Clause 1 of IEC 60601\u20111:2005+AMD1:2012+AMD2:2020 applies, except as follows:<\/p>\n
\nNOTE The general standard is IEC 60601\u20111:2005+AMD1:2012+AMD2:2020.<\/p>\n<\/blockquote>\n
201.1.1<\/b> * Scope<\/p>\n
Replacement:<\/i><\/p>\n
This document applies to the basic safety<\/i> and essential performance<\/i> of a high-frequency ventilator<\/i> (HFV<\/i>) in combination with its accessories<\/i>, hereafter referred to as ME equipment:<\/i><\/p>\n
\n
- \n
intended for use in an environment that provides specialized care for patients<\/i> whose conditions can be life-threatening and who can require comprehensive care and constant monitoring in a professional healthcare facility;<\/i><\/p>\n
\nNOTE 1 For the purposes of this document, such an environment is referred to as a critical care environment. High-frequency ventilators<\/i> for this environment are considered life-sustaining.<\/p>\n<\/blockquote>\n
\nNOTE 2 For the purposes of this document, such a high-frequency ventilator<\/i> can provide transport within a professional healthcare facility<\/i> (i.e., be a transit-operable ventilator<\/i>).<\/p>\n<\/blockquote>\n
\nNOTE 3 A high-frequency ventilator<\/i> intended for use in transport within a professional healthcare facility<\/i> is not considered as a ventilator<\/i> intended for the emergency medical services environment<\/i>.<\/p>\n<\/blockquote>\n<\/li>\n
- \n
intended to be operated by a healthcare professional operator<\/i>;<\/p>\n<\/li>\n
- \n
intended for those patients<\/i> who need differing levels of support from artificial ventilation<\/i> including ventilator-dependent patients;<\/i> and<\/p>\n<\/li>\n
- \n
capable of providing more than 150 inflations<\/i>\/min.<\/p>\n<\/li>\n<\/ul>\n
There are three principal designations of HFV<\/i>:<\/p>\n
\n
- \n
high-frequency percussive ventilation<\/i> [HFPV, with a typical HFV frequency<\/i> of (60 to 1 000) HFV inflations<\/i>\/min];<\/p>\n<\/li>\n
- \n
high-frequency jet ventilation<\/i> [HFJV, with a typical HFV frequency<\/i> of (100 to 1 500) HFV inflations<\/i>\/min]; and<\/p>\n<\/li>\n
- \n
high-frequency oscillatory ventilation<\/i> [HFOV, with a typical HFV frequency<\/i> of (180 to 1200) HFV inflations<\/i>\/min and typically having an active expiratory phase<\/i>].<\/p>\n<\/li>\n<\/ul>\n
Additionally, HFV<\/i> designations can be combined together or with ventilation<\/i> at rates<\/i> less than 150 inflations<\/i>\/min.<\/p>\n
* A high-frequency ventilator<\/i> is not considered a physiologic closed loop-control system<\/i> unless it uses a physiological patient<\/i> variable to adjust the ventilation<\/i> therapy settings.<\/p>\n
This document is also applicable to those accessories<\/i> intended by their manufacturer<\/i> to be connected to an HFV breathing system<\/i>, or to a high-frequency ventilator<\/i>, where the characteristics of those accessories<\/i> can affect the basic safety<\/i> or essential performance<\/i> of the high-frequency ventilator<\/i>.<\/p>\n
If a clause or subclause is specifically intended to be applicable to ME equipment<\/i> only, or to ME systems<\/i> only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME equipment<\/i> and to ME systems<\/i>, as relevant.<\/p>\n
Hazards<\/i> inherent in the intended physiological function of ME equipment<\/i> or ME systems<\/i> within the scope of this document are not covered by specific requirements in this document except in 7.2.13 and 8.4.1 of IEC 60601\u20111:2005.<\/p>\n
\nNOTE 4 Additional information can be found in 4.2 of IEC 60601\u20111:2005+AMD1:2012.<\/p>\n<\/blockquote>\n
