Jan Welinder, Christer Térnevik Ulf Bostrém, Bengt Lindberg Lars Atlegard, Bo Héjdefors The Introduction of DECT in Health Care Environments sP Swedish National Testing and Research Institute Physics & Electrotechnics SP REPORT 1997:182A Abstract The Introduction of DECT in Health Care Environment This report gives some recommendations for the introduction and use of DECT (a cordless tele- phone system) in health care environments. It is based on-several published practical investiga~ tions where medical equipment has-been tested together with DECT phones. A number of existing recommendations for the use of transmitters have also been analysed, ‘The main conclusion is that DECT with very limited restrictions can be used in most areas, Since the results may be unexpected due to the rather high field strength close to a DECT phone some results regarding immunity to high frequency electromagnetic fields are also discussed. Key words: DECT, EMC, medical equipment, immunity testing ‘Sveriges Provnings- och Swedish National Testing and Forskningsinstitut Research Institute SP Rapport 1997:18 SP Report 1997:18 ISBN 91-7848-676-9 ISSN 0284-5172 Boris 1997 Postal address: Box 857, SE-501 15 BORAS Sweden Telephone + 46 33 16 50 00 Telefax + 46 33 1355.022B CONTENTS Abstract Contents 1. Introduction 1.1 The DECT system 1.2 Similar telephony systems 2 Available investigations 2.1 Swedish report: Rapport om mobittelefont i sjukhusmiljs 2.2 Recommendations regarding the use of pocket telephones within health cate institutions 2.3 A Study to Examine the interaction between Cordless PABX handsets and Hospital Electronic Equipment 2.4 Electromagnetic compatibility of Medical Devices with Mobile ‘Communications 2.5 Other reports 2.6 Summary of the investigations 3 Published recommendations 3.1 Socialstyrelsen 3.2 VIFKA, 3.3 Telia Mobitel 3.4NHS 3.5 ANSI draft on-site test method 3.6 MDA, 4, Recommendations for introduction and use of DECT telephones Appendix A. EM-field limits A.1 Fields form handheld transmitters A.2 Field strength immunity limits Appendix B, Fields in buildnings B.1 Reflection and scattering B.2 Attenuation in various types of floors and walls Appendix C. In Situ Testing C1 Equipment C.2 Method Appendix D. Recommendations for the use of DECT systems in Swedish health care References 2A 2B Bee as 10 u 12 12 12 12 13 13 13 14 16 16 17 21 21 22 23 23 23 25 281. Introduction ‘The objective of this report is to establish.a set of recommendations that can be used when DECT systems are introduced in the health care environment. It is a well known fact that mobile transmitters can cause interference in electronic devices of various kinds if this is not foreseen in the construction, However, the disturbance potential is not the same for all (ypes of systems. DECT is a high frequency, low power system and can be expected to generate less interference than many other systems like VHF-transceivers and GSM mobile phones. ‘The results in this reports cannot directly be used for other environments without a thorough analysis of technical and other differences. It is also strictly limited to possible disturbances generated by DECT phones and does not deal with other transmitters or the numerous other sources of electromagnetic disturbances (electrostatic discharges etc.) that may interfere with the proper function of medical equipment. The type of equipment covered is only medical equipment, ‘The recommendations are based mainly on reports already published, These are briefly summarised but it is recommended for the reader to study the referenced documents more carefully. The technical electromagnetic field limits are based on the reports and also on experience from the EMC testing laboratory at SP which has handled a large number of EMC-tests during recent years. ‘The group which has taken part in the work is: Jan Welinder, SP Christer TSrnevik, Ericsson Radio Systems Ulf Bostriim, MTA, Clinical Engineering Dept,, University Hospital, Linképing Bengt Lindberg, MTA, Sahlgrenska Universitetssjukhuset/Ostra Lars Atlegard, ‘Telia Publicom, Bo Hojdefors, Swedish National Board of Health and Welfare ‘The report was financed by Ericsson Business Systems AB. 1.1 The DECT system DECT (Digital Enhanced Cordless Telecommunications) is « digital radio standard for cordless telephony in home and working environments, DECT has been a standard in the EU countries since 1993, and it has also been adopted in several countries outside of Europe. Today DECT is used in more than 30 countries around the world. ‘The DECT standard is mainly used for multipte-user wireless communications in offices, factories and other working environments. Such a business cordless system, which is also called cordless PBX (Private Branch Exchange), is a system consisting of a number of radio base stations which are connected to a central exchange. Users can make and receive calls when in range of a base station (up to about 50 meters indoors). Like in a cellular ‘mobile telephony system (e.g. GSM), the radio connection ts handed over from one base station to another when a user is moving within the area covered by the system. ‘The main feature of DECT cordless systems is that very high densities