TAT-5000S-RS232-CORO Exergen Temporal Scanner User Manual

TAT-5000S-RS232-CORO Exergen Temporal Scanner

Important Safety Instructions

READ ALL INSTRUCTIONS BEFORE USING

Intended Use: The Exergen TemporalScanner is a handheld infrared thermometer used by medical professionals for the intermittent measurement of human body temperature of people of all ages, by scanning the forehead skin over the temporal artery. Intended users are physicians, nurses, and nursing assistants at all levels who normally provide patient care. The thermometer provides a peak temperature reading from plural readings during the step of scanning. Electronic circuitry processes the measured peak temperature to provide a temperature display based on a model of heat balance relative to a detected arterial temperature, the electronic circuitry computing an internal temperature of the body as a function of ambient temperature (Ta) and sensed surface temperature.

Training materials that are supplementary to this instruction manual are available at www.exergen.com/s, and recommended for first time users. The TAT-5000S series thermometers are used by medical professionals in clinical environments. Such medical professionals include physicians, nurses, nurse’s aides, patient care technicians, and others who are trained to take the temperature of patients. Clinical environments include areas where medical professionals are providing medical services for patients, including hospitals, outpatient clinics, primary care offices, and other settings where temperature is taken as part of patient care. Additionally, the TAT-5000S series thermometers are not for use aboard aircraft or near High Frequency Surgical Equipment or Radio Frequency shielded rooms, such as MRI (Magnetic Resonance Imaging) areas. When using the product, basic safety precautions should always be followed, including the following:

• Use this product only for its intended use as described in this manual.

• Do not take temperature over scar tissue, open sores, or abrasions.

• The operating environmental temperature range for this product is 16° to 40°C (60.8° to 104°F).

• Always store and transport this thermometer in a clean, dry place where it will not become excessively cold (-20°C /-4°F), or hot (50°C /122°F). Relative humidity 93% Maximum non-condensing, atmospheric pressure 50 kPa to 106 kPa.

• The thermometer is not shockproof. Do not drop it or expose it to electrical shocks.

• Do not autoclave. Please note cleaning procedures in this manual.

• Do not use this thermometer if it is not working properly, if it has been exposed to
  temperature extremes, damaged, been subject to electrical shocks or immersed in water.

• There are no parts that you can service yourself except for the battery, which you should replace when low by following the instructions in this manual. For service, repair, or adjustments, return your thermometer to Exergen. Warning: No modification of this equipment is allowed.

• Never drop or insert any object into any opening, unless stated in this manual.

• If your thermometer is not used regularly, remove the battery to prevent possible damage due
  to chemical leakage.

• Follow the battery manufacturer’s recommendations or your hospital policy for the disposal of used batteries.

• Not suitable for use in the presence of flammable anesthetic mixtures.

• Communication cables for the TAT-5000S that are field replaceable are specific to the model and patient monitor. Only compatible cables may be used, to maintain compliance of the TAT-5000S thermometers with requirements for Emissions and Immunity.

• If the device fails to operate as described above, see the FAQ section of this manual. Additionally, ensure that you are not in the presence of electromagnetic disturbances.

• If you have any additional questions regarding use or care of the thermometer, please see www.exergen.com or call customer service at 1-617-923-9900.

Defibrillation-proof type BF Applied Part indicates degree of patient protection against electrical shock. The product is internally battery powered and electrically isolated from earth.

WARNING: Use of this equipment adjacent to or stacked with other equipment (other than TAT-5000S compatible patient monitors) should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally.

WARNING: Use of accessories, transducers and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation.

WARNING: Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the TAT-5000S thermometer, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.

Product Map of the Exergen

Temporal Scanner TAT-5000S-RS232-CORO

Instructions for TAT-5000S-RS232-CORO

Instruction for use of TAT-5000S-RS232-CORO with GE Corometrics Maternal/Fetal Monitor (selected models only. Consult your GE Corometrics Maternal/Fetal Monitor User Manual.) The TAT-5000S-RS232-CORO is permanently attached to the adapter cable with the RJ11 modular plug, via a D-sub connection. The adapter cable should not be removed under any circumstance. Do not touch the patient and the D-sub connector simultaneously.

1. Connect the RJ11 modular plug into the back of the Corometrics monitor (Consult your GE Corometrics Maternal/Fetal Monitor User Manual to determine which modular jack to use).
2. Use the TAT-5000S-RS232-CORO as described. The temperature information will be sent to the monitor automatically and appear on the printout (provided the printing function is enabled). The temperature will also appear on the display of the monitor. Consult your GE Corometrics Maternal/Fetal monitor for proper software setup.
3. Error messages (HI, LO, HI A, LO A, bAtt and Err) that appear on the TAT-5000SRS232- CORO LED display will not appear on the Corometrics monitor.
4. Note : The RJ11 connector is not for connection to a phone!

