BIOSURFIT spinit S40 User manual

English
User Manual
spinit® S40
spinit® E40

TABLE OF CONTENTS
Safety Informaon, Precauons and Limitaons 1
spinit® system 2
Introducon 3
About this User Manual 3
Unpacking the spinit® instrument 3
spinit® system descripon 4
The spinit® system 4
Descripon of the spinit® instrument 4
Descripon of the spinit® discs 5
How the spinit® instrument works 6
Internal process control 7
External process control 7
Geng Started 8
Installing your instrument 8
Connecng power supply 8
Connecng addional equipment 8
How to turn ON the instrument 9
How to turn o the instrument 9
How to operate the instrument 9
Sound Signals 10
Conguraon 11
The spinit® menus 11
Home Menu 11
spinit® sengs 11
Data 11
Language 12
HL7 Status 12
About 12
Quality Control 13
Running Controls 13
QC—Pass or failed 13
Paent and Control results 13
View, print and export paent control results 14
Advanced Sengs 14
Data 14
ID Sengs 15
Operator ID 15
Paent ID 15

TABLE OF CONTENTS
Assay Opons 17
Date / Time 18
Change Password 18
Congure Printer 18
Network Sengs 19
HL7 Conguraon 19
Erase Data 19
Soware Update 20
Device maintenance 20
Quality Controls tesng 21
Handling and tesng controls 21
Why control tesng 21
Choosing control material 21
Frequency of control tesng 22
Tesng Procedure 23
Operang Precauons 23
Preparing for sample analysis 23
Prepare for tesng > paent samples 24
Prepare for tesng > quality Control material 26
Info Codes and Troubleshoong 30
Service Informaon 30
Informaon codes for spinit® E40 and S40 31
Addional codes for spinit® S40 33
Maintenance and Warranty 34
Maintenance 34
Cleaning the exterior 34
Servicing 34
Warranty 34
Soware Update 34
Disposal and recycling of the instrument 34
Technical Specicaons 35
Instrument Specicaons 35
Addional equipment 36
Symbols and abbreviaons 37

Safety Informaon, Precauons and Limitaons
WARNING: For safe and proper use, read all operang instrucons in this User Manual
before using the spinit® instrument.
Please read all the following precauons and limitaons carefully:
• Please read and carefully follow the test specic informaon given in the Instrucons for Use
of all spinit® discs.
• Only spinit® discs and spinit® strips are to be used. Do not insert standard CDs or DVDs into
the spinit® instrument.
• Place the spinit® instrument in a well-venlated environment, allowing at least 20 cm of free
space at each side of the instrument.
• Do not spill any liquids or drop any objects onto or into the spinit® instrument. The spinit®
instrument should not be near or in contact with water.
• Spillage of potenally infecous material should be wiped o immediately with absorbent
paper ssue 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 specied by the manufacturer, the protecon pro-
vided by the instrument may be impaired.
• The screen representaons shown in this User Manual are for illustrave purposes only. The
screens do not necessarily show valid data or represent your spinit® instrument version.
spinit® User Manual 1

spinit® System
Intended Use
spinit® is for in vitro diagnosc use only, consisng of an instrument and discs targeng specic
treatment monitoring condions. The system is used by healthcare professionals in a variety of
healthcare sengs, and exclusively with spinit® discs and recommended controls.
Conformity to the IVD direcve
The spinit® instrument meets all provisions in the European direcve 98/79/EC on In Vitro Diag-
nosc Medical Devices and is CE marked accordingly.
Safety standards
The spinit® instrument has been tested and found to be in conformity with IEC 61010-2-101:2018
(Parcular requirements for in vitro diagnosc (IVD) medical equipment).
EMC standards
The spinit® instrument has been tested and found to be in conformity with EMC IVD instrument
standard EN 61326-2-6:2013 (In vitro diagnosc (IVD) medical equipment).
Rua 25 de Abril nº66,
2050-317 Azambuja, Portugal
ISO13485 cered company
2 spinit® User Manual

