Nonin LS1 Operator's Manual

Operator’s Manual

0123

LifeSense

Model LS1

Capnography/Pulse Oximetry

®

II

0123

Monitor

English

Nonin makes no claim for use of the product other than those uses specified herein and disclaims
any liability resulting from other uses. Observe all warnings, cautions, and notes.

Unauthorized use, copying, or distribution of this manual is prohibited without written consent from
Nonin Medical, Inc.

Nonin Medical, Inc.

13700 1st Avenue North

Plymouth, MN 55441, USA

[phone] (outside USA)

[phone] (USA and Canada)

Fax: [phone]

E-mail: [e-mail]

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: [e-mail]

nonin.com

01230123

EC

REP

MPS, Medical Product Service GmbH

Borngasse 20

D-35619 Braunfels, Germany

References to “Nonin” in this manual imply Nonin Medical, Inc. Nonin, LifeSense, Flexi-Form,
FlexiWrap, and PureLight are registered trademarks or trademarks of Nonin Medical, Inc. Other
trademarks and trade names are those of their respective owners.

© 2016 Nonin Medical, Inc.

111331-001-02

Contents

Indications for Use ........................................................................................ 1

Warnings ............................................................................................................... 1

Cautions ................................................................................................................ 2

Guide to Symbols .......................................................................................... 5

Introduction.................................................................................................... 7

About LifeSense II ................................................................................................. 7

About Capnometry................................................................................................. 7

About Pulse Oximetry............................................................................................ 7

System Components..................................................................................... 8

LifeSense II Monitor............................................................................................... 9

Rechargeable Battery.......................................................................................... 11

Battery Replacement ....................................................................................... 12

SpO

Sensors ..................................................................................................... 12

2

Sample Line ........................................................................................................ 12

Intended Use.................................................................................................... 12

Applying the Sample Line ................................................................................ 12

Nafion Tubing ...................................................................................................... 13

Attaching the Nafion Tubing............................................................................. 13

Single-Patient Use, Disposable Moisture Trap and Filter.................................... 13

Replacing the Moisture Trap/Filter................................................................... 13

PSG DAC Cables ................................................................................................ 14

Capno RTC Cable ............................................................................................... 14

Display Screens........................................................................................... 15

Select Alarm Group Screen................................................................................. 15

Operating Screen ................................................................................................ 17

Trend Screen....................................................................................................... 19

Using the LifeSense II Monitor ................................................................... 21

Start-up Sequence .............................................................................................. 21

Shut Down Modes ............................................................................................... 21

Standby Mode.................................................................................................. 21

Deep Sleep Mode ............................................................................................ 22

System Setup ...................................................................................................... 22

Monitoring a Patient............................................................................................. 23

Configuration Menu ............................................................................................. 24

Language/Units Screen....................................................................................... 25

Responsible Organization Settings Screen......................................................... 26

Minimum Alarm Volume................................................................................... 27

Default Alarm Volume ...................................................................................... 27

Alarm Limits – PR, SpO

Reset Device to Factory Defaults .................................................................... 28

, EtCO2, RR.............................................................. 27

2

i

Contents (Continued)

New PIN............................................................................................................ 28

Factory Service................................................................................................. 28

Date/Time Screen ................................................................................................ 29

Alarm Lock Mode Screen..................................................................................... 30

Calibration Screen................................................................................................ 30

Calibration Procedure....................................................................................... 30

Alarm Limit Settings ................................................................................... 32

Alarm Limits ......................................................................................................... 32

Alarms .......................................................................................................... 34

High Priority Alarms ............................................................................................. 34

Medium Priority Alarms ........................................................................................ 36

Inoperable Alarms ................................................................................................ 37

Low Priority Alarms .............................................................................................. 37

Data Output and Software .......................................................................... 38

Device Memory .................................................................................................... 38

Download Patient Data ........................................................................................ 38

USB Drive Requirements.................................................................................. 38

Recommended SanDisk

Download Data from the Monitor...................................................................... 39

Clear Memory....................................................................................................... 39

Data Format ......................................................................................................... 40

Monitor Software .................................................................................................. 41

Connecting the Device into a Medical System..................................................... 42

®

USB Flash Drives ................................................... 38

Maintenance and Inspection ...................................................................... 43

Maintenance......................................................................................................... 43

Ensuring Optimal Performance......................................................................... 43

Cleaning the Sensor ......................................................................................... 43

Cleaning the Monitor......................................................................................... 43

Recommended Inspections and Functional Check.............................................. 44

Troubleshooting .......................................................................................... 45

Accessories ................................................................................................. 49

Monitor Accessories............................................................................................. 49

PureLight Sensors................................................................................................ 50

Service, Support, and Warranty................................................................. 51

Warranty............................................................................................................... 51

Technical Information ................................................................................. 52

Operating Environment ........................................................................................ 52

Storage Environment ........................................................................................... 52

ii

Contents (Continued)

Power Requirements ........................................................................................... 52

Manufacturer’s Declaration.................................................................................. 53

Equipment Response Time ................................................................................. 55

Testing Summary ................................................................................................ 56

SpO

Accuracy Testing.................................................................................... 56

2

Pulse Rate Accuracy Testing........................................................................... 56

Low Perfusion Accuracy Testing...................................................................... 56

System Specifications ......................................................................................... 57

Pulse Oximeter Specifications............................................................................. 58

Capnography Specifications................................................................................ 58

iii

Figures

Figure 1. Monitor Features.......................................................................................... 9

Figure 2. Replacing the Moisture Trap/Filter............................................................. 14

Figure 3. Select Alarm Group Screen....................................................................... 15

Figure 4. Operating Screen....................................................................................... 17

Figure 5. Trend Screen............................................................................................. 20

Figure 6. Start-up Screen.......................................................................................... 21

Figure 7. Access Configuration Menu (Nonin Logo)................................................. 24

Figure 8. Configuration Menu ................................................................................... 24

Figure 9. Language/Units Screen ............................................................................. 25

Figure 10. Responsible Organization Settings Screen ............................................. 26

Figure 11. Date/Time Screen.................................................................................... 29

Figure 12. Alarm Lock Mode Screen ........................................................................ 30

Figure 13. Calibration Screen ................................................................................... 31

Figure 14. Operating Screen with Alarms................................................................. 34

Figure 15. Sample Patient Data (_gd.csv File) ......................................................... 40

Figure 16. Sample Capnography Waveform Data (_cw.csv File)............................. 40

Figure 17. Sample Pulse Timing Data (_pt.csv File)................................................. 40

iv

Tables

Table 1. Symbols....................................................................................................... 5

Table 2. Monitor Features ....................................................................................... 10

Table 3. Select Alarm Group Screen – Display Descriptions.................................. 16

Table 4. Operating Screen – Display Descriptions.................................................. 17

Table 5. Trend Screen – Display Descriptions........................................................ 20

Table 6. Alarm Limit Settings .................................................................................. 32

Table 7. High Priority Alarms................................................................................... 35

Table 8. Medium Priority Alarms ............................................................................. 36

Table 9. Inoperable Alarms ..................................................................................... 37

Table 10. Low Priority Alarms ................................................................................. 37

Table 11. Electromagnetic Emissions ..................................................................... 53

Table 12. Electromagnetic Immunity....................................................................... 53

Table 13. Guidance and Manufacturer’s Declaration—Electromagnetic Immunity. 54

Table 14. Recommended Separation Distances..................................................... 55

v

Indications for Use

Indications for Use

The LifeSense II, Model LS1, capnography/pulse oximetry monitor is indicated for use in
simultaneously measuring, displaying, monitoring, and recording functional oxygen saturation of
arterial hemoglobin (SpO
poorly perfused adult, pediatric, and infant patients. It is intended for use in environments where
patients require continuous, non-invasive monitoring of these parameters by a healthcare
professional, including hospitals, long-term care, medical facilities, sleep laboratories, home
healthcare, subacute environments, and Emergency Medical Services (EMS), including patient
transport.

Contraindication: Do not use the monitor in an MR environment or in the presence of flammable anesthetics or gases.

Warnings

This system is not intended to be used simultaneously on multiple patients.

This device is intended only as an adjunct device in patient assessment. It must be used in conjunction with other methods of
assessing clinical signs and symptoms.

The monitor is not classified as an apnea monitor.

This monitor is not intended for use with inhalation halogenated agents.

Verify all alarm settings and limits during system start-up to ensure that they are set as intended.

Before each use, it is the operator’s responsibility to verify that the alarm limits are appropriate for the patient being monitored.

Ensure that all alarm volumes are audible in all situations. Do not cover or obstruct any speaker openings.

When turning on the monitor, verify that a beep is heard. If a beep is not heard, do not use the device. The speaker may not be
functioning properly.

Atmospheric pressure compensation occurs during system startup.

- An increase in the surrounding environment’s atmospheric pressure may cause the system to display incorrect readings until
the system stabilizes.

- A decrease in the surrounding environment’s atmospheric pressure may cause the system to not detect an occlusion when
the condition exists.

A hazard can exist if different presets are used on multiple LifeSense II monitors in one care area.

To prevent improper performance and/or patient injury, verify compatibility of the monitor, sensor, and accessories before use.

Never allow liquids to enter into or to be spilled onto the monitor. If liquid has penetrated into the monitor, it must be checked by
Nonin Technical Service.

This device is only defibrillation proof when used with Nonin-specified power supplies, cables, and accessories. To avoid
patient injury, only use Nonin-specified power supplies, cables, and accessories (see Accessories).

To avoid patient injury, use only Nonin-branded PureLight
the accuracy specifications of Nonin pulse oximeters. Using other manufacturers’ sensors can result in improper pulse
oximeter performance.

Inspect the pulse oximeter sensor application site at least every 4 hours to ensure correct sensor alignment and skin integrity.
Patient sensitivity to sensors and/or adhesive strips may vary due to medical status or skin condition.

Avoid excessive pressure to the sensor application site as this may cause damage to the skin beneath the sensor.

Do not use a damaged sensor. If the sensor is damaged in any way, discontinue use immediately and replace the sensor.

Misuse or improper handling of the pulse oximeter sensor could damage the sensor or the cable, which may lead to inaccurate
readings. Never alter or modify the device or the sensor since this may affect the performance or accuracy.

), end tidal carbon dioxide (EtCO2), respiration, and pulse rate of well or

2

®

pulse oximeter sensors. These sensors are manufactured to meet

1

Indications for Use

!

Warnings (Continued)

The monitor displays a flashing yellow battery indicator (low battery) when it has approximately 60 minutes of use remaining
before it shuts itself off.

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.

Prior to connecting the monitor to the power supply and a power outlet, be sure to verify the voltage and frequency rating on
the power supply are the same as the outlet. If this is not the case, do not connect the monitor and power supply to the outlet.

The use of accessories other than those specified in this manual may result in increased electromagnetic emission and/or
decreased immunity of this device.

As with all medical equipment, carefully route cables and cannula to reduce the possibility of entanglement, strangulation, or
tripping.

Refer to the applicable sensor instructions for use for additional warnings and cautions.

Cautions

LifeSense II should only be operated by trained licensed practitioners.

To prevent damage to the monitor, operate and store the monitor in an upright position.

Visually inspect the monitor for damage before each use. Do not use a damaged monitor or system.

Verify display functionality before each use.

Setting alarm limits to extremes can render the alarm system useless.

Each time the system is turned on, audible alarms are silenced for 2 minutes unless the operator presses the Audio Pause
button.

When an alarm is acknowledged and audible alarms are paused, new alarms will have visual indicators, but not an audible
indicator.

