[ { "clause_number": "5.1", "sub_id": "5.1-a", "applicable": "待评估", "compliance": "待确定", "description": "自动判定输出结构不完整，已转为待人工评估：ValidationError: 1 validation error for BatchVerdicts\n Input should be an object [type=model_type, input_value=[{'clause_number': '5.1',...}], 'confidence': 0.85}], input_type=list]\n For further information visit https://errors.pydantic.dev/2.13/v/model_type", "references": [], "confidence": 0.0, "revised_by": "text", "triage_reason": "", "standard_code": "YY_0833-2020", "checkpoint_id": "YY_0833-2020#5.1#cp0" }, { "clause_number": "5.1", "sub_id": "5.1-b", "applicable": "待评估", "compliance": "待确定", "description": "自动判定输出结构不完整，已转为待人工评估：ValidationError: 1 validation error for BatchVerdicts\n Input should be an object [type=model_type, input_value=[{'clause_number': '5.1',...}], 'confidence': 0.85}], input_type=list]\n For further information visit https://errors.pydantic.dev/2.13/v/model_type", "references": [], "confidence": 0.0, "revised_by": "text", "triage_reason": "", "standard_code": "YY_0833-2020", "checkpoint_id": "YY_0833-2020#5.1#cp1" }, { "clause_number": "5.1", "sub_id": "5.1-c", "applicable": "待评估", "compliance": "待确定", "description": "自动判定输出结构不完整，已转为待人工评估：ValidationError: 1 validation error for BatchVerdicts\n Input should be an object [type=model_type, input_value=[{'clause_number': '5.1',...}], 'confidence': 0.85}], input_type=list]\n For further information visit https://errors.pydantic.dev/2.13/v/model_type", "references": [], "confidence": 0.0, "revised_by": "text", "triage_reason": "", "standard_code": "YY_0833-2020", "checkpoint_id": "YY_0833-2020#5.1#cp2" }, { "clause_number": "5.1", "sub_id": "5.1-d", "applicable": "待评估", "compliance": "待确定", "description": "自动判定输出结构不完整，已转为待人工评估：ValidationError: 1 validation error for BatchVerdicts\n Input should be an object [type=model_type, input_value=[{'clause_number': '5.1',...}], 'confidence': 0.85}], input_type=list]\n For further information visit https://errors.pydantic.dev/2.13/v/model_type", "references": [], "confidence": 0.0, "revised_by": "text", "triage_reason": "", "standard_code": "YY_0833-2020", "checkpoint_id": "YY_0833-2020#5.1#cp3" }, { "clause_number": "5.1", "sub_id": "5.1-e", "applicable": "待评估", "compliance": "待确定", "description": "自动判定输出结构不完整，已转为待人工评估：ValidationError: 1 validation error for BatchVerdicts\n Input should be an object [type=model_type, input_value=[{'clause_number': '5.1',...}], 'confidence': 0.85}], input_type=list]\n For further information visit https://errors.pydantic.dev/2.13/v/model_type", "references": [], "confidence": 0.0, "revised_by": "text", "triage_reason": "", "standard_code": "YY_0833-2020", "checkpoint_id": "YY_0833-2020#5.1#cp4" }, { "clause_number": "5.1", "sub_id": "5.1-f", "applicable": "待评估", "compliance": "待确定", "description": "自动判定输出结构不完整，已转为待人工评估：ValidationError: 1 validation error for BatchVerdicts\n Input should be an object [type=model_type, input_value=[{'clause_number': '5.1',...}], 'confidence': 0.85}], input_type=list]\n For further information visit https://errors.pydantic.dev/2.13/v/model_type", "references": [], "confidence": 0.0, "revised_by": "text", "triage_reason": "", "standard_code": "YY_0833-2020", "checkpoint_id": "YY_0833-2020#5.1#cp5" }, { "clause_number": "5.1", "sub_id": "5.1-g", "applicable": "待评估", "compliance": "待确定", "description": "自动判定输出结构不完整，已转为待人工评估：ValidationError: 1 validation error for BatchVerdicts\n Input should be an object [type=model_type, input_value=[{'clause_number': '5.1',...}], 'confidence': 0.85}], input_type=list]\n For further information visit https://errors.pydantic.dev/2.13/v/model_type", "references": [], "confidence": 0.0, "revised_by": "text", "triage_reason": "", "standard_code": "YY_0833-2020", "checkpoint_id": "YY_0833-2020#5.1#cp6" }, { "clause_number": "5.1", "sub_id": "5.1-h", "applicable": "待评估", "compliance": "待确定", "description": "自动判定输出结构不完整，已转为待人工评估：ValidationError: 1 validation error for BatchVerdicts\n Input should be an object [type=model_type, input_value=[{'clause_number': '5.1',...