Caution: Federal law (USA) restricts this device to sale by or on
the order of a physician.
Caution: Read this manual carefully before using the Model 9843.
The information in this manual has been carefully checked and is believed
to be accurate. In the interest of continued product development,
NONIN reserves the right to make changes and improvements to this
manual and the products it describes at any time, without notice or
obligation.
Nonin Medical, Inc.
13700 1st Avenue North
Plymouth, MN 55441-5443
USA
(763) 553-9968
(800) 356-8874 (USA and Canada)
Fax (763)
553-7807
mail@nonin.com
www.nonin.com
0123
References to “NONIN” in this manual shall imply Nonin Medical, Inc.
Nonin is a registered trademarks of Nonin Medical, Inc.
CE Marking indicating conformance to EC
directive No. 93/42/EEC concerning medical
devices.
Indicates separate collection for electrical and
electronic equipment (WEEE).
I
S
F
I
E
A
L
C
U
C
L
IPX1
IPX4
Do Not Reuse
UL Mark for Canada and the United States
D
U
with respect to electric shock, fire, and
mechanical hazards only in accordance with UL
60601-1 30EM and CAN/CSA C22.2 No. 601.1.
Protected Against Vertically Falling Water
Drops per IEC 60529.
Protected Against Splashing Water per IEC
60529.
1
Guide to Symbols1
Page 4
Introduction
Indications for Use
The NONIN Model 9843 Pulse Oximeter and Carbon Dioxide Detector is
indicated for use in measuring and displaying functional oxygen saturation
of arterial hemoglobin (SpO
(CO
) changes in the airway of intubated patients. These functions may be
2
used separately or simultaneously.
), pulse rate, and approximate carbon dioxide
2
Figure 1. The Model 9843 Pulse Oximeter and Carbon Dioxide Detector
Pulse Oximeter Intended Use
The pulse oximeter is intended to be used for noninvasively monitoring
oxygen saturation and pulse rate for adult, pediatric, and neonatal patients in
hospital, ambulatory, and Emergency Medical Services (EMS)
environments. The pulse oximeter may be used for spot checking and/or
continuous monitoring when attended by a healthcare professional.
Carbon Dioxide Detector Intended Use
The CO2 detector is a mainstream device intended to be used for
semi-quantitative detection of CO
patient transport, and for short-term hospital use (e.g., emergency rooms or
crash carts), and where gaseous anesthetic is not present. The CO
may be used to initially confirm proper placement of the endotracheal tube
and to provide continued confirmation of correct endotracheal tube
placement and patient respiration status. The CO
for prolonged CO
term monitoring of end-tidal CO
in patients younger than 3 years old and weighing less than 10 kg.
monitoring. The CO2 detector is not intended for long-
2
levels in intubated patients during
2
detector
2
detector is not intended
2
. The CO2 detector is not intended for use
2
2Introduction
1
Page 5
Precautions for Use
Contraindications
•Do not operate the Model 9843 in an MRI environment.
•Do not use the Model 9843 in a situation where alarms are required.
The Model
9843 has no audible alarms.
•Do not use the Model 9843 CO
years old and under 10 kg due to the dead space introduced by the
airway adapter tube.
•Do not use the Model 9843 CO
ventilation. The presence of CO
person performing resuscitation will cause inaccurate readings.
•The Model 9843 CO
oropharyngeal tube placement and endotracheal tube placement if
the airway is patent. Standard clinical assessment must be used.
detector cannot distinguish between
2
detector for patients less than 3
2
detector during mouth-to-tube
2
in the exhaled breath from the
2
Warnings
•Explosion hazard. Do not use the Model 9843 in the presence of
flammable anesthetics.
•The Model 9843 is intended only as an adjunct in patient assessment.
It must be used in conjunction with other methods of assessing
clinical signs and symptoms.
•As with all medical equipment, carefully route patient cabling to
reduce the possibility of patient entanglement or strangulation.
•General operation of the Model 9843 may be affected by the use of
an electrosurgical unit (ESU).
•Do not use a damaged sensor.
•This device should not be used adjacent to or stacked with other
equipment. If adjacent or stacked use is necessary, the device should
be observed carefully to verify normal operation.
•The use of accessories, sensors, and cables other than those specified
in this manual may result in increased emission and/or decreased
immunity of this device.
•Use only NONIN manufactured pulse oximeter sensors. These
sensors are manufactured to meet the accuracy specifications for
NONIN Pulse Oximeters. Using other manufacturer's sensors may
cause improper pulse oximeter performance.
Precautions for Use3
1
Page 6
•Check the pulse oximeter sensor application site frequently to
determine the circulation, positioning, and skin sensitivity of the
patient. Each patient's sensitivity to NONIN sensors may vary
depending on their medical status or the condition of their skin.
•Discontinue use of the NONIN double-backed adhesive tape strips or
the Hydrogel tape strips if the patient exhibits allergic reactions to the
adhesive material.
•Do not stretch the adhesive tape while applying the pulse oximeter
sensor. This may cause inaccurate readings or skin blisters.
•Do not reuse the Model 9840AAT Airway Adapter Tube.
•If the airway adapter tube becomes contaminated or damaged, discard
it and replace it with a new one. Cleaning the interior will damage the
anti-fog coating and cause inaccurate readings.
•The Model 9840AAT Airway Adapter Tube will increase dead space by
approximately 6 cubic centimeters; this may adversely affect ventilation
for patients with small tidal volumes.
•Do not use the airway adapter tube if the airway adapter tube is below
5 °C. An airway adapter tube that is below 5 °C may frost, causing a false
reading. Warm the airway adapter tube to above 5 °C by putting it in a
warm place (for example in your hands or in a vehicle) before use.
•If the Model 9843 CO
anatomic location of the endotracheal tube must be confirmed by other
methods.
•Do not use the Model 9843 CO
in the breathing circuit, as the fine mist may cause erroneous readings.
detector results are inconclusive, the correct
2
detector with a humidifier or nebulizer
2
Cautions
•Federal law (USA) restricts this device to sale by or on the order of a
physician.
