Operation Manual. snapshot. cuvettes. Pi-102 Luminometer

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1 Operation Manual Pi-102 Luminometer snapshot cuvettes Version: 2.0 Hygiena International Ltd. January 2013

2 Contents Page 1. The instrument Instrument details 1.2 Cuvette size to be used 1.3 Explanation of the keys and indicators 1.4 Power supply 1.5 Placing the chamber extension for the snapshot test 2. Measurements Quick Start 2.2 Measurement options Lists Options 3. Software Installation 3.2 Working with the software Preparing a sample list Installing the USB-driver Transfer a saved sample list to the Pi Operating the Pi-102 using a programmed list Transfer data from the Pi-102 to the software Measuring and transferring results on-line Other software options 4. Maintenance & Trouble Shooting Maintenance 4.2 Trouble Shooting WARRANTY STATEMENT: Hygiena warrants the performance and proper functioning of the Pi-102 for a period of 12 months after delivery. Damage caused by incorrect operation of the Pi-102 is excluded from warranty. The use of unauthorised parts or components may lead to loss of warranty. DISCLAIMER: Please read this Manual carefully before using the Pi-102 luminometer. Always disconnect the Power Supply before cleaning. Do not use any cleaning chemicals (these may damage the keypad), but only a moistened cloth. Only use the Power Supply supplied with the Pi-102, the use of another Power Supply may damage the Pi-102. Repair and maintenance may only be done by authorised and trained staff. This Manual has been written with care. Hygiena will not be liable for damage caused by incorrect operation. All rights to this document are reserved. No part of this document may be reproduced without written confirmation from Hygiena. Hygiena International Ltd. and Hygiena LLC are affiliates of Medical Packaging Corporation Inc., Camarillo (CA), USA 2

3 1. THE INSTRUMENT 1.1 Instrument details: The Pi-102 luminometer is a highly sensitive instrument for measuring bio- and chemiluminescence. It is operated either as stand alone, or in connection with a PC and dedicated software. 1.2 Cuvette size to be used: Standard Hygiena cuvettes have a dimension of 12x55 mm. However, the Pi-102 can take cuvettes with a width of mm and a height of mm. The Pi-102 is also supplied with a chamber extension for the Hygiena snapshot test device (hygiene monitoring application). No cuvettes are necessary in this case. 1.3 Explanation of the keys and indicators: ON/OFF : ON/OFF key PC/PRINT : for up/downloading to a PC or print results from the Pi-102 : return to previous menu, or ESCAPE key and : scroll through the menu : select option from menu, or ENTER key O Load : led indicator to indicate active battery recharge On the side of the Pi-102: Supply : connection for power supply 1.4 Power supply: The user can choose between operating the Pi-102 from the mains or from the USB connector, connector to a computer. The instrument also operates cordless from the internal rechargeable battery, which is charged when connecting the power supply. When operated from the mains, the Pi-102 will be charging the battery in the background. 1.5 Placing the chamber extension for the snapshot test: It is advisable to do this before the Pi-102 is switched on. The chamber extension can be easily mounted by carefully pulling off the chamber lid from the Pi-102, place the extension and place the chamber lid on top. Make sure that the parts are properly connected and clicked in the right position. The Pi-102 is now ready to measure the snapshot device. To remove the chamber extension, pull off the chamber lid and chamber extension and place the chamber lid back on the chamber. 2. MEASUREMENTS 2.1 Quick start: Push the ON/OFF key Press (lists) Press (OK), or select list by pressing before Press (New), old results in the list are erased Press to start measurement Results are stored in the memory and previous results in the list can be viewed by pressing. To quit measuring, press twice. To switch the Pi-102 off, hold ON/OFF button for 1 second. Note: KEEP THE MEASURING CHAMBER CLOSED DURING MEASUREMENT & REMOVE THE SAMPLE AFTER MEASUREMENT. 3

