User Manual

2
Copyright
Copyright © 2018 biosurfit SA
No part of this manual may be reproduced, distributed, translated, or
transmitted in any form or by any means, electronic or mechanical, including
photocopying, recording, or storing in any information storage and retrieval
system, without the prior written permission of biosurfit SA.

3
 Contents

5 Chapter 1: spinit® at Glance

5 Overview & Intended Use
5 Accessories
6 Safety Information, Precautions and Limitations

7 Chapter 2: Getting Started

7 Unpack
7 Connect & Start the spinit® instrument
8 User Interface

9 Chapter 3: spinit® Settings

9 Settings
10 spinit® Advanced Settings

4
16 Chapter 4: Using the spinit® instrument
16 Daily Operations
18 Perform a Test
20 View & Print Results
21 View Past Results
21 Export Results to USB
22 Run Quality Controls
23 Instrument shutdown

24 Chapter 5: Support and Other Information

24 Information codes and Troubleshooting
29 Maintenance & Software Update
29 Service & Recycling
29 Warranty
30 Instrument Specifications
31 Symbols

Contents 5
spinit® at Glance
1
Overview
spinit® is a point of care system for the
rapid quantitative measurement of a
number of different blood parameters.
It was developed to analyse different
test panels, using only one drop of
blood and spinit® test cartridges.

Intended Use
spinit® is an in vitro diagnostics, point of care system, consisting of an instrument
and test cartridges targeting specific diagnostic and treatment monitoring
conditions. The system is used by healthcare professionals in a variety of different
healthcare settings, and exclusively with spinit® test cartridges and recommended
controls.

Accessories
The following accessories are included with the spinit® instrument:

Power supply unit Power-supply cord USB barcode scanner

Optional equipment, not provided with your spinit® instrument is:

Dymo LabelWriter® 450 is the recommended printer for

optional print out of test results (not provided with your spinit®
instrument). For additional information regarding the printer,
please contact your local supplier.

6
Safety Information, Precautions and Limitations

Warning: For safe and proper use, read all operating instructions in this User
Manual before using the spinit® instrument.

Please read all the following precautions and limitations carefully:

• Please read and carefully follow the test specific information given in
the Instructions for Use following all spinit® test cartridges.
• Only spinit® test cartridges and materials are to be used. Do not insert
standard CDs or DVDs into the spinit® instrument.
• Place the spinit® instrument in a well-ventilated environment, allowing
at least 20cm of free space at each side of the instrument.
• Do not spill any liquids or drop any objects onto or into the spinit®
instrument. Electrical devices should not be near or in contact with
water.
• Spillage of potentially infectious material should be wiped off
immediately with absorbent paper tissue and the contaminated areas
swabbed with a standard disinfectant or 70% ethyl alcohol. Materials
used to clean spills, including gloves, should be disposed of as
bio-hazardous waste.
• If the instrument is used in a manner not specified by the manufacturer,
the protection provided by the instrument may be impaired.
• The screen representations shown in this User Manual are for
illustrative purpose only. The screens do not necessarily show valid
data.

Chapter 1 | spinit® at a glance 7

Getting Started
Unpack
2
When unpacking, check your spinit® instrument package unit and examine the
components for signs of shipping damage. Each package unit includes:
• 1 spinit® instrument
• 1 Power Supply Unit
• 1 Power Supply Cord
• 1 Barcode Scanner and respective user manual
• 1 spinit® User Manual

If the package unit is found incomplete, please report missing items or shipping
damage to your local supplier. It is recommended to keep the shipping box in case of
later transportation of the instrument.

Connect & Start the spinit® instrument

Place the spinit® instrument on a dry, clean, vibration-free and horizontal surface.
Only use parts approved by biosurfit SA. The use of non-approved parts may result in
malfunction of the instrument and may render the warranty null and void.

Connect the power supply cord to the power supply unit. Insert the plug from the
power supply cord into the power socket  and the USB barcode scanner to one of
the rear USB ports . Connect the instrument to grounded power outlets only. The
power supply voltage must match the information quoted in section Instrument
Specifications, page 30.

The spinit® instrument may be connected to a remote Laboratory or Hospital

Information System (LIS/HIS) using a standard Ethernet cable plugged into the RJ-45
connector (LAN port is considered as in house SELV)  The spinit® can be tuned ON
by pressing the button “ ”.

