HealthSens NEPHROPOC User Manual

Hide thumbs

Table Of Contents

Table of Contents

Quick Links

Download this manual

USER MANUAL

INSTRUCTIONS FOR USE

Table of Contents

Need help?

Do you have a question about the NEPHROPOC and is the answer not in the manual?

Questions and answers

Summary of Contents for HealthSens NEPHROPOC

Page 1 USER MANUAL INSTRUCTIONS FOR USE...
Page 2 POCT FOR THE EARLY DIAGNOSIS AND MONITORING OF RENAL DISEASE. Enzymatic creatinine biosensor that measures the creatinine concentration and estimates the glomerular filtration rate in a single drop of peripheral blood, fundamental parameters for the early diagnosis and monitoring of kidney disease USER MANUAL INSTRUCTIONS FOR USE...
Page 3 IMPORTANT Dear Healthsens Nephropoc to aid you and your healthcare ® Owner: Thank you for choosing professionals in the monitoring of Healthsens Nephropoc as your your blood creatinine levels. If you ® blood creatinine monitoring system. have any questions regarding the...
Page 4: Symbols And Icons Of The Device
SYMBOLS AND ICONS OF THE DEVICE Battery low Battery empty Precautions and warnings: refer to the user manual and the documentation included with your system to consult the safety information. Direct current (DC) Refer to user manual Manufacturer Lot number Serial number Temperature storage limits In vitro diagnostic product...
Page 5: Table Of Contents
INFORMATION �� CARE AND MAINTENANCE �� Interferences in the creatinine measurement Storage of the device Analysis results Cleaning and disinfection BATTERY OF THE DEVICE �� HEALTHSENS NEPHROPOC ® CONTENT �� Battery indicator SYSTEM CONFIGURATION �� Charging the battery Warning screens...
Page 6: Important Safety Instructions
Read this before using your Healthsens Nephropoc device. These basic safety ® precautions should always be taken: • The reader, test strips, lancets and lancing device of Healthsens Nephropoc are to be used exclusively by one patient. Do not share with ®...
Page 7: Important Health-Related
IMPORTANT HEALTH-RELATED INFORMATION Interferences in the creatinine measurement Blood creatinine measurement with the reader device Healthsens Nephropoc is not ® affected by creatinine most common interferences� Analysis results The reader device Healthsens Nephropoc provides creatinine results between ® 0.9 mg/dL and 15 mg/dL. Normal blood creatinine values in adults are lower than 1.2 mg/dL.
Page 8: Healthsens Nephropoc
HEALTHSENS NEPHROPOC CONTENT ® Reader device Healthsens Nephropoc ® Battery charger Healthsens Nephropoc ® Case for the Healthsens Nephropoc ® Creatinine test strips Healthsens Creatinine Strip ® Healthsens Nephropoc ® USER MANUAL INSTRUCTIONS FOR USE...
Page 9 Lancing device Healthsens Nephropoc ® Sterile lancets for the lancing device Healthsens Nephropoc ® *The test strips are sold separately. To obtain test strips please contact the Personal Hotline or ask your pharmacist or healthcare professional. NOTE To use the lancing device, please refer to its specific instructions manual�...
Page 10: System Configuration
SYSTEM CONFIGURATION System functionalities of the Healthsens Nephropoc device for the determination ® of blood creatinine. Sample application canal Analysis Strip Introduce the strip into the device as shown Silver extension introduce into the entry Entry port of port of the test strip...
Page 11: Turning The Device On
Turning the device on Press and hold the (picture of the on/off button) button for two seconds. In the display screen, the message “Waiting for the drop” will appear. SYSTEM PREPARATION Before using the device for the first time, you must introduce your demographic information (weight, age, gender and race) and the lot serial number of the test strip you were about to use.
Page 12 Step 1 Set WEIGHT To set the Weight, you must navigate the menu pressing the buttons to hover over the Weight option (should be highlighted in green) and press the Weight 70kg middle button to enter the selected Age 48 years Gend.
Page 13 Step 3 Set GENDER In the option Gend you have the option to select male or female. In case the predetermined gender is correct you do not have to change anything. To Weight 70kg change the Gender you must navigate Age 48 years Gend.
Page 14: Configuring Test Strip S/N
Configuring TEST STRIP s/n TEST STRIP refers to the reactive creatinine test strip of the Healthsens Nephropoc � ® User profile Depending on the production lot, two A and Test strip S/N B parameters, that correspond exclusively to Last measure...
Page 15: Configuring Language
® of the estimated glomerular filtration rate (eGFR) according to four different formulas: CDK-EPI, MDRD- 4 IDMS, HS (Healthsens) and Cockroft-Gault. User profile To visualize the eGFR that you wish you must first Test strip S/N press the settings button .
Page 16: View Different Egfr
To choose the eGFR you wish to view, press to enter. To return to the Settings menu press the button once. If you wish to return to the initial screen press once more. NOTE by default the selected eGFR is the HS option�...
Page 17: Start Of The Test
The eGFR value of the currently selected option appears on the screen, next to the creatinine concentration. TEST PROCEDURE The items that you need are: the Healthsens Nephropoc(R) reader device, the Healthsens Creatinine Strip reactive test strips for creatinine, the user manual, the ®...
