GE MAC 5 A4 User Manual

Regulatory and Safety Information
Table 149: Serial Number Format
Item Name Description
1 Product Code A three-character code that uniquely identifies the product line.
2 Year Manufactured A two-digit code identifying the year the device was manufactured.
Values range from 00 to 99. For example: 00 = 2000, 04 = 2004, 17 =
2017 (and so on).
3 Fiscal Week
Manufactured
A two-digit code identifying the week the device was manufactured.
Values range from 01 to 52. GE Healthcare's fiscal weeks
correspond to the calendar week. For example, 01 = the first week in
January.
4 Product Sequence A four-digit number identifying the order in which this device was
manufactured.
Values range from 0001 to 9999.
5 Manufacturing Site A one-letter code identifying the site where the device was
manufactured.
For example, F = Milwaukee, N = Freiburg, P = Bangalore, W = Wuxi,
H = Helsinki, S = Mexico
6 Miscellaneous
Characteristic
A one-letter code identifying manufacturing status.
For example, P = the device is a prototype, R = the device was
refurbished, U = the device was upgraded to meet the specifications
of another product code, A = device is in production.
Unique Device Identifier
Medical devices require a unique marking for identification—the Unique Device
Identifier (UDI). In the event that you need the UDI for this product, check the product
label on the back of the device.
Wireless Regulations
The wireless and wired LAN functionality of the MAC 5 A4/MAC 5 A5/MAC 5 Lite is
used to retrieve ECG orders and send ECG reports to an ECG Management System. In
addition, the wireless and wired LAN functionality can be used to interface to other
hospital information systems to provide additional data to the care giver operating
the electrocardiograph. These tasks are an adjunct to the device’s intended use
of acquiring, analyzing, displaying and printing an electrocardiogram. Because
the wireless and wired LAN functionality is not required for the device to fulfill its
intended use, network performance is not critical to the performance of the device.
Furthermore, the MAC 5 A4/MAC 5 A5/MAC 5 Lite does not transmit any real-time
data or alarm information over the network. Network Quality of Service (QoS)
parameters such as reliability of data transmission, latency, transfer rate, error rate,
and priority levels are not critical to the MAC 5 A4/MAC 5 A5/MAC 5 Lite functionality
and are not specified.
5864335-001-1  MAC
™
5 A4/MAC
™
5 A5/MAC
™
5 Lite 371

GE MAC 5 A4 Specifications

General

Brand	GE
Model	MAC 5 A4
Category	Measuring Instruments
Language	English