ZAFENA CONNECTOR MANUAL Husbyvägen 16 590 31 Borensberg SWEDEN
Sidan av 9 version:2011-11-01 Page 2 of 9 TABLE OF CONTENTS 1. Introduction... 3 2. The product... 3 3. Schematic sketch of Zafena Connector... 4 4. Product components... 4 5. Startup guide to Zafena Connector... 5 6. Instructions for use... 6 7. Zafena barcodes... 7 8. Special barcodes... 8 9. ASTM protocol... 9 Zafena Connector is manufactured by: Husbyvägen 16 590 31 Borensberg SWEDEN Tfn: +46-(0)141-405 20 e-mail: info@zafena.se website: www.zafena.se
Sidan av 9 version:2011-11-01 Page 3 of 9 1. Introduction In the health care sector correct analysis answers are critical for making accurate diagnoses, observe pathological processes and to supervise and monitor the effect of different treatments. A major point of failure is identified as manual transmission errors of measurement values and test results. Other sources of error can be incorrect sample storage, test confusion, incorrect sampling, etc. To ensure accurate test results, the health care raises requirements for documentation, traceability and automatic transmission of results by data support to laboratory data and journal systems. Zafena Connector is an IT solution that enables the storage and transmission of point of care analysis to receiving data systems. 2. The product Connector communicates with the host system through a network. The analytical instruments communicate by USB through a data box where the analytical result has to be transferred. Prior to data transfer it is required that necessary supplemental information is fed with bar code readers, such information may be personal ID, laboratory ID, instrument ID, operator ID and test type. Protocols and software: Typically the complete data sets are transferred; analysis results and necessary supplementary data, to LIS by Protocol LIS02-A2 (formerly ASTM E1394-97). Adaptations and modifications are of course possible. All data systems that support the data transfer protocol can be used for transmission. The whole software, including the operator system, is dedicated to the task, the software is completely unable to take own communication initiatives (good data security). The software is provided on an SD card (camera memory). On the same SD card everything is stored, which gives complete documentation and traceability.
Sidan av 9 version:2011-11-01 Page 4 of 9 3. Schematic sketch of Zafena Connector Up to tree (3) different POC-instruments can be connected to Connector. 4. Product components Zafena Connector contains: Data unit ASUS Eee Box, including power cord and network cable, productnumber ZAF 501, equipped with memory card, productnumber ZAF 505 Screen: USB Monitor Lilliput, including screen-cord with two USB-males, productnumber ZAF 503 Barcodereader and USB cable, productnumber ZAF 504 1 USB cable to connect the Simple Simon PT reader.
Sidan av 9 version:2011-11-01 Page 5 of 9 5. Startup guide to Zafena Connector System parts are: Simple Simon PT reader, product number ZAF 101-1 Data unit ASUS Eee Box, including power-cord and network-cable, product number ZAF 501, including memory-card, product number ZAF 505 Screen: USB Monitor Lilliput, including screen-cable with two USB-males, product number ZAF 503 Barcode-reader + USB cable, product number ZAF 504 1 USB cable to connect the Simple Simon PT reader. The data unit ASUS Eee Box is delivered with memory-card, containing software and memory-unit, installed. The screen Lilliput is delivered configured to the software and no further installations are needed. Simple Simon PT reader and barcode-reader are ready to use, just plug-in. Starting the system 1. Connect SSPT, Lilliput and barcode-reader to ASUS Eee Box (optional order) 2. Connect to the network by the network cable 3. Connect the power-cable (ASUS Eee Box) to wall socket. 4. Start the system by pushing the start-button of ASUS Eee Box. The estimated time to start is 2-4 minutes 5. Start SSPT by pushing the button and follow instructions on the screen to start an analysis. The system goes into stand by mode by pushing the on/off button of Lilliput. The system is shut down by pushing the on/off button of ASUS Eee Box. Please be aware; when the button of the box, illuminated blue, is hit, nothing appears to happen, but in about 15 seconds the system is shut down. The power up also takes time. When the on/off button is hit, the button immediately lights up in blue colour, but the first sign of the start is seen 30 seconds later on the screen.
