SureTemp® Plus REF 690 and 692 - Directions for use

SureTemp® Plus REF 690 and 692 - Directions for use
SureTemp Plus
®
REF 690 and 692
Directions for use
ii
Welch Allyn SureTemp
© 2016 Welch Allyn, Inc. To support the intended use of the product described in this
publication, the purchaser of the product is permitted to copy this publication, for internal
distribution only, from the media provided by Welch Allyn.
Welch Allyn assumes no responsibility for any injury, or for any illegal or improper use of
the product, that may result from failure to use this product in accordance with the
instructions, cautions, warnings, or indications for use published in this manual.
Welch Allyn is a registered trademark of Welch Allyn, Inc.
Patent information
For patent information, please visit www.welchallyn.com/patents.
Welch Allyn Technical Support:
http://www.welchallyn.com/about/company/locations.htm
106701 (CD)
Material No. 411744,
80018382 Ver. A
Revision date: 2016-07
Welch Allyn, Inc.
4341 State Street Road
Skaneateles Falls, NY 13153 U.S.A.
www.welchallyn.com
Regulatory Affairs Representative
Welch Allyn Limited
Navan Business Park
Dublin Road, Navan
County Meath, Republic of Ireland
Directions for use
iii
TABLE OF CONTENTS
Conforms With . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Symbols and Descriptions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Safety and Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
SureTemp Plus Model Comparison Chart . . . . . . . . . . . . . . . . . . . . 5
Indications/Contraindications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Latex Statement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Parts and Features. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Button Functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Set-Up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Display Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Oral Temperature Measurement. . . . . . . . . . . . . . . . . . . . . . . . . . 11
Axillary Temperature Measurement . . . . . . . . . . . . . . . . . . . . . . . 12
Rectal Temperature Measurement . . . . . . . . . . . . . . . . . . . . . . . . 13
Monitor Mode Temperature Measurement . . . . . . . . . . . . . . . . . 15
Instrument Security . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Cleaning and Disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Performance and Technical Specifications . . . . . . . . . . . . . . . . . . 19
Guidence and Manufacturer’s Declaration . . . . . . . . . . . . . . . . . . 20
EMC compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Emissions and Immunity Information . . . . . . . . . . . . . . . . . . . 20
Replacement Parts and Accessories . . . . . . . . . . . . . . . . . . . . . . . 23
Accessories List . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Service. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Welch Allyn Service Policy . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Contacting Welch Allyn . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Limited Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Service Centers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
iv
Welch Allyn SureTemp Plus
Directions for use
1
Conforms With
IEC/UL/CSA/EN 60601-1
Australian Communications and Media Authority (ACMA) Radio
Compliance Mark (RCM)
Symbols and Descriptions
Consult directions for use (DFU). A copy of the DFU is available on this website.
A printed copy of the DFU can be ordered from Welch Allyn for delivery within 7
calendar days.
Type BF Applied Part
Fragile
+55°C
Temperature Limit
-25°C
95%
Humidity Limitation
15%
Internally Powered Alkaline Battery - AA 1.5V
IPXØ
Not protected against the ingress of water.
Does not contain natural rubber latex.
Keep Dry
Do not re-use, Single use device
Recyclable
Separate collection of Electrical and Electronic Equipment. Do not dispose as
unsorted municipal waste.
Product Identifier.
Reorder Number
2
Welch Allyn SureTemp Plus
Safety and Warnings
WARNING No modification of this equipment allowed.
WARNING Patient injury risk. Prior to taking a temperature, instruct the patient
not to bite down on the probe as patient injury and damage to the probe may
result.
WARNING Patient injury risk. Use only Welch Allyn single-use disposable probe
covers. A new probe cover needs to be used with each new temperature
taken. Never take a temperature measurement without a single-use probe cover
securely attached. Failure to use a probe cover can cause patient discomfort from
a heated probe, patient cross-contamination, and inaccurate temperature
readings.
WARNING Patient injury risk. Inaccurate measurement risk. Oral/axillary probes
(blue ejection button at top of probe) and blue removable probe wells are used for
taking oral and axillary temperatures only. Rectal probes (red ejection button) and
red removable probe wells are used for taking rectal temperatures only. Use of
the incorrect removable probe well could result in patient cross-contamination.
Use of the probe at the wrong site will result in temperature errors.
WARNING Patient injury risk. When taking rectal temperatures, insert the probe
tip only 5/8 inch (approximately 1.5 cm) inside the rectum of adults and only 3//8
inch (approximately 1 cm) inside the rectum of children to avoid the risk of bowel
perforation.
WARNING Inaccurate measurement risk. Never take an axillary temperature
through the patient’s clothing. Carefully place the probe in the axilla, avoiding
contact with other objects or material.
WARNING Patient injury risk. Continuous measurement durations of 3 minutes
at the oral and rectal sites and 5 minutes at the axillary site are recommended for
accurate measurement. Do not continuously measure beyond 10 minutes in any
mode.
WARNING To ensure patient safety and temperature measurement accuracy,
use only accessories and supplies recommended or supplied by Welch Allyn.
WARNING Never use a damaged temperature probe. The thermometer consists
of high-quality precision parts and should be protected from severe impact or
shock. Do not use the thermometer if you notice any signs of damage to the
probe or instrument. If the thermometer probe is dropped or damaged, remove it
from use and have it inspected by qualified service personnel.
WARNING Equipment is not suitable for use in the presence of a flammable
anesthetic mixture with air or with oxygen or nitrous oxide.
WARNING Inaccurate measurement risk. For rectal measurements, apply a thin
layer of lubricant to probe cover, if necessary, for patient comfort. Use of
excessive lubricant may affect reading accuracy.
