平成24年度 分担研究報告書 米国における医用電気機器のIFUの利用
Contents
1. CE ECRI 1 US Food and Drug Administration FDA 1 khttps www ecr1 org2. 1 500 6 ee DIFU Operation Manual Operation Manual Quick Reference Guide IFU IFU olg Operation Manual ht
3. CE Ce DIFU CE Operation Manual CE Operation Manual
4. 24 IFU ME ABE a ARRA Clinical Engineer CE 4 Instructions For Use IFU
5. What material is used to convey the changes of the IFUs to hospital staff 1 Original provided by the manufacturer or a duplicate of it 2 Material re made in accordance with the format specified by hospital 3 Other 8 IFU How is the information on changes of the IFU transferred to hospital staff 1 Handing out hard copies 2 Posting the information on the notice board in hospital 3 Sending by email 4 Holding a briefing session to explain the changes 5 Meeting and explaining individually 6 Other 9 IFU
6. Cc Caro IFU lalate We 4 Westchester Medical Center Mr Tamotsu Tsunekage CE CE Mr Chris Smith M CE 1 640 K 100 ICU Cardiac ICU Surgical ICU payee
7. 4 IFU 25 OVE COD G ole H Fletcher Allen Health Care Tobey Clark 3 IFU How To Obtain the Instructions for Use or IFU 1 IFU Instructions for Use Operating Procedure 2 IFU
8. Quick Refarence Guide ER NOT NT A FAs Maintenance Manual Quick Refarence Guide 1 800 50 da Vinci 5 2 CE CE CE 8 BMET 9 17 in hospital
9. IFU CE IFU IFU STOD OEE ADI A
10. ZOLL LAN CE PC cla PC CE AAT AN NO 2 Joint Commission 50 450 7 http www jointcommissionintern ational org CE CE BMET
11. CE Perfusionist PEI FRYE Respiratory Therapist RT CE DOCETA CVC 4 IFU IFU CE Operation Manual Maintenance Manual IFU Operation Manual Quick Reference Guide
12. 100 90 Joint Commission International LAF JCI 2 CE 60 70 American Hospital Association AHA A
13. Purchasing who buys the equipment receives product communications for all devices CE FU BE Only the staff who use the devices 5 Not applicable IFU Original is provided by the manufacturer is duplicated FU BE Handing out h
14. During training when a device is installed When there is a change in the IFU due to precautions recall IFU Somewhat dissatisfied l 5 Comments on the Japanese IFU Performance Clinical results References and bibliography Condition for approval
15. How much time is required for training Are educational curriculums available 2 Maintenance and Training of Medical Devices How many units are maintained per day What are the intervals of routine inspections of medical devices What is the status of implementation How are the measuring devices calibrated Are they entrusted to manufacturers Are routine inspections lists provided by the manufacturers or created by yourselves 5 Are you involved in maintenance of the electrical installations and medical gas 6 Who gives education of safe handling of medical devices Is it conducted periodically or only when a new device is purchased 7
16. Ce Ceo IFU atk 4 8 000 1 p E RE Gre cCMBAYSaLl_ y
17. 3 Swedish Medical Center First Hill Campus 747 Broadway Seattle WA USA 98122 Evergreen Medical Center 12040 North East 128th Street Kirkland WA USA 98034 Fletcher Allen Health Care Hospital Westchester Medical Center 100 Woods Rd Valhalla NY 105 2 1 OCE 1 IFU IFU 2 LU
18. Cn EA ee E IFU IFU CE BMET IFU LOBI IFU Operation Manual
19. Ns IFU A EMDR ORED IED DD D 7h en IFU Operation Manual i CE Che YOO E OES CHS ics ee Reference Guide COV Cla Hees PSM i i 3 oe CMe ics 2 4 CE
20. a PMDA How can the hospital staff read the IFU 1 Through in hospital information system intranet 2 At the department that manages medical devices 3 In the ward or treatment room where the medical device is used 4 Ask the manufacturer when necessary 5 On the manufacturer s website when necessary 6 7 6 On the FDA s or public or private organization s website when necessary 7 Other 10 IFU
21. BOT ASAT ILE DIGS EO bic Quick Refarence Guide Maintenance Manual Operation Manual CD ROM USB On iine SM IFU ene COU Clay Hei CE BEMT IFU LDL SO WO NK be
22. CE _ CE IFU Operation Manual IFU FAZ PETLA OL XX 2 Evergreen Medical Center Mr Mark Ruark CE 1 25 285 2 CE CE Modern Medical System 8 CE BMET CE 8 500 2 CE
