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INTERCEPT

Blood System

Pathogen Inactivation Process

ILLUMINATOR

Operator Manual

Software Version 6

Содержание INTERCEPT INT100

Страница 1: ...INTERCEPT Blood System Pathogen Inactivation Process ILLUMINATOR Operator Manual Software Version 6...

Страница 2: ...Europe B V 2550 Stanwell Drive Stationsstraat 79 D Concord CA 94520 USA 3811 MH Amersfoort Made in USA The Netherlands www interceptbloodsystem com Cerus and INTERCEPT are trademarks of Cerus Corpora...

Страница 3: ...INTERCEPT ILLUMINATOR INT100 Operator Manual Software Version 6 Illuminator Serial Number_________________ MAN EN 00601 v3 0...

Страница 4: ...This page intentionally left blank MAN EN 00601 v3 0...

Страница 5: ...Contents CHAPTERS PAGE 1 What the Illuminator Does 1 1 2 How to Use this Manual 2 1 3 Illuminator Description 3 1 4 How to Use the Illuminator 4 1 5 Troubleshooting 5 1 6 Maintenance Transportation an...

Страница 6: ...Master Table of Contents ii This page intentionally left blank MAN EN 00601 v3 0...

Страница 7: ...he Illuminator Does SECTIONS PAGE 1 1 What the Illuminator Does 1 3 1 2 Intended Use of the Illuminator 1 4 1 3 Indications for Use 1 5 1 4 Contraindications for Use 1 6 1 5 Notes to Transfusionists 1...

Страница 8: ...Chapter 1 What the Illuminator Does 1 2 This page intentionally left blank MAN EN 00601 v3 0...

Страница 9: ...Each blood product uses a specific processing set It is important to use the correct processing set and use sets approved by your local regulatory authority A brief overview of the pathogen inactivati...

Страница 10: ...he INTERCEPT Illuminator is intended only for use in the pathogen inactivation process to deliver UVA light for the photochemical treatment of blood products The illuminator should be used only by per...

Страница 11: ...Indications for Use 1 5 Section 1 3 Indications for Use Platelets and plasma treated with the INTERCEPT Blood System process are indicated for support of patients requiring transfusions according to...

Страница 12: ...aindications for Use 1 6 Section 1 4 Contraindications for Use Use of platelets and or plasma treated with the INTERCEPT Blood System process is contraindicated in patients with a history of allergic...

Страница 13: ...pathogen inactivation process that has been shown to eliminate all pathogens INTERCEPT platelets or plasma components should not be prescribed to neonatal patients treated with phototherapy devices t...

Страница 14: ...y be opened by a qualified field service engineer There are no user serviceable parts accessible by the side access panel Section 3 9 Features for Safety and Function Chapter 4 HOW TO USE THE ILLUMINA...

Страница 15: ...ng device Section 6 2 Selecting a Place for the Illuminator Section 6 4 Transportation and Storage WARNING Do not stack illuminators more than two high Section 6 2 Selecting a Place for the Illuminato...

Страница 16: ...ion 7 2 Illuminator Compliance with Standards WARNING The pins of connectors identified with the ESD warning symbol should not be touched and connections should not be made to these connectors unless...

Страница 17: ...r Section 3 6 Illuminator Settings CAUTION Illumination labels are not suitable for freezing and thawing Section 3 6 Illuminator Settings CAUTION Once an account has been disabled it cannot be reactiv...

Страница 18: ...CAUTION The illuminators need special precautions regarding electromagnetic compliance EMC and need to be installed and put into service according to the EMC information provided in the above tables S...

Страница 19: ...Chapter 2 How to Use this Manual 2 1 Chapter 2 How to Use this Manual SECTIONS PAGE 2 1 Getting Started 2 3 2 2 Symbols 2 5 2 3 Conventions Used in this Manual 2 9 MAN EN 00601 v3 0...

Страница 20: ...Chapter 2 How to Use this Manual Section 2 1 Getting Started 2 2 This page intentionally left blank MAN EN 00601 v3 0...

Страница 21: ...or function or procedure with photographs and screen images Some chapters have Questions and Answers at the end The manual contains these chapters Chapter 1 What the Illuminator Does This explains wha...

Страница 22: ...ing and general maintenance and provides information on how to store and move the illuminator It contains the warranty statement and service instructions Chapter 7 Specifications This provides the tec...

Страница 23: ...hat the Symbol Means Warning Caution Note Q A Questions and Answers Warnings will alert you to potential hazards that may cause personal injury Cautions will alert you to conditions that could damage...

Страница 24: ...d contents have to be handled with care This Way Up The package must be kept the right way up Temperature limitations The shipping carton and contents must be kept within a certain temperature range w...

Страница 25: ...his is the button that tilts the drawer Sun this side of the tray is exposed to light during the illumination process Spanner or wrench this shows the maintenance light When this light is amber the il...

Страница 26: ...rd This marking reflects compliance with the Medical Devices Directive 93 42 EEC issued by the Council of the European Communities Serial number Date of manufacture Catalogue number Container chamber...

