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pH SAFE

Reader

Model: BCSI pH1000

Operator Manual

Doc. No. 120001-09

Blood Cell Storage, Inc.

4203 23rd Ave W

Seattle, WA 98199 USA

MedEnvoy Global B.V.

Prinses Margrietplantsoen 33 - Suite 123

2595 AM The Hauge

The Netherlands

C
V

Содержание pH SAFE PH1000

Страница 1: ...pH1000 Operator Manual Doc No 120001 09 Blood Cell Storage Inc 4203 23rd Ave W Seattle WA 98199 USA MedEnvoy Global B V Prinses Margrietplantsoen 33 Suite 123 2595 AM The Hauge The Netherlands 2022 A...

Страница 2: ......

Страница 3: ...13 3 3 Software Setup 11 3 3 1 Configure pH SAFE Reader Options 11 4 Using the pH SAFE Reader Software 14 4 1 Overview 14 4 1 1 Power On Self Check SELF CHK 14 4 1 2 Run Options Prompt 15 4 1 3 Power...

Страница 4: ...Memory 42 6 5 7 Pack Memory 43 6 5 8 Ethernet Setup 44 6 5 9 Read Ratio 46 6 5 10 Set QC Values 48 6 5 11 Set User Correction Values 49 6 5 12 Print Service Report 49 6 5 13 Exit System Settings 50 6...

Страница 5: ...device is not intended for self testing by lay users 1 2 Using this Manual Chapters in this manual provide comprehensive information describing the technology and operation of the pH SAFE Reader Chap...

Страница 6: ...components The manufacturer warranty is voided if the instrument cover is removed Use only Supplied AC Power Adapter Cables for pH SAFE Reader and Printer A power adapter is supplied for specific use...

Страница 7: ...is used in a manner not specified by the installation operation procedures included in this manual the safety protections provided by the equipment may be impaired 1 5 Informational Symbols The follo...

Страница 8: ...th fiber optic probe on pH SAFE Reader Avoid scraping the sensor on the probe Quick Reference Guide Check the information on the pH SAFE Reader Screen and the barcoded information for correct barcode...

Страница 9: ...any breach of warranty Any instrumentation to be returned for repair or replacement must be properly packaged and shipped via prepaid freight in accordance with BCSI instructions This limited warranty...

Страница 10: ...t s in the bag are registered US Canadian and or European trademarks The pH SAFE technology is covered by multiple issued and pending US and International equivalent Patents including but not limited...

Страница 11: ...s standard platelet storage bags for platelet collection and transfusion purposes Refer to the BCSI Platelet Storage Bag package insert for complete information about the characteristics and intended...

Страница 12: ...e intensities of the two wavelengths of interest are collected by photodetectors in the pH SAFE Reader A ratio of the two wavelengths is calculated and converted into a pH By using a ratio of the emis...

Страница 13: ...e bag ID and User ID information Keypad for data entry of platelet storage bag ID and User ID information and menu navigation RS 232 Serial port for output of results data to a Printer or for upload o...

Страница 14: ...impulse withstand over voltage category II of IEC 60364 4 443 Adapter output power 9V DC 1 7A max NOTE Input connectors are available for Continental Europe the United Kingdom North America and Austra...

Страница 15: ...nd Laboratory Use Part 1 General Requirements EN 61010 1 Safety requirements for Electrical Equipment for Measurement Control and Laboratory Use Part 1 General Requirements CAN CSA C22 2 No 61010 2 10...

Страница 16: ...Code Scanner and the Bar Code Scanner User s Manual If the optional Printer is purchased a second box will also be shipped Box 2 contains 1 Printer box containing the Printer the printer power adapte...

Страница 17: ...inter 2 Connect the instrument power adapter to the Power Input port on the back panel of the instrument and to the facility AC power source 3 If the Bar Code Scanner will be used connect the Bar Code...

Страница 18: ...pplied to the instrument using the ON OFF switch located on the right side panel of the instrument Figure 2 2 the software executes a startup sequence the Power On Self Check SELF CHK This automatic t...

Страница 19: ...n parameters The LCD screen updates to display access to the first function available from the menu Use of the Options Menu functions is fully described in Chapter 6 Using the Options Menu Automatic R...