23. BE Operating manual Procedure instruction Instruction for use 3 IFU Yes 4 IFU Web Not sure Website is advantageous 5 IFU Brief operating instructions may be on the device 6 4 5 IFU Medical staff may request 7 IFU Wieb Hardcopy with product Upload form website Printed on product all three 8 IFU
24. How is the maintenance of home care devices performed 8 When failures and incidents occur at hospital who collects the case reports 9 Who consolidates the safety information on medical devices provided from outside the hospital 10 How do you obtain knowledge and techniques on maintenance of medical devices 11 CE How is the CE Department assessed from the economic standpoint 3 IFU How To Obtain the Instructions for Use or IFU 1 IFU What is it when you say IFU May we have a look 2 IFU BE Is the IFU different from the following documents 1 Operating manual 2 Procedure instructions 3 Maintenance manual 4 P
25. Who is appointed as chief administrator responsible for management of IFUs What is his her job in the hospital 3 CE IFU CE CE Regarding the medical devices managed by the CE Department who or what department receives the information on the changes in the IFUs 1 CE Department receives the change information collectively 2 Both CE Department and the department s or medical staff that actually use the medical device receive it 3 Other 4 CE CE IFU CE OCE BR If the CE Department manages only a part of medical devices who or what department receives the information when there ar
26. 6 1 T5 80 FEE CE CE a 3 CE T CE 4 IFU IFU
27. TSP Tobey Clark 31 400 50 000 100 95 ECRI ICU CE IABP PCPS a CVD CE BMET ILABP PCPS CE
28. 3 site Liha tae caution 2 CE 13 000 CE in hospital CE 9 TriMedx CE 8 8 4 9 17 15 23 2 IFU On call 24 CE CT General Electric 15 CE
29. 1 WAR FU Research on Maintenance of Medical Devices and the Use of IEUs in the U S A Research Questions 1 Basic Information 1 1 Size of hospital what is the number of 1 hospital beds 2 departments and 3 outpatients per day Scope and total number of medical devices that are managed in your hospital CE How many clinical engineers manage the above medical devices and what is their average age 4 What is the average starting salary at your hospital At Kitasato Unversity Hospital where Prof Hirose works a university graduate is paid JPY 210 000 US 2 625 per month 5 Do you also undertake the maintenance of other hospitals medical devices 6 What are working conditions work hours shifts night work etc at your hospital
30. IFU are necessary for any item that is complex Not intuitive to operate Improper operation could result in death or injury IFU Whichever document was used by the operator during the procedure Operators manuals can be very lengthy and lawyers would have a difficult time proving they have to be completely understood FU Very detailed Could be shortened Newsletter of the American College of Clinical Engineering Volume 22 Issue 5 September October 2012 HTF Facilitates CE Education Assessment dif Healthcarelechnology Guide for patients and caregiv ers has been published to im prove the ventilator safety in the home This document is available in both English and Spanish on the HTF website FOUN DATION Presenting HTF Board Over 500 responses were received to the needs assessment survey that was posted on line by the Healthcare Technology Foundation ACCE AAMI and ASHE plus promotion of local BMET chapters and the VA CE Network This jointly created sur vey wi
31. Pages defau It aspx 5 OR ER 3 Fletcher Allen Health Care Mr Tobey Clark TSP CE 6 CE PBMET CE 562 2 CE TSP Technical Service Partnership 36 CE 4 BMET 32 13 000
32. When do hospital staff read the IFU 1 During training when newly employed or assigned to another department 2 During training when a new device or new model with new functions is installed 3 When they want to confirm how to handle or operate the device 4 When they want to make sure of the maintenance and inspection methods 5 When they want to check predicted failures and health hazards 6 When they experienced incidents or failures of medical devices 7 When there was a change to the IFU such as Precautions for Use 8 When educational materials and procedures of operation etc are created 9 When t inspection procedures and check lists are made up When the purchase of new device is considered Other 1 IFU DHE What is the overall satisfaction rating of IFUs by medical staff 1 Very satisfied 2 Somewhat satisfied 3 Neither satisfied nor dissatisfied 4 Somewhat dissatisfied 5 Very dissatisfied 2 March 11 2009 Fourth edition January 20 2006 Third edition Highly Controlled Medical Device E Specially Desigualed Maimlenance Control Reguired Medical Device Approval Number 151 00BZY00901000 Category Instrument amp Apparams 7 Organ Function Re
