text:
Radio Frequency Wireless Technology in Medical Devices - Guidance for Industry and Food and Drug Administration Staff
Document Issued on: August 13, 2013
The draft of this document was issued on January 3, 2007.
For questions regarding this document, contact Donald Witters (CDRH) at 301-796-2483 or by electronic mail at email@example.com or CBER's Office of Communication, Outreach and Development (OCOD) at 1-800-835-4709 or 301-827-1800.
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Devices and Radiological Health
Office of Science and Engineering Laboratories
Center for Biologics Evaluation and Research
Contains Nonbinding Recommendations
Public Comment
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Table of Contents
- Introduction
- Scope
- Considerations for Design, Testing, and Use of Wireless Medical Devices
- Recommendations for Premarket Submissions for Devices that Incorporate RF Wireless Technology
- Appendix A: Glossary for Wireless Medical Devices and Device Systems
- Appendix B: Reference Standards and Information
Radio Frequency Wireless Technology in Medical Devices - Guidance for Industry and Food and Drug Administration Staff
This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance.
1. Introduction
FDA has developed this guidance document to assist industry and FDA staff in identifying and appropriately addressing specific considerations related to the incorporation and integration of radio frequency (RF) wireless technology in medical devices. There has been rapid growth in medical devices that incorporate RF wireless technology due to the expansion of this technology. With the increasing use of RF wireless medical devices, continuing innovation and advancements in wireless technology, and an increasingly crowded RF environment, RF wireless technology considerations should be taken into account to help provide for the safe and effective use of these medical devices. This guidance highlights and discusses RF wireless technology considerations that can have an effect on the safe and effective use of medical devices. These considerations include the selection of wireless technology, quality of service, coexistence, security, and electromagnetic compatibility (EMC). Consideration of these areas can help provide reasonable assurance of safety and effectiveness for medical devices that incorporate RF wireless technology, and are supplementary to other device-specific guidances or guidelines.
FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.
2. Scope
This guidance document addresses considerations that may affect the safe and effective use of medical devices that incorporate RF wireless technology (also referred to as wireless medical devices), including the selection of wireless technology, quality of service, coexistence, security, and EMC. These issues should be considered for all medical devices that incorporate RF wireless technology, such as Wireless Medical Telemetry Service (WMTS); Medical Device Radiocommunication Service (MedRadio) (including the former Medical Implant Communications Service (MICS)) as well as Medical Micropower Network (MNN) and Medical Body Area Network (MBAN); cellular communication chipsets; and RF identification (RFID) products. Such RF wireless technologies operate under a grant of certification and/or issuance of a license from the Federal Communications Commission (FCC).
This guidance also provides recommendations for information to be included in FDA premarket submissions for medical devices and device systems that incorporate RF wireless technology. Requirements by other agencies are not covered within this document, although we note that requirements established by the FCC may be applicable.
The recommendations in this guidance are intended for RF wireless medical devices including those that are implanted, worn on the body or other external wireless medical devices intended for use in hospitals, homes, clinics, clinical laboratories, and blood establishments. Both wireless induction-based devices and radiated RF technology device systems are within the scope of this guidance. The use of RF energy to generate images of the internal structures of the body such as in magnetic resonance imaging systems is outside the scope of this guidance document.
See Appendix A for a glossary of key terms associated with RF wireless technology and wireless medical devices that have been adapted from the IEC 60050-161 International Electrotechnical Vocabulary (IEV) and other sources.
3. Considerations for Design, Testing, and Use of Wireless Medical Devices
Designers and manufacturers of wireless medical devices should consider the ability of their devices to function properly in the intended use environments where other RF wireless technologies will likely be located. In the design, testing, and use of wireless medical devices, the correct, timely, and secure transmission of medical data and information is important for the safe and effective use of both wired and wireless medical devices and device systems. This is especially important for medical devices that perform critical functions such as those that are life-supporting or life-sustaining. For wirelessly enabled medical devices, risk management should include considerations for robust RF wireless design, testing, deployment, and maintenance throughout the life cycle of the product.1 Examples of potentially problematic wireless-related hazards and effects include:
- poorly characterized or poorly utilized wireless systems (e.g., wireless networks);
- lost, corrupted, or time-delayed transmissions, and degradations in wireless transmissions including when caused by competing wireless signals or electromagnetic interference (EMI) to the medical device or its wireless transmissions;
- lack or compromise of wireless security; and
- potential misuse of a wireless medical device because of lack of or inadequate instructions for use.
As part of a comprehensive quality system under 21 CFR Part 820, medical device manufacturers must manage risks including those associated with RF wireless technology that is incorporated into the medical device or device system. ISO 14971 Second edition 2007-03-01 Medical devices—Application of risk management to medical devices can be a useful tool in risk analysis and risk management.2 Because there are risks associated with RF wireless systems, we recommend that you carefully consider which device functions should be made wireless and which device functions should employ wired connectivity.
FDA recommends that you address known safety issues involving RF wireless technologies early in the device design and development process. Safety issues might be discovered during the design and development process for which risk mitigation measures might be necessary to ensure an overall acceptable level of risk. FDA also recommends that risk acceptability criteria be based on information about the device and its intended use, including, but not limited to, applicable standards, accepted design practices, and experience with similar devices. For example, FDA recommends that you use reports of EMI-related events and other relevant experience when estimating probability of occurrence as part of risk analysis. In addition, where multiple alarms are incorporated into a device or device system via wireless links, we recommend that you address priorities for accessing the wireless system, and priorities related to the function of the wireless technology itself.
In validating the design of your wireless medical device under 21 CFR 820.30(g), you must include risk analysis of RF wireless communications and control functions as part of your design validation. Because it is possible for an electromagnetic disturbance (EMD) to affect important medical device functions, mitigation measures for some risks could aid the device operator in recognizing a hazardous situation and taking action to prevent harm. For example, design validation might reveal that steps to reestablish an RF wireless connection such as re-initialization could compromise safety under some use conditions.
When considering possible adverse outcomes, you should also consider risks to other devices and patients whose wireless connections might suffer from, or be the source of, interference. In addition, you should consider the potential impact of unintended interference and purposeful attempts to disrupt a wireless medical device or an associated device network's functionality.
The following considerations should be appropriately tailored to the selected RF wireless technology, and the intended use and use environments for your medical device. The following discussion of these considerations includes information dealing with general and design considerations, risk management, verification and validation, and information shared with users. Note that access to information (e.g., user manual, other device labeling) concerning these key considerations plays an important role in users being able to properly set up, use and maintain medical devices and device systems with wireless technology.
a. Selection and performance of wireless technology
When selecting the type(s) of wireless technology, it is vital to determine and understand the medical device functions that are to be wirelessly enabled and the intended use of the medical device. The medical device functions and intended uses should be appropriately matched with the wireless technology's capabilities and expected performance. In addition, issues relating to the integrity of data transmitted wirelessly (including latency and throughput, detection, correction, and corruption control and/or prevention) and safety-related requirements of your device should be considered. Potential risks that can affect consistent and timely wireless medical device functions include data corruption or loss and interference from simultaneous transmitters in a given location, which can increase latency and transmitted signal error rates. For wireless medical devices and device systems, error control processes should be incorporated to assure the integrity of data transmitted wirelessly and to manage potential risks related to maximum delay of data transfer. Parameters such as bit error rate, packet loss, and signal-to-noise ratio are useful tools in assessing and assuring data integrity and timeliness of data transmission.
In addition, the device performance and specifications related to the wirelessly enabled medical device functions should be considered in choosing the appropriate RF wireless technology (e.g., WMTS, IEEE 802.11) and RF frequency of operation. It is important to note that many medical devices are authorized to operate as unlicensed devices (under Part 15 of the FCC rules3) in the industrial, scientific, and medical (ISM) frequency bands (e.g., 2400-2493.5 MHz), and as such, are not entitled to interference protection. There is a potential for interference in this frequency band because it is already heavily used by many other communications and industrial products. In many cases, RF wireless medical devices and transmission streams can incorporate technology (e.g., frequency hopping protocols, correction protocols) to minimize effects of interference that may lead to data errors or corruption. Also, to help protect against EMI to other medical devices in the vicinity, FDA recommends that wireless medical device manufacturers limit the RF output of their devices to the lowest power necessary to reliably accomplish the intended functions.
Consideration should be given to any limitations or restrictions for proper operation and RF wireless performance (e.g., alarms, back-up functions, alternative modes of operation) when the RF wireless link is lost or corrupted. In addition, worldwide frequency band allocation and international compatibility is critical to the operations of RF wireless devices, and should be considered in the design and development of wireless medical devices.
When choosing a RF wireless frequency band or a commercial wireless radio component, FDA recommends that you consider:
- International availability and band allocation (e.g., applicable International Telecommunication Union Radiocommunication Sector (ITU-R)4 recommendations) for medical devices because medical devices serve patients located in multiple geographic locations and patients may change their geographic locations.
- Whether your device needs to have primary or secondary radio service classification, which depends upon the wireless frequency band you choose.
