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General cautions – Welch Allyn 901061 Propaq LT Vital Signs Monitor - User Manual User Manual

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Directions for Use

Introduction

7

General cautions

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 bandwidth
between 5.25 GHz and 5.35 GHz and between 5.65 GHz and 5.85 GHz. These
radars can cause interference with this device and can damage this device.

WARNING Do not use the pulse oximeter as a replacement or substitute for
ECG-based arrhythmia analysis.

WARNING The bedside patient monitor is the primary alarming source for the
patient and a central station is a backup alarm source. The central station is only
as reliable as its network and should be relied on only as a backup alarming
device.

WARNING The leading cause of patient death or serious injury reported with the
use of patient monitoring equipment is failure to respond to alarms notifying the
user of an adverse change in patient condition. If you are relying on visual alarm
notifications, maintain a clear line of sight and remain within 4 meters of the
monitor or the central station. If you are relying on audio alarm notifications, make
sure that you can hear audio alarms from where you are. Set the volume as
needed considering the environment and ambient noise levels. Verify that the
alarm is audible to a clinician working at the maximum distance from the monitor
or central station.

WARNING Auto-reboots occur and wireless connection is occasionally
disrupted. During this period, the bedside monitors continue to provide their
primary alarming functions. Auto-reboots occur infrequently, due to poor
environmental conditions. Failure to perform preventative maintenance can
increase the frequency of occurrence.

WARNING False alarms may occur in some situations. You must understand
and address the cause of the false alarms whenever possible to eliminate the
possibility of repeated false alarms and alarm fatigue, which might result in a
failure to respond to an actual alarm situation.

Caution Do not autoclave the monitor.

Caution Autoclave accessories only if the manufacturer's instructions clearly
direct you to do so. Many accessories can be damaged by autoclaving.

Caution Changes or modifications not expressly approved by Welch Allyn could
void the purchaser’s authority to operate the equipment.

Caution This product contains no user-serviceable components. Any
unauthorized changes to the product invalidate Welch Allyn’s warranty and also
invalidate all applicable regulatory certifications and approvals.