33. was having its monthly conference call during their visit the group joined via WEBEX to introduce them selves and to discuss clinical engineering in Japan TSP Director Tobey Clark is a member of the international committee The group was very appreciative of the donations and support provided by ACCE membership to the Japan Association for Clinical Engineering Technologists following the earthquake and tsunami disaster in 2011 The Japanese association hopes to establish a relationship with ACCE in the future
34. 12 You see firsthand how your colleagues are making a difference you can share their great work with the industry Then nominate your colleague for the 2012 ACCE HIMSS Excellence in Clini cal Engineering and Information Tech nology Synergies Award Past Recipients of this award 2011 Paul Schluter PhD 2010 Stephen Grimes FACCE FAIME FHIMSS 2009 Adrian Johnson BTECH BEPS 2008 Todd H Cooper 2007 John D Hughes Jr M S Award recipients will be recognizedat 2006 Elliot B Sloane PhD and Raymond the 2013 HIMSS Annual Conference amp Zambuto CCE FASHE FHIMSS FAC Exhibition in New Orleans March CE ACCE News Volume 22 Issue 5 September October 2012 New ACCE Members Lets welcome our newest members recommended by Membership Commit tee and approved by the Board of Direc tors on September 25 2012 Individual members Barrett Franklin Chief Clinical Engi neer Dept of Veterans Affairs Bedford MA Christopher Gutmann Chief Clinical Engineer VA Connecticut Healthcare System Jacklyn M Kelso Biomedical Engi neer at VA Milwaukee Healthcare Sys tem Kedaki Shesh Healthcare Technology Planner at NBB LLC Ohio Ali Wasfy Project Engineer at Her mitage Medical Clinic in Dublin Ireland Shashi Avadhani Director Biomedi cal Engineering Crothal Clinical Equip ment Solutions NJ Associate member Brad Peterson CEO at Level 3 Medi cal Designs AZ Candidate membe
35. CE CE 100 90 JCI WC 3 CE CE 6 COUN CII AAS ee Gan
36. Clinical Engineer CE Biomedical Equipment Technician BMET Clinical Engineer CE CE HU Instructions For Use UF IFU B 1 24 8 28 9 4 8 4 CE CE CE
37. FDA Web BE Change may be part of a recall or product update 4 IFU Management of medical devices and IFUs within hospital 1 Chair medical equipment management committee 2 IFU No one is administrator CE IFU CE CE Change may be part of a recall or product update Clinical engineering receives changes for devices under its responsiblity CE CE IFU CE OCE
38. PC IFU Quick Reference Guide Operation Manual 1 IFU 1IFU TIFU IFU IFU 2 6
39. Patient Safety ACCE News Volume 22 Issue 5 September October 2012 7 Members ACCE President and HTF advisory board member James Keller presented in the System Level Design Considerations for Safety Critical Technologies session at the recent AAMI FDA Interoperability Summit In November William Hyman ScD Past President of HTF will be making a keynote talk at the 4 Annual Medical Device Connectivity Confer ence on Meaningful Use Stage 2 James Keller Marge Funk PhD HTF Board member and Tobey Clark HTF Presi dent will be making presentations in the Cardiac Monitoring and Alarm Fa tigue Session at the American Heart Association Annual Meeting New HTF Website The Healthcare Technology Founda tion website at http www thehtf org has been redesigned Visit the en hanced site to see all the latest news from the foundation our programs and resources While you are there feel free to hit the DONATE NOW button We will accept them anytime and they are always tax deductible Jennifer C Ott HTF Secretary Tobey Clark HTF President Tobey clark uvm edu Japanese Clinical Engineers Visit At the end of August a team of clinical engineering professionals from Japan visited HTM departments at the Univ of Vermont in Burlington and Westchester Medical Center Westchester NY along with the Fluke Biomedical Corp The contingent in cluded Minoru Hirose Ph D Professor Clinical Engineering Kitasato Univer
