Safety considerations, Warnings – ZOLL M Series Defibrillator Rev M User Manual

Page 4

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M S

ERIES

O

PERATOR

S

G

UIDE

- O

PTION

I

NSERT

SpO

2

- 2

Safety Considerations

Warnings

General

Sensors

Before use, carefully read the M Series
Operator’s Guide
, these operating instructions,
and the ZOLL/ Masimo LNCS Sensor directions
for use.

The M Series Pulse Oximeter is to be operated
by qualified personnel only.

Do NOT use the pulse oximeter as an apnea
monitor.

Do NOT immerse the M Series device, patient
cables or sensors in water, solvents, or cleaning
solutions.

A pulse oximeter should be considered an early
warning device. As a trend towards patient
deoxygenation is indicated, blood samples
should be analyzed by a laboratory co-oximeter
to completely understand the patient's condition.

If an alarm occurs while the alarms are
suspended, the suspended alarm indications
will only be visual displays and symbols.

To ensure patient safety, the ECG-out jack and
modem (if available) should only be connected
to other equipment with galvanically isolated
circuits.

Interfering Substances: Carboxyhemoglobin and
methemoglobin may erroneously alter SpO

2

readings. The level of change is approximately
equal to the amount of carboxyhemoglobin or
methemoglobin present. Dyes, or any substance
containing dyes, that alter arterial pigmentation
may cause erroneous readings.

Do not use the M Series pulse oximeter or
LNCS sensors during magnetic resonance
imaging (MRI). Induced current could potentially
cause burns. The M Series Pulse Oximeter may
affect the MRI image, and the MRI unit may
affect the accuracy of the oximetry
measurements.

Carefully route patient cabling to reduce the
possibility of patient entanglement or
strangulation.

Use ONLY the line cord supplied by ZOLL
Medical Corporation for continued safety and
EMI performance.

Use only ZOLL/Masimo LNCS Oximetry
Sensors for SpO

2

measurements. Other

manufacturer’s sensors may cause improper
oximeter performance.

Tissue damage can result from incorrect
application or use of an LNCS sensor, for
example by wrapping the sensor too tightly.
Inspect the sensor site as directed in the
sensors' Directions for Use to ensure skin
integrity, correct positioning and adhesion of the
sensor.

Do NOT use damaged LNCS sensors or cables.

Do NOT use an LNCS sensor with exposed
optical components.

Do NOT sterilize the sensor by irradiation,
steam, or ethylene oxide. See the cleaning
instructions in the Directions for Use for reusable
Masimo LNCS sensors.

Do NOT allow the sensor to remain on one site
for a prolonged period of time, especially when
monitoring neonates. Check the application site
at regular intervals - at least every two hours -
and change the site if any compromise in skin
quality should occur. Refer to the sensor's
specific directions for use.

Do NOT attach the SpO

2

sensor to a limb being

monitored with a blood pressure cuff or limb with
restricted blood flow.

A poorly applied sensor may give incorrect
saturation values. The signal strength indicator
can be used to identify a poorly applied sensor
or poorly chosen site.

Choose a site with sufficient perfusion to ensure
accurate oximetry values.

Certain nail aberrations, nail polish, fungus, etc.
may cause inaccurate oximetry readings.
Remove the nail polish and/or move the sensor
to an unaffected digit.

Before use, carefully read the SpO

2

Sensor

directions for use.

High ambient light sources such as surgical
lights (especially those with xenon light source),
bilirubin lamps, fluorescent lights, infrared
heating lamps, and direct sunlight can affect the
accuracy of SpO

2

readings.

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