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silex_whitepaper_Medical_Grade_Wi-Fi Flipbook PDF
silex_whitepaper_Medical_Grade_Wi-Fi
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Medical Grade Wi-Fi The term “Medical Grade Wi-Fi” is widely used but not well defined. It is based on a generally accepted belief that the needs of medical device manufacturers that are implementing Wi-Fi in a hospital environment differ from most other applications. This white paper provides information on the steps required to successfully evaluate and implement Wi-Fi connectivity for your medical device.
White Paper by Silex Technology America, Inc. Copyright © 2013 Silex Technology America, Inc.
Table of Contents Executive Summary Part 1: Learn Why Wi-Fi Is a Mandatory Feature for Portable Medical Devices Strong Market Adoption Better Patient Care Improved Clinical Workflow Part 2: Understand Key Medical Device Connectivity Requirements Proven Wi-Fi Silicon Provider Dual-Band Support Access Point Roaming Enterprise Security Interoperability Low Power Consumption Long Product Lifecycle Supplier Qualification Part 3: Integrate Wireless Connectivity into Your Device Hardware Options Driver/Security Supplicant Options Other Considerations Part 4: Address Customer-Specific Application Requirements Non-Linux/Android RTOS Implementations Other Requirements Part 5: Get Support from Silex Technology Evaluation Support Implementation Support Post-Launch Support Part 6: About Silex Technology
Copyright © 2013 Silex Technology America, Inc.
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Executive Summary Medical device connectivity has many unique requirements beyond what is demanded by the typical wireless customer. The Wi-Fi silicon suppliers typically focus their attention and energy on the requirements of high-volume consumer applications. As a medical device manufacturer, how can you implement a Wi-Fi solution that addresses your specific needs? This guide was written specifically for medical device manufacturers who need to add Wi-Fi connectivity. Silex Technology has provided wireless connectivity solutions for medical device manufacturers for more than 10 years. Over this time, our product offerings have evolved to specifically address this vertical market application. This guide will help you get started with wireless connectivity for your medical device.
“Worldwide sales of Wi-Fi technology into the healthcare market are expected to reach $4.9 billion in 2014.” - ABI Research, 2010
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Part 1: Learn Why Wi-Fi Is a Mandatory Feature for Portable Medical Devices For most hospital systems, medical devices are just beginning to transition from proprietary private networks to Wi-Fi networks. As this transition continues, medical device manufacturers are being forced by the market to implement Wi-Fi into their devices. The question today is not whether Wi-Fi is required but how device manufacturers can optimize their Wi-Fi solutions to provide reliable and secure connectivity.
Strong Market Adoption Need more evidence? More than 500,000 Wi-Fi infrastructure endpoints, or access points (APs), were deployed in U.S. healthcare facilities in 2010, representing a 50-percent increase from 2009 (ABI Research, 2010). For patients and visitors, Wi-Fi networks provide convenient Internet access from laptops and smartphones. For clinicians and administrators, Wi-Fi networks provide access to hospital networks and record-keeping databases from various mobile computing devices. Hospital IT administrators are facing an ever-increasing need to attach medical devices and applications to the Wi-Fi network in order to support electronic medical records (EMRs) and clinical information systems (CISs), deliver better patient care, improve clinical workflow, and even help speed patient recovery time by providing mobility via wearable wireless devices (WWDs). Wi-Fi Alliance, February 2011
Better Patient Care Wi-Fi is among one of several technological advancements that has positively impacted the quality of healthcare. Patient benefits include:
Reduced Errors. Data transfers between the medical device and the hospital information system eliminate manual entry, making patient information more current, with fewer errors.
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Better Decisions. Once a medical device is linked to a patient, medical device data can be stored in the patient’s electronic medical record (EMR). More complete data on a patient leads to better patient care as doctors will have constant access to important information such as patient blood type, prescribed drugs, medical conditions, and other aspects of the patient’s medical history. Healthcare providers improve their ability to make well-informed treatment decisions with more complete patient information.
Increased Time to Spend with Patients. The seamless integration of patient information helps clinicians improve their workflow and increase efficiencies. In theory, nurses and other healthcare professionals can spend more quality time attending to patient needs.
Improved Clinical Workflow Using Wi-Fi for medical device connectivity to a hospital network provides many benefits to caregivers, device administrators, and even those on the business side of the hospital.
Simplified Workflow and Charge Capture. Orders can be sent directly to the medical device, and the results can be uploaded to the hospital information system. Billing can then be automatically processed. No delays. No missed charges. No loss of revenue!
Monitoring. A network-connected device can be monitored from a central point, such as a nurses' station. Nurses can monitor the health of many patients without constantly moving from one patient room to the next. It also can give nurses visual alerts of potential issues with patients, augmenting an audible alarm that a nurse may not hear.
Device management. A centrally monitored device can also be beneficial, for example, if a network-connected infusion pump needs a new drug library. In that case, the network can be leveraged to download the library to the pump, where an application can install the library on the pump.
