HealthSens NEPHROPOC User manual

USER MANUAL INSTRUCTIONS FOR USE

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

IMPORTANT
Dear Healthsens Nephropoc®
Owner: Thank you for choosing
Healthsens Nephropoc®as your
blood creatinine monitoring system.
Please read this manual carefully
before using the device for the
first time as it contains important
information regarding its correct
usage. The user manual has all the
instructions needed to analyze blood
creatinine levels and effectively use
the Healthsens Nephropoc®device.
The creatinine analyzers Healthsens
Nephropoc®have been designed
to aid you and your healthcare
professionals in the monitoring of
your blood creatinine levels. If you
have any questions regarding the
Healthsens Nephropoc®system, the
test strips, analysis results or these
instructions, immediately contact our
Customer Service at the telephone
number [phone] (available
Monday to Friday from 9:00 to 18:00,
UTC+1).
USER MANUAL INSTRUCTIONS FOR USE 3

SYMBOLS AND ICONS OF THE DEVICE
Battery low
Battery empty
Direct current (DC)
Refer to user manual
Manufacturer
Lot number
Serial number
Temperature storage limits
In vitro diagnostic product
Do not reuse
Sterilized by irradiation
Do not dispose of with general waste
Expiration date
Contains enough material for <n> analysis
Biohazard
Precautions and warnings: refer to the user manual and
the documentation included with your system to consult the
safety information.
USER MANUAL INSTRUCTIONS FOR USE4

CONTENT
IMPORTANT ������������������������������������������� 3
SYMBOLS AND ICONS OF THE DEVICE 4
IMPORTANT SAFETY INSTRUCTIONS ��� 6
IMPORTANT HEALTH-RELATED
INFORMATION �������������������������������������� 7
Interferences in the creatinine measurement 7
Analysis results 7
HEALTHSENS NEPHROPOC®
CONTENT���������������������������������������������� 8
SYSTEM CONFIGURATION������������������ 10
Turning the device on 11
SYSTEM PREPARATION������������������������� 11
Configuring user profile 11
Configuring TEST STRIP s/n 14
Configuring language 15
Configuring eGFR 15
View different eGFR 16
START OF THE TEST������������������������������ 17
TEST PROCEDURE�������������������������������� 17
ANALYSIS RESULTS ������������������������������ 20
UNEXPECTED CREATININE RESULTS���� 21
Possible error sources 21
Actions 21
CONSULT PREVIOUS RESULTS������������� 23
CARE AND MAINTENANCE����������������� 24
Storage of the device 24
Cleaning and disinfection 25
BATTERY OF THE DEVICE ��������������������� 27
Battery indicator 27
Charging the battery 27
Warning screens 28
Actions 28
SPECIFICATIONS���������������������������������� 29
Performance characteristics 29
Precision 29
TECHNICAL SPECIFICATIONS�������������� 31
GUARANTEE ���������������������������������������� 32
ELECTRICAL AND SAFETY RULES ��������� 32
OUR COMMITMENT TO YOU�������������� 33
CONTACT INFORMATION������������������� 34
USER MANUAL INSTRUCTIONS FOR USE 5

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
anyone, not even relatives. Do not allow different patients to use the
same system.
•Strict supervision is required when the device is to be used by, or in close
vicinity, to children or people with disability or invalidity.
•Use the device only for its intended purpose, described in this manual.
•Do not use test strips that were not supplied by the manufacturer.
•Do not use the device if it is not working correctly or has sustained damage.
•Before using any product to verify your blood creatinine levels, read
carefully the instructions and perform the test.
•Store the vial with the test strips out of the reach of children, as the cover of
the vial and the test strips could pose a choking hazard.
•Never chew or swallow a test strip. If this occurs, go to a medical center
immediately.
• Every single component of this Kit can be considered of a high risk and capable
of transmitting contagious diseases, even when cleaned and disinfected.
•The purpose of these devices is to be used for the self-monitoring of the
patient. They must never be used by more than one patient as this could
cause the transmission of contagious diseases such as Hepatitis or HIV.
USER MANUAL INSTRUCTIONS FOR USE6

