1. MULTISTIX 10SG with CLINITEK Status Connect
In-Service Training
Maria Peluso-Lapsley, CDM Marketing October 2018, HOOD ver 1.0

2. Training Agenda System overview MULTISTIX® 10SG Overview
Performing testing:
Quality control testing
Patient testing
Performing maintenance
Ordering information
This course has been designed for Marketing, Sales and training personnel.
Our learning objective is to give appropriate information for a basic understanding of our product offerings. At the end of the session you will be able to differentiate between all of our new product offerings within the CLINITEK Status portfolio.
You should be able to identify the correct product options available to meet the needs of our differing market segments and you should be able to identify upgrade options that are available for our current installed base of the CLINITEK Status users.
In this session, we will not cover the key selling messages, positioning, or pricing. This information will be provided to you in the second session of this series. During the second session of this series we will also review the marketing sales tools that will be available.
Maria Peluso-Lapsley| CDM Marketing

3. What is the CLINITEK Status Connect System?
Automated POC urinalysis analyzer with a broad testing menu
Routine urinalysis, albumin-to-creatinine ratio, protein-to-creatinine ratio and hCG pregnancy test
Automates the timing and result interpretation for routine urinalysis tests, kidney checks and hCG pregnancy tests
Auto-Checks® features identify test strip type, perform strip integrity check for humidity overexposure – prevents testing with un- validated test strips and strips compromised by humidity over-exposure
Automatically transmits data to DMS/LIS or EMR
Maria Peluso-Lapsley| CDM Marketing

4. System Overview

5. CLINITEK Status Connect System Overview
The CLINITEK Status® Connect System is a portable, easy to use analyzer. It is designed to read only Siemens Healthineers Urinalysis test strips and Clinitest® hCG tests.
Measures the following in urine: Albumin, Bilirubin, Blood (Occult), Creatinine, Glucose, Ketone, Leukocytes, Nitrite, pH, Protein, Protein-to-Creatinine Ratio, Albumin-to-Creatinine Ratio, Specific Gravity, Urobilinogen, and human Chorionic Gonadotropin (hCG)
These measurements are used to assist diagnosis in the following areas: Kidney function, Urinary tract infections, Metabolic disorders (such as diabetes mellitus), Liver function, and Pregnancy
Maria Peluso-Lapsley| CDM Marketing

6. Setting up the Analyzer

7. CLINITEK Status Connect System Configuration
CLINITEK Status®+ Urine
Chemistry Analyzer
CLINITEK Status Connector Base
CLINITEK Status
Connect System
Includes Barcode Scanner
Maria Peluso-Lapsley | CDM Marketing

8. System Overview Printer Interactive Display Test Compartment On/Off
Button
Serial Port
Power Cord
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9. Test Table Overview and Set Up
Inserting the test table is only done during set up or when cleaning the test table:
Insert the test table into the analyzer
Hold the tray by the Drip Tray end
Do not touch the calibration bar – careful not to scratch or soil as this will impact performance
With the calibration bar facing upwards push the test tray into the analyzer just over halfway
Do not force the tray table as it may become jammed (The analyzer will automatically pull in the tray when the power is turned on)
Place the Table Insert onto the Drip Tray
Maria Peluso-Lapsley| CDM Marketing

10. CLINITEK Status Connector Overview5
Adding the connector platform provides the following:
Barcode scanning for entry of patient and operator IDs, test strip, cassette and QC material lot number and expiration dating
Interfacing to data management systems and network via Ethernet
Bi-directional functionality such as operator ID downloading and remote QC lock out
QC mode for QC lock out and separate database for QC testing data
Wireless capability (if site access points are compatible)
Short DC power cable
Optional wireless adapter
Serial (RS-232) cable
Power supply adaptor
Optional barcode scanner
Maria Peluso-Lapsley| CDM Marketing

11. Loading the Printer Paper
To load the thermal printer paper or label roll, perform the following steps:
Turn the back of the analyzer to face you
Pull on the tab to open the printer cover
Open the paper roll compartment
Lift the paper holding arm into the open, upright position
Insert a new paper roll  it should unroll from underneath and roll toward the compartment wall
Feed the paper up along the wall and through the printer until 4 inches of paper feeds through
Feed the edge of the paper through the printer cover
Push the paper holding arm down in the closed position (if this step is missed the printer will not print)
Close both covers by clicking into place
1 Paper holding arm
2 Printer paper
Maria Peluso-Lapsley| CDM Marketing

