Healthcare Wireless and Device Connectivity

High Performance Smart Card- First All-In-One Converged Security Credential

Integra Systems is currently working with the 2nd generation or SKU #1 of now the Sentry Card. It is the first "All-In-One" converged security credential. This solution combines physical access, logical access, and passive proximity tracking in a single ISO compliant form factor. It's proven and reliable technology offers extremely consistent read range that is unaffected by body shielding or variable environmental conditions. At the size of a credit card it can be worn as a simple ID badge with embossment of a picture, a bar code of 1D, 2D or matrix. The five year battery (projected 7 year utility), allows for a minimum of over 30,000 OTP (one time password) transactions. We see a large opportunities to enable the next level of security within both the healthcare end use and the medical device space.

Set up and seeding: via secure, passwords protected, type-4 NFC interface
Configurable items: OTP algorithm
Algorithms supportedL OATH HOTP (event based)-SHA1,SHA256
OATH HOTP (time based)- SHA1, SHA256
Physical Access Control: Frequency 13.56MHz, supported protocols, NXP Mifare, or HID iCLASS (production option), HID transponder eUnit 2070
Tracking and Positioning: UHF RFID chip NXP UCODE-8 Supported bands US UHF RFID (FFF) and European (ETSI), Detection range measured in >15 m in open space conditions, RF Protocol EPC global V.2.0.1 TID 96-bit factory-locked with a 48-bit unique serial number.

Challenges of the non-IOT connected AED (Automated External Defibrillator)

In the current AED space it seems that there has been no innovation of real time device connectivity for the AED device check up or ongoing and audited provided required maintenance.

The engineering design of the entire industry since its inception from our perspective is with the AED non-connected.

It is a stand alone use model.

We currently look at this use model in 2019 as a legacy "walk around" approach for AED maintenance. Every single AED simply needs to be touched to ensure everything is correct.

This needs to change!

The reality is that any AED has to be available and working in the presence of a sudden cardiac event..and it has to be accessible.

While first responders may have an AED or there may be one on site, there is often not the time to find one when starting CPR. The golden window of time for response is under twelve minutes. So in reality, the problem to solve is accessibility.

Todays's cost of IOT connectivity is at a price point that we can ensure the health and integrity of every AED in a mobile environment and in a fixed location.

Why is this important?

The ability of the AED to deliver the shock to patient is dependent upon many variables.
- You have to know where it is and be able retrieve it in a timely matter.
- The battery needs to be fully charged and ready.
- The gel pads of the electrodes need to be fresh and not dried out.
- All software and firmware need to be current in the device to the latest refresh.

What are the risks if you cannot accomplish this?

- The AED cannot be retrieved in the window of time that will save the patient.
- The battery is not charged fully, thus a shock cannot be delivered.
- Gel pads of the electrodes are dried out, thus useless to deliver a shock.
- Application software or firmware, is not current, thus potentially compromising the patient.

AEDs need to function at the five nines of reliability: 99.999.

The next generation of AEDS should leverage all current IoT connectivity of 4G, LTE-M1, NB-IoT, and coming 5G.

What would be the value of this IoT connectivity?

- An application that could show by GPS and/or in-building location of each and every available AED.
- Remote check of the battery health of the AED
- Validation and verification of the quality of the electrode gel.
- OTA (over the air), updates of software and firmware.

While fire extinguishers are checked and tags are signed and dated, there is to date no consistent approach to the validation and verification of AEDs in the field. It is a manual process. In my travels both domestically and internationally, I have seen where AEDS are not there or are taken out of service with notes (out for service).
Today's IoT connectivity technology will allow the next generation of AEDs to be tracked, allow the location of each one to be know, allow vital checks of the battery health of a delivery of a shock, ensure electrode gel quality is correct for the delivery of a shock, and allow for software and firmware updates as needed for each AED.

This can also provide a quality audit trail of the device for both the manufacturer and the enterprise where this is deployed.

Smart Medical Devices – The SMART drill® is now registered and listed with the FDA!

It is now commercially available.

