Professional Documents
Culture Documents
M1225162
Revision E
Class A
修订日期: 2020.01
保修
产品保修服务仅由GE 维修厂提供。本产品的现场服务不在保修范围内。
产品名称 新生儿黄疸治疗仪
型号、规格 Giraffe Blue Spot PT Lite
注册人名称 Datex-Ohmeda, Inc. 德恩欧美达公司
注册人住所 9900 Innovation Drive Wauwatosa WI 53226 USA
注册人联系方式 9900 Innovation Drive Wauwatosa WI 53226 USA
售后服务单位 通用电气医疗系统贸易发展(上海)有限公司
代理人名称 通用电气医疗系统贸易发展(上海)有限公司
代理人住所 中国(上海)自由贸易试验区意威路96号1幢
代理人联系方式 400 812 8188
生产企业名称 Datex-Ohmeda, Inc. 德恩欧美达公司
生产企业住所 9900 Innovation Drive Wauwatosa WI 53226 USA
生产地址 8300 Dow Circle Suite 400 Strongsville, OH 44136
生产企业联系方式 8300 Dow Circle Suite 400 Strongsville, OH 44136
生产许可证编号 NA
医疗器械注册证编号 国械注进20192091730
产品技术要求编号 国械注进20192091730
使用期限/失效日期 7年
生产日期 请见产品标签
Table of Contents
关于本手册.................................................................... 5
范围和目标用户............................................................ 5
约定...................................................................... 5
用户责任.................................................................. 6
第 1 部分:操作和维护.................................................. 7
重要操作安全信息.............................................................. 9
禁忌症................................................................... 11
第 1 章:产品概述............................................................ 13
1.1 指定用途............................................................. 13
1.2 产品说明............................................................. 13
1.3 控制器、指示器及连接................................................. 14
第 2 章:产品设置及操作...................................................... 17
2.1 用前检验程序......................................................... 17
2.2 操作................................................................. 19
第 3 章:操作员维护.......................................................... 23
3.1 清洁和维护........................................................... 23
3.2 选装件............................................................... 25
第 4 章:操作员故障排除...................................................... 27
第 5 章:规范................................................................ 29
5.1 电气规范............................................................. 29
5.2 环境规范............................................................. 29
5.3 性能规范............................................................. 30
5.4 标准................................................................. 31
3
目录
4
关于本手册
范围和目标用户
本手册操作和维护零件的目标用户是设备的最终用户,主要是医疗机构中的医务人员。本手册保
养零件的目标用户是医院生物医学工程保养人员和 GE 保养人员。
只有经过设备操作培训且熟悉此类设备操作风险和益处的人员,才能操作此设备。
约定
本手册中使用各种类型的图片或图标来加强印刷信息,以警告您注意以下各种安全隐患:
警告:
在可能对病人和操作员造成人身伤害时使用“警告”提示。
注意:
在可能对设备造成损坏时使用“注意”提示。
注意,对静电释放敏感
显示静电释放 (ESD) 敏感性符号以警告保养人员该零件对静电释放敏感,并且静电控制
程序必须用于防止损坏设备。
5
关于本手册
用户责任
按照说明组装、操作、维护和维修本产品时,本产品性能将符合本操作手册及其随附标签和/或插
页中的描述。本产品必须进行定期检查。不得使用不合格的产品。如有零件损坏、丢失、明显磨
损、变形或被污染,应立即更换。如果这种维修或更换确有必要,GE Healthcare 建议您向距离最近
的 GE Healthcare 地区服务中心致电或发送书面请求以获取维修建议。除非有 GE Healthcare 以及 GE
Healthcare 专业人员提供的书面指示,否则不得对本产品或其任何零件进行维修。未经 GE Healthcare
的质保部门事先书面批准,不得对本产品进行任何改动。对于使用不当、不正确维护、维修不当、损
坏或非 GE Healthcare 人员进行改装所引起的任何故障,本产品的使用者应承担全部责任。
警告:
不得对本设备进行任何更改。
注意:
美国联邦法律限制本设备仅可由有执照的医疗从业者销售,并仅可销售给有执照的
医疗从业者。
6
第 1 部分:操作和维护
7
第 1 部分:操作和维护
本页为故意留白页。
8
重要操作安全信息
警告:
切勿在存在可燃性麻醉气体(例如乙醚)与可助燃的空气或氧气或一氧化二氮混合气体的
场合下使用 Giraffe Blue Spot PT Lite;在此条件下可能存在爆炸危险。
警告:
蓝光会掩盖皮肤颜色的变化,如发绀,从而干扰临床观察。
警告:
切勿挡住电源线插头。有时可能需要紧急关闭电源。
警告:
长时间暴露在任何光疗灯下均可能会造成眼部损伤。长时间逗留在光疗设备辐射区域可能会
对操作员造成一定的影响。切勿直视光疗灯。婴儿在治疗过程中应配戴护目用具。请注意保
护好毗邻治疗区域婴儿的双目。
警告:
根据医院的政策和程序,定期给接受光疗的婴儿测量其胆红素水平。
警告:
所有光疗疗法均存在风险,包括但不限于婴儿青铜综合征、 腹泻、色素沉着增红、 水泡皮
肤病、皮肤刺激。在光疗过程中密切监测婴儿是否有出现这些症状的迹象。
警告:
胆红素光异构体可能会导致毒性反应。
警告:
卟啉是胆红素分子光化学分解的副产物。在某些情况下,卟啉暴露于光疗条件下可能会导致
婴儿皮肤局部变红。因此,皮肤测定结果以所有光疗类型来表示。
警告:
在进行光疗时,请采取适当的措施以保持患者体液的平衡。
警告:
为避免患者受伤,切勿在患者躺在床上时安装该系统。
警告:
为避免电击风险,系统仅可连接至带有保护接地的供电干线。
警告:
灯光可能会对药物及其他输液液体产生不良影响。在光疗过程中使用静脉输液系统时,请使
用适当的材料将输液管挡住。切勿将药物或输液液体存储在直接受到灯光照射的位置。
警告:
如果要在辐射暖箱使用该设备,请确保灯罩未直接受到辐射热光线的照射。如果灯罩直接受
到辐射热的照射,可能会阻挡患者受热并可能损坏灯罩。
9
重要操作安全信息
警告:
在光疗灯照射下使用这些设备时,建议将培养箱或暖箱的模式设为婴儿控制(伺服)模式。
始终监测婴儿体温并做出相应调整以避免光疗过程中出现体温波动。
警告:
光疗灯会影响体温调节设备(培养箱、辐射暖箱或加热床垫)的温度,并可能会使患者的体
温上升。始终监测婴儿体温并对这些设备做出相应调整,以避免光疗过程中出现体温波动。
警告:
使用 反射铝箔以提高光疗疗效可能会导致患者体温达到危险的温度。
警告:
富氧环境会大幅度降低材料的燃烧温度。供氧期间使用光疗灯从直接受到灯光照射的位置取
下所有不透明的材料时要格外小心。
警告:
如果系统安装在便携式轧钢机架上,请锁住机轮,以防设备在治疗期间发生移动。
警告:
电源线存在绊脚危险。 当把电源线放置在行走区时,请勿置之不管。
警告:
请定期检查患者是否位于设备的治疗区内。
警告:
请遵循医院有关在光疗过程中的胆红素、温度、皮肤及眼睛评估的相关政策和程序。
警告:
切勿使用易燃的清洁溶液清洗 Giraffe Blue Spot PT Lite。
注意:
保养该产品,应根据保养手册并仅使用适当的工具、测试设备以及在清楚和充分了解最新版
保养手册的基础上进行。
注意:
为避免设备过热,切勿阻塞灯箱的任何通风孔。
注意:
在直接受到辐射热照射的位置切勿放置不透明的物体。光能量会加热不透明的材料并导致其
损坏。
注意:
仅使用 GE Healthcare 许可的零件。
10
重要操作安全信息
禁忌症
光疗的禁忌症*:
• 先天性卟啉症或有卟啉症的家族病史
• 同时使用其他具有感光性的药物或药剂
• 同时采用金属卟啉血红素加氧酶抑制剂治疗
伴有胆汁淤积(直接胆红素血症)症状,光疗的疗效可能会下降。
* MacDonald & Ramasethu (2007)。《新生儿临床操作图谱》,宾夕法尼亚州 (PA)费城Lippincott Williams & Wilkins 出版社出版
符号定义
本节介绍在 Giraffe Blue Spot PT Lite 新生儿黄疸治疗仪上所显示的符号:
符号 说明
请参阅随附的文档。
高压、电击危险
~ 表示交流电
欧盟代表
计时显示器
待机/开机开关
在光疗过程中请遮住婴儿的双目。
过温/低温条件下
电位均衡器螺栓
患者与灯罩之间的建议距离
11
重要操作安全信息
符号 说明
此符号表示电气和电子设备废弃物不得作为未分类的城市废弃物处置,必须分开
回收。有关如何将设备进行报废处置的信息,请联系制造商的授权代表。
12
第 1 章:产品概述
1.1 指定用途
只有经过培训的专业医护人员及执业的医生
才能执行本疗法。
1.2 产品说明
将设备连接到电源插座板上,便可使用。设备前
部的待机/开机开关可打开和关闭治疗灯。
不可复位的计时显示器位于开关附近,可显示该
产品在使用寿命范围内发出治疗光的时间。当设
备处于待机状态时,计时显示器下方的指示灯显
示为绿色,该设备发出治疗光时,该指示灯显示
为蓝色,如果风扇尚未正常运转或设备过热,指示灯显示为红色并闪烁。如果该设备温度过低,风扇
运转时红色指示灯将持续发亮。风扇可(根据具体情况)冷却或加热以使系统的操作温度适宜。
向患者照射的灯光强度随着灯罩与床垫距离的变化而变化。手动调节此距离可改变灯光强度及光点尺