- Incumbent users of the selected and adjacent bands, if any, and how they can impact a medical device's operation.
- Applicable interference mitigation techniques if you are planning to use a shared RF wireless frequency band.
- For implantable and body-worn medical devices, tissue propagation characteristics and specific absorption rate as appropriate.
When considering commercial off-the-shelf RF wireless components or systems that conform to industry standards (such as IEEE 802.11 standards), medical device manufacturers should take into account that some equipment might not have been adequately tested or qualified to address the needs and risks for use in medical devices. This is because such equipment may conform to standards that are not written specifically for medical devices. Under the quality system regulation, procedures and controls must be established for wireless medical devices and their components, including components that are purchased and included as part of the device or device system, to ensure that the device and its components conform to specified design requirements related to the RF wireless considerations noted above.5
b. Wireless Quality of Service
Wireless Quality of Service (QoS) refers to the necessary level of service and performance needed for the wireless functions of the medical device. While the QoS of cellular telephone networks might be acceptable for voice communication, it might not be sufficient for certain medical functions. Connections lost without warning, failure to establish connections, or degradation of service can have serious consequences, especially when the medical device relies heavily on the wireless connection. Such situations can compromise the wireless transmission of high-priority medical device alarms, time-sensitive continuous physiological waveform data, and real-time control of therapeutic medical devices (such as wireless footswitches).
If the wireless medical device will be part of a network, wireless QoS should be carefully considered in conjunction with the intended use of the wireless medical device. The following should be assessed: acceptable latency, acceptable level of probability for loss of information within the network, accessibility, and signal priorities of the network.
When the network is chosen or designated, FDA recommends use of a risk management approach to deployment, security, and maintenance of the network's QoS. Depending on the intended use of the device, additional failure modes may need to be considered. Once failure modes and associated risks are identified, we recommend a justification of acceptable risk, or testing or other measures to demonstrate appropriate risk mitigation.
c. Wireless coexistence
A key factor affecting a wireless medical device's performance is the limited amount of RF spectrum available, which can result in potential competition among wireless technologies for simultaneous access to the same spectrum. Because conflicts among wireless signals can be expected, most wireless communication technologies incorporate methods to manage these conflicts and minimize disruptions in the shared wireless environment. The selection of RF wireless operating frequency and modulation should take into account other RF wireless technologies and users that might be expected to be in the vicinity of the wireless medical device system. These other wireless systems can pose risks that could result in medical device signal loss or delay that should be considered in the risk management process. To address this issue, FDA recommends that you address your device's environmental specifications and needs, including:
- Associated sources of EMD expected in specific known use environments, and
- Co-channel and adjacent channel interference from medical devices and other users of the RF band.
If the RF wireless medical device is expected to be used in proximity to other RF wireless in-band (i.e., the same or nearby RF frequency) sources, FDA recommends addressing such risks through testing for coexistence of the device wireless system in the presence of the number and type of in-band sources expected to be in proximity to the device. Depending upon the wireless medical device, this should also include multiple units of the subject device operating in the same vicinity, such as when patients are sitting adjacent to one another in a waiting room. Once failure modes and associated risks are identified, we recommend a justification of acceptable risk, or testing or other measures to demonstrate appropriate risk mitigation.
d. Security of wireless signals and data
Security of RF wireless technology is a means to prevent unauthorized access to patient data or hospital networks and to ensure that information and data received by a device are intended for that device. Authentication and wireless encryption play vital roles in an effective wireless security scheme. While most wireless technologies have encryption schemes available, wireless encryption might need to be enabled and assessed for adequacy for the medical device's intended use. In addition, the security measures should be well coordinated among the medical device components, accessories, and system, and as needed, with a host wireless network. Security management should also consider that certain wireless technologies incorporate sensing of like technologies and attempt to make automatic connections to quickly assemble and use a network (e.g., a discovery mode such as that available in Bluetooth™ communications). For certain types of wireless medical devices, this kind of discovery mode could pose safety and effectiveness concerns, for example, where automatic connections might allow unintended remote control of the medical device.
FDA recommends that wireless medical devices utilize wireless protection (e.g., wireless encryption,6 data access controls, secrecy of the "keys" used to secure messages) at a level appropriate for the risks presented by the medical device, its environment of use, the type and probability of the risks to which it is exposed, and the probable risks to patients from a security breach. FDA recommends that the following factors be considered during your device design and development:
- Protection against unauthorized wireless access to device data and control. This should include protocols that maintain the security of the communications while avoiding known shortcomings of existing older protocols (such as Wired Equivalent Privacy (WEP)).
- Software protections for control of the wireless data transmission and protection against unauthorized access.
Use of the latest up-to-date wireless encryption is encouraged. Any potential issues should be addressed either through appropriate justification of the risks based on your device's intended use or through appropriate design verification and validation.
For more information on this topic, see FDA's draft guidance "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices." FDA's draft guidance represents FDA's proposed approach on this topic.
e. EMC of the wireless technology
FDA recommends that EMC be an integral part of the development, design, testing, and performance for RF wireless medical devices. This should include consideration of applicable telecommunications standards and regulations and the potential for device RF emissions that might cause EMI with other equipment. In addition, RF wireless technology (by itself and in conjunction with the medical device) would also need to meet applicable FCC requirements. Risk management activities should include using risk analysis to identify any potential issues associated with EMC and determining risk acceptability criteria based on information about the device and its intended use, including foreseeable misuse, sources of environmental EMD (e.g., radio transmitters, computer RF wireless equipment), and the potential for RF emissions to affect other devices.
EMC testing should include tests focused on the medical device wireless functions and technology. Some voluntary consensus standards such as the FDA-recognized7 consensus standard IEC 60601-1-2 "Medical Electrical Equipment – Part 1-2: General requirements for safety and essential performance – Collateral standard: Electromagnetic compatibility – Requirements and tests" contain an exemption from the electromagnetic immunity provisions in the "exclusion band" (passband) where the medical device's RF wireless receiver or transmitter operates. Consequently, such standards do not adequately address whether the wireless communications will operate properly in the presence of in-band EMD (e.g., other RF emissions overlapping the frequency band utilized by the medical device wireless signals). Therefore, the medical device's wireless communication(s) should be actively transmitting while testing for susceptibility during all EMC immunity testing.
EMC considerations are also covered in other standards that might be helpful for medical devices that incorporate RF wireless technology. For example, EMC considerations for active implantable medical devices are covered under documents such as the ISO 14708-1 standard (see Appendix B).
Adequate information for the user is especially important if the device might be used in high electric or magnetic field strength environments, and particularly if the device cannot be made to function as intended in these environments. To help ensure safe and effective use of your device, FDA recommends that the information for users include the following:
- Conformance to the IEC 60601-1-2 standard or other appropriate standards, and
- EMC susceptibilities discovered during testing, and mitigations such as recommended separation distances from other devices or EMD sources.
The IEC 60601-1-2 standard specifies that certain information based upon the EMC testing be included in "accompanying documents." This information includes a summary of the test findings and additional EMC-related information such as classification of the electrical power supply and use conditions.
f. Information for proper set-up and operation
To help assure proper set-up, configuration, and performance of the wireless medical device, appropriate information should be provided to users. The following are suggested items to consider as part of this information:
- The specific RF wireless technology type (e.g., IEEE 802.11b), characteristics of the modulation, and effective radiated RF power.
- Specification of each RF frequency or frequency band of transmission and the preferred frequency or frequency band (if applicable), and specification of the bandwidth of the receiving section of the equipment or system in those bands.
- Appropriate FCC labeling.
- A warning that other equipment could interfere with the medical device or device system, even if the other equipment complies with CISPR8 emission requirements.
- Information about the needed quality of service and security for the wireless technology.
- Functions and performance of the wireless data transmissions including data throughput, latency, and data integrity.
- Information about any limitations on the number, output power, or proximity of other in-band transmitters used in the vicinity that might adversely impact a device's system operation.
- Information for the user to understand the RF wireless technology's capabilities and be able to recognize and address issues that might arise. For devices with intended use locations that are in complex RF wireless environments and consist of multiple wireless products, this should include assessment and management of the RF wireless transmitters and their use in the vicinity including transmitters both inside and outside the facility.
- Information for the user to understand the implications and limitations of using RF wireless technology outside the United States, where allocations and technical parameters may be different, possibly affecting the functioning of the device.
g. Considerations for maintenance
Device Life Cycle - FDA recommends that you continue to manage the risks associated with the use of wireless technology described above for the entire life cycle of your device. Your procedures for implementing corrective and preventive action must include, among other things, analyses for possible trends in nonconformance information and complaints, such as reports of failures, which could include erratic or unexpected behavior of the medical device.9 Examples of such behavior include reprogramming of stimulation devices, commands missed or misinterpreted by operating room controllers, unexplained inconsistencies of an infusion pump, and failure to activate alarm signals in alarm conditions.
