SenSmart X 100 IFU ENG

Operator’s Manual
Model X-100
Universal Oximetry System
English
CAUTION: Federal law (USA) restricts this device to sale by or on the order of a
licensed practitioner.
Follow Instructions for Use.
Nonin® reserves the right to make changes and improvements to this manual and the products
it describes at any time, without notice or obligation.
Nonin Medical, Inc.

13700 1st Avenue North
Plymouth, Minnesota 55441, USA
+1 (763) 553-9968
(800) 356-8874 (USA and Canada)
Fax: +1 (763) 553-7807
E-mail: info@nonin.com
Nonin Medical B.V.

Prins Hendriklaan 26
1075 BD Amsterdam, Netherlands
+31 (0)13 - 79 99 040 (Europe)

Fax: +31 (0)13 - 79 99 042
E-mail: infointl@nonin.com
nonin.com
EC REP
MPS, Medical Product Service GmbH

Borngasse 20
D-35619 Braunfels, Germany
References to “Nonin” in this manual shall imply Nonin Medical, Inc.
Nonin, EQUANOX, and are registered trademarks of Nonin Medical, Inc.
The Bluetooth word mark and logos are owned by the Bluetooth SIG, Inc. and any use of such
marks by Nonin Medical, Inc. is under license. Other trademarks and trade names are those
of their respective owners.
© 2019 Nonin Medical, Inc.

10566-001-05
Contents
Indications for Use ................................................................................................... 1
Warnings ............................................................................................................................. 1
Cautions .............................................................................................................................. 3
Declaration of Conformity with FCC and Canadian Ministry of Health Rules for
Electromagnetic Compatibility ..................................................................................... 5
Federal Communications Commission (FCC) Notice ......................................................... 5
Guide to Symbols..................................................................................................... 6
System Components and Set Up.......................................................................... 12
System Configurations ...................................................................................................... 12
Multiple Channels.......................................................................................................... 12
Single Channel .............................................................................................................. 14
X-100M (Monitor) .............................................................................................................. 15
X-100H (Hub) .................................................................................................................... 18
Connect/Disconnect the Hub......................................................................................18
X-100HH (Hub Holster) ..................................................................................................... 19
Using the Hub Holster ................................................................................................19
X-100SP (Signal Processor)............................................................................................... 20
Connect a Signal Processor to Hub or Monitor ..........................................................20
Disconnect a Signal Processor from Hub or Monitor .................................................20
Connect/Disconnect an INT-100 Intermediate Cable to the Signal Processor...........21
Connect/Disconnect a Sensor to the Signal Processor..............................................21
Replacing the Lock on the Signal Processor..............................................................22
Cable Clips .................................................................................................................... 22
INT-100 (Intermediate Cable) ........................................................................................... 22
Connect/Disconnect a Sensor to the Intermediate Cable ..........................................23
X-100EC (Extension Cable) .............................................................................................. 23
rSO2 and SpO2 Sensors ................................................................................................... 24
Battery............................................................................................................................... 24
System Operation................................................................................................... 25
Start-up Sequence ............................................................................................................ 25
Sensor Application ............................................................................................................ 26
Monitoring a Patient .......................................................................................................... 26
Operating Screens and Menus ......................................................................................... 27
Monitoring Screen.................................................................................................. 28
Monitoring Screen – Description ....................................................................................... 28
Channels ....................................................................................................................... 28
Event Marks .................................................................................................................. 29
Event Mark Table .......................................................................................................... 29
Timescale ...................................................................................................................... 29
Scrolling Cursor and Cursor Values .............................................................................. 30
Graphs........................................................................................................................... 30
Monitoring Screen – Procedures....................................................................................... 31
Set All rSO2 Channel Baselines to Current %rSO2 Values........................................... 31
Mark an Event ............................................................................................................... 31
View the Event Mark Table ........................................................................................... 31
Change the Timescale .................................................................................................. 31
Scroll Through the Timescale........................................................................................ 31
i
Contents (Continued)
Graph Set-up ................................................................................................................ 31
Settings Menu Screen ............................................................................................ 32
Settings Menu – Description............................................................................................. 32
Sensor Site ................................................................................................................... 32
Sensor Type ................................................................................................................ 33
Baseline (rSO2 channels only)...................................................................................... 33
Alarm Limits .................................................................................................................. 34
Graph Position .............................................................................................................. 35
Preset #: ....................................................................................................................... 35
Settings Menu – Procedures ............................................................................................ 36
Open the Settings Menu ............................................................................................... 36
Assign a Pre-Defined Sensor Site Name...................................................................... 36
Customize a Sensor Site Name.................................................................................... 36
Clear a Sensor Site Name ............................................................................................ 36
Set Sensor Type ........................................................................................................... 37
Set Individual Baseline Values...................................................................................... 37
Set Alarm Limits............................................................................................................ 38
Set Graph Position(s).................................................................................................... 38
Review/Select a Preset................................................................................................. 38
Presets Menu Screen.............................................................................................. 39
Presets Menu – Description.............................................................................................. 39
Presets Menu – Procedures ............................................................................................. 40
Open the Presets Menu ................................................................................................ 40
Activate a Preset........................................................................................................... 40
Save Current Settings as a Preset................................................................................ 40
Delete a Preset ............................................................................................................. 41
Rename a Preset .......................................................................................................... 41
Lock/Unlock a Preset .................................................................................................... 42
Case Menu Screen .................................................................................................. 43
Case Menu – Description ................................................................................................. 43
Start New Case............................................................................................................. 43
Edit Patient ID ............................................................................................................... 43
Case Menu – Procedures ................................................................................................. 43
Open the Case Menu.................................................................................................... 43
Start a New Case.......................................................................................................... 44
Edit a Patient ID ............................................................................................................ 44
System Menu Screen.............................................................................................. 45
System Menu – Description.............................................................................................. 45
Brightness ..................................................................................................................... 46
Alarm Volume ............................................................................................................... 46
rSO2 Low Alarm Mode .................................................................................................. 46
Pulse Tone Volume ...................................................................................................... 46
Pulse Tone Source ....................................................................................................... 47
Data Output Modes....................................................................................................... 47
Clear Memory ............................................................................................................... 47
Restore Factory Defaults .............................................................................................. 47
System Information ....................................................................................................... 47
Date / Time ................................................................................................................... 48
ii
Nurse Call Mode............................................................................................................ 48
Bluetooth ....................................................................................................................... 49
Language ...................................................................................................................... 49
Patient ID Request ........................................................................................................ 50
System Name................................................................................................................ 50
Default Preset................................................................................................................ 50
Institution Default Limits ................................................................................................ 50
Institution Password ...................................................................................................... 51
System Menu – Procedures.............................................................................................. 51
Open the System Menu................................................................................................. 51
Adjust the Display Brightness........................................................................................ 51
Adjust the Alarm Volume............................................................................................... 52
Set the rSO2 Low Alarm Mode ...................................................................................... 52
Adjust the Pulse Tone Volume ...................................................................................... 52
Select a Pulse Tone Source.......................................................................................... 53
Set Bluetooth and/or RS-232 Data Output Formats...................................................... 53
Clear the Memory.......................................................................................................... 53
Restore Factory Defaults............................................................................................... 54
Review System Information........................................................................................... 54
Set the Date and Time .................................................................................................. 54
Set-up Nurse Call .......................................................................................................... 54
Enable/Disable Bluetooth Radio.................................................................................... 55
Change Language......................................................................................................... 55
Set Patient ID Request.................................................................................................. 55
Assign System Name .................................................................................................... 56
Select Default Preset..................................................................................................... 56
Set Institution Default Limits.......................................................................................... 57
Change the Institution Password................................................................................... 57
Alarms ..................................................................................................................... 58
High Priority Alarms .......................................................................................................... 58
Medium Priority Alarms ..................................................................................................... 59
Silencing Alarms ............................................................................................................... 59
Error Codes....................................................................................................................... 60
Memory and Data Output Features....................................................................... 61
Memory ............................................................................................................................. 61
Patient Data Output........................................................................................................... 61
Bluetooth Technology.................................................................................................... 62
Bluetooth Connection .................................................................................................... 62
Determine the Bluetooth Address and PIN for the Monitor ........................................62
Bluetooth Security ......................................................................................................... 63
RS-232 Connection to Printer ....................................................................................... 63
Using the Dymo Printer ..............................................................................................63
Connecting the Device into a Medical System .................................................................. 64
Data Output Formats......................................................................................................... 64
Nonin 1 .......................................................................................................................... 65
Nonin 2 .......................................................................................................................... 68
Nonin 3 .......................................................................................................................... 69
Nonin 4 .......................................................................................................................... 70
Nonin 5 .......................................................................................................................... 71
iii
Printer ........................................................................................................................... 72
SenSmart Download Software............................................................................... 73
System Requirements ...................................................................................................... 73
Installing SenSmart Download Software .......................................................................... 73
Care and Maintenance............................................................................................ 74
Cleaning Instructions ........................................................................................................ 74
Parts and Accessories ........................................................................................... 75
Troubleshooting...................................................................................................... 76
Service, Support, and Warranty ............................................................................ 79
Service and Support ......................................................................................................... 79
Warranty ........................................................................................................................... 79
Technical Information............................................................................................. 81
Manufacturer’s Declaration............................................................................................... 81
Essential Performance.................................................................................................. 81
Equipment Response Time .............................................................................................. 83
Example – SpO2 Exponential Averaging ................................................................... 83
Testing Summary.............................................................................................................. 84
rSO2 Principles of Operation......................................................................................... 84
SpO2 Principles of Operation........................................................................................ 84
rSO2 Accuracy Testing ................................................................................................. 84
SpO2 Accuracy Testing................................................................................................. 85
Pulse Rate Accuracy Testing (Motion and Non-motion) ............................................... 85
Low Perfusion Accuracy Testing................................................................................... 85
Specifications ................................................................................................................... 86
Transmitter........................................................................................................................ 88
External Monitor Installation Instructions ............................................................ 89
Philips Monitors ................................................................................................................ 89
Components ................................................................................................................. 89
VueLink Components................................................................................................. 89
IntelliBridge Components........................................................................................... 89
Connection Specifications ................................................................................................ 89
Connecting the X-100M Monitor to the Philips Monitor .................................................... 90
X-100M Configuration .................................................................................................. 90
Philips Interface Module Installation and Configuration ............................................... 90
Setting Up the Connection – VueLink ........................................................................ 90
Setting Up the Connection – IntelliBridge .................................................................. 92
Philips Monitor Display Configuration ........................................................................... 93
Setup Philips Monitor with VueLink Interface Module to Display X-100M Numerics . 93
Setup Philips Monitor with IntelliBridge Interface Module to Display X-100M Numerics
94
Alerts................................................................................................................................. 95
Patient Alarms .............................................................................................................. 96
Equipment Alarms......................................................................................................... 97
iv
Figures
Figure 1. Monitoring Screen Symbols (Four-Channel View)................................................................ 8
Figure 2. System Set Up (≥40 kg Sensors, INT-100, 4 Channels Connected).................................. 13
Figure 3. System Set Up (≤40 kg Sensors, 4 Channels Connected)................................................. 13
Figure 4. System Set Up (≥40 kg Sensors, 4 Channels Connected)................................................. 14
Figure 5. System Set Up (≥40 kg Sensor, INT-100, Single Channel)................................................ 14
Figure 6. X-100M Front View ............................................................................................................. 15
Figure 7. X-100H – Hub ..................................................................................................................... 18
Figure 8. Connect Hub or Signal Processor to Monitor ..................................................................... 18
Figure 9. X-100HH – Hub Holster ...................................................................................................... 19
Figure 10. Insert Hub into Hub Holster .............................................................................................. 19
Figure 11. X-100SP – Signal Processor ............................................................................................ 20
Figure 12. Connect Intermediate Cable or Sensor to Signal Processor ............................................ 21
Figure 13. Signal Processor Lock Replacement................................................................................ 22
Figure 14. INT-100 – Intermediate Cable .......................................................................................... 22
Figure 15. Connect Sensor to Intermediate Cable............................................................................. 23
Figure 16. X-100EC – Extension Cable ............................................................................................. 23
Figure 17. Start-up Screen ................................................................................................................ 25
Figure 18. Select a Preset Screen ..................................................................................................... 25
Figure 19. Monitoring Screen with Four Channels Connected (3 rSO2 and 1 SpO2)........................ 28
Figure 20. Event Marks, Timescale, and Scrolling Cursor................................................................. 29
Figure 21. Event Mark Table ............................................................................................................. 29
Figure 22. Graphs .............................................................................................................................. 30
Figure 23. Settings Menu Screen ...................................................................................................... 32
Figure 24. Presets Menu Screen ....................................................................................................... 40
Figure 25. Case Menu Screen ........................................................................................................... 43
Figure 26. System Menu Screen ....................................................................................................... 45
Figure 27. System Information Pop-up .............................................................................................. 48
Figure 28. Bluetooth Information Pop-up ........................................................................................... 49
Figure 29. Institution Defaults Pop-up ............................................................................................... 51
Figure 30. RS-232 Serial Data Port ................................................................................................... 61
Figure 31. Sample Label from Dymo Printer...................................................................................... 63
Figure 32. X-100M Connection to Philips Monitor with VueLink ........................................................ 91
Figure 33. Philips Indicator on Model X-100M Display ...................................................................... 91
Figure 34. X-100M Connection to Philips Monitor with IntelliBridge .................................................. 92
v
Tables
Table 1. Labeling and Packaging Symbols ......................................................................................... 6
Table 2. X-100M Monitoring Screen Symbols and Indicators ............................................................. 8
Table 3. X-100M Features................................................................................................................. 15
Table 4. X-100H Features ................................................................................................................. 18
Table 5. X-100HH Features............................................................................................................... 19
Table 6. X-100SP Features ............................................................................................................... 20
Table 7. INT-100 Features ................................................................................................................ 22
Table 8. Commonly-Used Sensor Site Names.................................................................................. 33
Table 9. Alarm Limit Settings............................................................................................................. 34
Table 10. Factory Default Alarm Limit Settings ................................................................................. 47
Table 11. High Priority Alarms........................................................................................................... 58
Table 12. Medium Priority Alarms ..................................................................................................... 59
Table 13. Error Codes ....................................................................................................................... 60
Table 14. Nonin 1 Data Output Format ............................................................................................. 65
Table 15. Electromagnetic Emissions ............................................................................................... 81
Table 16. Electromagnetic Immunity ................................................................................................. 82
Table 17. Philips Monitor Patient Alarms........................................................................................... 96
Table 18. Philips Monitor Equipment Alarms..................................................................................... 97
vi
Indications for Use
Indications for Use

