Operators Manual
64 Pages
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Operators Manual
TIR-1™ Thermometer
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. Manufactured by: TaiDoc Technology Corporation B1-7F, No.127, Wugong 2nd Road, Wugu Dist. 24888 New Taipei City, Taiwan Manufactured for: Masimo Corporation 52 Discovery Irvine, CA 92618, USA Tel.: 949-297-7000 Fax.: 949-297-7001 www.masimo.com EU authorized representative for TaiDoc Technology Corporation: MedNet GmbH Borkstrape 10 48163 Munster, Germany TD-1241
5009094
MEDICAL ELECTRICAL EQUIPMENT WITH RESPECT TO ELECTRIC SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH 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®, Rad-97®, Rad®, 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. © 2022 Masimo Corporation
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Contents About this Manual ---------------------------------------------------------------------------------------------------------------------------------- 5 Product Description, Features and Intended Use ---------------------------------------------------------------------------------------- 5 Safety Information, Warnings and Cautions ----------------------------------------------------------------------------------------------- 7 Chapter 1: Technology Overview ------------------------------------------------------------------------------------------------------------- 11 Chapter 2: Description --------------------------------------------------------------------------------------------------------------------------- 13 Chapter 3: Basic Setup and Use -------------------------------------------------------------------------------------------------------------- 17 Chapter 4: Operation ------------------------------------------------------------------------------------------------------------------------------ 23 Chapter 5: Alarms and Messages ------------------------------------------------------------------------------------------------------------ 39 Chapter 6: Troubleshooting -------------------------------------------------------------------------------------------------------------------- 43 Chapter 7: Specifications------------------------------------------------------------------------------------------------------------------------ 45 Chapter 8: Service and Maintenance -------------------------------------------------------------------------------------------------------- 57
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.
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. This device is an adjusted mode thermometer.
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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.
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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.
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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. 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.
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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. 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
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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.
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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.
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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
7. Room Temperature Indicator
2. Date Indicator
8. Bluetooth indicator
3. Date/Time
9. Memory Mode
4. Temperature Reading
10. Unit of Measurement °F/°C
5. Object Surface Temperature Indicator
11. Error Warning
6. Body Temperature Indicator
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Controls
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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
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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 20.
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
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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 the Masimo device screen.
Installing Batteries 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
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Figure 3
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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 23. TIR-1 defaults to °F temperature scale and BODY mode.
Note: If TIR-1 will be stored for a long period, remove the batteries.
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Body Temperature Measurement
Figure 1
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. •
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 13. 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 13.
5.
If properly paired to a Masimo device, the TIR-1 reading also displays in the Temperature window on the Main Screen. See Temperature Window on page 27.
Figure 2 For additional information on TIR-1 operation such as changing temperature scale and modes, see Chapter 4: Operation on page 23. Note: If temperature is suspected to be incorrect or display reads LO or HI, see TIR-1 Messages on page 39.
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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 31. 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 19. The Bluetooth indicator appears on the display and the Bluetooth LED blinks. See Bluetooth Indicator and LED on page 15.
.
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.
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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 27. Note: TIR-1 can be paired to multiple Masimo devices, however, TIR-1 will only send measurements to the last device it communicated with.
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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 13. 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 13.
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.
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