SteriPEN MED-3000 - Infrared Thermometer Manual

INTRODUCTION

MED-3000 advantages include:

1. 3 in 1 thermometer
   Human body/ object/ ambient temperature
2. One-second reading
3. Accurate and reliable
4. Traffi c lights backlight
   (Human Body Mode)
5. Tracking light
6. 25-memory recall
7. Large LCD Display
8. °C/°F Switchable function

INTENDED PURPOSE

The device is intended for the intermittent measurement and monitoring of human body temperature from forehead measurement at home, clinics and hospital.

A control measurement using a conventional thermometer is recommended in the following cases:

1. If the reading is surprisingly low.
2. For new-born infants up to 100 days old.
3. For children under three years of age who have a weakened immune system or who react unusually in the presence or absence of fever.

PRECAUTIONS

When using this product, please be sure to follow all the notes listed below. Any action against these notices may cause injury or affect the accuracy.

1. Close supervision is necessary when the thermometer is used by, on, or near children, handicapped persons or invalids.
2. Use the thermometer only for the intended use described in this manual.
3. Do not use the thermometer if it is not working properly, or if it has suffered any damage.

and
As with any thermometer, proper technique is crucial to obtaining accurate temperature readings.

Please read this manual thoroughly and carefully before using.

• Always operate the thermometer in an operating temperature range 5°C to 40°C (41°F to 104°F), and relative humidity 15 to 93%.
• Always store the thermometer in a cool and dry place -25°C to 70°C (-13°F to 158°F) and relative humidity 15% to 93%.
• The device requires no calibration.
• The device contains no user serviceable parts.
• The user must check that the equipment functions safely and see that it is in proper working condition before being use.
• The manufacturer does not require such preventive inspections by other persons.
• No modifi cation of this equipment is allowed.
• The device is not suitable for use in the presence of fl ammable anesthetic mixtures with air or with oxygen or nitrous oxide.
• Do not clean or maintenance the device is in use.
• Avoid direct sunlight.
• Avoid dropping the thermometer, if it happens and you think the thermometer may be damaged, please contact customer services immediately.
• Do not touch the lens.
• Do not disassemble the thermometer.
• Basic safety precautions should always be observed, especially when the thermometer is used on or near children and disabled persons.
  This thermometer is not intended to substitute for a consultation with your physician.
• Under any circumstances, the temperature taking result is ONLY for reference. Before taking any medical action, please consult your physician.
• When the measured temperature falls within the fever temperature range of >37.9°C (100.2°F) and <42.9°C (109.3°F), as indicated by the red LCD on display, please consult with your physician immediately.
• This thermometer and the subject must remain in a stable environment for at least 30 minutes before measuring the temperature.

CONTRAINDICATIONS

Contraindications: are not revealed.

PRODUCT IDENTIFICATION

DESCRIPTION OF LCD DISPLAY

WHAT IS A "NORMAL" TEMPERATURE?

The temperature in the forehead and temple area differs from the internal temperature, which is taken orally or rectally.
Vasoconstriction, an effect which constricts the blood vessels and cools the skin, can occur during the early stages of a fever. In this case, the temperature measured by the MED-3000 Infrared thermometer may be unusually low. If the measurement therefore does not match the patient's own perception or is unusually low, repeat the measurement every 15 minutes. As a reference, you can also measure the internal body temperature using a conventional oral or rectal thermometer. Body temperature can vary from one individual/ person to next. It also varies by location on the body and time of day. Below show the statistical normal ranges from different sites. Please keep in mind that temperatures measured from different sites, even at the same time, should not be directly compared. Fever indicates that the body temperature is higher than normal. This symptom may be caused by infection, overdressing or immunization. Some people may not experience fever even when they are ill. These include, but are not limited to, infants younger than 3 months old, persons with compromised immune systems, persons taking antibiotics, steroids or antipyretics (aspirin, ibuprofen, acetaminophen), or persons with certain chronic illnesses. Please consult your physician when you feel ill even if you do not have fever.

Normal Temperature Range of various body sites

BATTERY INSTALLATION/ REPLACEMENT

Low battery warning:
The thermometer comes with two 1.5 V AAA alkaline batteries. The thermometer will display " " to alert you when its power is getting low. Please follow the steps below to replace new batteries immediately.

Replacing the Battery:

1. Gently slide the battery cover back.
2. Carefully remove the old batteries and properly discard.
3. Insert new batteries (two 1.5V AAA size alkaline batteries) according to the proper polarity.
4. Slide the battery cover back on.

NOTE:

1. Although the thermometer works when "" appearing, we still recommend that you change the batteries.
2. It is recommended to remove the batteries if the unit will not be used for an extended period of time.
3. The batteries should be kept away out of children's reach. If they are swallowed, promptly see a doctor for help.
4. Dispose of used batteries in accordance with the applicable legal regulations. Never dispose of batteries in the normal household waste.

