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
Product and Packaging Information
Table 3: Label Descriptions on the Device and Packaging
Item Label Location Description
1 Device Address
Label and Rating
Plate
Back of the
device
Provides regulatory and cautionary information. See
"Device Address Label and Rating Plate" on page 17
for an explanation of the label.
2 Country-specific
Label
Back of the
device
Contains registration information for China and Latin
America.
3 Serial Number
Label
Back of the
device
Identifies this device. See "Serial Number Label" on
page 17 for a description of the label contents.
4 Option Code
Label
Back of the
device
Use the option codes to setup the purchased options
in your system.
5 Wireless Label Back of the
device
Depending on the customer's wireless option, the label
will differ:
Default wireless option:
FIPS wireless option:
6 MAC Address
Label
Back of the
device
Indicates the MAC address of the device.
2109599-003 A MAC
™
7 Resting ECG Analysis System 15