Nonin’s SenSmart™ Model X-100 Universal Oximetry System is a modular system and is
indicated for use in simultaneously measuring, displaying, monitoring, and recording up to
six (6) channels of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate
or cerebral or somatic hemoglobin oxygen saturation (rSO2) of blood underneath the sensor.
Patient populations include adult, pediatric, infant, and neonate through the use of SenSmart-
compatible sensors.
The SenSmart system is intended for use in hospitals, long-term care, medical facilities, sleep
laboratories and subacute environments. The X-100 SenSmart system may be used for spot-
checking and continuous monitoring with patient alarms. The SenSmart pulse oximetry (SpO2)
functionality is suitable for use in both motion and non-motion conditions, including patients
who are well or poorly perfused.
Warnings
Do not use this device in an MR environment.
Explosion Hazard: Do not use in an explosive atmosphere or in the presence of flammable anesthetics or gases.
This system is not intended to be used simultaneously on multiple patients.
Refer to the applicable sensor instructions for use for additional contraindications, warnings, and cautions.
This device is intended only as an adjunct device in patient assessment. It should not be used as the sole basis
for diagnosis or therapy decisions. It must be used in conjunction with other methods of assessing clinical signs
and symptoms.
Use only Nonin-branded SenSmart oximeter signal processors, sensors, and accessories, otherwise patient
injury can result. These sensors are manufactured to meet the accuracy specifications for this device. Using
other manufacturers’ sensors can result in improper oximeter performance.
Inspect the sensor application sites in accordance with the sensor instructions for use to ensure correct sensor
alignment and skin integrity. Patient sensitivity to the sensor may vary due to medical status or skin condition.
Avoid excessive pressure to the sensor application site(s) as this may cause damage to the skin beneath the
sensor.
Always inspect the device before use. Do not use a damaged device or sensor. Before using any sensor,
carefully read the sensor instructions for use, which contains sensor application information for each sensor.
To prevent improper performance and/or patient injury, verify compatibility of the monitor, sensor(s), and
accessories before use.
No modifications to this device are allowed as it may affect device performance.
Verify all alarm settings and limits during system startup to ensure that they are set as intended.
Protect from exposure to water or any other liquid, with or without AC power.
Use the device only with Nonin-specified power supplies.
As with all medical equipment, carefully route patient cables and connections to reduce the possibility of
entanglement, strangulation, or tripping.
For remote monitoring, use the X-100M monitor only within its designated range (approximately 100 meters
(300 feet) spherical radius from monitor to remote location). Moving outside this range may cause missing or lost
data at the remote monitoring location.
1
Indications for Use
Warnings (Continued)
Memory is cleared if error code E06 appears on the display screen.
The device presets are deleted if error code E09 appears on the display screen.
The device configuration is deleted if error code E10 appears on the display screen.
This device turns off after approximately 30 minutes when in low battery alarm condition.
If this device is used adjacent to or stacked with other equipment, the device should be observed carefully to
verify normal operation.
The battery pack must be installed at all times while the device is operating—even when operating on AC power.
Do NOT use the device without the battery pack installed.
The use of signal processors, sensors, accessories, and cables other than those listed in the Parts and
Accessories List may result in increased electromagnetic emission and/or decreased immunity of this device.
The device’s Nurse Call and Bluetooth features should not be used as the primary source of alarm notification.
The user must verify the device Bluetooth pairing to ensure the correct patient is remotely monitored.
Ensure all alarm volumes are set appropriately and are audible in all situations. Do not cover or otherwise block
any speaker openings.
This device is a precision electronic instrument and must be repaired by qualified technical professionals. 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.
The device must be able to measure the pulse properly to obtain an accurate SpO2 measurement. Verify that
nothing is hindering the pulse measurement before relying on the SpO2 measurement.
Operation of this device below the minimum amplitude of 0.3% modulation may cause inaccurate results for SpO2.
Readings of this device may be affected by the use of an electrosurgical unit (ESU). Keep electrosurgical/
electrocautery instruments away from the sensors and signal processors, as they may cause damage or result in
erroneous readings.
When defibrillation voltages are applied to the patient, the X-100M monitor may recover to a menu screen. The
X-100M will return to the monitoring screen after the menu screen times out (2 minutes) or with operator
interaction (press Menu button).
It is the user’s responsibility to implement the interface between the nurse call system and the Model X-100M,
and to adequately test the interface between the Model X-100M and the nurse call system to ensure operation.
The X-100M monitor has not been evaluated with specific nurse call systems.
A hazard can exist if different presets are used on multiple X-100M monitors in one care area.
Portable RF communications equipment such as cell phones or radios (including peripherals such as antenna
cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the medical
electrical system, including cables specified by the manufacturer. Otherwise, degradation of the performance of
this equipment could result.
2
Indications for Use
! Cautions
The value of rSO2 data from the system has not been demonstrated in specific disease states, under conditions
of hemoglobinopathies or clinical conditions that may affect blood volume, or under hypocapnic and hypercapnic
conditions.
When using this device in an operating room, it must remain outside the sterile field.
When mounting the monitor to a mobile pole, mounting the monitor higher than 1.5 meters or mounting more
than 2 kilograms of equipment onto the pole may result in tipping, damage to the equipment, or injury.
This equipment complies with IEC 60601-1-2 for electromagnetic compatibility (EMC) 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.
Exposure to Radio Frequency Radiation. The radiated output power of the display device is far below FCC radio
frequency exposure limits. Nevertheless, the device must be used in such a way that the potential for human
contact during normal operation is minimized. To avoid the possibility of exceeding FCC radio frequency
exposure limits, remain at least 20 cm (8 in.) away from the display unit’s internal antenna during normal
operation. The monitor has been tested and meets allowed limits for exposure.
This device is designed to determine regional hemoglobin oxygen saturation of blood underneath the sensor
when used with SenSmart regional oximetry sensors. Factors that may degrade performance or affect the
accuracy of the measurement include the following:
- excessive ambient light or direct - placement over bony prominence - carboxyhemoglobin and other
sunlight - incorrect sensor type dyshemoglobins
- excessive motion - skin barriers used between sensor and - hemoglobinopathies
- electrosurgical interference patient skin - billirubinemia and/or icterus (jaundice)
- metal plate or other foreign object in - anemia or low hemoglobin - non-normocapnic conditions or other
sensor path concentrations conditions that affect blood volume
- moisture on skin - cardiogreen or other intravascular or
- improperly applied sensor tissue dyes
This device is designed to determine the percentage of arterial oxygen saturation of functional hemoglobin when
used with SenSmart pulse oximetry sensors. Factors that may degrade pulse oximeter performance include the
following:
- excessive ambient light - blood flow restrictors (arterial - anemia or low hemoglobin
- excessive motion catheters, blood pressure cuffs, concentrations
- electrosurgical interference infusion lines, etc.) - cardiovascular dyes
- moisture in the sensor - incorrect sensor type - dysfunctional hemoglobin
- improperly applied sensor - poor pulse quality - artificial nails or fingernail polish
- carboxyhemoglobin - venous pulsations - residue (e.g., dried blood, dirt, grease,
- methemoglobin oil) in the light path
Batteries are a fire hazard if damaged. Do not damage, mishandle, disassemble, service, or replace with non-
specified components.
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 apply sensor over open wound, incision, or compromised skin. Inspect the sensor site(s) prior to applying
the sensor(s).
Do not autoclave, sterilize, immerse, or spray this device with liquid or use caustic or abrasive cleaning agents.
Do not use cleaning agents or cleaning products that contain ammonium chloride.
Follow local, state and national governing ordinances and recycling instructions regarding disposal or recycling
of the device and device components, including batteries. Use only Nonin-approved battery packs.
3
Indications for Use
! Cautions (Continued)
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.
Data is written continuously to memory when the device is on. If the entire memory is filled, portions of the oldest
record will be overwritten when new data is written.
Setting alarm limits to extremes can render the alarm system useless.
A preset cannot be saved with %rSO2 or %SpO2 low alarm limit settings that are lower than the institution default
settings. %rSO2 and %SpO2 low alarm limits that are lower than the institution defaults will be replaced in the
preset with the institution default setting(s).
A 2-minute alarm silence is automatically engaged at startup.
A functional tester cannot be used to assess the accuracy of the oximeter monitor or sensor.
If this device fails to respond as described, discontinue use until the situation is corrected by qualified technical
professionals.
Between patients, turn the X-100M monitor off (Standby mode) or start a new case (Case Menu). Failure to do so
could result in inaccurate baseline values for the new patient. When the device is turned on or a new case is
started, the monitor clears the baseline values, resets the limits to the default values, and begins a new patient
record in data memory.
For SpO2 monitoring, the device may not work when circulation is reduced. Warm or rub the finger, or reposition
the device.
In some circumstances, the device may interpret motion as good pulse quality during SpO2 monitoring. Minimize
patient motion as much as possible.
Do not connect more than one hub in the system. The system will not function.
Do not use an extension cable between the monitor and the hub. The system will not function.
Duplicate signal processors cannot be used simultaneously and will result in an error message.
Do not connect multiple extension cables between the monitor and a signal processor or between the hub and a
signal processor.
Do not simultaneously touch the accessible connector pins and the patient.
The device has been designed for use within the specified ranges. Use outside of these ranges has not been
tested and may result in improper oximeter performance.
All parts and accessories connected to the serial port of this device must be certified according to at least
IEC Standard EN 60950, IEC 62368-1, or UL 1950 for data processing equipment.
Failure of a network data coupling (serial cable/connectors/wireless connections) will result in loss of data
transfer.
Before first use and before storing this monitor, fully charge battery.
If not in continuous use, fully charge battery at six-month intervals.
4
Indications for Use
Declaration of Conformity with FCC and Canadian

Ministry of Health Rules for Electromagnetic
Compatibility
• Nonin Medical, Inc., of 13700 1st Avenue North, Plymouth, Minnesota, 55441, declares under
its sole responsibility that the Model X-100M, to which this declaration relates, comply with
part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) this device
may not cause harmful interference, and (2) this device must accept any interference
received, including interference that may cause undesired operation.
• Ministry of Health (Canada), Safety Code 6: standards include a substantial safety margin
designed to ensure the safety of all persons, regardless of age and health. The exposure
standard for wireless mobile phones employs a unit of measurement known as the Specific
Absorption Rate, or SAR. The SAR limit set by the FCC is 1.6 W/kg.
Federal Communications Commission (FCC) Notice

This equipment has been tested and found to comply with the limits for a class B digital device,
pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable
protection against harmful interference in a residential installation. This equipment generates,
uses, and can radiate radio frequency energy. If not installed and used in accordance with the
instructions, it may cause harmful interference to radio or television reception, which can be
determined by turning the equipment off and on. The user is encouraged to try to correct the
interference by one or more of the following measures: (1) Reorient or relocate the receiving
antenna, (2) Increase the distance between the equipment and the receiver, (3) Connect the
equipment to an outlet on a circuit different from the outlet where the receiver is connected, or
(4) Consult the dealer or an experienced radio/TV technician for assistance.
The Model X-100M is designed and manufactured not to exceed the emission limits for
exposure to radio frequency (RF) energy set by the Federal Communications Commission of
the U.S. Government. These limits are part of comprehensive guidelines and establish
permitted levels of RF energy for the general population. The guidelines are based on the
safety standards previously set by both U.S. and international standards bodies. This EUT has
been shown to be capable of compliance for localized specific absorption rate (SAR) for
uncontrolled environment/general population exposure limits specified in ANSI/IEEE Std.
C95.1-2005.
The FCC requires the user to be notified that any changes or modifications to this device that
are not expressly approved by Nonin Medical, Inc. may void the user’s authority to operate the
equipment.
NOTE: No modifications to this device are allowed that in any way affect or alter its antenna
or antenna configuration.
5
Guide to Symbols
Guide to Symbols
This chapter describes the symbols that are found on the Model X-100 system components
and packaging. Detailed information about functional symbols can be found in "System
Components and Set Up" on page 12.
Table 1. Labeling and Packaging Symbols
Symbol Description
CAUTION!
!
EC REP Authorized Representative in the European Community.
Consult instructions for use.
Follow instructions for use.
UL Mark for Canada and the United States with respect to electric shock,
fire, and mechanical hazards in accordance with:
• ANSI/AAMI ES60601-1 (2005, 3rd Ed.), CAN/CSA C22.2
No. 60601-1 (2008, 3rd Ed.), ISO 80601-2-61:2011,
IEC 60601-1-8:2006
• UL 60601-1 and CAN/CSA C22.2 No. 601.1
CE Marking indicating conformance to all applicable directives, including
EC Directive No. 93/42/EEC concerning medical devices.
Class II, double insulated
SN Serial number
Protected against vertically falling water drops when enclosure is tilted up

IP32 to 15 degrees and ingress of solid foreign objects greater than or equal to
2.5 mm in diameter, per IEC 60529.
Direct current
Type BF Applied Part (X-100M, X-100H)
Indicates separate collection for waste electrical and electronic equipment

(WEEE).
Non-ionizing electromagnetic radiation. Equipment includes RF

transmitters. Interference may occur in the vicinity of equipment marked
with this symbol.
Defibrillation-Proof Type BF Applied Part (patient isolation from electrical
shock). (X-100SP)
6
Guide to Symbols
Table 1. Labeling and Packaging Symbols (Continued)
Symbol Description
Do not discard.
Do not pull on cable. Retract connector and remove.
LOT Lot Number
REF Catalogue number
QTY Quantity
Date of manufacture
Manufacturer
Non-sterile
NON
STERILE
Storage/shipping temperature range
Handle with care.
Keep dry.
Medical prescription required.
Use by date
7
Guide to Symbols
1 5 6
2 3 7
15
19
14
16
10
17
18 9
11 12 13
Figure 1. Monitoring Screen Symbols (Four-Channel View)
Table 2. X-100M Monitoring Screen Symbols and Indicators
No. Symbol Description
1 Event Marks
example:
A B Located at the top of the monitoring screen, event marks (A, B, C, D,
etc.) display when the Event Mark button is pressed.
2 Timescale
example:
30MIN Located below the event marks, the timescale shows the amount of data
time displaying on the screen.
3 Scrolling Cursor
Located below the timescale, the yellow scrolling cursor allows the user
to view a channel’s rSO2 or SpO2 reading at a specific time on the
trendline.
The scrolling cursor does not display until the Left navigation button has
been pressed.
4 Cursor Values
97 When the scrolling cursor is active, cursor oximetry (rSO2 or SpO2)
65 values display on the left side of the monitor screen in a yellow box.
NOTE: Pulse rate values are not displayed in the cursor values.
8
Guide to Symbols
Table 2. X-100M Monitoring Screen Symbols and Indicators (Continued)
5 Ch Channel
Located at the top of each channel, this indicator shows the channel’s
number (e.g., Ch 1, Ch 2, etc.). If set, the sensor site name displays to
the right of the channel indicator.
6 %rSO2 Regional Hemoglobin Oxygen Saturation
or NOTE: %rSO2 displays when an absolute regional sensor is attached

to a signal processor. %rSO2-T displays when a trending regional
%rSO2-T sensor is attached to a signal processor.
%rSO2 displays from 0 to 100% when a signal processor receives an
adequate signal from an attached regional sensor.
The channel background display flashes:
• Yellow during medium priority alarm conditions (equipment alarms
and rSO2 values that are 5% or less above the rSO2 low alarm limit).
• Red during high priority rSO2 alarm conditions (set by the high and
low rSO2 alarm limits).
7 BL Baseline
When the monitor is turned on, the BL display shows dashes until the
user sets the baseline values.
The user must set the baselines for each new patient.
• For instructions on setting the baseline values to the current rSO2
values, see "Set All rSO2 Channel Baselines to Current %rSO2
Values" on page 31.
• For instructions on setting the baseline values separately or to make
finite adjustments to the baseline value, see "Set Individual Baseline
Values" on page 37.
8 Area Under the Curve (cumulative saturation below low alarm limit)
AUC
For each channel, the rSO2 values below the low alarm limit are
integrated together and displayed as the cumulative saturation below
low alarm limit, also known as AUC (Area Under the Curve). The value
is expressed in units of % minutes (%Min). When a baseline value is
changed, the AUC recalculates from the beginning of the current record.
The AUC will not calculate if a channel’s %rSO2 Low setting is OFF.
NOTE: In order for the AUC display to match the Society of Thoracic
Surgeons (STS) database definition, the low alarm limit value for each
channel must be set to 25% below the patient's baseline.
9
Guide to Symbols
9 Low Alarm Limit

example:
The low alarm limit is determined by the %rSO2 Low setting and
displays as the following:
• Numeric value – This value displays to the right of a trendline graph.
46 The color of the value matches the color of the associated channel.
• White, dotted line – This line only displays in a graph when the
.......... graph shows a single rSO2 trendline. The dotted line does not
display when multiple trendlines are set to display in one graph.
NOTE: A low alarm limit does not display on the monitoring screen if the
channel’s %rSO2 Low setting is OFF.
10 %SpO2 Percent Functional Hemoglobin Oxygen Saturation

%SpO2 data displays from 0 to 100% when a signal processor receives
an adequate signal from an attached pulse oximetry sensor.
The background of the SpO2 portion of the channel display flashes red
during high priority SpO2 alarm conditions (set by the high and low SpO2
alarm limits) and low perfusion alarm conditions.
11 PR Pulse Rate and Pulse Rate Bar Graph
Pulse rate data displays along with the %SpO2 display when a channel
is set up to measure pulse oximetry. The bar graph indicates pulse
strength as determined by the oximeter. The height of the bar graph is
proportional to the pulse amplitude.
The background of the pulse rate portion of the channel display flashes
red during high priority pulse rate alarm conditions (set by the high and
low pulse rate alarm limits) and low perfusion alarm conditions.
12 Sensor Fault
This yellow indicator flashes when a sensor is disconnected, has failed,
has not received any usable data in the last 90 seconds, or is not
compatible with the monitor.
13 Poor Signal
This yellow indicator flashes when there has been a sustained period of
poor patient signals from the sensor.
Check the sensor site and reposition or replace the sensor if necessary.
14 Signal Processor Communication Error
This yellow indicator flashes and the message X-100SP not connected
displays when the respective signal processor has stopped
communicating with the display.
Check the signal processor connections or replace the signal processor
to correct the issue.
If the message appears in each channel, check the hub’s connection to
the monitor.
10
Guide to Symbols
15 Alarm Silence
This yellow indicator flashes once every 2 seconds when the audible
alarm is silenced for 2 minutes.
If the alarm volume is at step 4 or lower (less than 45 decibels), the
Alarm Silence indicator is solidly lit.
16 Bluetooth
The Bluetooth indicator is green when Bluetooth is connected to a host,
white when it is enabled but not connected, and gray when it is disabled.
See "Enable/Disable Bluetooth Radio" on page 55 for more information.
17 Battery
The battery indicator shows the approximate percentage of battery life
Full
remaining. When AC power is connected, the battery indicator fills up
repeatedly to indicate the battery is charging. The indicator stops filling
Empty when the battery is fully charged.
l
• Low – battery indicator flashes yellow
• Critical – battery indicator flashes red
NOTE: When the monitor reaches a low or critical battery condition,
an audible alarm sounds. To clear the alarm, connect the monitor to
the AC power adapter.
18 example: Date and Time
The date and time display in 24-hour clock format. To set the date and/
2013 or time, see "Set the Date and Time" on page 54.
09-25
14:27
19 rSO2 Axis Scale
Fixed scale with a range from 0 to 100%.
11
System Components and Set Up

NOTES:
• Before using the SenSmart system, please review all contraindications, warnings, and
cautions.
• Before using the Model X-100M for the first time, the battery should be charged for 4 hours.
• Additional, but recommended, set-up tasks include: setting the clock, setting the institution
defaults, changing the institution password, and setting up presets.
Carefully remove the monitor and accessories from the shipping carton. Save the packaging
materials in case the monitor or accessories must be returned. Compare the packing list with
the accessories received to make sure the shipment is complete.
The standard system configuration includes these non-sterile components:
• X-100M, SenSmart universal oximetry monitor
• X-100H, hub
• X-100HH, hub holster
• X-100SP-1 and X-100SP-2, oximetry signal processors for channels 1 and 2 (a garment clip
is shipped with each signal processor)
• X-100EC1, 1-meter extension cable, quantity 2
• INT-100, intermediate cable, quantity 2
• Operator’s manual/parts and accessories list (CD)
• Power supply and cord
• SenSmart download software (CD)
For a list of compatible sensors and other accessories, see the Parts and Accessories List on
the operator’s manual CD.
System Configurations
Multiple Channels
When using the X-100H hub, up to six signal processors can be connected to the hub. If
needed, an extension cable may be used between the hub and a signal processor.
• The example in figure 2 shows a system set up using regional sensors for patients weighing
≥ 40 kg. The 8204CA sensor connects to the X-100SP signal processor via the INT-100
intermediate cable. The 8100S(X) pulse oximetry sensor connects directly to the signal
processor.
≤ 40 kg. These sensors (8004CB, 8004CB-NA) connect directly to the X-100SP signal
processor. The 8100S(X) pulse oximetry sensor connects directly to the signal processor.
≥ 40 kg. These sensors (8003CA, 8004CA) connect directly to the X-100SP signal processor.
The 8100S(X) pulse oximetry sensor connects directly to the signal processor.
12
X-100M
X-100H
X-100SP
INT-100
4 CA
4 CA
820
820
CA 4
4C
4 CA
A
820
CA
82
04
04
82
A C
4 CA
Sensors
CA
04
82
820
4 CA
4 CA
820
4 CA
820
Figure 2. System Set Up (≥40 kg Sensors, INT-100, 4 Channels Connected)
X-100M 100
50 52
0
100
50
0
100
50
X-100H 0
X-100SP
Sensors
Figure 3. System Set Up (≤40 kg Sensors, 4 Channels Connected)
13
X-100M
100
50
0
100
50
0
100
50
X-100H 0
X-100SP
Sensors
Figure 4. System Set Up (≥40 kg Sensors, 4 Channels Connected)
Single Channel
When using a single channel (figure 5), the signal processor can be connected directly to the
monitor. If needed, an extension cable can be used between the monitor and the signal
processor.
X-100M
66
X-100SP
INT-100
4CA
8204
CA
Sensor
CA
8204
CA
8204
Figure 5. System Set Up (≥40 kg Sensor, INT-100, Single Channel)
14
X-100M (Monitor)
The X-100M monitor (figure 6) allows the user to view up to six channels of rSO2 and SpO2
data. Each channel is color coded and numbered to match a signal processor. See table 3 for
monitor features and descriptions.
For cleaning instructions, refer to "Care and Maintenance" on page 74.
13
1
7
2
3
8 4
11
10 12
Figure 6. X-100M Front View
Table 3. X-100M Features
1 Alarm Silence Button

