ZOLL E Series Monitor Defibrillator Rev R User Manual

Page 21

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General Information

9650-1210-01 Rev. R

1-13

The AutoPulse Plus is only intended for use on adults 18 years of age or older. When using the E Series and
AutoPulse Plus as a system, this age restriction applies to the E Series as well.

Carefully route the patient cables to reduce the possibility of patient entanglement or strangulation.

Do not use the unit’s AED function on patients under 8 years of age.

Neonatal and pediatric defibrillation energy levels should be set based on site-specific clinical protocols.

The device detects ECG electrical signals only. It will not detect a pulse (i.e. effective circulatory perfusion). Always
verify pulse and heart rate by physical assessment of the patient. Never assume that a non-zero heart rate display
means that the patient has a pulse.

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.

Use only high quality ECG electrodes. ECG electrodes are for rhythm acquisition only. Do not attempt to defibrillate
or pace through ECG electrodes.

This equipment is suitable for use in the presence of electrosurgery.

To avoid electrosurgery burns at monitoring sites, ensure proper connection of the electrosurgery return circuits so
that the return paths cannot be made through monitoring electrodes or probes.
Do not use ECG electrodes or MFE Pads if the gel is dried, separated, torn, or split from the foil; patient burns may
result from using such electrodes. Poor adherence and/or air under the MFE Pads can lead to the possibility of
arcing and skin burns.

The ECG rhythm analysis function does not warn the operator of patient asystole, as it is not a shockable rhythm.

Excessive body hair or wet, diaphoretic

skin can inhibit good coupling (contact), which can lead to the possibility of

arcing and skin burns. Clip excess hair and dry surrounding moisture from the area where the electrode is to be
attached. MFE Pads should be replaced after 8 hours of continuous pacing (2 hours for Radiolucent stat-padz) to
ensure maximum patient benefit.

Prolonged pacing (in excess of 30 minutes), particularly in neonates or adults with severely restricted blood flow,
may cause burns. Periodically inspect the underlying skin.

Check leakage levels prior to use. Leakage current may be excessive if more than one monitor or other piece of
equipment is connected to the patient.

Do not simultaneously touch the patient and battery pins on the unit.

Do not simultaneously touch the patient and non-medical electrical equipment connected to the unit.

CAUTIONS

Do not install the battery into the device when storage may exceed 90 days. Battery damage may occur.

The LOW BATTERY message display-to-shutdown interval may be less than one minute when older batteries
become depleted.

Do not sterilize the device.

Do not sterilize the CPRD-to-MFC connector.

Do not immerse any part of the device in water.

Do not use alcohol or ketones (MEK, acetone, etc.) on the device.

Avoid using abrasives (e.g. paper towels) on the display window.

Grounding reliability can only be certain when the equipment is connected to an equivalent receptacle marked
HOSPITAL ONLY or HOSPITAL GRADE. If the grounding integrity of the line cord or AC receptacle is in doubt,
operate on battery only.

Multiple portable socket-outlets or extension cords should not be connected to the unit.

Do not use accessories not specified for use with the E Series units.

Use only ECG cables (namely, ones with internal current-limiting resistors) specified or supplied by ZOLL Medical
Corporation to protect the E Series from damage during defibrillation, for accurate ECG information, and for
protection against noise and other interference.

FCC Statement Regarding Bluetooth Operation

This device complies with Part 15 of FCC Rules. Operation is subject to the following two
conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference
received, including interference that may cause undesired operation.

Bluetooth equipped E Series units may contain FCC ID: PVH070101 or FCC ID: PVH090202S.

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