Sidan av 9 version:2011-11-01 Page 6 of 9 6. Instructions for use 1. Start Simple Simon PT (SSPT) by pressing the button. 2. Start the Connector by pressing the screen-button, if the system has been in off-mode, by the screen button (start button lights up). If the Connector had been turned off by the data box (start button of the box does nt light up) start must be made by starting the box. 3. Scan specific SSPT ID found in bar code format on the reader's front. 4. Scan the sample ID 5. Scan sample type; capillary sample/ venous sample/ plasma sample. 6. Perform INR-analysis with SSPT 7. When the analysis is completed, approve the analysis or reject the analysis (technical error) by scanning the accept/reject barcode 8. When technical approval is made, the test-result is automatically transferred to the host system when the Connector is connected to the system 9. Shut down SSPT by pressing the button for approximately 3 seconds. Thereafter, a new analysis can be started. As long as the screen or the data box not have been turned off, a new scan of reader ID is not necessary. Start repeating from point 4, i.e. "scan new test ID, etc.
Sidan av 9 version:2011-11-01 Page 7 of 9 7. Zafena barcodes LMC-7927 LID Capillary sample Venous sample Plasma sample Accept Reject
Sidan av 9 version:2011-11-01 Page 8 of 9 8. Special barcodes Restart system Restarts the programme. Is used when new server settings have been made. Startar om pr Ntp sync Syncronises the clock with a time server Time Shows the time Test EDI Checks transfer to server
Sidan av 9 version:2011-11-01 Page 9 of 9 9. ASTM protocol Header H \^& ZAF101^SS291^I485M^J113X P LIS2-A2 20100217162100 H.2 \^& = vilka tecken som kommer användas som avgränsare under överföringen, vi kommer för enkelhets skull enbart att använda \^& H.5 SS291^I485M^J113X = ZAF101 (produktnummer för ZAFENA Simple Simon PT)^SS291 (Anger vilken simple simon som utfört analysen)^i485m (vilket lotnr den anslutna simple simon använder)^j113x (vilken lot/versionsnummer som används i kommunikationsbox mjukvaran för data överföringen). H.12 P = Produktion vi kommer enbart att ange P i detta fält. H.13 LIS2-A2 = Vilken standard som används H.14 20100217162100 = Datum och tid när denna överföring utförs formaterat enligt ÅÅÅÅMMDDTTMMSS Patient P 1 NKP272M0dVB P.2 1 = Sequence number Vi kommer enbart att överföra en patient per anslutning så detta nummer kommer alltid vara 1. P.6 NKP272M0dVB = LIDnr Order O 1 NKP272M0dVB 3289-6^^^ R X SS291^1234 F O.2 1 = Sequence number Vi kommer enbart att överföra en order per anslutning så detta nummer kommer alltid vara 1. O.3 NKP272M0dVB = Specimen ID vi kommer att ange LIDnr O.5 3289-6 = Universal test id 3289-6 ar LOINC kod for PT O.6 R = Priority R = routine vi kommer enbart att ange R i detta fält. O.7 = Datum och tid när analysen begärdes, vi kommer inte att ange när analysen begärdes då vårat system inte hanterar query anrop. O.12 X = Action code X = specimen or test already in process. Vi kommer inte att ange något annat än X här. 0.16 = Specimen descriptor. Koder som används kommer från HL7 Specimen type. Indikerar vilken provtyp som användes vid analys på Simple Simon där PLAS = plasma (centifugerat antikotagulerat prov från cirtatrör/edta) BLDV = venöst blod (lätt utspätt i citrat rör) BLDC = kappilärt blod (från fingret) O.25 SS291^1234 = Instrument Section Identification O.25.1 SS291 = vilken simple simon som utförde analysen O.25.2 1234 = tilldelat LMC läsarnummer O.26 F = Final vi kommer enbart att ange F i detta fält. Result R 1 3289-6^^^ 1.19 INR N F 20070803170300 SS291^1234 R.2 1 = Sequence number vi kommer enbart att överföra ett resultat per anslutning så detta nummer kommer alltid vara 1. R.3 3289-6^^^ = Universal test id 3289-6 ar LOINC kod for PT R.4 = Svar i INR med. som decimaltecken. R.5 INR = Enhet, vi kommer att ange INR som enhet. R.7 N = Vi kommer ange N för Normalt svar inom mätområdet eller > när svaret är över 8.0 INR. R.9 F = Final vi kommer enbart att ange F i detta fält. R.13 20070803170300 = Datum och tid när analysen utfördes formaterat enligt ÅÅÅÅMMDDTTMMSS R.14 SS291^1234 = Instrument Identification SS291(vilken simple simon som utförde Analysen)^1234 = tilldelat LMC läsarnummer Terminator L 1 N L.2 1 = Sequence number vi kommer enbart att överföra ett terminator meddelande per anslutning så detta nummer kommer alltid vara 1. L.2 N = Normal termination, Vi kommer enbart att ange N i detta fält.