These operating instructions provide the necessary information for proper operation of all
models of the TIR-1. There may be information provided in this manual that is not relevant
for your system. General knowledge of pulse oximetry and an understanding of the features
and functions of TIR-1 are prerequisites for its proper use. Do not operate TIR-1 without
completely reading and understanding these instructions.
CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.
For professional use. See instructions for use for full prescribing information, including
indications, contraindications, warnings, and precautions.
TaiDoc Technology Corporation
B1-7F, No.127, Wugong 2nd Road, Wugu Dist.
24888 New Taipei City, Taiwan
Distributed by:
Masimo Corporation
52 Discovery
Irvine, CA 92618, USA
Tel.: 949-297-7000
Fax.: 949-297-7001
www.masimo.com
MEDICAL ELECTRICAL EQUIPMENT
WITH RESPECT TO ELECTRIC SHOCK, FIRE AND MECHANICAL HAZARDS ONLY
IN ACCORDANCE WITH
5009094
AAMI ES60601-1, IEC 60601-1 & ISO 80601-2-56. Certified to STD C22.2
#60601-1 Standards for which the product has been found to comply by Intertek.
Patents: www.masimo.com/patents
Root®, Masimo® and ®, are federally registered trademarks of Masimo Corporation.
TIR-1™ is a trademark of Masimo Corporation.
All other trademarks and registered trademarks are property of their respective owners.
Index --------------------------------------------------------------------------------------------------------- 49
www.masimo.com 4 Masimo
About this Manual
This manual explains how to set up and use TIR-1™ Thermometer. Important safety
information relating to general use of TIR-1 appears in this manual. Read and follow any
warnings, cautions, and notes presented throughout this manual. The following are
explanations of warnings, cautions, and notes.
A warning is given when actions may result in a serious outcome (for example, injury, serious
adverse effect, death) to the patient or user.
WARNING: This is an example of a warning statement.
A caution is given when any special care is to be exercised by the patient or user to avoid
injury to the patient, damage to this device, or damage to other property.
CAUTION: This is an example of a caution statement.
A note is given when additional general information is applicable.
Note: This is an example of a note.
www.masimo.com 5 Masimo
Product Description, Features and
Intended Use
Product Description
The TIR-1™ Thermometer is a noninvasive, infrared, clinical thermometer that can be used as
a standalone device or with Masimo devices.
Features
Features of TIR-1 include:
• Fast measurement that meets ASTM and ISO standards.
• Simple 1-button operation, no scanning required.
• Audible and visual indication of completed temperature.
• Backlit LCD display and Low Battery indication.
• Long Battery Life of more than 10,000 temperatures (typical).
• Memory recall of up to 30 temperature readings (with date and time stamp).
• Can communicate via Bluetooth LE to Masimo devices.
Intended Use
TIR-1™ Thermometer is an infrared thermometer intended for the measurement of human
body temperature in people of all ages without contact to the body and is to be used by
medical professionals.
www.masimo.com 7 Masimo
Safety Information, Warnings and
Cautions
The manual, accessories, directions for use, all precautionary information, and specifications
should be read before use. Refer to Masimo Operator's Manuals for additional safety
information, warnings, and cautions.
Safety Warnings and Cautions
WARNING: Do not use TIR-1 during magnetic resonance imaging (MRI) or in an MRI
environment.
WARNING: Do not place TIR-1 or accessories in any position that might cause it to fall on the
patient.
WARNING: Do not use TIR-1 during defibrillation.
WARNING: Do not use TIR-1 during electrosurgery.
WARNING: Do not use TIR-1 in the presence of flammable anesthetics or other flammable
substances, oxygen-enriched environments, or nitrous oxide to avoid the risk of explosion.
WARNING: Do not leave the TIR-1 unattended around children. Small items such as the
battery door, battery, and lanyard may become choking hazards.
Performance Warnings and Cautions
WARNING: TIR-1 should not be used as the sole basis for medical decisions. It must be used
in conjunction with clinical signs and symptoms.
WARNING: Do not use TIR-1 if it appears or is suspected to be damaged. Damage to internal
parts can result in no or inaccurate readings.
WARNING: Do not repair, open, or modify TIR-1. Damage to internal parts can result in no or
inaccurate readings.
WARNING: Do not use the TIR-1 if the internal parts have been exposed to liquids. Damage to
the internal parts may result in no or inaccurate readings.
CAUTION: Remove perspiration and excess oil from the forehead as this may affect the
accuracy of the reading.
CAUTION: Do not use on patients with the following as they may affect the accuracy of the
readings:
•Scarred tissue or tissue compromised by skin disorders or trauma in the
vicinity of the forehead measurement area.
•Patients treated with certain drug therapies that may affect normal body
temperature or use on patients while skin is exposed to external sources of
heat or cold such as direct sunlight, fireplace heat, cold compress therapies,
air conditioner flow, etc.
CAUTION: Keep the TIR-1 away from electrical equipment that emits radio frequencies to
minimize radio interference. Radio interference may result in no or inaccurate readings.
www.masimo.com 9 Masimo
TIR-1 Thermometer Safety Information, Warnings and Cautions
CAUTION: When using the TIR-1 Thermometer connected via Bluetooth, keep both devices
within the recommended 8 to 10 feet range of each other; moving outside of this range may
cause a loss in connection.
CAUTION: When paired to a Masimo device, the time and date of the Masimo device is used
as the time stamp.
CAUTION: When paired to a Masimo device, the temperature unit of measure of TIR-1 and the
Masimo device is are not synchronized.
Note: If coming from a warmer or cooler environment or after a period of exertion, allow the
patient and thermometer to acclimate to room temperature for 20 minutes prior to taking
temperature.
Note: Replace protective sensor cap when not in use.
Cleaning and Service Warnings and Cautions
WARNING: Properly use and dispose of Alkaline batteries or they may leak or explode.
WARNING: Remove alkaline batteries when the TIR-1 will not be in use for more than 30
days to avoid damage to the device due to batteries that may leak.
WARNING: Replace both batteries at the same time to avoid mixing fully and partially
charged batteries. These actions may cause the batteries to leak; resulting in possible
damage to the device.
