1. Clinitek Status Plus User Manual

The CLINITEK® and MULTISTIX® family of urine analysers and strips offers one of the most comprehensive and trusted urinalysis portfolios with highly effective tools for broad clinical insight into patients’ health. The CLINITEK Status®+ Analyser features new automatic checks (Auto-Checks.).

The analyser automatically checks each test strip for humidity exposure, common sample interferences and strip identification for Siemens test strips. Together, these provide improved clinical information. Enhances confidence in clinical decisions with (Auto-Checks) performed on every test. Ensures consistent results interpretation with automatic timing and reading of every urine specimen. Offers a comprehensive point-of-care urinalysis menu for routine testing and detection of early kidney disease, including but not limited to, Multistix® 10SG, Multistix® 5, Hemastix®, Uristix® and CLINITEK® Microalbumin 2.Only available when using Siemens urine test strips with IR (instrument read) or colour bands ARTG #175890 Intended Use The CLINITEK Status®+ Analyser is a point-of-care urinalysis analyser designed to read only Siemens urine test strips. The CLINITEK Status®+ Analyser is the latest addition to the CLINITEK® family. The CLINITEK Status+ Analyser is even easier to use and features new automatic checks (Auto-Checks.).

The analyser automatically checks each test strip for humidity exposure, common sample interferences and strip identification for Siemens urine test strips. Together, these provide improved clinical information.

The term 'OPL16' is used to denote the version of OPL for the SIBO (16-bit) Psion machines. Psion series 3 programming manual.

ARTG #175890 Intended Use The CLINITEK Status®+ Analyser is a point-of-care urinalysis analyser designed to read only Siemens urine test strips. What warranty is provided with the CLINITEK Status®+ Analyser? The CLINITEK Status®+ Analyser has a 12 month warranty.

For full details refer to “Conditions of Supply of Product for Professional Use (Healthcare)” Q. Are there any circumstances where the CLINITEK Status®+ Analyser and or Multistix ® Test Strips should not be used? Siemens Healthcare recommends you read the CLINITEK Status ®+ Analyser Operators Guide before using. Do not use the CLINITEK Status ®+ Analyser if the white calibration strip on the test table is scratched or covered in dried urine. Refer to the CLINITEK Status ®+ Operators Manual Section 9 for cleaning instructions. Ensure that work areas and specimen containers are always free of detergent and other contaminating substances.

Some substances can interfere with patient results. Do not use the test strips after their expiration date. Discolouration or darkening of the test pads may indicate deterioration. If this is evident, or if test results are questionable or inconsistent with expected findings, confirm that the product is within its expiration date and is reacting properly using known negative and positive control materials. Refer to “How should I store my CLINITEK Status ®+ Urine Reagent Strips” for detailed instructions.

Substances that cause abnormal urine colour may affect the readability of test pads on urinalysis test strips. These substances include visible levels of blood or bilirubin and drugs containing dyes, nitrofurantoin, or riboflavin. Levels of ascorbic acid normally found in urine do not interfere with these tests. What is the sample collection procedure and sample size required to complete a test? Siemens Healthcare recommends you read the package insert carefully before using the product. Collect freshly-voided urine in a clean, dry container.

Mix the sample before testing and test it within two hours after voiding, sooner if testing for bilirubin or urobilinogen. Contamination of the urine specimen with skin cleansers containing chlorhexidine may affect protein (and to a lesser extent specific gravity and bilirubin) test results. Work areas and specimen containers should always be free of detergents and other contaminating substances. If unable to test within the recommended time, refrigerate the specimen immediately and let it return to room temperature before testing. Ensure there is sufficient urine sample to dip all test pads. How do I clean the CLINITEK Status ®+ Analyser? Please refer to the CLINITEK Status ®+ Operators Manual Section 9, Cleaning and Maintenance for detailed instructions for how to clean the analyser and components.

Can I run the CLINITEK Status ®+ on batteries? Yes, the CLINITEK Status ®+ Analyser can run on batteries. It requires 6 alkaline AA-size batteries. Reagents and Consumables Q.

What reagents and consumables do I need to operate the CLINITEK Status®+ Analyser? The following items are required to operate the CLINITEK Status ®+ Analyser – Power Supply – included with new instrument Power Cord – included with new instrument Test Table – included with new instrument Test Table Insert. included with new instrument The following consumable options can be ordered separately. Please refer to “Which urine strip should I order” to help chose the right strip for your needs. – Siemens Healthcare Urine Strips.

