Warnings – ZOLL M Series Defibrillator Rev H User Manual

Page 4

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OPTION INSERT

9650-0215-01

12-lead - 2

WARNINGS

Before use, carefully read the M Series Operator’s Guide and these operating instructions.

• The

M Series with 12SL is designed to acquire and interpret ECG data from resting, supine patients. Use of the device to

acquire ECG signals from moving or shaking patients may produce erroneous 12-lead interpretation results. Always
ensure that the patient is kept motionless during 12-lead ECG signal acquisition and analyses.

• The

M Series 12SL option is not intended for use with neonatal patients.

Excessive body hair or wet, sweaty skin may interfere with electrode adhesion. Remove the hair and/or moisture from the
area where the electrode is to be attached.

• Using previously opened or out of date electrodes may degrade the ECG signal quality. ECG electrodes should be

removed from their sealed package immediately prior to use.

• Monitoring electrodes may become polarized during defibrillator discharge, causing the ECG waveform to briefly go off

screen. ZOLL Medical Corporation recommends the use of high quality silver/ silver chloride (Ag/AgCl) electrodes to
minimize this effect, and circuitry in the instrument will return the trace to the monitor display within a few seconds.

Wait 15 seconds after defibrillator discharge before attempting a 12-lead acquisition. Electrode polarization subsequent to
defibrillator discharge may result in excessive noise on the 12-lead ECG printout.

• Cover the patient cable's V-lead connector with the plastic cap supplied when the V-leads are not in use. Failure to do so

may result in a shock hazard during defibrillation attempts.

• To assure protection against the effects of defibrillator discharge, use only 12-lead cables supplied by ZOLL Medical

Corporation.

To avoid a shock hazard and interference from nearby electrical equipment, keep electrodes and patient cables away from
grounded metal and other electrical equipment.

• Do

NOT sterilize the M Series unit or any of its accessories except internal handles or as directed.

• Check

the

operation

and integrity of the M Series and 12-lead cable regularly by performing the Daily Operational

Verification Test.

• All computerized ECG analysis results must be reviewed by a physician prior to their use for determining patient

treatment.

• Grounding reliability can ONLY be achieved when the equipment is connected to an equivalent receptacle marked

“HOSPITAL ONLY” or “HOSPITAL GRADE”.

The frequency response of the monitor screen is intended only for basic ECG rhythm identification; it does not provide the
resolution required for diagnostic and ST segment interpretation. Use the strip chart recorder for this purpose.

• Implanted pacemakers may cause the heart rate meter to count the pacemaker rate during incidents of cardiac arrest or

other arrhythmias. Pacemaker patients should be carefully observed. Check the patient's pulse; do not rely solely on heart
rate meters. Dedicated pacemaker detection circuitry may not detect all implanted pacemaker spikes. Patient history and
physical exam are important in determining the presence of an implanted pacemaker.

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