Capnography alarms are not active until the first breath is detected.

Oximetry alarms are not active until the first pulse is detected.

To ensure the longevity and safety of the monitor, the carrying case must be used when operating the monitor in an emergency
medical services (EMS) environment.

Do not mount the monitor directly above the patient. If the monitor is mounted, be sure to check that the adjustable mounting
clamp is securely affixed.

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 result in tipping, damage to the equipment, or injury.

Do not use cables longer than 3 meters (10 feet).

Always turn off the monitor prior to cleaning the monitor. Do not place the device in liquid or clean it with agents containing
ammonium chloride or bleach. Do not sterilize or autoclave the monitor or accessories.

Do not simultaneously touch the accessible connector pins and the patient.

After exposing the monitor to an environment outside of normal room temperature/humidity conditions, always replace the
moisture trap and filter before each use.

The sample line, moisture trap, filter, and Nafion tubing are single-patient use, disposable components. Do not reuse
disposable accessories. Accessories marked “single-use” must be used on one patient only and be disposed of after usage.
Dispose of all components in accordance with your local, state or national regulations regarding waste management.

Set or adjust alarm parameters one at a time.

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.

2

Indications for Use

!

- excessive ambient light

- excessive motion

- blood flow restrictors (arterial
catheters, blood pressure cuffs,
infusion lines, etc.)

- moisture in the sensor

- improperly applied sensor

- incorrect sensor type

- inadequate signal

- venous pulsations

- anemia or low hemoglobin
concentrations

- cardiogreen and other
intravascular dyes

- carboxyhemoglobin

- methemoglobin

- dysfunctional hemoglobin

- artificial nails or fingernail polish

- residue (e.g., dried blood, dirt,
grease, oil) in the light path

Cautions (Continued)

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:

The patient’s nasal passage may dry out if continuous monitoring is required. Check patient hourly for nasal comfort.

When using sample lines that also deliver oxygen to the patient, it is important to be aware that the EtCO
when used in combination with supplemental oxygen. To obtain a true EtCO
oxygen be disconnected for a few seconds to establish a baseline.

If the EtCO
Troubleshooting). Replace the single-use, disposable moisture trap and perform the calibration procedure. If the problem
persists, contact Nonin Technical Service.

In order to prevent damage to the equipment, always charge the battery to full capacity before storing the monitor.

Avoid rapid temperature change or extreme temperatures. This can cause malfunction.

Never store or transport the monitor where condensation can occur. If condensation does occur, wait until all condensation has
evaporated before using the monitor.

The temperature of the monitor may exceed 41 °C, but will not exceed 49 °C when operating at high ambient temperatures
(40 °C). Limit skin contact to less than 1 minute and inspect the contact area often. Patient sensitivity may vary due to medical
status or skin condition.

Do not attempt to replace the battery inside the monitor. The battery is not field replaceable and cannot be replaced by the
operator. Use only Nonin-specified components. Use of another battery may present a risk of fire or explosion. Contact Nonin
Technical Service when the battery needs replacing. Battery replacement by inadequately trained personnel could result in a
hazardous situation.

Do not charge Li-Ion batteries at a temperature of 0 °C (32 °F) or less as this may result in significantly reduced battery life.

Do not use the power supply if the integrity of the AC cord conductors or the outlet is in doubt.

This device is a precision electronic instrument and must be repaired by Nonin Technical Service. 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.

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.

When using the monitor in the home, avoid exposing the monitor to lint and dust.

When using the monitor around small children and pets, avoid leaving the monitor unattended. Cables and cannulas pose a
risk of injury, including strangulation. Small items (e.g., filter) are choking hazards.

Be careful not to drop the monitor on the floor or strike it against hard surfaces. If such an incident happens, do not use the
monitor until a functional test has been performed.

The monitor is equipped with automatic barometric pressure compensation. End tidal pCO
based on an atmospheric pressure of 760 mmHg and pH

This monitor is equipped with isolation and protects the patient against burns when used with high-frequency surgical
equipment.

Water or other liquid in the sample line may cause erroneous EtCO

Ensure that all connections are tight, leak-free, and properly attached.

value is out of normal range (4.4 – 5.7 Vol%/kPa or 33 – 43 mmHg) an internal air leak is possible (see

2

value may be diluted

reading, it is recommended that the supplemental

2

values displayed are calculated

O of 47 mmHg (example: 760 – 47 = 713, 713 x 5% = 36 mmHg).

2

readings or an occlusion.

2

2

2

3

Indications for Use

!

Cautions (Continued)

If the Nafion tubing becomes contaminated or damaged during use, discard it and replace it with a new one.

A functional tester cannot be used to assess the accuracy of a pulse oximeter monitor or sensor.

Portable and mobile RF communications equipment can affect medical electrical equipment.

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 towers and TV broadcast towers may affect accuracy.

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 in this manual.

All parts and accessories connected to the USB 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.

Failure of a network data coupling (USB cable/connectors) will result in loss of data transfer.

If the entire memory is filled, portions of the oldest record will be overwritten when new data is written.

Refer to the applicable sensor instructions for use for additional warnings and cautions.

4

Guide to Symbols

!

01230123

EC

REP

C

L

A

S

S

I

F

I

E

D

US

C

U

L

Guide to Symbols

This chapter describes the symbols that are found on the system components and packaging.

Table 1. Symbols

Symbol Description/Function

CAUTION!

Follow Instructions for Use.

CE Marking indicating conformance to EC Directive No. 93/42/EEC
concerning medical devices.

Authorized representative in the European Community.

Indicates separate collection for electrical and electronic equipment (WEEE).

IP22

Class II, double insulated

UL Mark for Canada and the United States with respect to electric shock, fire,
and mechanical hazards only in accordance with:

• ANSI/AAMI ES60601-1:2005/(R)2012 and CAN/CSA-C22.2 No.
60601-1:14

• ISO 80601-2-61:2011, IEC 60601-2-49:2011, IEC 60601-2-55:2011,
IEC 60601-1-8: 2006+A1:2012

Defibrillation-Proof Type BF-Applied Part (patient isolation from electrical
shock). Defibrillator-proof isolation is implemented into the device, so any
sensor connected to the device is protected.

Protected against vertically falling water drops when enclosure is tilted up to
15 degrees and against access to hazardous parts with a finger per
IEC 60529.

Green charging indicator (LED)

On/Standby button

Audio Pause button

Power supply input

USB port

NONIN SpO

Sensor input

2

Luer lock connector for sample line, Nafion tubing, or cannula

Do not reuse (moisture trap)

5

Table 1. Symbols (Continued)

REF

SN

QTY

USUS

Symbol Description/Function

Federal law (USA) restricts this device to sale by or on the order of a licensed
practitioner.

Manufacturer

Catalogue number

Serial number

Guide to Symbols

QTY

Quantity

Temperature limitation for storage/shipping

RoHS compliant (China)

Date of manufacture

Country of manufacture

6

Introduction

!

Introduction

Each operator should read this manual before using the monitor.

About LifeSense II

LifeSense II allows healthcare professionals to non-invasively monitor pulse oximetry and capnometry
on either intubated or spontaneously breathing patients.

When measuring EtCO
adapter for an endotracheal tube, a nasal cannula, or a nasal cannula with supplemental oxygen
delivery. A variety of sample lines can be used and connected to a specially designed moisture trap,
which is easily snapped into the monitor. The sample lines can be used with or without Nafion
Pulse rate and SpO
with the system. Use only those accessories recommended by Nonin. Refer to the Accessories
section for more information.

The monitor has a touch screen display where settings and adjustments are made. The only buttons
on the monitor, On/Standby (off) and Audio Pause, are located on the upper right corner of the front
panel. Next to these buttons there is a small indicator that turns green when the monitor is connected
to a power outlet. The monitor operates on a fully-charged battery for approximately 5 hours.

, the patient is attached to the monitor by a sample line that can be an airway

2

®

tubing.

are measured by a Nonin-branded PureLight pulse oximetry sensor, provided

2

About Capnometry

The monitor uses sidestream non-dispersive infrared (NDIR) spectroscopy to continuously measure
the amount of CO
has been proven to be a reliable method for detecting esophageal intubation, hypoventilation, and
disengagement of the endotracheal tube during mechanical ventilation.

CAUTION: When using sample lines that also deliver oxygen to the patient, it is
important to be aware that the EtCO
combination with supplemental oxygen. To obtain a true EtCO
recommended that the supplemental oxygen be disconnected for a few seconds to
establish a baseline.

present at the end of exhalation (EtCO2), and respiratory rate (RR). Capnometry

2

value may be diluted when used in

2

reading, it is

2

About Pulse Oximetry

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
red and infrared light as the volume fluctuates with each pulse.

) from this color difference by measuring the ratio of absorbed

2

7

System Components

System Components

Carefully remove the monitor and accessories from the shipping carton. The standard system
configuration includes these non-sterile components:

• LifeSense II monitor

• Power supply and plug

• Nonin PureLight reusable pulse oximetry sensor

• Single-use, disposable moisture trap with filter

• Single-use, disposable filters (qty 3)

• Adult nasal cannula (qty 3)

• Sample line

• T-connector

• Operator’s manual (CD)

See Accessories for information on optional accessories.

After unpacking the monitor and accessories, connect the monitor to the power supply and a power
outlet and ensure the green LED charge indicator is lit.

Before using the monitor, charge it for at least 6 hours.

8

System Components

®

12 VDC

1.5A

0123

5

Front

Side

Back

1

2

34

10

11

12

7

8

9

6

5

LifeSense II Monitor

REF S/N

12 VDC, 1.5A

Use with Nonin Power Adapters

MEDICAL EQUIPMENT

30EM

MASS: 865g

IP22

Nonin Medical, Inc. Plymouth, MN USA

0123

110572-001-01

Figure 1. Monitor Features

9

Table 2. Monitor Features

No. Symbol/Name Description

1

Touch Screen
Display

The monitor’s LCD displays parameters, graphs, menus, and other
information.The display is a touch screen from which all operator-defined
settings are made.

See Display Screens section for additional screen information and
descriptions.

2 Charging Indicator

The LED indicator is green whenever the power supply is connected and
the battery is charging.

NOTE: When the external power supply is disconnected, the device
automatically switches to battery power without loss of functionality.

3 On/Standby Button

• On – Pressing this button once turns on the monitor.

System Components

• Standby (off) – When the monitor is on, pressing this button for
at least 3 seconds shuts down the monitor, putting it into Standby
mode. In Standby mode, all device functions are shut off, with the
following exceptions:

• The charging indicator is lit whenever the device is plugged in.

• Batteries are charged whenever the device is plugged in.

See Shut Down Modes for information about Standby and Deep Sleep
modes.

4 Audio Pause Button

Pressing the Audio Pause button temporarily silences audible alarms for
2 minutes. The operator can reactivate the alarms before the 2 minutes
are up by pressing the button again.

5 Luer Lock Connector

For attaching the sample line, Nafion tubing, or cannula.

6

Moisture Trap
with Filter
(Single-Use,
Disposable)

The moisture trap and filter are single-use, disposable components and
should be replaced after each patient. The filter fits into the moisture trap
and protects the monitor from moisture.

See Replacing the Moisture Trap/Filter for more information.

7

Mounting
Bracket
Attachment

The mounting bracket is screwed onto the back of the monitor. After
attaching the mounting bracket to the monitor, securely clamp the
monitor to the pole. See Accessories.

Holes

8

Label See the Guide to Symbols section for descriptions of the label symbols.