40. ardcopies Email Posting on notice board IFU PMDA BE Handing out hardcopies Email Posting on notice board IFU
41. atient manual 5 Other 3 IFU Are all medical devices required to be provided with the printed IFU 4 IFU Web Is it allowed not to provide the printed IFU but upload it on the website If yes what products are allowed to do this and are there any conditions for it 5 IFU Is it allowed to print the content of the IFU on the box package and or bag If yes what products are allowed to do this and are there any conditions for it 6 4 5 IFU If it is allowed to upload the IEU on the website or print it on the package are the printed versions of the IFU supplied at the request of medical staff 7 IFU Web As a healthcare professiona
42. ding this aspect of medical device regulation in Japan funding was provid ed from the Japanese government for the trip During their visit to the Technical Ser vices Partnership in Vermont they had a conference call with the FDA and toured the university s Clinical Simula Continued on page 8 yA Japanese CE visit continued earthquake and tsunami disaster in 2011 They hope to establish a relation ship with ACCE in the future Tobey Clark Tobey dark uvm edu Continued from page 7 tion Center Fletcher Allen Health Care the campus and the Burlington region Lake Champlain and the Green Mountains As the ACCE International Committee was having its monthly conference call during their visit the group joined via WEBEX to introduce themselves and to it discuss clinical engi neering They were very appreciative of the support provided by ACCE member ship to the Japan As sociation for Clinical Engineering Technol ogists following the Japanese contingent visits Elekta LINAC at the University of Vermont Nominees Sought for the ACCE HIMSS Excellence in CE IT Synergies Award The ACCE HIMSS Excellence in Clini cal Engineering and Information Tech nology Synergies Award nominations are now being accepted through Octo ber 15 2013 ACCE members are encouraged to nominate their peers who have made lasting contributions within ACCE HIMSS and to the greater healthcare community by October 15 20
43. e minimum pacing rate required for the patient 4 3 6 7 Pacemaker Inhibition To ensure reliable pacemaker mhibiton the semsmg level of the patents R wave should be preset as follows The EV4543 winch has been subjected to conditions of transport or storage at temperatures below 10 C or above 40 C should he allowed to sit at room temperature for more than an 1 Set the On CH Switch tn CHT 2 Set the Mode Select Swich to Demand 1 Set the Rate Control to a value below the patients spontanemis rate 2 Set the Output Control to 0 2 W 3 Set the Sensitivity Control to 1 0 mW 4 Set the On Off Switch to X1 3 Tum the Sensitivity Control counterclockwise until the Sensing Incheator stops flashing Note the sensme threshold 6 For reliable R wave detection mmcrease the semsilivity three times the sense threshold II noted seting is 3 mV the recommended setting 1 1 mW 7 Increase the pacing rate to the desired level and the Output Control three tuues the pacing threshold Toterfercoce Tf the level of detected interference 1 greater than 46 Hz when operating in the Demand mode both the Pacing and Sensing Indicators flash and the EW4444 automatically swatches from the Demand mode to the Asynchronous pacing mode At this time pacing is continued at a rate 25 higher than the selected rate Normal function is resumed when the level of interference is reduced Hish Rate Protection If an electronic compo
44. e changes in the IFUs of the devices that are not under the management of the CE Department 1 CE Department receives all information on all medical devices including those are not under the management of the CE Department 2 Other department receives the information what department s 3 Department or medical staff that actually use the medical device receive it 4 Other 5 CE IFU BE When the CE Department receives the information on changes of the IFU what other departments or whom is the information forwarded to 1 All hospital staff 2 Only the staff who use the said medical devices 3 Other 6 5 BE If the changes of IFU are conveyed to all hospital staff what is the reason for it 1 Because the department that uses the said medical device is not clear 2 Because who uses the said medical said device is not unclear Doctors nurses CEs etc 3 Other 7 FU
