WARNINGS:
Immediate hazards that will result in
serious personal injury or death.
•
Hazardous electrical output. This equipment is for use only by
qualified personnel.
•
Possible fire or explosion. Do not use in the presence of
flammable gases or anesthetics. Use care when operating this
device close to oxygen sources (such as bag-valve-mask devices
or ventilator tubing). Turn off gas source or move source away
from patient during defibrillation, if necessary.
•
The DDU-100 Series AED has not been evaluated or approved
for use in hazardous locations as defined in the National Electric
Code standard. In compliance with IEC classification, the DDU-
100 Series AED is not to be used in the presence of flammable
substance/air mixtures.
Conditions, hazards, or unsafe practices that may
result in serious personal injury or death.
•
Not intended to be used in an environment with high-
frequency electrosurgical equipment.
•
Improper use can cause injury. Use the DDU-100 Series AED
only as instructed in the User Manual and Operating Guide.The
DDU-100 Series AED delivers electrical energy that can potentially
cause death or injury if it is used or discharged improperly.
•
Improper maintenance can cause the DDU-100 Series AED
not to function. Maintain the DDU-100 Series AED only as
described in the User Manual and Operating Guide. The AED
contains no user-serviceable parts — do not take the unit apart.
•
No modification of this equipment is allowed.
•
Electrical Shock Hazard. Dangerous high voltages and currents
are present. Do not open unit, remove cover (or back), or attempt
repair. There are no user serviceable components in the DDU-
100 Series AED. Refer servicing to qualified service personnel.
•
Lithium metal battery packs are not rechargeable. Any attempt
to recharge a lithium metal battery pack may result in fire or
explosion. Do not attempt to recharge the primary battery pack
or lithium 9V battery.
•
Do not immerse battery pack in water or other liquids.
Immersion in fluids may result in fire or explosion.
•
Do not attempt to recharge, short-circuit, puncture, or deform
battery. Do not expose battery to temperatures above 50°C
(122°F). Remove battery when depleted.
•
Do not let fluids get into the DDU-100 Series AED. Avoid
spilling fluids on the AED or its accessories. Spilling fluids into
the DDU-100 Series AED may damage it or cause a fire or
shock hazard.
WARNINGS (continued)
•
Do not sterilize the DDU-100 Series AED or its accessories.
•
Use only Defibtech disposable self-adhesive defibrillation pads,
battery packs, and other accessories supplied by Defibtech
or its authorized distributors. Substitution of non-Defibtech
approved accessories may cause the device to perform
improperly.
•
Do not open sealed pads package until pads are to be used.
The packaging should be opened only immediately prior to use,
otherwise the pads may dry out and become non-functional.
•
Do not touch the patient during defibrillation. Defibrillation
current can cause operator or bystander injury.
•
Do not allow pads to touch metal objects or equipment in
contact with the patient. Do not touch equipment connected to
the patient during defibrillation. Disconnect all non-defibrillator
proof equipment from the patient before defibrillation to prevent
electrical shock hazard and potential damage to that equipment.
•
Do not shock with defibrillation pads touching each other. Do
not shock with gel surface exposed.
•
Do not allow defibrillation pads to touch each other, or to touch
other ECG electrodes, lead wires, dressings, transdermal
patches, etc. Such contact can cause electrical arcing
and patient skin burns during defibrillation and may divert
defibrillating energy away from the heart.
•
The defibrillation pads are intended for one-time use only and
must be discarded after use. Reuse can lead to potential cross
infection, improper performance of the device, inadequate
delivery of therapy, and/or injury to the patient or operator.
•
Avoid contact between parts of the patient’s body and
conductive fluids such as water, gel, blood or saline, and
metal objects, which may provide unwanted pathways for
defibrillating current.
•
Aggressive or prolonged CPR to a patient with defibrillation
pads attached can cause damage to the pads. Replace the
defibrillation pads if they become damaged during use.
•
Possible Radio Frequency (RF) interference from RF devices
such as cellular phones and two-way radios can cause
improper AED operation. Normally using a cell phone near the
AED should not cause a problem; however, a distance of 2
meters (6 feet) between RF devices and the DDU-100 Series
AED is recommended.