CAUTION: Use only AA alkaline batteries. Use of non-alkaline batteries may affect the
accuracy of the battery status indicator.
CAUTION: Only perform maintenance procedures specifically described in the manual;
otherwise, return TIR-1 for servicing. Improper maintenance may result in damage to the
internal parts. Damage to internal parts may result in no or inaccurate readings.
CAUTION: Do not clean TIR-1 with any chemical other than those specified in Maintenance
and Cleaning of this manual. These substances may affect the device’s materials and damage
internal parts.
CAUTION: Do not submerge TIR-1 in any cleaning solution or attempt to sterilize by
autoclave, irradiation, steam, gas, ethylene oxide or any other method. This will seriously
damage the device.
CAUTION: Do not use undiluted bleach (5% - 5.25% sodium hypochlorite) or any cleaning
solution other than those recommended in Maintenance and Cleaning of this manual.
Permanent damage to TIR-1 may occur if other unspecified solutions are used.
CAUTION: Never submerge TIR-1 in water or any other liquid solution this may cause
permanent damage to the TIR-1.
Note: Ensure that sensor end is clean and free of debris. See Maintenance and Cleaning of
this manual for proper cleaning instructions.
Compliance Warnings and Cautions
WARNING: Any changes or modifications not expressly approved by Masimo shall void the
warranty for this equipment and could void the user’s authority to operate the equipment.
CAUTION: Comply with local laws in the disposal of the instrument and/or its accessories,
including batteries.
www.masimo.com 10 Masimo
TIR-1 Thermometer Safety Information, Warnings and Cautions
Note: When using The TIR-1 with a device with wireless features, consideration should be
taken to local government frequency allocations and technical parameters to minimize the
possibility of interference to/from other wireless devices.
Note: In accordance with international telecommunication requirements, the frequency band
of 2.4 GHz is only for indoor usage to reduce potential for harmful interference to co-channel
mobile satellite systems.
Note: This device complies 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.
Note: 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 and, if not installed and
used in accordance with the instructions, may cause harmful interference to radio
communications. However, there is no guarantee that interference will not occur in a
particular installation. If this equipment does 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:
• Reorient or relocate the receiving antenna.
• Increase the separation between the equipment and receiver.
• Consult the dealer or an experienced radio/TV technician for help.
Note: This equipment has been tested and found to comply with the Class B limits for
medical devices according to the EN 60601-1-2: 2007, Medical Device Directive 93/42/EEC.
These limits are designed to provide reasonable protection against harmful interference in all
establishments, including domestic establishments.
Note: This Class B digital apparatus complies with Canadian ICES-003.
Note: This device complies with Industry Canada license-exempt RSS standard(s). Operation
is subject to the following two conditions: (1) this device may not cause interference, and (2)
this device must accept any interference, including interference that may cause undesired
operation of the device.
www.masimo.com 11 Masimo
Chapter 1: Technology Overview
About Body Temperature and Fever
Body temperature can vary from one person to the next and also varies by location on the
body and time of day. Temperatures measured from different sites, even at the same time,
should not be directly compared.
Fever indicates that body temperature is higher than normal. This may be caused by a
number of conditions including infection, overexertion, overdressing or immunization. Some
people may not experience fever even when they are ill. These include, but are not limited to,
infants younger than 3 months old, persons with compromised immune systems, persons
taking antibiotics, steroids or antipyretics (aspirin, ibuprofen, acetaminophen), or persons
with certain chronic illnesses. Please consult your physician when you feel ill even if you do
not have fever.
www.masimo.com 13 Masimo
Chapter 2: Description
General System Description
The TIR-1™ Thermometer includes:
• The TIR-1 device
• Two (2) AA alkaline batteries
• Infrared sensor cover
Features
Display
1. Low battery indicator
2. Date Indicator
3. Date/Time
4. Temperature Reading
5. Object Surface Temperature
Indicator
6. Body Temperature Indicator
7. Room Temperature
Indicator
8. Bluetooth indicator
9. Memory Mode
10. Unit of Measurement
°F/°C
11. Error Warning
www.masimo.com 15 Masimo
TIR-1 Thermometer Chapter 2: Description
Controls
1. Power/Start Measurement
2. Bluetooth LED
3. Infrared Sensor
4. Change Scale °C/°F
5. SET: Set Date/Time
6. Battery Compartment
7. MEM: Recall Stored temperature
8. MODE: Body, Surface, or Room
Bluetooth Function
Temperature may be transmitted from TIR-1 to a Masimo device using a Bluetooth
connection. Pairing must be completed before data will be received. To pair TIR-1 to a
Masimo device, see Pairing TIR-1 to a Masimo Device on page 18.
Bluetooth Indicator and LED
The Bluetooth indicator on the display remains solid and does not indicate connection
status. The Bluetooth LED indicates connection status.
Bluetooth LED Status
Flashing Bluetooth function ON and waiting for connection
Solid Bluetooth connection is established
www.masimo.com 16 Masimo
Chapter 3: Basic Setup and Use
The following information provides instructions to setup TIR-1 and begin taking patient
temperatures, as well as pair to a Masimo device.
1. Install batteries into TIR-1.
2. Take a patient's temperature using TIR-1.
3. Pair TIR-1 to a Masimo device to display patient's temperature measurements on
Installing Batteries
the Masimo device screen.
1. To remove Battery Cover, press down at the arrow mark and also on the center of
the cover; SLIDE it in the direction of the arrow as shown in Figure 1.
2. Install (2) AA alkaline batteries with polarity as shown in the battery
compartment. All LCD display segments will briefly illuminate during self-test, and
you will hear a “beep”.
3. Close the battery cover by pressing down both the arrow mark and the bottom of
the cover, SLIDING the cover in the opposite direction of the arrow as shown in
Figure 2.
Figure 1
Figure 2
Figure 3
DO NOT press the battery cover to force it closed. If the battery cover does not close tight as
shown in Figure 3, remove the battery cover by SLIDING as described in Step 1. Repeat Step 3
to close the battery cover tight.
CAUTION: Closing the battery cover by force may damage the battery cover latch and result
in battery damage. Always follow the instructions and close the battery cover by SLIDING
only.
• Set Date and Time as described in Setting Date/Time on page 21.
• TIR-1 defaults to °F temperature scale and BODY mode.
