Download Tempa-DOT Single-Use Clinical Thermometer Instructions and Safety Information and more Study notes Pediatrics in PDF only on Docsity!
HEAT POCKETS
98.O
98.O 98.
98.O
101
100
102 103 104
96
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97 98 99
101
100
102 103 104
96
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97 98 99
1. Open Package
Fold along perforation and tear off a single Tempa•DOT Thermometer strip. Peel back top of wrapper to expose handle of thermometer. Remove thermometer by pulling exposed handle.
2. Insert Thermometer
Place thermometer into patient’s mouth under tongue, as far back as possible into either heat pocket, as you would any oral thermometer (see diagram). Generally, adult lips should touch the middle of the Tempa•DOT logo. The dots can face either up or down. Have patient press tongue down on thermometer while keeping mouth closed.
**3. Wait 60 Seconds, but less than 2 minutes
- Remove Thermometer**
Before reading, wait approximately 10 seconds for dots to lock in.
5. Read Temperature
The last blue dot on the matrix indicates the correct temperature.
6. Discard Thermometer
Reminder
Before taking oral temperatures, wait at least 15 MINUTES:
- After ingesting hot or cold food or drink
- After exposure to extremely hot or cold weather.
- After smoking
How to
Use the
Single-Use
Clinical Thermometer
HOW TO READ
ORAL USE
The last blue dot indicates the correct temperature
This example reads 98.6° Fahrenheit This example reads 100.4° Fahrenheit
Also available in Celsius.
How to
Use the
Single-Use
Clinical Thermometer
AXILLARY USE
RECTAL USE - Tempa•DOT PLUS THERMOMETER
1. Open Package
Fold along perforation and tear off a single Tempa•DOT® Thermometer strip. Peel back top of wrapper to expose handle of thermometer. Remove thermometer by pulling exposed handle.
2. Insert Thermometer
Place thermometer high in the axilla with the dot matrix side against the torso and parallel to the length of the body (see diagram). Use the patient’s arm to hold thermometer in place.
**3. Wait 3 Minutes, but less than 5 minutes
- Remove Thermometer**
Before reading, wait approximately 10 seconds for dots to lock in.
5. Read Temperature
The last blue dot on the matrix indicates the correct temperature.
6. Discard Thermometer 1. Open Package
Remove Tempa•DOT®^ PLUS Thermometer from the dispenser on top of the box. Do not remove the plastic sheath.
2. Insert Thermometer
Lubricate thermometer and insert into rectum until the dot matrix and numbers are completely covered.
**3. Wait 3 Minutes, but less than 5 minutes
- Remove Thermometer**
Withdraw thermometer and sheath from rectum and discard sheath. Wait approximately 10 seconds for dots to lock in.
5. Read Temperature
The last blue dot on the matrix indicates the correct temperature.
CAUTION: Any object inserted into the rectum could cause perforation. 6. Discard Thermometer.
DO NOT USE FORCE. Axillary method is recommended by the American
academy of Pediatrics for infants.
STORAGE INFORMATION:
Store Tempa•DOT Single-Use Clinical Thermometer in an area where temperatures do not exceed 95°F.
When exposed to high temperatures, matrix dots will turn blue. If this occurs:
- Place in freezer for one hour per box of 100.
- Let stand at room temperature for one day.
- Thermometers are now ready for use.
This process will not affect the accuracy of the thermometers.
101101102103104
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MATRIX
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Temperature offset - When tested in vitro in a controlled-tempera-
ture water bath, the thermometer will read 0.6°F (0.3°C) higher than
the actual temperature of the water. This is because of its “tempera-
ture offset,” which compensates for the difference in heat-transfer
characteristics between sub-lingual tissues and a water bath. The
temperature sensor incorporates a consistent temperature offset
of +0.6°F (+0.3°C) throughout the recording range. This special
thermometric design facilitates accurate in vivo measurement of oral
temperature in 60 seconds.
Efficacy studies - In vivo accuracy of Tempa•DOT Single-Use
Clinical Thermometers was evaluated in a special study at the Amer-
ican Enka Medical Center, Enka, North Carolina. The Tempa•DOT
Thermometer was compared to glass-mercury thermometers
selected for their higher-than-normal accuracy. This study involved
376 patients and 1,500 temperature measurements. Based on this
study, it was concluded that in a reasonably conditioned mouth, the
accuracy of the Tempa•DOT Thermometer is equivalent to that of
the glass-mercury thermometers used in the study. In this study, a
mean temperature difference of less than 0.1°F was noted.
In a second study,^1 the temperatures of 95 hospital patients were
measured for 3 minutes with a calibrated glass-mercury thermom-
eter. This was followed by a 60-second reading with a Tempa•DOT
Thermometer, and another 3-minute glass-mercury thermometer
reading. The average temperatures were 98.00°F, 98.12°F and
98.06°F, respectively. Analysis revealed no statistical differences
between the average temperatures obtained by these two types of
thermometers. Copies of other accuracy studies done by indepen-
dent institutions are available upon request.
