日期 2010/5/7

 

致 HM-JACK用戶：

經本公司技術部門針對新進批號品管液之交叉比對測試結果發現，Kyowa HM-JACK品管液(原廠貨號：409984; 產品編號：Y2-CONTROL)批號134AJB於實際測試結果之mean值均有低於Kyowa原廠所發佈之mean值之現象，特此通知各使用用戶，科室可根據  貴各科室之實際狀況修改符合科室之mean值。在此，本公司亦提出本公司經測試後所下修之QC範圍與mean值，以提供科室參考，造成不便之處，敬請見諒。

ps: 杏全公司測試中所使用之試劑資訊

                            Latex Lot: 191AIK

                            Calibrator Lot: 152AIG,153AIJ

                            Control Lot : 134AJB

原廠品管液資訊與建議修正之品管液資訊


 

 

Mean

Range

134AJB

 

原廠

修正

原廠

修正

L

24

22

20-28

18-26

H

95

95

76-114

76-114

  

 

技術部


杏全實業股份有限公司

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KYOWA HM-JACK 日:週:月保養點檢記錄表.jpg

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HM-JACK 簡易問題排除

 

於主畫面設定檢體數時，機器無法接受指令？

請檢查主畫面上，reagent之設定檢體數是否足夠使用，若不足量，應調整reagent之體積數，以符合上機之檢體數即可運作。

機器操作過程中，發生probe碰撞之狀況，因此而使機器停止運作

可按操作面板上之 “ STANDBY”鍵，使機器手臂歸位，再重新操作

若分析數據超過線性範圍該如何處理

若分析出之結果超過線性，可依院內需求做下列處理：

I. data若大於線性範圍

(1) 直接發＞800

(2) 若科室需要發一數值，將採便棒剪開後，取出溶液後，稀釋後以檢體杯上機，再回乘稀釋倍數即可

II. data若小於線性範圍

可發＜7

QC所呈現之值，無法落入期望範圍

請check reagent與 calibrator之資訊輸入是否正確

確定Latex, buffer與wash buffer之狀況與保持量充足

機器並無異常狀態，如異音

每批品管液均有其各自之期望值，故於 “ out of range ” 發生後，可先確認是否引用之數據是否正確。

重複混合步驟，同杯QC再上機一次

若依舊 品管並未如預期進入期望值，wash 兩次機器

確定Latex、buffer回溫是否至適合溫度(原廠推薦在20-30℃)且混合均勻

重新自冰箱取出新的一批QC上機測試

若上述步驟依舊未成功使 品管進入期望值，請重新回溶QC以規定之步驟與回溶時間重新泡製後上機

依舊無法通過時，請重新校正程序

若上述步驟依舊無法通過校正程序，請立即通知杏全服務團隊

檢測結果顯示”P” 或”B”

“B”: 請檢查機器之Buffer與reagent之量是否足夠，reagent probe是否異常、buffer中之吸管是否有插入瓶中

“P”：檢體中Hb之濃度過高有prozone現象產生時，機器會顯示”P”以警告，此時即可以cup稀釋上機即可

data異常全偵測不到任何Hb

請檢查是否因wash buffer tank中之體積不足夠而造成

機器運作中忽然停止

檢查丟棄使用過之比色管之tank是否已滿，而阻塞排出孔所導致，此時，請將阻塞物清除，按”STANDBY”使機器reset，重新上機。

 

 

註：若上述簡易問題排除方法無法排除問題請立即通知杏全服務團隊

 

 

 

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HM-JACK操作步驟

 

執行開機校正與品管分析

 

LATEX與BUFFER回溫至少30分鐘

Wash machine 2次

回溫STD&CONTROL至少30分鐘

將LATEX&BUFFER裝上機器適當位置

將STD&CONTROL放在Sample Table中的S1與S2，C1與C2

進入Sample Set畫面中，移動游標至欲分析項目後Set部分，按(Enter)鍵，已進行設定執行動作。

按(START)，再按(Enter)鍵而確認且執行校正與品管分析

 

執行檢體分析

 

將採便棒置於Sample Table上

進入Sample Set畫面中，移動游標至欲分析項目後Set部分，按(Enter)鍵，已進行設定執行動作。

按(START)，再按(Enter)鍵而確認且執行

 

關機前清潔

用 distilled water 取代 buffer，wash 2次

 

關機後清潔與保養

 

將LATEX&BUFFER至於4℃中儲存

將STD&CONTROL儲存於-20℃中儲存

用沾了酒精之棉棒清潔sample probe, reagent probe, Mixer (注意關機後執行)

 

 

PS:

泡製STD&CONTROL後靜置40分鐘，混和均勻完畢後每杯200uL分裝冷凍

calibration: 每週至少一次

QC: 每天一次

 

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Traceability(English).jpg

 

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*Revised January 2010

Established January 2004

 


EXTEL ®
HM Control for Fecal Occult Blood Measurement

Be sure to read through these instructions before use.

 

[Lot Number]    :    Lot XXXAAA    [Expire Date]     :　　January、20XX　　 

 

[Package Contents]


Reagents

Quantity

Constituent

Low-concentration control

For 1mL

Human hemoglobin

High-concentration control

For 1mL

 

[Application]

This product is used for sample for the quality control of the EXTEL ® HEMO AUTO, a special-purpose reagent for the fully automatic human fecal hemoglobin analyzer, HM-JACK.

 

[Procedure]

1.  Reagent Preparation

Add exactly 1mL of distilled water to dissolve. After the solution has been stood for 30 to 45 minutes at

room temperature, gently turn upside down to homogenize and start using.