Introduction to Temporal Artery Thermometry

Temporal artery thermometry (TAT) is a unique method of temperature assessment, using infrared technology to detect the heat naturally emitting from the skin surface. In addition, and of key importance, this method incorporates a patented arterial heat balance system to automatically account for the effects of ambient temperature on the skin. This method of temperature assessment has been shown to improve results and reduce costsby non-invasively measuring body temperature with a degree of clinical accuracy unachievable with any other thermometry method.

Before Using, Familiarize Yourself with the Instrument

• To Scan : Depress the red button. The instrument will continually scan for the highest temperature (peak) as long as the button is depressed.
• Clicking : Each fast click indicates a rise to a higher temperature, similar to a radar detector. Slow clicking indicates that the instrument is still scanning, but not finding any higher temperature.
• To Retain or Lock Reading : The reading will remain on the display for 30 seconds after button is released. If measuring room temperature, the temperature will remain on the display for only 5 seconds.
• To Restart : Depress the button to restart. It is not necessary to wait until the display is clear, the thermometer will immediately begin a new scan each time the button is depressed.

Basics of Using the TemporalScanner

1. Measure only the exposed side. Brush hair aside if covering the Temporal Artery area. With probe flush on the center of forehead, depress red button, keep depressed
2. Slowly slide probe straight across forehead to the hair line, not down side of face
3. Brush hair away if covering ear. Keeping the button depressed, lift probe from forehead, touchbehind ear halfway down the mastoid process and slide down to the soft depression behind the earlobe.
4. Release the button, read, and record temperature.

Alternate sites when temporal artery or behind ear are unavailable:

• Femoral artery : slowly slide the probe across groin.
• Lateral thoracic artery : slowly scan side-to-side in the area midway between the axilla and the nipple

2-Step Infant Temperature Measurement

1. Step 1 Place probe flush on center of forehead and depress button. Keeping button depressed, slowly slide probe mid-line across forehead to the hair line.
2. Step 2 Release button remove from head and read.

How to improve the accuracy of your measurements on infants

1. The preferred site is the temporal artery area. Unless visibly diaphoretic, one measurement here is typically all that is required
2. If the temporal artery is covered, then the area behind the ear, if exposed, can be an alternate site
3. Measure straight across the forehead and not down side of face. At mid-line, the temporal artery is about 2 mm below the surface, but can go deeply below the surface on the side of the face.
4. Brush the hair aside if covering the area to be measured. Measurement site must be exposed.

3-Step Adult Temperature Measurement

1. Step 1 Slide across forehead. Place probe flush on center of forehead and depress button. Keeping button depressed slowly slide probe mid-line across forehead to the hair line
2. Step 2 Slide behind ear. Keeping button depressed, lift probe from forehead, touch behind ear halfway down the mastoid process and slide down to the soft depression behind the earlobe
3. Step 3 Release button and read.

How to improve the accuracy of your measurements on adults

1. Measure only the up-side on a patient in a lateral position. The down-side will be insulated preventing the heat from dissipating, resulting in falsely high readings.
2. Think of a sweatband. Measure straight across the forehead and not down the side of the face. At mid-line, the temporal artery is about 2 mm below the surface, but can go deeply below the surface on the side of the face.
3. Measure exposed skin. Brush the hair and bangs aside if covering the area to be measured

FAQs

How does the temperature from a temporal scanner relate to core temperature?
Temporal artery temperature is considered a core temperature because it has been demonstrated as accurate as the temperature measured by a pulmonary artery and esophageal catheter, and as accurate as a rectal temperature on a stable patient. Rule of thumb: Rectal temperature is about 0.5°C (0.9°F) higher than an oral temperature and 1°C (1.8°F) higher than an axillary temperature. It will be easy to remember if you think of core temperature as a rectal temperature, and apply the same protocol you would use for a rectal temperature. If your thermometer is marked Oral Calibration and has a serial number beginning with “O” (standard model starts with “A”), it is programmed to compute the normal average cooling effect at the mouth, and automatically reduces the higher arterial temperature by that amount. This calibration allows the hospital to maintain existing protocols for fever workups based on oral temperature, and results in a reading consistent with the 37°C (98.6°F) mean normal oral temperature, in the range of 35.9 – 37.5°C (96.6 – 99.5°F) you now see.

What should I do if I get an abnormally high or low reading, how do I confirm my reading?

• Repeat the reading with the same TemporalScanner; a correct reading will be reproducible.
• Repeat the reading with another TemporalScanner. Two TemporalScanners with the same reading will confirm the reading.
• Sequential readings on the same patient in rapid succession will cool the skin; it is best to wait about 30 seconds for the skin to recover from the cold probe.

Possible causes of abnormal readings.