4 2.2 Measurement options: After switching the Pi-102 on, the display will show three lines: Lists, Options and Settings Lists: You can select 8 different lists, each can store 100 measurements. Select lists by pressing. The display will show: List 01 Name 100 pos, 00 used Esc < > Ok Select one of the four possibilities to choose from: Press to go back to the main menu Press to select a list with a lower number Press to select a list with a higher number Press to confirm the displayed list After pressing you will see the following display: List: Old results from (date + time) 100 positions Esc Old New Select one of the three possibilities to choose from: Press to go back to the main menu Press to view and mark old results in the selected list. If there are no old results the Pi-102 will ask you to insert the first sample. Press to delete the old results from the selected list After pressing you will see the following display: List: MP01: Name1 Insert Sample No Thresholds Esc < > OK Insert a sample and press. The measurement will start and when ready you will see the following display: List: MP01: Name1 RLU No Thresholds Esc < > OK To start the next measurement, press. In case you would like to overwrite the last result, press once to select Overwrite result and press. When all samples have been measured, press the key twice. You can now switch off the Pi-102 by holding the ON/OFF for 1 second. 4

5 Options: From the start menu you can select the Options menu. In this menu you have the possibility to use and change some features of the luminometer. Below you will find the explanations of the different options: From the main menu, select Options by using the key and press. The following display will appear: Units Counting time Self Test Print List Units: possibility to select results expressed in RLU or fg ATP. In normal operation, the setting should be in RLU. The fg ATP setting allows the user to determine the amount of ATP in the sample. To determine the amount of ATP, the sample is measured first. A known amount of ATP is added to the sample and a second measurement is performed. From the difference between result 1 and 2, the amount of ATP in the sample can be calculated. Counting time: the default setting is 5.0 seconds, and is programmable between 0.2 and seconds using the key and confirm by pressing. The RLU value does not change with a different counting time, because the displayed value is the average of n x 0.2 second intervals. The longer the counting time, the more accurate the RLU value will be. Self Test: This is to check if the measuring chamber is light tight. The Pi-102 will do a blank test. Before starting a self test, check if the counting chamber is empty. Print List: When a (serial) printer is connected, the Pi-102 will print the results from the lists Settings: From the start menu you can select the Settings menu. In this menu you have the possibility to change some factory settings of the luminometer. Below you will find the explanations of the possible settings: Disp. light time Battery Status LCD Contrast the default setting is 55 seconds before the backlight of the display is switched off. When working from the mains, the backlight will be lit continuously. This shows a number of lines, indicating the present status of the battery. To adjust the contrast of the LCD display 5

3. SOFTWARE 3.1 Installation: Hardware requirements: PC with Windows XP or higher.

On the installation CD you will have the following files and folders: To install the software, click on

6 3. SOFTWARE 3.1 Installation: Hardware requirements: PC with Windows XP or higher. To install the software, insert the CD- ROM. On the installation CD you will have the following files and folders: To install the software, click on the file called Hygiena2010.exe Working with the software: To start the program, double click the Hygiena 2010 icon on the Desktop, or via the appropriate folder where the program is installed. If you attempt to open the software without the Pi-102 luminometer connected, you will see the following message before the software is opened: Clicking <ok> will open up the home screen: 6

The program then comes up with the screen below. By default, the Demo.lst file is available for test results.

lst file, the program will show an empty list with 100 positions, from No. 1 until 100 (see Fig below).

10 characters) and a further explanation of the sample in the Explanation column (no limits in number of characters).

7 The program then comes up with the screen below. By default, the Demo.lst file is available for test results. You can create new lists in the software that will then also be displayed in this screen Preparing a sample list: After opening the Demo.lst file, the program will show an empty list with 100 positions, from No. 1 until 100 (see Fig below). By clicking the Edit Headlines button, the operator has the possibility to enter the names of the samples to be tested in the Name column (max. 10 characters) and a further explanation of the sample in the Explanation column (no limits in number of characters). When the Use Thresholds box is ticked, threshold values for pass/fail limits can be entered for each sample (see following Fig below). When using thresholds, the status column will also be displayed on the screen. When finished with editing the list, the list can be saved. Click on File and Save as. Type in the name you want to use for the file and close the window. To open a saved sample list, click on File and Open and select the file name you want to open. You can edit the list and save it under a different name, or under the same name. 7

