The Nonin® Model 9847 Pulse Oximeter and Carbon Dioxide Detector is indicated for use in measuring
and displaying functional oxygen saturation of arterial hemoglobin (SpO
carbon dioxide (CO
) changes in the airway of intubated patients. These functions may be used
2
separately or simultaneously.
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
), pulse rate, and approximate
2
The CO2 detector is a mainstream device intended to be used for semi-quantitative detection of CO2
levels in intubated patients during patient transport, and for short-term hospital use (e.g., emergency
rooms or crash carts), and where gaseous anesthetic is not present. The CO
detector may be used to
2
initially confirm proper placement of the endotracheal tube and to provide continued confirmation of
correct endotracheal tube placement and patient respiration status. The CO
prolonged CO
The CO
2
monitoring. The CO2 detector is not intended for long-term monitoring of end-tidal CO2.
2
detector is not intended for use in patients younger than 3 years old and weighing less than
detector is not intended for
2
10 kg (22 lb).
Contraindication: Do not use in an explosive atmosphere or in the presence of flammable anesthetics or gasses.
Warnings
Do not use this device in an MR environment.
Do not use the Model 9847 CO
the dead space introduced by the airway adapter tube.
This device is not defibrillation proof per IEC 60601-1.
This device is intended only as an adjunct in patient assessment. It must be used in conjunction with other methods of
assessing clinical signs and symptoms.
Do not use the Model 9847 CO
from the person performing resuscitation will cause inaccurate readings.
detector for patients younger than 3 years old and weighing less than 10 kg (22 lb) due to
2
detector during mouth-to-tube ventilation. The presence of CO2 in the exhaled breath
2
The Model 9847 CO
placement if the airway is patent. Standard clinical assessment must be used.
Oximeter readings of this device may be affected by the use of an electrosurgical unit (ESU).
Do not use a damaged sensor. If the sensor is damaged in any way, discontinue use immediately and replace the sensor.
Verify all alarm settings and limits during system startup to ensure that they are set as intended.
A hazard can exist if different presets are used on multiple 9847 monitors in one care area.
detector cannot distinguish between oropharyngeal tube placement and endotracheal tube
2
1
Page 9
Indications for Use
Warnings (Continued)
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 the Parts and Accessories List may result in
increased electromagnetic emission and/or decreased immunity of this device.
To avoid patient injury, use only with Nonin-branded PureLight® pulse oximeter sensors. These sensors are manufactured
to meet the accuracy specifications for Nonin Pulse Oximeters. Using other manufacturers’ sensors can result in improper
pulse oximeter performance.
To prevent improper performance and/or patient injury, verify compatibility of the monitor, sensor(s), and accessories
before use.
No modifications to this device are allowed as it may affect device performance.
Check the pulse oximeter sensor application site every 4 hours 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.
As with all medical equipment, carefully route patient cabling to reduce the possibility of entanglement, strangulation, or
injury to the patient.
Discontinue use of adhesive tape strips if the patient exhibits an allergic reaction to the adhesive material.
Avoid excessive pressure to the sensor application site as this may cause damage to the skin beneath the sensor.
Do not reuse the Model 9840AAT Airway Adapter Tube. Cleaning the interior will damage the anti-fog coating and cause
inaccurate readings.
If the airway adapter tube packaging appears to be damaged or open, discard it and replace it with a new one.
The Model 9840AAT Airway Adapter Tube will increase dead space by approximately 6 cubic centimeters (0.4 cubic
inches); this may adversely affect ventilation for patients with small tidal volumes.
If the Model 9847 CO
confirmed by other methods.
Do not use the Model 9847 CO
erroneous readings.
This device must be able to measure the pulse properly to obtain an accurate SpO
hindering the pulse measurement before relying on the SpO
Operation of this device below the minimum amplitude of 0.3% modulation may cause inaccurate results.
Before changing the batteries, make sure the device is off and the sensor is not attached to a digit.
detector results are inconclusive, the correct anatomic location of the endotracheal tube must be
2
detector with a humidifier or nebulizer in the breathing circuit, as the fine mist may cause
2
measurement. Verify that nothing is
measurement.
2
2
Cautions
Before use, carefully read the Instructions for Use provided with sensors and airway adapters.
This device is a precision electronic instrument and must be repaired by trained Nonin personnel only. Field repair of the
device is not possible. Do not attempt to open the case or repair the electronics. Opening the case may damage the
device and void the warranty.
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.
When mounting the monitor to a mobile pole, mounting the monitor higher than 1.5 meters (5 feet) or mounting more than
2 kilograms (4.5 pounds) of equipment onto the pole may results in tipping, damage to the equipment, or injury.
This device is not an apnea monitor.
2
Page 10
Indications for Use
Cautions (Continued)
Verify that all visible indicators illuminate during the startup (initialization) sequence. If any indicator is not lit, do not use
the device. Contact Nonin Technical Service for assistance.
Review all limits to ensure they are appropriate for the patient.
Setting alarm limits to extremes can render the alarm system useless.
The presence of a defibrillator may interfere with the performance of this device.
This device may not work on all patients. If you are unable to achieve stable readings, discontinue use.
This device has motion tolerant software that minimizes the likelihood of motion artifact being misinterpreted as good
pulse quality. In some circumstances, however, the device may still interpret motion as good pulse quality. Minimize
patient motion as much as possible.
Ear Clip and Reflectance sensors are not recommended for pediatric or neonatal use. The accuracy of these sensors has
not been established for pediatric or neonatal use.
Do not autoclave or immerse the device or sensors in liquid. Do not expose the device or components to excessive
moisture or liquids.
Do not use caustic or abrasive cleaning agents on the device or the sensors.
The oximeter sensor might not work on cold extremities due to reduced circulation. Warm or rub the finger to increase
circulation, or reposition the sensor.
The device is not designed to retain data in memory once the batteries are removed. Memory will clear 60 seconds after
removing the batteries. Replacing the batteries before 60 seconds have elapsed most likely will result in corrupt data.
Always replace the batteries with fully charged batteries. Do not use fully charged and partially charged batteries at the
same time as this may cause the batteries to leak.
Use only Nonin-specified battery types with this device.
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.
Batteries may leak or explode if used or disposed of improperly.
Remove the batteries if the device will be stored for more than 1 month.
Follow local, state and national governing ordinances and recycling instructions regarding disposal or recycling of the
device and device components, including batteries.
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.
All parts and accessories connected to the serial port of this device must be certified according to at least IEC Standard
EN 60950, IEC 62368-1. or UL 1950 for data-processing equipment.
This equipment complies with IEC 60601-1-2 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 radio-frequency 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.
- residue (e.g., dried blood, dirt,
grease, oil) in the light path.
Cautions (Continued)
Do not use the airway adapter tube if the airway adapter tube is below 5 °C (41 °F). An airway adapter tube that is below
5 °C (41 °F) may frost, causing a false reading. Warm the airway adapter tube to above 5 °C (41 °F) by putting it in a warm
place (for example, in your hands or in a vehicle) prior to use.
An airway adapter that is between 5 °C (41 °F) and 10 °C (50 °F) may cause inaccurate reading due to fogging of optical
surfaces. It is recommended that the airway adapter tube be warmed to above 10 °C (50 °F) before use.
This device is designed to determine the percentage of arterial oxygen saturation of functional hemoglobin. Factors that
may degrade pulse oximeter performance or affect the accuracy of the measurement include the following:
Portable and mobile RF communications equipment can affect medical electrical equipment.
A functional tester cannot be used to assess the accuracy of a pulse oximeter monitor or sensor.
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
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
Ensure that this device, the airway adapter tube, and the sensors have stabilized at the specified environmental operating
conditions before use.
Gastric distention with air prior to intubation may introduce CO
Observe six breaths before interpreting results.
This device’s CO
Do not block the audible indicator speaker holes. Blocking the speakers will significantly reduce the sound volume.
Verify that the audible alarms can be heard over the ambient noise of the operating environment.
Failure of a network data coupling (serial cable/connectors) will result in loss of data transfer.
sensor.
2
detector must not be used with gaseous anesthetics.
2
sensor may cause erroneous readings.
2
into stomach and esophagus and yield false results.
2
4
Page 12
Guide to Symbols
!
0123
EC
REP
REF
QTY
US
Guide to Symbols
This table describes the symbols that are found on the Model 9847 and in this manual.
Table 1: Symbols
SymbolsDescription
CAUTION!
Consult Instructions for Use.
Follow Instructions for Use.
Type BF Applied Part (Patient isolation from electrical shock).
UL Mark for Canada and the United States with respect to electric shock, fire, and
mechanical hazards only in accordance with UL 60601-1 and CAN/CSA C22.2
No. 601.1.
SN
IP32
0123
REF
QTY
Serial Number (located on the back cover).
Protected against vertically falling water drops when enclosure is tilted up to
15 degrees and ingress of solid foreign objects greater than or equal to 2.5 mm
(0.1 in.) in diameter per IEC 60529.
Indicates separate collection for electrical and electronic equipment (WEEE).
CE Marking indicating conformance to EC Directive No. 93/42/EEC concerning medical
devices.
Authorized Representative in the European Community.
Manufacturer
Catalogue Number
Quantity
Date of Manufacture
Country of Manufacture
Storage/Shipping Temperature Range
RoHS Compliant (China)
5
Page 13
Table 1: Symbols (Continued)
SymbolsDescription
Federal law (USA) restricts this device to sale by or on the order of a licensed
practitioner.
