Abaxis i-STAT Alinity v User Manual Download Page 5

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i-STAT

Alinity v

— User Manual

650-7100 Rev. A

Regulatory Compliance

(Continued)

Burkina Faso

ARCEP Type Approval 2017-000031

Autorite de Regulation des Communications

Electroniques et des Postes Authority of Regulations

of Communications Electronic and Posts

Canada

Industry Canada RSS 210: Licence-Exempt Radio

Apparatus: Category I Equipment

Certification

No.:

7228C-SDABGN

Cayman Islands

Utility Regulation and Competition Office

GRANT OF EQUIPMENT AUTHORISATION IN THE

CAYMAN

ISLANDS

Certificate.

No:

KY1504003

Colombia

Communications Regulatory Commission (CRC) -

Exempt
Curacao

Director Bureau Telecommunicatie en Post

Type Approval Nos. 2017/054/TA and 2017/054a/TA

Dominica

National Telecommunications Regulatory Commission

(NTRC)

Type Approval No. DMA-0217-0539p

Dominican Republic

Istituto Dominicano de las Telecomunicaciones

(INDOTEL)

Type

Approval

17003658

Egypt

NTRA National Telecom Regulatory Authority

European Union (EU)

DIRECTIVE 2014/53/EU OF THE EUROPEAN

PARLIAMENT AND OF THE COUNCIL of 16 April 2014

EN 300 328: Wideband transmission systems; Data

transmission equipment operating in the 2,4 GHz ISM

band and using wide band modulation techniques;

Harmonised Standard covering the essential

requirements of article 3.2 of Directive 2014/53/EU.

EN 301 893: 5 GHz RLAN; Harmonised Standard

covering the essential requirements of article 3.2 of

Directive

2014/53/EU.

Grenada

National Telecommunications Regulatory Commission

EQUIPMENT TYPE APPROVAL NTRC REGISTRATION

NUMBER: CL 1090 | 17 – TA

Honduras

CONATEL Comision Nacional De Telecomunicaciones

20161024HM32
Hong Kong

CERTIFICATE OF TYPE APPROVAL per HKCA 1039

Issue 6, June 2015

India

Ministry of Communcations & IT

Equipment Type Approval, ETA Certification No: ETA

–

3319/16-RLO(WR)

Japan

Article 2 Section 1 No. 19, 19-3, 19-3-2

Radio Type Approval, Construction Designed

Certificate

No:

208-160178

Summary of Contents for i-STAT Alinity v

Page 1: ...U S E R M A N U A L GLOBAL DIAGNOSTICS FOR VETERINARY USE ONLY v ...

Page 2: ...Analyzer is intended for veterinary use only Additional information regarding the use of the i STAT Alinity v Analyzer and i STAT test cartridges can be found at www abaxis com An Abaxis Technical Support personnel can also be reached 24 hours a day 7 days a week at 1 800 822 2947 toll free phone for USA and Canada International Technical Support is available from 8 30 am to 5 00 pm CET at 49 6155...

Page 3: ...aining alkaline or other non acid electrolytes Safety requirements for portable sealed secondary cells and for batteries made from them for use in portable applications International UN Manual of Tests and Criteria Recommendations on the Transport of Dangerous Goods Section 38 3 Lithium Batteries EMC Regulations USA FCC 47 CFR Part 15 Subpart B Class A Unintentional Radiators Canada CAN ICES 001 C...

Page 4: ...2015 made under section 407 of the Telecommunications Act 1997 Bahamas Utilities Regulation Competition Authority URCA Type Approval UCRA_TA 2017_023 FCC ID 2AAEX SDABGN Bahrain Telecommunications Regulatory Authority SPECT 0617 COM 150 Barbados Complies with GOVERNMENT OF BARBADOS TELECOMMUNICATIONS UNIT Division of Energy Telecommunications MED Approval Number 1905 Belize Complies with Telecommu...

Page 5: ...iones INDOTEL Type Approval 17003658 Egypt NTRA National Telecom Regulatory Authority European Union EU DIRECTIVE 2014 53 EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 April 2014 EN 300 328 Wideband transmission systems Data transmission equipment operating in the 2 4 GHz ISM band and using wide band modulation techniques Harmonised Standard covering the essential requirements of article ...