Accuracy - When tested in accordance with the manufacturer’s
methodology, the mean accuracy of the Tempa•DOT Single-Use
Clinical Thermometer will be within 0.2°F (0.1°C) for all of the
temperature dots on the thermometer.
The Tempa•DOT Thermometer conforms to the accuracy require-
ments specified in ASTM specification E 825-98 (Reapproved 2009)
for disposable fever thermometers.
This accuracy standard is the same as that for glass thermometers.
Test method and lot acceptance criteria - Due to the destructive
nature of accuracy tests, statistically valid samples (usually between
315 and 500 thermometers per manufacturing lot) are tested in
water baths at 20 points distributed throughout the thermometer
scale. One thermometer is used per datum point. Lot acceptance is
based on a 4% AQL.
NOTE: To compensate for the temperature offset, 0.6°F (0.3°C) is
added to the temperature of each water bath.
From concept to reality - The Tempa•DOT Single-Use Clinical
Thermometer represents the culmination of many years of intensive
research and development to incorporate this thermometric tech-
nique into a product that is accurate, safe, stable, easy to use, and
economical. It is a story of hundreds of progressive modifications
and refinements not only in the chemistry and crystallography of
the temperature-sensitive indicating system but also in the physical
design and selection of suitable materials for the instrument and its
package.
Fahrenheit Scale Celsius Scale
Maximum Maximum
Range Error Range Error
Below 98.0°F ±0.4°F 35.8°C to 36.9°C ±0.2°C
98°F to 102°F ±0.2°F 37.0°C to 39.0°C ±0.1C
Above 102°F ±0.4°F 39.1°C to 40.4°C ±0.2°C
Directions for use - Recording and reading oral temperatures with
the Tempa•DOT Single-Use Clinical Thermometer is an extremely
simple procedure, but to assure most accurate results it must be
done In accordance with directions.
- Remove thermometer from wrapper. Peel back top of wrapper
to expose handle end of thermometer. Remove thermometer by pulling exposed handle, taking care not to touch the dot matrix portion which is to be placed in the patient’s mouth.
- Place thermometer under tongue. Insert thermometer into
patient’s mouth under tongue as far back as possible into either heat pocket. Indicator dots may face either up or down. Have patient press tongue down on thermometer while keeping mouth closed. Remove after 60 seconds.
- Read temperature. Wait approximately 10 seconds for dots to
stabilize. The last blue dot on the matrix indicates the correct temperature. Discard thermometer.
Attention to proper usage - Since the Tempa•DOT Thermometer is
highly sensitive, failure to register accurate temperature may result
from:
- Improper placement in the mouth - be sure to place the
thermometer at the base of the tongue as far back as possible on either side.
- Failure of patient to keep mouth closed for 60 seconds without
displacing the thermometer by movement of tongue.
- Inadequate thermometer placement time - less than 60 seconds.
- Failure to wait at least 10 seconds for dots to stabilize after
removal.
METHOD OF USING Tempa•DOT
SINGLE-USE CLINICAL THERMOMETER
- Exposure to cold weather, smoking, eating or drinking - wait at
least 15 minutes before inserting thermometer so that mouth
temperature may stabilize.
- Prolonged thermometer placement time - longer than
2 minutes
In rare instances, a dot may not “fire” (change to blue). Always read
the last dot that has fired as the correct temperature.
Rectal temperature taking - The Tempa•DOT Single-Use Clinical
Thermometer is designed primarily for oral temperature mea-
surement. Rectal temperatures can be obtained in 3 minutes by
using the Tempa•DOT PLUS Single-Use Clinical Thermometer in
accordance with the instructions included in the package. Axillary
temperatures are recommended for children under one year of age.
Axillary temperature taking - The Tempa•DOT Thermometer is
completely suited to taking axillary temperatures whenever oral use
is not feasible (e.g., in young children, comatose patients, patients
with recent oral or jaw surgery). In this use, the sensor tip should
be placed into the axilla with the dot matrix side against and parallel
to the length of the body and held in place by the arm for 3 minutes.
Temperatures recorded in this manner may be about 0.5°F lower
than oral temperatures and as much as 1.0°F lower than rectal
temperatures.
This variation also holds true for glass-mercury thermometers since
it is not a function of the method of temperature measurement, but
is, instead, related to the lower thermal security of the axillary site.
HEAT POCKETS 98.4 98.
98.O
98.O 98.
