TWI465226B - 診斷測試之系統 - Google Patents

診斷測試之系統 Download PDF

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TWI465226B
TWI465226B TW97141349A TW97141349A TWI465226B TW I465226 B TWI465226 B TW I465226B TW 97141349 A TW97141349 A TW 97141349A TW 97141349 A TW97141349 A TW 97141349A TW I465226 B TWI465226 B TW I465226B
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housing
test
instrument
test media
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TW200930337A (en
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Gary T Neel
Brent E Modzelewski
George R Rounds
Carlos Oti
Allan Javier Caban
Jeffrey Akins
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Nipro Diagnostics Inc
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Description

診斷測試之系統 相關申請案之交叉參考
此申請案係對於2007年11月1日提申的美國專利申請案11/934,004主張優先權，該案係為2006年3月13日提申的美國編號11/373,284之部分接續案，其整體合併於本文中以供參考。
發明領域
本發明有關診斷測試之領域，且更特別有關使用電子儀器之診斷測試系統。
 發明背景
診斷測試系統常用來在不同型樣本上進行不同型的診斷測試。診斷測試可為一定性或定量測試以決定一樣本中之一或多個分析物的出現、濃度或數量。分析物可為一譬如血液、尿液、組織、唾液等生物樣本中所含之醫學顯著性分析物-譬如，葡萄糖、酮、膽固醇、三酸甘油酯、人類絨毛膜激素(HCG)、血紅素AlC、果糖胺、碳水化合物、腫瘤標記、鉛、抗癲癇藥、膽紅素、肝功能標記、毒素或其代謝物、管制物質、血凝因子(PT、ATPP)等。但診斷測試不侷限於醫學領域。此外，診斷測試儀器可用來監測諸如水、土壤、污水、沙、空氣、或任何其他適當樣本等非醫學樣本中的分析物或化學參數。
此等診斷測試系統可包括一測試媒體(譬如，一測試條帶、籤片、碟等)，其構形為可對於一樣本中的分析物出現起反應，及一分離的電子儀器，其構形為可與測試媒體構成介面藉以執行診斷測試並將診斷測試的結果指示予使用者。
為了執行診斷測試，使用者首先必須自一容器獲得一樣本測試媒體，譬如一測試條帶，然後利用一取樣裝置獲得一樣本(譬如利用一刺血針抽血)，然後將樣本施加至測試媒體(在測試媒體插入儀器介面內之前或之後)。儀器隨後在樣本上進行診斷測試並將結果指示予使用者，譬如利用一數值顯示器。
先前技藝的診斷儀器有時因為殼體容納有顯示器、電子件及測試媒體所以會佔體積。此外，一血液測試診斷系統的使用者必須管理及攜載不只儀器，亦包括一測試媒體容器及一取樣裝置。這三個組件必須以一特定次序操縱，其需要大量心力及操縱來執行一成功的測試。不但對於部分使用者來說步驟很麻煩，測試媒體容器、取樣裝置及儀器亦有可能彼此分離，所以使用者可能發現缺少執行診斷測試所需要的一或多個組件。