Page 6: ... Nacional das Comunicacoes de Mocambique INCM Telecommunication and Radiocommunications Agreements approved by Decree 37 2009 of 13 August No 1 R IMS 2017 New Zealand Conforms to Ministry of Business Innovation Employment Radio Spectrum Management as required by notices under Section 134 1 g of the New Zealand Radiocommunications Act 1989 Oman Telecommunication Regulatory Authority Approval Number...

Page 7: ...2002 Certification of Type Approval Certificate No LCT AP17 118D St Maarten Bureau of Telecommunication and Post Type Approval Certificate no 2017 018 b TA St Vincent the National Telecommunications Regulatory Commission Grenadines Telecommunications Terminal Equipment and Public Networks Regulations No 13 of 2002 Certificate of Type Approval Certificate No SVG_050520171055 Turks and Caicos Turks ...

Page 8: ...ncy Electromagnetic Fields Canada Industry Canada RSS 102 Radio Standards Specification 102 Radio Frequency RF Exposure Compliance of Radiocommunication Apparatus All Frequency Bands European Union EU EN 50360 Product standard to demonstrate the compliance of mobile phones with the basic restrictions related to human exposure to electromagnetic fields Frequency range of 300 MHz 3 GHz EN 62209 1 Me...

Page 9: ...r own expense Changes or modifications not expressly approved by the manufacturer could void your authority to operate the equipment Canadian Department of Communications Industry Canada Notice Canada only This Class A digital apparatus complies with Canadian ICES 001 FCC Part 15 Industry Canada Information This device complies with Part 15 Subpart C and Subpart E of FCC Rules and Industry Canada ...

Page 10: ...nly channels 1 11 can be operated Selection of other channels is not possible If this device is to be operated in the 5 15 5 25 GHz frequency range it is restricted to indoor environments only Antenna Laird Technologies Mini NanoBlade Antenna gain information Embedded Antenna 2 5dBi 2 4 GHz 4 8dBi 5 GHz Frequency Tolerance 20ppm Wireless Labeling The i STAT Alinity v Analyzer includes the FCC mark...

Page 11: ...r Humidity limitation On Off Direct current power supply Alternating current power supply Table 2 Regulatory and Safety Related Miscellaneous Symbol Definition Use Biological risks Temperature limitations The upper and lower limits for storage are adjacent to upper and lower arms Serial number The serial number will appear adjacent to this symbol Catalog number list number or reference USB Do not ...

Page 12: ...azard ATTENTION See instructions for use CAUTION Indicates a hazardous situation which if not avoided could result in minor or moderate injury or damage to the equipment WARNING Indicates a hazardous situation which if not avoided could result in serious injury or death Separate waste collection for this electrical electronic item indicated Equipment manufactured put on the market after 13 August ...

Page 13: ...urce to the analyzer i STAT Alinity Base Station Used to recharge the battery installed in the i STAT Alinity v Analyzer i STAT Alinity Test Cartridges Contains sensors and reagents for all patient and quality testing i STAT Alinity Portable Printer Used to print records stored in the analyzer i STAT Alinity Electronic Simulator Provides an independent check on the analyzer s thermal controls and ...

Page 14: ...rm clinical testing and administrative tasks related to the quantification of various analytes in a whole blood sample The i STAT Alinity v Analyzer includes the following subsystems analytical measurement module interfaces with the i STAT single use test cartridges and controls execution of the measurement test cycle user module a central computing unit with embedded firmware that controls the us...

Page 15: ...s service and the printed results must not be used If another printer is available retry Clinical settings that demand fail safe testing should have a backup analyzer or test source available Follow site specific guidelines for integration of wireless devices into the facility facility environment Check with authorities for local state and or national requirements for disposal DO NOT Attempt to re...

Page 16: ...nriched atmospheres In the event of a battery leaking do not allow any leakage to come into contact with the skin or eyes If contact has been made wash the affected area with copious amounts of water and seek medical advice The analyzer can become contaminated with blood during use Operators should use standard precautions whenever handling the analyzer cartridge and peripherals to protect themsel...