•Read this manual carefully before using the Model 9843.
•Before use, carefully read the package insert provided with the sensors.
•Model 9843 Pulse Oximeter and Carbon Dioxide Detectors are
sensitive electronic instruments and must be repaired by knowledgeable
and specially trained personnel only.
•Ensure that the Model 9843, the airway adapter tube, and the sensors
have stabilized at the specified environmental operating conditions
before use.
•Verify that all audible and visible indications are operating properly
during the power on self-test. If any self-test event does not occur or
functions incorrectly, do not use the Model
troubleshooting guide or contact NONIN Customer Support.
9843. Consult the
4Precautions for Use
1
Page 7
•Do not immerse the Model 9843 or NONIN sensors in liquid.
•Do not use caustic or abrasive cleaning agents on the Model 9843 or
the sensors.
•Do not use different types of batteries at the same time. Do not mix
fully charged and partially charged batteries at the same time. These
actions may cause the batteries to leak.
•Do not remove any covers other than the battery cover when
replacing batteries. There are no user serviceable parts inside other
than the replaceable batteries.
•Follow local governing ordinances and recycling instructions
regarding disposal or recycling of device components, including
batteries.
•Alkaline batteries may leak or explode if used or disposed of
improperly.
•Do not block the audible indicator speaker holes. Blocking the
speakers will significantly reduce the sound volume.
•This equipment complies with International Standard EN 60601-1-
2:2001 for electromagnetic compatibility for medical electrical
equipment and/or systems. This standard is designed to provide
reasonable protection against harmful interference in a typical
medical installation. However, because of the proliferation of radiofrequency transmitting equipment and other sources of electrical
noise in healthcare and other environments, it is possible that high
levels of such interference due to close proximity or strength of a
source might disrupt the performance of this device. Medical
electrical equipment needs special precautions regarding EMC, and
all equipment must be installed and put into service according to the
EMC information specified in this manual.
•Portable and mobile RF communications equipment can affect
medical electrical equipment.
•The Model 9843 pulse oximeter is intended for spot checking or
monitoring by an attending healthcare professional. Because the
Model
requirements (EN 865) dictate it be labeled “Not for Continuous
Monitoring.”
9843 has no audible alarms, international labeling
•The Model 9843 pulse oximeter must be able to measure the pulse
properly to obtain an accurate SpO
nothing is hindering the pulse measurement before relying on the
SpO
measurement.
2
•The Model 9843 pulse oximeter may not work on all patients. If you
are unable to achieve stable readings, discontinue use.
Precautions for Use5
1
measurement. Verify that
2
Page 8
•The Model 9843 pulse oximeter may interpret motion artifact as good
pulse quality.
•The Model 9843 pulse oximeter is designed to determine the
percentage of arterial oxygen saturation of functional hemoglobin.
Significant levels of dysfunctional hemoglobin such as
carboxyhemoglobin or methemoglobin may affect the accuracy of the
measurement.
•Cardiogreen and other intravascular dyes, depending on the
concentration, may affect the accuracy of the SpO
measurement.
2
•Some fingernail polish colors (particularly blues and blacks) may reduce
light transmission and thereby affect SpO
accuracy.
2
•Ear Clip and Reflectance pulse oximeter sensors are not recommended
for pediatric or neonatal use. The accuracy of these sensors has not
been established for pediatric or neonatal use.
•Remove earrings from the patient’s ear before applying the Ear Clip
Sensor.
•Water or other liquid between the airway adapter tube and the CO
2
sensor may cause erroneous readings.
•Ensure that all connections to the airway adapter tube are tight and
leak-free, and that the airway adapter tube is properly attached to the
CO
sensor.
2
•An airway adapter tube that is between 5 °C and 10 °C may cause
inaccurate readings due to fogging of optical surfaces. It is
recommended that the airway adapter tube be warmed to above 10°C
before use.
•Gastric distention with air prior to intubation may introduce CO
into
2
the stomach and esophagus and yield false results. Observe six breaths
before interpreting results.
•This device has not been tested for immunity to electromagnetic
disturbances.
•The Model 9843 CO
detector should not be used with gaseous
2
anesthetics.
•In compliance with the European Directive on Waste Electrical and
Electronic Equipment (WEEE) 2002/96/EC, do not dispose of this
product as unsorted municipal waste. This device contains WEEE
materials; please contact your distributor regarding take-back or
recycling of the device. If you are unsure how to reach your distributor,
please call Nonin for your distributor’s contact information.
6Precautions for Use
1
Page 9
Manufacturer’s Declaration
Refer to the following tables for specific information regarding this
device’s compliance to IEC Standard 60601-1-2.
This device is intended for use in the electromagnetic environment specified below.
The customer and/or user of this device should ensure
that it is used in such an environment.
RF Emissions
CISPR 11
RF Emissions
CISPR 11
Harmonic Emissions
IEC 61000-3-2
Voltage Fluctuations/
Flicker Emissions
IEC 61000-3-3
Group 1This device uses RF energy only for its
internal function. Therefore, its RF emissions are very low and are not likely to cause
any interference in nearby electronic equipment.
Class BThis device is suitable for use in all estab-
lishments, including domestic and those
N/A
N/A
directly connected to the public low-voltage
power supply network that supplies buildings used for domestic purposes.
Precautions for Use7
1
Page 10
General Description
The Model 9843 Pulse Oximeter and Carbon Dioxide Detector is a handheld, battery-operated, noninvasive monitoring device that has visible and
audible indicators for tracking patient status. The Model
operate for 90 hours continuously between battery replacements when used
for pulse oximetry alone, or for 20 hours continuously when used for both
CO
detection and pulse oximetry. The Model 9843 requires no routine
2
calibration or maintenance.