45. er electrode pacing lead eomected to it and performs supplementary treatment of bradycardia proplrylactie pacing or temporary assistance of tachycardia control Tulsnmllerll or complete alnoventricular block assocmled with asystole or bradycardia syuuptomatie smus bradyeurdia smrgicalhr imdhnced heart block heart block accompanying acute myocardial infarction atrial arrhythmia inchoiding atnal flutter etc Also read the Instruction Manual 14 Specifications 2 Performance at 20 C EFC 5000 E 1 Operating performance Demand Mode Asynchronos Rate Mode XS Asynchronas rate Pulse rate X1 30 150 ppm AF 90 450 ppm Output voltage 03 Pulse width High rate protection 1 57015 ms 200 ppm X1 mode 400 pom X4 mode Refractory period after pacing 330 30 ms after sensing 1504 15 ms Electrical Safety Classification Internally powered equipment Type CF 8 Operating environment Temperature 10 40 C Relative humidity 30 70 8 Power supply One 9 volt alkaline battery Operational Method or Method of Use 1 Preparations and Confirmation of Safety 11 Monitor the patients ECG contimwasty When introducing and positioning the pacing lead in the heart mnrntnr the patient s miracardiac ECG Make sure that the battery ts in the device For added satety keep an adequate sipply of batteries at hand Use the extension cable if necessary a Be sure to connect the e
46. l what means do you think is best to provide the IFU for medical materials and medical devices Medical Materials Medical Devices 1 In hard copy provided with the product 1 In hard copy provided with the product 2 Printed on the product package 2 Printed on the product package 3 Uploaded on the website 3 Uploaded on the website 4 Other 4 Other 8 IFU FDA Web BE When any content of the IFU is changed how is the change information provided for you DA manufacturer person comes visit you to provide the information Information is sent from the manufacturer by email 3 Obtaining information on the FDA website or the manufacturer s website 4 Other 4 IFU Management of medical devices and IFUs within hospital 1 Who is appointed as chief administrator responsible for management of medical devices What is his her job in the hospital 2 IFU
47. ll be used to focus a new education program on specifically needed tools for managing risk related to integrated tech nology in healthcare delivery organiza tions The target audience would include biomedical equipment technicians clinical engineers facility engineers IT engineers and others responsible for implementing and planning device and IT integration sys tems in a healthcare facility With updated competencies members of this community may gain new opportuni ties to become responsible for healthcare technology management and similar clinical engineering services in integrated environ ment of collaborative systems The results of this survey will be invaluable as the plan for the course curriculum progresses It is particularly important to gauge the size of the gap in skills so that the coming training will provide the bridge to cross this gap and delivers the knowledge about how to deal with growing complex issues sur rounding facility readiness for more and more wireless technologies systems of systems networks IT device integration pending FCC rulings on WMTS devices and much more The next step will be to analyze the vol ume of responses received and to collabo rate in developing the course curriculum The survey results will reveal critical infor mation for the project profession and healthcare New brochure is available Through a joint effort of HTF and ECRI Institute the Home Ventilation