Page 17: ...3 048 meters 10 000 feet System Components Continued i STAT Alinity v User Manual 650 7100 Rev A 15 This Lithium Ion rechargeable battery is designed for use only with the i STAT Alinity v Analyzer Keep a spare charged battery on hand at all times and store charged battery in the original packaging Operational range Temperature and humidity Testing Environment Altitude Storage range Temperature an...

Page 18: ...le surface Avoid nearby vibration equipment such as centrifuges Avoid direct sunlight Up to 3 048 meters 10 000 feet 10 to 60ºC 14 to 140ºF 10 to 90 non condensing with maximum saturation temperature of 34ºC 93 2F Input 110 240 VAC 50 60 Hz 1 5A Output 5 3V DC 6 6A The Base Station is intended for use only with the i STAT Alinity v Analyzer Use only the power supply shipped in the box with the Bas...

Page 19: ...lyzer to any printer other than an i STAT Alinity printer may be unsuccessful Use only a rechargeable battery pack purchased from Abaxis designed for the i STAT Alinity printer System Components Continued i STAT Alinity Electronic Simulator Operational range Temperature and humidity Storage range Temperature and humidity Altitude 16 to 30ºC 61 to 86ºF 10 to 90 non condensing with maximum saturatio...

Page 20: ...ess and hold button for 2 seconds to power up or power down the analyzer Barcode Capture Button Press and hold button in order to capture a barcode Audible cues indicate successful and unsuccessful barcode captures Cartridge Port Cartridge or Electronic Simulator is inserted into the cartridge port to initiate testing Camera and IR Port Camera is activated by pressing and holding the barcode captu...

Page 21: ...uence the LED light will turn green and i STAT Alinity will appear briefly on the display screen During the power up sequence the i STAT Alinity v Analyzer performs a series of self checks If all the self checks pass the analyzer will display the Home Screen See page 20 If one or more self checks fail the analyzer will display the Alerts Screen See page 21 ...

Page 22: ...n which contains A See Page 23 for screen icons and their meanings Screen Components and Their Meanings Continued B C D A Header Date Time Wireless Wired Status Battery Status Body Buttons provide access to pathways Perform Patient Test More Options Footer left Home Button Footer right Software Pending Installation Button Displays only when software has been downloaded but not installed on the ana...

Page 23: ... User Manual 650 7100 Rev A 21 If one or more start up self checks fail the analyzer will display the Alerts Screen as shown in the example above Anatomy of Alerts Screen Warning or Lockout Icon Indicates status of alert Analyzer is locked until requirement is satisfied or Analyzer warning Alerts Indicator Displays number of alerts Alert Title Corrective Action Button Displays corrective action pa...

Page 24: ...omy of a Pathway Screen Header Identification Tab Displays details such as patient ID cartridge name liquid quality control name Header Action Tabs Provide options for screen navigation Page Title Message area Body Buttons in this area provide access to pathways OR Location of details such as data entry field help graphics selection options Side Action Tabs Provide access to area or action indicat...

Page 25: ...ediately Bolt Indicates Actively Charging Bolt Indicates Actively Charging Bolt Indicates Actively Charging Mandatory Connected Disabled Pass Fail Warning Analyzer Locked Information Low Battery Screen Components and Their Meanings Continued Software Pending Installation i STAT Alinity v User Manual 650 7100 Rev A 23 A B C A Wireless Status Battery Status Network Status Battery Charging Instructio...

Page 26: ...ted storage temperature indicator 2 8 C 35 46 F Indicates shelf life when stored at room temperature Refrigerated storage expiration date Cartridge LOT number Location to record room temperature expiration date 8 C 46 F 2 C 35 F 09P31 25 OR A B C D E A B C D E 30 C 86 F 18 C 64 F Exp REF XXXXX XX ...

Page 27: ...ing ved stuetemperatur Förvaring i rumstemperatur Säilytys huoneenlämmössä Oppbevaring ved romtemperatur Φυλάσσεται σε θερμοκρασία δωματίου Oda Sıcaklığında Saklama monate mois mesi meses meses maanden måneder månader kuukautta måneder μήνες ay 2 months 8ºC 46ºF 2ºC 35ºF 30ºC 86ºF 18ºC 64ºF Exp XXXX xX XXX2 XX2 XXX3 XXX2 XX xX2 01 10054749000132 17 170414 10 M16228 92 00000000000078 M16228 2025 10...