9843 typically will
Serial
Data
Infrared
Link
SpO2 Display
(Percent
Oxygen
Saturation)
Pulse Rate
Display
On / Off
Switch
Pulse Oximeter
Sensor Connector
%SpO
Tri-Color Pulse
Quality Indicator
CO
Display
CO
2
Low Battery
Indicator
CO
Sensor
2
Connector
Advance
Switch
Setup /
Touch Print
Switch
Figure 2. Model 9843 Controls and Indicators
8General Description
1
Audible
Indicators
(Speakers)
Page 11
Pulse Oximeter
The Model 9843 determines functional oxygen saturation of arterial
hemoglobin (SpO
passed through perfused tissue. Changes in absorption caused by
pulsation of blood in the vascular bed are used to determine arterial
saturation and pulse rate.
Oxygen saturation and pulse rate values are indicated on light-emitting
diode (LED) digital displays. On each detected pulse, the pulse quality
indicator flashes. Patient pulse quality signals are graded as good,
marginal, or inadequate and are indicated as such by the pulse quality
indicator flashing green, yellow, or red respectively. This simple method
gives the user a pulse-by-pulse visual indication of waveform signal
quality without requiring the user to perform complex waveform analysis
during critical patient care situations.
If the pulse oximeter sensor is disconnected or malfunctions, or an
adequate pulse oximeter sensor signal is not detected, then a dash will
appear to the left of the SpO
values will freeze for 10 seconds.
) by measuring the absorption of red and infrared light
2
value on the SpO2 display and the displayed
2
If, 10 seconds after the first dash appeared, adequate pulse signals still are
not detected, the SpO
and pulse rate numerical values will be replaced
2
by dashes in the middle digit of each display.
Carbon Dioxide Detector
The Model 9843 determines approximate CO2 changes in the airway of
intubated patients by measuring the absorption of mid-infrared light
passed through the airway adapter tube. The approximate CO
concentration change is indicated by an 8-segment LED bar graph
display (the CO
the inhaled air contains negligible amounts of CO
display). The CO2 detector relies on the assumption that
2
.
2
Breaths are indicated when the CO2 level increases by approximately
5
mmHg during exhalation. A detected breath is indicated on the CO2
display and by an audible breath beep.
2
General Description9
1
Page 12
If the CO2 sensor is initially connected and operating and then:
•the CO
•the airway adapter tube is removed from the CO
sensor is unplugged, or
2
sensor, or
2
•the light path is blocked, or
•a CO
then the third and sixth bars on the CO2 display will be steadily illuminated.
This visible indication is defined as a CO
sensor failure occurs,
2
sensor fault.
2
Unpacking Your Model 9843
Contact the carrier immediately if the shipping carton for the Model 9843 is
damaged. Carefully unpack the instrument and its accessories. Confirm that
the items listed below are packed with the Model
Carbon Dioxide Detector.
9843 Pulse Oximeter and
The Model 9843 complete system includes:
n
1 Model 9843 Pulse Oximeter and Carbon Dioxide Detector
n
1 Operator’s Manual for the Model 9843
n
1 Model 8000AA-1 Adult Articulated Finger Clip Sensor
n
1 Model 9840SA Carbon Dioxide Sensor
n
3 Model 9840AAT Airway Adapter Tubes
n
6 AA Size Alkaline Batteries
If any item on this list is missing or damaged, contact your local distributor.
10General Description
1
Page 13
Basic Operation
Batteries
The Model 9843 Pulse Oximeter and Carbon Dioxide Detector is
powered by six AA size alkaline batteries that will typically provide 20 to
90 hours of continuous operation, depending on how the 9843 is used.
The 9843 will typically operate for 90 hours continuously between
alkaline battery replacements for pulse oximetry alone, or 20 hours
continuously with both CO
concurrently.
The low battery indicator steadily illuminates when
the battery power is marginal. The batteries should
then be replaced as soon as possible.
batteries reach a critically low level the low battery indicator flashes, and
no patient data is displayed. The batteries must be replaced before using
the 9843.
In order to conserve battery life, the 9843 will automatically power off
after 10 minutes of both no SpO
detection and pulse oximetry operating
2
When the
readings and no breath detection.
2
If the batteries are critically low at power on, setup mode will be disabled
and the displays will be blank. If the battery level then returns to a
marginal level (after removing a sensor or after the power on self-test, for
example), the Model
9843 will be functional but setup mode will remain
disabled.
Notes:
n
To conserve battery life, NONIN recommends disconnecting
the CO
use. The flashing lamp in the CO
sensor from the 9843 when CO2 detection is not in
2
sensor consumes a
2
significant amount of energy.
n
Setting the month to “00” disables the clock function and helps
conserve battery life. Refer to
“Calendar Settings” on page 19
for more information.
n
The memory of the 9843 may be erased when the batteries are
removed.
n
Replacing batteries may erase the clock settings of the 9843.
Refer to
“Clock Settings” on page 20 for more information.
Basic Operation11
1
Page 14
Replacing Batteries in the Model 9843:
1.Remove the battery door on the bottom of the 9843.
2.Remove all six used batteries. If necessary, gently tap the device
against the palm of your hand to dislodge all of the batteries.
3.Replace all six used batteries with fresh AA size batteries. Be sure to
use the correct battery orientation when installing the new batteries.
IMPORTANT:
Insert these two
batteries first.
Battery
Door
Figure 3. Replacing Batteries in the Model 9843
Battery
Door
IPX1
SN
NONIN MEDICAL, INC.
PLYMOUTH, MN USA
MADE IN U.S.A.
MODEL 9843
PULSE OXIMETER/CO2 DETECTOR
6x1.5V AA IEC LR6
US PATENT # Re. 33,643
2577-001 06
UL2601-1
30EM
0123
Battery
Orientation
Serial
Number
Battery
Orientation
Figure 4. Rear View of the Model 9843
12Basic Operation
1
Page 15
Connecting the Sensors
Pulse Oximeter Sensor
Connect the pulse oximeter sensor (with the NONIN logo facing up) to
the top of the 9843 as shown in
sensor is firmly plugged in, and position the sensor on the patient.
Figure 5. Connecting Sensors to the Model 9843
Figure 5. Ensure that an appropriate
Pulse Oximeter
Sensor
Sensor and
CO
2
Airway Adapter Tube
Carbon Dioxide Sensor and Airway Adapter Tube
Connect the CO2 sensor (with the NONIN logo facing up) to the side of
the 9843 as shown in
Figure 5. Ensure that the sensor is firmly plugged
in. Refer to “Carbon Dioxide Sensor” on page 29 for more information.