8
User Interface
Shortly after the spinit® instrument has been
turned ON, an automatic start-up procedure
will be initiated.

The spinit® instrument user interfaces are

the touchscreen and the spinit® tray. The
screen is operated by touching virtual
buttons on a coloured touchscreen  both
with finger or gloves.

Only a light touch is required, applying too much pressure or using sharp items may
damage the touchscreen surface; spinit® test cartridges are inserted in the spinit®
tray . The tray protects the instrument from dust, light and humidity while
performing an assay and when the instrument is not in use.

The user can perform tests, see past results, print a or transfer data, perform quality
control measurements or change the system settings.

On the main menu the user may directly start a test or move into other options
through settings menu.

Chapter 2 | Getting Started 9

spinit® Settings
Settings
3
Different optional tasks are available in the spinit® settings menu, namely retrieval of
past results, language selection, HL7 connection status, access to spinit® software
versions, performance of quality control measurements, and definition of additional
options on Advanced Settings menu.

English is the default language, other languages are available and may be selected in
first panel of spinit® settings. Select the menu Languages, click on the preferred
language and this will be set for all menus and instructions.

10
spinit® Advanced Settings
The user can define the level of authentication required for normal operation in the
Advanced Settings menu.
Advanced settings include the level of authentication required for each test
(operator ID, patient ID, measurement ID), user management (create and delete new
users) and erase data.

Operators

On the menu Operators the system owner may add or remove operators to manage
the list of users qualified to use the system.

Chapter 3 | spinit® Settings 11

ID Settings
On the ID Settings menu the system owner can setup: Operator ID, Patient ID,
Measurement ID and Operator mode. All these inputs are optional, and can be ena-
bled or disabled.

If Operator ID is ON and operator mode is List, then operator ID must be selected

from the list before proceeding with each test.

If patient ID is ON and operator mode is Barcode, then the operator must scan his
barcode ID before proceeding with each test.

Chapter 3 | spinit® Settings 12

Date/Time

The correct date and time should be set as all patient and control results will be
displayed with the respective date and time of the assay. On the Advanced Settings
menu, by selecting Date/Time is possible to adjust date/time and save the new
definitions.

Change Password
The spinit® Settings menu is protected by a password owned by the system manager.
The default factory password is 0000. To change the password, on the Advanced
Settings menu press the button Change Password, type a new password and click
Next.

Chapter 3 | spinit® Settings 13

Erase Data
By selecting the menu Erase Data, the system owner must confirm his intention to
erase all data. This action will delete all assay related data stored in the instrument.

Configure Printer
Before printer configuration the user shall connect the printer while the spinit®
instrument is powered off. For printer configuration, on the Advanced Settings menu,
the user shall select the menu Configure Printer.

The DYMO printer driver is installed by default. Select the printer and press Set to
conclude printer configuration.

Network Settings
By selecting the menu Network Settings, the system owner can view and configure
the IP Address.

Chapter 3 | spinit® Settings 14

HL7 Configuration

The spinit® uses the HL7 standard protocol to send information to the LIS/HIS. The
connectivity settings can be defined in the HL7 Config menu. In order to enable this
feature as well as the Order Material Request (ORM) feature, please contact your
local supplier.

To verify the status of HL7, the user must go to the spinit® settings menu and click
on HL7 Status button. This will provide information regarding: network connectivity,
HL7 configuration status of the device, and the number of HL7 messages that the
system was unable to send to the LIS/HIS.
Additionally, the user has the option to manually resend these messages by pressing
the Upload button.

Chapter 3 | spinit® Settings 15

Assay Options
The spinit® system allows the user to define assay options for each spinit® test:
spinit® CRP, spinit® HbA1c and spinit® BC. On Advanced Settings menu, the user shall
press the button Assay Options and choose the desired test.

The default factory units for spinit® CRP test are

µg/ml. The user may define other units for the
assay. All test results will be calculated and shown
in the selected units. This setting may be changed
anytime. The results stored in the instrument will
be shown in the selected units.

Concerning the spinit® HbA1c test, the default

assay option for the determination of glycated
haemoglobin A1c (HbA1c) is both units mmol/mol
(IFCC units) and % (DCCT units). The user may
choose to add the estimated average glucose (eAG)
determination. eAG units may be mmol/L or mg/dL.
This feature shall be set before performing a
spinit® HbA1c test.