Page 28: ... 1 hour before use Once cartridge is at room temperature the expiration date changes Cartridge pouch displaying the tage jours giomi dîas dias dagen dage dagar päivää dager gün days d indicates the cartridge expires in 14 days Example cartridge reaches room temperature on 2025 10 13 new expiration date is 2025 10 27 Cartridge pouch displaying the indicates the cartridge expires in 2 months Example...

Page 29: ...Chamber Sample Well Always handle cartridges by the sides or the bottom Do not touch the sensor area at the top of the cartridge or the calibrant pack area in the middle of the cartridge Improper handling may damage the cartridge and result in a Cartridge Quality Check Failure instead of results Dispose of used cartridges as biohazardous waste Follow facility policy for disposal Top Bottom Top Bot...

Page 30: ... Collect in a syringe containing balanced heparin Arterial whole blood Collect in an arterial blood gas syringe containing balanced heparin Capillary whole blood Collect in a balanced heparin capillary tube Recommend 150 μl capillary tube Not all cartridges are available in all regions Contact Abaxis Technical Support for availability in specific markets Crea CG8 CG4 Chem8 E3 EC8 G 6 Venous and ar...

Page 31: ... user This guide does not include instruction on blood collection Follow facility specific guidelines Standard precautions should be used when handling materials that may contain transmissible infectious agents More Options Perform Patient Test Home Home 16FEB2025 09 45 How to Perform Patient Testing i STAT Alinity v User Manual 650 7100 Rev A 29 From the Home screen touch Perform Patient Test Thi...

Page 32: ...er will advance to the next step in the pathway To enter information manually touch icon A numeric keyboard displays automatically For alpha touch the Abc button After entering the information touch Enter and the analyzer will advance to the next step in the pathway 1 2 3 4 5 6 7 8 9 0 Abc x Enter OPERATOR ID and then touch Enter Close Enter Scan or Enter OPERATOR ID Home Patient Test Next Patient...

Page 33: ... SAMPLE TYPE then touch Next When the text is preceded by a the information is mandatory Important Warning Interpreting the patient result is dependent on selecting the correct sample type Patient Testing Pathway Cont Next View Entered Info Previous Scan or Enter PATIENT ID Home Patient Test Select SAMPLE TYPE Arterial Capillary Venous Unspeciﬁed Home View Entered Info Next Previous Patient Test P...

Page 34: ...ge View Entered Info Previous Close and Insert Cartridge Prepare material per manufacturer s instruction Immediately fold over snap closure until a soft click is heard and the closure is secured Insert ﬁlled cartridge into instrument Page 3 of 3 Home i STAT CHEM8 Pt 123456 Scan CARTRIDGE POUCH Barcode Home View Entered Info Next Previous Patient Test Pt 123456 If an Invalid Cartridge Type window i...

Page 35: ...w Entered Info i STAT Alinity v User Manual 650 7100 Rev A 33 Once the cartridge is inserted Contacting Cartridge will display followed by the countdown bar This allows the user to estimate the time to results Alerts such as Cartridge Locked and Analyzer Must Remain Level are also displayed Patient Testing Pathway Cont How to Perform Patient Testing Continued ...

Page 36: ...appears when there is more than one page of results All action tabs are inactive until the second page of results has been viewed Occasionally numeric results will be replaced with the following symbols When displayed a new test must be performed Analyzer cannot calculate the result Analyzer is unable to determine a result A sample may also yield results that are preceded by a greater than or less...

Page 37: ...g method B A B Options Menu Page i STAT CHEM8 Pt 123456 Home View Entered Info Options Menu Print 16FEB2025 09 45 Na mmol L 145 139 150 Ref BUN mg dL 17 10 26 Ref Glu mg dL 72 60 115 Ref K mmol L 4 5 3 4 4 9 Ref Crea mg dL 1 1 0 5 1 3 Ref iCa mmol L 1 21 1 12 1 40 Ref AnGap mmol L 19 8 25 Ref Cl mmol L 110 106 127 Ref TCO2 mmol L 20 17 25 Ref How to Perform Patient Testing Continued ...