Turning On the Model 9843
Turn on the Model 9843 by pressing the on/off switch on the front of
the unit. Refer to
information about entering setup mode and general operation of the
9843.
“Detailed Operation” on page 17 for detailed
Basic Operation13
1
Page 16
Power On Self-Test
When the 9843 is turned on for normal operation, it cycles through a
self-test before displaying valid data. When entering setup mode at power
on, the 9843 cycles through the same self-test routine.
Verify that all audible and visible indications are operating properly during
the power on self-test. If any self-test event does not occur or functions
incorrectly, do not use the 9843. Consult the troubleshooting guide or
contact NONIN Customer Support.
•The audible breath beep will sound three times.
•The low battery indicator will display for
approximately 2
the batteries are low.
•The pulse quality indicator will first flash red, then
green, then will either continue to flash if a pulse
oximeter sensor is connected to the unit, or will
turn off if no pulse oximeter sensor is connected.
seconds, then will remain off unless
•The SpO
and pulse rate ♥ displays will cycle
2
through the following sequence:
–“888 888”;
–the current time (if set) or “0000” if the time
is not set;
–the software revision number;
–a single dash (-) in the middle digit of both displays if no pulse
oximeter sensor is connected to the 9843,
or
–a single dash (-) in the middle digit of both displays if a pulse
oximeter sensor is connected to the 9843 but is not detecting an
adequate signal. (The 9843 will then begin to display values when
the pulse oximeter detects an adequate signal.)
or
–“Prn” and the current printer mode if entering setup
mode.
•The CO
sequence: ramp up and then down; turn all bars off;
and finally either remain blank (until a CO
connected to the unit, and after exiting the setup
display will cycle through the following
2
sensor is
2
75
m
50
m
H
30
g
20
10
mode, if applicable) or illuminate the bottom bar
when ready for use.
10
k
7
P
a
4
2.6
1.3
0.8
6
0.3
2
14Basic Operation
1
Page 17
Overview of Monitoring
Pulse Oximeter
Verify that the sensor is properly positioned, and ensure that the pulse
oximeter is sensing adequate pulse quality by:
•verifying that the pulse quality indicator ( ) is flashing green and
•verifying that the pulse rate (♥) and SpO
(%SpO2) displays are
2
showing readings and
•verifying that the pulse quality indicator flashing is correlated to the
pulse rate for at least 10
If the pulse quality indicator light is flashing red or yellow or is flashing
erratically, reposition the pulse oximeter sensor or try a different sensor.
If no pulse oximeter sensor is attached to the pulse oximeter after system
initialization (a few seconds after powering on), only a dash (
displayed in the middle segment of both the SpO
displays.
seconds
- ) will be
and pulse rate ♥
2
Carbon Dioxide Detector
Verify that the airway adapter tube is properly attached to the CO2 sensor
and that the CO
that the lower bar of the CO
the CO
sensor is flashing on and off. (When CO2 is detected, the
2
illuminated bars on the CO
in CO
level.)
2
sensor is properly connected to the 9843. Next, verify
2
display is illuminated and the lamp inside
2
display will indicate the approximate change
2
Attach the CO2 sensor/airway adapter tube assembly to the patient’s
endotracheal tube. The CO
breath beeps for each breath (if the breath beep sound volume is not set
to “off ”).
If the CO2 sensor is initially connected and operating and then the CO
sensor is unplugged, the airway adapter tube is removed from the CO
sensor, the light path is blocked, or a CO2 sensor failure occurs, then the
third and sixth bars of the CO
CO
sensor fault.
2
Basic Operation15
1
detector will reflect appropriate values and
2
display will be illuminated indicating a
2
2
2
Page 18
Cleaning the Model 9843
CAUTION!Do not immerse the 9843 or sensors in liquid.
CAUTION!Do not use caustic or abrasive cleaning agents.
Clean the 9843 unit separately from the sensors. Refer to the appropriate
cleaning instructions for each sensor type.
Notes:
•For instructions on cleaning pulse oximeter sensors, refer to the
respective pulse oximeter sensor instruction inserts.
•For instructions on cleaning the CO2 sensor refer to “Cleaning the
Carbon Dioxide Sensor” on page 30.
Cleaning the 9843
äClean the 9843 (device only) with a soft cloth dampened with
isopropyl alcohol. Do not pour or spray any liquids onto the 9843, and
do not allow any liquid to enter any openings in the device. Allow the
9843 to dry thoroughly before reusing.
16Basic Operation
1
Page 19
Detailed Operation
Controls
All functions of the 9843 are controlled by switches found on the front
of the unit.
Powering the 9843
1.With the unit off, press the on/off
switch one time to power the unit.
2.Press the on/off switch again to turn
off the displays and put the circuitry
into a low power standby mode.
NOTE: In order to conserve battery
life, the 9843 will automatically
power off after 10 minutes of
both
no SpO2 readings and no
breath
detection. Each time an SpO
2
value is displayed or a breath is detected, the 10-minute
timer is restarted.
On / Off
Switch
Advance
Switch
Setup /
Touch
Print
Switch
Setup Mode
Setup mode is used to control the internal time-of-day clock. In setup
mode, the advance switch
used to make the menu selections.
NOTE: Setting the month to “00” disables the calendar and clock
functions and helps conserve battery life. Setup mode will
be disabled if the batteries are critically low at power on.
Detailed Operation17
and the setup/touch print switch are
1
Page 20
Entering Setup Mode
1.With the unit off, press and hold the setup/touch print switch while
pressing and then releasing the on/off switch.
2.Release the setup/touch print switch when “888 888” is displayed
on the SpO
and “
Prn” will appear in the SpO
and pulse rate ♥ displays. Three brief beeps will sound,
2
display.