Abnormally low Temperature

| Dirty Lens| Clean lens of scanner every two weeks.
Releasing the button before finished measuring| Release the button after finished measuring.
Measuring when an ice pack or wet compress is on the forehead| Remove ice pack or wet compress, wait 2 minutes, and re- take temperature.

Measuring a completely diaphoretic patient

| Complete diaphoresis includes diaphoresis of area behind the ear and suggests that the temperature is rapidly dropping.

Use an alternative method of temperature measurement in these cases until the patient is dry and the temporal artery measurement can be repeated.

Improperly scanning down the side of the face| Scan straight across forehead. The temporal artery is closest to skin in that area.

Abnormally high temperature

| Anything covering the area to be measured would insulate and prevent heat from dissipating, resulting in false high readings.| Confirm measurement site has not recently been in contact with heat insulators such as hats, blankets, and hair.

Scan the area not covered or wait about 30 seconds for the previously covered area to equilibrate to the environment.

DISPLAY DIAGNOSTICS CHART
The following chart summarizes the conditions that may occur while the TemporalScanner is in use, and the associated indications:

persists.
Scanning

(Normal Operation)

| – – – –|

Care and Maintenance

• Battery: A standard alkaline 9V battery provides approximately 15,000 readings. To replace, insert the end of a bent
  paper clip into the pinhole on the side of the unit to release the battery compartment door. Disconnect the old battery and replace with a new one in the same location. Replace the cover. See pictures below. Use only high quality alkaline
  batteries. (Approximate number of readings when scanning for 5 seconds and reading the temperature display for 3
  seconds before turning thermometer off)

• Handling: The TemporalScanner is designed and built to industrial durability standards in order to provide long and trouble-free service. However, it is also a high precision optical instrument, and should be accorded the same degree of care in handling as you would provide other precision optical instruments, such as cameras or otoscopes.

• Cleaning the case : The TemporalScanner case can be wiped down using a cloth dampened with 70% isopropyl alcohol. The industrial grade housing and design of the electronic components allow for completely safe cleaning with 70% isopropyl alcohol, but should not be immersed or autoclaved.

• Cleaning the sensor lens : With normal use, the only maintenance required is to keep the lens on the end of the probe clean. It is made of special mirror-like, silicon infrared-transmitting material. However, dirt, greasy films or moisture on the lens will interfere with the passage of infrared heat and affect the accuracy of the instrument. Regularly clean the lens with a cotton swab dampened with an alcohol wipe. Use only light force for cleaning, to avoid damaging the lens. Water can be used to remove any residual film left by the alcohol. Do not use bleach or other cleaning solutions on the sensor lens. Use 70% isopropyl alcohol.

• Calibration : Factory calibration data is installed via a computer which communicates with the TemporalScanner’s microprocessor. The instrument automatically self-calibrates each time it is turned on using this data, and will never require recalibration. If readings are not correct, the instrument should be returned for repair. See page 11 for the return process.

Instructions for Fahrenheit or Celsius Conversion
The TemporalScanner can be used in either °F or °C. The TemporalScanner will come preset based on your preference at the time of purchase. To convert from one scale to the other, the only tools necessary are a paper clip and the tip of a small screwdriver.

For °F/°C Conversion:

• Insert the end of a bent paper clip into the pinhole on the side to release and remove the cover. Remove the battery from the compartment. See pictures above.
• Locate the switch, and with the tip of a screwdriver, slide left or right to the opposite position.
• Replace cover.

Guidance and manufacturer’s declaration-electromagnetic emissions

The infrared forehead thermometer model TAT-5000S series is intended for use in the electromagnetic environment specified below. The user of the TAT-5000S series should assure that it is used in such an environment.
Emissions test| Compliance| Electromagnetic environment- guidance

RF emissions CISPR 11

|

Group 1

| The TAT-5000S series thermometer uses no RF energy therefore any emissions are unlikely to cause any interference in nearby electronic equipment
RF emissions CISPR 11| Class B|

The TAT-5000S series thermometer is suitable for use by a healthcare professional in a typical health care environment.

Harmonic emissions| Not applicable
Voltage fluctuations| Not applicable
Guidance and manufacturer’s declaration-electromagnetic immunity

The TAT-5000S series thermometer is intended for use in the electromagnetic environment specified below. The user of the TAT- 5000S series should assure that it is used in such an environment.
Immunity test| IEC 60601 test level| Compliance level| Electromagnetic environment-guidance

Conducted RF IEC

61000-4-6

|

3Vrms

150 kHz to 80 MHz

|

3Vrms

| Portable and mobile RF communications equipment should be used no closer to any part of the TAT-5000S series including cables if applicable, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Recommended separation distance

d=1,2*P1/2

d=1,2P1/2 80 MHz to 800MHz d=1,2P1/2 800MHz

to 2,7 GHz

Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters(m).

