Pulse Oximetry (SpO2)
9650-0202-01 Rev. J
This issue date or revision level for this operation guide is shown on the front cover.
ZOLL and M Series are trademarks of ZOLL Medical Corporat ion.
© 2002 by ZOLL Medical Corporation. All rights reserved
PULSE OXIMETRY (SpO2)
General Information
Product Description
The M Series Pulse Oximeter (SpO2) continuously and non-invasively measures the oxygen saturation of arteriolar
hemoglobin at a peripheral measurement sit e , (i.e. foot, toe or finger). It is used for monitoring patients who are at risk of
developing hypoxemia. SpO
details of oxygen transportation in the body. It is widely used because it is non-invasive, continuous, easily applied and
painless.
The oximetry sensor contains two light emitting diodes (LEDs) that transmit red and infrared light through the body’s
extremities. The transmitted light is then received by a photodetector.
Oxygen-saturated blood absorbs light differently than unsaturated blood. Thus the amount of red and infrared light absorbed
by blood flowing through a suitable peripheral area of the body, typically the finger in adults and the foot in neonates, can be
used to calculate the ratio of oxygenated hemoglobin to total hemoglobin in arteria l blood. The monitor displays this ratio as
percent SpO
The quality of SpO
. Normal values typically range from 95% to 100% at sea level.
2
measurements depends on correct application and size of the sensor, adequate blood flow through the
2
sensor site, and exposure to ambient light. For correct placement and location of the sensors refer to the Directions for
Use contained on all LNOP
monitoring gives information about both the cardiac and respiratory systems, and provides
2
oximetry sensor packages.
How to Use This Manual
This section explains how to set up and use the M Series Pulse Oximeter. Important safety information relating to general
use of the M Series Pulse Oximeter appears in the “Safety Considerations” section of this manual. Other important safety
information is located in the “Safety Considerations” section of the LNOP
The M Series Operator's Guide provides information operators need for the safe and effective use and care of the
M Series products. It is important that persons using this device read and understand all the information contained within.
Please thoroughly read both safety considerations and warnings sections before operating your
M Series product.
SpO2 Accessories
LNOP
•
LNOP
•
LNOP
•
LNOP
•
LNOP
•
PC04 : 4’ Reusable Patient Cable
•
PC08 : 8’ Reusable Patient Cable
•
PC12 : 12’ Reusable Patient Cable
•
- Adt : Single use sensor for patients > 30kg
- Pdt : Single use sensor for Pediatrics and Slender Adults >10kg and < 50kg
- Neo : Single use sensor for Neonates < 10kg
- Neo Pt : Single use sensor for Neonates < 1kg (Pre - Term)
- DC1 : Reusable sensor for Adults and Pediatrics > 30kg
* Masimo SET and LNOP are registered trademarks of Masimo Corporation.
oximetry sensor packages.
9650-0202-01 SpO2 - 1 Rev. J
OPTION INSER T
SpO2 Intended Use
The ZOLL M Series Pulse Oximeter with Masimo SET
technology and the LNOP
for the continuous noninvasive monitoring of arterial oxygen
saturation (SpO
) and pulse rate during both no motion and
2
patient motion conditions for adult patients, and no motion
conditions for pediatric and neonatal patients, i n a hospital
and pre-hospital environment.
Oxygen saturation measurements using pulse oximetry are
highly dependent on proper placement of the sensor and
patient conditions. Patient conditions such as smoke
inhalation may result in erroneous oxygen saturation
readings. If pulse oximetry measurements are suspect,
verify the reading using another clinically accepted
measurement method, such as arterial blood gas
measurements.
The M Series Pulse Oximetry option is intended for use
only with ZOLL / Masimo LNOP
Series of Sensors are indicated
sensors.
Measurement Complications
• There is arterial occlusion prox imal to the sensor.
• The patient is in cardiac arrest or shock.
SpO2 Connector and Sensors
The SpO2 connector is located on the rear panel of the
M Series unit. Only ZOLL or Masimo accessories and
sensors can be used with the M Series Pulse Oximetry
option.
Each sensor is designed for application to a specific
anatomical site on patients within a certain weight range. To
ensure optimal performance, use an appropriate sensor,
apply it as described in the sensor's Directions for Use, keep
the sensor at the lev el of the patient's heart, and always
observe all warnings and cautions.
Tissue damage can result from incorrect application or use
of a sensor (e.g., wrapping the sensor too tightly, applying
supplemental tape, failing to periodically inspect the sensor
site). Refer to the Directions for Use provided with each
sensor for specific instructions on application and use.
If the accuracy of any reading is suspect, first check the
patient's vital signs by alternate means and then check the
M Series Pulse Oximeter for pr oper functioning.