Note: If TIR-1 will be stored for a long period, remove the batteries.
www.masimo.com 17 Masimo
TIR-1 Thermometer Chapter 3: Basic Setup and Use
Body Temperature Measurement
1. Remove the protective cap (if installed)
and inspect the sensor. Remove any
debris and clean the sensor as
necessary.
2. Remove hair and perspiration from
center forehead area as shown in Figure
1.
Figure 1
Figure 2
•If the patient was lying face down
or was wearing a hat or garment
covering the skin, allow the
forehead to be exposed to the air in
the room for 5 minutes prior to
taking reading.
•Relocate patient if in drafty
environment.
3. Aim at center forehead area 1/2" to 2"
(1.2 to 5 cm) away from skin surface. Be
sure thermometer is perpendicular to
skin surface (at right angle) as shown in
Figure 2.
4. Press and release the Power/Start
Measurement button. See Features on
page 15. Hold thermometer in place
until a double beep is heard and the
temperature is displayed on the LCD.
Ensure the Body temperature icon is
displayed. See Display on page 15.
5. If properly paired to a Masimo device,
the TIR-1 reading also displays in the
Temperature window on the Main
Screen. See Temperature Windowon
page 23.
For additional information on TIR-1 operation such as changing temperature scale and
modes, see Chapter 4: Operation on page 21.
Note: If temperature is suspected to be incorrect or display reads LO or HI, see TIR-1
Messages on page 31.
Pairing TIR-1 to a Masimo Device
Note: Verify compatibility between the TIR-1 and the Masimo device before attempting to
pair.
Note: If pairing TIR-1 to a Root with noninvasive blood pressure and temperature, the
temperature probe must be disabled. See Active Channels on page 26.
www.masimo.com 18 Masimo
TIR-1 Thermometer Chapter 3: Basic Setup and Use
To pair TIR-1 with a Masimo device:
1. On the Masimo device, at the bottom right corner of the touchscreen, press the
Main Menu icon .
2. Select the Device Settings menu icon.
3. Select the Bluetooth menu icon.
4. On the Bluetooth screen, ensure Bluetooth is turned On.
5. Select the Thermometer Pair button.
6. To place TIR-1 into paring mode, take a measurement. See Body Temperature Measurement on page 18. The Bluetooth indicator appears on the display and the
Bluetooth LED blinks. See Bluetooth Indicator and LED on page 16.
Note: TIR-1 remains in pairing mode until it powers down (Sleep Mode) after 30
seconds of non-use.
Note: To exit pairing mode, press the MODE, SET, MEM or C/F buttons.
7. After the measurement is taken and the LED is blinking (within the 30 seconds
after being placed in pairing mode), hold the TIR-1 close to the Masimo device
(Root shown in the example).
8. TIR-1 should appear under the Devices Found list on the Masimo device screen.
Select the TIR-1 thermometer under the Devices Found list.
Note: The MAC Address for TIR-1 may also be displayed next to the name to assist
in identifying the correct thermometer to pair.
9. Select the Pair button. TIR-1 will pair with the Masimo device.
10. After successfully pairing, each measurement taken using TIR-1 is displayed in the
Temperature window on the Main Screen of the Masimo device. See Temperature
Window on page 23.
Note: TIR-1 can be paired to multiple Masimo devices, however, TIR-1 will only
send measurements to the last device it communicated with.
www.masimo.com 19 Masimo
Chapter 4: Operation
The following information describes TIR-1 operation and settings on Root when properly
paired using the Bluetooth connection and is to be used with the information in the
Operator's Manual for Root and Operator's Manual for Root with noninvasive blood pressure
and temperature.
TIR-1 Stand-Alone
The following information provides instructions for settings and temperature memory recall
on TIR-1.
Power ON/OFF
TIR-1 is powered on by pressing the Power/Start Measurement button. See Features on page
15. TIR-1 automatically powers down (Sleep Mode) after 30 seconds of non-use.
Setting Date/Time
The time and date displayed on TIR-1 are both set using the following procedure. This setting
is necessary at initial setup and when the batteries are changed.
CAUTION: When TIR-1 is paired to a Masimo device, the time and date of the Masimo device
is used as the time stamp. To synchronize the date/time of the TIR-1 to the Masimo device,
adjust the date/time settings on the TIR-1 to match the Masimo device.
1. Press the Power/Start Measurement button to turn TIR-1 ON.
2. Press and hold the SET button until the currently set date displays. The "months"
digits flash. See Display on page 15.
3. Press the MODE button to increase (+) the month or press the °C/°F button to
decrease (-) the month.
4. Press the SET button to save the month and change the day. The "day" digits flash.
5. Press the MODE button to increase (+) the day or press the °C/°F button to
decrease (-) the day.
6. Press the SET button to save the day and change the year. The "year" digits flash.
7. Press the MODE button to increase (+) the year or press the °C/°F button to
decrease (-) the year.
8. Press the SET button to save the year and change the hour and AM/PM. The "hour"
digits flashes and "AM" or "PM" displays.
9. Press the MODE button to increase (+) the hour or press the °C/°F button to
decrease (-) the hour. The AM or PM setting is determined by the hour setting.
10. Press the SET button to save the hour and change the minutes. The "minutes"
digits flash.
11. Press the MODE button to increase (+) the minutes or press the °C/°F button to
decrease (-) the minutes.
12. Press the SET button to save the date and time settings. TIR-1 automatically turns
OFF.
www.masimo.com 21 Masimo
TIR-1 Thermometer Chapter 4: Operation
Changing Temperature Scale
The temperature scale may be changed to Celsius or Fahrenheit using the following
procedure. When properly paired, the temperature scale setting on TIR-1 determines the
displayed temperature scale on the Masimo device. The Masimo device temperature scale
settings cannot change the temperature scale settings on TIR-1.
1. Press the Power/Start Measurement button to turn TIR-1 ON.
2. Press and hold the °C/°F button until a single beep is heard. The current scale is
displayed. See Display on page 15.
3. Press the °C/°F button again to change scale.
4. When the desired scale is displayed, press the Power/Start Measurement button to
save the scale setting and exit this function.
