(406 days)
No
The summary does not mention AI, ML, or any related concepts like training/test sets for algorithmic performance. The device description and performance studies focus on basic temperature measurement, safety, and biocompatibility.
No
The device is described as a "temperature detector" and its "Intended Use / Indications for Use" state it is "intended to measure the body temperature." While it measures a physiological parameter, it does not explicitly state an intention to treat or cure a disease or condition, which is a key characteristic of a therapeutic device.
Yes
The device is a thermometer, which is explicitly stated to "measure the body temperature," a common diagnostic parameter.
No
The device description explicitly mentions physical components that contact the user (elastic band, sensor head, silicone belt) and describes modifications to the physical device (addition of an elastic band). It also details performance tests related to hardware (mechanical shock, storage, biocompatibility).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "measure the body temperature on axillary region." This is a direct measurement of a physiological parameter (body temperature) from the body surface.
- Device Description: The device is described as a "temperature detector" that measures body temperature and transmits data. It involves a sensor that contacts the user's skin.
- Lack of IVD Characteristics: IVD devices are designed to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnostic purposes. This device does not involve the collection or analysis of such specimens.
The device is a medical device, specifically a thermometer, but it falls under the category of devices that measure physiological parameters directly from the body, not IVDs.
N/A
Intended Use / Indications for Use
TD-1035 Thermometer is a temperature detector which is intended to measure the body temperature on axillary region. The device is intended for population age of six months and above, which is designed for home use.
Product codes
FLL
Device Description
TD-1035 Thermometer is a temperature detector which is intended to measure the body temperature on axillary region, and transmit data to personnel device via Bluetooth pairing. The design concept is equivalent to the predicate device, K152680. There are two modifications made to the subject device: (1) indication for use (2) an elastic band was added. The elastic band is designed for more suitable and comfortable wearing. Moreover, the detected sensor contacts user skin directly, which is located on the silicone belt. The parts that contact the user are: (1) elastic band (2) sensor head (3) silicone belt.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
axillary region / Armpit
Indicated Patient Age Range
six months and above
Intended User / Care Setting
home use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Storage Test Report
- Study Type: Performance Test
- Intended Use: This report is intended to evaluate the accuracy of Thermometer after having been stored or transported within manufacturer's claimed range.
- Acceptance Criteria: The pass/fail criteria is to simulate the worst case of the transportation and the storage conditions of the device when exposing at -13°F and at 158°F environment. The greatest calculated error δ should not be greater than 0.09°F (0.05°C) between the measuring range from 95.00°F to 100.40°F (35.00°C to 38.00°C). The greatest calculated error δ should not be greater than 0.18°F (0.10°C) between the measuring range from 68.00°F to 94.98 °F (20.00°C to 34.99°C) and the measuring range from 100.42°F to 113.00°F (38.01°C to 45.00°C).
- Key Results: When error δ
§ 880.2910 Clinical electronic thermometer.
(a)
Identification. A clinical electronic thermometer is a device used to measure the body temperature of a patient by means of a transducer coupled with an electronic signal amplification, conditioning, and display unit. The transducer may be in a detachable probe with or without a disposable cover.(b)
Classification. Class II (performance standards). The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter, subject to the limitations in § 880.9 and the following conditions for exemption:(1) Device is not a clinical thermometer with telethermographic functions;
(2) Device is not a clinical thermometer with continuous temperature measurement functions; and
(3) Appropriate analysis and testing (such as that outlined in the currently FDA-recognized editions, as appropriate, of 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,” or ASTM E1965, “Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature,” or ASTM E1112, “Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature,” or ASTM E1104, “Standard Specification for Clinical Thermometer Probe Covers and Sheaths”) must validate specifications and performance of the device.
0
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October 22, 2018
TaiDoc Technology Corporation Sylvia Liu Regulatory Affairs Specialist B1-7F, No.127, Wugong 2nd Rd., Wugu District New Taipei City, 24888 Taiwan
Re: K172733
Trade/Device Name: TD-1035 Thermometer Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: September 14, 2018 Received: September 18, 2018
Dear Sylvia Liu:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice
(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Alan M.
