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Siemens Healthcare Clinitek Status Connect System, Operator'S Manual

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Siemens Healthcare Clinitek Status Connect System Operator'S Manual Download Page 35

Clinitek Status Connect System  

35 

Operator’s Guide 

 

Cause Corrective 

Action 

Deterioration of the quality 
control product. 

Prepare control solution using a fresh 
bottle of control product. 
Repeat the quality control procedure. 
If the fresh control solution fails to give 
results within the expected values, 
proceed to the next possible cause. 

Clinitek Status analyzer 
malfunction. 

If you cannot successfully complete the 
quality control procedure, an analyzer 
malfunction or reagent strip problem may 
exist. Check the calibration bar for dust, 
dirt, or scratch marks, or contact your 
local technical support provider for 
assistance. 

 

Summary of Contents for Clinitek Status Connect System

Page 1: ...Clinitek Status Connect System Operator s Guide For US Only 10490852 2009 12 135055 Rev A ...

Page 2: ...ealthcare Diagnostics Origin UK The information in this guide was correct at the time of printing However Siemens continues to improve products and reserves the right to change specifications equipment and maintenance procedures at any time without notice If the Clinitek Status Connect system is used in a manner differently from that specified by Siemens the protection provided by the equipment ma...

Page 3: ...RATING THE CONNECTOR 15 OVERVIEW 15 GETTING STARTED 15 Using the Start Up Wizard 15 Getting to the Select Ready Screen 16 Enabling the Connector 16 MANAGING OPERATORS LIST 17 Setting Operator IDs 17 Adding Operator IDs 18 Viewing Editing Printing and Deleting Operator IDs 18 SCANNING PATIENT INFORMATION 19 MANAGING URINE COLORS 20 Setting and Customizing Urine Colors 20 Adding Customized Colors 21...

Page 4: ... SYSTEM CONFIGURATION 41 OVERVIEW 41 RECORD THE WARRANTY INFORMATION 41 UNPACKING 41 INSTALLING 43 INSTALLING THE OPTIONAL BAR CODE SCANNER 45 STARTING THE CONNECT SYSTEM 45 CONFIGURING THE CONNECTOR 45 COPYING CONFIGURATION SETTINGS 46 MANAGING NETWORK CONNECTIVITY 47 Connecting to the LAN 48 Connecting to the LAN Wired Settings 48 Connecting to the LAN Wireless Settings 50 MANAGING PRINTOUT SETT...

Page 5: ...uirements 65 Regulatory Specifications 67 Electrical Precautions 67 APPENDIX E BAR CODE SCANNER 69 GENERAL INFORMATION 69 INSTALLING THE OPTIONAL BAR CODE SCANNER 69 TESTING THE OPTIONAL BAR CODE SCANNER 69 TROUBLESHOOTING 69 SPECIFICATIONS 70 Bar Code Formats 70 Bar Code Symbols and Labels 70 BAR CODE SCANNER MAINTENANCE 71 APPENDIX F COMPUTER INTERFACE LIS 73 OVERVIEW 73 CONNECTION SPECIFICATION...

Page 6: ...Clinitek Status Connect System 6 Operator s Guide ...

Page 7: ...ms Section 4 Troubleshooting learn about record and data management Section 5 Data Management install the system or modify system parameters Section 6 System Configuration review additional information such as the glossary or the supplies list Appendices Conventions The Clinitek Status Connect System Operator s Guide uses text and symbol conventions in the following table Convention Description BI...

Page 8: ...e user interface For example if the word Select appears as Select it refers to the Select key on the user interface System icons are also indicated by words in bold type For example the words Next Screen refer to a system icon A complete list of system icons and their equivalents is in Appendix C Symbols Italic Italic type refers to the title of a document a section title in this guide or screen n...

Page 9: ...unctionality provided by the connector For complete information on using the analyzer refer to the Clinitek Status Analyzer Operator s Manual The connector includes the following key features Centralized control Communication with LIS Bar code scan to easily enter data Operator management and security Password protection Improved data management Quality control QC lockout QC reminder Communication...

Page 10: ...ctivity The connector supports the 802 11b and 802 11g wireless specifications by connecting a wireless card to the rear USB port Standard wired connectivity is available using the supplied Ethernet cable and the RJ45 port You can also send CSV formatted results to an LIS or PC using the serial RS 232 port on the back of the connector Memory The analyzer operating system software and settings are ...

