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General| Intended Use | Measurement of creatinine and eGFR in blood samples |
|---|---|
| Methodology | Enzymatic |
| Sample Type | Whole blood, plasma, serum |
| Calibration | Automatic calibration with reagent change |
| Interference (Bilirubin) | ≤ 20 mg/dL no significant interference |
| Interference (Hemoglobin) | <10% interference at concentrations up to 500 mg/dL |
| Interference (Lipemia) | <10% interference at concentrations up to 1000 mg/dL triglycerides |
| Operating Temperature | 15 - 30°C |
| Storage Temperature | 2 - 8°C |
| Dimensions | Varies by model |
| Weight | Varies by model |
| Power Requirements | 100 - 240 VAC, 50/60 Hz |
Safety guidelines for handling bloodborne pathogens.
FCC and RSS compliance statements for the device.
General safety procedures for meter operation.
Guidelines for proper disposal of batteries and accessories.
Essential preparation steps before performing tests.
Identification of key components of the Nova Max Pro meter.
Explanation of the meter's screen interface and navigation.
Procedure for setting the meter's date and time.
How to adjust sound alerts and select the display language.
Information on software and strip reader versions.
Settings for eGFR equation, units, and decimal separator.
Steps to confirm meter and test strip functionality.
Storage, expiration, and usage guidelines for control solution.
Step-by-step guide for running a control solution test.
Entering patient ID, age, gender, and ancestry.
Procedures for proper blood sample collection.
Step-by-step guide for running a blood test.
Storing results and post-test hand washing instructions.
Explanation of eGFR result color flags and meaning.
Correlation between eGFR values and CKD stages.
Navigating to view past patient test results.
Viewing quality control test results.
Information on battery levels and charging procedures.
Detailed steps for cleaning and disinfecting the meter.
Meanings and actions for meter error codes (E-2 to E-4).
Troubleshooting for meter not turning on or starting tests.
Technical specifications of the Nova Max Pro meter.
Clinical accuracy and precision study results.
List of supplies and parts for the meter system.
Details on the product warranty and limitations.
Reporting serious incidents and document revision details.
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