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.
USER MANUAL INSTRUCTIONS FOR USE 7

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 USE8

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�
WARNING Keep the reader and analysis material out
of the reach of children. The small parts, such as the test
strips, lancets and lancet protectors could pose a choking
hazard if they are ingested. DO NOT ingest or swallow
these components.
USER MANUAL INSTRUCTIONS FOR USE 9

Analysis Strip
Introduce the strip
into the device as shown
Entry port of
the test strip
Display Screen
Creatinine Measurement,
eGFR, time and
battery charge
Incorrect Positions
of the introduction of
the analysis strips
Sample application
canal
Silver extension
introduce into the entry
port of the test strip
Navigation Buttons
Power Button
(press and hold 2 s.) Settings and
Return Button
Micro USB port
Battery charging,
software updating
and data accessing
SYSTEM CONFIGURATION
System functionalities of the Healthsens Nephropoc®device for the determination
of blood creatinine.
USER MANUAL INSTRUCTIONS FOR USE10

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. Make sure the predetermined time, date and
language are correct so that all the analysis results are accompanied by their
appropiate date and time.
Configuring user profile
To configure the User Profile you must press the settings button . In the menu
that appears, press or to hover over USER PROFILE (should be highlighted
in green) and press the middle button to enter the selected option.
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.
USER MANUAL INSTRUCTIONS FOR USE 11

Weight 70kg
Age 48 years
Gend. male
Race other
Weight 70kg
Age 48 years
Gend. male
Race other
Step 1 Set WEIGHT
To set the Weight, you must navigate
the menu pressing the or buttons
to hover over the Weight option (should
be highlighted in green) and press the
middle button to enter the selected
choice. Change the weight value with the
button to lower the value or to
raise the value. Press the middle button
to enter the selected choice.
Step 2 Set AGE
To set the Age, you must navigate the
menu pressing the or buttons
to hover over the Age option (should
be highlighted in green) and press the
middle button to enter the selected
choice. Change the age value with the
button to lower the value or to
raise the value. Press the middle button
to enter the selected choice.
USER MANUAL INSTRUCTIONS FOR USE12

Weight 70kg
Age 48 years
Gend. male
Race other
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
change the Gender you must navigate
the menu pressing the or buttons
to hover over the Gender option (should
be highlighted in green) and press the
middle button to enter the selected
choice. Change the gender value with the
or buttons. Press the middle button
to enter the selected choice.
Step 4 Set RACE
In the option Race you have the option to
select afroamerican (afroam) or other. In
case the predetermined race is correct you
do not have to change anything. To change
the Race you must navigate the menu
pressing the or buttons to hover over
the Race option (should be highlighted in
green) and press the middle button to
enter the selected choice. Change the race
value with the or buttons. Press the
middle button to enter the selected choice.
To return to the Settings menu press the
button once. If you wish to return to the
main screen press once more.
Weight 70kg
Age 48 years
Gend. male
Race other
USER MANUAL INSTRUCTIONS FOR USE 13

User profile
Test strip S/N
Last measure
eGFR
Configuration
Configuring TEST STRIP s/n
TEST STRIP refers to the reactive creatinine
test strip of the Healthsens Nephropoc®�
Depending on the production lot, two A and
B parameters, that correspond exclusively to
that particular lot, will have to be introduced
into the system so that the creatinine
concentration results are correct.
To set the TEST STRIP S/N values press the
settings button . In the menu press or
to hover over TEST STRIP S/N (should be
highlighted in green) and press the middle
button to enter the selected choice.
Two series of numbers will appear on the screen, separated by a slash /. The first series
consists of four digits that correspond to the A parameter, and the second series of four
digits, preceeded by a negative (-) or positive (+) sign, correspond to the B parameter.
Look in the test strip vial for the A and B parameters that correspond to that lot.
To select the correct values you will have to navigate the menu pressing the or
buttons to hover over the digit you wish to change (should be highlighted in green) and
press the middle button to enter the selected choice. Change the value with the
button to lower the value or to raise the value (the digit you are changing would be
highlighted in blue). Press the middle button to enter the selected choice.
Repeat the procedure until all the digits are the same as the A and B parameters
printed on the test strips vial, do not forget to introduce the positive or negative sign of
the B parameter.
To return to the Settings menu press the button once. If you wish to return to the
main screen press the button once more.
USER MANUAL INSTRUCTIONS FOR USE14