Field strength from the fixer RF transmitters, as determined by an electromagnetic site survey, a. should be less than the compliance level in each frequency range and b. interference may occur in the vicinity of equipment with the following symbol:

Radiated RF IEC

61000-4-3

|

10V/m

80 MHz to 2,7 GHz

|

10V/m

Note 1 At 80MHz and 800MHz, the higher range applies.

Note 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people.

a.     Field strengths from fixed transmitter, 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 strengths in the location in which the TAT-5000S series thermometer is used exceeds the applicable RF compliance level above, the TAT- 5000S series thermometer should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the TAT-5000S.

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

c.     Portable and mobile RF communications equipment can affect performance.

Guidance and manufacturer’s declaration-electromagnetic immunity (cont.)

The TAT-5000S series thermometer is intended for use in the electromagnetic environment specified below. The user of the TAT- 5000S series should assure that it is used in such an environment.
Immunity test| IEC 60601 test level| Compliance level| Electromagnetic environment-guidance
Electrostatic discharge

(ESD) IEC61000-4-2

|

8kV contact 15kV air

|

8kV contact 15kV air

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

IEC 61000-4-4

| 2kV for power supply lines 1kV for input output lines|

Not applicable

|

Mains power quality should be that of a typical health care environment.

Surge IEC 61000-4-5| 1kV line(s) to line(s)

2kVline(s) to earth

|

Not applicable

| Mains power quality should be that of a typical health care environment.

Interruptions and voltage variations on power supply Input lines

IEC 61000-4-

11

| <5% UT

(>95% dip in UT) for 0,5 cycle

40% UT

(60% dip in UT) for 5 cycles

70% UT

(30% dip in UT) for 25 cycles

< 5% UT

(>95% dip in UT) for5 sec.

|

Not applicable

|

Mains power is not applicable. The TAT-5000S series is powered by battery and battery

only.

Power frequency (50/60 Hz)

magnetic field

IEC 61000-4-8

|

30A/m

|

30A/m

|

Power frequency magnetic fields should be at the level characteristic of a typical location in a typical health care environment.

Note UT is the a.c. mains voltage prior to the application of the test level
Specifications| TAT-5000S-RS232-CORO
---|---
Clinical Accuracy| ± 0.1°C or 0.2°F Per ASTM E1112
Temperature Display Range| 15.5 to 43.3°C (60.0 to 110°F)
Arterial Heat Balance Range for Body Temperature *| 34.5 to 43°C (94 to 110°F)
Operating Environment| 16 to 40°C (60.8 to 104°F)
Resolution| 0.1° C or F
Response Time| ~0.04 seconds
Battery Life| 15,000 readings **
Time Displayed On Screen| 30 seconds
Size| Instrument: 21 cm X 5 cm X 4 cm (8.3″ X 1.8″ X 1.5″)

Cable: 3.6 m (12′)

Weight| 0.40 kg (0.89 lb)
EMI and RFI Protection| Alloy cast enclosure on upper part inside of casing
Storage Conditions| -20 to 50°C (-4 to 122°F)
Display Type and Size| Large bright LEDs

Construction Method

| ·         Industrial duty impact resistant casing

·         Chemically resistant casing and lens

·         Hermetically sealed sensing system

·         Alloy cast head

Warranty| Lifetime

Automatically applied when temperature is within normal body temperature range, otherwise reads surface temperature.

Repair

If repair is required:

• Contact Exergen at 1-617-923-9900 or repairs@exergen.com for a Return Materials Authorization (RMA) Number.

• Mark the RMA number on the outside of your package and packing slips.

• Include a description of the fault.

• Send the instrument to:
  Exergen Corporation 400 Pleasant Street Watertown, MA 02472 USA

• Include the address the instrument should be returned to.

Symbol for Manufacturer

Degree of Protection Against Electrical Shock

Defibrillation-Proof Type BF Applied Part, Battery Operated

Caution
Consult Instructions for Use
“On” (only for part of Equipment)
Do not throw this device away in the trash, contact Exergen Corp. for disposal and recycling instructions.
Ordinary Equipment
MEDICAL EQUIPMENT

ANSI/AAMI/ES60601-1: 2005/(R)2012 3rd Edition including Amendment 1; CAN/CSA-C22.2 No. 60601.1:2014; IEC 60601-1-6;

ISO 80601-2-56: Particular Requirements for Basic Safety and Essential Performance of Clinical Thermometers For Body

Temperature Measurement

EMERGO EUROPE Prinsessegracht 20 2514 AP The Hague The Netherlands EXERGEN CORPORATION 400 PLEASANT STREET WATERTOWN, MA 02472, USA PH 617-923-9900 www.exergen.com

References

• Home Page - Exergen Corporation
• Home Page - Exergen Corporation
• World Wide Virtual Classroom - Exergen Medical

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