Press Alarm Silence to silence alarms for 2 minutes. Audible alarms
may be reactivated before the 2 minute silence period is over by pressing
Alarm Silence again.
All silenced audible alarms are automatically reactivated when a new
physiological alarm condition occurs.
2 Event Mark Button
Momentarily pressing this button marks an event in memory and on the
trendline. Events are denoted by increasing alphabetic letters. If more than
26 events are marked, the event marks begin at A again.
NOTE: It may take up to 4 seconds for the event mark to appear on the display.
Pressing this button for 2 seconds opens the event mark table. Momentarily
pressing the button closes the event mark table.
15
Table 3. X-100M Features (Continued)
3 Menu Button
Pressing this button opens the Settings menu and allows access to the
Presets, Case, and System menus:
• Settings – allows users to assign a sensor site name to a channel,
select sensor type (rSO2 or SpO2), set limits and graphs, and review
presets. See "Settings Menu Screen" on page 32 for more information.
• Presets – allows user to save current settings as a new preset, select a
preset to use, and delete a preset. See "Presets Menu Screen" on page
39 for more information.
• Case – allows user to start a new case and edit the patient ID. See
"Case Menu Screen" on page 43 for more information.
• System – allows user to set system settings. See "System Menu
Screen" on page 45 for more information.
4 Select Button
Pressing Select allows the user to save values when entering labels,
settings, and parameters. The monitor has two Select buttons:
• Right side of the monitor (between Menu and Baseline)
• Center of the navigation buttons
5 Baseline Button
This button is used to quickly set the baseline(s). Pressing this button twice
sets the baselines for all connected rSO2 channels to the patient’s current
readings.
6 On/Standby Button
• On – Pressing this button once turns on the monitor. Each time the
monitor is turned on, the monitor clears the baseline values, resets the
limits to the default values, and begins a new patient record in data
memory.
• Cancel – While operating the monitor, momentarily pressing this button
returns the display to the monitoring screen.
• Standby (off) – When the monitor is on, pressing this button for at least
1 second shuts down the monitor, putting it into Standby mode. In
Standby mode, all device functions are shut off, with the following
exceptions:
• The AC power adapter LED is lit whenever the device is plugged in.
• Batteries are charged whenever the device is plugged in.
16
Table 3. X-100M Features (Continued)
7 Navigation Buttons
These buttons are used to navigate between fields, scroll, and change the
timescale.
(Up) and (Down): In menus, used to navigate between items. On
the monitoring screen, used to change the rSO2 trendline timescale.
(Right): In menus, used to navigate between items. On the monitoring
screen, used to scroll forward in time in the current case.
(Left): In menus, used to navigate between items. In the monitoring
screen, used to scroll back in time in the current case.
(Select): See Select button description (#4) in this table.
8 Speaker
WARNING: Do not cover or otherwise block any speaker openings.
9 AC Power Adapter LED
This light-emitting diode (LED) indicator is lit when an external power supply provides
power to the device.
• Yellow – battery pack is charging
• Green – battery pack is fully charged
NOTE: When the external power supply is disconnected, the device automatically
switches to battery power without loss of functionality.
10 Power Adapter Input
Located on the bottom of the monitor below the AC power adapter LED, this input
connects the external power supply to the monitor.
11 Monitor Connector Port
Located on the front of the monitor, this port allows an X-100H hub or a single X-100SP
signal processor to connect to the monitor.
12 Nurse Call Input
Located on the bottom of the monitor below the On/Standby button, this input connects a
nurse call cable to the monitor.
WARNING: It is the user’s responsibility to implement the interface between the
Nurse Call system and the Model X-100M, and to adequately test the interface
between the Model X-100M and the Nurse Call system to ensure operation. The
X-100M monitor has not been evaluated with specific nurse call systems.
13 RS-232 Cable Input
Located on the back of the monitor (shown in figure 30).
CAUTION: All parts and accessories connected to the serial port of this device must be
certified according to at least IEC Standard EN 60950, IEC 62368-1, or UL 1950 for data
processing equipment.
17
X-100H (Hub)
The X-100H hub (figure 7) connects to the connector
port on the front of the monitor. The hub provides 2
connections for up to six X-100SP signal processors
via the hub ports. Each hub port has a protective port
cover.
CAUTION: Do not connect more than one hub

! in the system. The system will not function. 1
CAUTION: Do not use an extension cable

! between the monitor and the hub. The
system will not function.
For cleaning instructions, refer to "Care and 3

Maintenance" on page 74.
4
Connect/Disconnect the Hub
Figure 7. X-100H – Hub
1. To connect:
a. Align the arrow on the hub cable connector Table 4. X-100H Features
with the small triangle on the monitor No. Description
connector port (figure 8).
b. Push the hub cable connector straight into the 1 Cable connector
port. The hub cable connector will click when it 2 4-meter (13-foot) cable
locks into the monitor connector port.
3 Port
2. To disconnect:
a. Grasp the retractable sleeve (figure 8-1) on 4 Port cover
the hub cable connector.
b. Retract the sleeve and pull the hub cable
connector straight back. The hub will unlock and detach from the monitor.
Figure 8. Connect Hub or Signal Processor to Monitor
18
X-100HH (Hub Holster) 3 2
The hub fits inside the X-100HH hub holster

(figure 9). The hub holster clamp allows the hub to
be attached to bed rails, equipment poles, and
linen.
Using the Hub Holster 1
1. To insert the hub:

a. Align the hub and hub cable to the hub Figure 9. X-100HH – Hub Holster
holster (figure 10).
Table 5. X-100HH Features
b. Push firmly to insert the hub into the hub
holster. No. Description
2. To remove the hub:
1 Holster
a. Pull the clip (figure 9-3) back on the tip of
the hub holster. 2 Clamp
b. Pull the hub out of the hub holster. The back 3 Clip
of the hub holster has a cutout, which allows
the user to grasp the hub when removing it
from the holster.
For cleaning instructions, refer to "Care and Maintenance" on page 74.
Figure 10. Insert Hub into Hub Holster
19
X-100SP (Signal Processor)

Up to six signal processors can be connected to
the hub. Each signal processor is programmed
to be a specific channel on the monitor, so a
signal processor may be connected to any hub
port.
CAUTION: Duplicate signal processors

! cannot be used simultaneously and will
result in an error message.
5
A single signal processor may be connected
directly to the monitor with or without an
extension cable.
The signal processors are color coded: 4
X-100SP-1, Channel 1: blue

2
X-100SP-2, Channel 2: orange
1
X-100SP-3, Channel 3: white
X-100SP-4, Channel 4: purple 3
X-100SP-5, Channel 5: green
X-100SP-6, Channel 6: pink
Figure 11. X-100SP – Signal Processor
For cleaning instructions, refer to "Care and
Maintenance" on page 74. Table 6. X-100SP Features
Connect a Signal Processor to Hub or No. Description

Monitor 1 Signal processor cable connector
1. Align the arrow on the signal processor 2 Port (for sensor or INT-100)
cable connector with the arrow on one of the
hub ports or the monitor connector port. 3 Lock (for sensor or INT-100)
2. Push the signal processor cable connector 4 Channel number
straight into the port.
5 Cable clips
3. The signal processor cable connector will
click when it locks into the hub or monitor.
NOTE: An extension cable may be used between the hub and the signal processor, or
between the monitor and the signal processor.
Disconnect a Signal Processor from Hub or Monitor

1. Grasp the retractable sleeve on the X-100SP signal processor cable connector.
2. Retract the sleeve and pull the X-100SP connector straight back. The X-100SP will unlock
and detach from the hub or monitor.
NOTE: When removing the signal processor from the hub or the monitor, do not pull on the
signal processor cable.
20
Connect/Disconnect an INT-100 Intermediate Cable to the Signal Processor

NOTE: The INT-100 is used to connect the 8204CA (patients ≥40 kg) sensor to the signal
processor.
1. To connect:
a. Flip the clear lock on the signal processor back to expose the connection port.
b. Align the arrows on the INT-100 connector and the signal processor (figure 12-A).
Insert the INT-100 connector into the signal processor connection port.
c. Flip the lock over the connector and click it into place (figure 12-B).
d. Connect a compatible sensor to the INT-100.
2. To disconnect:
a. Flip the clear lock on the signal processor back to disengage the lock from the
connector.
b. Grasp the connector and remove it from the signal processor.
A B
Figure 12. Connect Intermediate Cable or Sensor to Signal Processor
Connect/Disconnect a Sensor to the Signal Processor

NOTE: The following sensors connect directly to the signal processor: 8003CA (patients
≥40 kg), 8004CA (patients ≥40 kg), 8004CB (patients ≤40 kg), 8004CB-NA (patients ≤40 kg),
and the 8100S(X) pulse oximetry soft sensors.
1. To connect:
a. Flip the clear lock on the signal processor back to expose the connection port.
b. Align the arrows on the sensor connector and the signal processor (figure 12-A). Insert
the sensor connector into the signal processor connection port.
c. Flip the lock over the sensor connector and click it into place (figure 12-B).
2. To disconnect:
a. Flip the clear lock on the signal processor back to disengage the lock from the
connector.
b. Grasp the connector and remove it from the signal processor.
21
Replacing the Lock on the Signal Processor

NOTE: Replacement locks may be ordered if the lock is lost or damaged.
1. Align the lock hinge with the connector end of the signal processor (figure 13-A).
2. Gently spread the lock hinge so it fits over the end of the signal processor.
3. Click the lock into place (figure 13-B).
A B
Figure 13. Signal Processor Lock Replacement
Cable Clips
The signal processor is delivered with 2 pre-attached, color-coded clips that match the color
of the channel (e.g., X-100SP-1 has two blue clips attached to the cable). One cable clip is
attached at the connector end and another cable clip is attached in the middle of the cable.
INT-100 (Intermediate Cable)

An intermediate cable (figure 14) is used between an
X-100SP signal processor and a compatible sensor.
1
The following sensors are compatible with the
INT-100 intermediate cable:
• 8204CA regional sensor for patients ≥40 kg
NOTES: 3
• The INT-100 is not an extension cable. 2
• The 8003CA and 8004CA regional sensors (for
patients ≥40 kg); 8004CB and 8004CB-NA Figure 14. INT-100 –
regional sensors (for patients ≤40 kg); and Intermediate Cable
8100S(X) pulse oximetry sensors do not use the
INT-100; these sensors connect directly to the Table 7. INT-100 Features
signal processor.
• Do not discard the INT-100 intermediate cable. No. Description
Connector (to signal

1
For cleaning instructions, refer to "Care and processor)
Maintenance" on page 74.
2 Port (for sensor)
3 Sensor lock
22
Connect/Disconnect a Sensor to the Intermediate Cable

NOTE: The INT-100 is used to connect the 8204CA (patients ≥40 kg) sensor to the signal
processor.
1. To connect:
a. Slide the sensor lock on the INT-100 away from the port.
b. Align the arrows on the sensor connector and the INT-100 (figure 15-A). Insert the
sensor connector into the INT-100 port.
c. Slide the sensor lock to the port. Secure the sensor lock so it covers the sides of the
port and the sensor connector. The sensor cable fits into the notch on the sensor lock
(figure 15-B).
A B
2
2
Figure 15. Connect Sensor to Intermediate Cable

2. To disconnect:
a. Disengage the sensor lock from the joined sensor and cable and slide it away from the
INT-100 port.
b. Grasp the sensor connector and remove it from the INT-100 port.
X-100EC (Extension Cable)

Extension cables are available in 1- or 2-meter lengths.
An extension cable may be used:
• Between the hub and a signal processor.
• Between the monitor and a signal processor.
CAUTION: Do not use an extension cable

! between the monitor and the hub. The system
will not function.
CAUTION: Do not connect multiple extension

! cables between the monitor and a signal
processor or between the hub and a signal
processor.
For cleaning instructions, refer to "Care and

Maintenance" on page 74. Figure 16. X-100EC –
Extension Cable
23
rSO2 and SpO2 Sensors

See the Parts and Accessories List on the operator’s manual CD for a complete list of
compatible sensors. Detailed information regarding specific sensor use (e.g., patient
population, body/tissue, application, connecting the sensor to the system) can be found in the
respective sensor instructions for use.
Battery
! CAUTION: Before first use and before storing this monitor, fully charge battery.
! CAUTION: If not continuous use, fully charge battery at six-month intervals.
For more information, see the Internal Power section of the "Specifications" on page 86.
CAUTIONS:
!
• Follow local, state and national governing ordinances and recycling instructions
regarding disposal or recycling of the device and device components, including
batteries.
• Use only Nonin-approved battery packs.
• Batteries are a fire hazard if damaged. Do not damage, mishandle, disassemble,
service, or replace with non-specified components.
• 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.
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.
24
System Operation
System Operation
CAUTION: Between patients, turn the X-100M monitor off (Standby mode) or start a
! new case (Case Menu). Failure to do so could result in inaccurate baseline values for
the new patient. When the device is turned on or a new case is started, the monitor
clears the baseline values, resets the limits to the default values, and begins a new
patient record in data memory.
Start-up Sequence
Each time the monitor is turned on, it performs a
brief start-up sequence.
1. Press On/Standby.
2. The LCD display lights up and displays the
Nonin logo (figure 17).
3. An audible tone sounds.
Verify each of the above items occur on
initialization. If any do not occur, contact Nonin
Technical Service for assistance.
Figure 17. Start-up Screen
Following the start-up sequence, the monitor displays the Select a Preset screen (figure 18).
However, depending on the system configuration, the monitor may first display one or both of
the following screens:
• If the clock is not set, the message System clock is not set! will briefly display.
• If the system is set up to require entry of a patient ID, the Enter patient ID screen displays. If
a patient ID is not needed, allow the screen to time out (2 minutes) or press Menu to advance
to the Select a Preset screen.
Once the Select a Preset screen (figure 18)
displays, the user can select a preset. The
default preset is highlighted at start-up.
Other choices include the last used preset
and the other presets on the monitor.
Once a preset is selected, the Settings Menu
screen displays so the limits can be
reviewed. If the connected system
configuration does not match the selected
preset, the message Verify sensor type and
limits! displays before the monitor displays Figure 18. Select a Preset Screen
the Settings Menu screen.
WARNING: A hazard can exist if different presets are used on multiple X-100M
monitors in one care area.
25
System Operation
Sensor Application
Refer to the sensor instructions for use for proper sensor application sites and sensor
application cautions and warnings.
WARNING: This device is intended only as an adjunct device in patient assessment. It

should not be used as the sole basis for diagnosis or therapy decisions. It must be
used in conjunction with other methods of assessing clinical signs and symptoms.
WARNING: As with all medical equipment, carefully route patient cables and
connections to reduce the possibility of entanglement, strangulation, or tripping.
Monitoring a Patient
After setting up the monitor and applying the sensor(s) to the patient:
1. Press On/Standby to turn on the monitor.
2. Verify active preset or select a new preset.
3. Verify the alarm limits in the preset are appropriate.
4. If using rSO2 sensors, establish a baseline rSO2 value(s) and set the patient’s baseline
(see “Baseline (rSO2 channels only)” on page 33 for more information).
the new patient. When the device is turned on or a new case is started, the monitor
26
System Operation
Operating Screens and Menus

The X-100M monitoring screen can be configured to display up to six channels of rSO2 and
SpO2 data, along with rSO2 trendlines and SpO2 plethysmograms. See “Monitoring Screen”
on page 28 for more information.
The operating menus display when the Menu button is pressed. The Settings Menu screen
opens and additional menu tabs for Presets, Case, and System display across the top of the
screen. In this manual, each operating menu has its own section, which contains a description
of the menu and procedures. See the following for more information:
• “Settings Menu Screen” on page 32
• “Presets Menu Screen” on page 39
• “Case Menu Screen” on page 43
• “System Menu Screen” on page 45
NAVIGATION TIPS:
• When viewing the monitoring screen, the Right/Left navigation buttons scroll through the
current case. The Up/Down navigation buttons change the trendline timescale.
• When scrolling through a case, quickly return to the current time by pressing Menu twice or
momentarily pressing On/Standby.
• Menu screens time out and return to the monitoring screen after 2 minutes.
• When a menu tab is active, the box around the tab is yellow and the text is highlighted. When
a field on a menu screen is active, the box around the tab is yellow and the tab text is white.
• When in a menu or submenu, pressing Menu once backs the highlighted field up one level.
• When on a main menu (i.e., Settings, Presets, Case, System) screen, pressing Menu once
activates the tab at the top of screen. Pressing Menu twice returns the user to the monitoring
screen.
• When a settings name is highlighted in yellow, the field is active. When a field has small yellow
arrows around it, the field can be modified.
• When in a pop-up menu, pressing Menu once cancels the pop-up.
• When in a menu, momentarily pressing On/Standby returns the display to the monitoring
screen.
• Passwords for presets are set by the user and are 4 numbers in length. Preset passwords
can be overridden by the institution password.
27
Monitoring Screen
Monitoring Screen
This section contains:
• Description of the monitoring screen features
• Monitoring screen procedures (see page 31)
Monitoring Screen – Description

Channels
When up to four channels are monitoring, real-time numeric data displays by channel on the
right side of the screen. When more than four channels are monitoring, the channels display
on the right side and along the bottom of the screen.
rSO2 Channels
rSO2 channels display the channel number, the sensor site name (if set), %rSO2, BL, and
AUC.
SpO2 Channels
SpO2 channels display the channel number, the sensor site name (if set), pulse rate, pulse
amplitude bar graph, and %SpO2.
Figure 19. Monitoring Screen with Four Channels Connected (3 rSO2 and 1 SpO2)
28
Monitoring Screen
Event Marks
Event marks are located at the top of the monitoring screen above the timescale (figure 20).
When pressed, the Event Mark button places a mark above the displayed graphs, in the
memory, and in the real-time serial data output. Events are marked with increasing alphabetic
letters. When Z is reached, the letters start over at A.
Figure 20. Event Marks, Timescale, and Scrolling Cursor
Event Mark Table

The event mark table (figure 21) shows the last 10 event marks, along with the date and time
the event was marked, the event mark letter, and the readings for each connected channel.
The event mark table screen automatically closes after 2 minutes. To quickly exit the event
mark table, momentarily press Event Mark, Menu, Select, or On/Standby.
Figure 21. Event Mark Table
Timescale
The timescale is located in the upper left corner of the monitoring screen and is the duration
of data that will display on the screen (figure 20). The default timescale is 30 minutes. Using
the Up and Down navigation buttons, the range can be set so the monitoring screen shows as
few as 7.5 minutes of data or up to 24 hours of data. The timescale uses a 24-hour clock.
29
Monitoring Screen
Scrolling Cursor and Cursor Values