Page 18 Step 1 Turn on the device Once the device is on, adjust the required parameters (User profile, Test strip S/N,...) if necessary, and return to the initial screen. When the message “Waiting for the drop” is displayed, the device is ready to carry out the creatinine determination.
Page 19 If the strip’s cell did not fill up, the result could be inaccurate. If you had any problem filling up the strip, get in contact with Healthsens’ Customer Service at the telephone number +34 985 232 428�...
Page 20: Analysis Results
ANALYSIS RESULTS The Healthsens Neprhopoc reader device delivers creatinine results between ® 0.90 mg/dL and 15 mg/dL. If the creatinine result is lower than 0.90 mg/dL the screen will display ≤0.90 mg/dL. The normal blood creatinine values for healthy adults are under 1.2 mg/dL. If your creatinine levels were high, a warning message “Please see your Doctor”...
Page 21: Unexpected Creatinine Results
985 232 428� Have you introduced Confirm the A and B parameters printed on the test correctly the A and B strip vial are correctly introduced into the Healthsens parameters that correspond Nephropoc device (TEST STRIP S/N). If this is not ®...
Page 22 Repeat the measurement with a warmed up test strip. its use? Are you not sure yet of what Contact Healthsens Customer Service at the caused the error? telephone number +34 985 232 428� USER MANUAL INSTRUCTIONS FOR USE...
Page 23: Consult Previous Results
CONSULT PREVIOUS RESULTS The device keeps a register of the 56 most recent results, which include the blood creatinine, the eGFR, and the time and date the measurement was performed. To view previous results, press the settings button . In the menu, press to select Last measurement (should be highlighted in green) and press the middle button to enter selected choice.
Page 24: Care And Maintenance
Do not use the test strips after their expiry date (printed on their container). Avoid dust, food products or liquids from entering the test strip. Do not bend, cut or alter in any way the Healthsens Nephropoc test strips. ®...
Page 25: Cleaning And Disinfection
Cleaning and disinfection Cleaning and disinfection are two different procedures, both of which are to be performed. Cleaning is part of the usual care and maintenance routine, and must be done prior to disinfection. However, cleaning does not eliminate all germs.
Page 26 Disinfection of the reader You must periodically clean the reader. Clean it before disinfecting. For disinfection you can use domestic bleach (with a minimum 5.5% content of sodium hypochlorite)*. Prepare the disinfection solution by mixing 1 part of domestic bleach with 9 parts of water.
Page 27: Battery Of The Device
If the battery is low or the reader does not turn on, charge the battery. Charging the battery Connect the USB cable to the micro USB port of the Healthsens Nephropoc ® device, and the plug to a power outlet.
Page 28: Warning Screens
Warning screens The Healthsens Nephropoc device can display the following warnings on ® the screen. Warning screens Actions Battery Low� Change the battery or connect Battery Low the charger. Temperature Error� The device only works Temperature Error when the ambient temperature is between 15ºC to 40ºC.
Page 29: Specifications
0.9 to 15 mg/ ® dL of creatinine. Precision The precision data was obtained by testing the Healthsens Nephropoc with ® certified creatinine standard solutions and venous blood samples. Tables 1 and 2 present the results typically obtained with a test strip lot.
Page 30 Table 2 Precision Blood samples Creatinine levels Number of samples CV (%) 12,0 1,16 12,6 11,1 2,02 7,88 The precision results indicate that, when blood samples are measured, the maximum expected variability is 12.6%. Lot reproducibility The precision of two different test strip lots was evaluated measuring certified creatinine standard solutions.
Page 31: Technical Specifications
TECHNICAL SPECIFICATIONS Size 95 (L) x 48 (W) x 20 (H) mm. Weight 58,67 grams Analysis methodology Enzymatic Power +5VDC/4W Display screen Memory 56 test results including date and time Operating conditions 15ºC-40ºC and between 20 of relative humidity (without condensation) Storage conditions 15ºC-40ºC and less than 85 of relative humidity...
Page 32: Guarantee
GUARANTEE Healthsens guarantees that the Healthsens Nephropoc device will be devoid ® of material and fabrication defects for a period of three years after the initial purchasing date. The guarantee is only valid for the original buyer and is non- transferable.
Page 33: Our Commitment To You
OUR COMMITMENT TO YOU Our goal is to provide high-quality healthcare products and an efficient service commitment to our clients. If you are not completely satisfied with this product, or if you have any question regarding the use of any of our products, please contact our Customer Service line at +34 985 232 428 (from Monday to Friday, 9:00 to 18:00 UTC+1).
Page 34: Contact Information
CONTACT INFORMATION Healthsens S.L. Colegio Santo Domingo de Guzmán s/n (Vivero de la Salud) 33011 Oviedo, Asturias Telephone number: +34 985 232 428 Email Address: servicios@health-sens.com USER MANUAL INSTRUCTIONS FOR USE...
Page 36 health-sens.com...