Every device has a unique serial number for identification.

10

System Components

!

Table 2. Monitor Features (Continued)

No. Symbol/Name Description

9 Speaker

WARNING: Ensure that all alarm volumes are audible in all
situations. Do not cover or obstruct any speaker openings.

10 USB Port

Connects a USB flash drive, PSG DAC cable, or Capno RTC cable to
the monitor.

CAUTION: All parts and accessories connected to the USB 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.

11

NONIN SpO

12 Power Supply Input

Sensor Input

2

Connects the SpO
for a complete list of compatible sensors. No other sensors may be
used.

WARNING: To avoid patient injury, use only Nonin-branded
PureLight pulse oximeter sensors. These sensors are
manufactured to meet the accuracy specifications of Nonin pulse
oximeters. Using other manufacturers’ sensors can result in
improper pulse oximeter performance.

Connects the power supply to the monitor. Only use Nonin-specified
power supplies.

sensor to the monitor. See the Accessories section

2

Rechargeable Battery

The monitor is designed to operate continuously when connected to a power outlet or for
approximately 5 hours on a fully-charged battery.

• A flashing yellow battery indicator (low battery) displays when the battery is almost depleted.
This gives the operator approximately 60 minutes of use, or time to plug in the monitor before
it switches itself off.

• A flashing red battery indicator (critical battery) displays when 10 minutes of power is left
before the monitor switches itself off.

Recharging a fully-depleted battery takes approximately 9 hours when using a Nonin-specified power
supply. Always connect the monitor to an outlet whenever it is not in use.

For more information, see the Internal Power section of the System Specifications.

CAUTION: Do not charge Li-Ion batteries at a temperature of 0 °C (32 °F) or less as
this may result in significantly reduced battery life.

WARNING: To avoid patient injury, only use Nonin-specified power supplies, cables,
and accessories (see Accessories).

11

System Components

!

!

!

Battery Replacement

The battery, made of Lithium Ion (Li-Ion) rechargeable cells, is integral to the device and cannot be
replaced by anyone other Nonin Technical Service. The life expectancy of the battery is approximately
1 year.

CAUTION: Do not attempt to replace the battery inside the monitor. The battery is
not field replaceable and cannot be replaced by the operator. Use only Nonin­specified components. Use of another battery may present a risk of fire or explosion.
Contact Nonin Technical Service when the battery needs replacing. Battery
replacement by inadequately trained personnel could result in a hazardous situation.

For optimal performance, the battery should be replaced once per year to limit the amount of Li build
up if the battery is charged in a cold environment.

SpO2 Sensors

See the Accessories section for a complete list of compatible sensors. Detailed information regarding
specific sensor use (e.g., patient population, body/tissue, application) can be found in the respective
sensor instructions for use.

Sample Line

Intended Use

The sample line is used to measure the content of carbon dioxide in exhaled air (EtCO2). It is single­use, disposable tubing that connects to the monitor’s moisture trap with a Luer lock connector. One
sample line is included in the standard kit. The monitor can be fitted with several types of sample lines
to best suit the patient (see Accessories).

The following instructions refer to the nasal cannula supplied in the standard system configuration.
Other sample lines have separate instructions included in their packaging.

Applying the Sample Line

1. Insert the cannula into the patient’s nostrils.

2. Place the tubing behind each ear.

3. Connect the Luer lock fitting to the moisture trap and twist to tighten.

WARNING: To avoid patient injury, only use Nonin-specified power supplies, cables,
and accessories (see Accessories).

CAUTION: The sample line, moisture trap, filter, and Nafion tubing are single-patient

use, disposable components. Do not reuse disposable accessories. Accessories
marked “single-use” must be used on one patient only and be disposed of after
usage. Dispose of all components in accordance with your local, state or national
regulations regarding waste management.

CAUTION: The patient’s nasal passage may dry out if continuous monitoring is
required. Check patient hourly for nasal comfort.

12

System Components

!

!

!

!

!

Nafion Tubing

The Nafion tubing is a single-use, disposable component designed to be placed between the moisture
trap and the nasal cannula or sample line to remove water vapor.

Attaching the Nafion Tubing

1. Connect male end of the Nafion tubing to the moisture trap. Turn clockwise to tighten.

2. Connect female end of the Nafion tubing to the sample line or cannula. Turn clockwise to
tighten.

3. Ensure that the Nafion tubing is firmly attached.

CAUTION: Water or other liquid in the sample line may cause erroneous EtCO
readings or an occlusion.

CAUTION: Ensure that all connections are tight, leak-free, and properly attached.

CAUTION: If the Nafion tubing becomes contaminated or damaged during use,

discard it and replace it with a new one.

2

Single-Patient Use, Disposable Moisture Trap and Filter

The moisture trap and filter are single-patient use, disposable components. During long-term
monitoring of a patient, the moisture trap fills up with liquid (condensed moisture from breathing).
Check the moisture trap frequently and replace when necessary.

Make sure to keep a sufficient supply of new moisture traps and filters within easy reach.

When the moisture trap is removed, guide marks (numbered 1 and 2) and arrows, are visible on the
back of the monitor. These guide marks help the operator insert the moisture trap.

Replacing the Moisture Trap/Filter

CAUTION: The sample line, moisture trap, filter, and Nafion tubing are single-patient

use, disposable components. Do not reuse disposable accessories. Accessories
marked “single-use” must be used on one patient only and be disposed of after
usage. Dispose of all components in accordance with your local, state or national
regulations regarding waste management.

CAUTION: After exposing the monitor to an environment outside of normal room
temperature/humidity conditions, always replace the moisture trap and filter before
each use.

1. Place the filter in the moisture trap so the silicone gasket faces up and hydrophobic material
fits inside the moisture trap opening (figure 2-A).

2. Using the guide marks on the back of the monitor, align the groove at the top of the moisture
trap with the ridge at the top of the trap housing on the monitor (figure 2-B).

13

System Components

A

B

C

3. The trap is tilted in top first, then bottom. Press the moisture trap into position using the tab
(figure 2-C). There should be a tactile click and the moisture trap should be flush with the side
and back of the monitor.

4. To remove the moisture trap and replace the filter, use the tab to pull the moisture trap away
from the monitor. Remove the filter from the moisture trap. If the filter is not in the moisture
trap, check to see if it is still attached to the monitor.

Figure 2. Replacing the Moisture Trap/Filter

PSG DAC Cables

Nonin’s PSG DAC (Polysomnography Digital-to-Analog Converter) cables connect the monitor to a
polysomnograph to record data (EtCO

Refer to the individual PSG DAC cable instructions for use for more information.

, respiratory rate, SpO2, and CO2).

2

Capno RTC Cable

Nonin’s Capno RTC digital USB cable transmits real-time data from the monitor to another device
(e.g., computer).

Refer to the Capno RTC instructions for use for more information.

14

Display Screens

1

2

3

Display Screens

The following section describes the icons and their functions on the select alarm group, operating, and
trend screens.

Select Alarm Group Screen

NOTE: This screen does not display if the monitor has locked alarm limits (see Alarm Lock Mode
Screen section).

The select alarm group screen (figure 3) displays after the start-up screen. On this screen, the
operator may select alarm limits for a patient under 30 kg, over 30 kg, or select the last used alarm
settings.

If a selection is not made within approximately 8 seconds, the monitor defaults to the over 30 kg alarm
limits.

Figure 3. Select Alarm Group Screen

15

Table 3. Select Alarm Group Screen – Display Descriptions

No. Description

1 Alarm Limits ≤30kg / 66lbs

Pressing this icon selects the default alarm limits for patients weighing 30 kg (66 lbs) or
less.

• If the Responsible Organization Settings have not been set, the alarm limits will be
the factory default settings (see table 6).

• If the Responsible Organization Settings are set, the alarm limits may be restricted
by the Responsible Organization alarm limits.

2 Alarm Limits >30kg / 66lbs

Pressing this icon selects the default alarm limits for patients weighing more than 30 kg
(66 lbs).

• If the Responsible Organization Settings have not been set, the alarm limits will be
the factory default settings (see table 6).

• If the Responsible Organization Settings are set, the alarm limits may be restricted
by the Responsible Organization alarm limits.

Display Screens

3 Last Used Alarm Setting

Pressing this button selects the last used alarm settings and alarm volume.

16

Display Screens

Operating Screen

The main operating screen (figure 4) displays parameters, graphs, and other information.

NOTE: If a pop-up window displays while monitoring, the icons and alarm limit up/down arrows
cannot be used until the pop-up window is closed.

12

11

2

1

14

6

3

8

9

4

10

5

13

7

15

Figure 4. Operating Screen

Table 4. Operating Screen – Display Descriptions

No. Symbol/Name Description

1 Alarm Limits

The high alarm limit is always located above the displayed
value, and the low alarm limit is always located below the
displayed value.

When the parameter readings fall between the low and high
settings, they are treated as normal values. Values outside
these limits activate both audible and visual alarms. The limit
that triggered the alarm flashes on the display.

See Alarm Limits for more information.

2

3

PR BPM

SpO2 %

Displays the pulse rate as beats per minute (BPM).

Displays percent (%) oxygen saturation (%SpO2).

17

Table 4. Operating Screen – Display Descriptions (Continued)

No. Symbol/Name Description

Display Screens

4

EtCO2 mmHg

or

Displays the volume of end tidal CO2 in exhaled air. EtCO2 is
shown as mmHg or kPa.

EtCO2 kPa

5

6

RR BrPM

SpO

Messages

2

Example:

7

EtCO

Messages

2

Example:

8 Audible Alarm

9

Displays the respiration rate in breaths per minute.

Shows pulse oximeter alarm messages. See Alarms for more
information.

Shows capnometer alarm messages. See Alarms for more
information.

No symbol means audible alarms are enabled.

A bell with dashed lines indicates that audible alarms are
paused.

A bell with solid lines indicates that audible alarms are off.

Battery

The battery indicator shows the approximate percentage of
battery life remaining.

Full Partial

• Full/Partial – Battery indicator is green.

• Low – Battery indicator flashes yellow.

• Critical – Battery indicator flashes red.

• Charging – Battery indicator displays a lightning bolt
when the monitor is connected to the power supply and

Low Critical Charging

a power outlet.

NOTE: When the monitor reaches a low or critical battery
condition, an audible alarm sounds if the audible alarm is on.
To clear the alarm, connect the monitor to the power supply
and a power outlet.

10 Trend

Touch this icon to display the trend screen. The trend screen
automatically closes after 1 minute or if an alarm activates.

11

Pulse Plethysmogram Displays a graph of the pulse signal. The signal displays

75 samples per second.

12

/1, /2, /4, or /8

Plethysmogram Scale Factor

Scale factor will be either /1, /2, /4, or /8 and is automatically
set by the monitor.

18

Display Screens

Medium

Maximum (default)

Off

Table 4. Operating Screen – Display Descriptions (Continued)

No. Symbol/Name Description

13

Respiration Capnogram Displays a graph of the respiration and EtCO

14 Brightness

Pressing this icon allows the operator to change the
brightness of the display while monitoring. Options are
maximum (default), medium, and low.

15 Audible Alarm Volume

Pressing this icon allows the operator to change the audible
alarm volume while monitoring. The minimum alarm value is
set on the Responsible Organization Settings screen.

.

2

To set the volume to Off, the operator must press

OK

in the
“Audible Alarms Off” pop-up window. The audible alarm may
only be shut off if allowed by the Responsible Organization
Settings.