Because electromagnetic emissions and exposure can vary significantly with various structures, materials, and RF wireless emitter sources in the vicinity, FDA recommends that in analyzing failure trends, you consider factors such as location, user application, and repeat component failures. Potential problems include:
- Additional events that may have contributed to the EMI or disruption of wireless technology resulting in inappropriate or unnecessary diagnostic procedures or interventions;
- Additional equipment used in conjunction with the device;
- Environmental conditions that might have contributed to the event; and
- Repeated device failures at the same facility or in other geographic areas.
If you identify a failure or malfunction of an RF wireless function, you must investigate the cause and take action(s) to correct the problem and prevent its recurrence.10 You must analyze production and repair records and other sources of quality data to determine the cause of the nonconformance.11 Any corrective action and preventative action taken must be verified or validated to ensure that such action is effective and does not adversely affect the finished device.12 FDA further recommends that you assess any product lines that use similar designs or are subject to the same environment to determine whether corrective and preventive actions are needed for those products.
Servicing - When servicing electrically powered medical devices, FDA recommends that you maintain the integrity of RF wireless functions and design elements intended to ensure EMC. Care should be taken to ensure EMI protection is present and in good condition. Such EMI protection can include components that may be removed during service such as shields, metal covers, ferrite beads, bonds, screws, ground wires and straps. In addition, FDA recommends that you do not paint metal surfaces that are intentionally left bare for RF shielding continuity. To reduce EMI susceptibility as electronic equipment ages, we recommend that you clean connector contacts that might have oxidized because oxidized contacts can act as semiconductors.
4. Recommendations for Premarket Submissions13 for Devices that Incorporate RF Wireless Technology
When preparing a premarket submission for a device that incorporates RF wireless technology, FDA recommends that you include the following information, as appropriate, for your specific medical device.
a. Description of device
In order to facilitate the review of the submission, the device description for a wireless medical device should include the following information specific to the wireless technology and functions:
- A description of the wireless technology and functions, and the intended use of the medical device and intended use environment. This should include the form and specific type of wireless technology that is incorporated into the device (e.g., IEEE 802.11b, IEEE 802.15 BluetoothTM), RF frequencies and maximum output powers, range, and where and how the wireless technology is to be used.
- A description of how the design of the device's wireless function(s) assures timely, reliable, accurate, and secure data and wireless information transfer. This includes the wireless QoS needs and security measures.
- If wireless technology is used for transmission, reception, or process involving alarm signals, a description of the alarm signal, its priority, and how the RF wireless-related risks are managed and, if appropriate, mitigated.
- Identify whether other wireless products or devices are able to make a wireless connection to the device. If so, summarize the products or devices and their function and how the subject medical device functions are protected from adverse effects of such connections to the other products or devices.
b. Risk-based approach to verification and validation
1. Wireless Quality of Service – The submission should include information to describe the wireless QoS needed for the intended use and use environment of the medical device. This includes addressing any risks and potential performance issues that might be associated with data rates, latency, and communications reliability as described in Section 3-b.
2. Wireless coexistence – Any risks and potential performance issues that might be associated with wireless coexistence in a shared wireless environment should be addressed via testing and analysis with other wireless products or devices that can be expected to be located in the wireless medical device's intended use environment. See Section 3-c. The information addressing coexistence should include the following:
- A summary of the coexistence testing, set-up, findings, and analysis.
- The wireless products (interferers) that were used in the coexistence testing, and their wireless RF frequencies, maximum output powers, and separation distances from the device.
- The specific pass/fail criteria for this testing.
- How the device and wireless functions were monitored during the testing and determined to meet the pass/fail criteria.
- If it is reasonable to expect multiple units of the subject wireless medical device to be used in the same vicinity, the information should also address how the association and security between devices is established and maintained to prevent cross-talk among the devices.
3. Security of wireless signals and data - The submission should identify any risks, potential performance issues, and, if appropriate, risk mitigation measures that might be associated with wireless security. The information should include the specific measures needed to protect against unauthorized wireless access to the medical device control or data and to ensure that information and data received by a device are intended for that device. For wireless technology with a discovery mode or similar active connection mode, specific information should be included addressing the discovery mode and how outside users can be prevented from sensing or connecting to the medical device. See Section 3-d.
4. EMC of the wireless technology – Information should be provided about how EMC has been addressed for the device and all wireless functions. However, as mentioned in section 3-e., the widely used IEC 60601-1-2 consensus standard does not at present adequately address wireless technology EMC. Therefore, testing, analysis, and appropriate mitigation might be necessary to adequately address any risks or potential performance issues that might be associated with the EMC of the wireless medical device. If modifications to the medical device were made to pass any EMC testing, please include a description of, and justification for, the modifications.
c. Test data summaries
FDA recommends that the final RF wireless and EMC testing14 and results be summarized in your premarket submission, which should contain the following information:
- Description of the tests performed (e.g., RF wireless performance, EMC immunity and emissions, test levels or limits) and the protocol used;
- Reference to appropriate medical device, RF wireless technology, or EMC standards for the tests;
- Explanations for any deviations from the selected standards;
- Mode(s) of device operation during testing, with an explanation of the significance of these modes;
- Specific pass/fail criteria for the testing such as specific device-related acceptability criteria for each device mode or function tested. These criteria should include the following:
- Specific device functions that should not degrade (such as CPU failure);
- Device functions that may degrade (such as display fluctuation); and
- Device recovery from degradation (such as after removal of the electrostatic discharge (ESD)).
- If modifications were made to the medical device in order to pass testing, a statement that all modifications will be incorporated into all final production units.
d. Labeling related to wireless medical devices
To facilitate the safe and effective use of the wireless medical device, the proposed labeling should include risk mitigation measures that address RF wireless issues and any precautions users should take. You should be aware that while labeling statements, such as warnings, may be helpful, they are not a substitute for risk mitigation measures or other design control activities, and are typically not adequate to prevent adverse events.
FDA recommends that the following information be included in the device labeling:
- A summary of the medical device wireless functions and specific wireless technology incorporated into the medical device or device system including equipment or system specifications (e.g., the standard IEEE 802.11 b/g, IEEE 802.15.4 BluetoothTM class II);
- A summary of the operating characteristics of the wireless technology, effective RF radiated power output and operating range, modulation, and bandwidth of receiving section;
- A brief description of the wireless QoS needed for safe and effective operation;
- A brief description of the recommended wireless security measures such as the WPA2 wireless encryption for IEEE 802.11 technology;
- Information addressing wireless issues and what to do if problems occur;
- Information about any wireless coexistence issues and mitigations. This can include precautions for proximity to other wireless products, and specific recommendations for separation distances from such products;
- Appropriate EMC and telecommunications standards compliance and test results summary;
- Appropriate RF wireless communications information such as those required by FCC rules; and
- Warnings about possible effects from RF sources in the vicinity of the device (e.g., electromagnetic security systems, cellular telephones, RFID or other in-band transmitters).
In addition, FDA recommends that your labeling also include all of the information as outlined in the appropriate reference standards (e.g., IEC 60601-1-2). You should also consider any other appropriate FDA guidances or special controls guidelines applicable to your device for additional labeling information.
Appendix A: Glossary for Wireless Medical Devices and Device Systems
The following definitions were adapted from IEC 60050-161 International Electrotechnical Vocabulary (IEV), IEEE Standard 802.15.2™-2003, the IEEE Standard 11073-00101™ -2008, and other sources.15
Data integrity — Assurance that transmitted files are not deleted, modified, duplicated, or forged without detection.
Electromagnetic compatibility (EMC) — the ability of a device to function (a) properly in its intended electromagnetic environment, and (b) without introducing excessive electromagnetic disturbances that might interfere with other devices.
Electromagnetic disturbance (EMD) — any electromagnetic phenomenon that might degrade the performance of an equipment, such as medical devices or any electronic equipment. Examples include power line voltage dips and interruptions, electrical fast transients (EFTs), electromagnetic fields (radio frequency radiated emissions), electrostatic discharges, and conducted emissions.
Electromagnetic interference (EMI) — degradation of the performance of a piece of equipment, transmission channel, or system (such as medical devices) caused by an electromagnetic disturbance. Note: Disturbance and interference are cause and effect, respectively.
Electrostatic discharge (ESD) — the rapid transfer of an electrostatic charge between bodies of different electrostatic potential, either in proximity in air (air discharge) or through direct contact (contact discharge).
Emissions — electromagnetic energy emanating from a device generally falling into two categories: conducted and radiated. Both categories of emission can occur simultaneously, depending on the configuration of the device.
Conducted emissions — electromagnetic energy emanating from a product through a conductor by means of resistance, inductance, or capacitance. Conductors include AC power cords, metallic enclosures of a subsystem, or cables that interconnect subsystems or the patient to the product. Conducted emissions include power line harmonics, surges, and radio frequency energy, especially in the frequency range 150 kHz to 80 MHz.
Radiated emissions — electromagnetic energy emanating from a device and propagating through space or a medium (which can affect the distance and direction of propagation). Radiated emissions include both intentional emissions such as radio transmissions carrying information and unintentional emissions associated with electrically powered equipment such as motors, power supplies, and computer components.
