TECHNICAL FILES EN 60601-1-8 Test Report for Anaeston5000 Anaesthetic Machine | ||||||||
Code: 5000/CE-10 | Version: B | Issuing Date:20080424 | ||||||
EN 60601-1-8 Test Report | ||||||||
Revid Record: 纯净物的定义 | ||||||||
Revision Status | Page No | Revid Content | Issuing Date | |||||
Approved by: | Reviewed by: | Established by: | Revid by: | |||||
Signed by: __________ __________ __________ __________ □QA Dept □R&D Dept □Manufacture Dept □Sales Dept | ||||||||
Clau | Requirement | Result - Remark | P/NA |
6 | ALARM SYSTEMS | ||
6.1 | ALARM CONDITION | ||
6.1.1 * | General If ALARM CONDITIONS are grouped into PHYSIOLOGICAL ALARM CONDITIONS, TECHNICAL ALARM CONDITIONS or other ALARM CONDITION groups by the MANUFACTURER, this shall be disclod in the instructions for u. | 如果警报条件被归类为生理警报条件，技术警报条件或其他由制造商定义的，则在使用说明书中应指出。 | |
6.1.2 * | ALARM CONDITION priority ALARM CONDITIONS shall be assigned to one or more of the following priorities: HIGH PRIORITY, MEDIUM PRIORITY, or LOW PRIORITY. Unless a particular ALARM CONDITION 重庆医科大学是几本priority is specified in a relevant particular standard, the assignment of priorities is part of the RISK MANAGEMENT PROCESS and shall be bad on Table 1. The priority of each ALARM CONDITION shall be disclod in the instructions for u. Priorities may be identified in groups. | Anaeston5000 Anaesthesia Machine Operation Manua from 4-2 to 4-11 | P |
6.2 * | Disclosures for INTELLIGENT ALARM SYSTEM If an INTELLIGENT ALARM SYSTEM is provided, the instructions for u shall include, as applicable, an overview of how the ALARM SYSTEM: a) determines an ALARM CONDITION on the basis of time, weightings, multiple variables, or other advanced processing (including, but not limited to, algorithms, neural networks, fuzzy logic, etc.); | 如果提供智能报警系统，使用说明书将包括以下概要:报警系统怎样 a)根据时间、加权、多重变量或者其他高级的处理过程如算法， 模糊逻辑等,来计算警报条件 | |
b) generates ALARM SIGNALS for two or more ALARM CONDITIONS of equal priority (including, but not limited to, internal ranking, effect on generation of ALARM SIGNALS); | The first priority alarming will be prented on region 1. The cond priority alarming will be prented on region 2.If all regions occupied, alarming information will be displayed periodically with 1 cond. | P | |
c) changes the previously-assigned priority or relative prioritization of a particular ALARM CONDITION (e.g., ESCALATION or DE-ESCALATION); | 改变一预先指定好优先级的特殊警报的相对优先顺序 (即，逐步升级或降级); | NA | |
d) changes the ALARM SIGNAL GENERATION DELAY or ALARM CONDITION DELAY; and | 改变报警信号延迟或警报条件延迟 | ||
e) changes the characteristics of the generated ALARM SIGNALS (for example, volume, pitch, tempo, urgency). | 改变引起的报警信号的特征(例如，音量,音调，节拍,缓急程度)。 | ||
6.3 | Generation of ALARM SIGNALS | ||
6.3.1 | General Each ALARM CONDITION shall cau the generation of visual ALARM SIGNALS as specified in this collateral standard. If deemed necessary by RISK ASSESSMENT regarding the environment in which the ALARM SYSTEM is intended to be ud, additional ALARM SIGNALS shall be generated. The additional ALARM SIGNALS may be auditory, verbal, vibratory or produced by other means. | 每个警报条件应引起该标准指定的视觉报警信号, 如果有必要,应设有辅助的报警信号关于环境的风险评估,(即报警系统所使用的环境),。 这些辅助的报警信号可以是声音，文字，振动或者其他. | |
6.3.2 * | Visual alarm signals | ||
