JIS T 80601-2-61:2014 医用電気機器―第２－６１部：パルスオキシメータの基礎安全及び基本性能に関する個別要求事項 | ページ 17

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[23] BLAND, J.M., ALTMAN, D.G. Statistical methods for assessing agreement between two methods of clinical
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[27] BURNETT, et al. Blood gas and pH analysis and related measurements. NCCLS, 21 (14) 2)
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[35] FDA Draft Guidance Document: Pulse oximeters premarket notification submissions [510(k)   s], Center for
     Devices and Radiological Health, Anesthesiology and Defibrillator Devices Branch, Division of
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[36] FDA Excerpts Related to EMI from Anesthesiology and Respiratory Devices Branch, November 1993. Section
     (i) (7),17を参照。
[37] FDA Quality System Regulation: 21 CFR 820.3 (z): validation
[38] GEHRING, H., HORNBERGER, C., DIBBELT, L., ROTHSIGKEIT, A., GERLACH, K., SCHUMACHER, J.,
     SCHMUCKER, P. Accuracy of point-of-care-testing (POCT)   or determining haemoglobin concentrations.
     Acta Anaesthesiol. Scand. 2002, 46, pp. 980-986
[39] GOLDEN, S.M. Skin craters−A complication of transcutaneous oxygen monitoring. Pediatrics 1981, 67 (4,
     Apr), pp. 514-516
[40] GREENHALGH, D.G., LAWLESS, M.B., CHEW, B.B., CRONE, W.A., FEIN, M.E., PALMIERI, T.L.
     Temperature threshold for burn injury: An oximeter safety study. J. Burn Care Rehabil. 2004, 25, pp. 411-415.
[41] Guidance for industry: Cardiac Monitor Guidance, 1998-11-05
[42] HARPIN, V.A., CHELLAPPAH, G., RUTTER, N. Responses of the newborn infant to overheating. Biol.

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     Neonate 1983, 44 (2), pp. 65-75
[43] HORNBERGER, C., et al. Design and validation of a pulse oximeter calibrator, Anesth. Analg. 2002, 94, pp.
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[44] HORNBERGER, C., et al. Prototype device for standardized calibration of pulse oximeters. J. Clin. Monit.
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[45] HUCH, R., HUCH, A., LBBERS, D.W. Transcutaneous PO2, p. 78. Stuttgart: Thieme, 1981
[46] HUCH, R., HUCH, A., LBBERS, D.W. Transcutaneous PO2. p. 91. Stuttgart: Thieme, 1981
[47] IAIZZO, P.A., KVEEN, G.L., KOKATE, J.Y., LELAND, K.J., HANSEN, G.L., SPARROW, E.M. Prevention
     of pressure ulcers by focal cooling: histological assessment in a porcine model. In Wounds: A compendium of
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[48] JASZCZAK, P., POULSEN, J. tcPO2 dependence on a sufficient blood flow. In: Continuous transcutaneous
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     Reproductive Medicine, Volume 5). New York, NY: Marcel Dekker, pp. 35-43, 1983a. (Papers presented at the
     Second International Symposium on Continuous Transcutaneous Blood Gas Monitoring, at the University of
     Zurich, 1981-10-14/16)
[49] JASZCZAK, P., POULSEN, J. The effects of a heated tcPO2 electrode on skin and blood temperature. In:
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     E.M., ZUSPAN, F.P. Reproductive Medicine, Volume 5). New York, NY: Marcel Dekker, pp. 45-55, 1983b.
     (Papers presented at the Second International Symposium on Continuous Transcutaneous Blood Gas
     Monitoring, at the University of Zurich, October 14-16, 1981)
[50] JUBRAN, A. Pulse oximetry, Crit. Care 4) 1999, 3 (doi:10.1186/cc341), pp. R11-R17
[51] KOKATE, J.Y., et al. Temperature-modulated pressure ulcers: a porcine model. Arch. Phys. Med. Rehab. 1995,
     76, pp. 666-673
[52] LAPTOOK, A., OH, W. Transcutaneous carbon dioxide monitoring in the newborn period. Crit. Care Med.
     1981, 9 (10), pp. 759-760
[53] LFGREN, O., ANDERSSON, D. Transcutaneous carbon dioxide and transcutaneous oxygen monitoring in
     neonatal intensive care patients. In: Continuous transcutaneous blood gas monitoring. (Eds: HUCH, R.,
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     Marcel Dekker, pp. 413-419, 1983. (Papers presented at the Second International Symposium on Continuous
     Transcutaneous Blood Gas Monitoring, University of Zurich, October 14-16, 1981)
[54] LYNN, L.A. Interpretive oximetry: Future directions for the diagnostic application of the SpO2 timeseries.
     Anesth. Analg. 2002, 94 (S1), pp. S84-88
[55] MALIN, S.W., BAUMGART, S. Optimal thermal management for low birth weight infants nursed under
     high-powered radiant warmers. Pediatrics 1987, 79 (1, Jan), pp. 47-54
[56] MANZINGER, H. Temperaturgrenzen fr die Verbrennung der Haut−Ultraschall B Scan Untersuchung.
     [Temperature limits for skin burning; ultrasound B scan investigation.] Dissertation, Medizinischen Fakultt
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[57] MONACO, F., MCQUITTY, J.C. Transcutaneous measurements of carbon dioxide partial pressure in sick
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[58] MONCRIEF, J.A. The body's response to heat. In: Burns: a team approach. (Eds: ARTZ, C.P., MONCRIEF,