寸。灵活的光管可弯曲到新的位置,并将灯罩固定在适当位置。灵活的光管可从 LED 发射灯光至灯
罩,而灯罩可使灯光照射到患者。
13
第 1 章:产品概述
1.3 控制器、指示器及连接
13
3 14
4
5
6
7
8
12
11 10 9
前部 后部 底部
图 1.1
1. 灯罩 8. 灯箱
2. 光管 9. 电源线插座*
* 将设备与供电干线隔离开来:
• 对于连接在墙壁上的设备,请拔下电源线。
• 对于连接至微环境的附件插座的设备,请关闭微环境之外的主电源开关。
14
第 1 章:产品概述
下表介绍了各个指示器每种状态下的含义:
表 1.1 指示器
指示器 状态 通常意味着什么
关 该设备未接通电源。
待机/开机指示器 绿色 该设备处于待机状态并且未发光。
蓝色 该设备正在发光。
关 该设备未接通电源。
计时显示器 该设备处于待机状态或正在发光。该数字表示该设备
显示时数
在使用寿命范围内发光的小时数。
关 未检测到温度问题。
过温/低温指示器 红色灯稳定 温度过低条件下
红色灯闪烁* 温度过高条件下
*按下待机/开机开关打开治疗灯可确认警报指示器的功能,此时过温/低温指示器显示为红色并会短暂地闪
烁。
有关操作员故障排除说明,请参阅第 4 章。
15
第 1 章:产品概述
本页为故意留白页。
16
第 2 章:产品设置及操作
在装运时,光管被从灯箱上卸下。首次使用前,需要将光管连接并固定在灯箱上,再将设备安装在微
环境或便携式机架的燕尾形导轨上。
仅授权保养人员才能对该设备进行安装。相关说明,请参阅7.4。
警告:
为避免患者受伤,切勿在患者躺在床上时安装该系统。
警告:
为避免电击风险,系统仅可连接至带有保护接地的供电干线。
2.1 用前检验程序
首次使用系统及在设备投入使用之前,请遵循以下检验说明:
1. 确认设备是否有零件缺失或明显的损坏迹象,包括电源线、光管、灯箱及标签。如果发现
损坏,切勿使用该设备并联系保养人员。
2. 检查灯箱是否已牢固连接至燕尾形辅助导轨或机架上,例如,该设备不会沿着燕尾形导轨
向上或向下滑动。
3. 移动光管以确认其可自由移动并可停留在适当位置。
4. 连接电源线至合适的电源。待机/开机指示器将显示为绿色以指示进入待机模式。
5. 按下待机/开机开关可打开治疗灯。待机/开机指示器将由绿色变为蓝色,并且过温/低温显示器将
短暂亮起。
6. 当感觉该设备有空气流出时,将您的手短暂靠近排气口以确认冷却风扇是否运转。
17
第 2 章:产品设置及操作
5 2
3.5”
1
3.5”
4 3
3.5” 3.5”
图 2-1 光测量点
18
第 2 章:产品设置及操作
2.2 操作
警告:
长时间暴露在任何光疗灯下均可能会造成眼部损伤。长时间逗留在新生儿黄疸治疗仪
辐射区域可能会对操作员造成一定的影响。切勿直视光疗灯。婴儿在治疗过程中应配
戴护目用具。请注意保护好毗邻治疗区域婴儿的双目。
警告:
灯光可能会对药物及其他输液液体产生不良影响。在光疗过程中使用静脉输液系统
时,请使用适当的材料将输液管挡住。切勿将药物或输液液体存储在直接受到灯光
照射的位置。
警告:
在光疗灯照射下使用这些设备时,建议将培养箱或暖箱的模式设为婴儿控制(伺服)
模式。始终监测婴儿体温并做出相应调整以避免光疗过程中出现体温波动。
警告:
光疗灯会影响体温调节设备(培养箱、辐射暖箱或加热床垫)的温度,并可能会使
患者的体温上升。始终监测婴儿体温并对这些设备做出相应调整,以避免光疗过程中
出现体温波动。
警告:
使用 反射铝箔以提高光疗疗效可能会导致患者体温达到危险的温度。
警告:
富氧环境会大幅度降低材料的燃烧温度。供氧期间使用光疗灯从直接受到灯光照射的
位置取下所有不透明的材料时要格外小心。
警告:
请遵循医院有关在光疗过程中的胆红素、温度、皮肤及眼睛评估的相关政策和程序。
注意:
为避免设备过热,切勿阻塞灯箱的任何通风孔。
注意:
在直接受到辐射热照射的位置切勿放置不透明的物体。光能量会加热不透明的材料
并导致其损坏。
19
第 2 章:产品设置及操作
警告:
如果要在辐射暖箱使用该设备,请确保灯罩未直接受到辐射热光线的照射。如果灯罩
直接受到辐射热的照射,可能会阻挡患者受热并可能损坏灯罩。
1. 将婴儿放在床垫中央。
2. 使用护目用具将婴儿的双目遮住。临床医师应参阅关于适当应用和使用特殊护目用具的使用
说明。
3. 最大限度地将婴儿皮肤暴露于治疗灯之下。例如,使用最小尺寸的尿布,避免使用会遮挡光源
的毛毯抱被或辅助定位仪。
4. 如果系统被安装在便携式机架上,可锁定轮子以防止治疗过程中设备发生移动。
5. 按下待机/开机开关可打开治疗灯。
7. 分别使用校准后的蓝光毯照度计 II 在婴儿仰卧和俯卧时测量肚脐位置以及腰间的辐照度。
8. 抬高灯罩可调整光辐射及所需的全身表面覆盖率。
9. 在光疗过程中监测婴儿体温。
10. 在光疗过程中监测患者体液摄取和输出量。
20
第 2 章:产品设置及操作
注释:有关系统指示器以及如何对其进行解释的信息,请参阅Figure 7-4。
注释:建议根据医院政策与程序监测光疗过程中的辐照度。
注释:光疗的疗效取决于灯光强度、患者全身表面覆盖区域、距离以及新生儿黄疸治疗仪所使用的光
谱。
21
第 2 章:产品设置及操作
本页为故意留白页。
22
第 3 章:操作员维护
本章包括由操作员进行的有计划的维护程序。有关由医院生物医学工程保养人员进行的有计划的维护
程序,请参阅Chapter 8。
3.1 清洁和维护
3.1.1 清洗步骤
警告:
切勿使用易燃的清洁溶液清洗 Giraffe Blue Spot PT Lite。
注意:
使用非易燃清洁器和不起毛的软布清洗灯罩防护罩。如果使用乙醇溶液,请彻底擦干
其盖子以确保未留有残留的清洁剂。
注意:
请始终遵循医疗法规或当地法规了解必需的清洁和维护频率。
1. 清洗之前请拔下电源线并让系统散热至少十分钟。
2. 使用非易燃清洁器清洗灯罩防护罩。
3. 使用 3.1.2 节中所列出的清洁剂清洗灯箱、光管及灯罩的外部。可使用医院消毒剂和微杀菌剂的水
溶液。切勿让液体渗入外壳。用干净的布片或海绵蘸清洁溶液进行擦拭。切勿将清洁剂
喷入通风孔中,因为这将污染 LED、光学器件和电子器件。
4. 始终使用干净的软湿布擦干零件,以避免刮花并擦除清洁剂残留物。
3.1.2 防损伤设备清洁溶液
下表列出一些可以安全使用的防损伤=设备清洁溶液及浓度:
通用配方 最高浓度
次氯酸钠(漂白粉) 0.5% 水溶液
戊二醛 2%
过氧化氢 6%
100% 喷雾(喷洒在抹布上 - 而不是直接喷洒在设备上)
Cavicide®
活性成分:苄索氯铵 (0.28%),异丙醇 (17.20%),惰性成分 (82.54%)
季胺盐 0.28%
异丙醇 <15%
23
第 3 章:操作员维护
切勿使用下列清洁剂;它们会损坏要清洗的零件,建议不要使用:
• 异丙醇(浓度高于 15%)
• 溶剂(如丙酮)
• 碘氟
注释:切勿将零件浸泡在清洁溶液中。务必擦干零件上的所有清洁溶液。遵循这两项建议将大大延长
零件的使用寿命。
注释:使用碘氟溶液清洗后的零件会发黄。
3.1.3 影响产品使用寿命的因素
因素 说明
设备操作时冷却风扇未运行或滤清器堵塞,均会减少 LED 的
保温床垫
使用寿命。
折叠或过度弯曲光管 切勿折叠或弯曲光管大于 60 度。
注释:为保持风扇的最佳性能,如果发现滤清器变脏,请清洗或更换滤清器。
3.1.4 清洗或更换风机滤清器
1. 断开设备的电源。
2. 从设备底部取下滤清器制动装置。
3. 检查滤清器 (M1225816)。用清水冲洗,必要时请更换。
4. 一旦发现滤清器变干,返回设备底部并重新安装滤清器制动装置。
24
第 3 章:操作员维护
3.1.5 产品存储
产品存储过程中建议将光管连接至灯箱上。如果光管被从灯箱上卸下,光管和光管管口(原本系统自
带)的保护盖可用于光管和光管管口,以保护治疗灯的 LED 以及光纤并且防止灰尘和污垢。
注意:
切勿折叠或弯曲光管大于 60 度以避免光管损坏。
3.2 选装件
便携式机架....................................................................................6600-0894-216
GE Healthcare 蓝光毯照度计 II............................................6600-0198-900
注释:仅在设备上使用 GE 许可的选装件。
25
第 3 章:操作员维护
本页为故意留白页。
26
第 4 章:操作员故障排除
本章列出了可能出现的症状、可能的原因及操作员可以实施的解决方案。所有其他可能出现的
故障现象和原因需要由专业人士做出判断(专业保养技术人员可参阅Chapter 10)。
27
第 4 章:操作员故障排除
检查滤清器。必要时致电保养人员进行清洗
当系统连接到电源输
系统温度偏高 或更换。
OS3 出口时,过温/低温
(温度过高条件下)。
指示器红色灯闪烁。
注释:若通风孔未堵塞,风扇会继续运转以
冷却 LED 组件。LED 组件冷却后,过温/低温
指示器也将关闭并且待机/开机指示灯将显
示为绿色。此过程可能需要几分钟。
使用清洁剂和不起毛的软布轻柔地清洗防
灯罩防护罩变脏
护罩。
该系统产生的光辐射 未使用正确的用于测量 确保使用所推荐的用于测量光辐射度的照
OS4 度较低(平均小于 光辐射度的照度计。 度计。
27 µW · cm-2 · nm-1 )。 灯罩至少距离床面 38 聚焦治疗灯使距床面光点直径为 35.5 厘米
厘米(15 英寸)或未 (14 英寸)或灯罩直径为 38 厘米(15 英
直射床面。 寸),并且治疗灯要瞄准床面。
28
第 5 章:规范
5.1 电气规范
设备类型:I 类
• 操作:持续操作
• 额定输入:100-240VAC 50/60 Hz,130-170VA
注释:将设备与供电干线隔离开来:
- 对于连接在墙壁上的设备,请拔下电源线。
- 对于连接至微环境的附件插座的设备,请关闭微环境之外的主电源开关。
5.2 环境规范
5.2.1 操作条件
环境温度为 18 至 30°C
相对湿度 10 至 95% 无冷凝
大气压强 64 kPa 至 106 kPa
• 此设备不适合在存在可燃性麻醉气体与空气或氧气或一氧化二氮混合气体的场合下使用。
• IPX0 - 不防水。
5.2.2 运输和存储条件
(在运输过程中包装密封)
温度 -20 至 60°C
湿度 0 至 95% 无冷凝的相对湿度
压强 64 kPa 至 106 kPa
29
第 5 章:规范
5.3 性能规范
按照其设计该产品可达到 7 年的使用期限。然而,如果维护和维修适当,
使用期限
只要保养零件可用,便可延长其使用期限。
* IEC 标准建议在输出降低 25% 的情况下可更换 LED,累计工作时数约达 10000 小时时可能会出现此种情况。但是下
降 25% 后光疗仍保持充足的辐照度。
蓝光毯照度计 II 相对光谱响应
1
0.9
0.8
0.7
相对光谱响应
0.6
0.5
0.4
0.3
0.2
0.1
0
380 400 420 440 460
波长
480
(nm)
500 520 540 560 580
30
第 5 章:规范
距离 38 cm 时的总分光照度 Ebi
波长 (nm)
距离 表面面积 胆红素的平均总照度
(H cm) (A cm2) (毫瓦每厘米-2)
38 990 2.94
50 1713 1.70
5.4 标准
产品符合以下标准:
带有此标志的系统,在按照其操作与维护手册所提供的说明进行使用时,符合欧
洲理事会指令 93/42/EEC 医疗器械指令的规定。
XXXX 是被通知主体的验证编号。
31
第 5 章:规范
本页为故意留白页。
32
Part II: Service
33
Part II: Service
34
Important Service Safety Information
The service information presented in Part II is important for the safety of both the patient and operator
and also serves to enhance equipment reliability.