Page 38: ... Manual 650 7100 Rev A 36 BUN mg dL 21 Glu mg dL 72 60 115 Ref Crea mg dL 2 1 iCa mmol L 1 21 1 12 1 40 Ref L 8 14 0 7 1 5 Options Menu Page AnGap mmol L 19 8 25 Ref View Entered Info Options Menu Print Transmit 8 16FEB2025 09 45 Wireless Wired B C D C D How to Perform Patient Testing Continued Options Menu Page View Entered Info Options Menu Print Transmit 16FEB2025 09 45 Glu mg dL 72 60 115 Ref ...

Page 39: ...lt is high or low Yellow arrow in page button indicates one or more results on second page are outside the reference range Red arrow in page button indicates one or more results on second page are not within the system range White arrow in page button indicates all results on second page are within the reference range How to Perform Patient Testing Continued Page Options Menu Na mmol L 139 150 Ref...

Page 40: ...ions Menu Page View Second Page View Entered Info Options Menu Print 16FEB2025 09 45 When running a sample selected under Other reference ranges will not be displayed Result will appear with no highlighted indicators How to Perform Patient Testing Continued Resetting the analyzer to Factory Default or deleting the current profile will display results without reference ranges or highlighted indicat...

Page 41: ...em Range These normal intervals are provided only as a guideline The most definitive reference intervals are those established for your patient population Test results should be interpreted in conjunction with the patient s clinical signs How to Perform Patient Testing Continued ...

Page 42: ...is being cleaned Remove a new disposable wipe from the container and squeeze to remove excess solution Gently wipe all outside surfaces noting the Sensitive Areas until all visible soil is removed Inspect all surfaces If necessary repeat until all visible soil is removed Wipe with dry gauze until dry i STAT Alinity v Analyzer Base Station Printer Rechargeable Battery and Elec tronic Simulator Avoi...

Page 43: ... a wipe from the container and squeeze out any excess fluid before you begin to wipe the surface Wipe all surfaces three times This includes front back sides top and bottom WIPE WIPE 3X 3X WIPE WIPE 3X 3X W I P E 3 X 3 X Wipe with gauze until dry Allow all surfaces to remain wet for 3 minutes Sensitive Areas Avoid forcing liquid into these areas i STAT Alinity v Analyzer Cartridge Port 10 Pin Conn...

Page 44: ...om the container and squeeze out any excess fluid before you begin to wipe the surface Wipe with gauze until dry Allow all surfaces to remain wet for 3 minutes 1 3 4 2 Wipe the front as shown flip products on back side and repeat Wipe 3X Left Right Wipe 3X Up Down Base Station 10 Pin Connector Gold contact pins 2 USB Port Electronic Simulator Area between protective cap retaining ring and white se...

Page 45: ...y for the removal of visible organic soil Disinfecting is intended to kill microorganisms Due to the portability of the i STAT Alinity v Analyzer it may be subject to splatter or splash of bodily fluids when used in proximity of patients Failure to wear clean gloves will result in contamination of the analyzer CaviWipes EPA 46781 13 Super Sani Cloth EPA 9480 4 APPROVED DISINFECTANT PRODUCTS ...

Page 46: ...te and installation using USB memory device via Base Station is a two step process It requires downloading the software from the Abaxis website onto a USB memory device and then downloading and installing the software onto the analyzer via the Base Station Software update and installation via Abbott Managed Cloud with a wired or wireless network connection requires the operator to check for softwa...

Page 47: ...Next touch the Perform Electronic Simulator Test button Return Cal Ver View Disabled Cartridges Quality Control Perform Proﬁciency Test Perform Electronic Simulator Test Update eVAS Quality Options Home More Options Quality Options 16FEB2025 09 45 By carefully observing the text and graphic instruction the user will be able to successfully complete an Electronic Simulator test In the event that th...