Immunity — the ability of an electrical or electronic product to operate as intended without performance degradation in the presence of an electromagnetic disturbance.
Latency — the time it takes for a unit of information to cross a wireless link or network connection from sender to receiver, which is also known as transfer delay.
Quality of service (QoS) — the necessary level of performance in a data communications system or other service, typically encompassing multiple performance parameters, such as reliability of data transmission, transfer rate, error rate, and mechanisms and priority levels for time-critical signals.
Radio frequency (RF) — a frequency in the portion of the electromagnetic spectrum that is between the audio-frequency and the infrared portions, and is useful for radio transmission. Commonly used radio frequencies range from 9 kHz to 100 GHz.
Radio frequency interference (RFI) — one type of EMI resulting from radiated emissions at one or more radio frequencies, which causes degradation of the reception of a wanted signal by a radio-frequency electromagnetic disturbance.
Radio frequency (RF) wireless medical device — a medical device that includes at least one function that is implemented using RF wireless communications; examples of functions that might be implemented wirelessly include data transfer, device control, programming, power transmission, remote sensing and monitoring, and identification.
Security — a collection of services, policies, mechanisms, and controls that provides information confidentiality, integrity, and availability by restricting unauthorized parties from accessing, manipulating, or leveraging particular system resources. Some security services might include data encryption, data integrity-checking, user and device authentication, and non-repudiation.
Specific absorption rate (SAR) — a measure of the rate at which energy is absorbed by the body when exposed to an RF electromagnetic field. It is defined as the power absorbed per mass of tissue and has units of watts per kilogram. SAR is usually averaged either over the entire body, or over a small sample volume (typically 1 g or 10 g of tissue).
Susceptibility — the potential for equipment (including medical devices) to respond to an electromagnetic disturbance. The inability of a device, equipment or system to perform without degradation in the presence of an electromagnetic disturbance. Note: Susceptibility is a lack of immunity.
Wireless coexistence — the ability of one wireless system to perform a task in a given shared environment where other systems (in that environment) have an ability to perform their tasks and might or might not be using the same set of rules.
Appendix B: Reference Standards and Information
FDA recommends that you refer to the FDA Recognized Consensus Standards Database, and type "electromagnetic compatibility" in the title search for EMC standards that FDA recognizes for use in premarket submissions. For information on recognized consensus standards, see the guidance document "Frequently Asked Questions on Recognition of Consensus Standards."
The list below illustrates national and international consensus standards and other standards, and documents and information related to EMC, medical device EMC, and telecommunications. FDA recognizes some of these standards for use in regulatory submissions. However, this list serves as a reference only and is not intended to substitute for or represent specific suggestions or recommendations. We recommend that you refer to FDA guidances or special controls guidelines applicable to your specific device.
Association for the Advancement of Medical Instrumentation (AAMI)
AAMI TIR No. 18-2010, Guidance on electromagnetic compatibility of medical devices in healthcare facilities
ANSI/AAMI PC69:2007, Active implantable medical devices—Electromagnetic compatibility—EMC test protocols for implantable cardiac pacemakers and implantable cardioverter defibrillators
ANSI/AAMI/IEC 60601-1-2:2007/ (R) 2012, Medical Electrical Equipment—Part 1–2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility – Requirements and tests. This is the U.S. version of the IEC 60601-1-2 standard (see IEC below)
American National Standards Institute (ANSI) Accredited Standards Committee C63 (ASC C63)
ANSI C63.4:2009, American National Standard for Methods of Measurement of Radio-Noise Emissions from Low-Voltage Electrical and Electronic Equipment in the Range of 9 kHz to 40 GHz
ANSI C63.10:2009, American National Standard for Methods for Testing Unlicensed Wireless Devices
ANSI C63.18:1997, American National Standard Recommended Practice for an On-Site, Ad Hoc Test Method for Estimating Radiated Electromagnetic Immunity of Medical Devices to Specific Radio-Frequency Transmitters
ANSI C63.19:2007, American National Standard Methods of Measurement of Compatibility between Wireless Communications Devices and Hearing Aids
Electrostatic Discharge Association (ESD Association)
ANSI/ESD S20.20-2007, ESD Association Standard for the Development of an Electrostatic Discharge Control Program for Protection of Electrical and Electronic Parts, Assemblies and Equipment (Excluding Electrically Initiated Explosive Devices)
Federal Communications Commission16
Code of Federal Regulations, Title 47 – Telecommunications, Chapter I - Federal Communications Commission, Subchapter A – General
- Part 2 – Frequency Allocations and Radio Treaty Matters; General Rules and Regulations
- Part 15 – Radiofrequency Devices
- Part 18 – Industrial, Scientific, and Medical Equipment
Subchapter D - Safety and Special Radio Services
- Part 95 – Personal Radio Services
International Electrotechnical Commission (IEC)
The IEC 60601 family specifies safety standards for medical electrical equipment. EMC is addressed in IEC 60601-1-2, and IEC 60601-2-X provides standards for particular types of medical electrical equipment.
IEC 60601-1-2:2007, Medical Electrical Equipment – Part 1-2: General requirements for basic safety and essential performance– Collateral standard: Electromagnetic compatibility – Requirements and tests. This is a collateral standard to the third edition of IEC 60601‑1. The third edition of IEC 60601-1-2 was published in 2007 and contains essentially the same information that was in the second edition IEC 60601-1-2:2001 and Amendment 1:2004, reformatted according to the third edition of the IEC 60601-1 standard. Emissions and immunity requirements in the third edition IEC 60601-1 are specified under Clause 17.
IEC 60601-2-X standards are for particular types of medical electrical equipment. Requirements of IEC 60601-2-X standards supersede those of IEC 60601-1 and IEC 60601-1-2. Some IEC 60601-2-X standards specify higher immunity test levels or special test setups for EMC. Some might not have been amended yet to reference the third (2007) edition of IEC 60601-1-2 and might still reference an earlier edition. Modifications to IEC 60601-1 for EMC are specified in Clause 17 in the IEC 60601-1-2:2007 edition and Clause 36 in earlier editions. (NOTE: Subclause numbers for similar provisions in IEC 60601-1-2:2007 are different from those in earlier editions.)
IEC 61326-1:2005, Electrical equipment for measurement, control and laboratory use – EMC requirements - Part 1: General requirements. Edition 2.0 was published in 2012.
IEC 61326-2-1:2005, Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-1: Particular requirements - Test configurations, operational conditions and performance criteria for sensitive test and measurement equipment for EMC unprotected applications. Edition 2.0 was published in 2012.
IEC 61326-2-6:2005, Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment. Edition 2.0 was published in 2012.
IEC 60050-161:1990, International Electrotechnical Vocabulary – Chapter 161: Electromagnetic compatibility. Amendment 2 was published in 1998. IEV online: http://www.electropedia.org/
IEC TR 80001-2-3: 2012, Application of Risk Management for IT-Networks Incorporating Medical Devices – Part 2-3: Guidance for wireless networks
Institute of Electrical and Electronic Engineers (IEEE)
P11073-00101™-2008 - Guide for Health Informatics–Point-of-Care Medical Device Communication–Guidelines for the Use of RF Wireless Technology. There are several standards under the IEEE 11073 family that address health informatics point-of-care medical device communications and provide useful information.
IEEE Std 802.15.2™-2003 IEEE Recommended Practice for Information Technology— Telecommunications and Information Exchange between Systems— Local and Metropolitan Area Networks— Specific Requirements Part 15.2: Coexistence of Wireless Personal Area Networks with Other Wireless Devices Operating in Unlicensed Frequency Bands.
International Organization for Standardization (ISO)
Most ISO standards for medical electrical equipment reference clauses in IEC 60601-1, including Clause 17 (previously Clause 36) and IEC 60601-1-2.
ISO/TR 16056-1, Health informatics – Interoperability of telehealth systems and networks — Part 1: Introduction and definitions
ISO/TR 16056-2, Health informatics – Interoperability of telehealth systems and networks — Part 2: Real-time systems
ISO/TR 18307, Health informatics – Interoperability and compatibility in messaging and communication standards – Key characteristics
ISO 14708-1, Implants for surgery – Active implantable medical devices – Part 1: General requirements for safety, marking, and for information to be provided by the manufacturer
ISO 14708-2, Implants for surgery — Active implantable medical devices — Part 2: Cardiac pacemakers
ISO 14708-3, Implants for surgery - Active implantable medical devices - Part 3: Implantable neurostimulators.
ISO 14708-4, Implants for surgery — Active implantable medical devices — Part 4: Implantable infusion pumps
ISO 14971 Second edition 2007-03-01 Medical devices — Application of risk management to medical devices
ISO 14117, Active implantable medical devices – Electromagnetic compatibility – EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators, and cardiac resynchronization devices.
ISO technical report TR 21730, Health Informatics – Use of mobile wireless communications and computing technology in healthcare facilities – Recommendations for the management of unintentional electromagnetic interference with medical devices (ISO/TR 21730: 2007(E)).
RTCA, Inc.
RTCA/DO-160G, Environmental Conditions and Test Procedures for Airborne Equipment
1 Risk management is a key component of the quality system, and includes risk analysis, which is part of the design control requirements under the quality systems regulation. 21 CFR 820.30(g).
2 ISO 14971 is on FDA's list of recognized consensus standards, which is available at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/detail.cfm?standard__identification_no=30268.
3 For additional information on frequency bands and use, please refer to
http://www.fcc.gov/encyclopedia/accessing-spectrum and http://www.fcc.gov/encyclopedia/rules-regulations-title-47.
4 http://www.itu.int/en/ITU-R/Pages/default.aspx
5 See, e.g., 21 CFR 820.30(f) (design verification); 21 CFR 820.30(g) (design validation); 21 CFR 820.50 (purchasing controls); and 21 CFR 820.80 (acceptance activities).
6 At the time of publication of this guidance, this included WiFi Protected Access (WPA2) for IEEE 802.11 technology.
7 For a current list of FDA-recognized consensus standards, see the Recognized Consensus Standards Database at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm.
8 Comité Internationale Spécial des Perturbations Radioelectrotechnique (International Special Committee on Radio Interference). CISPR electromagnetic emission standards are referenced in the IEC 60601-1-2 standard. See Appendix B.
13 This guidance document applies to the following premarket submissions for devices: premarket notifications (510(k)), de novo petitions, premarket approval applications (PMA), product development protocols (PDP), humanitarian device exemption (HDE) applications, and Biologics License Applications (BLA). Manufacturers may also consider applying the recommendations provided in this guidance, as appropriate, to investigational device exemption (IDE) applications and investigational new drug (IND) submissions to CBER related to BLA devices.
14 By final testing we refer to testing performed on the final integrated product.
15 Sources include: Federal Standard 1037C Telecommunications: Glossary of Telecommunications Terms.
16 For further information about these or other FCC requirements, please refer to http://www.fcc.gov/encyclopedia/rules-regulations-title-47.