48. ne with every pulse delivered by the pacemaker Selection of the X3 mode overndes the Demand mode of the Mode Select Switch Output Voltage 0 2 V 12 V The amplitude of the pacing pulse is set with the Pulse Output Control The EV4543 displays the amplitude in the volt Battery Indicator The Battery Indicator flashes simultaneously with the flashing of the Seming or Pacmyg Indivator When the Battery Indicator becomes dimmer less visible replace the battery wath a new 9 volt alkaline battery If the battery meerls to be replaced while the EV4543 is in use keep it connected to the patient and change the battery within 10 seconds The EV4543 has a back up function and will continue to pace normally for 10 seconds To replace the battery read Mamtenance and Inspections explained later in this document Determination of Pacing Threshold When pacing will be contimed tor several days it 1s recommended that pacing threshold is readjusted every day in the following method 1 Set the Ow Off Switch to OFF 2 Set the Output Control to 4 V 4 Set the Rate Control to a value higher than the patients spontaneons rate Select the desmed pacing mode Denund or Async and sel the OwO Switeh to XL Tum the Ohtput Control slowly until pacing ceases Tum the Output Control slowly until pacing resumes Note the For reliable capture increase output to a value three times the pacing threshold If necessary readjust the pulse rate to th
49. nent failure occurs in the wiit the maximum hich asynchronous rate is limited to 200 ppm in the XI mode and 500 ppm m the X3 mode Precautions for Use 1 Important Basic Notes Make sure that functions and characteristics of the FV4543 are autable for the patrent s condition Use of this device is only by qualified medical personnel Conduct all operations in a sterile environment aAvcid using line powered momtonng equipment Even mmmmute leakage currents flowing through the heart may cause Veitricnlar filbrillations The X3 mode should be used for special short term high rate atnal pacing only High rate atrial pacing could induce a venlrieular anhythows meluding ventricular Gbrillation In case ins happens mmmediately stop procedure and take lifesaving TA SS Prior to use make sure that there is no damage to the device In case a problem or operation Gulure is found stop using the device hour before being placed in use on a patient When the FV4543 is used in the proximity of the equipment that generates high frequency such as electric motors PCs mobile eqHipment electrosurgical devices cte keep them away from the EV4543 It could result in malfunctioning and damaging the EW4543 and the comected pacing lead wWhen the cleewocautery or electrosurgical devices are msed lt ther use to short bursts or program the EV4543 to a non semsing mode during procedure The EV4543 is resistant to 400 joule
50. placement Device General Nomenclature Non invasive External Cardiac Pacemaker JMDN Code 33822000 External Pacemaker Warnings The EV 4543 should be operated only by medical persounl who have a thorough knowledge of cardiac pacmyg and the funchons of this pacemaker Monitor the patient s prior to pacing dwing any pacing procedure and m the wmomediate post operative phase Equipment for defibrillation LV infusion endotracheal intubation and oxygen adnunistration must be immediately available The X3 mode is for special short term high rate atrial pacing only Do not use this mode for ventricular pacing When the EV4543 is med in the proximity of the equipment that generates hieh frequency such as clectnic motors PCs mobile phones radio cquipment electrocautery and electrosurmical devices etc keep them away from the EV4543 It could result in malfimctionine of serious damaring of the EV4543 and the connected pacing lead When the electrocautery or elecirosurmieal devices are used howl their use to short bursts or program the EV4543 to a non sensing mode durme procedure When an extension cable is necessary to be used commect it to the EV4543 first and them conmect the pacmg leads to the extension cable Even temporarily the EV4543 should not be left in a location where the ambient temperature is either below 20 or above C This could damage the intemal parts Do not sterilize the HV 4544 b
