SIST EN 301 839-1 V1.1.1:2003
(Main)Electromagnetic compatibility and Radio spectrum Matters (ERM); Radio equipment in the frequency range 402 MHz to 405 MHz for Ultra Low Power Active Medical Implants and Accessories; Part 1: Technical characteristics, including electromagnetic compatibility requirements, and test methods
Electromagnetic compatibility and Radio spectrum Matters (ERM); Radio equipment in the frequency range 402 MHz to 405 MHz for Ultra Low Power Active Medical Implants and Accessories; Part 1: Technical characteristics, including electromagnetic compatibility requirements, and test methods
To add this piece of standard to the EN 300 220-1 Rev1 and to support CEPT/ERC Rec 1 and to support CEPT/ERC Rec 70-03 Annex 12. Technical characteristics and test methods for Ultra Low Power Active medical implants.
Elektromagnetna združljivost (EMC) in zadeve v zvezi z radijskim spektrom (ERM) - Radijska oprema v frekvenčnem območju od 402 MHz do 405 MHz za aktivne medicinske implantate in pribor ultra majhnih moči - 1. del: Tehnične karakteristike, vključno z zahtevami elektromagnetne združljivosti in s preskuševalnimi metodami
General Information
Standards Content (Sample)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.WLYQHLþQHElectromagnetic compatibility and Radio spectrum Matters (ERM); Radio equipment in the frequency range 402 MHz to 405 MHz for Ultra Low Power Active Medical Implants and Accessories; Part 1: Technical characteristics, including electromagnetic compatibility requirements, and test methods33.100.01Elektromagnetna združljivost na splošnoElectromagnetic compatibility in generalICS:Ta slovenski standard je istoveten z:EN 301 839-1 Version 1.1.1SIST EN 301 839-1 V1.1.1:2003en01-april-2003SIST EN 301 839-1 V1.1.1:2003SLOVENSKI
STANDARD
ETSI EN 301 839-1 V1.1.1 (2002-06)European Standard (Telecommunications series) Electromagnetic compatibilityand Radio spectrum Matters (ERM);Radio equipment in the frequency range 402 MHz to 405 MHzfor Ultra Low Power Active Medical Implants and Accessories;Part 1: Technical characteristics, includingelectromagnetic compatibility requirements, and test methods
ETSI ETSI EN 301 839-1 V1.1.1 (2002-06) 2
Reference REN/ERM-RP08-0404-1 Keywords radio, SRD, testing ETSI 650 Route des Lucioles F-06921 Sophia Antipolis Cedex - FRANCE
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Important notice Individual copies of the present document can be downloaded from: http://www.etsi.org The present document may be made available in more than one electronic version or in print. In any case of existing or perceived difference in contents between such versions, the reference version is the Portable Document Format (PDF). In case of dispute, the reference shall be the printing on ETSI printers of the PDF version kept on a specific network drive within ETSI Secretariat. Users of the present document should be aware that the document may be subject to revision or change of status. Information on the current status of this and other ETSI documents is available at http://portal.etsi.org/tb/status/status.asp If you find errors in the present document, send your comment to: editor@etsi.fr Copyright Notification No part may be reproduced except as authorized by written permission. The copyright and the foregoing restriction extend to reproduction in all media.
© European Telecommunications Standards Institute 2002. All rights reserved.
