SureTemp Plus 690 and 692 Series Service Manual Ver A May 2018

© 2018 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 80021463 Ver. A Revision date: 2018-05

Welch Allyn, Inc. 4341 State Street Road Skaneateles Falls, NY 13153 U.S.A

Regulatory Affairs Representative Welch Allyn Limited Navan Business Park Dublin Road, Navan County Meath, Republic of Ireland

www.welchallyn.com 901053 ELECTRONIC THERMOMETER

Table of Contents 1

General Information... 1 1.1 About this Manual... 1 1.2 Safety and Warnings... 1 1.3 Conforms with... 3 1.4 Symbols and descriptions... 3

2

Operating Characteristics... 6 2.1 Basic System Description... 6 2.2 Model Features... 8 2.3 Operating Features... 8 2.4 Instrument Security... 14

3

Preventive Maintenance... 17 3.1 Six-Month Maintenance... 17 3.2 Twelve-Month Maintenance... 17 3.3 Standard Storage... 17 3.4 Cleaning... 17 3.5 Replacing the Batteries... 18 3.6 Calibration Testing... 19

4

Troubleshooting... 21 4.1 Types of Errors... 21 4.2 Field Serviceable Repairs... 26 4.3 Field Serviceable Parts... 26

5

Theory of Operation... 28 5.1 Technical Overview... 28

Appendix A

Specifications...A

Appendix B

Limited Warranty...B

Appendix C

Guidance and Manufacturer’s Declaration...C

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1. General Information 1.1

About this Manual This manual describes maintenance and troubleshooting procedures for the SureTemp® Plus Model 690 and 692 Thermometers. Most topics and procedures described in this manual are applicable to both products. Where there are differences, it is noted to which product the topic refers.

1.1.1 Related Document End-user operation of the Model 690 and 692 Thermometers is covered in the SureTemp® Plus Model 690 and 692 Operator's Manual.

1.2

Safety and Warnings

WARNING: No modification of this equipment allowed WARNING: In order to obtain accurate and reliable temperature results and ensure patient safety, it is important that this manual is read thoroughly prior to using the instrument. If you have any technical or clinical questions concerning the thermometer’s use and/or care, please contact the Welch Allyn Customer Service Department. WARNING: Use single-use Welch Allyn disposable probe covers to limit patient cross-contamination. The use of any other probe cover may produce temperature measurement errors or result in inaccurate readings. 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. WARNING: Long-term continuous monitoring beyond three to five minutes is not recommended in any mode. WARNING: Biting the probe tip while taking a temperature may result in damage to the probe. WARNING: Oral/axillary probes (blue ejection button at top of probe) and blue oral/axillary removable probe wells are used for taking oral and axillary temperatures only. Rectal probes (red ejection button) and red rectal removable probe wells are used for taking rectal temperatures only. Use of the probe at the wrong site will result in temperature errors. Use of the incorrect removable probe well could result in patient cross contamination. WARNING: To ensure patient safety and temperature measurement accuracy, use only accessories and supplies recommended or supplied by Welch Allyn. WARNING: Equipment is not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide. WARNING: Do not take an axillary temperature through patient’s clothing. Direct probe cover to skin contact is required.

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WARNING: The Welch Allyn SureTemp Plus thermometer consists of high quality precision parts. Protect it from severe impact and shock. A qualified service technician must check any SureTemp Plus thermometer which is dropped or damaged to ensure proper operation prior to further use. Do not use the thermometer if you notice any signs of damage to the probe or instrument. Contact the Welch Allyn Customer Service Department for assistance. Caution: Welch Allyn recommends that batteries are removed for long term storage since batteries can deteriorate and leak over extended periods of time, and possibly cause damage to the thermometer. Caution: Do not autoclave. Please note the cleaning procedures described on page 15 of this manual. Caution: Do not use this instrument for any purpose other than that specified in this manual. 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: The thermometer case, connectors, and probe are not waterproof. Do not immerse or drip fluids on these items. Should this occur, dry the device with warm air. Check all operating functions for proper operation.