51. rs Thomas Kofi Kudah Clinical Engi neer Ghana Health Service Ghana Evelyn Orozco grad student at UCONN and intern at VA Health Sys tem Karen Taborda Marin grad student at UCONN and intern at Baystate Medi cal Center Urania M Michael grad student at UCONN and intern at UMASS Memorial Medical Center Christine A Vogel grad student at UCONN and intern at Brigham Woman Hospital Michael Heusser grad student at UCONN Jordan Elizabeth Anderson grad student at UCONN and intern at VA Health System RI James Wear Membership Chair james wear gmail com Fletcher Allen Health Care News At the end of August a team of clinical engineering profes sionals from Japan visited the Technical Services Partnership TSP at the University of Vermont in Burlington This is the second visit by clinical engineers from Japan with the first occurring in 2006 The purpose of their visit was to under stand the profession in the US visit TSP a best practices leader with all clinical engineers certified CCE by the Healthcare Technology Certification Commission and to research US requirements for medical device Instructions for Use IFU documents what is required what is the content how are they used etc In Japan it is required to provide the IFU document called Tempu Bunsho with the device separately from the full operator s manual This usually 4 5 page document consists of the informa
52. s when il is commected to the patient phones radio electrocautery and Bio case it is subjected to shocks immediately stop using the EWV4545 even if the damage 1s not visible thoroughly and repaired When the EV4543 is used aller a whole of no use set a battery and make sure that it functions correctly and sately When the FV4543 indicates a low battery comdition promptly replace the battery with a new one Have it mspected Tow to replace the battery 1s tionnd in Maintenance and Inspection explained later in this document l System Complications and Adverse Events System Complications Exce for simple programme errors and pacing Hallume due to low battery power the following are the typical problems with the cardiac pacing 1 Less of Capture Such events as lead dislodpement lead failure increased threshold inappropriate use of electrosurgical device defective components and loose comlact of the beals may cause decreased outputs 2 Loss of Semsimg Reasons an smalar to those listed for loss of capture Plectncal interterence EMI could also create a symptom simular to loss of sensig 4 mtpmt Faile Detective components and lead talure Adverse Events 1 Avery powerful electromagnetic fields mcmcratcd by the electrocautery or electrasurpical devices cold indnce fibnillatery currents flowime in pacing leads implanted im a paticnt 2 High rate atrial pacing camies with it a risk of precipitating
53. si ty Takashi Kano Ph D Professor Clinical Engineering Saitama Medical University Teruhiko Takakura Direc tor Department of Clinical Engineering Kameda Medical Center Fumika Aoki Japanese Pharmaceuticals and Medical Devices Agency and Atsuko Kakehi Overseas Operations Manager Taisho Biomed Instruments Co who served as the interpreter In Japan clinical engineers are individu als who operate life support equipment such as cardio pulmonary bypass units dialysis equipment and ventilators in addition to being responsible for the testing maintenance and management of medical devices Their training in cludes intensive education in medical sciences and clinical procedures along with technical and engineering studies In addition to understanding what clini cal engineers do in the US and how a department is run a key purpose of their visit to the US was to research medical device Instructions for Use docu ments what is required what is the con tent how are they used etc In Japan it is required to provide the document called Tempu Bunsho with the device separately from the full operator s man ual This usually 4 5 page document consists of the information such as warnings contraindications usage and operations specifications etc This document is thought to be far from user friendly as there are so many warnings listed at the beginning As clini cal engineers are key professionals re gar