This document is not applicable to ME equipment<\/i> that is intended solely to augment the ventilation<\/i> of spontaneously breathing patients<\/i> within a professional healthcare facility<\/i>.<\/p>\n
This document does not specify the requirements for:<\/p>\n
\n
- \n
non-high-frequency ventilators<\/i> or accessories<\/i> which provide conventional ventilation<\/i> for use in critical care environments, which are given in ISO 80601\u20112\u201112[23]<\/sup>;.<\/p>\n
\nNOTE 5 An HFV<\/i> can incorporate conventional critical care ventilator operational modes<\/i>, in which case ISO 80601\u20112\u201112 is applicable to those modes.<\/p>\n<\/blockquote>\n<\/li>\n
- \n
ventilators<\/i> or accessories<\/i> intended for anaesthetic applications, which are given in ISO 80601\u20112\u201113[24]<\/sup>;<\/p>\n<\/li>\n
- \n
ventilators<\/i> or accessories<\/i> intended for the emergency medical services environment<\/i>, which are given in ISO 80601\u20112\u201184, the replacement for ISO 10651\u20113[13]<\/sup>;<\/p>\n
\nNOTE 6 An HFV<\/i> can incorporate EMS ventilator<\/i> capability.<\/p>\n<\/blockquote>\n<\/li>\n
- \n
ventilators<\/i> or accessories<\/i> intended for ventilator-dependent patients<\/i> in the home healthcare environment,<\/i> which are given in ISO 80601\u20112\u201172[26]<\/sup>;<\/p>\n<\/li>\n
- \n
ventilators<\/i> or accessories<\/i> intended for home-care ventilatory support devices, which are given in ISO 80601\u20112\u201179[27]<\/sup> and ISO 80601\u20112\u201180[28]<\/sup>, the replacements for ISO 10651\u20116[15]<\/sup>;<\/p>\n<\/li>\n
- \n
sleep apnoea breathing therapy ME equipment<\/i>, which are given in ISO 80601\u20112\u201170[25]<\/sup>;<\/p>\n<\/li>\n
- \n
bi-level positive airway pressure<\/i> (bi-level PAP<\/i>) ME equipment<\/i>;<\/p>\n<\/li>\n
- \n
continuous positive airway pressure<\/i> (CPAP<\/i>) ME equipment<\/i>;<\/p>\n<\/li>\n
- \n
respiratory high-flow ME equipment<\/i>, which are given in ISO 80601\u20112\u201190:\u20141<\/sup>; and<\/p>\n<\/li>\n
- \n
cuirass or \u201ciron-lung\u201d ventilation<\/i> equipment.<\/p>\n<\/li>\n<\/ul>\n
This document is a particular standard in the IEC 60601 series, the IEC 80601 series and the ISO 80601 series.<\/p>\n
201.1.2<\/b> Object<\/p>\n
Replacement:<\/i><\/p>\n
The object of this document is to establish particular basic safety<\/i> and essential performance<\/i> requirements for a high-frequency ventilator,<\/i> as defined in 201.3.201, and its accessories<\/i>.<\/p>\n
\nNOTE 1 Accessories<\/i> are included because the combination of the high-frequency ventilator<\/i> and the accessories<\/i> needs to be adequately safe. Accessories<\/i> can have a significant impact on the basic safety<\/i> or essential performance<\/i> of a high-frequency ventilator<\/i>.<\/p>\n<\/blockquote>\n
\nNOTE 2 This document has been prepared to address the relevant essential principles<\/i>[39]<\/sup> and labelling[40]<\/sup> guidances of the International Medical Devices Regulators Forum (IMDRF) as indicated in Annex CC.<\/p>\n<\/blockquote>\n
\nNOTE 3 This document has been prepared to address the relevant essential principles ofsafety and performance<\/i> of ISO 16142\u20111:2016 as indicated in Annex DD.<\/p>\n<\/blockquote>\n
\nNOTE 4 This document has been prepared to address the relevant general safety and performance requirements of European regulation (EU) 2017\/745[38]<\/sup> as indicated in Annex FF.<\/p>\n<\/blockquote>\n
201.1.3<\/b> Collateral standards<\/p>\n
Amendment (add after existing text):<\/i><\/p>\n
This document refers to those applicable collateral standards that are listed in Clause 2 of the general standard and 201.2 of this document.<\/p>\n
