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General warnings and cautions – Welch Allyn 246 Propaq CS Vital Signs Monitor v.3.7X - User Manual User Manual

Page 7

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Directions for Use

General information

3

General warnings and cautions

Familiarize yourself with all warnings and cautions before using the Propaq CS monitor. In
addition to the following, other warnings and cautions appear throughout this manual.

The CE Mark and Notified Body Registration
Number signify the device has met all
essential requirements of European Medical
Device Directive 93/42/EEC

The Canadian Standards Association has
evaluated this device according to CSA 601-1
and Underwriters Laboratory Standard UL
2601-1.

Restrictions for use of wireless device in
Europe. European Communities Class 2 radio
equipment

This device has been tested and certified by
the Canadian Standards Association
International to comply with applicable U.S.
and Canadian medical safety standards.

Apply the NIBP cuff as shown.

Apply the NIBP cuff as shown.

Single-use only (not reusable).

NRTL/C

Evaluated to CSA 601-1
and UL2601-1

NIBP cuff sizes:
Thigh
Large adult
Adult
Small adult
Child
Infant

FCC ID:
PGUWA11A07
IC:
4168a-WA11A07

This device complies with FCC and
Industry Canada requirements for
international radiators (802.11
wireless)

WARNING Safe interconnection between the Propaq CS monitor and other
devices must comply with applicable medical systems safety standards such as
IEC 60101-1-1. Within certain governmental jurisdictions, all interconnected
accessory equipment must be labeled by an approved testing laboratory. After
interconnection with accessory equipment, risk (leakage) current and grounding
requirements must be maintained.

WARNING This monitor is to be operated by qualified personnel only. The
operator of this monitor should read this entire manual and all accessory
directions for use before operating the monitor.

WARNING Before you use a Propaq CS monitor on a new patient, always turn
off the monitor for a few seconds, then turn it on again. This clears the prior
patient’s trend values, alarm limit settings, and NIBP cuff inflation target.

WARNING Always check the patient mode when monitoring a new patient. The
patient mode determines default alarm limits, maximum cuff inflation pressure,
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 Place the Propaq monitor and accessories in locations where they
cannot harm the patient if they fall from their shelf or mount. Lift the monitor only
by its handle; do not lift it by any attached cables.