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Related Manuals for BIOSURFIT spinit S40
Summary of Contents for BIOSURFIT spinit S40
- Page 1 User Manual spinit® S40 spinit® E40 English...
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Page 2: Table Of Contents
TABLE OF CONTENTS Safety Information, Precautions and Limitations spinit® system Introduction About this User Manual Unpacking the spinit® instrument spinit® system description The spinit® system Description of the spinit® instrument Description of the spinit® discs How the spinit® instrument works Internal process control External process control Getting Started... - Page 3 TABLE OF CONTENTS Assay Options Date / Time Change Password Configure Printer Network Settings HL7 Configuration Erase Data Software Update Device maintenance Quality Controls testing Handling and testing controls Why control testing Choosing control material Frequency of control testing Testing Procedure Operating Precautions Preparing for sample analysis Prepare for testing >...
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Page 4: Safety Information, Precautions And Limitations
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 of all spinit®... -
Page 5: Spinit® System
spinit® System Intended Use spinit® is for in vitro diagnostic use only, consisting of an instrument and discs targeting specific treatment monitoring conditions. The system is used by healthcare professionals in a variety of healthcare settings, and exclusively with spinit® discs and recommended controls. Conformity to the IVD directive The spinit®... -
Page 6: Introduction
INTRODUCTION About this User Manual This User Manual will guide you through installation, operation 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 troubleshooting. For analyzing patient samples or controls, please also read the test specific information given in the Instructions for Use found in the spinit®... -
Page 7: Spinit® System Description
spinit® SYSTEM DESCRIPTION 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. Description of the spinit® instrument The spinit® instrument is a stand-alone, small benchtop medical device with a user friendly interactive touchscreen and an automatic tray designed to accommodate any spinit®... -
Page 8: Description Of The Spinit® Discs
Description of the spinit® discs The spinit® disc is unique for each analyte to be measured and integrates test specific reagent compositions and volumes. The spinit® discs have a unique color for each test and are separately packed in foil pouches to protect the reagents and plastic devices from light, dirt and humidity. A single disc contains all necessary reagents for one test and is ready to use. -
Page 9: How The Spinit® Instrument Works
How the spinit® instrument works The spinit® instrument is a stand-alone, small benchtop in vitro medical device intended to deliver a diagnostic platform designed to work with the spinit® discs. The spinit® platform is based on a proprietary technology designed to offer rapid results from a single drop of blood, providing fast, safe and effective clinical monitoring and improved patient care. -
Page 10: Internal Process Control
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- ating according to established specifications. The self-test validates: • Hardware and software integrity The fail-safe mechanisms The spinit® instrument is designed to be maintenance free by the user and it performs multiple functional and operational tests to guarantee proper performance. -
Page 11: Getting Started
Installing your instrument Place the spinit® instrument on a dry, clean, vibration-free and horizontal surface. Only use parts approved by biosurfit. The use of non-approved parts may result in malfunction of the instrument and may render the warranty null and void. -
Page 12: How To Turn On The Instrument
How to turn ON the instrument Turn on the instrument on the back by pressing the ON button (Figure 3) . An automatic start-up procedure will be initiated. Please wait until stabilization period is complete The instrument is ready for use when the stabilizing is complete and the Start button becomes available. -
Page 13: Sound Signals
Figure 4. Text message Touch buttons Tray with a ready to use disc Sound signals A short beep indicates completion of an analysis. spinit® User Manual Getting started... -
Page 14: Configuration
CONFIGURATION The spinit® menus The major instrument configuration options are available through the Settings or Advanced settings menu. Home Menu On the Home menu the user may directly start a test selecting Start, a quality control check by click- ing QC Mode, watch the Training videos or move into other options through the Settings icon spinit®... -
Page 15: Language
The spinit® menus Language English is the default language, other languages are available and may be selected in the first panel of spinit® settings. Select the menu Languages, click on the preferred language and it will be set for all menus and instructions. HL7 Status To verify the status of HL7, the user must click on HL7 Status button. -
Page 16: Quality Control
The spinit® menus 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 multiple integrated quality control verification steps to ensure reliability of the tests. If the user chooses to perform additional Quality Control checks, bio- surfit recommends testing spinit®... -
Page 17: View, Print And Export Patient Control Results
The spinit® menus View, print and export patient and control results To view or print a specific analysis, select the analysis and press Details. The results can be trans- ferred to a USB pen drive. For privacy matters, exported data encrypts patient and operator infor- mation. -
Page 18: Id Settings
The spinit® menus ID Settings On the ID Settings menu the system Admin can setup: Operator ID, Patient ID, Measurement ID and Operator mode. All these inputs are optional, and can be enabled or disabled. Operator ID If enabled, the operator’s identification (ID) is required before processing a spinit® test. The operator ID will be displayed with the result and stored along with the other specific data for this run (see Patient and control results records, page 13). -
Page 19: Assay Options