12. Powering Analyzer On/Off
If you power on the analyzer for the first time, the Start Up Wizard will guide the set-up procedure:
Press the on/off button on the front of the analyzer
Analyzer performs automatic checks when powered on
To power off the analyzer, perform the following steps:
Ensure that no strip or cassette is on the test table and that the table and insert are clean
Hold the on/off button down for at least 2 seconds
Analyzer pulls in the test table and will turn off .
If the test table hasn’t been cleared of test strip or cassette, it will be pushed out by the analyzer and powered off
To power off, the analyzer must be powered back on, and the test strips or cassette must be cleared
Maria Peluso-Lapsley| CDM Marketing

13. Customize Set-up
Select the testing mode that best fits your site needs.
There are three modes to select from:
Quick test – does not require any patient operator data to be entered
Full test – requires operator, patient and other fixed data to be entered
Custom
Path: Select Instrument Set Up > Operator and Patient Information
Maria Peluso-Lapsley| CDM Marketing

14. Customize Set-up
Instrument set up allows for customization and standardization of running your urinalysis program.
Review each area to select your settings:
Results format – units and flagging
Connectivity – define connectivity settings
Urinalysis test setting – handling of lot and expiration dating
Authorized operators – to set up operator access and lock out
Printer settings – define printing requirements
QC settings – define QC testing needs
For more detailed instructions, refer to the operator manual or analyzer in-service training tool.
Path: Select Instrument Set Up > Instrument Settings
Maria Peluso-Lapsley| CDM Marketing

15. MULTISTIX 10SG Overview

16. MULTISTIX® 10SG Test Overview
For professional in vitro diagnostic use in near patient (point of care) and centralized laboratory locations
The strips are intended for use in at-risk patient groups to assist diagnosis in the following areas:
kidney function, urinary tract infections, carbohydrate metabolism (e.g., diabetes mellitus), liver function
measure physical characteristics, including acid-base
For use on CLINITEK Status® family of analyzers
Results reported in 1 minute
CLIA-waived when tested on the CLINITEK Status® family of analyzers
The analyzer has many automatic features designed to reduce errors and give you confidence in the results generated. All our analyzers have operator lockout features to prevent unauthorized users from accessing the analyzer and data.
For measuring protein, blood, leukocytes, nitrite, glucose, ketone (acetoacetic acid), pH, specific gravity, bilirubin and urobilinogen.
Maria Peluso-Lapsley| CDM Marketing

17. MULTISTIX 10SG Configuration
Urine test strip bottle:
100 test strips
desiccant to prevent moisture
Instructions for use can be downloaded from the internet
New P/N
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18. Test Bottle Storage and Stability
All unused strips must remain in the original bottle.
Transfer to any other container may cause reagent strips to deteriorate and become unreactive
Store at temperatures between 15–30°C (59– 86°F)
Do not use the strips after their expiration date (Note: analyzer can be programmed to prevent use of expired test strips)
Do not store the bottle in direct sunlight and do not remove the desiccant from the bottle
Maria Peluso-Lapsley| CDM Marketing

19. Getting Ready for Testing

20. Supplies Needed to Conduct Testing
Analyzer and Tests
(supplied by Siemens Healthineers or authorized distributor):
CLINITEK Status Family of Analyzers
MULTISTIX 10 SG Test Strips
Chek-Stix Quality Control Materials
Recommended Supplies:
(non Siemens Healthineers items):
Urine specimen collection containers

21. Performing Quality Control Testing

22. Quality Control Testing Modes
CLINITEK Status+ Analyzer (stand-alone):
CLINITEK Status Connect System (with connector base):
No QC mode.
Has a separate QC mode and database for QC results
Control samples are treated and stored as patient samples. User must enter control name or ID to distinguish results
CLINITEK Status® Connect Systems can be set-up by user to automatically check QC results and initiate a QC lock out when results fail
Control results must be manually compared to the values assigned by the control manufacturer
If the control results are not favorable, do not test patient samples until quality control is passed
If the control results are not favorable, do not test patient samples until quality control is passed
Maria Peluso-Lapsley| CDM Marketing

