This document applies to the basic safety and essential performance of an infant cardiorespiratory monitor, as defined in 3.10, hereafter also referred to as ME equipment, in combination with its accessories: \u2014 intended for use in the home healthcare environment; \u2014 intended for use by a lay operator; \u2014 intended to monitor cardiorespiratory parameters in sleeping or resting children under three years of age; and \u2014 intended for transit-operable use. NOTE An infant cardiorespiratory monitor can also be used in professional health care facilities. This document is also applicable to those accessories intended by their manufacturer to be connected to the infant cardiorespiratory monitor, where the characteristics of those accessories can affect the basic safety or essential performance of the infant cardiorespiratory monitor. EXAMPLE probes, cables distributed alarm system<\/p>\n
| PDF Pages<\/th>\n | PDF Title<\/th>\n<\/tr>\n | ||||||
|---|---|---|---|---|---|---|---|
| 102<\/td>\n | undefined <\/td>\n<\/tr>\n | ||||||
| 104<\/td>\n | European foreword Endorsement notice <\/td>\n<\/tr>\n | ||||||
| 108<\/td>\n | Foreword <\/td>\n<\/tr>\n | ||||||
| 110<\/td>\n | Introduction <\/td>\n<\/tr>\n | ||||||
| 111<\/td>\n | 1 Scope 2 Normative references <\/td>\n<\/tr>\n | ||||||
| 112<\/td>\n | 3 Terms and definitions <\/td>\n<\/tr>\n | ||||||
| 116<\/td>\n | 4 General requirements 4.1 General 4.2 Essential performance 4.3 ME equipment or ME system parts that contact the patient 4.4 Single fault condition for ME equipment 5 General requirements for testing of ME equipment 5.1 General 5.2 Infant cardiorespiratory monitor testing errors <\/td>\n<\/tr>\n | ||||||
| 117<\/td>\n | 6 Classification of ME equipment and ME systems 6.1 General 6.2 Additional requirements for classification of ME equipment and ME systems 7 ME equipment identification, marking and documents 7.1 General 7.2 Information to be supplied by the manufacturer 7.3 Additional requirements for accessories <\/td>\n<\/tr>\n | ||||||
| 118<\/td>\n | 7.4 Additional requirements for marking on the outside of ME equipment or ME equipment parts 7.5 General instructions for use 7.6 Additional requirements for warnings and safety notices <\/td>\n<\/tr>\n | ||||||
| 119<\/td>\n | 7.7 Additional requirements for start-up procedure 7.8 Additional requirements for operating instructions 7.8.1 General 7.8.2 Lay operator operating instructions <\/td>\n<\/tr>\n | ||||||
| 120<\/td>\n | 7.8.3 Healthcare professional operator operating instructions 7.9 Cleaning, disinfection, and sterilization 7.10 Additional requirements for maintenance 7.11 Additional requirements for accessories, supplementary equipment, used material 7.12 Additional requirements for the technical description <\/td>\n<\/tr>\n | ||||||
| 121<\/td>\n | 8 Protection against electrical hazards from ME equipment 9 Protection against mechanical hazards of ME equipment and ME systems 9.1 General 9.2 Additional requirements for instability from unwanted lateral movement 9.3 Grips and other handling devices 10 Protection against unwanted and excessive radiation hazards 11 Protection against excessive temperatures and other hazards 11.1 General <\/td>\n<\/tr>\n | ||||||
| 122<\/td>\n | 11.2 Cleaning and disinfection of ME equipment or ME system 11.3 Sterilization of ME equipment or ME system 11.4 Biocompatibility of ME equipment and ME systems <\/td>\n<\/tr>\n | ||||||
| 123<\/td>\n | 11.5 Interruption of the power supply \/ supply mains to ME equipment 11.5.1 General 11.5.2 Power sources <\/td>\n<\/tr>\n | ||||||
| 124<\/td>\n | 11.5.3 Alternative power supply\/supply mains 12 Accuracy of controls and instruments and protection against hazardous outputs 12.1 General 12.2 Accuracy of controls and instruments <\/td>\n<\/tr>\n | ||||||
| 125<\/td>\n | 12.3 Accuracy of controls and instruments 12.3.1 General 12.3.2 Cardiorespiratory monitoring 12.3.3 Direct monitoring – respiration 12.3.4 Indirect monitoring \u2013 heart rate 12.3.5 Indirect monitoring from pulse oximetry <\/td>\n<\/tr>\n | ||||||