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1.3

Conforms with IEC/UL/CSA/EN 60601-1 Australian Communications and Media Authority (ACMA) Radio Compliance Mark (RCM)

1.4

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

+

Temperature Limit

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

Reorder Number

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Product Identifier

Separate collection of Electrical and Electronic Equipment. Do not dispose as unsorted municipal waste.

Global Trade Item Number Meets essential requirements of European Medical Device Directive 93/ 42/EEC Intertek Testing Laboratories Approved (ETL)

Manufacturer

Serial Number

4

2. Operating Characteristics 2.1

Basic System Description The Welch Allyn® SureTemp® Plus Model 690 and 692 thermometers are portable electronic thermistor thermometers. Users can measure a patient's temperature in the oral, axillary, and rectal body sites of adult, pediatric, and newborn patients. Probe Cover Ejection Button Probe Box of Probe Covers

Thermometer

Removable Probe Well LCD Display

Latching Probe Connector

Celsius/Fahrenheit Toggle Button

Battery Door/Probe Cover Storage Holder

Pulse Timer Button/Monitor Mode (692 only) Recall Button Mode Selection Button

Figure 1: Model 692 Thermometer The thermometer consists of six main components: the instrument, the probe, the removable probe well, the probe cover, the batteries, and the wall mount.

2.1.1 Instrument The instrument includes a removable probe well and detachable probe.

2.1.2 Probe The detachable probes are available in short (standard) or long cord versions and include a mechanical probe cover ejection mechanism, which is triggered by the user through a simple finger press. The probes are designed for easy exchange in the clinical environment. •

The short (standard) coiled cord probe stretches to approximately 4' and has a retracted length of approximately 10".

•

The long version stretches to approximately 9’ and has a retracted length of approximately 28".

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Four probe types are available and interchangeable on the thermometer: 1. A blue Oral/Axillary probe with a short (standard) coiled cord 2. A red Rectal probe with a short (standard) coiled cord 3. A blue Oral/Axillary probe with a long coiled cord 4. A red Rectal probe with a long coiled cord

2.1.3 Probe well This unit has a removable probe well to allow for ease of cleaning and replacement. The blue probe well is used with Oral and Axillary probes, and the red probe well is used with Rectal probes.

2.1.4 Probe covers The SureTemp® Plus Thermometers must use the standard Welch Allyn® thermistor probe covers. The probe covers are compatible across all Welch Allyn® thermistor-based thermometers.

2.1.5 Batteries The Model 690 and 692 thermometers use three AA batteries. No battery charging is available. The thermometer display will indicate when the batteries need replacement.

2.1.6 Wall Mount The wall holder is easily secured to a wall. A locking mechanism with a removable key for securing the instrument is standard on the Model 692 Thermometer and is available as an option for the Model 690. Through the use of available long cord probes, the thermometer may be used without removing it from the wall holder.

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2.2

Model Features Features of the SureTemp® Plus Thermometer models (690 and 692) are listed below. Table 2-1: Feature differences between Models 690 and 692

Feature

Model 690

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

Optional

Standard

Wall-Holder

2.3

Pulse Timer

X

Backlight

X

Security (Electronic)

X

On-Screen Labeling for Instrument Identification

X

Operating Features 2.3.1 Instrument Reset To perform a reset: 1. Remove the batteries from the instrument to reset the internal microprocessor electronics. Follow the battery removal instructions in “Replacing the Batteries” on page 16. 2. Remove the probe and the probe well from the instrument. Then, unplug the probe connector by depressing the locking tab and pulling on the connector body. DO NOT pull on the cord. 3. While watching the display, install the batteries per the instructions in “Replacing the Batteries” on page 16 and observe the Power-On Self Test described below.