Concerning the spinit® BC test, the default assay

option of the instrument is to perform both white
blood cell count (WBC) and haematocrit (HCT)
measurements. The user may choose to perform
HCT measurement by selecting WBC+HCT using
Change button. This feature shall be set before
performing a spinit® BC test.

Chapter 3 | spinit® Settings 16

Using the spinit® instrument
Daily Operations
4
Daily operations include the routine tasks that are required to prepare and monitor
the system, and to analyse samples.
The following table describes the routine tasks necessary for daily operation.

Task Step Panel Options

1. Starting the
Switch on the device >ON/OFF button
instrument

LANGUAGES menu

2. Preparing the > Language

Set system Language > Select the preferred language
instrument Settings

ADVANCED SETTINGS menu

Define Date/Time > Date/Time > Set and press Save

> Change
Change Password > Introduce the new password
Password

> ID Settings
Operator ID
Define Authentication Patient ID > Select 'ON/OFF'
level
Measurement
ID
Operator mode > Select 'List/Barcode'

Add Operator > Operators > Add/Remove Operator

Configure HL7 > HL7 config > Load the file provided by the local supplier

> Select Automatic or Manual

Configure Network > Network
Settings Settings if Address mode Manual
> Set IP address and Set Netmask

> CRP > Choose CRP units

> Assay > BC > Press Change to enable/disable HCT

Define Assay mode
Options assay

> HbA1c > Choose units

> Printer
Configure Printer > Select printer > Press Set
Configuration
17
Daily Operations (continued)

Task Step Panel Options

MAIN menu

a. Settings should be
n/a n/a
previously defined

b. Press Start or read

n/a n/a
barcode from cartridge
3. Starting a test
c. Follow cartridge sample
n/a > Press Next
loading instructions

d. Insert cartridge on the tray n/a > Press Next

Monitoring test Test

4. n/a monitoring n/a
progress panel

Reviewing test
5. a. View Results n/a > Result panel
Results

spinit® SETTINGS menu

View & Print test > Press Show

6. View Past Results > Data
results By Operator or By Patient

a. Select Quality Control n/a n/a

b. Read barcode from n/a n/a

cartridge or type it
Performing
c. Enter control n/a > Press Next
7 Quality Control
concentration
test
d. Follow cartridge sample n/a > Press Next
loading instructions
e. Insert cartridge on the tray n/a > Press Next

Chapter 4 | Using spinit® instrument 18

Perform a Test
To start a test press Start in the main menu or read the barcode directly from the test
cartridge pouch.

Settings should have been previously defined.

For additional information see spinit® Settings (chapter 3).

In case Start button was pressed, read barcode from the test cartridge pouch before
opening it. Each spinit® test lot has its own specific calibration data coded on the
barcode of the cartridge pouch label.
The instrument verifies that the spinit® test is valid.

Chapter 4 | Using spinit® instrument 19

Perform a Test (continued)
Follow the sample and cartridge handling instructions described in each spinit®
cartridge Instructions for Use (IFU). Only trained users should operate the
instrument.

Once the disc is ready, press Next on the touchscreen and place it on the spinit®
tray.

Chapter 4 | Using spinit® instrument 20

Perform a Test (continued)
The assay will be performed and time to results will be shown on screen.

View & Print Results

Results are automatically shown on screen, along with the respective parameter
reference values of the test performed. The results vary depending on the spinit®
test used. The following example corresponds to a spinit® BC result.

To print results, printer must be connected. Only recommended printers can be used
(see information on printer—chapter 1). Eject the disc to conclude the procedure.
Dispose test cartridge as described in spinit® cartridge IFU.

Chapter 4 | Using spinit® instrument 21

View Past Results
Patient and Control results are stored in the memory of the spinit® instrument.
The user can view past results by clicking Data on the spinit® settings menu.

Results can be sorted by date, Operator/Patient or type of test.