WARNING:
Before servicing the Giraffe Blue Spot PT Lite, read through this entire manual. As with all
medical equipment, attempting to use this device without a thorough understanding of
its operation may result in patient or user injury. This device should be serviced only by
authorized service personnel. Additional precautions specific to certain procedures are
found in the text of this manual.
The information contained in this service manual pertains only to those models of products which are
marketed by GE Healthcare as of the effective date of this manual or the latest revision thereof. This
service manual was prepared for exclusive use by GE Healthcare service personnel in light of their
training and experience as well as the availability to them of parts, proper tools, and test equipment.
Consequently, GE Healthcare provides this service manual to its customers purely as a business
convenience and for the customer’s general information only without warranty of the results with
respect to any application of such information.
Furthermore, because of the wide variety of circumstances under which maintenance and repair
activities may be performed and the unique nature of each individual’s own experience, capacity, and
qualifications, the fact that a customer has received such information from GE Healthcare does not imply
in any way that GE Healthcare deems said individual to be qualified to perform any such maintenance
or repair service. Moreover, it should not be assumed that every acceptable test and safety procedure
or method, precaution, tool, equipment, or device is referred to within, or that abnormal or unusual
circumstances may not warrant or suggest different or additional procedures or requirements. This
manual is subject to periodic review, update, and revision. Customers are cautioned to obtain and
consult the latest revision before undertaking any service of the equipment.
WARNING:
The user or service staff should dispose of all the waste properly as per federal, state, and
local waste disposal regulations. Improper disposal could result in personal injury and
environmental impact.
Do not use malfunctioning equipment. If the system is under warranty, contact GE technical support at
the number on the back of the manual PRIOR to performing any repairs on the system.
35
Important Service Safety Information
WARNING:
This service manual is available in English only.
• If a customer’s service provider requires a language other than English, it is the
customer’s responsibility to provide translation services.
• Do not attempt to service the equipment unless this service manual has been
consulted and is understood.
• Failure to heed this warning may result in injury to the service provider, operator, or
patient from electric shock, mechanical hazards, or other hazards.
ПРЕДУПРЕЖДЕНИЕ
Това упътване за работа е налично само на английски език.
• Ако доставчикът на услугата на клиента изиска друг език, задължение на клиента
е да осигури превод.
• Не използвайте оборудването, преди да сте се консултирали и разбрали
упътването за работа.
• Неспазването на това предупреждение може да доведе до нараняване на
доставчика на услугата, оператора или пациентa в резултат на токов удар,
механична или друга опасност.
警告
本维修手册仅提供英文版本。
• 如果客户的维修服务人员需要非英文版本,则客户需自行提供翻译服务。
• 未详细阅读和完全理解本维修手册之前,不得进行维修。
• 忽略本警告可能对维修服务人员、操作人员或患者造成电击、机械伤害或其他形式
的伤害。
警告
本服務手冊僅提供英文版本。
• 倘若客戶的服務供應商需要英文以外之服務手冊,客戶有責任提供翻譯服務。
• 除非已參閱本服務手冊及明白其內容,否則切勿嘗試維修設備。
• 不遵從本警告或會令服務供應商、網絡供應商或病人受到觸電、機械性或其他的危
險。
警告
本維修手冊僅有英文版。
• 若客戶的維修廠商需要英文版以外的語言,應由客戶自行提供翻譯服務。
• 請勿試圖維修本設備,除非 您已查閱並瞭解本維修手冊。
• 若未留意本警告,可能導致維修廠商、操作員或病患因觸電、機械或其他危險而受
傷。
36
Important Service Safety Information
UPOZORENJE
Ovaj servisni priručnik dostupan je na engleskom jeziku.
• Ako davatelj usluge klijenta treba neki drugi jezik, klijent je dužan osigurati prijevod.
• Ne pokušavajte servisirati opremu ako niste u potpunosti pročitali i razumjeli ovaj
servisni priručnik.
• Zanemarite li ovo upozorenje, može doći do ozljede davatelja usluge, operatera ili
pacijenta uslijed strujnog udara, mehaničkih ili drugih rizika.
VÝSTRAHA
Tento provozní návod existuje pouze v anglickém jazyce.
• V případě, že externí služba zákazníkům potřebuje návod v jiném jazyce, je zajištění
překladu do odpovídajícího jazyka úkolem zákazníka.
• Nesnažte se o údržbu tohoto zařízení, aniž byste si přečetli tento provozní návod a
pochopili jeho obsah.
• V případě nedodržování této výstrahy může dojít k poranění pracovníka prodejního
servisu, obslužného personálu nebo pacientů vlivem elektrického proudu, respektive
vlivem mechanických či jiných rizik.
ADVARSEL
Denne servicemanual findes kun på engelsk.
• Hvis en kundes tekniker har brug for et andet sprog end engelsk, er det kundens
ansvar at sørge for oversættelse.
• Forsøg ikke at servicere udstyret uden at læse og forstå denne servicemanual.
• Manglende overholdelse af denne advarsel kan medføre skade på grund af elektrisk
stød, mekanisk eller anden fare for teknikeren, operatøren eller patienten.
WAARSCHUWING
Deze onderhoudshandleiding is enkel in het Engels verkrijgbaar.
• Als het onderhoudspersoneel een andere taal vereist, dan is de klant verantwoordelijk
voor de vertaling ervan.
• Probeer de apparatuur niet te onderhouden alvorens deze onderhoudshandleiding
werd geraadpleegd en begrepen is.
• Indien deze waarschuwing niet wordt opgevolgd, zou het onderhoudspersoneel, de
operator of een patiënt gewond kunnen raken als gevolg van een elektrische schok,
mechanische of andere gevaren.
37
Important Service Safety Information
HOIATUS
See teenindusjuhend on saadaval ainult inglise keeles
• Kui klienditeeninduse osutaja nõuab juhendit inglise keelest erinevas keeles, vastutab
klient tõlketeenuse osutamise eest.
• Ärge üritage seadmeid teenindada enne eelnevalt käesoleva teenindusjuhendiga
tutvumist ja sellest aru saamist.
• Käesoleva hoiatuse eiramine võib põhjustada teenuseosutaja, operaatori või patsiendi
vigastamist elektrilöögi, mehaanilise või muu ohu tagajärjel.
VAROITUS
Tämä huolto-ohje on saatavilla vain englanniksi.
• Jos asiakkaan huoltohenkilöstö vaatii muuta kuin englanninkielistä materiaalia,
tarvittavan käännöksen hankkiminen on asiakkaan vastuulla.
• Älä yritä korjata laitteistoa ennen kuin olet varmasti lukenut ja ymmärtänyt tämän
huolto-ohjeen.
• Mikäli tätä varoitusta ei noudateta, seurauksena voi olla huoltohenkilöstön, laitteiston
käyttäjän tai potilaan vahingoittuminen sähköiskun, mekaanisen vian tai muun
vaaratilanteen vuoksi.
ATTENTION
Ce manuel d’installation et de maintenance est disponible uniquement en anglais.
• Si le technicien d’un client a besoin de ce manuel dans une langue autre que l’anglais,
il incombe au client de le faire traduire.
• Ne pas tenter d’intervenir sur les équipements tant que ce manuel d’installation et de
maintenance n’a pas été consulté et compris.
• Le non-respect de cet avertissement peut entraîner chez le technicien, l’opérateur ou
le patient des blessures dues à des dangers électriques, mécaniques ou autres.
WARNUNG
Diese Serviceanleitung existiert nur in englischer Sprache.
• Falls ein fremder Kundendienst eine andere Sprache benötigt, ist es Aufgabe des
Kunden für eine entsprechende Übersetzung zu sorgen.
• Versuchen Sie nicht diese Anlage zu warten, ohne diese Serviceanleitung gelesen und
verstanden zu haben.