6.3.2.1 | General ALARM SYSTEMS shall generate visual ALARM SIGNALS to indicate the prence of ALARM CONDITIONS, their priority and each specific ALARM CONDITION. | Anaeston5000 Anaesthesia Machine Operation Manua from 4-2 to 4-11 | P |
6.3.2.2 * | Characteristics of visual ALARM SIGNALS If a visual indicator is necessary for the OPERATOR to identify the equipment or part of the equipment that requires OPERATOR respon or awareness, at least one visual ALARM SIGNAL shall be provided that: a) indicates the priority of the highest priority ALARM CONDITION; and b) can be perceived correctly at a distance of 4 m from the ALARM SYSTEM. If an alarm indicator light or graphical simulation of an indicator light is ud for the purpos, it shall comply with the colour and flashing requirements given in Table 2. Alternatively, this indication may be generated by some other type of visual display or device. ALARM SYSTEMS that do not contain HIGH PRIORITY or MEDIUM PRIORITY ALARM CONDITIONS are exempt from this requirement if their visual indication cannot be confud with a HIGH PRIORITY or MEDIUM PRIORITY alarm indicator light complying with Table 2. | Anaeston3000 Anaesthesia Machine Operation Manua 4-1 Red bottom stands for High priority Yellow bottom with Black word stands for Medium Priority White bottom With Purple word stands for Low Priority | P |
6.3.3 * | Auditory ALARM SIGNALS | ||
6.3.3.1 * | Characteristics of auditory ALARM SIGNALS An ALARM SYSTEM provided with auditory ALARM SIGNALS shall have at least one t of ALARM SIGNALS that: a) is priority encoded and meets the requirements of Table 3 and Table 4; or b) is generated by means of different technology (e.g., voice synthesizing of verbal ALARM SIGNALS) and is VALIDATED (e.g., by clinical or simulated clinical USABILITY testing). If the ALARM SYSTEM is additionally provided with other ts of auditory ALARM SIGNALS, the following shall apply: c) auditory ALARM SIGNALS shall be priority encoded; d) HIGH PRIORITY auditory ALARM SIGNALS of a particular t of ALARM SIGNALS shall convey a higher level of urgency than the MEDIUM or LOW PRIORITY ALARM SIGNALS and INFORMATION SIGNALS of that ALARM SIGNAL t; e) MEDIUM PRIORITY auditory ALARM SIGNALS of a particular t of ALARM SIGNALS shall convey a higher level of urgency than the LOW PRIORITY ALARM SIGNALS and INFORMATION SIGNALS of that ALARM SIGNAL t; f) auditory ALARM SIGNALS shall be VALIDATED, e.g., by clinical or simulated clinical USABILITY testing; g) means shall be provided to store a t of auditory ALARM SIGNALS in the DEFAULT ALARM PRESET; and h) means may be provided to store a t of auditory ALARM SIGNALS in any ALARM PRESET. | HIGH PRIORITY: Number of puls in burst: 10 tb =10 s x =100 ms y =250 ms fo =333 Hz td =150 ms tr =20% tf =20% × td MEDIUM PRIORITY: Number of puls in burst: 3 tb =25 s x =100 ms y =250 ms fo =210 Hz td =150 ms tr =20% tf =20% × td LOW PRIORITY: Number of puls in burst: 1 No repeat x =100 ms y =250 ms fo =210 Hz td =150 ms tr =20% tf =20% × td Malfunction alarm: fo =666 Hz | |
