MONITOR DESCRIPTION
Model 7600/7800 Operation Manual 13
6.1 Intended Use
The Ivy Biomedical Model 7000 Series Cardiac Trigger Monitors are simple-to-use instruments for monitoring ECG
and Heart Rate. They are designed for use in the ICU, CCU and operating room conditions. They can sound an
alarm when HR falls outside of preset limits. They provide an output pulse, synchronized to the R-wave for use in
applications requiring precision R-wave synchronization.
6.2 Patient Population
The Model 7000 Series Cardiac Trigger Monitor is intended to perform ECG monitoring and R-wave pulse
detection on adult, geriatric, pediatric and neonatal patients. R-Wave synchronization is typically used for gating
nuclear scanners, CT scanners, or other imaging devices.
6.3 Contraindications
The Model 7000 Series is limited to use by trained and qualified medical professionals. This device is not intended
for use as life support equipment or for performing cardiac diagnostics. The product is not intended for use in home
care monitoring or for use in an MRI environment.
6.4 Classification (in accordance with ANSI/AAMI ES60601-1:2005)
Protection against electric shock: Class 1.
Degree of protection against electric shock: Type CF applied part. Defibrillator proof: ECG
Degree of protection against harmful ingress of water: Ordinary Equipment IPX1 per IEC-60529
Methods of Maintenance and Cleaning: See Maintenance and Cleaning section of this manual
Degree of safety of application in the presence of a Equipment not suitable for use in the presence of a
flammable anesthetic mixture with air or oxygen flammable anesthetic mixture
or nitrous oxide:
Mode of operation: Continuous
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