IEC 60601\u20111\u20112, IEC 60601\u20111\u20116 and IEC 60601\u20111\u20118 apply as modified in Clauses 202, 206 and 208 respectively. IEC 60601\u20111\u20113[29]<\/sup>, IEC 60601\u20111\u20119[30]<\/sup>, IEC 60601\u20111\u201111 and IEC 60601\u20111\u201112[31]<\/sup> do not apply. All other published collateral standards in the IEC 60601\u20111 series apply as published.<\/p>\n
201.1.4<\/b> Particular standards<\/p>\n
Replacement:<\/i><\/p>\n
In the IEC 60601 series, particular standards may modify, replace or delete requirements contained in the general standard, including the collateral standards, as appropriate for the particular ME equipment<\/i> under consideration, and may add other basic safety<\/i> or essential performance<\/i> requirements.<\/p>\n
A requirement of a particular standard takes priority over IEC 60601\u20111:2005+AMD1:2012+AMD2:2020 or the collateral standards.<\/p>\n
For brevity, IEC 60601\u20111:2005+AMD1:2012+AMD2:2020 is referred to in this particular document as the general standard. Collateral standards are referred to by their document number.<\/p>\n
The numbering of clauses and subclauses of this document corresponds to those of the general standard with the prefix \u201c201\u201d (e.g. 201.1 in this document addresses the content of Clause 1 of the general standard) or applicable collateral standard with the prefix \u201c2xx\u201d where xx is the final digits of the collateral standard document number (e.g. 202.4 in this document addresses the content of Clause 4 of the IEC 60601\u20111\u20112 collateral standard, 208.4 in this document addresses the content of Clause 4 of the IEC 60601\u20111\u20118 collateral standard, etc.). The changes to the text of the general standard are specified by the use of the following words:<\/p>\n
\u201cReplacement\u201d means that the clause or subclause of IEC 60601\u20111:2005 or the applicable collateral standard is replaced completely by the text of this document.<\/p>\n
\u201cAddition\u201d means that the text of this document is additional to the requirements of IEC 60601\u20111:2005 or the applicable collateral standard.<\/p>\n
\u201cAmendment\u201d means that the clause or subclause of IEC 60601\u20111:2005 or the applicable collateral standard is amended as indicated by the text of this document.<\/p>\n
Subclauses, figures or tables that are additional to those of the general standard are numbered starting from 201.101. However, due to the fact that definitions in the general standard are numbered 3.1 through 3.147, additional definitions in this document are numbered beginning from 201.3.201. Additional annexes are lettered AA, BB, etc., and additional items aa),<\/i> bb),<\/i> etc.<\/p>\n
Subclauses or figures that are additional to those of a collateral standard are numbered starting from 20x, where \u201cx\u201d is the number of the collateral standard, e.g. 202 for IEC 60601\u20111\u20112, 203 for IEC 60601\u20111\u20113[29]<\/sup>, etc.<\/p>\n
The term \u201cthis document\u201d is used to make reference to the general standard, any applicable collateral standards and this particular document taken together.<\/p>\n
Where there is no corresponding clause or subclause in this document, the clause or subclause of IEC 60601\u20111:2005+AMD1:2012 or the applicable collateral standard, although possibly not relevant, applies without modification; where it is intended that any part of IEC 60601\u20111:2005+AMD1:2012 or the applicable collateral standard, although possibly relevant, is not to be applied, a statement to that effect is given in this particular document.<\/p>\n