Front Panel Buttons
ON/Standby
Advance/Breath Beep Volume Control
Alarm Limit Review
Audible Alarm Disable
Display Indicators
Guide to Symbols
SpO
2
CO2
No Breath
%SpO2 Display
Battery Indicator
Pulse Rate Display
Pulse Quality Indicator
Change in CO2 Concentration
Absence of CO2 Detection
6
Page 14
General Description
CO
2
%SpO
2
8
88
Model 9847
888
No Breath
m
m
H
g
k
P
a
SpO2 Display
CO
2
Sensor
Connector
Audible Indicator
(Speaker)
On / Standby
Alarm Limit
Review
“Audible Alarm
Disabled” Indicator
(Yellow)
Tri-Color Pulse Quality
(LED) Indicator
CO
2
Bar Graph
Display
Pulse Rate (LED)
Display
Low Battery
(LED) Indicator
Alarm Indicator
Pulse Oximeter
Sensor Connector
Advance/Breath
Beep Volume
Control
Audible Alarm
Disable
No Breath
Indicator
Keypad
General Description
Nonin 9847 Pulse Oximeter and Carbon Dioxide Detector is a hand-held, battery-operated, noninvasive
monitoring device that has visible and/or audible indicators for tracking patient and equipment status. The
9847 will typically 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.
2
Figure 1: Model 9847 Pulse Oximeter and Carbon Dioxide Detector with Alarms
Figure 2: Model 9847 Controls and Indicators
7
Page 15
General Description
Audible Alarms and Informational Tones
9847 uses audible alarms and informational tones (along with visible indicators) to alert healthcare
providers to several patient and equipment conditions. A high priority (patient) alarm alerts the healthcare
provider of a patient’s absence of breath, high or low oxygen saturation, pulse rate, or inadequate pulse
quality signal. A medium priority (equipment) alarm indicates the batteries have reached critically low
capacity, or that a sensor alarm condition is occurring. An informational tone (a beep) indicates a nonalarm event (a breath).
The audible alarms can be silenced or temporarily disabled using the audible alarm disable button.
About Pulse Oximetry
9847 determines functional oxygen saturation of arterial hemoglobin (SpO2) by measuring the absorption
of red and infrared light 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 blinks. Patient pulse quality signals are graded as good,
marginal, or inadequate and are indicated as such by the pulse quality indicator blinking 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 an inadequate pulse is detected, the pulse quality indicator will blink red and a high priority patient
audible alarm will sound.
If the SpO
value will blink on the SpO
or the pulse rate meets or exceeds user-defined alarm limits, the corresponding numerical
2
or pulse rate displays and a high priority patient audible alarm will sound.
2
If the pulse oximeter sensor is disconnected, malfunctions, or an adequate signal is not detected:
• a dash appears in the leftmost position of the SpO
• the displayed SpO
and pulse rate values will freeze for 10 seconds, and
2
display,
2
• a medium priority equipment alarm will sound (unless the audible alarms are disabled or unless
overridden by a high priority patient alarm).
• 10 seconds after the first dash appears, the SpO
and pulse rate values will be replaced by dashes,
2
if the condition is not corrected, and
• dashes will blink if there was a patient alarm in process.
8
Page 16
General Description
Carbon Dioxide Detector
9847 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 assumption that the inhaled air contains minimal amounts of CO
Breaths are indicated when the CO
detected breath is indicated on the CO
level increases by approximately 5 mmHg during exhalation. A
2
bar graph and by an audible breath beep.
2
.
2
detector relies on
2
When no breath is detected:
• a high priority patient audible alarm sounds,
• the no breath indicator blinks,
• the lowest CO
bar graph segment will be illuminated, and CO2 readings will be displayed with the
2
next breath detected.
Medium priority (equipment) alarms occur when:
2
•the CO
• the airway adapter tube is removed from the CO
sensor is unplugged,
2
sensor,
2
• the light path is blocked, or
•a CO
sensor failure occurs.
2
A high priority (patient) alarm overrides a medium priority alarm. If the audible alarms are disabled, the
third and sixth bars will be solidly illuminated.
Unpacking the Model 9847
Contact the carrier immediately if the shipping carton is damaged. Carefully unpack the device and its
accessories. Nonin’s standard package configuration consists of the following items:
• 1 Model 9847 Pulse Oximeter and CO
• 1 Operator’s Manual (on CD)
• 1 Model 8000AA-1 Adult Articulated Finger Clip Sensor
• 1 Model 9840SA Carbon Dioxide Sensor
• 3 Model 9840AAT Airway Adapter Tubes
• 6 AA-Size Alkaline Batteries
If any item on this list is missing or damaged, contact your distributor.
Indicator
2
9
Page 17
Installing and Using the Batteries
!
!
9847 is powered by six AA size alkaline batteries. Approximate battery capacity:
General Description
• Pulse Oximeter (SpO
•CO
•CO
Low battery indicator illuminates when the battery capacity is low. The batteries should be
replaced as soon as possible.
Critical battery capacity is indicated by:
• low battery indicator blinks
• medium priority (equipment) alarm
To avoid loss of monitoring, batteries must be replaced immediately.
NOTE: Audible high priority patient alarms override medium priority alarms.
If the batteries are critically low when the device is turned on, setup mode will be disabled and the
displays will be blank. Replace the batteries before continuing.
NOTE: To conserve battery life disconnect the CO2 sensor not in use.
and Pulse Oximeter: 20 hours.
2
only: 24 hours.
2
CAUTION: Use only Nonin-specified battery types with this device.
) only: 90 hours
2
NOTE: Setting the month to “00” disables the calender and clock functions and helps conserve
battery life. Refer to “Calender Settings” on page 20 for additional information.
Replacing Batteries
WARNING: Before changing the batteries, make sure the device is off and the sensor
is not attached to a digit.
1. Slide open and remove the battery door on the bottom of the device.
2. Remove all six batteries.
3. Replace all six batteries with new AA size batteries as illustrated below with the proper battery
orientation noted on the back of the device.
CAUTION: The device is not designed to retain data in memory once the batteries
are removed. Memory will clear 60 seconds after removing the batteries. Replacing
the batteries before 60 seconds have elapsed most likely will result in corrupt data.
Always replace the batteries with fully charged batteries. Do not use fully charged
and partially charged batteries at the same time as this may cause batteries to leak.
10
Page 18
General Description
IMPORTANT: Insert these
two batteries first.
Battery Door
Battery Orientation
5808-005-04
US PATENT # Re. 33,643
6x1.5V AA IEC LR6
PULSE OXIMETER/CO2 DETECTOR
MODEL 9847
PLYMOUTH, MN USA
NONIN MEDICAL, INC.
IP32
UL 60601-1
30EM
SEE ACCOMPANYING DOCUMENTS
0123
Serial
Number
Battery
Orientation
Battery
Door
Figure 3: Replacing Batteries - Model 9847, example only
Figure 4: Rear View - Model 9847, example only
11
Page 19
General Description
!
!
When batteries are critically low, the digital displays will go blank, and the Pulse Quality display will blink
yellow or red, but not green.
.
CAUTION: Replace the batteries as soon as possible after a low battery indication.
Always replace the batteries with fully charged batteries. Do not use fully charged and
partially charged batteries at the same time. This may cause the batteries to leak.
CAUTION: Remove the batteries if the device will be stored for more than 1 month.
Important Notes about Battery Use
• To conserve battery life, Nonin recommends disconnecting the CO2 sensor from the 9847 when CO2
detection is not in use. The flashing lamp in the CO
• Setting the month to “00” disables the calendar and clock functions and helps conserve battery life.
Refer to “Calendar Settings” on page 20 for additional information.
• The memory of the 9847 may be erased when the batteries are removed.
sensor consumes a significant amount of energy.
2
• Replacing batteries may erase the clock settings of the 9847.
• Six AA alkaline batteries provide the device with approximately 90 hours of continuous operation.
• Calendar/clock/ settings can affect battery storage life. Batteries drain during storage, but they
drain more quickly when the unit’s calendar/clock functions are set. Refer to “Calendar Settings” and
“Clock Setting” (starting on page 19) for more information.
–If the calendar/clock is not set when the unit is stored, alkaline batteries will need replacement in
10–12 months if the unit has not been used.
–If the calendar/clock is set when the unit is stored and if the unit has not been used, alkaline
batteries will require replacement in about 6 weeks.
12
Page 20
Displays and Indicators
Displays and Indicators
SpO2 Display
The SpO2 display is identified by the SpO2 symbol. This 3-digit light-emitting diode (LED) display shows
the current oxygen saturation percentage.
Pulse Rate Display
The Pulse Rate display is identified by the symbol. This 3-digit LED display shows the pulse rate in
pulses per minute.
Pulse Quality Indicator
The Pulse Quality Indicator display, identified by the symbol, is a tricolor LED that blinks once for
each detected pulse. The color of the Pulse Quality indicator changes with the pulse strength signal, as
described below.
• Green indicates a good pulse strength signal.
• Yellow indicates a marginal pulse strength signal. To improve signal quality, reposition the sensor,
try a different sensor type, reduce patient movement, or improve the site’s circulation.