NOTES:

• Configure the alarm volume options using the

Responsible Organization Settings screen (see the
Minimum Alarm Volume and Default Alarm Volume
sections).

• Audible alarms cannot be shut off if the Minimum Alarm

Volume field is set to Medium or Maximum.

• The default alarm volume is either the saved Default

Alarm Volume or the last used volume (if Last Used
Alarm Setting is selected at start-up).

Trend Screen

The trend screen displays up to 4 hours of trending data for pulse rate, SpO2, EtCO2, and respiration
rate. The scale of the graphs is automatically set and cannot be adjusted. The 4-hour timescale is
divided into 30-minute segments.

To access the trend screen (figure 5), press the Trend icon on the operating screen.

NOTE: If a new alarm activates while the trend screen is displayed, the trend screen closes and
the display returns to the operating screen so the alarm condition is visible.

The trend screen automatically closes after 1 minute. To manually exit the trend screen, press Close.

All trend data clears when the device is turned off.

19

Display Screens

2

1

4

5

6

3

Figure 5. Trend Screen

Table 5. Trend Screen – Display Descriptions

No. Description

1 Trend Graphs – Pulse Rate (PR), SpO

, EtCO2, and Respiration Rate (RR)

2

2 Trend Timescale

3 Alarm Indicators

Indicates the parameter’s reading is outside the defined high alarm limit.

Indicates the parameter’s reading is outside the defined low alarm limit.

4 Audible Alarm

No symbol means audible alarms are enabled.

A bell with dashed lines indicates that audible alarms are paused.

A bell with solid lines indicates that audible alarms are off.

5 SpO

Messages

2

Shows pulse oximeter alarm messages. See Alarms for more information.

6 EtCO

20

Messages

2

Shows capnometer alarm messages. See Alarms for more information.

Using the LifeSense II Monitor

!

!

Figure 6. Start-up Screen

Using the LifeSense II Monitor

Before use, ensure the battery is fully charged by viewing the battery indicator on the display.

CAUTION: To ensure the longevity and safety of the monitor, the carrying case must
be used when operating the monitor in an emergency medical services (EMS)
environment.

CAUTION: To prevent damage to the monitor, operate and store the monitor in an
upright position.

Start-up Sequence

Each time the monitor is turned on, it performs a brief
start-up sequence.

1. Press and hold On/Standby until the LCD lights

up and displays “Please Wait....” An audible beep

sounds while holding the button.

2. A second audible beep (speaker test) sounds
when the Nonin logo start-up screen (figure 6)
displays. The lower left corner of the screen
shows the monitor’s software revision.

Verify each of the above items occur on initialization.
If any do not occur, contact Nonin Technical Service
for assistance.

If the clock is not set, the message “System Time is
Not Set” displays above the software revision.

If the warning “Settings File CRC Error, Restoring Factory Default Settings” pop-up displays, all
settings but the clock revert back to the factory defaults.

If the “Calibration Due” pop-up displays, press OK to continue or allow the message to time out
(5 seconds). This message will display during start-up until the monitor is calibrated.

NOTE: The Responsible Organization Settings screen is accessed through the start-up screen.
See the Responsible Organization Settings Screen section for more information.

Shut Down Modes

To conserve battery life, the monitor has two shut down modes – Standby mode and Deep Sleep
mode. Start-up from Standby mode is slightly faster than start-up from Deep Sleep mode.

Standby Mode

The monitor enters Standby mode if the battery indicator at shut down is green or if the monitor is
connected to a power supply.

21

Using the LifeSense II Monitor

!

Deep Sleep Mode

If the monitor is not plugged in and has been in Standby mode for more than an hour, it enters Deep
Sleep mode.

The monitor immediately enters Deep Sleep mode if the battery level at shut down is either low (yellow
battery indicator) or critical (red battery indicator).

System Setup

1. Place the monitor in a position so the display can be clearly seen.

• If using the monitor portably or in an environment without power, the monitor can operate for

approximately 5 hours on a fully-charged battery. The battery indicator on the display shows
the battery capacity.

• If using the monitor while connected to the power supply and a power outlet, the green

charging indicator is lit. The battery indicator on the display shows a lightning bolt to indicate
the battery is charging.

2. Visually inspect the monitor and make sure it has no visible signs of damage.

3. Examine the sensor for obvious defects. Ensure the sensor is clean if it has been previously
used.

4. Connect the sensor to the SpO

5. Replace the single-use, disposable moisture trap and filter before each use. Refer to Single-
Patient Use, Disposable Moisture Trap and Filter for instructions on how to replace the
moisture trap and filter.

CAUTION: After exposing the monitor to an environment outside of normal room
temperature/humidity conditions, always replace the moisture trap and filter before
each use.

6. Connect the sample line to the connector on the moisture trap and secure it by turning the
Luer lock connector clockwise. Only use sample lines recommended by Nonin (see
Accessories).

7. See Monitoring a Patient.

WARNING: Prior to connecting the monitor to the power supply and a power outlet, be
sure to verify the voltage and frequency rating on the power supply are the same as
the outlet. If this is not the case, do not connect the monitor and power supply to the
outlet.

WARNING: The monitor displays a flashing yellow battery indicator (low battery) when
it has approximately 60 minutes of use remaining before it shuts itself off.

port located on the side of the monitor.

2

22

Using the LifeSense II Monitor

!

!

!!!

Monitoring a Patient

1. Verify the system has been set up (see System Setup).

2. Apply the Nonin-branded sensor to the patient.

3. Attach the sample line to the patient, as described in Applying the Sample Line, or refer to the
individual sample line instructions for use.

4. Press On/Standby to turn the monitor on.

WARNING: When turning on the monitor, verify that a beep is heard. If a beep is not
heard, do not use the device. The speaker may not be functioning properly.

5. Monitor runs a self-test (see Start-up Sequence).

6. Select alarm limits. If alarm limits are locked, this screen does not display.

CAUTION: Each time the system is turned on, audible alarms are silenced for
2 minutes unless the operator presses the Audio Pause button.

CAUTION: Capnography alarms are not active until the first breath is detected.

CAUTION: Oximetry alarms are not active until the first pulse is detected.

7. Verify the graphs and alarm limits display on the touch screen display.

8. If allowed, adjust the alarm limits for the patient. Refer to Alarm Limit Settings for instructions
on how to change alarm limits.

9. The audible alarm function activates approximately 2 minutes after start-up. The operator can
activate the audible alarm before the 2 minutes are up by pressing the Audio Pause button.

10. The monitor is ready to use.

WARNING: Inspect the pulse oximeter sensor application site at least every 4 hours to
ensure correct sensor alignment and skin integrity. Patient sensitivity to sensors and/
or adhesive strips may vary due to medical status or skin condition.

CAUTION: The patient’s nasal passage may dry out if continuous monitoring is

required. Check patient hourly for nasal comfort.

CAUTION: Set or adjust only one parameter at a time.

11. When done monitoring, press On/Standby for 3 seconds to turn off the monitor.

12. Disconnect the patient.

NOTE: If the monitor is on and the patient is no longer connected, the alarm will activate.

23

Configuration Menu

Figure 7. Access Configuration

Menu (Nonin Logo)

The Configuration Menu allows the operator to:

• Change the display language and units of measurement (mmHg or kPa)

• Configure the Responsible Organization Settings

• Set the date and time

• Lock the alarm limits

• Calibrate the device

Access the Configuration Menu

1. Press On/Standby to turn the monitor on.

2. Start-up sequence begins.

3. When the Nonin logo start-up screen displays, press
the Nonin logo twice (double-tap). In figure 7, the
Nonin logo is highlighted with a white box.

4. Configuration Menu (figure 8) displays.

Using the LifeSense II Monitor

5. After configuring the monitor, click OK to close the
Configuration Menu and begin monitoring.

24

Figure 8. Configuration Menu

Using the LifeSense II Monitor

Language/Units Screen

This screen allows the operator to change the display language and the EtCO2 unit of measurement.

This screen is accessed through the Configuration Menu (see Access the Configuration Menu).

Defaults are English and mmHg.

Set Language and/or Units of Measurement

NOTE: When the Units of Measurement are changed, the Responsible Organization Settings
revert to the factory defaults.

1. On the Configuration Menu, press Language/Units. Language/Units screen (figure 9)
displays.

2. Press desired language. A check mark displays to the left of the selection.

3. Press desired units of measure. A check mark displays to the left of the selection.

4. When finished, press Save to save the changes, close the screen, and return to the
Configuration Menu. To exit without saving changes, press Cancel.

Figure 9. Language/Units Screen

25

Using the LifeSense II Monitor

Responsible Organization Settings Screen

This screen allows the operator to establish institution default high and low limits for pulse rate, SpO2,
EtCO

This screen is accessed through the Configuration Menu (see Access the Configuration Menu).

NOTES:

• The operator is required to enter a new 4-digit PIN the first time the Responsible Organization

• The Responsible Organization Settings are populated with factory default settings until

• Once a PIN is saved, the alarm limits become restricted to the high and low limits on the

1. On the Configuration Menu, press Responsible Organization Settings.

2. Enter the responsible organization PIN and press OK. Responsible Organization Settings

3. From this screen, the operator may:

, and respiration rate.

2

Settings screen is accessed or after restoring factory defaults.

changed by the organization.

Responsible Organization Settings screen.

screen displays (figure 10).

• Set the minimum alarm volume

• Set the default alarm volume

• Set the responsible organization’s alarm limits: pulse rate (PR), SpO

, EtCO2, and

2

respiration rate (RR)

• Reset the device to the factory defaults

• Change the 4-digit PIN

4. Press Save when all changes to the Responsible Organization Settings are complete. To exit
without saving changes, press Cancel.

26

Figure 10. Responsible Organization Settings Screen

Using the LifeSense II Monitor

Minimum Alarm Volume

This setting controls the monitor’s available audible alarm volume levels.

The default minimum alarm volume is Medium.

Set the Minimum Alarm Volume

1. Access the Responsible Organization Settings screen.

2. In the Minimum Alarm Volume field, press one of the options. Options include Off, Medium
(default), and Maximum. A check mark displays to the left of the selection.

• Off – all options are available when monitoring, including shutting audible alarms off.

• Medium – both medium and maximum alarm volumes are available when monitoring.

• Maximum – only the maximum alarm volume is available when monitoring.

Default Alarm Volume

The default alarm volume is Maximum.

Set the Default Alarm Volume

1. Access the Responsible Organization Settings screen.

2. In the Default Alarm Volume field, press one of the volume options. Options include Medium
and Maximum (default). A check mark displays to the left of the selection.

Alarm Limits – PR, SpO2, EtCO2, RR

The alarm limit settings allow the Responsible Organization to restrict upper and lower alarm limits.

Use the up/down arrows to adjust the high and low alarm limits to the desired values.

Set the Responsible Organization Alarm Limits

1. Access the Responsible Organization Settings screen.

2. In the PR (pulse rate) field, use the up/down arrows to adjust the high and low alarm limits to
the desired values.

3. Repeat, as needed, for each parameter.

27

Using the LifeSense II Monitor

Reset Device to Factory Defaults

This setting discards all user settings and returns the monitor to the factory default settings and alarm
limits.

Restore Factory Defaults

1. Access the Responsible Organization Settings screen.

2. Press Reset Device to Factory Defaults.

3. In the “Factory Restore” pop-up window:

•Press Yes to restore the factory defaults. The monitor:

- Reverts to the factory default minimum alarm volume, default alarm volume, and alarm
limits (see table 6).

- Deletes the PIN.

- Removes the Responsible Organization Settings limit restrictions.