Страница 27: ...onventions Used in this Manual When messages from the illuminator screen are quoted in the manual they will appear in bold type and quote marks for example Select a function screen Some Chapters inclu...

Страница 28: ...Chapter 2 How to Use this Manual 2 10 This page intentionally left blank MAN EN 00601 v3 0...

Страница 29: ...ner 3 9 Buttons 3 9 Function Buttons 3 10 Keypad Buttons 3 12 Backspace and Advance 3 13 3 5 Illumination Door and Drawer 3 14 3 6 User Access Levels 3 18 3 7 Illuminator Settings 3 20 Date and Time 3...

Страница 30: ...ts 3 42 Export Treatments in Date Range 3 43 Export All Service Data 3 44 Export Service Data in Date Range 3 45 Data Management System 3 47 3 8 Change Password 3 49 3 9 Features for Safety and Functi...

Страница 31: ...sured by sensors called photodiodes There is one sensor for each two bulbs so four sensors for each blood product These sensors are calibrated when each illuminator is installed and at prescribed peri...

Страница 32: ...de 128 including ISBT 128 and Eurocode All 128 ASCII characters Refer to Chapter 7 of this manual for details Each blood product is identified and traced by the combination of the donation number and...

Страница 33: ...The illuminator has two main areas of interest to the operator the front panel where the operator controls are located the door and drawer where blood products are placed for illumination Data ports a...

Страница 34: ...e parts is explained below Color Screen The screen is a liquid crystal display that gives instructions and other messages It is not a touch screen To move between screens or to select a function use t...

Страница 35: ...me Illuminator Identification Exporting Service Data Exporting Treatment Records Configurations Service Tasks Exporting Languages Messages appear in the middle of the screen In addition to routine ope...

Страница 36: ...stem Issue Barcode symbols Status Lights The status lights refer to the small round lights on the front panel of the illuminator Left hand light This light is green when the power is on Right hand lig...

Страница 37: ...lood System process and can be found on the final storage container label of the INTERCEPT Processing Set The barcode scanner may be used to enter operator identification into the illuminator and reco...

Страница 38: ...tter and special character function The arrow buttons are to the right of the screen Buttons Function Up arrow allows you to scroll up through the menu Down arrow allows you to scroll down through the...

Страница 39: ...reen 2 Cancel out of the illumination process in an error Enter Continue Login Stop Agitator Start Use this button to 1 Enter information on the screen 2 Continue to the next screen 3 Stop the agitato...

Страница 40: ...rized service representative to disable the keypad NOTE Only capital letters can be entered via the keypad Symbol Needed Number of Times to Press the Button Number Press once First Letter Press twice...

Страница 41: ...ill delete the last number or letter only To delete all the numbers and letters you need to push the button several times The advance button is used to let you enter the next number or letter using th...

Страница 42: ...he drawer The drawer is on a flatbed agitator so that blood products are agitated when they are in the illuminator There are four compartments in the tray to hold blood products and the accompanying p...

Страница 43: ...you must place it in the front chamber If however the front chamber has malfunctioned and cannot be used then you may illuminate one blood product in the rear chamber When you scan the INTERCEPT set...

Страница 44: ...You cannot illuminate one container of plasma and one container of platelets during the same illumination Illuminator trays may be tilted downward to make set loading and unloading and tray cleaning...

Страница 45: ...aged Do not attempt to service the UVA light sources or open areas of the illuminator which are not described in this operating manual Contact a Cerus authorized service company or representative for...

Страница 46: ...service engineer will work with your center s designated representative to establish the first Administrator account in each illuminator This Administrator can then set up operator accounts and addit...

Страница 47: ...print X X Select password expiration policy options are disable 30 days 60 days 90 days X X Connect and configure a data management system X X Electronic Data Export Export treatment and service data...

Страница 48: ...authorized Cerus Service representative will assist you to set up the first Administrator account Before you are able to select the setting you must access the Select a setting screen To access this...

Страница 49: ...ll not be a confirmation screen The Enter password screen will appear Use the keypad to enter your password and press the Enter button A confirmation screen will appear If the password is correct pres...

Страница 50: ...previous screen Date and Time The date time setting allows you to change the date and time as well as the format of each CAUTION Do not change date or time while units are in the illuminator NOTE The...

Страница 51: ...are a 12 hour clock or a 24 hour clock NOTE If using a data management system select the 24 hour clock format Press the Enter button to select the format The Enter time screen will appear Use the keyp...

Страница 52: ...rform the following From the Select a setting screen use the arrow buttons to choose the Language option Press the Enter button to select the option The Select a language screen will appear Use the ar...

Страница 53: ...ually The serial number is located inside the front door of the illuminator NOTE If you are using a File Transfer Protocol use the keypad to enter both your facility s site code and the instrument 9 d...

Страница 54: ...erval Export data export all treatments treatments in a date range all service data and service data in a date range Enable a data management system send information to a data management system To set...

Страница 55: ...last treatment report a specific treatment report a shift report for a given day or all treatment reports in a date range If not using the optional printer select the Off option Refer to Chapter 4 for...

