BD P100采血管

英文名稱 BD P100 Blood Collection System，BD P100 collection tube

中文名稱 BD P100 血漿蛋白保存系統(tǒng)，BD P100采血管

BD P100采血管含有EDTA和蛋白酶抑制劑，適合血漿蛋白質(zhì)保存。其中8.5mL 規(guī)格（貨號(hào)：366448）的BD P100采血管含有機(jī)械分離裝置，離心后作為物理屏障隔開(kāi)血漿和細(xì)胞。

華雅再生醫(yī)學(xué)旗艦公司：紅榮微再（上海）生物工程技術(shù)有限公司代理BD采血管系列。BD P100 血漿管（貨號(hào)：366448 采血量：8.5mL）現(xiàn)貨*（2018年5月）。

BD P100說(shuō)明書(shū)

BD P100

用于血漿蛋白質(zhì)保存的血液采集系統(tǒng)，科研級(jí)別

應(yīng)用

BD P100 血液采集系統(tǒng)帶有機(jī)械分離裝置，提供了血漿采集、分離、運(yùn)輸和保存的手段，以便用于下游蛋白質(zhì)分析。

該產(chǎn)品僅供科研使用，嚴(yán)禁使用本產(chǎn)品進(jìn)行診斷程序和對(duì)象管理（subject management）。

體外診斷程序的臨床使用和性能特征，BD P100采血管都沒(méi)有建立。

產(chǎn)品描述

BD P100 采血管含有噴干的K2EDTA抗凝劑和適合的添加劑。

離心時(shí)，分離裝置被激活，并移動(dòng)到血漿和細(xì)胞層之間。分離結(jié)束后，血漿可以從BD P100采血管中直接吸出，免除轉(zhuǎn)移血漿到第二個(gè)試管的步驟。

未提供的必需設(shè)備

采血針+持針器+防護(hù)

1.帶有12英寸管道的血液采集裝置（采血針），如BD Vacutainer® Safety-Lok™或BD Vacutainer® Push Button Blood Collection Set。

2.必須使用BD Vacutainer®持針器（Holder），例如BD Vacutainer® One Use Holder，以確保其功能發(fā)揮正常。

3.如果不使用儀器直接取樣或者樣品分開(kāi)存放，則使用一次性移液器。

4.離心機(jī)要求：在管底部能夠產(chǎn)生1100-3000g的離心力。

5.必要的手套，護(hù)目鏡和其他個(gè)人防護(hù)裝備，以防止接觸血源性病原體。

采血配件（非說(shuō)明書(shū)配圖）

防止回流

BD P100采血管含有化學(xué)添加劑，與血液混合可能發(fā)生副反應(yīng)，因此需要避免采血管內(nèi)液體倒流人體。為防止回流，請(qǐng)遵守以下預(yù)防措施：

1.使用血液采集裝置，例如BDVacutainer®Safety-Lok™或BD Vacutainer®Push Button Blood Collection Set（采血針）。

2.肢體向下放置。

3.握住采血管時(shí)塞子向上。

4.一旦血液開(kāi)始流入管道，立即釋放止血帶。

5.靜脈穿刺過(guò)程中，確保采血管內(nèi)添加劑不會(huì)碰到塞子或針頭末端。

建議抽血順序

1. 無(wú)菌樣本采血管

2. 無(wú)添加劑采血管

3. 用于凝集研究（如檸檬酸）的采血管

4. 含有其它凍干添加劑的采血管（如BD Vacutainer®，肝素管，EDTA管，BD P100血漿管或血清管）

5. 含有液體添加劑的采血管（如PAXgene® 采血管）

靜脈穿刺技術(shù)和樣本采集指導(dǎo)

1. 采用BDVacutainer®Safety-Lok™或BD Vacutainer® Push Button Blood Collection Set采集血液時(shí)，必需使用12英寸血液采集裝置（采血針）。

2. 在靜脈穿刺過(guò)程中和處理采血管時(shí)要戴手套，以盡量減少血液接觸危險(xiǎn)。

3. 選擇所需樣本的管子。

4. 將帶有12英寸管的血液采集裝置（采血針）組裝到BD Vacutainer® One Use Holder（持針器）中。確保采血針牢固地連接到持針器上，并且在使用過(guò)程中不會(huì)松脫。