Page 48: ...fer to the package inserts for handling instructions When the analyzer is customized by the System Administrator the Quality Control Pathway may present screens not displayed in this guide It is essential to follow the prompts on the analyzer screen On screen graphics and text are provided to assist the user Return Cal Ver View Disabled Cartridges Quality Control Perform Proﬁciency Test Perform El...

Page 49: ...25 09 45 Scan or Enter OPERATOR ID Home Quality Control Test Next How to Perform Quality Testing Continued i STAT Alinity v User Manual 650 7100 Rev A 47 The next step in the pathway is Scan or Enter OPERATOR ID The next step in the pathway is Perform Unscheduled QC How to Perform Quality Testing Liquid Quality Control Cont ...

Page 50: ...ins the control level being tested Barcode on the ampule must be scanned before the ampule is opened Scan FLUID LOT barcode on control vial Manual entry is not an option Scanning is required When the text is preceded by a the information is mandatory How to Perform Quality Testing Liquid Quality Control Cont How to Perform Quality Testing Continued Scan CARTRIDGE POUCH barcode Scanning is required...

Page 51: ...Home 16FEB2025 09 45 i STAT Alinity v User Manual 650 7100 Rev A 49 Results Use Value Assignment Sheet to determine if results are in range Follow facility policy if results are outside the assigned range For experienced users the help screens may be bypassed by inserting a filled cartridge Once the cartridge is inserted Contacting Cartridge will display followed by the countdown bar This allows t...

Page 52: ...ons Menu Cause Excess blood added to cartridge When ﬁlling this cartridge the blood advanced past the level indicated by the ﬁll to arrow Help i STAT CHEM8 Pt 654321 Options Menu Home Cartridge Quality Check Failure Cartridge Was Overﬁlled Code 37 01 13OCT2025 08 33 Print View Cause View Entered Info Options Menu Cartridge Quality Check Failure Resolution Cartridge Was Overﬁlled When ﬁlling a cart...

Page 53: ...st column find the QCF code as found in Review Results 2 Identify the pathway in which the failure occurred and in the Cause column find the cause number then see Quality Check Failure Causes for the description in the Resolution column find the resolution letter then see Quality Check Failure Resolutions for corrective action Table of Quality Check Failure Codes An empty cell indicates that there...

Page 54: ...14 26 01 6 2 1 26 01 6 2 2 26 01 6 2 3 26 01 6 2 4 27 01 4 1 1 28 01 4 1 2 29 01 4 1 3 30 01 6 1 4 30 01 6 1 7 30 02 4 1 4 31 01 4 1 5 31 02 6 1 16 32 01 4 1 6 33 01 4 1 8 34 01 4 1 11 35 01 4 1 7 36 01 4 1 10 37 01 4 1 9 4 4 4 4 4 4 5 5 6 6 6 7 7 7 8 8 6 G G G G G G G G G G G G G G G G G H H H G G G G G H H H F F F F F F F F F F F F F F F F F F F F F F F F F F F F 4 4 4 4 4 4 5 5 12 12 12 7 7 7 1...

Page 55: ...49 01 3 3 1 50 01 2 1 1 50 01 2 1 2 50 01 2 1 3 50 01 2 1 6 51 01 2 1 4 51 01 2 1 9 52 01 2 1 5 53 01 2 9 3 57 01 2 4 1 59 01 4 5 1 60 01 1 6 2 63 01 2 9 1 63 01 2 9 2 66 01 2 2 1 66 01 2 2 2 66 01 2 2 3 68 01 2 4 2 69 01 4 6 1 9 9 5 5 G G G G G G G N B G G G G G G G G T B B B D D B B B B G F F F F F F F N B F F F F F F F F T B B B D D B B B B F 9 9 5 5 38 01 39 01 40 01 41 01 42 01 44 01 46 01 47...

Page 56: ... 10 72 01 2 1 11 79 01 2 3 1 80 01 3 4 1 80 01 3 4 2 80 01 3 4 3 80 01 3 4 4 82 01 1 2 1 82 01 2 10 3 87 01 3 2 1 88 01 1 6 33 89 01 2 7 32 G G G G G K K K K K K K B D D G G G G G B B G B B F F F F F K K K K K K K B D D F F F F F B B F B B 69 01 69 01 69 01 69 01 69 01 69 02 69 02 69 02 69 02 69 02 69 02 69 02 69 03 69 03 69 04 70 01 72 01 72 01 79 01 80 01 80 01 80 01 80 01 82 01 82 01 87 01 88 0...

