ZOLL M Series Defibrillator Rev YH - Manual (Page 17)

General Information
1-9
• The ECG out signal is delayed by up to 25 ms. This delay
must be considered when the ECG out signal is used as an
input to other devices requiring R-wave synchronization.
• The M Series device may not perform to specifications
when stored at the upper or lower extreme limits of
storage temperature and immediately put into use.
• Avoid using the M Series adjacent to, or stacked on other
equipment. If unavoidable, verify that the M Series
operates normally in this configuration before clinical
use.
• The M Series should be installed and put into service
according to the Electromagnetic Compatibility (EMC)
information in Appendix A of this manual.
• The use of accessories, transducers, and cables other than
those specified in this manual and related M Series
option manual inserts may result in increased emissions
or decreased immunity of the M Series.
Operator Safety
•
Do not use M Series products in the presence of oxygen-
rich atmospheres, flammable anesthetics or other
flammable agents (such as gasoline). Using the
instrument near the site of a gasoline spill may cause an
explosion.
• Do not use the instrument near or within puddles of
water. Electrical safety of the device may be
compromised when wet.
• Do not discharge with paddles or MFE Pads shorted
together or in open air.
• Warn all persons in attendance of the patient to STAND
CLEAR prior to defibrillator discharge.
• Do not touch the bed, patient, or any equipment
connected to the patient during defibrillation. A severe
shock can result. Do not allow exposed portions of the
patient's body to come in contact with metal objects, such
as a bed frame, as unwanted pathways for defibrillation
current may result.
• For defibrillation using paddles, utilize only high
conductivity electrolyte gel specified by the manufacturer
for such use.
• To avoid risk of electrical shock, do not allow electrolyte
gel to accumulate on hands or paddle handles.
• To avoid risk of electrical shock, do not touch the gelled
area of the MFE Pads while pacing.
• When defibrillating with paddles use your thumbs to
operate the SHOCK buttons in order to avoid inadvertent
operator shock. No portion of the hand should be near the
paddle plates.
• Only use thumbs to depress the paddle SHOCK buttons.
Failure to do so could result in the inadvertent depression
of the energy select buttons, causing the defibrillator to
disarm itself.
• Do not discharge the defibrillator except as indicated in
the instructions. Do not discharge the defibrillator if the
MFE Pads are not properly attached to the patient.
• Always check that the equipment functions properly and
is in proper condition before use.
• Disconnect all electro-medical equipment that is not
defibrillation protected from the patient prior to
defibrillation.
• 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
• Evidence that the safety certification of the
ACCESSORY has been performed in accordance with
the appropriate IEC (EN) 60601-1 and/or
IEC (EN) 60601-1-1 harmonized national standards.
Patient Safety
•
Neonatal and pediatric defibrillation energy levels should
be set based on site-specific clinical protocols.
• Do not use the unit’s AED function on patients under
8 years of age. *
• 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.
• The ECG rhythm analysis function does not warn the
operator of patient asystole, as it is not a shockable
rhythm.
• 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.
• Excessive body hair or wet, sweaty 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).
WARNINGS (Continued)