• Red indicates an inadequate pulse strength signal. While the Pulse Quality display is red, SpO
pulse rate values are not updated. After about 10 seconds, the values are replaced with dashes,
indicating that readings are not possible.
and
2
Low Battery Indicator
When battery level is low, the low battery indicator is lit. When the batteries reach critically low level,
the display will be blank and the low battery indicator will blink.
Sensor Fault or Inadequate Signal Display
If the device determines that a sensor fault or inadequate signal condition exists (a sensor disconnect,
failure, misalignment or incompatibility with the monitor) or if a pulse oximeter sensor signal is no longer
detected, a dash (-) appears in the leftmost position of the %SpO
yellow. The readings that are displayed will freeze for 10 seconds if the pulse oximeter sensor fault or the
inadequate signal continues.
If the sensor fault or the inadequate signal is not corrected, the frozen readings and the dash in the
leftmost position will be replaced by dashes in the middle of both the %SpO
When the sensor fault or the inadequate signal is corrected, the %SpO
to normal operation.
display and the alarm indicator blinks
2
and the Pulse Rate displays.
2
and pulse rate displays will return
2
13
Page 21
Using the 9847 Pulse Oximeter
Pulse Oximeter
Sensor
CO
2
Sensor/
Airway Adapter
Tub e
No Breath
Using the 9847 Pulse Oximeter
Connecting the Sensors
Pulse Oximeter Sensor
Attach the sensor (with the Nonin logo facing up) to the device as shown in Figure 5. Verify the sensor is
securely connected.
Figure 5: Connecting Sensors to the Model 9847
Carbon Dioxide Sensor and Airway Adapter Tube
Connect the CO2 sensor (with the Nonin logo facing up) to the side of the device as shown in Figure 5.
Verify the sensor is securely attached. Refer to “Carbon Dioxide Sensor” for more information.
Turn On/Standby
Turn on (or off) the device by pressing the ON/Standby button.
Startup Self-Test
When the device is turned on, the device will cycle through a startup/initialization sequence before
displaying valid data. During startup, always check for any missing indicators or LED display segments.
If any indicator is not functioning, do not use the device. Contact Nonin Technical Service for repair or
replacement.
During its normal startup sequence, the device will cycle as follows:
• The audible breath beeps three times.
• The No Breath indicator will display for approximately 2 seconds.
• The low battery indicator will display for approximately 2 seconds, unless the batteries
are low.
• The pulse quality indicator will blink red, then green. The device will enter standby if no
pulse oximeter sensor is connected.
14
Page 22
Using the 9847 Pulse Oximeter
%SpO
2
888
88
8
Audible
Alarm
Disabled
Indicator
(Yellow)
•The %SpO2 and pulse rate displays will sequence as follows.
1. “888 888”.
2. The current time (if set) or “00 00” if the time is not set.
3. Display 3 software revision numbers; oximetry/display software rev #, then CO
2
memory software rev #, then sound module software rev. # approx 1 second each.
4. Any sensor connections issues:
–if a sensor is not connected the display will revert to blank, or
–if a sensor is connected but is not detecting an adequate signal, a single dash (-) will appear in
the middle position of both displays, or
–if entering setup mode, the device will display “ALr” and “dFt”.
The CO
bar graph sequence is:
2
• each segment illuminates once,
• remains blank (until CO
• only the bottom segment illuminates when ready for use if CO
sensor is connected to the device), or
2
sensor is connected to the device.
2
• The yellow audible alarm disabled indicator is lit until initialization is complete
and a CO
NOTE:
or pulse oximeter sensor is connected.
2
The audible alarm disabled indication cannot be turned off until a sensor
is plugged in.
NOTE: When 9847 is turned on and the alarms are disabled, the yellow audible alarm disabled
indicator will remain illuminated.
Pulse Oximeter Startup
Apply the pulse oximeter sensor to the patient as directed in the sensor Instructions for Use. Verify
operation by:
• the pulse quality indicator is blinking green,
• the pulse rate and SpO
• the pulse quality indicator blinking is correlated to the pulse rate for at least 10 seconds.
(%SpO2) displays are showing values, and
2
If the pulse quality indicator LED is blinking red or yellow or is blinking inconsistently, reposition the
sensor or replace the sensor.
15
Page 23
Carbon Dioxide Detector
ΔΔCOCO
2
m
m
H
g
k
P
a
75
30
50
2
6
10
20
10
4
7
0.3
0.8
1.3
2.6
On / Standby
Advance /
Breath Beep
Vol ume
Control
Audible
Alarm Disable
Alarm Limit
Review
Audible Alarm
Disabled
Indicator
(Yellow)
Keypad
Low Battery
(LED)
Indicator
Verify:
Using the 9847 Pulse Oximeter
• that the airway adapter tube is properly attached to the CO
•the CO
• the lower bar of the CO
•the CO
•the CO
sensor is properly connected to the device,
2
display is lit,
2
sensor light is blinking, and
2
bar graph segments indicate change in CO2 level.
2
sensor,
2
Attach the CO2 sensor/airway adapter tube to the patient’s endotracheal tube. The CO2 detector will reflect
values and breath beeps for each breath (if the breath beep sound volume is not turned off).
Medium priority (equipment) alarm will occur (if the alarms are not disabled), when:
•the CO
• the airway adapter tube is removed from the CO
sensor is disconnected,
2
sensor,
2
• the light path is blocked, or
•a CO
sensor failure occurs.
2
High priority patient alarms override medium priority (equipment). The third and sixth
segments of the CO
bar graph will be illuminated, indicating a CO2 sensor fault.
2
Setup
All functions of the 9847 are controlled by buttons found on the keypad on
the front of the device.
Press the On/Standby button to turn the device on or to enter Standby
mode.
Setup Mode
Setup mode is used to control the audible and visible patient alarm limits,
the breath beep pitch, the calendar, and the internal time-of-day clock. In
setup mode, the alarm limit review button is used to make the menu
selections, and the advance button is used to change the value.
Entering Setup Mode
1. With the unit in Standby mode, press and hold the alarm limit review
button while pressing and then releasing the On/Standby button.
2. Release the alarm limit review button when “888 888” is displayed on the %SpO
rate displays. Three brief beeps will sound, and “ALr” and the “dFt” will appear in the %SpO
and pulse rate displays.
NOTE: Entering setup mode with audible alarms disabled:
1. Press and hold the alarm limit review and audible alarm disable buttons while pressing and
releasing the On/Standby button;
2. Release the alarm limit review and audible alarm disable buttons; and the display will appear
as described in #2 above; the audible alarm limit indicator will illuminate steadily.
16
and pulse
2
2
Page 24
Using the 9847 Pulse Oximeter
NOTE: You may exit setup mode at any point and save your current patient alarm limit changes
(without stepping through the remainder of the setup mode menu options). Complete the desired
selections, then turn off the 9847. Next, enter setup mode again and choose “rCL” (recall stored
limits) from the alarm mode settings.
NOTE: Setting the month to “00” disables the calendar and clock functions and helps conserve
battery life.
NOTE: Setup mode will be disabled if the batteries are critically low at power on.
Making Selections in Setup Mode
1. Upon entering setup mode, “ALr” (the first parameter) will appear in the %SpO2 display. Press
the advance button (or press and hold to quickly scroll) to increment the number (the menu
value) on the pulse rate display. The menu starts at the current value stored in memory for the
parameter designated in the %SpO
Table 2.
2. When the value appears in the pulse rate display, press the alarm limit review button to store the
value and advance the %SpO
2
alarm limit, etc.) as listed in Table 2.
3. Continue this process until all parameters are set.
display and will cycle through the range of values listed in
2
display to the next sequential parameter (no breath delay time,
When the setting sequence has been completed, the 9847:
1. exits the setup mode,
2. briefly displays “rCL ALr” (recall alarm settings), followed by the alarm limit settings, and
3. begins normal operation.
Disabling the Audible Alarms
The audible alarms can be temporarily disabled, or they can be disabled at power on or when entering
setup mode using the audible alarm disable button.
When the audible alarms are disabled, informational beeps will continue to sound at the set loudness
level, and the visible alarm indicators will remain enabled.
Temporarily Disabling the Audible Alarms (Maximum Two Minutes)
With the unit on, press and then release the audible alarm disable button. The “audible alarm disabled”
indicator will blink. The audible alarms will be disabled for two minutes (unless overridden by an audible
critical battery alarm). The audible alarms can be re-enabled by pressing the audible alarm disable button
again before the two minute period has expired.
Disabling the Audible Alarms During Power On
1. With the unit in Standby, press and hold the audible alarm disable button while pressing and
then releasing the on/standby button.
17
Page 25
Using the 9847 Pulse Oximeter
2. Release the audible alarm disable button when “888 888” is displayed on the %SpO2 and
pulse rate displays. After the power on self-test, the “audible alarm disabled” indicator will
illuminate steadily. The patient alarms will be set at the default limits. The audible alarms can be
re-enabled by pressing the audible alarm disable button again.