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Part 2: Understand Key Medical Device Connectivity Requirements Wi-Fi networks offer reliable, security-protected, proven technology. To maximize the benefits of a hospital Wi-Fi network, several characteristics unique to hospital environments must be reviewed and taken into consideration. Among these are security requirements for patient records, the mobility needs of devices, “always on” network uptime requirements to accommodate patient monitors and applications, real-time access to records and data transfers, and continuously increasing bandwidth demands. Best practices for these areas are provided in this paper.
Proven Wi-Fi Silicon Provider The underlying technology of any Wi-Fi solution is the Wi-Fi radio itself. For best performance and reliability, chose a solution that comes from a silicon provider that has an industry leadership position in Wi-Fi. Financial stability will help to ensure longterm supply. Finally, understand roadmaps to support next generation standards like 802.11ac to understand continued commitment to the Wi-Fi market.
Dual-Band Support Dual-band support (2.4 GHz/5 GHz) is an important feature for new Wi-Fi implementations. The 5 GHz band support was first introduced in IEEE 802.11a-1999 as an amendment to the IEEE 802.11 specification. It has seen widespread, worldwide implementation, particularly within the corporate workspace. Like 802.11a, 802.11n radios support either single-band (2.4 GHz) or dual-band (2.4 GHz/5 GHz) implementation. Using the 5 GHz band provides a significant advantage, as the 2.4 GHz band is heavily used, to the point of being crowded. Degradation caused by such conflicts can cause frequent dropped connections and degradation of service. However, the high carrier frequency also has a slight disadvantage: The effective overall range of 5 GHz is slightly less than that of 2.4 GHz because 5 GHz signals are absorbed more readily by walls and other solid objects in their path. The increased number of usable channels (four to eight times as many in FCC countries) and the near absence of other interfering systems (e.g., microwave ovens, cordless phones, and baby monitors) give dual-band implementations significant aggregate bandwidth and reliability advantages.
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Access Point Roaming Radio chipset’s built-in roaming is very simplistic and designed primarily for high-volume laptop and cell phone manufacturers. The typical usage scenario is as follows: User becomes stationary with device (e.g., conference room with laptop) User makes a wireless connection to access point #1 User moves to another location and again becomes stationary with device (e.g., office with laptop) User makes a wireless connection to access point #2 In the above example, the laptop is not being used while in motion. On the other hand, medical devices often transmit critical data such as ECG waveforms while the patient is in transit (e.g., on a gurney). The medical device manufacturer needs a solution that handles access point roaming seamlessly without data loss caused by wireless connectivity problems. Providing “true” mobile connectivity requires a sophisticated management scheme including these enhancements: User configurable handoff threshold User configurable multiple SSID list Tracking of five or more access points Silex Technology solutions based on the Qualcomm Atheros AR6003 chipset (with the enhanced Silex Technology driver/supplicant) are validated to roam, on average, in 100 ms or less in an open system environment.
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Be sure to understand the roaming performance of the Wi-Fi solution you are considering, along with the underlying algorithms used to make “roaming” decisions.
Enterprise Security A number of different security standards should be considered by medical device manufacturers. Security is an important component of any medical device connectivity solution to ensure compliance with HIPAA patient confidentiality requirements. Equally important is the need for compatibility with existing hospital wireless networks. If the medical device does not support the same encryption/authentication used by a specific medical facility, the device will not be deployed. Encryption and authentication are the two key components of wireless security. Encryption is the process of transforming information by using an algorithm to make it unreadable to anyone except those possessing special knowledge. Authentication is a process that involves communications among a supplicant, an authenticator, and an authentication server (generally a RADIUS database). The supplicant (i.e., client device) is not allowed access through the authenticator to the protected side of the network until the supplicant’s identity is authorized. Wi-Fi solutions used in an enterprise or hospital environment should support the following: Encryption Protocols WPA2-CCMP Authentication Methods EAP-TLS (802.1x) EAP-TTLS (802.1x) EAP-PEAP (802.1x) EAP-FAST (802.1x) Cisco LEAP WPA/WPA2 Pre-Shared Key (PSK)
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Interoperability While Wi-Fi standardization and proliferation have greatly improved interoperability, testing against multiple access points is still advised. For consumer and small/home office applications, vendors such as Netgear, Cisco, D-Link, and Belkin are the most common. For enterprise and hospital applications, Cisco is the dominant supplier (with more than 50-percent market share), followed by Aruba Networks, Hewlett-Packard, and Meru. Given the popularity of Cisco access points, Cisco compatibility is an especially important consideration. Cisco Compatibility Extensions (CCX) certification is recommended by Cisco to ensure the widespread availability of client devices that are interoperable with a Cisco WLAN infrastructure and to take advantage of Cisco innovations for enhanced security, mobility, quality of service, and network management. We recommend that you perform your own interoperability tests and review the test plans provided by your Wi-Fi supplier.
Low Power Consumption Because portable medical devices are battery powered, low power consumption is an important consideration. But what is the specific requirement? In general, the lower the power, the better! That being said, the minimum expectation is that the device can be used for a complete 12-hour shift. The specific wireless power requirement depends on the battery and the power requirements of the medical device itself. An intelligent module will always need more power than a wireless radio module because it adds an extra CPU and memory to support the basic networking protocols. Low-power wireless chipsets today have the following power characteristics: Transmit Active