SWITCHING BETWEEN FAHRENHEIT AND CELSIUS

This thermometer can display results in either degrees Celsius (°C) or degrees Fahrenheit (°F).

1. Be sure the thermometer is OFF before selecting the temperature unit.
2. Long-press the ON Button for 8 seconds until the signal °C or °F displayed on the LCD panel as fi gure shown. Re-press the ON Button to select °C or °F unit.
3. Long-press the ON Button for 3 seconds, it will automatically save your choice and turn off.

TURNING ON THE TRACKING LIGHT

This thermometer provides Tracking Light (LED Light) to help users placing the thermometer at the correct position.

1. Be sure the thermometer is OFF.
2. Long-press the ON Button for 10 seconds until signal displayed on the LCD panel.
3. Short press the ON Button to turn on or off LED light – when LED is turned on, the blue light will indicate, while it is turned off there is no light.
4. Long-press the ON Button for 3 seconds, it will automatically save your choice and turn off.

SWITCHING BETWEEN MEASURING MODES

Following modes can be selected:

1. Body Mode
   This mode is used to measure the forehead temperature.
   
   
2. Object Mode
   This mode is used to measure the object temperature.
   

Choose the mode you need using a slider on the side of the device.

Silent mode
Beeps may be switched off:

1. Be sure the infrared thermometer is off.
2. Hold the ON Button for about 12 seconds after "ON" shows on the LCD panel. (Note: keep holding the button when "°C/°F" is displayed on the LCD panel).
3. Press the ON Button again to turn ON the beep.
4. Then long-press the Button for 3 seconds, it will automatically save your choice and turn off.

MEASURING HUMAN TEMPERATURE

Tips for measuring human temperature
Bear in mind that the thermometer needs to have been in the room in which the measurement is taken for at least 30 minutes before use.

NOTE:

• Attempting to take temperature readings from sites on the body other than the forehead may produce inaccurate results.
• If the patient's skin is covered with hair, sweat, or dirt, clean the area and wait 10 minutes before taking a measurement.
• Ensure that the thermometer is held fi rmly during measurement and that the patient does not move until the measurement is complete.
  Movement can impact the measurement.
• If the probe is placed at an angle close to the forehead measurement, the reading will be affected by surrounding temperature.
• Babies' skin reacts very quickly to the ambient temperature.
  Therefore, do not take their temperature with the MED-3000 infrared thermometer during or after breastfeeding, because the skin temperature may then be lower than the internal body temperature.
• Readings taken while asleep should not be compared directly to readings taken while awake, as body temperature while asleep is typically lower.
• Avoid measuring temperature in 30 minutes after exercise, bathing, or returning from outdoor.

Measuring Human Temperature
Taking a Measurement

1. Press ON Button to turn on the thermometer fi rst. The unit will run a self-test and the LCD will briefl y display all of its symbols during this time.
2. Push the Mode switch to select Body mode.
   The device sounds one short beep when it is turned on and the temperature unit (°C or °F) fl ashes to confi rms the readiness to perform the measurement.
3. Position the thermometer at a distance within 3 cm from the center of the patient's forehead. Make sure the probe is fl at and close to the forehead, not at an angle.
4. Press and release the ON Button. The measurement result will be done in 1 second. The reading is shown together with LCD lighting and one long beep informs about the temperature measurement, and after a while another, short, confi rming the saving of the result to the memory and readiness for the next measurement.
   
   
5. If the reading is ≤37,4°C, the display will stay green.
   If the reading is ≥37,5°C - ≤37,9°C (≥99,5°F - ≤100,2°F), the display will turn yellow.
   If the reading is >37,9°C (100,2°F), the display will show together with red LCD and six short beeps.
6. Press the ON Button to turn off the unit, or leave it idle for 10 seconds, the unit will switch off automatically.

MEASURING OBJECT/ LIQUID TEMPERATURE

Taking a Measurement

1. Press ON Button to turn on the thermometer fi rst. The unit will run a self-test and the LCD will briefl y display all of its symbols during this time.
2. Push the Mode switch to select Object mode.
   The device sounds two short beeps indicating that the object mode is turned on and the temperature unit fl ashes.
3. Position the thermometer at a distance within 3 cm from the object. Make sure the probe is fl at and close to the object, not at an angle.
4. Press and release the ON Button. The measurement result will be done in 1 second. The reading is shown together with LCD lighting and one long beep informs about the temperature measurement, and after a while another, short, confi rming the saving of the result to the memory and readiness for the next measurement.
   
   
5. Press the ON Button to turn off the unit, or leave it idle for 10 seconds, the unit will switch off automatically.

MEMORY FUNCTION

Memory Recall
You can recall up to 25 measurements currently stored in memory to share with your physician or trained healthcare professional.