5. 將采血管放入持針器。注意：不要刺破塞子。

6. 選擇靜脈穿刺部位。

7. 使用止血帶。靜脈穿刺部位進(jìn)行無(wú)菌消毒。消毒后請(qǐng)勿觸診靜脈穿刺部位。

8. 將受檢者的肢體置于向下的位置。

9. 拆下針頭護(hù)套。肢體向下管塞向上進(jìn)行靜脈穿刺（參見(jiàn)防止回流部分）。

10. 在持針器中心放置采血管，以防止側(cè)壁穿透并導(dǎo)致過(guò)早的真空損失。

11. 快速將采血管推到針頭的非患者端（NP端），以盡量減少機(jī)械分離器與塞子的過(guò)早分離。在抽血過(guò)程中將管保持在NP端。

12. 如果采血過(guò)程中分離器在采血管中移動(dòng)，請(qǐng)丟棄管并重新抽血。

13. 一旦血液出現(xiàn)在采血管中，立即取下止血帶。在操作過(guò)程中，不要讓管子的內(nèi)容物接觸塞子或針頭。

14. 在從針頭的NP（非患者）端拔出試管之前，要耗盡管內(nèi)真空。

15. 將樣本與試管添加劑混合。為了達(dá)到*混合效果，在離心分離前立即將采血管輕輕顛倒混勻8至10次。

離心

為了盡量減少血小板數(shù)量，離心條件參考推薦。

BD P100采血管在平衡離心機(jī)中可承受高達(dá)3000g的離心力。

相對(duì)離心力（g）與離心機(jī)轉(zhuǎn)速設(shè)定（rpm）有關(guān)，用以下任一方程式：其中“r” 的單位是cm，表示的是從離心機(jī)頭中心到管底部的徑向距離。

rpm=√（g×10⁵/1.12×r）或近似的rpm=10000/√r

BD Vacutainer® Hemogard™ 安全頭蓋的拆除說(shuō)明

1. 用一只手抓住采血管，將拇指放在BD Hemogard™安全頭蓋下（為了更加穩(wěn)固，可將手臂靠在堅(jiān)硬的平面上）。另一只手扭轉(zhuǎn)Hemogard頭蓋同時(shí)用另一只手的拇指往上提頭蓋。

直到塞子松動(dòng)。

2.拔開(kāi)之前移開(kāi)拇指。不要使用大拇指推開(kāi)蓋子。

注意：任何試管都有破裂危險(xiǎn)。如果試管含有血液，則存在血液接觸危險(xiǎn)。為了防止在頭蓋拆除過(guò)程中受到傷害，一旦Hemogard™安全頭蓋有松動(dòng)，推頭蓋的大拇指就要移開(kāi)，不要在接觸管子。

3. 拔開(kāi)頭蓋。如果塑料保護(hù)與膠塞分離，不要把頭蓋裝回去。小心將塞子從試管中拔出。

保存

除非包裝標(biāo)簽上另有說(shuō)明，請(qǐng)將試管保存在4-25ºC（39-77ºF）。使用前建議將試管保存在原裝密封包裝中。包裝帶有干燥劑提供防潮層以保持添加劑的效力。

警告和注意事項(xiàng)

1.使用BDVacutainer®Safety-Lok™或BD Vacutainer®Push Button Blood Collection Set等采集血液時(shí)，一定要使用12英寸血液采集裝置。

2.對(duì)眼睛、呼吸系統(tǒng)和皮膚有刺激性。如接觸眼睛，立即用大量清水沖洗并尋求醫(yī)療指導(dǎo)。佩戴合適的手套和眼睛/臉部保護(hù)裝置。

3.不要重復(fù)使用BD P100采血管。

4.由于試管管中含有化學(xué)添加劑（抗凝血?jiǎng)┖蛢龈商砑觿虼顺檠^(guò)程中應(yīng)采取措施以防止液體從管中回流至人體（請(qǐng)參閱防止回流部分并參閱MSDS了解化學(xué)預(yù)防措施）。