Page 57: ...1 2 10 2 93 01 2 5 32 93 01 2 5 33 94 01 1 6 32 95 01 1 7 1 99 01 2 13 1 99 02 2 2 4 D D D D D D D D D D D B B B B B B B B B B B R G D D D D D D D D D D D B B B B B B B B B B B R F 90 01 90 01 90 01 90 01 90 01 90 01 90 01 90 01 90 01 90 01 90 01 90 02 90 02 90 02 90 02 90 02 91 01 92 01 92 01 93 01 93 01 94 01 95 01 99 01 99 02 D D D D D D D D D D D C C C C C D D D D D D C C Troubleshooting Conti...

Page 58: ...filling the cartridge the blood advanced past the level indicated by the fill to arrow 7 Sample was rejected during the testing cycle Probable cause Snap closure not secure 8 An insufficient amount of blood was used to fill the cartridge When filling the cartridge the blood did not reach the level indicated by the fill to arrow 9 Sample was rejected during the testing cycle Probable causes Bubbles...

Page 59: ... same quality check failure displays contact the system administrator for further instruction G Repeat testing with a freshly filled cartridge Carefully observe the help provided throughout the testing pathway If the same quality check failure displays contact the system administrator for further instruction H When filling a cartridge use care to advance blood to the level indicated by the fill to...

Page 60: ...nserted when the click is heard If the same quality check failure displays contact the system administrator for further instruction M Reserved for future use N The cartridge was not fully inserted Repeat testing with a freshly filled cartridge Ensure the cartridge is fully inserted The cartridge is fully inserted when the click is heard If the same quality check failure displays contact the system...

Page 61: ... network Define the network to which the analyzers are to connect SSID authentication protocol Supply network access credentials for the network that is username password security certificates keys Identify connection details proxy server IP address and DNS server address modes etc Have available i STAT Alinity base station FAT32 formatted USB 2 0 memory stick Some preformatted USB flash drives ma...

Page 62: ...guration will be used for Select one of these radio buttons Multiple analyzers Use this NC file for multiple analyzers This is the default This option may not be available if your facility requires individual Enterprise Security Certificates for each analyzer Instrument This NC file will apply only to one analyzer If this option is selected the analyzer s serial number is required SNSerial number ...

Page 63: ...NC file you wish to copy Attempting to rename an NC file causes unpredictable results Instead use the function Copy info from an existing file and save the file to a new name Edit an existing file Click this option to edit an existing NC file Navigate to the folder containing the NC file you wish to edit The next section of the NCi screen is for configuring a connection to a proxy server Connectiv...

Page 64: ...s check box displays the following prompts Proxy Server Type Select either HTTP HTTP proxy intercepts web access Socks Provides proxy service for UDP data and DNS look up operations in addition to web access Proxy Server Address Required IP address of the proxy server Port Port used by the proxy server The default is 8080 Proxy Server User Name Network name of the proxy server Proxy Server Passwor...

Page 65: ...ct to my facility s WIRELESS network Select this check box to configure wireless network connectivity Network Name SSID Name of the wireless local area network WLAN Connect to a specific Access Point BSSID Select this check box to connect to a single wireless access point WAP by specifying its unique BSSID Specify the BSSID address in this format DD DD DD DD DD DD DD where D is a hexadecimal digit...

Page 66: ...s of analyzer in decimal dot notation Example 172 16 254 1 Subnet Mask IPv4 mask that defines the Subnet in decimal dot notation Example 255 255 255 0 Default Gateway IP address for routing device that passes traffic between different subnets and networks in decimal dot notation Example 172 16 254 1 DNS Server Address Mode Select either Automatic DHCP Obtain IP addresses and networking parameters ...

Page 67: ...rprise the options shown here are enabled EAP Method Select one of the following TLS TTLS MSCHAPv2 PEAPv0 EAP MSCHAPv2 Validate the Server Certificate Select this check box to configure the analyzer to validate the server certificate Unselect the check box if this is not required Server Name Network name of the authentication server CA Certificate File Name of the file that contains the Certificat...

