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)
Guidance and Manufacturer’s Declaration—
Electromagnetic Emissions
The system described in this document is intended for use in the following specified
electromagnetic environment. It is the responsibility of the customer or user to ensure
that this system is used in such an environment.
Table 8: EMC Emissions Test
Emissions Test Compliance Electromagnetic Environment
RF emissions (Radiated)
EN 55011
Group 1
Class B
RF emissions (Conducted)
• EN 55011
Group 1
Class B
This device 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.
Class B equipment is
suitable for use in all
establishments, including
domestic establishments and
those directly connected to
the public low-voltage power
supply network that supplies
buildings used for domestic
purposes.
Harmonic emissions
IEC 61000-3-2
Class A
Voltage fluctuations/Flicker
emissions
IEC 61000-3-3
Complies
Guidance and Manufacturer’s Declaration—
Electromagnetic Immunity
The system described in this document is intended for use in the following specified
electromagnetic environment. It is the responsibility of the customer or user to ensure
that this system is used in such an environment.
24 MAC
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7 Resting ECG Analysis System 2109599-003 A