User's Manual Part 1

Directions for Use Chapter 1 General information 5
WARNING Always check the patient mode at Acuity when monitoring a new
patient. The patient mode determines default alarm limits and internal algorithm
settings.
WARNING The monitor may not meet its performance specifications if stored
or used outside the specified temperature and humidity ranges.
WARNING Do not connect more than one patient to a monitor. Do not connect
more than one monitor to a patient.
WARNING During defibrillation, keep the discharge paddles away from ECG
and other electrodes, as well as other conductive parts in contact with the
patient.
WARNING Do not operate this product in the presence of flammable
anesthetics or other flammable substances in combination with air, oxygen-
enriched environments, or nitrous oxide; explosion can result.
WARNING Do not use the monitor in a Magnetic Resonance Imaging (MRI)
suite or a hyperbaric chamber. Such use can cause fire or explosion resulting in
patient injury and monitor damage.
WARNING Electronic equipment that emits strong electromagnetic or radio
frequency signals can cause electrical interference with monitor operation. This
interference may distort the ECG signal, thereby preventing accurate rhythm
analysis. Avoid operating this device near equipment of this type.
WARNING Exposure to Radio Frequency (RF) radiation. To comply with Federal
Communications Commission (FCC) RF exposure requirements, this device
shall be used in accordance with the operating conditions and instructions
provided in this manual, including the section ”Install the carrying pouch” on
page 28.
WARNING Pacemaker signals can differ from one pacemaker to the next. The
Association for Advancement of Medical Instrumentation (AAMI) cautions that
“in some devices, rate meters may continue to count the pacemaker rate during
occurrences of cardiac arrest or some arrhythmias. Do not rely entirely upon rate
meter alarms. All pacemaker patients should be kept under close or constant
observation.” See ”ECG specifications” on page 51 for disclosure of the
pacemaker pulse rejection capability of this instrument.
WARNING This wireless medical device was tested and, when used with a
metal-free accessory between the monitor and the patient, complies with FCC
RF Exposure (SAR) guidelines. The use of accessories containing metal may not
ensure compliance with FCC RF exposure guidelines. Specific Absorption Rate
(SAR) is a measurement of radio frequency energy. The FCC permits a
maximum SAR value of 1.6 mW/g. The highest SAR value for this patient
monitor, when worn by a patient in accordance with the directions for use, is
0.560 mW/g.
WARNING High-power radars are allocated as primary users of the 5.25 to
5.35 GHz and 5.65 to 5.85 GHz bands. These radar stations can cause
interference with and/or damage this device.
WARNING Changes or modifications not expressly approved by Welch Allyn
could void the purchaser’s authority to operate the equipment. This product
does not contain any user serviceable components. Any unauthorized product
changes or modifications will invalidate Welch Allyn’s warranty and all applicable
regulatory certifications and approvals.