DECTTM, PLUGTESTSTM and UMTSTM are Trade Marks of ETSI registered for the benefit of its Members. TIPHONTM and the TIPHON logo are Trade Marks currently being registered by ETSI for the benefit of its Members. 3GPPTM is a Trade Mark of ETSI registered for the benefit of its Members and of the 3GPP Organizational Partners. SIST EN 301 839-1 V1.1.1:2003
ETSI ETSI EN 301 839-1 V1.1.1 (2002-06) 3
Contents Intellectual Property Rights.6 Foreword.6 Introduction.7 1 Scope.8 2 References.9 3 Definitions, symbols and abbreviations.10 3.1 Definitions.10 3.2 Symbols.12 3.3 Abbreviations.12 4 Overview of technical requirement specifications.12 4.1 Essential requirements.12 4.1.1 Transmitter requirements.12 4.1.2 Receiver requirements.12 4.2 Presentation of equipment for testing purposes.12 4.2.1 Choice of model for testing.13 4.2.2 Testing of equipment with alternative power levels.13 4.2.3 Testing of equipment that does not have an external 50
RF connector (integral antenna equipment).13 4.2.3.1 Equipment with an internal permanent or temporary antenna connector.13 4.2.3.2 Equipment with a temporary antenna connector.13 4.2.3.3 Equipment intended to be implanted in a human body.13 4.3 Mechanical and electrical design.14 4.3.1 General.14 4.3.2 Controls.14 4.3.3 Transmitter shut-off facility.14 4.3.4 Marking (equipment identification).14 4.3.4.1 Equipment identification.14 4.3.4.2 Regulatory marking.14 4.4 Declarations by the applicant.14 4.5 Auxiliary test equipment.14 4.6 Interpretation of the measurement results.15 5 Test conditions, power sources and ambient temperatures.15 5.1 Normal and extreme test conditions.15 5.2 Test power source.15 5.2.1 External test power source.15 5.2.2 Internal test power source.16 5.3 Normal test conditions.16 5.3.1 Normal temperature and humidity.16 5.3.2 Normal test power source.16 5.3.2.1 Mains voltage.16 5.3.2.2 Regulated lead-acid battery power sources.16 5.3.2.3 Other power sources.16 5.4 Extreme test conditions.17 5.4.1 Extreme temperatures.17 5.4.1.1 Procedure for tests at extreme temperatures.17 5.4.1.1.1 Procedure for equipment designed for continuous operation.17 5.4.1.1.2 Procedure for equipment designed for intermittent operation.17 5.4.1.2 Extreme temperature ranges.18 5.4.2 Extreme test source voltages.18 5.4.2.1 Mains voltage.18 5.4.2.2 Regulated lead-acid battery power sources.18 5.4.2.3 Power sources using other types of batteries.18 5.4.2.4 Other power sources.19 SIST EN 301 839-1 V1.1.1:2003
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6 General conditions.19 6.1 Normal test signals and test modulation.19 6.1.1 Normal modulation test signals for data.19 6.2 Antennas.19 6.3 Artificial antenna.19 6.3.1 Artificial antenna for transmitters with 50 Ω impedance connector.19 6.4 Test fixture for non-implanted equipment.20 6.5 Test fixture for equipment intended to be implanted in a human body.20 6.6 Test sites and general arrangements for radiated measurements.20 6.7 Modes of operation of the transmitter.21 6.8 Measuring receiver.21 7 Measurement uncertainty.21 8 Methods of measurement and limits for transmitter parameters.22 8.1 Frequency error.22 8.1.1 Definition.22 8.1.1.1 Systems with an unmodulated carrier frequency operating mode.22 8.1.1.1.1 Method of measurement.22 8.1.1.2 Systems with a modulated carrier frequency.23 8.1.1.2.1 Method of measurement.23 8.1.2 Limit.23 8.2 Emission bandwidth measurement.23 8.2.1 Definition.23 8.2.1.1 Method of measurement.23 8.2.2 Limits.24 8.3 Effective radiated power of the fundamental emission.24 8.3.1 Definition.24 8.3.1.1 Methods of measurement.24 8.3.2 Limits.25 8.4 Spurious emissions.25 8.4.1 Definition.26 8.4.1.1 Method of measuring the effective radiated power of spurious emissions.26 8.4.2 Limits.27 8.5 Frequency stability under low voltage conditions.27 8.5.1 Definition.27 8.5.1.1 Method of measurement.27 8.5.2 Limits.27 9 Methods of measurement and limits for receiver parameters.27 9.1 Spurious radiation.28 9.1.1 Definition.28 9.1.1.1 Method of measuring the effective radiated power of spurious emissions.28 9.1.2 Limits.29 10 Methods of measuring and requirements for monitoring systems.29 10.1 Monitoring system threshold power level.30 10.1.1 Measurement procedure using out-of-operating-region disturbance.30 10.1.2 Measurement procedure using frequency administration commands.31 10.1.3 Results based on