Page 11: ...or also supports importing certain information using an optional bar code scanner When a screen prompts for patient information operator ID and name or QC control and level you can use the bar code scanner to enter the information Figure 2 Bar Code of Patient Information Clinitek Status Connect System 11 Operator s Guide ...

Page 12: ...eas Round buttons Boxed areas Scroll arrows Round buttons typically appear on screens that require a selection among several items The button with a filled circle is the current selection Some screens allow more than one selection Boxed areas are text or symbols on the screen enclosed in boxes of varying sizes To activate that function touch any area within the box Scroll arrows are the up and dow...

Page 13: ...tor and patient information Custom Test allows you to set which options are prompted and displayed in results Setting the Password The analyzer default is to have the password disabled You can set the password through Instrument Settings One password allows all users who know it to modify system settings The password differs from the Operators ID list in that you can permit individual operators to...

Page 14: ...Clinitek Status Connect System 14 Operator s Guide ...

Page 15: ...th remote systems Getting Started This section explains how to set up the Clinitek Status Connect system for the first time using the Start Up Wizard For unpacking and installation instructions see System Configuration Using the Start Up Wizard After you connect the instrument and connector and turn the system on the instrument completes self checking and the Start Up Wizard screen displays Use th...

Page 16: ...o run urine strip tests cassette tests QC tests and to recall data or modify system settings When you turn the power on the system initializes and the Select Ready screen displays After modifying system settings or running tests you may need to select Done several times to return to the Select Ready screen Enabling the Connector To enable the connector to communicate with the analyzer perform the ...

Page 17: ...ttings Operator screen 1 of 5 CAUTION Once the Operator ID and Operator Name settings are made do not change the Operator ID setting If you change the Operator ID setting all patient results are erased Setting Operator IDs To set up operator IDs perform the following steps 1 At the Select Ready screen select Instrument Set Up The Choose Settings screen displays 2 Use the arrow keys to select Instr...

Page 18: ...of 2 displays 6 To allow this operator to run patient tests select Enabled To prevent patient tests select Disabled 7 To allow this operator to run QC tests select Enabled To prevent QC tests select Disabled 8 Select Next The Authorized Operator Operator access screen 2 of 2 displays 9 To allow this operator to recall results select Enabled To prevent recall results select Disabled 10 To allow thi...

Page 19: ...elect Done 3 times to return to the Select Ready screen NOTE Enabling the instrument password restricts access to Instrument Setup to those who know the password If both Operator ID and password are enabled the Operator ID has priority Scanning Patient Information You can require operators to only enter patient information with the bar code scanner and not allow operators to manually enter patient...

Page 20: ...lude instrument provided colors perform the following steps 1 At the Select Ready screen select Instrument Set Up The Choose Settings screen displays 2 Use the arrow keys to select Operator and Patient information 3 Select Select The Input Settings screen displays 4 Select Custom Set Up 5 Select Next The Custom Settings Operator screen 1 of 5 displays 6 Select Next 3 times The Custom Settings Samp...

Page 21: ...n screen displays 5 Select Done twice to return to the Select Ready screen Entering Urine Color and Clarity during Test Cycle While a strip test is in progress you can choose one of the instrument provided or custom urine colors and clarity options for a urine sample Or you can indicate the standard option of Yellow and Clear NOTE This option is only available in Full Test or Custom mode During a ...

Page 22: ...ip Information Prompt To set the prompt for strip information perform the following steps 1 At the Select Ready screen select Instrument Set Up The Choose Settings screen displays 2 Use the arrow keys to select Instrument Settings 3 Select Enter The Instrument Settings screen displays 4 Use the arrow keys to select Urinalysis Test Settings 5 Select Select The Urinalysis Test Settings screen displa...

Page 23: ...lpha keyboard to enter text To enter numeric text select 123 4 Select Enter The Strip Expiration screen displays 5 Use the arrow keys to indicate the strip expiration date 6 Select Enter The Prepare Test screen displays 7 Select Start Refer to the Clinitek Status Operator s Manual as needed ...

Page 24: ...Clinitek Status Connect System 24 Operator s Guide ...