• Wird diese Warnung nicht beachtet, so kann es zu Verletzungen des
Kundendiensttechnikers, des Bedieners oder des Patienten durch Stromschläge,
mechanische oder sonstige Gefahren kommen.
38
Important Service Safety Information
ΠΡΟΕΙΔΟΠΟΙΗΣΗ
Το παρόν εγχειρίδιο σέρβις διατίθεται μόνο στα αγγλικά.
• Εάν ο τεχνικός σέρβις ενός πελάτη απαιτεί το παρόν εγχειρίδιο σε γλώσσα εκτός των
αγγλικών, αποτελεί ευθύνη του πελάτη να παρέχει τις υπηρεσίες μετάφρασης.
• Μην επιχειρήσετε την εκτέλεση εργασιών σέρβις στον εξοπλισμό αν δεν έχετε
συμβουλευτεί και κατανοήσει το παρόν εγχειρίδιο σέρβις.
• Αν δεν προσέξετε την προειδοποίηση αυτή, ενδέχεται να προκληθεί τραυματισμός
στον τεχνικό σέρβις, στο χειριστή ή στον ασθενή από ηλεκτροπληξία, μηχανικούς ή
άλλους κινδύνους.
FIGYELMEZTETÉS
Ezen karbantartási kézikönyv kizárólag angol nyelven érhető el.
• Ha a vevő szolgáltatója angoltól eltérő nyelvre tart igényt, akkor a vevő felelőssége a
fordítás elkészíttetése.
• Ne próbálja elkezdeni használni a berendezést, amíg a karbantartási kézikönyvben
leírtakat nem értelmezték.
• Ezen figyelmeztetés figyelmen kívül hagyása a szolgáltató, működtető vagy a beteg
áramütés, mechanikai vagy egyéb veszélyhelyzet miatti sérülését eredményezheti.
AÐVÖRUN
Þessi þjónustuhandbók er aðeins fáanleg á ensku.
• Ef að þjónustuveitandi viðskiptamanns þarfnast annas tungumáls en ensku, er það
skylda viðskiptamanns að skaffa tungumálaþjónustu.
• Reynið ekki að afgreiða tækið nema að þessi þjónustuhandbók hefur verið skoðuð og
skilin.
• Brot á sinna þessari aðvörun getur leitt til meiðsla á þjónustuveitanda, stjórnanda eða
sjúklings frá raflosti, vélrænu eða öðrum áhættum.
AVVERTENZA
Il presente manuale di manutenzione è disponibile soltanto in lingua inglese.
• Se un addetto alla manutenzione richiede il manuale in una lingua diversa, il cliente è
tenuto a provvedere direttamente alla traduzione.
• Procedere alla manutenzione dell’apparecchiatura solo dopo aver consultato il
presente manuale ed averne compreso il contenuto.
• Il mancato rispetto della presente avvertenza potrebbe causare lesioni all’addetto
alla manutenzione, all’operatore o ai pazienti provocate da scosse elettriche, urti
meccanici o altri rischi.
39
Important Service Safety Information
警告
このサービスマニュアルには英語版しかありません。
• サービスを担当される業者が英語以外の言語を要求される場合、翻訳作業はその
業者の責任で行うものとさせていただきます。
• このサービスマニュアルを熟読し理解せずに、装置のサービスを行わないでくだ
さい。
• この警告に従わない場合、サービスを担当される方、操作員あるいは患者 さん
が、感電や機械的又はその他の危険により負傷する可能性があります。
경고
본 서비스 매뉴얼은 영어로만 이용하실 수 있습니다.
• 고객의 서비스 제공자가 영어 이외의 언어를 요구할 경우, 번역 서비스를 제공하는
것은 고객의 책임입니다.
• 본 서비스 매뉴얼을 참조하여 숙지하지 않은 이상 해당 장비를 수리하려고
시도하지 마십시오.
• 본 경고 사항에 유의하지 않으면 전기 쇼크, 기계적 위험, 또는 기타 위험으로 인해
서비스 제공자, 사용자 또는 환자에게 부상을 입힐 수 있습니다.
BRĪDINĀJUMS
Šī apkopes rokasgrāmata ir pieejama tikai angļu valodā.
• Ja klienta apkopes sniedzējam nepieciešama informācija citā valodā, klienta
pienākums ir nodrošināt tulkojumu.
• Neveiciet aprīkojuma apkopi bez apkopes rokasgrāmatas izlasīšanas un saprašanas.
• Šī brīdinājuma neievērošanas rezultātā var rasties elektriskās strāvas trieciena,
mehānisku vai citu faktoru izraisītu traumu risks apkopes sniedzējam, operatoram vai
pacientam.
ĮSPĖJIMAS
Šis eksploatavimo vadovas yra tik anglų kalba.
• Jei kliento paslaugų tiekėjas reikalauja vadovo kita kalba – ne anglų, suteikti vertimo
paslaugas privalo klientas.
• Nemėginkite atlikti įrangos techninės priežiūros, jei neperskaitėte ar nesupratote šio
eksploatavimo vadovo.
• Jei nepaisysite šio įspėjimo, galimi paslaugų tiekėjo, operatoriaus ar paciento
sužalojimai dėl elektros šoko, mechaninių ar kitų pavojų.
ADVARSEL
Denne servicehåndboken finnes bare på engelsk.
• Hvis kundens serviceleverandør har bruk for et annet språk, er det kundens ansvar å
sørge for oversettelse.
• Ikke forsøk å reparere utstyret uten at denne servicehåndboken er lest og forstått.
• Manglende hensyn til denne advarselen kan føre til at serviceleverandøren,
operatøren eller pasienten skades på grunn av elektrisk støt, mekaniske eller andre
farer.
40
Important Service Safety Information
OSTRZEŻENIE
Niniejszy podręcznik serwisowy dostępny jest jedynie w języku angielskim.
• Jeśli serwisant klienta wymaga języka innego niż angielski, zapewnienie usługi
tłumaczenia jest obowiązkiem klienta.
• Nie próbować serwisować urządzenia bez zapoznania się z niniejszym podręcznikiem
serwisowym i zrozumienia go.
• Niezastosowanie się do tego ostrzeżenia może doprowadzić do obrażeń serwisanta,
operatora lub pacjenta w wyniku porażenia prądem elektrycznym, zagrożenia
mechanicznego bądź innego.
AVISO
Este manual de assistência técnica encontra-se disponível unicamente em inglês.
• Se outro serviço de assistência técnica solicitar a tradução deste manual, caberá ao
cliente fornecer os serviços de tradução.
• Não tente reparar o equipamento sem ter consultado e compreendido este manual
de assistência técnica.
• A não observância deste aviso pode ocasionar ferimentos no técnico, operador ou
paciente decorrentes de choques elétricos, mecânicos ou outros.
ATENÇÃO
Este manual de assistência técnica só se encontra disponível em inglês.
• Se qualquer outro serviço de assistência técnica solicitar este manual noutro idioma,
é da responsabilidade do cliente fornecer os serviços de tradução.
• Não tente reparar o equipamento sem ter consultado e compreendido este manual
de assistência técnica.
• O não cumprimento deste aviso pode colocar em perigo a segurança do técnico, do
operador ou do paciente devido a choques eléctricos, mecânicos ou outros.
ATENŢIE
Acest manual de service este disponibil doar în limba engleză.
• Dacă un furnizor de servicii pentru clienţi necesită o altă limbă decât cea engleză, este
de datoria clientului să furnizeze o traducere.
• Nu încercaţi să reparaţi echipamentul decât ulterior consultării şi înţelegerii acestui
manual de service.
• Ignorarea acestui avertisment ar putea duce la rănirea depanatorului, operatorului
sau pacientului în urma pericolelor de electrocutare, mecanice sau de altă natură.
41
Important Service Safety Information
ОСТОРОЖНО!
Данное руководство по техническому обслуживанию представлено только на
английском языке.
• Если сервисному персоналу клиента необходимо руководство не на английском, а
на каком-то другом языке, клиенту следует самостоятельно обеспечить перевод.
• Перед техническим обслуживанием оборудования обязательно обратитесь к
данному руководству и поймите изложенные в нем сведения.
• Несоблюдение требований данного предупреждения может привести к тому,
что специалист по техобслуживанию, оператор или пациент получит удар
электрическим током, механическую травму или другое повреждение.
UPOZORENJE
Ovo servisno uputstvo je dostupno samo na engleskom jeziku.
• Ako klijentov serviser zahteva neki drugi jezik, klijent je dužan da obezbedi
prevodilačke usluge.
• Ne pokušavajte da opravite uređaj ako niste pročitali i razumeli ovo servisno uputstvo.
• Zanemarivanje ovog upozorenja može dovesti do povređivanja servisera, rukovaoca ili
pacijenta usled strujnog udara ili mehaničkih i drugih opasnosti.
UPOZORNENIE
Tento návod na obsluhu je k dispozícii len v angličtine.
• Ak zákazníkov poskytovateľ služieb vyžaduje iný jazyk ako angličtinu, poskytnutie
prekladateľských služieb je zodpovednosťou zákazníka.
• Nepokúšajte sa o obsluhu zariadenia, kým si neprečítate návod na obluhu a
neporozumiete mu.
• Zanedbanie tohto upozornenia môže spôsobiť zranenie poskytovateľa služieb,
obsluhujúcej osoby alebo pacienta elektrickým prúdom, mechanické alebo iné
ohrozenie.
ATENCION
Este manual de servicio sólo existe en inglés.
• Si el encargado de mantenimiento de un cliente necesita un idioma que no sea el
inglés, el cliente deberá encargarse de la traducción del manual.
• No se deberá dar servicio técnico al equipo, sin haber consultado y comprendido este
manual de servicio.
• La no observancia del presente aviso puede dar lugar a que el proveedor de
servicios, el operador o el paciente sufran lesiones provocadas por causas eléctricas,
mecánicas o de otra naturaleza.
42
Important Service Safety Information
VARNING
Den här servicehandboken finns bara tillgänglig på engelska.
• Om en kunds servicetekniker har behov av ett annat språk än engelska, ansvarar
kunden för att tillhandahålla översättningstjänster.
• Försök inte utföra service på utrustningen om du inte har läst och förstår den här
servicehandboken.
