Software Technology for “Non-contact medical thermometer for distance sensing and compensation.”

Medical Device – Aleksan Yildizyan, Jiawei Hu, Charles Squires, James Christopher Gorsich, Helen of Troy Ltd

Abstract for “Non-contact medical thermometer for distance sensing and compensation.”

“A non-contact medical thermometer” is disclosed. It includes an IR sensor assembly for sensing IR radiation from a targeted, a distance sensor to determine the distance of the thermometer from that target, and a memory part operatively coupled to at least the IR sensor assemblies and the distance sensors. Predetermined compensation information is stored in the memory component that corresponds to predetermined temperatures for targets and predetermined distances from predetermined targets. The memory component is operationally coupled with a microprocessor. The microprocessor can perform temperature calculations based upon the IR radiation from target, distance of thermometer from target and predetermined compensation information.

Background for “Non-contact medical thermometer for distance sensing and compensation.”

According to different embodiments of the invention, a non-contact IR thermometer includes an IR sensor and a distance sensor. A microprocessor is also included. The memory can communicate with the microprocessor. An interface device that receives inputs from the microprocessor is also included. The memory may include compensation information such as a look-up table, mathematical equation, or other information that can be used to calculate a compensated temperature for a body portion based on measurements of another body part. The compensation information could be used, for example, to calculate a compensated temperature for a forehead using a measured temperature. The compensation information can also be used to calculate a compensated oral temperature or equivalent temperature using a forehead temperature. The IR thermometer can be set up to simultaneously measure the temperature of the target, ambient temperature, temperature of thermometer, as well as distance between thermometer and target. These values may be combined with the compensation information to calculate a temperature compensated and communicate it to the user interface device. This device may then communicate the compensated temperature to a person.

“Remote IR thermometer” is described. It includes an IR sensor package, or assembly, with at least one IR sensor and a temperature sensor, a radiation emitter device and receiver device, a microprocessor and a memory containing compensation data, which can communicate with the microprocessor. A user interface device that receives inputs from the microprocessor. Below are several examples that illustrate principles according to various embodiments of this invention. The claims and equivalents should be considered the only limit to the invention’s scope. Examples are not intended to limit it.

“FIG. “FIG. This embodiment comprises an IR sensor package/assembly 12 and a distance sensor 14. A microprocessor 16 and memory 18 are included. 20 is an interface device for the user. 22 is housing 22. Housing 22 includes all the components and at least one button. It also contains a circuit board with an electronics circuit and a power supply.

“IR sensor package/assembly 12, which includes an IR sensor, and in some embodiments, a thermometer for sensing temperature of the IR sensors and/or temperature of the surrounding environment, 12” The IR sensor captures thermal radiation from a target object, or part of a target, and converts it into an electrical temperature signal. This signal is communicated to microprocessor 16 along with a signal about the temperature of IR sensor measured by temperature sensor. Distance sensor 14 can emit radiation from IR thermometer 10, and capture at most a portion the reflected radiation from the target. This is then converted into an electric distance signal, and communicated with microprocessor 16. Microprocessor 16 can, among other functions, determine a target temperature based upon the signal from IR package/assembly 12. Determine an ambient temperature or thermometer temperature. It also determines a distance value corresponding with the distance between IR temperature sensor 10 and target using a correlation program based on signal from distance sensor 14. The characteristics of the reflected radiation are also used to calculate this distance value. Memory 18 may store, in various ways, the temperature signal and distance signal, as well as any combination thereof, according to different embodiments.

“For example, where d is defined as a distance between the target and IR thermometer 10, the predetermined compensation information for obtaining a compensated temperature in degrees Fahrenheit may be a linear function or functions defined by the following relationships:\nCompensated Temperature=Target Temperature+A*d+B\nor\nCompensated Temperature=Target Temperature+C*d+D {for 0

“It is also possible for the mathematical function to be of a higher degree or order, for example, a mathematical function that is non-linear with respect to the measured distance to obtain the compensated temperature, such as the following quadratic equation:\nCompensated Temperature=Target Temperature+G*d 2 ?H*d+L\nWhere G, H, and L are coefficients determined from the clinical tests. The following approximate and exemplary values of the coefficients are given for illustration purposes only. As ordinary skilled persons in the art will recognize, different values may be used for each coefficient depending on design aspects and other aspects of an IR thermometer 10.