Any melody shall preclude the possibility of confusion with the auditory ALARM SIGNALS of Table 3, Table 4 and Annex F, unless their meaning is the same. If any of the melodies of Annex F is ud to meet the requirements of Table 3 and Table 4, its meanings shall be as specified in Annex F. When a TECHNICAL ALARM CONDITION that precludes the generation of the usual ALARM SIGNALS occurs, e.g. power or ALARM SYSTEM failure, the ALARM SYSTEM may generate an auditory ALARM SIGNAL that does not comply with the above requirements. | 任何音调不能与表格3,4及附件F规定的声音报警信号相混淆,除非它们的意思相同. 如果用到附件F中的任一音调符合表3和4的要求 则该音调所代表的意思应如附件F规定的那样. 当一个技术报警条件会阻碍正常报警信号的产生时,(如断电或报警系统故障),该报警系统可以产生一个不用符合上述要求的声音报警信号. | ||
6.3.3.2 * | Volume of auditory ALARM SIGNALS and INFORMATION SIGNALS The auditory ALARM SIGNAL sound pressure range, as measured in accordance with this subclau, shall be disclod in the instructions for u. The sound pressure level of MEDIUM PRIORITY ALARM SIGNALS shall not exceed that of HIGH PRIORITY ALARM SIGNALS. If provided, the sound pressure level of LOW PRIORITY ALARM SIGNALS shall not exceed that of MEDIUM PRIORITY ALARM SIGNALS. If auditory INFORMATION SIGNALS are provided, they shall be distinguishable from tho of auditory ALARM SIGNALS and their characteristics shall be disclod in the instructions for u. | The sound pressure level of ALARM SIGNALS HIGH PRIORITY: 60dB MEDIUM PRIORITY: 55dB LOW PRIORITY: 47dB | P |
6.3.4 * | Characteristics of verbal ALARM SIGNALS When applicable, the MANUFACTURER shall address in the RISK MANAGEMENT PROCESS the RISKS associated with verbal ALARM SIGNALS. | 若适用，制造者应在风险管理过程中写明文字报警信号的风险。 | NA |
6.4 * | Disclosure of delays | ||
6.4.1 * | ALARM SYSTEM delays If the sum of the maximum ALARM CONDITION DELAY plus the maximum ALARM SIGNAL GENERATION DELAY is greater than 10 s, then the statistics of each distribution or statistics of 冷画屏the distribution of the sum shall be disclod in the instructions for u. 《荷塘月色》课文If the sum of the mean ALARM CONDITION DELAY plus the mean ALARM SIGNAL GENERATION DELAY is greater than 5 s, then each delay or their sum shall be disclod in the instructions for u. | the maximum ALARM CONDITION DELAY: the maximum ALARM SIGNAL GENERATION DELAY <10s | P |
6.4.2 * | Delays to or from a DISTRIBUTED ALARM SYSTEM If an ALARM SYSTEM is provided with a means to nd or receive ALARM CONDITIONS in a DISTRIBUTED ALARM SYSTEM: a) the delay time from the ont of the ALARM CONDITION to the point that the reprentation of the ALARM CONDITION leaves the SIGNAL INPUT/OUTPUT PART shall be disclod in the instructions for u; and b) the maximum remote ALARM SIGNAL GENERATION DELAY or the time to determine the generation of the TECHNICAL ALARM CONDITION (e 6.11.2.2) shall be disclod in the instructions for u. | 在一个分布式报警系统中如果提供方法发送或接收报警条件，则： a)从警报条件开始到表示报警条件离开信号输入-输出部件的那个点的延时，应在说明书中指出。 b)远程警报信号发生的最大延时，或决定技术警报条件的时间(参见6.11.2.2)应在说明书中指出。 | NA |
For a DISTRIBUTED ALARM SYSTEM, the ALARM SIGNAL GENERATION DELAY may be measured and reported, as applicable: c) from the ont of the ALARM CONDITION; d) from the time of the local ALARM SIGNAL generation; e) to or from the point that the prentation of the ALARM CONDITION leaves the SIGNAL INPUT/OUTPUT PART; f) to or from the point that the prentation of the ALARM CONDITION arrives at the SIGNAL INPUT/OUTPUT PART; or g) to the time of the remote ALARM SIGNAL generation. Compliance is checked by functional testing and inspection of the instructions for u. | 作为一个分布式的报警系统，其报警信号的延迟可以被测量，并报告 c)从警报条件的开始; d)从本地方报警信号产生时; e)出现警报条件的这个点到/从信号输入-输出零件; f)到/从点警报条件的介绍到达信号输入-输出零件; 或者 g)对远程警报信号世代的时期。 Compliance由功能使用说明书的测试和检查检查。 | NA | |