1. Be sure the thermometer is OFF before recalling the memory. Press for 2 seconds the ON Button to enter the memory mode.
2. Each time you press the Button, a result will be displayed in the order of dates (latest result shown fi rst), together with "MEM" and number (from 1 to 25).
3. The symbol or symbol will appear with each measurement stored in memory to indicate whether a body or object temperature was taken. Body Mode measurements: LCD backlight will turn green, yellow or red according to the memory reading.
4. Exit the memory. Long press ON Button to exit the memory or keep the thermometer in idle for 10 seconds to switch off automatically.

Memory Deletion

1. Remove one of the batteries, long press the ON Button.
2. Reload the battery until "" on the LCD screen.
   

Automatically on the 26th measurement: when the 25 memories have been used up, any new measurement will be recorded and the oldest memory deleted without you having to do anything.

NOTE:
All the readings will be cleared no matter record in Body Mode or Object Mode.

CLEANING INSTRUCTIONS

For the device disinfection, 75% alcohol (available in the pharmacy) can be used.

Measurement Sensor:
Please wipe with a clean and dry cotton swab to clean the Sensor on the inside. Do not use water, the Sensor is not waterproof.

Thermometer:
Use a soft and dry cloth to clean the thermometer body. Do not use abrasive cleaners. The body of the thermometer is not water-resistant. Never put the thermometer under a running tap or submerge it into water.
Store the thermometer in a cool and dry location. Free from dust and away from direct sunlight. Do not expose the thermometer to extreme temperatures, humidity, or shock.

TROUBLESHOOTING

FAULT OR FAULT SYMBOL	FAULT DESCRIPTION	CORRECTIIVE MEASURE
No display On the LCD pane.	The battery has run out. Incorrect battery polarity.	Replace the battery. Please note: The (+) side of the battery must face Positive (+) indication on the device.
Measurement not possible (or an abnormal value is displayed).	The thermometer is not ready.	Wait until the °C symbol is displayed.
An abnormal temperature value is displayed.	The Sensor is dirty or damaged.	Clean the Sensor or get it repaired.
	The thermometer was removed too early (before the beep sound).	Wait until you hear the beep before removing the thermometer from the forehead.
symbol is displayed.	The temperature measured is outside the measuring range. Body Mode: LO – temperature <32°C (89.6°F). HI – temperature ≥42,9°C (109.3°F) Object Mode: LO – temperature <0°C (32°F). HI – temperature ≥100°C (212°F).	Check that the probe tip is clean and that the thermometer is properly placed on the forehead.
Symbol is displayed.	The battery has run out.	Replace the battery.
Symbol is displayed.	The ambient temperature is outside the operating temperature range or is changing too fast.	To ensure accurate measurement, let the thermometer rest at operating temperature for 30 minutes prior to use.

APPLIED STANDARDS

Device Standards:
Device Corresponds to the requirements of the standard for infrared thermometers
IEC 60601-1:2012
IEC 60601-1-2:2014 ISO 80601-2-56:2009

Classification:
Anti-electric Shock Type: Internally powered equipment
Applied part: Type BF
Mode of operation: Continuous Operation
EMC: type B class I

Electromagnetic Compatibility:
Device fulfi lls the stipulations of the standard IEC 60601-1-2
The stipulations of EU-Directive 93/42/EEC for Medical Devices
Class Ila have been fulfi lled.

PRODUCT SPECIFICATIONS

THERMOMETER SET

Thermometer set:

1. Thermometer
2. Battery 2 x 1.5V AAA size alkaline batteries
3. Soft bag
4. Instructions for use

UTILIZATION

The unit must be utilized in accordance with current standards separately from domestic wastes. For utilizing it is necessary to contact special organizations licensed to make utilization.

WARRANTY

Warranty period is 2 years from the date of purchase.
This warranty doesn't cover any damages caused by improper using, and also battery, protective cover and packaging. When a manufacturing defect is revealed during the warranty period a faulty unit would be repaired or, if repairing is impossible, replaced with another one.
Manufacturing date is on the unit in a serial number: last 2 fi gures of the year, then month number.
The manufacturer may change units partially or completely if necessary, without prior notice.

SYMBOL INFORMATION

FOLLOW INSTRUCTIONS BEFORE USE

MANUFACTURER'S NAME

ARTICLE NUMBER

SERIAL NUMBER

TYPE BF EQUIPMENT

DISPOSAL FOR SEPARATE COLLECTION

CE MARK (0044)

OPERATING CONDITION, TEMPERATURE 5˚C ~ 40˚C

STORAGE CONDITION, TEPERATURE -25˚C ~ 70˚C

KEEP DRY

HOUSING INGRESS PROTECTION RATE: IP20

ELECTROMAGNETIC COMPATIBILITY INFORMATION
Manufacturer's Declaration of the Electromagnetic Compatibility
Table 1
Guidance and manufacturer's declaration – еlectromagnetic emissions

Table 2
Guidance and manufacturer's declaration – еlectromagnetic immunity

Table 3
Guidance and manufacturer's declaration – electromagnetic Immunity

Last revision 2020-W51

B.Well Swiss AG
Bahnhofstr. 24, 9443 Widnau, Switzerland
www.bwell-swiss.ch