Table 2: Patient Alarm Limit, Breath Beep Pitch, Calendar, and Clock Mode Parameters
Parameter
Appears in
Display
SpO
2
Pulse Rate
♥ Display
Range of Values
Default Value
Alarm Mode
(dFt =default limits;
rCL = recall stored limits;
C02 = only
no breath and the sensor
ALrdFt, rCL, C02dFt
alarms)
No Breath Delay (seconds)nbd15 to 60 by 5, OFF20
Oxygen Saturation Low Limit (%)02L50 to 95 by 1, OFF85
Pulse Rate Low Limit (beats/minute)H L30 to 110 by 5, OFF50
Pulse Rate High Limit (beats/minute)H H75 to 275 by 5, OFF200
Oxygen Saturation High Limit (%)02H
80 to 100 by 1, OFFOFF
a
Breath Beep Pitch (fixed or variable)FPtON or OFFOFF (fixed pitch off)
Yeary00
Monthnn00
Dayd01
- 9909
- 1200
- 3100
Hoursh00
Minutesnn00
a.The default setting for “02H” is “OFF” (disabled). Any of the other patient alarm limit parameters can be individually
disabled by setting to “OFF”.
18
- 2300
- 5900
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Using the 9847 Pulse Oximeter
!
!
Alarm Mode Setting
WARNING: Verify all alarm setting and limits during system startup to ensure that
they are set as intended.
CAUTION: Review all limits to ensure they are appropriate for the patient.
CAUTION: Setting alarm limits to extremes can render the alarm system useless.
NOTE: The Advance button sets your selection. The Alarm Limits button moves you to the next
setting.
1. Upon entering setup mode, “ALr” will appear in the SpO
alarm mode may be set to “dFt”, “rCL”, or “C02”.
Choosing “dFt” (default alarm limits) will set up the system-defined (default) patient alarm limit
settings.
Choosing “rCL” (recall stored limits) will set up the last stored patient alarm limit settings of the 9847.
Choosing “C02” (no breath alarm limits and sensor alarms) will disable the oxygen saturation high
and low and the pulse rate high and low settings temporarily by setting them to “0FF”. Only the no
breath alarm and the sensor alarms will be enabled, along with the breath beep pitch mode selection.
Setup mode will skip over the other patient alarm settings (“C02” alarm mode first goes to “nbd”,
then to “FPt”, etc.).
2. When the alarm mode setting has been selected, setup mode continues to the no breath delay
time setting.
display indicating alarm mode. The
2
No Breath Delay Time Setting
1. Upon entering the no breath delay time setup, “nbd” will appear in the SpO2 display. The no
breath delay time may be set from 15 to 60 (seconds) in increments of 5, or to “0FF”. Make the
no breath delay time setting selection.
2. When the no breath delay time has been selected, setup mode continues to the SpO
limit setting, described in the next section (“C02” alarm mode next goes to “FPt”, then to “y”,
etc.).
low alarm
2
SpO2 Low Alarm Limit Setting
1. Upon entering the SpO2 low alarm limit, “02L” will appear in the SpO2 display. The SpO2 low
alarm limit may be set from 50 to 95 (%) in increments of 1, or to “0FF”. Make the SpO
alarm limit selection.
low alarm limit setting has been selected, setup mode continues to the pulse rate
2
low
2
19
Page 27
Using the 9847 Pulse Oximeter
Pulse Rate Alarm Limit Settings
1. Upon entering the pulse rate low alarm limit, “H L” will appear in the SpO2 display. The pulse
rate low alarm limit may be set from 30 to 110 (beats per minute) in increments of 5, or to “0FF”.
2. After selecting the pulse rate low alarm limit, the SpO
display will show “H H” indicating the
2
setup mode for the pulse rate high alarm limit. The pulse rate high alarm limit may be set from 75
to 275 (beats per minute) in increments of 5, or to “0FF”.
3. When the desired pulse rate high alarm limit setting has been selected, setup mode continues to
the SpO
high alarm limit.
2
SpO2 High Alarm Limit Settings
1. Upon entering the SpO2 high alarm limit, “02H” will appear in the SpO2 display. The SpO2 high
alarm limit may be set from 80 to 100 (%) in increments of 1, or to “0FF”.
2. When the SpO
high alarm limit setting has been selected, setup mode continues to the breath
2
beep pitch settings.
Settings
Breath Beep Pitch
Upon entering the breath beep pitch, “FPt” will appear in the SpO2 display. The breath beep pitch
defaults to “variable pitch” (fixed pitch off). Refer to “Audible Breath Beep” on page 26 for additional
information. The breath beep pitch selection may be toggled between “ON” or “OFF”.
Calendar Settings
NOTE: Setting the month to “00” disables the calendar and clock functions. The calendar and
clock functions are used to time stamp real-time data for memory. Unless you intend to use realtime data output or memory playback options, skip this section.
1. After the calendar setting has been selected in the setup mode, “y” will appear in the SpO
2
display indicating the calendar setup mode for the year. The year may be set to “00” through
“99”.
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”.
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”. After selecting the day, the setup mode
continues to the clock settings.
Clock Setting
1. After the calendar settings have been selected in the setup mode, “h” will appear in the SpO2
display indicating clock setup mode for the hour. The hour may be set to “00” through “23”.
2. After selecting the hour, the SpO
display will show “nn” indicating the setup mode for the
2
minutes. The minutes may be set to “00” through “59”.
3. After selecting the minutes, the device will:
a. exit the setup mode,
b. briefly display “rCL ALr” (recall alarm settings) and then the current alarm limit settings, and
c. begin normal operation.
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Using the 9847 Pulse Oximeter
%SpO
2
888
888
%SpO
2
66
-89
%SpO
2
-
-
%SpO
2
---
---
Visible Indicators
Refer to Figure 2 on page 7 for a detailed illustration of the 9847 controls and indicators.
The intended operator’s position for correctly perceiving a visual alarm signal and its priority is 1 meter
(3.3 feet), per IEC 60601-1-8.
SpO2 Display
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.
SpO2 and Pulse Rate Displays
A pulse oximeter sensor fault will occur if the 9847 pulse oximeter detects:
• a pulse oximeter sensor disconnect,
• a pulse oximeter sensor dislodgment, or
• a pulse oximeter sensor failure.
If a pulse oximeter sensor fault occurs or a sensor signal is no longer detected, a medium
priority equipment alarm is started. A dash ( - ) appears in the left digit of the SpO
display.
2
The readings that are displayed will freeze for 10 seconds if the sensor fault or inadequate
signal continues. (Also during this medium priority alarm, an audible indicator will occur.)
If the sensor fault or inadequate signal is not corrected, dashes will be displayed in the middle
digit of both the SpO
and pulse rate displays 10 seconds after the first dash appears. The
2
corresponding dash(es) will blink if there was a prior high priority patient alarm. When the
sensor fault or inadequate signal is corrected, the SpO
normal operation.
When the SpO
or pulse rate alarm limits are met or exceeded, a high priority patient alarm
2
and pulse rate displays will return to
2
condition exists. The corresponding numbers on the display will blink.
When the SpO
or pulse rate alarm limits are met or exceeded, a high priority patient alarm
2
condition exists and the numerical values of the corresponding parameter will blink. (Also
during these high priority alarms, an audible alarm indication will occur.)
If latched for a pulse oximeter medium priority equipment alarm (a sensor fault or inadequate signal), a
single blinking dash will be displayed in the corresponding middle digit of the SpO
or the pulse rate
2
display.
The visible and audible indicators will stop when the condition is cleared.
21
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Using the 9847 Pulse Oximeter
%SpO
2
!
Alarm Limit Review
When the alarm limit review button is pressed and held, the patient alarm limits in effect for
no breath delay time (in seconds), SpO
setting will display in sequence for approximately 2 seconds in the order and format shown
in Table 3. If the button is released, the review mode is exited and normal operation is
resumed.
Table 3: Alarm Limits Displayed During an Alarm Limit Review
, and pulse rate, as well as the breath beep pitch
2
Parameter
Appears in SpO
Display
2
Alarm Limits
(Default Values Are Shown)
No Breath Delay (seconds)nbd20
Oxygen Saturation Low Limit (%)02L85
Pulse Rate Low Limit (beats/minute)H L50
Pulse Rate High Limit (beats/minute)H H200
Oxygen Saturation High Limit (%)02HOFF
Breath Beep Pitch (fixed or variable)FPtOFF (fixed pitch off)
During the alarm limit review only the SpO
and pulse rate displays will be affected. The current SpO2
2
and pulse rate measurements will be displayed after completing the limit review. If a critical battery state
exists, the alarm limit review sequence will not appear.
NOTE: Pressing and holding the alarm limit review button can be used to review alarm limits and
to activate an event marker.
Pulse Quality Indicator
CAUTION: The device may misinterpret motion artifact as good pulse quality.
The pulse quality indicator blinks 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
2
data.
The pulse quality indicator may blink one of three colors:
• Green indicates that the pulse waveform signal is of good quality and the SpO
and pulse rate data
2
are accurate.
• 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
2
should be considered if the indicator continues to blink 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.
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Using the 9847 Pulse Oximeter
m
m
H
g
k
P
a
75
30
50
2
6
10
20
10
4
7
0.3
0.8
1.3
2.6
Bottom
Bar
m
m
H
g
k
P
a
75
30
50
2
6
10
20
10
4
7
0.3
0.8
1.3
2.6
Sixth
Bar
Third
Bar
m
m
H
g
k
P
a
75
30
50
2
6
10
20
10
4
7
0.3
0.8
1.3
2.6
Threshold
Val ues
• Red indicates that the pulse waveform amplitude is inadequate. During red pulse quality, SpO2 and
pulse rate values are not updated. A high priority patient alarm occurs. After approximately
20 seconds, the values are replaced with dashes indicating that SpO
and pulse rate measurements
2
are not possible. (Also during this high priority patient alarm, the high priority audible pulse quality
alarm sounds if the audible alarms are not disabled.)