6.5 | ALARM PRESETS | ||
6.5.1 * | General requirements Any ALARM PRESET that us mechanical adjustment is exempt from the requirements of 6.5. Example 1 A switch that indicates the value of a t point. An ALARM SYSTEM is exempt from the requirements of 6.5 if in NORMAL USE it: a) can only retain current ALARM SETTINGS, and b) does not otherwi provide ALARM PRESETS, and c) displays each adjustable ALARM SETTINGS continuously. | 所有用机械调整的方法（例如一个开关指示一个设定点的值）进行报警预设的无需满足该项要求规定。 报警系统在正常使用时也无需满足该要求： a)只保留当前警报设置，和 b)不提供报警预设，和 c)连续地显示每个可调的报警设置。 | |
priority, or they shall be determined from information available to the ALARM SYSTEM concerning the current PATIENT. ALARM PRESETS may include other parameters that affect or modify performance of the ALARM SYSTEM. The instructions for u shall contain a warning statement to the effect that a HAZARD can exist if different ALARM PRESETS are ud for the same or similar equipment in any single area, | Anaeston5000 Anaesthesia Machine Operation Manua from 6-12优先权或者根据当前病人的情况决定优先级，报警预设可以包括其他参数，这些参数影响或改变报警系统的性能。 使用说明书应包含警告声明，大意是若报警预设被单方面用在相同或相似的仪器上，则存在危险 | P | |
6.5.2 | MANUFACTURER-configured ALARM PRESETS An ALARM SYSTEM shall be provided with at least one MANUFACTURER-configured ALARM PRESET. The ALARM LIMITS and a summary of any algorithms ud in any MANUFACTURER-configured ALARM PRESETS shall be disclod in the instructions for u. | 报警系统应提供至少一种制造商配置的报警预设定.使用说明书中应指出报警限制和关于制造商配置的报警预设使用算法的一个概述 | |
6.5.3 * | RESPONSIBLE ORGANIZATION- and OPERATOR-configured ALARM PRESETS | ||
6.5.3.1 | ALARM SYSTEMS with one ALARM PRESET If the ALARM SYSTEM can store only one ALARM PRESET: a) means shall be provided to prevent the OPERATOR from saving changes to this ALARM PRESET. Saving changes to this ALARM PRESET shall be restricted to the RESPONSIBLE ORGANIZATION (e 6.7); and b) means shall be provided to the RESPONSIBLE ORGANIZATION to restore the ALARM PRESET to its MANUFACTURER-configured state. | 如果报警系统只能存放一种预设定： a)应提供方法,防止操作员对这报警预设进行改动后被保存下来. b)提供方法使可靠的结构将报警预设复位到制造商配置的状态。 | NA |
6.5.3.2 | ALARM SYSTEMS with more than one ALARM PRESET If the ALARM SYSTEM provides means to store or activate one or more RESPONSIBLE ORGANIZATION-configured or OPERATOR-configured ALARM PRESETS in addition to any MANUFACTURER-configured ALARM PRESETS: a) means shall be provided for the OPERATOR to choo between the available ALARM PRESETS; | 如果报警系统提供方法存放或激活一个或多个可靠的由制造商配置或操作员配置的报警预设定. a)应提供方法使得操作员能选择合适的报警预设定 | |
b) means shall be provided for the OPERATOR to readily identify which ALARM PRESET is in u; | b) 提供方法让操作员能够容易识别哪种报警预设定正被使用; | ||
c) the instructions for u shall contain a warning statement to the effect that the OPERATOR should check that the current ALARM PRESET is appropriate prior to u on each PATIENT; | Anaeston5000 Anaesthesia Machine Operation Manua from 6-12 | P | |
d) the means for configuration and storage of ALARM PRESETS shall be disclod in the ACCOMPANYING DOCUMENTS; | d)构造和存储报警预设定的方法应在随机文件中指出. | ||
e) means shall be provided to prevent the OPERATOR from saving changes to any RESPONSIBLE ORGANIZATION-configured or MANUFACTURER-configured ALARM PRESET. Saving changes to any RESPONSIBLE ORGANIZATION-configured or MANUFACTURER-configured ALARM PRESET shall be restricted to the RESPONSIBLE ORGANIZATION (e 6.7); | 提供方法防止操作员保存改动到任何可靠的机构或制造商配置的报警预设定.或手段将提供防止操作员对其中任一的挽救变动 | ||