above test procedure.31 10.2 Monitoring system bandwidth.31 10.2.1 Measurement procedure using out-of-operating-region disturbance.32 10.2.2 Measurement procedure using frequency administration commands.32 10.2.3 Results based on above test procedure.32 10.3 Monitoring system scan cycle time and minimum channel monitoring period.33 10.3.1 Measurement procedure using out-of-operating-region disturbance.33 10.3.1.1 Scan cycle time.33 10.3.1.2 Minimum channel monitoring period.33 10.3.2 Measurement procedure using frequency administration commands.33 10.3.3 Results based on above test procedure.34 10.3.3.1 Scan cycle time.34 10.3.3.2 Minimum Channel Monitoring Period.34 10.4 Channel access based on ambient levels relative to the calculated access threshold level, Thp.34 SIST EN 301 839-1 V1.1.1:2003
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10.4.1 Access based on lowest ambient level above Thp using out-of-operating-region disturbance.34 10.4.2 Access based on lowest ambient level above Thp using frequency administration commands.35 10.4.3 Results based on above test procedure.35 10.5 Discontinuation of MICS session if a silent period greater than or equal to 5 s occurs.35 10.5.1 Measurement procedure.35 10.5.2 Results based on above test procedure.36 10.6 Use of pre-scanned alternate channel.36 10.6.1 Measurement procedure for alternate channel selection using out-of-operating-region disturbance.36 10.6.2 Measurement procedure for alternate channel selection using frequency administration commands.37 10.6.3 Results based on above test procedure.37 11 Safety issues related to non-ionizing radiation.38 12 Electromagnetic compatibility.38 12.1 Method of measurement for electromagnetic compatibility.39 12.1.1 Programmer/Controller.39 12.1.2 Active implantable medical device.39 12.2 Requirements.40 12.2.1 Programmer/controller.40 12.2.2 Active implantable medical device.40 Annex A (normative): Radiated measurements.41 A.1 Test sites and general arrangements for measurements involving the use of radiated fields.41 A.1.1 Outdoor test site.41 A.1.1.1 Standard position.41 A.1.1.2 Equipment in close proximity to the human body but external to it.42 A.1.1.3 Active medical implant equipment.42 A.1.2 Test antenna.43 A.1.3 Substitution antenna.43 A.1.4 Optional additional indoor site.44 A.2 Guidance on the use of radiation test sites.45 A.2.1 Measuring distance.45 A.2.2 Test antenna.45 A.2.3 Substitution antenna.45 A.2.4 Artificial antenna.45 A.2.5 Auxiliary cables.45 A.3 Further optional alternative indoor test site using an anechoic chamber.46 A.3.1 Example of the construction of a shielded anechoic chamber.46 A.3.2 Influence of parasitic reflections in anechoic chambers.46 A.3.3 Calibration of the shielded RF anechoic chamber.47 Annex B (normative): Technical performance of the spectrum analyser.49 Annex C (informative): Bibliography.50 History.51
ETSI ETSI EN 301 839-1 V1.1.1 (2002-06) 6
Intellectual Property Rights IPRs essential or potentially essential to the present document may have been declared to ETSI. The information pertaining to these essential IPRs, if any, is publicly available for ETSI members and non-members, and can be found in ETSI SR 000 314: "Intellectual Property Rights (IPRs); Essential, or potentially Essential, IPRs notified to ETSI in respect of ETSI standards", which is available from the ETSI Secretariat. Latest updates are available on the ETSI Web server (http://webapp.etsi.org/IPR/home.asp). Pursuant to the ETSI IPR Policy, no investigation, including IPR searches, has been carried out by ETSI. No guarantee can be given as to the existence of other IPRs not referenced in ETSI SR 000 314 (or the updates on the ETSI Web server) which are, or may be, or may become, essential to the present document. Foreword This European Standard (Telecommunications series) has been produced by ETSI Technical Committee Electromagnetic compatibility and Radio spectrum Matters (ERM). The present document is part 1 of a multi-part deliverable covering Radio equipment in the frequency range 402 MHz to 405 MHz for Ultra Low Power Active Medical Implants and Accessories, as identified below: Part 1: "Technical characteristics, including electromagnetic compatibility requirements, and test methods"; Part 2: "Harmonized EN covering essential requirements of article 3.2 of the R&TTE Directive".