Stevens -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K172733
Device Name TD-1035 Thermometer
Indications for Use (Describe)
TD-1035 Thermometer is a temperature detector which is intended to measure the body temperature on axillary region. The device is intended for population age of six months and above, which is designed for home use.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Image /page/3/Picture/3 description: The image shows the logo for TaiDoc. The logo consists of the word "TaiDoc" in gray font, followed by three red hearts. Below the hearts is the website address "www.taidoc.com" in white font on a gray background.
9. 510(k) Summary
This summary of 510(k) information is being submitted in accordance with the requirements of 21 CFR 807.92.
The Assigned 510(k) number is: K172733
| 1. Submitter Information | |
|---|---|
| Company Name: | TaiDoc Technology Corporation |
| Contact Person: | Sylvia Liu |
| Title: | Regulatory Affairs Specialist |
| Address: | B1-7F., No. 127, Wugong 2nd Rd., Wugu District, New Taipei |
| City 24888, TAIWAN | |
| Phone: | +886-2-6625-8188 #6134 |
| Fax: | +886-2-6625-0288 |
| E-mail: | Sylvia.liu@taidoc.com.tw |
| Prepared Date: | October 22, 2018 |
| 2. Device Name | |
| Proprietary Name: | TD-1035 Thermometer |
| Common Name: | Electronic Thermometer |
| Product Code: | FLL |
| Review Panel: | General Hospital |
| Device Class: | Class II |
| Regulation Number: | 21 CFR §880.2910 |
| 3. Predicate Device | |
| Proprietary Name: | TD-1035 Thermometer |
| 510(K) no. | K152680 |
4. Device Description
TD-1035 Thermometer is a temperature detector which is intended to measure the body temperature on axillary region, and transmit data to personnel device via Bluetooth pairing. The design concept is equivalent to the predicate device, K152680. There are two modifications made to the subject device: (1) indication for use (2) an elastic band was added. The elastic band is designed for more suitable and comfortable wearing. Moreover, the detected sensor contacts user skin directly, which is located on the silicone belt. The parts that contact the user are: (1) elastic band (2) sensor head (3) silicone belt.
Principle of Operation
As the Bluetooth (BT) signals the CPU to display the temperature measurement. The thermistor is the type of temperature sensor and the CPU is a control center to process the device function.
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The operating principle is based on differential temperature sending the signal to CPU which gets the signal than processes it and calculates the results.
5. Indications for Use
TD-1035 Thermometer is a temperature detector which is intended to measure the body temperature on axillary region. The device is intended for population age of six months and above, which is designed for home use.
6. Technological Characteristics
The concept of design is same as predicate product, K152680. There are two modifications were made to the proposed device: (1) indication for use (2) an elastic band was added. The modifications are changing the indication for use for population age of six months and above, which Thermometer is used at home. Also, the elastic band is design for more suitable and comfortable wearing.