f) means shall be provided to prevent an individual OPERATOR from saving changes to ALARM PRESETS that were stored by any other OPERATOR (e 6.7); and g) the ALARM SYSTEM may store the current ALARM SETTINGS for later recall.宁济 | 提供方法,防止单一操作员保存对其他操作员报警德预设定的改动(参见6.7); 并且 g)报警系统可以保存当前的设定值,以便接下来能返回到此。 | ||
6.5.4 | DEFAULT ALARM PRESET | ||
6.5.4.1 | General requirements If the DEFAULT ALARM PRESET can be t to values that differ from the MANUFACTURER-configured values: a) means shall be provided to prevent any OPERATOR from storing changes to the DEFAULT ALARM PRESET. Storing changes to the DEFAULT ALARM PRESET shall be restricted to the RESPONSIBLE ORGANIZATION (e 6.7); and | Done | P |
b) means shall be provided to the RESPONSIBLE ORGANIZATION to restore the DEFAULT ALARM PRESET to its MANUFACTURER-configured values.草原歌曲大全 | Done | P | |
6.5.4.2 * | Selection of DEFAULT ALARM PRESET Whenever: a) the OPERATOR switches the ALARM SYSTEM on after an interval specified by the MANUFACTURER as being longer than might be considered unintentional; or b) the ALARM SYSTEM is enabled; or c) the OPERATOR indicates to the ALARM SYSTEM, preferably through an “admit new PATIENT” function, that a different PATIENT has been connected to the ALARM SYSTEM; or d) power is restored to the ALARM SYSTEM after it has experienced a total loss of power (SUPPLY MAINS and/or INTERNAL ELECTRICAL POWER SOURCE) beyond the time that it automatically restores the ALARM SETTINGS (e 6.5.5); | 报警预设定默认值的选择 任何时候 ： a)操作员在指定的间隔时间以后打开报警系统 ,该间隔时间是由制造商定义的,比无意识长.或 b)报警系统开着; 或者 c)操作员指示报警系统,最好是通过“新病人许可”功能的.该功能显示非同一名病人被连接入报警系统.或 d)经历一段时间完全断电后,恢复电源供应,该短时间超过自动储存报警设定需要的时间 (参见6.5.5); | |
then: e) the DEFAULT ALARM PRESET shall be automatically lected; or | 然后： e)报警预设定的默认值能自动被选定 或者 | ||
f) means shall be provided for the OPERATOR to lect an ALARM PRESET; or | f) 提供方法由操作员进行选择报警预设定 或者 | ||
g) means may be provided for the OPERATOR to lect the retained ALARM SETTINGS from the previous u. | g) 提供方法使操作员能够选择先前使用时保存的报警设定值。 | ||
The MANUFACTURER shall disclo in the instructions for u an estimate of the duration of the power interruption after which the ALARM SYSTEM is unable to restore the ALARM SETTINGS and the subquent behaviour of the ALARM SYSTEM. | 制造商在使用说明书中应指出断电持续时间,在该段时间以后,报警系统将不能保存报警设置值以及随后的行为. | ||
6.5.5 * | Interruptions of less than or equal to 30 s When power is lost for less than or equal to 30 s, the ALARM SETTINGS prior to the power loss shall be restored automatically. This behaviour shall be described in the instructions for u. | 当断电时间小于或等于30 s，在断电前的报警设置应能自动地恢复。 在使用说明书要对这进行描述 | |
6.6 | ALARM LIMIT | ||
6.6.1 | General requirements An ALARM LIMIT may be non-adjustable, a simple OPERATOR-adjustable tpoint or an algorithmically determined criterion. Compliance is checked by inspection. | Done | P |
6.6.2 * | Adjustable ALARM LIMIT | ||
6.6.2.1 | Indication of OPERATOR-adjustable ALARM LIMIT If an OPERATOR-adjustable ALARM LIMIT is provided, the ALARM LIMIT shall be indicated continuously or by OPERATOR action. | 如果提供一个操作员可调的警报极限，则该极限应能连续显示或由操作员决定。 | NA |