Page 25: ...lyzers may contain up to 200 QC test results Clinitek Status analyzers may contain up to 50 QC test results You can run QC tests for strips or cassettes at any time or when a QC test is due based on a schedule you set When a QC test is due the QC button on the Select Ready screen displays the type of test that is due strip or cassette To run a QC test at any time select QC Test at the Select Ready...

Page 26: ...he results Accessing QC Strip Set Up To access the QC Set Up procedure for strip tests perform the following steps 1 At the Select Ready screen select Instrument Set Up The Choose Settings screen displays 2 Use the arrow keys to select Instrument Settings 3 Select Select The Instrument Settings screen displays 4 Use the arrow keys to select QC Settings 5 Select Select The QC Settings screen displa...

Page 27: ...perform the following steps 1 To set the number of levels to complete a QC test select 1 2 or 3 2 For each control set in Step 1 select the corresponding Control Level 1 2 or 3 For example if you set 2 controls you must define Control Level 1 and Control Level 2 The Control Level 1 Strip test screen displays 3 Select Enter name of control The Name of Control screen displays 4 Enter the name of thi...

Page 28: ...ton is filled Each test is excluded if the corresponding button is blank If you do not select a radio button that parameter is disabled for the QC test When you complete entering pass ranges for the tests the QC Level 1 Tests and pass ranges screen 3 of 3 displays 8 Select Done The Control Level 1 Strip test screen displays 9 Select Done The QC Settings Strip test screen 3 of 3 displays 10 If nece...

Page 29: ...s to ranges you specified in the QC Set Up procedure Or you can have the operator determine QC test pass fail after viewing the results Accessing QC Cassette Set Up To access the QC Set Up procedure for cassette tests perform the following steps 1 At the Select Ready screen select Instrument Set Up The Choose Settings screen displays 2 Use the arrow keys to select Instrument Settings 3 Select Sele...

Page 30: ... screen displays 3 Select Enter name of control The Name of Control screen displays 4 Enter the name of this control Use the alpha keyboard to enter text To enter numeric text select 123 5 Select Enter The Control Level 1 Cassette test screen displays 6 To set the control level as positive select Positive To set the control level as negative select Negative 7 Select Done The QC Settings Cassette t...

Page 31: ... At the Select Ready screen select QC Test Strip due The QC Test screen displays 2 Select QC Strip Test Required 3 If the instrument is set to determine pass fail the Control Lot screen displays Go to Step 8 If the operator is set to determine pass fail the Name of Control screen displays 4 Enter the control name Use the alpha keyboard to enter text To enter numeric text select 123 5 Select Enter ...

Page 32: ... cannot be run until the QC tests pass 22 To repeat a failed QC test select Repeat failed QC test 23 Select Done to return to the Select Ready screen Running a QC Cassette Test NOTE Prepare the controls according to the manufacturer s instructions This section describes how to run a QC cassette test when it is due and for one QC level Repeat the procedure if more than one QC level is set To perfor...

Page 33: ...l as needed The Results screen displays NOTE When the instrument is set to determine pass fail if the test results pass the Results QC Test Pass screen displays If the test results fail the Results QC Test Fail screen displays 17 To print the results select Print 18 To view the next page select More And to return to the previous page select Back 19 Select Done The QC Test Select PASS or FAIL scree...

Page 34: ...ality control and urinalysis strip or cassette package inserts The following table lists possible sources of error and suggested corrective action Cause Corrective Action Incorrect analyzer setup If using a reagent strip verify that the reagent strip used corresponds to the reagent strip selected Repeat the control procedure Improper technique Carefully repeat the control procedure Refer to the Cl...

Page 35: ...rol procedure If the fresh control solution fails to give results within the expected values proceed to the next possible cause Clinitek Status analyzer malfunction If you cannot successfully complete the quality control procedure an analyzer malfunction or reagent strip problem may exist Check the calibration bar for dust dirt or scratch marks or contact your local technical support provider for ...

Page 36: ...Clinitek Status Connect System 36 Operator s Guide ...

Page 37: ...n to continue Not all required QC levels were run Exiting now will cause the QC test to fail The QC test has failed Patient tests cannot be run until a QC test is passed Disabling authorized operators will cause all stored data to be deleted Operator is not authorized to access this area Deleting records will clear the selected stored data Editing this custom color will cause all stored data to be...

