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)
Separation Distance (meters) According to Frequency of Transmitter
1
150 kHz to 80 MHz
d (meters) = 3.5/V1 x √ P
d (meters) for V1 = 3 Vrms
80 MHz to 800 MHz
2
d = 3.5/E1 x √ P
d for E1 = 3 V/m
800 MHz to 2.5 GHz
d = 7/E1 x √ P
d for E1 = 3 V/m
Rated
Maximum
Output
Power of
Transmitter
in Watts (W)
Meters Feet Meters Feet Meters Feet
10 3.689 12.104 3.689 12.104 7.379 24.208
100 11.667 38.276 11.667 38.276 23.333 76.552
NOTE:
1
These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects, and people.
2
At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
For transmitters rated at a maximum output power not listed above, estimate the recommended
separation distance d in meters (m) using the equitation applicable to the frequency of the
transmitter, where P is the maximum output power rating of the transmitter in watts (W) according
to the transmitter manufacturer.
28 MAC
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7 Resting ECG Analysis System 2109599-003 A