TRUST AND RELIABILITY
FOR IN-HOME MEDICAL SENSORS

Trust and Reliability for In-Home Medical Sensors

Quality of life might mean different things to different people. However, when it comesto healthcare, quality of life takes on a more specific meaning. Medical professionals
must prove or quantify actions to determine and justify treatment. Testing, measuring,and other processes are done with devices that must deliver reliable data repeatedly.
This paper will review how the medical industry is working to provide accurate robust
devices to improve quality of life with a focus on mobility and at-home care.
To manufacture a consistent product, it is imperative tocontrol the materials and processes. There are techniquessuch as Six Sigma that guide product design andmanufacturing. There are also standards such as ISO13485
which set requirements for medical devices’ quality
management systems.
Often there must be documentation proving that the materials
and components are trusted, and that the processes werecontrolled to validate a device’s outputs. Whether a medical
device is in a professional medical facility or at home, it mustdeliver the same quality and accuracy. The ability to monitor
or treat patients at home reduces healthcare costs and frees
up hospital resources. While at-home care introduces several
benefits there are many challenges OEMs must overcome.

Benefits and Challenges in Medical Devices for At-Home Care
The following are only a few examples to provide a brief overview of the benefits modern devices can provide, and the challenges
manufacturers must deliver to ensure homecare meets the same standards and quality of care as a medical facility.

• Benefit: Remote monitoring
provides doctors data frombetween visits for a more completepicture of the patient’s overallhealth.
• Challenge: Connectivity andsecurity to receive medical datafrom the remote patient to thedoctor while following regulations
such as HIPAA. Also, remote devices
make it more difficult to monitor
device health. It is necessary toensure proper calibration or provethe data collected is accurate.

TE CONNECTIVITY SENSORS / WHITE PAPER• Benefit: Portable devices can offer
patients new levels of mobility andquality of life.
• Challenge: Low energy
consumption for mobile medical
devices is important so patients
do not have to travel with a heavy
battery, need to recharge regularly,
or lose power.

• Benefit: Patients with chronic healthneeds can automate medication
management with devices thatprovide continuous monitoring anddrug administration to improve
quality of life.
• Challenge: Administering drugs
automatically must ensure the data
received is accurate and verify
the amount was delivered to thepatient. This can require constant
power for monitoring with multiple
sensors which increase the energy
consumption and complexity of thedevice.

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Trust and Reliability for In-Home Medical Sensors

Applications of Medical Devicesfor At-Home Care

How Medical Sensors areExpanding At-Home Care

In general, many medical applications are to collect datafor health care providers. At-home devices can help nurse
practitioners (NP) and physician assistants (PA) validate
writing prescriptions or make more informed decisions.
Health information is often only collected at a doctor’s office.
However, wearables and other monitoring devices can provide
a complete view of the patient’s wellbeing between visits.

Five common vitals that help determine patients’ health aretemperature, pulse, respiratory rate, blood pressure andblood oxygen level (SpO2). The ability to measure a patient’s
blood oxygen levels can be used to adjust the flow of oxygen
delivered to the patient.

Home care also includes more critical care equipment, suchas respiratory equipment or dialysis equipment. Adding
connectivity to these devices can confirm the patient is using
the equipment as prescribed. Quality of life is improved
when a patient can be at-home or on the go for care. The
challenge for medical devices is measuring accurate data in avariable environment while being operated by a patient. Someapplications include:• Battery powered oxygen concentrators that make it easierfor patients with asthma and chronic obstructive pulmonary
disease (COPD) to be mobile.
• Travel continuous positive airway pressure (CPAP) machines
let patients continue therapy while away from home.
• Smart insulin pumps communicate with glucose sensors toautomatically regulate insulin delivery.
• Smart inhalers help patients comply with dosage
requirements and reduce ER visits.
Improving quality of life through at-home care hinges on
the accuracy and reliability of the components which makeup these devices. Manufacturers are tasked to deliver userfriendly, quality devices that are no longer operating incontrolled medical facilities by trained staff. Adding to the listof challenges is the lifecycle of at-home devices. Products thatwill be used in the home need to withstand heat, humidity,
rapid changes in temperature, being dropped, vibration andothers while providing accurate and repeatable measurements
or treatments. Addressing these challenges requires provendesign and manufacturing experience.

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Oxygen concentrators can use pressure sensors to determine
when a patient is exhaling and inhaling. Previous solutions
would simply provide a constant flow of oxygen which led
to patients being tethered to, or having to carry around,large oxygen tanks. This method wasted much of the oxygen
because the flow would not stop between breadths.
With digital or analog pressure sensors that can detectextremely low full scale pressure ranges, it is possible todeliver oxygen only when the patient is inhaling. This reduces
the amount of oxygen needed which reduces the time themachine runs. In oxygen concentrator applications, thistechnology reduces the load on the equipment which extends
the machine’s battery life and its overall lifecycle.
To add value to respiratory devices, efficient sensors must
detect small changes in pressure. For example, pressure
sensors such as TE Connectivity’s (TE) LMI and LME sensors
offer an extremely low full scale pressure range to monitor
a patient’s respiration accurately enough to only dispense
oxygen when they are inhaling. Accurate low-pressure devices
also provide monitoring for patients with shallow breathing
and pulmonary problems.
Efficient features are reducing cost for at-home care, butdevices that require maintenance or replacement canimpede ROI. Selecting the right technology and design for arobust device is increasingly important to address concerns
around drift, fatigue, and while maintaining cost-effective
manufacturability. Modern piezoelectric, board mounted
MEMS technology, such as the LMI and LME designs fromTE are capable of producing cost-effective mass production,
low power medical sensors with high-pressure sensitivity andreduced drift.