The Smart Medical Device solution has been several years in development; but now with the release to the commercial space this will dramatically in a positive sense change the landscape of surgical procedures where a surgical drill is required.

Nothing like this has come onto the surgical drill market in the past fifty years.

Today’s surgical drills (not the SMART drill®) are essentially the same type of drill you would literally buy in your local hardware store, “but they cost a lot more money”!

The surgical drill of today consists of a drill, a chuck, a drill bit, and a rechargeable lithium ION battery. The current surgical drilling process of today is essentially a manual limited tactile feedback procedure that has resulted in validated drilling plunges that can cause potential trauma to the patient, excess exposure of radiation to the surgical team, and a waste of technology, i.e. extra screws, plates, etc.

The value add of the SMART drill® technology and the total solution as described will provide the following benefits; it will lessen potential patient trauma, lower procedural costs, and decrease risk of exposure to radiation to the surgical team. The overall value is less cost and less risk. This should be as provided evidence and become the new standard and norm of care for orthopedic and other surgical procedures that require a use of a surgical drill.

From a technology perspective, you now have a surgical drill that measures drilling energy in Joules and will provide this information real time via a wireless interface in a graphical display for the surgeon.

The surgeon now has the ability to absolutely control with precision the entire aspect of surgical drilling. Think of this as a sophisticated drill press with a HUD (Heads Up Display). This concept mirrors why we have moved from manual cockpit gauges to a glass cockpit and HUDS in fighter aircraft today.

This also should have a major impact on decreasing the liability aspects of a surgical procedure.

As a side, Integra Systems, Inc. provided engineering expertise on wireless connectivity, but also on other design aspects of the SMART drill®

See study attached: Dual Motor Continuously Measures Drilling Energy to Calculate Bone Density and Screw Pull-out Force in Real Time.
Innovation Presentation next week in Las Vegas next week

Download Dual_Motor_Drill_Continuously_Measures_Drilling.4-2

Download Innovation_Theater_Schedule

Integra Systems Predictive Analytics Location Based Solution

Over the past two months we have been working with a variety of organizations to architect a Bluetooth to Wi-Fi to 4G cloud based solution. The goal of this design was to obtain location based information to enable improvements in workflow and productivity.

Integra Systems has been around the RTLS space for around nineteen years. We have been exposed to all kinds of technologies to include ultra-wideband, ultrasound, IR, and Zigbee. However, we feel that since Bluetooth Low Power when introduced in 2010 and that this was introduced in virtually every smart phone; that this will be the RTLS solution of the future. Bluetooth location services have been growing by leaps and bounds over the past few years. According to ABI research, it is predicting over 400 million Bluetooth location services devices are forecasted to ship by 2022.

Bluetooth location services are two types, proximity solutions and positioning systems. Proximity solutions in essence use your smart phone to assess of another Bluetooth device within range and how far away. Small transmitters referred to as beacons are deployed within a facility and your smart phone would be presented with information from the beacons as you come within proximity. Bluetooth RTLS solutions can be used for asset tracking and well as people tracking. Bluetooth receivers are generally deployed in fixed locations within a given environment. The receivers then connect back to a centralized receiver; or location engine. BTLE tags are then programmed to transmit on a periodic basis which is determined how you desire to track the asset. This location information is used along with the RSSI to estimate the position based on a process called trilateration. The accuracy of location is dependent on several factors, but generally you can provide meter level accuracy.

In version 5.1 of the Bluetooth Core Specification added optional direction finding.
https://www.silabs.com/products/wireless/learning-center/bluetooth/bluetooth-direction-finding?cid=pad-gos-ble-020619&gclid=EAIaIQobChMIg9-KrpPu4AIVzICfCh1xFg0cEAAYASAAEgK08fD_BwE

Now you can actually find the direction of the transmitted signal from another Bluetooth device. This direction finding feature supports two ways for the actual determination of the BTLE signal of which uses an antenna array: angle of arrival (AoA) and angle of departure (AoD). Adding this direction finding feature adds not only directional capabilities, while also improving location accuracy.