Inaccurate measurements may be caused by:
• Incorrect sensor application or use.
• Significant levels of dysfunctional hemoglobins
(e.g., carboxyhemoglobin or methemoglobin).
• Intravascular dyes such as indocyanine green or
methylene blue.
• Exposure to excessive illumination, such as surgical
lamps (especially those with a xenon light source),
bilirubin lamp s , fluoresc en t lights, infrared heating
lamps, or direct sunlight. Exposure to excessive
illumination can be corrected by covering the sensor
with a dark or opaque material.
• Excessive patient movement .
• Venous pulsations.
• Placement of a sensor on an extremity with a blood
pressure cuff, arterial catheter, or intravascular line.
Loss of pulse signal can occur under any of the following
situations:
• The sensor is applied too tightly.
• There is excessive illumination from light sources such
as a surgical lamp, a bilirubin lamp, or sunlight.
• A blood pressure cuff is inflated on the same extremity
as the one with a SpO
sensor attached.
2
• Excessive patient movement.
• The patient has hypotension, severe vasoconstriction,
or hypothermia.
9650-0202-01 SpO2 - 2
SAFETY CONSIDERATIONS
Warnings
General
•
•
•
•
•
•
•
•
•
•
•
Before use, carefully read the M Series Operator’s
Guide, these operating instructions, and the ZOLL /
Masimo LNOP
The M Series pulse oximeter is to be operated by
qualified personnel only.
A pulse oximeter should NOT be used 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
readings. The level of change is approximately
equal to the amount of carboxyhem oglobin 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 LNOP
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.
As with all medical equipment, carefully route
patient cabling to reduce the possibility of patient
entanglement or strangulat ion.
Use ONLY the line cord supplied by ZOLL Medical
Corporation for continued safety and EMI
performance.
Sensor directions for use.
PULSE OXIMETRY
Sensors
•
Tissue damage can result from incorrect application
•
Do not use damaged LNOP sensors or cables.
•
Do not use an LNOP sensor with exposed optical
•
Do not sterilize the sensor by irradiation, steam, or
•
•
2
•
•
•
•
•
•
Use only ZOLL / Masimo LNOP Oximetry Sensors
for SpO
sensors may cause improper oximeter performance.
or use of an LNOP
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.
components.
ethylene oxide. See the cleaning instructions in the
Directions for Use for reusable Masimo LNOP
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 SpO2 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 chose n si te .
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 SpO2 Sensor directions
for use.
High ambient light sources such as surgical lights
(especially those with xenon light source), bilir ubin
lamps, fluorescent lights, infrared heating lamps, and
direct sunlight can affect the accuracy of S pO
readings.
measurements. Other manufacturers’
2
sensor, for example by wrapping
2
9650-0202-01 SpO2 - 3
OPTION INSER T
Warranty (U.S. Only)
(a) ZOLL Medical Corporation warrants to the original
equipment purchaser that beginning on the date of
installation, or thirty (30) days after the date of shipment
from ZOLL Medical Corporation's facility, whichever first
occurs, the equipment (other than accessories and
electrodes) will be free from defects in material and
workmanship under normal use and service for the period
of one (1) year. During such period ZOLL Medical
Corporation will, at no charge to the customer, either repair
or replace (at ZOLL Medical Corporation's sole option) any
part of the equipment found by ZOLL Medical Corporation
to be defective in material or workmanship. If ZOLL Medical
Corporation's inspection detects no defects in material or
workmanship, ZOLL Medical Corporation's regular service
charges shall apply. (b) ZOLL Medical Corporation shall not
be responsible for any equipment defect, the failure of the
equipment to perform any function, or any other
nonconformance of the equipment, caused by or
attributable to: (i) any modification of the equipment by the
customer, unless such modification is made with the prior
written approval of ZOLL Medical Corporation; (ii) th e use of
the equipment with any associated or complementary
equipment, (iii) installation or wiring of the equipment other
than in accordance with ZOLL Medical Corporation's
instructions. (c) This warranty does not cover items subject
to normal wear and burnout during use, including but not
limited to lamps, fuses, batteries, pat ient cables and
accessories. (d) The foregoing warranty constitutes the
exclusive remedy of the customer and the exclusive liability
of ZOLL Medical Corporation for any breach of any
warranty related to the equipment supplied hereunder. (e)
Limita tion of Liability: ZOLL shall not in any event be liable
to Purchaser, nor shall Purchaser recover, for special,
incidental or consequential damages resulting from any
breach of warranty, failure of essential purpose, or under
any other legal theory including but not limited to lost profits,
lost savings, downtim e, goodwill, damage to or replacement
of equipment and property, even if ZOLL has been advised
of the possibility of such damages.