}], 'confidence': 0.85}], input_type=list]\n For further information visit https://errors.pydantic.dev/2.13/v/model_type", "references": [], "confidence": 0.0, "revised_by": "text", "triage_reason": "", "standard_code": "YY_0833-2020", "checkpoint_id": "YY_0833-2020#5.1#cp7" }, { "clause_number": "5.10", "sub_id": "5.10-a", "applicable": "适用", "compliance": "通过", "description": "文档在“第4章 安装与调试”中明确引用了GB 9706.1-2020标准，并指出设备连接及安全性需遵照该标准要求，满足条款对引用该标准的要求。", "references": [ { "page": 26, "section": "4.1/4.2 安装与调试", "section_title": null, "quote": "GB9706.1-2020《医用电气设备第1部分：基本安全和基本性能的通用要求》", "document_id": "doc_rev_ab9be6a0304d", "bbox": [ 303.6000061035156, 226.49069213867188, 464.3999938964844, 238.49069213867188 ], "verified": true, "verification_method": "exact", "similarity": 1.0, "context_before": "字设备必须通过指定GB标准（比如：GB4943.1-2011《信息技术设备安全第1部分：通用要求》和", "context_after": "）认证，且所有设备都应遵照GB9706.1-2020《医用电气设备第1部分：基本安全和基本性能的通用", "supports_which": "both", "source_kind": "text", "figure_label": null, "locator_kind": "pdf", "locator_json": { "kind": "pdf", "page": 26, "bbox": [ 303.6000061035156, 226.49069213867188, 464.3999938964844, 238.49069213867188 ] }, "field_id": null, "field_path": null, "content_control_tag": null, "source_version": null, "char_start": null, "char_end": null } ], "confidence": 0.95, "revised_by": "text", "triage_reason": "", "standard_code": "YY_0833-2020", "checkpoint_id": "YY_0833-2020#5.10#cp0" }, { "clause_number": "5.11", "sub_id": "5.11-a", "applicable": "适用", "compliance": "通过", "description": "条款要求引用EMC标准。文档第1.7节及第8章明确声明设备符合YY9706.102-2021电磁兼容标准。YY 0505为已废止的旧版标准，已被YY 9706.102替代，文档引用现行有效标准实质满足条款关于引用EMC标准的要求。", "references": [ { "page": 14, "section": "1.7", "section_title": null, "quote": "空气波压力治疗系统符合YY9706.102-2021标准电磁兼容有关要求。", "document_id": "doc_rev_ab9be6a0304d", "bbox": [ 75.00779846191406, 603.6423175048828, 447.6655908203125, 617.9546179199218 ], "verified": true, "verification_method": "exact", "similarity": 1.0, "context_before": "·", "context_after": "", "supports_which": "both", "source_kind": "text", "figure_label": null, "locator_kind": "pdf", "locator_json": { "kind": "pdf", "page": 14, "bbox": [ 75.00779846191406, 603.6423175048828, 447.6655908203125, 617.9546179199218 ] }, "field_id": null, "field_path": null, "content_control_tag": null, "source_version": null, "char_start": null, "char_end": null }, { "page": 59, "section": "8", "section_title": null, "quote": "AirPro-800/AirPro-600 空气波压力治疗系统符合YY9706.102标准电磁兼容有关要求。", "document_id": "doc_rev_ab9be6a0304d", "bbox": [ 75.0, 178.49069213867188, 456.5986022949219, 462.89068603515625 ], "verified": true, "verification_method": "exact", "similarity": 1.0, "context_before": "·", "context_after": "。它不会对其他电磁设备产生不利的影响，也不受其他已知电子设备的影响。一旦本治疗系统与其他电子设备（例", "supports_which": "both", "source_kind": "text", "figure_label": null, "locator_kind": "pdf", "locator_json": { "kind": "pdf", "page": 59, "bbox": [ 75.0, 178.49069213867188, 456.5986022949219, 462.89068603515625 ] }, "field_id": null, "field_path": null, "content_control_tag": null, "source_version": null, "char_start": null, "char_end": null } ], "confidence": 0.9, "revised_by": "text", "triage_reason": "", "standard_code": "YY_0833-2020", "checkpoint_id": "YY_0833-2020#5.11#cp0" }, { "clause_number": "5.12", "sub_id": "5.12-a", "applicable": "不适用", "compliance": null, "description": "条款规定的是设备环境试验的执行要求（试验方法/程序），属于制造商设计验证或质量管理体系文件范畴。