Configuring language
To configure the LANGUAGE you must press the
settings button. In the menu, press or to
hover over Configuration (should be highlighted
in green) and press the middle button to enter
the selected choice. Inside this menu press or
to hover over Language (should be highlighted
in green) and press the middle button to enter
the selected choice. To select the correct language
press or and to enter. To return to the
Settings menu press the button once. If you wish
to return to the main screen press once more.
Configuring eGFR
The Healthsens Nephropoc®enables the calculation
of the estimated glomerular filtration rate (eGFR)
according to four different formulas: CDK-EPI, MDRD-
4 IDMS, HS (Healthsens) and Cockroft-Gault.
To visualize the eGFR that you wish you must first
press the settings button . In the menu, press
or to hover over Configuration (should be
highlighted green) and press the middle button .
Inside this menu, press or to hover over eGFR
(should be highlighted green) and press the middle
button to enter the selected choice.
User profile
Test strip S/N
Last measure
eGFR
Configuration
User profile
Test strip S/N
Last measure
eGFR
Configuration
USER MANUAL INSTRUCTIONS FOR USE 15

To choose the eGFR you wish to view, press
or and 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�
View different eGFR
If you wish to view an eGFR different to the
currently selected option, you can do so once
the blood creatinine determination has finished.
To view the rest of the eGFR values, you must
press the settings button . In the menu, press
or to select eGFR (should be
highlighted in green) and press the middle
button to enter the selected choice. Inside
this menu the values of eGFR calculated with
four different methods will appear.
To return to the Settings menu, press the
button once. If you wish to return to the initial
screen press the button once more.
User profile
Test strip S/N
Last measure
eGFR
Configuration
USER MANUAL INSTRUCTIONS FOR USE16

START OF THE TEST
The reactive test strip Healthsens Creatinine Strip®consists of an electrode with
a mix of chemical reagents. The creatinine of the blood sample mixes with
these special reagents contained in the test strip, and a small electric current is
produced. The intensity of this current is directly proportional to the amount of
creatinine contained in the blood sample.
The Healthsens Neprhopoc®reader calculates the estimated glomerular
filtration rate (eGFR) by the means of four different equations that use the
creatinine value obtained and the demographic information of the patient as
input values. 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
lancing device, and a new and sterile lancet.
NOTE Please refer to your User Manual and the instructions of the lancing device
to obtain detailed information on its use�
USER MANUAL INSTRUCTIONS FOR USE 17

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.
Step 2 Insert the test strip
Take a test strip from the test strip
vial and cover the vial afterwards
immediately. Wait for 10 minutes
for the test strip to warm up to room
temperature and insert it into the test
strip entry port, silver extension first
and facing upwards. Push the strip
into the device until it does not go any
further. Make sure the lot code number
introduced into the device is the same
as the one on the vial of the test strip.
ATTENTION The test strip must ALWAYS be picked up
by its sides. If the test strip is picked up incorrectly the
determination of blood creatinine could not be correct.
USER MANUAL INSTRUCTIONS FOR USE18

Step 3 Apply the sample
When the screen displays “Waiting
for the drop”, place the blood drop
closer to the device and make
contact between the drop and the
sample application canal located
in the outer border of the test strip.
With the inside of the finger pointing
upwards, keep the blood drop in
contact with the canal until the strip’s
cell is full. The reader will begin the
measurement automatically.
If the reader begins measuring before
the strip’s cell is full, do not add more
blood to the strip; dispose of the strip
and start again. 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 [phone]�
Step 4 Precise results
The results of the creatinine and
eGFR analysis will appear on the
screen in 40 seconds.
USER MANUAL INSTRUCTIONS FOR USE 19

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”
would appear on the screen.
NOTE If the creatinine value is different from your usual values repeat the test�
USER MANUAL INSTRUCTIONS FOR USE20