THE WARRANTY SET FORTH HEREIN IS EXCLUSIVE
AND ZOLL MEDICAL CORPORATION EXPRESSLY
DISCLAIM S ALL OTHER WARRANTIES WHETHER
WRITTEN, ORAL, IMPLIED, OR STATUTORY,
INCLUDING BUT NOT LIMITED TO ANY WARRANTIES
OF MERCHANTABILITY OR FITNESS FOR A
PARTICULAR PURPOSE.
For additional information, please call ZOLL Medical
Corporation at 1-800-348-9011 (in Massachusetts:
1-781-229-0020). I nt er nat ional customers should call the
nearest authorized ZOLL Medical Corporation service
center.
Software License
Read this Operator's Manual and License agreement
carefully before operating any of the M Series products.
Software incorporated into the system is protected by
copyright laws and international copyright treaties as well as
other intellectual property laws and treaties. This software is
licensed, not sold. By taking delivery of and using this
system, the Purchaser signifies agreement to and
acceptance of the following terms and conditions:
1. Grant of License: In consideration of payment of the
software license fee which is part of the price paid for
this product ZOLL Medical Corporation grants the
Purchaser a non-exclusive license, without right to
sublicense, to use the system software in object-code
form only.
Ownership of Softwa re/Firmware: Title to, ownership
2.
of and all rights and interests in the system software
and all copies thereof remain at all times vested in the
manufacturer, and Licensors to ZOLL Medical
Corporation and they do not pass to Purchaser.
3. Assignment: Purchaser agrees not to assign, sub-
license or otherwise transfer or share its rights under
the license without the express written permission of
ZOLL Medical Corporation.
4. Use Restrictions: As the Purchaser, you may
physically transfer the products from one location to
another provided that the software/firmware is not
copied. You may not disclose, publish, translate,
release or distribute copies of the software/firmware to
others. You may not modify, adapt, translate, rever s e
engineer, decompile, crosscompile, disassemble or
create derivative works based on the
software/firmware.
NO IMPLIED LICENSE
Possession or purchase of this device does not convey any
express or implied license to use the device with
replacement parts which would, alone, or in combination
with this device, fall within the scope of one or more of the
patents relating to this device.
NOTE: The M Series software has been validated for use
with Masimo SET
pulse oximetry technology.
9650-0202-01 SpO2 - 4
PULSE OXIMETRY
SELECTING A LNOP
SENSOR
When selecting a sensor, consider the patient's weight, the
adequacy of perfusion, the available sensor sites, and the
anticipated duration of monitoring. For mo re information
refer to the following table or contact ZOLL Medical
Corporation. Use only ZOLL / Masimo sensors and patient
cables. Select an appropriate sensor, apply it as directed,
and observe all warnings and cautions presented in the
directions for use accompanying the sensor.
Sensor Single Use /
Patient Weight
Reusable
LNOP-Adt Single Use Adults > 30 kg
LNOP- Pdt Single Use Pediatrics and Slender
Adults >10 kg and < 50 kg
LNOP- Neo Single Use Neonates < 10 kg
LNOP- Neo Pt Single Use Neonates < 1 kg
LNOP- DC1 Reusable Adults and Pediatrics > 30 kg
APPLICATION OF THE REUSABLE SENSOR
Site Selection
Choose a site that is well perfused and will restrict a
conscious patient’s movements the least. The ring finger or
middle finger of the non-dominate hand is preferred.
Alternatively, the other digits on the non-dominate hand
may be used. Be sure the sensor's detector is fully
covered by flesh. The great toe or long toe (next to the
great toe) may be used on restrained patients or patients
whose hands are unavailable.
Attaching Sensor to Patient
Place the selected digit over the sensor window of the
•
LNOP
• DC1. The fleshiest part of the digit should be
covering the detector window in the lower half of the
sensor. (Refer to Figure A).
Figure B
• The hinged tabs of the sensor should open to evenly
distribute the grip of the sensor along the length of the
finger. Check position of sensor to verify correct
positioning. Position is deemed correct when the top
and bottom halves of the sensor are parallel. Complete
coverage of the detector window is needed to ensure
accurate data. (Refer to Figure C).
Figure C
• Orient the sensor so that the cable will be running
towards the top of the patient’s hand. Connect the
LNOP
• DC1 connector to a patient cable
(PC04/PC08/PC12).
NOTE: With smaller digits, in order to completely cover the
detector window, the digit might not need to be pushed all
the way to the stop. The sensor is not intended for use on
the thumb or across a child’s hand or foot.
