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Directions for Use Chapter 1 General information 5
WARNING Magnetic Resonance (MR) Safety. This monitor is designated Not
MR Safe, as defined in the ACR Guidance for Safe MR Practices, 2007. Do not
place this monitor in Zones 3 or 4, in MR environments for which Zones have
been established and marked in accordance with the Guidance. In MR
environments for which Zones have not been designated, do not place this
monitor into a magnetic field with field strength larger than the field strength
that your facility permits to exist in areas that are accessible by personnel,
patients, and guests without MR safety precautions. Failure to follow these
precautions creates a risk that the magnetic field will damage the monitor,
causing it to overheat and potentially burn patents and cause a fire. The damage
to the monitor caused by exposure to magnetic fields may be immediate or
latent. If the damage is latent, it can cause the monitor to overheat at some time
subsequent to its exposure to the magnetic field.
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 53 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 Military radars are allocated as primary users in the bandwidths
between 5.25 - 5.35 GHz and 5.47 to 5.725 GHz. In the event a radar signature
is detected, the Access Point moves to a new channel, which can temporarily
interrupt patient monitoring. If the device is operated near a military radar, the
radar could cause damage to the 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.
WARNING Motion artifact can affect the accuracy of patient vital sign
measurements. Minimize patient motion whenever possible.