如該技藝所已知，來自不同製造廠的測試媒體或來自不同製造批量的媒體可能對於樣本中分析物的出現或濃度具有不同響應。為了獲得較精確的結果，可藉由對於電子儀器提供可令來自一特定品牌或批量的測試媒體之信號響應與一經標準化參考物呈交叉相關之一或多個品牌或批量特定性校準參數，使得電子儀器相對於來自一品牌或批量的測試條帶之一給定測試條帶被校準。藉由此校準，儀器所記錄的結果可更精確地代表一樣本中的分析物數量。
執行一診斷測試之前，儀器需被妥當地校準。使用者可能需要在一分離的“編碼”步驟中對於儀器提供適當的校準參數。譬如，測試媒體容器可擁有一被輸入儀器中的碼號，且儀器可自其存取儀器的記憶體中所儲存之適當校準資訊。碼號可被人工式輸入(譬如，利用按鈕或儀器上的其他使用者輸入裝置)藉以將校準資料提供予儀器。或者，校準資料可自製造廠網址下載。另一途徑中，測試媒體容器可設有一相聯結的碼晶片，譬如一ROM，其中電子式儲存有校準資料。使用者可將碼晶片插入儀器上之一對應的埠中藉以使校準資料提供予儀器。
這些先前技藝的編碼方法可能對於使用者並不方便或有困難。譬如，年老或衰弱使用者可能有困難下載校準資料或插入碼晶片，其必須被妥當地實體對準藉以達成與儀器的一資料連接。碼晶片可能被誤置或遺失，導致無法使用對應的測試媒體、或以一不匹配的編碼裝置來使用測試媒體。並且，使用者可能忘記校準配合一新品牌或批量的測試媒體所使用之儀器。因此，使用者可能輸入不正確的校準參數或碼，或者使用者可能對於針對使用來自一品牌或批量的測試媒體所校準之一儀器使用來自一不同品牌或批量的測試媒體。一旦一儀器對於一給定批量的測試媒體被校準，該儀器若使用於來自另一批量的測試媒體則可能導致會對於使用者造成嚴重後果之錯誤的結果。例如，若該測試為血液葡萄糖位準的自我測試，錯誤的結果會導致使用者以有害其健康的方式採取行動、或不行動。
上述編碼問題之一種可能的解決方案係在於確保所有銷售的媒體皆有相同行為。此途徑稱為“通用編碼”。通用編碼方案使用依據一狹窄接受判別標準所控制及分類之條帶批量，亦即，所有條帶皆符合單組的校準參數，故儀器中不再需要儲存多組的參數。通用編碼藉由讓儀器可與許多不同測試條帶容器配合使用來節省更換儀器之成本。從製造觀點來看，通用編碼媒體需受到緊密控制以使製成的條帶批量具有相同行為、且因此碼亦然，藉以配合儀器的固定校準資料。此方法並不仰賴技術而定且有助於防止由於混合的條帶批量所導致之錯誤。尚且，通用編碼總是具有正確的碼所以在儀器與條帶批量碼之間不具有錯誤匹配。然而，此方法所施加的狹窄限制並未良好地符合大規模製造製程，其包括有先天變異數。幾乎不可能使用高產出、批次導向式製造技術來確保測試媒體將展現完美一致的行為；因此，通用編碼方案總是導致不相符合的媒體批量。此媒體將不堪用，而增添成本及不良的浪費。
為此，需要可方便攜帶並盡量降低使用者以來自並未對其校準儀器之一品牌或批量的測試媒體使用一診斷儀器的機會之診斷測試系統。
亦需要可自一測試容器被移除且與一不同測試容器重新使用之可移除式儀器。
 發明概要
此處所描述的示範性實施例藉由提供一診斷測試系統來符合這些及其他需求，該診斷測試系統包括一用於在一施加至一測試媒體的樣本上進行一診斷測試之儀器，該儀器具有一殼體及一用於接收一代表編碼資訊的信號之介面，及一構形為可容納與儀器相容的測試媒體之容器，容器具有一與其相聯結的編碼元件，其中將儀器自一相聯結的測試容器轉移至一新容器係包括使用用於將批量特定性碼資訊自媒體的新容器轉移至儀器之數個編碼方法的一者。
此處亦進一步提供一儀器殼體，其具有一可接收一測試條帶容器之容槽。此外，儀器殼體可構形為可接收諸如媒體播放器、地面或衛星收音機、旅行鬧鐘、測試警告器、備忘錄音機、PDA、行動電話、或其他添加機能的至少一者等之裝置，藉此可讀取一類似於放置在測試條帶容器上者之碼以使該裝置連同儀器使用。