High ambient light sources such as surgical lights
(especially those with a xenon light source), bilirubin lamps,
fluorescent lights, infrared heating lamps, and direct
sunlight can interfere with the performance of an SpO
2
sensor. To prevent interference from ambient light, ensure
that the sensor is properly applied, and cover the sensor
site with opaque material, if required. Failure to take this
precau tion in high ambient light conditions may result in
inaccurate measurements.
Attaching Sensor to the Patient Cable
Orient the connecting tab so that the “shiny” contacts
•
are pointed up and mate the Masimo SET
(
logo on the patient cable.
Refer to Figure D
logo to the
).
Match Logos
Figure A
• On finger sites, the tip of the finger should touch the
raised digit stop inside the sensor. If the fingernail is
Push
to lock into
patient cable
the
long, it may extend over and past the finger stop.
(Refer to Figure B).
Insert the LNOP • DC1 connector over the patient
•
Figure D
cable connector until there is a tactile or audible click
connection. Gently tug on the connectors to ensure a
positive contact. Tape may be used to secure the cable
to the patient for ease of movement.
9650-0202-01 SpO2 - 5
OPTION INSER T
APPLICATION OF THE ADULT DISPOSABLE
(LNOP
SENSOR
Site Selection
Choose a site that is well perfused and restricts a
conscious patient’s movements the least. The ring finger or
middle finger of the non-dominate hand is preferred.
Alternatively, the other digits on the non-dominate hand
may be used. Be sure the sensor's detector is fully covered
by flesh. The great toe or long toe (next to the great toe)
may be used on restrained patients or patients whose
hands are unavailable.
• Adt)
• Complete coverage of the detector window is needed
to ensure accurate measurements.
• The connector tab is now oriented on the top side of
the patient’s finger so that the “shiny” contacts are
pointed up. Mate the Masimo SET
logo on the sensor
to the logo on the patient cable. Insert the patient
cable to the sensor tab until there is a tactile or
audible click of connection. Gently tug on the
connectors to ensure a positive contact. If required,
tape may be used to secure the cable to the patient.
(Figure C)
Attaching Sensor to Patient
Match Logos
• Open the pouch and remove the sensor. Holding the
sensor with the tan printed side downward, bend the
sensor backward and remove backing material from
the sensor.
• Orient the sensor so that the digit can be attached to
the detector side of the sensor first. (Figure A)
Figure C
The sensor may be reapplied to the same patient if
•
the emitter and detector windows are clear and the
adhesive still adheres to the skin.
Push se nsor
tab into the
patient
cable.
• The adhesive can be partially rejuvenated by wiping
with an alcohol wipe and allowing the sensor to
thoroughly air dry prior to replacement on the patient.
Emitter
NOTE: LNOP
• Adt sensors are not intended for use
across a child’s hand or foot.
Detector
Figure A
• Press the detect or onto the fleshy part of the finger near
the tip of the finger.
• Press down the “T” shaped adhesive end of the sensor
onto the finger and secure the wings in place.
• Next, wrap the sensor with the emitter positioned over
the finger nail and secure the wings down one at a time
around finger. When properly applied, the emitter and
the detector should be vertically aligned. (Figure B)
For instructions on proper application of the neonatal
sensors refer to the directions for use accompanying the
LNOP
• Neo sensor.
ENSURING ACCURATE MONITORING
The following general points will aid in ensuring oximetry
monitoring success:
• Choose a site that is well perfu s e d and allows for
proper alignment of the light emitter and detector.
• Select a site that has unrestri cted blood flow.
• Do not restrict blood flow when securing a sensor with
tape.
• Do not select a site near potential sources of electrical
interference (electrical cords, for example).
• Do not use a damaged sensor or one with exposed
electrical circuits.
• Ensure that the sensor site is not subject to excessive
When folded, the
emitter & detector
should be vertically
aligned
Figure B
• Check position of sensor to verify correct positioning
and reposition, if necessary, so that the emitter and
motion. Excessive motion may adversely affect the
performance of the sensor.
• Inspect t he SpO
sensor site at least once every
2
two (2) hours to ensure adhesion, skin integrity, and
correct alignment of the light emitter and detector.
Should alterations of skin integrity occur, remove the
sensor and reapply at another recommended site.
the det ector are vertically aligned.
9650-0202-01 SpO2 - 6
PULSE OXIMETRY
Avoid application of the se nsor to edematous or fragile
tissue.
• The sensor must be removed and repositioned every
eight (8) hours and, if indicated by circulatory condition
or skin integrity, reapplied to a different monitoring site.
• Do not wrap the adhesive too tightly and do not use
additional tape to secure the sensor, as this can cause
venous pulsations that could potentially lead to
inaccurate saturation measurements.
• If the sensor fails to track the pulse consistently, the
sensors may be incorrectly positioned. Reposition the
sensor or choose a different monitoring site.