The scrolling cursor and the cursor values display when the Left navigation button is pressed.
The scrolling cursor displays directly below the timescale and moves back and forth across
the top of the channel graph display area (figure 20). Use the Left and Right navigation buttons
to move the cursor.
While scrolling, patient readings (rSO2 and SpO2) display on the left side of the monitoring
screen as a list of cursor values.
NOTE: Pulse rate values are not displayed in the cursor values.
To quickly exit scrolling mode and return to the current time in the case, press Menu twice or
momentarily press On/Standby.
Graphs
The user may choose to have each connected channel display a graph on the monitoring
screen, for a total of up to six graphs. Graphs may also be shut off. Graph height will vary
depending on how many graphs are set to display on the monitoring screen. rSO2 channels
display trendlines and SpO2 channels display plethysmograms.
rSO2 Trendlines
The color-coded trendlines (figure 22-A) can be displayed individually or can be combined so
multiple trendlines appear in a single graph. The channel’s color-coded low alarm limit value
displays to the right of each trendline graph when turned on.
The default setting has each channel displaying as a separate graph.
SpO2 Plethysmograms
Each color-coded plethysmogram (figure 22-B) displays as a separate graph. The
plethysmogram is normalized and the scale is automatically determined by how many graphs
are set up to display on the monitoring screen. The plethysmogram timescale is approximately
14 mm/s, and it cannot be modified.
The default setting is On.
NOTE: When displayed, the color-coded plethysmograms are automatically located below
the rSO2 trendlines and may not be located next to their channel number. To keep an SpO2
channel box near its plethysmogram, connect the SpO2 sensor to a signal processor that has
a higher channel number than any of the connected rSO2 sensors.
Figure 22. Graphs

30
Monitoring Screen
Monitoring Screen – Procedures

Set All rSO2 Channel Baselines to Current %rSO2 Values
1. (OPTIONAL STEP) Press Event Mark to mark an event. Record the letter of the event in
the hospital records.
2. While in the monitoring screen, press Baseline. “Update baselines for rSO2 channels”
screen displays with the patient’s baseline values.
3. Press Baseline or Select.
4. rSO2 channel baseline values are set to the current baseline readings and the display
returns to the monitoring screen.
Mark an Event
1. While monitoring, momentarily press Event Mark.
2. The event mark letter appears on the screen and is stored in memory.
NOTE: It may take up to 4 seconds for the event mark to appear on the display.
View the Event Mark Table

1. While monitoring, press Event Mark for approximately 2 seconds.
2. The event mark table (figure 21) displays on the monitor.
3. The event mark table screen automatically closes after 2 minutes. To quickly exit the event
mark table, momentarily press Event Mark, Menu, Select, or On/Standby.
Change the Timescale

While monitoring, press Up/Down to change the timescale to the desired setting.
Available settings are:
• 7.5 minutes • 1 hour • 8 hours
• 15 minutes • 2 hours • 12 hours
• 30 minutes • 4 hours • 24 hours
(default)
Scroll Through the Timescale

1. While monitoring, press Left to display the cursor above the graph(s).
2. When the scrolling cursor displays, the color-coded cursor values display on the left side
of the monitoring screen below the timescale rate.
3. To quickly exit scrolling mode and return to the current time in the case, press Menu twice
or momentarily press On/Standby.
Graph Set-up
Graphs are set up on the Settings Menu screen. See “Graph Position” on page 35 or “Set
Graph Position(s)” on page 38 for more information.
31
Settings Menu Screen

• Description of the Settings Menu
• Settings Menu procedures (see page 36)
Settings Menu – Description

The Settings screen allows the user to configure the system for specific use case needs. From
the Settings screen, the user can review and configure the following settings and alarm limits.
• Sensor site • %SpO2 high

• Sensor type • %SpO2 low
• Baseline • PR high
• %rSO2 high • PR low
• %rSO2 low (% BL) or • Graph position
%rSO2 low (Abs) • Preset #:
Figure 23. Settings Menu Screen
Sensor Site
The sensor site setting allows the user to select, customize, or clear a sensor site name.
Table 8 lists the pre-defined, commonly-used sensor site names.
32
Table 8. Commonly-Used Sensor Site Names
Head Arms Torso Legs Leg Compartments
L Cere L Delt Abdomen L Thigh LAC

(Left Cerebral) (Left Deltoid) (Abdominal) (Left Thigh) (Left Anterior Calf)
R Cere R Delt L Flank R Thigh LLC
(Right Cerebral) (Right Deltoid) (Left Flank) (Right Thigh) (Left Lateral Calf)
L Ear L Fore R Flank L Calf LDP
(Left Ear) (Left Forearm) (Right Flank) (Left Calf) (Left Deep Posterior)
R Ear R Fore Up R Abd R Calf LP
(Right Ear) (Right Forearm) (Upper Right (Right Calf) (Left Posterior)
FH L Then Abdomen) L Foot RAC
(Forehead) (Left Thenar) (Left Foot) (Right Anterior Calf)
R Then R Foot RLC
(Right Thenar) (Right Foot) (Right Lateral Calf)
L Hand L Toe RDP
(Left Hand Finger) (Left Foot Toe) (Right Deep Posterior)
R Hand R Toe RP
(Right Hand Finger) (Right Foot Toe) (Right Posterior)
Sensor Type
When creating a preset, this setting allows the user to select the type of sensor that will be
attached to that channel. The sensor type options are rSO2 or SpO2. This field is disabled
when a compatible sensor is attached.
Baseline (rSO2 channels only)

If the patient’s baseline values have not been set by the user, the BL display shows dashes.
When starting a new case and the rSO2 Low Alarm Mode is set to “% below Baseline,” the
rSO2 low alarm limit values are the institution’s or preset’s default %rSO2 Low (Abs) value.
Once the user sets the baseline, the rSO2 low alarm limit will become a percentage of the
baseline.
The rSO2 baseline values need to be set by the user for each patient so that subsequent rSO2
changes are measured relative to this baseline. As soon as rSO2 values appear on the
monitoring screen, the device begins plotting trend data on the screen. At this point, if the
patient condition is stable, a baseline value should be set for each rSO2 channel in use. For
example, in surgical patients, the baseline should be set prior to induction.
Baselines may be set to the current rSO2 values displayed on the monitor or be set to specific
values.
the new patient. When the device is turned On or a new case is started, the monitor
33
Alarm Limits
Most alarm limits can be set and saved in a preset according to the options listed in table 9.
The exceptions are the “%rSO2 Low” and “%SpO2 Low” alarm limits, which cannot be saved
in a preset with a value lower than the institution default settings. See the “%rSO2 Low” and
“%SpO2 Low” sections below for more information.
NOTE: The institution default limits are populated with factory default values until changed by
the institution.
Table 9. Alarm Limit Settings
Adjustment
Alarm Limit Factory Defaults Adjustment Options
Increments
%rSO2 High Off Off, 20% to 95% 1%
%rSO2 Low*
%rSO2 Low (% BL) Baseline - 25% Off, - 40% to - 5% 1%
% below baseline (Baseline minus 25%) (minus 40% to minus 5%)
or
%rSO2 Low (Abs) Absolute 50% Off, 15% to 90% 1%
%SpO2 High Off Off, 80% to 100% 1%
%SpO2 Low 85% Off, 50% to 95% 1%
Pulse High 200 BPM Off, 75 to 275 BPM 5 BPM
Pulse Low 50 BPM Off, 30 to 110 BPM 5 BPM

* Depending on how the rSO2 Low Alarm Mode is set on the System Menu screen, this setting will be either
“%rSO2 Low (% BL)” or “%rSO2 Low (Abs).”
CAUTION: A preset cannot be saved with %rSO2 or %SpO2 low alarm limit settings
! that are lower than the institution default settings. %rSO2 and %SpO2 low alarm limits
that are lower than the institution defaults will be replaced in the preset with the
institution default setting(s).
WARNING: Verify all alarm settings and limits during system startup to ensure that
they are set as intended.
NOTE: The AUC will not calculate if the “%rSO2 Low (% BL)” setting or “%rSO2 Low (Abs)”
setting is OFF.
%rSO2 Low
When a case begins, the rSO2 low alarm limit will be the “%rSO2 Low” value in the selected
preset. During the case, the rSO2 low alarm limit can be modified; however, the “%rSO2 Low”
setting is restricted by the device’s defaults when saving a preset. The rSO2 low alarm limit
cannot be saved with a value lower than the institution default setting.
34
Anytime the low alarm limit is modified, the AUC recalculates from the beginning of the current
record.
The rSO2 low alarm limit displays as a value to the right of a trendline graph on the monitoring
screen. When a graph shows a single rSO2 trendline, the low alarm limit also displays as a
white, dotted line in the graph.
A low alarm limit value does not display on the monitoring screen if the channel’s “%rSO2 Low”
setting is OFF.
Depending on how the rSO2 Low Alarm Mode is set on the System Menu screen, this setting
will be either “%rSO2 Low (% BL)” or “%rSO2 Low (Abs).”
%rSO2 Low (% BL) (default): When using the “%rSO2 Low (% BL)” setting, the low alarm limit
is set to a percentage between -40% to -5%. The low alarm limit calculation is the set baseline
minus the selected percentage. The factory default is the baseline value minus 25% of the
baseline value (see table 9).
Example: if the BL is 60, then the low alarm limit is 45 (60 minus 25% = 45).
%rSO2 Low (Abs): When using the “%rSO2 Low (Abs)” setting, the low alarm limit is set to a
specific value between 15% to 90%. The factory default setting is 50%.
%SpO2 Low
When a case begins, the SpO2 low alarm limit will be the “%SpO2 Low” value in the selected
preset. During the case, the SpO2 low alarm limit can be modified; however, the “%SpO2 Low”
setting is restricted by the device’s defaults when saving a preset. The SpO2 low alarm limit
cannot be saved with a value lower than the institution default setting.
Graph Position
This setting determines the location of individual channel trendlines or plethysmograms.
TIPS:
• The trendlines and plethysmograms are color-coded and match the signal processor
channel colors
• A graph may not align with its respective channel on the monitoring screen.
• Multiple rSO2 trendlines can be placed on one graph.
• rSO2 trendlines and SpO2 plethysmograms cannot be on the same graph.
• rSO2 graphs display at the top of the monitoring screen in the order they are set (A – F).
• Each SpO2 plethysmogram is a separate graph. SpO2 graphs display below rSO2 graphs
and are ordered based on channel number.
Preset #:
The setting allows the user to quickly access and review the monitor’s presets.
Asterisks appear around the preset name when the active preset has been modified on the
Settings Menu screen or the System Menu screen. To save these changes for future use, save
the preset (see "Presets Menu – Procedures" on page 40).
35
Settings Menu – Procedures

Open the Settings Menu
1. Press Menu. Settings Menu screen displays.
Assign a Pre-Defined Sensor Site Name

1. While in the Settings Menu screen, use the navigation buttons to move to and highlight the
desired channel’s “Sensor Site” setting.
2. Press Select. Pop-up menu displays.
3. Use the navigation buttons to move to and highlight the desired sensor site category.
4. Press Select. Pop-up submenu displays.
5. Use the navigation buttons to move to and highlight the desired sensor site name.
6. Press Select to save. Display returns to the Settings menu. The abbreviated sensor site
name displays below the channel number.
7. Change additional settings, press Menu twice to return to monitoring screen, or allow the
screen to time out.
Customize a Sensor Site Name

3. Use the navigation buttons to move to and highlight “Custom.”
4. Press Select. Alphanumeric keyboard screen displays.
5. Enter sensor site name (maximum of 8 characters):
a. Use the navigation buttons to move to and highlight the desired character.
b. Press Select.
c. Repeat steps a and b as needed to enter the name.
6. Press Down until “Save” is highlighted.
7. Press Select. Display returns to the Settings Menu screen. The custom sensor site name
displays below the channel number.
screen to time out.
Clear a Sensor Site Name

3. Use the navigation buttons to move to and highlight “Clear.”
4. Press Select. Display returns to the Settings Menu screen. The sensor site field displays
“blank” below the channel number.
screen to time out.
36
Set Sensor Type

NOTE: Sensor type is automatically set and cannot be manually changed when a Nonin
SenSmart-compatible rSO2 or SpO2 sensor is attached to the signal processor.
desired channel’s “Sensor Type” setting.
2. Press Select. Small arrows display above and below the setting.
3. Press the Up/Down navigation buttons to change the setting.
4. Press Select to set the sensor type. When the sensor type is set, the Settings Menu
screen activates the settings for that sensor type:
rSO2 settings: SpO2 settings:
• Baseline • %SpO2 high
• %rSO2 high • %SpO2 low
• %rSO2 low (% BL) or • PR high
%rSO2 low (Abs) • PR low
screen to time out.
Set Individual Baseline Values

1. (OPTIONAL STEP) While monitoring, press Event Mark to mark an event. Record the
letter of the event in the hospital records.
2. Press Menu. Settings Menu screen displays.
3. Use the navigation buttons to move to and highlight the desired channel’s “Baseline”
setting.
6. Press Select to set the baseline value.
7. Repeat as needed for each rSO2 channel.
screen to time out.
NOTE: Alarm limits reset to currently active default values each time the unit is powered up.
37
Set Alarm Limits

1. Follow steps 1 – 4 of the "Set Sensor Type" on page 37 or connect a Nonin SenSmart-
compatible sensor to the signal processor.
2. Use the navigation buttons to move to and highlight the desired channel’s alarm limit
setting.
4. Press the Up/Down navigation buttons to change the setting. See table 9 for alarm limit
setting options.
5. Press Select to set the limit.
6. Repeat as needed for each of the high and low alarm limit settings.
screen to time out.
Set Graph Position(s)

1. While in the Settings Menu screen, use the navigation buttons to move to and highlight a
channel’s “Graph Position” setting.
• rSO2 channels can be set to a letter from A to F, or Off. Up to six rSO2 channel trendlines
can display in one graph.
• SpO2 channels can be set to On or Off.
4. Press Select to set the graph position.
screen to time out.
Review/Select a Preset
1. While in the Settings Menu screen, press Down to move to and highlight the “Preset” field
at the bottom of the Settings Menu screen.
2. Use the Right/Left navigation buttons to scroll through the presets and review the settings
for each preset.
3. To select a preset, stop scrolling through the presets. The preset on the screen becomes
the active preset.
4. Press Menu twice to return to the monitoring screen.
38
Presets Menu Screen
Presets Menu Screen

• Description of the Presets Menu
• Presets Menu procedures (see page 40)
TIPS:
• All channel-specific settings on the Settings Menu screen can be saved in a preset.
• Six of the System Menu settings will be saved in a preset: Brightness, Alarm Volume, rSO2
Low Alarm Mode, Pulse Tone Volume, Pulse Tone Source, and Data Output Modes.
Presets Menu – Description

A preset is a collection of channel and system settings that can be saved and recalled. The
Presets Menu screen allows the user to save the current settings as a preset, activate a saved
preset, and delete, rename, lock, or unlock a preset.
The monitor can save up to 10 presets. The 10 presets are initially designated as default
presets and are set to the factory default settings. If the institution default limits have been set,
the default presets use those settings.
One preset can be designated as the institution default preset. When the monitor is turned on,
the institution default preset is applied to the new case. The user may use this preset or
activate another preset.
When a preset is deleted, the name reverts to “Defaults” and the settings revert to the factory
default values, or the institution defaults if they have been set.
WARNING: Verify all alarm settings and limits during system startup to ensure that
they are set as intended.
WARNING: A hazard can exist if different presets are used on multiple X-100M
monitors in one care area.
NOTE: Presets are retained even when both external and battery power are lost.
NOTE: If the user changes the settings in an active preset and then wants to save the new
settings as the preset, see "Save Current Settings as a Preset" on page 40.
39
Presets Menu Screen
Figure 24. Presets Menu Screen
Presets Menu – Procedures

Open the Presets Menu
1. Press Menu.
2. Press Right once to highlight the Presets tab. Presets Menu screen displays.
Activate a Preset
1. While in the Presets Menu screen, use the navigation buttons to move to and highlight the
desired preset.
2. Press Select. Pop-up menu displays with “Use This Preset” highlighted.
3. Press Select. Preset activates and display returns to the Settings screen.
4. Change additional settings, press Menu to return to monitoring screen, or allow the
screen to time out.
Save Current Settings as a Preset

1. Using the Settings and System menus, set all parameters and settings to the desired
values.
2. Use the navigation buttons to move to and highlight the Presets tab.
3. While in the Presets Menu screen, use the navigation buttons to move to and highlight
“Save Current Settings as New Preset.”
40
Presets Menu Screen
5. Using the Up/Down navigation buttons, select a preset to overwrite.
NOTE: If the preset is locked, the message Cannot overwrite locked preset! displays. To
unlock the preset, see “Lock/Unlock a Preset” on page 42.
6. Press Select. Preset name box displays along with alphanumeric keyboard screen. If
updating an existing preset, continue to step 8.
7. Enter Preset name (maximum of 11 alphanumeric characters):
b. Press Select.
9. Press Select to save. Preset activates and the display returns to the monitoring screen.
Delete a Preset
desired preset.
2. Press Select. Pop-up menu displays. If needed, unlock the preset (see “Lock/Unlock a
Preset” on page 42).
3. Press Down once to highlight “Delete.”
4. Press Select. “Delete selected preset?” pop-up displays with “No” highlighted.
• To cancel deletion, press Select.
• To delete preset, press Down to highlight “Yes,” and then press Select. The preset name
reverts to “Defaults” and the preset values become the institution defaults.
Rename a Preset
desired preset.
2. Press Select. Pop-up menu displays. If needed, unlock the preset (see “Lock/Unlock a
Preset” on page 42).
3. Press Down twice to highlight “Rename.”
4. Press Select. Alphanumeric keyboard screen displays
5. Enter Preset name (maximum of 11 alphanumeric characters):
b. Press Select.
7. Press Select. Display returns to the Presets Menu screen.
41
Presets Menu Screen
Lock/Unlock a Preset
NOTE: An unlocked preset displays an open lock symbol next to the preset name, and a
locked preset displays a closed lock symbol next to the preset name.
desired preset.
• To unlock a preset, press Down to highlight “Unlock.”
• To lock a preset, press Down to highlight “Lock.”
3. Press Select.
4. Enter a preset password. This is a user-specific password, which can be overridden by the
institution password.
5. Display returns to the Presets Menu screen.
42
Case Menu Screen
Case Menu Screen

• Description of the Case Menu
• Case Menu procedures (see page 43)
Case Menu – Description

The Case menu screen (figure 25) allows the user to view the current patient’s ID
(identification), start a new case, or edit a patient’s ID.
Figure 25. Case Menu Screen
Start New Case

This setting allows the user to begin a new case using the current preset. When a new case
is started, the baselines are cleared and a new record starts in memory.
Edit Patient ID
This setting allows the user to edit an existing patient ID or add a patient ID to a case. Patient
IDs may be a maximum of 15 alphanumeric characters.
Case Menu – Procedures

Open the Case Menu
1. Press Menu.
2. Press Right twice to highlight the Case tab. Case Menu screen displays.
43
Case Menu Screen
Start a New Case