“In some embodiments, compensation information can be provided in the form a look-up list. This may be derived from information such as distance measured and target temperature measured. If the measured values do not match the table values, then the nearest table value may be used or additional values may be interpolated from table values. Other embodiments may use a combination of several approaches to compensate (e.g., mathematical functions, offset values, look-up tables).

Microprocessor 16 can use a temperature value corresponding with a target and a distance to calculate a compensated temperature by using predetermined compensation information stored within memory 18. Microprocessor 16 can be configured to use an ambient temperature and/or thermometer temperature for this purpose in some embodiments. The predetermined compensation information in some embodiments may be partly based on temperature. Microprocessor 16 can be configured to calculate a compensation temperature for those embodiments that include predetermined information about oral or equivalent temperatures.

“Microprocessor 16 can also store compensated temperature values in memory 18, and communicate them to the user interface device 20. The microprocessor can also be configured to interpolate additional value from values in a lookup table stored in memory 18. The user interface device 20 can communicate the compensated temperatures value to a person. User interface device 20 could include, for example, a display that displays at least the compensated temperatures value, and/or a speaker that makes an audible sound, such as sounding an alarm or speaking the compensated thermo value.

Referring to FIG. “Referring to FIG. 2 The flow chart illustrates an embodiment of a method that determines a compensated temp based on the measured temperature of a subject on that subject. Step 102 is where the process of determining the compensated temperatures begins. This can be done by pressing a start button to activate an IR thermometer. Step 104 uses distance sensor 14 to emit radiation and collect reflected radiation from a target in order to generate a distance signal that is sent to microprocessor 16. Microprocessor 16 calculates distance values from distance signals. This information may be stored in memory by microprocessor 16. Step 106 is where IR sensor package/assembly 12, which captures thermal radiation from the target, generates a temperature signal and optionally captures an ambient or thermometer temperature. These are transmitted to microprocessor 16. Microprocessor 16 calculates the temperature value using the temperature signal. This temperature value may be stored in microprocessor 16. Optional step 108 is when predetermined compensation information contains a look-uptable. Microprocessor 16 calculates the relationship between distance and temperature values using predetermined compens information. Microprocessor 16 calculates a compensated temperature value using predetermined compensation information in step 110. The microprocessor 16 stores the compensated temperatures in memory 18 at step 112. The compensated temperature value for step 114 is communicated to the user interface 20.

“While various embodiments have been shown and described, it is clear to those skilled in art that they can be modified in form and details without affecting the spirit or scope of the invention. These embodiments of the invention are not intended to limit the scope of the invention. The invention should therefore be understood only in terms of the claims and equivalents.

Summary for “Non-contact medical thermometer for distance sensing and compensation.”

According to different embodiments of the invention, a non-contact IR thermometer includes an IR sensor and a distance sensor. A microprocessor is also included. The memory can communicate with the microprocessor. An interface device that receives inputs from the microprocessor is also included. The memory may include compensation information such as a look-up table, mathematical equation, or other information that can be used to calculate a compensated temperature for a body portion based on measurements of another body part. The compensation information could be used, for example, to calculate a compensated temperature for a forehead using a measured temperature. The compensation information can also be used to calculate a compensated oral temperature or equivalent temperature using a forehead temperature. The IR thermometer can be set up to simultaneously measure the temperature of the target, ambient temperature, temperature of thermometer, as well as distance between thermometer and target. These values may be combined with the compensation information to calculate a temperature compensated and communicate it to the user interface device. This device may then communicate the compensated temperature to a person.

“Remote IR thermometer” is described. It includes an IR sensor package, or assembly, with at least one IR sensor and a temperature sensor, a radiation emitter device and receiver device, a microprocessor and a memory containing compensation data, which can communicate with the microprocessor. A user interface device that receives inputs from the microprocessor. Below are several examples that illustrate principles according to various embodiments of this invention. The claims and equivalents should be considered the only limit to the invention’s scope. Examples are not intended to limit it.