• Ensure that the signal strength bar graph indicates the
presence of a strong signal associated with each heart
beat.
• Avoid placing an SpO
sensor on any extremity with an
2
arterial catheter, blood pressure cuff, or intravascular
line.
CLEANING AND REUSE OF SENS ORS
Reusable sensors can be cleaned per the following
procedure:
1. Remove the sensor from the patient cable.
2.
Wipe the entire sensor clean with a 70% isopropyl
alcohol pad.
3. Allow the sensor to air dry before returning it to use.
Reattachment of Single Use Sensors
• LNOP
single use sensors may be reapplied to the
same patient if the emitter and detector windows are
clear and the adhesive still adheres to the skin.
• The adhesive can be partially rejuvenated by wiping
with an alcohol wipe and allowing the sensor to
thoroughly air dry prior to replacement on the patient.
PATIENT CABLES
ZOLL offers three reusable patient cables: PC04, a 4 foot
cable, PC08, an 8 foot cable and PC12, a 12 foot cable.
The cables are designed to work exclusively with LNOP
sensors and with the M Series pulse oximeter.
CLEANING AND REUSE OF PA T I ENT CABLES
How SpO
is Displayed
2
The M Series Pulse Oximetry option displays a
plethysmograph waveform derived from the sensor. The
numeric oxygen saturation value is displayed as “SpO2 %”.
A signal strength indicator, left of the SpO
field, shows the
2
relative change in the pulsatile signal. (See below).
Signal Strength
Indicator
SETUP
SpO
2
Numeric Oxygen
Saturation
Attach the sensor to the patient (Refer to the “Attaching the
Sensor to Patient” Section).
Plug the sensor into the SpO
patient cable.
2
Attach the patient cable to the rear of the M Series
product.
Turn the selector switch to MONITOR mode.
A dashed line will be displayed in the SpO2 field until a
pulse is detected. Once the measurement has been
established, the saturation values will be displayed in the
numeric window (e.g., 98).
NOTE: If ECG Leads are not at tached, the patient’s
pulse rate as measured by the SpO
sensor will be
2
displayed as the Heart Rate (HR) in the ECG field and
the heart symbol will not flash.
The SpO
display field consists of the label “SpO2%”, an
2
alarm indicator, a numerical value representing the
saturation level, and a bar graph used as a signal strength
indicator.
PHYSIOL O GICAL MONITORING
When the user turns the M Series device to MONITOR
mode, the physiological monitoring menu will be displayed
with th e following softkeys: “Param”, “Wave2”, “ID#”,
“Alarms” and “12 Lead.”
Patient cables can be cleaned per the following procedure:
1.
Remove the cable from the sensor.
2.
Disconnect the cable from the rear of the M Series.
3.
Wipe clean with a 70% isopropyl alcohol pad.
4.
Allow the cable to dry before returning it to use.
9650-0202-01 SpO2 - 7
OPTION INSER T
R
“Param” Softkey
When the “Param” softkey is pressed, the following
softkeys will be displayed: “Select”, “Enter”, and “ Return”.
Pressing the “Select” softkey will scroll the highlighted area
among the different available physiological parameters.
Pressing the “Enter” softkey allows the user to select the
parameter that is highlighted. Pressing the “Return” softkey
allows the user to return to the physiological monitoring
menu.
Selecting the SpO
parameter causes the following softkeys
2
to appear; “Sens.”, “Average”, “Alarms” and “Return”.
“Sens.” (Sensitivity) Softkey
The “Sens.” softkey allows the us er t o select either
“Normal” or “High” sensitivity for SpO
The “Normal” sensitivity setting is the recommended setting
and should be selected for most patients.
The “High” sensitivity setting allows SpO
performed even under very low perfusion conditions. Such
conditions may include severe hypotension or shock. When
the “High” sensitivity setting is used however, SpO
are more easily contaminate d by artifact. In order to assure
accuracy of SpO
readings when the “High” sensitivity
2
setting is in use, it is recommended that the patient be
carefully and continuously observed.
Normal and High sensitivity modes can be selected by
pressing the “Sens.” softkey. The highlight toggles between
“Normal” and “High” allowing the user to select the
appropriate sensitivity.
Pressing “Enter” allows the user to enter the highlighted
sensitivity. Pressing “Return” will return the user to the
SpO
submenu.
2
monitoring.
2
monitoring to be
2
results
2
setting (default) is inadequate due to extremely high artifact
conditions.
The user can select the averaging period (4, 8, or 16
seconds) by pressing the “Average” sof t key. When the
“Average” softkey is pressed the following softkeys will be
displayed: “Average”, “Enter” and “Return”.