No Breath Indicator
The visible no breath indicator is a high priority patient visible alarm that flashes when a breath has not
been detected for a period of time exceeding the set no breath delay time (measured in seconds). During
this alarm, the high priority audible no breath alarm sounds if the audible alarms are not disabled. (See
“Audible No Breath Alarm” on page 27 for additional information.)
If a CO
sensor alarm occurs, existing visible and audible absence of breath indicators will latch. In most
2
cases, however, during “fixed pitch” breath beep mode, when the airway adapter tube is unsnapped from
the CO
sensor, the visible and audible absence of breath indicators will stop.
2
When a breath is again detected, the visible and audible no breath indicators will stop. The no breath
delay timer is first started when the CO
mode (when the lower bar is illuminated on the CO
sensor is plugged into the 9847 and the system is not in setup
2
display).
2
CO2 Bar Graph
The CO2 bar graph will remain blank until the CO2 sensor is plugged in. When an
airway adapter tube is connected to the CO
detected, the bottom bar is initially illuminated. The bars will be illuminated to
indicate the change in CO
level as the patient exhales and inhales through the
2
airway adapter tube.
The 3rd and 6th bars of the CO
bar graph will be illuminated if a medium priority
2
(equipment) alarm is started. (See page 25 for additional alarm information.)
sensor and an adequate signal is
2
values are displayed as a range between two threshold values. The threshold
CO
2
values are located between each CO
and kPa) are an approximate measurement of the change in CO
airway adapter tube. For example, if four bars are illuminated, the detected CO
level change lies within the range >
bar. The values (displayed in both mmHg
2
level in the
2
10 mmHg and <20 mmHg (the threshold
2
values).
NOTE: Because the CO2 detector is a semi-quantitative device, the rising and falling CO2 bar
graph should NOT be interpreted as a CO2 waveform.
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Using the 9847 Pulse Oximeter
Audible
Alarm
Disabled
Indicator
(Yellow)
Low Battery Indicator
The low battery indicator steadily illuminates when the battery level is marginal. The
batteries should then be replaced as soon as possible.
When the battery level is low:
• the low battery indicator blinks,
• a medium priority equipment audible alarm is started (unless an audible high priority patient alarm is
in progress),
• if the respective alarms are not “latched” (continuing), the SpO
, pulse rate, and CO2 bar graph will
2
be blank,
• if not “latched”, the pulse quality indicator will blink yellow or red but not green, and
• an existing visible high priority patient alarm will “latch” (continue):
• a latched no breath alarm will blink the no breath indicator,
• a latched high or low SpO
or pulse rate alarm will display three dashes blinking in the
2
corresponding numeric display, and
• a latched pulse quality alarm will blink red.
When batteries are critically low:
• low battery indicator blinks,
• set-up mode is disabled,
• displays are blank (no patient data), and
• batteries must be replaced.
The device will not monitor a patient once the batteries reach a critically low level. The batteries must
then be replaced before further use of the 9847.
NOTE: Removing batteries may delete memory and all user defined settings, including calendar
and clock.
Audible Alarm Disabled Indicator
If the device is turned on with the audible alarms permanently disabled, the
yellow “audible alarm disabled” indicator will be steadily illuminated. If the audible
alarms are temporarily disabled, the “audible alarm disabled” indicator will blink.
After the 9847 is turned on (and after exiting the setup mode, if applicable) and
until a pulse oximeter or CO
alarm disabled” indicator will blink (or will remain steadily illuminated if the audible alarms are
“permanently” disabled).
This “audible alarm disabled” indication cannot be turned off until a sensor is plugged in. (This is the only
illuminated indicator until a sensor is detected, and provides an “on” indication to the user.) If the audible
alarms are not disabled, a 2-minute “temporarily disabled” timer starts the first time a sensor is plugged
in after power on. See “Disabling the Audible Alarms” on page 17 for additional information.
24
sensor is plugged in for the first time, the “audible
2
Page 32
Using the 9847 Pulse Oximeter
!
!
Audible Indicators
CAUTION: Do not block the audible indicator speaker holes. Blocking the speakers
will significantly reduce the sound volume.
CAUTION: Verify that the audible alarms can be heard over the ambient noise of the
operating environment.
Audible Indicators include medium priority equipment and high priority patient alarms, and informational
tones (breath beeps). For information on disabling the audible alarms, see “Disabling the Audible Alarms”
on page 17.
Audible and Visible Indicator Functions During Alarm Conditions
Table 4 summarizes the audible and visible indications that occur during the equipment and patient alarm
conditions.
NOTE: These rules assume that the audible alarms have not been temporarily or permanently
disabled using the “audible alarm disabled” switch.
Table 4: Audible and Visible Functions During Alarm Conditions
• Display “dash” sign in leftmost SpO
digit and freeze numeric displays for
10 seconds
• Display dashes in middle digit of SpO
and pulse rate displays 10 seconds
after first dash
• Corresponding dashes will blink if prior
Pulse oximeter sensor
disconnect, dislodgment, or
pulse oximeter sensor failure
Medium priority alarm
until valid signal again
detected, unless
audible high priority
patient alarm is latched
high priority pulse oximeter patient
alarms are latched
sensor reduced signal due
CO
2
to:
•CO
sensor disconnection
2
or
• Malfunction or
• Blocked light path or
Medium priority alarm
until valid signal again
detected, unless
audible high priority
• Third and sixth bars of CO
steadily illuminated
• Latched prior no breath indicator
blinking
display
2
patient alarm is latched
• Airway adapter tube
removed from the CO
2
sensor
a.Note that if a critical battery condition occurs while the audible alarms are disabled, the audible alarms will become re-
enabled. A medium priority alarm will sound unless there is a high priority alarm condition in effect.
2
2
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. The breath beeps
will only sound during the quiet part of an alarm burst sequence.
The “variable pitch” (fixed pitch “off”) breath beep is the default setting at setup. During variable pitch
breath beeps, the tone of the breath beeps is indexed to the number of bars illuminated on the CO
graph. The more bars lit, the higher the pitch. In variable pitch mode, breath beeps will sound at
inspiration (on the falling edge of the CO
waveform).
2
However, if desired the “fixed pitch” breath beep (fixed pitch “on”) can be selected at setup. The “fixed
pitch” breath beep has a pitch higher than the highest bar graph-indexed pitch. In fixed pitch mode,
breath beeps will sound during exhalation (on the rising edge of the CO
waveform). During power on
2
initialization and when changing the breath beep sound volume, beeps will sound as fixed pitch.
Each time the 9847 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, unless an audible alarm is in progress.
NOTE: The advance switch will not alter the volume of the medium and high priority audible
alarms.
bar
2
26
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Using the 9847 Pulse Oximeter
!
Audible Critically Low Battery Alarm
The audible critically low battery alarm is a medium priority equipment alarm indicating that the batteries
have reached a critically low level and must be replaced immediately. The 9847 will not monitor patients
after the batteries reach a critical power level. Also during this medium priority alarm, the visible low
battery indicator blinks.
If a high priority patient alarm condition exists before reaching critically low battery level, the audible and
visible alarms will “latch”. A “latched” patient alarm condition will sound a high priority patient audible
alarm. A high priority patient visible alarm indicator that is “latched” for a critically low battery will either
blink (for no breath or pulse quality) or will display three blinking dashes (for SpO
CAUTION: The critically low battery state overrides the audible alarm disable switch.
If a critically low battery condition occurs and the audible alarms are either
temporarily or permanently disabled, the audible alarms will become re-enabled. A
medium priority alarm will sound unless there is a high priority alarm condition in
effect. The “audible alarm disabled” indicator will not be illuminated.
The audible critically low battery alarm cannot be disabled by the alarm disable switch.
or pulse rate).
2
Audible SpO2 High or Low Alarm
The audible SpO2 alarm is a high priority patient alarm that sounds (if the audible alarms are not disabled)
when the SpO
visible alarm indication will occur. See “SpO
The audible and visible indicators will stop when the condition is cleared.
high or low alarm limits are reached or exceeded. (Also during this high priority alarm, a
2
and Pulse Rate Displays” on page 21 for more information.)
2
Audible Pulse Rate High or Low Alarm
The audible pulse rate alarm is a high priority patient alarm that sounds (if the audible alarms are not
disabled) when the pulse rate high or low alarm limits are matched or exceeded. (Also during this high
priority alarm, a visible alarm indication will occur. See “SpO
more information.) The audible and visible indicators will stop when the condition is cleared.
and Pulse Rate Displays” on page 21 for
2
Audible Pulse Quality Alarm
The audible pulse quality alarm is a high priority patient alarm that sounds (if the audible alarms are not
disabled) when the pulse signals that are detected are of inadequate pulse quality. (During this high
priority alarm, the pulse quality indicator will blink red as it normally does in inadequate pulse quality
situations, and can be latched (will continue) for the critical battery state. See “Pulse Quality Indicator”
on page 22 for additional information.) The audible and visible indicators will stop when the condition is
cleared.
Audible No Breath Alarm
The audible no breath alarm is a high priority patient alarm that sounds (if the audible alarms are not
disabled) when a breath has not been detected for a period of time exceeding the set no breath delay
time (measured in seconds). (Also during this high priority alarm, the visible no breath indicator blinks.)