待审文档为产品使用说明书，不承担记录或执行此类检验步骤的义务。", "references": [], "confidence": 0.95, "revised_by": "text", "triage_reason": "", "standard_code": "YY_0833-2020", "checkpoint_id": "YY_0833-2020#5.12#cp0" }, { "clause_number": "5.2", "sub_id": "5.2-a", "applicable": "适用", "compliance": "通过", "description": "文档3.2.2节明确说明“气囊内的极限压力正压不超过300mmHg(40kPa)”，满足最大压强限值要求。", "references": [ { "page": 22, "section": "3.2.2", "section_title": null, "quote": "气囊内的极限压力正压不超过300mmHg(40kPa)", "document_id": "doc_rev_ab9be6a0304d", "bbox": [ 284.3999938964844, 135.29067993164062, 529.2000122070312, 147.29067993164062 ], "verified": true, "verification_method": "exact", "similarity": 1.0, "context_before": "疗压力因治疗的部位不同而不同。下图为不同压力等级下不同部位的所产生的标准压强，误差为±20mmHg，", "context_after": "，且超过 22.5mmHg(3kPa)的持续时间不大于10min。", "supports_which": "both", "source_kind": "text", "figure_label": null, "locator_kind": "pdf", "locator_json": { "kind": "pdf", "page": 22, "bbox": [ 284.3999938964844, 135.29067993164062, 529.2000122070312, 147.29067993164062 ] }, "field_id": null, "field_path": null, "content_control_tag": null, "source_version": null, "char_start": null, "char_end": null } ], "confidence": 0.95, "revised_by": "text", "triage_reason": "", "standard_code": "YY_0833-2020", "checkpoint_id": "YY_0833-2020#5.2#cp0" }, { "clause_number": "5.2", "sub_id": "5.2-b", "applicable": "适用", "compliance": "通过", "description": "文档3.2.2节明确标注治疗压力误差为“±20mmHg”，该值在标准要求的±20%或±22.5mmHg（二者取大）范围内，满足误差限值要求。", "references": [ { "page": 22, "section": "3.2.2", "section_title": null, "quote": "误差为±20mmHg", "document_id": "doc_rev_ab9be6a0304d", "bbox": [ 187.55567932128906, 135.29067993164062, 272.03997802734375, 147.29067993164062 ], "verified": true, "verification_method": "exact", "similarity": 1.0, "context_before": "可调范围：分为四级，治疗压力因治疗的部位不同而不同。下图为不同压力等级下不同部位的所产生的标准压强，", "context_after": "，气囊内的极限压力正压不超过300mmHg(40kPa)，且超过 22.5mmHg(3kPa)的持续", "supports_which": "both", "source_kind": "text", "figure_label": null, "locator_kind": "pdf", "locator_json": { "kind": "pdf", "page": 22, "bbox": [ 187.55567932128906, 135.29067993164062, 272.03997802734375, 147.29067993164062 ] }, "field_id": null, "field_path": null, "content_control_tag": null, "source_version": null, "char_start": null, "char_end": null } ], "confidence": 0.9, "revised_by": "text", "triage_reason": "", "standard_code": "YY_0833-2020", "checkpoint_id": "YY_0833-2020#5.2#cp1" }, { "clause_number": "5.2", "sub_id": "5.2-c", "applicable": "适用", "compliance": "通过", "description": "文档3.2.2节明确规定“超过22.5mmHg(3kPa)的持续时间不大于10min”，与条款要求完全一致。", "references": [ { "page": 22, "section": "3.2.2", "section_title": null, "quote": "超过 22.5mmHg(3kPa)的持续时间不大于10min", "document_id": "doc_rev_ab9be6a0304d", "bbox": [ 50.60049896240235, 109.44700317382812, 541.7229888916016, 172.5895050048828 ], "verified": true, "verification_method": "exact", "similarity": 1.0, "context_before": "的所产生的标准压强，误差为±20mmHg，气囊内的极限压力正压不超过300mmHg(40kPa)，且", "context_after": "n。", "supports_which": "both", "source_kind": "text", "figure_label": null, "locator_kind": "pdf", "locator_json": { "kind": "pdf", "page": 22, "bbox": [ 50.60049896240235, 109.44700317382812, 541.7229888916016, 172.5895050048828 ] }, "field_id": null, "field_path": null, "content_control_tag": null, "source_version": null, "char_start": null, "char_end": null } ], "confidence": 0.95, "revised_by": "text", "triage_reason": "", "standard_code": "YY_0833-2020", "checkpoint_id": "YY_0833-2020#5.2#cp2" }, { "clause_number": "5.2", "sub_id": "5.2-d", "applicable": "适用", "compliance": "通过", "description": "文档操作界面及参数设置章节均使用mmHg作为压强单位（如治疗压力显示区标注“mmHg”），符合单位表示要求。", "references": [ { "page": 30, "section": null, "section_title": null, "quote": "mmHg", "document_id": "doc_rev_ab9be6a0304d", "bbox": [ 119.05999755859375, 110.2889031982422, 491.71778991699216, 334.23430969238285 ], "verified": true, "verification_method": "visual_exact", "similarity": 