23. Quality Control Testing Recommendations
Test positive and negative quality controls with new lots, new shipments of reagents, and when you open a new bottle of reagent strips
Test reagents monthly that are stored for more than 30 days
Run QC tests to ensure reagent strips integrity; train new users; confirm test performance; and when patients’ clinical conditions or symptoms do not match
Run QC tests per your laboratory procedures
Liquid ready-to-use controls are available
Do not use water as a negative control
Maria Peluso-Lapsley| CDM Marketing

24. Quality Control Materials
Some urinalysis commercial controls tend to be very dark in color because of added analytes
See below the commercial controls that are compatible with MULTISTIX 10SG tests: *
*Dropper style controls should only be used with urine test strips if the control
is transferred to an appropriate test tube before use. Applying a drop of control to the top of a test pad does not ensure optimum performance for each reagent. Do not drop control solutions onto the ID band.
Maria Peluso-Lapsley| CDM Marketing

25. Chek-Stix Storage and Stability
Reconstitution Stability
Reconstituted controls are stable for 8 hours at 18–23°C (64–73°F)  except for bilirubin in the Positive Control, which is stable for 3 hours
If your laboratory operates outside of this temperature range, reconstituted solution should be refrigerated at 2–8°C (34–46°F) to maintain the 8 hour stability
Allow refrigerated control solutions to equilibrate to ambient temperature prior to use
Store Chek-Stix® Control Strips in the original, tightly capped bottle at temperatures between 15–30°C
Do not store the bottle in direct sunlight.
Do not remove the desiccant from bottle
Control strips are stable until the expiration date shown on the bottle label
Maria Peluso-Lapsley| CDM Marketing

26. Prepare Chek-Stix Quality Controls
Directions:
Place 12 mL of distilled or deionized water in an appropriately labeled specimen tube. Do not use tap water.
Remove a Chek-Stix Control Strip from the bottle and replace the cap immediately and tightly.
Place the strip into the tube. Cap tightly.
Repeat Steps 1–3 if using a second control.
Gently invert the tube(s) back and forth for 2 minutes.
Allow the tube(s) to stand for 30 minutes at room temperature.
Invert one more time, then remove and discard the strip(s), according to your standard laboratory procedures.
Maria Peluso-Lapsley| CDM Marketing

27. Run QC Testing New Product Features
Ensure the connector platform is enabled by checking for the connector icon in the upper left hand corner of the screen
Select QC test button
Choose to run QC for urine test strip.
Enter lot and expiration date by scanning barcode from the urine test strip bottle
Quality Control Testing:
QC testing options are available.
In the upper left hand corner of the screen, the user will see the connector icon and this lets the customer know that the connecter is enabled.
Once the user enables the connecter, the QC functions will be available for set up. When all QC options are selected, the user will see the “QC radio button” shown here in red outline. This means that the QC function is activated and the analyzer is ready to test QC, when needed.
The user can simply press the “QC Test” button when ready to run a QC test. The system will keep track of all QC samples, store up to 200 QC test results on the on-board data base and, if set up, will transfer results to LIS/HIS or data management system and identify these results as being QC results for either urinalysis test strips or hCG.
The current CLINITEK Status "Classic"” cannot do this.
Maria Peluso-Lapsley| CDM Marketing

28. Running a Quality Control Test
Enter lot and expiration date of the control level (manually or using the barcode scanner)
Enter the lot and expiration date of the urine test strip
Touch Start first, then dip the test strip
Maria Peluso-Lapsley| CDM Marketing

29. Performing Patient Testing

30. Specimen Collection and Handling
Collect urine into a clean, dry container
First morning or random collections are acceptable
Test fresh urine samples within 2 hours of collection
If cannot be tested within 2 hours, refrigerate specimens at 2° to 8°C (36° to 46°F) for up to 72 hours, if the testing is not performed immediately
If samples are refrigerated, bring them to room temperature 15° to 30°C (59° to 86°F) before testing
The use of urine preservatives is not recommended
Do not use urine that looks bloody or is not a normal color
Maria Peluso-Lapsley| CDM Marketing

