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
4
Equipment Identification
Serial Number Label
The serial number label is in the following format:
Table 4: Serial Number Label Format
Item Description
1 Product Name
2 Date of Manufacture in YYYY-MM-DD Format
3 Country of Origin
4 Device Serial Number
5 UDI Barcode
6 Product Part Number
Device Address Label and Rating Plate
The device address label and rating plate is in the following format:
2109599-003 A MAC
™
7 Resting ECG Analysis System 17