Operation Modes
Body Temperature Mode
In Body temperature mode, the icon at the left is shown on the display and temperature
is adjusted to an oral (sublingual) temperature approximation. See Display on page 15.
Normal oral temperature is typically 95.0°F to 100.7°F (35.0°C to 38.2°C) but varies by
age, gender and time of day [1]. Body is the default mode of operation.
[1] Sund-Levander, M., Forsberg, C. & Wahren, L. (2002). Normal oral, rectal and axillary body
temperature in adult men and women; a systematic review. Scandinavian Journal of Caring
Science, 16(2), 122-128.
Surface and Room Temperature Modes
Surface temperature mode measures the surface temperature of an object placed within the
Field Of View (FOV) of the thermometer. At 2" (5cm) away, the FOV is a 0.84" (2.1cm) circle
(±8° cone angle FOV). Accuracy varies with the type of object being measured and the
temperature of the surrounding environment.
Room temperature mode measures the temperature of the room in which the thermometer is
located. Allow 20 minutes for the thermometer to adjust to abrupt changes in room
temperature.
Setting Mode of Operation
TIR-1 remains in the set Mode with each press of the Power/Start Measurement button. If
TIR-1 is allowed to power OFF (as opposed to pressing the Power/Start Measurement button
and taking a new measurement), the Mode changes back to Body.
1. Press the Power/Start Measurement button to turn TIR-1 ON.
2. Press and hold the MODE button until a beep is heard and the currently set mode
(Body, Surface or Room) flashes. See Display on page 15.
3. Press the MODE button until the desired mode displays.
4. Press the Power/Start Measurement button to save the mode setting and exit this
function.
www.masimo.com 22 Masimo
TIR-1 Thermometer Chapter 4: Operation
Temperature Recall
Up to 30 temperature measurements are stored on TIR-1 memory and can be viewed at a
later time. Once 30 are reached, the oldest is deleted with each new measurement thereafter.
If only 10 temperature readings are stored, only 10 stored temperatures can be recalled and
displayed.
Note: The stored temperature measurements on TIR-1 cannot be recalled on the Masimo
device. The Masimo device records temperature measurements separately. See Temperature Window on page 23.
1. Press the Power/Start Measurement button to turn TIR-1 ON.
2. Press and hold the MEM button. The date and a number from 1 to 30 display
indicating the stored temperature number. See Display on page 15. Example:
DATE 03/12/2018; 01 (01 is the most recent temperature measurement and 30 is
the oldest).
3. Release the MEM button. The time, temperature reading and mode displays.
Example: 12:26AM; 98.6 °F; SURFACE.
4. Press and release the MEM button to cycle through the stored temperatures.
5. Press the Power/Start Measurement button to exit this function.
TIR-1 with Root
The following information describes TIR-1 operation and settings on Root when properly
paired using the Bluetooth connection and is to be used with the information in the
Operator's Manual for Root and Operator's Manual for Root with noninvasive blood pressure
and temperature.
Temperature Window
Ref. Feature Description
1 Numeric Value
www.masimo.com 23 Masimo
Indicates current reading of the measurement. Touch to access
settings.
TIR-1 Thermometer Chapter 4: Operation
Ref. Feature Description
2 Trend Graph
Alarm Limits
3
and Unit of
Measure
Displays measurements taken over a period of time. Touch to display
measurement. See Trends for Temperature on page 27.
Indicates high and low alarm limits and the selected unit of
measurement. Touch to access settings. See Alarms for Temperature
on page 27 and Alarms for Temperature on page 27.
After successfully pairing TIR-1 with the Masimo device, the temperature and scale data is
transmitted with each measurement taken. The reading is displayed in the Temperature
window on the Main Screen of the Masimo device, and the TIR-1 name is displayed at the top
of the window (Root shown in the example).
Note: If pairing TIR-1 to a Root with noninvasive blood pressure and temperature, the
temperature probe must first be disabled before the reading can be displayed. See Active Channels on page 26.
Accessing Main Menu Options
To access the Main Menu options
At the bottom right corner of the touchscreen, press the Main Menu icon.
On Root and Root with NIBP devices, with TIR-1 connected, the following Main Menu option
content changes.
Layout
See Layout on page 25.
Temperature
See Temperature on page 26.
Device Settings
See Device Settings on page 28.
About
See About on page 29.
www.masimo.com 24 Masimo
TIR-1 Thermometer Chapter 4: Operation
Layout
The Layout menu allows the user to view and customize settings for the Main Screen Layout
through the following options:
Available layouts
See Available Layouts on page 25.
Active Channels*
See Active Channels on page 26.
* Applies to Root with noninvasive blood pressure and temperature only.
Available Layouts
When a Radical-7 or Radius-7 is docked to Root and/or multiple MOC-9 modules and TIR-1 are
connected, the user will have the option to select from several pre-configured layouts. Image
below shows layout options available with Radical-7 docked in Root with SedLine connected
through MOC-9, and TIR-1 is connected through Bluetooth.
Note: On Root with noninvasive blood pressure and temperature, the layouts are the same, as
only the device measuring temperature changes.
www.masimo.com 25 Masimo
TIR-1 Thermometer Chapter 4: Operation
Active Channels
When attempting to pair TIR-1 to a Root with noninvasive blood pressure and temperature,
the temperature channel must be disabled in order to use TIR-1 with Root (if not, Unable to handle Temperature channel on bluetooth message displays).
Note: On Root (without noninvasive blood pressure and temperature) Active Channel, menu
changes are not necessary for TIR-1 operation.
On Root with noninvasive blood pressure and temperature, from the Layouts screen, touch
Active Channels, and then change any of the following options:
Options Description
Enables or disables the Root with
Temperature
noninvasive blood pressure and
temperature, built-in temperature probe.
Factory
Default
Settings
Enabled
Configurable
Options*
Enabled or
Disabled
* If the Masimo device is currently monitoring a patient, or there is an active alarm, the alarm
must be cleared or acknowledged, or the ability to disable the temperature probe is locked
out.
Temperature
The Temperature menu allows the user to view and customize settings for TIR-1 by changing
any of the following options:
Alarms
See Alarms for Temperature on page 27.
About
Displays information about the parameter.