54. tion such as warnings contraindications usage and operations specifications etc The team wants to improve the document as it is far from user friendly As clinical engineers are key professionals regarding this aspect of medical device regulation in Japan funding was provided from the Japanese Ministry of Health for the trip The contingent included Minoru Hirose Ph D Professor Clinical Engineering Kitasato University Takashi Kano Ph D Professor Clinical Engineering Saitama Medical University Teruhiko Takakura Director Department of Clinical Engineering Kameda Medical Center Fumika Aoki Japanese Pharmaceuticals and Medical Devices Agency and Atsuko Kakehi Overseas Operations Manager Taisho Biomed Instruments Co who served as the interpreter In Japan clinical engineers are individuals who operate life support equipment such as cardio pulmonary bypass units dialysis equipment and ventilators in addition to being responsible for the testing maintenance and management of medical devices Their training includes intensive education in medical sciences and clinical procedures along with technical and engineering studies During their visit to the Technical Services Partnership in Vermont TSP arranged a conference call with the FDA toured the universitys Clinical Simulation Center Fletcher Allen Health Care UVM campus and the Burlington area As the American College of Clinical Engineering ACCE International Committee
55. ventneular tachy arhythomas meluding fibrillation C 1 IFU IFU 4 IFU Operation Manual Operator s Guide User Manual Instractions For Use Operating Procedure Operation Manual Operation Manual 2 az IFU 1 Swedish Medical Center First Hill Campus Mr Steave M Sands CE CD ROM USB On Line
56. xtension cable to the pacemaker first and then connect the pacing lead to the extension cable Before connecting the extension cable switch the EW4543 off Connect the extension cable to the EV4545 correctly Tighten terminals securely by hand Do not use tools Lead connector pins with 0 25 mm mm diameter can be connected Loosen the terminal caps to connect the proximal end of the pacing lead to the red termumal and the distal end to the black terminal e Switch the EV4543 off and then coumect the pacing lead Lead commector pans wath 0 25 mr mm diameter can be connected Be sure to tighten the ternunals by hand Do not use tools Also read the instructions for use of the pacing lead and the extension cable 2 Operations and Setting On Of Switel x1 X1 mode OFF Power oft x3 Pulse rate is multiphed by 3 times Lift the switch and turn it to the X3 position The X3 position is only for short term hich rate atrial pacing Do not set the Switch at this position for ventricular pacing Sensitivity 1 0 mV 12 mV Sensitivity is set with the Senativity Control Sensitivity cannot be adjusted when the Mode Select Swatch is sel to ASYNC or the OwO Switch to KS In the Demand mode the Sensing Indicator flashes once for every sensed spontaneous R wave Pulse Kate 30 1350 ppm 90 430 ppm Pulse rate is set with the Rate Control The Pacing Indicator flashes in sy
57. y use of autoclaving or gamma imadiation l o not immerse it in cleaning or sterilizing solimons This could cause a serions damage to the deviec When the low battery condition is indicated promptly replace the battery with a new correct onc Contraindications and Prohibitions There are no lmown contrandications to the use of temporary cardiac pacing as a therapeutic nr prophylactic modality Nevertheless pay close attention to the following Do not apply atrial pacing andor sensing on patients who demonstrate chronic persistent atmal fibrillation These modes will not be effective in controlling ainal actnaty and carry the risk of inappropriately responding to detected atrial fibrillatory waves Do not apply atrial pacing on patients who demonstrate AV conduction disorder Do not use any asynchronous mode of pacing that competes with an intrinsic rhythm Shape Composition and Principle Model HV4543 Lead Terminal Negative Lead Terminal Positive _ Pacing Indicator Sensing Indicator Sensilivily aontrol On Off Switch Plashe Cover 145 76 33 mm 280 g Dumensio8rs Actuation and Operating Principle The demand type external cardiac pacemaker EV4544 is operates with an alkalme battery Used wath the pacmg leads this device changes stumulahion rate energy and syuchromous sensitivity Intended Use Efficacy or Effects 1 Intended Use The EV4543 is wed with the cathet
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