If a CO
most cases, however, during “fixed pitch” breath beep mode, when the airway adapter tube is
disconnected from the CO
sensor alarm occurs, existing audible and visible no breath indicators will latch (continue). In
2
sensor, the audible and visible no breath (apnea) indicators will stop.
2
27
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Using the 9847 Pulse Oximeter
When a breath is again detected, the audible and visible no breath indicators will stop. The no breath
delay timer is first started when the CO
mode (that is, when the lower bar is illuminated on the CO
sensor is connected into the 9847 and the system is not in setup
2
bar graph).
2
Audible Pulse Oximeter Sensor Alarm
The pulse oximeter sensor alarm is a medium priority equipment audible alarm that sounds when the
pulse oximeter sensor is either disconnected, dislodged, or a pulse oximeter sensor failure occurs. (Also
during this medium priority alarm, visible indicators will occur.) The audible and visible pulse oximeter
sensor alarm indicators will stop when the condition is corrected.
Audible CO2 Sensor Alarm
The CO2 sensor alarm is a medium priority equipment audible alarm. Conditions that may cause the
audible equipment alarm include:
•the CO
• the airway adapter tube is removed from the CO
sensor is unplugged,
2
sensor,
2
• the light path is blocked, or
•a CO
Also during this medium priority alarm, a visible indication occurs (a CO
and sixth bars on the CO
audible and visible CO
sensor failure occurs.
2
bar graph will be steadily illuminated (see “CO2 Bar Graph” on page 23). The
2
sensor alarm indicators will stop when the condition is corrected.
2
sensor fault) where the third
2
Description of Alarm Sounds
The pitch of the alarm sounds is the same as a “volume” beep (the tone heard when changing the breath
beep sound volume).
NOTE: Audible alarm volumes are fixed. The audible alarms can be disabled, but their volumes
are not user-adjustable.
The sound sequence for the high priority alarm consists of 3 short beeps, a delay, and then 2 more beeps
within a 1 second period; then an identical pattern after a 1 second delay. This sound sequence then
repeats every 10 seconds until the high priority patient alarm condition is cleared.
The sound sequence for the medium priority alarm consists of 3 medium long beeps within a 1 second
period. This sound sequence will repeat every 25 seconds until the medium priority equipment alarm
condition is cleared.
Audible Indicator Sound Control Priorities
Only one audible alarm or informational tone may sound at a time. However, more than one type of alarm
condition may occur at the same time. (For example, a critical battery condition could begin while a no
breath condition is occurring). Therefore, the 9847 software uses a set of “rules” to determine the priority
of these sounds. These sound control rules are described in Table 5.
NOTE: These priorities assume that the audible alarms have not been temporarily or
“permanently” disabled using the “audible alarm disabled” button.
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Using the 9847 Pulse Oximeter
ConditionSound Control Priorities
Table 5: Audible Indicator Sound Control Priorities
Low Battery Level
• Critically Low Battery
Level or
• Pulse Oximeter Sensor
Alarm or
•CO2 Sensor Alarm
(medium priority equipment
alarm)
•SpO
high or low or
2
• Pulse rate high or low or
• Inadequate pulse
quality or
• No breath
(high priority patient alarm)
Normal sound operation; steadily illuminated low battery
indicator only.
Medium priority audible alarm unless a prior high priority patient
alarm is “latched”. When “latched” it will sound a high priority
patient alarm.
If a critically low battery condition occurs and the audible alarms
are either temporarily or permanently disabled, the audible
alarms will become re-enabled. A medium priority alarm will
sound unless there is a high priority alarm condition in effect.
The medium priority sound cycle will not be restarted should a
new equipment alarm condition occur; the existing sound will be
maintained.
The onset of a high priority patient alarm condition will cause the
initiation of the high priority patient alarm.
If a medium priority equipment alarm condition occurs after the
onset of a patient alarm condition, the patient alarm state will be
latched and will not be overridden by the equipment alarm.
When the patient alarm condition is cleared and there is an
equipment alarm in effect, then the medium priority sound will be
started.
Audible alarms re-enabled
via Audible Alarm Disable
Button or ending of 2-minute
disable
Breath beep
When the audible alarms are re-enabled, and at least one alarm
condition exists, the sound cycle for the highest priority alarm
condition in effect at that time will be started.
Note: The critically low battery state overrides the audible alarm
disable. If a critically low battery condition occurs and the audible
alarms are either temporarily or permanently disabled, the
audible alarms will become re-enabled. A medium priority alarm
will sound unless there is a high priority alarm condition in effect.
Informational beeps will occur only during the “quiet” part of any
alarm sound in progress. (Or the beep volume can be set to
“OFF”.)
29
Page 37
Carbon Dioxide (CO2) Sensor and Airway Adapter Tube
!
!
!
Carbon Dioxide (CO2) Sensor and Airway Adapter
Tube
WARNING: Do not use the Model 9847 CO
old and weighing less than 10 kg (22 lb) due to the dead space introduced by the
airway adapter tube.
WARNING: Do not use a damaged sensor. If the sensor is damaged in any way,
discontinue use immediately and replace the 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 CO
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 CO
detector for patients younger than 3 years
2
2
sensor.
2
Carbon Dioxide Sensor
The Model 9840SA CO2 Sensor is a crescent-shaped device containing light emitting and detecting
elements (Figure 6) on the end of a cable that connects to the 9847. The CO
the Model 9840AAT Airway Adapter Tube, which in turn is connected between the endotracheal tube and
the breathing circuit of intubated patients.
sensor is connected on to
2
Figure 6: Model 9840SA Carbon Dioxide Sensor
30
Page 38
Carbon Dioxide (CO2) Sensor and Airway Adapter Tube
!
Windows
Tabs
(To Breathing
Device)
(To Endotracheal
Tube )
Reflector
Airway Adapter Tube
WARNING: Do not use the Model 9847 CO
detector for patients younger than 3 years
2
old and weighing less than 10 kg (22 lb) due to the dead space introduced by the
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 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.
WARNING: The Model 9840AAT Airway Adapter Tube will increase dead space by
approximately 6 cubic centimeters (0.4 cubic inches); this may adversely affect
ventilation for patients with small tidal volumes.
CAUTION: 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.
The Model 9840AAT Airway Adapter Tube (Figure 7) 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 connects to the CO
sensor so that the two devices do not move relative to each other (you
2
may notice the connection by feel or sound).
The CO
detector will not function properly unless the light emitting and detecting elements of the CO2
2
sensor are properly aligned with the windows in the airway adapter tube.
Figure 7: Model 9840AAT Airway Adapter Tube
31
Page 39
Carbon Dioxide (CO2) Sensor and Airway Adapter Tube
(Note: The ends of the airway adapter tube can be placed
in either direction relative to the CO
2
sensor.)
B
A
C
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
NOTE: It is possible to force the airway adapter tube and the CO2 sensor into an improper
alignment and connection. However, the CO
pieces are correctly attached to each other.
sensor (Figure 8-A). The reflector should face away from the CO2 sensor.
2
detector will not function properly unless these
2
2. Join the tabs on one side of the airway adapter tube onto either side of the CO
sensor (Figure 8-
2
A), then rotate the airway adapter tube (Figure 8-B) and push firmly to set the other pair of tabs.
You should hear a clicking sound as the pieces are connected together (Figure 8-C).
Figure 8: Connecting the Airway Adapter Tube to the CO
3. Ensure that the airway adapter tube and the CO
sensor are firmly attached to each other. Gently
2
Sensor
2
tug on the assembly to make sure the pieces are tightly connected.
NOTE:
Both sides of the airway adapter tube must be connected 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.
See Figure 9 for an illustration of the configuration.
NOTE: Not all tapered connectors are compatible with the airway adapter tube. Ensure that all
connections are secure.
32
Page 40
Carbon Dioxide (CO2) Sensor and Airway Adapter Tube
Model 9840AAT
Airway Adapter
Tube
Model 9847
Endotracheal
Tub e
Model 9840SA
CO
2
sensor
The Breathing Circuit (a breathing
device, breathing bag, ventilator,
etc.)
Figure 9: The Airway Adapter Tube and the Breathing Circuit
33
Page 41
Care and Maintenance
Care and Maintenance
Wipe the device with a soft cloth dampened with a mild detergent or 10% bleach solution. Do not use
undiluted bleach or any cleaning solution other than those recommended here, as permanent damage
could result. Dry with a soft cloth, or allow to air dry.
Clean the device separately from the sensors. For instructions on cleaning pulse oximeter sensors, refer
to the respective sensor instructions for use.
CAUTION: Do not place the Model 9847 in liquid or clean it with agents containing
!
ammonium chloride, isopropyl alcohol, or products that are not listed in this User’s
Guide.
Maintenance
The 9847 requires no routine calibration or maintenance, other than battery replacement.
CAUTION: Do not use caustic or abrasive cleaning agents on the device or the
!
sensors.
CAUTION: Do not autoclave or immerse the device or sensors in liquid. Do not
!
expose the device or components to excessive moisture or liquids.
Plus7
The Oxitest
by Datrend Systems, Inc. can be used to verify operation of the pulse oximeter.
Cleaning the CO2 Sensor
CAUTION: Do not immerse the CO
!
abrasive cleaning agents on the CO
The CO2 sensor is protected against splashing water.