5.過(guò)度的離心速度（超過(guò)10000g）可能導(dǎo)致試管破裂，接觸血液并可能造成傷害。

6.裝有血液樣本的試管儲(chǔ)存在0℃或0℃以下時(shí)可能會(huì)導(dǎo)致試管破裂。

7.不要用拇指滾動(dòng)打開(kāi)安全頭蓋。通過(guò)扭轉(zhuǎn)和拉動(dòng)來(lái)移除頭蓋（參見(jiàn)BD Vacutainer® Hemogard™ 安全頭蓋的拆除說(shuō)明）。

8.內(nèi)毒素未被控制。BD P100采血管收集和處理血液和血液成分不適用于輸液和引入人體。

注意：

1.練習(xí)標(biāo)準(zhǔn)注意事項(xiàng)。使用手套、長(zhǎng)袍、護(hù)目鏡、其他個(gè)人防護(hù)裝備和工程控制裝置，以防止血液飛濺，血液滲漏和潛在的血液傳播病原體接觸。

2.根據(jù)處理安全規(guī)范處理所有生物樣本和采血用“尖銳物品”（柳葉刀、針頭、魯爾接頭和血液采集器）。萬(wàn)一接觸到生物樣本（例如因穿刺而受傷），應(yīng)采取適當(dāng)?shù)尼t(yī)療措施，因?yàn)檫@些樣本可能帶有肝炎病毒，HIV或其他傳染病。若采血器材具備安全裝置，請(qǐng)善加利用。 BD不建議將用過(guò)的針頭重新復(fù)帽。但是，您的設(shè)施的政策和程序可能有所不同，必須始終遵守。

3.采集血液用的任何“尖銳物品”應(yīng)當(dāng)丟進(jìn)專門處置危險(xiǎn)物品的容器中。

4.不建議使用注射器和針頭將收集的樣本轉(zhuǎn)移到試管中。額外的“尖銳物品”操作，如空心針會(huì)增加針刺傷害的可能性。

5.出于下述原因，應(yīng)謹(jǐn)慎使用非尖銳裝置將樣品從注射器轉(zhuǎn)移到管中。 •在傳輸過(guò)程中按壓注射器柱塞可能會(huì)產(chǎn)生正壓，使塞子和樣本移位，造成飛濺和潛在的血液接觸。 •使用注射器進(jìn)行血液轉(zhuǎn)移也可能導(dǎo)致試管過(guò)量灌注或沒(méi)有注滿，導(dǎo)致血液與添加劑比率不正確，影響分析結(jié)果。 •BD P100采血管設(shè)計(jì)用來(lái)吸取標(biāo)示體積，當(dāng)真空耗凈時(shí)，試管注滿。但是當(dāng)從注射器注血時(shí)，由于柱塞阻力，一些試管可能部分注滿。使用這些樣品時(shí)應(yīng)該咨詢實(shí)驗(yàn)室有關(guān)情況。

6.如果通過(guò)靜脈（I.V.）管收集血液，在注采血管之前要確保管內(nèi)I.V.溶液已清除。這對(duì)避免來(lái)自I.V.液體污染造成錯(cuò)誤的實(shí)驗(yàn)室數(shù)據(jù)至關(guān)重要。

7.試管的過(guò)度灌裝或沒(méi)有注滿會(huì)導(dǎo)致血液與添加劑的比例不正確，并可能導(dǎo)致分析結(jié)果不正確或產(chǎn)品性能不佳。

8.使用前，讓BD P100 采血管達(dá)到室溫。

BD P100采血管說(shuō)明書(shū)中文版翻譯：紅榮微再編輯。請(qǐng)與英文原版說(shuō)明書(shū)配合使用。

華雅再生醫(yī)學(xué)旗艦公司：紅榮微再（上海）生物工程技術(shù)有限公司代理BD采血管系列。BD P100 血漿管（貨號(hào)：366448 采血量：8.5mL）現(xiàn)貨*（2018年5月）。

BD P100英文原版說(shuō)明書(shū)

BD P100

Blood Collection System

for Plasma Protein Preservation

For Research Use Only

Not For Use in Diagnostic Procedures

INTENDED USE

BD™ P100 is a Blood Collection System with a integrated mechanical separator that provides a means for collection, separation, transportation and preservation of plasma to be used in protein analysis. This product is for research use only and therefore the use of this product for diagnostic procedures and subject management is strictly prohibited. Neither the clinical utility nor the performance characteristics of the tube as part of an in vitro diagnostic procedure has been established.