“FIG. “FIG. This embodiment comprises an IR sensor package/assembly 12 and a distance sensor 14. A microprocessor 16 and memory 18 are included. 20 is an interface device for the user. 22 is housing 22. Housing 22 includes all the components and at least one button. It also contains a circuit board with an electronics circuit and a power supply.

“IR sensor package/assembly 12, which includes an IR sensor, and in some embodiments, a thermometer for sensing temperature of the IR sensors and/or temperature of the surrounding environment, 12” The IR sensor captures thermal radiation from a target object, or part of a target, and converts it into an electrical temperature signal. This signal is communicated to microprocessor 16 along with a signal about the temperature of IR sensor measured by temperature sensor. Distance sensor 14 can emit radiation from IR thermometer 10, and capture at most a portion the reflected radiation from the target. This is then converted into an electric distance signal, and communicated with microprocessor 16. Microprocessor 16 can, among other functions, determine a target temperature based upon the signal from IR package/assembly 12. Determine an ambient temperature or thermometer temperature. It also determines a distance value corresponding with the distance between IR temperature sensor 10 and target using a correlation program based on signal from distance sensor 14. The characteristics of the reflected radiation are also used to calculate this distance value. Memory 18 may store, in various ways, the temperature signal and distance signal, as well as any combination thereof, according to different embodiments.

“For example, where d is defined as a distance between the target and IR thermometer 10, the predetermined compensation information for obtaining a compensated temperature in degrees Fahrenheit may be a linear function or functions defined by the following relationships:\nCompensated Temperature=Target Temperature+A*d+B\nor\nCompensated Temperature=Target Temperature+C*d+D {for 0

“It is also possible for the mathematical function to be of a higher degree or order, for example, a mathematical function that is non-linear with respect to the measured distance to obtain the compensated temperature, such as the following quadratic equation:\nCompensated Temperature=Target Temperature+G*d 2 ?H*d+L\nWhere G, H, and L are coefficients determined from the clinical tests. The following approximate and exemplary values of the coefficients are given for illustration purposes only. As ordinary skilled persons in the art will recognize, different values may be used for each coefficient depending on design aspects and other aspects of an IR thermometer 10.

“In some embodiments, compensation information can be provided in the form a look-up list. This may be derived from information such as distance measured and target temperature measured. If the measured values do not match the table values, then the nearest table value may be used or additional values may be interpolated from table values. Other embodiments may use a combination of several approaches to compensate (e.g., mathematical functions, offset values, look-up tables).

Microprocessor 16 can use a temperature value corresponding with a target and a distance to calculate a compensated temperature by using predetermined compensation information stored within memory 18. Microprocessor 16 can be configured to use an ambient temperature and/or thermometer temperature for this purpose in some embodiments. The predetermined compensation information in some embodiments may be partly based on temperature. Microprocessor 16 can be configured to calculate a compensation temperature for those embodiments that include predetermined information about oral or equivalent temperatures.

“Microprocessor 16 can also store compensated temperature values in memory 18, and communicate them to the user interface device 20. The microprocessor can also be configured to interpolate additional value from values in a lookup table stored in memory 18. The user interface device 20 can communicate the compensated temperatures value to a person. User interface device 20 could include, for example, a display that displays at least the compensated temperatures value, and/or a speaker that makes an audible sound, such as sounding an alarm or speaking the compensated thermo value.

