GE MAC 5 A4 Operator's Manual page 367

Resting ecg analysis system
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Table 148: Symbols, Icons, and Descriptions on the device or packaging
Symbol
IPxx
5864335-001-1
Description
Catalog or Orderable Part Number
The manufacturer's catalog or part number.
Serial Number
The manufacturer's serial number.
Batch Code or Lot Number
The manufacturer's batch code or lot number.
Medical Device
The device is used for medical purpose.
Date of Manufacture
The original manufacture date for this device.
Manufacturer
The name and address for the manufacturer of this device. It may also
include the date it was manufactured.
Authorized Representative in the European Community
The name and address of the authorized representative in the European
Community for this device.
Rx Only
US Federal law restricts this device to sale by or on the order of a physician.
12SL
The device uses the Marquette
interpret ECG readings.
IP Code (Ingress Protection Rating)
Classifies and rates the degree of protection provided against the intrusion
of solid objects (such as body parts, dust, accidental contact), and liquids.
The first numeral (x) represents the degree of protection against the ingress
of solid objects.
The second numeral (x) represents the degree of protection against the
ingress of liquids.
For products with an IPxx rating, see the Classification of Medical Device in
this chapter for a description of that rating. Not all products have an IPxx
rating.
CE Mark
The device or product conforms with applicable EU (European Union)
directives.
  MAC
5 A4/MAC
5 A5/MAC
Regulatory and Safety Information
12SL ECG Analysis Program to analyze and
5 Lite
 367

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