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
NOTE:
• Do not use portable or mobile RF communications equipment closer to any part of the
system, including the cables, than the recommended separation distance calculated for the
equation applicable to the frequency of the transmitter.
• Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radio, AM and FM radio broadcast, and TV broadcast cannot,
theoretically, be predicted with accuracy. To assess the electromagnetic environment
due to fixed RF transmitters, consider conducting an electromagnetic site survey. If the
measured field strength in the location the system is used exceeds the applicable RF
compliance level listed in this table, observe the system to verify normal operation. If
abnormal performance is observed, additional measures may be necessary, such as re-
orienting or relocating the system.
• At 80 MHz and 800 MHz, the higher frequency range applies.
• These guidelines may not apply in all situations. Electromagnetic propagation is affected by
the reflection from structures, objects, and people.
Recommended Separation Distances
The following table provides the recommended separation distances (in meters)
between portable and mobile RF communication equipment and the system
described in this manual, for equipment and systems that are not life-supporting.
The system is intended for use in the electromagnetic environment in which radiated
RF disturbances are controlled. The customer or the user of the system can help
prevent electromagnetic interference by maintaining the following recommended
minimum distance between portable and mobile RF communications equipment
(transmitters) and the system, according to the maximum output power of the
communications equipment.
Table 10: Recommended Separation Distances
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
0.01 0.117 0.383 0.117 0.383 0.233 0.766
0.1 0.369 1.210 0.369 1.210 0.738 2.421
1 1.167 3.828 1.167 3.828 2.333 7.655
2109599-003 A MAC
™
7 Resting ECG Analysis System 27