5
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Tel : +886-2-6625-8188 Fax : +886-2-6625-0288
Table of Specification Comparison
| Item | Predicate device | Proposed device | Comparison |
|---|---|---|---|
| 510K Number | K152680 | K172733 | |
| Indication for Use | The TD-1035 Thermometer device is a | ||
| thermometer intended for body temperature | |||
| measurement at axillary temperature | |||
| measurement site. The device is intended for | |||
| measurement in patients 12 years and older in | |||
| a home use environment. | TD-1035 Thermometer is a temperature | ||
| detector which is intended to measure the | |||
| body temperature on axillary region. The | |||
| device is intended for population age of | |||
| six months and above, which is | |||
| designed for home use. | Similarity | ||
| Population | 12 years and older | Six months and above | Difference |
| Intended | |||
| Environment | Home use | Same as the predicate | Same |
| Item | Predicate device | Proposed device | Comparison |
| 510K Number | K152680 | K172733 | |
| Principles of operation | The Temperature Monitor detects the body | ||
| temperature by thermistor which provides | |||
| signals to the microcontroller where signals are | |||
| converted into a digital temperature value that | |||
| displayed in LCD screen. The thermistor is as a | |||
| temperature sensor and the microcontroller is | |||
| used for signal processing. The basic operating | |||
| principle is that a change of thermistor caused | |||
| by changes of temperature provides a signal to | |||
| the microcontroller which gets the signal than | |||
| processes it and calculates the results. | Same as the predicate | Same | |
| General Functions | |||
| Low temperature display | 109.40°F (43.00°C):Display: Hi °F (Hi °C) | Same as the predicate | Same |
| Measurement area | Armpit | Same as the predicate | Same |
| Measurement units | °C or °F | Same as the predicate | Same |
| Power source | one 3V CR2032 lithium battery | Same as the predicate | Same |
| Battery life | Approx. 25 days (1 time measurement/day) | Same as the predicate | Same |
| Beeper | None | Same as the predicate | Same |
| Operating condition | 41°F to 104°F (5°C to 40°C);15% to 93% R.H. | Same as the predicate | Same |
| Item | Predicate device | Proposed device | Comparison |
| 510K Number | K152680 | K172733 | |
| Storage condition | -13°F to 158°F (-25°C to 70°C);10% to 95% | ||
| R.H. | Same as the predicate | Same | |
| Data transmission | Bluetooth | Same as the predicate | Same |
| Dimensions (mm) | 40.5 (L) x 27.5 (W) x 11.7 (H) | Same as the predicate | Same |
| Weight (g) | 18 g | Same as the predicate | Same |
| Outer casing | On/off button, LCD display, armband | Same as the predicate | Same |
| Atmospheric | |||
| pressure range | 700 hPa to 1060 hPa | Same as the predicate | Same |
| Operation altitude | 2000 m | Same as the predicate | Same |
| Expected service life | 3 years | Same as the predicate | Same |
| Type BF applied | |||
| part | Type BF Applied part | Same as the predicate | Same |
| Safety | IEC 60601-1 | Same as the predicate | Same |
| EMC | IEC 60601-1-2 | Same as the predicate | Same |
| Harmonized | |||
| standard | ISO 80601-2-52:2009 | Same as the predicate | Same |
| Water-resistance | IP22 | Same as the predicate | Same |
| Material Description | |||
| Top and Bottom | |||
| Case | ABS | Same as the predicate | Same |
| Battery Cover | ABS | Same as the predicate | Same |
| M-Key | Silicone | Same as the predicate | Same |
| Lens | PC | Same as the predicate | Same |
| Stainless Steel Cap | |||
| (Patient Contact Part) | SUS304 | Same as the predicate | Same |
| Silicone Belt | |||
| (Patient Contact Part) | Silicone | Same as the predicate | Same |
| Item | Predicate device | Proposed device | Comparison |
| 510K Number | K152680 | K172733 | |
| Elastic Band | |||
| (Patient Contact Part) | NA | Nylon & Polyester 190D/Polyester 230g | Difference |
| Biocompatibility Information | |||
| Description | TD-1035 Thermometer detect the temperature by contact to user skin directly, which the contact time shall less than 24 | ||
| hours. A part of silicone belt which is connected with sensor, without cover of the elastic band, located on the back on | |||
| device and contact to user skin directly. | |||
| Standard | ISO 10993-1 | ||
| ISO 10993-5 | |||
| ISO 10993-10 | |||
| ISO 10993-12 | |||
| Patient Contact | |||
| Parts | Stainless Steel Cap, Silicone belt | Stainless Steel Cap, Silicone belt, Elastic | |
| band | Similarity | ||
| Patient Contact Material Information | |||
| Stainless Steel Cap | SUS 304 | Same as the predicate | Same |
| Silicone Belt | Silicone | Same as the predicate | Same |
| Elastic Band | NA | Nylon & Polyester 190D/Polyester 230g | Difference |
6
Image /page/6/Picture/0 description: The image contains the word "TaiDoc" in gray font. Below the word are three red hearts in a row. The hearts are all the same size and shape.