Cleaning the CO2 Sensor
Clean the Model 9840SA CO2 Sensor with a soft cloth dampened with isopropyl alcohol. Do not pour or
spray any liquids onto the Model 9840SA CO
thoroughly before reusing.
sensor in liquid, and do not use caustic or
2
sensor.
2
Sensor. Allow the Model 9840SA CO2 Sensor to dry
2
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 Technical Service department for
shipping instructions.
34
Page 42
Memory Functions
Memory Functions
Memory
The 9847 can collect and store up to 24 hours of SpO2 and pulse rate information.
Nonin offers nVISION
computer. nVISION is an easy to use Windows
analysis, report generation, and data storage.
The solid-state memory in the device 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 device 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
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.
®
Data Management Software for Oximetry Screening, for use with a personal
®
-based program for pulse oximetry data retrieval,
and pulse rate are sampled
2
NOTE: CO2 detector data is not stored in memory.
During data retrieval, the last data recorded is the first displayed. For example, the last four minutes of
data recorded are the first four minutes displayed.
Recording Sessions
Each time the device is turned on (except while setting the clock) data is automatically collected.
NOTE: Only recording sessions greater than one minute in length are kept in memory for later
printing.
Memory Playback Mode
1. With the unit off, press and hold the alarm limit review button while pressing and then releasing
the on/standby button.
2. Release the alarm limit review button when “888 888” is displayed on the SpO
displays. Three brief beeps will sound and “ALr” and “dFt” appear in the SpO
displays.
3. Data will be automatically played back from the memory.
NOTE: The keypad sequence for starting memory playback is identical to the sequence used for
entering setup mode.
and pulse rate
2
and pulse rate
2
Data are played back at a rate of 20 minutes of collected data per second. A 24-hour recording session
(the maximum memory saved) is played back in approximately 1 minute. After all data are played back
the device should be shut off before collecting new patient data. The patient information is held in
35
Page 43
Memory Functions
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 24 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.
36
Page 44
Communications
Communications
Real-Time Serial Output
The 9847 provides real-time data output capability via the pulse oximeter sensor connector (a 9-pin
Sub-D connector). The sensor connector pin assignments are listed below.
Pin NumberAssignment
1Sensor Detect
2IR Drive
3Red Drive
4Serial Data Output
5Signal
6Sensor Type
7Ground
8NC
9Sensor Bias
Real-time data can also be transmitted to another device through the serial data infrared link (Sensor
Connector) at the top of the device. Refer to Figure 2 on page 7 for the location of the Sensor Connector.
The information from the device 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.
Real-time data may be printed or displayed by compatible devices. 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 device
in the following format:
HH:MM:SS SPO2=XXX HR=YYY
NOTE: Marked events will display as an asterisk (*) at the end of the line.
where “HH” represents the hour the real-time clock is set to, “MM” represents the minutes, “SS”
represents the seconds, “XXX” represents the SpO
and pulse rate will be displayed as “---” if there are no data available for the data reading.
SpO
2
value, and “YYY” represents the pulse rate. The
2
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.
37
Page 45
Communications
!
Connecting the Device into a Medical System
Incorporating the device into a medical system requires the integrator to identify, analyze, and evaluate
the risks to patient, operators, and third parties. Subsequent changes to the medical system after device
integration could introduce new risks and will require additional analysis. Changes to the medical system
that must be evaluated include:
• Changing the system configuration
• Adding devices to or disconnecting devices from the system
• Updating or upgrading equipment connected to the system
Issues resulting from user-initiated system changes may include corruption or loss of data.
NOTES:
• When using the serial port to connect the device to other equipment, follow each device’s
cleaning instructions.
• Verify all equipment connected to the device is suitable for the patient’s environment.
CAUTION: Failure of a network data coupling (serial cable/connectors) will result in
loss of data transfer.
38
Page 46
Service, Support and Warranty
!
!
Nonin Medical, Inc.
13700 1st Avenue North
Plymouth, Minnesota 55441, USA
+1 (763) 553-9968
(800) 356-8874 (USA and Canada)
Fax +1 (763) 553-7807
E-mail: technicalservice@nonin.com
Nonin Medical B.V.
Prins Hendriklaan 26
1075 BD Amsterdam, Netherlands
+31 (0)13 - 79 99 040 (Europe)
Fax: +31 (0)13 - 79 99 042
E-mail: technicalserviceintl@nonin.com
Service, Support and Warranty
CAUTION: This device is a precision electronic instrument and must be repaired by trained Nonin
personnel only. Field repair of the device is not possible. Do not attempt to open the case or repair the
electronics. Opening the case may damage the device and void the warranty.
CAUTION: 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 advanced digital circuitry within the Model 9847 requires no periodic maintenance or calibration. Nonin does
not recommend field repair of the Model 9847.
For additional technical information, contact Nonin’s Technical Service department at:
nonin.com
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 a complete retest of the Model 9847 using factory test fixtures.
Warranty
NONIN MEDICAL, INCORPORATED, (Nonin) warrants to the purchaser, for a period of three years from the
date of purchase, each Model 9847 Pulse Oximeter and CO
batteries. (Refer to the individual package inserts for specific warranty information for sensors, cables, and other
accessories.) Nonin shall repair or replace any Model 9847 found to be defective in accordance with this
warranty, 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 Model 9847 delivered to the purchaser which is 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. Nonin reserves the right to charge a fee for a warranty repair request on any unit
found to be within specifications.
The Model 9847 is a precision electronic instrument and must be repaired by knowledgeable and specially
trained Nonin personnel only. Accordingly, any sign or evidence of opening the Model 9847, field service by
non-Nonin personnel, tampering, or any kind of misuse or abuse of the Model 9847, 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:
Detector exclusive of sensors, cables, and
2
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.
39
Page 47
Parts and Accessories
Parts and Accessories
For more information about Nonin parts and accessories:
• See the Parts and Accessories List on the Operator’s Manual CD.
• Contact your distributor or Nonin at (800) 356-8874 (USA and Canada), +1 (763) 553 9968, or
+31 (0)13 - 79 99 040 (Europe).
• Visit nonin.com
Detailed information regarding specific sensor use (patient population, body/tissue, and application) can
be found in the respective sensor Instructions for Use.
WARNING: The use of accessories, sensors, and cables other than those specified in
the Parts and Accessories List may result in increased electromagnetic emission and/
or decreased immunity of this device.
WARNING: To avoid patient injury, use only with Nonin-branded PureLight pulse
oximeter sensors. These sensors are manufactured to meet the accuracy
specifications for Nonin Pulse Oximeters. Using other manufacturers’ sensors can
result in improper pulse oximeter performance.
40
Page 48
Troubleshooting
Troubleshooting
ProblemPossible CausePossible Solution
The device won’t turn on.The batteries are depleted.Replace all 6 batteries.
The batteries are installed incorrectly.Verify battery orientation, illustrated
inside the battery compartment or on
the device label.
The Low Battery indicator is
steadily lit or flashing.
A dash appears in the leftmost
position of the SpO
display.
2
The middle digits display
dashes in both the SpO
pulse rate
displays.
and
2
The displayed pulse rate does
not correlate to the pulse rate
displayed on the ECG monitor
when used together.
The battery level is low or critically low.Replace all six batteries of the 9847.
An incorrect battery installation.Verify correct battery orientation.
A SpO
failure, misalignment, or incompatibility
with the monitor).
sensor fault exists (disconnect,
2
Verify that the sensor is correctly
connected to the device and the
patient; replace sensor if the
condition persists.
A non-compatible SpO
used.
No SpO
signal is detected.Verify the sensor connection.
2
sensor is being
2
Replace the sensor with a Noninbranded PureLight sensor.
A sensor failure.Replace the sensor with a Nonin-
branded PureLight sensor.
Excessive motion at the sensor site may
be prohibiting the device from detecting
a consistent pulse signal.
The patient may have an arrhythmia
Eliminate or reduce the cause of the
motion or
reposition the sensor to a
new sensor site.
Assess the patient.
resulting in some heart beats that do not
detect a pulse quality signal at the
sensor site.
A non-compatible sensor is being used.Replace the sensor with a Nonin-
branded PureLight sensor.
An inconsistent Pulse Rate or
a yellow Pulse Quality display
during the use with
electrosurgical unit (ESU).
The Pulse Quality LED is
blinking yellow with each
pulse.
The ECG monitor may not be
functioning properly.
The ESU may be interfering with the
pulse oximeter performance.
The quality of the pulse signal at the
sensor site is inadequate.
Assess the patient.
Assess the patient. Move the device,
cables, and sensors as far away
from the ESU as possible.
Assess the patient. Reposition
sensor or
select an alternate sensor
site.
41
Page 49
Troubleshooting
ProblemPossible CausePossible Solution
Pulse Quality LED does not
blink green.
The Pulse Quality display is
blinking red and the SpO
and/
2
or Pulse Rate displays are
dashes.
Inadequate pulse signal
Reposition the sensor.
or
the sensor site is poorly perfused
or
the sensor is not correctly positioned.
The sensor is restricting blood
circulation at the sensor site.
Circulation is reduced due to excess
pressure between the sensor and a
hard surface.
Remove the restriction to increase
blood circulation at the sensor site
relocate the sensor.
or
Allow the sensor and the application
site to rest comfortably on the
surface.
Excessive ambient light.Reduce ambient light.
Excessive patient motion.Reduce patient motion.
