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使用說明

EDAN

iM50/iM60/iM70/iM80

病人監護儀

1.0版

0123

闡明書信息

部件號:01.54.456438-10發行時間:2023年4月版權?深圳市理邦精密儀器股份有限企業2023

申明

本闡明書為操作、保養和維修產品H勺參照資料。顧客應嚴格根據闡明書內容操作,對于不按

照闡明書內容操作而導致口勺故障或事故,深圳市理邦精密儀器股份有限企業(如下簡稱“理邦儀

器”)不承擔任何法律責任。

理邦儀器擁有本闡明書中所有內容日勺版權,未經我司的明確書面許可,任

何人不得攝影復制、復印或翻譯成其他語言。本產品闡明書包括受版權法保護

的專有資料,包括但不限于技術秘密、專利信息等商業秘密,顧客具有保密義

務,不得向無關第三方披露本闡明書中H勺任何內容。顧客持有本產品闡明書并

不表達理邦儀器對產品所含知識產權的授權許可。本闡明書日勺修改權、更新權

及最終解釋權均屬于理邦儀器。

注冊信息

醫療器械生產企業許可證編號:粵食藥監械生產許20230086號

粵制()0()00556號

產品注冊證號:國食藥監械(準)字2023第3210404號執行原則號:YZB/國0681-2023產品名

稱:病人監護儀產品型號:iM50、iM60、iM70、iM80

制造商的責任

理邦儀器僅在下列狀況下才認為應對儀器H勺安全性、可靠性和性能負責,即:裝配操作、

擴充、重調、改善和維修均由理邦儀器承認H勺人員進行,對應房間的電氣安裝環境符合國標,以

及儀器按照操作指導進行使用。

理邦儀器將在顧客提出規定期有償提供電路圖及其他信息,以協助顧客由合適H勺、合格的

技術人員來維修那些理邦儀器歸類為可由顧客維修的儀器部分。

本闡明書日勺術語闡明

警告:針對也許導致人員傷亡日勺操作或情形。

小心:針對也許導致設備損壞、產生錯誤數據,或使過程失效的操作或情形。

注意:您應當理解的重要信息。

目錄

1預期用途和安全信息............................................................1

1.1預期用途...................................................................1

1.2安全信息..................................................................1

1.3監護儀上使用的符號的解釋.................................................3

2安裝..........................................................................7

2.1初始檢查..................................................................7

2.2安裝監護儀................................................................7

2.2.1將監護儀置于水平臺面上.................................................7

2.2.2安裝到墻上.............................................................7

2.2.3安裝到臺車上...........................................................7

2.3連接交流電源線............................................................7

2.4檢查監護儀................................................................8

2.5檢杳記錄儀................................................................8

2.6設定日期與時間............................................................8

2.7移交監護儀................................................................8

3基本操作.....................................................................9

3.1概況......................................................................9

3.1.1正面圖.................................................................9

3.1.2背面圖................................................................12

3.1.3側面圖.................................................................15

3.1.4功能配置...............................................................16

3.2操作與瀏覽...............................................................17

3.2.1使用按鍵..............................................................18

3.3工作模式................................................................20

3.3.1Y黃工I.....................................................................20

3.3.2待機模式..............................................................20

333夜間模式..............................................................20

3.4更改監護儀設置...........................................................20

3.4.1調整屏幕亮度..........................................................20

3.4.2更改日期與時間........................................................21

3.5調整音量.................................................................21

3.5.1設置鍵盤音量..........................................................21

3.5.2設置報警音量..........................................................21

3.5.3調整心跳音量..........................................................21

3.6檢查監護儀版本...........................................................21

3.7聯網監護.................................................................21

3.8設置語言.................................................................22

3.9理解屏幕.................................................................22

3.10觸摸屏校準..............................................................22

3.11嚴禁觸摸屏操作..........................................................22

3.12使用條形碼掃描儀........................................................22

3.13處理IBP標名沖突........................................................23

4報警.........................................................................24

4.1報警分類.................................................................24

4.1.1生理報警..............................................................24

4.1.2技術報警..............................................................24

4.1.3提醒信息..............................................................24

4.2報警級別.................................................................24

4.3報警控制.................................................................25

4.3.1設置參數報警..........................................................25

4.3.2報警音暫停............................................................26

4.3.3靜音...................................................................26

4.3.4報警音量控制..........................................................26

4.4報警栓鎖.................................................................26

4.5探頭脫落報警.............................................................27

4.6報警自檢.................................................................27

5報警信息列表.................................................................28

5.1患者報警消息.............................................................28

5.2技術報警.................................................................31

5.3提醒信息.................................................................42

5.4報警限范圍...............................................................43

6管理病人.....................................................................48

6.1接受病人.................................................................48

6.1.1病人類型和“起搏的”狀態...............................................49

6.2迅速接受病人.............................................................49

6.3編輯病人資料.............................................................49

6.4更新病人.................................................................49

6.5中央監護系統.............................................................50

7顧客界面.....................................................................51

7.1設置界面風格.............................................................51

7.2選擇參數.................................................................51

7.3更改波形.................................................................51

7.4更改界面布局.............................................................51

7.5觀測趨勢共存.............................................................51

7.6觀測呼吸氧合圖...........................................................52

7.7大字體界面...............................................................52

7.8它床觀測.................................................................52

7.8.1打開它床觀測窗口......................................................53

7.8.2設置它床觀測窗口.....................................................53

7.9更改參數和波形顏色.......................................................53

7.10顧客配置管理............................................................53

7.11默認配置................................................................54

8監護ECG........................................................................................................................................55