Trend
See Trends for Temperature on page 27.
www.masimo.com 26 Masimo
TIR-1 Thermometer Chapter 4: Operation
Additional Settings
See Additional Settings for Temperature on page 28.
Alarms for Temperature
From the Temperature screen, touch Alarms, and then change any of the following options:
Options Description
Alarm
Priority
Factory
Default
Settings
Configurable Options
80.20-109.9
High Limit
°F (°C)*
The High Limit is upper
threshold that triggers an
alarm.
Medium Off
(26.9-43.2) in steps of
0.1, or Off
When set to Off, alarm
is disabled
80.1-109.8 (26.8-43.1)
in steps of 0.1, or Off
When set to Off, alarm
is disabled
30 sec, 1 min, 2 min, 5
min
Low Limit
°F (°C)*
Silence
Duration
Low Limit is the lower
threshold that triggers an
alarm.
Temporarily suspend
audible alarms for a
period of time.
Medium Off
None 2 min
* When TIR-1 in NOT actively measuring and sending data to the Masimo device, these items
are Grayed out.
Trends for Temperature
From the Temperature screen, touch Trends, and then change any of the following options:
Options Description
Factory Default
Settings
User Configurable Settings
Y-axis
Min
Y-axis
Max
The lower limit a
measurement will be shown.
The upper limit a
measurement will be shown.
80.0°F (26.7°C)
110.0°F
(43.3°C)
80.0°F to 109.9°F (26.7°C to
43.2°C) in steps of 0.1
80.1°F to 110.0°F (26.8°C to
43.3°C) in steps of 0.1
www.masimo.com 27 Masimo
TIR-1 Thermometer Chapter 4: Operation
Additional Settings for Temperature
From the Temperature screen, touch Additional Settings, and then change any of the
following options:
Options Description
Unit of Measure*
Measurement
Timeout
* When properly paired, the temperature scale setting on TIR-1 determines the displayed
temperature scale on the Masimo device. The Masimo device temperature scale settings
cannot change the temperature scale settings on TIR-1.
The unit of measure for
temperature.
Spot Check timing
customization.
Factory Default
Settings
°F °F, °C
5 minutes
User Configurable
Settings
5, 10, 15, 30, 60 and 90
minutes
Device Settings
The Device Settings menu allows the user to view and customize settings for the Masimo
device.
The Device Settings options are:
Bluetooth
See Bluetooth on page 28.
Bluetooth
Use the Bluetooth screen to enable or disable Bluetooth connectivity, connect devices to the
Masimo device using a Bluetooth connection or view connected device information. For
complete information on the Masimo device Bluetooth menu, see the Operator's Manual for
the Masimo device.
Option Description Factory Default
Bluetooth
www.masimo.com 28 Masimo
Enables or disables Bluetooth
connectivity.
Setting
Off On or Off
Configurable
Settings
TIR-1 Thermometer Chapter 4: Operation
Option Description Factory Default
Setting
Thermometer*
Pairs the TIR-1 thermometer to
Root.
NA Pair
Configurable
Settings
* After paring, the TIR-1 MAC address is displayed. The Pair button is also replaced with the
Info button to access the Info Screen. See the Accessing the Thermometer Info Screen on
page 29.
About
Listed under Temperature, use the About screen to view the serial number as well as software
version and MAC address information for TIR-1. These details may be helpful during
troubleshooting.
Option* Description
Serial Number Displays the serial number for the device.
SW Version Displays software version number.
MAC address** Displays the TIR-1 Bluetooth MAC address.
* These fields are read-only and cannot be configured by the user.
** The MAC address is also located on the TIR-1 label.
Accessing the Thermometer Info Screen
The following information is for viewing the TIR-1 Thermometer Info screen. Bluetooth
information as well as disconnecting (un-pairing) from the Masimo device is available on this
screen.
To access the Thermometer Info screen:
1. On the Masimo device, go to the Bluetooth device settings.
2. Next to the Thermometer (and MAC address for the paired TIR-1), touch the
www.masimo.com 29 Masimo
information icon to display the Thermometer Info screen.
TIR-1 Thermometer Chapter 4: Operation
TIR-1 Info
The Thermometer Info screen displays the following information for TIR-1:
Option* Description
Serial Number Displays the serial number for the device.
FW Version Displays firmware version number.
MAC address** Displays the TIR-1 Bluetooth MAC address.
* These fields are read-only and cannot be configured by the user.
** The MAC address is displayed on the Bluetooth screen as well as on the TIR-1 label on the
device.
Disconnecting TIR-1 from the Masimo Device
While viewing the Thermometer Info screen:
1. Touch the Forget button.
2. On the Forget Device pop-up window, select the Forget button to confirm.
Note: Select the Cancel button to leave TIR-1 paired to the Masimo device.
www.masimo.com 30 Masimo
Chapter 5: Alarms and Messages
The following information is to be used with the Operator's Manual for Root and Operator's
Manual for Root with noninvasive blood pressure and temperature.
Alarms
When TIR-1 is paired to a Root with noninvasive blood pressure and temperature with the
temperature channel enabled, Unable to handle Temperature: Bluetooth message displays
and a High priority alarm sounds.
This alarm and message indicates that the temperature probe on Root with noninvasive
blood pressure and temperature cannot be used simultaneously with TIR-1 to measure a
patient's temperature. In order to use TIR-1 on Root with noninvasive blood pressure and
temperature, the temperature probe function must be disabled. See Active Channels on page
26.
TIR-1 Messages
The following information is displayed on the TIR-1 display.
Message Explanation Next Step
Low Battery Replace batteries as soon as practical.
Very Low Battery Replace batteries prior to further use.
Ambient temperature
too LOW
Ambient temperature
too HIGH
Sensor error or ambient
temperature unstable
Body Mode temperature
is below 94°F (34.4°C)
Allow TIR-1 to warm to temperature above 50°F (10°).
Allow TIR-1 to cool to temperature below 104°F
(40°C).
•Allow TIR-1 to equilibrate to the current room
temperature for 20 minutes.
•Contact Masimo Support if this error persists.
Remove Sensor Lens cap. Allow patient to warm up in
ambient room temperature above 50°F (10°C).
www.masimo.com 31 Masimo
TIR-1 Thermometer Chapter 5: Alarms and Messages
Message Explanation Next Step
Body Mode temperature
is above 108°F (42.2°C)
• Repeat the temperature.