INTRODUCTION
About this User Manual
This User Manual will guide you through installaon, operaon and maintenance of your spinit®
instrument. The User Manual also explains how the instrument works, describes the quality assur-
ance system and assists you in troubleshoong.
For analyzing paent samples or controls, please also read the test specic informaon given in
the Instrucons for Use found in the spinit® test kit. The Quick Guide highlights the main steps of
the test procedures and contains informaon on proper quality control rounes.
We recommend that you become familiar with the user instrucons before you start operang the
spinit® instrument.
Unpacking the spinit® instrument
When unpacking, check the components for signs of shipping damage.
Each spinit® package includes:
• 1 spinit® instrument
• 1 Power Supply Unit
• 1 Power Supply Cable
• 1 Barcode Scanner and respecve user manual
• 1 spinit® User Manual
If the package is found incomplete, please report missing items or shipping damage to your local
supplier. We recommend keeping the shipping box if shipping of the device is needed.
spinit® User Manual | Introducon 3

4 spinit® User Manual | spinit® system descripon
Do not open or close the tray manually.
Descripon of the spinit® instrument
Figure 1.
1. Power ON buon
2. Connecon to power supply;
3. Two (2) USB ports: to connect an external printer, a barcode reader or a USB pen drive. The
USB pen drive can be used to export data and upload soware updates;
4. RJ-45 connector to Ethernet cable (LAN port is considered as in house SELV): connecvity
opon to remote Laboratory or Hospital Informaon System (LIS/HIS);
5. Touch screen - spinit® instrument user interface operated by touching virtual buons on a
colored touchscreen;
6. Tray: The tray protects the instrument and the disc from dust, light and humidity while per-
forming an assay and when the instrument is not in use;
The spinit® instrument is a stand-alone, small benchtop medical device with a user friendly interacve
touchscreen and an automac tray designed to accommodate any spinit® disc. Figure 1 shows the
main exterior parts of the spinit® instrument.
The spinit® System
The spinit® system includes the spinit® instrument, spinit® discs, spinit® controls and spinit® strips.
All components were designed and developed to be used exclusively.
spinit® SYSTEM DESCRIPTION

Figure 2.
Test disc: spinit® strip:
1. Sample well 5. Sampling area (collecon chamber)
2. Internal Quality Control 6. Handling area
3. Blister with buer or reagent 7. Breaking Line
4. QR Code
* similar for spinit® CRP and spinit® BC**;
** only available for spinit® S40 version.
spinit® User Manual | spinit® system descripon 5
Descripon of the spinit® discs
The spinit® disc is unique for each analyte to be measured and integrates test specic reagent
composions and volumes. The spinit® discs have a unique color for each test and are separately
packed in foil pouches to protect the reagents and plasc devices from light, dirt and humidity. A
single disc contains all necessary reagents for one test and is ready to use. For paent sample or
control collecon, a spinit® strip is used. The disc cannot be re-used.
Figure 2 illustrates spinit® HbA1c* disc and spinit® strip funconal parts.