National transposition dates Date of adoption of this EN: 7 June 2002 Date of latest announcement of this EN (doa): 30 September 2002 Date of latest publication of new National Standard or endorsement of this EN (dop/e):
31 March 2003 Date of withdrawal of any conflicting National Standard (dow): 31 March 2003
ETSI ETSI EN 301 839-1 V1.1.1 (2002-06) 7
Introduction The present document is drafted on the assumption that type test measurements, performed in an accredited test laboratory will be accepted by the various National Regulatory authorities in order to grant type approval, provided the National Regulatory requirements are met. This is in compliance with CEPT/ERC/REC 01-06E [2]. Included are methods of measurement for Ultra Low Power Active Medical Implants (ULP-AMI) and accessories, fitted with antenna connector and/or integral antenna. Equipment designed for use with an integral antenna may be supplied with a temporary or permanent internal connector for the purpose of testing, providing the characteristics being measured are not expected to be affected. If equipment, which is available on the market, is required to be checked it should be tested in accordance with the methods of measurement specified in the present document. Clauses 1 through 3 provide a general description on the types of equipment covered by the present document and the definitions and abbreviations used. Clause 4 provides a guide to essential requirements, the number of samples required in order that type tests may be carried out and any markings on the equipment that the applicant has to provide. Clauses 5 and 6 provide general test conditions to be used. Clause 7 gives the maximum measurement uncertainty values. Clauses 8, 9, 10 and 11 specify the spectrum utilization and safety parameters that are required to be determined for the protection of the public. They contain the maximum limits and monitoring system performance specifications that have been chosen to minimize harmful disturbance to other equipment or services, reduce the potential for disturbance to this equipment from ambient sources, and protect the public. The clauses provide details on how the equipment should be tested and the conditions that should be applied. Clause 12 specifies the electromagnetic compatibility testing and measurement requirements for insuring the health and safety of the users of active medical implants and accessories are protected. Annex A provides normative specifications concerning radiated measurements. Annex B provides normative specifications for test equipment.
ETSI ETSI EN 301 839-1 V1.1.1 (2002-06) 8
1 Scope The present document covers, for Ultra Low Power-Active Medical Implants (ULP-AMI) and accessories used in a Medical Implant Communications Service (MICS), the required characteristics considered necessary to efficiently use the available spectrum and protect the public. ULP-AMI equipment and accessories in the MICS service is a unique new technology, available world wide in the medical field, that will provide high speed communications capability between individuals with implanted devices and medical practitioners engaged in utilizing these implants for the purposes of diagnosing and delivering therapy to individuals with various illnesses. The specifications contained in the present document were developed to insure that the health and safety of the patients that are using this equipment under the direction of medical practitioners is protected. Of particular importance is the inclusion of spectrum monitoring and access requirements (listen before talk protocol) designed to significantly reduce any interference potential between MICS systems operating in the band or between a MICS system and the primary users of the band. Equipment in the MICS service consists of active medical implants that communicate only to other active medical implants or to external programmer/control transmitters. The present document is a specific product standard applicable to active medical implants operating in the frequency band, 402 MHz to 405 MHz, and other radio devices that are considered to be accessories to active medical implants as described in Directive 90/385/EEC [6]. It is intended that the present document applies to operation in the band 402 MHz to 405 MHz only and that devices that can also operate in spectrum outside this band also meet any applicable requirements for operation in such bands. The present document contains the technical characteristics for ULP-AMI radio equipment and is referencing CEPT/ERC/REC 70-03 [3] and annex 12 to that document. It does not necessarily include all the characteristics, which may be required by a user, nor does it necessarily represent the optimum performance achievable. It applies to ULP-AMI devices and accessories operating in the band 402 MHz to 405 MHz: - for telecommand and telemetry to/from an implant in a patient's body to an external programmer/controller unit; or - for telecommand and telemetry to/from an implant to another implant within the human body; - with or without an integral antenna; and/or - with an antenna connection provided only for the purpose of connecting an external dedicated antenna. Compliance with the radiated emissions provisions of the present document is determined using a substitution technique. However, if calibrated half wave dipole antennas are used to measure the radiated field strength of the emissions from the EUT, it is permissible to calculate the erp levels of those emissions to show compliance. NOTE: If this technique is used, the ground reflected component of the measured field strength needs to be accounted for. For purposes of computing erp levels, the contribution to the measured level that is due to the ground reflected ray is considered to be 5 dB if measurements are performed on an open area test site or equivalent. For non-Harmonized parameters, national regulatory conditions can apply regarding the type of modulation, equipment marking and the inclusion of an automatic transmitter shut-off facility as a condition of the issue of an individual or general licence, or, as a condition of use under licence exemption. The extreme temperature and voltage ranges are fixed and are given in clauses 5.4.1 and 5.4.2 respectively. The present document covers requirements for radiated emissions above 25 MHz. Additional standards or specifications may be required for equipment such as that intended for connection to the Public Switched Telephone Network (PSTN). SIST EN 301 839-1 V1.1.1:2003