Страница 20: ...lly pressed to accept the first character and move the cursor one character position to the right for entry of the next desired character Alternatively once the first desired character is displayed wa...

Страница 21: ...sive labels with these two codes on them are also provided for convenience 4 4 Software Security The software may be configured to allow or restrict user access to the Run Test and or the Options Syst...

Страница 22: ...he Options System Settings functions is specified by the current setting of the Options System Settings Supervisor PIN parameter When the Supervisor PIN value is disabled or the value is left undefine...

Страница 23: ...er to Section 4 4 1 Security Access to Run Test and Section 6 5 4 Enable User ID and PIN Three security access settings are available for definition of the Options System Settings Enable User ID PIN p...

Страница 24: ...User List NOTE The default User ID definitions contained in the list are USER1 USER8 Refer to Section 6 5 5 Edit User ID PIN for complete information about editing User ID definitions in the User Lis...

Страница 25: ...r User PIN No User Currently Logged On If the currently defined setting of the Options System Settings Enable User ID PIN parameter is specified as ENABLE ID PIN and no user is currently logged on the...

Страница 26: ...e is incorrect use the Down Arrow key to move the cursor down to select NO then press the Enter key 3 The instrument will log off the current user and display the following screen From this screen pro...

Страница 27: ...tion key Pressing the Options key with no pH ID information entered causes the display to return to the Run Options prompt Bar Code Scanner 2 Use the Bar Code Scanner to input pHID data from a bar cod...

Страница 28: ...t measurement platform and insert the Fiber Optic Probe of the instrument into the opening at the top of the pH SAFE Sensor of the bag Figure 5 1 Insert Fiber Optic Probe into pH SAFE Sensor 4 Slide t...

Страница 29: ...des the user with options to save print or discard the results data for this test From the test result screen Press any key to continue The screen updates to display the Results menu with the first op...

Страница 30: ...nal test results In the above example 92 additional measurements can be performed and saved before the memory is full After displaying the above screen for approximately two seconds the screen returns...

Страница 31: ...e following message After displaying this message for approximately two seconds the screen returns to the Run Options prompt NOTE The RS 232 Serial port hardware and corresponding firmware of the BCSI...

Страница 32: ...ect use of this option the screen updates to briefly display a message similar to the following example This function proceeds in the same manner described in Section 5 6 1 Save pH Additionally after...

Страница 33: ...he instrument will pause until the upload is complete and display the following message After the pause typically less than 2 3 seconds the latest test result will be saved to the instrument memory NO...

Страница 34: ...desired option is displayed on the lower line of the screen 2 When the desired option is displayed press the Enter key to access the use of this function 3 To return to the Run Options prompt from th...

Страница 35: ...in the instrument memory the instrument emits an alarm tone and displays the following message After any key is pressed the screen returns to the Options Menu 6 3 1 pH Test Results List 4 When the Opt...

Страница 36: ...f the current user PIN does match the Supervisor PIN the Delete Record prompt is displayed Proceed to Section 6 3 3 Delete Record If the current setting of the Options System Settings Enable User ID P...

Страница 37: ...wish to delete the record use the Down Arrow key to move the cursor to the lower line so as to point to YES then press the Enter key The following message is briefly displayed Next the screen returns...

Страница 38: ...stored records ensure the cursor is positioned on the top line pointing to ALL RECORDS then press the Enter key Proceed to Step 5 b To output only selected records use the Down Arrow key to move the...

Страница 39: ...tions System Settings Enable User ID PIN parameter is set to Enable User ID and PIN refer to Section 6 5 4 Enable User ID and PIN and the current user PIN does not match the Supervisor PIN the screen...

Страница 40: ...eturns to the Options Menu b If you do wish to erase the results records from the instrument memory use the Down Arrow key to move the cursor to the lower line so as to point to YES then press the Ent...

Страница 41: ...e System Menu Proceed to Section 6 5 1 System Menu Incorrect PIN 6 If the entered PIN value does not match the currently defined Supervisor PIN value the following message is displayed From this scree...

Страница 42: ...System Settings function is accessed the System Menu screen is displayed The first function available from the menu is displayed on the lower line of the screen The following functions are available f...