Multistix® 10SG. Multistix® 5. Uristix®. Hemastix®.

CLINITEK® Microalbumin 2. If you are using a test strip that has 4 or fewer test pads you must order a CLINITEK Status ®+ Spare Insert 3.5” (Short Test Table). This excludes the CLINITEK ® Microalbumin 2 test strip. How should I store my CLINITEK Status®+ Urine Test Strips? Store the CLINITEK Status ®+ Urine Test Strips at temperatures between 15°C–30°C. Do not store the bottle in direct sunlight and do not remove the desiccant from the bottle. PROTECTION AGAINST EXPOSURE TO LIGHT, HEAT AND AMBIENT MOISTURE IS MANDATORY TO GUARD AGAINST ALTERED REAGENT REACTIVITY.

Does the CLINITEK Status®+ read all types of strips? The CLINITEK Status®+ Analyser is designed to read only Siemens Healthcare Diagnostics urine test strips including Multistix ® 10SG, Multistix ® 5, Uristix ®, CLINITEK ® Microalbumin and Hemastix ®. What Siemens strips are available and what do they test for? Refer to “Compare Multistix ®” on the home page Q. What does the Specific Gravity (SG) Parameter measure and how does this affect my results?

Urinary SG is a quick, convenient and reliable test for monitoring the concentrating and diluting power of the kidney, recognising dehydration and aiding interpretation of other test results. For example, a trace protein result with a high SG reading may well be normal, while trace protein with low SG is usually abnormal. High SG may cause falsely lowered Glucose (GLU) results.

High SG may cause falsely lowered Leukocyte (LEU) results. How many results can be printed per roll of printer paper or labels? For paper, each unit size contains 5 x 20m rolls (100m total) before the pink strip appears. For labels, each unit size contains 5 x 10.7m rolls (53.5m total). The number of result printouts depends on the strip type used.

Multistix 10SG contains the most printed information and in ‘Full Test’ mode, is 11.5cm (without sample interference notes). This works out to approximately 174 printouts per paper roll (870 total), and approximately 87 printouts per label roll (435). There is an option to purchase either printer paper or printer labels.

Both are thermal paper however the difference is the printer label has an adhesive backing which provides for direct attachment to patient notes without the need to use tape. Printer paper requires tape to be used if attaching to patient notes.

Why is the printer not working? Check the instrument is set up to automatically print the results. Instructions can be found in the CLINITEK Status ®+ Operators Manual – Section 5, Instrument Set Up. Ensure you are using the Siemens CLINITEK Status ®+ Printer Paper or Labels and check to see if it has been loaded the correct way. The CLINITEK Status ®+ Printer Paper and Labels are thermal so will only print on one side. If the printer paper or labels have recently been changed, check that the printer’s paper holding arm/lever is down and engaged in the closed position. Refer CLINITEK Status®+ Operators Manual for directions.

If the results will still not print please call Technical Assistance on 1800 310 300. Can I use the Multistix ® Test Strips to test fluids other than urine? Siemens Multistix ® Test Strips have been developed and validated for use with human urine only. While the test pads on the strips may appear to react with other fluids there is no guarantee as to the accuracy of the results and Siemens takes no responsibility for these results. When I visually read the Multistix ® Test Strip and leave it for longer than 2 minutes I get positive results. Is this correct?

No, the test pad colour must be read at the time as specified on the reagent bottle label, starting with the shortest time. Colour changes that occur after 2 minutes are of no diagnostic value. Quality Control Q. Why do I need to run Quality Control? Quality Control (QC) is used to ensure patient results being reported by the Clinitek Status ®+ Analyser are true and accurate. QC does this by testing the reagent test pads are reacting and being read correctly by the CLINITEK Status ®+ Analyser prior to the running of patient samples.

Quality control testing also detects errors resulting from incorrect user technique. When results do not match the patient’s clinical condition or symptoms it is advisable to check the functioning of the analyser by using the Quality Control. How often do I need to run Quality Control? Chek-Stix ® Combo Pak Positive and Negative Urine Control Strips should also be used on a regular basis as part of a urinalysis quality control program. As per the requirements documented in ISO 15189 Medical Testing Field Application Document: QC testing must be performed on all PoCT devices and for every analyte/test for which the PoCT device is being used. Devices using strip technology, a minimum of one liquid QC sample must be tested per month unless a higher frequency is suggested by the manufacturer (once made up, Chek-Stix ® is a liquid QC). Where only one QC sample is tested, it should have a concentration in the clinically relevant range for the analyte being measured.