PDF Catalog<\/h4>\n
\n
\n PDF Pages<\/th>\n PDF Title<\/th>\n<\/tr>\n \n 2<\/td>\n undefined <\/td>\n<\/tr>\n \n 5<\/td>\n European foreword
Endorsement notice <\/td>\n<\/tr>\n\n 9<\/td>\n Introduction <\/td>\n<\/tr>\n \n 10<\/td>\n 201. 1 Scope, object and related standards
201. 1.1 * Scope <\/td>\n<\/tr>\n\n 12<\/td>\n 201. 1.2 Object
201. 1.3 Collateral standards
201. 1.4 Particular standards <\/td>\n<\/tr>\n\n 13<\/td>\n 201. 2 Normative references <\/td>\n<\/tr>\n \n 15<\/td>\n 201. 3 Terms and definitions <\/td>\n<\/tr>\n \n 35<\/td>\n 201. 4 General requirements
201. 4.3 Essential performance
201. 4.3.101 * Additional requirements for essential performance <\/td>\n<\/tr>\n\n 36<\/td>\n 201. 4.4 Additional requirements for expected service life
201. 4.6 * ME equipment or ME system parts that contact the patient
201. 4.11.101 * Additional requirements for pressurized gas input
201. 4.11.101.1 Overpressure requirement <\/td>\n<\/tr>\n\n 37<\/td>\n 201. 4.11.101.2 Compatibility requirement
201. 5 General requirements for testing of ME equipment <\/td>\n<\/tr>\n\n 38<\/td>\n 201. 5.101 Additional requirements for general requirements for testing of ME equipment
201. 5.101.1 Ventilator test conditions
201. 5.101.2 * Gas flowrate and leakage specifications
201. 5.101.3 * Ventilator testing errors
201. 6 Classification of ME equipment and ME systems
201. 7 ME equipment identification, marking and documents
201. 7.1.101 Information to be supplied by the manufacturer <\/td>\n<\/tr>\n\n 39<\/td>\n 201. 7.2.3 * Consult accompanying documents
201. 7.2.4.101 Additional requirements for accessories
201. 7.2.18 External gas source
201. 7.2.101 Additional requirements for marking on the outside of ME equipment or ME equipment parts <\/td>\n<\/tr>\n\n 40<\/td>\n 201. 7.4.3 * Units of measurement
201. 7.9.2.1.101 Additional general requirements <\/td>\n<\/tr>\n\n 41<\/td>\n 201. 7.9.2.2.101 * Additional requirements for warnings and safety notices <\/td>\n<\/tr>\n \n 42<\/td>\n 201. 7.9.2.8.101 * Additional requirements for start-up procedure
201. 7.9.2.9.101 * Additional requirements for operating instructions <\/td>\n<\/tr>\n\n 43<\/td>\n 201. 7.9.2.12 Cleaning, disinfection and sterilization
201. 7.9.2.14.101 * Additional requirements for accessories, supplementary equipment, used material <\/td>\n<\/tr>\n\n 44<\/td>\n 201. 7.9.3.1.101 * Additional general requirements
201. 7.9.3.101 Additional requirements for the technical description
201. 8 Protection against electrical hazards from ME equipment <\/td>\n<\/tr>\n\n 45<\/td>\n 201. 9 Protection against mechanical hazards of ME equipment and ME systems
201. 9.6.2.1.101 * Additional requirements for audible acoustic energy <\/td>\n<\/tr>\n\n 46<\/td>\n 201. 9.101 * Additional requirements for suction procedures <\/td>\n<\/tr>\n \n 48<\/td>\n 201. 10 Protection against unwanted and excessive radiation hazards
201. 11 Protection against excessive temperatures and other hazards
201. 11.1.2.2 * Applied parts not intended to supply heat to a patient <\/td>\n<\/tr>\n\n 49<\/td>\n 201. 11.6.5.101 * Additional requirements for ingress of water or particulate matter into ME equipment or ME system
201. 11.6.6 * Cleaning and disinfection of ME equipment or ME system <\/td>\n<\/tr>\n\n 50<\/td>\n 201. 11.6.7 Sterilization of ME equipment or ME system
201. 11.7 Biocompatibility of ME equipment and ME systems
201. 11.8.101 * Additional requirements for interruption of the power supply\/supply mains to ME equipment <\/td>\n<\/tr>\n\n 52<\/td>\n 201. 12 Accuracy of controls and instruments and protection against hazardous outputs