of users are permitted, However, unlike celular mobile telephone systems, DECT telephones generally cannot be. used outside of the working environment.DECT is based on the TDMA (Time Division Multiple Access) technology, which means that each of the radio channels (RF carriers) are divided into 24 time slots (12 duplex time slots), One user is allocated two time slots, one for transmission and one for reception. Consequently, each radio channel can be used for 12 simultaneous calls. The total time of ‘24 slots is 10 milliseconds, which means that a DECT telephone transmits with a time slot repetition rate of 100 Hz. DECT uses 10 radio channels in a 20 MHz frequency band between 1880 and 1900 MHz. ‘The telephones and the base stations have a peak ontput power of 250 mW, Since the handsets only use 1 time slot out of 24 for transmission, the average oulput power is 10 mW. In the table below, key system data for DEC are listed. DECT system data Peak power/mean power: handset: 250 mW/ 10 mw base station: 250 mW/ max 125 mW (depending on number of channels used) Frequency band 1.88 - 1.90 GHz Multiple access method ‘TDMA (Time Division Multiple Access) Duplexing method ‘TDD (Time Division Duplex) Time slots per channel 24 (12 duplex slots) Time slot duration 0.417 ms ‘Time slot repetition rate 100 Hz, 1.2 Similar telephony systems A number of similar wireless telephony systems exist. The results in this report are not valid for those systems, However, some conclusions may be drawn by the reader based on the various systems technical specifications. For this reason the basic characteristics of some commonly used systems are described below. The parameters in the technical specifications have an influence which can be described as follows: Power. Increasing power increases the probability of interference and interference occurring at larger distance, Frequency, A bigher frequency will normally decrease the risk of interference in an adjacent equipment. This explains why electronic devices does not react to the presence. of the modem telephony systems in a way like laboratory testing result seems to predict, This is due to the fact that less power is received due the decreasing efficient antenna area athigher frequencies (see appendix A), Experience shows that for a constant field strength most devices including external cables and susceptible to electromagnetic fields will show most of its reactions for frequencies below 400 MHz, As mentioned before DECT work at 1.9 GHz. In rare cases the immunity will decrease at high frequencies due to the better penetration of higher frequencies through slots and holes or due to the small size of the device. Modulation, Many devices like audio and video equipment are more susceptible for a modulated signal (in this context AM-modulation or a time multiplexed carrier wave) than for only the high frequency carrier wave, For other systems the degree of interference may be depending on the peak or mean power instead, but as a general rulemore interaference can be expected with a TDMA system than with an analogue FM- modulated systems when all other parameters are similar, ‘A general trend is that interference is less likely with modern systems that use higher frequency and less power than older. E.g.a “walkie-talkie” has a considerably higher interference potential than a GSM telephone. System: ct ‘Type/use: Analogue cordless PBX Peak power/mean power handset: 10mW/10mw base station: 10 mW/10 mW Frequency: 900 MHz Multiple access method: FDMA (Frequency Division Multiple Access) Duptexing method: FDD (Frequency Division Duplex) ‘Time slot repetition rate: : System: cr ‘Typefuse: Digital cordless PBX Peak power/mean power handset: 10 mW/5 mW base station: 20 mW /10mw Frequency: 900 MHz Multiple access method: FDMA Duplexing method: ‘TDD (Time Division Duplex) ‘Time slot repetition rate: 500 He, System: NMT450 ‘Typefuse: Analogue mobile telephony Peak power/mean power handset: 1,5 W/ 1,5W (sce note) Frequency: 450 MHz Multiple access method: FDMA Duplexing method: FDD ‘Time slot repetition rate: - System: NMT 900 Type/use: Analogue mobile telephony Peak power/mean power handset: 1 W/ TW (see note) Frequency: 900 ME Multiple access method: FDMA Duplexing method: FDD ‘Time slot repetition rate: rp ‘System: GSM ‘Typeluse: Digital mobile telephony Peak power/mean power handset: 2. W/ 250 mW (see note) Frequency: 900 MHz. Multiple access method: TDMA Duplexing method: FDD Time slot repetition rate: 217 He,‘System: ‘Typesuse: Peak power/mean power handset: Frequency: Multiple access method: Duplexing method: ‘Time slot repetition rate: DCS 1800 (GSM 1800) Digital mobile telephony 1 W/ 125 mW 1800 MHz, TDMA FDD 27 Note: Other types of telephones with higher output power exist for these systems. The figures relates to the handheld phones,2 Available investigations Since it is widely recognised that radio transmitters in general may cause hazardous electromagnetic interference in the health care environment several investigations haye been carried out, This report is based on the reports described below, all including tests with DECT. Common properties for all the reports ate that it has for obvious reasons not been possible