| 126<\/td>\n | 12.3.6 Apnoeic patient alarm condition <\/td>\n<\/tr>\n | ||||||
| 127<\/td>\n | 12.3.7 Sensor fault 12.3.8 Clinical performance evaluation 12.4 Usability of ME equipment <\/td>\n<\/tr>\n | ||||||
| 128<\/td>\n | 13 Hazardous situations and fault conditions for ME equipment 14 Programmable electrical medical systems (PEMS) 15 Construction of ME equipment 15.1 General 15.2 Mode of operation 15.3 Pre-use check <\/td>\n<\/tr>\n | ||||||
| 129<\/td>\n | 16 ME systems 17 Electromagnetic compatibility of ME equipment and ME systems 18 Requirements for the accessories 18.1 General 18.2 Labelling 19 Training 20 Functional connection 20.1 General 20.2 Connection to an electronic health record 20.3 Connection to a distributed alarm system <\/td>\n<\/tr>\n | ||||||
| 130<\/td>\n | 21 Electromagnetic disturbances \u2013 Requirements and tests 21.1 General 21.2 Compliance criteria 21.3 Requirements applicable to all ME equipment and ME systems 21.4 Additional general requirements 22 Usability 22.1 General <\/td>\n<\/tr>\n | ||||||
| 131<\/td>\n | 22.2 Primary operating functions 23 General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems 23.1 General 23.2 Volume and characteristics of auditory alarm signals and information signals 23.3 Additional requirements for termination of alarm signal inactivation <\/td>\n<\/tr>\n | ||||||
| 132<\/td>\n | 23.4 Additional requirements for alarm system logging 24 Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment <\/td>\n<\/tr>\n | ||||||
| 133<\/td>\n | Annex A (informative) General guidance and rationale <\/td>\n<\/tr>\n | ||||||
| 138<\/td>\n | Annex B (informative) Sequence of testing <\/td>\n<\/tr>\n | ||||||
| 139<\/td>\n | Annex C (informative) Guide to marking and labelling requirements for ME equipment and ME systems <\/td>\n<\/tr>\n | ||||||
| 142<\/td>\n | Annex D (informative) Symbols on marking <\/td>\n<\/tr>\n | ||||||
| 143<\/td>\n | Annex E (informative) Examples of the connection of the measuring device (MD) for measurement of the patient leakage current and patient auxiliary current <\/td>\n<\/tr>\n | ||||||
| 144<\/td>\n | Annex F (informative) Suitable measuring supply circuits <\/td>\n<\/tr>\n | ||||||
| 145<\/td>\n | Annex G (informative) Protection against hazards of ignition of flammable anaesthetic mixtures <\/td>\n<\/tr>\n | ||||||
| 146<\/td>\n | Annex H (informative) PEMS structure, PEMS development life-cycle and documentation <\/td>\n<\/tr>\n | ||||||
| 147<\/td>\n | Annex I (informative) ME systems aspects <\/td>\n<\/tr>\n | ||||||
| 148<\/td>\n | Annex J (informative) Survey of insulation paths <\/td>\n<\/tr>\n | ||||||
| 149<\/td>\n | Annex K (informative) Simplified patient leakage current diagrams <\/td>\n<\/tr>\n | ||||||
| 150<\/td>\n | Annex L (informative) Insulated winding wires for use without interleaved insulation <\/td>\n<\/tr>\n | ||||||
| 151<\/td>\n | Annex M (informative) Reduction of pollution degrees <\/td>\n<\/tr>\n | ||||||
| 152<\/td>\n | Annex N (informative) Data interface requirements <\/td>\n<\/tr>\n | ||||||
| 155<\/td>\n | Annex O (informative) Considerations for a clinical performance study <\/td>\n<\/tr>\n | ||||||
| 157<\/td>\n | Annex P (informative) Reference to the IMDRF essential principles and labelling guidances <\/td>\n<\/tr>\n | ||||||
| 159<\/td>\n | Annex Q (informative) Reference to the essential principles <\/td>\n<\/tr>\n | ||||||
| 161<\/td>\n | Annex R (informative) Reference to the general safety and performance requirements <\/td>\n<\/tr>\n | ||||||
| 164<\/td>\n | Bibliography <\/td>\n<\/tr>\n | ||||||
| 165<\/td>\n | Terminology \u2014 Alphabetized index of defined terms <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" Tracked Changes. Respiratory equipment. Particular requirements for basic safety and essential performance of infant cardiorespiratory monitors<\/b><\/p>\n |