How the spinit® instrument works
The spinit® instrument is a stand-alone, small benchtop in vitro medical device intended to deliver
a diagnosc plaorm designed to work with the spinit® discs.
The spinit® plaorm is based on a proprietary technology designed to oer rapid results from a
single drop of blood, providing fast, safe and eecve clinical monitoring and improved paent
care. The instrument is designed to be a universal, mul-assay instrument plaorm capable of
accommodang dierent tests developed to address the most urgent needs in the clinic. The
barcode on the disc prompts the instrument to conduct the appropriate program.
Two versions of the spinit® instrument are currently CE marked.
The spinit® S40 is the complete version of the spinit® instrument and is designed to include all ana-
lycal modules enabling the customer to run all three types of spinit® tests currently available on
the market, the spinit® CRP (measures C-Reacve Protein levels in whole blood), spinit® HbA1c
(measures glycated haemoglobin A1c concentraon in whole blood and BC (measures total white
blood cell count and 5-part dierenal).
The spinit® E40 is the Essenal version of the spinit® instrument and only reads spinit® CRP and
spinit® HbA1c discs.
Both spinit® S40’s and E40´s analycal modules are comprised of a spectrophotometer. The spec-
trophotometer is made up of two light eming diodes (LEDs), two photodiodes that funcon as
detectors and an electronic circuit board that processes the LEDs independently. Emied light is
reected inside the disc and passes through a detecon chamber. Transmiance of light through
the opcal path is measured and will vary depending on the reacon occurring inside the cham-
ber. The transmission of light through the blood sample in the detecon chamber is measured and
is correlated to the concentraon of the specic analyte. The instrument accepts several types of
spinit® discs. The analycal process is fully automated and the completed test results are shown
on the screen. In addion, only the S40 integrates a microscopy module for image acquision and
a precise angular disc posioning module. The microscopy module is composed of the following
components: illuminaon stage, miniaturized microscope with auto-focus capability and a digital
camera.
Moreover the soware version must include the following features: remote control of disc angular
posion and auto-focusing funcon, digital image treatment (illuminaon correcons, background
correcon, etc.), object detecon within a image (segmentaon) and WBC feature analysis and
classicaon.
The barcode on the pouch label prompts the instrument to conduct the appropriate test.
The instrument is delivered to the user pre-calibrated. If the instrument detects a malfuncon, the
test will be interrupted with a display of the informaon code and the paent results will not be
reported. The user must refer to the spinit® User Manual to understand the cause of the infor-
maon code.
6 spinit® User Manual | spinit® system descripon

spinit® User Manual | spinit® system descripon 7
Internal process control
The instrument self-test
A self-test is performed during start-up of the instrument to ensure that the instrument is oper-
ang according to established specicaons. The self-test validates:
• Hardware and soware integrity
The fail-safe mechanisms
The spinit® instrument is designed to be maintenance free by the user and it performs mulple
funconal and operaonal tests to guarantee proper performance. A Hardware Mainte-
nance procedure is performed on a periodic and automac basis.
External process control
Paent ID
The spinit® paent ID funcon will, if enabled, allow 100 000 number of paents to be entered.
The Paent ID will be stored with each paent test result in the results panel.
Operator ID
The spinit® operator funcon will, if congured, allow the operators to insert their idencaon
before tesng.
The operator ID will be stored with each test result in the results panel.
Quality Control
For manufacturer recommendaons see Frequency of control tesng page 21.
Calibraon
The spinit® instrument has been manufactured to deliver reliable and accurate results. During
manufacturing, the instruments are calibrated against a reference system. This procedure has
been established to ensure that all instruments operate within idencal tolerance limits.
Each spinit® test has its own lot specic calibraon data coded on the barcode of the disc pouch
label. The instrument veries that the spinit® test is valid by reading the unique QR code printed
on each disc to conrm the correct calibraon. A plug-and-play barcode reader is provided to this
eect.

Installing your instrument
Place the spinit® instrument on a dry, clean, vibraon-free and horizontal surface. Only use parts
approved by biosurt. The use of non-approved parts may result in malfuncon of the instrument
and may render the warranty null and void.
Make sure it is in a well-venlated environment, allowing at least 20 cm of free space at each side
of the instrument.
Acclimate the instrument to ambient operang temperature (15-30°C).
The instrument might be impaired by:
• Condensing humidity and water
• Heat and large temperature variaons
• Direct sunlight
• Vibraons (e.g. from centrifuges and dishwashers)
• Movement of the instrument during processing of a Test
Connecng power supply
Connect the power supply cable to the power supply unit (Figure 3).
Insert the plug from the power supply cable into the power socket in the back of the instrument.
Connect the instrument to grounded power outlets only.
Always use the correct supply voltage. The power supply voltage must match the informaon
quoted in the secon Technical specicaons, page 35.
1. Power ON buon.
2. Power input for power supply connecon.
Connecng addional equipment
Oponal equipment not provided with your spinit® instrument are:
• Printer – for oponal print out of test results.
For addional informaon regarding the barcode reader, printer, and connecon to HIS or LIS
systems, please contact your local spinit® instrument supplier.
Connecng the equipment should be done while the instrument is powered o.
Figure 3.
8 spinit® User Manual | Geng Started
GETTING STARTED

