DAC-U2530EN-AG rev E
DAC-U2530EN-AG rev E
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For more detailed information, refer to the User Manual (at www.defi btech.com).
WARNINGS AND CAUTIONS
!
WARNINGS:
Immediate hazards that will result in
serious personal injury or death
.
• Hazardous electrical output. This equipment is for use only by
qualifi ed personnel.
• Possible fi re or explosion. Do not use in the presence of
fl ammable 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 defi brillation, if necessary.
• The DDU-2000 Series AED has not been evaluated or approved
for use in hazardous locations as defi ned in the National Electric
Code standard. In compliance with IEC classifi cation, the DDU-
2000 Series AED is not to be used in the presence of fl ammable
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-2000 Series AED only
as instructed in the User Manual and Operating Guide. The DDU-
2000 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-2000 Series AED
not to function. Maintain the DDU-2000 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 modifi cation 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-
2000 Series AED. Refer servicing to qualifi ed service personnel.
• Lithium metal battery packs are not rechargeable. Any attempt
to recharge a lithium metal battery pack may result in fi re or
explosion. Do not attempt to recharge the primary battery pack.
• Do not immerse battery pack in water or other liquids. Immersion
in fl uids may result in fi re 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 fl uids get into the DDU-2000 Series AED. Avoid spilling
fl uids on the AED or its accessories. Spilling fl uids into the DDU-
2000 Series AED may damage it or cause a fi re or shock hazard.
WARNINGS
(continued)
• Do not sterilize the DDU-2000 Series AED or its accessories.
• Use only Defi btech disposable self-adhesive defi brillation pads,
battery packs, and other accessories supplied by Defi btech or its
authorized distributors. Substitution of non-Defi btech 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 defi brillation. Defi brillation 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 defi brillation. Disconnect all non-defi brillator
proof equipment from the patient before defi brillation to prevent
electrical shock hazard and potential damage to that equipment.
• Do not shock with defi brillation pads touching each other. Do not
shock with gel surface exposed.
• Do not allow defi brillation 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 defi brillation and may divert defi brillating energy
away from the heart.
• The defi brillation 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
fl uids such as water, gel, blood or saline, and metal objects,
which may provide unwanted pathways for defi brillating current.
• Do not connect the DDU-2000 Series AED to a PC or other
device (using the USB port) while the unit’s electrodes are still
connected to the patient.
• Aggressive or prolonged CPR to a patient with defi brillation pads
attached can cause damage to the pads. Replace the defi brillation
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-2000 Series AED is
recommended.
• CPR during analysis can cause incorrect or delayed diagnosis by
the patient analysis system.
• Do not place adult defi brillation pads in the anterior-posterior
(front-back) position. A shock or no shock decision may be
inappropriately advised. The DDU-2000 Series AED requires
that the adult defi brillation 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 in any way 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-2000 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 defi brillation, air pockets between the skin and
defi brillation pads can cause patient skin burns. To help
prevent air pockets, make sure self-adhesive defi brillation pads
completely adhere to the skin. Do not use dried out or expired
defi brillation pads.
• Defi brillation may cause skin burns around the defi brillation pads
area.
• User-initiated and automatic self-tests are designed to assess the
DDU-2000 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.
• Possible misinterpretation of ECG data. The frequency response
of the LCD display is intended for basic ECG rhythm identifi cation;
it does not provide the resolution required for pacemaker pulse
identifi cation or accurate measurements, such as QRS duration
and ST segment interpretation. For such purposes an ECG
Monitor with an appropriate frequency response should be used.
• Follow voice prompts if the LCD screen becomes blank or
unreadable.
• 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 defi brillation.
• 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 defi brillation occurs, the sudden cardiac arrest event may
not result in survival.
• Defi brillation 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.
WARNINGS
(continued)
• While in demonstration mode, the AED cannot perform a rescue.
If at any time during the demonstration there is a need to perform
a rescue, press and hold the green on/off button for two seconds
to power off the AED. Then press the green on/off button to power
on the unit and begin a rescue protocol. The demonstration card
does not need to be removed in order to perform a rescue.
!
CAUTIONS:
Conditions, hazards, or unsafe practices that
may result in minor personal injury, damage to
the DDU-2000 Series AED, or loss of data.
• Follow all battery pack labeling instructions. Do not install battery
packs after the expiration date.
• Follow all defi brillation pad label instructions. Use defi brillation
pads prior to their expiration date.
• The defi brillation 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 defi brillation pads. Remove
the defi brillation 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 fi re and explosion hazard, do not burn or incinerate the
battery pack. Do not crush.
• Use and store the DDU-2000 Series AED only within the range of
environmental conditions specifi ed in the technical specifi cations.
• If possible, disconnect the DDU-2000 Series AED from the patient
prior to use of other defi brillators.
• Using non-Defi btech Data Cards (DDC cards) may damage the
unit and will void the warranty.
• Defi bView software is not intended for clinical use. Information
presented by Defi bView should not be used for making clinical
decisions.
• Although the DDU-2000 Series AED is designed for a wide variety
of fi eld use conditions, rough handling beyond specifi cations may
result in damage to the unit.
• Federal Law (USA) restricts this device to sale by or on the order
of a physician.
Refer to User Manual Section 9.1 for
Summary of Primary Clinical Studies
and Potential Adverse Effects
of the Device on Health.
