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Siemens Healthineers, CLINITEK Novus Automated Urine Chemistry Analyzer (Urinalysis 2017)

Siemens Healthineers, CLINITEK Novus Automated Urine Chemistry Analyzer (Urinalysis 2017)

Urinalysis instrumentation, December 2017

Contact Information

Siemens Healthineers
Maya Daaboul
2 Edgewater Drive
Norwood, MA 02062

Name of urinalysis instrument CLINITEK Novus Automated Urine Chemistry Analyzer
Type of instrument urine chemistry
First year instrument sold in U.S. 2015
No. of units installed in U.S./No. of units installed outside U.S.
Intended urine sample volume per day 50–1,000
Dimensions (HxWxD)/Weight 21× 25 × 27 in./93 lbs.
Power requirements 100–240 VAC (48–62 Hz)
Mean time between failure of instrument
Events that cause instrument to lock or stop analysis user ID failure, QC failure, short sample, barcode/sample ID misread, result error, sampling error, consumables replacement/expiration, calibration failure, humidity exposure, rinse errors, hardware failure
Urine chemistry: (Information in this box is specific to urine chemistry)
• Testing methodology: Specific gravity/Color/Clarity refractometer/test strip/turbidity within an analyzer well
• Urine chemistry tests available on instrument bilirubin (0.5–2.7 mg/dL), red blood cells (at a trace level), hemoglobin (0.013–0.3 mg/dL), glucose (36–820 mg/dL), ketone (3.6–156 mg/dL), leukocyte esterase (6.0–91 cells/mL), nitrite (positive and negative; >0.06 mg/dL), pH (5.3–8.7), protein (10.8–1,000 mg/dL), specific gravity (1.000–1.099), urobilinogen (0.24–6.24 mg/dL)
• Color compensation pad included yes
• Flagging thresholds customizable yes
• Test strip configuration cartridge
• Calibration required after each test strip lot No. change yes
• Frequency of customer-performed calibration with every Novus cassette change or every 24 hours when multiple same-lot Novus cassettes are used within 24 hours
• Form of calibration liquid and dry
• How results are displayed for urine chemistry semiquantitative
• Reporting format customizable yes
• No. of sample results/Control results that can be held in internal memory 7,500/400
Microscopy/sediment: (Information in this box is specific to microscopy/sediment)
• Microscopy/sediment technology
• Microscopy/sediment analysis parameters
• Instrument eliminates amorphous crystal interference before sample analysis
• How results are displayed for microscopy/sediment
• Reporting format customizable
• No. of sample results/Control results that can be held in internal memory
Reagent shelf-life and storage temperature for unopened containers 365 days, 15–30°C
Reagent shelf-life and storage temperature for opened containers
Reagent barcode-reading capability yes
How often quality control samples are run — (after calibration and according to lab guidelines)
Sample throughput per hour/Time to first result 240/~2 min.
Analyzer has stat mode yes (minimum sample volume, 2 mL)
Sample dilutions required for urinalysis no
Sample dilutions required for body fluid analysis
Special sample handling required for body fluid analysis
Minimum width of sample tube/Minimum height of sample tube 16 mm/95–106 mm
Conditions or substances that prevent sample from being run mucus, high fluorescence, visible turbidity, grossly bloody samples
Means of sample ID entry barcode scan, worklist download from host, manual entry
Built-in liquid-level sensing for samples yes
Information that can be barcode scanned on instrument operator identifier, specimen identifier, reagent lot No.
How LOINC codes for results are made available website, e-mail query, communication from Siemens
Software includes reflex testing functionality yes
Software includes cross-check functionality yes
Instrument automatically generates consolidated report* no
Instrument connections to transfer information data-management system, which connects to LIS/EHR, or data-management system, which cannot further transmit data, or directly to LIS/EHR/lab automation system, or via commercial middleware
Interface standards supported ASTM 1394-91, ASTM 1381, HL7
Connection to LIS or EHR to upload patient and QC results direct serial, hospital network
Information included in transmission from instrument to data-management software device unique identifier, operator ID, patient ID, specimen ID, result, QC identifier
No. of days of on-site training with purchase 1–2
No. of days of training at vendor office 2.5
Approximate scheduled maintenance time required 5–10 min. per shift; 5–10 min. daily based on 1 shift; 5–10 min. weekly; 5–10 min. monthly
Instrument list price
Cost of annual service contract/Length of warranty —/1 year
Provide list of client sites to potential customers on request yes (partial list of comparable sites)
Clients restricted from sharing their experience with company or software no
Distinguishing instrument features (supplied by company) • digital color camera for improved accuracy of result measurement, including detection of intact RBC • reagent cassette format with RFID that provides complete traceability and 14 days of onboard stability • uses same dry pad reagent chemistry as CLINITEK family of analyzers—that is, Multistix 10 SG strips
*chemistry and microscopy results in one report
Note: a dash in lieu of an answer means company did not answer question or question is not applicable
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