Operating instructions

ER910/920 and ER910/920 AF Event Monitor
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Table of Contents
Overview...................................................................................................2
Indications for Use....................................................................................2
Precautions...............................................................................................2
Monitor Components ................................................................................3
Setup Steps ..............................................................................................4
Electrode Application and Placement .......................................................4
1 and 2 Channel (4 Lead) Electrode Placement .......................................5
Monitor Preparation ..................................................................................6
Patient Operating Instructions ................................................................13
Troubleshooting......................................................................................16
Event Markings.......................................................................................18
Service and Maintenance .......................................................................19
Service Items and Accessories...............................................................19
Equipment Symbols................................................................................20
Specifications .........................................................................................21
Electromagnetic Emissions.....................................................................23
Electromagnetic Immunity ......................................................................23
Recommended Separation Distances ....................................................26
ER910/920 and ER910/920 AF Event Monitor
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Overview
The ER910/920 and ER910/920 AF Event Monitors are battery operated,
solid state, looping event recorders designed to record symptomatic heart
arrhythmias. Event recording is activated by the patient or by automatic
event detection.
The ER910 (1 channel) and ER920 (2 channel) event monitors provide
up to 30 minutes of total recording time and will operate as a simple
looping event recorder for a minimum of 30 days with two AAA
Alkaline batteries. They offer multiple programmed recording options
allowing the physician to determine their own parameters. Selectable
parameters include number of events, pre-event time, post-event time,
audible operation, pacemaker detection, and arrhythmia detection.
The ER910/920 Event Monitors are enhanced with Arrhythmia Detection
firmware which will capture and automatically record asymptomatic,
infrequent, or elusive heart arrhythmia events such as Bradycardia,
Tachycardia, and Pause. The ER910/920 AF includes all of these
features and in addition, Atrial Fibrillation.
Once an event is recorded, patients may transmit their ECG
transtelephonically.
Indications for Use
The device is indicated for diagnostic evaluation of patients who
experience transient symptoms such as; dizziness, palpitations, syncope,
or chest pain. The device is intended to record cardiac activity associated
with these infrequent and transient symptoms. Once data is recorded,
patients transmit the recorded ECG data over the telephone or directly to
a host PC for review by a licensed physician.
Precautions
A. Patient leads must be removed from electrodes before defibrillation.
B. Observe local laws for disposal of alkaline batteries.
C. Do not leave the batteries in the Monitor when it is not in use.
Damage from corrosion could result.
D. Patient should be instructed to avoid close proximity to heavy
electrical equipment or other sources of electromagnetic
interference.
E. Use of rechargeable batteries is not recommended.
F. Do not use cellular phone to transmit patient data.
G. Monitor is not for infant use.
H. No automatic analysis algorithm can replace data review by a
qualified physician. Review and confirmation of analysis results is
required.