ZHCU623 January   2019

 

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2.4.4 System Accuracy

For compliance under the ISO-80601 and ASTM E1112 medical standards for intermittent patient temperature monitors, system accuracy must be verified using a liquid bath and a highly accurate reference. Table 2 shows a summary of these accuracy requirements as specified by ASTM E1112. The TMP117 is designed to exceed these requirements, but the designer must also consider the temperature offset caused by the integration of the device into a design for total system accuracy. A single-point calibration around the center of the desired range can specify accuracy within most systems, and this offset correction can be stored within the temperature offset register of the TMP117. The design accuracy for the BLE flex patch was tested in a sample set inside a liquid oil bath and was within the requirements listed in Table 2 without the need for any offset correction.

If an offset is necessary in production systems, the designer must test a statistically significant sample of the final product to determine the ideal offset for the TMP117.

Table 2. Temperature Accuracy Requirements Under ASTM E1112

Temperature (ºC) Maximum Error (ºC)
< 35.8 ± 0.3
35.8 - 37 ± 0.2
37.0 - 39.0 ± 0.1
39.0 - 41.0 ± 0.2
> 41.0 ± 0.3