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     J.A., PRUITT, B.A.)   .B. Saunders, pp. 23-44, 1979
[59] MORITZ, A.R., HENRIQUES, F.C. Jr. Studies of thermal injury. I. The relative importance of time and
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[60] MORITZ, A.R., HENRIQUES, F.C. Jr. Studies of thermal injury. II. The relative importance of time and
     surface temperature in the causation of cutaneous burns. Am. J. Pathol. 1947, 23, pp. 714-715
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     Bristol: Institute of Physics Publishing, 1997
[62] POLER, S.M., WALKER, S.S., KIBELBEK, M.J., MAROON, M. Cutaneous injuries associated with pulse
     oximeters. J. Clin. Monit. 1992, 8 (2, April), p. 185
[63] PREIS, N, M.D. pediatric dermatologist, Duke University Medical Center, private communication to S.
     Weitzner, M.D.
[64] RHEINECK-LEYSSIUS, A.T., KALKMAN, C.J. Influence of pulse oximeter lower alarm limit on the
     incidence of hypoxaemia in the recovery room. Br. J. Anaesth. 1997, 79, pp. 460-464
[65] RYAN, T.J. Structure, pattern and shape of the blood vessels of the skin. In: JARRETT, ed., Physiology and
     pathophysiology of the skin, pp. 577-651. London: Academic Press, 1973
[66] SCHACHINGER, H., SEILER, D. First experiences with transconjunctival PO2 measurement. In: Continuous
     transcutaneous blood gas monitoring. (Eds: HUCH, R., HUCH, A.) (Series Eds: SYMONDS, E.M., ZUSPAN,
     F.P. Reproductive Medicine, Volume 5). New York, NY: Marcel Dekker, 1983. (Papers presented at the Second
     International Symposium on Continuous Transcutaneous Blood Gas Monitoring, at the University of Zurich,
     October 14-16, 1981)
[67] SCHMITT, J. M. Simple photon diffusion analysis of the effects of multiple scattering on pulse oximetry.
     IEEE Trans. Biomed. Eng. 1991, 38 (12), pp. 1194-1203; 1992, 39 (3), p. 314
[68] SEGUIN, J. Effects of transcutaneous monitor electrode heat on skin servo-controlled environments. J.
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[69] SEVERINGHAUS, J.W., NAIFEH, K.H., KOH, S.O. Errors in 14 pulse oximeters during profound hypoxia. J.
     Clin. Mon. 1989, 5, pp. 72-81
[70] SEVERINGHAUS, J.W., NAIFEH, K.H. Accuracy of response of six pulse oximeters to profound hypoxia.
     Anesthesiology 1987, 67, pp. 551-558
[71] SEVERINGHAUS, J.W., KELLEHER, J.F. Recent developments in pulse oximetry. Anesthesiology 1992, 76
     (6, June), pp. 1018-1038 (pp. 227-228)
[72] SEVERINGHAUS, J.W. private communication to ASTM F-29
[73] TEMPLEMAN, M.C., BELL, E.F. Head insulation for premature infants in servocontrolled incubators and
     adiant warmers. Am. J. Dis. Child 1986, 140 (9, Sep), pp. 940-942
[74] TOPPER, W.H., STEWART, T.P. Thermal support for the very-low-birth-weight infant: Role of supplemental
     conductive heat. J. Pediatr. 1984, 105 (5, Nov), pp. 810-814
[75] VENUS, B., PATEL, K.C., PRATAP, K.S., KONCHIGERI, H., VIDYASAGAR, D. Transcutaneous PO2
     monitoring during pediatric surgery. Crit. Care Med. 1981, 9 (10), pp. 714-716
[76] VYAS, H., HELMS, P., CHERIYAN, G. Transcutaneous oxygen monitoring beyond the neonatal period. Crit.
     Care Med. 1988, 16 (9, Sep), pp. 844-847
[77] WIENERT, V., SICK, H., ZUR MHLEN, J. Lokale thermische Belastbarkeit der menschlichen Haut [The