to test all equipment in their normal environment. In many cases it has been necessary to use some kind of simulator for the patient. Like in all similar testing it has not been possible to test all modes of each equipment but in most cases the equipment is, tested in a mode that as closely as possible simulates the normal functions. Some functions of the equipment like alarms and the like may not have been active, ‘The tested equipment are of various kinds. The majority is medical devices but some are ‘used for e.g. chemical analysis. All are used in hospitals, 2.1 Swedish report: Rapport om mobiltelefoni i sjukhusmiljé (Report on mobile telephones in hospital environment). ‘This project was financed by ‘Telia Mobitel, Sweden. Active participants were also the ‘Swedish National Testing and Research Institute and persons representing clinical engineering departments from two hospitals (3). Objective ‘The objective of the project was a broad investigation of possible interference with transmitters in a hospital environment, Another objective was to investigate the occurrence of ineidents in hospitals due to the use of transmitters. None of the reported incidents include the use of DECT or any other system with similar or lower power. ‘Test method and result The project included a part in which medical equipment was tested for immunity to transmitters, A number of mobile transmitters, in total eleven different types, in the frequency range 27 - 1900 MHz were selected. The output power varied from 10 mW to 20 W. The number of medical devices that were tested was 24. However, only a limited number was tested together with DECT. The equipment was selected more'or less randomly among the normally used equipment. Real transmitters were tested in normal use in the vicinity of the medical equipment. ‘The tests were performed in hospital environment but in a safe area using various means to simulate real operation of the device, The equipment was in most cases placed on a wooden table and the transmitter was switched on and moved from a distance of 5 m to 10 cm from the EUT (equipment under test). At fixed transmitter distances the EUT was observed for any type of interference, This was repeated four times and the EUT was rotated 90 degrees in between. Small hand held transmitters were also swept around the EUT at 10 cm distance and placed on top of the EUT where that was possible,‘The test results were as below, DECT: 6 devices were tested and none showed any susceptibility. Other systems: 12 of 24 were susceptible to GSM or NMT and 20 of 24 for transmitters in the power range 5-20 W. 2.2 Recommendations regarding the use of pocket telephones within health care institutions VIFKA Telecommunicatic is the Dutch trade body for the telecommunications industry, ‘The tests included were performed by TNO Prevention & Health, Leiden. More complete reports arc published by TNO in dutch [1], (21. Objective ‘The objective was to find recommendations for use of pocket phones in health care enyironment. This was one of the reports where this clearly was stated as the objective. ‘The reason for starting the project was a ban of the use of pocket phones advised by the ‘Dutch National Health Sector Inspectorate 1994, ‘Test method and results ‘Three types of phones were used, GSM, CT2 and DECT. The tested equipment were in normal use when possible, otherwise some kind of patient simulator was used. ‘The phone was held initially at a distance of 1 m and then moved towards the equipment until zero distance. This was done from several directions. Tests were also performed close to cable connections and the like, ‘The test results were as below. DECT: 131 devices were tested and 19 reacted in some way. ‘Three medical devices reacted when the distance to the phone was more than 10 cm: — HPLC analyser reacted at 50 om — Hearing aid reacted at 50 cm (see 2.5) — Acoustic equipment for locating veins reacted at 3m ‘One device reacted at close distance in a way that could be indirectly dangerous (judgement in the report): = Analyser/osmometer giving incorrect reading. Other systems: 101 out of 205 were disturbed by GSM telephones and 2 out of 106 by cT2.2.3 A Study to Examine the interaction between Cordless PABX handsets and Hospital Electronic Equipment ‘The investigation was performed by ECS Ld for the National Health Service, UK [41 Objective The objective was to identify possible operational electromagnetic incompatibility between cordless PBX equipment and medical equipment commonly found in NHS hospitals. A second objective was to see if any medical equipment could affect the operation of the handsets. This was not seen. ‘Test method and result Five transmitters were used in the tests, two different DECT handsets, CT2, TACS and a 3 W VHF portable radio, ‘The number of tested medical equipment was 26, ‘The hand portables were characterised on an open area test site without ground plane as a separate part of the test, A difference in output power from two DECT manufacturers were noted (150 and 237 mW respectively), Both were within the allowed tolerance, ‘The immunity tests were carried out by setting up various pieces of hospital equipment and testing their susceptibility