text: The Pasadena Police Department will be conducting traffic enforcement at high collision intersections throughout the City of Pasadena, on Friday September 14, 2012. This program will be conducted from 6:00 a.m. to 12:00 p.m. The Pasadena Police Department is committed to reducing the number of traffic collisions, resulting from drivers running red lights or driving aggressively through intersections. The ultimate goal is to enforce and educate the driving public and at the same time, reduce serious injuries and fatal collisions. Funding for this program was provided by a grant from the California Office of Traffic Safety, through the National Highway Traffic Safety Administration. For More information: Lieutenant Randell Taylor (626) 744-7159

subset: commoncrawl


text:
BP Comment Quick Links
|Strength of Schedule Report
October 28, 2013
Minor League Update
AFL Recap for Games of October 25-26
Games of October 25
Hitter of the Day: Kris Bryant, 3B, Cubs (Mesa Solar Sox): 3-5, 3 R, 2 2B, 3B, 2 K. You'd think it would get tiring talking about the same prospects over and over again, but when it's a prospect like Bryant, it doesn't. Friday was a great sign for Bryant, who had a dynamic game despite not hitting a home run. Despite his .429 fall batting average, he still has 13 strikeouts in 10 games, so that's something to keep an eye on, but if the production continues, no one will care about the strikeouts.
Pitcher of the Day: Tim Berry, LHP, Oriles (Surprise Saguaros): 4 IP, 3 H, 0 R, 0 BB, 2 K. Berry doesn't have overpowering stuff, but he pounds the strike zone and when he hits his spots, he can be quite effective. He's done exactly that this fall, walking just two in 11 innings but striking out just six.
Seeing it Well
Finding the Zone
Bad Days at the Plate
Forgettable Outings
Games of October 26
Hitter of the Day: The Salt River Rafters Lineup: 17-45, 20 R, 5 2B, 4 HR, 9 BB, 3 K. The Rafters went off on Javelinas pitching on Saturday, putting up a 20-spot including four home runs. Dustin Garneau, a 25-year-old Rockies catcher, led the way with two home runs, and while he's not really much of a prospect, he's a catcher with decent pop, so there's something to work with. Garneau's Rockies teammate Cristhian Adames added a home run of his own (a tool he doesn't usually feature) as part of a four-hit day. Cardinals outfielder Stephen Piscotty stayed red-hot with three more hits and is now hitting .356 on the fall.
Pitcher of the Day: Bo Schultz, RHP, Diamondbacks (Salt River Rafters): 5 IP, 2 H, 0 R, 0 BB, 5 K. At 27, Schultz is not a prospect, but he has been incredibly effective this fall, lowering his AFL ERA to 1.47. Never a big strikeout guy, Schultz saw a big spike in Triple-A this season and has continued to strike out more than a batter per inning this fall. He's gotten away from his four-seam fastball in favor of more cutters/sliders, which could help explain the change.
Seeing it Well
Finding the Zone
Bad Days at the Plate
Forgettable Outings
1 comment has been left for this article.
BP Comment Quick Links
Bret Sayre
BP staff
Dustin Garneau, Justin Morneau's evil twin.
Oct 28, 2013 09:50 AM
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text:
(This is Part 3 of Aakash's recollections of India's tour of Australia in 2003-04. Read Part 1 & Part 2)
We were set for Australia — strategies meticulously worked out, team combinations finalised and all of us were buoyant with energy so palpable. A last minute touch-up was important, and psychologist Sandy Gordon's interactive session did the trick. Gordon knew what we needed to hear — his words bolstered our resolve. He gave us a good brief on the Australian team, media and the fans, lest they intimidated us.
He also handed out forms that asked us our goals, both short and long term, along with positive affirmations and such like. The team met a last time before the trip officially began and agreed to compose a slogan for the tour — something which would reflect our mindset and our collective goal. After much brainstorming, we settled on Change The Trend.
Earlier that year, the slogan for India's World Cup campaign in South Africa was Now Or Never, resonating the team's mood. We hadn't come close to winning the World Cup for a while and the team vowed to make it happen in 2003. As for us, India had always been the underdog on Australian tours and we agreed to Change The Trend. We decided that whenever the chips were down, somebody would remind all of us of the reason we were present on the ground — to Change The Trend. It also worked brilliantly to lift the spirits and fight once more whenever a session went against us, for changing the trend was also swimming against the tide.
The first Test match at the Gabba was a huge test for everyone. The vows, the preparation and the resolve would have counted for nothing had we fallen short at the first hurdle. And on the contrary, if we crossed that hurdle, the sky was the limit. Doing well in Australia was a lot about how we started. A poor start would have been enough to dampen our spirits and bring back the ghosts.
Surviving Gabba
It was overcast and the track was greenish and damp. Sourav won the toss and elected to field first. We did reasonably well to restrict Australia for 323 with Zaheer taking five wickets. But the real challenge began when we started to bat, since India's abject failure overseas was largely due to poor batting.
We started decently, lost our way in the middle but found saviors in Ganguly and Laxman, who first stabilised the innings and then put India in command. Taking the first innings lead set the tone for the rest of the series. In Brisbane (where Australia remain unbeaten since 1988), we had seen into the opponent's eyes and traded on equal terms for the duration of the game. A draw in this game was as important as a win for us.
Adelaide: The trend changes
Our resilience didn't go down well with the Australians — they weren't used to being dictated. They came hard at us on the first day in Adelaide, made 400-5, and believed that normal business had resumed.
But the team they were up against now was on a mission to Change The Trend. We bounced back, dismissed them for 556, started strongly with the bat, only to lose our way again. But two men played extraordinary innings of skillful batting and unwavering temperament.
Rahul Dravid and VVS Laxman batted like a dream and took us to a respectable position, though we conceded a slender lead. The Aussies in their attempt to keep fighting played right into our hands. Agarkar took six wickets and set up the game nicely for us to win. We did the unthinkable by chasing down the 223 needed for a win. Dravid, once again, architected the chase with an unbeaten 72. We had indeed changed the trend.
Melbourne: Hurricane Sehwag
Both Sehwag and I felt like we were in a boxing ring and not a cricket ground. We took several blows on our helmets during the first session. We'd elected to bat first on a dampish wicket because the pitch was expected to deteriorate considerably in the course of the match. The first session was about weathering the storm. Then, Hurricane Sehwag engulfed the Australians. He went berserk in the noon and evening sessions and played a counter-attacking innings people hadn't seen hitherto.
We finished the day strongly at 329/4. A good first session on Day 2 would have tilted the match in our favor but we were in for a surprise. We lost six wickets for 37 runs and, with it, the match. We also realised that every day brought forth a new battle, and it was like playing a brand new Test match every day. You give the opposition an inch and they'll take a mile. The series was locked at 1-1 heading to Sydney.
Fair result in Sydney
This match is fondly remembered for Sachin's momentous 242* and Steve Waugh's farewell. While we dominated most of the match, we couldn't deliver the final blow. The result — a draw was, perhaps, a fitting end to close series. It was like a high-quality heavyweight boxing bout where both players stood their ground till the end.
Every time a team needed a hero, someone stood up and delivered. The quality of cricket was of an extremely high level and every session of every match produced engrossing cricket. Nobody could ever take his strong position for granted.
Let's hope that the series that starts on Monday lives up to its hype and we see quality cricket throughout. India winning the series for the first time in Australia would make it even better.
(This is Part 3 of Aakash's recollections of India's tour of Australia in 2003-04. Read Part 1 & Part 2)


