Physio logic AccuflexPro+ Digital Thermometer User Guide

Physio logic AccuflexPro+ Digital Thermometer

OVERVIEW

Product Information

The PRO+ LCD Thermometer is a digital thermometer designed for accurate temperature measurement. It is equipped with a probe and an easy-to-read LCD display. The thermometer comes with 1 Thermometer, 1 Owner’s Manual, and 1 Storage Case.

WARNING: The device’s performance may be affected under certain conditions such as operating outside the manufacturer’s stated temperature and humidity range, storing outside the stated temperature and humidity range, experiencing mechanical shock or degraded sensor, using it in an MR Environment, or when the patient’s temperature is below ambient temperature. Portable and mobile RF communications can also affect the device.

Precautions

• Operate within the manufacturer’s stated temperature and humidity range.
• Store within the manufacturer’s stated temperature and humidity range.
• Avoid mechanical shock or dropping the device.
• Do not use the device in an MR Environment.
• Avoid using the device when the patient’s temperature is below ambient temperature.
• Be aware that portable and mobile RF communications can affect the device.

Thank you for purchasing the Physio Logic® AccuflexPro+® Thermometer.

PLEASE READ INSTRUCTIONS CAREFULLY BEFORE USE

• To better understand the AccuflexPro+® Thermometer, please read all instructions thoroughly before using.
• This digital thermometer provides a quick and accurate reading of an individual’s body temperature.
• Your thermometer features a comfortable and flexible tip along with beeper and memory functions.
• It is intended to measure body temperature orally, rectally, or under the arm.
• Perfect for clinical or home use for people of all ages

WARNING: DO NOT ALLOW CHILDREN TO USE THIS DEVICE WITHOUT PARENTAL SUPERVISION.

• Do not use thermometer in ear. Designed use is for oral, rectal, and armpit (axilla) readings only.
• The use of temperature readings for self-diagnosis is dangerous. Consult your doctor for the interpretation of results. Self-diagnosis may lead to the worsening of existing disease conditions.
• Do not attempt measurements when the thermometer is wet, as inaccurate readings may result.
• Do not bite the thermometer. Doing so may lead to breakage and/or injury.
• Do not attempt to disassemble or repair the thermometer. Doing so may result in inaccurate readings.
• After each use, disinfect the thermometer especially in case the device is used by more than one person.
• Do not force the thermometer into rectum. Stop insertion when pain is present.
• Failure to do so may lead to injury.
• Do not use thermometer orally after being used rectally.
• For children who are two years old or younger, please do not use the device orally.
• If the unit has been stored at temperatures under 5° C or over 40°C (41° F –104° F), leave it in 5° C – 40° C (41° F – 104° F) ambient temperature for about 15 minutes before using it.

Note: Use of the probe cover may result in a 0.01 °C (0.02 °F) discrepancy from actual temperature.

PRECAUTIONS

The performance of the device may be impacted should one or more of the following occur:

• Operation outside the manufacturer’s stated temperature and humidity range
• Storage outside the manufacturer’s stated temperature and humidity range
• Mechanical shock (for example, drop test) or degraded sensor
• Patient temperature is below ambient temperature
• Portable and mobile RF communications can affect the device
• Do not use the device in an MR Environment

Taking Temperature
Clean and disinfect your AccuflexPro+® thermometer according to the instructions in this user guide.
Operation Mode Set-up (orL / udr / rct / bth): Press ON / OFF for around 4 seconds until the thermometer LCD displays “orL” and release the button. Press ON / OFF again and toggle between modes until the desired one is displayed and release button. When you press the On / Off button to turn the unit on, it will display your selected mode.

Note: Drinking hot or cold fluids, exercising, smoking, or performing other activities may raise or lower your temperature. It is important for the patient to relax for approximately 5 minutes, mouth closed, prior to taking a reading.

Oral Use

1. Press the ON/OFF button to turn the unit on. The unit will beep once, display the last stored temperature, and then show the mode of measurement, in this case “orL”. Then the thermometer will enter into testing mode and will display three dashes with either the Celsius or Fahrenheit symbol.

2. Place the probe tip under the tongue as near as possible to a pocket as shown in Figure 2.
   Avoid moving the unit.

3. A series of beeps will signal that peak temperature is reached.

Rectal Use

Note: Rectal temperatures are an appropriate and reliable method for infants and young children. Otherwise, this method should only be used when it is impossible or impractical to take an oral or axillary temperature.

1. Press the ON/OFF button to turn the unit on. The unit will beep once, display the last stored temperature, and then show the mode of measurement, in this case “rct”. Then the thermometer will enter into testing mode and will display three dashes with either the Celsius or Fahrenheit symbol.
2. Lubricate silver probe tip with petroleum jelly for easy insertion. Gently insert sensor approximately 1 cm (less than 1/2 “) into rectum.
3. A series of beeps will signal that peak temperature is reached.

Axillary Use

1. Wipe the underarm with a dry towel.
2. Press the ON/OFF button to turn the unit on. The unit will beep once, display the last stored temperature, and then show the mode of measurement, in this case “udr”. Then the thermometer will enter into testing mode and will display three dashes with either the Celsius or Fahrenheit symbol.
3. Place the probe tip under the arm so the tip is touching the skin, with the thermometer perpendicular to the body and keep arm pressed firmly to the side so that the probe tip is well covered by the arm. This also ensures the probe is not affected by the room’s air.
4. A series of beeps will signal that peak temperature is reached.