2.3.2 Power-On Self Test (POST) The self-test will check the internal microprocessor, instrument electronics, and display for correct operation. The instrument performs the self-test series following all power-on or reset cycles. During the self test sequence the thermometer displays all LCD segments for 2 seconds. Concurrently, the thermometer plays the power-on audible notification and performs necessary self-testing. Figure 2: Model 690 and 692 Thermometer Displays

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Immediately following the LCD segment test, the software revision is displayed on the screen for 2 seconds. At the end of the self-test, the display goes blank and the unit is ready to operate.

2.3.3 Low Power Mode The Low Power mode allows the thermometer to conserve power when it is not in use. The unit will automatically enter the Low Power mode following one of these conditions: 1. After a final predicted temperature has been taken, the probe has not been returned to the well, and the displayed temperature has been on the screen for 30 seconds. 2. When the instrument is in Monitor mode and the probe tip is out of the patient temperature range (80 F to 110 F) for a period greater than 5 minutes. 3. At the completion of the Recall mode time-out of 5 seconds. 4. Whenever the probe is returned to the well and the probe is plugged into the thermometer. 5. Whenever the probe is unplugged from the thermometer. 6. Whenever the unit is in the Biotech mode and there are no button presses for 5 minutes. The unit will exit Low Power mode when any button on the instrument is pushed or the probe switch is activated. When the unit exits Low Power mode after the probe is removed from the well, all LCD segments are displayed for approximately 2 seconds.

2.3.4 Predict Mode Predict mode operation is the rapid mode of temperature taking. This is the default mode and is automatically selected when the probe is withdrawn from the probe well. This mode provides the clinical user with predictive temperature capability for obtaining oral, rectal, pediatric axillary (17 years and younger), and adult axillary (18 years and older) temperatures. If the mode is changed from Predict mode to Monitor mode during normal operation, it will change back to Predict mode when the probe is returned to the probe well. 1. Upon withdrawal of the probe from its storage well, every segment on the display is illuminated. The display will then show ORAL, ADULT AXILLARY, PED AXILLARY or RECTAL, depending on the probe and mode selected. It will also display C or F. In the upper left hand corner the ID will be displayed if one has been set (Model 692 only), and in the lower right hand corner the battery icon will be displayed. At the same time that the mode is displayed, a short beep will sound. 2. To change between the Oral, Adult Axillary, and Pediatric Axillary modes, press and release the Mode button. Observe that the display changes between ORAL, ADULT AXILLARY, and PED AXILLARY when the Mode button is pressed and released. 3.

When the correct mode has been selected load a probe cover and take a temperature.

Note: It is possible that the walking segments will start and stop several times before the probe is inserted into the temperature site. This is acceptable and will not adversely affect the temperature taken.

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2.3.5 Monitor Mode The Monitor mode provides continuous temperature monitoring capability. The recommended wait time for a Monitor mode oral temperature and a Monitor mode rectal temperature is 3 minutes. The recommended wait time for a Monitor mode axillary temperature is 5 minutes. The thermometer will automatically switch to Monitor mode under the following conditions: 1. If 60 seconds have passed since the thermometer was removed from the probe well. 2. If the instrument determines that room temperature is above 34.2C (93.5F). 3. If the thermometer is unable to predict an oral or axillary temperature after 20 seconds due to improper technique or excessive probe movement. In the normal Predict mode, with correct use, the patient’s oral temperature is displayed in approximately 4 seconds. The instrument will beep to signal completion of the Predict mode temperature cycle. If the probe is left out of the storage well after completion of a Predict mode temperature, the unit will shut down after 30 seconds and enter Low Power mode to conserve power. Replace the probe in the storage well to prepare for the next temperature. WARNING: Long-term continuous monitoring beyond three to five minutes is not recommended in any mode.

For Model 692, press and release the Pulse Timer / Monitor Mode button after you have withdrawn the probe from the probe well to switch the device into Monitor Mode. The Monitor Mode indicator appears on the LCD.

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.

For Model 690, take the patient’s temperature using the normal Oral, Rectal, Pediatric Axillary, or Adult Axillary Mode as previously described. Continue to hold the probe in position after the temperature is displayed. Press the Mode Selection button until the Monitor Mode indicator appears on the LCD.