PRODUCT DESCRIPTION

The BD P100 Tube contains spray-dried K2EDTA anticoagulant and proprietary additives.

During centrifugation, the separator device is activated and moves into position between the plasma and cellular elements. After separation, plasma may be aspirated directly from the collection tube, eliminating the need to transfer the plasma to a secondary tube.

BLOOD COLLECTION AND HANDLING

Required Equipment Not Provided

1. Blood Collection Set with 12 inch tubing such as the BD Vacutainer® Safety-Lok™ or

BD Vacutainer® Push Button Blood Collection Set.

2. A BD Vacutainer® Holder such as the BD Vacutainer® One Use Holder must be used to

ensure proper function.

3. Disposable transfer pipettes if direct sampling from the instrument is not used or if the

specimen is stored separay.

4. Centrifuge capable of generating 1100 – 3000 g at the bottom of the tube.

5. Gloves, eye protection and other personal protective equipment as necessary for

protection from exposure to blood borne pathogens.

Prevention of Backflow

The BD P100 blood collection tube contains chemical additives. It is important to avoid

possible backflow from the tube, with the possibility of adverse subject reaction. To guard

against backflow observe the following precautions:

1. Use a blood collection set such as the BD Vacutainer® Safety-Lok™ or BD Vacutainer®

Push Button Blood Collection Set.

2. Place limb in a downward position.

3. Hold tube with stopper upper-most.

4. Release tourniquet as soon as blood starts to flow into the tube.

5. Make sure that tube additives do not touch the stopper or the end of the needle during venipuncture.

Recommended Order of Draw

1. Tubes for sterile samples

2. Tubes without additives

3. Tubes for coagulation studies (e.g., citrate)

4. Tubes with other lyophilized additives (e.g., BD Vacutainer®, Heparin, EDTA, Plasma

BD P100, or Serum Tubes)

5. Tubes with other liquid additives (e.g. PAXgene® Tubes)

Venipuncture Technique and Specimen Collection General Instructions

1. It is absoluy essential to use a 12 inch blood collection set, when collecting blood using this device such as BD Vacutainer® Safety-Lok™ or BD Vacutainer® Push Button Blood Collection Set.

2. Wear gloves during venipuncture and when handling blood collection tubes to minimize exposure hazard.

3. Select tube or tubes for required specimen.

4. Assemble a blood collection set with 12 inch tubing into a BD Vacutainer® One Use Holder.

Be sure that blood collection set is firmly attached to holder and does not unthread during use.

5. Place tube into holder. Note: Do not puncture stopper.

6. Select site for venipuncture.

7. Apply tourniquet. Prepare venipuncture site with appropriate antiseptic. Do not palpate venipuncture site after cleansing.

8. Place subject’s limb in a downward position.

9. Remove needle shield. Perform venipuncture with limb downward and tube stopper up (refer to the Prevention of Backflow section).

10. Center tubes in the holder, to prevent sidewall penetration and resultant premature vacuum loss.

11. Push tube onto non-patient-end (NP-end) of needle in one swift action in order to minimize premature separation of the mechanical separator from the stopper. Hold tube on NP-end during drawing.

12. If separator moves in the tube during blood collection, discard the tube and redraw.

13. Remove tourniquet as soon as blood appears in tube. Do not allow contents of the tube to contact the stopper or end of the needle during procedure.

14. Allow vacuum to be exhausted prior to removing the tube from the NP (non-patient) end of the needle.

15. Mix specimen with tube additives. For optimal mixing,slowly invert tube 8 to 10 times immediay after blood collection before centrifugation.

Centrifugation

To achieve the lowest plaet count, refer to the recommended centrifugation conditions outlined in the following table.

The tube will withstand up to 3000 g in a balanced centrifuge.

Relative Centrifuge Force (g) is related to centrifuge speed setting (rpm) using either of the

following equations: where “r” expressed in cm, is the radial distance from the center of the

centrifuge head to the bottom of the tube.

Instructions for Removal of BD Vacutainer® Hemogard™ Closure

1. Grasp the BD P100 Tube with one hand, placing the thumb under the BD Hemogard™Closure. (For added stability, place limb on solid surface.) With the other hand, twist the Hemogard Closure while simultaneously pushing up with the thumb of the other hand

ONLY UNTIL THE TUBE STOPPER IS LOOSENED.