6.6.2.2 * | Indication of automatically t ALARM LIMIT An ALARM LIMIT may be automatically t, with or without OPERATOR action, to ranges or percentages above or below: a) the value of a monitored variable at a point in time; or b) recent values of a monitored variable; or c) a current control tting. | 警报极限可以自动设定，有或没有操作员操作，在范围或百分比上下： a)在一个时间点的被监测到的变量值 或者 b)最近监测到的变量值; 或者 c)一个当前控制的设置。 | NA |
If such an automatically t ALARM LIMIT is provided, its value shall be indicated continuously or by OPERATOR action, unless: d) this ALARM LIMIT is obvious from the associated control tting and the behaviour is described in the instructions for u; or e) the ALARM LIMIT is determined by an INTELLIGENT ALARM SYSTEM (e 6.2). | 如果提供这样一个自动设定的警报极限，其值应连续显示,或通过操作员操作显示,除非： d)这个警报极限明显是伴生于控制的设置，且在使用说明书中描述过的; 或者 e)该报警极限由一个智能报警系统来决定. (参见6.2)。 | NA | |
6.6.2.3 * | ALARM SYSTEM operation during adjustment of ALARM LIMIT or ALARM PRESET During adjustment of any ALARM LIMIT or OPERATOR-adjustable ALARM PRESET, the ALARM SYSTEM shall continue to operate normally. Compliance is checked by functional testing. | Done 在任何警报极限或操作员可调的报警预设定的调整期间，警报系统应能继续正常运行. | P |
6.7 * | ALARM SYSTEM curity Means of restricting access to changing or to the storage of changes shall be described in the technical description (e 6.3.3.1, 6.5.3.1, 6.5.3.2, 6.5.4.1, 6.8.2 b) and c), 6.8.3 b), 6.8.5, and 6.10): | 技术描述中应提供方法限制改动或保存改动 | |
6.8 * | ALARM SIGNAL inactivation states | ||
6.8.1 * | 6.8.1 * General Means shall be provided for the OPERATOR to inactivate the auditory, or the visual and auditory, generation of ALARM SIGNALS. Means may be provided to inactivate the generation of other ALARM SIGNALS. Inactivation may apply to an individual ALARM CONDITION, to a group of ALARM CONDITIONS, to the entire ALARM SYSTEM or to any part of a DISTRIBUTED ALARM SYSTEM. The inactivation of the generation of ALARM SIGNALS may be indefinite (i.e., ALARM OFF or AUDIO OFF) or timed (i.e., ALARM PAUSED or AUDIO PAUSED). Flashing visual ALARM SIGNALS specified in 6.3.2.2 may be inactivated by AUDIO PAUSED or AUDIO OFF. | The inactivation of the generation of ALARM SIGNALS is indefinite ( AUDIO OFF) Alarming silence key | P |
If ALARM SIGNAL inactivation applies to an individual ALARM CONDITION or a group of ALARM CONDITIONS, the generation of ALARM SIGNALS from other ALARM CONDITIONS shall be unaffected. | NA | ||
6.8.2 * | 6.8.2 * REMINDER SIGNALS | ||
The ALARM SYSTEM may be provided with a REMINDER SIGNAL. If an ALARM SYSTEM is provided with a REMINDER SIGNAL: a) the nature of the REMINDER SIGNAL and the intervals between REMINDER SIGNALS shall be disclod in the instructions for u; | 报警系统可带有提示信号。 如果报警系统带有提示信号： a)提示信号和在提示信号之间的间隔时间的性质应在使用说明书中指出; | ||
b) the ALARM SYSTEM shall include a means, accessible only to the RESPONSIBLE ORGANIZATION (e 6.7): – to enable and disable the REMINDER SIGNAL; and – to configure the maximum REMINDER SIGNAL interval, if adjustment is provided. | 报警系统应提供方法,只针对可靠机体 (参见6.7) ：启动或关闭提示信号, 并且如果是可调的,则应设置提示信号最大间隔时间。 | ||
c) the ALARM SYSTEM may include a means, accessible only to the RESPONSIBLE ORGANIZATION (e 6.7): – to permit designated (e 6.7) OPERATORS to enable and disable the REMINDER SIGNAL; – to permit any OPERATOR to enable and disable the REMINDER SIGNAL. | c) 报警系统可提供方法 ：允许指定操作者启动或关闭提示信号(参见6.7) –;允许任何操作员启动或关闭提示信号 | ||