Page 38: ...Clinitek Status Connect System 38 Operator s Guide ...

Page 39: ...tient and QC records stored on the instrument Recalling Patient or QC Data To recall patient or QC records perform the following steps 1 At the Select Ready screen select Recall Results The Recall Options screen displays 2 Use the arrow keys to select Recall Patient Tests or QC Tests 3 Select Select The Recall Results screen displays 4 To search patient tests select Patient tests To search QC test...

Page 40: ...ect Send all but no data exists to send a screen with the message No data to send displays NOTE Printing all the records may take a long time Deleting Records You can delete all patient and QC records stored on the instrument To delete patient and QC records perform the following steps 1 At the Select Ready screen select Recall Results The Recall Options screen displays 2 Use the arrow keys to sel...

Page 41: ...9 or lower upgrade the software to the latest version Refer to the software upgrade instructions in the Clinitek Status Software Upgrade Kit Record the Warranty Information 1 Locate the serial number The instrument serial number is located under the printer cover The connector serial number is on the bottom of the connector 2 Print the Pre service Checklist and the Warranty Information from Append...

Page 42: ...cable 7 6 cm 3 inch DC power cable Retain the connector shipping carton and packing materials which offer the best protection against damage if you need to ship the connector 1 Connector 2 Power supply adaptor 3 Plastic clips 4 Ethernet cable 5 15 2 cm 6 inch Serial RS 232 cable 6 Short DC power cable Figure 3 Hardware Package Contents Clinitek Status Connect System 42 Operator s Guide ...

Page 43: ... may affect test results 3 After ensuring the instrument is unplugged from the main power supply fasten the instrument into the slots of the connector as shown on the diagram There are two options for securing the units to each other Use the clips to secure the instrument to the connector Use only the cables mentioned in Steps 4 and 5 below CAUTION Use caution if moving the system as the two units...

Page 44: ...ert an optional wireless card into the rear USB port as shown 2 Insert the Ethernet network cable into the RJ45 port and connect the other cable end to a LAN socket 7 Plug in the power supply adaptor to the connector and then to an AC electrical wall outlet 4 If the software version on your instrument is 2 0 proceed to Step 8 below If you run analyzer software version 1 9 or lower upgrade the soft...

Page 45: ...ormation Model Name Software Version Copyright Information Start Up Tests After you turn the power on a message displays explaining that the system is starting up The system performs hardware functionality tests to verify that the internal optics and the mechanical system are operating correctly Verifying that the System is Ready The instrument displays the current date and time and verifies that ...

Page 46: ...Use the arrow keys to select System Information 3 Select Select The System Information screen displays 4 Select System Configuration The Configuration Settings screen displays 5 Select Copy set up The Copy Set Up screen displays 6 To copy the configuration settings from this instrument to a memory stick select Copy to memory stick To copy the configuration settings from a memory stick to this inst...

Page 47: ...instrument and connector are connected you can connect to a Local Area Network LAN via the RJ45 port or via an optional wireless card plugged into the rear USB port The Clinitek Status connector supports the HL7 or POCT1A communication protocol You can also send data in CSV format using the rear serial port For serial connectivity settings and requirements including baud rate parity and start stop...

Page 48: ...displays 9 Use one of the following four options for network connectivity To connect to the LAN using the Ethernet cable select Wired connection select Edit wired settings and see below To connect to the LAN using the wireless card select Wireless connection select Edit wireless settings and see below To connect to an external computer system using the serial connection select Serial connection an...

Page 49: ...s 6 Select Next The Wired Settings screen 2 of 4 displays 7 To use a Gateway select Yes To bypass a Gateway select No Go to Step 10 8 If you selected Yes to edit or create the Gateway address select Enter Gateway address 9 Select Enter 10 To edit or create the Subnet mask select Enter Subnet mask The Subnet mask screen displays 11 Select Enter The Wired Settings screen 2 of 4 12 Select Next The Wi...

Page 50: ...e Wireless Settings screen displays NOTE As needed consult with your Network Administrator before entering information 2 There are four options for the security settings To bypass security settings select Disabled To use WEP select WEP To use WPA select WPA To use WPA PSK select WPA PSK 3 Select Next If you selected Disabled go to Host Setup below Step 10 If you selected WEP go to WEP Security bel...