•Press No to cancel.

New PIN

NOTE: The operator is required to enter a new 4-digit PIN the first time the Responsible

Organization Settings screen is accessed or after restoring factory defaults.

The PIN, which may be set to any 4-digit number, is used to unlock parameter settings on the
Responsible Organization Settings screen.

Change the PIN

1. Access the Responsible Organization Settings screen.

2. Press New PIN.

3. In the “Enter New PIN” pop-up window, enter a 4­digit PIN.

NOTE: If the PIN is less than four digits, the “Invalid
PIN Entered” pop-up window displays. Press OK to
acknowledge and press New PIN again.

4. Press OK to save the new PIN. To exit without
saving changes, press Cancel.

5. Display returns to the Responsible Organization
Settings screen.

Factory Service

This feature is only used by Nonin Medical, Inc.

28

Using the LifeSense II Monitor

Date/Time Screen

This screen allows the operator to set the monitor’s date and time (24-hour clock). The date/time is
used in the file name when downloading data. If the operator will not be downloading data, setting the
date/time is not required.

This screen is accessed through the Configuration Menu (see Access the Configuration Menu).

1. On the Configuration Menu, press Date/Time. Date/Time screen (figure 11) displays.

2. To select a field, press the up or down arrow for that field.

3. Tap the up arrow to increase the value; tap the down arrow to decrease the value. Steadily
press the arrow to scroll through the values.

4. When finished, press Save to save the date and time, close the screen, and return to the
Configuration Menu. To exit without saving changes, press Cancel.

Figure 11. Date/Time Screen

NOTE: When monitoring a patient after a complete loss of battery power, the date/time recorded

in new patient data files will begin counting from the date/time of the last shutdown.

29

Using the LifeSense II Monitor

Alarm Lock Mode Screen

This screen allows the operator to set and lock the monitor’s alarm limits.

NOTES:

• The locked alarm limits cannot be set to limits outside of the Responsible Organization limits.

• When alarm limits are locked, limits cannot be adjusted when monitoring.

This screen is accessed through the Configuration Menu (see Access the Configuration Menu).

1. On the Configuration Menu, press Alarm Lock Mode. Alarm Lock Mode screen (figure 12)
displays.

2. To lock the alarm limits, press On. A check mark displays to the left of the selection.

3. Use each parameter’s up/down arrows to adjust the high and low alarm limits.

4. When finished, press Save to save the changes, close the screen, and return to the
Configuration Menu. To exit without saving changes, press Cancel.

Figure 12. Alarm Lock Mode Screen

Calibration Screen

This screen is accessed through the Configuration Menu (see Access the Configuration Menu).

Calibration Procedure

The monitor has a built-in zero-point calibration function for CO2. Perform the calibration procedure
at least every 6 months, or if the baseline of the CO

The calibration apparatus (see Accessories) is reusable for approximately 100 times. When the
pellets start to turn purple they cannot absorb any more CO

30

graph is elevated.

2

and the calibration apparatus must be

2

Using the LifeSense II Monitor

!

replaced. Dispose of the calibration apparatus in accordance with your local, state, or national
regulations concerning waste materials.

1. Attach a calibration apparatus to the moisture trap.

2. Press On/Standby to turn on the monitor.

3. Access the Configuration Menu.

4. Press Calibration. Calibration screen (figure 13) displays.

Figure 13. Calibration Screen

5. Press Calibrate CO2. The monitor starts the calibration procedure.

6. Calibration takes 15 minutes to complete. When calibration is finished, the monitor returns to
the Configuration Menu.

7. Press OK to exit the Configuration Menu.

8. Disconnect the calibration apparatus.

9. Verify calibration:

a. Connect the gas valve, which is already equipped with a T-connector, to a gas bottle

containing 5 Vol% of CO

(verifying gas) and the monitor.

2

b. Verify that the gas valve needle is in the green zone of the dial indicator. If the gas valve

needle is in the red zone, the CO

tank is empty and should be replaced.

2

c. Release gas for 1 – 3 seconds (until the ball rises to the top of the column) and then turn off

the gas valve. This equals one exhale. The ball should return to the bottom of the column
when the gas valve is turned off. Repeat 2 – 3 times.

d. Verify the EtCO

reading on the display. A reading of 33 – 43 mmHg (4.4 – 5.7 kPa) is

2

considered normal. This should agree with the device accuracy claims found in the
Capnography Specifications section.

CAUTION: If the EtCO

value is out of normal range (4.4 – 5.7 Vol%/kPa or 33 –

2

43 mmHg) an internal air leak is possible. Replace the single-use, disposable
moisture trap and perform the calibration procedure. If the problem persists, contact
Nonin Technical Service.

31

Alarm Limit Settings

!

Alarm Limit Settings

If not locked, the operator can increase or decrease the alarm limit settings for individual patients. The
alarm limit settings may be restricted by the Responsible Organization Settings.

Press the up arrow to increase an alarm limit and the down arrow to decrease an alarm limit.

The high alarm limit is always located above the displayed value, and the low alarm limit is always
located below the displayed value.

Alarm Limits

CAUTION: Set or adjust only one parameter at a time.

During start-up, the operator can select from two different default settings or the last used alarm limits.

All parameters have built-in limits that cannot be exceeded.

Table 6. Alarm Limit Settings

Alarm Limit

Adjustment

Options

PR high 75 – 275 beats per

Adjustment

Increments

> 30 kg / 66 lbs

Patient (Defaults)

≤ 30 kg / 66 lbs

Patient (Defaults)

5 BPM 200 BPM 200 BPM

minute (BPM)

PR low 30 – 110 BPM 5 BPM 50 BPM 80 BPM

high 80 – 100% 1% 100% 95%

SpO

2

SpO

low 50 – 95% 1% 85% 85%

2

EtCO

EtCO

RR high 3 – 60 breaths per

high 0 – 99 mmHg

2

(0 – 13.2 kPa)

low 0 – 99 mmHg

2

(0 – 13.2 kPa)

1 mmHg
(0.1 kPa)

1 mmHg
(0.1 kPa)

57 mmHg
(7.6 kPa)

13 mmHg
(1.7 kPa)

57 mmHg
(7.6 kPa)

13 mmHg
(1.7 kPa)

1 BrPM 28 BrPM 60 BrPM

minute (BrPM)

RR low 3 – 60 BrPM 1 BrPM 6 BrPM 20 BrPM

WARNING: Verify all alarm settings and limits during system startup to ensure that
they are set as intended.

WARNING: Before each use, it is the operator’s responsibility to verify the alarm
limits are appropriate for the patient being monitored.

32

Alarm Limit Settings

!

!

WARNING: Ensure that all alarm volumes are audible in all situations. Do not cover or
obstruct any speaker openings.

CAUTION: Setting alarm limits to extremes can render the alarm system useless.

CAUTION: The monitor is equipped with automatic barometric pressure

compensation. End tidal pCO
atmospheric pressure of 760 mmHg and pH

values displayed are calculated based on an

2

O of 47 mmHg (example: 760 – 47 =

2

713, 713 x 5% = 36 mmHg).

33

Alarms

Alarms

The monitor has audible and visual alarm indicators to alert the operator in case immediate patient
attention is required or an equipment alarm occurs (figure 14). An audible or visual alarm remains
active until the condition is no longer present. Each parameter can only have one high or low limit
alarm at a time.

The Audio Pause button temporarily silences audible alarms for 2 minutes. The operator can
reactivate the audible alarm before the 2 minutes are up by pressing the button again.

NOTE: If a new alarm activates while the trend screen is displayed, the trend screen closes and
the display returns to the operating screen so the alarm condition is visible.

The intended operator’s position for correctly perceiving a visual alarm signal and its priority is 1 meter
(3.3 feet).

Figure 14. Operating Screen with Alarms

High Priority Alarms

High priority alarms require immediate attention to the patient. An alarm (table 7) occurs if any of the
parameters are outside the defined limits.

High priority alarms are both audible and visual.

34

Alarms

Table 7. High Priority Alarms

Alarm Visual Indicator Audible Indicator

PR High Limit – displays when pulse
rate is above the high alarm limit

PR Low Limit – displays when pulse
rate is below the low alarm limit

SpO

High Limit – displays when

2

SpO

is above the high alarm limit

2

SpO

Low Limit – displays when

2

is below the low alarm limit

SpO

2

EtCO
EtCO

EtCO
EtCO

High Limit – displays when

2

is above the high alarm limit

2

Low Limit – displays when

2

is below the low alarm limit

2

RR High Limit – displays when
respiration rate is above the high
alarm limit

PR high limit flashes red 2 times
per second.

PR low limit flashes red 2 times
per second.

high limit flashes red 2 times

SpO

2

per second.

SpO

low limit flashes red 2 times

2

per second.

EtCO

high limit flashes red

2

2 times per second.

EtCO

low limit flashes red 2 times

2

per second.

RR high limit flashes red 2 times
per second.

3 beeps, pause,
2 beeps, pause,
3 beeps, pause,
2 beeps, and a 6-second
pause.

This cycle repeats until
silenced or the alarm
condition is cleared.

RR Low Limit – displays when
respiration rate is below the low

RR low limit flashes red 2 times
per second.

alarm limit

No breath is detected for
approximately 30 seconds

“NO BREATH” displays with a red
background that flashes 2 times
per second.

Critical Low Battery Battery indicator flashes red

2 times per second.

35

Alarms

!

Medium Priority Alarms

A medium priority alarm indicates that an equipment fault has occurred and the device is unable to
provide a measurement value. See table 8 for medium priority alarms.

Medium priority alarms are both audible and visual.

Table 8. Medium Priority Alarms

Alarm Visual Indicator Audible Indicator

Low battery Battery indicator flashes yellow

once every 2 seconds.

Sensor fault:

• Sensor is not connected to
the monitor.

• Sensor is not connected to
the finger.

Poor signal quality. Hard to detect
pulse.

Occlusion:

• Low or no flow from sample
line or cannula

• Clogged filter in the moisture
trap

• Kinked sample line or
cannula

• Full trap

The indicator flashes yellow
once every 2 seconds.

The indicator flashes yellow
once every 2 seconds.

“OCCLUSION” displays with a
yellow background that flashes
once every 2 seconds.

To prevent damage to the pump,
the pump stops after 10 seconds
of occlusion and then displays a
pop-up window:

“Occlusion
Press OK To Resume”

3 beeps followed by a
20-second pause.

This cycle repeats until
silenced or the alarm
condition is cleared.

Incompatible USB flash drive has
been connected to the monitor.

When not using the SpO
medium and low priority oximetry alarms:

1. Turn the monitor off.

2. Disconnect the sensor.

3. Turn the monitor on.

Medium priority capnography alarms cannot be intentionally disabled.

CAUTION: Capnography alarms are not active until the first breath is detected.
Oximetry alarms are not active until the first pulse is detected.

36

and pulse rate parameters, the clinical operator can intentionally disable

2

“Incompatible USB” pop-up
window displays.

Alarms

Inoperable Alarms

Inoperable alarms (table 9) are medium priority alarms. To correct the condition, perform these steps:

1. Turn the monitor off and then back on again to remove the error message.

2. If the error persists, note the error code and contact Nonin Technical Service at (800) 356­8874 (USA and Canada), [phone], or +31 (0)13 - 79 99 040 (Europe).

Table 9. Inoperable Alarms

Message/Error Code Probable Cause

NO OXIMETER E03 No communication from the pulse oximetry unit.

NO CAPNO E04 No communication from capnography unit.