WARNING Inaccurate measurement risk. To ensure optimal accuracy, always
confirm that the correct mode and site are selected.
Directions for use
3
Caution Liquids can damage electronics inside the thermometer. Prevent
liquids from spilling on the thermometer. If liquids are spilled on the
thermometer, dry off the thermometer with a clean cloth. Check for proper
operation and accuracy. If liquids possibly entered the thermometer, remove the
thermometer from use until it has been properly dried, inspected, and tested by
qualified service personnel.
Caution Welch Allyn recommends that batteries are removed for long term
storage since alkaline batteries can deteriorate and leak over extended periods of
time, and possibly cause damage to the thermometer.
Caution Do not autoclaveany component of this product. Please note the
cleaning procedures described on page 18 of this manual.
Caution Do not use this instrument for any purpose other than that specified in
this booklet. Doing so will invalidate the instrument’s warranty.
Caution This thermometer complies with current required standards for
electromagnetic interference and should not present a problem to other
equipment nor is it effected by other devices. As a precaution, avoid using this
device in close proximity to other equipment.
Caution Inaccurate measurement risk. Patient activites such as strenuous
exercise, ingesting hot or cold liquids, eating, chewing gum or mints, brushing
teeth, or smoking may effect oral temperature measurements for up to 20
minutes.
Caution Probe covers are disposable, nonsterilized, and single-use. Probes are
also nonsterilized. Do not autoclave probes and probe covers. Ensure that probe
covers are disposed of according to facility requirements or local regulations.
4
Welch Allyn SureTemp Plus
Introduction
Please follow the operating and maintenance instructions provided in this manual to
ensure years of accurate and reliable service. Please read these instructions thoroughly
before using the instrument, and then store these instructions in a safe place for future
reference.
The Welch Allyn SureTemp Plus is a portable thermistor thermometer used for accurately
measuring body temperatures at oral, axillary, or rectal sites. The device measures
temperature by default in predictive (Normal) mode, during which it uses a predictive
algorithm to calculate patient temperature. If you cannot correctly measure the patient’s
temperature in Normal Mode, the unit will automatically enter Monitor (Direct) Mode.
Normal body temperature is a range, which varies from person to person and is
influenced by factors such as time of day and an individual’s level of activity, ingested
medications, age, and gender. A person’s normal temperature tends to decrease with
age.
The following table shows that ranges of normal also vary by site. Do not directly compare
measurements from different sites.
This booklet provides informative tips and instructions for using the SureTemp Plus model
690 and model 692 thermometers. The chart on the following page provides details about
the differences between these SureTemp Plus instruments.
Directions for use
5
SureTemp Plus Model Comparison Chart
This manual describes features found in SureTemp Plus model 690 and 692
thermometers. Certain features are not available to users of the model 690 thermometer.
SureTemp Plus Model
690
SureTemp Plus Model
692
Probe Cover Storage
X
X
F/C Conversion
X
X
Last Temperature Recall
X
X
Monitor Mode
X
X
Detachable Probe
X
X
Oral / Axillary / Rectal
Modes on Each
Thermometer
X
X
Color-Coded Removable
Probe Well
X
X
Wall-Holder Standard
X
Pulse Timer
X
Backlight
X
Security (Electronic)
X
Configurable On-Screen
Labeling for
Identification of
Instrument
X
Sold in U.S./Canada
X
X
Sold Internationally
X
X
Instrument Warranty
2 years
3 years
Removable Probe Well
90 days
90 days
1 year
1 year
Probe Warranty
Indications/Contraindications
The Welch Allyn SureTemp Plus thermometer measures patient’s temperature in the oral,
axillary, and rectal body sites of adult, pediatric, and newborn patients. The device is not
designed, sold, or intended for use except as indicated.
6
Welch Allyn SureTemp Plus
Latex Statement
The components of the SureTemp Plus device that could contact the user or patient were
not made with natural rubber latex. This includes all items that could be contacted during
normal operation, and all other functions, such as user maintenance and cleaning, as are
defined in the Directions for use.
No internal components are known to be made with natural rubber latex.
Parts and Features
You can find the serial number of your device on a label affixed to the rear housing inside
the unit’s probe cover storage compartment. Please note the parts of your Welch Allyn
SureTemp Plus thermometer as shown below:
Ejection Button (blue or red)
Probe
Box of Probe Covers
Thermometer
Removable Probe Well (blue or red)
Latching Probe Connector
LCD Display
C/F (Celsius/
Fahrenheit) Button
Pulse Timer Button
(692 Only)
Recall Button
Mode Selection
Button
Battery Door/Probe Cover
Storage Compartment
Directions for use
7
Button Functions
Buttons
Procedure
C/F
Press and release the C/F (Celsius/Fahrenheit) button to toggle
between temperature scales any time a temperature is displayed
on the LCD.
Pulse Timer
Press and release the Pulse Timer button to activate the timer.
Audible beeps sound at 0, 15, 30, 45, and 60 seconds. The timer
turns off automatically after 60 seconds. You can stop the timer
at any time by pressing the Pulse Timer button or by removing
the probe from the probe well.
(692 Only)
Mode Selection
Press and release the Mode Selection button after you have
withdrawn the blue probe from the probe well to change the
current measurement site to Oral, Adult Axillary, or Pediatric
Axillary. The selected measurement site is displayed by a
flashing body site icon. Note that no other measurement sites
are available when using the red probe in the Rectal Mode.
Recall
Press and release the Recall button when the display is blank to
recall the last completed predicted temperature. The LCD will
display the recalled temperature for five seconds along with the
battery icon, temperature scale, mode selection, and probeposition icon (if applicable).