Page 68: ...lect one of these values Automatic DHCP Obtain IP addresses and networking parameters automatically from a DHCP server Use the following IP Address Select this button to use a static IP address If you specify a static IP address you must also specify DNS addresses IP Address IPv4 address of analyzer in decimal dot notation Subnet Mask IPv4 mask that defines the Subnet in decimal dot notation Defau...

Page 69: ...btain IP addresses and networking parameters automatically from a DHCP server Use the following IP Address Specify values for Preferred DNS IPv4 address of the server in decimal dot notation Alternate DNS IPv4 address of the server in decimal dot notation You must specify DNS addresses if you specify a static IP address Connectivity Continued 4G 4H 4I ...

Page 70: ...ll be saved to the Downloads directory or at the bottom of the screen a banner may display with the prompts shown below Note Best practice is to select Save which will save the file to the Downloads directory Opening NC ancc files in a text editor is not recommended Do you want to open or save filename ancc Open Open the ancc file in a text editor Save Save the file to the Downloads directory Save...

Page 71: ...o upload the non serialized ancc file Use the following steps to copy the ancc file onto the USB memory stick 1 Plug the USB memory stick into the USB slot of the computer A message displays indicating that the operating system recognizes the drive and it is ready to use 2 From the Start menu click Computer Downloads 3 In the displayed list find the filename ancc file and right click on it 4 Click...

Page 72: ...r the ethernet symbol displays indicating an active connection To check a wireless network connection remove the i STAT Alinity v Analyzer from the base station On the analyzer screen in the upper right corner the wireless internet symbol displays This symbol represents a strong signal Some or all of the bars in the signal should be filled in depending upon the signal strength in the location A lo...

Page 73: ... accident alteration modification tampering negligence misuse any analyzer not used in accordance with Abaxis operating procedures and instructions any analyzer which has been repaired or serviced by anyone not authorized by Abaxis to render such service or any analyzer whose model or serial number has been altered tampered with defaced or removed Abaxis makes no warranty other than the express li...

Page 74: ...RS SHALL NOT BE LIABLE FOR ANY INDIRECT SPECIAL INCIDENTAL PUNITIVE EXEMPLARY OR CONSEQUENTIAL DAMAGES OR FOR ANY DAMAGES RELATING TO LOSS OF BUSINESS TELECOMMUNICATION FAILURES THE LOSS CORRUPTION OR THEFT OF DATA VIRUSES SPYWARE LOSS OF PROFITS OR INVESTMENT USE OF THE SOFTWARE WITH HARDWARE OR OTHER SOFTWARE THAT DOES NOT MEET APOC S SYSTEMS REQUIREMENTS OR THE LIKE WHETHER BASED IN CONTRACT TO...

Page 75: ... and other intellectual property laws APOC and its licensors own the title copyright and other worldwide intellectual property rights in the Software and all copies of the Software This EULA does not grant you any rights to trademarks or service marks of APOC Alinity i STAT i STAT Alinity v and related brand marks are trademarks of the Abbott Group of Companies in various jurisdictions 4 TERM AND ...

Page 76: ...CORRUPTION OR THEFT OF DATA VIRUSES SPYWARE LOSS OF PROFITS OR INVESTMENT USE OF THE SOFTWARE WITH HARDWARE OR OTHER SOFTWARE THAT DOES NOT MEET APOC S SYSTEMS REQUIREMENTS OR THE LIKE WHETHER BASED IN CONTRACT TORT INCLUDING NEGLIGENCE PRODUCT LIABILITY OR OTHERWISE EVEN IF APOC AND OR ITS SUPPLIERS OR EITHER OF THEIR REPRESENTATIVES HAVE BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES AND EVEN I...

Page 77: ...sions of this EULA are determined to be invalid or unenforceable under applicable law such provision shall be ineffective to the limited extent of such invalidity or unenforceability without rendering invalid or unenforceable the remaining provisions of this EULA If a court of competent jurisdiction declares any such provisions to be invalid or unenforceable the parties hereto shall request that s...

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