1. While in the Case Menu screen, use the navigation buttons to move to and highlight “Start
new case.”
2. Press Select. “Start new case?” pop-up displays with “No” highlighted.
3. Press Down to highlight “Yes.”
4. Press Select.
• If system is set up to require the entry of a patient ID at the start of a new case (see
“Patient ID Request” for more information):
- Alphanumeric keyboard screen displays. Follow steps 3 – 5 in the next procedure,
“Edit a Patient ID.”
- After patient ID is entered, “Starting new case...” displays. Monitor returns to
monitoring screen and all baselines from the previous case are cleared.
• If system is not set up to require entry of a patient ID at the start of a new case:
- “Starting new case...” displays. Monitor returns to monitoring screen and all baselines
from the previous case are cleared.
- The case will not have a patient ID. To enter a patient ID, see the next procedure,
“Edit a Patient ID.”
Edit a Patient ID
1. While in the Case Menu screen, use the navigation buttons to move to and highlight “Edit
patient ID.”
2. Press Select. Alphanumeric keyboard screen displays.
3. Enter the Patient ID (maximum of 15 alphanumeric characters).
b. Press Select.
5. Press Select to save. Current patient ID displays on the Case Menu screen.
6. Press Menu twice to return to the monitoring screen, or allow the screen to time out.
44
System Menu Screen
System Menu Screen

• Description of the System Menu
• System Menu procedures (see page 51)
System Menu – Description

The System Menu screen (figure 26) allows the user to access the following settings:
• Brightness* • Date / time

• Alarm volume* • Nurse call mode
• rSO2 low alarm mode* • Bluetooth
• Pulse tone volume* • Language
• Pulse tone source* • Patient ID request
• Data output modes* • System name
• Clear memory • Default preset
• Restore factory defaults • Institution default limits
• System information • Institution password
* These settings can be included as a preset parameter.
Figure 26. System Menu Screen
45
System Menu Screen
Brightness
This setting determines the display screen brightness. The brightness slider has 15 steps. The
default brightness is maximum brightness (15). This setting can be saved as a preset
parameter.
Alarm Volume
This setting determines the volume of audible alarms. The alarm volume slider has 15 steps.
The default alarm volume is maximum volume (15). This setting can be saved as a preset
parameter.
If the alarm volume is at step 5 or higher, the slider is green. If the alarm volume is at step 4
or lower (less than 45 decibels), the slider is yellow, and the yellow Alarm Silence indicator is
lit solidly on the monitoring screen.
rSO2 Low Alarm Mode

This setting determines how the low alarm limit will be calculated. This setting can be set to
either “% Below Baseline” or “Absolute.” Default is “% Below Baseline.”
Once set, either %rSO2 Low (% BL) or %rSO2 Low (Abs) will display on the Settings Menu
screen. See page 34 for more information about rSO2 low alarm limits.
This setting can be saved as a preset parameter.
% Below Baseline
To have the rSO2 low alarm limit value automatically calculated as a percentage below the
baseline, set the rSO2 Low Alarm Mode to “% Below Baseline” (default). The factory default
is the baseline value minus 25% of the baseline value (table 9 on page 34).
Example: if the BL is 60, then the low alarm limit is 45 (60 minus 25% = 45).
When starting a new case and the rSO2 Low Alarm Mode is set to “% Below Baseline,” the
rSO2 low alarm limit values are the institution’s or preset’s default %rSO2 Low (Abs) value.
Once the user sets the baseline, the rSO2 low alarm limit will become a percentage of the
baseline.
Absolute
To have the %rSO2 low alarm limit be a specific value, set the rSO2 Low Alarm Mode to
“Absolute.”
When starting a new case and the rSO2 Low Alarm Mode is set to “Absolute,” the rSO2 low
alarm limit values are the selected preset’s %rSO2 Low (Abs) values.
Pulse Tone Volume

This setting determines the volume of the pulse beep. The pulse tone volume slider has
15 steps. The default pulse tone volume is off (0). This setting can be saved as a preset
parameter.
46
System Menu Screen
Pulse Tone Source

This setting determines which SpO2 channel will provide the pulse tone. Only one SpO2
channel can be set as the pulse tone source. This setting can be saved as a preset parameter.
Data Output Modes

This device features 5 different once-per-second, real-time data output formats (Nonin 1,
Nonin 2, Nonin 3, Nonin 4, Nonin 5). In addition, the RS-232 port outputs data for the optional
Dymo printer (Printer).
This setting can be saved as a preset parameter.
NOTE: Bluetooth and the RS-232 port have separate selection options and may use different
data output formats.
For more information on data formats, see "Memory and Data Output Features" on page 61.
Clear Memory
This setting deletes patient data recordings from the monitor. This setting does not delete
presets from the monitor.
Restore Factory Defaults

This setting discards all presets, institution defaults, and other user settings and returns the
monitor to the factory default alarm limit settings (table 10).
Table 10. Factory Default Alarm Limit Settings
Alarm Limit Setting Factory Default
rSO2 High Off
rSO2 Low (% BL) % below baseline Baseline - 25% (Baseline minus 25%)
rSO2 Low (Abs) Absolute 50%
SpO2 High Off
SpO2 Low 85%
Pulse High 200 BPM
Pulse Low 50 BPM
System Information
This pop-up window provides system information for the monitor and any attached signal
processors. If calling Nonin’s Technical Service department, the service representative may
request this information.
47
System Menu Screen
Figure 27. System Information Pop-up
Date / Time
This setting allows the user to set the monitor’s date and time (24-hour clock).
Nurse Call Mode

This setting allows alarm notification at a central monitoring location. Nurse call functions on
AC or battery power. The facility determines the alarm condition as audible, visual, or both.
The nurse call options are:
• Normally open, continuous (default setting) – The nurse call contact is normally open, but
closes during alarm conditions. The nurse call contact changes state for the duration of an
alarm condition and only reverts to the original non-alarm state when the alarm condition is
cleared.
• Normally open, momentary – The nurse call contact is normally open, but closes during
alarm conditions. The nurse call contact temporarily changes state at the onset of an alarm
condition and repeats the 1 second change each minute for the duration of the alarm
condition.
• Normally closed, continuous – The nurse call contact is normally closed, but opens during
alarm conditions. The nurse call contact changes state for the duration of an alarm condition
and only reverts to the original non-alarm state when the alarm condition is cleared.
• Normally closed, momentary – The nurse call contact is normally closed, but opens during
alarm conditions. The nurse call contact temporarily changes state at the onset of an alarm
condition and repeats the 1 second change each minute for the duration of the alarm
condition.
NOTE: The Nurse Call feature overrides silenced alarms.
48
System Menu Screen
WARNING: It is the user’s responsibility to implement the interface between the

Nurse Call system and the Model X-100M, and to adequately test the interface
between the Model X-100M and the Nurse Call system to ensure operation. The
X-100M monitor has not been evaluated with specific nurse call systems.
WARNING: The device Nurse Call and Bluetooth features should not be used as the
primary source of alarm notification.
Bluetooth
This pop-up window provides the user with the information needed to pair the Model X-100M
to a Bluetooth master device and the option to turn off the Bluetooth radio.
For more information on Bluetooth technology, see page 62.
Figure 28. Bluetooth Information Pop-up
Language
This feature allows the user to change the language displayed on the monitor. The available
languages are:
• English • Italian (Italiano)
• German (Deutsch) • Dutch (Nederlands)
• Spanish (Español) • Swedish (Svenska)
• French (Français) • Portuguese (Português)
49
System Menu Screen
Patient ID Request
This setting determines whether or not the user will be asked to enter patient identification (ID)
when a new case is started. If set to “At Start of New Case,” the Enter Patient ID screen will
display when the monitor is turned on and when “Start a new case” is selected on the Case
Menu screen.
System Name
This setting allows the user to assign a name to the system. The default name is X-100.
Default Preset
This setting allows the user to select one of the presets to be the default preset. Once the
preset has been selected as the default preset, it automatically locks. When the monitor is
turned on, the default preset is shown on the “Select a Preset” start-up screen. The default
preset will be the active preset unless another preset is selected.
Institution Default Limits

NOTE: The institution default limits are populated with factory default values until changed by
the institution.
This setting allows the user to establish institution default high and low limits for %rSO2,
%SpO2, and pulse rate. When the institutional default limits are set, these values become the
default values in any default presets.
After updating the institutional defaults, the message Presets with SpO2 or rSO2 low alarm
limits lower than the new institution limits have been updated to the new limits displays. The
institution low alarm limit defaults take precedent over any low alarm limits saved in a preset
if the low alarm limits violate the institutional low alarm limits.
50
System Menu Screen
Figure 29. Institution Defaults Pop-up
Institution Password
The default institution password is 0000. The institution password may be set to any four-digit
number and is used to unlock parameter settings on the System Menu screen. The institution
password can be used to unlock saved presets.
System Menu – Procedures

Open the System Menu
1. Press Menu.
2. Press Right three times to highlight the System tab. System Menu screen displays.
Adjust the Display Brightness

1. While in the System Menu screen, use the navigation buttons to move to and highlight
“Brightness.”
2. Press Select. Brightness slider displays.
3. Press the Up/Down navigation buttons to adjust the setting.
4. Press Select to save the setting. Display returns to System Menu screen.
screen to time out.
51
System Menu Screen
Adjust the Alarm Volume

“Alarm Volume.”
2. Press Select. Alarm volume slider displays.
3. Press the Up/Down navigation buttons to adjust the setting.
• Green slider – volume is above 45 decibels (steps 5 – 15).
• Yellow slider – volume is below 45 decibels and the alarm silence indicator displays on
the monitor (steps 0 – 4).
screen to time out.
WARNING: Ensure all alarm volumes are set appropriately and are audible in all
situations. Keep speaker openings clear of all obstructions.
Set the rSO2 Low Alarm Mode

“rSO2 Low Alarm Mode.”
• % Below Baseline
• Absolute
screen to time out.
Adjust the Pulse Tone Volume

“Pulse Tone Volume.”
2. Press Select. Pulse tone volume slider displays. Default volume is off.
screen to time out.
52
System Menu Screen
Select a Pulse Tone Source

NOTE: When setting a channel as the pulse beep source, verify the pulse tone volume has
been adjusted so it is audible.
“Pulse Tone Source.”
2. Press Select. Pulse tone source pop-up window displays.
screen to time out.
Set Bluetooth and/or RS-232 Data Output Formats

“Data Output Modes.”
2. Press Select. Pop-up window displays with Bluetooth setting highlighted. If not using
Bluetooth, proceed to step 3.
a. Press Select. Small arrows display above and below the setting.
b. Press Up/Down to select a Bluetooth data output format.
c. Press Select to save the setting. Continue with RS-232 output mode, or skip to step 4 if
RS-232 is not needed.
3. Press Down to highlight RS-232 setting.
a. Press Select. Small arrows display above and below the setting.
b. Press Up/Down to select a RS-232 data output format.
c. Press Select to save the setting.
4. Press Menu to close the pop-up and return to the System Menu screen.
screen to time out.
Clear the Memory

“Clear Memory.”
2. Press Select. “Clear ALL patient data recordings?” pop-up displays with “No” highlighted.
• To cancel, press Select.
• To clear memory, press Down to highlight “Yes,” and then press Select.
3. Memory cleared! message displays. Display returns to the System Menu screen.
screen to time out.
53
System Menu Screen
Restore Factory Defaults

“Restore Factory Defaults.”
2. Press Select. “Discard ALL presets and settings?” pop-up displays with “No” highlighted.
• To cancel, press Select.
• To restore factory defaults, press Down to highlight “Yes,” and then press Select.
3. Enter the institution password.
4. Factory defaults restored! message displays. Display returns to monitoring screen.
NOTE: Institution-specific defaults are lost when factory defaults are restored.
Review System Information

“System Information.”
2. Press Select. System information pop-up window displays (figure 27).
3. To close the window, press Menu or Select. Display returns to System Menu screen.
Set the Date and Time

NOTE: To save the date and time, Menu must be pressed.
“Date / Time.”
2. Press Select. Pop-up window displays.
a. To move between fields, use the navigation buttons.
b. To update a field, press Select (small arrows display above and below the setting) and
then press Up/Down to change the setting. To close a field, press Select or Menu.
c. Repeat as needed for each date/time field.
3. When finished, press Menu to save the date and time, close the pop-up, and return to the
System Menu screen.
screen to time out.
Set-up Nurse Call

“Nurse Call Mode.”
2. Press Select to review current setting. Pop-up window displays setting along with “Edit...”
highlighted.
• To change the setting, press Select and continue with step 3.
• To cancel, press Menu. Display returns to System Menu screen.
3. Enter the institution password. Pop-up menu displays.
54
System Menu Screen
5. Press Select to save. Display returns to System Menu screen.

screen to time out.
Enable/Disable Bluetooth Radio

“Bluetooth.”
2. Press Select. Bluetooth information pop-up window (figure 28) displays with “Edit...”
highlighted.
3. To change the setting, press Select.
4. Enter the institutional password.
7. Press Select to save. If turning Bluetooth on, the message Please wait... displays while
the Bluetooth radio is enabled. Bluetooth information pop-up window displays.
8. Press Menu to return to the System Menu screen.
screen to time out.
Change Language
“Language.”
screen to time out.
Set Patient ID Request

“Patient ID Request.”
2. Press Select to review current setting. Pop-up window displays settings along with “Edit...”
highlighted.
3. Enter the institution password. Pop-up menu displays.
screen to time out.
55
System Menu Screen
Assign System Name

“System Name.”
highlighted.
3. Enter the institution password. Alphanumeric keyboard screen displays.
4. Enter the System Name (maximum of 15 alphanumeric characters).
a. If needed, delete existing system name.
b. Use the navigation buttons to move to and highlight the desired character.
c. Press Select.
d. Repeat steps b and c as needed to enter the name.
screen to time out.
Select Default Preset

“Default Preset.”
highlighted.
3. Enter the institution password. “Select default preset” pop-up displays.
4. Current default preset is highlighted. Press the Up/Down navigation buttons to move to
and highlight the desired preset.
5. Press Select to save. Display returns to System Menu screen. The selected default
setting will be the active setting the next time the monitor is turned on.
screen to time out.
56
System Menu Screen
Set Institution Default Limits

“Institution Default Limits.”
2. Press Select to review current settings. Pop-up window displays settings along with
“Edit...” highlighted.
3. Enter the institution password.
4. “Institution Defaults” pop-up displays (figure 29). The following institution default limits may
be set:
• %rSO2 High • %SpO2 High • PR High
• %rSO2 Low (% BL) • %SpO2 Low • PR Low
• %rSO2 Low (Abs)
5. Press the Up/Down navigation buttons to move to and highlight a setting.
7. Press Up/Down navigation buttons to change the setting.
8. Press Select to set.
9. Repeat steps 5 – 8 until all desired institution defaults are set.
10. Press Menu. Monitor displays the following message: Institution Defaults Changed.
Presets with SpO2 and rSO2 low alarm limits lower than the new institution limits have
been updated to the new limits. Display returns to System Menu screen.
screen to time out.
Change the Institution Password

“Institution Password.”
2. Press Select and follow the on-screen instructions:
a. Enter current institution password.
b. Enter new institution password.
c. Enter new password again to confirm change.
- If confirmation is successful, monitor displays New password saved! and returns to
System Menu screen.
- If password change is not successful, monitor displays Confirmation failed and
returns to System Menu screen.
screen to time out.
57
Alarms
Alarms
The Model X-100M has audible and visual alarm indicators to alert the operator in case
immediate patient attention is required or an equipment alarm occurs.
The intended operator’s position for correctly perceiving a visual alarm signal and its priority
is 1 meter (3.3 feet).
High Priority Alarms

High priority alarms require immediate attention to the patient.
Table 11. High Priority Alarms
Alarm Visual Indicator Audible Indicator
rSO2 High Limit – displays Channel background flashes RED

when rSO2 is equal to or 2 times per second. Channel text
above high alarm limit becomes white.
rSO2 Low Limit – displays Channel background flashes RED
when rSO2 is equal to or below 2 times per second. Channel text
low alarm limit becomes white.
SpO2 High Limit – displays SpO2 portion of channel background
when SpO2 is equal to or flashes RED 2 times per second.
above high alarm limit SpO2 value becomes white.
SpO2 Low Limit – displays SpO2 portion of channel background
when SpO2 is equal to or flashes RED 2 times per second. 3 beeps, pause, 2 beeps,
below low alarm limit SpO2 value becomes white. pause, 3 beeps, pause,
2 beeps, and a 6-second
Pulse High Limit – displays Pulse rate portion of channel pause.
when pulse is equal to or background flashes RED 2 times per This cycle repeats until
greater than the Pulse High second. Pulse rate value becomes silenced or the alarm
alarm limit white. condition is cleared.
Pulse rate portion of channel
Pulse Low Limit – displays
background flashes RED 2 times per
when pulse is equal to or less
second. Pulse rate value becomes
than the Pulse Low alarm limit
white.
Low Perfusion – displays when
Channel background flashes RED
the system detects low
2 times per second. Channel text
perfusion at the SpO2 sensor
becomes white.
site.
Battery indicator flashes RED
Critical Low Battery
2 times per second.
58
Alarms
Medium Priority Alarms

Medium priority alarms signal potential problems with the equipment or other non-life-
threatening situations. On the Model X-100M, the medium priority alarms are as follows:
Table 12. Medium Priority Alarms
Alarm Visual Indicator Audible Indicator
rSO2 Warning rSO2 background flashes YELLOW once

(rSO2 5% or less above every 2 seconds. Channel text becomes
low rSO2 alarm limit) gray.
Battery indicator flashes YELLOW
Low Battery
once every 2 seconds. 3 beeps followed by a
20-second pause.
Sensor fault indicator flashes
Sensor Fault This cycle repeats until
YELLOW once every 2 seconds.
silenced or the alarm
Communication lost indicator condition is cleared.
Signal Processor
flashes YELLOW once every 2 seconds
Communication Error
and X-100SP not connected displays.
Poor Signal indicator flashes
Poor Signal
YELLOW once every 2 seconds.
Silencing Alarms
Press Alarm Silence to silence alarms for 2 minutes. Audible alarms may be reactivated
before the 2-minute silence period is over by pressing Alarm Silence again. All silenced
audible alarms are automatically reactivated when a new physiological alarm condition occurs.
• The Alarm Silence indicator blinks while alarms are temporarily silenced.
• The Alarm Silence indicator is lit solidly when the alarm volume slider is yellow (step 4 or lower
[less than 45 decibels]).
• Audible indicators can be turned off in the Alarm Volume setting on the System Menu screen.
59
Alarms
Error Codes
This device includes error codes that indicate problems with the unit. When an error occurs,
the device emits a loud, two-tone, steadily beeping signal and an error code displays on the
monitor screen. Error codes are indicated by the letter “E” and a two-letter code (table 13).
To correct error conditions, perform these steps:
1. Turn the unit off and then back on again to remove the error code.
2. If the error persists, note the error code and contact Nonin Technical Service at
(800) 356-8874 (USA and Canada), +1 (763) 553-9968, or +31 (0)13 - 79 99 040
(Europe).
Table 13. Error Codes
Error Visual Indicator
Stuck Key E01

Sound Module Fault E02
Sound Module Communications Fault E03
Signal Processor Overcurrent E04
Memory Alarm
WARNING: Memory is cleared if error code E06 appears on the E06
display screen.
Battery Fault (fails precondition) E08
Corrupt Preset
WARNING: The device presets are deleted if error code E09 E09
appears on the display screen.
Corrupt Device Configuration
WARNING: The device configuration is deleted if error code E10 E10
appears on the display screen.
60
Memory and Data Output Features