by moving the handsets progressively closer to the equipment until they touched the EUT or they caused a discernible effect. Particular attention was paid to the front panel area of each EUT and any other area where the BUT enclosure might not form good RF screen, ‘The rest results were as below. DECT: 26 equipment were tested and 2 were found to be susceptible — Electrocardiograph, trace affected — Electrocardiograph, vibrating noise but no change of trace ‘One of the two equipment reacted when the distance to the phone was more than 10 cm: ~ Hlectrocardiograph at 0.30 m and 0.37 m for the two DECT phones. This reaction was not deemed to be directly dangerous. Other systems: 1 of 26 were susceptible for CT2, 2 of 26 for TACS and 20 of 26 for VHF. 2.4 Electromagnetic compatibility of Medical Devices with Mobile Communication ‘The investigation was performed by the Medical Devices Agency, UK [10].10 Objective The objective was to try (o answer the two questions: - Does mobile communication equipment present a real risk when operated in the vicinity of medical devices ? = If $0 what actions should be taken to minimise the risks 7 ‘Test method and result ‘Several types of transmittors were used including DECT, other cellular and cordless. systems and also several types of handheld transmitters, These transmitters are described by model name in the report but figures regarding output power and frequency are not reported. The number of tested devices was large, in total 178, but only 31 of these were tested together with DECT handsets, For some of handsets including DECT the field strength was measured on an open area test site and described in antenna diagrams. Somewhat higher values are measured in this report compared to other measurements, ‘The immunity tests were carried out by setting up the medical devices operating "within ‘normal operating parameters”. Sometimes the equipment was connected to a patient during the tests, The handsets were move at a steady rate of 1 cm/s over all accessible surfaces, Any observable effects were noted. The test was repeated at 0.5 and 1 m distance and if any effect still was observed the largest distance where the effect continued to occur was noted. ‘Some statistical results are shown for DECT but they are based on only one or two observed effects. ‘The test results were as below: DECT: 31 devices were tested and 1 was found to be susceptible: = CO,-0,-meter showed minor interference to 0,-trace at 0.5 m. Other systems: A large number of effects are reported for systems with higher power and lower frequency. 2.5 Other reports Several other investigations exist but some are not published. Other reports are published ‘but do not include DECT as one of several tested systems. Several investigations of these ‘two types have been reviewed. Their results are often difficult to directly apply to the use of DECT but the main impression is that the summarised results below are comparable also to these reports, A number of reports deal with hearing aids and pacemakers, This type of equipment is not included because their general use are not specific for the health care environment. However, a single type of hearing aid was included in the VIFKA [1] report. Hearing aids are often susceptible to high frequency transmitters with amplitude modulation in the acoustic frequency range (ike 100 Hz. for DECT).u 2.6 Summary of the investigations ‘The above investigations can be summarised as below. A relatively large number of medical equipment (11 %) are susceptible when the handset is in direct contact with medical equipment. However, nearly all of the shown reaction are of a type that has not ‘been deemed to be dangerous. Further, nearly all reactions disappear when the handset is ‘moved to a distance of 0.5 m, It should be noted that 67 % of the devices were included in the VIFKA [1] report, No of devices Devices tested (with DECT) 194 ‘Susceptible devices 22 ‘The judgemens in the reports of degree of impact on patient, Have no direct impact on patient 21 Could have impact on patient 1 Largest distance for susceptibility Susceptible at 0 - 0.1m 7 Susceptible at 0.3 - 0.5 m Susceptible at 3 m 1 Distance for effect with possible impact on patient Possible impact < 0.1m) i Possible impact > 0.1 m 012 3 Published recommendations ‘There arc recommendations ayailable from several sources. Some of them are briefly described below, 3.1 Socialstyrelsen (Swedish National Board of Health and Welfare, Competent Authority for medical devices) Socialstyrelsen has an existing recommendation [9] regarding use of cellular telephones, cordless telephones etc. It is at the moment being revised and will in the new version [10] especially address the use of the DECT-system as well as risk analysis and immunity requirements on medical devices. The revised recommendation corresponds in essential parts to the statements made in this report. Socialstyrelsen has had a representative in the group. 