6.8.3 * | Global indefinite ALARM SIGNAL inactivation states If deemed acceptable by RISK ASSESSMENT with regard to the intended environment of u of the ALARM SYSTEM, a global ALARM OFF or AUDIO OFF may be provided. If an ALARM SYSTEM is provided with a global ALARM OFF or AUDIO OFF, the ALARM SYSTEM shall be provided with: a) a REMINDER SIGNAL; and b) means to configure (enable or disable) any global ALARM OFF or AUDIO OFF. Such means shall be restricted to the RESPONSIBLE ORGANIZATION and shall prevent the clinical OPERATOR from changing the configuration in NORMAL USE (e 6.7). | 如果视为可接受由风险评估关于对的用途的意欲的环境the也许提供报警系统、一个全球性警报或音频。 如果报警系统是与一个全球性警报或音频的provided，报警系统将供给： a)提示信号; 并且 b)手段配置(使能或功能失效)任何全球性警报或音频。 这样意味 shall限于负责任的组织，并且防止临床从改变配置的OPERATOR在正常使用(参见6.7)。 | NA |
6.8.4 * | Termination of inactivation of ALARM SIGNALS Means shall be provided for the OPERATOR to terminate any ALARM SIGNAL inactivation state. An ALARM SIGNAL inactivation state may terminate automatically, when the ALARM CONDITION that was generating an ALARM SIGNAL when this state was entered, ceas. When an ALARM SIGNAL inactivation state is terminated, the ALARM SIGNALS of any current ALARM CONDITION shall cau the re-generation of ALARM SIGNALS. | 当关闭报警信号时,应提供方法使得下次报警条件发生时,报警信号能再次被触发 | |
6.8.5 * | Indication and access The ALARM SIGNAL inactivation states AUDIO PAUSED, ALARM PAUSED, AUDIO OFF, and ALARM OFF shall be visually indicated (marked) with the appropriate symbol referenced in Table 5. This indication shall be perceived correctly (be legible) at a distance of 1 m from the equipment or part of the equipment or from the OPERATOR’S POSITION. The means of control ud to enter one of the ALARM SIGNAL inactivation states may be marked with a symbol referenced in Table 5. If a symbol that is referenced in Table 5 is ud, it shall initiate the associated ALARM SIGNAL inactivation state. | NA | |
The duration of AUDIO PAUSED or ALARM PAUSED, if provided, shall be disclod in the instructions for u. If the AUDIO PAUSED or ALARM PAUSED interval is OPERATOR adjustable, means to adjust the maximum interval shall only be provided to the RESPONSIBLE ORGANIZATION (e 6.7) and means may be provided for the OPERATOR to adjust the interval up to the maximum interval. | |||
6.9 * | ALARM RESET The means of ALARM RESET may be marked with symbol IEC 60417-5309 (DB-2002-10) (e symbol 2 of Table C.1) or marking 5 of Table C.2. | NA | |
6.10 * | NON-LATCHING and LATCHING ALARM SIGNALS A NON-LATCHING ALARM SIGNAL shall automatically cea being generated when its triggering event no longer exists. A LATCHING ALARM SIGNAL shall continue to be generated after its triggering event no longer exists. An ALARM SYSTEM 怎么追水瓶女may consist of a mixture of LATCHING ALARM SIGNALS and NON-LATCHING ALARM SIGNALS. NOTE 1 An INTELLIGENT ALARM SYSTEM can decrea the priority of a LATCHING ALARM SIGNAL. In the ca of an ALARM CONDITION of short duration, a MEDIUM PRIORITY auditory ALARM SIGNAL shall complete at least one full BURST and a HIGH PRIORITY auditory ALARM SIGNAL shall complete one half of one full BURST, unless inactivated by the OPERATOR. | NON-LATCHING ALARM SIGNALS 当报警条件解除,则该非锁定报警信号应也停止. 而当报警条件解除,其锁定报警信号依然继续存在. 一个报警系统可由锁定和非锁定两种报警信号组成. | |
