7.3.2 Performance Test

ACUTE IDEAS CO.,LTD

QA Division

EN 12470 – 3 (2000) Test Report

Approved By Checked By Written By

Tony Peterpan Peterpan Model No： MT905/MT803

Sample Status: Mass Production

Quantity: 10 PCS

Test Result: Comply With The Requirement

Testing Report (Based on EN 12470-3:2000) Model﹕MT905/MT803 Page﹕2 of 13

Items Requirements Result Verdict

6.1 Probe cover If protective probe covers are

recommended or supplied,

the thermometer together

with the probe cover shall

meet the requirements

specified in the standard No probe cover is

supplied N.A

6.2 Metrological requirements

6.2.1 Measuring range﹕ The thermometer shall cover

the minimum measuring range from 35.5℃~42.0℃ 32.0℃~44℃ P

6.2.2 Digital increment﹕ Shall be 0.1℃ or less. 0.1℃ P

6.2.3 Maximum permissible error For measuring range 35.5℃

to 42.0℃ shall be 0.1℃

within the ambient 18℃to 28

℃. Outside the range shall not be greater than 0.2℃ See T0 P

6.2.4 Time response Thermometer at a

temperature of (23±2)℃ is immersed to (37

±1)℃ for 60s﹐the indicated

temperature shall not differ

from the reference

temperature by more than the

maximum permissible error See T1 P

6.2.5 Maximum energy dissipation The probe shall not cause an

increase in indicated

temperature by more than 0.01℃ ﹤0.01℃ P

6.2.6 Long term stability 55℃ 288h﹐or 80℃ 96h See T2 P

6.3 Environmental requirements

6.3.1 Ambient operating range The minimum ambient

operating

range of the thermometer shall be +10℃~+35℃ See T3 P

Testing Report (Based on EN 12470-3:2000) Model﹕MT905 /MT803Page﹕3 of 13

Items Requirements Result Verdict

6.3.2 Effect of storage

(24±1)h at －(25±2) ℃

(24±1)h at ﹢(25±2) ℃

(24±1)h at ﹢(55±2) ℃

(24±1)h at ﹢(25±2) ℃

(24±1)h at -(25±2) ℃ (With

package) After that﹐thermometer shall

comply with 6.2.3 See T4 P

6.3.3 Thermal shock

1h at a temperature of (0±2)

℃ 1h at a temperature of (55±2)

℃

Perform these test cycles five times After that﹐thermometer shall

comply with 6.2.3 See T5 P

6.3.4 Humidity 45℃﹐85% 48h

After that﹐thermometer shall

comply with 6.2.3 See T6 P

6.3.5 Electromagnetic compatibility

Shall comply with EN 60601-1-2 See 60601-1-2reporte P

6.3.6 Mechanical shock Drop from 1m height onto

hardwood (700Kg/m3). The drop

shall be performed once for each of

three physical orientations of the

complete thermometer. After that﹐thermometer shall

comply with 6.2.3 See T7 P

6.3.7 Water resistance a) The highest point of the

thermometer is located at least

15cm below the surface of the

water. b) The duration of the test is (30±1)

℃ After that﹐thermometer shall

comply with 6.2.3 NA NA

Testing Report (Based on EN 12470-3:2000) Model﹕MT905/MT803 Page﹕4 of 13

Items Requirements Result Verdict

6.4 Construction requirement

6.4.1 Functional units

6.4.1.1 Voltage limit indication Visual or auditory warning for

low battery. When the voltage is within the specified limits﹐

thermometer shall comply

with 6.2.3 See T8 P

6.4.1.2 (1) Numerical values on the display Shall be at least 4mm high or

optically magnified so as to

appear that height ＞4mm P

(2) After power on all segments shall be

activated For at least 1s ＞1s P

6.4.1.3 Functional safe test Shall have a self-testing

routine Yes P

6.4.2 Material Shall be free from biological

hazards Yes P

6.5 Electrical safety

6.6 Mechanical safety Shall comply with EN

60601-1 Yes P

6.6.1 Thermometer Thermometers shall not have

sharp ends or angles that

could injure the user or

patient.

The probe shall be smoothly

rounded in order to prevent

tissue damage during use. Yes P

6.6.2 Resistance to breakage A thermometer with a housing

of glass shall comply with

6.1.2.7 of EN 12470-1 N.A.

Summary﹕

The test result shows the thermometers under test comply with the requirement specified in the standard.

Abbreviation- P﹕Pass F﹕Fail N.A.﹕Not applicable N.T.﹕Not tested.

Testing Report (Based on EN 12470-3:2000)

Model﹕MT905/MT803 Page﹕5 of 13

Test Record (T0)

0. Normal

Ambient temperature﹕27℃ Humidity﹕55%R.H. Test Date﹕Aug 04﹐2009

32.20℃ 35.00℃ 37.00 ℃ 41.00℃ 42.00℃ NO

Measur

ed. Error Measur

ed. ErrorMeasur

ed. ErrorMeasur

ed. Error Measur

ed. Error

1 32.2 0.0 35.0 0.0 37.0 0.0 41.0 0.0 42.0 0.0

2 32.3 0.1 35.1 0.1 37.1 0.1 41.0 0.0 42.0 0.0

3 32.2 0.0 35.0 0.0 37.0 0.0 41.0 0.0 42.0 0.0

4 32.2 0.0 35.0 0.0 37.0 0.0 41.0 0.0 42.0 0.0

5 32.2 0.0 35.0 0.0 37.0 0.0 41.0 0.0 42.1 0.1

6 32.2 0.0 35.0 0.0 37.0 0.0 41.0 0.0 42.0 0.0

7 32.2 0.0 35.0 0.0 37.0 0.0 41.1 0.1 42.1 0.1

8 32.2 0.0 35.0 0.0 37.0 0.0 41.0 0.0 41.9 -0.1

9 32.2 0.0 35.0 0.0 37.0 0.0 41.0 0.0 42.0 0.0

10 32.2 0.0 35.0 0.0 37.0 0.0 41.0 0.0 42.0 0.0

Result﹕The maximum permissible error of the 10 samples under the normal condition are