Set-Up
ASSEMBLING THE UNIT
Your SureTemp Plus thermometer is shipped to you with three 1.5V AA batteries installed.
1. Install the oral/axillary probe (blue ejection button) or optional rectal probe (red Ejection button) by inserting the latching probe connector on the end of the coiled cord
into the unit’s plug receptacle. Ensure that the connector snaps into place. The LCD
will illuminate for approximately 7 seconds and will then turn off.
2. Connect the appropriate removable probe well to the thermometer. Note that the cutout in the probe well fits over the probe cord strain relief. Ensure that the removable
probe well “snaps” into position and is completely seated to the thermometer. Place
the probe into the well.
3. Insert the box of Welch Allyn disposable probe covers into the probe cover storage
holder. To open the box of probe covers, remove and discard the tear-away corner. You
will see the ends of the probe covers in the box.
MOUNTING THE UNIT
Mount the wall-mount bracket in a location such as an interior wall or wall divider so that
the thermometer remains at ambient room temperature. Mounting the unit on an
uninsulated exterior wall, in an area directly hit by sunlight, above heat radiators or
powered equipment (including computers and lights), or below air conditioning outlets is
not recommended.
8
Welch Allyn SureTemp Plus
Proper mounting of the unit will prevent tangling of the probe cord with other equipment
at the patient’s bedside.
1. Mount the instrument
so that all other objects
are no closer than 4
inches (10.25 cm) from
the sides and bottom
of the unit.
2. Mount the wall mount
a maximum of 48
inches (122 cm) from
the floor.
3. Install the wall mount
to allow at least 12
inches 30.5 cm)
clearance on top of the
instrument. This
provides ease of
removing and installing
the probe and probe
well or installing probe
covers onto the probe.
Directions for use
9
Display Indicators
Instrument Malfunction
The device is not working properly. Contact Welch Allyn’s
Customer Service Department for assistance.
Broken Probe
The probe is broken. Replace probe or contact Welch Allyn’s
Customer Service Department for assistance.
Loss of Tissue Contact
The probe has lost contact with the patient’s tissue. The icon
will disappear once proper contact is achieved. The icon will
later reappear at the end of the temperature measurement.
It is recommended that you take a new temperature reading.
ID Field
This is a seven-character field that allows customized
identification of the instrument via user-selected letters and
numbers. See the Model 690/692 Service Manual for set-up
instructions.
Walking Segments
The dark bar will move around the display when the
thermometer is in the process of taking a temperature.
Oral Mode
This flashing icon and/or word are displayed to show that the
Oral Mode is selected.
Adult Axillary Mode
This flashing icon and/or words are displayed to show that
the Adult Axillary Mode is selected.
Ped Axillary Mode
This flashing icon and/or words are displayed to show that
the Pediatric Axillary Mode is selected.
10
Welch Allyn SureTemp Plus
Rectal Mode
This flashing icon and/or word are displayed to show that the
Rectal Mode is selected.
Monitor Mode
This icon is displayed while in Monitor Mode. Monitor Mode
is used for continuous temperature monitoring when difficult
situations prevent accurate temperatures in the Normal
Mode. For oral and rectal sites, three minutes of continuous
monitoring is recommended for an accurate temperature
reading. For axillary sites, five minutes of continuous
monitoring is recommended.
Patient Temperature Exceeds Upper Measurement
Range Limit of 110.0 °F (43.3 °C)
Patient Temperature Is Lower than Measurement Range
Limit of 80.0 °F (26.7 °C)
Ambient Temperature Exceeds Upper Measurement
Range Limit of 104.0 °F (40.0 °C)
Ambient Temperature Is Lower than Measurement
Range Limit of 50.0 °F (10.0 °C)
Pulse Timer
This icon indicates that the device is in the Pulse Timer
Mode.
Low Battery
A single flashing segment appears on the battery symbol.
Normal operation is not affected. Replace the batteries.
Dead Battery
An open battery symbol remains on the LCD and the device
will not operate. Replace the batteries.
Security Mode
The instrument is in Security Mode. Return the thermometer
to the wall holder to resume normal operation See page 17
to set the instrument in Security Mode (Model 692 only).
Directions for use
11
Oral Temperature Measurement
Using Probe with Blue Ejection Button and Blue Probe Well
When used correctly, the SureTemp Plus thermometer accurately measures an oral
temperature in approximately 4–6 seconds. The ability of the SureTemp Plus
thermometer to take an accurate oral temperature requires correct user technique.
TAKING AN ORAL TEMPERATURE
WARNING Do not take a patient’s temperature without using a Welch Allyn
disposable probe cover. Doing so can cause patient discomfort, patient cross
contamination, and erroneous temperature readings.
1. Ensure that the oral probe (blue ejection button) and the blue probe well are
installed.
2. Holding the probe handle with your thumb and two fingers on the indentations of the
probe handle, withdraw the probe from the probe well.
3. Verify that the oral model icon is selected by observing the flashing head icon on
the instrument’s display. If this icon is not flashing, press the Mode Selection
button until the head icon appears.
4. Load a probe cover by inserting the probe into a probe cover and pressing the
probe handle down firmly. The probe handle will move slightly to engage the probe
cover.
WARNING Use only Welch Allyn probe covers. The use of other
manufacturer’s probe covers or no probe cover may produce temperature
measurement errors and/or inaccuracy.
.
5. With the Oral Mode indicator flashing, quickly place the
probe tip under the patient’s tongue on either side of the
mouth to reach the rear sublingual pocket. Have the
patient close his/her lips around the probe.