• If this condition persists, the ambient
temperature of the thermometer may be outside
the acceptable limits. Allow to cool for 20
minutes.
Displayed temperatures
appear to be too low
--
•Remove sensor lens cap. Allow thermometer and
patient to adjust to room temperature for 20
minutes.
•Remove perspiration, oil and makeup from
forehead.
Root Messages
Message Explanation Alarm
Unable to handle
Temperature:
Bluetooth
A TIR-1 is paired, with the
temperature channel
enabled, to a Root with
noninvasive blood pressure
and temperature.
Unable to handle
Temperature:
Internal
The temperature channel is
enabled, with a TIR-1 paired,
to a Root with noninvasive
blood pressure and
temperature.
Priority
High On Root with noninvasive blood
High On Root with noninvasive blood
Next Step
pressure and temperature,
disable the temperature channel
before pairing TIR-1. See Active Channels on page 26.
pressure and temperature,
unpair TIR-1 before enabling the
temperature channel. See
Active Channels on page 26.
www.masimo.com 32 Masimo
The paired device
Chapter 6: Troubleshooting
For information on troubleshooting Root, refer to the Operator's Manual for Root and
Operator's Manual for Root with noninvasive blood pressure and temperature.
Symptom Possible Cause Correction
TIR-1 does not take a
measurement when the
Power/Start Measurement
button is pressed.
Cannot pair TIR-1 to Root.
When the Power/Start
Measurement button is pressed,
a measurement displays on TIR-1
but not on the paired device.
•The batteries in
TIR-1 may be
depleted.
• Internal failure.
•
Bluetooth may be
off.
•TIR-1 may be out
of Bluetooth
range with Root.
• Internal failure.
• TIR-1 may be out
of Bluetooth
range with the
paired device.
•TIR-1 is not
paired to a
device.
•TIR-1 may be
paired to
multiple devices.
•Paired device
Bluetooth may be
turned off.
• Internal failure.
• Replace the batteries in
TIR-1.
•TIR-1 requires service. See
Service and Return
Procedure on page 45.
•Ensure Bluetooth on the
paired device is turned on.
•Ensure TIR-1 is within
range of the paired device
when pairing.
•TIR-1 requires service. See
Service and Return
Procedure on page 45.
•Ensure TIR-1 is within
range of the paired device.
•Ensure TIR-1 is paired with
a device.
•Identify if TIR-1 is paired
with multiple devices.
Either forget (unpair), or
turn Bluetooth off on the
other device(s).
•Ensure Bluetooth on the
paired device is turned on.
•TIR-1 requires service. See
Service and Return
Procedure on page 45.
www.masimo.com 33 Masimo
Chapter 7: Specifications
The following specifications apply to TIR-1 unless otherwise noted. For Root, the following
information is to be used with the content in the Operator's Manual, Root® or the Operator's Manual, Root® with noninvasive blood pressure and temperature.
Display Range
TIR-1
Measurement Mode Display Range
Temperature Body 94˚F to 108˚F
(34.4˚C to 42.2˚C)
Surface 32˚F to 140˚F
(0˚C to 60˚C)
Accuracy not specified below 71.6˚F (22˚C) or above 108˚F (42.2˚C).
TIR-1 with Root
Measurement Display Range
Temperature 94˚F to 108˚F
(34.4˚C to 42.2˚C)
Accuracy
Range Accuracy
96.8˚F to 102.2˚F (36˚C to 39˚C) ±0.4˚F (±0.2˚C)
71.6˚F to 96.7˚F (22˚C to 35.9˚C) ±0.5˚F (±0.3˚C)
102.3˚F to 108.0˚F (39.1˚C to 42.2˚C) ±0.5˚F (±0.3˚C)
www.masimo.com 35 Masimo
TIR-1 Thermometer Chapter 7: Specifications
Body Mode Clinical Accuracy
Temperature
All patient populations. N=295. TIR-1 measuring site is center of
forehead.
Reference Body Site Number of
Subjects
Clinical
Bias (°C)
Limits of
Agreement (°C)
Bias= -0.03°F
(-0.02°C)
Clinical
Repeatability (°C)
Oral (Adults>5 yrs) 170 - 0.11° 0.54° 0.09°
Rectal (Peds<5yrs) 125 0.08° 0.44° 0.08°
•CLINICAL BIAS (Avg. difference between reference thermometer and TIR-1
thermometer)
• LIMITS OF AGREEMENT (LA)
• CLINICAL REPEATABILITY ( r)
• REFERENCE BODY SITE and MEASURING SITE
Resolution
TIR-1 with Root
Parameter Resolution
Temperature 0.1 °F
0.1 °C
Response Time
Response Time
Approx. 1 second
www.masimo.com 36 Masimo
TIR-1 Thermometer Chapter 7: Specifications
Electrical
Battery
Power Two 1.5V "AA" Alkaline Batteries
Battery Life > 10,000 Temperatures (Typical)
Batteries 3V 2XAA
Environmental
Environmental Conditions
Operating Temperature 10˚C to 40˚C (50˚F to 104˚F)
Storage Temperature -20˚C to +60˚C (-4˚F to 140˚F)
Degree of Protection of Electrical Shock This device has been tested and conforms to
ASTM.
Mode of Operation Continuous operation
Protection against harm from liquid
IPX0, None
ingress
Environment Not for use in the presence of flammable
anesthetics.
Wireless Specifications
Communication (Bluetooth)
Modulation Type GFSK
Max Output Power -3.64 dBm
Frequency Range
Antenna Peak Gain 5.16 dBi
Recommended Range 8 to 10 m
Quality of Service 5 to 10 seconds
Security No
www.masimo.com 38 Masimo
TIR-1 Thermometer Chapter 7: Specifications
Radio Compliance
Radio Modes Bluetooth LE
USA TM79030A01
FCC Parts 15.207 and 17.247
Canada RSS-210
Europe EN 300 328
EN 301 489-17
Guidance and Manufacturer's Declaration-Electromagnetic
Emissions
Guidance and Manufacturer's Declarations - Electromagnetic Emissions
The ME Equipment is intended for use in the electromagnetic environment specified below.