Page 51: ...ter numeric text select 123 5 Select Enter The WPA PSK Network key screen displays 6 Select Next Go to IP Address below IP Address 1 To use the Dynamic Host Configuration Protocol to assign a dynamic IP address select DHCP Go to Step 4 To manually enter a static IP address select Static 2 If you selected Static to edit or create the IP address select Enter IP address The IP address screen displays...

Page 52: ...e the Host port number select Enter Port number The Port number screen displays Use the alpha keyboard to enter text To enter numeric text select 123 6 Select Enter 7 When the settings are complete select Next 8 To use the POCT1 communication protocol select POCT1 To use the HL7 communication protocol select HL7 NOTE If you select POCT1 the Enter Patient Information screen displays when running a ...

Page 53: ...for example Color Clarity or Custom Information to include in the printout select the option button To remove a selected option select that option button again 9 Select Next The Printer Settings Set Up Custom Header screen 3 of 4 displays 10 To include a custom header in the printout select Enabled To exclude a custom header select Disabled 11 To edit or create line 1 of a custom header select Ent...

Page 54: ...Clinitek Status Connect System 54 Operator s Guide ...

Page 55: ...n contact the local Siemens service provider Support Information Call for assistance if one of the following occurs If the error message continues after performing the steps described on screen If additional assistance is required concerning a system problem If the problem is beyond the scope of this guide If the problem cannot be solved and a system failure is apparent Our local technical support...

Page 56: ...Addresses www siemens com diagnostics Clinitek Status Connect System 56 Operator s Guide ...

Page 57: ...nd this information 1 Turn system power off 2 Wait approximately 15 seconds 3 Turn system power on The software version displays after the initialization screen 2 Are any error messages or warnings displayed If so what are they List the error description and any numbers that display 3 Have you performed the appropriate steps suggested on the display for the error being displayed 4 Is the printer a...

Page 58: ...Clinitek Status Connect System 58 Operator s Guide ...

Page 59: ...m Documentation The following table lists the system documentation available for the connector Part Number Description 10376827 English Quick Reference Guide 10376828 Multi language Documentation CD 10378409 Clinitek Status Connect System LIS Specification 10376829 Operator s Guide English 10376830 Operator s Guide French 10376831 Operator s Guide German 10376839 Operator s Guide Italian 10376832 ...

Page 60: ...us Connect System 60 Operator s Guide Part Number Description 10376837 Operator s Guide Chinese 10376841 Operator s Guide Dutch 10376842 Operator s Guide Polish NOTE Part numbers are subject to change without notice ...

Page 61: ... for both Warnings and Cautions A Warning indicates the risk of personal injury or loss of life if operating procedures and practices are not correctly followed A Caution indicates the possibility of loss of data or damage to or destruction of equipment if operating procedures and practices are not strictly observed This symbol alerts you to a biohazard This symbol indicates that the input electri...

Page 62: ...l indicates that the product is fragile and you need to handle it with care This symbol indicates that you should keep the product dry This symbol indicates that you should not spray any liquids in this area This symbol indicates that you should keep the product away from sunlight and heat This symbol indicates a temperature hazard This symbol indicates to follow the appropriate procedures for dis...

Page 63: ...applicable directives of the European Union User Interface This table describes the symbols that display on the system user interface Symbol Feature Description Connector This symbol indicates that the Clinitek Status analyzer is connected to the Clinitek Status connector Connector This symbol indicates that the Clinitek Status analyzer is not connected to the Clinitek Status connector Connectivit...

Page 64: ...Clinitek Status Connect System 64 Operator s Guide ...

Page 65: ...ument on battery power when using the connector Dimensions Dimension Value Length 23 8 cm 9 357 inch Width 15 9 cm 6 252 inch Weight 0 62 kg 1 36 lbs Environmental Specifications Specification Value Ambient Operating Temperature 18 30 C 41 104 F Operating Humidity 18 80 RH non condensing Indoor Use Only For use at altitudes up to 2000 meters Electrical Requirements Requirement Value Electrical Rat...

Page 66: ...er to the Declaration of Conformity shipped with the Clinitek Status Connect system Safety UL CUL CSA C22 2 No 1010 1 EN61010 1 IEC61010 1 UL61010A 1 CLASSIFICATIONS Type of protection Class 3 product Pollution Degree 2 Over Voltage Category Category 2 For use with the following plug in power supply unit provided The direct plug in of the power supply is considered as the disconnecting device Posi...