Memory
The Model X-100M monitor can collect and store:
• 840 hours of data when 2 channels are in use.
The memory in the Model X-100M functions much like an “endless loop” tape. When the
memory is full, the unit begins overwriting the oldest data with new data.
CAUTION: Data is written continuously to memory when the device is on. If the entire
! memory is filled, portions of the oldest record will be overwritten when new data is
written.
Each time the Model X-100M is turned on, the current time/date information (if the clock is set
properly) is stored in memory and a new recording session starts.
Oximetry data for each channel (rSO2 or SpO2 and pulse rate) is sampled and recorded in
memory once every 4 seconds. Oxygen saturation values are stored in 1% increments in the
range of 0 to 100%. Pulse rate values are stored in 1 BPM increments in the range of
18 – 300 BPM.
Patient data is retained even when power is lost.
To clear patient memory, refer to "Clear the Memory" on page 53.
Patient Data Output

The Model X-100M provides real-time patient data output. The device may be connected to a
PC via a Bluetooth connection or using the RS-232 serial data port on the back of the X-100M
monitor (figure 30).
Figure 30. RS-232 Serial Data Port

61
NOTE: Use only a null modem serial cable to connect the Model X-100M to a PC.
NOTE: Verify Bluetooth status as follows: Bluetooth symbol is green when Bluetooth is
connected to a host, white when it is enabled but not connected, and gray when it is disabled.
CAUTION: All parts and accessories connected to the serial port of this device must
! be certified according to at least IEC Standard EN 60950, IEC 62368-1, or UL 1950 for
data processing equipment.
Bluetooth Technology
Bluetooth technology allows wireless connections between electronic communications and
computing devices. The technology is based on a radio link that offers fast and reliable data
transmissions. Bluetooth technology uses a license-free, globally available frequency range in
the ISM band—intended to ensure communication compatibility worldwide.
Nonin’s use of Bluetooth wireless technology allows oxygen saturation information to be
transmitted through a Bluetooth radio to a compatible Bluetooth-enabled device. Nonin’s
wireless system removes the need for a physical connection from the X-100M monitor to a
remote monitor location, giving increased ability to move the monitor freely. Nonin’s X-100M
monitor uses an automatically switchable class I/class II Bluetooth radio with a maximum
range of about 100 meters (328 feet) (spherical radius).
The Model X-100M features point-to-point communications, allowing one master device (the
remote monitor) to be paired to one slave device (the X-100M monitor). Once connected, the
X-100M monitor will not connect with any other Bluetooth-enabled device.
Bluetooth Connection
The Bluetooth setting is used to connect (pair) the monitor with output devices via Bluetooth.
Before a Bluetooth master device can connect with the X-100M (slave device), the devices
must be paired. The X-100M will connect when the master device initiates a connection.
On the X-100M monitor, the Bluetooth symbol is green when Bluetooth is connected to a host,
white when it is enabled but not connected, and gray when it is disabled.
Determine the Bluetooth Address and PIN for the Monitor

1. Press Menu.
2. Press Right three times to highlight the System tab. System Menu screen displays.
3. Use the navigation buttons to move to and highlight “Bluetooth.”
4. Press Select. Bluetooth information pop-up window displays.
5. Note the Bluetooth Address and PIN on the screen. These numbers are used when
pairing the device to the host system. Refer to the host system’s operator’s manual for
additional information.
WARNING: The user must verify the device Bluetooth pairing to ensure the correct
patient is remotely monitored.
62
NOTE: If the Bluetooth radio in the X-100M monitor needs to be disconnected from the host
device, there are three ways to disconnect it: 1) use the host device, 2) disable the monitor’s
Bluetooth radio (see "Enable/Disable Bluetooth Radio" on page 55”), or 3) cycle power on the
monitor.
Bluetooth Security
The Bluetooth radio contained in the X-100M monitor is compliant to version 2.0 of the
Bluetooth Specification. It supports the Serial Port Protocol (SPP) with security mode 2
(service level enforced). The supported encryption key size is up to 128 bits and encryption is
enforced on all outgoing and incoming data channels. While the X-100M monitor is in a
Bluetooth connection, it will be unavailable for other connections. If the Bluetooth connection
is unused, it is recommended that the Bluetooth radio be disabled to provide additional security
from unintended connections.
RS-232 Connection to Printer

The optional Dymo LabelWriter® SE450 printer connects to
Date Time
the monitor via the RS-232 port. When the printer is 2012-05-15 14:00:00
connected and the RS-232 port data output mode is set to Event A _________________________
Printer, an event summary label prints each time the Event Oximeter First Alert? Yes No
Mark button is pressed. The label (figure 31) provides the Notes:
following information: Regional Oximetry

# Location rSO2 AUC BL
1 L Cere --- --- --
• Event date and time (if date and time are set correctly 2 R Cere --- --- --
on the monitor). 4 Abdomen
5 L Thigh
---
---
---
---
--
--
• Event mark letter and space to write a patient 6 R Thigh --- --- --
summary for the event.

Pulse Oximetry
• Ability to track if oximeter provided first alert of event. # Location SpO2 PR
3 R Hand 98 78
• Space to write notes.
• Regional and pulse oximetry parameters, by channel, System Name - Preset Name
at the time of the event (rSO2, AUC, BL, SpO2, and Patient ID 0123456789ABCDE
PR).
• System and preset name.
• Patient ID and bar code. Figure 31. Sample Label
from Dymo Printer
The label size is 2 5/16 x 4 inches (59 x 101 mm). Refill rolls
(Dymo 30256, or compatible) are available at office supply
stores.
Using the Dymo Printer

1. Set the RS-232 port so it outputs to the printer.
a. Press Menu.
b. Press Right three times to highlight the System tab. System Menu screen displays.
c. Use the navigation buttons to move to and highlight “Data Output Modes.”
d. Press Select. Pop-up window displays with Bluetooth settings highlighted.
e. Press Down to highlight RS-232 settings.
63
f. Press Select. Small arrows display above and below the setting.
g. Press Up/Down to select “Printer.”
h. Press Select to save the setting.
i. Press Menu to close the pop-up and return to the System Menu screen.
j. Press Menu to return to the monitoring screen.
2. Connect the printer cable to the RS-232 port.
3. When monitoring a patient, an event summary label prints each time the Event Mark
button is pressed.
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 serial port to connect the device to other equipment, follow each device’s
cleaning instructions.
• Verify all equipment connected to the device is suitable for the patient’s environment.
CAUTION: Failure of a network data coupling (serial cable/connectors/wireless

! connections) will result in loss of data transfer.
Data Output Formats

This device features 5 once-per-second, real-time data output formats (Nonin 1 – Nonin 5).
Each data format includes an ASCII header containing model number, time, and date
information. In addition, the RS-232 port outputs data through the Dymo printer (Printer).
Formats are selected from the System Menu screen (see "Set Bluetooth and/or RS-232 Data
Output Formats" on page 53). Under the Data Output Modes setting, the Bluetooth and
RS-232 ports have separate selection options and may use different data output formats.
NOTE: When using SenSmart download software with the monitor, the port used to
download data (either Bluetooth or RS-232) must be set to Nonin 1 or Nonin 5 before
connecting to the SenSmart software.
64
Nonin 1
NOTE: This format is not compatible with all of the X-100M’s features.
Baud Rate 57,600

Delimiter See format in table 13
Line Terminator CR [0x0D] LF [0x0A]
CRC CRC-16 CCITT (XMODEM)
Data from the device are sent once per second in the following format:
Ch1=XXX Ch2=XXX Ch3=XXX Ch4=XXX 1234&$*|
yyyy-mm-ddThh:mm:ss|rSO2=xxx,xxx,xxx,xxx|HbI=xx.x,xx.x,xx.x,xx.x|
AUC=xxxx,xxxx,xxxx,xxxx|REF=xxx,xxx,xxx,xxx|HI_LIM=xxx,xxx,xxx,xxx|
LOW_LIM=xxx,xxx,xxx,xxx|ALM=xxx,xxx,xxx,xxx|SIG_QUAL_ALM=x,x,x,x|
POD_COMM_ALM=x,x,x,x|SNS_FLT=x,x,x,x\LCD_FLT=x\
LOW_BATT=x\CRIT_BATT=x\BATT_FLT=x\STK_KEY=x\SND_FLT=x\
SND_ERR=x\EXT_MEM_ERR=x\CKSUM=xxxx<CR><LF>
NOTE: The 1234&$* order shall be preserved in all alarm conditions.
Table 14. Nonin 1 Data Output Format
Following
Parameter Value
Delimiter
Channel 1 regional oximeter value.

Ch1=XXX space
Leading zeros blank; --- if no value available.
Ch2=XXX space
Ch3=XXX space
Ch4=XXX space
Patient alarm indication for channel 1,2,3,4. Appears
only if a channel’s patient alarm is active. If not
1234 none
active, number does not appear (e.g., 14 means
channel 1 and 4 patient alarms are active).
& Appears if an equipment alarm is active. none
$ Appears if the critical battery state is detected. none
* Appears if the event is marked. |
International date and time format: year, month, day,
yyyy-mm-ddThh:mm:ss |
hour, minutes, seconds.
65
Table 14. Nonin 1 Data Output Format (Continued)
Following
Parameter Value
Delimiter
Regional oximetry values for channels 1,2,3,4 in %.

rSO2=xxx,xxx,xxx,xxx |
Hemoglobin index values for channels 1,2,3,4 in
HbI=xx.x,xx.x,xx.x,xx.x grams per deciliter. |
Leading zeros blank; --.- if no value available.
Area under curve for channels 1,2,3,4. Leading zeros
AUC=xxxx,xxxx,xxxx,xxxx |
blank.
Reference (low alarm limit) line values for channels
REF=xxx,xxx,xxx,xxx |
1,2,3,4. Used to calculate AUC. Leading zeros blank.
High limit alarm setting for channels 1,2,3,4.
HI_LIM=xxx,xxx,xxx,xxx |
Leading zeros blank. “OFF” if no limit set.
Low limit alarm setting for channels 1,2,3,4.
LOW_LIM=xxx,xxx,xxx,xxx |
Leading zeros blank. “OFF” if no limit set.
Active alarm indication for channels 1,2,3,4.
ALM=xxx,xxx,xxx,xxx |
Valid values: HI, MAR (marginal), LOW, OFF.
Signal quality alarm indication for channels 1,2,3,4.
SIG_QUAL_ALM=x,x,x,x 0 = no active alarm. |
1 = active alarm.
Pod communication alarm indication for channels
1,2,3,4.
POD_COMM_ALM=x,x,x,x |
0 = no active alarm.
1 = active alarm.
Sensor fault indication for channels 1,2,3,4.
SNS_FLT=x,x,x,x 0 = no active alarm. \
1 = active alarm.
Display fault indicator.
LCD_FLT=x 0 = no fault active. \
1 = fault active.
Low battery indicator.
LOW_BATT=x 0 = no low battery state. \
1 = low battery state.
Critical battery indicator.
CRIT_BATT=x 0 = no critical battery state. \
1 = critical battery state.
66
Table 14. Nonin 1 Data Output Format (Continued)
Following
Parameter Value
Delimiter
Battery fault indicator.

BATT_FLT=x 0 = no battery fault. \
1 = battery fault active.
Stuck key fault indicator.
STK_KEY=x 0 = no stuck key fault active. \
1 = stuck key fault active.
Sound fault indicator.
SND_FLT=x 0 = no sound fault active. \
1 = sound fault active.
Sound error indicator.
SND_ERR=x 0 = no sound error active. \
1 = sound error active.
External memory error indicator.
EXT_MEM_ERR=x 0 = no external memory error active. \
1 = external memory error active.
CRC-16 CCITT (XMODEM)1 of all parameters and
CKSUM=xxxx values beginning with the “C” of “Ch1” and ending <CR><LF>
with “CKSUM=”. Leading zeros if appropriate.
1
CRC-16 CCITT (XMODEM) Algorithm
Algorithm Details:
• Initial value: 0
• Polynomial: x16 + x12 + x5 + 1 [0x1021]
• XOR out: 0
• Reflection: none
Test
• Run algorithm against the string of ASCII characters “123456789”
• Result should be 0x31C3
67
Nonin 2
Baud Rate 9,600

Delimiter Comma [0x2C]
CRC N/A
Column 1 Column 2 Column 3 Column 4

Current value Current value Average of Channel 1
0
of Channel 1 of Channel 2 and Channel 2
Missing data is output as -1.
68
Nonin 3
Baud Rate 9,600

Delimiter One or more consecutive spaces [0x20]
Line Terminator LF [0x0A] CR [0x0D]
CRC N/A
Channel
Version Date Time rSO2 Event Status Baseline AUC UAL LAL A B C
Name
99.99.99/1/1 mm/dd/yy hh/mm/ss These columns repeat per channel
Continues with:
Sensor ID 1 Sensor ID 2 Sensor ID 3 Sensor ID 4
s/n s/n s/n s/n
Version is 99.99.99/1/1.
Date: month, day, year
Time: hour, minutes, seconds
Channel names:
L = Channel 1
R = Channel 2
S1 = Channel 3
S2 = Channel 4
rSO2 readings for missing data outputs as 0.

Event: 0 = no event; 1 = miscellaneous event.
Status values:
1 = Pod connected with no sensor (sensor fault)
2 = Excessive light indication (used for poor signal quality)
4 = Good signal quality, valid rSO2 readings occurring
5 = rSO2 high alarm
6 = rSO2 low alarm
7 = Pod became connected to the system
9 = Critical battery alarm
11 = Pod is not connected to the system
Baseline and AUC are the current values.

UAL is the upper alarm limit. 0 = OFF.
LAL is the lower alarm limit. 0 = OFF.
A, B, C are 0.
Sensor ID is the sensor image number.
69
Nonin 4
Baud Rate 9,600

Delimiter One or more consecutive spaces [0x20]
Line Terminator LF [0x0A] CR [0x0D]
CRC N/A
Sensor Sensor Sensor Sensor

Date Time rSO2 Event Status A B C D
ID 1 ID 2 ID 3 ID 4
mm/dd/yy hh/mm/ss These columns repeat per channel s/n s/n s/n s/n
Date: month, day, year

rSO2 readings for missing data outputs as 0.
Event: 0 = no event; 1 = miscellaneous event
Status values:
1 = Pod connected with no sensor (sensor fault)

2 = Excessive light indication (used for poor signal quality)
4 = Good signal quality, valid rSO2 readings occurring
5 = rSO2 high alarm
6 = rSO2 low alarm
7 = Pod became connected to the system
9 = Critical battery alarm
11 = Pod is not connected to the system
A, B, C, and D are 0.
Sensor ID is the sensor image number.
70
Nonin 5
This data format was designed to be extensible. Future enhancements to the Model X-100M
may be included in the data output. As these enhancements become available, new column
labels may be added at any position within the data format.
Baud Rate 57,600

Delimiter Comma [0x2C]
CRC CRC-16 CCITT (XMODEM)
System Preset Error

Date Time Channel Data Columns Event CRC16
Name Name Code
yyyy- hh:mm: The data columns for each connected channel vary
EXX
mm-dd ss depending on the type of sensor connected.
Date: year, month, day

System name is the name assigned to the system.
Preset name is the name of the preset in use.
Channel data columns: see below for regional oximeter columns, pulse oximeter columns, and
unrecognized oximeter columns.
Event: 0 = no event; 1 = miscellaneous event.
Error_Code: See table 13 in the Error Codes section for error code information.
CRC16 is CRC-16 CCITT1.
1
CRC-16 CCITT (XMODEM) Algorithm
Algorithm Details:
• Initial value: 0
• Polynomial: x16 + x12 + x5 + 1 [0x1021]
• XOR out: 0
• Reflection: none
Test
• Run algorithm against the string of ASCII characters “123456789”
• Result should be 0x31C3
Regional Oximeter Columns

When a regional sensor is attached to the signal processor, the channel data columns are the
following:
Channel Name rSO2 HbI AUC BL UAL_rSO2 LAL_rSO2 Status
Channel is the channel number.

