Mckesson 413 series User manual

CALIBRATION

The thermometer is initially calibrated at the time of manufacture. If the

thermometer is used according to the use instruction, periodic readjustment is

not required. However, we recommend checking calibration every two years or

whenever clinical accuracy of the thermometer is in question. Turn on the

thermometer and insert into the water bath and then check the laboratory

accuracy. Please send the complete device to the dealers or manufacturer.

ASTM laboratory accuracy requirements in the display range of 98.6 to 102.2°F

(37.0 to 39.0°C) for electronic thermometers is ±0.2°F(±0.1°C).

The above recommendations do not supersede the legal requirements. The

user must always comply with legal requirements for the control of the

measurement, functionality, and accuracy of the device which are required by

the scope of relevant laws, directives or ordinances where the device is used.

FCC INFORMATION

Caution: Changes or modifications to this unit not expressly approved by the

party responsible for compliance could void the user authority to operate the

equipment.

*Note:

This equipment has been tested and found to comply with the limits for a Class

B digital device, pursuant to Part 15 of the FCC Rules. These limits are

designed to provide reasonable protection against harmful interference in a

residential installation. This equipment generates, uses, and can radiate radio

frequency energy. If this equipment does cause harmful interference to radio or

television reception, which can be determined by turning the equipment off and

on, the user is encouraged to try and correct the interference by one or more of

the following measures:

• Reorient or relocate the receiving antenna.

• Increase the distance between the equipment and the receiver.

• Connect the equipment to an outlet on a circuit different from that to which

the receiver is connected.

• Consult the dealer or an experienced radio/TV technician for help.

Disposal of this product and used batteries should be carried out

in accordance with the national regulations for the disposal of

electronic products.

BATTERY REPLACEMENT

1. Replace battery when “ ” appears in the lower right corner of LCD display.

2. Pull battery cover off as shown in Figure 3.

3. Gently pull out plastic circuit board with battery chamber approximately 1

cm (slightly less than1/2 in.) (See Figure 4)

4. Use pointed object such as a pen to remove old battery. Discard battery

lawfully. Replace with new 1.5V DC button type LR41 or SR41,UCC392, or

equivalent. Be sure battery is installed with “+” polarity facing up. (See

Figure 5)

5. Slide battery chamber back into place and attach cover.

WARNING

• Read instructions thoroughly before using digital thermometer.

• Choking Hazard: Thermometer cap and battery may be fatal if swallowed. 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.

• Do not place thermometer battery near extreme heat as it may explode.

• Note: Use of the probe cover may result in a 0.2ºF(0.1ºC) discrepancy from

actual temperature.

• 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 the rectum. Stop insertion and abort the

measurement when pain is present. Failure to do so may lead to injury.

• For children who are two years old or younger, please do not use the devices

orally.

• If the unit has been stored at temperatures over 104ºF (40ºC), leave it in

41ºF~104ºF (5ºC~40ºC) ambient temperature for about 15 minutes before

using it.

PLEASE READ CAREFULLY BEFORE USING

This digital thermometer provides a quick and highly accurate reading of an

individual's body temperature. The digital thermometer is intended to measure

the human body’s temperature in regular mode orally, rectally or under the

arm, and the device is reusable for clinical or home use on people of all ages.

To better understand its functions and to provide years of dependable results,

please read all instructions first.

This appliance 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 60601-1-11 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 and complies with the requirements

of IEC 60601-1-2(EMC), AAMI/ANSI ES60601-1(Safety) standards. And the

manufacturer is ISO 13485 certified.

CONTENTS

MFR #s 16-412GM-00, 16-413BGM-00, 16-413RGM-00, 16-413BGM,

16-413RGM, 16-415GMHT, and 16-415GMST come with 1 thermometer, 1

owner’s manual, 1 storage case, and 5 probe sheaths.

MFR #s 16-413BKGM and 16-413RKGM come with 1 thermometer, 1 owner’s

manual, 1 storage case, and 20 probe sheaths.

PRODUCT ILLUSTRATION

Digital Thermometers

OWNER’S MANUAL

For use with MFR #’s 16-412GM-00, 16-413BGM-00, 16-413RGM-00,

16-413BGM, 16-413RGM, 16-413BKGM, 16-413RKGM, 16-415GMHT,

and 16-415GMST.

PRECAUTION

*The performance of the device may be degraded 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. The device

needs special pre-cautions regarding EMC according to the EMC information

provided in the accompany documents.

*Do not use the devices in the MR environment.

SYMBOL EXPLANATION

SPECIFICATIONS

ºF/ºC SWITCHABLE

Temperature readings are available in the Fahrenheit or Celsius scale (ºF/ºC;

located in the upper right corner of LCD.) With the unit off, press and hold the

On/Off Button for approximately 2 seconds to change the current setting.

DIRECTIONS

1. Press the On/Off Button next to LCD display. A tone will sound as the screen

shows , followed by last recorded temperature. After showing the

self-test temperature, the thermometer is now in the testing mode.

2. Position thermometer in desired location (mouth, rectum, or armpit.)

a) Oral Use: Place thermometer under tongue as indicated by“√”

position shown in Figure 2. Close your mouth and breathe

evenly through the nose to prevent the measurement from

being influenced by inhaled/exhaled air. Normal temperature

between 96.3ºF and 99.1ºF (35.7ºC and 37.3ºC).

b) Rectal Use: Lubricate silver probe tip with petroleum jelly for easy

insertion. Gently insert sensor approximately 1cm (less than 1/2 in) into

rectum. Normal temperature between 97.2ºF and 99.9ºF

(36.2ºC and 37.7ºC).

c) Armpit Use: Wipe armpit dry. Place probe in armpit and keep arm

pressed firmly at side.

3. The degree sign flashes throughout the testing process. When flashing stops

an alarm will beep for approximately 10 seconds. The measured reading will

appear on the LCD simultaneously. The minimum measurement time until

the signaling tone (beep) must be maintained without exception. The

measurement continues even after the buzzer notification. So that in order

to achieve better body temperature measurement result, recommend to

keep the probe in mouth and rectum about 2 minutes, or in armpit about 5

minutes regardless of the beep sound and at least 30 seconds measurement

interval should be maintained.

*Note: Normally the buzzes are “Beep-Beep-Beep-Beep-”; Alarm beeps more

rapidly when temperature reaches 100ºF (37.8ºC) or higher, and the buzzes

are“Beep-Beep-Beep-------Beep-Beep-Beep-------Beep-Beep-Beep”

4. To prolong battery life, press the On/Off Button to turn unit off after testing is

complete. If no action is taken, the unit will automatically shut off after

around 10 minutes.

CLEANING AND DISINFECTION

Wipe the thermometer with a soft clean cloth.

For stubborn stains, wipe the thermometer with a cloth that has been

dampened with water or a neutral detergent solution and then wring

thoroughly. Finish by wiping with a soft dry cloth. For disinfection, 75% Ethanol

or Isopropyl alcohol can be used.

Observe the following to prevent damage to the thermometer.

• Do not use benzene, thinner, gasoline or other strong solvents to clean the

thermometer.

• Do not attempt to disinfect the sensing section (tip) of the thermometer by

immersing in alcohol or in hot water (water over 122ºF (50ºC)).

• Do not use ultrasonic washing to clean the thermometer.

LCD

Battery Cap

On/Off Button

Probe

16-412GM-00, 413 SERIES 415 SERIES