Bath Use

1. Press the ON/OFF button to turn the unit on. The unit will beep once, display the last stored temperature, and then show the mode of measurement, in this case “bth”. Then the thermometer will enter into testing mode and will display “Lo” with either the Celsius or Fahrenheit symbol flashing.

2. Place probe tip into bath water until the thermometer beeps indicating that peak temperature is reached.
   Note:

3. If the temperature reading is less than 32°C or 90°F, the LCD will display “Lo”.

4. If the temperature reading is higher than 42.9°C or 109.2°F, the LCD will display “Hi”.

5. To prolong battery life, press the On/Off Button to turn unit off after testing is completed.
   If no action is taken, the unit will automatically shut off after around IO minutes.

°C /°F Switchable
Temperature readings are available in Celsius or Fahrenheit (located in the upper right corner of LCD). The AccuflexPro+® has been set to Celsius readings by default. To switch the reading mode to Fahrenheit, press and release the On / Off button. When the display shows the last temperature taken, press and hold the On / Off button until “C” appears and then press again to toggle between °C /°F modes.

Cleaning and Disinfection Instructions

Before and after each use, wipe the thermometer several times with a soft, clean cloth and 75% Ethanol or Isopropyl alcohol.

To prevent damage to the thermometer

1. The unit must not be sterilized by boiling, gas, or steam
2. Do not immerse or soak in either alcohol or hot water
3. Do not use ultrasonic washing to clean the thermometer
4. Do not use benzene, thinner, gasoline or other strong solvents to clean the thermometer

For stubborn stains, wipe the thermometer with a clean cloth that has been dampened with water or a neutral detergent solution. Finish by wiping with a soft dry cloth.
The use of any other solution or cleaning method beyond the above noted instructions may result in reliability issues and voids warranty.

General Care

1. Clean the thermometer before and after each use.
2. Store the unit in its protective case when it is not in use.
3. Do not bite the probe.
4. Do not store the unit where it will be exposed to direct sunlight, dust or humidity. Avoid extreme temperatures.
5. Avoid dropping the thermometer or subjecting it to strong shock.
6. Do not attempt to disassemble the unit.
7. The thermometer should only be used under the supervision of an adult.
8. Do not walk, run, or talk during temperature taking.

Troubleshooting

wait one minute and take a new reading following User Guide.
HI| Temperature taken is higher than 42.9 °C (109.2° F)| Turn off thermometer, wait one minute and take a new reading following User Guide.
__

Er 1

| Thermometer moved while taking temperature| Retest temperature. Stay still when taking reading.
Er 2| Measurement time exceeds 10 seconds| The probe tip may not have cooled down,

please wait 30 seconds between each measurement.

The thermometer moved while taking temperature.

Wait 30 seconds and retest temperature. Stay still when taking reading.

Drinking hot or cold fluids, exercising, smoking or performing other activities may raise or lower your temperature. It is important to relax

for approximately 5 minutes, mouth closed, prior to taking another reading.

ERR| The system is not functioning properly| Contact the AMG Customer Service Team at: 1-800-363-2381

Disposal
Disposal of this product should be carried out in accordance with local regulations for the disposal of electronic products.

Product Specifications

Accuracy:

| ±0.1°C (±0.2 °F) during 35.5°C – 42.0°C (95.9 °F – 107.6 °F)

at 18°C–28°C (64.4 °F – 82.4 °F) ambient operating range

±0.2°C (±0.4 °F) for other measuring and ambient operating range

Operating Mode:| Predictive Mode: Oral, Rectal, Underarm – Direct Mode: Bath
Display:| Liquid crystal display, 3 1/2 digits
Memory:| Last Measurement
Battery:| One 3.0 V DC Button Battery Size CR2032
Battery Life:| Approximately 200 hours of continuous operation or 1 year with 3 measurements per day
Dimension:| 13.4 cm x 3.1 cm x 1.6 cm (L x W x H)
Weight:| Approximately 23 grams including battery
Expected Service Life:| Three years

Ambient Operating Range:

| Temperature: 5°C – 40°C (41°F –104°F)

Ambient Operating Range: Relative Humidity: 15%–95%RH Atmospheric Pressure: 700hPa – 1060hPa

Storage and Transportation Condition:

| Temperature: -20°C–55°C (-4°F–131°F)

Relative humidity: 15% – 95%RH Atmospheric Pressure: 700hPa – 1060hPa

Ingress Protection Rating:| IP 27
Classification:| Type BF

This device conforms to the following standards: IEC 60601-1-11:2015 Medical electrical equipment — Part 1-11: General requirements for basic safety and essential performance — Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment; IEC 60601-1-2:2014 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests; EN 60601-1:2006 Medical electrical equipment. General requirements for basic safety and essential performance (+A12:2014); ANSI/AAMI ES60601-1:2005 Medical Electrical Equipment, Part 1: General Requirements For Basic Safety And Essential Performance. The manufacturer is ISO 13485 certified.

Limited Warranty

The Physio Logic® AccuflexPro+® Thermometer is guaranteed for one year from the date of purchase. If the thermometer does not function properly due to defective components or poor workman-ship, we will repair or replace it free of charge. All components are covered by this warranty excluding the battery. The warranty does not cover damages due to improper handling of this thermometer. To obtain warranty service, an original or copy of the sales receipt from the original retailer is required.

Rev1 0521 P/N 861-016658

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