2
Making Selections in Setup Mode
1.Upon entering setup mode, “Prn” (the first
parameter, see
Table 1 on page 18) will appear in
the SpO2 display. Press the advance switch (or
press and hold to quickly scroll) to increment the
number on the pulse rate display. The menu starts
at the current value stored in memory for the
parameter designated in the SpO
cycle through the range of values listed in
2.When the desired value appears in the pulse rate display, press the
setup/touch print switch to store the value and advance the SpO
display and will
2
Table 1.
2
display to the next parameter (year, month, etc.), as listed in Table 1.
3.Continue this process until all parameters are set. When the setting
sequence has been completed, the 9843 exits the setup mode and
begins normal operation.
The settings can be easily checked, since the first value displayed for each
parameter represents the current setting.
Table 1. Printer, Calendar, and Clock Mode Parameters
ParameterAppears in
SpO
Display:
2
PrinterPrn00 - 1500
Yeary
Month
Dayd01 - 3100
Hoursh00 - 2300
Minutesnn00 - 5900
a
Note: If the calendar is set properly, on 1 January 2000 the year
will be displayed as “00”.
nn
Pulse Rate ♥ Display
Range of Values
00 - 99
00 - 1200
a
Default
Value
98
18Detailed Operation
1
Page 21
Calendar Settings
NOTE:Setting the month to “00” disables the calendar and
clock functions and helps conserve battery life. The
calendar and clock functions are used to time stamp
real-time data for printing or memory. Unless you
intend to use real-time data output or memory
playback options, skip this section.
To Choose Calendar Settings:
1.After the printer setting has been selected in the setup mode, “y”
will appear in the SpO
display indicating the calendar setup mode
2
for the year. The year may be set to “00” through “99”. Make the
year selection. Refer to
Figure 6 for a flowchart for setting the
calendar.
2.After selecting the year, the display will show “nn” indicating the
setup mode for the month. The month may be set to “00” through
“12”. Make the month selection.
3.After selecting the month, the display will show “d” indicating the
setup mode for the day of the month. The day may be set to “01”
through “31”. Make the day selection.
4.After selecting the day, the setup mode continues to the clock
settings. (Refer to
(year)
(month)
(day)
(hour)
“Clock Settings” on page 20.)
SpO
Display
Setup
Mode
y
nn
d
h
2
Press
Press
Press
Pulse Rate
Display
Default
Setting
Press
98
Press
PressPress
00
Press
Press
00
Proceed to
clock setup
Increment
year
Increment
month
Increment
day
Press
Press
Press
Detailed Operation19
1
Figure 6. Flowchart for Setting the Calendar
Page 22
Clock Settings
y
NOTE:Setting the month to “00” disables the calendar and
clock functions and helps conserve battery life. The
calendar and clock functions are used to time stamp
real-time data for printing or memory. Unless you
intend to use real-time data output or memory
playback options, skip this section.
To Choose Clock Settings:
1.After the calendar settings have been selected in the setup mode, “h”
will appear in the SpO
display indicating clock setup mode for the
2
hour. The hour may be set to “00” through “23”. Make the hour
selection. Refer to
Figure 7 for a flowchart for setting the clock.
2.After selecting the hour, the SpO
display will show “nn” indicating
2
the setup mode for the minutes. The minutes may be set to “00”
through “59”. Make the minutes selection.
3.After selecting the minutes, the Model 9843 will exit setup mode and
the SpO
and pulse rate ♥ displays will return to normal operation.
2
Pulse Rate
Display
Press
Increment
Press
Press
Increment
Press
hour
Press
minute
(hours)
(minutes)
SpO
Displa
Setup
Mode
h
nn
2
Default
Setting
00
Press
00
(returns to
normal
display)
-
Figure 7. Flowchart for Setting the Clock
20Detailed Operation
1
Press
Press
Continue with
normal operation
Page 23
Indicators
Refer to Figure 2 on page 8 for a detailed illustration of the Model 9843
controls and indicators.
Visible Indicators
SpO2 Display ( %SpO2 )
The SpO2 display is the upper numeric display. This
3-digit light-emitting diode (LED) display shows the
current oxygen saturation percentage.
Pulse Rate Display ( ♥ )
The pulse rate display is the lower numeric display. This
3-digit LED display shows pulse rate in pulses per minute.
Dashes in the SpO2 and Pulse Rate Displays ( - )
A pulse oximeter sensor fault will occur if the Model 9843 pulse oximeter
detects:
•a pulse oximeter sensor disconnect, or
•a pulse oximeter sensor dislodgment, or
•a pulse oximeter sensor failure.
If a pulse oximeter sensor fault occurs or a pulse oximeter
sensor signal is no longer detected, a dash (
left digit of the SpO
display. The readings that are displayed
2
will freeze for 10 seconds if the pulse oximeter sensor fault
or the inadequate signal continues.
If the pulse oximeter sensor fault or the inadequate signal is
not corrected, dashes will be displayed in the middle digit of
both the SpO2 and the pulse rate displays 10 seconds after
the first dash appeared. When the pulse oximeter sensor fault
or the inadequate signal is corrected, the SpO
displays will return to normal operation.
- ) appears in the
and pulse rate
2
Detailed Operation21
1
Page 24
Pulse Quality Indicator ( )
CAUTION! The 9843 may interpret motion artifact as good
pulse quality.
The pulse quality indicator (identified by the waveform
symbol
) flashes once for each pulse while measuring
oxygen saturation. The pulse quality indicator changes
color to indicate changes in the pulse waveform signal that
may affect the SpO
data.
2
The pulse quality indicator may flash one of three colors:
n
Red indicates that the pulse waveform amplitude is inadequate.
During red pulse quality, SpO
updated. After approximately 20
with dashes indicating that SpO
and pulse rate values are not
2
seconds, the values are replaced
and pulse rate measurements are
2
not possible.
n
Yellow indicates that the pulse waveform amplitude is marginal or
that the pulse oximeter has detected artifact. Although the SpO
and pulse rate data may be acceptable, corrective measures should
be considered if the indicator continues to flash yellow frequently.