ETSI ETSI EN 301 839-1 V1.1.1 (2002-06) 9
2 References The following documents contain provisions which, through reference in this text, constitute provisions of the present document. • References are either specific (identified by date of publication and/or edition number or version number) or non-specific. • For a specific reference, subsequent revisions do not apply. • For a non-specific reference, the latest version applies. [1] Directive 1999/5/EC of the European Parliament and of the Council of 9 March 1999 on radio equipment and telecommunications terminal equipment and the mutual recognition of their conformity (R&TTE Directive). [2] CEPT/ERC/REC 01-06: "Procedure for mutual recognition of type testing and type approval for radio equipment". [3] CEPT/ERC/REC 70-03: "Relating to the use of Short Range Devices (SRD)". [4] ETSI ETR 028: "Radio Equipment and Systems (RES); Uncertainties in the measurement of mobile radio equipment characteristics". [5] ITU-T Recommendation O.153: "Basic parameters for the measurement of error performance at bit rates below the primary rate". [6] Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (AMD Directive). [7] EN 60601-1-2: "Medical electrical equipment; Part 1: General requirements for safety; Part 2: Collateral standard: Electromagnetic compatibility - Requirements and tests". [8] ITU-R Recommendation SA.1346: "Sharing between the meteorological aids service and medical implant communication systems (MICS) operating in the mobile service in the frequency band 401-406 MHz". [9] CISPR 16-1: "Specification for radio disturbance and immunity measuring apparatus and methods; Part 1: Radio disturbance and immunity measuring apparatus". [10] ICNIRP: "Guidelines for Limiting Exposure to Time-Varying Electric, Magnetic, and Electromagnetic Fields (up to 300 GHz), International Commission on Non-Ionizing Radiation Protection, Health Physics Vol. 74, No 4, pp 494-522, 1998". [11] Radiofrequency Radiation Dosimetry Handbook (October 1986), USAF School of Aerospace Medicine, Aerospace Medical Division (AFSC), Brooks Air Force Base, TX 78235-5301. [12] ANSI C63.17 (1998): "Methods of Measurement of the Electromagnetic and Operational Compatibility of Unlicensed Personal Communications Services (UPCS) Devices". [13] EN 45502-1: "Active implantable medical devices; Part 1: General requirements for safety, marking and information to be provided by the manufacturer". [14] Council Recommendation 1999/519/EC on limitation of exposure of the general public to electromagnetic fields 0 Hz-300 GHz. [15] ETSI ETS 300 683: "Radio Equipment and Systems (RES); ElectroMagnetic Compatibility (EMC) standard for Short Range Devices (SRD) operating on frequencies between 9 kHz and 25 GHz". [16] ETSI EN 301 489-3: "Electromagnetic compatibility and Radio spectrum Matters (ERM); ElectroMagnetic Compatibility (EMC) standard for radio equipment and services; Part 3: Specific conditions for Short-Range Devices (SRD) operating on frequencies between 9 kHz and 40 GHz". SIST EN 301 839-1 V1.1.1:2003
ETSI ETSI EN 301 839-1 V1.1.1 (2002-06) 10 3 Definitions, symbols and abbreviations 3.1 Definitions For the purposes of the present document, the following terms and definitions apply: access protocol: specification for measuring natural and man-made ambient background levels for the purpose of providing a technique for spectrum access that reduces the potential for harmful disturbance to/from other users of the spectrum active medical implant: diagnostic or therapeutic device designed to be implanted in a human body containing a power source and a transceiver using the 402 MHz to 405 MHz frequency band for the purpose of providing a two-way digital communications link artificial antenna: tuned reduced-radiating dummy load equal to the nominal impedance specified by the applicant assigned frequency band: frequency band within which the device is authorized to operate channel bandwidth: 3 MHz divided by the system emission bandwidth plus any specified guard band at each channel edge conducted measurements: measurements that are made using a direct connection to the equipment under test dedicated antenna: permanently attached or removable antenna supplied and type tested with the radio equipment, designed as an indispensable part of the equipment emission bandwidth: measured as the width of the signal between the points on either side of carrier centre frequency that are 20 dB down relative to the maximum level of the modulated carrier NOTE: Compliance is determined using instrumentation employing a peak detector function and a resolution bandwidth approximately equal to 1 % of the emission bandwidth of the device under test. fixed station: equipment intended for use in a fixed location full tests: all tests specified in EN 301 839-1 integral antenna: permanent fixed antenna designed as an indispensable part of the equipment Least Interfered Channel (LIC): channel, among the available channels that has the lowest potential for causing disturbance to or receiving disturbance from other users of the band, determined by measuring the level from both natural