The highlight area will scroll among the different averaging
periods of 4, 8, and 16 seconds every time the “Average”
softkey is pressed.
Pressing the “Enter” softkey allows the user to select the
highlighted averaging period. Pressing the “Return” softkey
will return the user to the SpO
submenu. Pressing the
2
“Return” s o ftkey again will return the user to the
physiological monitoring menu.
Displaying the Plethysmographic “Waveform”
M Series systems allow the user to display one or two
waveforms when in Monitor or Defib mode. Only one
waveform will be displayed in pace mode.
Pressing the “Wave2” softkey from the physiological
monitoring menu cycles the display from the capnogram
waveform, to the plethysmograph waveform, to no second
waveform displayed.
A second waveform can be displayed provided that the
defibrillator is not charging or an ECG analysis is not in
progress. The waveform will be temporarily removed from
the display, if currently visible, when any of the following
buttons are pressed: CHARGE, ANALYZE, ENERGY
SELECT, SYNC ON/OFF. The second waveform will be
restored to the dis play under the following conditions:
• 3 seconds after a shock is delivered
• 3 seconds after an analysis is completed, unless the
defibrillator is charging
• 4 seconds after the last ENERGY SELECT button press
• 3 seconds after Sync mode is turned off
SpO2 %
98
ECG
ECG
LEAD
PADS
SIZE
x1
H
70
“Average” Softkey
SpO2
The M Series provides three (3) different time periods over
which SpO
(default) and 16 seconds.
values are averaged: 4 seconds, 8 seconds
2
Param.
Wave 2
ID #
Alarms
12 Lead
The averaging period is rarely changed from the 8 second
default setting. For high risk patients with rapidly changing
SpO
conditions, the 4 second setting is recommended. The
2
16 second setting should only be used when the 8 second
9650-0202-01 SpO2 - 8
PULSE OXIMETRY
Alarms
Press the “Alarms” softkey to display the S et Alarm screen
and softkeys.
Press the Inc or Dec softkeys to select "ENABLE",
"DISABLE", or "AUTO" in the State field. Pressing the Next
Field softkey when either “ENABLE or “DISABLE” has been
chosen will set the selected State and move the highlight to
the next field (Low limit field).
When "AUTO" has been selected and the Next Field
softkey is pressed, the unit will set the lower and upper
limits to 95% and 105% of the patient’s currently measured
saturation percentage (maximum setting bei ng 100%) if
valid measurements are present for the vital sign. The
highlight then shifts to the next Parameter field. Refer to the
Alarms Section of the M Series Operator’s Guide for
further details.
The M Series device has three levels of alarms.
1. High Priority: If enabled, t hese alarms reflect
physiological parameters that are out of bounds. They
will cause a continuous audio tone, highlight the
alarming parameter and flash the associated alarm
bell.
2. Medium Priority: These alerts reflect equipment
related user correctable faults such as LEAD OFF and
CHECK SPO2 SENSOR. They will cause a two beep
audio tone and display a message for a timed period.
3. Low Priority: These are informa tional messages to
the user only and have the same audio indication as
the Medium priority alarms.
highlighted and the bell associated with that parameter will
flash.
Press the ALARM SUSPEND button to silence the alarm
for approximat ely 90 seconds. An “X” will be placed through
the flashing bell (
with the affected parameter have been temporarily
disabled. Pressing the ALARM SUSPEND button again
will reactivate the alarm processing.
When the alarm suspend period has timed-out and t he
alarm condition has not been corrected, the following will
occur:
• a continuous audible tone will return
• the value of the alarming parameter will continue to be
highlighted
• the bell associated with that parameter will flash.
When the alarm suspend period has timed-out and the
violation has been corrected the M Series will return to
normal operating mode.
If a second alarm occurs while the first alarm is suspended,
press the ALARM SUSPEND button to suspend the
second alarm tone. The old alarm continues a separate
time out of its suspension.
Activating / Deactivating Alarms
Pressing and holding the ALARM SUSPEND button for
approximately 3 seconds will deactivate alarm functions. All
bells will have an “X” through them (
alarms are deactivated.
to indicate that alarms associated
)
to indi cate that
)
Alarm Limits
The Low Heart Rate Alarm Limit range is 20 to 100 bpm
with a default setting of 30 bpm.
When a patient’s heart rate is being monitored using ECG,
the High Heart Rate Alarm Limit range is 60 to 280 bpm
with a default setting of 150 bpm. When the heart rate is
being monitored using pulse oximetry, however, the
maximum High Heart Rate Alarm Limit is lowered to
235 bpm automatically if it was previously set higher for
ECG monitoring. The original High Alarm Limit setting will
be restored when ECG monitoring resumes.