此處亦揭露一能夠自一第一容器被移除且附接至一第二容器之儀器殼體。儀器殼體可構形具有至少一頂安裝附接件，其構形為可釋放式接合儀器殼體及容器。
一實施例中，儀器殼體構形為可藉由將儀器殼體旋轉一充分距離使儀器殼體自容器分離而被移除。譬如，儀器殼體可旋轉至少約轉、至少約轉、或至少約轉。
另一實施例中，容器構形為可藉由將容器旋轉一充分距離使容器自儀器殼體分離而被移除。譬如，容器可旋轉至少約轉、至少約轉、或至少約轉。
又另一實施例中，頂安裝附接件係為一能夠自容器釋放儀器殼體之鉤件。另一實施例中，頂安裝附接件為一環件。另一實施例中，儀器殼體包含一壓入配合柱且容器包含一構形為可接收該壓入配合柱之孔口。一實施例中，頂安裝附接件係為一鎖及一突件的一組合。一實施例中，頂安裝附接件為一籤片。
本發明的額外態樣及優點將部份地由下文描述所確立，且將部份地自該描述得知，或可經由實行本發明獲知。可藉由申請專利範圍中特別指出的元件及組合來實現及達成本發明的優點。
請瞭解上文一般描述及下文詳細描述只是示範性及說明性，而未限制由申請專利範圍所界定之本發明。
圖式簡單說明
被併入此說明書且構成其一部份之圖式係顯示本發明的數項實施例並連同該描述用來說明本發明的原理。
第1A圖為與此處所揭露的實施例一致之一整合式系統的立體圖；
第1B圖為第1A圖所示的整合式系統之另一圖式；
第2A圖為與此處所揭露的實施例一致之一整合式系統的立體圖；
第2B圖為第2B圖所示的整合式系統的另一圖式；
第3A圖為與此處所揭露的實施例一致之一整合式系統的立體圖；
第3B圖為第3A圖所示的整合式系統之另一圖式；
第3C圖為第3A圖所示的整合式系統之另一圖式；
第4A圖為與此處所揭露的實施例一致之一整合式系統的立體圖；
第4B圖為第4A圖所示的整合式系統之另一圖式；
第4C圖為第4A圖所示的整合式系統之另一圖式；
第5A圖為與此處所揭露的實施例一致之一整合式系統的立體圖；
第5B圖為第5A圖所示的整合式系統之另一圖式；
第6A圖為與此處所揭露的實施例一致之一整合式系統的立體圖；
第6B圖為第6A圖所示的整合式系統之另一圖式；
第7A圖為一包括一能夠藉由按壓一退出按鈕自一容器被釋放的儀器殼體之整合式系統的一實施例之圖式；
第7B圖為第7B圖所示的整合式系統之另一圖式；
第7C圖為第7A及7B圖所示的儀器殼體之圖式。
 較佳實施例之詳細說明
現在將詳細參照本發明的示範性實施例，其範例顯示於圖式中。各圖中將盡可能使用相同編號來代表相同或相似的部份。
第1A及1B圖描繪根據本發明的一示範性實施例之一用於執行一診斷測試之整合式系統200。示範性整合式系統200包括一用於容納諸如測試條帶等測試媒體之容器210，及一用於利用容器210中所容納的測試條帶進行一診斷測試之儀器230。
儀器230可被容納於一儀器殼體231內。儀器殼體231附接至或包括一頂安裝附接件270，其接合容器210藉以選擇性關閉容器的一開口211。如一般熟習該技藝者所瞭解、且如此處所討論，“附接”用語係可代表聯合於、聯結於、附裝於/附裝至、連接於/連接至、耦合於/耦合至、緊固於/緊固至、固定於/固定至、固接於/固接至等。
第1A及1B圖所示的實施例中，頂安裝附接件270為一鎖。鎖270自儀器殼體231延伸且構形為可接合容器210上的一對應突件288。突件288可沿著容器210的上唇之一部分設置。
又另一實施例中，儀器殼體231包含一沿著殼體231側壁被定位之籤片272。籤片272延伸超過側壁以便利使用者譬如藉由將一諸如手指或姆指往上推押抵住籤片272而自容器210移除殼體231。
一實施例中，籤片272包含一或多個脊件以輔助使用者施力至籤片272。脊件可用來防止使用者的手指或姆指自籤片272滑移。
另一實施例中，籤片272可以一角度延伸遠離殼體231的側壁。當相對於一平行於殼體231側壁之垂直平面作測量時，籤片272角度介於從約1度至約90度、從約20度至約70度、或從約40度至約50度之間。角度可測得約45度。