31. Performing a Test
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32. Performing a Test
To avoid, errors, follow the process and do not dip the tests strip early.
Maria Peluso-Lapsley| CDM Marketing

33. Performing a Test
To avoid, errors, follow the process. Do not dip the tests strip until after pressing the start button.
Once you press the start button, you will have 8 seconds to dip, drag, blot and place test strip on tray.
Maria Peluso-Lapsley| CDM Marketing

34. Performing a Test
If interfaced, results will be automatically transmitted to the DMS/LIS.
Maria Peluso-Lapsley| CDM Marketing

35. Interpretation of Test Results
Units
Results (Normal System)
Results (Plus System)
Glucose
GLU
mg/dL
Negative
100
250
500
≥ 1000
Trace 1+ 2+ 3+
Bilirubin
BIL
Small
Moderate
Large
Ketone
KET 15 40 80
≥160 4+
Source: CLINITEK Status Operator Manual.
Maria Peluso-Lapsley| CDM Marketing

36. Interpretation of Test Results
Units
Results (Normal System)
Results (Plus System)
Specific
Gravity SG
n/a
≤ 1.005
1.010
1.015
1.020
1.025
≥1.030
No difference
Occult
Blood
BLO
Negative
Trace-lysed
Trace-intact
Small
Moderate
Large
Trace-Intact 1+ 2+ 3+ pH
5.0
5.5
6.0
6.5
7.0
7.5
8.0
8.5
Source: CLINITEK Status Operator Manual.
Maria Peluso-Lapsley| CDM Marketing

37. Interpretation of Test Results
Units
Results (Normal System)
Results (Plus System)
Protein
PRO
mg/dL
Negative
Trace
100
250
≥300 1+ 2+ 3+
Urobilinogen
URO
E.U./dL
0.2
1.0
2.0
4.0
≥8.0
No difference
Nitrite
NIT
n/a
Negative, Positive
Leukocytes
LEU
Small
Moderate
Large
Source: CLINITEK Status Operator Manual.
Maria Peluso-Lapsley| CDM Marketing

38. Avoiding Errors
Do not remove the strip from the bottle until immediately before it is to be used for testing
Replace the cap immediately and tightly after removing the reagent strip
Discoloration or darkening of the test pads may indicate deterioration:
Auto-Checks technology will detect overexposure to humidity for urine test strips and prevent patient testing.
Analyzer automatically detects if test strips, cassette materials or QC materials are expired and prevent patient testing.
Do not touch the test areas of the strip
Contamination of the urine specimen with skin cleansers containing chlorhexidine may affect protein (and to a lesser extent specific gravity and bilirubin) test results
The user should determine whether the use of such skin cleansers is warranted
It is especially important to use fresh urine to obtain optimal results with the tests for bilirubin and urobilinogen, as these compounds are very unstable when exposed to room temperature and light
Maria Peluso-Lapsley| CDM Marketing

39. Performing Routine Maintenance/Cleaning

40. CLINITEK Status® Family  Analyzer Maintenance
Clean the test table at least once a week to remove any build up. The test table can be soaked in 5% hypochlorite and rinsed thoroughly – do not use solvents.
Maria Peluso-Lapsley| CDM Marketing

41. CLINITEK Status Family - Analyzer Maintenance
Check that the calibration strip on the instrument is clean every day. If not, clean with a cotton swab or soft cloth and water only, ensuring that you do not scratch it.
Maria Peluso-Lapsley| CDM Marketing

42. Replacing the Printer Paper
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43. Ordering Information

44. Ordering Information
Maria Peluso-Lapsley | CDM Marketing

45. Ordering Information
Maria Peluso-Lapsley | CDM Marketing

46. Thank you!
CLINITEK, CLINITEK Status, MULTISTIX, CLINITEST, Chek-Stix, Auto-Checks, CLINITEK Advantus, DCA Vantage, MULTISTIX PRO, Albustix, Azostix, Hemastix, Hema-Combistix, Labstix, Uristix and all associated marks are trademarks of Siemens Healthcare Diagnostics Inc., or its affiliates. All other trademarks
and brands are the property of their respective owners.
Maria Peluso-Lapsley| CDM Marketing