6. Hold the probe in place, keeping the tip of the probe in
contact with the oral tissue throughout the measurement
process. Rotating “walking” segments appear on the
display, indicating that measurement is in progress.
7. The unit will beep three times when the final temperature
is reached. The measurement site, temperature scale, and
patient temperature will display on the LCD. The final temperature will remain on the
display for 30 seconds.
8. If you cannot correctly measure the patient’s temperature in Normal
Mode, the unit will automatically enter Monitor Mode. In this mode,
measurement time is extended. Either repeat the temperature
measurement in Normal Mode in the opposite sublingual pocket or
keep the probe in place for three minutes in Monitor Mode. The
thermometer will not beep to indicate a final temperature. Record the temperature
12
Welch Allyn SureTemp Plus
before removing the probe from the site, as the temperature reading is not
maintained in memory.
WARNING Patient injury risk. Do not exceed the recommended temperature
measurement durations in Direct Mode. Continuous measurement durations of
3 minutes at the oral and rectal sites and 5 minutes at the axillary site are
recommended for accurate measurement. Do not continuously measure
beyond 10 minutes in any mode.
9. After the temperature measurement is complete, remove the probe from the
patient’s mouth. Eject the probe cover by firmly pressing the ejection button on the
top of the probe.
10. Return the probe to the probe well. The LCD display will go blank.
Caution Patient actions may interfere with accurate oral temperature
readings. Ingesting hot or cold liquids, eating food, chewing gum or mints,
brushing teeth, smoking, or performing strenuous activity may affect
temperature readings for up to 20 minutes after activity has ended.
Axillary Temperature Measurement
Using Probe with Blue Ejection Button and Blue Probe Well
When used correctly, the SureTemp Plus thermometer accurately measures an axillary
temperature for pediatric patients (ages 17 and younger) in approximately 10–13 seconds
and for adult patients (ages 18 and older) in approximately 12–15 seconds.
PLACING THE THERMOMETER INTO AXILLARY MODE
WARNING Do not take a patient’s temperature without using a Welch Allyn
disposable probe cover. Doing so can cause patient discomfort, patient cross
contamination, and erroneous temperature readings.
1. Ensure that the axillary probe (blue ejection button) and the blue probe well are
installed.
2. Holding the probe handle with your thumb and two fingers on the indentations of the
probe handle, withdraw the probe from the probe well.
3. Verify that the axillary mode is selected by observing
the correct flashing axillary icon on the instrument’s
display. If this icon is not flashing, press the Mode
Selection button to select the Adult Axillary or
Pediatric Axillary icon is displayed.
Adult Axillary
Mode Icon
Pediatric Axillary
Mode Icon
Caution To ensure optimal accuracy, always confirm that the correct axillary
mode is selected.
Caution After a temperature is taken and the probe is returned to the probe
well, the instrument reverts to the original measurement site mode.
Directions for use
13
TAKING AN AXILLARY TEMPERATURE
WARNING Do not take an axillary temperature through patient’s clothing.
Direct contact between patient’s skin and the probe is required.
1. Load a probe cover by inserting the probe into a probe cover and pressing the probe
handle down firmly. The probe handle will move slightly to engage the probe cover.
WARNING Use only Welch Allyn probe covers. The use of other
manufacturer’s probe covers or no probe cover may produce temperature
measurement errors and/or inaccuracy.
2. With the correct axillary mode indicator flashing, lift the patient’s arm so that the
entire axilla is easily seen. Place the probe as high as possible in the axilla. Do not
allow the probe tip to come into contact with the patient until the probe is placed in
the measurement site. Before this, any contact between the probe tip and the tissue
or other material may cause inaccurate readings.
3. Verify that the probe tip is completely surrounded by axillary tissue and place the arm
snugly at the patient’s side. Hold the patient’s arm in this position and do not allow
movement of the arm or probe during the measurement cycle. Rotating “walking”
segments appear on the display, indicating that measurement is in progress.
4. The unit will beep three times when the final temperature is reached. The
measurement site, temperature scale, and patient temperature will display on the
LCD. The final temperature will remain on the display for 30 seconds.
5. If you cannot correctly measure the patient’s temperature in Normal
Mode, the unit will automatically enter Monitor Mode. In this mode,
measurement time is extended. Either repeat the temperature
measurement in Normal Mode in the opposite axilla or keep the probe
in place for five minutes in Monitor Mode. The thermometer will not beep to indicate
a final temperature. Record the temperature before removing the probe from the site,
as the temperature reading is not maintained in memory.
WARNING Long-term continuous monitoring beyond five minutes is not
recommended in the Axillary Mode.
6. After the temperature measurement is complete, remove the probe from the
patient’s axilla. Eject the probe cover by firmly pressing the ejection button on the top
of the probe.
7. Return the probe to the probe well. The LCD display will go blank.
WARNING Probe contact with electrodes, bandages, etc., poor tissue
contact, taking a temperature over clothing, or prolonged exposure of axilla
to ambient air can cause inaccurate temperature readings.
Rectal Temperature Measurement
Using Probe with Red Ejection Button and Red Probe Well
When used correctly, the SureTemp Plus thermometer accurately measures rectal
temperature in approximately 10–13 seconds.
TAKING A RECTAL TEMPERATURE
14
Welch Allyn SureTemp Plus
WARNING Cross contamination or nosocomial infection risk. Thorough handwashing greatly reduces the risk of cross-contamination and nosocomial
infection.
WARNING Do not take a patient’s temperature without using a Welch Allyn
disposable probe cover. Doing so can cause patient discomfort, patient cross
contamination, and erroneous temperature readings.