• Om du inte tar hänsyn till den här varningen kan det resultera i skador på
serviceteknikern, operatören eller patienten till följd av elektriska stötar, mekaniska
faror eller andra faror
DİKKAT
Bu servis kılavuzunun sadece ingilizcesi mevcuttur.
• Eğer müşteri teknisyeni bu kılavuzu ingilizce dışında bir başka lisandan talep ederse,
bunu tercüme ettirmek müşteriye düşer.
• Servis kılavuzunu okuyup anlamadan ekipmanlara müdahale etmeyiniz.
• Bu uyarıya uyulmaması, elektrik, mekanik veya diğer tehlikelerden dolayı teknisyen,
operatör veya hastanın yaralanmasına yol açabilir.
43
Important Service Safety Information
44
Chapter 6: System Description
The Giraffe Blue Spot PT Lite is a medical device designed to treat neonatal jaundice by providing blue
therapeutic light to patients. White light is comprised of light wavelengths from throughout the spectrum.
However, the wavelengths of light that actually provide therapy reside only between 410 and 460
nanometers. This light appears blue to the eye and is the specific output of the Giraffe Blue Spot PT Lite.
The system is composed of a light box generating light and a light pipe through which the light from the
LED is transmitted and projected upon patients.
1. Light box: The light box functions as the light generator, user control panel, and the device mounting
structure through use of a dovetail clamp. The light box contains the following major components:
Component Description
The therapeutic-light LED is mounted directly to a fan-cooled heat sink and also
has a built-in thermistor output which is used to produce the temperature fault
alarms. The thermistor signal is first conditioned by the LED driver board and
then routed to the control board. The LED assembly contains a reflector which
serves to narrow and direct the output LED light into the light pipe. A 12 VDC
Therapeutic- brushless fan is mounted to the heat sink. The fan pulls air from the lower
light LED chamber through a dividing baffle. The baffle ensures that the heat sink exhaust
assembly heat is directed to the exhaust vents to prevent recirculation. The fan is installed
in a certain position to pull air from the lower chamber (cool zone) to the upper
chamber (hot zone). Backward installation of the fan causes reverse air flow
from hot zone to cool zone and negatively impacts the heat sink cooling. During
over-temperature/under-temperature conditions, the fan keeps running to
bring the LED assembly temperature to the ambient temperature.
This board generates a 5 VDC supply for powering therapeutic-light LED and
control board and routes the 12 VDC supply to the cooling fan. The driver board
is set in the factory such that sufficient driver current for the therapeutic-
LED driver
light LED is provided. The voltage and current to the therapeutic-light LED are
board
factory-sealed and non-adjustable in the field. Therefore, the LED driver board
and the therapeutic-light LED assembly shall always be replaced in pair with a
new factory-set pair (Mixing and matching is not allowed.).
The control board is mounted to the inside of the unit cover and provides the
system controls, indicator LEDs, hour meter display, standby/on switch, and user
interface. The control board 5 VDC supply is provided by the LED driver board.
The control board sends the commands to the LED driver board to operate the
therapeutic-light LED and the fan.
Control board
The control board includes the hour meter display which shows the total
time the therapeutic-light LED is illuminated. The hour meter is not resettable.
Therefore, new product units ship with readings other than zero from the
factory because of production tests. The hour meter illuminates whenever the
AC power is provided to the system.
45
Chapter 6: System Description
Component Description
Colored indicators on the front face of the system provide information as to
the device status. The standby/on indicator is illuminated in green whenever
AC Power is applied and the system is in standby mode indicating there are no
alarms/faults and the system is ready to operate. When the standby/on switch
is briefly depressed to activate the system and turn light on, the standby/on
indicator turns blue and the over-temperature/under-temperature red indicator
briefly illuminates to indicate that it functions. Turning off the light is controlled
in the same fashion by pressing the standby/on switch to put the system in
User standby mode. The standby/on indicator turns green. The over-temperature/
interface under-temperature indicator provides alarm indications for both internal
indicators over-temperature and under-temperature conditions. The temperature limits
are factory set and non-adjustable. If the temperature limits are reached, the
therapeutic-light LED is automatically turned off but the internal fan continues
to operate during the fault conditions in order to bring the internal temperatures
back to normal operating conditions. Once the temperature is within the normal
range, the fan turns off and the standby/on indicator turns green signifying that
the device is ready for operation. The over-temperature/under-temperature
indicator is on continuously during under-temperature conditions and flashes
repeatedly during over-temperature conditions.
The system includes a universal switching power supply board that can accept
Power supply
AC input voltages in the range of 90-264 VAC at frequency range of 47-63 Hz to
board
generate 12 VDC output that feeds the LED driver board.
The power cord connects to the input power connector located on the bottom
Power input
of the device. This input power connector provides EMI protection and also
connection
houses two AC line fuses (T3.15A @ 250V~, slo-blo type) which are accessible
and fuses
from the outside of the system unit.
2. Light pipe: The light pipe provides a stable self-supporting, adjustable arm that allows easy, low-force
positioning of the light onto the patient. It also allows for easy unobstructed access for the operator
to the patient. The light pipe contains optical components; therefore it should be treated with
extreme care as damaging these components can severely diminish the light output. The light pipe
contains an internal fiber that is used to transmit the light generated by the light box out to the light
shade. The light shade includes an output reflector which serves to uniformly project the light over a
desired area. The shade also includes a protective cover which serves to enclose the output reflector,
protecting it from dust and debris while simultaneously protecting users from touching the fiber end.
If needed, the protective cover can be cleaned gently using an optical cleaner and a lint-free wipe.
46
Chapter 7: Installation
This chapter provides information required to prepare for and perform installation of the Giraffe Blue
Spot PT Lite.
Upon shipment, the light pipe is detached from the light box. Prior to first use, the light pipe needs to be
attached and secured to the light box as described in section 7.4.1.
The average installation time for the Giraffe Blue Spot PT Lite is about 5 minutes. The required checkout
procedures after installation take approximately 20 minutes.
The system shall be installed, serviced, and operated within the environmental conditions described in
section 5.2.
The hex key provided with the system (No other tools are required).
47
Chapter 7: Installation
1. Make sure that the system is unplugged from the power outlet.
2. Use the provided hex key to remove the top mounting screw on the back plate (Refer to
Figure 7-1).
3. Remove the plastic protective caps of the light pipe and the light pipe port. Remove the plastic
protective sleeve of the light pipe mounting clip.
4. Insert the light pipe tip into the light pipe port until the clip is aligned to the top mounting screw hole
(Refer to Figure 7-2).
48
Chapter 7: Installation
WARNING:
To avoid patient injury, do not mount the system while a patient occupies the bed.
1. Make sure the light pipe is securely attached to the system as instructed in section 7.4.1.
2. Use the provided hex key to loosen the two mounting screws on the side of the dovetail mount
bracket (Refer to Figure 7-3).
4. Secure the system to the dovetail rail by using the hex key to tighten the two mounting screws (Refer
to Figure 7-4).
Note: If you intend to plug the power cord into an accessory outlet on a microenvironment, refer to
the microenvironment manual for proper power cord connection.
5. Plug the power cord into the power inlet connector and rotate the retainer to grip and secure the
power cord and then plug it into the power outlet.
NOTE: If you intend to plug the power cord into an accessory outlet on a microenvironment, refer to
the microenvironment manual for proper power cord connection.
49
Chapter 7: Installation
50
Chapter 8: Service Maintenance and Checkout
This chapter includes planned maintenance procedures as well as checkout procedures required after
Giraffe Blue Spot PT Lite installation, repair, or corrective maintenance. These procedures must be
performed by authorized service personnel.
The following table lists all maintenance and checkout procedures, specifies when and how often each
procedure should be performed, and provides the average time that it takes to perform each procedure.
WARNING:
Do not service the Giraffe Blue Spot PT Lite while it is in clinical use, or attached to a warmer
or incubator with a patient in the bed.
CAUTION:
Table 8-1 shows the minimum frequencies required for maintenance. Always follow hospital
and local regulations for required frequencies.
The system shall be serviced and operated within the environmental conditions described in section 5.2.
51
Chapter 8: Service Maintenance and Checkout
The following table lists the service tools required to perform the planned maintenance and checkout
procedures:
2. Examine the power cord for any signs of damage. Replace the cord if damage is evident and perform
electrical safety test as instructed in section 8.4.3.
4. Examine the system overall for any damaged (cracked or broken) or missing parts, such as the plastic
unit cover, standby/on switch, standby/on indicator, over/under temperature indicator, hour meter
display, light pipe, light shade, air filter guard, or potential equalization stud. If any part is damaged or
missing, replace it (Refer to Chapter 11).
6. Examine the system for any missing or damaged labels. For a list of labels, and for the proper
location of each label, refer to section 12.2.
7. For units on portable roll stand, examine the roll stand for any damaged or missing parts. Check the
wheel locks of the roll stand and confirm that they are functional.
52
Chapter 8: Service Maintenance and Checkout
1. Move the light pipe to verify that it moves freely and stays in position.
NOTE: The light pipe will typically experience some minor deflection (less than 1.3cm) after
positioning.
2. Plug the power cord into the power outlet. Confirm that the hour meter display turns on and the
standby/on indicator illuminates in green.
3. Press and release the standby/on switch, and confirm the over-temperature/under-temperature red
indicator flashes briefly and the standby/on indicator changes to blue.
4. Confirm that the fan is operating by momentarily placing your hand close to the exhaust vent when
the device is on to feel the air flow coming out of the device.
WARNING:
Never look directly at the light. Exposure can cause eye damage.
53
Chapter 8: Service Maintenance and Checkout
- For a system plugged into a wall outlet, measure the leakage current and confirm that it is less than
500 microamperes.
- For a system plugged into an accessory outlet on a microenvironment, measure the leakage current
and confirm that it does not increase leakage current of the microenvironment by more than 500
microamperes.
Cleaning activity as described below can be done annually or whenever there is hazy reflective surfaces
or reduced light intensity is observed.
1. Remove the system from service an ensure that it is unplugged from any power outlet.
2. Use the Allen wrench to remove the Light Pipe from the Light Box. Do not remove the light shade
assembly from the light pipe for this preventive maintenance.
IMPORTANT: The clear protective cover of the light shade will need to be removed. It will be required
to ensure that the outside face of the protective cover remains facing outward when it is reinstalled.