To improve the signal quality, try repositioning the sensor, try a
different sensor type, eliminate patient movement, or improve
circulation at the site by massaging the area.
2
n
Green indicates that the pulse waveform signal is of good quality
andthe SpO
and pulse rate data are accurate.
2
Low Battery Indicator ( )
The low battery indicator steadily illuminates when the
battery power is marginal. The batteries should then be
replaced as soon as possible.
When the batteries reach a critically low level, the low battery indicator
flashes and no patient data is displayed. The batteries must be replaced
before using the 9843. If the batteries are critically low at power on, setup
mode will be disabled and the displays will be blank.
22Detailed Operation
1
Page 25
CO2 Display ( Δ CO2 )
The CO2 display will remain blank until the
CO
sensor is plugged in. When an airway
2
adapter tube is connected to the CO
sensor
2
and an adequate signal is detected, the bottom
bar is initially illuminated. Additional bars will
be illuminated to indicate an increase in CO
2
level as the patient exhales through the airway
adapter tube.
If, after an adequate signal has been detected:
Bottom
Bar
75
m
50
m
H
30
g
20
10
10
k
7
P
a
4
2.6
1.3
0.8
6
0.3
2
•the CO
sensor is unplugged, or
2
•the airway adapter tube is removed from
the CO
sensor, or
2
•the light path is blocked, or
•a CO
then a CO2 sensor fault exists. The third and
sixth bars of the CO
When the sensor fault is corrected, the CO
display will return to normal operation.
CO2 values are displayed as a range between
two threshold values. The threshold values are
located between each CO
values (displayed in both mmHg and kPa) are an
approximate (semi-quantitative) measurement
of the change in CO
airway adapter tube.
sensor failure occurs,
2
display will be illuminated.
2
display bar. The
2
level (Δ CO2) in the
2
2
Sixth
Bar
Third
Bar
Threshold
Values
75
m
50
m
H
30
g
20
10
m
m
H
g
10
k
7
P
a
4
2.6
1.3
0.8
6
0.3
2
10
75
50
30
20
10
6
2
7
4
2.6
1.3
0.8
0.3
k
P
a
For example, if four bars are illuminated, the
detected CO
≥10
mmHg and <20 mmHg (the threshold
2
values).
CAUTION! Because the CO2 detector is a semi-quantitative
Detailed Operation23
1
level change lies within the range
device, the rising and falling CO2 display (the bar
graph) should NOT be interpreted as a CO
2
waveform.
Page 26
Audible Indicators
CAUTION!Do not use the 9843 in situations where alarms
are required. The 9843 has no audible alarms.
CAUTION!Do not block the audible indicator speaker holes.
Blocking the speakers will significantly reduce the
sound volume.
Audible Breath Beep
When the detected CO2 increases (during exhalation) by approximately
5
mmHg, a breath is detected and the audible breath beep will sound. One
beep is sounded for each breath detected.
Each time the 9843 is turned on, the audible breath beep will default to the
medium sound volume setting. During normal operation, pressing the
advance switch cycles the audible breath beep sound volume between low,
medium, high, and off. A “volume” beep will sound each time the advance
switch is pressed to indicate the current setting.
24Detailed Operation
1
Page 27
Communications
Real-Time Printer/Serial Output
The Model 9843 provides real-time data output capability via the pulse
oximeter sensor connector (a 9-pin Sub-D connector). The pulse
oximeter sensor connector serves as a pulse oximeter sensor input
connector as well as a printer interconnect device. The pulse oximeter
sensor connector pin assignments are listed in
Real-time data can also be transmitted to another device through the
serial data infrared link at the top of the Model
9843. Refer to Figure 2
on page 8 for the location of the infrared link.
The information from the Model 9843 in the real-time mode is sent in an
ASCII serial format at 9600 baud with 9 data bits, 1
start bit, and 1 stop
bit. The data are output at a rate of once per second.
NOTE:The 9th data bit is used for parity in memory playback
mode. In real-time mode, it is always set to the mark
condition. Therefore the real-time data may be read as
8 data bits, no parity.
Detailed Operation25
1
Page 28
Real-time data may be printed or displayed. On power up a header is sent
identifying the format and the time and date. Thereafter, the data are sent
once per second by the Model
9843 in the following format:
HH:MM:SS SPO2=XXX HR=YYY
where “HH” represents the hour the real-time clock is set to, “MM”
represents the minutes, “SS” represents the seconds, “XXX” represents the
SpO
value, and “YYY” represents the pulse rate. The SpO2 and pulse rate
2
will be displayed as “---” if there are no data available for the data reading.
If a breath was detected in the previous interval a “B” will be appended to
the data line and will be printed by some devices.
26Detailed Operation
1
Page 29
Memory
The Model 9843 can collect and store up to 18 hours of SpO2 and pulse
rate information.
Nonin offers nVISION® Data Management Software for Oximetry
Screening, for use with a personal computer. nVISION is an easy to use
Windows
report generation, and data storage. Refer to
The solid-state memory in the Model 9843 functions much like an
endless loop. When the memory fills up, the unit begins overwriting the
oldest locations with the latest data.
Each time the Model 9843 is turned on, the current time/date
information (if the clock is set properly) is stored in memory to allow
quick differentiation of recording sessions. Patient SpO
are sampled and stored every four seconds. The oxygen saturation values
are stored in 1% increments in the range of 0 to 100%. The stored pulse
rate ranges from 18 to 300 pulses per minute. The stored values have
increments of 1 pulse per minute from 18 to 200 pulses per minute, and
increments of 2 pulses per minute from 201 to 300 pulses per minute.
®
-based program for pulse oximetry data retrieval, analysis,
“Accessories” on page 38.
and pulse rate
2
NOTE:CO2 detector data are not stored in memory.
During printing of the data, the last data recorded are the first data
printed. For example, the last four minutes of data recorded would be the
first four minutes of printout.
Recording Sessions
Each time the Model 9843 is turned on (except while setting the clock)
data are automatically collected.
NOTE: Only recording sessions greater than one minute in
length are kept in memory for later printing.