If two levels of QC are available, then QC samples with both a normal and abnormal (High & Low, Positive & Negative) level should be tested. In addition to the above QC program, QC testing should also be undertaken when:. The lot number of the consumables changes;.

There is a new delivery of consumables;. An operator lacks confidence in a patient result;. The health care professional does not believe that the PoCT result fits the patients clinical picture;. Substantial maintenance procedures have been carried out on the device;. The device has suffered a physical insult (e.g. Dropped, temperature extremes – hot or cold, etc.). Other major areas of use are:.

To determine if Siemens test strips are reacting properly. To confirm the user’s ability to properly perform and reliably interpret the test strip tests.

For demonstrations and teaching. Note: Water should not be used as a negative control. What water should I use to make up the Chek-Stix ® Combo Pak Positive and Negative Urine Control Strips? 12mL of either distilled or deionised water should be used. If using deionised water, it must meet the minimum quality specified in CLSI Guideline C03-A4 ‘Preparation and Testing of Reagent Water in the Clinical Laboratory.’ Sterile Water for irrigation is suitable for use. Do Not use Sterile Water for Injection. Do Not Use Tap Water.

How do I prepare/make up the Chek-Stix ® Combo Pak Positive and Negative Urine Control Strips? For detailed directions refer to the “Instructions for Use” found in the box of Chek-Stix ® Combo Pak Positive and Negative Urine Controls.

Place 12 mL of distilled or deionised water in an appropriately labelled specimen tube. Do not use tap water or Sterile Water for Injections. Remove a Chek-Stix ® Urine Control Strip from the bottle and replace the cap immediately and tightly. Place the strip into the tube of water. 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 Chek-Stix ® Urine Control strip(s),according to your standard laboratory procedures. After reconstitution, the control solutions should be treated and tested in the same manner as a urine specimen. How should I store my Chek-Stix ® Combo Pak Positive and Negative Urine Control Strips? Chek-Stix® Combo Pak Positive and Negative Urine Control Strips should be stored in the original, tightly capped bottle at temperatures between 15 °C – 30 °C. Do not store the bottle in direct sunlight. Do not remove the desiccant from the bottle.

Prepared control solutions should be stored at temperatures below 30 °C. The solutions are stable for 8 hours after preparation, except for Bilirubin in the Positive Control, which is table for 3 hours under normal laboratory conditions (Bilirubin has limited stability in aqueous solution; protection from light will help maintain its reactivity). Ketone reactivity in the Positive Control will increase with time due to continued hydrolysis of the reactive ingredient.

How should I interpret the results from the Chek-Stix ® Combo Pak Positive and Negative Urine Control Strips? Results from the Chek-Stix ® Combo Pak Positive and Negative Urine Control Strips should be evaluated against the expected result ranges quoted in the “Instructions for Use”. The “Instructions for Use” can be found inside the box of Chek-Stix® Combo Pak Positive and Negative Urine Control Strips. If any results are out of range do not continue with patient testing and refer to the Chek-Stix® Combo Pak Positive and Negative Urine Control Strips Guide for assistance. All education and training for the CLINITEK Status®+ Analyser is available exclusively online.

Clinitek Status Plus User Manual

Please refer to the following tools: 1. Complimentary Urinalysis App for iPhone or iPad Download UA Guide from App Store 2. PEPconnect: Online, virtual competency-based education training for Siemens products. PEPconnect is a technologically advanced, virtual, competency-based education and training solution that focuses on increasing the knowledge, skills, and abilities of each individual user - ultimately reducing the time to achieve job competency. Through this customisable approach, individual learners can plan, achieve, and maintain proficiency standards directly from any device at their convenience.

Access education and real-time performance support, anytime, anywhere, on any device. Construct your personalised learning experience. Share and connect your learning experience with others. Utilise an intuitive interface.

POCkit: Just in time educational information for healthcare professionals performing diagnostic testing at the point-of-care Siemens POCkit™ is a web based education solution designed for healthcare professionals performing point-of-care testing. It provides immediate access to the latest topics, videos, and links to access information on how to use Siemens POC testing solutions. Connects people to knowledge, with just-in-time performance support, anytime, anywhere from any device. Quick and easy for healthcare professionals to find the information they need when operating our POC instruments. Incorporate training materials directly into your hospital Learning Management Systems or share knowledge directly through email, text, or social media channels.

The analyzer automatically checks each test strip for humidity exposure, common sample interferences. and strip identification for Siemens test strips. Together, these provide improved clinical information.