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2.3.6 Pulse Timer/ Monitor Mode (Model 692 only) Pulse Timer mode is activated from Low Power or Recall mode by pressing the Pulse Timer button. The display will then count up in seconds, and the unit will emit an audio beep at 0, 15, 30, 45 and 60 seconds. Pulse Timer mode terminates automatically after 60 seconds. The thermometer then returns to Low Power mode. The Pulse Timer can be stopped at any time during the 0-60 count by pressing the Pulse Timer button a second time. Pressing the Recall button, connecting a probe, or removing the probe from the probe well will also terminate the pulse timer. For Monitor Mode, press and release the Pulse Timer button after you have withdrawn the probe from the probe well to switch the device into Monitor Mode.

2.3.7 Backlight (Model 692 only) A backlight is provided by two high-efficiency amber LEDs, each supplied by a separate ballast resistor. The backlight is turned on automatically in any mode except Low Power mode and remains on. The backlight will automatically shut off when the unit goes into Low Power mode.

2.3.8 Horn The horn is a miniature piezoelectric speaker which produces the audible tones that signal significant warning events to the user. The following audible signals will be played by the thermometer. Table 2- 2: SureTemp® Plus Audible Signals

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Signal

Description

Sound

POWER ON

Batteries are inserted in the device.

Charge up sound. Sound starts at a low frequency, increases in frequency, gets shorter in duration between each frequency.

POWER OFF

Battery level is too low and the unit is shutting down.

Charge down sound or losing power sound. Sound starts at a high frequency, decreases in frequency, gets longer durations between each frequency.

COMPLETE

Successful completion of a predict temperature or pulse timer.

Three quick beeps

OK

Start of Pulse Timer, Recall or Monitor mode

Two quick beeps

OK

Auto Monitor mode

One long beep

ERROR

Final temperature in error or Error mode

Two long beeps

CONFIRM

Any button press

One medium length beep

PULSE

Pulse Timer 15 second sound

One quick beep

SECURITY

Security State; i.e. device removed from security holder while security enabled and instant on = ON

Continuous series of beeps

READY

When probe is ready to insert into mouth (not when probe removed from well).

One medium length beep

2.3.9 F/C Conversion The temperature switches to F or C scale by pressing and releasing the C/F button. The default temperature scale can be set to F or C in the biotech mode. A temperature must be displayed on the screen to switch between F and C.

2.3.10 Temperature Recall This mode displays the most recently completed predicted temperature. Whenever the instrument is in Low Power or Pulse Timer mode, pressing and releasing the Recall button on the front panel will cause the most recently predicted temperature to display for 5 seconds. The unit will then automatically go into Low Power mode. Pulling the probe from the well in Recall mode will start a predict cycle. To enter Biotech mode, hold the Recall button down and then pull the probe from the well. Model 692 units must be in the wall holder to enter Biotech mode. Pressing the Pulse Timer button on the Model 692 thermometer will interrupt the temperature recall function. Note: No Monitor mode temperatures are saved for recall. When a temperature is recalled, the mode in which it was obtained (Oral, Adult Axillary, Pediatric Axillary, or Rectal) is displayed, regardless of the current mode the thermometer is in.

2.3.11 Biotech Mode This mode is used to set and check special features of the thermometer listed in Table 2-1. All Biotech mode settings are saved so they are not lost when the batteries are replaced. 1. Place the thermometer in the wall holder (Model 692 Only). 2. Press and hold the Recall button, while removing the probe from the probe well. Once the probe is removed, release the Recall button. 3. Press and release the Recall button to move sequentially through the various program categories. Changes within each category are made by pressing and releasing either the Mode Selection or C/F button. 4. The Biotech mode control settings are stored in nonvolatile memory so that they are not lost when the batteries are changed. The Biotech mode will automatically time out after 5 minutes of inactivity. 5. Replacing the probe into the probe well at any time will exit the Biotech mode and return the unit to normal operation.

