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
Equipment Identification
Table 5: Device Address Label and Rating Plate Format
Item Description
1 Product name
2 Manufacturer name and address
3 Electrical rating of the device
4 Symbols
See "Symbol Descriptions" on page 18 for a description of the symbols used on this
label.
Symbol Descriptions
The following table describes symbols or icons that are on the device or its packaging.
Any symbol on your device or packaging with markings in color indicates there
may be a danger, warning, or mandatory action. Any symbol on your device or
packaging that is in black and white provides additional information or may indicate
a caution. Familiarity with these symbols assists in the proper use and disposal of the
equipment.
For equipment symbols not shown, refer to the original equipment manufacturer
(OEM) manuals.
Table 6: Symbols, Icons, and Descriptions
Symbol Description
Catalog or Orderable Part Number
Indicates the manufacturer’s catalog or part number.
Serial Number
Indicates the manufacturer's serial number.
18 MAC
™
7 Resting ECG Analysis System 2109599-003 A