201. 12.1 * Accuracy of controls and instruments
201. 12.1.101 * Mean airway pressure <\/td>\n<\/tr>\n\n 56<\/td>\n 201. 12.1.102 Mean airway pressure limiting means for an HFV without a patient-connection port <\/td>\n<\/tr>\n \n 57<\/td>\n 201. 12.1.103 FiO2 concentration <\/td>\n<\/tr>\n \n 58<\/td>\n 201. 12.1.104 * Response of the ventilator to an increase in set O2 concentration <\/td>\n<\/tr>\n \n 62<\/td>\n 201. 12.4 Protection against hazardous output
201. 12.4.101 Oxygen monitor <\/td>\n<\/tr>\n\n 63<\/td>\n 201. 12.4.102 * Measurement of mean airway pressure and low and high mean airway pressure alarm conditions <\/td>\n<\/tr>\n \n 64<\/td>\n 201. 12.4.103 Measurement of mean airway pressure at the distal outlet of the jet system and high mean airway pressure alarm condition <\/td>\n<\/tr>\n \n 65<\/td>\n 201. 12.4.104 Measurement of pressure amplitude and low and high pressure amplitude alarm conditions <\/td>\n<\/tr>\n \n 66<\/td>\n 201. 12.4.105 Measurement of HFV volume and low and high HFV volume alarm condition <\/td>\n<\/tr>\n \n 67<\/td>\n 201. 12.4.106 * Maximum limited pressure protection device
201. 12.4.107 * High-pressure protection device <\/td>\n<\/tr>\n\n 68<\/td>\n 201. 12.4.108 Obstruction alarm condition
201. 12.4.109 * Disconnection alarm condition <\/td>\n<\/tr>\n\n 69<\/td>\n 201. 12.4.110 Minimum limited pressure protection device
201. 12.101 * Protection against accidental or unintentional adjustments
201. 13 Hazardous situations and fault conditions for ME equipment
201. 13.101 * Additional specific single fault conditions <\/td>\n<\/tr>\n\n 70<\/td>\n 201. 13.102 * Failure of one gas supply to a ventilator
201. 13.103 * Independence of ventilation control function and related risk control measures <\/td>\n<\/tr>\n\n 71<\/td>\n 201. 13.104 * Failure of a functional connection to a ventilator control or monitoring means
201. 14 Programmable electrical medical systems (PEMS)
201. 14.101 Software life cycle
201. 15 Construction of ME equipment
201. 15.3.5.101 Additional requirements for rough handling
201. 15.3.5.101.1 * Shock and vibration (robustness) <\/td>\n<\/tr>\n\n 73<\/td>\n 201. 15.3.5.101.2 * Shock and vibration for a transit-operable ventilator during operation <\/td>\n<\/tr>\n \n 74<\/td>\n 201. 15.4.1 Construction of connectors
201. 15.101 Mode of operation
201. 15.102 Delivered oxygen concentration
201. 15.103 Accessory self-check <\/td>\n<\/tr>\n\n 75<\/td>\n 201. 16 ME systems
201. 16.1.101 Additional general requirements for ME systems
201. 17 Electromagnetic compatibility of ME equipment and ME systems
201. 101 Gas connections
201. 101.1 * Protection against reverse gas leakage
201. 101.2 Connection to a high-pressure inlet
201. 101.2.1 Connector
201. 101.2.2 * Filter <\/td>\n<\/tr>\n\n 76<\/td>\n 201. 101.3 HFV breathing system connectors
201. 101.3.1 * General
201. 101.3.2 Other named ports
201. 101.3.2.1 Patient-connection port
201. 101.3.2.2 Gas output port and gas return port
201. 101.3.2.3 Emergency intake port <\/td>\n<\/tr>\n\n 77<\/td>\n 201. 101.3.2.4 Flow-direction-sensitive components
201. 101.3.2.5 * Accessory port
201. 101.3.2.6 Gas exhaust port
201. 102 Requirements for the HFV breathing system and accessories
201. 102.1 * General <\/td>\n<\/tr>\n\n 78<\/td>\n 201. 102.2 Labelling
201. 102.3 Breathing tubes
201. 102.4 * Water vapour management
201. 102.5 Breathing system filters
201. 102.6 * Leakage from the complete VBS <\/td>\n<\/tr>\n\n 79<\/td>\n 201. 103 * Spontaneous breathing during loss of power supply
201. 104 * Indication of duration of operation <\/td>\n<\/tr>\n\n 80<\/td>\n 201. 105 Functional connection