3.2.2 Installing the USB-driver: To install the

Go to the Pi-102 Software Folder and open the

on the file called <DPIst> and this will open

the end user license agreement on the pop up

If you get the Windows security message shown

8 3.2.2 Installing the USB-driver: To install the USB driver, you will need to do the following: Go to the Pi-102 Software Folder and open the Folder called CDM: After opening, double click on the file called <DPIst> and this will open the wizard needed to install the driver Accept the end user license agreement on the pop up screen: The Driver will now be installed. If you get the Windows security message shown below, select the option <install this driver software anyway>. 8

The first time you do this you may see a message saying that new software is being installed.

9 Once the installation is complete, you will see the following message: Connect the Pi-102 luminometer to the USB cable and switch it on. The first time you do this you may see a message saying that new software is being installed. Once this is complete, look in the device manager to find out what COM port you are using for the USB cable: Within the Pi-102 software you can configure the COM port within the Configuration tab like shown below: 9

10 Select the correct COM port number from the drop down menu and press <ok>. 10

3.2.3 Transfer a saved sample list to the Pi-102: To transfer a prepared and saved list to the Pi-102 luminometer, click on Read/write lists and select Transfer list to luminometer.

11 3.2.3 Transfer a saved sample list to the Pi-102: To transfer a prepared and saved list to the Pi-102 luminometer, click on Read/write lists and select Transfer list to luminometer. The following screen will appear: Under Available lists, click on the list you wish to transfer and under Pos. in, select the number of the list in the Pi-102. If for instance lists 1 and 2 are already occupied by another sample list, you may want to store the new sample list under list 3. It is always possible to overwrite/refresh old lists in the Pi-102 by overwriting it with a new sample list. The Pi-102 needs to be switched in the Dialog PC mode and must be connected to the PC using the USB interface cable. This is done by pressing the PC/PRINT key once when you are in the main menu. You will see the following message on the Pi-102 display: Dialog PC Esc The Pi-102 is now in the Dialog PC mode and is able to read data from the software. When you have selected the appropriate sample lists and the number of the list in the Pi-102 you want to send it to, click on Transfer list(s) to Luminometer. The sample list will now be stored in the Pi-102 under the list number you have selected. To quit the Dialog PC mode, press the key once Operating the Pi-102 using a programmed list: When you have programmed a list in the Pi-102, you can select it from the main menu in the Pi-102. Lists Options 11

12 Select Lists. In the example under 3.2.2, the list was placed under 25 June 02 in list number 1. You will see the following on the display: List 01 Name 25 June pos, 00 used Esc < > Ok Select Ok. The Pi-102 will ask you if you want to delete any old results in list 1 (this message will always appear, also if there are no old results). Old results from.. (Date + Time) 100 pos Esc Old New To read and mark old results, select Old. To overwrite, select New. Place the first sample in the Pi-102 and start the measurement by pressing the key. For the next sample, remove the previous sample and place the new sample. Press the key twice to start the measurement. Repeat this until all samples have been measured. To quit the measurement mode, press twice. The results are stored in the memory, also when you switch the Pi-102 off Transfer data from the Pi-102 to the software After measurement you can transfer the results to the software for review and printing. Switch the Pi-102 on and in the main menu press the PC/PRINT button once. You will see the following display: Dialog PC Esc The Pi-102 is now in the Dialog PC mode and is able to read data from the Pi-102. In the software, select Read/write lists from the menu, followed by Read lists results. After clicking on Read and check lists from Luminometer you will see a dialog box where you can select the lists you want to transfer from the Pi-102 to the software. 12

13 In the dialog box, the lists with new results will appear in green font. To transfer the results, tick the box next to the green line and click on Read selected results. The screen will show the sample list with the results (see example in Fig. 6). The Status column will show the interpretation of the results, based on the programmed thresholds. The Comment field can be used for additional comments. To print the results, click on File and Print. To save the results, click on File and Save Measuring and transferring results on-line : Transferring data on-line from the Pi-102 to the software after each measurement is also possible. Start the software and prepare a sample list. On the screen, tick the boxes Connect to Lum. and Synchronize CP (see Fig. 7) 13

On the Pi-102, select one of the available lists, insert the first sample and start the measurement. After each measurement, the value and the interpretation will be displayed (Fig. 8).