3.2 VIFKA ‘The VIFKA research [1] was primarily carried out to write recommendations, The recommendations are mainly aimed at visitors and patients using pocket phones. The use is not banned but it should be based on knowledge about the involved risks. The recommendations require that information should be given to personnel, patients and visitors and describe involved hazard and measutes to prevent them. A risk analysis should be carried out at the institute to find areas where the risk may be higher. For pocket phones there are some precise rules like that the phones should be kept at a distance of at least 1.5 m from medical equipment, If this is not possible the phone has to be switched off. In certain areas the use should be banned. ‘New medical equipment shall comply with the European EMC-regulations, A separate part describes the use of CT2 and DECT together with a local PBX, It is recommended to check whether interference may occur. No details are given but itis, instead advised that recommendations should be written together with the exchange supplier. However, it is pointed out that the phone should be supplied with a warning text telling that the phones cannot cause interference if used according to the rules of the institute. This is to inform patients and visitors. 3,3 Telia Mobitel Ina final discussion, written by the person representing Telia Mobitel, some conclusions are discussed but no detailed recommendations are given. It is only stated that measures like using signs etc, should be taken to minimise risks and that recommendations should be based on the local electrical environment [3].13 3.4 NHS Inthe conclusion it is stated that the effects are few [4] . ‘The following brief recommendations that are applicable to DECT are given: = Ask for EMC-specifications when purchasing health care equipment. — Establish safe working distances with simple EMC-tests before taking into use, 3.5 ANSI draft on-site test method. ‘The document [5] gives detailed recommendations on how in situ tests may be performed on existing equipment in health care facilities. General recommendations regarding EMC are also given. In an appendix some guidelines for the use of hand-held transmitters are given. Itis noted that the use of portable transmitters may need to be restricted. Specific daa like a recommended separation distance between the transmitter and the equipment are based on known immunity of the equipment, 3.6 MDA. ‘The reports have detailed recommendations for the use of several types of systems including e.q. GSM but only the following short recommendation regarding DECT: These systems are very unlikely to cause EMI under most circumstances, and need not to be restricted.”4 4, Recommendations for the introduction and use of DECT Introduction First it must be stated that itis the opinion of the project group that DECT may be used in health care environments. However, its use must not be totally without control. The following discussion show a way to control the introduction and use of DECT. It should be observed that the possibility of a dangerous malfunction of a device is limited even if these rules are not observed. In appendix D the recommendations are written in a form directly useful for hospitals, General use of DECT handsets "The project group has agreed on the following rules for use of DECT handsets: — The DECT handsets can as a general rule be used in all areas of the health care environment. ~ A safety distance between the handset and any medical device of 0.5 m has to be observed. — Aspecific waming for placing the handset in direct contact with any electronic device should be given. = There may exist areas were specific precautions has to be observed. ‘Comments ‘The test data from nearly 200 pieces of medical equipment tested together with DECT handsets show few reactions if the handset is kept not to close to the tested device. A single reaction occured when the handset was in close connection with the device that was deemed to be indirectly dangerous for the patient, The result may be unexpected if the generated field strength is compared to normal test limits since the field strength close to a DECT handset is quite high. In appendix A the frequency behaviour for susceptible equipment is discussed and itis explained why as a general rule quite high immunity can be expected for the DECT frequencies around 1.9 GHz. This has also been shown by the practical tests. ‘The recommendations above are based on the referenced practical tests and on the discussion about increased immunity at higher frequencies, The practical use of DECT. ‘phones has also been taken into consideration. A safety distance of more than 0.5. implies that the user cannot wear the handset while operating medical equipment, However, if the distance of 0.5 m shall be observed there must be rules on how the handset is worn, It cannot be placed in any pocket. It is therefore important that all personnel using DECT have a knowledge about not only the rules but also their background, Risk analysis Since rules seldom are observed to 100 % and something like 10 % of all medical equipment is susceptible for a direct contact with an operating handset there may be situations where the involved risk are too high. Equipment may have known or observed very Jow immunity, or impact of an equipment failure is not acceptable etc, In these cases the group recommend a risk analysis and exceptions from the general rule.