SPEAKER FAULT E05 Speaker is not working properly.

SYSTEM FAILURE E06 General system error.

BUTTON FAILURE E07 Audio Pause button is damaged.

MEMORY CORRUPT E08 Error detected in memory structure.

Low Priority Alarms

Low priority alarms do not have an audible alarm.

Table 10. Low Priority Alarms

Alarm Visual Indicator

Low perfusion. “LOW PERFUSION” displays with a cyan

background.

A poor pulse signal was detected. The cyan indicator displays.

37

Data Output and Software

!

Data Output and Software

Device Memory

The monitor can collect and store a minimum of 36 hours of patient data, including 8 hours of
waveform. To store data in memory, the monitoring duration must be at least 2 minutes.

Data may be downloaded from the monitor using a USB flash drive. Memory may be cleared once
data is downloaded.

Patient data are sampled every second.

• Oxygen saturation values are stored in 1% increments in the range of 0 – 100%.

• Pulse rate values are stored in 1 BPM increments in the range of 18 – 321 BPM.

•EtCO

13.2 kPa).

• Respiration rate values are stored in 1 BrPM increments in the range of 0 – 99 BrPM.

Patient data are retained even when both external and battery power are lost.

values are stored in 1 mmHg (0.1 kPa) increments in the range of 0 – 99 mmHg (0 –

2

The memory in the device functions much like an “endless loop” tape. When the memory is full, the
monitor begins overwriting the oldest data with new data.

CAUTION: If the entire memory is filled, portions of the oldest record will be
overwritten when new data is written.

Download Patient Data

USB Drive Requirements

• Formatted with FAT32 file system

• Compatible with USB 2.0 or 2.1

• More than 1 GB available space

• 100 mA maximum current draw

Recommended SanDisk® USB Flash Drives

Nonin has tested these flash drives with the monitor:

Name Size SanDisk P/N

Cruzer Glide™ 8 GB SDCZ60-008G-A46 (see Accessories section)

Cruzer Edge™ 8 GB SDCZ51-008G-A11

Cruzer Force™ 8 GB SDCZ71-008G-A46

Cruzer Blade™ 4 GB SDCZ50-004G-A46

NOTE: If USB flash drive performance issues occur, see the Troubleshooting section for more
information before contacting Nonin. Nonin cannot guarantee USB flash drive performance if a
recommended flash drive is not used.

38

Data Output and Software

Download Data from the Monitor

NOTE: Data cannot be downloaded if there is a

medium or high priority alarm.

1. With the monitor on, but not connected to a patient,
connect a USB flash drive to the monitor.

2. In the “USB Flash Drive Detected” pop-up window,
Download Memory? displays.

3. Press OK to download data. Press Cancel to return to the
operating screen.

4. Once the data download is complete, the “Download
Memory Complete” pop-up window displays. See Clear
Memory.

If the USB drive is disconnected during the download, the
“USB Drive Failure” pop-up displays.

Clear Memory

This procedure deletes patient data recordings from the
monitor.

1. In the “Download Memory Complete” pop-up window, Clear
Memory? displays.

2. Press OK to clear memory.

3. In the “Clear Memory” pop-up window, Are you sure?
displays.

4. Press Yes.

5. Memory Cleared displays.

6. Press OK and remove USB flash drive.

7. Operating screen displays.

39

Data Output and Software

Data Format

The download directory name is the monitor’s serial number (XXXXXXXXX) followed by the current
date and time.

Example: XXXXXXXXX_YYYY_MM_dd_hh_mm_ss

NOTE: If the correct date/time does not display, see Date/Time Screen for more information on
setting the clock.

Within the directory, patient data records are downloaded using a comma separated values (.csv)
format. The file names are automatically generated using the record number (XXXX), the start date
and time of the record, and the data type (zz).

Example: XXXX_ YYYY_MM_DD_hh_mm_ss_zz.csv

The data type (“_zz” in example) options are _gd (patient readings, alarm limits, and volume), _cw
(capnography waveform data), and _pt (pulse timing data).

NOTE: The patient data and capnography waveform data files are read and displayed using the
Capno Report Converter software (see Accessories).

Figure 15. Sample Patient Data (_gd.csv File)

Figure 16. Sample Capnography Waveform

Data (_cw.csv File)

Date: month, day, year

Time:

Hours, minutes, seconds (_gd.csv files)

Hours, minutes, seconds, 1/10 second (_cw.csv files if using “hh:mm:ss:0” custom cell format)
Hours, minutes, seconds, 1/100 second (_pt.csv files if using “hh:mm:ss:00” custom cell format)

Figure 17. Sample Pulse Timing Data

(_pt.csv File)

SpO

, PR, EtCO2, and RR are the current values (_gd.csv files). CO2 is the current value (_cw.csv

2

files). Pulse_Time is the time between consecutive pulses in seconds (_pt.csv files). Blank if data is
missing [dashes on display].

40

Data Output and Software

PulseOx_Status, Capno_Status, and Sys_Status Bits:

PulseOx_Status

Bit

Description

23 Reserved 23 Reserved 7 Alarm Silence

22 Sensor Disconnect Bit 22 Reserved 6 Low Batt

21 Artifact Bit 21 Reserved 5 Reserved

20 Out of Track Bit 20 Reserved 4 Reserved

19 Sensor Alarm Bit 19 Reserved 3 Reserved

Perfusion Bits

18

‘10’ – red perfusion
‘01” – green perfusion

17

‘11’ – yellow perfusion

16 Reserved 15 Reserved

15 Reserved 14 Reserved

14 Reserved 13 Reserved

13 Reserved 12 Reserved

12 Reserved 11 Occlusion – Pump Off

11 No S p O

10 Reserved 9 No Breath Alarm

2

Capno_Status

Bit

Description

18 Reserved 2 Reserved

17 No Breath 1 Reserved

16 No CO

10 Reserved

2

Sys_Status

Bit

Description

0 Reserved

9 Reserved 8 Occlusion

8 Reserved 7 EtCO

7 PR High Alarm Active 6 EtCO

6 PR Low Alarm Active 5 RR High Alarm Active

5SpO

4SpO

3 Reserved 2 Reserved

2 Reserved 1 Reserved

1 Reserved 0 Reserved

0 Reserved

High Alarm Active 4 RR Low Alarm Active

2

Low Alarm Active 3 Reserved

2

High Alarm Active

2

Low Alarm Active

2

UAL is the current upper alarm limit value for each parameter.

LAL is the current lower alarm limit value for each parameter.

Alarm volume is Off, Medium or Maximum.

CRC is a 16-bit CCITT for the entire row.

Monitor Software

Visit nonin.com for more information about the monitor’s software, including the latest monitor
software revision.

41

Data Output and Software

!

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:

• Use of a multiple-socket outlet with multiple devices results in a Medical Electrical System.

• When using the USB 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 (USB cable/connectors) will result in
loss of data transfer.

42

Maintenance and Inspection

!

Maintenance and Inspection

Maintenance

Ensuring Optimal Performance

In order to ensure safety and optimal performance of the monitor, Nonin recommends a yearly
inspection and functional check be performed on the monitor (see Recommended Inspections and
Functional Check). The inspection and functional check may be performed by Nonin Technical
Services or at your facility.

Perform the calibration procedure at least every 6 months, or if the baseline of the CO
elevated (see Calibration Procedure). After calibration, the monitor should be verified using 5% CO
gas. The calibration apparatus, gas valve, and 5% CO
Accessories).

Please contact Nonin Technical Service if monitor maintenance cannot be performed at your facility.

Plus7

The Oxitest
of the pulse oximeter.

(software rev. 2.5 or greater) by Datrend Systems, Inc. can be used to verify operation

verification gas are available from Nonin (see

2

graph is

2

Cleaning the Sensor

Refer to individual sensor Instructions for Use for details.

Cleaning the Monitor

1. Clean the monitor with a soft cloth moistened with isopropyl alcohol. Do not use any cleaning
solution other than what is recommended here, as permanent damage could result.

2. Dry with a soft cloth, or allow to air dry.

CAUTION: Always turn off the monitor prior to cleaning the monitor. Do not place the
device in liquid or clean it with agents containing ammonium chloride or bleach. Do
not sterilize or autoclave the monitor or accessories.

2

43

Maintenance and Inspection

!

!

!

Recommended Inspections and Functional Check

1. Before each use, verify the equipment is clean and in optimal operating condition. See
Cleaning the Monitor.

2. Verify the single-use, disposable sample line or cannula is free of bends and kinks for optimal
performance.

3. Verify the single-use, disposable moisture trap and filter are in position.

CAUTION: After exposing the monitor to an environment outside of normal room
temperature/humidity conditions, always replace the moisture trap and filter before
each use.

4. Verify the reusable sensor is clean, if previously used. Visually examine the accessories for
defects prior to use.

5. Press On/Standby to turn the monitor on.

6. Verify battery capacity. If the battery indicator is yellow or red, connect the monitor to the
power supply and a power outlet.

NOTE: To ensure the monitor is always ready to use, always connect the monitor to an outlet
whenever it is not in use.

7. Verify all parameters display correctly and, if allowed, adjust any alarm limits according to the
patient.

8. Verify alarm function/status by simulating alarm situations for all parameters.

9. Visually verify the zero-point of the CO

graph is not elevated.

2

WARNING: If the monitor fails to respond as described, discontinue use and contact
Nonin Technical Service.

WARNING: Never allow liquids to enter into or to be spilled onto the monitor. If liquid
has penetrated into the monitor it must be checked by Nonin Technical Service.

CAUTION: Be careful not to drop the monitor on the floor or strike it against hard

surfaces. If such an incident happens, do not use the monitor until a functional test
has been performed.

CAUTION: This device is a precision electronic instrument and must be repaired by
Nonin Technical Service. 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.

44

Troubleshooting

Troubleshooting

Detected fault conditions messages display on the operating screen. The fault conditions are either
operator- or system-generated. The table below lists common messages, descriptions, and actions to
take.

If these solutions do not correct the problem, please contact Nonin Technical Service at (800) 356­8874 (USA and Canada), [phone], or +31 (0)13 - 79 99 040 (Europe).

Message/Problem Possible Cause Possible Solution

No EtCO
waveform displays
after monitor start-up.

value or

2

Patient is not connected to
monitor.

Filter is incorrectly inserted
into moisture trap or is
missing.

Moisture trap is not properly
seated in the monitor.

The monitor has an internal
air leak.

Verify sample line or cannula are properly
connected to the patient and the moisture trap.

Remove the moisture trap from the monitor to
verify filter is properly inserted into the moisture
trap.

Verify the moisture trap and filter are properly
inserted in the monitor by creating an occlusion:

1. Using a finger, cover the Luer lock connector
inlet. After 10 seconds, the pump shuts off and
the “Occlusion” pop-up window displays.

2. Remove the finger and press OK to resume.

3. If there is still no value or waveform, the
moisture trap is not inserted properly.

4. Remove and reinsert the moisture trap in the
monitor.

5. Repeat occlusion test.

Verify that there is not an internal leak to the
pump by creating an occlusion:

1. Remove the moisture trap
from the monitor.

2. Using a finger, cover the small
hole in the recessed area of
the monitor (see arrow in
figure at right).

3. After 10 seconds, the pump
shuts off and the “Occlusion”
pop-up window displays.

4. Remove the finger and press
OK to resume.

5. If there is still no value or waveform, contact
Nonin Technical Service.

45

Message/Problem Possible Cause Possible Solution

Troubleshooting

“OCCLUSION”
displays in the EtCO

Sample line or cannula
occlusion.