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Trust and Reliability for In-Home Medical Sensors

Pressure sensors also provide air flow, respiration control,
and filter cleanliness monitoring. For example, board
mounted MEMS pressure sensors SM9000 and SM7000
provide ultra-low pressure ranges down to 125 Pa to detect
minimal pressure changes. When it comes to manufacturingsystem integration, mounting orientation, and other factors
are important. The SMI sensors from TE provide a 16-bit
digital or analog output interface, simplified signal read-out,easy system integration, and are insensitive to mounting
orientation. While pressure sensors work together to improve
respiratory devices, other factors may jeopardize a patient’s
ability to absorb oxygen into the bloodstream.
Blood Oxygen Sensors use optical sensors to detect oxygenin the bloodstream. A simple to use non-invasive finger
clamp is able to house a light source, commonly LEDs, anda photodetector to monitor a patient’s pulse rate, oxygen
saturation, blood flow, and more. This is a simple device thatpatients can use at home. Regular monitoring of oxygen
saturation and other vitals help health care providers
understand what is causing a change. This additional datacollected can also help determine if a patient needs to visit aprovider and what tests to order before the patient arrives.
Digital trends are increasing the adoption of connecteddevices. With the right sensor technology, a low energy
connection such as Bluetooth Low-Energy (BLE) can senddata to a phone, or intermediary device, to securely senddata to a doctor online. This can help doctors collect more
information while improving mobility and quality of life for thepatient.
Using photo optic sensors in oxygen saturation devices
requires a small size, low-power consumption, and fast
response times in addition to common concerns such as drift
and fatigue. For example, the EPM series of optical sensors
is designed specifically for medical applications. The EPM
sensor design uses a silicon planar diffused photodiodewith dual drive to deliver a small, power-efficient sensor
capable of detecting blood oxygen saturation. For improved
manufacturability and to eliminate compatibility issues, theEPM is matched with TE’s ELM series of photo emitters andothers that operate at 660 nm. The ELM’s 660 nm ±3 nm peakwavelength red LED and three IR wavelength work well in
pulse oximetry, SpO2 Finger/Ear Reusable Probes, and SpO2
Disposable Strip or Butterfly Probe applications.

Infusion Pumps are used in many medical applications.
Sensors including force, ultrasonic, position, and temperature
can work with infusion pumps to monitor and deliver nutrientsand medications to the patient automatically. For someapplications, technology is small and power-efficient enoughso the patient can wear the pump throughout the day.
For diabetics a glucose sensor must precisely monitor sugars
in the bloodstream and communicate with the infusion pump.
However, ensuring the right dose is delivered properly isessential. Position sensors can track the displacement of thepump, but blockages or bubbles can occur.
In some applications bubbles are deadly. Fortunately, piezoelectric transducers paired with a receiver are able to detectbubbles. Ultrasonic waves, emitted by the transducer, travel
through liquids differently than gases. For example, theAD-101 ultrasonic sensor can detect a break in the flow ofa liquid and can work with infusion pumps to keep the patient
safe.
Force sensors are also commonly added to infusion pumps
to detect blockages or resistance in the flow of nutrients ormedications. Too much resistance or a blockage can expand
the tubing running to or from the pump.
Sensors such as the FS20 series are an example of how
medical technology is changing. The easy to integrate board
mounted sensor delivers low compression force sensors withnormalized zero and span for interchangeability, and thermalcompensation for changes in zero and span with respect
to temperature. The FS20 offers an operating temperature
range of -40°C to +85°C, and in percent of FS the zero andsensitivity shift (in CTR) is ±.05.
More sensors can provide features or options that may solve
challenges medical device OEMs run into during development.
Devices are becoming more complex as home care increases
and continues to drive demand for accurate, reliable sensors.
Additionally, the increase in complexity reiterates the need forsmall, power-efficient sensors.

As devices expand further into the home, it is possible to use
data to dynamically change treatment to best fit a patient’s
needs in real-time. Accurate monitoring can drive automation
in at-home devices to improve quality of life by helping toautomate manual monitoring and treatment. For example,
Type 1 diabetics must monitor their glucose levels and inject
themselves with insulin throughout the day. Small wearable
devices are not only monitoring but administering treatment
with accurate sensors and infusion pumps.

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Trust and Reliability for In-Home Medical Sensors

Trends in Medical Devices
As healthcare costs, demands, and regulations increase,
it is imperative to reduce the time patients need to spend
in medical facilities. However, moving to at-home caremust be done with equal or better quality. OEMs will needto find manufacturers with experience designing andmanufacturing accurate sensors built with compatibility andmanufacturability for medical applications. These sensors will
monitor and aid in the delivery of treatments in addition toconfirming the success of these at-home medical devices.
MEMS and connectivity trends are increasing the need for
manufacturers to interact with and deliver more digital
options. Digital and connected devices could accelerate as
more standards and regulations are passed for wearables
and at-home care devices. Technology and manufacturing
capabilities will continue to enforce strict standards andregulations to document and prove that medical devices areworking properly.
To learn more about how medical sensors are improving
quality of life visit TE’s Medical Sensor Applications andSolutions page.

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About TE Connectivity
TE Connectivity is a global industrial technology leader creating a safer, sustainable, productive and connected future. Ourbroad range of connectivity and sensor solutions, proven in the harshest environments, enable advancements in transportation,industrial applications, medical technology, energy, data communications and the home. With approximately 80,000 employees,including more than 7,500 engineers, working alongside customers in approximately 140 countries, TE ensures that EVERYCONNECTION COUNTS. Learn more at www.te.com and on LinkedIn, Facebook, WeChat and Twitter.

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