The Low SpO2 Alarm Limit range is 70% to 98% saturation
with a default setting of 8 5%. The High SpO2 Alarm Limit
range is 72% to 100% saturation with a default setting of
100%. (See the M Series Configuration Guide for
information on setting alarm limit defaults).
Suspending Alarms
When a high priority alarm occurs, a continuous audible
tone will sound, the value of the alarming parameter will be
9650-0202-01 SpO2 - 9
If all alarms are deactivated and the ALARM SUSPEND
button is briefly pressed, all of the enabled alarm functions
will be activated. (Refer to SET ALARMS Section of the
M Series Operator’s Guide).
Automated External Defibrillator (AED)
Operation
M-Series AED’s equipped with Pulse Oximetry operate in a
slightly different way than Manual and Advisory models
equipped with SpO
below.
Semi-Automatic Operation
The plethysmographic waveform cannot be displayed in
Semi-Automatic mode.
Although SpO2 alarm functions are operational in semiautomatic mode, Heart Rate alar m func tions are disabled.
Background ECG analysis functions, however, continue to
operate as described in the AED section of the M Series
Operator’s Guide.
. These differences are explained
2
OPTION INSER T
The ALARM SUSPEND button can be used to activate,
deactivate, or suspend the SpO
alarms as described
2
previously. The alarm limit settings cannot, however, be
changed in semi-automatic mode; only the default alarm
limits are available. See the M Series Configuration Guide
for information on setting alarm l imit defaults.
The SpO
monitoring parameters can be changed by
2
pressing the “Param” softkey.
Manual Mode Operati on
The plethysmographic waveform can be displayed by
pressing the “Wave2” softkey provided that the defibrillator
is not charging or an ECG analysis is not in progress. The
waveform will be temporarily removed from the display, if
currently visible, when any of the following buttons are
pressed: CHARGE, ANALYZE, ENERGY SELECT,
SYNC ON/OFF. The second waveform will be restored to
the display under the following conditions:
• 3 seconds after a shock is delivered
• 3 seconds after an analysis is completed, unless the
defibrillator is charging
• 4 seconds after the last ENERGY SELECT button
press
• 3 seconds after Sync mode is turned off
The waveform cannot be displayed in pace mode.
Both Heart Rate and SpO
alarms are operational. The
2
alarm limits can be changed by pressing the “Alarms”
softkey. The SpO
by pressing the “Param” softkey.
monitoring parameters can be changed
2
Using SpO2
• Inspect t he M Series case and cables for damage.
• Check that the sensor is a compatible model before
connecting it to the M Series Pulse Oximeter. (See
Accessories Section).
• If using a reusable sensor, make sure it opens and
closes smoothly and check for foreign material such
as tape or cotton on the emitter and detector windows.
Remove any substances that may interfere with the
transmission of light between the sensor's light source
and detector.
• Attach the sensor to the patient (see Attaching
Sensors to Patient Sections of this manual).
• Attach sensor to the patient cable; make sure it is a
firm connection.
• If a “SpO2 FAULT XX” message is displayed shortly
after powering the M Series on, the SpO
monitoring
2
subsystem of the unit has failed. Cont act ZO LL
Technical Service Department.
• Ensure that appropriate numeric oxygen saturation
values are being displayed.
• Ensure that the signal strength bar indicates the
presence of a strong signal associated with each
heartbeat.
• Adjust the alarm limits and enable SpO
alarms if
2
desired.
• The SpO
numeric will display dashes (-----) whenever
2
pulse oximetry values are likely to be contaminated
due to the presence of excessive ambient light,
inadequate perfusion, high signal artifact, a defective
or disconnected sensor, etc.
Checkout Procedure
1. With alarms enabled, verify that the patient alarms are
functional by placing the sensor on your finger and
adjusting the high and low limits until:
• a continuous audio tone sounds.
• the alarming parameter’s value is highlighted and
the alarm bell flashes on the display.
2. Disconnect the ECG cable and verify that your pulse
rate is equal to the rate that appears on the M Series
heart rate display.
3. Verify the sensor alarms are functional by
removing the sensor from the sensor site.
• “CHECK SpO2 SENSOR” appears in the me s sage
area of the graphic display.
• A two beep audio tone sounds.
4. Unplug the sensor from the oximeter. Make sure
• “CHECK SpO2 SENSOR” message appears.
• A two beep audio tone sounds.
5. Verify second waveform display:
• Plug the sensor into the oximeter.
• Attach the sensor to test subject (yourself).
• Press the “Wave2” softkey.
• Verify that the plethysmographic waveform
appears and repeats at test subject’s (your own)
pulse rate or di sappears if originally present.
• Connect the patient cable to the SpO
connector
2
located on the rear of the M Series product.