The customer or the user of the ME Equipment should assure that it is used in such an
environment.
ME Equipment uses RF energy only for its internal
function. Therefore, its RF emissions are very low and are
not likely to cause any interference in nearby electronic
equipment.
Suitable for use in all establishments, including domestic
environments and those directly connected to the public
low-voltage power supply network that supplies buildings
used for domestic purposes.
Voltage
fluctuations/
Flicker emissions
NA
IEC 61000-3-3
www.masimo.com 39 Masimo
TIR-1 Thermometer Chapter 7: Specifications
Guidance and Manufacturer's Declaration-Electromagnetic
Immunity
Guidance and Manufacturer's Declaration - Electromagnetic Immunity
The ME Equipment is intended for use in the electromagnetic environment specified below.
The customer or the user of the ME Equipment should assure that it is used in such an
environment.
Immunity TestIEC 60601
Electrostatic
discharge (ESD)
IEC 61000-4-2
Electrical fast
transient/ burst
IEC 61000-4-4
Surge
IEC 61000-4-5
Voltage dips, short
interruptions and
voltage variations on
power supply input
lines
IEC 61000-4-11
Test Level
+6 kV
contact
+8 kV air
+/- 2 kV for
power lines
+/- 1 kV for
input/
output
lines
+/-1 kV
line(s) to
line(s)
+/- 2 kV
line(s) to
earth
<5% UT
(>95% dip
in UT) for
0.5 cycles
100% dip
in mains
voltage for
0.5 cycle
60% dip in
mains
voltage for
5 cycle
30% dip in
mains
voltage for
25 cycle
Compliance
Level
+6 kV
contact
+8 kV air
NA Mains power quality should be that of
NA Mains power quality should be that of
NA Mains power quality should be that of
Electromagnetic Environment Guidance
Floors should be wood, concrete or
ceramic tile. If floors are covered with
synthetic material, the relative
humidity should be at least 30%.
a typical commercial or hospital
environment.
a typical commercial or hospital
environment.
a typical commercial or hospital
environment.
www.masimo.com 40 Masimo
TIR-1 Thermometer Chapter 7: Specifications
Guidance and Manufacturer's Declaration - Electromagnetic Immunity
Power frequency (50 /
60 Hz) magnetic
field.
IEC 61000-4-8
3 A/m 3 A/m Power frequency magnetic fields
should be at levels characteristic of
typical location in a typical hospital
environment.
Portable and mobile RF communications equipment should be used no closer to any part of
the ME Equipment, including cables, than the recommended separation distance
calculated from the equation applicable to the frequency of the transmitter.
Immunity Test IEC 60601
Test Level
Conducted RF IEC
3 Vrms NA
Compliance
Level
Recommended separation distance
61000-4-6
Radiated RF IEC
61000-4-3
3 V/m
80 MHZ to
2.5 GHz
150 kHz to 80 MHz
3 V/m
80 MHz to 800 MHz
800 MHz to 2.5 GHz
where P is the maximum output power
rating of the transmitter in watts (W)
according to the transmitter
manufacturer and d is the
recommended separation distance in
meters (m).
Field strengths from fixed RF
transmitters, as determined by an
electromagnetic site survey
a
, should
be less than the compliance level in
each frequency rangeb.
Interference may occur in the vicinity
of equipment marked with the
following symbol:
Note 1: At 80 MHz and 800 MHz, the higher frequency range applies.
www.masimo.com 41 Masimo
TIR-1 Thermometer Chapter 7: Specifications
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is
for
Guidance and Manufacturer's Declaration - Electromagnetic Immunity
affected by absorption and reflection from structures, objects and people.
(a) Field strengths from fixed transmitters, such as base stations for radio
(cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio
broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the
electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey
should be considered. If the measured field strength in the location in which the ME
Equipment is used exceeds the applicable RF compliance level above, the ME Equipment
should be observed to verify normal operation. If abnormal performance is observed,
additional measures may be necessary, such as re-orienting or relocating the ME
Equipment.
(b) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [V1]
V/m.
Symbols
The following symbols may appear on the product or product labeling:
Symbol Description Symbol Description
Follow instructions for use
Caution: Federal (USA) law
restricts this device to sale by or
on the order of a physician
Type BF applied part
Industry Canada identification
Keep dry
Caution
electrical and electronic
equipment (WEEE)
ETL Intertek certification
See Declarations on Page 1
certifications
Authorized representative in
the European community
Federal Communications
Commission (FCC) Licensing
Non-ionizing electromagnetic
radiation
Storage humidity limitation
www.masimo.com 42 Masimo
Separate collection for
TIR-1 Thermometer Chapter 7: Specifications
Symbol Description Symbol Description
Storage temperature range
Manufacturer
Not made with natural rubber
latex
Fragile, handle with care
Date of manufacture
YYYY-MM-DD
Product contains no PVC
(polyvinyl chloride) material
Instructions/Directions for Use/Manuals are available in electronic format
@http://www.Masimo.com/TechDocs
Note: eIFU is not available for CE mark countries.
www.masimo.com 43 Masimo
Chapter 8: Service and Maintenance
Maintenance and Cleaning
• TIR-1 has no user serviceable internal parts except battery replacement.
• Always replace Sensor Cap when not in use.
• Store in a dry location free of dust and away from direct sunlight.
• Use a soft dry cloth to clean the plastic housing or a cloth dampened with a
solution of water and mild detergent. Occasionally, 70% isopropanol solution may
be used.
• Never submerge in liquid.
• The sensor window is recessed to assist in keeping it clean and free of debris.
Inspect the lens and remove any debris. Smudges may be cleaned by gently wiping
the window with a small foam-tipped swab (non-linting) moistened with 70%
Service and Return Procedure
Contact Masimo for product support. If needed, an RMA will be provided for repair or
replacement. Masimo can be reached at 800-326-4890. For customers outside the United
States, local contact information can be found at http://service.masimo.com.
Clean contaminated/dirty equipment before returning per Maintenance and Cleaning
instructions. Make sure the equipment is fully dry before packing. Package the device
securely, in the original shipping box if possible, and enclose the following information and
items:
alcohol. Wait 10 minutes prior to taking temperature.
