GE MAC 1600, Operator'S Manual

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1-12 MAC™ 1600 2028451-182B
Introduction
Accuracy Of the Input Signal Reproduction
„
Overall System Error is tested using the method described in
AAMI EC11 3.2.7.1. Overall System Error is +5%.
„
Frequency Response is tested using the method described in
AAMI EC11 3.2.7.2 methods A and D.
Modulating Effects in Digital Systems
This device uses digital sampling techniques that may produce some
variation in amplitudes of Q, R, and/or S waves from one heart beat to
the next, which may be particularly noticeable in pediatric recordings. If
this phenomenon is observed, the clinician should be aware that the
origin of amplitude variations is not entirely physiologic. For measuring
voltages of Q, R, and S waves, it is advisable to use the QRS complexes
with the largest deflection of the particular waves.
Installation and Connection
If the installation of this equipment, in the USA, will use 240 V rather
than 120 V, the source must be a center-tapped, 240 V, single-phase
circuit.
Contact GE for information before connecting any devices to this
equipment not recommended in this manual.
Parts and Accessories
To ensure patient safety, use only parts and accessories manufactured or
recommended by GE. Browse to
www.gehealthcare.com to obtain
information about GE-recommended supplies and accessories.
Parts and accessories used must meet the requirements of the applicable
IEC 601 series safety standards, and/or the system configuration must
meet the requirements of the IEC 60601-1-1 medical electrical systems
standard.
The use of ACCESSORY equipment not complying with the equivalent
safety requirements of this equipment may lead to a reduced level of
safety of the resulting system. Consideration relating to the choice shall
include:
„
use of the accessory in the PATIENT VICINITY; and
„
evidence that the safety certification of the ACCESSORY has been
performed in accordance to the appropriate IEC 60601-1 and/or IEC
60601-1-1 harmonized national standard.