新北市24888五股區五工二路127號6樓 6F., No.127, Wugong 2nd Rd., Wugu Dist., New Taipei City 24888, Taiwan
Tel : +886-2-6625-8188 Fax : +886-2-6625-0288
7
Image /page/7/Picture/0 description: The image shows the word "TaiDoc" in gray font. Below the word are three red hearts in a row. The hearts are evenly spaced and appear to be a design element associated with the text above.
泰博科技股份有限公司 新北市24888五股區五工二路127號6樓 6F., No.127, Wugong 2nd Rd., Wugu Dist., TaiDoc Technology Corp. New Taipei City 24888, Taiwan
Tel : +886-2-6625-8188 Fax : +886-2-6625-0288
8
Image /page/8/Picture/0 description: The image shows the word "TaiDoc" in gray font. Below the word are three red hearts in a row. The hearts are evenly spaced and appear to be the same size.
Tel : +886-2-6625-8188 Fax : +886-2-6625-0288
9
Image /page/9/Picture/0 description: The image shows the logo for TaiDoc. The logo consists of the word "TaiDoc" in gray letters above three red hearts. Below the hearts is the website address "www.taidoc.com" in white letters on a gray background.
Tel · +886-7-6675
Discussion
The conceptual design of the subject device K172733 is similar with the predicate device K152680, which has the additional component of elastic band.
Considering the user individual circumstances which the predicate device (K152680) could cause the risk of uncomfortable wearing under the long-term effects of temperature monitoring because of the silicone belt has fixed holes size and holes number that are fewer armpit adjustment space. Thus, to modify this issue that the additional elastic band design of the proposal device( K172733) has more space for users to adjust the device wearing, and let the thermo-detector effectively contact the user skin. Additionally, the temperature measurement accuracy of the subject device K172733 have met the criteria of the 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.
Also, each parts of the subject device materials passed the biocompatibility test. Furthermore, the clinical trials have demonstrated that the subject device has met the temperature measurement criteria of ISO 80601-2-56. Overall, the performance tests demonstrate the elastic band does not impact device performance.
Conclusions
The concept of design is similar to the predicate device. K152680, which is a detector to measure the body temperature on axillary region, and transmit data to personal device via Bluetooth pairing. There are two modifications were made to the subject device: (1) indication for use (2) an elastic band was added. The elastic band is design for more suitable and comfortable wearing. Moreover, the temperature sensor is still contacting the user skin directly, which is located on the silicone belt.
The material of elastic band has passed the biocompatibility test. Also, the arm girth of elastic band is adjustable for users to apply on the axillary, and more convenient for using on children by guardian. A part of the silicone belt, which is connected with sensor, without cover of the elastic band, located on the back of device and contact to user skin directly. Overall, the performance tests demonstrate that the elastic band does not impact device performance.
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Image /page/10/Picture/0 description: The image shows the logo for TaiDoc, a company that specializes in medical devices. The logo consists of the word "TaiDoc" in gray letters, followed by three red hearts. Below the hearts is the company's website address, "www.taidoc.com", also in gray letters. The background of the logo is white.