Referring to FIG. “Referring to FIG. 2 The flow chart illustrates an embodiment of a method that determines a compensated temp based on the measured temperature of a subject on that subject. Step 102 is where the process of determining the compensated temperatures begins. This can be done by pressing a start button to activate an IR thermometer. Step 104 uses distance sensor 14 to emit radiation and collect reflected radiation from a target in order to generate a distance signal that is sent to microprocessor 16. Microprocessor 16 calculates distance values from distance signals. This information may be stored in memory by microprocessor 16. Step 106 is where IR sensor package/assembly 12, which captures thermal radiation from the target, generates a temperature signal and optionally captures an ambient or thermometer temperature. These are transmitted to microprocessor 16. Microprocessor 16 calculates the temperature value using the temperature signal. This temperature value may be stored in microprocessor 16. Optional step 108 is when predetermined compensation information contains a look-uptable. Microprocessor 16 calculates the relationship between distance and temperature values using predetermined compens information. Microprocessor 16 calculates a compensated temperature value using predetermined compensation information in step 110. The microprocessor 16 stores the compensated temperatures in memory 18 at step 112. The compensated temperature value for step 114 is communicated to the user interface 20.

“While various embodiments have been shown and described, it is clear to those skilled in art that they can be modified in form and details without affecting the spirit or scope of the invention. These embodiments of the invention are not intended to limit the scope of the invention. The invention should therefore be understood only in terms of the claims and equivalents.

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What is a software medical device?

The FDA can refer to software functions that include ” Software As a Medical Device” and “Software in a Medical Device(SiMD)”, which are software functions that are integral to (embedded in a) a medical device.

Section 201(h),?21 U.S.C. 321(h),(1) defines a medical device to be?an apparatus, implements, machine, contrivances, implant, in vitro regulator, or other similar or related articles, as well as a component or accessory. . . (b) is intended for diagnosis or treatment of disease or other conditions in humans or animals. (c) Is intended to alter the structure or function of human bodies or animals. To be considered a medical device, and thus subject to FDA regulation, the software must meet at least one of these criteria:

• It must be used in diagnosing and treating patients.
• It must not be designed to alter the structure or function of the body.

If your software is designed to be used by healthcare professionals to diagnose, treat, or manage patient information in hospitals, the FDA will likely consider such software to be medical devices that are subject to regulatory review.

Is Your Software a Medical Device?

FDA’s current oversight, which puts more emphasis on the functionality of the software than the platform, will ensure that FDA does not regulate medical devices with functionality that could be dangerous to patient safety. Examples of Device Software and Mobile Medical Apps FDA is focused on

• Software functions that aid patients with diagnosed mental disorders (e.g., depression, anxiety, and post-traumatic stress disorder (PTSD), etc.) by providing “Skill of the Day”, a behavioral technique, or audio messages, that the user can access when they are experiencing anxiety.
• Software functions that offer periodic reminders, motivational guidance, and educational information to patients who are recovering from addiction or smokers trying to quit;
• Software functions that use GPS location data to alert asthmatics when they are near high-risk locations (substance abusers), or to alert them of potential environmental conditions that could cause symptoms.
• Software that uses video and games to encourage patients to exercise at home.
• Software functions that prompt users to choose which herb or drug they wish to take simultaneously. They also provide information about interactions and give a summary of the type of interaction reported.
• Software functions that take into account patient characteristics, such as gender, age, and risk factors, to offer patient-specific counseling, screening, and prevention recommendations from established and well-respected authorities.
• Software functions that use a list of common symptoms and signs to give advice about when to see a doctor and what to do next.
• Software functions that help users to navigate through a questionnaire about symptoms and to make a recommendation on the best type of healthcare facility for them.
• These mobile apps allow users to make pre-specified nurse calls or emergency calls using broadband or cell phone technology.
• Apps that allow patients or caregivers to send emergency notifications to first responders via mobile phones
• Software that tracks medications and provides user-configured reminders to improve medication adherence.
• Software functions that give patients access to their health information. This includes historical trending and comparisons of vital signs (e.g. body temperature, heart rate or blood pressure).
• Software functions that display trends in personal healthcare incidents (e.g. hospitalization rates or alert notification rate)
• Software functions allow users to electronically or manually enter blood pressure data, and to share it via e-mail, track it and trend it, and upload it to an electronic or personal health record.
• Apps that offer mobile apps for tracking and reminders about oral health or tools to track users suffering from gum disease.
• Apps that offer mobile guidance and tools for prediabetes patients;
• Apps that allow users to display images and other messages on their mobile devices, which can be used by substance abusers who want to quit addictive behaviors.
• Software functions that provide drug interaction and safety information (side effects and drug interactions, active ingredient, active ingredient) in a report based upon demographic data (age and gender), current diagnosis (current medications), and clinical information (current treatment).
• Software functions that allow the surgeon to determine the best intraocular lens powers for the patient and the axis of implantation. This information is based on the surgeon’s inputs (e.g., expected surgically induced astigmatism and patient’s axial length, preoperative corneal astigmatism etc.).
• Software, usually mobile apps, converts a mobile platform into a regulated medical device.
• Software that connects with a mobile platform via a sensor or lead to measure and display electrical signals from the heart (electrocardiograph; ECG).
• Software that attaches a sensor or other tools to the mobile platform to view, record and analyze eye movements to diagnose balance disorders
• Software that collects information about potential donors and transmits it to a blood collection facility. This software determines if a donor is eligible to collect blood or other components.
• Software that connects to an existing device type in order to control its operation, function, or energy source.
• Software that alters or disables the functions of an infusion pump
• Software that controls the inflation or deflation of a blood pressure cuff
• Software that calibrates hearing aids and assesses sound intensity characteristics and electroacoustic frequency of hearing aids.