Detailed Operation27
1
Page 30
Memory Playback Mode
Playing Back Data Stored in Memory
1.With the unit off, press and hold the setup/touch print switch while
pressing and then releasing the on/off switch.
2.Release the setup/touch print switch when “888 888” is displayed
on the SpO
“
Prn” will appear in the SpO
3.Data will automatically be played back from the memory.
and pulse rate displays. Three brief beeps will sound and
2
display.
2
NOTE: The keypad sequence for starting memory playback is
identical to the sequence used for entering setup mode.
Data are played back at a rate of 20 minutes of collected data per second. An
18-hour recording session (the maximum memory saved) is played back in
approximately 1 minute. After all data are played back, the 9843 should be
shut off before collecting new patient data. The patient information is held
in memory as long as the batteries are good, so if the memory must be
cleared, remove the batteries for a period of 60 seconds or longer. Playing
back the data in memory does not clear any data from the memory.
The size of this file will depend on the amount of data saved in the memory.
The most recent data are played back first. The memory data format is in
binary. Bad data is represented by FF (hexadecimal) or 255 (decimal). If the
memory “wrapped around” (the recording time exceeded 18 hours) and the
final (i.e., the oldest) file of data has been truncated, the final start time will
be represented by zeroes and the start times for that file will then not match
up.
28Detailed Operation
1
Page 31
Carbon Dioxide Sensor and
Airway Adapter Tube
WARNING! The Model 9840AAT Airway Adapter Tube will
increase dead space by approximately 6 cubic
centimeters, which may adversely affect ventilation
for patients with small tidal volumes.
WARNING! Do not use a damaged sensor.
CAUTION!Before use, carefully read the instruction insert
provided with the sensors.
CAUTION!Water or other liquid between the airway adapter
tube and the CO2 sensor may cause erroneous
readings.
CAUTION!Ensure that all connections to the airway adapter
tube are tight and leak-free, and that the airway
adapter tube is properly attached to the CO2 sensor.
Carbon Dioxide Sensor
The Model 9840SA CO2 Sensor is a crescent-shaped device containing
light emitting and detecting elements on the end of a cable that connects
to the 9843. The CO
Airway Adapter Tube, which in turn is connected between the
endotracheal tube and the breathing circuit of intubated patients.
sensor is snapped onto the Model 9840AAT
2
Figure 8. Model 9840SA Carbon Dioxide Sensor
Carbon Dioxide Sensor and Airway Adapter Tube29
1
Page 32
Cleaning the Carbon Dioxide Sensor
CAUTION!Do not immerse the CO2 sensor in liquid, and do not
use caustic or abrasive cleaning agents on the CO
sensor.
The CO2 sensor is protected against splashing water.
Cleaning the CO2 Sensor
äClean the Model 9840SA CO2 Sensor with a soft cloth dampened
with isopropyl alcohol or a commonly used disinfectant. Do not pour
or spray any liquids onto the Model
Model 9840SA CO2 Sensor to dry thoroughly before reusing.
9840SA CO2 Sensor. Allow the
Returning the CO2 Sensor for Service
If the Model 9840SA CO2 Sensor must be returned to NONIN for service,
the product should be free of any contaminants, and sterilization may be
required. Contact NONIN’s Customer Support department for shipping
instructions.
2
30Carbon Dioxide Sensor and Airway Adapter Tube
1
Page 33
Airway Adapter Tube
WARNING! Do not reuse the Model 9840AAT Airway Adapter
Tube.
WARNING! If the airway adapter tube becomes contaminated or
damaged, discard it and replace it with a new one.
Cleaning the interior will damage the anti-fog
coating and cause inaccurate readings.
WARNING! Do not use the airway adapter tube if it is below 5°C.
An airway adapter tube that is below 5°C may frost,
causing a false reading. Warm the airway adapter
tube to above 5°C by warming it before use.
CAUTION!An airway adapter tube that is between 5°C and 10°C
may cause inaccurate readings due to fogging of
optical surfaces. Warm the airway adapter tube to
above 10°C before use.
The Model 9840AAT Airway Adapter Tube (Figure 9 on page 31) is a
single-use only disposable adapter designed to be placed between the
endotracheal tube and the breathing circuit of intubated patients. The
airway adapter tube snaps onto the CO
sensor so that the two devices
2
do not move relative to each other.
The CO2 detector will not function properly unless the light emitting and
detecting elements of the CO
sensor are properly aligned with the
2
windows in the airway adapter tube.
Windows
(To Breathing
Device)
Reflector
(To Endotracheal
Tube)
Snaps
Carbon Dioxide Sensor and Airway Adapter Tube31
1
Figure 9. Model 9840AAT Airway Adapter Tube
Page 34
Attaching the Airway Adapter Tube to the Carbon Dioxide Sensor
1.While grasping the large end of the airway adapter tube, place the clear
windows of the tube toward the CO
sensor (Figure 10A). The
2
reflector should face away from the CO2 sensor.
NOTE:It is possible to force the airway adapter tube and the CO
2
sensor into an improper alignment and connection.
However, the CO2 detector will not function properly
unless these pieces are correctly attached to each other.
2.Join the snaps on one side of the airway adapter tube onto either side
of the CO
sensor (Figure 10A), then rotate the airway adapter tube
2
(Figure 10B) and push firmly to set the other pair of snaps. You should
hear a clicking sound as the pieces are snapped together (Figure 10C).
BAC
(Note: The ends of the airway adapter tube can be
placed in either direction relative to the CO
Figure 10. Connecting the Airway Adapter Tube to the CO
sensor.)
2
Sensor
2
3.Ensure that the airway adapter tube and the CO
sensor are firmly
2
attached to each other. Gently tug on the assembly to make sure the
pieces are tightly snapped together.
CAUTION!Both sides of the airway adapter tube must be
snapped onto the CO2 sensor. If only one side of the
airway adapter tube is attached to the CO2 sensor, the
pieces will come apart.
The airway adapter tube attaches between the endotracheal tube of the
patient and the breathing circuit.
CAUTION!Not all tapered connectors are compatible with the
airway adapter tube. Ensure that all connections are
secure.