新北市24888五股區五工二路127號6樓 6F., No.127, Wugong 2nd Rd., Wugu Dist., New Taipei City 24888, Taiwan
Tel : +886-2-6625-8188 Fax : +886-2-6625-0288
7. Performance Data
| Attachment | Standard | Title | Intended Use | Acceptance Criteria | Results |
|---|---|---|---|---|---|
| A1.1 | IEC62304 | Medical device | |||
| software - Software | |||||
| life cycle processes | This validation is to test for product by | ||||
| itself to verify software is safe for | |||||
| patients using the medical device or not. | The pass/fail criteria is to | ||||
| evaluate the safety and | |||||
| effectiveness of software | |||||
| are met the device's | |||||
| indication for use. | PASS | ||||
| A1.2 | IEC | ||||
| 60601-1 | General requirements | ||||
| for basic safety and | |||||
| essential performance | This study is to test for the basic safety | ||||
| and essential performance of medical | |||||
| electrical equipment and medical | |||||
| electrical systems which are intended by | |||||
| their manufacturer for use. | The pass/fail criteria is to | ||||
| evaluate the basic safety | |||||
| and essential performance | |||||
| of medical electrical | |||||
| equipment and medical | |||||
| electrical systems. | PASS | ||||
| A1.3 | IEC | ||||
| 60601-1- | |||||
| 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 | This study is to evaluate to the basic | ||||
| safety and essential performance of | |||||
| medical electrical equipment and medical | |||||
| electrical systems which are intended by | |||||
| their manufacturer for use in the home | |||||
| healthcare environment, regardless of | |||||
| whether the medical electrical equipment | |||||
| or medical electrical system is intended | |||||
| for use by a lay operator or by trained | |||||
| healthcare personnel. | The pass/fail criteria is to | ||||
| evaluate the basic safety | |||||
| and essential performance | |||||
| of medical electrical | |||||
| equipment and medical | |||||
| electrical systems for use | |||||
| in the home healthcare | |||||
| environment. | PASS | ||||
| A1.4 | IEC | ||||
| 60601-1- | |||||
| 2 | EMC Test Report | IEC 60601-1-2:2014 applies to the basic | |||
| safety and essential performance of | |||||
| Medical Equipment (ME) equipment and | |||||
| ME systems in the presence of | |||||
| electromagnetic disturbances and to | The pass/fail criteria is | ||||
| limited to maintain the | |||||
| Essential Performance | |||||
| and Basic Safety of EMC | |||||
| requirements. | PASS | ||||
| electromagnetic disturbances emitted by | |||||
| me equipment and me systems. | |||||
| A2.1 | ISO | ||||
| 14971 | Risk Management | ||||
| Report | The failure of the function resulting in | ||||
| wrong analytical result which may have | |||||
| serious impairment to the health of a | |||||
| patient may happen. Control measures | |||||
| were taken to reduce the risk to as | |||||
| minimum as possible. Safety and | |||||
| effectiveness of use about the system was | |||||
| then verified. | The risk criteria were | ||||
| established when setting | |||||
| the context, the level of | |||||
| risk would against this | |||||
| criteria in order to | |||||
| determine whether the | |||||
| risk is acceptable. | Overall | ||||
| the risks | |||||
| are | |||||
| acceptable |
11
Image /page/11/Picture/0 description: The image shows the logo for TaiDoc. The text "TaiDoc" is written in gray, with three red heart shapes underneath the text. The hearts are evenly spaced and aligned horizontally.
泰博科技股份有限公司 新北市24888五股區五工二路127號6樓 6F., No.127, Wugong 2nd Rd., Wugu Dist., TaiDoc Technology Corp. New Taipei City 24888, Taiwan
Tel : +886-2-6625-8188 Fax : +886-2-6625-0288
General Performance Test:
| Attachment | Standard | Title | Intended Use | Acceptance Criteria | Results |
|---|---|---|---|---|---|
| A1.5 | ISO | ||||
| 80601-2- | |||||
| 56 | Storage Test | ||||
| Report | This report is intended to | ||||
| evaluate the accuracy of | |||||
| Thermometer after having been | |||||
| stored or transported within | |||||
| manufacturer's claimed range. | The pass/fail criteria is to simulate the worst | ||||
| case of the transportation and the storage | |||||
| conditions of the device when exposing at - | |||||
| -13°F and at 158°F environment. | |||||
| The greatest calculated error δ should not | |||||
| be greater than 0.09°F (0.05°C) between | |||||
| the measuring range from 95.00°F to | |||||
| 100.40°F (35.00°C to 38.00°C). The greatest calculated error δ should not | |||||
| be greater than 0.18°F (0.10°C) between | |||||
| the measuring range from 68.00°F to 94.98 | |||||
| °F (20.00°C to 34.99°C) and the measuring | |||||
| range from 100.42°F to 113.00°F (38.01 | |||||
| °C to 45.00°C). | When error | ||||
| δ |