雖然第2A及2B圖描繪單一突件，熟習該技藝者可易於瞭解頂安裝附接件可包含不只一個籤片。譬如，兩籤片彼此可分開最多達到約180度，且使用者可在各籤片上往上推押固持住容器210同時譬如將容器錨固於兩手掌中或一表面上。
第3A、3B及3C圖描繪用於將儀器殼體231可釋放地附接至容器210之又另一頂安裝附接件。此實施例中，儀器殼體231包含互連的至少一槓桿274及至少一鉤件290以藉由施力予至少一槓桿274來移動至少一鉤件290。槓桿274包含一撓性材料及/或撓性組態。容器210包含至少一能夠接收鉤件290之掣件276。一使用者藉由將槓桿274擠往殼體231來移除殼體231。在朝向殼體231的方向中擠壓槓桿274係使鉤件290自掣件276釋放。殼體231可隨後自容器210頂端被移除。
第3A至3C圖描繪被構形為可以作為單一閉合機構一起工作之一槓桿、一鉤件及一掣件。熟習該技藝者可易於瞭解可使用槓桿、鉤件及掣件的不只一個組合。一示範性實施例中，頂安裝附接件包含兩槓桿、兩鉤件、及兩對應的掣件。
另一實施例中，儀器殼體包含一機構，譬如一按鈕，其構形為可致動至少一鉤件。第4A、4B及4C圖包含對於頂安裝附接件之又另一組態，其包含至少一槓桿274、至少一掣件276、及一按鈕278。按鈕278及至少一掣件276係互連藉以壓抵按鈕278接合掣件276。當掣件276被定位於容器210的一凹入區域(未圖示)內，壓抵按鈕278將掣件276自凹入區域釋放。為了將殼體231附接至容器210，使用者可將殼體231定位為與容器210相鄰以使掣件276及凹入區域呈對準。壓抵按鈕278可讓掣件276接合凹入區域。
另一實施例中，按鈕278構形為可使掣件276自儀器殼體231分離。此實施例中，壓抵按鈕278的步驟可讓儀器殼體231自容器210移除。為了將儀器殼體231重新附接至一第二容器，使用者可將儀器殼體231鉚扣在容器210或一第二容器上。
可以右姆指或食指舒適地壓抵按鈕278同時整合式系統200被固持於右手中。但按鈕278可被定位於儀器殼體231上的他處。譬如，按鈕278可放置在儀器殼體231的一右手側藉以更方便左撇子使用者或在儀器230的一頂部分上。
第5A及5B圖描繪一頂安裝附接件，其包含一壓入配合柱282。容器231包含壓入配合柱282，且容器210包含一尺寸可接收壓入配合柱282之孔口284。壓入配合柱282配合於孔口284內，藉此密封住孔口284不受光、液體及蒸氣滲透。第5B圖所示的一實施例中，壓入配合柱282包含部份柱282’及部份柱282”。部份柱282’及部份柱282”係分開而生成一中空條帶。
又另一實施例中，一連接器將容器210附接至殼體231。連接器可被可釋放地附接至容器210及/或殼體231。第6A及6B圖所示的實施例中，連接器包含一鉚扣式轉接器環286。鉚扣式轉接器環286的尺寸可容納容器210的橫剖面形狀。鉚扣式轉接器環286可構形為鬆弛且摩擦性地接合容器210。
另一實施例中，連接器為一可釋放地螺接於容器210上之螺接式轉接器環。環286內表面上的相互接合螺紋係接合容器210外表面上的螺紋。螺紋亦可接合儀器殼體231上的螺紋。
另一實施例中，連接器可譬如藉由熔接、膠接及類似方式被附裝至容器210或殼體231。例如，若連接器被永久性或半永久性附裝至容器210，則殼體231可被可釋放地附接至連接器。譬如，連接器210的可釋放式特徵構造可為直角迴轉、鉚扣配合、或螺紋。另一範例中，連接器可永久性或半永久性附裝至儀器殼體231且可釋放地附接至容器210。
環286的形狀可採行與容器210及儀器殼體231橫剖面形狀一致之形狀。一實施例中，環286的形狀為圓形。另一實施例中，環286的形狀為卵形。又另一實施例中，環286的形狀為橢圓形。另一實施例中，環286的形狀為長方形。