Auditory ALARM SIGNALS shall cea being generated when: a) an OPERATOR has initiated the AUDIO PAUSED, AUDIO OFF, ALARM PAUSED or ALARM OFF state; or b) an OPERATOR has ALARM RE SET the ALARM CONDITION. Means shall be provided to prevent the OPERATORS from lecting between LATCHING and NONLATCHING ALARM SIGNALS. The lection between LATCHING and NON-LATCHING ALARM SIGNALS shall be restricted to the RESPONSIBLE ORGANIZATION (e 6.7). | Auditory ALARM SIGNALS shall cea being generated when OPERATOR has ALARM RE SET the ALARM CONDITION. | P | |
6.11 * | DISTRIBUTED ALARM SYSTEM | ||
6.11.1 * | Existence of DISTRIBUTED ALARM SYSTEM The details necessary for the safe u of a DISTRIBUTED ALARM SYSTEM shall be disclod in the technical description. A DISTRIBUTED ALARM SYSTEM is a permitted form of an ALARM SYSTEM. An ALARM SYSTEM is permitted to nd or receive data, including the indication of INFORMATION SIGNALS and ALARM CONDITIONS, to or from other parts of a DISTRIBUTED ALARM SYSTEM. A DISTRIBUTED ALARM SYSTEM is permitted to be located outside of the PATIENT ENVIRONMENT. Part(s) of a DISTRIBUTED ALARM SYSTEM are permitted to be located outside of the PATIENT ENVIRONMENT. Data are permitted to be transmitted between different parts of a DISTRIBUTED ALARM SYSTEM by wire, by telemetry or by other means. | 技术说明书中应详细指出分布式报警系统的安全使用. 一个分布式的报警系统是警报的一个被允许的形式SYSTEM. 报警系统允许以一个分布式报警系统 的形式存在. 报警系统允许接收或发送数据，包括信息,信号和警报条件，从分布式报警系统的这部分到那部分. 分布式报警系统被允许定位在病人环境之外.分布式报警系统的某个部分也rt被允许位于病人环境之外. 各部分间允许数据传输. 通过电线或遥控或其他方法 | NA |
6.11.2 | Requirements for DISTRIBUTED ALARM SYSTEM communication of ALARM CONDITIONS | ||
6.11.2.1 | Source and identification of ALARM CONDITIONS In a DISTRIBUTED ALARM SYSTEM, means shall be provided to identify the source of the remote ALARM CONDITION at every site of ALARM SIGNAL generation. | 在一个分布式的报警系统中，应提供能辨认报警信号产生处的远程报警条件来源的方法. | NA |
6.11.2.2 * | Failure of remote communication of ALARM CONDITIONS A DISTRIBUTED ALARM SYSTEM shall be so designed that a communications failure or failure in any remote part of the DISTRIBUTED ALARM SYSTEM: a) shall not adverly affect any part of the DISTRIBUTED ALARM SYSTEM other than the loss of the distributed functionality; and b) shall create a TECHNICAL ALARM CONDITION in any affected parts of the DISTRIBUTED ALARM SYSTEM that can generate ALARM SIGNALS, or the DISTRIBUTED ALARM SYSTEM shall be marked with a warning to the effect that it shall not be relied upon for receipt of ALARM SIGNALS. | 远距离警报条件沟通失败 分布式的报警系统在设计时应考虑到各个远距离部件沟通故障时: a)不会反过来影响分布式报警系统的任何其他部分 b)在分布式警报的所有受影响的部分将创造一个技术警报条件,该条件能引起报警信号,或给出一条警示说该系统收到报警信号不可靠 | NA |
6.12 * | ALARM CONDITION logging If an ALARM SYSTEM is provided with a log of the occurrence of ALARM CONDITIONS: a) the ALARM SYSTEM shall log the occurrence and identity of HIGH PRIORITY ALARM CONDITIONS; b) the MANUFACTURER shall disclo in the instructions for u whether the log is maintained when the ALARM SYSTEM is powered down; and c) the MANUFACTURER shall disclo in the instructions for u what happens to the contents of the log after the ALARM SYSTEM has experienced a total loss of power (SUPPLY MAINS and/or INTERNAL ELECTRICAL POWER SOURCE) for a finite duration. | 警报条件的记录 如果系统带有警报条件发生的记录： a)该报警系统要记录高优先级报警条件的生成和有限级别 b)制造商在使用说明书中应指出,当电压下降时该记录是否能够维持. c)制造商在使用说明书中应指出,当完全断电(网电源或内部电源)一定时间,该记录的内容会发生什么变化 | |
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