10 2018 Mutistix 10sg With Clinitek Status Connect in Service Training Rou-05990463

MULTISTIX 10SG
with CLINITEK Status Connect

In-Service Training
Maria Peluso-Lapsley, CDM Marketing

October 2018, HOOD05162002962479 ver 1.0
1
Unrestricted © Siemens Healthcare Diagnostics Inc., 2018
Training Agenda
• System overview
• MULTISTIX® 10SG Overview
• Performing testing:
 Quality control testing
 Patient testing
• Performing maintenance
• Ordering information
Maria Peluso-Lapsley| CDM Marketing 2

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

System
Overview
Click to add footnote 4

second line Unrestricted
Restricted © Siemens Healthcare Diagnostics Inc., 2018
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

Setting up the
Analyzer

CLINITEK Status Connect System Configuration
CLINITEK Status®+ Urine

CLINITEK Status Connector Base CLINITEK Status
Chemistry Analyzer
Connect System
Includes Barcode Scanner
Maria Peluso-Lapsley | CDM Marketing 7

System Overview
Printer
Interactive Display
On/Off
Button
Test Serial Port Power Cord

Compartment

Test Table Overview and Set Up
Inserting the test table is only done during set

up or when cleaning the test table:
1. Insert the test table into the analyzer
2. Hold the tray by the Drip Tray end
3. Do not touch the calibration bar – careful not
to scratch or soil as this will impact
performance
4. With the calibration bar facing upwards push
the test tray into the analyzer just over
halfway
5. 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)
6. Place the Table Insert onto the Drip Tray

CLINITEK Status Connector Overview
• 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
5
operator ID downloading and remote QC
lock out
 QC mode for QC lock out and separate
database for QC testing data 1. Short DC power cable
 Wireless capability (if site access points are 2. Optional wireless adapter
compatible) 3. Serial (RS-232) cable
4. Power supply adaptor
5. Optional barcode scanner

Loading the Printer Paper
To load the thermal printer paper or label roll, perform the

following steps:
1. Turn the back of the analyzer to face you
2. Pull on the tab to open the printer cover
3. Open the paper roll compartment
4. Lift the paper holding arm into the open, upright position
5. Insert a new paper roll  it should unroll from
underneath and roll toward the compartment wall
6. Feed the paper up along the wall and through the printer
until 4 inches of paper feeds through
7. Feed the edge of the paper through the printer cover
8. Push the paper holding arm down in the closed position 1 Paper holding arm
(if this step is missed the printer will not print) 2 Printer paper
9. Close both covers by clicking into place
Powering Analyzer On/Off
If you power on the analyzer for the first time, the Start Up
Wizard will guide the set-up procedure:
1. 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:

1. Ensure that no strip or cassette is on the test table and
that the table and insert are clean
2. Hold the on/off button down for at least 2 seconds
3. 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
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

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
Path: Select Instrument Set Up
 Printer settings – define printing
> Instrument Settings
requirements
 QC settings – define QC testing needs
For more detailed instructions, refer to the

operator manual or analyzer in-service
training tool.
MULTISTIX
10SG
Overview

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 For measuring protein, blood, leukocytes, nitrite,
• Results reported in 1 minute glucose, ketone (acetoacetic acid), pH, specific
• CLIA-waived when tested on the CLINITEK gravity, bilirubin and urobilinogen.
Status® family of analyzers
MULTISTIX 10SG Configuration
• Urine test strip bottle:

 100 test strips
 desiccant to prevent moisture
• Instructions for use can be downloaded from
the internet

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

Getting Ready
for Testing

Supplies Needed to Conduct Testing
Analyzer and Tests Recommended Supplies:

(supplied by Siemens Healthineers or authorized (non Siemens Healthineers items):
distributor): Urine specimen collection containers
CLINITEK Status Family of Analyzers
MULTISTIX 10 SG Test Strips
Chek-Stix Quality Control Materials

Performing
Quality
Control Testing

Quality Control Testing Modes
CLINITEK Status+ Analyzer CLINITEK Status Connect

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

Quality Control Testing Recommendations
1. Test positive and negative quality controls with

new lots, new shipments of reagents, and when
you open a new bottle of reagent strips
2. Test reagents monthly that are stored for more
than 30 days
3. Run QC tests to ensure reagent strips integrity;
train new users; confirm test performance; and
when patients’ clinical conditions or symptoms
do not match
4. Run QC tests per your laboratory procedures
5. Liquid ready-to-use controls are available
6. Do not use water as a negative control

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.

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
• Store Chek-Stix® Control Strips in the original, should be refrigerated at 2–8°C (34–46°F) to
tightly capped bottle at temperatures maintain the 8 hour stability
between 15–30°C
• Allow refrigerated control solutions to
• Do not store the bottle in direct sunlight. equilibrate to ambient temperature prior to
• Do not remove the desiccant from bottle use
• Control strips are stable until the expiration

date shown on the bottle label

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

Run QC Testing
New Product Features
1. Ensure the connector platform is enabled by

checking for the connector icon in the upper left
hand corner of the screen
2. Select QC test button
3. Choose to run QC for urine test strip.
4. Enter lot and expiration date by scanning
barcode from the urine test strip bottle

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

Performing
Patient Testing

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

Performing a Test

Performing a Test
To avoid, errors, follow

the process and do not
dip the tests strip early.

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.

Performing a Test
If interfaced, results will

be automatically
transmitted to the
DMS/LIS.