Name is the sensor site name.
rSO2, HbI, AUC and BL are the current values. Blank if data is missing [dashes on display].
UAL is the current upper alarm limit value.
LAL is the current lower alarm limit value.
71
Status is defined by the following and are active high:

Bit 7 Bit 6 Bit 5 Bit 4 Bit 3 Bit 2 Bit 1 Bit 0
Measurement
Low Alarm: Pod
Accuracy: rSO2 rSO2 rSO2 Sensor Signal
0 = Auto Comm.
0 = Absolute High Low Marginal Fault Quality
1 = Manual Lost
1 = Trending
Pulse Oximeter Columns

When a pulse oximetry sensor is attached to the signal processor, the channel data columns
are the following
Channel Name SpO2 PR UAL_SpO2 LAL_SpO2 UAL_PR LAL_PR Status

SpO2, PR are the current values. Blank if data is missing [dashes on display].
UAL is the current upper alarm limit value.
LAL is the current lower alarm limit value.
Low Sensor Pod Comm. Signal
PR High PR Low SpO2 High SpO2 Low
Perfusion Fault Lost Quality
Unrecognized Oximeter Columns

When there is no sensor attached to the signal processor, the channel data columns are the
following
Channel Name Status

Unrecognized Pod Comm.
Unused Unused Unused Unused Unused Unused
Sensor Lost
Printer
This data output format was designed to work with the Dymo LabelWriter SE450 Label Printer.
See "RS-232 Connection to Printer" on page 63 for more information.
72
SenSmart Download Software
SenSmart Download Software

The SenSmart oximetry system has comprehensive data management capability. Confidential
patient data is extracted from the system via Bluetooth or the RS-232 serial port using the
SenSmart Download Software. During memory download, TX displays on the left side of the
monitoring screen along with a percentage that shows the download progression.
Each data record in the SenSmart system is identified by date and time. On a host computer,
files are identified by the date and time, extracted, and stored as either raw data or as a .pdf.
The files comply with standards defined in the STS National Adult Cardiac Surgery Database.
For instructions on using the data management feature, please see the SenSmart Download
Software User Guide, which is found on the SenSmart Download Software CD included with
the system.
System Requirements
• Operating system: Windows® 7 (32 and 64 bit), Windows 8 (32 and 64 bit), Windows 10 (32
and 64 bit)
• Bluetooth communication device or RS-232 serial port
• 1024 x 768 monitor resolution
• CD/DVD drive
• 50 MB free space on hard drive
Installing SenSmart Download Software

Nonin’s SenSmart patient data management software works with Microsoft Windows
operating systems. It allows users to transfer recorded patient data from the device to a PC
and then analyze, report, and archive the data.
To install the software:
1. Insert the CD into the computer’s CD/DVD drive.
2. Installation should start automatically. If it does not start automatically, initiate installation by:
• Windows 7 operating systems: From the Start menu, place the cursor in the Search box
and type D:\setup.exe (where D is the letter of the CD/DVD drive).
• Windows 8 operating systems: Right click on the Start screen to display the App bar.
Click or tap All apps on the App bar, and then click or tap Computer. Double-click or
double-tap the CD/DVD icon or the folder with the installation set-up. Double-click or
double-tap setup.exe.
• Windows 10 operating systems: Open File Explorer. Browse to the CD/DVD drive.
Double-click Setup.exe.
3. Follow the on-screen instructions until the software install completes.
4. For help using the SenSmart Download Software, open the software and then go to Help >
User Guide.
73
Care and Maintenance
Care and Maintenance

The advanced digital circuitry within the Model X-100 system components requires no
calibration or periodic maintenance other than battery replacement in the X-100M monitor by
qualified technical professionals.
Field repair of the Model X-100 system components is not possible. Do not attempt to open
the case of any of the system components or repair the electronics. Opening the case may
damage the component and void the warranty. If the device or system is not functioning
properly, see "Troubleshooting" on page 76.
The OxitestPlus7 (software rev. 2.5 or greater) by Datrend Systems, Inc. can be used to verify
operation of the pulse oximeter.
CAUTIONS:
!
• Follow local, state and national governing ordinances and recycling instructions
regarding disposal or recycling of the device and device components, including
batteries.
• Use only Nonin-approved battery packs.
• Batteries are a fire hazard if damaged. Do not damage, mishandle, disassemble,
service, or replace with non-specified components.
• 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.
Cleaning Instructions
The following cleaning instructions apply to the X-100M monitor, X-100SP signal processor,
X-100H hub, X-100HH hub holster, X-100EC extension cable, and INT-100 intermediate
cable.
1. Wipe the component with a soft cloth dampened with a 10% bleach/90% water solution
(household bleach [containing less than 10% sodium hypochlorite]). Do not use undiluted
bleach or any cleaning solution other than those recommended here, as permanent
damage could result.
2. Dry with a soft cloth or allow to air dry.
.
WARNING: Protect from exposure to water or any other liquid, with or without AC
power.
CAUTION: Do not place the device in liquid or clean it with agents containing
! ammonium chloride, isopropyl alcohol, or products that are not listed in this operator’s
manual.
74
Parts and Accessories
Parts and Accessories

For more information about Nonin parts and accessories:
• See the Part and Accessories List on the operator’s manual CD.
• Contact your distributor or Nonin at (800) 356-8874 (USA and Canada), +1 (763) 533-9968,
or +31 (0)13 - 79 99 040 (Europe).
• Visit www.nonin.com
WARNING: Use the Model X-100M only with power adapters supplied by Nonin
Medical.
WARNING: The use of signal processors, sensors, accessories, and cables other
than those listed in the Parts and Accessories List may result in increased
electromagnetic emission and/or decreased immunity of this device.
WARNING: Use only Nonin-branded oximeter sensors. These sensors are

manufactured to meet the accuracy specifications for Nonin oximeters. Using other
manufacturers’ sensors can result in improper oximeter performance.
75
Troubleshooting
Troubleshooting
Problem Possible Cause Possible Solution
Monitor will not
The unit has no power Plug in the AC power adapter.
activate.
The battery pack is not Plug in the Model X-100M AC power
Monitor will not charged. adapter to charge the battery pack.
operate on battery
power. Contact Nonin Technical Service for
The battery pack is inoperable.
repair or replacement.
Monitor displays
The sensor types connected to Verify the sensors connected are
the message
the monitor do not match the correct for the case. Verify the alarm
Verify sensor
preset selected for the case. limits in the preset.
types and limits!
Turn the monitor off and then back on
again. If the signal processor still does
Signal processor is
not display, go to the System Menu, and
attached, but the
The signal processor is then the System Information pop-up. If
channel does not
damaged. the channel is not in the list of attached
appear on the
sensors, the signal processor is not
display.
communicating to the display device.
Contact Nonin Technical Service.
One or more
Verify that duplicate signal processors
channels display the Duplicate signal processors are
are not attached to the hub. Remove or
message Duplicate attached to the hub.
replace the duplicate signal processor.
X-100SP.
Check the connections between the
sensor, the intermediate cable, and the
Sensor or signal processor is
signal processor and between the hub
disconnected.
and the monitor. Ensure all connections
are secure.
The Model X-100M display is
not functioning.
Dashes (---) appear in rSO2:
a %rSO2 or %SpO2
Reposition sensor.
display.
Position sensor at different site.
The signal from the sensor is SpO2:
inadequate. Reposition the sensor or apply the
sensor to a different digit, and keep the
sensor motionless for at least
10 seconds.
Warm the sensor application site.
76
Troubleshooting

Remove the sensor from the patient
and observe the sensor emitters while
Dashes (---) appear in
The sensor is damaged. the system is on. If both emitters do not
a %rSO2 display.
flash red, replace the sensor. Ensure
both emitters flash red on new sensor.
Dashes (---) appear in The digit was removed from the Reapply the sensor or apply the sensor
a %SpO2 display. sensor. to a different digit.
Reposition the sensor or apply the
sensor to a different digit, and keep the
The patient pulse strength is
sensor motionless for at least
low.
10 seconds. Warm the sensor
application site.
Circulation is reduced due to
Identify the source of the pressure.
excess pressure on the sensor
Allow the hand to rest comfortably
(between the sensor and a
without squeezing or pressing the
hard surface) after inserting the
sensor on a hard surface.
digit.
Apply the sensor according to the
The sensor is applied
instructions for use provided with the
incorrectly.
sensor.
Unable to obtain a
Possible interference from one
pulse rate display.
of the following sources:
• arterial catheter
Reduce or eliminate any interference.
• blood pressure cuff
• electrosurgical procedure
• infusion line
The red LED is not illuminated
in the finger insertion area.
There is excessive ambient
Shield the sensor from the light source.
light.
The sensor is applied to a Apply the sensor to a digit without
polished or artificial fingernail. fingernail polish or an artificial nail.
Excessive patient motion. Reduce patient motion.
Turn the monitor off and then back on
An error code again to remove the error code.
The monitor encountered an
appears in the
error. If the error persists, note the error code
display area.
and contact Nonin Technical Service.
77
Troubleshooting

Press Alarm Silence to re-engage
The monitor is in The 2-minute Alarm Silence alarm volume, or wait 2 minutes. After
alarm mode, but no button is activated. 2 minutes, alarm tones automatically
audible alarms can re-engage.
be heard. Adjust volume through the System
Audible volume is turned down.
Menu screen.
Disconnect the signal processor. Wait
Signal processor initialization 5 seconds and reconnect signal
Sensor LED is not lit.
error. processor. If problem continues,
contact Nonin Technical Service.
Bluetooth symbol is Fault within the Bluetooth
yellow. module.
If these solutions do not correct the problem, please contact Nonin Technical Service at
(800) 356-8874 (USA and Canada), +1 (763) 553-9968, or +31 (0)13 - 79 99 040 (Europe).
78
Service, Support, and Warranty

Service and Support
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 55441-5443 USA
(800) 356-8874 (USA and Canada)

+1 (763) 553-9968 (outside USA and Canada)
Fax: +1 (763) 553-7807
E-mail: technicalservice@nonin.com
Nonin Medical B.V.

Prins Hendriklaan 26
1075 BD Amsterdam, Netherlands
+31 (0)13 - 79 99 040 (Europe)

Fax: +31 (0)13 - 79 99 042
E-mail: technicalserviceintl@nonin.com
nonin.com
WARNING: This device is a precision electronic instrument and must be repaired by

qualified technical professionals. 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.
Warranty
NONIN MEDICAL, INCORPORATED, (Nonin) warrants to the purchaser, for a period of 1 year
from the date of purchase, each Model X-100M battery pack and INT-100 intermediate cable.
Nonin warrants the X-100M monitor, X-100SP signal processors, X-100H hub, X-100HH hub
holster, and X-100EC extension cables for a period of 3 years from the date of purchase.
Extended warranties are available on most Nonin oximeter models. Please consult your local
Nonin distributor for additional information.
Nonin shall repair or replace any X-100M monitor, X-100SP signal processor, X-100H hub,
X-100HH hub holster, X-100EC extension cable, or INT-100 intermediate cable found to be
defective in accordance with this warranty, free of charge, for which Nonin has been notified
by the purchaser by serial number that there is a defect, provided said notification occurs
within the applicable warranty period. This warranty shall be the sole and exclusive remedy by
the purchaser hereunder for any Model X-100 system component delivered to the purchaser
which is found to be defective in any manner, whether such remedies be in contract, tort, or by
law.
79
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 device that is found to be within specifications.
The Model X-100 oximetry system is a precision electronic instrument and must be repaired
by qualified technical professionals. Accordingly, any sign or evidence of opening the device,
field service by non-authorized personnel, tampering, or any kind of misuse or abuse of the
device, 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.
80
Technical Information
NOTE: This product complies with ISO 10993, Biological Evaluation of Medical Devices
Part 1: Evaluation and Testing.
CAUTION: A functional tester cannot be used to assess the accuracy of the oximeter
! monitor or sensor.
WARNING: Portable RF communications equipment such as cell phones or radios

(including peripherals such as antenna cables and external antennas) should be used
no closer than 30 cm (12 inches) to any part of the ME system, including cables
specified by the manufacturer. Otherwise, degradation of the performance of this
equipment could result.
Manufacturer’s Declaration
Essential Performance
Essential Performance of the SenSmart X-100 Oximetry System includes SpO2 Accuracy,
Pulse Rate Accuracy, rSO2 Accuracy, and Limit Alarm Conditions or generation of a Technical
Alarm Condition. Accuracies or alarms may be affected as a result of exposure to
electromagnetic disturbances that are outside of the environments listed in the Indications For
Use. If issues are experienced, move Nonin system away from the source of electromagnetic
disturbances.
Refer to the following table for specific information regarding this device’s compliance to
IEC 60601-1-2.
Table 15. Electromagnetic Emissions
Emissions Test Compliance
This device is intended for use in the electromagnetic environment specified in the Indications For Use.
RF Emissions
Group 2
CISPR 11
RF Emissions
Class B
CISPR 11
Harmonic Emissions
Class A
IEC 61000-3-2
Voltage Fluctuations/Flicker Emissions

Within limits of IEC 61000-3-3
IEC 61000-3-3
81
Table 16. Electromagnetic Immunity
Immunity Test Compliance Level
This device is intended for use in the electromagnetic environment specified in the Indications For Use.
Electrostatic Discharge (ESD) ±8 kV contact

IEC 61000-4-2 ±15 kV air
Electrical Fast Transient/Burst ±2 kV for power supply lines

IEC 61000-4-4 ±2 kV for input/output lines
Surge ±0.5kV, ±1kV, ±2kV for Line-to-Ground

IEC 61000-4-5 ±0.5kV, ±1kV for Line-to-Line
Voltage dips, short interruptions, and 0% UT for 0.5 Cycles at 50 Hz at 0, 45, 90, 135, 180, 225,
voltage variations on power supply and 315° Phase
input lines 0% UT for 1 Cycle at 50 at 0°Phase
IEC 61000-4-11 70% UT for 25 Cycles at 50 Hz at 0°Phase
0% UT for 250 cycles at 50 Hz at 0°Phase
Power Frequency (50/60 Hz) Magnetic 30 A/m
Field
IEC 61000-4-8
Conducted RF IEC 61000-4-6 150 kHz to 80 MHz 3 Vrms
ISM and Amateur radio bands 6 Vrms

between 150 kHz to 80 MHz
Radiated RF IEC 61000-4-3 80 MHz – 2.7 GHz 10 V/m
380 – 390 MHz 27 V/m
430 – 470 MHz 28 V/m
704 – 787 MHz 9 V/m
800 – 960 MHz 28 V/m
1.7 – 1.99 GHz 28 V/m
2.4 – 2.57 GHz 28 V/m
5.1 – 5.8 GHz 9 V/m
Note: UT is the AC mains voltage before application of the test level.
82
Equipment Response Time

If the signal from the sensor is inadequate, the last measured values freeze for 20 seconds
and are then replaced with dashes.
SpO2 Values Response Latency

Fast Averaged SpO2 3 second or faster exponential time constant 2 beats
Pulse Rate Values Response Latency

Fast Averaged Pulse Rate 3 second or faster exponential time constant 2 beats
Equipment Delays Delay

Display Update Delay 1.5 – 2.5 seconds*
Alarm Signal Generation Delay 0 seconds
* In all configurations, the display update delay is typically less than 2 seconds.
Example – SpO2 Exponential Averaging

SpO2 decreases 1.0% every 2 seconds (5% over 10 seconds)
Pulse Rate = 75 BPM
Specific to this example:

• The response of the SpO2 average is 6 seconds.
83
Testing Summary
rSO2 Principles of Operation
Model X-100SP signal processor uses calculations based on the Beer-Lambert law or Beer’s
law, to determine regional oxygenation. The Beer-Lambert law relates the absorption of light
to the properties of the material through which the light is traveling. The law states that there
is a logarithmic relationship between the concentration of compounds and the transmission of
light through it. By utilizing wavelengths of light that are absorbed by the compounds to be
measured, the concentration of the compounds can be determined. For regional oximetry, the
compounds of interest are hemoglobin, deoxygenated hemoglobin, and tissue.
The oximetry sensors use a proprietary, patented arrangement of light emitters (LEDs) and
light detectors (photodiodes). This arrangement effectively provides a “deep tissue”
absorption measurement focused on the cerebrum. The absorption measurement is largely
unaffected by surface or near-surface features, irregularities, or substances.
SpO2 Principles of Operation

Pulse oximetry is a non-invasive method that passes red and infrared light through perfused
tissue and detects the fluctuating signals caused by arterial pulses. Well-oxygenated blood is
bright red, while poorly oxygenated blood is dark red. The pulse oximeter determines
functional oxygen saturation of arterial hemoglobin (SpO2) from this color difference by
measuring the ratio of absorbed red and infrared light as the volume fluctuates with each
pulse.
rSO2 Accuracy Testing

rSO2 accuracy testing was conducted by Nonin Medical, Inc., as described below:
8003CA/8004CA/8204CA
At an independent research laboratory, rSO2 accuracy testing was conducted during induced
hypoxia studies on healthy, non-smoking, light- to dark-skinned subjects that were 18 years of
age and older. The measured regional hemoglobin saturation value (rSO2) of the sensors was
compared to arterial/venous hemoglobin oxygen (SavO2) value, determined from venous and
arterial blood samples. The model used for blood in the brain was 70% venous and 30%
arterial, which is applicable under normocapnic conditions. The venous blood was drawn from
the right jugular bulb. The accuracy of the sensors in comparison to the blood gas analyzer
samples measured over the rSO2 range of 45 – 100%. Accuracy data was calculated using
the root-mean-squared (Arms value) for all subjects, per ISO 80601-2-61, Medical Electrical
Equipment—Particular requirements for basic safety and essential performance of pulse
oximeter equipment.
84
8004CB/8004CB-NA
rSO2 accuracy testing was conducted in cardiac catheterization laboratories on sick, male and
female, pediatric patients ranging in age from 4 days to 10 years with light- to dark-skin. The
measured regional hemoglobin saturation value (rSO2) of the sensors is compared to arterial/
venous hemoglobin oxygen (SavO2) value, determined from venous and arterial blood
samples. The model used for blood in the brain was 70% venous and 30% arterial. The venous
blood was drawn from the right jugular bulb. The accuracy of the sensors in comparison to the
blood gas analyzer samples measured over the rSO2 range of 45 – 95%. Accuracy data was
calculated using the root-mean-squared (Arms value) for all subjects, per ISO 80601-2-61,
Medical Electrical Equipment—Particular requirements for basic safety and essential
performance of pulse oximeter equipment.
SpO2 Accuracy Testing

During motion and no-motion conditions at an independent research laboratory, SpO2
accuracy testing was conducted during induced hypoxia studies on healthy, male and female,
non-smoking, light- to dark-skinned subjects that were 18 years of age and older. The
measured arterial hemoglobin saturation value (SpO2) of the sensors was compared to arterial
hemoglobin oxygen (SaO2) value, determined from blood samples with a laboratory co-
oximeter. The accuracy of the sensors in comparison to the co-oximeter samples measured
over the SpO2 range of 70 – 100%. Accuracy data was calculated using the root-mean-
squared (Arms value) for all subjects, per ISO 80601-2-61, Medical Electrical Equipment—
Particular requirements for basic safety and essential performance of pulse oximeter
equipment.
Pulse Rate Accuracy Testing (Motion and Non-motion)

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.
Low Perfusion Accuracy Testing

This test uses an SpO2 Simulator to provide a simulated pulse rate, with adjustable amplitude
settings at various SpO2 levels for the oximeter to read. The oximeter must maintain accuracy
in accordance with ISO 80601-2-61 for pulse rate and SpO2 at the lowest obtainable pulse
amplitude (0.3% modulation).
85
Specifications
CAUTION: The device has been designed for use within the specified ranges. Use
! outside of these ranges has not been tested and may result in improper oximeter
performance.
Oxygen Saturation Display Ranges:

rSO2: 0 to 100%
SpO2: 0 to 100%
Pulse Rate Display Range: 18 to 300 beats per minute (BPM)
Sensor Accuracy: For declared accuracy data for compatible sensors, refer to
the sensor Instructions for Use (IFU). Sensor IFUs are
included on the operator’s manual CD.
Measurement Wavelengths and Output Refer to sensor IFU for details. Sensor IFUs are included on
Power a: the operator’s manual CD.
Alarm Volume (at 1 m): 15: 75 dBA
8: 61 dBA
Informational Tone Volume (at 1 m): 67 dBA
Memory: 840 hours (operating with 2 channels)
420 hours (operating with 4 channels)
280 hours (operating with 6 channels)
Temperature (X-100M, X-100SP, X-100H, INT-100):
Operating: 0 ºC to 40 ºC (32 ºF to 104 ºF)
Storage/Transportation: -30 ºC to 70 ºC (-22 ºF to 158 ºF)
Humidity (X-100M, X-100SP, X-100H, INT-100):
Operating: 15% to 93% noncondensing
Storage/Transportation: Up to 93% noncondensing
Altitude (X-100M, X-100SP, X-100H, INT-100):
Operating: 0 to 4,000 meters (13,124 feet)
Power Requirements (Mains): 100 – 240 VAC 50 – 60 Hz
Internal Power:
Battery: 7.4 volt Li-ion battery pack, 3.8 Ah when charged
Operating Life (fully charged battery and 6 hours minimum (operating with 1 channel)
screen at default brightness): 3 hours minimum (operating with 2 channels)
2 hours minimum (operating with 4 channels)
1 hour minimum (operating with 6 channels)
Storage Life: 20 days minimum
Recharge Time to 90% Capacity: 2.5 hours maximum
a. This information is especially useful for clinicians performing photodynamic therapy.
86
Dimensions:
X-100M: 305 mm W x 180 mm H x 130 mm D
(12.0 in. W x 7.2 in. H x 5.0 in. D)
X-100H: 105 mm W x 66 mm H x 22 mm D with 4.0 m cable
(4.14 in. W x 2.6 in. H x 0.86 in. D with 13.1 ft cable)
X-100SP: 21.4 mm H x 21.7 mm W x 72.7 mm L (including strain
relief) with 0.75 m cable
(0.84 in. H x 0.85 in. W x 3.1 in. L (including strain relief)
with 2.5 ft cable)
INT-100: Approximately 40.6 cm (16 in.)
Weight:
X-100M: Approximately 900 grams (2 pounds)
X-100H: 243 grams (8.6 ounces)
X-100SP: 40 grams (1.4 ounces)
INT-100: Approximately 19 grams (0.67 ounces)
Warranty:
X-100M, X-100SP, X-100H, X-100HH,
X-100EC: 3 years
X-100M Battery Pack, INT-100: 1 year
Classification per IEC 60601-1 / CAN/CSA-C22.2 No. 601.1 / UL60601-1:
Type of Protection: Internally powered (on battery power).
Class II with AC adapter.
Degree of Protection: Defibrillation Proof Type BF Applied Part
Mode of Operation: Continuous
Enclosure Degree of Ingress Protection:
X-100M, X-100H, X-100SP: IP32
87
Transmitter
Bluetooth Compliance: Version 2.0
Operating Frequency: 2.4 to 2.4835 GHz
Output Power: < 20 dBm
Operating Range: 100-meter (328-feet) radius indoors
(line of sight when connected to a class I device)
Network Topology: Star
Operation: Bluetooth Slave
Antenna Type: Internal
Modulation Type: Gaussian Frequency Shift Keying
Band Width: 1 MHz
Bluetooth Profiles Supported: Serial Port Profile (SPP)
Security Mode: Mode 2 (service level enforced security)
Authentication and Encryption: Enforced on all data channels (outgoing and incoming)
Encryption Key Size: Up to 128 bits
88
External Monitor Installation Instructions