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     local heat tolerance of the human skin]. Anasth. Intensivther. Notf. Med. 1983, 18, pp. 88-90
[78] ASTM F2761-09,Medical devices and medical systems−Essential safety requirements for equipment
     comprising the patient-centric integrated clinical environment (ICE)−Part 1: General requirements and
     conceptual model
[79] JIS Z 8103:2000 計測用語
    注1)   he National Fire Protection Association, 1 Batterymarch Park, PO Box 9101, Quincy, MA 02269-2101,
          USAで入手可能。
       2)   CCLSのホームページで入手可能。http://www.nccls.org/free/C46-A.pdf
       3)   APのホームページで入手可能。
          http://www.cap.org/apps/docs/laboratoryaccreditation/lapinfo/progdesccrit.pdf
       4) ホームページで入手可能。http://ccforum.com/content/3/2/R11

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                                      定義用語の索引
(ア) アラーム音中断 AUDIO PAUSED                                    JIS T 60601-1-8:2012,3.13
        アラームシステム ALARM SYSTEM                                 JIS T 60601-1-8:2012,3.11
        アラーム状態 ALARM CONDITION                                  JIS T 60601-1-8:2012,3.1
        アラーム状態遅延時間 ALARM CONDITION DELAY                    JIS T 60601-1-8:2012,3.2
        アラーム初期設定 DEFAULT ALARM PRESET                         JIS T 60601-1-8:2012,3.16
        アラーム信号 ALARM SIGNAL                                     JIS T 60601-1-8:2012,3.9
        アラーム信号発生遅延時間 ALARM SIGNAL GENERATION DELAY        JIS T 60601-1-8:2012,3.10
        アラーム設定状態 ALARM SETTINGS                               JIS T 60601-1-8:2012,3.8
        アラーム設定値 ALARM LIMIT                                    JIS T 60601-1-8:2012,3.3
        アラーム中断 ALARM PAUSED                                     JIS T 60601-1-8:2012,3.5
        アラームプリセット ALARM PRESET                               JIS T 60601-1-8:2012,3.6
(イ) 移動形 MOBILE                                                  JIS T 0601-1:2012,3.65
        イミュニティ試験レベル IMMUNITY TEST LEVEL                    IEC 60601-1-2:2007,3.15
        医用電気機器(ME機器) MEDICAL ELECTRICAL EQUIPMENT           JIS T 0601-1:2012,3.63
        医用電気システム(MEシステム) MEDICAL ELECTRICAL SYSTEM      JIS T 0601-1:2012,3.64
(オ) オキシヘモグロビン分画 FRACTIONAL OXYHAEMOGLOBIN               201.3.207
(カ) 外装 ENCLOSURE                                                 JIS T 0601-1:2012,3.26
        患者 PATIENT                                                  JIS T 0601-1:2012,3.76
        患者環境 PATIENT ENVIRONMNET                                  JIS T 0601-1:2012,3.79
(キ) 危害 HARM                                                      JIS T 0601-1:2012,3.38
        機器アラーム状態 TECHNICAL ALARM CONDITION                    JIS T 60601-1-8:2012,3.36
        危険状態 HAZARDOUS SITUATION                                  JIS T 0601-1:2012,3.40
        基礎安全 BASIC SAFETY                                         JIS T 0601-1:2012,3.10
        機能試験器 FUNCTIONAL TESTER                                  201.3.209
        機能的酸素飽和度 FUNCTIONAL OXYGEN SATURATION                 201.3.208
        基本性能 ESSENTIAL PERFORMANCE                                JIS T 0601-1:2012,3.27
        局所かたより LOCAL BIAS                                       201.3.210
(ケ) 形式名称 MODEL OR TYPE REFERENCE                               JIS T 0601-1:2012,3.66
        携帯形 PORTABLE                                               JIS T 0601-1:2012,3.85
        検証 VERIFICATION (VERIFY)                                    JIS T 0601-1:2012,3.138
(コ) 公称範囲 DECLARED RANGE                                        201.3.205
(サ) 再生 REPROCESSING (REPROCESSED)                                201.3.221
        在宅医療環境 HOME HEALTHCARE ENVIRONMENT                      IEC 60601-1-11:2010,3.2
(シ) 情報信号 INFORMATION SIGNAL                                    JIS T 60601-1-8:2012,3.23
        信号入出力部 SIGNAL INPUT/OUTPUT PART                         JIS T 0601-1:2012,3.115
(ス) 据置形 STATIONARY                                              JIS T 0601-1:2012,3.118
(セ) 正規化した NORMALIZED                                          201.3.212

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