and man-made signal sources in available channels and selecting the channel with the lowest measured ambient power level or the channel with the lowest measured ambient power level that exceeds the calculated maximum permissible threshold power level listen before talk: performance requirement, usually in the form of a protocol, that requires a communications system to determine if the channel it intends to communicate in is occupied by another user and select from the available spectrum a channel for communication that reduces, to the extent possible, the potential for interference to/from another user of the spectrum Medical Implant Communications System (MICS): system specifically for the purpose of providing two way non-voice digital communications between an external programmer/control transceiver and an active medical implant transceiver or between active medical implant transceivers placed in a human body Medical Implant Communications System (MICS) channel: any continuous segment of spectrum that is equal to the emission bandwidth of the device with the largest bandwidth that is to participate in a MICS communications session NOTE 1: All medical implant communications systems must be designed to access a minimum of nine channels evenly distributed across the band. NOTE 2: Annex 12 to CEPT/ERC/Recommendation 70-03 [3] does not specify a channelling plan for ULP-AMI devices. It permits aggregation of 25 kHz segments up to a maximum of 300 kHz for each channel bandwidth. SIST EN 301 839-1 V1.1.1:2003
ETSI ETSI EN 301 839-1 V1.1.1 (2002-06) 11 Medical Implant Communications System (MICS) session: collection of transmissions that may or may not be continuous, between co-operating medical implant devices and accessories, including programmer/controllers, transferring patient related information in communications service Medical Implant Communications System (MICS) transmitter: transmitter with an integral receiver authorized to operate in the ULP-AMI band from 402 MHz to 405 MHz
Medical Implant Device: apparatus that includes a transmitter with an integral receiver that operates in the ULP-AMI band that is placed inside the human body for the purpose of performing diagnostic functions and/or delivery of therapeutic treatment Medical Implant event: occurrence or the lack of an occurrence recognized by a medical implant device or duly authorized health care professional that requires the immediate transmission of data from a medical implant transmitter in order to protect the safety of the person in whom the medical implant transmitter has been placed NOTE: It is not permitted that this is the only mechanism a medical implant transmitter can use to access spectrum. All medical implant transmitters must have the ability and typically use this ability to transfer information to/from a medical implant programmer/control transmitter on a frequency that has been selected by the programmer/control transmitter using the LIC spectrum access protocol specified in the present document. medical implant programmer/control transmitter: transmitter, operating outside of a human body in the ULP-AMI frequency band, that is designed to monitor the channel or channels the MICS system devices intend to occupy that selects, a communications channel for a link to a medical implant transmitter based on the use of the LBT access protocol, and transfers information to/from the implant after initiating the communications link medical implant transmitter: a transmitter with an integral receiver operating in the ULP-AMI frequency band, whose frequency of operation is determined by an associated transmitter that uses the LIC access protocol specified in the present document, that is designed to be placed within a human body for the purpose of providing two-way digital communications NOTE: A medical implant transmitter, designed and capable of operation in accordance with the above definition, may transmit without using the LIC spectrum access protocol if a medical implant event occurs as defined above. mobile station: equipment normally fixed in a vehicle and intended to be used at a distance more than 20 cm from a human body monitoring system: circuitry in a medical implant transmitter or an associated programmer/control transmitter that assures conformity with the spectrum access protocol requirements portable station: equipment intended to be carried, attached or implanted in a human body that is operated at a separation distance less than 20 cm from or internal to a human body radiated measurements: measurements, which involve the absolute measurement of a radiated field telecommand: use of radio communication for the transmission of signals to initiate, modify or terminate functions of equipment at a distance telemetry: use of radio communication for indicating or recording data at a distance threshold power level: ambient signal power level above which the monitoring system shall select spectrum for use in a MICS communication session according to the next available channel with the lowest level of ambient signal power or least interfered channel (LIC) NOTE: The maximum permitted threshold power level is calculated using the equation
Thp = 10logB(Hz) - 150 (dBm/Hz) + G (dBi). Ultra Low Power Active Medical Implant (ULP-AMI): active medical implant transmitter or medical implant programmer/control transmitter that is designed to radiate RF energy in accordance with the provisions of annex 12 to CEPT/ERC/Recommendation 70-03 and EN 301 839-1 wideband: equipment used in the ULP-AMI frequency band with an emission bandwidth ≥ 50 kHz and ≤ 300 kHz SIST EN 301 839-1 V1.1.1:2003
ETSI ETSI EN 301 839-1 V1.1.1 (2002-06) 12 3.2 Symbols For the purposes of the present document, the following symbols apply: dB decibel E electr
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