• 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.
• 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 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-2000 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-2000 Series AED requires that the adult defibrillation pads be placed in the
anterior-anterior (front-front) position.
• 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 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-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 identification; it does not provide the resolution required for pacemaker pulse identification 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 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.
WARNINGS (continued)
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