2.     Storage after reconstitution

After dissolving, the solution remains stable for 1 week when stored at 2 - 8°C,or for 30 days when stored below -30°C.

 

[Warnings and Precautions]

1.   This product contains ingredients of human origin and when tested for HB antigens, HIV and HCV antibodies gives a negative result. It is possible however that other infectious factors may be present. Be sure therefore to take the same precautions as you would do when handling patient samples by wearing gloves or other protection to prevent infection.

2.   This product contains sodium azide as an antiseptic (0.1% or less). On contact with lead, it reacts vehemently with formation of highly explosive metal azides. When you discard the reagent be sure therefore to dilute and wash with plenty of water.

3.   Do not mix controls of different lot numbers for use.

4.   Do not use controls that have exceeded their shelf life or standards that have been dissolved and stood for 1 week or longer even when stored at 2-8°C.

5.   Do not use the containers and accessories of this product for any other purpose.

 

[Storage and Shelf Life]

1.   Storage: Store in a dark and cool place (at 2-8°C).

2.   The shelf life is displayed on each container label.

 

[Target Value]


Reagents

Target Value

Low-concentration control

17  -   27  ng / mL

High-concentration control

75  -  113  ng / mL

*Value varied by lot.

 

[Packaging Unit]


Product

Package size

Hemoglobin Controls

for fecal occult blood analysis

For 1mL x 4 containers

each (Low-/High-conc.)

 

For all inquiries please do not hesitate to contact:

Kyowa Medex Co., Ltd.

Scientific & Technical Affairs Department

1-8-10 Harumi, Chuo-ku, Tokyo 104-6004

Toll Free No.: 0120-17-4898

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Established January 2004

EXTEＬ ®
Hemoglobin Standard for Fecal Occult Blood Measurement

 

 

Be sure to read through these instructions before use

 [Package Contents]


 

 

Reagents

Quantity

Constituent

 

Low-concentration standard

 

 

For 1mL

Human hemoglobin

 

High-concentration standard

 

 

For 1mL


 

 

This product is provided with a “Standard Concentration” card.

 

 

[Application]

This product is used for calibrating (2-point calibration) the master curve of the EXTEL ® HEMO AUTO, a special-purpose reagent for the fully automatic human fecal hemoglobin analyzer, HM-JACK.

 

[Procedure]

Calibrate the master curve by measuring the hemoglobin standard for fecal occult blood analysis (called “standard” for short). For details about the intervals at which the master curve should be calibrated consult the instruction leaflet for the EXTEL® HEMO AUTO. For details about the operating procedure, refer to the instruction manual for the fully automatic human fecal hemoglobin analyzer HM-JACK.

1.  Reagent Preparation

Add exactly 1mL of distilled water to dissolve. After the solution has been stood for 30 to 45 minutes at room temperature, gently turn upside down to homogenize and start using. After dissolving, the solution remains stable for 1 week when stored at 2 - 8°.

2.  Procedure

(a(a) Enter the measurement menu of the fully automatic human fecal hemoglobin analyzer HM-JACK.

(b(b) Gently mix the prepared standard solution, introduce the necessary quantity into the sample cup and place in the specified position on the specimen table.

Note:  Once you have transferred the standard solution into the test cup do not return to the vial. If the standard quantity is not sufficient do not make any addition to make up the shortage. Prepare a new sample cup instead.

(c(c)   Place the reagent in the specified position.

(d(d) Press the START key of the HM-JACK. The entire process from sampling the specimen to the processing of the data after measurement is fully automated.

3.  Entering the Standard Concentration

When the Production (lot) number of the standard has changed enter the concentration by using the barcode of the standard concentration card.

 

[Warnings and Precautions]

1.   The standard contains ingredients of human origin and when tested for HB antigens, HIV and HCV antibodies gives a negative result. It is possible however that other infectious factors may be present. Be sure therefore to take the same precautions as you would do when handling patient samples by wearing gloves or other protection to prevent infection.

2.   This product contains sodium azide as an antiseptic (0.1% or less). On contact with lead, it reacts vehemently with formation of highly explosive metal azides. When you discard the reagent be sure therefore to dilute and wash with plenty of water.

3.   Do not mix standards of different lot numbers for use.

4.   Do not use standards that have exceeded their shelf life or standards that have been dissolved and stood for 1 week or longer even when stored at 2-8°C.

5.   All specimens, all standards and all containers and apparatuses, including the sample cups must be either treated by anyone of the following methods or discarded in accordance with the manual in force at the respective facility for the disposal of infectious medical wastes.

·    Sterilize under pressure at 121°C in an autoclave for 15 minutes or longer. However, do not autoclave wastes containing sodium hypochlorite solutions.

·    Immerse in a sodium hypochlorite solution (with an effective chlorine concentration of over 1000ppm) for 1 hour or longer.

·    Incinerate if wastes are combustible.

6.   Do not use the containers and accessories of this product for any other purpose.


*[Storage and Shelf Life]

1.   Storage: Store in a dark and cool place (at 2-8°C).

2.   The shelf life is displayed on each container label.

 

[Packaging Unit]

Product

Package size

 

Hemoglobin standards Plus

for fecal occult blood analysis

 

 

For 1mL x 4 containers

each (Low-/High-conc.)

 

For all inquiries please do not heistate to contact:

Kyowa Medex Co., Ltd.

Scientific & Technical Affairs Department

1-8-10 Harumi, Chuo-ku, Tokyo 104-6004

Toll Free No.: 0120-17-4898

 

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