Smart Phones and the Challenges of Healthcare VoIP (Voice over IP)

Integra Systems, Inc., has had the opportunity to be associated with the WLAN space before Wi-Fi actually came to the market. That being said, we have learned a lot about mobile devices and the proper enterprise design by actual field design and deployment over eighteen years. Integra Systems was retained several years ago by a technology firm to design and deploy a WLAN VoIP solution in a very challenging environment. We just had to make it work. It worked in a flawless fashion.

So what are the challenges to the design of a WLAN voice over IP solution?
This is being described as the mobile device and WLAN radio. It has to be enterprise grade. What does this mean enterprise grade? Simply put the roaming algorithms have to be robust enough to maintain a secure connection back the WLAN controller while mobile. If not the call will drop.

The Design
Any WLAN design today should use predictive modeling based upon the actual construction materials of the building. For WLAN voice over IP, you need a signal strength of -65dBm and a co-channel interference of less than 2%.

The Gotchas
Smart phones were never designed to work in a highly mobile WLAN VoiP environment because of the inherent WLAN radio contained in the device. The primary use model is 3G/4G with the occasional connection to a hotspot. Integrators have attempted to try to resolve the client radio deficiencies by adding more WLAN access points. This only raises the noise floor and increases co-channel interface.

The Solution
Use a purpose built enterprise mobile solution that has WLAN client radio that supports fast roaming with the ability to handle all current security supplicants.
Design taking into account all the building materials with a criteria of -65dBm with a CCI of less than 2%

Evaluation of LANforge from Candela Technologies

In the past month, Integra Systems has had the opportunity to get a “hands on” with LANforge from Candela Technologies. They have graciously sent us equipment to evaluate in our lab and provided a technical deep dive.

This is a solution that provides Wi-Fi testing of the ecosystem, AP, and client that is the next generation Wi-Fi testing solution in our opinion. It is extremely comprehensive, enables both wired and wireless to the application server, but also is compact and feature rich.

Every medical device company and the risk avoidance vertical will need to test, validate and verify their Wi-Fi enabled device using this type of testing. This is not considered only best of practice; but also, is required for ongoing risk mitigation in the constantly changing Wi-Fi landscape. The on-going regulatory requirements will demand and require this type of testing moving forward.
Whether the acquisition of this equipment or a services test model; this solution and services arrives at the right price point with the forward-looking technology to help the build better WiFi products.

Candela Technologies Overview: https://www.youtube.com/watch?v=oGNCE8C3rpY

Integra Systems Deployment of IOT in the Enterprise

Integra Systems, Inc., is working with www.reelyactive.com to deploy a multi-layered IOT solution to gather location data for the use in predictive analytics modeling. We have engineered a unique networking design using Bluetooth Low Energy to Wi-Fi. (This is the reelyactive solution), with connection to a Wi-Fi infrastructure then to a complete secure router solution finally integrated LTE/4G to a secure cloud model.

Wi-Fi 6 Rolling Out in 2019

Wi-Fi 6 Rolling out in 2019

Wi-Fi as we know it has come very long way since the introduction in 1999 of 802.11b and the founding of the Wi-Fi Alliance in 2000.

Wi-Fi is literally everywhere from the home, hospitals, hotels, airports, stadiums, you name it.
High traffic areas such as hospitals with hundreds of Wi-Fi mobile devices often have challenges to get beyond the noise, which can result in slower speeds, dropped packets, and potential connection loss.

While having all the speed is great you also need to have the efficiency and network capacity.

Welcome to Wi-Fi 6 or 802.11ax

First like the Wi-Fi Alliance has proven, 802.11ax is backwards compatible with 802.11a/b/g/n/ac.

- Network efficiency is improved by providing downlink and uplink by using 8x8 MU-MIMO, which simply allows more MU-MIMO clients to connect to the AP in a simultaneous fashion. This really benefits high bandwidth application requirements.

- 1024 quadrature amplitude modulation mode (1024 QAM) enables throughput increases by as much as 25 percent over Wi-Fi 5 or 802.11ac.

- Target wait time. This is somewhat similar to CAM (Continuous Aware Mode)and PSP (Power Saving Polling Mode) in mobile devices. It provides a better way to handle packets those increasing sleep time. Essentially, allows Wi-Fi devices to become more power efficient increasing battery time.