1.0, "context_before": "", "context_after": "mmHg", "supports_which": "both", "source_kind": "visual", "figure_label": "fig_p30_1", "locator_kind": "visual", "locator_json": { "kind": "visual", "figure_label": "fig_p30_1", "page": 30, "bbox": [ 119.05999755859375, 110.2889031982422, 491.71778991699216, 334.23430969238285 ] }, "field_id": null, "field_path": null, "content_control_tag": null, "source_version": null, "char_start": null, "char_end": null }, { "page": 21, "section": "3.2.1", "section_title": null, "quote": "可调节治疗压强，调节精度1mmHg", "document_id": "doc_rev_ab9be6a0304d", "bbox": [ 96.0, 286.49066162109375, 273.0, 298.49066162109375 ], "verified": true, "verification_method": "exact", "similarity": 1.0, "context_before": "", "context_after": "，支持快速调节；", "supports_which": "both", "source_kind": "text", "figure_label": null, "locator_kind": "pdf", "locator_json": { "kind": "pdf", "page": 21, "bbox": [ 96.0, 286.49066162109375, 273.0, 298.49066162109375 ] }, "field_id": null, "field_path": null, "content_control_tag": null, "source_version": null, "char_start": null, "char_end": null } ], "confidence": 0.9, "revised_by": "text", "triage_reason": "", "standard_code": "YY_0833-2020", "checkpoint_id": "YY_0833-2020#5.2#cp3" }, { "clause_number": "5.2", "sub_id": "5.2-e", "applicable": "适用", "compliance": "待确定", "description": "条款要求在使用说明书中说明多腔设备梯度压强的自动设定规则。文档第3.2.2节及第5.6.1节展示了梯度参数设置界面（含远端/近端压力值、等级选择等），并提及“通常仪器出厂时已经按默认参数设置好”，但全文未明确说明设备内部自动设定梯度压强的具体规则或逻辑，仅提供了用户手动调节梯度参数的操作指引。原判定依赖的引用经回验失败，且无其他明确证据覆盖“自动设定规则”的说明要求，故保守判定为待确定。", "references": [], "confidence": 0.8, "revised_by": "text", "triage_reason": "", "standard_code": "YY_0833-2020", "checkpoint_id": "YY_0833-2020#5.2#cp4" }, { "clause_number": "5.2", "sub_id": "5.2-f", "applicable": "适用", "compliance": "通过", "description": "文档3.2.3节及5.5.4节说明了设备提供30种治疗方案，每种方案具备掉电记忆功能，并详细列出了不同方案的充气时序与压力等级变化规则，符合治疗过程中压强自动改变需在说明书中说明规则的要求。", "references": [ { "page": 22, "section": "3.2.3", "section_title": null, "quote": "系统提供30 种治疗方案，每种方案都具备掉电自动记忆性...充气治疗时序示意图", "document_id": "doc_rev_ab9be6a0304d", "bbox": [ 78.0, 505.0116882324219, 276.4786376953125, 517.01171875 ], "verified": true, "verification_method": "exact_multi", "similarity": 1.0, "context_before": "", "context_after": "性，下次开机无需重新设置即可启动治疗，充气治疗时序示意图（四腔套筒腿部气囊视图参考）如下：", "supports_which": "both", "source_kind": "text", "figure_label": null, "locator_kind": "pdf", "locator_json": { "kind": "pdf", "page": 22, "bbox": [ 78.0, 505.0116882324219, 276.4786376953125, 517.01171875 ] }, "field_id": null, "field_path": null, "content_control_tag": null, "source_version": null, "char_start": null, "char_end": null }, { "page": 41, "section": "5.5.4", "section_title": null, "quote": "系统提供30 种治疗方案...充气时序请参考3.2章节", "document_id": "doc_rev_ab9be6a0304d", "bbox": [ 78.0, 156.7716827392578, 204.0, 168.7716827392578 ], "verified": true, "verification_method": "exact_multi", "similarity": 1.0, "context_before": "系统提供30 种治疗方案，每种方案都具备掉电自动记忆性，下次开机无需重新设置即可启动治疗，", "context_after": "：", "supports_which": "both", "source_kind": "text", "figure_label": null, "locator_kind": "pdf", "locator_json": { "kind": "pdf", "page": 41, "bbox": [ 78.0, 156.7716827392578, 204.0, 168.7716827392578 ] }, "field_id": null, "field_path": null, "content_control_tag": null, "source_version": null, "char_start": null, "char_end": null } ], "confidence": 0.85, "revised_by": "text", "triage_reason": "", "standard_code": "YY_0833-2020", "checkpoint_id": "YY_0833-2020#5.2#cp5" }, { "clause_number": "5.2", "sub_id": "5.2-g", "applicable": "不适用", "compliance": null, "description": "条款针对治疗压强不可调节的设备要求使用仪表或标识指示压强。