Export Results to USB

Past results can be transferred to a standard USB pen drive through the Data menu
on the Advanced Settings panel. Additionally, system owner can define if data can be
exported directly through the Data menu on the spinit® settings panel. For that, the
system owner shall select Yes on the Allow export without password button on Ad-
vanced Settings.
To export data connect the USB pen and press Export to USB. After exporting the
data, disconnect the UBS pen. When exporting results, the complete data set is
exported as comma-separated value (.csv) file for each test type. These files can be
processed with any spreadsheet program that can import csv files. For additional
information please contact your local supplier.
Note: It is the user’s responsibility to comply with local regulations on protection of personal
health information when exporting data that contains patients information.

Chapter 4 | Using spinit® instrument 22

Run Quality Controls
Before starting the spinit® instrument, quality control testing may be performed to
confirm the spinit® instrument is working properly and providing reliable results.
biosurfit recommends using specific quality controls with the spinit® instrument and
provides the established reference ranges for the spinit® system upon request. Refer
to your local supplier for specific information on the type of quality control
reagents that can be used with each specific spinit® test.
The measured value should be within the acceptable range stated in the external
quality control reference sheet provided by biosurfit. If the controls are not within
the acceptable limits, the frequency of control failures should be analysed to make
sure that there is no trend in out-of-range quality control results. If the problem
persists, contact your local supplier before using the instrument to test patient
samples. If the controls are within the acceptable ranges, patient samples may be
tested and results reported.
biosurfit recommends testing at least one control for each type of test the user
intends to perform at the time of installation.
Controls should be analysed in any of the following circumstances:
• when installing the spinit® instrument for the first time;
• when testing each new lot of spinit® test cartridges;
• when the frequency of testing is less than 15 tests/month, controls should
be analysed at least every 30 days;
• anytime an unexpected value test result is obtained;
• after installing a software update;
• when training new personnel in the correct use of the spinit® instrument;
• if national or local regulations require more frequent testing of control
materials, quality control testing shall be performed according to facility
regulations.

Chapter 4 | Using spinit® instrument 23

Run Quality Controls (continued)
The user shall select Quality Control in the spinit® settings menu to run a QC
procedure. The spinit® instrument then follows the standard assay protocol.
Acceptance values for each recommended quality control reagent is available upon
request.

Results are then shown in the standard format with the indication of control. The
user may later view, print or transfer information on all previously run QC controls.

Instrument shutdown
The spinit® instrument should be turned OFF after the end of a working day. The
stored results will not be lost when the spinit® is powered off or the power supply
disconnected. To shut down the spinit® instrument, go to spinit® settings menu and
select Shutdown.

Chapter 4 | Using spinit® instrument 24

Support and Other Information 5
Information codes and Troubleshooting
In some cases, the spinit® instrument may display information codes. Refer to
Information Codes table below for more details.

Before contacting technical support, please gather the following information:

• spinit® instrument serial number (s/n) - see About menu (see page 9).
• Software version number - see About menu.
• spinit® test cartridge type and lot number (if applicable).
• Control reagent and lot number (if applicable).
• Description of the problem with reference to information codes or messages.

General
system Cause Solution
malfunction

Power supply inadequately connected Connect power supply.

spinit® does not
start
Start-up procedure failed Contact your local supplier.

Touchscreen Restart instrument. If the problem persists,

Touchscreen failure
malfunction contact your local supplier.

Barcode scanner inadequately connected Connect barcode scanner to USB port.

Barcode scanner
malfunction
Barcode scanner malfunction or Instrument
Contact your local supplier.
electronic malfunction

Printer inadequately connected Reconnect the printer and verify printer settings
Printer settings not correct (See page 5 for help).
Printer
malfunction
Printer malfunction or Instrument electronic
Contact your local supplier.
malfunction

25
Information codes (continued)

Information
Source Cause Solution
code

Collect a new sample and repeat the test, using a

spinit® instrument did not reach the
Instrument new test cartridge as per Instructions for Use
100 correct rotation for signal
(software) (IFU). If the problem persists, please contact your
acquisition.
local supplier.

Collect a new sample and repeat the test, using a

Instrument
113 General software failure. new test cartridge as per IFU. If the problem
(software)
persists, please contact your local supplier.

Not enough sample volume to be

measured due to:
• no sample; Collect a new sample and repeat the test, using a
• misuse of capillary tube (while new test cartridge as per IFU.
Usage collecting sample from finger or  Release the sample into the disc by gently
114 when introducing sample into the pressing the upper part of the capillary tube. After
disc); releasing the sample into the disc, keep the
Disc
• incorrect/partial sealing of the pressure on the upper portion of the capillary and
cartridge adhesive flap; discard it.
• spinit® test cartridge
compromised.