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The following features and selections are available in the Biotech mode. Table 2- 3: Biotech Mode Features

Function

Setting

DEVICE VERSION

The display will show “X.X”, where “X.X” is the device software version number (i.e. 1.0). This is helpful when discussing operation with Welch Allyn Customer Care.

ALGORITHM VERSION

The display should show “X.X” where “X.X” is the mode Software Version (i.e. 7.5). This is helpful when discussing operation with Welch Allyn Customer Care.

ID (Model 692 Only)

This section of the display is designed to store up to a seven digit alpha-numeric thermometer ID. To store the thermometer's ID, press and release either the Mode or the C/F button to change the value of the flashing digit. Press the Pulse Timer button to move to the next digit.

DEFAULT MODE

You may choose between four settings as the default predictive mode: Oral, Adult Axillary, Pediatric Axillary, and Last (last prediction). To change the default mode, press and release the C/F button or the Mode Selection button to advance to the next mode. This setting is retained in nonvolatile memory when the batteries are replaced.

UNITS DEFAULT

This section displays the temperature measurement scale. To change the measurement scale from °F to °C, press and release the C/F button or Mode Selection button. This setting is retained in non-volatile memory when the batteries are replaced.

SITE INDICATION

Three options are available for mode indication: icon and words, words only, and icon only. To change the setting, press and release the Mode Selection button or C/F button to advance to the next type of indication. This setting is retained in non-volatile memory when the batteries are replaced.

SECURITY COUNT (Model 692 Only)

The anti-theft function uses a temperature counter that can be set at OFF, 25, 50, 100, or 200. • Press and release the Mode Selection button to select the desired security count. • Press and release the C/F button to select descending security count option (i.e. 200, 100, 50, 25, OFF). The instrument is set to the selected security count after the probe is returned to the probe well. This setting is retained in non-volatile memory when the batteries are replaced.

INSTANT ON (Model 692 Only)

The thermometer can be set to alarm when removed from the wall holder. This alarm can be disabled by the user by simultaneously pressing the Mode Selection button while pulling the probe from the probe well. When this security feature is set to ON and the thermometer is returned to the wall holder the security feature is reactivated. To set this security feature, press and release the Mode Selection button or C/F button to select ON (activated) or OFF (deactivated). This setting is retained in nonvolatile memory when the batteries are replaced.

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Table 2- 3: Biotech Mode Features

2.4

Function

Setting

BATTERY

This setting displays the current battery voltage with 10 mV resolution. The battery is considered acceptable if it measures higher than 3.4 volts. A new battery should produce 4.5 volts or more.

COUNTER Predictive Temperature Counter

This setting displays the number of predictive temperature measurements that have been completed (in 100's).

ERROR LOG

This setting displays the last 10 saved error messages in a last-in, first-viewed sequence. This is helpful when discussing operation with Welch Allyn Customer Care. If there are no error messages, the display shows EMPTY LOG.

CLEAR LOG

This setting appears if the thermometer has logged any error messages. Press and release the Mode Selection button to select YES to clear the error log or NO to keep the entries in the log.

Instrument Security Security options include two different electrical security options that alarms after a user designated number of temperatures is reached or when the unit is removed from the wall holder (Model 692 only). A mechanical security option is also available to prevent removal of the unit from the wall mount or mobile stand without a special tool. The design of the SureTemp® Plus Thermometers allows a facility to apply magnetic or RF security tags to the unit without adversely affecting the unit’s performance or functionality. The SureTemp® Plus Model 692 Thermometer has two distinct anti-theft systems available that are user selectable. Both systems require the use of a holder system with the thermometer. This setting will be retained in non-volatile memory when the batteries are replaced.

2.4.1 Temperature Count Security Feature 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 instrument 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. This setting is programmable through the Biotech mode (page 11).

2.4.2 Instant-On Security Feature When the Instant-On security 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

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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. This setting is programmable through the Biotech mode (page 11).