Страница 43: ...alue type a new 5 digit value numeric characters only then press the Enter key The display returns to the System Menu screen To leave the PIN value unchanged press either the Enter key or the Options...

Страница 44: ...onth parameter 5 In the same manner edit values for the Month Day Hour and Minute as necessary 6 When all displayed values are correct press the Enter key to accept all values and return to the System...

Страница 45: ...ion to edit User ID and PIN definitions Up to eight 8 User IDs and PINs may be stored in the instrument memory Proceed as follows 1 From the System Menu screen use the Up Down Arrow keys as necessary...

Страница 46: ...User ID is displayed The screen returns to the Enter User ID prompt 6 When the User ID has been entered the following screen is displayed If the User ID has a previously defined PIN this value is disp...

Страница 47: ...ine pointing to NO then press the Enter key The screen returns to the System Menu If you do wish to erase the results records use the Down Arrow key to move the cursor to the lower line so as to point...

Страница 48: ...as provided by the site s LIS System Administrator Proceed as follows 1 From the System Menu screen use the Up Down Arrow keys as necessary to scroll the list until the 7 ETHERNET SETUP option is disp...

Страница 49: ...ions key again to return to the System Menu Netmask 5 From the Ethernet Menu use the Up Down Arrow keys as necessary to scroll the list until the 2 Netmask option is displayed on the lower line of the...

Страница 50: ...nu NOTE If you make an error when entering the Default Gateway information press the Options key to clear the current entry and start over To cancel use of this function press the Options key again to...

Страница 51: ...evious read 2 After entering the pHID the following screen is displayed 3 Refer to Figure 6 2 Place the platelet storage bag onto the instrument measurement platform and insert the Fiber Optic Probe o...

Страница 52: ...rement tests using the Read Ratio utility the instrument will not again attempt output of results to the serial port If a serial device is later connected to the instrument in order to output new resu...

Страница 53: ...ment instrument as follows pH displayed UCV_SLOPE pH measurement UCV_INTR 1 From the System Menu screen use the Up Down Arrow keys as necessary to scroll through the list until the 10 SET UCV VALUES o...

Страница 54: ...e System Menu and return to the Options Menu Proceed as follows 1 From the System Menu screen use the Up Down Arrow keys as necessary to scroll the list until the 12 EXIT SETTINGS option is displayed...

Страница 55: ...e tip surface does not indicate cleaning is necessary Clean the probe tip only if dust and or debris particles are obviously visible on the probe tip surface Never use solvents or water when cleaning...

Страница 56: ...VER attempt to open or repair the QC standard The user should determine at what frequency the standard is used to ensure proper operation of the pH SAFE Reader BCSI recommends the standard be used onc...

Страница 57: ...comparing it to the set QC value A QC Confidence value is measured and if the value is 1000 10 the pH SAFE Reader is determined to be within specification The result of the test is displayed as During...

Страница 58: ...to temperature of the standard 22 2 C cleanliness of the probe tip and correct placement of the standard on the probe If failures persist contact BCSI Technical Support Save Print QC Results Following...

Страница 59: ...cksum mismatch was detected in Reader calibration data during Power On Self Test Contact Technical Support for re calibration servicing RESETTING CLOCK PRESS KEY TO PROCEED The clock is not running Cl...

Страница 60: ...t for this platelet storage bag is not possible MEMORY NOW FULL 100 tests have been stored in memory Print out the records and erase them from memory or Consult supervisor to pack memory or delete rec...

Страница 61: ...n alarm tone and the screen displays the following error message Further operation of the instrument is prohibited at this point In this case the instrument requires repair servicing and or a re calib...

Страница 62: ...to the LIS before last being powered down the Test Record memory will not be empty when the instrument is next powered up If the Test Record memory is not empty it is copied to the CSV data file which...

Страница 63: ...Parity 1 Stop Bit This output is designed to be compatible with small 40 character serial Printers such as those available from Citizen Model iDP 3110 Dot Matrix Printer The output is also compatible...

Страница 64: ...e test results in the following format 1234567890abcdefghij USER1 30 Nov 2020 11 51 00 6 87 QC Test USER1 30 Nov 2020 12 32 00 1003 Bag ID User ID Test Date Time pH or QC reading 20 Chars 11 Chars 11...

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