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Table 1 Guidance and manufacturer’s declaration – electromagnetic emissions-
for all EQUIPMENT and SYSTEMS
Guidance and manufacture’s declaration – electromagnetic emission
RF emissions
CISPR 11
Group 1
Class B
Not applicable
Not applicable
Compliance
The TMB-1018-BT is intended for use in the electromagnetic environment specified
below.The customer of the user of the TMB-1018-BT should assure that it is used in
such anenvironment
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations/
flicker emissions IEC
61000-3-3
RF emission
CISPR 11
Emission test Electromagnetic environment - guidance
The
TMB-1018-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-1018-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.
The Matched Components
Please use the BodyGauge
authorized adaptor
2.Storage bag.
Complied European Standards List
Contact Information
UE08WCP-060100SPA
100-240V50-60Hz,400mA
6V 1A
Adaptor
Type:
Input:
Output:
(Expected Service Life: 50,000 Hours)
AUTHORIZED COPMONENT
EN 60601-1:2006/A1:2012
EN 62304:2006/AC:2008
EN 60601-1-6:2010
EN 60601-1-11:2010
EN 1060-1:1995+A2:2009
EN 1060-3:1997+A2:2009
EN 60601-1-2:2007/AC:2010
EN/ISO 14971:2007
EN 980:2008
EN 1041:2008
EN 1060-4:2004
Risk Management
Labeling
User Manual
Generl Requirements
for Safety
Non-invasive
Sphygmomanometers
General
Requirements
Electromagnetic
Compatibility
For more information about our products, please visit:
Authorized European Representative:
Manufactured by:
GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO., LTD
Company:
GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO., LTD
Address:
Zone A, 5/F., Investment Building , No. 12, Huizhan East Rd., Torch
Development District, Zhongshan, Guangdong, 528437, China
Company: MDSS - Medical Device Safety Service GmbH
Address:
Schiffgraben 41, 30175 Hannover, Germany
EMC Guidance
BodyGauge, Postbus 654, 3720 AR Bilthoven, The Netherlands
Tel. +31 858769819, email: info@bodygauge.eu
12


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