Physio Logic DigiPro+ Digital Clinical Thermometer User Guide

Physio Logic DigiPro+ Digital Clinical Thermometer

USER GUIDE

Thank you for purchasing the Physio Logic® DigiPro+™ Thermometer.

PLEASE READ INSTRUCTIONS CAREFULLY BEFORE USE

This digital thermometer provides a quick and accurate reading of an individual’s body temperature.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 a MR Environment

Taking Temperature

Clean and disinfect your DigiPro+™ thermometer according to the instructions in this user guide.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 show the displays above along with the last stored temperature. After showing the self-test reading, the °C symbol will start flashing, which means it is now taking temperature.
2. Place the probe tip under the tongue as near as possible to a pocket as shown in Figure 2. Close the patient’s mouth and avoid moving the unit.
3. Once the °C symbol on the display has stopped flashing, a series of ten beeps will signal that peak temperature is reache

Rectal Use

Note: Rectal temperatures is 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 show the displays above along with the last stored temperature. After showing the self-test reading, the °C symbol will start flashing, which means it is now taking temperature.
2. Lubricate silver probe tip with petroleum jelly for easy insertion. Gently insert sensor approximately 1cm (less than 1/2 “) into rectum.
3. Once the °C symbol on the display has stopped flashing, a series of ten 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 show the displays above along with the last stored temperature. After showing the self-test reading, the °C symbol will start flashing, which means it is now taking temperature.
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. Once the °C symbol on the display has stopped flashing, a series of ten beeps will signal that peak temperature is reached.Note:
   1. If the temperature reading is less than 32 °C or 90 °F, the LCD will display “Lo”.
   2. If the temperature reading is higher than 42.9 °C or 109.2 °F, the LCD will display “Hi”.
   3. 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 10 minutes.

°C /°F SwitchableTemperature readings are available in Celsius or Fahrenheit (located in the upper right corner of LCD).The DigiPro+™ has been set to Celsius readings by default. To switch the reading mode to Fahrenheit,turn the device off. Then press and hold the On/Off button for approximately 3 seconds to change the current setting.

Cleaning and Disinfection Instructions

Before and after each use, wipe the thermometer 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 thermometerFor stubborn stains, wipe the thermometer with a clean cloth that has been dampened with wateror 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 warrantyon this thermometer.

General Care

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

Troubleshooting

Troubleshooting
Error Message	Problem	Solution
	Temperature reading is lower than 32 °C (90 °F)	Turn off thermometer, wait one minute and take a new reading following User Guide
	Temperature reading is higher than 42.9 °C (109.2 °F)	Turn off thermometer, wait one minute and take a new reading following User Guide
	The system is not functioning properly	Contact the AMG Customer Service Team at: 1-800-363-2381

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

Product Specifications

Type	Digital Thermometer
Measure Range:	32 °C – 42.9 °C (90 °F – 109.2 °F)
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:	Direct Mode
Display:	Liquid crystal display, 3 1/2 digits
Memory:	Last Measurement
Battery:	One 1.5V button battery
Battery Life:	Approximately 200 hours of continuous operation or 1 year with 3 measurements per day
Dimension:	12.2 cm x 1.8 cm x 1.1 cm (L x W x H)
Weight:	Approximately 10 grams including battery
Expected Service Life:	Three years
Ambient Operating Range:	Temperature: 5 °C – 40 °C (41 °F –104 °F) Relative Humidity: 15%–95%RH Atmospheric Pressure : 700 hPa – 1060 hPa
Storage and Transportation Condition:	Temperature: -20 °C – 55 °C (-4 °F–131 °F) Relative humidity: 15% – 95%RH Atmospheric Pressure : 700 hPa – 1060 hPa
Ingress Protection Rating:	IP 27
Classification:	Type BF

This device conforms to the following standards:ASTM E1112 standard specification for electronic thermometer for intermittent determination of patient temperature, ISO 80601-2-56 Medical Electrical Equipment- Part 2-56:Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement. IEC/EN 60601-1 Medical Electrical Equipment -Part 1: General requirements for basic safety and essential performance; IEC 60601-1-11 Part 1-11: Collateral Standard:Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment; and IEC 60601-1-2 (EMC) Part 1-2: Collateral Standard:Electromagnetic disturbances – requirements and tests. The manufacturer is ISO 13485 certified.

Limited Warranty

The Physio Logic® DigiPro+ Thermometer is guaranteed for one year from the date of purchase. If the thermometer does not function properly due to defective components or poorworkmanship, 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 improperhandling of this thermometer. To obtain warranty service, an original or copy of the sales receipt from the original retailer is required.