text:
921 items found in this collection
Man with no fingers on right hand lighting a cigarette; view from interior of ...
Men changing tire on truck.
Boy leaning on car with house, girls, and hanging laundry in background.
Boy giving a small boy a piggyback ride down gravel road.
Girl on porch with other children below.
Three girls in kitchen.
Boy in driver's seat of truck.
Boy at sewing machine.
Girls washing hair in washtub.
Young man in chair on porch; girl playing with toy elephant.
Men without shirts; kicking car starter on the ground.
Man and boy without shirts working on truck.
Men on hood of car; drinking beer.
Boy pretending to drive broken down car.
Young couple.
Girl in front of truck.
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"Is Mark Davis a patient man?"
There was some discontent from the Raiders owner last season about his team's regression in November and his desire was to see progress.
General manager Reggie McKenzie jettisoned so many high-paid players the Raiders are operating with nearly $50 million in "dead" money under the salary cap and he remade the defense with bargain-priced, under-the-radar players who were looking for a chance.
McKenzie and coach Dennis Allen also retooled the offensive scheme. During training camp, however, the Raiders had as many as 20 players out with injuries, the team has been slow to jell and most prognosticators are seeing something like last year's 4-12 season — or worse.
Davis is fond of saying "I know what I don't know" but he's growing tired of seeing a storied franchise be identified with bad football.
If the Raiders are also-rans again, will Davis be patient enough to keep McKenzie and/or Allen around to reap the benefits of next year's salary cap space of up to $50 million?
Sept. 15 vs. Jacksonville Jaguars
With playoff teams Indianapolis and Denver coming on the road in Weeks 1 and 3, the Raiders are looking at 0-3 if they can't beat one of the supposed easy marks on their schedule in their home opener.
Terrelle Pryor, QB
Pryor's running ability can break open a game and put stress on even the best defense. An improving but still erratic passer, he can also be a difference-maker in a negative way.
Charles Woodson, strong safety
Woodson's play in the preaseason was minimal, but he believes, as do his coaches and teammates, that he still has his Hall of Fame ball skills (and ball-stripping skills) at age 36.
Denarius Moore, WR
The Raiders would like to see more consistency from Moore. But fact is, he remains the wide receiver most likely to come up with a big play (84 receptions for 1,359 yards and 12 touchdowns in 28 games and 25 starts).
Darren McFadden, RB
Getting McFadden back on track is the mission of new offensive coordinator Greg Olson, and with good reason. Since McFadden arrived in 2008, the Raiders are 10-2 when he rushes for 100 or more yards and 20-48 when he doesn't or is out with injury.
Sio Moore, LB
A third-round draft pick out of Connecticut, the Raiders instantly made Moore a starter at strongside linebacker. Defensive coordinator Jason Tarver likes his "position flexibility," meaning he can rush the passer, play the run and play in coverage.


text:
St John's School in Marlborough will be closed to pupils in years 7-10 on Wednesday because of strike action by the National Union of Teachers .
The school will be open for students in years 11, 12 and 13 but some of their lessons may be affected depending on which NUT members strike.
Pupils in year 7 can go into school and work under supervision but they will not have any formal lessons and parents have to contact the school before Wednesday if they want to make use of this provision.
Pewsey Vale School is expected to open as normal.


text:
Welcome to Saddleback College Office of Grants and Contracts!
The Grants Office is responsible for researching and developing grant proposals while providing leadership for the administration of grant awards at the college. The Grants Office assists with the development of budgets and all required reporting for granting agencies. Additionally, the Grants Office coordinates all grant applications sponsored by the State of California, Federal agencies and private foundations.
Grants Analysts are available to assist you with:
Pre-award Training and Assistance Services
- Ideation/brainstorming
- Identifying funding sources
- Assist in development of program models & designs
- Writing grant proposals
- Securing institutional approvals
- Submitting grant applications
Post-award Grant Oversight, Assistance, and Support Services
- Contract development and review
- Securing signatures on contracts & agreements
- Assisting with funding agency approvals for budget transfers/modifications, change of scope and no-cost extensions
- Liaison with program officer or representative at funding agency
- Troubleshooting
- Providing research, analysis, and internal reports when necessary
- Monitoring compliance with terms of award, budget & grant agreement
- Maintaining grants submission and award files for audits, etc.
This web page is designed to assist you and your department throughout the grant's development and management process. The Documents and Resources section provides you with forms, worksheets, the Grants Office Manual as well as other helpful materials.
Office of Grants and Contracts Principles
The Saddleback College Office of Grants and Contracts works with Deans and Faculty to pursue funding to ensure students are provided with "cutting edge" curriculum and supportive services -- helping them compete in the 21st century workplace and local and global economies.
PARTNERSHIP and COLLABORATION
The Saddleback Grants Office encourages strategic alliances with our sister campuses (Irvine Valley College and ATEP) as well as developing more significant relationships with other community colleges, businesses, workforce partners, and community non-profit organizations across California. Successfully acquiring state and federal grant funds requires College faculty, administration and staff to seek opportunities to form strategic partnerships and to explore innovative "outside the box" educational programs.
Saddleback Grants Analysts work with faculty, administrators and classified staff to develop funding opportunities which support academic and career technical educational programs which enhance and support student education.
The Grants Office fully supports an integrated or regional approach to grant/program development so that financial resources, facilities, technology, and areas of expertise are combined to the benefit of students, faculty, the regional economy, and the ability of the state to attract and retain quality employers, students/employees, and businesses.


text:
Dog and Cat BreedsLanguage brain teasers are those that involve the English language. You need to think about and manipulate words and letters.
Your task is to discover the name of a cat or dog breed.
From the clues given, you are to find the synonym for the word suggested. I have given you the number of letters for each word in brackets.
You have to rearrange the letters of each synonym to find the name of a dog or cat breed.
Brief sleep (3) + Caesar salad lettuce (7)
NAP + ROMAINE = Pomeranian
1. Close to (4) + Drink slowly (3)
2. Unrestricted choice (3) + Unwarranted preference (4) + Trespass (3)
3. Pea covering (3) + Astrological lion (3)
4. Male goose (6) + Consume (3)
5. Sweet potato (3) + Unit of Medication (4)
Answer1. NEAR + SIP = Persian
2. ANY + BIAS + SIN = Abyssinian
3. POD + LEO = Poodle
4. GANDER + EAT = Great Dane
5. YAM + DOSE = Samoyed
What Next?
See another brain teaser just like this one...
Or, just get a random brain teaser
If you become a registered user you can vote on this brain teaser, keep track of
which ones you have seen, and even make your own.
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text:
A HAMPSHIRE education chief has approved one part of a £2 million investment at a Winchester primary school.
Winnall school is to be enlarged after county councillor Roy Perry, executive member for children's services, approved the £777,000 extension and refurbishment of the school in Garbett Road.
The extension will provide two new classrooms, an extension to the staffroom, toilet and reconfigured library, special education needs space and IT suite. The school is contributing £39,000 to the extension project.
A re-cladding of the building costing around £1.17m is set to be approved by Hampshire County Council Leader, Ken Thornber.
The extension will provide an additional 30 school places, taking its capacity to 210.
Work is due to start in February 2013 and be completed for the start of the new year in September 2013.
The works are part of a £10.8m package of investment into primary school places in the city.
Cllr Perry said: "I am pleased to approve this project which will create capacity at the school to accommodate an additional 30 pupils to meet the increasing demand for primary school places. It is part of a wider programme of investment at schools across the city which will see hundreds of additional school places for 2013.
"Hampshire, like many parts of the country, is experiencing increased demand for primary school places. Winchester in particular, is attracting more and more young families not least because of the excellent quality of education our schools offer. The County Council is committed to ensuring pupils and staff have access to high quality facilities and this project will also see enhanced teaching and learning spaces for pupils and staff."
Last July Cllr Perry approved 400 additional places across the following primary schools: All Saints, Harestock, Oliver's Battery, St Bede, St Faith's, St Peter's, Stanmore, Weeke, Western and Winnall.


text:
Logo template suitable for musicians. The design incorporates the back end of a guitar and some musical notes.
- Color model: RGB & CMYK.
- Editable: everything (text, colors, dimensions, shapes etc.).
- Versions: 8 versions with different colors (check screenshots too).
- Font: link provided in the final files.
- Bonus: help file.
- AI – Adobe Illustrator (CC / CS).
- EPS – Encapsulated PostScript (CC / CS / V10).
- PSD – Photoshop file.
For any question don't hesitate to ask me, and please don't forget to rate!
Thank you!


text:
Affeldt upbeat after completing final step in recovery
TEMPE, Ariz. -- A 25-pitch appearance in an extended spring game was only part of Jeremy Affeldt's extensive throwing regimen Wednesday morning.
Affeldt's outing against Angels farmhands was expected to be the final step in his recovery from a strained right oblique. Assuming he continues to feel comfortable -- the next day is always a critical period -- the left-hander likely will be activated from the disabled list before Friday's series opener against the Los Angeles Dodgers at AT&T Park.
"Overall, it was good," Affeldt said. "I could have been a little more aggressive. But sometimes in those situations it's tough to feel the same aggression that you do [in a game]."
Affeldt certainly underwent an aggressive throwing program, however. He limbered up his arm with long toss, warmed up in the bullpen and pitched in the game before playing more long toss. "I put as much pressure as I possibly could on it, and it was fine," he said.
Assistant athletic trainer Anthony Reyes and strength and conditioning coach Carl Kochan were present to supervise Affeldt. Neither general manager Brian Sabean nor any of his top assistants appeared to be on hand, perhaps reflecting the organization's confidence in Affeldt's health.
In the game, Affeldt faced seven batters and allowed two singles, neither of which was hit particularly hard. He coaxed four groundouts and recorded a strikeout.
Chris Haft is a reporter for MLB.com. This story was not subject to the approval of Major League Baseball or its clubs.