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3. Preventive Maintenance The following preventive maintenance is recommended to maximize uninterrupted service with the SureTemp® Plus Model 690 and 692 Thermometers.

3.1

Six-Month Maintenance Units that are in service on a regular basis should have the following preventive maintenance performed every six months: 1. Visually inspect the thermometer for any physical damage that might cause future product failure. 2. Clean the unit per instructions in the Operator’s Manual supplied with the thermometer and/or per the instructions below.

3.2

Twelve-Month Maintenance For units in service on a regular basis, perform the Power-On Self Test and Model 9600 or 9600 Plus Calibration Testing procedure every 12 months. The preventive maintenance procedure is located in the Model 9600 or 9600 Plus Operation Manual.

3.3

Standard Storage Units which are stored for an extended period should have the following maintenance performed every 12 months: 1. Remove the batteries before storage. 2. Reinstall the batteries and perform the Power-On Self Test and Model 9600 or 9600 Plus Calibration Testing procedure found in the Model 9600 or 9600 Plus Operation Manual before use.

3.4

Cleaning 3.4.1 Cleaning and Disinfection the Thermometer and Probe Wipe the thermometer and probe with an appropriate health care low- or intermediate-level 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.

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3.4.2 Cleaning 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 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.

• • • •

3.5

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.

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 batteries and replace all three batteries with AA 1.5 Vdc batteries. Match the +/- polarity of each battery to the +/- symbols inside the battery compartment. WARNING: Use size AA 1.5 Vdc 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. 6. Replace the probe and probe well. Note: 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.

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3.6

Calibration Testing Whenever the clinical accuracy of the thermometer is in question, verify the instrument calibration. Your hospital biomedical department should establish a routine schedule for verifying instrument calibration. It is recommended the unit be tested annually.

3.6.1 Cal-Key Verification This method uses a fixed value to verify that the device is calibrated properly. 1. Remove any probe currently connected to the SureTemp® Plus Thermometer. 2. Connect the SureTemp® Plus Cal-Key (PN 06138-000). 3. Wait one minute for the device to enter Monitor mode and display the temperature. 4. The temperature should read 36.3 +/- 0.1ºC or 97.3 +/- 0.2ºF. 5. Remove the SureTemp® Plus Cal-Key. 6. Connect the original probe back to the device.

3.6.2 Model 9600 Plus Calibration Tester Verification This method is used to verify the calibration of the unit and probe at three set point temperatures 36.0ºC (96.8ºF), 38.5ºC (101.3ºF), 41.0ºC (105.8ºF). Use a verified thermometer from the Cal-Key Verification (3.5.1) and a functioning probe. CAUTION: Store thermometers for testing in the same room as the 9600 Plus Calibration Tester for approximately 30 minutes prior to testing to allow for thermal accommodation. 1. Plug in the Model 9600 Plus Calibration Tester wall transformer to electrical power. 2. The 36.0ºC (96.8ºF) temperature setting is selected when the calibration tester is first powered on. If the calibration tester is all ready powered on, change the temperature setting on the Model 9600 Plus Calibration Tester to 36.0ºC (96.8ºF) with the up/down arrow key (temperature will scroll through the 3 settings). It is important to use the lower temperature setting first because the stabilization time from high temperature to low temperature takes about twenty (20) minutes. Stabilization time from a lower temperature to a higher temperature takes about six (6) minutes. 3. Wait for the displayed temperature to stop blinking. The actual temperature displayed blinks until the set temperature has stabilized. 4. Remove the probe from the thermometer well and clean it with either a 70% isopropyl alcohol solution, a 10% chlorine bleach solution, or a non-staining disinfectant. Let the probe air dry for at least five minutes. Do not apply a probe cover. Place the thermometer in Monitor Mode. Refer to the thermometer’s Operator’s Manual. 5. Rotate the dust cover down so the Thermistor Device Port is open/available, leaving the Ear Device Port covered, and insert the probe fully into the small hole on top of the Model 9600 Plus Calibration Tester.

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