又另一實施例中，連接器的尺寸可連接一具有第一橫剖面形狀的容器以及一具有第二橫剖面形狀的儀器殼體。
第7A至7C圖描繪一使殼體231包括一退出按鈕292之實施例。退出按鈕292係構形為可在受到按壓時自容器210釋放殼體231。
第7A至7C圖中，退出按鈕292被描繪為位居殼體231的上部分上，但熟習該技藝者瞭解退出按鈕292可設置於沿著殼體231之任何適當位置。
一示範性實施例中，容器210及閉合件240利用一射出成型製程由聚丙烯形成。然而，可使用其他材料及製程而不脫離本發明的範圍。
熟習該技藝者將考慮此處揭露的說明書及實施例實行方式而得知其他實施例。說明書及範例只預定被視為示範用。
200．．．整合式系統
210．．．容器
211．．．容器的開口
230．．．儀器
231．．．儀器殼體
270．．．頂安裝附接件
272．．．籤片
274．．．槓桿
276．．．掣件
278．．．按鈕
282．．．壓入配合柱
282’,282”．．．部份柱
284．．．孔口
286．．．鉚扣式轉接器環
288．．．突件
290．．．鉤件
292．．．退出按鈕
第1A圖為與此處所揭露的實施例一致之一整合式系統的立體圖；
第1B圖為第1A圖所示的整合式系統之另一圖式；第2A圖為與此處所揭露的實施例一致之一整合式系統的立體圖；
第2B圖為第2B圖所示的整合式系統的另一圖式；
第3A圖為與此處所揭露的實施例一致之一整合式系統的立體圖；
第3B圖為第3A圖所示的整合式系統之另一圖式；
第3C圖為第3A圖所示的整合式系統之另一圖式；
第4A圖為與此處所揭露的實施例一致之一整合式系統的立體圖；
第4B圖為第4A圖所示的整合式系統之另一圖式；
第4C圖為第4A圖所示的整合式系統之另一圖式；
第5A圖為與此處所揭露的實施例一致之一整合式系統的立體圖；
第5B圖為第5A圖所示的整合式系統之另一圖式；
第6A圖為與此處所揭露的實施例一致之一整合式系統的立體圖；
第6B圖為第6A圖所示的整合式系統之另一圖式；
第7A圖為一包括一能夠藉由按壓一退出按鈕自一容器被釋放的儀器殼體之整合式系統的一實施例之圖式；
第7B圖為第7B圖所示的整合式系統之另一圖式；
第7C圖為第7A及7B圖所示的儀器殼體之圖式。
200．．．整合式系統
210．．．容器
230．．．儀器
270．．．頂安裝附接件
288．．．突件

Claims (21)

  1. 一種用於診斷測試之系統，包含：一儀器，其用於在一施加至測試媒體的樣本上進行一診斷測試，該儀器包含一具有一測試媒體埠的殼體，及一用於接收一代表編碼資訊的信號之介面；與該儀器相容的複數個測試媒體，該等複數個測試媒體中之各測試媒體具有一第一端及第二端，而該第一端具有一寬度及一高度，其中該測試媒體埠的一寬度及一高度係大致與該第一端的寬度及高度相等，以供該第一端插入該測試媒體埠；及一容器，其構形為可容納與該儀器相容的該等複數個測試媒體，該容器具有一與其相聯結的編碼元件及一頂端；其中該殼體及該容器中的至少一者包含一頂安裝附接件，該頂安裝附接件係構形為將該殼體可釋放地附接至該容器，而當該殼體被附接至該容器時，與該容器相聯結的該編碼元件傳送該編碼資訊至該介面。
  2. 如申請專利範圍第1項之系統，其中該頂安裝附接件係構形為將該殼體可釋放地安裝至該容器的頂端。
  3. 如申請專利範圍第1項之系統，其中該頂安裝附接件包含至少一鎖及相對應的至少一突件，該至少一鎖係自該殼體突起，該至少一突件係自該容器之一唇的至少一部分突起，各鎖係構形為可滑動地橫越各突件的至少一部分，其中在一第一位置中，各鎖及各突件係分離以使該 殼體能夠自該容器的頂端被移開，且其中在一第二位置中，各鎖及各突件係接合以防止該殼體自該容器的頂端被移開。
  4. 如申請專利範圍第3項之系統，其中該殼體沿一中央軸線被旋轉以自該第一位置移至該第二位置。