•Include the RMA form provided, or a letter describing in detail any difficulties
experienced with TIR-1. Include the RMA number in the letter.
•Warranty information, a copy of the invoice or other applicable documentation
must be included. Purchase Order number to cover repair if the thermometer is
not under warranty, or for tracking purposes if it is.
•Ship-to and bill-to information. Person (name, telephone/Telex/fax number and
country) to contact for any questions about the repairs.
•A certificate stating that the thermometer has been decontaminated for
bloodborne pathogens.
•Return the thermometer to Masimo at the address listed in Contacting Masimo on
page 46 below.
www.masimo.com 45 Masimo
TIR-1 Thermometer Chapter 8: Service and Maintenance
Contacting Masimo
Masimo Corporation
52 Discovery
Irvine, California 92618
Tel:+1 949 297 7000
Fax:+1 949 297 7001
Limited Warranty
Masimo warrants to the original end-user purchaser the Masimo-branded hardware product
TIR-1 and any software media contained in the original packaging against defects in material
and workmanship when used in accordance with Masimo’s user manuals, technical
specifications, and other Masimo published guidelines for a period of 12 months from the
original date the Product was obtained by the end-user purchaser.
Masimo’s sole obligation under this warranty is the repair or replacement, at its option, of any
defective Product or software media that is covered under the warranty.
To request a replacement under warranty, Purchaser must contact Masimo and obtain a
returned goods authorization number so that Masimo can track the Product. If Masimo
determines that a Product must be replaced under warranty, it will be replaced and the cost of
shipment covered. All other shipping costs must be paid by purchaser.
Exclusions
The warranty does not apply to any non-Masimo branded product or any software, even if
packaged with the Product, or any Product that was: (a) not new or in its original packaging
when supplied to purchaser; (b) modified without Masimo’s written permission; (c) supplies,
devices, or systems external to the Product; (d) disassembled, reassembled, or repaired by
anyone other than a person authorized by Masimo; (e) used with other products, like new
sensors, reprocessed sensors, or other accessories, not intended by Masimo to be used with
the Product; (f) not used or maintained as provided in the operator’s manual or as otherwise
provided in its labeling; (g) reprocessed, reconditioned, or recycled; and (h) damaged by
accident, abuse, misuse, liquid contact, fire, earthquake or other external cause.
No warranty applies to any Product provided to Purchaser for which Masimo, or its authorized
distributor, is not paid; and these Products are provided AS-IS without warranty.
Limitation of Warranty
Except as otherwise required by law or altered by the purchase agreement, the above warranty
is the exclusive warranty that applies to the Product and software media, and Masimo does
not make any other promises, conditions, or warranties regarding the Product. No other
warranty applies, express or implied, including without limitation, any implied warranty of
merchantability, fitness for a particular purpose, satisfactory quality, or as to the use of
reasonable skill and care. See the licensing terms for the terms and conditions that apply to
and Software accompanying the Product. Additionally, Masimo will not be liable for any
incidental, indirect, special, or consequential loss, damage, or expense arising from the use or
loss of use of any Products or Software. In no event shall Masimo’s liability arising from any
Product or Software (under contract, warranty, tort, strict liability, or otherwise) exceed the
amount paid by purchaser for the Product or Software. The above limitations do not preclude
any liability that cannot legally be disclaimed by contract.
www.masimo.com 46 Masimo
TIR-1 Thermometer Chapter 8: Service and Maintenance
End-User License Agreement
This document is a legal agreement between you (“purchaser”) and Masimo Corporation
(“Masimo”) for the purchase of this Product (“Product”) and a license in the included or
embedded Software (“Software”) except as otherwise expressly agreed in a separate contract
for the acquisition of this Product, the following terms are the entire agreement between the
parties regarding your purchase of this Product. If you do not agree to the terms of this
agreement, promptly return the entire Product, including all accessories, in their original
packages, with your sales receipt to Masimo for a full refund.
Restrictions
1. Copyright Restrictions: The Software and the accompanying written materials are
copyrighted. Unauthorized copying of the Software, including Software that has
been modified, merged, or included with other software, or the written materials is
expressly forbidden. Purchaser may be held legally responsible for any copyright
infringement that is caused or incurred by Purchaser’s failure to abide by the terms
of this Agreement. Nothing in this License provides any rights beyond those
provided by 17 U.S.C. §117.
2. Use Restrictions: Purchaser may physically transfer the Product from one location
to another provided that the Software is not copied. Purchaser may not
electronically transfer the Software from the Product to any other instrument.
Purchaser may not disclose, publish, translate, release, distribute copies of, modify,
adapt, translate, reverse engineer, decompile, disassemble, or create derivative
works based on the Software or the written materials.
3. Transfer Restrictions: In no event may Purchaser transfer, assign, rent, lease, sell,
or otherwise dispose of the Product or the Software on a temporary basis.
Purchaser shall not assign or transfer this License, in whole or in part, by operation
of law or otherwise without Masimo's prior written consent; except that the
Software and all of Purchaser’s rights hereunder shall transfer automatically to any
party that legally acquires title to the Product with which this Software is included.
Any attempt to assign any rights, duties or obligations arising hereunder other
than as set forth in this paragraph shall be void.
4. U.S. Government Rights: If Purchaser is acquiring Software (including the related
documentation) on behalf of any part of the United State Government, the
following provisions apply: the Software and documentation are deemed to be
“commercial software” and “commercial computer software documentation,”
respectively pursuant to DFAR Section 227.7202 FAR 12.212, as applicable. Any
use, modification, reproduction, release, performance, display or disclosure of the
Software (including the related documentation) by the U.S. Government or any of
its agencies shall be governed solely by the terms of this Agreement and shall be
prohibited except to the extent expressly permitted by the terms of this
Agreement.
www.masimo.com 47 Masimo
Index
A
About • 24, 29
About Body Temperature and Fever • 13
About this Manual • 5
Accessing Main Menu Options • 24
Accessing the Thermometer Info Screen •
29
Accuracy • 35
Active Channels • 18, 24, 25, 26, 31, 32
Additional Settings for Temperature • 27,
28
Alarms • 31
Alarms for Temperature • 24, 26, 27
Available Layouts • 25