待审设备明确支持“可调节治疗压强，调节精度1mmHg”及“充气压强1～7级可调”，属于可调压设备，故本项不适用。", "references": [], "confidence": 0.95, "revised_by": "text", "triage_reason": "", "standard_code": "YY_0833-2020", "checkpoint_id": "YY_0833-2020#5.2#cp6" }, { "clause_number": "5.3", "sub_id": "5.3-a", "applicable": "适用", "compliance": "通过", "description": "文档3.2.4节明确说明了过压保护机制：当压强超过阈值维持1s以上时，仪器会触发过压提示并自动泄放气囊气体，从而限制压强。", "references": [ { "page": 24, "section": "3.2.4", "section_title": null, "quote": "当仪器超过压强阈值且维持1s以上，仪器应当有过压提示，并在过压提示时，泄放气囊中气体，以保证在单一故障状态下能够在气囊和连接管路中产生的最大压强，不大于设备最大治疗压强的1.2倍。", "document_id": "doc_rev_ab9be6a0304d", "bbox": [ 50.00519897460938, 276.98510803222655, 544.1041888427735, 340.9695098876953 ], "verified": true, "verification_method": "exact", "similarity": 1.0, "context_before": "", "context_after": "", "supports_which": "both", "source_kind": "text", "figure_label": null, "locator_kind": "pdf", "locator_json": { "kind": "pdf", "page": 24, "bbox": [ 50.00519897460938, 276.98510803222655, 544.1041888427735, 340.9695098876953 ] }, "field_id": null, "field_path": null, "content_control_tag": null, "source_version": null, "char_start": null, "char_end": null } ], "confidence": 0.95, "revised_by": "text", "triage_reason": "", "standard_code": "YY_0833-2020", "checkpoint_id": "YY_0833-2020#5.3#cp0" }, { "clause_number": "5.3", "sub_id": "5.3-b", "applicable": "适用", "compliance": "通过", "description": "文档3.2.4节明确承诺在单一故障状态下，气囊和管路中的最大压强不大于设备最大治疗压强的1.2倍，且触发保护的时间阈值为1s，完全覆盖条款要求。", "references": [ { "page": 24, "section": "3.2.4", "section_title": null, "quote": "当仪器超过压强阈值且维持1s以上，仪器应当有过压提示，并在过压提示时，泄放气囊中气体，以保证在单一故障状态下能够在气囊和连接管路中产生的最大压强，不大于设备最大治疗压强的1.2倍。", "document_id": "doc_rev_ab9be6a0304d", "bbox": [ 50.00519897460938, 276.98510803222655, 544.1041888427735, 340.9695098876953 ], "verified": true, "verification_method": "exact", "similarity": 1.0, "context_before": "", "context_after": "", "supports_which": "both", "source_kind": "text", "figure_label": null, "locator_kind": "pdf", "locator_json": { "kind": "pdf", "page": 24, "bbox": [ 50.00519897460938, 276.98510803222655, 544.1041888427735, 340.9695098876953 ] }, "field_id": null, "field_path": null, "content_control_tag": null, "source_version": null, "char_start": null, "char_end": null } ], "confidence": 0.95, "revised_by": "text", "triage_reason": "", "standard_code": "YY_0833-2020", "checkpoint_id": "YY_0833-2020#5.3#cp1" }, { "clause_number": "5.4", "sub_id": "5.4-a", "applicable": "适用", "compliance": "通过", "description": "文档3.2.1节明确说明“可启动、停止和暂停治疗，可随时中止治疗程序”；5.4.4节及治疗界面截图展示了暂停/停止控制功能，满足随时中止治疗的要求。", "references": [ { "page": 21, "section": "3.2.1", "section_title": null, "quote": "可启动、停止和暂停治疗，可随时中止治疗程序;", "document_id": "doc_rev_ab9be6a0304d", "bbox": [ 96.0, 333.2906799316406, 348.0, 345.2906799316406 ], "verified": true, "verification_method": "exact", "similarity": 1.0, "context_before": "", "context_after": "", "supports_which": "both", "source_kind": "text", "figure_label": null, "locator_kind": "pdf", "locator_json": { "kind": "pdf", "page": 21, "bbox": [ 96.0, 333.2906799316406, 348.0, 345.2906799316406 ] }, "field_id": null, "field_path": null, "content_control_tag": null, "source_version": null, "char_start": null, "char_end": null } ], "confidence": 0.95, "revised_by": "text", "triage_reason": "", "standard_code": "YY_0833-2020", "checkpoint_id": "YY_0833-2020#5.4#cp0" }, { "clause_number": "5.4", "sub_id": "5.4-b", "applicable": "适用", "compliance": "通过", "description": "条款要求停止开关独立于电源开关。文档5.4.6节说明关机需操作主机侧面的物理电源开关；而治疗的中止/暂停通过触摸屏UI界面按钮（见5.2.1及5.4.4节）实现。