  5. 如申請專利範圍第1項之系統，其中該殼體包含自該殼體的一側壁延伸出之至少一籤片，其中該籤片具有一頂表面。
  6. 如申請專利範圍第5項之系統，其中各籤片的頂表面包含一或多個脊件。
  7. 如申請專利範圍第5項之系統，其中該籤片自該側壁以一角度延伸，其中相對於一垂直平面、而該平面係實質平行於該側壁的該角度係介於從約1度至約90度之間。
  8. 如申請專利範圍第1項之系統，其中該頂安裝附接件包含至少一槓桿而其與該殼體呈一體地模製，各槓桿被互連至一鉤件，且該容器包含至少一掣件而其構形為可接收該鉤件。
  9. 如申請專利範圍第1項之系統，其中該殼體包含一互連至一鉤件及一槓桿之按鈕，且該容器包含一掣件，其中推押該按鈕係伴隨地使該鉤件自該掣件分離。
  10. 如申請專利範圍第1項之系統，其中該殼體包含一壓入配合柱，且該容器包含一尺寸可接收該壓入配合柱之孔口。
  11. 如申請專利範圍第10項之系統，其中該壓入配合柱包含一第一部份柱及一第二部份柱，其中該第一部份柱及該 第二部份柱係分開。
  12. 如申請專利範圍第1項之系統，進一步包含一介於該殼體與該容器之間的連接器。
  13. 如申請專利範圍第12項之系統，其中該連接器包含一尺寸可容納該容器的橫剖面形狀之鉚扣式轉接器環。
  14. 如申請專利範圍第13項之系統，其中該鉚扣式轉接器環構形為可永久性或半永久性附接至該容器，其中該殼體能夠被可釋放地附接至該鉚扣式轉接器環。
  15. 如申請專利範圍第13項之系統，其中該鉚扣式轉接器環構形為可永久性或半永久性附接至該殼體，其中該容器能夠被可釋放地附接至該鉚扣式轉接器環。
  16. 如申請專利範圍第12項之系統，其中該連接器包含一螺接式轉接器環。
  17. 如申請專利範圍第12項之系統，其中該連接器的尺寸可容納該具有一第一橫剖面形狀的容器、及可容納該具有一第二橫剖面形狀的殼體。
  18. 如申請專利範圍第1項之系統，其中該殼體包含一構形為可自該容器釋放該殼體之退出按鈕。
  19. 如申請專利範圍第1項之系統，其中該測試媒體埠係定位成在該殼體的一外表面。
  20. 一種用於診斷測試之系統，包含：一電子儀器，其用於在一施加至測試媒體的樣本上進行一診斷測試，該電子儀器包含一具有一測試媒體埠的殼體，及一用於接收一代表編碼資訊的信號之介面； 與該電子儀器相容的複數個測試媒體，該等複數個測試媒體中之各測試媒體具有一第一端及第二端，而該第一端具有一寬度及一高度，其中該測試媒體埠的一寬度及一高度係大致與該第一端的寬度及高度相等，以供該第一端插入該測試媒體埠；及一容器，其構形為可容納與該電子儀器相容的測試媒體，該容器具有一與其相聯結的編碼元件及一頂端；其中該殼體及該容器中的至少一者包含一頂安裝附接件，該頂安裝附接件係構形為將該殼體可釋放地附接至該容器，而當該殼體被附接至該容器時，與該容器相聯結的該編碼元件傳送該編碼資訊至該介面；其中該頂安裝附接件包含至少一鎖及相對應的至少一突件，該至少一鎖係自該殼體突起，該至少一突件係自該容器之一唇的至少一部分突起，且各鎖係構形為在該殼體及該容器相對於彼此而旋轉時可滑動地橫越各突件的至少一部分；其中在一第一旋轉位置中，各鎖及各突件係分離，因此該殼體係能夠自該容器的頂端移開；且其中在一第二旋轉位置中，各鎖及各突件係接合，因此該殼體被防止自該容器的頂端移開。
  21. 如申請專利範圍第20項之系統，其中，當該等複數個測試媒體中之一測試媒體被插入該測試媒體埠時，該測試媒體的第一端延伸進入該測試媒體埠，且該測試媒體的第二端延伸遠離該測試媒體埠及該電子儀器。
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US20170203291A1 (en) 2017-07-20
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