8.1概述.....................................................................55

3.2安全信息.................................................................55

8.3ECG顯示................................................................56

8.3.1更改ECG波形大小.....................................................56

8.3.2更改ECG濾波設定.....................................................57

8.4使用ECG報警............................................................57

8.5選擇計算導聯.............................................................57

8.6ECG監護................................................................57

8.6.1備皮以供粘貼電極......................................................57

8.6.2連接心電圖電纜........................................................58

8.7選擇導聯類型............................................................58

8.8安裝電極................................................................58

8.8.13導聯日勺電極安放......................................................59

8.8.25導聯日勺電極安放......................................................59

8.8.312導聯的電極安放.....................................................61

8.8.4為外科患者推薦日勺ECG導聯連接.......................................62

8.9ECG菜單設置...........................................................63

8.9.1設置心率報警源........................................................63

8.9.2智能導聯脫落..........................................................63

8.9.3心跳音量..............................................................64

8.9.4ECG監護類型.........................................................64

8.9.5設定起搏狀態..........................................................64

8.9.6ECG校準.............................................................65

8.9.7ECG波形設置.........................................................65

8.10ST分析.................................................................65

8.10.1打開和關閉ST...............................................................................................................65

8.10.2ST顯示.............................................................66

8.10.3報警限設置..........................................................66

8.10.4確定ST段分析點.....................................................66

8.10.5調整ISO、ST測量點.................................................66

3.11心律失常監護..........................................................67

8.11.1心律失常分析........................................................67

8.11.2心律失常分析菜單....................................................68

8.1212導監護...............................................................68

8.12.1進入12導監護界面...................................................68

8.12.212導診斷回憶........................................................69

9監護RESP......................................................................................................................................70

9.1概述.....................................................................70

9.2安全信息................................................................70

9.3安放呼吸電極............................................................70

9.4心臟重疊................................................................71

9.5胸廓擴張................................................................71

9.6腹式呼吸................................................................71

9.7選擇呼吸導聯............................................................71

9.8更改計算類型............................................................71

9.9更改波形.................................................................72

9.10使用“呼吸”報警..........................................................72

9.11設置窒息報警時間........................................................72

10監護SpO2.................................................................73

10.1概述....................................................................73

10.2安全信息...............................................................73

10.3SpO2測量...............................................................74

10.4測量環節................................................................74

10.5理解SpCh報警..........................................................75

10.6調整報警限..............................................................75

10.7將SpO2/Pleth(體積插記)設為脈搏源......................................75

10.8設置脈搏調制音.........................................................75

10.9設置敏捷度.............................................................75

10.1()SI(信號強度)........................................................76

11監護PR...................................................................77

11.1概述....................................................................77

11.2設置PR來源...........................................................77

11.3設置脈搏音量............................................................77

11.4使用脈搏報警............................................................77

11.5選擇處在活動的報警源...................................................77

12監護NIBP.................................................................................................................................78

12.1概述....................................................................78

12.2安全信息................................................................78

12.3簡介NIBP測量..........................................................79

12.4測量的限制..............................................................79

12.5測量模式................................................................79

12.6測量環節................................................................80

12.7操作提醒................................................................8()

12.8肢體與心臟不在同一水平高度時對測量的修正...............................81

12.9NIBP報警...............................................................81

12.10NIBP復位..............................................................81

12.11NIBP校準..............................................................81

12.12漏氣檢測...............................................................82

12.12.1漏氣檢測過程........................................................82

12.13設置預充氣模式.........................................................83

13監護TEMP..................................................................................................................................84

13.1概述....................................................................84

13.2安全信息................................................................84

13.3溫度測量設置............................................................84

13.4計算溫差................................................................84

14監護IBP........................................................................................................................................85

14.1概述....................................................................85

14.2安全信息................................................................85

14.3監護環節................................................................85

14.4選擇監護的壓力..........................................................86

14.5壓力傳感器校零..........................................................86

14.6壓力測量校零............................................................87

14.7壓力校零故障排除(以Art為例闡明).....................................87

14.8IBP壓力校準............................................................87

14.9壓力校準故障排除........................................................89

14.10IBP報警...............................................................89

14.11更改IBP波形標尺......................................................89

15監護CO2............................................................90

15.1概述....................................................................90

15.2安全信息................................................................90

15.3監護環節................................................................91

15.3.1傳感器校零...........................................................91

15.3.2旁流CCh模塊測量設置................................................91

15.3.3主流CO2模塊測量設置................................................93

15.4設置CO2波形............................................................95

15.5修正CCh...........................................................................................................................95

