3.2.9IR thermometer ,n —optoelectro

3.2.9IR thermometer ,n —optoelectronic instrument that is capable of noncontact infrared temperature measurement when placed into the auditory canal of a subject (ear canal type)or from the subject’s body surface (skin type).3.2.10transducer ,n —device that provides a measurable output (for example,resistance,emf,etc.)as a function of temperature.4.Requirements4.1Temperature range —As a minimum,the instrument shall display temperature over the following range:35.5to 41.0°C [96.0to 106.0°F].4.2Accuracy —Within the manufacturer’s specified tem-perature range for patient temperature measurement,no indi-vidual reading shall be in error by more than the values shown in Table 1.4.3Environment :4.3.1Operating Environment —The instrument must meet the accuracy requirements of 4.2when operated in an environ-ment of 16to 40°C [60.8to 104°F]and a relative humidity of 15to 95%noncondensing.4.3.2Storage Environment —The instrument shall meet the requirements of 4.2after having been stored or transported,or both,at any point in an environment of −20to 50°C [−4to 120°F],and a relative humidity of 15to 95%,noncondensing,for a period of one month.4.3.3Labeling —The instruction manual shall include a statement that informs the user if the performance of the device may be degraded should one or more of the following occur:4.3.3.1Operation outside the manufacturer’s stated tem-perature and humidity range.4.3.3.2Storage outside the manufacturer’s stated tempera-ture and humidity range.4.3.3.3Mechanical shock (for example,drop test).4.3.3.4Patient temperature is below ambient temperature (operating environment see 4.3.1).4.4Resolution :4.4.1Analog Display :4.4.1.1Celsius Graduations —Celsius display thermometers shall be graduated in intervals of not greater than 0.1°C.All full-degree graduations shall be long time.Half-degree gradu-ations may be long lines.All other graduations shall be short lines (see 4.4.1.3).As a minimum,appropriate numerals shall be at every full-degree graduation except the numeral 37,which is optional (see 4.4.1.5).Graduation lines shall be spaced at least 0.50mm [0.02in.]center to center.4.4.1.2Fahrenheit Graduations —Fahrenheit display ther-mometers shall be graduated in intervals of not greater than 0.2°F.All full-degree graduations shall be long lines (see 4.4.1.3and 4.4.1.5).Half-degree graduations may be long lines.All other graduations shall be short lines.Appropriate numerals shall be placed as a minimum at every even degree graduation.Graduation lines shall be spaced at least 0.55mm [0.022in.]center to center.4.4.1.3Scales Graduation Marks —All short graduation lines shall not be less than 1.3mm [0.05in.]in length.All long graduation lines shall be no less than 25%longer than the short lines.The lines shall be essentially straight and in line with the pointer.They shall not be wider than the spaces between the graduations,nor wider than 0.45mm [0.018in.]and shall not be narrower than 0.10mm [0.004in.].4.4.1.4Pointer Width —The pointer shall have a maximum width of one-half of the spacing between graduation marks (see 4.4.1.1or 4.4.1.2).4.4.1.5Reference Marking —The line at 37°C [98.6°F]may be designated by an arrow or other suitable mark.If a reference mark is used,the position shall be within a tolerance of one-half of the minimum graduated interval.4.4.2Digital Display :4.4.2.1Resolution —The digital display shall have incre-mental steps of not more than 0.1°C or 0.1°F.4.4.2.2Readability —At the outside surface of the instru-ment,the numerals shall appear to be at least 2.5mm [0.1in.]high and 1.5mm [0.059in.]wide and appear to be separated from one another by a space of at least 0.7mm [0.027in.].4.5Battery Condition —When battery operated,the instru-ment accuracy and condition shall not be affected by battery condition unless a continuous automatic indication of unreli-able condition is provided.The indication of unreliable condi-tion must be presented until the battery condition is corrected.When an instrument uses a rechargeable battery,a position indication shall be provided with the instrument system to indicate that the battery is charging.4.6Construction :4.6.1Electrical —The instrument and accessories (such as battery chargers)shall meet the electrical safety requirements of UL 544(see5.3).4.6.2Material :4.6.2.1Case Material —The case material of the instrument and nondisposable accessories shall withstand biological and physical cleaning without performance degradation (see5.2).It shall also withstand dropping without presenting an electrical safety hazard.4.6.2.2Patient Contact Materials —Those parts of the elec-tronic thermometer system intended for contact with anatomi-cal sites for the purpose of temperature measurement as specified by the manufacturer shall be nontoxic (see5.3).4.7Marking —All markings for purposes of identification or instruction must be clear and legible.Deterioration shall not occur when subjected to cleaning (see 5.2).4.7.1Instrument Marking —The instrument shall be marked with the manufacturer’s or distributor’s name,model designa-tion,serial number or lot number (to indicate the specific period,not to exceed 90days,in which the thermometer wasTABLE 1Maximum Error Temperature RangesTemperatureMaximum ErrorCelsius Scale:Less than 35.8°C60.3°C 35.8°C to less than 37°C 60.2°C 37.0°C to 39.0°C60.1°C Greater than 39.0°C to 41.0°C 60.2°C Greater than 41.0°C 60.3°C Fahrenheit Scale:Less than 96.4°F60.5°F 96.4°F to less than 98.0°F 60.3°F 98.0°F to 102.0°F60.2°F Greater than 102.0°F to 106.0°F 60.3°F Greater than 106.0°F6