Interpretation of Test Results
Test Units Results (Normal System) Results (Plus System)

Glucose GLU mg/dL Negative Negative
100 Trace
250 1+
500 2+
≥ 1000 3+
Bilirubin BIL mg/dL Negative Negative
Small 1+
Moderate 2+
Large 3+
Ketone KET mg/dL Negative Negative
Trace Trace
15 1+
40 2+
80 3+
≥160 4+

Source: CLINITEK Status Operator Manual. Unrestricted © Siemens Healthcare Diagnostics Inc., 2018

Specific SG n/a ≤ 1.005 No difference
Gravity 1.010
1.015
1.020
1.025
≥1.030
Occult BLO n/a Negative Negative
Blood Trace-lysed Trace-lysed
Trace-intact Trace-Intact
Small 1+
Moderate 2+
Large 3+
pH pH n/a 5.0 7.0 No difference
5.5 7.5
6.0 8.0
6.5 8.5

Protein PRO mg/dL Negative Negative
Trace Trace
100 1+
250 2+
≥300 3+
Urobilinogen URO E.U./dL 0.2 No difference
1.0
2.0
4.0
≥8.0
Nitrite NIT n/a Negative, Positive No difference
Leukocytes LEU n/a Negative Negative
Trace Trace
Small 1+
Moderate 2+
Large 3+
Avoiding Errors
• Do not remove the strip from the bottle until • Contamination of the urine specimen with
immediately before it is to be used for testing skin cleansers containing chlorhexidine may
affect protein (and to a lesser extent specific
• Replace the cap immediately and tightly after
gravity and bilirubin) test results
removing the reagent strip
• The user should determine whether the use of
• Discoloration or darkening of the test pads
may indicate deterioration: such skin cleansers is warranted
1. Auto-Checks technology will detect • It is especially important to use fresh urine to
overexposure to humidity for urine test obtain optimal results with the tests for
strips and prevent patient testing. bilirubin and urobilinogen, as these
2. Analyzer automatically detects if test compounds are very unstable when exposed
strips, cassette materials or QC materials to room temperature and light
are expired and prevent patient testing.
• Do not touch the test areas of the strip

Performing
Routine
Maintenance/
Cleaning

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.

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.

Replacing the Printer Paper

Ordering
Information

Ordering Information

Ordering Information

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.


10 2018 Mutistix 10sg With Clinitek Status Connect in Service Training Rou-05990463

Uploaded by

Document Information

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

10 2018 Mutistix 10sg With Clinitek Status Connect in Service Training Rou-05990463

Uploaded by

Copyright:

Available Formats

MULTISTIX 10SG

with CLINITEK Status Connect

Maria Peluso-Lapsley, CDM Marketing

Maria Peluso-Lapsley| CDM Marketing 2

• Automated POC urinalysis analyzer with a

Maria Peluso-Lapsley| CDM Marketing 3

Click to add footnote 4

The CLINITEK Status® Connect System is a portable,

• Measures the following in urine: Albumin, Bilirubin,

• These measurements are used to assist diagnosis in

Maria Peluso-Lapsley| CDM Marketing 5

Click to add footnote 6

CLINITEK Status®+ Urine

Maria Peluso-Lapsley | CDM Marketing 7

Test Serial Port Power Cord

Maria Peluso-Lapsley| CDM Marketing 8

Inserting the test table is only done during set

Maria Peluso-Lapsley| CDM Marketing 9

• Adding the connector platform provides the

Maria Peluso-Lapsley| CDM Marketing 10

To load the thermal printer paper or label roll, perform the

To power off the analyzer, perform the following steps:

• Select the testing mode that best fits your site

Path: Select Instrument Set Up

Maria Peluso-Lapsley| CDM Marketing 13

• Instrument set up allows for customization

For more detailed instructions, refer to the

Click to add footnote 15

• For professional in vitro diagnostic use in near

• Urine test strip bottle:

Maria Peluso-Lapsley| CDM Marketing 17

• All unused strips must remain in the original

Maria Peluso-Lapsley| CDM Marketing 18

Click to add footnote 19

Analyzer and Tests Recommended Supplies:

Maria Peluso-Lapsley | CDM Marketing 20

Click to add footnote 21

CLINITEK Status+ Analyzer CLINITEK Status Connect

Maria Peluso-Lapsley| CDM Marketing 22

1. Test positive and negative quality controls with

Maria Peluso-Lapsley| CDM Marketing 23

Maria Peluso-Lapsley| CDM Marketing 24

• Control strips are stable until the expiration

Maria Peluso-Lapsley| CDM Marketing 25

Maria Peluso-Lapsley| CDM Marketing 26

1. Ensure the connector platform is enabled by

Maria Peluso-Lapsley| CDM Marketing 27

• Enter lot and expiration date of the control

Maria Peluso-Lapsley| CDM Marketing 28

Click to add footnote 29

• Collect urine into a clean, dry container

Maria Peluso-Lapsley| CDM Marketing 30

Maria Peluso-Lapsley| CDM Marketing 31

To avoid, errors, follow

Maria Peluso-Lapsley| CDM Marketing 32

To avoid, errors, follow

Once you press the start

Maria Peluso-Lapsley| CDM Marketing 33

If interfaced, results will

Maria Peluso-Lapsley| CDM Marketing 34

Test Units Results (Normal System) Results (Plus System)

Maria Peluso-Lapsley| CDM Marketing 35

Test Units Results (Normal System) Results (Plus System)