15.6CO2報警................................................................95

15.7設置窒息報警延遲........................................................96

16監護AG.............................................................97

16.1概述....................................................................97

16.2安全信息................................................................97

16.2.1旁流式麻醉模塊的安全信息............................................97

16.2.2主流式麻醉模塊H勺安全信息.............................................99

16.3監護環節..............................................................100

16.3.1旁流式的監護環節....................................................100

16.3.2主流式歐I監護環節....................................................102

16.4設置窒息報警時間......................................................106

16.5旁流式麻醉模塊日勺工作狀態..............................................106

16.6主流式麻醉模塊日勺工作狀態.............................................106

16.702賠償................................................................107

16.8濕度影響...............................................................107

17凍結......................................................................108

17.1概述..................................................................108

17.2凍結狀態的進入與退出..................................................108

17.2.1進入凍結狀態.......................................................108

17.2.2退出凍結狀態.......................................................108

17.3凍結波形回憶..........................................................109

18回憶......................................................................110

18.1趨勢圖回憶............................................................110

18.1.1挑選不一樣參數H勺趨勢圖顯示...........................................110

18.1.2調整幅度...........................................................110

18.1.3設定辨別率.........................................................111

18.1.4移動圖形...........................................................111

18.1.5切換到趨勢表.......................................................111

18.1.6在記錄儀上輸出趨勢曲線............................................111

18.2趨勢表回憶.............................................................111

18.2.1設置辨別率..........................................................111

18.2.2移動圖形............................................................111

18.2.3切換到趨勢圖........................................................112

18.2.4在記錄儀上輸出趨勢表...............................................112

18.3NIBP回憶..............................................................112

18.3.1移動圖形............................................................112

18.3.2在記錄儀上輸出NIBP回憶數據........................................112

18.4報警事件回憶...........................................................112

18.4.1移動圖形............................................................112

18.4.2選擇特定參數的報警事件回憶.........................................112

18.4.3設置時間索引........................................................113

18.4.4在記錄儀上輸出報警事件回憶.........................................113

18.512導診斷回憶...........................................................113

18.5.1刪除分析成果........................................................113

18.5.2診斷成果與波形之間日勺切換...........................................114

18.5.3在記錄儀上輸出波形或分析成果.......................................114

19計算和滴定表...............................................................115

19.1藥物計算...............................................................115

19.1.1計算環節............................................................115

19.1.2計算單位............................................................116

19.2滴定表.................................................................116

19.3血液動力學計算.........................................................117

19.3.1計算環節............................................................117

19.3.2輸入參數............................................................117

19.3.3輸出參數............................................................117

20記錄.......................................................................119

20.1記錄儀日勺一般資料.......................................................119

20.2記錄儀性能.............................................................119

20.3記錄類型...............................................................120

20.4記錄啟動和停止.........................................................120

20.5記錄儀操作及狀態信息...................................................121

21其他功能...................................................................124

21.1護士呼喊...............................................................124

21.2無線網絡...............................................................124

21.3在可移動存儲設備上進行數據存儲........................................124

22電池.......................................................................127

22.1電池燈.................................................................127

22.2主屏幕上的電池狀態信息.................................................127

22.3檢查電池性能...........................................................127

22.4更換電池...............................................................128

22.5電池回收...............................................................129

22.6電池時保養.............................................................129

23保養與清潔.................................................................130

23.1概述...................................................................13()

23.2清潔...................................................................13()

23.3消毒...................................................................133

23.4對其他附件進行清潔及消毒..............................................135

24維護.......................................................................136

24.1檢查....................................................................136

24.2維護計劃...............................................................136

25保修及售后服務.............................................................137

25.1保修....................................................................137

25.2售后服務...............................................................137

26電子信息產品污染控制......................................................138

26.1標識....................................................................138

26.2有毒有害物質或元素的名稱及含量........................................138

27附件.......................................................................139

27.1ECG附件...............................................................139

27.2SpCh附件...............................................................141

27.3NIBP附件..............................................................141

27.4TEMP附件.............................................................142

27.5IBP附件................................................................142

27.6CO?附件................................................................142

27.7GAS附件...............................................................144

27.8其他附件...............................................................145

A產品規格...................................................................146

A.1監護儀類型..............................................................146

A.2監護儀規格..............................................................146

A.2.1物理規格.............................................................146

A.2.2工作環境.............................................................146

A.2.3顯示屏規格...........................................................147

A.2.4電池.................................................................148

A.2.5記錄儀...............................................................148

A.2.6數據存儲.............................................................149

A.3ECG規格................................................................149

A.4RESP規格...............................................................153

A.5NIBP規格...............................................................154

A.6SpO2規格................................................................155

A.7TEMP規格...............................................................155

A.8IBP規格.................................................................156

A.9C02規格.................................................................157

A.10AG規格...............................................................160

A.10.1旁流.............................................................160

A.10.2主流.............................................................163

A.ll無線網絡規格..........................................................165

BEMC測試等級申明一指南和制造商的申明.....................................166

B.1電磁發射...............................................................166

B.2電磁抗擾度.............................................................166

B.3電磁抗擾度.............................................................167

B.4推薦隔離距離...........................................................169

C出廠默認設置..............................................................170

C.1病人信息...............................................................170

C.2報警.......................................................

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