98.O
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MATRIX
TECHNICAL SPECIFICATIONS
Length 91 millimeters
Width of sensor matrix 9 millimeters
Temperature range Fahrenheit thermometer:
96.0° to 104.8°
Celsius thermometer:
35.5° to 40.4°
Temperature Fahrenheit thermometer: 0.2°
increments from one Celsius thermometer: 0.1°
dot to the next
Matrix arrangement Fahrenheit thermometer:
Two arrays-one of 4 rows x
5 dots measures temperatures
from 96.0° to 99.8°, the other of
5 rows x 5 dots measures
temperatures from 100.0° to 104.8°.
Celsius thermometer:
Two arrays-one of 5 rows x 5 dots
measures temperatures from 35.5°
to 37.9°; the other of 5 rows x 5 dots
measures temperatures from 38.0°
to 40.4°.
Sterility Extensive precautions are taken
during the manufacturing process
to guard the sterile integrity of the
Tempa•DOT Single-Use Clinical
Thermometer. Thermometers are
sterilized by cobalt-60 gamma
irradiation to assure sterility for
patient protection. Tempa•DOT
Thermometers are also available in
non-sterile form.
Storage Avoid excessive heat and humidity.
Store in cool area (below 86°F/30°C).
Warning: Exposure to temperatures
greater than 95°F (35°C) will activate
thermometer.
Regeneration of The Tempa•DOT Single-Use
fired thermometers Clinical Thermometer may fire (turn
blue) if accidentally exposed to
elevated temperatures. The thermom-
eters can be returned to functional
condition by placing them in a
standard freezer. The storage time
required for regeneration ranges from
1 hour for a box of 100 thermometers
to 16 hours for a case of 2.000. After
regeneration, the fired dots may not
return to their original beige appear
ance but could be slightly off-color.
This will not affect accuracy nor can it
be confused with the vivid blue color
the dots turn in normal use.
Full function and accuracy will return
after 16 hours storage at room
temperature.
Shelf-life Two years from date of manufacture
as established by the expiry date.
Animal delayed hypersensitivity -To test delayed hypersensitivity,
0.2 ml of an aqueous extract of 150 Tempa•DOT Single-Use Clinical
Thermometers was rubbed into excoriated skin on the shoulder of
guinea pigs on days 0, 2, 4 and 7. The guinea pigs were challenged
21 days later, and no signs of delayed hypersensitivity were elicited.
Summary of toxicology findings - The entire program of toxicity
testing was carried out by independent laboratories according to
standard procedures and protocols recommended by government
and industrial testing groups. None of the tests showed evidence
of clinically significant toxicity or indication that the Tempa•DOT
Thermometer components cause primary irritation, sensitization or
photo-sensitivity of the skin.
The conclusion reached after analysis of all the evidence is that the
Tempa•DOT Thermometer is innocuous to patients in its intended
use as an oral, rectal or axillary thermometer. Furthermore, the
chemicals on the sensor matrix are fully shielded from any contact
with the oral mucosa or saliva by a sealed plastic laminate that
covers both the top and bottom surfaces of the entire sensor matrix.
The plastic is tough and resilient and, consequently, resistant to
puncturing or tearing even if bitten by the patient.
A major source of error in glass-mercury thermometers is usually
traced to nonlinearity, which usually results in an error throughout
most of its range. The principle utilized in the single-use thermome-
ter avoids this completely since each dot is a separate thermometer
that acts independently of all other dots. Thus, there can be no
cumulative error.
The Tempa•DOT Single-Use Clinical Thermometer undergoes
numerous separate quality control tests. The procedures that follow
are typical of the tests that are performed to ensure the chemical
and physical integrity, accuracy, uniformity and stability of the
thermometers.
Raw materials - Precise determination 91melting points; gas chro-
matography to determine chemical purity; Instron Universal Testing
Machine determinations of the strengths of films, adhesives and
laminated structures; identification of plastic films by IR spectro-
scopy printing, film and laminate dimensions.
In-process testing and monitoring - Dimensional requirements by
mechanical and optical methods; online monitoring to ensure chem-
ical fill level; Instron peel-strength testing of assembled laminations;
temperature - bath checks on melting points of chemical mixtures;
and the correct location and completeness of sealing of the dot
mixtures.
Final product testing - A statistically valid sample, per MIL-
STD-105, is drawn from each lot. Water baths are used to verify
accuracy. These water baths are adjusted by a thermometer whose
calibration is traceable to the National Institute of Standards and
Technology. The thermometer and its sterilizable package are
determined to be free of mechanical defects.
Retention of samples, all identified by lot number for traceability
- Raw materials, subassembly materials and finished product are
retained for a period of three years.
American Society for Testing and Materials - The Tempa•DOT
Single-Use Clinical Thermometer conforms to the requirements
established in ASTM Standard E 825-98 (Reapproved 2009) for
disposable fever thermometers.
PRINCIPLE OF THERMOMETRY
QUALITY CONTROL STANDARDS