•
CPR during analysis can cause incorrect or delayed diagnosis
by the patient analysis system.
•
Do not place adult defibrillation pads in the anterior-posterior
(front-back) position. A shock or no shock decision may be
inappropriately advised. The DDU-100 Series AED requires
that the adult defibrillation pads be placed in the anterior-
anterior (front-front) position.
WARNINGS (continued)
•
Some very low amplitude or low frequency VF rhythms may
not be interpreted as shockable. Some very low amplitude
or low frequency VT rhythms may not be interpreted as
shockable.
•
Handling or transporting the patient during ECG analysis can
cause incorrect or delayed diagnosis, especially if very low
amplitude or low frequency rhythms are present. If the patient is
being transported, stop vehicle before beginning ECG analysis.
•
In patients with cardiac pacemakers, the DDU-100 Series AED
may have reduced sensitivity and not detect all shockable
rhythms. If you know the patient has an implanted pacemaker,
do not place electrodes directly over an implanted device.
•
During defibrillation, air pockets between the skin and
defibrillation pads can cause patient skin burns. To help
prevent air pockets, make sure self-adhesive defibrillation pads
completely adhere to the skin. Do not use dried out or expired
defibrillation pads.
•
Defibrillation may cause skin burns around the defibrillation
pads area.
•
User-initiated and automatic self-tests are designed to assess
the DDU-100 Series AED’s readiness for use. However, no
degree of testing can assure performance or detect abuse,
damage, or a defect that occurred after the most recent test
is completed.
•
Use of damaged equipment or accessories may cause the
device to perform improperly and/or result in injury to the
patient or operator.
•
In the event the voice prompts cannot be heard for any reason
(e.g. noisy environment), follow the LEDs on the front of the
AED to complete the rescue.
•
It may be possible for the AED to not detect a shockable
rhythm, not deliver a shock to a shockable rhythm or not
deliver the intended energy during defibrillation.
•
It may be possible that the AED recommends a shock for a
non-shockable rhythm, and if a shock is delivered, VF or cardiac
arrest may occur.
•
Even if defibrillation occurs, the sudden cardiac arrest event
may not result in survival.
•
Defibrillation may cause myocardial damage or post-shock
dysfunction.
•
Therapy cannot be delivered while an AED software update
is in process.
•
Do not turn off the AED or remove the battery pack or the
update data card until an AED software update process is
complete as these actions may render the AED incapable
of delivering therapy. If any of these interruptions occur,
restart the update procedure from the beginning.
CAUTIONS:
Conditions, hazards, or unsafe practices that
may result in minor personal injury, damage to the
DDU-100 Series AED, or loss of data.
•
Follow all battery pack labeling instructions. Do not install
battery packs after the expiration date.
•
Follow all defibrillation pad label instructions. Use defibrillation
pads prior to their expiration date.
•
The defibrillation pads should not be in continuous contact
with the patient’s skin for more than 24 hours.
•
Allergic dermatitis or a minor skin rash may result in patients
that are sensitive to the materials used for the defibrillation
pads. Remove the defibrillation pads from the patient as soon
as practical.
•
Recycle or dispose of lithium battery packs in accordance with
local, state, provincial, and/or national regulations. To avoid fire
and explosion hazard, do not burn or incinerate the battery
pack. Do not crush.
•
Use and store the DDU-100 Series AED only within the
range of environmental conditions specified in the technical
specifications.
•
If possible, disconnect the DDU-100 Series AED from the
patient prior to use of other defibrillators.
•
Using non-Defibtech Data Cards (DDC cards) may damage the
unit and will void the warranty.
•
DefibView software is not intended for clinical use. Information
presented by DefibView should not be used for making clinical
decisions.
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Although the DDU-100 Series AED is designed for a wide
variety of field use conditions, rough handling beyond
specifications may result in damage to the unit.
•
Federal Law (USA) restricts this device to sale by or on the
order of a physician.