Philips Monitors
The Model X-100 SenSmart universal oximetry system communicates with the Philips Patient
Monitoring System using an Interface Module and a cable (figures 32 and 34). See the
appropriate “Setting up the Connection” section for detailed steps.
Components
• Nonin Model X-100 oximetry system
• Philips IntelliVue™ Patient Monitoring System (MP40/50/60/70/90, MX600/700/800, running
software revisions H.0 and above)
VueLink Components
• Philips M1032A#A05 VueLink Interface Module Auxiliary Plus (Type B) with Digital Open
Interface Driver (Philips P/N M1032-60605)
• VueLink Open Interface Cable with 9-Pin Connector (Philips P/N M1032-61699)
• Philips M1032A VueLink Module Handbook (Philips P/N M1032-9000D)
IntelliBridge Components
• IntelliBridge EC10 Interface Module (Philips P/N 865115 #A01), running the IB-ED101-A.2
Open Interface Device Driver
• IntelliBridge EC5 ID Module (Philips P/N 865114 #104)
• Patch cable, CAT5 or better, straight wired
• Philips Instructions for Use and Service Information for Devices Using the IntelliBridge Open
Interface (Philips P/N 4534 642 15921)
Connection Specifications
Baud Rate (X-100M Communication to Interface Module): 19200
Word Length: 8 Bit
Start Bit: 1
Stop Bit: 1
Parity: None
89
Connecting the X-100M Monitor to the Philips Monitor

Once the connection between the X-100M monitor and the Philips monitor is established, the
X-100M monitor transfers patient numerics (rSO2 and AUC), as well as patient and equipment
alarms, to the Philips monitor. A Philips monitor with a VueLink Interface Module can display
up to 6 numerics at a time. A Philips monitor with an IntelliBridge EC10 Interface Module can
display up to 8 numerics at a time.
The connection procedure only needs to be completed once. When complete, the X-100M and
Philips monitor should communicate even after disconnecting/reconnecting the X-100M or
after cycling power.
NOTES:
• The Open Interface Protocol is unidirectional. The Philips monitor can display data
received from the X-100M monitor, but cannot remotely control the X-100M.
• Due to the specific features of the Open Interface Protocol, the data transmission from the
X-100M to a Philips monitor may be delayed by several seconds.
X-100M Configuration
The X-100M monitor is a plug and play device. It does not require any configuration to be used
with the Philips monitor. The monitor detects the connection and begins communicating
automatically.
NOTE: If the X-100M monitor’s display language is changed during operation, the language
displayed on the Philips monitor will not update until the X-100M monitor is powered off and
then on again.
Philips Interface Module Installation and Configuration

A Philips-authorized technician installs the Interface Module. During installation, the technician
activates the module so it will operate with any external device that supports the Open
Interface.
NOTE: The instructions below refer to the Philips IntelliVue MP50 patient monitor. The
procedure to set up the connection may vary slightly for other Philips IntelliVue models.
Setting Up the Connection – VueLink

To connect the X-100M monitor to a Philips monitor:
1. Switch the Philips monitor OFF.
2. Verify the VueLink Interface Module has been inserted in the module rack of the Philips
monitor (done by a Philips authorized technician).
3. Connect the VueLink connection cable to the VueLink Interface Module (see figure 32).
4. Connect the VueLink connection cable to the RS-232 serial data port on the back of the
X-100M monitor. Use the screws to secure the cable to the serial data port.
NOTE: RS-232 extension cables should not be used.
90
5. Turn on the X-100M monitor.

6. Turn on the Philips monitor. Ensure the Open Interface LED on the VueLink Interface
Module is lit. This indicates the module has correctly been identified and configured by the
Philips monitor (contact a Philips authorized technician if the VueLink Interface Module
has not been configured).
7. Communication between the X-100M and Philips monitor should be established within
approximately 45 seconds. Once established, MPM (multi-parameter mode) displays on
the left side of the X-100M monitor (figure 33).
VueLink
Interface Philips
Module MP50
Monitor
VueLink Cable
RS-232
Serial Data
Port
Nonin X-100M Monitor -

Rear View
Figure 32. X-100M Connection to Philips Monitor with VueLink
Philips
indicator
Figure 33. Philips Indicator on Model X-100M Display
91
Setting Up the Connection – IntelliBridge

To connect the X-100M monitor to a Philips monitor:
1. Switch the Philips monitor OFF.
2. Verify the EC10 Interface Module has been inserted in the module rack of the Philips
monitor (done by a Philips-authorized technician).
3. Connect the IntelliBridge patch cable to the EC10 Interface Module (see figure 34).
4. Connect the patch cable to the IntelliBridge EC5 ID module.
5. Connect the EC5 module to the RS-232 serial data port on the back of the X-100M
monitor. Use the screws to secure the module to the serial data port.
NOTE: RS-232 extension cables should not be used.
6. Turn on the X-100M monitor.

7. Turn on the Philips monitor. Ensure the Open Interface LED on the Interface Module is lit.
This indicates the module has correctly been identified and configured by the Philips
monitor (contact a Philips-authorized technician if the Interface Module has not been
configured).
8. Communication between the X-100M and Philips monitor should be established within
approximately 45 seconds. Once established, MPM (multi-parameter mode) displays on
the left side of the X-100M monitor (figure 33).
IntelliBridge
EC10 Interface Philips
Module MP50
Monitor
Patch Cable
RS-232 Serial
Data Port
IntelliBridge
EC5 ID Module
Nonin X-100M Monitor - Rear View
Figure 34. X-100M Connection to Philips Monitor with IntelliBridge
92
Philips Monitor Display Configuration

The numerics transmitted from Nonin’s X-100M monitor to the Philips monitor will vary
depending on which type of Philips interface module is used.
VueLink Interface Module – Nonin’s X-100M rSO2 and AUC real-time numeric data are
transmitted to the Philips monitor through the VueLink Interface Module. Up to 12 numerics are
transmitted at a time, and up to 6 of the patient numerics can be displayed on the Philips
monitor.
IntelliBridge EC10 Interface Module – Nonin’s X-100M rSO2 and AUC real-time numeric
data are transmitted to the Philips monitor through the EC10 Interface Module. Up to 12
numerics are transmitted at a time, and up to 8 of the patient numerics can be displayed on
the Philips monitor.
The default numerics are rSO2 for channels 1 through 6. The rSO2 data trendlines for channels
1 through 4 are available on Philips IntelliVue MP40 to IntelliVue MP90 monitors running rev.
H.0 and above.
NOTE: A Philips monitor may accommodate several interface modules at once. They are
identified as AUXILIARY PLUS 1, AUXILIARY PLUS 2, etc. Be sure to select the proper
identifier.
Setup Philips Monitor with VueLink Interface Module to Display X-100M Numerics
1. Connect the X-100M monitor to the Philips monitor (see the “Setting up the Connection”
section).
2. Verify the X-100M and Philips monitors are on.
3. On the Philips monitor, enter Configuration Mode by selecting Main Setup key.
4. Select Operating Modes.
5. Select Config.
6. Enter the 5-digit Configuration Password and press Enter. The password can be found in
the Philips Configuration Guide.
7. Philips monitor enters Config Mode.
8. Select Main Setup.
9. Select Measurements.
10. Select NONIN X-100M (see note below). Setup NONIN X-100M window opens.
NOTE: If communications between the X-100M and Philips monitor have not been
established, VueLink X (where X is the VueLink module number) will appear in the
Measurements menu instead of NONIN X-100M. Select VueLink X.
NOTE: After NONIN X-100M is selected, the Philips monitor pauses while VueLink re-
synchronizes with the X-100M. Wait for values to appear.
11. Select a Numeric # to update.

a. Drop down list, which show the available and in-use numerics, displays to right of the
numerics. NOTE: The X-100M channel number appears at the end of the numeric
(e.g., AUC 1, rSO2-3).
b. Select available Numeric. If a numeric is in use, it is grayed out.
93
c. Repeat as needed until up to 6 numerics have been assigned.

12. User may also setup Device Alarms (options include Accepted or Ignored) and Default
Color. The X-100M numerics will display in the color chosen.
13. When setup is complete, select Store to Module to save settings to the VueLink module.
Other options include Restore from Module and Recall Mod. Def. (Module Defaults).
14. In the Please Confirm task bar, user is asked to select Confirm to store new settings.
Select Confirm.
15. Philips monitor stores active values as user defaults.
16. Close Setup NONIN X-100M window.
17. Close Measurements window.
18. Close Main Setup window.
19. To place a numeric on the Philips monitor:
a. Select the appropriate screen configuration for the Philips monitor (see Philips
IntelliVue Patient Monitor Instructions for Use [Philips P/N M8000-9001K] for screen
configuration information).
b. Using either the touch screen or the Navigation Point knob, select a numeric location
on the Philips monitor. White box displays on monitor.
c. Select the white box to open the Change Numeric window.
NOTE: If the Change Numeric window does not open, that location is not available for
X-100M numerics.
d. Scroll up to see the 6 numerics.

e. Choose a numeric to display on the Philips monitor.
f. Repeat until up to 6 numerics display.
20. Exit Config Mode by shutting off the Philips monitor.
21. Turn the Philips monitor back on. Monitor is ready to use.
Setup Philips Monitor with IntelliBridge Interface Module to Display X-100M Numerics
1. Connect the X-100M monitor to the Philips monitor (see the “Setting up the Connection”
section).
2. Verify the X-100M and Philips monitors are on.
3. On the Philips monitor, enter Configuration Mode by selecting Main Setup key.
4. Select Operating Modes.
5. Select Config.
6. Enter the 5-digit Configuration Password and press Enter. The password can be found in
the Philips Configuration Guide.
7. Philips monitor enters Config Mode.
8. Select Main Setup.
9. Select Measurements.
10. Select Auxiliary Device (see note below). Setup Auxiliary Device window opens.
NOTE: After Auxiliary Device is selected, the Philips monitor pauses while the interface
module re-synchronizes with the X-100M. Wait for values to appear.
11. Select Device Driver.

94
12. Select Setup Numerics.

a. Drop down list, which shows the in-use numerics, displays to right of the numerics.
NOTE: The X-100M channel number appears at the end of the numeric (e.g., AUC 1,
rSO2-3).
b. Numerics can be added or deleted. To add, select Add. Drop down list of numerics
displays. Select available Numeric. If a numeric is in use, it is grayed out.
c. Repeat as needed until up to 8 numerics have been assigned.
d. Close Setup Numerics window.
13. In Setup Auxiliary Device window, select Open Interface.
a. Device Alarms: Options include Accepted or Ignored.
b. Default Color: The X-100M numerics will display in the color chosen.
14. Close Setup Auxiliary Device window.
15. Close Measurements window.
16. Close Main Setup window.
17. To place a numeric on the Philips monitor:
a. Select the appropriate screen configuration for the Philips monitor (see Philips
IntelliVue Patient Monitor Instructions for Use [Philips P/N M8000-9001K] for screen
configuration information).
b. Using either the touch screen or the Navigation Point knob, select a numeric location
on the Philips monitor. White box displays on monitor.
c. Select the white box to open the Change Numeric window.
NOTE: If the Change Numeric window does not open, that location is not available for
X-100M numerics.
d. Scroll up or down to see the 8 numerics.

e. Choose a numeric to display on the Philips monitor.
f. Repeat until up to 8 numerics display.
18. Exit Config Mode by shutting off the Philips monitor.
19. Turn the Philips monitor back on. Monitor is ready to use.
Alerts
The Open Interface Protocol recognizes two types of alerts: patient alarms and equipment
alarms (also known as inops or inoperable conditions).
Only one alert message text of each alert type can be displayed at the Philips monitor at the
same time. Therefore, a priority is assigned to each alarm and inop. All other functions related
to alerts (e.g., flashing value, value removed from the display) of two or more active alerts may
occur simultaneously.
NOTES:
• By default, alerts are deactivated. Activation requires access to the configuration mode of
the monitor and can only be done by technical staff.
• The interface module does not allow the Philips monitor to generate audible signals at the
bedside for alarms and inops generated by the X-100M monitor.
95
Patient Alarms
The Open Interface Protocol defines two types of patient alarms:
• Red alarms: Indicate potentially life-threatening situations that require an immediate
response.
• Yellow alarms: Indicate less critical situations. A response is required, but is of less critical
importance.
Alarm Messages
On Philips IntelliVue patient monitors, red alarm messages may display in the upper right
corner of the monitor screen. Yellow alarm messages may display at the top of the monitor
screen in the middle. For more information on Philips monitor alarm messages, see the
specific monitor’s documentation.
Alarm Indicators
The Philips IntelliVue patient monitor may have alarm indicators at the top, left side of the
monitor. For more information on Philips monitor alarm indicators, see the specific monitor’s
documentation.
Table 17. Philips Monitor Patient Alarms
Alarm
X-100M Alarm Effect on Philips Display
Priority
Numeric flashes.
rSO2 Limit Low Red ***rSO2 LOW displays.
Alarm indicator flashes red.
Numeric flashes.
rSO2 Limit High Red ***rSO2 HIGH displays.
Alarm indicator flashes red.
Numeric flashes.
rSO2 Low Limit Warning Yellow **rSO2 LOW WARN displays.
Alarm indicator flashes yellow.
NOTE: For more information on X-100M alarms, see the “Alarms” chapter.
96
Equipment Alarms
The Philips monitor displays equipment alarms as “inops” or “inoperatives.” Each inop carries
information either on the validity of all related measurements (general inop) or on the validity
of a specific numeric. Depending on this information, the numeric may display differently on
the Philips IntelliVue monitor (e.g., it may blink or be replaced with “-?-”).
On the Philips IntelliVue patient monitor, inop messages may display in the upper left corner
of the monitor screen. Inop messages are blue. For more information on Philips monitor
equipment alarms, see the specific monitor’s documentation.
Table 18. Philips Monitor Equipment Alarms
X-100M Alarm
Effect on Philips Display
(Medium Priority)
Numeric data disappears.

Pod Communication Error
rSO2 SP COMM ERR displays.
Sensor Fault
rSO2 SENSOR FAULT displays.
Sensor Alarm ? displays next to numeric label.

(Signal Quality Alarm) rSO2 SENSOR ALARM displays.
Sensor Alarm Numeric data disappears.

(rSO2 Data Unavailable) rSO2 UNAVAILABLE displays.
Low Battery SENSMART LOW BATT displays.
Critical Battery SENSMART CRIT BATT displays.
Error Codes
SENSMART ERROR displays.
97

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Operator’s Manual

Universal Oximetry System

Follow Instructions for Use.

Nonin Medical, Inc.

Nonin Medical B.V.

+31 (0)13 - 79 99 040 (Europe)

MPS, Medical Product Service GmbH

References to “Nonin” in this manual shall imply Nonin Medical, Inc.

Nonin, EQUANOX, and are registered trademarks of Nonin Medical, Inc.

© 2019 Nonin Medical, Inc.

Indications for Use

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

No modifications to this device are allowed as it may affect device performance.

Use the device only with Nonin-specified power supplies.

A 2-minute alarm silence is automatically engaged at startup.

If not in continuous use, fully charge battery at six-month intervals.

Declaration of Conformity with FCC and Canadian

Federal Communications Commission (FCC) Notice

Consult instructions for use.

Follow instructions for use.

Class II, double insulated

Protected against vertically falling water drops when enclosure is tilted up

Type BF Applied Part (X-100M, X-100H)

Indicates separate collection for waste electrical and electronic equipment

Non-ionizing electromagnetic radiation. Equipment includes RF

Table 1. Labeling and Packaging Symbols (Continued)

Do not pull on cable. Retract connector and remove.

LOT Lot Number

REF Catalogue number

Storage/shipping temperature range

Handle with care.

Medical prescription required.

Figure 1. Monitoring Screen Symbols (Four-Channel View)

Table 2. X-100M Monitoring Screen Symbols and Indicators

No. Symbol Description

Table 2. X-100M Monitoring Screen Symbols and Indicators (Continued)

No. Symbol Description

or NOTE: %rSO2 displays when an absolute regional sensor is attached

Table 2. X-100M Monitoring Screen Symbols and Indicators (Continued)

No. Symbol Description

9 Low Alarm Limit

10 %SpO2 Percent Functional Hemoglobin Oxygen Saturation

Table 2. X-100M Monitoring Screen Symbols and Indicators (Continued)

No. Symbol Description

System Components and Set Up

Figure 2. System Set Up (≥40 kg Sensors, INT-100, 4 Channels Connected)

Figure 3. System Set Up (≤40 kg Sensors, 4 Channels Connected)

Figure 4. System Set Up (≥40 kg Sensors, 4 Channels Connected)

Figure 5. System Set Up (≥40 kg Sensor, INT-100, Single Channel)

Figure 6. X-100M Front View

Table 3. X-100M Features

No. Symbol Description

1 Alarm Silence Button

Table 3. X-100M Features (Continued)

No. Symbol Description

Table 3. X-100M Features (Continued)

No. Symbol Description

CAUTION: Do not connect more than one hub

CAUTION: Do not use an extension cable