Page 67: ...ential installation This system generates uses and can radiate radio frequency energy and if not installed and used in accordance with the instructions in the Clinitek Status Connect System Operator s Guide may cause harmful interference to radio communications There is no guarantee that interference will not occur in a particular installation If this system does cause harmful interference to radi...

Page 68: ...Clinitek Status Connect System 68 Operator s Guide ...

Page 69: ...ction is secure 4 Turn the system power on Testing the Optional Bar Code Scanner Ensure that your external bar code scanner has been correctly installed using the procedure in Installing the Optional Bar Code Scanner Ensure that the bar coded labels used in your laboratory comply with the specifications given later in this section Troubleshooting It is important that the labels be printed to the r...

Page 70: ... 39 with optional check digit required Code 128 standard includes check digit Coda Bar without check digit The following rules apply to data entered by the external bar code scanner Connector can read and display full ASCII character set You can enter and display characters in lower case Search to recall samples associated with the data entered by the external bar codes are not case sensitive The ...

Page 71: ...rade of C as defined by ANSI X3 182 1990 available from American National Standards Institute 1430 Broadway New York NY 10018 Wavelength of Light 630 nm visible red LED Bar Code Scanner Maintenance CAUTION Do not submerge the scanner in water The scanner s housing is not water tight Do not use laboratory wipes because they may scratch the window Do not use any type of solvent other then recommende...

Page 72: ...Clinitek Status Connect System 72 Operator s Guide ...

Page 73: ...nterface Specification 134292 for additional information on serial connections Ethernet Wired Connection The RJ45 port is used for TCP IP transmission between the system and the network The host listens for connections on the TCP IP port and accepts the connection when the system tries to connect To connect from the Ethernet port to a 10 100BaseT network use a standard straight through CAT 5 cable...

Page 74: ...the LIS to download the Set Up Configuration file to the system without first backing up patient and QC records Otherwise the records are deleted The connector can also send CSV formatted results to a host computer using the rear serial RS 232 port Clinitek Status Connect System 74 Operator s Guide ...

Page 75: ...l Bar Code Scanner An optional bar code scanner that is connected to the RS 232 port on the connector Used to enter data Instrument The Clinitek Status analyzer Onboard Printer The integrated roll printer Onboard Printer Cover The portion of the case that opens and closes to cover the on board printer Power Switch The switch that turns the system on and off Power Cord The cord that connects the sy...

Page 76: ...es the amount of time left in an operation Data Entry The act of entering data such as a patient or operator ID into the system Data Entry Box A UI object which displays data that is entered by the operator Diagnostic Screen A UI screen which enables the operator to perform a system diagnostic test when troubleshooting the system Disabled The state when a UI control such as a button is not availab...

Page 77: ...esults stored on the system Restore The act of copying data back onto a system to restore it Required Entry A data entry box that must have data entered into it Screen The display area that contains the controls the operators select when operating the system The system software UI comprises many screens Screen Title A text label that typically appears in the upper left corner of a screen which ser...

Page 78: ...cronyms commonly used on the Clinitek Status Connect system Acronym Full Title ASTM American Society for Testing and Measurement CSV Comma Separated Values DHCP Dynamic Host Configuration Protocol DNS Domain Name Server HIS Hospital Information System HL7 Health Level 7 protocol IP Internet Protocol LAN Local Area Network LIS Laboratory Information System PC Personal Computer POCT Point of Care Te...

Page 79: ... Connector 35 N Network Connection Options 39 Network Connectivity Setting up network 39 Network Options Wired 40 Wireless 41 O Operator IDs Add 14 Delete 15 Edit 15 P Patient Records Accessing 32 Printout Settings Customizing 44 Q QC 21 QC cassette test Running 28 QC cassette test controls Defining 26 QC cassette test schedule 26 QC cassette tests Set up 25 QC strip test Pass Fail ranges 23 Runni...

Page 80: ...umber 34 Start Up Wizard Using 12 Strip Managing lot expiration 19 Support 46 Symbols 51 T Troubleshoot Bar code Scanner 58 Checklist 47 Support Information 46 U Urine color Customize 17 W Warranty Record information 34 Wireless Connecting to wireless network 41 ...

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