1. Ensure that the rectal probe (red ejection button) and the red probe well are
installed. The instrument will only operate in Rectal Mode when the red rectal probe
and probe well are installed.
2. Holding the probe handle with your thumb and two fingers on the indentations of the
probe handle, withdraw the probe from the probe well.
3. Observe the flashing lower-body icon on the unit’s display. Load a probe cover by
inserting the probe into a probe cover and pressing the probe handle down
firmly. The probe handle will move slightly to engage the probe cover.
WARNING Use only Welch Allyn probe covers. The use of other
manufacturer’s probe covers or no probe cover may produce temperature
measurement errors and/or inaccuracy.
4. With the Rectal Mode indicator flashing, separate the patient’s buttocks with one
hand. Using the other hand, gently insert the probe only 1.5 cm (5/8 in.) inside the
rectum (less for infants and children). The use of a lubricant is optional.
WARNING Patient injury risk. When taking rectal temperatures, insert the
probe tip only 5/8 inch (approximately 1.5 cm) inside the rectum of adults and
only 3/8 inch (approximately 1 cm) inside the rectum of children to avoid the
risk of bowel perforation.
5. Tilt the probe so that the tip of the probe is in contact with tissue. Keep the hand
separating the buttocks in place, and hold the probe in place throughout the
measurement process. Rotating “walking” segments appear on the display,
indicating that measurement is in progress.
6. The unit will beep three times when the final temperature is reached. The
measurement site, temperature scale, and patient temperature will display on the
LCD. The final temperature will remain on the display for 30 seconds.
7. If you cannot correctly measure the patient’s temperature in Normal
Mode, the unit will automatically enter Monitor Mode. In this mode,
measurement time is extended. Either repeat the temperature
measurement in Normal Mode or keep the probe in place for three
minutes in Monitor Mode. The thermometer will not beep to indicate a
final temperature. Record the temperature before removing the probe from the site,
as the temperature reading is not maintained in memory.
WARNING Long-term continuous monitoring beyond three minutes is not
recommended in Rectal Mode.
8. After the temperature measurement is complete, remove the probe from the
patient’s rectum. Eject the probe cover by firmly pressing the ejection button on the
top of the probe.
9. Return the probe to the probe well. The LCD display will go blank.
Directions for use
15
10. Wash your hands.
WARNING Washing hands greatly reduces the risk of cross-contamination
and Nosocomial Infection.
Monitor Mode Temperature Measurement
Using Probe with Blue Ejection Button (Oral/Axillary) or Red Ejection Button
(Rectal)
Monitor Mode continuously displays the temperature of the probe for as long as the
probe remains in place at the measurement site and remains within the operating patient
temperature range. The patient’s oral and rectal temperature will reach final equilibrium in
approximately three minutes in the Monitor Mode. Axillary temperature will reach
equilibrium in approximately five minutes in the Monitor Mode.
Caution Monitored temperatures are not stored in memory for recall.
16
Welch Allyn SureTemp Plus
TAKING A TEMPERATURE USING MONITOR MODE
WARNING Do not take a patient’s temperature without using a Welch Allyn
disposable probe cover. Doing so can cause patient discomfort, patient
cross contamination, and erroneous temperature readings.
1. Ensure that both the appropriately colored probe and matching probe well for the
intended measurement site (oral/axillary or rectal) are installed.
2. Holding the probe handle with your thumb and two fingers on the indentations of the
probe handle, withdraw the probe from the probe well.
3. Load a probe cover by inserting the probe into a probe cover and pressing the probe
handle down firmly. The probe handle will move slightly to engage the probe cover.
WARNING Use only Welch Allyn probe covers. The use of other
manufacturer’s probe covers or no probe cover may produce temperature
measurement errors and/or inaccuracy.
4. Take the patient’s temperature using the normal Oral, Rectal, Pediatric Axillary, or
Adult Axillary Mode as previously described.
5. Continue to hold the probe in position after the temperature is displayed.
6. Press the Mode Selection button until the Monitor Mode indicator
appears on the LCD.
7. Hold the thermometer in place for the required duration:
Oral
3 minutes
Axillary
5 minutes
Rectal
3 minutes
WARNING Long-term continuous monitoring beyond three to five minutes is
not recommended in any mode.
8. Record the temperature before removing the probe from the site.
9. Eject the probe cover by firmly pressing the ejection button on the top of the probe.
10. Replace the probe in the probe well to clear the display and reset the thermometer to
Normal Mode. The thermometer will not beep to indicate a final temperature.
WARNING The unit will automatically enter Monitor Mode if the probe is
withdrawn from the probe well and is not replaced within 60 seconds of
inactivity.
Directions for use
17
Instrument Security
The SureTemp Model 692 thermometer is equipped with electronic security options
designed to reduce the risk of theft. These options include both Temperature Count and
Instant-On security features.
TEMPERATURE COUNT
The Temperature Count security feature allows you to take a set number of temperature
readings before the instrument goes into the security alarm state. The selectable counts
are 25, 50, 100, and 200. As the instruments nears the final reading, it will display
SECURITY COUNT as a warning, along with a number representing the last 5
temperature counts (i.e., 5,4,3,2,1) remaining on the security counter.
When the instrument enters the alarm state, it beeps for approximately 10 seconds. At
this time, the instrument displays SEC on the LCD along with SECURITY COUNT in the
ID field in the upper left-hand corner of the screen. The instrument is then disabled.
Returning the instrument to the wall holder resets the security count. If the count is set to
“OFF” the temperature count function is disabled and no security alarm will occur.
To set the Temperature Count security feature, please refer to the Service Manual.