201. 105.1 General
201. 105.2 * Connection to an electronic health record
201. 105.3 * Connection to a distributed alarm system
201. 105.4 Connection for remote control
201. 106 Display loops
201. 106.1 Pressure-volume loops <\/td>\n<\/tr>\n\n 81<\/td>\n 201. 106.2 Flow-volume loops
201. 107 Timed high-frequency oscillation pause
202 Electromagnetic disturbances \u2013 Requirements and tests
202.4.3.1 * Configurations
202.5.2.2.1 Requirements applicable to all ME equipment and ME systems <\/td>\n<\/tr>\n\n 82<\/td>\n 202.8.1.101 * Additional general requirements
206 Usability
206.101 Primary operating functions <\/td>\n<\/tr>\n\n 84<\/td>\n 206.102 * Training
208 General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
208.6.3.2.2.101 Additional requirements for 1 m (operator\u2019s position) visual alarm signals and information signals
208.6.8.3.101 Additional requirements for global indefinite alarm signal inactivation states <\/td>\n<\/tr>\n\n 85<\/td>\n 208.6.8.4.101 * Additional requirements for termination of alarm signal inactivation
208.6.12.101 * Additional requirements for alarm system logging <\/td>\n<\/tr>\n\n 86<\/td>\n Annex C (informative) Guide to marking and labelling requirements for ME equipment and ME systems
201.C.101 Marking on the outside of ME equipment, ME systems or their parts
201.C.102 Accompanying documents, general <\/td>\n<\/tr>\n\n 87<\/td>\n 201.C.103 Accompanying documents, instructions for use <\/td>\n<\/tr>\n \n 89<\/td>\n 201.C.104 Accompanying documents, technical description <\/td>\n<\/tr>\n \n 91<\/td>\n Annex D (informative) Symbols on marking <\/td>\n<\/tr>\n \n 92<\/td>\n Annex AA (informative) Particular guidance and rationale
AA.1 General guidance
AA.2 Rationale for particular clauses and subclauses <\/td>\n<\/tr>\n\n 122<\/td>\n Annex BB (informative) Data interface requirements
BB.1 Background and purpose <\/td>\n<\/tr>\n\n 123<\/td>\n BB.2 Data definition <\/td>\n<\/tr>\n \n 128<\/td>\n Annex CC (informative) Reference to the IMDRF essential principles and labelling guidances <\/td>\n<\/tr>\n \n 131<\/td>\n Annex DD (informative) Reference to the essential principles <\/td>\n<\/tr>\n \n 134<\/td>\n Annex EE (informative) Reference to the general safety and performance requirements <\/td>\n<\/tr>\n \n 137<\/td>\n Annex FF (informative) Terminology \u2014 alphabetized index of defined terms <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" Medical electrical equipment – Particular requirements for basic safety and essential performance of high-frequency ventilators<\/b><\/p>\n
\n\n
\n Published By<\/td>\n Publication Date<\/td>\n Number of Pages<\/td>\n<\/tr>\n \n BSI<\/b><\/a><\/td>\n 2021<\/td>\n 146<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":374794,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[137,2641],"product_tag":[],"class_list":{"0":"post-374783","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-11-040-10","7":"product_cat-bsi","9":"first","10":"instock","11":"sold-individually","12":"shipping-taxable","13":"purchasable","14":"product-type-simple"},"_links":{"self":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product\/374783","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product"}],"about":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/types\/product"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media\/374794"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=374783"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=374783"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=374783"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}