Masimo TIR-1 Operator's Manual
TIR-1™ Thermometer
Operators Manual
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.
© 2018 Masimo Corporation
www.masimo.com 1 Masimo
Contents
About this Manual ------------------------------------------------------------------------------------------ 5
Product Description, Features and Intended Use ------------------------------------------------------7
Product Description --------------------------------------------------------------------------------------7
Intended Use ---------------------------------------------------------------------------------------------7
Safety Information, Warnings and Cautions ----------------------------------------------------------- 9
Safety Warnings and Cautions ------------------------------------------------------------------------ 9
Performance Warnings and Cautions ---------------------------------------------------------------- 9
Cleaning and Service Warnings and Cautions ---------------------------------------------------- 10
Compliance Warnings and Cautions ---------------------------------------------------------------- 10
Chapter 1: Technology Overview ------------------------------------------------------------------------ 13
About Body Temperature and Fever ---------------------------------------------------------------- 13
Chapter 2: Description ------------------------------------------------------------------------------------ 15
General System Description -------------------------------------------------------------------------- 15
Features -------------------------------------------------------------------------------------------------- 15
Bluetooth Function ------------------------------------------------------------------------------------ 16
Chapter 3: Basic Setup and Use ------------------------------------------------------------------------- 17
Installing Batteries ------------------------------------------------------------------------------------ 17
Body Temperature Measurement -------------------------------------------------------------------- 18
Pairing TIR-1 to a Masimo Device ------------------------------------------------------------------- 18
Chapter 4: Operation -------------------------------------------------------------------------------------- 21
TIR-1 Stand-Alone ------------------------------------------------------------------------------------- 21
TIR-1 with Root ----------------------------------------------------------------------------------------- 23
Chapter 5: Alarms and Messages ----------------------------------------------------------------------- 31
Alarms ---------------------------------------------------------------------------------------------------- 31
TIR-1 Messages ----------------------------------------------------------------------------------------- 31
Root Messages ------------------------------------------------------------------------------------------ 32
Chapter 6: Troubleshooting ----------------------------------------------------------------------------- 33
Chapter 7: Specifications -------------------------------------------------------------------------------- 35
Display Range ------------------------------------------------------------------------------------------ 35
Accuracy ------------------------------------------------------------------------------------------------ 35
Resolution ---------------------------------------------------------------------------------------------- 36
www.masimo.com 3 Masimo
TIR-1 Thermometer Contents
Response Time ----------------------------------------------------------------------------------------- 36
Electrical------------------------------------------------------------------------------------------------- 37
Environmental ------------------------------------------------------------------------------------------ 37
Physical Characteristics ------------------------------------------------------------------------------ 37
Compliance --------------------------------------------------------------------------------------------- 37
Wireless Specifications ------------------------------------------------------------------------------- 38
Guidance and Manufacturer's Declaration-Electromagnetic Emissions ---------------------- 39
Guidance and Manufacturer's Declaration-Electromagnetic Immunity ---------------------- 40
Symbols-------------------------------------------------------------------------------------------------- 42
Chapter 8: Service and Maintenance ------------------------------------------------------------------ 45
Maintenance and Cleaning -------------------------------------------------------------------------- 45
Service and Return Procedure ----------------------------------------------------------------------- 45
Contacting Masimo ------------------------------------------------------------------------------------ 46
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
Loading...