INSTANT-ON
When the Instant-On feature is activated, the instrument goes into the security alarm
state within five seconds after removal from the wall holder. When the instrument enters
the alarm state, it beeps continuously and displays SEC on the LCD. Pressing the Mode
Selection button while removing the probe from the probe well, within 30 seconds of the
instruments removal from the wall holder, clears the alarm and allows the instrument to
operate. Returning the instrument to the wall holder will reset the instant audio alarm.
The options for the Instant-On feature are ON and OFF. In the OFF setting, no security
alarm will sound.
To set the Instant-On security feature, please refer to the Service Manual.
Maintenance
REPLACING THE BATTERIES
1. Remove the box of probe covers from the probe cover storage compartment on the
back of the unit.
2. Remove the probe and the probe well.
3. Press inward on the textured grips on each side of the assembly to remove the
battery door from the back of the unit.
4. Remove the three AA 1.5Vdc alkaline batteries and replace all three batteries with AA
1.5 Vdc alkaline batteries. Match the +/- polarity of each battery to the +/- symbols
inside the battery compartment.
WARNING Use size AA 1.5 Vdc alkaline batteries only. Use of any other
battery size or type could damage the thermometer and cause personal injury.
5. Snap the probe cover storage assembly back into place.
18
Welch Allyn SureTemp Plus
6. Replace the probe and probe well.
Caution Remove the batteries, if the instrument is not used for an extended
period of time, to avoid possible damage to the thermometer due to battery
leakage.
Cleaning and Disinfection
Clean and disinfect on a routine basis according to each facility's policy or whenever
contamination occurs.
CLEANING AND DISINFECTING THE THERMOMETER AND PROBE
Wipe the thermometer and probe with an appropriate health care low- or intermediatelevel cleaner/disinfecting wipe that incorporates either a 1:10 sodium hypochlorite (bleach)
solution or isopropyl alcohol as the active disinfection ingredient. Follow wipe
manufacturer's instructions for appropriate use, contact times and applicable warnings
and precautions.
Caution DO NOT immerse or soak the thermometer or probe in any type of
fluid.
Caution DO NOT use steam, heat, or gas sterilization on the thermometer or
probe.
Caution DO NOT autoclave the thermometer or the probe.
CLEANING AND DISINFECTING THE REMOVABLE PROBE WELL
•
Remove the probe well from the unit. Unplug the latching probe connector to prevent
the device from consuming battery power while you are cleaning the probe well.
•
Clean the inner surface of the probe well by swabbing the surface with a cloth
dampened with a 1:10 sodium hypochlorite (bleach) solution or isopropyl alcohol
solution as the active disinfection ingredient. Clean the probe well's outer surface by
swabbing or wiping the surface with one of the solutions mentioned above.
Caution DO NOT use hard or sharp objects to clean the probe well. This could
damage the probe well and cause the unit to not function properly.
Caution DO NOT use steam, heat, or gas sterilization on the probe well.
Caution DO NOT autoclave the probe well.
•
Thoroughly dry all surfaces before re-assembling the instrument.
•
Re-connect the latching probe connector to the thermometer. Ensure that the
connector snaps into place.
•
Re-install the probe well in the thermometer and snap the probe well into place.
•
Insert the probe into the probe well.
Disposal
DISPOSING OF EQUIPMENT
Do not dispose of this product as unsorted municipal waste. Prepare this product for
reuse or separate collection as specified by Directive 2002/96/EC of the European
Directions for use
19
Parliament and the Council of the European Union on Waste Electronic and Electrical
Equipment (WEEE). If this product is contaminated, this directive does not apply.
For more specific disposal information, see www.welchallyn.com/weee, or contact Welch
Allyn Customer Service at +44 207 365 6780.
DISPOSING OF BATTERIES
Dispose of used batteries properly. Consult your local recycling authority for proper
procedures.
DISPOSING OF PROBE COVERS
Ensure that probe covers are disposed of according to facility requirements or local
regulations.
Performance and Technical Specifications
Ambient Operating Temperature Range
50.0 F to 104.0 F (10.0 C to 40.0C)
Operating Altitude
-557 ft. to +16,000 ft / -170m to +4877m
Patient Temperature Range
80.0 F to 110.0 F (26.7 C to 43.3 C)
Temperature Predict Time*
Oral:
Approximately 4–6 secs.
Adult axillary (18 years and older):
Approximately 12–15 secs.
Pediatric axillary (17 years and younger):
Approximately 10–13 secs.
Rectal:
Approximately 10–13 secs.
Transport/Storage Temperature
-13°F to +131°F (-25°C to +55°C)
Calibration Accuracy
+/- 0.2 F (0.1 C) (Monitor Mode)
Humidity
15% to 95% non-condensing
Dimensions
8.46” x 3.18” x 2.43”
(215mm x 81mm x 62mm)
Weight
12.6 ounces/357 grams
Power
(3) 1.5Vdc AA batteries
Equipment Classification
Internally powered, Continuous Operation
Not AP or APG equipment
Applied Part
Thermometer probe
IPXØ
Not protected against the ingress of water.
* Predict time depends on probe placement and patient condition. Predict times do not
include tissue contact-detection time or time needed to place the probe into the
measurement site.
20
Welch Allyn SureTemp Plus
Guidence and Manufacturer’s Declaration
EMC compliance
Special precautions concerning electromagnetic compatibility (EMC) must be taken for all medical electrical
equipment. This device complies with IEC EN 60601-1-2:2007.
•
All medical electrical equipment must be installed and put into service in accordance with the EMC
information provided in this document and the Welch Allyn SureTemp PlusDirections for Use.
•
Portable and mobile RF communications equipment can affect the behavior of medical electrical
equipment.