text:
Refuge Distressed Low-Rise Skinny Jeans
Price $32.99
Special Offer
BUY 1, GET 1 FOR $12.50 Details
Promotional pricing valid for a limited time on select styles only. Excludes sale. Valid on items of equal or lesser value. Discount applied to lowest ticketed item. Discount applied automatically in bag. Offer may vary in Charlotte Russe stores. Offer limited to inventory on hand; no backorders will be taken. Offer cannot be combined with other offers.
Details content below
- Zip fly with top button
- Faux front pockets
- Brands We Love: Refuge
Product Model Size:Model is 5'9" tall
From our Refuge collection! The softest denim in the skinniest fit, you'll love the Refuge Skin Tight Leggings like a legging, but with the delightful style of jeans! Mid-rise skinnies have back patch pockets and faux front pockets, with a handy coin pouch snuggled in at the hip.
Returns content below
Return or exchange in any Charlotte Russe store within 30 days of your ship date, or use the mailing label included in your package to send it back right away.
We do not accept returns on jewelry, swim, intimates, nail polish, fragrance, gift cards, opened beauty products or anything marked as final sale.
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text:
Pegfilgrastim (Neulasta®)
Pronounced: peg-fil-GRAS-tim
Classification: Colony Stimulating Factor
About Pegfilgrastim (Neulasta®)
Pegfilgrastim is a type of colony stimulating factor, which is a group of medications that stimulate the production and function of blood cells, including white blood cells, red blood cells and platelets. Granulocyte colony-stimulating factor (G-CSF) is a protein produced by the body to increase production of white blood cells. Pegfilgrastim is a long-acting, man-made version of G-CSF that stimulates white blood cell production, and in particular, neutrophil production. A neutrophil is a type of white blood cell that is responsible for fighting infection and is often decreased during cancer therapy. When the number of these cells drops below 1000/mm3, it is called neutropenia and puts the patient at significant risk of infection. Pegfilgrastim is used to prevent or treat neutropenia related to chemotherapy.
Pegfilgrastim is not a cancer treatment, but a supportive care medicine. This means it is used to counteract the effects of cancer and its treatments.
How to Take Pegfilgrastim
Pegfilgrastim is given as an injection under the skin. It is typically given as a single dose for each chemotherapy cycle, no sooner than 24 hours after the last dose of chemotherapy, and no more than 14 days before beginning the next chemotherapy cycle. To lessen the sting of the injection, it should be taken out of the refrigerator 30 minutes ahead of time.
The medication is also available in an on-body injector, which is applied the same day you receive chemotherapy. The on-body injector then delivers the pegfilgrastim dose the next day. Follow the instructions provided by your oncology team for how to use and remove the injector. This on-body injector uses an acrylic adhesive. Be sure to report any allergy to acrylic adhesives to your healthcare team before utilizing the on-body injector.
Storage and Handling
Pegfilgrastim should be refrigerated. To lessen the sting of the injection, it should be taken out of the refrigerator 30 minutes ahead of time.
Do not reuse single dose vials, syringes or needles. Do not throw the vials, syringes, or needles in the household trash. Dispose of all used needles and syringes in a puncture-proof disposable container with a lid. The FDA provides further information about the disposal of vials, syringes and needles. Keep the vials out of the reach of children.
Where do I get this medication?
Depending on your insurance coverage, pegfilgrastim may be administered in your doctor's office or provided through home infusion or a specialty pharmacy. Your oncology team will work with your major medical and prescription drug plans to identify where you should receive this medication.
Insurance Information
This medication may be covered under your major medical plan or prescription drug plan. Patient assistance may be available to qualifying individuals without prescription drug coverage. Co-pay cards, which reduce the patient co-pay responsibility for eligible commercially (non-government sponsored) insured patients, may also be available. Your care team can help you find these resources, if they are available.
Possible Side Effects of Pegfilgrastim
There are a number of things you can do to manage the side effects of pegfilgrastim. Talk to your doctor or nurse about these recommendations. They can help you decide what will work best for you. These are some of the most common side effects:
Bone or Muscle Pain
Pegfilgrastim stimulates the bone marrow to produce many white blood cells, which can lead to pain in the bones. This pain is often felt in the bones or muscles of the thighs, hips and upper arms. Your healthcare team may not want you to take acetaminophen (Tylenol®) because it can "mask" a fever, so talk to them about what pain relievers you can take.
Irritation or Burning at the Injection Site
Some people experience redness, swelling, or itching at the site of injection. This is usually temporary. The injection is known to sting or burn if given when it is cold. Take the medication out of the refrigerator 30 minutes ahead of time to allow it to come up to room temperature before administration.
Allergic Reactions
In some cases, patients can have an allergic reaction to this medication. Signs of a reaction can include: shortness of breath or difficulty breathing, chest pain, rash, flushing or itching or a decrease in blood pressure. If you notice any changes in how you feel during the injection, let your nurse know immediately.
Capillary Leak Syndrome
Capillary leak syndrome is a condition in which blood and components of blood leak out of vessels and into body cavities and muscles. The movement of this fluid out of the vessels can cause hypotension (low blood pressure) and organ failure. Signs and symptoms of capillary leak syndrome include: a sudden drop in blood pressure, weakness, fatigue, sudden swelling of the arms, legs or other parts of the body, nausea, and lightheadedness. If you are having any of these symptoms notify your infusion nurse or provider immediately.
Sickle Cell Crisis
In patients with sickle cell anemia, pegfilgrastim can cause a sickle cell crisis. Contact your healthcare team immediately if you have symptoms of a sickle cell crisis including pain and trouble breathing.
Kidney Problems
Pegfilgrastim can cause a decrease in kidney function or damage to the kidney. For this reason, your healthcare team will monitor your kidney function with blood tests while taking pegfilgrastim. Some patients will need to stop the medication due to kidney function changes. Notify your provider if you notice any blood in your urine, decrease in urination or darkening of the urine.
Other Side Effects
Other rare side effects include:
- Rupture of the spleen. Your healthcare team will monitor you for an enlarged spleen or rupture while using this medication. If you have pain in the left side of your abdomen or shoulder pain after receiving pegfilgrastim, notify your healthcare team immediately.
- This medication can cause a serious lung program called acute respiratory distress syndrome. If you experience shortness of breath, fever, breathing trouble or a fast rate of breathing, contact your healthcare team or go to the emergency room.
Reproductive Concerns
Exposure of an unborn child to this medication could cause birth defects, so you should not become pregnant or father a child while on this medication. Effective birth control is necessary during treatment. Even if your menstrual cycle stops or you believe you are not producing sperm, you could still be fertile and conceive. You should consult with your healthcare team before breastfeeding while receiving this medication.


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DETROIT - Several metro Detroiters will be in Washington DC Monday for the second swearing-in ceremony for President Barack Obama including Local 4's Carman Harlan.
George Parker, 82, has never missed an election. She also encourages others to exercise their civic duty. In fact, she has been active in the Democratic party for 20 years.
"For Barack Obama, I have been working for eight years going from door to door encouraging people to register to vote. I got about 50 people to register this time," said Parker.
Parker secured a ticket to the inauguration. She was born in the South and moved to Michigan to live with her aunt so she could attend school. Having lived through segregation, she feels the significance of President Obama's accomplishment, the first black president now serving a second term.
"It's really happening. I dreamed one day that it would happen, but I thought it would never come true," said Parker.
Parker said she was the third black teacher hired in the school district in Mount Clemens. She taught second grade for 25 years, has traveled the world, earned her masters degree and said she feels very blessed.
"My motto is to help somebody every day of my life, and I do that. I even keep a record of what I do for somebody every day," said Parker.
This will be Parker's second visit to Washington DC for an inauguration. She saw President Clinton's swearing-in ceremony in 1993. He later attended the same inaugural ball as her and she tried to get in line to dance with him.
"He didn't stay there but 10 to 15 minutes and I was in line, I think about third or four back, trying to dance with him. I didn't get the chance but I saw him," said Parker.
Cass Technical High School's marching band will be 60 strong in the crowd Monday morning. The students performed in the Presidential Inauguration Festival on Saturday. They will also get a tour of the White House on Tuesday.
"To see President Obama be reelected to the White House for a second term, and me being a part of that history, it means a lot to me," said Abraham Duffie Jr., a junior at Cass Technical High School in Detroit.
The students are thrilled by this opportunity
"When I get older I will always have this with me and I can share with other people that I meet," said Deangila Jones, a senior at Cass Technical High School.
The Military Spouses of Michigan will be marching in the Inaugural Parade after the swearing-in ceremony on Monday. Members of the group said they feel they finally have a voice thanks to the efforts of First Lady Michelle Obama and Dr. Jill Biden. The two women launched the Joining Forces initiative in 2011 that shines a spotlight on the needs of military families while their loved ones are called to serve.
"Our family has been military for a long time, so it's just been nice to have someone in the White House who is supporting the families," said Rebecca Johnson.
About 90 people will march represent Military Spouses of Michigan, including 40 from metro Detroit.
"The support, just like these people here. If you're having a really bad day you can call and you don't have to explain anything, you can just say 'Hi,'" said Nancy Voss.
Voss brought her three sons to Washington DC. She lost about 40 pounds from stress while her husband Tim was serving in Afghanistan last year. Friends and military spouses like Rebecca Johnson help her get through it.
"It's like a once in a life time opportunity to go to Washington DC to see the President get sworn in and especially to bring my daughter to experience something like this," said Johnson.
After the parade, Voss and Johnson will be getting all dressed up to attend the Michigan Inaugural ball.
"My kids can't believe they're going to be that close to the President. It just seems surreal," said Voss.
Local 4's Carmen Harlan will be in Washington DC Monday for the inauguration. Stay tuned to Local 4 and ClickOnDetroit.com all day for complete coverage.
Copyright 2013 by ClickOnDetroit.com. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.