 Shutdown the device and unplug it from the

spinit® instrument was unable to power supply for 10 seconds.
Instrument
complete the assay successfully due  Restart the device and repeat a new test, using
(hardware)
201 to unexpected hardware communi- a new spinit® CRP test cartridge and according to
cation failure IFU.
If problem persists, please contact your local
supplier.

Collect a new sample and repeat the test, using a

Test cartridge does not pass QC
206 Disc new test cartridge as per IFU. If the problem
inspection.
persists, please contact your local supplier.

Collect a new sample and repeat the test, using a

spinit® test cartridge microfluids
new test cartridge as per IFU.
208 Disc compromised due to incorrect flows
 Follow all instructions regarding storage of
of fluids within the cartridge.
each test cartridge. See IFU for more details.

Collect a new sample and repeat the test, using a

Not enough reagent volume due to:
Usage new test cartridge as per IFU.
• incorrect rupturing of blister;
210  Make sure to press the blister firmly with your
Disc • spinit® test cartridge
thumb finger and that the test cartridge is placed
compromised.
on a flat and hard surface.

Chapter 5 | Support and Other Information 26

Information codes (continued)

Information
Source Cause Solution
code

Collect a new sample and repeat the test, using a

Usage new spinit® HbA1c test cartridge as per IFU.
211 Failure to perform sample check.
Disc If the problem persists, please contact your local
supplier.

→ Shutdown the device and unplug it from the

spinit® instrument was unable to power supply for 10 seconds.
Instrument
(hardware) complete the assay successfully due
→ Restart the device and repeat a new test, using
321 to invalid centrifugation, likely due
a new test cartridge as per IFU.
to motor malfunction or cartridge
Usage
misplacement If the problem persists, please contact your local
supplier.

→ Shutdown the device and unplug it from the

spinit® instrument was unable to power supply for 10 seconds.
complete assay due to unstable
Instrument → Restart the device and repeat a new test, using
323 (hardware)
motor rotation/behaviour or
a new test cartridge as per IFU.
measurement electronics
malfunction If the problem persists, please contact your local
supplier.

→ Shutdown the device and unplug it from the

power supply for 10 seconds.
spinit® instrument was unable to
Instrument → Restart the device and repeat a new test, using
325 (hardware)
complete assay due to unstable
a new test cartridge as per IFU.
measurement electronics
If the problem persists, please contact your local
supplier.

Allow instrument to cool down and perform

another test.

 Check if device is properly ventilated and

Usage Operating temperature outside operating range is within recommended range
401
spinit® instrument specified range (15-30°C).
Instrument
If the problem occurs more than once a week or
three times a month, please contact local
supplier.

601 Usage Operator cancelled the test.

Chapter 5 | Support and Other Information 27

Information codes (continued)

Information
Source Cause Solution
code

Collect a new sample and repeat the test, using a

Instrument General failure of the spinit® BC new spinit® BC test cartridge as per IFU. If the
1000
Disc test. problem persists, please contact your local
supplier.

Collect a new sample and repeat the test, using a

Instrument spinit® instrument auto-focus
new spinit® BC test cartridge as per IFU. If the
1001 function was performed but focus
problem persists, please contact your local
Disc quality is compromised.
supplier.

Collect a new sample and repeat the test, using a

Sample processing is compromised
Disc new spinit® BC test cartridge as per IFU. If
likely due to incomplete lysis of
1002 available, test a new spinit® BC test cartridge
Sample erythrocytes and/or poor staining of
from an alternative cartridge lot. If the problem
leukocytes.
persists, please contact your local supplier.

Collect a new sample and repeat the test, using a

Instrument new spinit® BC test cartridge as per IFU. Take
Low and/or compromised counts of particular attention to minimize time between
1003 Disc
leukocytes. sample loading and cartridge insertion on spinit.
Sample If the problem persists please contact your local
supplier.

Collect a new sample and repeat the test, using a

new spinit® BC test Cartridge as per IFU. If the
Abnormal sample (e.g. leukocyte problem persists, the sample should be tested
1004 Sample
aggregation, cellular debris). with a reference laboratory method. If the
problem persists please contact your local
supplier.