The Welch Allyn SureTemp Plus complies with all applicable and required standards for
electromagnetic interference.
•
It does not normally affect nearby equipment and devices.
•
It is not normally affected by nearby equipment and devices.
•
It is not safe to operate the SureTemp Plus in the presence of high-frequency surgical equipment.
•
However, it is good practice to avoid using the SureTemp Plus in extremely close proximity to other
equipment.
Emissions and Immunity Information
Electromagnetic Emissions
The Welch Allyn SureTemp Plus model 690 and 692 is intended for use in the electromagnetic environment specified
below. The customer or the user of the Welch Allyn thermometer should assure that it is used in such an
environment.
Emissions Test
Compliance
Electromagnetic Environment - Guidance
RF emissions
Group 1
The Welch Allyn SureTemp Plus uses RF energy only for its internal
function. Therefore, its RF emissions are very low and are not likely to
cause any interference in nearby electronic equipment.
Class B
The Welch Allyn SureTemp Plus models 690 and 692 are suitable for
use in all establishments other than domestic, and may be used in
domestic establishments and those directly connected to the public lowvoltage power supply network that supplies buildings used for domestic
purposes, provided the following warning is heeded:
CISPR 11
RF emissions
CISPR 11
Harmonic emissions Class A
IEC 61000-3-2
Voltage fluctuations/ Complies
flicker emissions
IEC 61000-3-3
WARNING: This equipment/system is intended for use by
healthcare professionals only. This equipment/system may
cause radio interference or may disrupt the operation of nearby
equipment. It may be necessary to take mitigation measures,
such as re-orienting or relocating the Welch Allyn SureTemp
Plus models 690 and 692 or shielding the location.
Directions for use
21
Electromagnetic Immunity
The Welch Allyn SureTemp Plus model 690 and 692 is intended for use in the electromagnetic environment specified
below. The customer or user of the Welch Allyn thermometer should assure that it is used in such an environment.
Immunity Test
IEC 60601 Test
Level
Compliance Level
Electromagnetic Environment - Guidance
± 6 kV contact
± 6 kV contact
± 8 kV air
± 8 kV 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
±2 kV for power
supply lines
±2 kV for power
supply lines
IEC 61000-4-4
±1 kV for input/
output lines
±1 kV for input/
output lines
±1 kV differential
mode
±1 kV differential
mode
±2 kV common
mode
±2 kV common
mode
<5% UT
(>95% dip in UT)
for 0.5 cycle
<5% UT
(>95% dip in UT)
for 0.5 cycle
40% UT
(60% dip in UT)
for 5 cycles
40% UT
(60% dip in UT)
for 5 cycles
70% UT
(>95% dip in UT)
for 25 cycles
70% UT
(>95% dip in UT)
for 25 cycles
<5% UT
(>95% dip in UT)
for 5 seconds
<5% UT
(>95% dip in UT)
for 5 seconds
3 A/m
3 A/m
Electrostatic
discharge (ESD)
IEC 61000-4-2
Surge
IEC 61000-4-5
Voltage dips, short
interruptions, and
voltage variations
on power supply
input lines.
IEC 61000-4-11
Power frequency
(50/60Hz) magnetic
field
Mains power quality should be that of a typical
commercial or hospital environment.
Mains power quality should be that of a typical
commercial or hospital environment.
Mains power quality should be that of a typical
commercial or hospital environment. If the user of
the Welch Allyn SureTemp Plus 690 and 692
requires continued operation during power mains
interruptions, it is recommended that the Welch
Allyn SureTemp Plus be powered from an
uninterruptible power supply or battery.
Power frequency magnetic fields should be at
levels characteristic of a typical location in a typical
commercial or hospital environment.
IEC 61000-4-8
Note: UT is the AC mains voltage prior to application of the test level.
22
Welch Allyn SureTemp Plus
Electromagnetic Immunity
The Welch Allyn SureTemp Plus models 690 and 692 is intended for use in the electromagnetic environment
specified below. The customer or user of the Welch Allyn thermometer should assure that it is used in such an
environment.
Immunity Test
IEC 60601
Test Level
Compliance Electromagnetic Environment - Guidance
Level
Portable and mobile RF communications equipment should be
used no closer to any part of the Welch Allyn SureTemp Plus
models 690 and 692, including cables, than the recommended
separation distance calculated from the equation applicable to
the frequency of the transmitter.
Recommended separation distance
Conducted RF 3 Vrms
IEC 61000-4-6 150 kHz to 80 MHz
3 Vrms
d = (1.17) P
Radiated RF
3 V/m
IEC 61000-4-3 80 MHz to 2.5 GHz
3 V/m
d = (1.17) P 80 MHz to 800 MHz
d = (2.33) P 800 MHz 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 metres (m).
Field strengths from fixed RF transmitters, as determined by
an electromagnetic site survey,a should be less than the
compliance level in each frequency range.b
Interference may occur in the vicinity of equipment marked
with the following symbol:
Note 1: At 80 MHz and 800 MHz, 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.
a Field strengths from fixed transmitters, 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 strength in the location in which the Welch Allyn SureTemp Plus is used
exceeds the applicable RF compliance level above, the Welch Allyn SureTemp Plus should be observed to verify
normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting
or relocating the Welch Allyn SureTemp Plus.
b Over
the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Directions for use
23
Recommended separation distances between portable and mobile RF communications equipment
and the Welch Allyn SureTemp Plus model 690 and 692
The Welch Allyn SureTemp Plus models 690 and 692 is intended for use in an electromagnetic environment in which
radiated RF disturbances are controlled. The customer or user of the Welch Allyn thermometer can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications
equipment (transmitters) and the Welch Allyn thermometer as recommended below, according to the maximum
output power of the communications equipment.