spinit® User Manual | Geng started 9
How to turn ON the instrument
1. Turn on the instrument on the back by pressing the
ON buon (Figure 3) .
An automac start-up procedure will be iniated.
Please wait unl stabilizaon period is complete
2. The instrument is ready for use when the stabilizing
is complete and the Start buon becomes available.
3. On the Home menu the user may directly start an as-
say, a quality control check, watch the training videos
or move into other opons through the Sengs
Icon .
How to turn OFF the instrument
Turn o the instrument by going into the Sengs icon and select Shutdown buon. The in-
strument should be powered o at the end of the day.
Please note:
• When the power is turned o, a closing down procedure is iniated.
• The instrument can be powered o, or the power supply disconnected, without loss of
stored results.
• The instrument cannot be turned o if the tray is open.
How to operate the instrument
The instrument is easily operated using the touch buons that appear on the screen. When a
buon is touched, its funcon will be acvated. Text messages that appear on the screen will help
guide you through the tesng procedure (Figure 4).
The other main operave part of the spinit® instrument is the disc tray. It is designed to receive
the disc in one orientaon only, with label facing up. The tray opens and closes automacally. To
automacally open the tray, click the Next buon aer reading the barcode; When a new disc is
placed in the tray, click the Next buon to automacally close the tray; closing the tray will iniate
the analysis. To discard the disc, you will need to click Eject. The tray protects the instrument from
dust, dirt, light and humidity during processing and when the instrument is not in use.
• The tray opens and closes automacally. Do not open or close the tray manually.
• Use the ngerps (with or without gloves) only on the touchscreen. Only a light touch is
required, applying too much pressure may damage the touchscreen surface.
• Do not use pens or other sharp instruments, may damage the touchscreen surface.

10 spinit® User Manual | Geng started
Figure 4.
1. Text message
2. Touch buons
3. Tray with a ready to use disc
Sound signals
A short beep indicates compleon of an analysis.

The major instrument conguraon opons are available through the Sengs or Advanced sengs
menu.
Home Menu
spinit® sengs
Data
On the Home menu the user may directly start a test selecng Start, a quality control check by click-
ing QC Mode, watch the Training videos or move into other opons through the Sengs icon
spinit® User Manual | Conguraon 11
The spinit® menus
Dierent conguraons are available in the spinit® sengs menu, namely retrieval of past results,
language selecon, HL7 connecon status, access to spinit® soware versions, performance of quali-
ty control measurements, and denion of addional opons on Advanced Sengs menu.
The user can view past results by clicking Data on the spinit® sengs menu.
Results can be sorted on the Results panel by operator or paent and exported to a USB pen drive.
CONFIGURATION

Language
English is the default language, other languages are available and may be selected in the rst panel
of spinit® sengs. Select the menu Languages, click on the preferred language and it will be set for
all menus and instrucons.
HL7 Status
To verify the status of HL7, the user must click on HL7 Status buon. It will provide informaon
regarding: network connecvity, HL7 conguraon status of the device, and the number of HL7
messages that the system was unable to send to the LIS/HIS. Addionally, the user has the opon
to manually resend these messages by pressing the Upload buon.
About
On the About buon, it is possible to have detailed informaon regarding your spinit® instrument
soware versions.
12 spinit® User Manual | Conguraon
The spinit® menus

spinit® User Manual | Conguraon 13
Quality Control
When running controls, the QC mode must be selected at Home menu, and an operator must be cre-
ated previously. Each spinit® disc contains mulple integrated quality control vericaon steps to
ensure reliability of the tests. If the user chooses to perform addional Quality Control checks, bio-
surt recommends tesng spinit® quality control kits with the acceptable ranges previously estab-
lished for the spinit® system.
Running Controls
To run a control, press the buon QC mode on the Home menu and proceed with instrucons on
screen.
spinit® control kits are available for roune quality control tesng. These control kits contain control
materials with established acceptable ranges for spinit® instrument.
Results are then shown in the standard format with the indicaon of Quality control. The user may
later view, print or transfer informaon on all previously run QC controls.
To go back the previous menu, press Done.
QC Pass or Failed
The result of the control is checked against the acceptable ranges for the corresponding lot number.
If the result is within the acceptable ranges, the informaon Pass is displayed on the screen.
If the result is not within the acceptable ranges specied for the spinit® control kit, the informaon
Fail is displayed on the screen.
Paent and Control results
The paent and control results are stored in the memory of the spinit® instrument. Paent results
and control results are saved in separate records. The following parameters are listed for each run:
Date and me, paent ID, operator ID, Result and QC result.
The spinit® menus