What does it mean if your software/SaaS is classified as a medical device?

SaaS founders need to be aware of the compliance risks that medical devices pose. Data breaches are one of the biggest risks. Medical devices often contain sensitive patient data, which is why they are subject to strict regulations. This data could lead to devastating consequences if it were to become unprotected. SaaS companies who develop medical devices need to take extra precautions to ensure their products are safe.

So who needs to apply for FDA clearance? The FDA defines a ?mobile medical app manufacturer? is any person or entity who initiates specifications, designs, labels, or creates a software system or application for a regulated medical device in whole or from multiple software components. This term does not include persons who exclusively distribute mobile medical apps without engaging in manufacturing functions; examples of such distributors may include the app stores.

Software As Medical Device Patenting Considerations

The good news is that investors like medical device companies which have double exclusivity obtained through FDA and US Patent and Trademark Office (USPTO) approvals. As such, the exit point for many medical device companies is an acquisition by cash rich medical public companies. This approach enables medical devices to skip the large and risky go-to-market (GTM) spend and work required to put products in the hands of consumers.

Now that we have discussed the FDA review process, we will discuss IP issues for software medical device companies. Typically, IP includes Patents, Trademarks, Copyrights, and Trade secrets. All of these topics matter and should be considered carefully. However, we will concentrate on patents to demonstrate how careless drafting and lack of planning can lead to problems, namely unplanned disclosures of your design that can then be used as prior art against your patent application.

In general, you should file patent application(s) as soon as practicable to get the earliest priority dates. This will help you when you talk to investors, FDA consultants, prototyping firms, and government agencies, among others. Compliance or other documents filed with any government agency may be considered disclosure to third parties and could make the document public. In general, disclosures to third parties or public availability of an invention trigger a one year statutory bar during which you must file your patent application. Failure to file your application within the required time frame could result in you losing your right to protect your invention.

The information from your FDA application may find its way into FDA databases, including DeNovo, PMA and 510k databases and FDA summaries of orders, decisions, and other documents on products and devices currently being evaluated by the FDA. Your detailed information may be gleaned from Freedom of Information Act requests on your application. This risk mandates that you patent your invention quickly.

When you patent your medical device invention, have a global picture of FDA regulatory framework when you draft your patent application. Be mindful of whether your software/SaaS application discusses the diagnosing and treating patients or affecting the structure or function of the body and add language to indicate that such description in the patent application relates to only one embodiment and not to other embodiments. That way you have flexibility in subsequent discussions with the FDA if you want to avoid classification of your software/SaaS/software as a medical device. In this way, if you wish to avoid FDA registration and oversight, you have the flexibility to do so.

An experienced attorney can assist you in navigating the regulatory landscape and ensure that you comply with all applicable laws. This area of law is complex and constantly changing. It is important that you seek legal advice if you have any questions about whether or not your software should be registered with FDA.

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