软硬件控制路径分离，满足独立性要求。", "references": [ { "page": 38, "section": "5.4.6", "section_title": null, "quote": "将主机侧面的电源开关打到OFF位置", "document_id": "doc_rev_ab9be6a0304d", "bbox": [ 100.44000244140625, 509.9410095214844, 290.5199890136719, 526.0809936523438 ], "verified": true, "verification_method": "exact", "similarity": 1.0, "context_before": "■", "context_after": "，液晶屏黑屏，这是已经切断电源仪器处于关机状态。", "supports_which": "both", "source_kind": "text", "figure_label": null, "locator_kind": "pdf", "locator_json": { "kind": "pdf", "page": 38, "bbox": [ 100.44000244140625, 509.9410095214844, 290.5199890136719, 526.0809936523438 ] }, "field_id": null, "field_path": null, "content_control_tag": null, "source_version": null, "char_start": null, "char_end": null }, { "page": 31, "section": "5.2.1", "section_title": null, "quote": "开始/停止治疗按键", "document_id": "doc_rev_ab9be6a0304d", "bbox": [ 108.0, 499.01165771484375, 210.0, 511.01165771484375 ], "verified": true, "verification_method": "exact", "similarity": 1.0, "context_before": "③ ", "context_after": "", "supports_which": "both", "source_kind": "text", "figure_label": null, "locator_kind": "pdf", "locator_json": { "kind": "pdf", "page": 31, "bbox": [ 108.0, 499.01165771484375, 210.0, 511.01165771484375 ] }, "field_id": null, "field_path": null, "content_control_tag": null, "source_version": null, "char_start": null, "char_end": null } ], "confidence": 0.9, "revised_by": "text", "triage_reason": "", "standard_code": "YY_0833-2020", "checkpoint_id": "YY_0833-2020#5.4#cp1" }, { "clause_number": "5.4", "sub_id": "5.4-c", "applicable": "适用", "compliance": "通过", "description": "条款要求治疗程序中止后设备应自动释放腔体内压力。文档3.2.7节“保护功能”明确规定“中断治疗时”仪器会自动卸压，直接满足该要求。", "references": [ { "page": 24, "section": "3.2.7", "section_title": null, "quote": "在下列情况下仪器会自动卸压：... b）中断治疗时；", "document_id": "doc_rev_ab9be6a0304d", "bbox": [ 78.0, 528.4116821289062, 210.0, 540.4116821289062 ], "verified": true, "verification_method": "exact_multi", "similarity": 1.0, "context_before": "", "context_after": "", "supports_which": "both", "source_kind": "text", "figure_label": null, "locator_kind": "pdf", "locator_json": { "kind": "pdf", "page": 24, "bbox": [ 78.0, 528.4116821289062, 210.0, 540.4116821289062 ] }, "field_id": null, "field_path": null, "content_control_tag": null, "source_version": null, "char_start": null, "char_end": null } ], "confidence": 0.95, "revised_by": "text", "triage_reason": "", "standard_code": "YY_0833-2020", "checkpoint_id": "YY_0833-2020#5.4#cp2" }, { "clause_number": "5.5", "sub_id": "5.5-a", "applicable": "待评估", "compliance": "待确定", "description": "自动判定输出结构不完整，已转为待人工评估：ValidationError: 1 validation error for BatchVerdicts\n Input should be an object [type=model_type, input_value=[{'clause_number': '5.5',...}], 'confidence': 0.95}], input_type=list]\n For further information visit https://errors.pydantic.dev/2.13/v/model_type", "references": [], "confidence": 0.0, "revised_by": "text", "triage_reason": "", "standard_code": "YY_0833-2020", "checkpoint_id": "YY_0833-2020#5.5#cp0" }, { "clause_number": "5.5", "sub_id": "5.5-b", "applicable": "待评估", "compliance": "待确定", "description": "自动判定输出结构不完整，已转为待人工评估：ValidationError: 1 validation error for BatchVerdicts\n Input should be an object [type=model_type, input_value=[{'clause_number': '5.5',...}], 'confidence': 0.95}], input_type=list]\n For further information visit https://errors.pydantic.dev/2.13/v/model_type", "references": [], "confidence": 0.0, "revised_by": "text", "triage_reason": "", "standard_code": "YY_0833-2020", "checkpoint_id": "YY_0833-2020#5.5#cp1" }, { "clause_number": "5.5", "sub_id": "5.5-c", "applicable": "待评估", "compliance": "待确定", "description": "自动判定输出结构不完整，已转为待人工评估：ValidationError: 1 validation error for BatchVerdicts\n Input should be an object [type=model_type, input_value=[{'clause_number': '5.5',...}], 'confidence': 0.95}], input_type=list]\n For further information visit https://errors.pydantic.dev/2.13/v/model_type", "references": [], "confidence": 0.0, "revised_by": "text", "triage_reason": "", "standard_code": "YY_0833-2020", "checkpoint_id": "YY_0833-2020#5.5#cp2" }, { "clause_number": "5.5", "sub_id": "5.5-d", "applicable": "待评估", "compliance": "待确定", "description": "自动判定输出结构不完整，已转为待人工评估：ValidationError: 1 validation error for BatchVerdicts\n Input should be an object [type=model_type, input_value=[{'clause_number': '5.5',...