14 spinit® User Manual | Conguraon
View, print and export paent and control results
To view or print a specic analysis, select the analysis and press Details. The results can be trans-
ferred to a USB pen drive. For privacy maers, exported data encrypts paent and operator infor-
maon.
Advanced Sengs
The Advanced Sengs are managed by the System Admin.
Advanced sengs include the level of authencaon required for each test (operator ID, paent ID,
measurement ID), user management (create and delete new users) and erase data.
Data
On the menu Data , the system Admin has the possibility to dene if results can be sorted without a
password. To export data, connect the USB pen drive and press Export to USB. Aer exporng the
data, disconnect the UBS pen drive. The complete data set is exported as comma-separated value
(.csv) le for each test type. These les can be processed with any spreadsheet program that can
import csv les. For addional informaon please contact your local supplier. The exported data will
show all the informaon regarding paent and operator ID. For addional informaon, contact your
local supplier.
The spinit® menus

ID Sengs
On the ID Sengs menu the system Admin can setup: Operator ID, Paent ID, Measurement ID
and Operator mode. All these inputs are oponal, and can be enabled or disabled.
Operator ID
If enabled, the operator’s idencaon (ID) is required before processing a spinit® test.
The operator ID will be displayed with the result and stored along with the other specic data for
this run (see Paent and control results records, page 13).
To add an Operator, select Operators on the Advanced sengs menu. Press Add to enter leers /
numbers or scan with your ID. Press Enter to conrm and select Back to go to previous menu.
Paent ID
If this funcon is enabled, the paent ID must be entered for each paent sample to be analyzed.
Use leers / numbers or scan barcode to add paent ID and press Enter to conrm.
The Paent ID will be stored in the memory and displayed along with the other specic data for
this run (See paent and control results, page 13).
spinit® User Manual | Conguraon 15
The spinit® menus

spinit® User Manual | Conguraon 17
The spinit® menus
Assay Opons
The spinit® instrument allows the user to dene assay opons for each spinit® test.
On Advanced Sengs menu, the user shall press the
buon Assay Opons and choose the desired test.
The default factory units for spinit® CRP test are µg/ml.
The user may dene other units for the assay. Aer se-
lecng the units, click Apply. All test results will be calcu-
lated and shown in the selected units. This seng may be
changed anyme. The results stored in the instrument
will be shown in the selected units.
Concerning the spinit® HbA1c test, the default assay op-
on for the determinaon of glycated hemoglobin A1c
(HbA1c) is both units mmol/mol (IFCC units) and % (DCCT
units). The user may choose to add the esmated average
glucose (eAG) determinaon. eAG units may be mmol/L
or mg/dL. This feature shall be set before performing a
spinit® HbA1c test.

Date/Time
The correct date and me should be set as all paent and control results will be displayed with the
respecve date and me of the assay. On the Advanced Sengs menu, by selecng Date/Time is
possible to adjust date/me and save the new denions.
Change Password
The Advanced Sengs menu is protected by a password owned by the System Admin. The default
factory password is 0000. To change the password, on the Advanced Sengs menu press the
buon Change Password, type a new password and click Next.
Congure printer
The user shall connect the printer while the spinit® instrument is turned o. To congure the
printer, go to the Advanced Sengs menu and select Congure printer. A list of all connected
printers will be shown. Select the desired printer and press Set to conclude printer conguraon.
The printer is ready to use. Before the conguraon, the user must switch on the printer to the
instrument while the instrument is sll powered o.
The spinit® menus
18 spinit® User Manual | Conguraon