Exergen TemporalScanner TAT-5000S-RS232-CORO User manual

English
EXERGEN
TemporalScanner TM Accurate Temperature with a
Gentle Forehead Scan
1
Operators Manual for
TAT-5000S-RS232-CORO

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.
Whenusing theproduct,basic safetyprecautionsshould always be followed, includingthefollowing:
•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 60° to 104°F (15.5° to 40°C).
•Always store and transport this thermometer in a clean, dry place where it will not become excessively
cold (-4°F/-20°C), or hot (122°F/50°C). 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 and sterilizing 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.
•If you have any additional questions regarding use or care of the thermometer, please see
www.exergen.com or call customer service at [phone].
•BF Applied Part indicates degree of patient protection against electrical shock. The
product is internally battery powered and electrically isolated from earth.
SAVE THESE INSTRUCTIONS.
1

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-5000S-
RS232-CORO LED display will not appear on the Corometrics monitor.
4. Note: The RJ11 connector is not for connection to a phone!
Probe Cone
Probe Lens
ON Button
Automatic turn-off in
30 seconds (when
measuring in body
temperature range,
otherwise 5 seconds)
LED Display Screen
Battery
Compartment
9-volt battery
Pinhole
Battery Compartment
Door
F/C switch
RJ11 Modular Plug
2

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 costs by
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, touch
behind 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.
3

2-Step Infant Temperature Measurement
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.
Step 2
Release button
remove from
head and read.
How to improve the accuracy of your measurements on infants
The preferred site is the
temporal artery area. Unless
visibly diaphoretic, one
measurement here is
typically all that is required
If the temporal artery is
covered, then the area
behind the ear, if exposed,
can be an alternate site.
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.
Brush the hair aside if
covering the area to be
measured. Measurement
site must be exposed.
3-Step Adult Temperature Measurement
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.
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.
Step 3
Release button and read.
How to improve the accuracy of your measurements on adults
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.
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.
Measure exposed skin.
Brush the hair and bangs
aside if covering the area
to be measured.
4

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 1°F (0.5°C) higher thanan oral temperature and 2°F (1°C) higher thanan 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 Arterial/Oral and has a serial number beginning with “O” (standardmodel start with “A”), it is programmed
to computethe normal averagecooling effect at the mouth, and
automatically reduces the higher arterial temperature by that amount.
This
calibration allows the hospital to maintainexisting protocolsfor fever workupsbased on oral temperature, and results in a reading
consistent with the 98.6°F (37°C) mean normal oral temperature, in the range of 96.6 - 99.5°F (35.9 - 37.5°C) 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 Temporal Scanner; a correct reading will be reproducible.
• Repeat the reading with another Temporal Scanner. Two Temporal Scanners 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.
Type of abnormal
Temperature Possible cause Helpful hint
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:
Condition Display Range
High Target HI >110 oF (43 oC)
Low Target LO <61 oF (16 oC)
High Ambient HIA >104 oF (40 oC)
Low Ambient LO A <60 oF (16 oC)
Low Battery bAtt
Dead Battery blank display
Processing Error Err Restart. Return to
Exergen for repair if error
message persists.
Scanning
(Normal Operation)
SCAN
5

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.
•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.
•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.
•Disinfection: The industrial grade housing and design of the electronic components allow for
completely safe disinfecting with 70% isopropyl alcohol. Do not immerse. Do not autoclave.
•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.
•Remove the screwdriver.
•Replace cover.
CLEANING
INSTRUCTIONS
F/C Switch
6

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
61000-4-3
3Vrms
150 kHz to 80 MHz
Not applicable
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*P
1/2
d=1,2*P1/2 80 MHz to 800MHz
d=1,2*P1/2 800MHz 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 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
3V/m
80 MHz to 2,5 GHz
3V/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.
d. ESD compliance has been verified by testing. Intertek Report Number 102297230BOX-001.
7

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
6KV contact 8KV air 6KV contact 8KV 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
3A/m 3A/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
8

Recommended separation distances between Portable and mobile RF communication equipment and the TAT 5000S Series
The TAT 5000S series forehead thermometer is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled or the user of the TAT 5000S series thermometer can help prevent electromagnetic interference by
maintaining a minimum distance between portable and mobile RF communications equipment (transmitters)and the TAT 5000S
series thermometer as recommended below, according to the maximum output power of the communications equipment.
Rated maximum output power
of transmitter
(W)
Separation distance according to frequency of transmitter
m
150 KHz to 80 MHz
d=1,2 P
1/2
80 MHz to 800 MHz
d=1,2 P
1/2
800 MHz to 2,5 GHz
D=2.3 P
1/2
0,01 0,12 0,12 0,23
0,1 0,38 0,38 0,73
11,2 1,2 2,3
10 3,8 3,8 7,3
100 12 12 23
For transmitters rated at a maximum output power not listed above, the recommended separation distance din meters (m) can be
estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter manufacturer.
Note 1 At 80 MHz and 800 MHz the separation distance for the higher frequency 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.
9

Specifications
TAT-5000S-RS232-CORO
Clinical Accuracy
± 0.2°F or 0.1°C
Per ASTM E1112
Temperature Range
61 to 110°F (16 to 43°C) ***
Arterial Heat Balance Range
for Body Temperature *
94 to 110°F (34.5 to 43°C)
Operating Environment
60 to 104°F (16 to 40°C)
Resolution
0.1°F or C
Response Time
~0.04 seconds
Battery Life
15,000 readings **
Time Displayed On Screen
30 seconds
Size
Instrument : 7.9" X 1.8" X 1.6" (20 cm X 4.6 cm X 4.1 cm)
Cable : 12' (3.7 m)
Weight
0.86 lb (390 g)
EMI and RFI Protection
Stainless steel enclosure on upper part inside of casing
Storage Conditions
-4 to 122°F (-20 to 50°C)
Display Type and Size
Large bright LED's
Construction Method
•Industrial duty impact resistant casing
•Chemically resistant casing and lens
•Hermetically sealed sensing system
•
Stainless steel probe
Warranty
Lifetime
*Automatically applied when
temperature is within normal body
temperature range, otherwise
reads surface temperature.
** Approximate number of readings when scanning for 5 seconds and
reading the temperature display for 3 seconds before turning
thermometer off.
*** 16 C rounded up from 15.5 C.
Repair
If repair is required:
• Contact Exergen at [phone] or [e-mail] for a Return Materials
Authorization (RMA) Number and method for no-cost shipping.
• Mark the RMA number on the outside of your package and packing slips.
• Include a description of the fault if possible.
• Send the instrument to:
Exergen Corporation
400 Pleasant Street
Watertown, MA 02472 USA
• Include the address the instrument should be returned to.
10

Symbol for Date of Manufacture
Symbol for Manufacturer
Degree of Protection Against Electrical Shock
Defibrillation-Proof Type BF Applied Part, Battery Operated
Attention, Consult Accompanying Documents
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 .
IPX0
Ordinary Equipment
MEDICAL EQUIPMENT
WITH RESPECT TO ELECTRICAL SHOCK
FIRE AND MECHANICAL HAZARDS ONLY
CONFORMS TO AAMI STD E6061-1, ISO STD 80601-2-56,
IEC STDS 60601-1, 60601-1-6 & 62366
EC REP
QHI Group LTD
Talisman House
Coldharbour Lane
Harpenden
Hertfordshire
AL5 4UT
UK
EXERGEN
Straight From the Hearto
EXERGEN CORPORATION • 400 PLEASANT STREET • WATERTOWN, MA 02472 • PH [phone]
www.exergen.com
5001979
PN 818770 Rev 2