Separation distance according to frequency of transmitter (m)
Rated maximum
output power of
transmitter (W)
150 kHz to 80 MHz
80 MHz to 800 MHz
800 MHz to 2.5 GHz
d = (1.17) P
d = (1.17) P
d = (2.33) P
0.01
0.12
0.12
0.23
0.1
0.37
0.37
0.74
1
1.20
1.20
2.30
10
3.70
3.70
7.40
100
12
12
23
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in
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.
Replacement Parts and Accessories
To order replacement parts and accessories, please contact the Welch Allyn office nearest
to you.
24
Welch Allyn SureTemp Plus
Accessories List
Part #
Description
01802-110
9600 Plus Calibration Tester
02891-000
Removable Probe Well (Blue)
02891-100
Removable Probe Well (Red)
02892-000
Probe and Well Kit (Incl. Probe) 4 ' Rectal
02892-003
Probe and Well Kit, 4’, Vet
02892-100
Probe and Well Kit (Incl. Probe) 9 ' Rectal
02892-103
Probe and Well Kit, 9’, Vet
02893-000
Probe and Well Kit (Incl. Probe) 4 ' Oral
02893-100
Probe and Well Kit (Incl. Probe) 9 ' Oral
05031-750
Disposable Probe Covers - 7500/Case
06138-000
SureTemp® Calibration Key
106701
Operators Manual (DFU)
406682
Soft Carrying Case
Service
Except for the replaceable AA batteries, this instrument contains no user-serviceable
parts. Return the thermometer to a Welch Allyn authorized service center for service and
repair. Refer to the Service Manual.
Welch Allyn Service Policy
Only a Welch Allyn Service Center can perform or approve all repairs on products under
warranty. Unauthorized repairs will void the warranty. Qualified electronics personnel or a
Welch Allyn Service Center should repair out-of-warranty products.
Contacting Welch Allyn
If you encounter an equipment problem that you cannot resolve, contact the Welch Allyn
Service Center nearest you for assistance.
Before returning a product for repair, you must first obtain authorization from Welch Allyn.
If you are advised to return a product to Welch Allyn for service or repair, you should
schedule the repair with the Welch Allyn Service Center nearest you.
Welch Allyn service personnel with provide you with a a Return Materials Authorization
(RMA) number. Print this number on the outside of your shipping box.
Welch Allyn does not accept returns that are missing an RMA number.
Directions for use
25
Limited Warranty
THREE-YEAR LIMITED WARRANTY ON MODEL 692 AND TWO-YEAR LIMITED
WARRANTY ON MODEL 690 INSTRUMENTS
Instrumentation purchased new from Welch Allyn, Inc. (Welch Allyn) is warranted to be
free from original defects in material and workmanship under normal use and service for a
period of three years for Model 692 and a period of two years for Model 690 from the
date of first shipment from Welch Allyn. This warranty shall be fulfilled by Welch Allyn or
its authorized representative repairing or replacing at Welch Allyn’s discretion, any such
defect, free of charge for parts and labor.
Welch Allyn must be notified via telephone of any defective product and the item must be
immediately returned, with an RMA number provided by Welch Allyn, securely packaged
and postage prepaid to Welch Allyn. Loss or damage in shipment shall be at the
purchaser’s risk.
Welch Allyn will not be responsible for loss associated with the use of any Welch Allyn
product that (1) has had the serial number defaced, (2) has been repaired by anyone other
than an authorized Welch Allyn Service Representative, (3) has been altered, (4) has been
used in a manner other than in accordance with the instructions, or (5) has been abused
or exposed to extreme environmental conditions.
ONE-YEAR LIMITED WARRANTY ON PROBES AND PROBE COVERS
Welch Allyn warrants probes and probe covers to meet Welch Allyn’s specifications for the
Product at the time of purchase and to be free from original defects in material and
workmanship under normal use and service for a period equal to one-year from the date
of first shipment of such Product to the customer by or on behalf of Distributor. Probe
covers are intended for single use only.
NINETY DAY LIMITED WARRANTY ON REMOVABLE PROBE WELLS
Removable probe wells (blue oral and red rectal) are warranted to be free from original
defects in material and workmanship under normal use and service for a period of ninety
days from the date of first shipment from Welch Allyn.
THIS WARRANTY IS EXCLUSIVE AND IN LIEU OF ANY IMPLIED WARRANTY OF
MERCHANTABILITY, FITNESS FOR PARTICULAR PURPOSE, OR OTHER WARRANTY OF
QUALITY, WHETHER EXPRESS OR IMPLIED. WELCH ALLYN WILL NOT BE LIABLE FOR
ANY INCIDENTAL OR CONSEQUENTIAL DAMAGES RESULTING FROM THE SALE, USE,
OR IMPROPER FUNCTIONING OF THE INSTRUMENTATION REGARDLESS OF THE
CAUSE. THE DAMAGES FOR WHICH WELCH ALLYN WILL NOT BE RESPONSIBLE
INCLUDE, BUT ARE NOT LIMITED TO, LOSS OF REVENUE OR PROFIT, DOWNTIME
COSTS, AND LOSS OF USE OF THE INSTRUMENTATION.
Service Centers
For information about any Welch Allyn product, contact Welch Allyn Technical Support:
http://www.welchallyn.com/about/company/locations.htm
26
Welch Allyn SureTemp Plus
4341 State Street Road
Skaneateles Falls, NY 13153
Tel: +1 800 535 6663
Fax: +1 315 685 3361
www.welchallyn.com
DIR# 80018382 Ver. A
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