14 On the Pi-102, select one of the available lists, insert the first sample and start the measurement. After each measurement, the value and the interpretation will be displayed (Fig. 8). After completing the measurements, the results can be printed and saved as explained under Other software options: In the software menu there are some more options which are explained underneath: Luminometer Luminometer date/time; to change data/time settings of the Pi-102. Luminometer parameters; to change the measurement settings of the Pi-102. Warning: this should only be done by experienced users!! Read Luminometer version; to view the firmware version of the Pi-102 Upload firmware to Luminometer; to upload a new version of the firmware to the Pi- 102 Configuration Serial port; to change the RS232 settings of the serial COM port. During installation, the software will try to select an available COM port. This can also be defined by the user by selecting an appropriate COM port from the Computer Control Panel. Warning: this should only be done by experienced users!! View Toolbar; to select or de-select viewing the Toolbar in the software Status Bar; to select or de-select viewing the Status Bar in the software Window Gives a list of the open Windows in use? Help; to access the on-line help file About; to view the software version 14

15 4. MAINTENANCE & TROUBLE SHOOTING 4.1 Maintenance: The Pi-102 is very robust and does not need special maintenance. Keep the Pi-102 free from dust and clean the casing with a clean cloth will be sufficient to keep the Pi-102 in good condition. However, please respect the following: Do not open the counting chamber during measurement. This can harm the photomultiplier tube, due to excessive light coming in. If this happens, please leave the Pi-102 switched off for 15 minutes to allow the photomultiplier tube to stabilise again. Do not spill any liquid in the counting chamber. This can cause false low readings due to the build-up of dirt in the chamber. In case liquid is spilled, clean the chamber with a clean, dry swab. Do not use acetone or other aggressive cleaning agents to clean the top of the Pi-102. Do not move the Pi-102 during the measurement. 4.2 Trouble Shooting: The table below lists possible errors which could appear when working with the Pi-102. In case the solution provided is not successful, please contact your distributor or send an to Hygiena (enquiries@hygiena.net). Problem Cause Solution No communication with the USB cable not properly Check cable connection PC connected Pi-102 not in 'Dialog PC' mode Make sure the Pi-102 is in 'Dialog PC' mode Overflow message on display Sample gives > 100,000 RLU Sample contains very high ATP amount, dilute the sample Pi-102 does not work from Battery charge too low Recharge battery battery Battery defect Replace battery Result is always 0 Photomultiplier tube or Send back for repair electronic defect Cuvette chamber not in correct position Check if chamber is positioned properly (click-fit) Dark count too high Counting chamber dirty Clean counting chamber Lid not closed properly Photomultiplier tube or electronic defect Close lid Check if dark count is still too high after 15 minutes. If not reduced, there is a problem with the photomultiplier tube or the electronics The battery pack can easily be exchanged, but only an educated electronic engineer should do this. At the bottom of the Pi-102, four small screws can be unscrewed and the battery pack can be removed. It is connected to the main board with a connecting cable that needs to be disconnected. Place the new battery pack and connector and close the Pi-102 again. If the exchange takes more than 20 minutes, the time/date settings are erased. All other settings and results remain stored. 15

STANDARD OPERATING PROCEDURES DIVISON OF COMPARATIVE MEDICINE UNIVERSITY OF SOUTH FLORIDA

STANDARD OPERATING PROCEDURES DIVISON OF COMPARATIVE MEDICINE UNIVERSITY OF SOUTH FLORIDA SOP#: 1139.5 Date Issued: 12/03 Date Revised: 8/16 Page 1 of 5 TITLE: SCOPE: RESPONSIBILITY: PURPOSE: Animal Care