If necessary, a removable sticker such as a Post-It note can be applied to the clear protective cover to
identify the outside surface. Do not use tape of any kind to mark the cover as this will leave adhesive
residue.
IMPORTANT: When using a moistened swab to clean the surfaces described below, only gentle pressure
should be applied. The hazing is easily cleared.
54
Chapter 8: Service Maintenance and Checkout
1. Hold the shade assembly with the clear protective cover facing up. Use a small flat head screwdriver
or equivalent to carefully pry the top end of the retaining spring out from the recessed groove. Be
careful to avoid scratching the cover. See Figures 8-1 and 8-2.
Figure 8-1
Figure 8-2
55
Chapter 8: Service Maintenance and Checkout
2. Once the retaining spring is completely removed, tilt the shade so that the clear protective cover falls
out while not losing track of the outside face. See Figure 8-3.
Figure 8-3
3. After removal of protective shade, output reflector and fiber end or glass disk are exposed (See Figure
8-4). Dip a clean optical swab in distilled/bottled water and be sure to shake off any excess. Use the
optical swab to gently wipe the exposed internal cone surface of the output reflector including the
fiber end or glass disc at the bottom of the reflector.
Figure 8-4
4. After cleaning the output reflector, reinstall the clear protective cover, paying attention to the outside
face, and then the retention spring by gently pressing the spring down against the glass and into the
groove on the inside of the shade head cone
56
Chapter 8: Service Maintenance and Checkout
8.4.4.3 Input Fiber Cleaning
1. With the light pipe removed from the light box, the proximal end of the fiber, or glass disc, can be
cleaned. Dip a new clean optical swab in distilled/bottled water and be sure to shake off any excess.
Use the optical swab to gently wipe the fiber surface or glass disc at the bullnose. See Figure 8-5.
.
Figure 8-5
2. Keep the Light Pipe aside and allow the surfaces to dry.
1. With the light pipe removed from the light box, the input reflector and LED can be cleaned. Dip a new
clean optical swab in distilled/bottled water and be sure to shake off any excess. Use the optical
swab to gently wipe inside surface of the reflector cone including the top of the LED. See Figures 8-6
and 8-7.
2. Once the Light Box surfaces have been allowed to thoroughly dry, the Light Pipe can be reinstalled
and complete the Light intensity Check (Refer to section 8.4.5) before being put back into service.
57
Chapter 8: Service Maintenance and Checkout
Figure 8-6
Figure 8-7
58
Chapter 8: Service Maintenance and Checkout
8.4.5 Light Intensity Check
In order to ensure uniform light distribution and the performance of all the optical components, perform
the following procedure.
2. Focus the light so that the spot diameter is 35.5 cm (14”) or when the shade is 38 cm (15”) from the
bed surface.
3. Using a calibrated Biliblanket Light Meter II, measure the light at the 5 points indicated on the below
diagram and calculate their average. Confirm that the average is at least 27 µW · cm-2 · nm-1. Refer to
symptom S11 in Chapter 10 for troubleshooting.
NOTE: IEC standards recommend LED module replacement at 25% output reduction, which
corresponds to 27 µW · cm-2 · nm-1 and occurs at approximately 10000 hours. However, sufficient
irradiance for effective phototherapy continues well after 25% reduction.
5 2
3.5”
1
3.5”
4 3
3.5” 3.5”
4. Divide the lowest reading by the highest reading. If the LED light is functioning properly, the result
should be greater than 0.4. Refer to symptom S12 in Chapter 10 for troubleshooting.
59
Chapter 8: Service Maintenance and Checkout
60
Chapter 9: Calibration
61
Chapter 9: Calibration
62
Chapter 10: Diagnostics and Troubleshooting
This chapter lists possible symptoms as well as the possible causes and solutions. For any necessary
part replacements or adjustments, follow the instructions provided in Chapter 11. Always read all the
warnings, cautions, notes, and other information provided in the “Important Service Safety Information”
before starting any troubleshooting.
NOTE: For each symptom, the possible causes are listed in a certain sequence to provide a quick and
effective troubleshooting guide. Therefore, investigate the possible causes of each symptom in order
from top to bottom to find the root cause of the symptom.
63
Chapter 10: Diagnostics and Troubleshooting
64
Chapter 10: Diagnostics and Troubleshooting
65
Chapter 10: Diagnostics and Troubleshooting
66
Chapter 10: Diagnostics and Troubleshooting
1. Access the system fuses as per instructions in section 11.2 to confirm that both fuses are present.
2. Verify the fuse continuity by measuring the fuse resistance using a multimeter.
3. If the fuse is open, try to locate a short circuit or other fault and fix it before replacing the fuse.
4. If no short circuits or wiring faults are found, replace the fuse as instructed in section 11.2.
67
Chapter 10: Diagnostics and Troubleshooting
10.2 Test Points and Adjustment Point Locations
3
2
6
5
4
68
Chapter 11: Replacement Procedures
This chapter describes the procedures used for replacement of the Giraffe Blue Spot PT Lite service parts.
After any replacement procedures, perform checkout procedures, as described in section 8.4.
Always read all the warnings, cautions, notes, and other information provided in “Important Service
Safety Information” on page 35 before starting any replacement or repair. All replacement and repair
procedures shall be performed by authorized service personnel only.
CAUTION:
Always perform electrical safety test after any replacement procedure.
NOTE: Standard service tools (such as a pair of small pliers, screwdrivers and nut drivers) and the
provided hex key tool are required to perform repair procedures.
69
Chapter 11: Replacement Procedures
1. Press the left and right sides of the air filter guard inward to release the guard and remove the filter
(Refer to Figure 11-1).
2. To re-install, put the air filter on the vents. Place the guard on the filter and insert the tabs into their
corresponding slots on the system to hold the filter in place.
1. Make sure the system power cord is unplugged from the power outlet.
2. Release the power cord retainer to unplug the power cord from the system.
3. Use a flat-head screwdriver to open the fuse compartment lid of the power inlet module and pull the
compartment out to access the fuses (Refer to Figure 11-2).
5. Replace these fuses with the two fuses (T3.15A @ 250V~, slo-blo type) in fuse kit 6600-0730-214.
CAUTION:
Always use the fuse type recommended by GE Healthcare for fuse replacement.
70
Chapter 11: Replacement Procedures
1. Make sure the system power cord is unplugged from the power outlet.
2. Use the provided hex key tool to loosen the two screws on the mounting bracket in the rear side of
the system and detach the system from the dovetail rail of the bed (Refer to Figure 11-3).
3. Lay the system on its front side on a flat surface. Use the provided hex key tool to remove the
mounting screw that attaches the light pipe ground clip to the device and detach the light pipe (Refer
to Figure 11-4).
4. To remove the O-rings, rotate the light pipe while pulling out the O-rings.
5. To remove the ground clip, hold the light pipe end close to the clip firmly and then use a pair of long
nose or pliers to pull out the clip.
CAUTION:
The LED light output is susceptible to dust and dirt. When the light pipe is detached
from the system, take care that dust or dirt does not get into the light pipe port on the
light box. When storing system with open light pipe port for an extended period, cover
the light pipe port.
71
Chapter 11: Replacement Procedures
1. Inspect the protective cover on the light shade and ensure that any protective plastic film from the
factory has been previously removed from the protective cover. See figure below.
2. Make sure the system power cord is unplugged from the power outlet.
3. Roll the shade sleeve up to access the orange tape underneath and remove the tape (Refer to Figure
11-5 which shows the shade with orange tape removed).
4. Use a pair of small pliers, or any appropriate tool, to grip and remove the plastic pin to release the
shade (Refer to Figure 11-6).
NOTE: When replacing the light shade, make sure to not touch the fiber. Residual dirt or grease on
the fiber can decrease the light output.
72
Chapter 11: Replacement Procedures
1. Make sure the system power cord is unplugged from the power outlet.
3. Release the power cord retainer to unplug the power cord from the system.
4. Use a Philips screwdriver to remove the back plate screws (Refer to Figure 11-7).
5. Slide off the unit cover gently until the control board harness is accessible and disconnect the
harness from the LED driver board (Refer to Figure 11-8).
6. To remove the control board, use a Philips screwdriver to remove the control board screws and pull
out the fish paper, control board and the LCD cover.
NOTE: When re-installing the unit cover, ensure the standby/on switch is aligned properly with its
corresponding hole on the unit cover prior to cover installation.
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Chapter 11: Replacement Procedures
1. Make sure the system power cord is unplugged from the power outlet.
2. Release the power cord retainer and pull the power cord out of the power inlet module.
5. Unplug the AC harness wires from the power module (Refer to Figure 11-9). Note how AC wires are
connected to power module terminals before unplugging them to avoid wrong connections during
re-installment.
6. Use a Philips screwdriver to remove the power inlet module screws and pull the module out.
7. To remove the AC harness, disconnect the AC harness from the power supply board. To remove the
AC harness ground wire, use a 7 mm nut driver to remove the nut that attached the wire to the back
plate to release the ground wire (Refer to Figure 11-10).
8. To remove the DC harness, disconnect the harness from the LED driver board and from the power
supply board.
CAUTION:
When re-installing, make sure to connect the AC harness phase and neutral wires
correctly to their corresponding terminals on power inlet module.
74
Chapter 11: Replacement Procedures
WARNING:
When replacing the LED module, always make sure the system power cord is unplugged
from the power outlet.
WARNING:
Never look directly at the therapeutic-light LED. Exposure can cause eye damage.
CAUTION:
The LED driver board and the LED module shall always be replaced in pair with a new
factory-set pair. Mixing and matching is not allowed.
SENSITIVE TO ELECTROSTATIC DISCHARGE CAUTION
This procedure includes ESD sensitive parts. ESD control guidelines must be followed
during this procedure to ensure that static charges are safely conducted to the ground
and not through the sensitive device, to prevent damage to the equipment.
1. Make sure the system power cord is unplugged from the power outlet.
3. Disconnect the LED anode and cathode wires from the LED driver board and pull them away from the
baffle (Refer to Figure 11-11).
4. Disconnect the thermistor harness from the LED driver board and pull it away from the baffle (Refer
to Figure 11-12).
5. To remove the LED driver board, disconnect the DC harness and the fan wire connector from the LED
driver board and then use a 5.5mm nut driver to remove the LED driver board nuts to release it.
