Mode of operation
Continuous operation
Degree of protection
Type B applied part
Protection against ingress of water
IPX-0
MANUFACTURER
Manufactured by:
CGTEC-EUROPE, LDA
Address:
PRAÇA MADRE DEUS Nº 107, CANELAS, VILA NOVA DE GAIA, 4410-307 PORTUGAL
Contact:
Complied European Standards list
Risk management is the application of medical device
EN/ISO 14971:2007
Graphical symbols for labeling medical devices
EN 980: 2008
Medical equipment manufacturers to provide information
EN 1041: 2008
Medical electrical equipment Part 1-1: General Requirements
for Safety Collateral Standard: Safety requirements for medical
electrical systems
EN 60601-1:1990+A1+A2+A13
Non-invasive blood pressure Part 1: General requirements
EN 1060-1:2001/A1:2002
Non-invasive blood pressure Part 3: Supplementary requirements for
electromechanical blood pressure measuring system
EN 1060-3:1997/A1:2005
Automatic Blood Pressure Monitor overall system Interventional
accuracy of the testing process
EN 1060-4: 2004
Medical electrical equipment Part 1-2: Basic safety and essential
performance of the general requirements Collateral Standard:
Electromagnetic compatibility requirements and tests
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
The TMB-1018 is intended for use in the electromagnetic environment specified
below. The customer of the user of the TMB-1018 should assure that it is used in
such and environment.
Emission test
RF emissions
C ISPR 11
RF emission
CISPR 11
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations/
flicker emissions IEC
61000-3-3