• Turn the unit to Monitor mode. Check that the
sensor's red LED is on. The oximeter is now fully
operational.
9650-0202-01 SpO2 - 10
PULSE OXIMETRY
DEFAULT SETTINGS
When the pulse oximeter is turned on, the following default settings are automatically selected and remain in operation until
changed.
Parameter Default Setting Range
High SpO2 Alarm Limit OFF (appears as: ---) 50% to 100% or OFF
Low SpO2 Alarm Limit 85% 50% to 100% or OFF
High Heart Rate Alarm Limit 150 bpm (beats/min)
Low Heart Rate Alarm Limit 30 bpm
60 to 280 bpm (monitoring via ECG)
60 to 235 bpm (monitoring via Pulse Oximetry)
20 to 100 bpm
Averaging Mode 8 seconds (medium) 4 seconds (short);
8 seconds (medium);
16 seconds (long).
Sensitivity Normal Normal or High
NOTE:
in System Configuration mode. See the M Series Configuration Guide for more information.
Only the default settings are available in AED Semi-Automatic operation. Default alarm limit setting may be adjusted
MESSAGES AND TROUBLESHOOTING
The following chart lists the messages that may appear on the M Series unit relating to SpO2, why the message appeared,
and the action(s) to take if the message indicates a problem.
The operator should become thoroughly familiar with this information before using the oximeter for patient monitoring.
Message Possible Cause(s) Recommended Action(s)
SpO2 AMBIENT LIGHT/
CHECK SpO2 SENSOR
Excessive ambient light. Relocate the sensor to a site more
shielded from light or reduce the
amount of light shining on the sensor.
SpO2 PULSE SEARCH Appears when the oximeter cannot detect a
patient’s pulse.
Reposition or relocate the sensor,
and/or increase perfusion.
CHECK SpO2 SITE Insufficient perfusion at sensor site. Reposition or relocate the sensor,
and/or increase perfusion.
CHECK SpO2 SENSOR Appears when SpO
invalid due to motion, to an unacceptable
readings may be
2
For all causes, reposition or relocate
the sensor, and/or increase perfusion.
sensor site, to poor placement, low
perfusion, or sensor is OFF.
SpO2 FAULT XX Appears when SpO
subsystem of the unit
2
has failed.
Dashes (-----) appear in place of
numeric and do not change
SpO
2
to a real number.
Excessive ambient light, inadequate
perfusion, high signal artifact, a defective or
disconnected sensor, etc.
9650-0202-01 SpO2 - 11
Call ZOLL Technical Service
Department.
Reposition or relocate the sensor,
and/or increase perfusion.
OPTION INSER T
SPECIFICATIONS
General
Saturation (% SpO2) Range 1% - 100%
Pulse Rate (bpm) Range 25 - 240
Saturation (% SpO
) Accuracy
2
During No Motion Conditions Adults 70%-100% ± 2 digits
0%-69% unspecified
Neonates 70%-100% ± 2 digits
0%-69% unspecified
Saturation (% SpO
) Accuracy Adults 70%-100% ± 3 digits
2
During Motion Conditions 0%-69% unspecified
Pulse (bpm) Accuracy
During No Motion Conditions 25 to 240 ± 3 digits
Pulse (bpm) Accuracy
During Motion Conditions 25 to 240 ± 5 digits
Alarm Limits On/Off displayed on monitor. User selectable, High 72-100 %
SpO
2
saturation, Low 70-98 % saturation.
Pulse Rate Alarm Limits On/Off displayed on monitor. User selectable, High 60-235 bpm,
Low 20-100 bpm
Saturation (% SpO
) Resolution 1%
2
Pulse Rate Resolution 1 bpm
Text Display Update Rate 100 milliseconds
Trace Update Rate 52 milliseconds
Bio - Compatibility Patient contacting material meets requirement s of I SO 10993-1,
Biological Evaluation of Medical Device - Part I, for external
devices, intact surfaces and short-term exposure.
Environmental
Operating Temperature: 0° to 40°C
Storage and Shipping Temperature: -20° to 60° C
NOTE:
The M Series device may not perform to specifications when
stored at the upper or lower extreme limits of storage
temperature and immediately put into use.
Electromagnetic Immunity
AAMI DF-2: IEC 1000-4-3 to 18 v/m.
(SpO2 Option Only)
Operating Time For a new, fully charged battery pack at 20°C: 35 defibrillator
discharges at maximum energy (360J), or 2.0 hours minimum of
continuous ECG monitoring, or 1.75 hours of continuous ECG
monitoring/pacing at 60 mA, 70 beats/min.
Note: The M Series Pulse Oximetry Option is calibrated for Functional saturation.
9650-0202-01 SpO2 - 12
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