The spinit® menus Assay Options The spinit® instrument allows the user to define assay options for each spinit® test. 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. -
Page 20: Date/Time
The spinit® menus 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 Advanced Settings menu is protected by a password owned by the System Admin. -
Page 21: Network Settings
The spinit® menus Network Settings By selecting the menu Network Settings, the system owner can view and configure the IP Address. 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 the Advanced Setting menu. In order to enable this feature as well as the Order Material Request (ORM) feature, please contact your local suppli- Erase Data By selecting the menu Erase Data, the System Admin must confirm his intention to erase all data. -
Page 22: Software Update
In the remote maintenance, the user has the possibility to make a remote connection with biosurfit technical support. The remote access has access to Log and System Files, both with infor- mation regarding database, performance issues and assay results. The user must agree with the Terms &... -
Page 23: Quality Controls Testing
Patient samples should not be run if controls are not performing as expected; • Contact your local supplier or biosurfit technical services if controls are out of range. Why quality control testing? Quality control testing should be done to confirm that your spinit® system is working properly and providing reliable results. -
Page 24: Frequency Of Control Testing
Frequency of control testing Testing of quality controls should be performed as per the established laboratory program. biosurfit also recommends testing controls: • When installing the spinit® instrument for the first time; • With each new shipment of spinit® test discs;... -
Page 25: Testing Procedure
TESTING PROCEDURE Operating Precautions When operating the instrument • Use your fingertips to operate the touch screen. Do not use pens or other objects that may scratch or damage the screen. • The tray opens and closes automatically. Do not try to open or close the tray manually. •... -
Page 26: Prepare For Testing > Patient Samples
Prepare for Testing > patient samples • Allow 5 minutes for the test disc to reach operating temperature (if applicable) (15°-30°C) before use. • Press Start and follow on-screen instructions. • Read spinit® disc barcode you want to test. • Open the foil pouch, remove the disc and place it on a flat surface with label facing up. - Page 27 Prepare for Testing > patient samples • Collect the second drop of blood (discard the first drop) with the strip by bringing the tip of the strip against the surface of the pa- tient sample. • Clean the strip and gently wipe each side on a non-absorbent paper paying special attention not to squeeze as this will remove the sam- ple.
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Page 28: Prepare For Testing > Quality Control Material
Prepare for Testing > quality control material • Allow 5 minutes for the test disc to reach operating temperature (if applicable) (15°-30°C) before use. • Select QC mode for control testing and follow on-screen instructions. • Select operator (mandatory for QC mode). •... - Page 29 Prepare for Testing > quality control material • Immediately insert the strip all the way into the disc and fold it back until it breaks. • Leave the loaded part of the strip inside the disc’s sample well. • Test analysis must start immediately after loading the disc. •...
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Page 30: Info Codes And Troubleshooting
INFO CODES AND TROUBLESHOOTING Information Codes that might appear during use of the spinit® instrument refer to specific infor- mation messages. The code numbers, the possible causes and actions to take are listed below. Service Information Before contacting technical support, please gather the following information: •... -
Page 31: Information Codes For Spinit® E40 And S40
Information Codes for spinit® E40 and S40: INFO SOURCE CAUSE SOLUTION CODE • spinit® instrument did not Collect a new sample and repeat the test, using a new disc as per reach the correct rotation Instructions for Use. Instrument • for signal acquisition. - Page 32 INFO SOURCE CAUSE SOLUTION CODE • spinit® instrument was Shutdown the device and unplug it from the power supply for 10 unable to complete assay seconds. • Instrument due to unstable motor rota- Restart the device and repeat the test, using a new disc as per In- (hardware) tion/behavior or measure- structions for Use.
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Page 33: Additional Codes For Spinit® S40
Additional Information Codes for spinit® S40: INFO SOURCE CAUSE SOLUTION CODE Collect a new sample and repeat the test, using a new spinit® BC disc Instrument General failure of the spinit® 1000 as per Instructions for Use. If the problem persists, please contact your BC disc. -
Page 34: Maintenance And Warranty
Cleaning the exterior biosurfit recommends the use of a cloth soaked with ethanol solution 70 % (v/v) in H O 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. -
Page 35: Technical Specifications
TECHNICAL SPECIFICATIONS Instrument specifications The spinit® instrument is a CE certified IVD medical equipment and conforms to the following di- rectives 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 61326-2-6:2013. For in vitro diagnostic use. -
Page 36: Additional Equipment
The spinit® instrument includes a 4-wire touchscreen with VGA resolution. The device has a micro- processor 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 bio- surfit Quality Management System (ISO13485 certified company). -
Page 37: Symbols And Abbreviations
SYMBOLS AND ABBREVIATIONS The following symbols and abbreviations are used in the product labelling and instructions for the spinit® system. Symbol Explanation CE marking of conformity to directive 98/79/EC on in vitro diagnostic medical devices Manufacturer´s name and address In vitro diagnostic medical device Serial Number Consult Instructions for Use Warranty void if seal is broken... - Page 38 Rua 25 de Abril nº66, 2050-317 Azambuja, Portugal ISO13485 certified company vww.biosurfit.com...
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