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By Courses Types: Ebook Courses
Courses Unavailable
Texas Real Estate Sae courses are currently unavailable
Please call 888-553-1267 for more information
Complete Your Sales Person Apprentice Education Online!
Take your Texas SAE Courses from the comfort of your home!
The choice you have made to utilize distance education as your method of learning can make all the difference! So, join the 750,000 and growing number of students achieving greater success using our proven distance education solutions. The Texas Real Estate Core Courses allow you to complete the Texas SAE courses from anywhere at any time. We offer you two formats for taking the required Texas real estate Salesperson Apprentice Education courses: Online and Correspondence.
One of the few pleasures of change would be achieving your goal of completing the Texas Real Estate Salesperson Apprentice Education requirements easily within the required first year.
Without a doubt, the first decision is whether to take the Texas Real Estate Salesperson Apprentice Education courses in-class or online. Adding to that challenge is choosing a provider that gives you the easiest most convenient solution. The key to success in today's Real Estate profession is not only knowledge and innovation – but also making a wise decision - day one. Choosing an education provider with a Proven Track Record Guarantees you have the foundation of knowledge to succeed.
Because our mission is enabling students to achieve their goal of completing their Texas Real Estate Salesperson Apprentice Education with time to spare, Career WebSchool offers the highest quality online real estate license courses. Built on twenty years of documented success, CompuTaught, the Nation's premier distance education provider has developed the ONLY online Texas Real Estate Prelicense course delivered using the proven Mastery and Fluency education methodology.
Complete your Salesperson Apprentice Education Now
You can be on your way to completing your Texas SAE courses in just One Click! Simply select your choice of the format for course delivery to the right to begin the registration process for the Texas Real Estate Salesperson Apprentice Education courses.
Career WebSchool was absolutely perfect for me. The online course allowed me to learn at my pace and also work on it around my schedule. I definitely would have had a difficult time learning the same material in a classroom environment. A traditional format would not have worked with my schedule demands. Also, after taking a few 'Continuing Education' real estate classes after licensing, I have found that it is actually harder to stay focused in the classroom setting! More often than not, the classes tend do go off topic and I occasionally feel that my time could have been better spent taking these classes through Career WebSchool.
The progressive learning format of the Career WebSchool courses made sure that I fully understood the subject and topics before moving on. This gave me confidence that I was not only learning the new material, but also retaining it. After I realized to just go through each module without arduously taking notes, I really began to move along in the learning process and it became very efficient. I particularly liked that I was able to refresh my knowledge by retaking completed reviews and test. This allowed me to narrow down the subject matter that I needed additional work on. I went back and re-took all the reviews and tests a few days before my state exam and felt very good about all the subject matter that I had learned.
The actual licensing exam was also in computer format, so there was no additional anxiety for me while I was taking the state exam. After all the modules I completed with Career WebSchool, I felt comfortable and right at home on the test terminal at the testing center.
All in all, it is a fantastic product and I would recommend it to anyone full heartedly. Thank you again for the opportunity to learn through Career WebSchool. It did an excellent job preparing me for the State Real Estate Salesperson Exam and definitely gave me a head start over my peers. In such a competitive industry, any and every edge helps.
Alfred S.
Salesperson Apprentice Education (SAE)
A salesperson is required to complete a total of 18 semester (270 classroom) hours of education, at least 14 semester (210 classroom) hours of which must be in Texas Core Real Estate Courses, by the end of their first year of licensure.
The information provided is designed to provide a summary of the minimum education, experience, and examination requirements established by the Texas Real Estate Commission.
Career WebSchool: Career WebSchool has offered CompuTaught online real estate pre-license courses since 1989. Career Web School Texas is an Online Real Estate School offering prospective real estate agents an easy, cost-effective method of obtaining their Texas Real Estate License. Existing Real estate agents may obtain their Texas Salesperson Apprentice Education or Continuing Education with ease as well. All of our real estate license courses are APPROVED by the Texas Real Estate Commission (TREC).
How does an online course work?
Each Texas Real Estate License online course is divided into lessons that take about 20-30 minutes on the average. Each lesson consists of text with multiple choice questions mixed in. The text is presented one small, easy-to-understand sentence or paragraph at a time. After a few screens of text, you willanswer a few questions about what you have read. As you progress through the lesson, thelearning processkeeps track of how you are doing on the questions. After all the text is presented, the computer will go back to the questions you missed or had problemswith and review them in random order. You'll keep working on the lesson until you've answered all the questions correctly on two occasions. At that point, the lesson will be marked as complete on the main menu. You can quit a lesson at any time and a bookmark will save your place, so you don't have to repeat work you've already done when you return to a lesson.
Completing the Online Course
All the lessons for the course are completed online. Each hour of approved credit will take approximately one hour of computer time to complete. The 30 hour Texas Real Estate Salesperson Apprentice Education courses will take approximately 30 hours each to complete. You may access the online courses immediately and begin working as soon as you complete the registration process.
End of Course Final Exams for Online Courses
Texas allows the Real Estate Salesperson Apprentice Education core course exams to be administered online. You may access the final exam as soon as you finish all course lessons in a particular course. Minimum grade of 70% is required on the end-of-course examination.
How does a Correspondence course work?
The 5 easy steps to taking correspondence courses:
- Order your courses now. You may immediately access your courses. [Via e-Book].
- Complete your courses at your own pace.
- All exams are delivered ONLINE open Book. No delays. No waiting.
- Upon successful completion of your online test, Certificate of Completion can be printed immediately.
- If you have chosen "Book" format, materials are shipped the next business day*
How do I Register for the eBook format?
- Select the e-Book format
- Choose your courses
- Download the e-Book
How do I Register for the Book format?
- Select the text book format
- Choose your courses
- Enter your shipping address (NO P.O. Box numbers)
- Orders received before 10 am CST processed the same business day.
- Orders received after 10 am CST will be shipped the next business day
End of Course Final Exams for Correspondence Courses
Texas allows the Real Estate Salesperson Apprentice Education course exams to be administered online. You must first pass with a score of 70% the practice exam for each core course prior to taking the end of course final exam. You have immediate access and unlimited tries to pass the practice exam. Once you've passed the practice exam you have access to the end of course final exam. Minimum grade of 70% is required on the end-of-course examination. After successfully passing the final exam you will have the ability to print out your completion certificate.
Fully Accredited
Our online delivery system for real estate license was one of the first in the nation to gain approval from ARELLO. The ARELLO standards insure the best quality in delivery and support is routinely delivered to the student. Online Real Estate Schools displaying this seal have met the high standards of quality required by The Association of Real Estate License Law Officials for online real estate courses and real estate classes. Career WebSchool went online in 1996 and was instrumental in the development of the ARELLO standards for certifying real estate license schools to offer online real estate license courses.


text:
US Airways is only the latest in a series of companies that have tweeted something stupid, offensive, or otherwise just plain head to desk-worthy.
Whether it's a "bro-grammer" whose white privilege let him get away with a mere firing, or it's a kitchen appliances company who thought it was cute to offend a President's dead grandmother, or even if it's Justine Sacco (who deserves a category onto herself), it's not just your ratchet Cousin NuNu or Struggle Rapper Pookie'n'Blu'n'em who just tweets through it.
Behold, 15 examples of how a corporate name can't hide the ratchet…
Photo: Twitter


text:
Gains in durable goods orders and pending home sales boosted the markets to a higher close with the Dow climbing 92 points to 12,627. Nasdaq gained 21 points to 2875.
On the upside
The Food and Drug Administration approved Arena Pharmaceuticals' (Nasdaq: ARNA) obesity treatment Lorcaserin.
The Financial Times Alphaville blog said that Linde AG may offer up to $3.4 billion for Lincare Holdings (Nasdaq: LNCR).
Moody's downgraded Arch Coal's (NYSE: ACI) corporate family rating.
On the downside
Atlantic Power (NYSE: AT) priced its public offering of 5.57 million shares at the discounted price of $12.76 per share.
Shares of AutoZone (NYSE: AZO) fell after competitor O'Reilly Automotive (Nasdaq: ORLY) cut its guidance.
ITG analyst Steve West expects sales growth to slow for Chipotle Mexican Grill (NYSE: CMG).
In the broad market, advancing issues outpaced decliners by a margin of 7 to 2 on the NYSE and by 5 to 2 on Nasdaq. The Russell 2000 which tracks small cap stocks climbed 11 points to 776.


text:
Jan 1, 2013
Interview with Peruvian finance minister Luis Miguel Castilla
Castilla: Growth is sustainable, but the
automatic pilot will not work any longer. We were helped out by
very favorable winds outside our country, with very favorable
terms of trade and commodity prices at historic peaks. Given
that the world is most likely going to go into a phase of
slower growth, we need to undertake a series of reforms to be
able to sustain growth. I would place them in four
The first is to improve our productivity, our
competitiveness. Our economy has opened up and we have pursued
integrating into the world economy, both trade-wise and in
terms of the capital account. This obviously entails boosting
our productivity, our competitiveness, closing the
infrastructure gap, upgrading the skills of our labor force
and, in general, sustaining an environment where human
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