2

message area.

To prevent damage to
the pump, the pump
stops after 10 seconds

Clogged filter. Replace the filter.

of occlusion and then
displays a pop-up
window:

Full moisture trap. If full, replace the moisture trap.

“Occlusion
Press OK to Resume”

Monitor pump has shut

Occlusion. To prevent damage to the pump, the pump stops

off.

Monitor has shut off. To avoid overheating, the

monitor shuts off if there is
an occlusion for 15 minutes.

The battery is depleted. Charge the monitor. Connect the monitor to the

Check the sample line or cannula for kinks or
occlusions. Replace the sample line or cannula.

Press OK to resume monitoring. If occlusion
reoccurs, check filter.

Press OK to resume monitoring. If occlusion
reoccurs, check moisture trap.

after 10 seconds of occlusion.

See above for “OCCLUSION” message solutions.

If the problem persists, contact Nonin Technical
Service.

See above for “OCCLUSION” message solutions.

If the problem persists, contact Nonin Technical
Service.

power supply and the power supply to an outlet.

“NO BREATH” displays
in the EtCO

message

2

area.

The indicator
displays in the SpO

2

message area.

The patient has stopped
breathing for 30 seconds or
longer.

Sample line is not properly
applied to the patient.

Sample line or Nafion tubing
is not connected to the
moisture trap.

Moisture trap is not properly
seated in the monitor.

The sensor is not connected
to the monitor.

The sensor is not connected
to the patient, or the sensor
is damaged.

Check the patient.

Verify sample line placement.

Verify connection to moisture trap is tight.

Verify the moisture trap and filter are properly
inserted in the monitor by creating an occlusion:

1. Using a finger, cover the Luer lock connector
inlet. After 10 seconds, the pump shuts off and
the “Occlusion” pop-up window displays.

2. Remove the finger and press OK to resume.

3. If “NO BREATH” still displays, the moisture
trap is not inserted properly.

4. Remove and reinsert the moisture trap in the
monitor.

5. Repeat occlusion test.

Check all sensor connections between patient
and the monitor.

Check sensor application site.

46

Troubleshooting

Message/Problem Possible Cause Possible Solution

The indicator
displays in the SpO

2

message area.

The indicator
displays in the SpO

2

message area.

“LOW PERFUSION”
displays in the SpO

2

message area.

Battery indicator
flashes yellow.

Battery indicator
flashes red.

The alarm
continuously sounds.

The pulse is hard to detect. Verify perfusion status at the sensor application

site, minimize motion, and verify that there is not
excessive ambient light.

Poor pulse signal. If condition persists, check the sensor application

The system detects low
perfusion at the SpO2
sensor site.

Battery is low. Monitor will
run for approximately
60 minutes.

Battery is critically low.
Monitor will shut off in
10 minutes.

site. Reapply sensor to another site if necessary.

Warm or rub the finger, or re-position the sensor.

If condition persists, check the sensor application
site. Reapply sensor to another site if necessary.

Charge the monitor. Connect the monitor to the
power supply and the power supply to an outlet.

If the monitor continues to show the low or critical
battery indicator after recharging, contact Nonin
Technical Service as the battery may need
replacement. The battery is integral to the device
and cannot be replaced by the operator.

The monitor is not
functioning. This indicates
that a problem has
occurred, possibly due to
interference or software
issues.

Turn off the monitor and then turn on again.

Charge the monitor. Connect the monitor to the
power supply and the power supply to an outlet.

If the problem persists, contact Nonin Technical
Service.

Low EtCO

alarm even

2

though the patient’s

is suspected to

EtCO

2

be normal.

An error code appears
in the display area.

Monitor will not turn
on.

Monitor will not
operate on battery
power.

All alarms for low EtCO
require the operator to
check the patient’s status. It
is also possible to get a low
reading if an air leakage has
occurred in the sample line,
Nafion tubing, moisture trap,
or internally.

Check patient status.

2

Verify the moisture trap and filter are properly
installed.

Replace the moisture trap and filter if necessary.

Check sample line connector and visually inspect
the sample line for signs of damage.

Check Nafion tubing connection.

If the problem persists, contact Nonin Technical
Service.

The monitor encountered an
error.

Turn the monitor off and then back on again to
remove the error code.

If the error persists, note the error code and
contact Nonin Technical Service.

The monitor has no power. Plug in the power supply and verify the charging

indicator is lit.

If the problem persists, contact Nonin Technical
Service.

The battery pack is not
charged.

The battery pack is

Charge the monitor. Connect the monitor to the
power supply and the power supply to an outlet.

Contact Nonin Technical Service.

inoperable.

47

Message/Problem Possible Cause Possible Solution

Troubleshooting

Charging indicator is
not lit when the power
supply is connected to
the monitor and the
power outlet.

Pressing the alarm
limit up/down arrows
does not adjust the
alarm limits.

“Incompatible USB” or
“USB Device Failure”
error displays.

The system may be

Contact Nonin Technical Service.

damaged.

The monitor may be in
Alarm Lock Mode.

Verify display functionality by pressing the
brightness icon. If the brightness changes, the
alarm limits are locked.

Contact the individual responsible for configuring
your organization’s devices.

The alarm limit settings may
be restricted by the
Responsible Organization
Settings.

A pop-up window displays
on the monitor screen.

The display may not be
functioning.

Access the Responsible Organization Settings
screen and adjust the high and low alarm limits.

Contact the individual responsible for configuring
your organization’s devices.

Address the pop-up window and then try
adjusting the alarm limits again.

Verify display functionality by pressing the
brightness icon. If the brightness does not
change, contact Nonin Technical Service.

USB flash drive is full. Delete unnecessary data from the flash drive.

or

Replace the USB flash drive with a Nonin­recommended USB flash drive.

“Settings File CRC
Error” warning pop-up
displays.

“Invalid PIN Entered”
pop-up message
displays.

“Calibration Due” pop­up message displays
during the start-up
sequence.

USB flash drive does not
have enough available
space.

USB flash drive has an
incorrect format.

Settings file is corrupted or
missing.

When entering a new PIN,
the PIN is not the correct
length.

The PIN entered does not
match the Factory PIN or
the Responsible
Organization PIN.

It has been 6 months since
the monitor was calibrated.

Replace the USB flash drive with a Nonin­recommended USB flash drive.

System reverts to factory defaults.

Contact the individual responsible for configuring
your organization’s devices.

Enter a PIN that is four digits.

Enter the default PIN (0000).

If 0000 is not the correct PIN, contact Nonin
Technical Service.

Press OK or allow the message to time out
(5 seconds). Start-up sequence continues.

Perform the Calibration Procedure, or contact the
individual responsible for configuring your
organization’s devices.

48

Accessories

Accessories

LifeSense II is designed to be used with Nonin-recommended accessories only. Use of other brands
will compromise the function and performance. For more information about Nonin parts and
accessories:

• Contact your distributor or Nonin at [phone] (USA and Canada), [phone],
or +31 (0)13 - 79 99 040 (Europe)

• Visit www.nonin.com

Nonin may update the accessories list at any time. It is the purchaser’s responsibility to always ask
for the current list, by model number, when ordering accessories.

Monitor Accessories

Item Description

Power Supply Approximately 100 – 240 VAC, 50 – 60 Hz

PSG DAC Digital-to-analog USB cable that connects the monitor to a polysomnograph to

record data. Several versions are available; contact Nonin or your distributor for
more information.

Capno RTC (Real Time
Cable)

USB Flash Drive SanDisk Cruzer Glide™ 8 GB USB flash drive (SanDisk P/N SDCZ60-008G-A46)

Capno Report
Converter

nVISION nVISION software for Microsoft Windows

Monitor Mounting
Bracket

Adjustable Mounting
Clamp

Carrying Case Protective carrying case in which the monitor can be fully connected without

Nasal CO

Oxygen Delivery CO
Nasal Cannula

Cannula Single-use, disposable, cannula with a male Luer lock connector.

2

Digital USB cable that transmits real-time data from the monitor to another device
(e.g., computer). Requires USB driver and USB port with 2.0 or greater.

Software to convert LifeSense II and RespSense II data into an nVISION­compatible format.

®

operating systems

Connector that enables adjustable mounting and hospital standard mounting.
Delivered with 3 screws for connecting to the back of the monitor.

Allows mounting on poles. Fits on poles up to 50 mm (2.0 in.) in diameter.

removing the bag.

Adult (Salter Labs
Pediatric (Salter Ref. 4100)
Infant (Salter Ref. 4200)

Single-use, disposable O2 delivery nasal cannula with male Luer lock connector.

2

Adult (Salter Ref. 4707)
Pediatric (Salter Ref. 4703)
Infant (Salter Ref. 4700)

®

Ref. 4000)

CO

Sample Line Single-use, disposable, straight sample line with male Luer lock connectors on

2

Straight T-Connector Single-use, disposable gas adapter, 15 and 22 mm connector ends.

both ends (Salter Ref. 4507).

49

Accessories

Item Description

Nafion Tubing Single-use, disposable Perma Pure Nafion tubing to remove water vapor from the

sample line.

Verification Gas Verification gas and tubing. Contains 5 Vol% of CO

To be used with a gas valve.

Gas Valve for
Verification Gas

Calibration Apparatus Used for 0-point calibration.

Moisture Trap with
Filter

Filters Available in 25 or 100 pack.

Reusable gas valve and tubing for controlling the flow from the verification gas.

10 packages, each containing 1 single-use, disposable moisture trap and 1 single­use, disposable filter.

PureLight Sensors

Model Number Description

Finger Clip Sensor, Reusable

8000AA
8000AP

8000SS
8000SM
8000SL

Adult (>30 kg; >66 lb)
Pediatric (8 – 30 kg; 18 – 66 lb)

Soft Sensor for Fingers / Toes, Reusable

Small (Digit thickness 7.5 – 12.5 mm; 0.3 and 0.5 in.)
Medium (Digit thickness 10 – 19 mm; 0.4 and 0.75 in.)
Large (Digit thickness 12.5 – 25.5 mm; 0.5 and 1.0 in.)

(equals 38 mmHg or 5.3 kPa).

2

Reflectance Sensor for Middle Forehead, Reusable

8000R
8000H

8000J
8008J
8000JFW
8008JFW

6000CA
6000CP
6000CI

7000A
7000P
7000I

8000Q2 Ear Clip Pulse Oximeter Sensor

Adult (>30 kg; >66 lb)
Sensor holder (10 pack with 20 adhesive collars)

Flex Sensor (Reusable) with Single-Use FlexiWrap

Adult Flex Sensor (>20 kg; >44 lb)
Infant Flex Sensor (2 – 20 kg; 4.4 – 44 lb)
Adult FlexiWrap (Pack of 25)
Infant FlexiWrap (Pack of 25)

6000C Cloth Series, Single-Use

Adult (>30 kg; >66 lb)
Pediatric (>10 kg; >22 lb)
Infant (>2 kg; >4 lb)

®

7000 Flexi-Form

Adult (>30 kg; >66 lb)
Pediatric (>10 kg; >22 lb)
Infant (>2 kg; >4 lb)

Patients weighing more than 40 kilograms (88 pounds)

III Series, Single-Use

®

50

Service, Support, and Warranty

Service, Support, and Warranty

A return authorization number is required before returning any product to Nonin. To obtain this return
authorization number, contact Nonin Technical Service:

Nonin Medical, Inc.