2. Move thumb away before lifting closure. DO NOT use thumb to push closure off the tube.

Caution: Any tube has the potential to crack. If the tube contains blood, an exposure hazard exists. To help prevent injury during removal, it is important that the thumb used to push upward on the closure be removed from contact with the tube as soon as the Hemogard™ Closure is loosened.

3. Lift closure off the tube. In the unlikely event of the plastic shield separating from the rubber stopper, DO NOT REASSEMBLE THE CLOSURE. Carefully remove stopper from the tube.

Storage

Store tubes at 4-25 ºC (39-77 ºF) unless otherwise noted on the package label. It is recommended to store the tubes in the original sealed packaging until use. The pouch with desiccant provides a moisture barrier to preserve the potency of the additives.

WARNINGS AND PRECAUTIONS

1. It is absoluy essential to use a 12 inch blood collection set, when collecting blood using these tubes such as BD Vacutainer® Safety-Lok™ or BD Vacutainer®Push Button Blood Collection Set.

2. Irritating to eyes, respiratory system and skin. In case of contact with eyes, rinse immediay with plenty of water and seek medical advice. Wear suitable gloves and eye/face protection.

3. Do not re-use the tube.

4. Since this tube contains chemical additives (anti-coagulant and a lyophilized additive) precautions should be taken to prevent possible backflow from the tube during blood drawing (see Prevention of Backflow section and refer to the MSDS for chemical precautions).

5. Excessive centrifugation speed (over 10,000 g) may cause tube breakage, exposure to blood and possible injury.

6. Storage of tubes containing blood at or below 0 ºC may result in breakage.

7. Do not remove closure by rolling with thumb. Remove with a twist and pull motion (see Instructions for Removal of the BD Hemogard™ Closure section).

8. Endotoxin not controlled. Blood and blood components collected and processed in the tube

are not intended for infusion or introduction into the human body.

CAUTION:

1. Practice Standard Precautions. Use gloves, gowns, eye protection, other personal protective equipment, and engineering controls to protect from blood splatter, blood leakage, and potential exposure to blood borne pathogens.

2. Handle all biologic samples and blood collection “sharps” (lancets, needles, luer adapters,and blood collection sets) according to the policies and procedures of your facility. Obtain appropriate medical attention in the event any exposure to biologic samples (for example, through a puncture injury), since they may transmit viral hepatitis, HIV (AIDS), or other infectious diseases. Utilize any built-in used needle protector, if the blood collection device provides one. BD does not recommend reshielding used needles. However, the policies and procedures of your facility may differ and must always be followed.

3. Discard all blood collection “sharps” in biohazard containers approved for their disposal.

4. Transferring a sample collected using syringe and needle to a tube is not recommended. Additional manipulation of sharps such as hollow bore needles increases the potential for needlestick injury.

5. Transferring samples from syringe to an tube using a non-sharps device should be performed with caution for the reasons described below. • Depressing the syringe plunger during transfer can create a positive pressure, forcefully displacing the stopper and sample,causing splatter and potential blood exposure. • Using a syringe for blood transfer may also cause over or underfilling of tubes, resulting in an incorrect blood-to-additive ratio and potentially incorrect analytic results. • Tubes are designed to draw the volume indicated. Filling is complete when vacuum no longer continues to draw, though some tubes may partially fill due to plunger resistance when filled from a syringe. The laboratory should be consulted regarding the use of these samples.

6. If blood is collected through an intravenous (I.V.) line, ensure that line has been cleared of I.V. solution before beginning to fill blood collection tubes. This is critical to avoid erroneous laboratory data from I.V. fluid contamination.

7. Overfilling or underfilling of tubes will result in incorrect blood-to-additive ratio and may lead to incorrect analytic results or poor product performance.

8. Allow the BD P100 Tube to come to room temperature before use.

華雅再生醫(yī)學(xué)旗艦公司：紅榮微再（上海）生物工程技術(shù)有限公司代理BD采血管系列。BD P100 血漿管（貨號(hào)：366448 采血量：8.5mL）現(xiàn)貨*（2018年5月）。