}], 'confidence': 0.95}], input_type=list]\n For further information visit https://errors.pydantic.dev/2.13/v/model_type", "references": [], "confidence": 0.0, "revised_by": "text", "triage_reason": "", "standard_code": "YY_0833-2020", "checkpoint_id": "YY_0833-2020#5.5#cp3" }, { "clause_number": "5.5", "sub_id": "5.5-e", "applicable": "待评估", "compliance": "待确定", "description": "自动判定输出结构不完整，已转为待人工评估：ValidationError: 1 validation error for BatchVerdicts\n Input should be an object [type=model_type, input_value=[{'clause_number': '5.5',...}], 'confidence': 0.95}], input_type=list]\n For further information visit https://errors.pydantic.dev/2.13/v/model_type", "references": [], "confidence": 0.0, "revised_by": "text", "triage_reason": "", "standard_code": "YY_0833-2020", "checkpoint_id": "YY_0833-2020#5.5#cp4" }, { "clause_number": "5.6", "sub_id": "5.6-a", "applicable": "适用", "compliance": "通过", "description": "文档3.2.4节明确说明仪器在过压提示时会“泄放气囊中气体”；5.2.3节过压提示说明中也指出“气泵停止工作”。内容完整覆盖条款要求的过压提示后停止输出并释压的机制。", "references": [ { "page": 24, "section": "3.2.4", "section_title": null, "quote": "当仪器超过压强阈值且维持1s以上，仪器应当有过压提示，并在过压提示时，泄放气囊中气体", "document_id": "doc_rev_ab9be6a0304d", "bbox": [ 50.00519897460938, 276.98510803222655, 544.1041888427735, 340.9695098876953 ], "verified": true, "verification_method": "exact", "similarity": 1.0, "context_before": "", "context_after": "，以保证在单一故障状态下能够在气囊和连接管路中产生的最大压强，不大于设备最大治疗压强的1.2倍。", "supports_which": "both", "source_kind": "text", "figure_label": null, "locator_kind": "pdf", "locator_json": { "kind": "pdf", "page": 24, "bbox": [ 50.00519897460938, 276.98510803222655, 544.1041888427735, 340.9695098876953 ] }, "field_id": null, "field_path": null, "content_control_tag": null, "source_version": null, "char_start": null, "char_end": null }, { "page": 33, "section": "5.2.3", "section_title": null, "quote": "如果充气完成后气囊压强超过250mmHg，并持续0.5s，则显示屏上出现的提示信息，气泵停止工作", "document_id": "doc_rev_ab9be6a0304d", "bbox": [ 78.0, 556.2506713867188, 324.6000061035156, 568.2506713867188 ], "verified": true, "verification_method": "exact", "similarity": 1.0, "context_before": "", "context_after": "，并持续发出“嘀嘀嘀...”的提示声音。", "supports_which": "both", "source_kind": "text", "figure_label": null, "locator_kind": "pdf", "locator_json": { "kind": "pdf", "page": 33, "bbox": [ 78.0, 556.2506713867188, 324.6000061035156, 568.2506713867188 ] }, "field_id": null, "field_path": null, "content_control_tag": null, "source_version": null, "char_start": null, "char_end": null } ], "confidence": 0.95, "revised_by": "text", "triage_reason": "", "standard_code": "YY_0833-2020", "checkpoint_id": "YY_0833-2020#5.6#cp0" }, { "clause_number": "5.6", "sub_id": "5.6-b", "applicable": "不适用", "compliance": null, "description": "条款为条件性要求（“若设备不提供过压提示”）。待审设备已明确提供过压提示功能（见3.2.4及5.2.3节），不满足该条件前提，故本子条款不承担此项内容。", "references": [], "confidence": 0.95, "revised_by": "text", "triage_reason": "", "standard_code": "YY_0833-2020", "checkpoint_id": "YY_0833-2020#5.6#cp1" }, { "clause_number": "5.7", "sub_id": "5.7-a", "applicable": "待评估", "compliance": "待确定", "description": "自动判定输出结构不完整，已转为待人工评估：ValidationError: 1 validation error for BatchVerdicts\n Input should be an object [type=model_type, input_value=[{'clause_number': '5.7',...}], 'confidence': 0.95}], input_type=list]\n For further information visit https://errors.pydantic.dev/2.13/v/model_type", "references": [], "confidence": 0.0, "revised_by": "text", "triage_reason": "", "standard_code": "YY_0833-2020", "checkpoint_id": "YY_0833-2020#5.7#cp0" }, { "clause_number": "5.7", "sub_id": "5.7-b", "applicable": "待评估", "compliance": "待确定", "description": "自动判定输出结构不完整，已转为待人工评估：ValidationError: 1 validation error for BatchVerdicts\n Input should be an object [type=model_type, input_value=[{'clause_number': '5.7',...