13700 1st Avenue North

Plymouth, Minnesota 55441

[phone] (USA and Canada)

[phone] (outside USA and Canada)

Fax: [phone]

E-mail: [e-mail]

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: [e-mail]

, USA

nonin.com

Warranty

NONIN MEDICAL, INCORPORATED, (Nonin) warrants to the purchaser, for a period of 1 year from the date of
purchase, each battery and touch panel display screen. Nonin warrants the LifeSense II monitor for a period of
3 years from the date of purchase. Extended warranties are available on most Nonin devices. Please consult
your local Nonin distributor for additional information. The device’s expected service life is 5 years.

Nonin shall repair or replace any LifeSense II 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 LifeSense II 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
LifeSense II that is found to be within specifications.

The LifeSense II 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 LifeSense II, field service by non-Nonin personnel, tampering,
or any kind of misuse or abuse of the LifeSense II, 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.

51

Technical Information

!

!

!

Technical Information

NOTE: This product complies with ISO 10993-1, Biological Evaluation of Medical Devices Part 1:

Evaluation and Testing.

CAUTION: All parts and accessories connected to the USB 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.

Operating Environment

The equipment must only be used in situations that meet the system’s specified environmental
conditions. Refer to System Specifications in this section.

Storage Environment

Refer to System Specifications in this section for the system’s specified storage conditions.

CAUTION: In order to prevent damage to the equipment, always charge the battery
to full capacity before storing the monitor.

Power Requirements

Power Ratings Unit

Rated supply voltages or voltage ranges for the power supply 100 – 240 VAC 50 – 60 Hz

Input voltage from the power supply 12 VDC, 1.5 A

WARNING: To avoid patient injury, only use Nonin-specified power supplies, cables,
and accessories (see Accessories).

52

Technical Information

Manufacturer’s Declaration

See the following tables for specific information regarding this device’s compliance to IEC 60601-1-2.

Table 11. Electromagnetic Emissions

Emissions Test Compliance 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.

RF Emissions

CISPR 11

RF Emissions

CISPR 11

Harmonic Emissions

IEC 61000-3-2

Voltage Fluctuations/ Flicker
Emissions

IEC 61000-3-3

Group 1 This 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 B This device is suitable for use in all establishments, including

domestic and those directly connected to the public low-voltage
power supply network that supplies buildings used for domestic
purposes.

Pass

Pass

Table 12. Electromagnetic Immunity

Immunity Test IEC 60601 Test Level Compliance Level

This device is intended for use in the electromagnetic environment specified below. The user of this device should ensure that it is

Electrostatic Discharge
(ESD)

IEC 61000-4-2

Electrical Fast Transient/
Burst

IEC 61000-4-4

Surge

IEC 61000-4-5

Voltage dips, short
interruptions, and voltage
variations on power supply
input lines

IEC 61000-4-11

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

±6 kV contact
±8 kV air

± 2 kV for power supply lines

± 1 kV for input/output lines

± 1 kV differential mode

± 2 kV for common mode

(>95% dip in UT) for

± 5% U

T

0.5 cycle

± 40% U
5 cycles

± 70% U
25 cycles

± 5% U
5 cycles

30 A/m 30 A/m Power frequency magnetic fields should

(60% dip in UT) for

T

(30% dip in UT) for

T

(>95% dip in UT) for

T

used in such an environment.

±6 kV contact
±8 kV air

± 2 kV for power supply lines

± 500V for input/output lines

± 1 kV differential mode

± 2 kV for common mode

± 5% U

0.5 cycle

± 40% U
5 cycles

± 70% U
25 cycles

± 5% U
5 cycles

(>95% dip in UT) for

T

(60% dip in UT) for

T

(30% dip in UT) for

T

(>95% dip in UT) for

T

Electromagnetic Environment—

Guidance

Floors should be wood, concrete, or
ceramic tile. If floors are covered with
synthetic material, the relative humidity
should be at least 30%.

Mains power quality should be that of a
typical commercial or hospital
environment.

Mains power quality should be that of a
typical commercial or hospital
environment.

Mains 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.

be at levels characteristic of a typical
location in a typical commercial or
hospital environment.

53

Technical Information

d1.17P=

d1.17P=

d2.33P=

Table 13. Guidance and Manufacturer’s Declaration—Electromagnetic Immunity

Immunity Test

This device is intended for use in the electromagnetic environment specified below. The user of this device should ensure that it is

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.

Conducted RF

IEC 61000-4-6

Radiated RF

IEC 61000-4-3

Radiated RF

IEC 61000-4-3

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. 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.

b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

IEC 60601
Test Level

3 Vrms

150 kHz to 80 MHz

3 V/m

80 MHz to 2.7 GHz

Professional Transport

20 V/m

80% AM 1 kHz modulation

80 MHz to 2.7 GHz

Compliance Level Electromagnetic Environment—Guidance

used in such an environment.

Recommended Separation Distance

3 V

3 V/m 80 MHz to 800 MHz

800 MHz to 2.7 GHz

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,
be less than the compliance level in each frequency

b

range.

Interference may occur in the vicinity of equipment
marked with the following symbol:

20 V/m

a

should

54

Technical Information

d1.17P=

d1.17P=

d2.33P=

Table 14. Recommended Separation Distances

This device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. Customers or
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

0.01 0.12 0.12 0.23

0.1 0.37 0.37 0.74

1 1.2 1.2 2.3

10 3.7 3.7 7.4

100 12 12 23

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 800 MHz, 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 2.7 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 Values Average Latency

Standard/Fast Averaged SpO

2

Pulse Rate Values Average Latency

Standard/Fast Averaged Pulse Rate 4 beat exponential 2 beats

Equipment Delays Delays

Display Update Delay 2 – 5 seconds

Alarm Signal Generation Delay* 0 – 5 seconds

*After adjusting the limits, it may take up to 5 seconds for the new limits to take effect.

Example: SpO2 Exponential Averaging

SpO2 decreases 0.75% per second (7.5% over 10 seconds)

Pulse Rate = 75 BPM

4 beat exponential 2 beats

55

Specific to this example, the response of the 4 beat-average is 1.5 seconds.

!

Technical Information

CAUTION: A functional tester cannot be used to assess the accuracy of a pulse
oximeter monitor or sensor.

Testing Summary

SpO2 accuracy and low perfusion testing were conducted by Nonin Medical, Inc., as described below:

SpO2 Accuracy Testing

SpO2 accuracy testing is conducted during induced hypoxia studies on healthy, non-smoking, light­to-dark-skinned subjects during motion and no-motion conditions in an independent research
laboratory. The measured arterial hemoglobin saturation value (SpO
arterial hemoglobin oxygen (SaO

) value, determined from blood samples with a laboratory co-

2

oximeter. The accuracy of the sensors in comparison to the co-oximeter samples measured over the
SpO

range of 70 – 100%. Accuracy data is calculated using the root-mean-squared (A

2

all subjects, per ISO 80601-2-61, Standard Specification for Pulse Oximeters for Accuracy.

Pulse Rate Accuracy Testing

This test measured pulse rate oximeter accuracy with and without 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

2

value) for

rms

Low Perfusion Accuracy Testing

This test uses an SpO2 Simulator to provide a simulated pulse rate, with adjustable amplitude settings
at various SpO
with ISO 80601-2-61 for pulse rate and SpO
(0.3% modulation).

56

levels for the oximeter to read. The oximeter must maintain accuracy in accordance

2

at the lowest obtainable pulse amplitude

2

Technical Information

System Specifications

Power Requirements:

Power Supply:

Power Consumption:

Internal Battery:

Battery Capacity:

Charging Time:

Dimensions: 200 x 135 x 50 mm (7.9 x 5.3 x 2 in.)

Weight: 865 grams (1.9 pounds)

Memory: 36 hours (assuming continuous operation)

100 – 240 VAC 50 – 60 Hz

3.6 W with battery operation

9 W with power supply

Input:

12 VDC, 1.5 A

Lithium Ion (Li-Ion) internal battery, non-field replaceable,

Type:

rechargeable

Approximately 5 hours

Approximately 9 hours

Temperature:

Operating: 0 to 40 °C (32 to 104 °F)

Storage/Transportation: -40 to 70 °C (-40 to 158 °F)

Time (from storage) for monitor to be

ready for its intended use:

Applied part temperature will not exceed 41°C as measured during a controlled environment test.

Humidity:

Operating:

Storage/Transportation:

Altitude:

Operating: Up to 2,740 meters (9,000 feet)

Atmospheric Pressure: 525 to 795 mmHg (700 to 1060 hPa)

Pump:

Pump Flow: 75 ml/min (minimum sample flow rate: 60 ml/min)

Flow Accuracy: ±15 ml/min

High and Medium Priority Alarms (at 1 m):

Sound Pressure Level: 74.6 to 75.5 dB

10 minutes to warm from -40 to 0 °C
19 minutes to cool from 70 to 40 °C

15% to 93% noncondensing

Up to 93% noncondensing

Classification per ANSI/AAMI ES60601-1 and CAN/CSA-C22.2 No. 60601-1:

Type of Protection: Internally powered class II (with power supply)

Degree of Protection: Type BF-Applied Part

Mode of Operation: Continuous

Enclosure Degree of Ingress Protection: IP22

57

Pulse Oximeter Specifications

Technical Information

Oxygen Saturation Display Range: 0 to 100% SpO

2

Pulse Rate Display Range: 18 to 321 beats per minute (BPM)

Measurement Wavelengths*:

Infrared: 660 nanometers @ 0.8 mW max. average

Red: 910 nanometers @ 1.2 mW max. average

Accuracy - Sensors: Declared accuracy data for compatible sensors can be found in

Nonin’s Sensor Accuracy document.

*This information is especially useful for clinicians performing photodynamic therapy.

Capnography Specifications

Respiration Range: 0 to 99 respirations/minute

Respiration Accuracy: 3 to 50 respirations/minute ±2

51 to 60 respirations/minute ±3

Test method summary: To determine the rated respiration rate, calibrated CO
respiration rate is changed from 3 to 60 BrPM.

EtCO

/CO2 Range: 0 to 99 mmHg (0 to 13.2 kPa)

2

EtCO

/CO2 Accuracy

2

1, 2

: ±0.2 kPa / ±2 mmHg, +8% of reading

525 – 795 mmHg (700 – 1060 hPA)

(EtCO

/CO2 reading reaches its steady state accuracy within 10 minutes

2

after power up. From maximum storage temperature, monitor reaches
steady state accuracy 19 minutes after power up.)

gas tanks are used as the

2

3

Calculated Update Frequency: Once every breath (“NO BREATH” alarm after 30 seconds)

Sampling Rate: 4 Hz (4 times per second)

Total System Response Time: <7 seconds (includes delay time and rise time)

Drift of Measurement: Within CO

Measurement: Automatic barometric pressure compensation and CO

accuracy specifications for 6 hours of continuous monitoring

2

temperature

2

compensation

1

There is no known adverse effect on performance due to cyclical pressure up to 10 kPa.

2

There is no degradation in EtCO2 measurement accuracy as a function of BrPM and inspiratory/expiratory (I/E) time

ratio.

3

Presented concentration of CO2 and EtCO2 can be false, indicating a high presence of nitrous oxide and other

interfering gases.

The table below shows the CO2 and EtCO2 concentration corrections. Only use agents listed in the
table below.

Agent Concentration Correction of Presented CO2 to Real Concentration

50 – 70% N

30 – 50% N2O Presented CO2 x 0.85 = Actual CO2

0 – 30% N

58

O Presented CO2 x 0.75 = Actual CO

2

O No correction

2

2