Intended Use-Warnings - Justec OxiEasy W60 User Manual

Justec Shenzhen CO., LTD.
1. Intended Use
The OxiEasy W60 pulse oximeter is intended for spot-checking
and continuous monitoring arterial oxygen saturation (SpO
pulse rate of adult and pediatric patients in hospital, hospital type
facilities, transport, emergency care, mobile environments and
home care.
Warnings
Warnings are indentified by the WARNING symbol shown
above. Warnings alert the user to potential serious outcomes,
such as death, injury, or adverse events to the patient or user.
Please read the instructions carefully to ensure accurate
measurement and safe operation.
Do not make any clinical judgments based solely on the
OxiEasy W60. The monitor is intended only as an adjunct in
patient assessment. It must be used in conjunction with
clinical signs and symptoms. The interpretation of the
measurement values should be done only by trained health
care professionals.
Explosion hazard. Do not use OxiEasy W60 in the presence
of flammable anesthetics mixture with air, oxygen, or
nitrous oxide.
Routinely monitor the patient to make sure the OxiEasy
W60 is functioning and that the sensor is correctly placed.
Pulse oximetry measurements and pulse signals can be
affected by certain environmental conditions, sensor
application errors, and certain patient conditions. See the
appropriate sections of this manual for specific safety
information.
If you are uncertain about the accuracy of any measurement,
check the patient's vital signs by alternate means; then make
sure that the OxiEasy W60 is functioning correctly.
The use of accessories ,sensors, and cables other than those
specified may result in inreased emission and/or create
invalid reading of the W60.
Failure to cover the sensor site with opaque material in high
ambiernt light conditions may result in inaccurate
measurement.
Disconnect the OxiEasy W60 and sensor from the patient
throughout magnetic resonance imaging(MRI) scanning.
Induced could potentially cause burns.
OxiEasy W60 User Manual
The OxiEasy is not defibrillator-proof. However, it may
remain attached to the patient throughout defibrillation or
whilst an electrosurgical unit is in use. The measurements
may be inaccurate throughout the defibrillation, or use of an
) and
2
electrosurgical unit, and shortly thereafter. To avoid shock,
the caregiver should not touch the OxiEasy while using a
defibrillation on a patient.
The OxiEasy W60 is a prescription device to be operated
only by trained personnel. The monitor is for attended
monitoring only.
Do not use a device that appears damaged. Do not use the
sensors where optical components lie open.
Changing lithium batteries when incorrect replacement by
inadequately trained personnel would result in an
unacceptable risk(e.g., excessive temperatures, fire or
explosion)
Do not modify this equipment without authorization of the
manufacturer.
Check the pulse oximeter sensor application site every 4
hours to determine the positioning of the sensor and the
circulation and skin sensitivity of the patient. Patient
sensitivity varies depending on medical status or skin
condition.
Carefully route patient cables and connections to reduce the
possibility of patient entanglement, strangulation, or
injury to the patient.
When using the monitor around pets,small child or baby,
avoid leaving the monitor unattended. Cables pose a
risk of injury, including strangulation. This device contains
small parts that may cause suffocation if swallowed by child
or baby.
Do not use the device when alarms are required.
When using the monitor in the home, avoid exposing the
monitor to lint and dust.
Version:2.0
3