Comparing and contrasting 802.11ac to 802.11ax can be summed up as follows.

- Both have the same channel bandwidth in (MHz) of 20, 40, 80, 80+80, 160.

- While 802.11ac is only in 5GHz, 80211ax is in both 2.4GHz and 5GHz.

- Maximum data rate is increased from 3.5Gbps to 9.6Gbps

- Highest subcarrier modulation increases from 256-QAM to 1024-QAM

- Spatial streams increase from 4 to 8.

Wi-Fi Testing Simplified

Since 802.11b was approved in 1999, the Wi-Fi revolution as we know it today was launched.

It is now 2019 and we can celebrate the 20-year anniversary of Wi-Fi and the two decades of business value that this technology has brought to the table.

During the early days of Wi-Fi both from the client side and the enterprise, things were fairly simplistic. However as the number of mobile devices increased; the different quality of service requirements (example voice over IP), combined with the unique security and roaming requirements, things became complex.

Manufactures of client devices tended to select Wi-Fi adapters based upon manufactures specifications.

Testing was mostly limited to in-house testing with limited validation and verification of the manufactures specifications.

This in-house testing did not mirror or replicate the actual field in a traditional deployment, i.e. a hospital ecosystem of data, voice, video, and life critical applications. Often time’s Wi-Fi mobility deployments resulted in dropped network connections for data or voice communications. The result was lack of confidence in the clinical use model and many times a total product redesign.

Most recently there is a heightened sense of concern to ensure that wireless medical devices operate correctly with the adherence to current and on-going security standards in the IEEE 802.11 space.

Medical device companies as well as any other manufacture will need to test, validate, and verify the performance characteristics of their Wi-Fi enabled device in the enterprise space. That is the space we live in 2019. This also is considered best of practice for risk management coupled with meeting the desired requirement by regulatory agencies.

There should be a requirement to test and validate against all requirements such as fast roaming, network assisted handoffs, band steering/load balancing and all current and future ongoing changes with the IEEE 802.11 standard.

The increasing complexity of the technology coupled with the proliferation and diversification of the use cases is creating the need for testing to be more affordable, automated and offered as a service.

To date, test Wi-Fiequipment has been a bottom line cost item and a major user complex. Companies have had a difficult time to justify the ROI for acquisition of the equipment, let alone the staffing. Also, there is not a current business model for testing services that is pervasive through all vertical markets.

Integra Systems is looking at Candela Technologies, Inc. www.candelatech.com as a technology source to provide Wi-Fi testing services based upon our proven experience in this space.

Companies can also purchase their testing equipment if it is decided to bring this testing in-house. Their test gear is very cost affordable, plus it covers the needs for comprehensive testing in today’s fast changing Wi-Fi landscape.

Integra Systems Service Offerings

Integra Systems, Inc is has been providing a variety of validation and verification services over a number of years for several vertical industries.

For the medical device industry we can provide the validation and verification of the correct and secure wireless connectivity solution..before a solution is built. We can provide the specifications that are required and help qualify the correct suppliers.

Ecosystem Validation and Verification

All Wi-Fi client solutions need to be validated and verified of how they will actually work in a ecosystem of load data, voice, and video. This is the only way that you can demonstrate how a wireless client solution will perform while roaming with enterprise grade security. We can provide this testing as a service to include the test plan and output of data. This data can be also be used for any FDA medical device 510(k) submittal.

Enterprise Wireless Site Design

Previous wireless site design was often a laborious on site plan. Integra Systems, Inc. can provide a more scientific way of wireless enterprise planning using predictive software modeling.

Wireless Co-Existence Testing

The majority of medical devices now incorporate various wireless emitters. Medical device companies will need to validate and verify how their wireless medical device will perform in the midst of various wireless emitters. Integra Systems, has performed wireless co-existence testing for many medical device companies of which included the authorship of the test plan, testing, and output documentation.

Human Factors Clinical Testing

Integra Systems, Inc. has partnered with a demonstrated leader approved by the FDA that can provide human factors testing for any medical device company.