Safety Manual
Table Of Contents
- Table of Contents
- Publication Information
- Regulatory Information
- Intended Use
- Indications for Use
- Contraindications
- Prescription Device Statement
- Classification of Medical Device
- Recording ECGs during Defibrillation
- Modulating Effects in Digital Systems
- Biocompatibility
- Legal Notice
- Responsibility of the Manufacturer
- Responsibility of the Purchaser/Customer
- Warranty Information
- Safety Information
- Product and Packaging Information
- Equipment Identification
- Electromagnetic Compatibility (EMC)
- Wireless Regulations
Electromagnetic Compatibility (EMC)
Immunity Test EN60601 Test Level Compliance Level Electromagnetic
Environment–
Guidance
Conducted RF
IEC 61000-4-6
3 Vrms
0.15 MHz to 80 MHz
6 Vrms in ISM bands
between 0.15 MHz and
80 MHz
3 Vrms
0.15 MHz to 80 MHz
6 Vrms in ISM bands
between 0.15 MHz and
80 MHz
Recommended
separation distance:
d = 12√P
Radiated RF
IEC 61000-4-3
3 V/m at 80 to 2700
MHz, AM Modulation
9 to 28 V/m at 385
to 6000 MHz, FM or
Digital Modulation
3 V/m at 80 to 2700
MHz, AM Modulation
9 to 28 V/m at 385
to 6000 MHz, FM or
Digital Modulation
d = 1.2 √P 80 MHz to
800 MHz
d = 2.3 √P 800 MHz to
2.5 GHz
At 80 MHz and 800
MHz, the higher
frequency range
applies.
Recommended
separation distance:
where P is the
maximum output
power rating of
the transmitter in
watts (W) according
to the transmitter
manufacturer, and d
is the recommended
separation distance in
meters (m).
Field strengths from
fixed RF transmitters,
as determined by an
electromagnetic site
survey, should be less
than the compliance
level in each frequency
range.
Interference may
occur in the vicinity
of equipment marked
with the following
symbol:
26 MAC
™
7 Resting ECG Analysis System 2109599-003 A