75
Chapter 11: Replacement Procedures
6. Use a 5.5mm nut driver to remove the nut that attached the LED Ground Harness to the back plate to
release the harness (Refer to Figure 11-10 ).
7. Use a 7mm nut driver to remove the nuts that attach the LED module to the back plate and pull out
the whole module and fan assembly (Refer to Figure 11-13).
NOTE: Skip step 8 if the LED module FRU kit is ordered for replacement. The kit contains the LED
module with a new fan attached to it.
8. To remove the fan, use a Philips screwdriver to remove the fan screws to release the fan (Refer to
Figure 11-14 ).
NOTE: When re-installing the fan, make sure that the arrow symbol on the top side of the fan
points towards the heat sink to avoid backward installation (Refer to Figure 11-15 ). Furthermore, to
re‑install the baffle, position it such that the baffle holes are on the left side (Refer to Figure 11-16 ).
76
Chapter 11: Replacement Procedures
1. Make sure the system power cord is unplugged from the power outlet.
4. Use a 5.5mm nut driver to remove the nuts that attach the power supply board to the back plate to
release it.
77
Chapter 11: Replacement Procedures
78
Chapter 12: Service Parts
This chapter illustrates the Giraffe Blue Spot PT Lite service parts and includes the orderable service kit/
component part numbers. A complete Field Replaceable Unit (FRU) list and a wiring diagram are also
provided.
79
Chapter 12: Service Parts
3 4
23
2, 2*
1
21, 22 (hidden)
17
15 16
5
8
6
7 20
19
18
13, 14
10
11
12 (hidden)
80
Chapter 12: Service Parts
Orderable Service
Callout Part Description Orderable Service Part Description
Part Number
M1225847 Cover FRU Kit (English)
M1225849 Cover FRU Kit (German)
M1225851 Cover FRU Kit (Spain)
M1225852 Cover FRU Kit (Italian)
M1225853 Cover FRU Kit (Dutch)
M1225855 Cover FRU Kit (French)
M1225856 Cover FRU Kit (Danish)
M1225857 Cover FRU Kit (Swedish)
M1225858 Cover FRU Kit (Czech)
M1225859 Cover FRU Kit (Polish)
M1225860 Cover FRU Kit (Chinese)
M1225870 Cover FRU Kit (Japanese)
M1225861 Cover FRU Kit (Finnish)
M1225862 Cover FRU Kit (Greek)
M1225863 Cover FRU Kit (Hungarian)
1 Unit cover
M1225864 Cover FRU Kit (Korean)
M1225865 Cover FRU Kit (Norwegian)
M1225867 Cover FRU Kit (Portuguese)
M1225868 Cover FRU Kit (Russian)
M1225869 Cover FRU Kit (Turkish)
M1236610 Cover FRU Kit (French/English)
2063154-001 Cover FRU Kit (Lithuanian)
2063156-001 Cover FRU Kit (Romanian)
2063158-001 Cover FRU Kit (Bulgarian)
2063160-001 Cover FRU Kit (Estonian)
2063162-001 Cover FRU Kit (Indonesian)
2063164-001 Cover FRU Kit (Latvian)
2063166-001 Cover FRU Kit (Serbian)
2063168-001 Cover FRU Kit (Slovakian)
2063926-001 Cover FRU Kit (Croation)
2 LED module M1225811 LED Module FRU Kit
2* LED module with new connector 5835947 LED Module FRU Kit, New Connector*
3 Back plate Non-orderable Non-orderable
4 Screw, M4 M1225820** Hardware FRU Kit or Cover FRU Kit
5 Power entry module 2065981-001 Power Entry Module FRU Kit
6 Power cord retention clip M1225819 Power Cord Retention FRU Kit
7 Air filter guard M1225816 Air Filter FRU Kit
M1225816 or
8 Air filter foam Air Filter FRU Kit or Air Filters (pack of 12)
M1232009
9 Screw, hex M1225820 Hardware FRU Kit
10 Dovetail rail lock M1225818 Dovetail Lock FRU Kit
11 Potential equalization stud M1225820 Hardware FRU Kit
12 Fuses, T3.15A, 250V, “slow blow” 6600-0730-214 Fuse FRU Kit
M1225820 or
13 Screw, Phillips Hardware FRU Kit or Power Cord Retention FRU Kit
M1225819
M1225820 or
14 Bar, retaining clip Hardware FRU Kit or Power Cord Retention FRU Kit
M1225819
15 AC harness ground wire M1225820 Hardware FRU Kit
81
Chapter 12: Service Parts
Orderable Service
Callout Part Description Orderable Service Part Description
Part Number
M1225817 or
16 LED ground harness Harness FRU Kit or LED module FRU Kit
M1225811
17 AC harness ground wire M1225817 Harness FRU Kit
18 Nut, M3 Nylok M1225820 Hardware FRU Kit
19 Spacer, nylon, 0.14” ID, 0.125”LG M1225820 Hardware FRU Kit
20 Rubber washer M1225820 Hardware FRU Kit
21 Cable tie M1225820 Hardware FRU Kit
22 Clip mount M1225820 Hardware FRU Kit
23 Washer M4, External tooth M1225820** Hardware FRU Kit or Cover FRU Kit
* Item 2: Check the serial number located on the light box and refer to the table on page 82 for FRU kit compatibility.
** Items 4 and 23: These parts can be ordered as part of the Cover FRU kits as well. See callout 1 for Cover FRU kit part numbers.
Beginning January 1st, 2020, all Blue Spot PT systems will be manufactured using a new style of connector, which is not backwards
compatible with the original. This new connector is found on the following three main components: Driver PCBA (LED Module FRU),
Control PCBA, Control Harness (Wire Harness FRU). To reduce the impact on the end user of the product, the LED Module, Control
PCBA, and Wire Harness FRU kits will be available with both the old style and new style of connector. Due to the incompatibility
between the parts, the system serial number must be used to determine which kit to order. The table below shows the correct kit to
order according to the serial number.
The 4th letter indicates the year of manufacture. For example, P=2010, Q=2011, Y=2019, Z=2020, and A=2021. I and O are not used.
The last 5 Digits indicate the running numeric serial number for that year.
82
Chapter 12: Service Parts
Orderable
Callout Part Description Service Part Orderable Service Part Description
Number
1 Light pipe assembly M1225812 Light Pipe FRU Kit *
M1225812 or
2 Grounding Clip 2075264-001 Light Pipe FRU Kit * or Grounding Clip FRU kit
M1225812 or Light Pipe FRU Kit* or Light pipe O-ring FRU kit
3 O-RING, Dash #022 EP M1226989
* This service kit contains a light pipe with an attached light shade, grounding clip and already-lubriacted O-rings. To see contents
of the service kit, or Light pipe O-ring FRU kit, refer to section 12.4.2.
83
Chapter 12: Service Parts
Orderable
Callout Part Description Service Part Orderable Service Part Description
Number
1 Sleeve, shade M1225813 Light Shade FRU Kit
2 Tape, orange M1225813 Light Shade FRU Kit
3 Retention pin, shade M1225813 Light Shade FRU Kit
4 Light shade M1225813 Light Shade FRU Kit
Orderable
Callout Part Description Service Part Orderable Service Part Description
Number
1 3” Woven Optical Swab 5514193 30 pc Multi pack 3” Woven Optical Swab
84
Chapter 12: Service Parts
2*
7
5
4 6
*For part compatibility, check the unit serial number and refer to page 82 for details
85
Chapter 12: Service Parts
2 6
Orderable Service
Callout Part Description Orderable Service Part Description
Part Number
1 LED Heatsink Assembly M1225811 or 5835947 LED Module FRU Kit***
M1225811 or 5835947 LED Module FRU Kit or Harness FRU Kit***
2 Cathode harness (black)* or M1225817
3 Driver board M1225811 or 5835947 LED Module FRU Kit***
M1225811 or 5835947 LED Module FRU Kit*** or Harness FRU Kit***
4 Anode harness (red)* or M1225817
5 Baffle M1225811 or 5835947 LED Module FRU Kit***
M1225811 or 5835947 LED Module FRU Kit*** or Fan FRU Kit***
6 Fan ** or M1236301
M1225811 or 5835947 Harness FRU Kit*** or LED Module FRU Kit***
7 LED Harness Ferrite or M1225817
* Anode & Cathode harnesses are also orderable through Harness FRU Kit. Refer to Figure 12-7 and section 12.4.2 to see the kit
contents.
** Fan is also orderable through Fan FRU Kit. Refer to section 12.4.2 to see the Fan FRU Kit contents.
*** Check the unit serial number for part compatibility, see page 82 for details.
86
Chapter 12: Service Parts
10
Orderable
Callout Part Description Service Part Orderable Service Part Description
Number
1 LED driver board support Non-orderable Non-orderable
2 Power supply M1226990 Power Supply FRU Kit
3 DC harness M1225817 Harness FRU Kit*
4 Power entry module 2065981-001 Power Entry Module FRU Kit
5 AC harness (hot & neutral) M1225817 Harness FRU Kit*
6 AC harness (ground) M1225817 Harness FRU Kit*
7 Hex Nut, M4 with tooth washer M1225820 Hardware FRU Kit
M1225820 or
8 Nut, M3, Nylok Hardware FRU Kit or Power supply FRU Kit
M1226990
M1225820 or
9 Spacer, Nylon, 0.14”ID x 0.25” LG Hardware FRU Kit or Power supply FRU Kit
M1226990
10 Back plate Non-orderable Non-orderable
* For part compatibility with your system, please check your serial number and refer to page 82 for details.
87
Chapter 12: Service Parts
ANODE CATHODE
(RED) (BLACK)
4 5 CONTROL
LED GROUND THERMISTOR 6, 6*
HARNESS
1 2 AC HARNESS
7
DC HARNESS
* For part compatibility, check the unit serial number and refer to page 82 for details.
88
Chapter 12: Service Parts
2
5
3* 3*
4
3* 3*
Orderable Part
Callout Label Description Orderable Part Description
Number
1 GE logo label M1231816 GE logo label
2 Giraffe brand label M1229489 Giraffe brand label
3* Warning Label Non-orderable Non-orderable
4 Serial Number Label Non-orderable Non-orderable
5 Date of Manufacture Label Non-orderable Non-orderable
*Warning labels are not orderable. Order an appropriate cover FRU Kit (see
Figure 12-1) to get a new unit cover with a language-specific warning label
attached to it.