Collect a new sample and repeat the test, using a

Instrument new spinit® BC test cartridge as per IFU. If the
1005 Haematocrit assay failure.
Disc problem persists, please contact your local
supplier.

Sample related Flags

IM - Presence of immature cells. The sample should be verified with a reference laboratory
method.
NRC - Presence of Nucleated Red Blood Cells. The sample should be verified with a reference
laboratory method.

Chapter 5 | Support and Other Information 28

Maintenance & Software Update
The spinit® instrument is designed to be maintenance free by the user and it
performs multiple functional and operational tests to guarantee proper
performance. By default, an auto-maintenance procedure is performed after each
test. The system owner has the possibility to disable this feature on the Device
Maintenance menu on the Advanced settings panel. However, biosurfit recommends
this feature should be enabled.
Software updates can be performed using a USB pen containing the latest software
package. As an alternative, biosurfit may perform the software update through re-
mote connection on a pre-arranged basis.
All functions available on the spinit® PM button are intended to be used by the
manufacturer and/or authorized third parties only.

Service & Recycling

In case of instrument malfunction, please contact your local supplier. Service and
repair must only be performed by authorized and qualified personnel.
The spinit® instrument is a low-voltage electronic device and it should be recycled as
electrical equipment waste. The device is designed in accordance with the RoHS
directive (Restriction of the Use of Certain Hazardous Substances in Electrical and
Electronic Equipment: Directive 2002/95/EC). The spinit® instrument packaging is
made of recyclable materials.
biosurfit recommends the use of a cloth soaked with ethanol solution 70 % (v/v) in
H2O to clean the external surface of the instrument. The touchscreen should be
cleaned with a dry cloth. The instrument must be switched off and unplugged before
cleaning. Do not use any cleaning liquid or equipment other than those
recommended above.

Warranty
The manufacturer’s warranty for the spinit® instrument covers defects in materials
or manufacturing for a period of twelve months from the date of delivery.
The manufacturer agrees to repair or replace the instrument if it becomes
inoperative due to the failure of any internal parts. The warranty does not cover
damage caused by use not in accordance to instructions. Any customer modification
to the instrument will render the warranty null and void.

The manufacturer is under no obligation to modify or update the instrument once it

has been manufactured, unless a manufacturing defect is identified.
In the advent of an instrument malfunction, please contact your local supplier.

Chapter 5 | Support and Other Information 29

Instrument Specifications
The spinit® instrument is a CE certified IVD medical equipment and conforms to the
following directives and standards: European Union In Vitro Medical Instruments
98/79/EC, Directive 2011/65/EU, EN/IEC 61010-2-101, and EMC IVD Instrument
Standard EN 61326-2-6:2006

For in vitro diagnostic use.

Product Name Product Reference No.

spinit® instrument spinit 03.00 and 04.00

Specifications
Dimensions 24.5 x 22.0 x 30.5 (cm)
Weight 4.1kg
Max Power 100W
Frequency a.c. ~ 50-60Hz
Power supply 100-240V
Operational temperature 15-30°C
Storage Temperature 5-40°C
Humidity <80%

The spinit® instrument includes a 4-wire touchscreen with VGA resolution. The
device has a microprocessor for controlling all the assay steps and data processing
for quantitative determination of blood parameters.

The design, development and manufacturing of the spinit® instrument is in

accordance with biosurfit’ s Quality Management System (ISO 13485 certified
company).

For further detailed information on technical specifications, detection methods and

available cartridge tests and accessories for your spinit® instrument, please contact
your local spinit® supplier.

Chapter 5 | Support and Other Information 30

31
Symbols

Manufacturer´s name and address

Serial Number

Consult Instructions for Use

in vitro diagnostic medical device

CE marking of conformity to directive 98/79/EC on in

vitro diagnostic medical devices

Class I laser product

Waste electronic and electrical equipment

11-2018

Warranty void if seal is broken

Rev: 01

Warning Biological Hazard

PL-006-03

Warnings and precautions

biosurfit SA
Rua 25 de Abril nº66
2050-317, Azambuja Portugal
info@biosurfit.com | www.biosurfit.com

© biosurfit SA 2018 32