The patient is wearing nail polish or
Remove nail polish or artificial nails.
artificial nails.
Performance degradation from:
Reduce or eliminate the source.
• arterial catheter
• blood pressure cuff
• infusion line.
Inadequate pulse signal at sensor site.Assess the patient. Reposition
sensor or select an alternate sensor
site.
Inadequate pulse signal due to
excessive motion.
Reduce patient motion. Reposition
relocate the sensor.
or
SpO
Sensor failure.Replace the SpO2 sensor.
2
Numeric display segments are
Defective LEDs.Discontinue use of the device.
missing.
The lower CO
bar is not
2
The CO2 sensor is not plugged in.Plug the CO2 sensor in.
illuminated.
Only the third and sixth CO
bars are illuminated.
The CO2 sensor has become
2
disconnected.
The airway adapter tube is not
connected to the CO
sensor.
2
Reconnect the CO2 sensor.
Verify that the airway adapter tube is
connected, with windows toward the
sensor.
The light path is blocked.Replace the airway adapter tube.
Degradation of device
performance.
The CO
Electromagnetic interference (EMI).Remove the device from the EMI
sensor lamp is burned out.Replace the CO2 sensor.
2
environment.
Note: If these solutions do not correct the problem with your device, please contact Nonin Technical
Service at (800) 356-8874 (USA and Canada), +1 (763) 553-9968, or +31 (0)13 - 79 99 040 (Europe).
42
Page 50
Technical Information
!
!
!
Technical Information
NOTE: This product complies with ISO 10993-1, Biological Evaluation of Medical Devices Part 1:
Evaluation and Testing.
CAUTION: A functional tester cannot be used to assess the accuracy of a pulse
oximeter monitor or sensor.
CAUTION: All parts and accessories connected to the serial port of this device must
be certified according to at least IEC Standard EN 60950, IEC 62368-1. or UL 1950
for data-processing equipment.
CAUTION: Portable and mobile RF communications equipment can affect medical
electrical equipment.
Manufacturer’s Declaration
Refer to the following table for specific information regarding this device’s compliance to IEC 60601-1-2.
This device is intended for use in the electromagnetic environment specified below. The 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 establishments,
including domestic and those directly connected to
N/A
N/A
the public low-voltage power supply network that
supplies buildings used for domestic purposes.
43
Page 51
Table 7: Electromagnetic Immunity
Technical Information
Immunity TestIEC 60601 Test Level
Compliance
Level
Electromagnetic Environment—
Guidance
This device is intended for use in the electromagnetic environment specified below. The user of this device
should ensure that it is used in such an environment.
Electrostatic
Discharge (ESD)
IEC 61000-4-2
±6 kV contact
±8 kV air
±6 kV contact
±8 kV air
Floors should be wood, concrete, or
ceramic tile. If floors are covered
with synthetic material, the relative
humidity should be at least 30%.
Electrical Fast
Transient/Burst
IEC 61000-4-4
±2 kV for power supply
lines
±1 kV for input/output
N/A
N/A
Mains power quality should be that
of a typical commercial or hospital
environment.
lines
Surge
IEC 61000-4-5
±1 kV differential mode
±2 kV common mode
N/A
N/A
Mains power quality should be that
of a typical commercial or hospital
environment.
Voltage dips, short
interruptions, and
voltage variations on
power supply input
lines
IEC 61000-4-11
±5% U
(>95% dip in UT)
T
for 0.5 cycle
±40% U
(60% dip in UT)
T
for 5 cycles
±70% U
(30% dip in UT)
T
for 25 cycles
<5% U
(>95% dip in UT)
T
N/AMains power quality should be that
of a typical commercial or hospital
environment. If the user of the
device requires continued operation
during power mains interruptions, it
is recommended that the device be
powered from an uninterruptible
power supply or battery pack.
for 5 sec.
Power Frequency (50/
60 Hz) Magnetic Field
IEC 61000-4-8
Note: U
is the AC mains voltage before application of the test level.
T
3 A/m3 A/mPower frequency magnetic fields
should be at levels characteristic of
a typical location in a typical
commercial or hospital environment.
44
Page 52
Technical Information
d1.17P=
d1.17P=
d2.33P=
Table 8: Guidance and Manufacturer’s Declaration—Electromagnetic Immunity
Immunity Test
IEC 60601
Test Level
Compliance
Level
Electromagnetic Environment—
Guidance
This device is intended for use in the electromagnetic environment specified below. The user of this device
should ensure that it is used in such an environment.
Portable and mobile RF communications equipment should be used no closer to any part of the device,
including cables, than the recommended separation distance calculated from the equation applicable to
the frequency of the transmitter.
Recommended Separation Distance
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms
150 kHz to 80 MHz
3 V/m
80 MHz to 1.0 GHz
3 V/m
1.0 GHz to 2.5 GHz
3 V
3 V/m
a
3 V/m
0.5 V/md
b
where P is the maximum output power rating
of the transmitter in watts (W) according to
the transmitter manufacturer and d is the
recommended separation distance in meters
(m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site
survey
level in each frequency range.
c
, should be less than the compliance
d
Interference may occur in the vicinity of
equipment marked with the following symbol:
NOTES:
• At 80 MHz and 800 MHz, the higher frequency range applies.
• These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption
and reflection from structures, objects, and people.
a. SpO2 and HR operate as intended.
b. Breath detection is affected at fields greater than specified level.
c. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land
mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with
accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey
should be considered. If the measured field strength in the location in which the device is used exceeds the
applicable RF compliance level above, the device should be observed to verify normal operation. If abnormal
performance is observed, additional measures may be necessary, such as reorienting or relocating the device.
d. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
45
Page 53
Technical Information
d1.17P=
d1.17P=
d2.33P=
Table 9: Recommended Separation Distances
This table details the recommended separation distances between portable and mobile RF
communications equipment and this device.
This device is intended for use in an electromagnetic environment in which radiated RF disturbances are
controlled. Users of this device can help prevent electromagnetic interference by maintaining a minimum
distance between portable and mobile RF communication equipment (transmitters) and the device as
recommended below, according to maximum output power of the communications equipment.
Separation Distance According to Frequency of Transmitter
Rated Maximum
Output Power of
Transmitter W
0.010.120.120.23
0.10.370.370.74
11.21.22.3
103.73.77.4
100121223
For transmitters rated at a maximum output power not listed above, the recommended separation
distance d in meters (m) can be estimated using the equation applicable to the frequency of the
transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the
transmitter manufacturer.
NOTES:
• At 80 MHz and 800MHz, the separation distance for the higher frequency range applies.
• These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption
and reflection from structures, objects, and people.
150 kHz to 80 MHz
80 MHz to 800 MHz
800 MHz to 2.5 GHz
Equipment Response Time
If the signal from the sensor is inadequate, the last measured SpO2 and pulse rate values freeze for
10 seconds and are then replaced with dashes.
SpO2 decreases 0.75% per second (7.5% over 10 seconds)
Pulse Rate = 75 BPM
Specific to this example:
• The response of the 4-beat average is 1.5 seconds.
Testing Summary
SpO2 accuracy, and low perfusion testing was conducted by Nonin Medical, Inc., as described below:
SpO2 Accuracy Testing
SpO2 accuracy testing is conducted during induced hypoxia studies on healthy, non-smoking, light- to
dark-skinned subjects during motion and no-motion conditions in an independent research laboratory.
The measured arterial hemoglobin saturation value (SpO
hemoglobin oxygen (SaO
) value, determined from blood samples with a laboratory co-oximeter. The
2
accuracy of the sensors in comparison to the co-oximeter samples measured over the SpO
70% to 100%. Accuracy data is calculated using the root-mean-squared (A
ISO 80601-2-61, Medical Electrical Equipment—Particular requirements for the basic safety and
essential performance of pulse oximeter equipment for medical use.
Pulse Rate Motion Testing
This test measures pulse rate oximeter accuracy with motion artifact simulation introduced by a pulse
oximeter tester. This test determines whether the oximeter meets the criteria of ISO 80601-2-61 for pulse
rate during simulated movement, tremor, and spike motions.
) of the sensors is compared to arterial
2
range of
2
value) for all subjects, per
rms
Low Perfusion Testing
This test uses an SpO2 Simulator to provide a simulated pulse rate, with adjustable amplitude settings at
various SpO
ISO 80601-2-61 for heart rate and SpO
levels for the oximeter to read. The oximeter must maintain accuracy in accordance with
2
at the lowest obtainable pulse amplitude (0.3% modulation).
2
47
Page 55
Technical Information
Principles of Operation
Pulse oximetry is a non-invasive method that passes red and infrared light through perfused tissue and
detects the fluctuating signals caused by arterial pulses. Well-oxygenated blood is bright red, while poorly
oxygenated blood is dark red. The pulse oximeter determines functional oxygen saturation of arterial
hemoglobin (SpO
) from this color difference by measuring the ratio of absorbed red and infrared light
2
as volume fluctuates with each pulse.
Specifications
Oxygen Saturation Display Range0% to 100% SpO
Pulse Rate Display Range18 to 321 beats per minute (BPM)
CO
Range0 to >75mmHg
2
CO
Response Time250 ms
2
Respiration Rate Range1 to 60 breaths per minute
Breath Detection Threshold5 mmHg
Accuracy – SensorsDeclared accuracy data for compatible sensors can be