89
Chapter 12: Service Parts
12.2 Labels
This section includes the Giraffe Blue Spot PT Lite labels. Labels are available in a variety of languages. If you
do not see labels in your language, please contact your service representative. For the location of each label,
refer to Figure 12-8.
NOTE: The following labels shown are for illustration purposes only. The content on the labels shown here
may be slightly different from the content of the actual labels on the system.
NOTE: Warning labels are not orderable. Order appropriate cover FRU Kit.
90
Chapter 12: Service Parts
91
Chapter 12: Service Parts
* For part compatibility, check unit serial number and refer to page 82 for details.
92
Chapter 12: Service Parts
*See Unit Cover on page 81 for appropriate language-specific Cover FRU Kit part numbers.
93
Chapter 12: Service Parts
Wiring Diagram
LED
Module
Therapeutic
Light LED
Ferrite
Heat sink
Thermistor1 1
Cathode Harness
Thermistor2
+5VDC Fan Heatsink
Ground
Anode Harness
GND
Enable Wire
Fan ON
Harness
Thermistor
Harness
Fan
LCD Display
Hour Meter P2
Cable
P3 P4
1
P6
Ferrite
P2
Control P7
P5
Harness
Control Board Pro
Protecve
DC Harness Earth
Ea
+12VDC
GND
J2
ower Supply
Power y Board
Supply Board
J1
AC Harness
Earth
L2
L1
94
Part III: Electromagnetic Compatibility
(EMC) Guidance and Declarations
(Operators and Service)
95
Part III: Electromagnetic Compatibility (EMC) Guidance and Declarations (Operators and Service)
96
Chapter 13: Electromagnetic Compatibility (EMC)
Guidance and Declarations
WARNING:
Medical Electrical Equipment needs special precautions regarding EMC and needs to be installed
and put into service according to the EMC information provided in this appendix.
WARNING:
Do not use the Blue Spot PT near High Frequency Surgical or MRI equipment.
WARNING:
Cell phones, walkie-talkies and other portable radio devices can degrade the Blue Spot PT
performance. Do not use such devices within 30 cm (12 inches) of the Blue Spot PT Light Box power
cord.
WARNING:
The Blue Spot PT may disrupt other nearby equipment. Relocate or reorient the devices to stop the
interference.
WARNING:
Stacking the Blue Spot PT with other equipment should be avoided. All equipment should be
checked that it is operating properly if the equipment is stacked. Improper operation of the
Blue Spot PT or the other devices can result.
WARNING:
To keep disruption of equipment at a minimum, only use replacement parts or power cords
provided by the manufacturer. Do not use extension cords.
The Giraffe Blue Spot PT is intended to be used in a hospital setting. Use of the Giraffe Blue Spot PT in
other settings may result in disruption of nearby devices, or the Giraffe Blue Spot PT itself.
Hospital personnel trained in the use of the Giraffe Blue Spot PT are the intended users.
Under normal operating conditions, the spectral irradiance output will be 45 μW · cm-2 · nm-1 +25%/ -20%
(after a 5 minute warm-up time, and 38 cm from the light shade to the center of the spot measured by a
calibrated Biliblanket Light Meter II).
97
Chapter 13: Electromagnetic Compatibility (EMC) Guidance and Declarations
13.1.2 Degraded Performance Characteristics
High levels of electromagnetic disturbance near the Giraffe Blue Spot PT can cause:
• Jumbled Hour Meter display.
• Blinking of the blue light output.
• Failure of the unit to emit blue light.
If the above disturbances are noticed, relocate the unit or the device causing the disturbance. Power
cycle Giraffe Blue Spot PT to restore normal operation. Contact service personnel, if the unit does not
operate.
NOTE: This equipment has been tested and found to comply with the limits for medical devices to
IEC 60601-1-2-2014 4th edition. These limits and test levels are intended to provide reasonable safety
with regard to electromagnetic disturbances when the device is used in a typical medical installation.
The Giraffe Blue Spot PT Lite is intended for use in the electromagnetic environment specified below. The
customer or the user of the Giraffe Blue Spot PT Lite should assure that it is used in such an environment.
98
Chapter 13: Electromagnetic Compatibility (EMC) Guidance and Declarations
13.3 Manufacturer’s Guidance and Declaration Regarding
Electromagnetic Immunity
The Giraffe Blue Spot PT Lite is intended for use in the electromagnetic environment specified below. The
customer or the user of the Giraffe Blue Spot PT Lite should assure that it is used in such an environment.
99
Chapter 13: Electromagnetic Compatibility (EMC) Guidance and Declarations
NOTE 2: The Giraffe Blue Spot PT should be observed to verify normal operation. If abnormal
performance is observed, additional measures may be necessary, such as reorienting or relocating the
Giraffe Blue Spot PT.
100
Chapter 13: Electromagnetic Compatibility (EMC) Guidance and Declarations
The Giraffe Blue Spot PT Lite is intended for use in the RF wireless environment specified below. The
customer or the user of the Giraffe Blue Spot PT Lite should assure that it is used in such an environment.
18 Hz
CDMA 850
930
LTE Band 5
1720 1700-1900 GSM 1800 50% Pulse 2 0.3 28
Modulation
CDMA 1900
1845 217 Hz
GSM 1900
1970 DECT
LTE Band
1,3,4,25 UMTS
101
Chapter 13: Electromagnetic Compatibility (EMC) Guidance and Declarations
RFID 2450
LTE Band 7
5240 5100-5800 WLAN 802.11 50% Pulse 0.2 0.3 9
a/n Modulation
5500
5785 217 Hz
The EMC Service Life will match the Expected Service Life of the product defined in Chapter 5 by:
• Following the recommended service and maintenance schedule found in the Service and
Maintenance Instructions (Part II of this manual).
• Using only recommended service parts as found in Chapter 12 within the Service and Maintenance
portion of this manual (Part II).
102
附录 A: 电磁兼容性 (EMC)
小心
1. 在系统附近使用便携式电话或其他射频辐射会设备,可能会对操作造成不可预料或
者不良的影响。
2. 该设备或系统不可在其他设备附近使用,或与其他设备堆叠放置。如果必须在其他
设备附近使用或与其他设备堆放在一起使用,应对该设备或系统进行测试,以确保
在使用的配置下能够正常工作。
A.1 电磁发射
GB 4824/ EN 55011
设备使用射频能量只是为了实现其内部功
射频发射 GB 4824/ EN 55011 A类 能。因此,其射频发射量非常低,不大
可能对附近的电子设备造成任何干扰。
电谐波发射 A类
设备仅适用于医院或门诊。该设备不适用
GB 17625.2/EN 61000-3-3
于为民用建筑供电的公用低电压电力网。
电压波动/闪烁发射 符合
GB 17625.2/EN 61000-3-3
103
附录 A
警告
除制造商作为内部元器件的备件出售的附件和电缆外,使用规定外的附件和电缆可能导
致设备或系统发射的增加或抗扰度的降低。
104
附录 A)
便携式和移动射频通信设备与Giraffe Blue Spot PT Lite 新生儿黄疸治疗仪之间的建议分隔距离
Giraffe Blue Spot PT Lite适合用于辐射射频干扰受到控制的电磁环境。客户或用户按照
下面的建议将便携式和移动射频通信设备(发射器)与Giraffe Blue Spot PT Lite 之间的
距离保持在最低(根据通信设备的最大输出功率),可帮助防止电磁干扰。
根据发射器频率计算出的分隔距离
(m)
发射器的最大 150 kHz 至 80 MHz 80 MHz 至 800 MHz 800 MHz 至 2.5 GHz
额定输出功率
3. 5 3. 5 7
d= P d= P d= P
(W) V1 E1 E1
3Vrms 3V/m 10V/m 3V/m 10V/m
0.01 0.12 0.12 0.04 0.23 0.07
0.1 0.38 0.38 0.11 0.73 0.22
1 1.2 1.2 0.35 2.3 0.7
10 3.8 3.8 1.11 7.3 2.2
100 12 12 1.11 23 7
注意 2:这些准则可能不适用于所有情况。建筑、物体和人体对电磁的吸收和反射会影响电磁传播。
A.2 CE 标记信息
合规性
105
附录 A
A.3 建议
用户应了解已知的射频源(如无线电广播或电视台和手持或移动双向无线电设备),
并在安装医疗设备或系统时将它们考虑进去。请注意,添加附件或元件,或修改医疗
设备或系统可能会降低 EMI 性能。有关系统配置的更改问题,请咨询合格人员。
在高于针对辐射抗扰性(磁场强度超过 3 V/m)的 EMC 标准 YY 0505—2012/EN60601-1-2
规定的条件下,在射频电磁干扰 (EMI) 附近操作系统可能会导致发生故障。
医疗电气设备需要采取特别的 EMC 预防措施,且需要按照本手册中提供的 EMC 信息进
行安装和使用。请参考美国医疗器械促进协会委员会 (AAMI Committee) 技术信息报告
(TIR) 18“关于临床/生物医学工程师的医疗设备电磁兼容性指南”。该指南文档提供了
一种评估和管理医院中 EMI 环境的方法。可执行以下操作来降低医疗设备 EMI 的风险
并达到 EMC 标准:
• 评估医疗保健设施的 EMC 环境(例如确定设施附近的无线电发射器),
并确定使用重要医疗设备的区域(如 ER、ICU、CCU、NICU)。
• 增加 EMI 源与敏感设备之间的距离。
• 移除对 EMI 高度敏感的设备。
• 在医院控制(即传呼系统)下,降低电气和电子设备(EMI 源)的传输功耗。
标记对 EMI 敏感的设备。
• 教导医疗保健设施工作人员(护士和医生)了解并认识潜在的与 EMI 相关的
问题。
注意
说明 编号
设备的序列号
注意:有关设备的序列号,请参见灯具上的规格标签。在上面提供的空间中记录设备的
序列号以供参考。
106
World Headquarters
GE Healthcare
9900 Innovation Drive
Wauwatosa, WI 53226 USA
Tel 1 800 345 2700