32Carbon Dioxide Sensor and Airway Adapter Tube
1
Page 35
The Breathing Circuit
(a breathing device,
breathing bag,
ventilator, etc.)
Model 9843
Model9840SA
CO2 sensor
Endotracheal
Tube
Model9840AAT
Airway Adapter Tube
Figure 11. The Airway Adapter Tube and the Breathing Circuit
Carbon Dioxide Sensor and Airway Adapter Tube33
1
Page 36
Specifications
1. Oxygen Saturation Range (SpO2) 0 to 100%
2. Pulse Rate Range18 to 300 Pulses Per Minute
3. CO2 Range0 to >75 mmHg
4. CO2 Response Time250 ms
5. Respiration Rate Range1 to 60 Breaths Per Minute
6. Breath Detection Threshold5 mmHg
7. Accuracy
SpO2 (± 1 Standard Deviation)
*
70 - 100% ± 2 digits for adults using Finger
Clip Sensors
70 - 100% ± 3 digits for adults using Flex,
Flexi-Form, or Reflectance Sensors
70 - 100% ± 4 digits using Ear Clip Sensors
70 - 95% ± 3 digits for neonates using infant
or neonatal sensors
Below 70% is not specified for all sensors
Pulse Rate
ΔCO2 Accuracy of Bar Graph
Thresholds
8. Measurement Wavelengths
Red
Infrared
Mid-Infrared
9. Indicators
Pulse Quality Indicator: LED, tri-color
Numeric Displays: 3-digit 7-segment LEDs, red
CO2 Display: 8-segment bar graph, red
Low Battery Indicator: Dedicated icon, red
Audible Breath Indicator: Miniature speakers (2)
*
Standard Deviation is a statistical measure: up to 32% of the readings may fall
outside these limits.
± 3% ± 1 digit
± 25% of reading (typical)
660 nanometers
910 nanometers
4260 nanometers
34Specifications
1
Page 37
10. Temperature
Operating
-20 to +50°C (Pulse Oximeter)
0 to +50°C (CO2 Detector)
Non-operating
-30 to +50°C (Pulse Oximeter and CO
Detector)
11. Humidity
Operating
Non-operating
15 to 90% non-condensing
10 to 95% non-condensing
12. Altitude
Operating
Non-operating
0 to 3,000 meters
0 to 10,000 meters
13. Power RequirementsSix 1.5V AA size alkaline batteries
90 hours typical operation for pulse oximetry
alone; 20 hours typical operation for pulse
oximetry
and CO2 detection
14. Degree of ProtectionType BF Applied Part
15. Dimensions8 cm wide x 15 cm high x 2 cm deep
(3 in wide x 6 in high x 1 in deep)
2
16. Weight310 g (11 oz.) with batteries
Specifications35
1
Page 38
Service
CAUTION!Model 9843 Pulse Oximeter and Carbon Dioxide
Detectors are sensitive electronic instruments and
must be repaired by knowledgeable and specially
trained personnel only.
Any sign or evidence of opening the system, field service by non-NONIN
personnel, tampering, or any kind of misuse or abuse of the system, shall
void the warranty in its entirety.
The solid state circuitry within the Model 9843 requires no periodic
maintenance or calibration.
NONIN does not recommend field repair of the Model 9843. The
circuit board in the Model
traces. Due to the very small trace size, extreme care must be used when
replacing components to prevent permanent non-repairable damage to the
circuit board. Most components are surface-mounted and require special
hot air jet soldering and desoldering equipment. After any repairs are made,
the Model
9843 must be tested to ensure correct operation.
9843 is a multi-layer board using very narrow
All repair work on the Model 9843 should be done by trained NONIN
personnel. For additional technical information contact NONIN’s
Customer Support department at:
Nonin Medical, Inc.
13700 1st Avenue North
Plymouth, Minnesota 55441-5443
(800)
356-8874 (USA and Canada)
FAX: (763)
All non-warranty work shall be done according to NONIN standard rates
and charges in effect at the time of delivery to NONIN. All repairs include
an 18-hour minimum burn-in and a complete retest of the Model
factory test fixtures.
USA
(763) 553-9968
553-7807
9843 using
36Service
1
Page 39
Warranty
NONIN MEDICAL, INCORPORATED, (NONIN) warrants to the
purchaser, for a period of three years from the date of delivery, each
system exclusive of sensors, cables, airway adapter tubes, and batteries.
(Refer to the individual package inserts for specific warranty information
for sensors, cables, and accessories.) NONIN shall repair all systems
found to be defective in accordance with this war ranty, free of charge, for
which NONIN has been notified by the purchaser by serial number that
there is a defect, provided said notification occurs within the applicable
warranty period. This warranty shall be the sole and exclusive remedy by
the purchaser hereunder for any systems delivered to the purchaser which
are found to be defective in any manner whether such remedies be in
contract, tort or by law.
This warranty excludes cost of delivery to and from NONIN. All
repaired units shall be received by the purchaser at NONIN's place of
business. For any system sent to NONIN for warranty repair which is
found to be within specification, the purchaser agrees to pay $100.00 (US
dollars).
These systems are sensitive and must be repaired by knowledgeable and
specially trained personnel only. Accordingly, any sign or evidence of
opening the system, field service by non-NONIN personnel, tampering,
or any kind of misuse or abuse of the system, shall void the warranty in
its entirety.
All non-warranty work shall be done according to NONIN standard
rates and charges in effect at the time of delivery to NONIN.
DISCLAIMER/EXCLUSIVITY OF WARRANTY
THE EXPRESS WARRANTIES SET FORTH IN THIS MANUAL
ARE EXCLUSIVE AND NO OTHER WARRANTIES OF ANY
KIND, WHETHER STATUTORY, WRITTEN, ORAL, OR IMPLIED
INCLUDING WARRANTIES OF FITNESS FOR A PARTICULAR
PURPOSE OR MERCHANTABILITY SHALL APPLY.
Warranty37
1
Page 40
Accessories
The following NONIN accessories function with the Model 9843: