be used adjacent to or stacked with other equipment and that if
adjacent or stacked use is necessary, this machine should be observed to verify normal operation in the
configuration in which it will be used
3) This product needs special precautions regarding EMC and needs to be installed and put into service
according to the EMC information provided, and this unit can be affected by portable and mobile RF
communications equipment.
4) The guidelines for avoiding or identifying and resolving adverse electromagnetic effects on other
equipment that may result from operation of the ME EQUIPMENT or ME SYSTEM.
5) Each frequency or frequency band of reception; the preferred frequency or frequency band, if applicable,
and the bandwidth of the receiving section of the ME EQUIPMENT or ME SYSTEM in those bands;
6) Warning: the TMB-1014-BT may be interfered with by other equipment, even if that other equipment
complies with CISPR EMISSION requirements.
7) Each frequency or frequency band of transmission, the type and frequency characteristics of the
modulation and the EFFECTIVE RADIATED POWER.