}], 'confidence': 0.95}], input_type=list]\n For further information visit https://errors.pydantic.dev/2.13/v/model_type", "references": [], "confidence": 0.0, "revised_by": "text", "triage_reason": "", "standard_code": "YY_0833-2020", "checkpoint_id": "YY_0833-2020#5.7#cp1" }, { "clause_number": "5.7", "sub_id": "5.7-c", "applicable": "待评估", "compliance": "待确定", "description": "自动判定输出结构不完整，已转为待人工评估：ValidationError: 1 validation error for BatchVerdicts\n Input should be an object [type=model_type, input_value=[{'clause_number': '5.7',...}], 'confidence': 0.95}], input_type=list]\n For further information visit https://errors.pydantic.dev/2.13/v/model_type", "references": [], "confidence": 0.0, "revised_by": "text", "triage_reason": "", "standard_code": "YY_0833-2020", "checkpoint_id": "YY_0833-2020#5.7#cp2" }, { "clause_number": "5.7", "sub_id": "5.7-d", "applicable": "待评估", "compliance": "待确定", "description": "自动判定输出结构不完整，已转为待人工评估：ValidationError: 1 validation error for BatchVerdicts\n Input should be an object [type=model_type, input_value=[{'clause_number': '5.7',...}], 'confidence': 0.95}], input_type=list]\n For further information visit https://errors.pydantic.dev/2.13/v/model_type", "references": [], "confidence": 0.0, "revised_by": "text", "triage_reason": "", "standard_code": "YY_0833-2020", "checkpoint_id": "YY_0833-2020#5.7#cp3" }, { "clause_number": "5.8.1", "sub_id": "5.8.1-a", "applicable": "不适用", "compliance": null, "description": "条款规定的是加压腔体、管路及接头的物理制造工艺与结构稳定性要求（如表面平整无毛刺、多腔相对位置固定等），属于产品设计规范或制造/检验要求。待审文档为产品使用说明书，主要面向用户操作、维护与安全警示指导，不承担载明此类制造公差与结构合规细节的义务。", "references": [], "confidence": 0.9, "revised_by": "text", "triage_reason": "", "standard_code": "YY_0833-2020", "checkpoint_id": "YY_0833-2020#5.8.1#cp0" }, { "clause_number": "5.8.4", "sub_id": "5.8.4-a", "applicable": "不适用", "compliance": null, "description": "条款要求对预期与患者皮肤接触的材料进行生物相容性评估并形成文件（依据GB/T 16886.1），该评估报告及详细材料信息属于医疗器械注册技术文件/生产企业内部质量文件范畴。待审文档为产品使用说明书，不承担载明此类生物相容性评估文件的义务。", "references": [], "confidence": 0.95, "revised_by": "text", "triage_reason": "", "standard_code": "YY_0833-2020", "checkpoint_id": "YY_0833-2020#5.8.4#cp0" }, { "clause_number": "5.9", "sub_id": "5.9-a", "applicable": "待评估", "compliance": "待确定", "description": "自动判定输出结构不完整，已转为待人工评估：ValidationError: 1 validation error for BatchVerdicts\n Input should be an object [type=model_type, input_value=[{'clause_number': '5.9',...}], 'confidence': 0.85}], input_type=list]\n For further information visit https://errors.pydantic.dev/2.13/v/model_type", "references": [], "confidence": 0.0, "revised_by": "text", "triage_reason": "", "standard_code": "YY_0833-2020", "checkpoint_id": "YY_0833-2020#5.9#cp0" }, { "clause_number": "5.9", "sub_id": "5.9-b", "applicable": "待评估", "compliance": "待确定", "description": "自动判定输出结构不完整，已转为待人工评估：ValidationError: 1 validation error for BatchVerdicts\n Input should be an object [type=model_type, input_value=[{'clause_number': '5.9',...}], 'confidence': 0.85}], input_type=list]\n For further information visit https://errors.pydantic.dev/2.13/v/model_type", "references": [], "confidence": 0.0, "revised_by": "text", "triage_reason": "", "standard_code": "YY_0833-2020", "checkpoint_id": "YY_0833-2020#5.9#cp1" }, { "clause_number": "5.9", "sub_id": "5.9-c", "applicable": "待评估", "compliance": "待确定", "description": "自动判定输出结构不完整，已转为待人工评估：ValidationError: 1 validation error for BatchVerdicts\n Input should be an object [type=model_type, input_value=[{'clause_number': '5.9',...}], 'confidence': 0.85}], input_type=list]\n For further information visit https://errors.pydantic.dev/2.13/v/model_type", "references": [], "confidence": 0.0, "revised_by": "text", "triage_reason": "", "standard_code": "YY_0833-2020", "checkpoint_id": "YY_0833-2020#5.9#cp2" } ]