Страница 56: ...s to choose the Configure Printing option Press the Enter button to select the Configure Printing option The Select a printer configuration setting screen will appear Use the arrow buttons to choose t...

Страница 57: ...tion screen will appear If the option is incorrect press the Edit button to return to the Select an auto printing option screen Use the arrow buttons to select the correct option If the selection is c...

Страница 58: ...Number Illumination Status Chamber Number The information on the labels will be printed in the same format it was scanned unless it was manually entered If manually entered no barcode will be printed...

Страница 59: ...screen use the arrow buttons to choose the Configure Printing option Press the Enter button to select the Configure Printing option The Select a printer configuration setting screen will appear Use t...

Страница 60: ...pear If the number of labels is incorrect press the Edit button to return to the Enter the number of platelet plasma labels screen Use the backspace button on the keypad to delete the number and re en...

Страница 61: ...n The Configure user accounts screen will appear Use the arrow buttons to choose the Add Account option Press the Enter button to select the Add Account option The User account type screen will appear...

Страница 62: ...n an acceptable username is entered NOTE Valid usernames are 2 to 17 characters in length and are limited to alphabetic characters digits and the special characters and Usernames are NOT case sensitiv...

Страница 63: ...nter button only appears when an acceptable password is entered NOTE Valid passwords are 3 to 17 characters in length and are limited to alphabetic characters digits and the special characters and Pas...

Страница 64: ...se the Configure User Accounts option Press the Enter button to select the Configure User Accounts option The Configure user accounts screen will appear Use the arrow buttons to select the Disable Acc...

Страница 65: ...manually entered username is correct press the OK button Reset Password An Administrator can reset the password for an Operator or another Administrator Use this feature if a password is forgotten Fr...

Страница 66: ...if the username is manually entered If the username is valid the Enter New Password screen will appear Enter the new password for the account either by scanning a barcode or by entering the password...

Страница 67: ...s are disabled no expiration 30 days 90 days or 180 days From the Select a configuration setting screen use the arrow buttons to choose the Configure User Accounts option Press the Enter button to sel...

Страница 68: ...iry time pop up window will appear If the expiry time is incorrect press the Edit button and correct it If the expiry time is correct press the OK button to confirm the expiry time Export Data Use to...

Страница 69: ...buttons to choose the Export Data option Press the Enter button to select the Export Data option The Select Data To Export screen will appear The following sections detail each of the export data opt...

Страница 70: ...e Export all treatment records screen will appear To cancel before the export operation begins press the Cancel button To start exporting all treatment records press the Export button The Exporting tr...

Страница 71: ...ress the Enter button The Confirm date range for export screen will appear NOTE After Enter is pressed there may be a delay while the illuminator prepares the files DO NOT re press Enter If the data e...

Страница 72: ...The Export all service data screen will appear To cancel before the export operation begins press the Cancel button To start exporting all service data press the Export button The Exporting service d...

Страница 73: ...Export Service Data in Date Range option Press the Enter button to select the Export Service Data in Date Range option The Specify date range screen will appear Use the keypad to enter the From date...

Страница 74: ...it the date range and correct it If the data entered is correct press the Export button to begin exporting service data The Exporting service data screen will appear Alternatively if the Export button...

Страница 75: ...option The Enter data management system TCP IP address screen will appear Use the keypad to enter the TCP IP address of the data management system connected to the illuminator Press the Enter button w...

Страница 76: ...e backspace button to delete the address Then re enter the correct address using the keypad NOTE You must enter a unique 12 digit number for the TCP IP address in this format XXX XXX XXX XXX Press the...

Страница 77: ...he system will prompt the user to change the password once a day for 7 days prior to password expiry for the account If a user s password has expired the user will be required to change it prior to ga...

Страница 78: ...Select the Change Password option and press the Enter button The Enter New Password screen will appear Enter the new password either by scanning a barcode or by entering the password manually with th...

Страница 79: ...ord 3 51 The Confirm password pop up window will appear if the password was manually entered If the manually entered password is incorrect press the Edit button and correct it If the manually entered...

Страница 80: ...ioned correctly for illumination Door lock to lock the door during treatment Door lock sensor to ensure the door is locked during treatment Magnetic door sensor to ensure the door is closed Interlock...

Страница 81: ...ree connectors on the rear of the illuminator Refer to Section 7 3 for details NOTE There are panels on each side of the illuminator that have no customer serviceable parts Opening either panel of the...

Страница 82: ...ent time to make sure that it is within the appropriate range set by the authorized service representative The bulbs will need changing if the time approaches the limit for adequate illumination The l...

Страница 83: ...orrect dose of light is being administered to the blood product so pathogen inactivation is being appropriately achieved The treatment time automatically increases as the bulbs gradually become dimmer...

Страница 84: ...Chapter 3 Illuminator Description 3 56 This page intentionally left blank MAN EN 00601 v3 0...

Страница 85: ...s 4 6 4 4 Scan Barcodes 4 11 4 5 Repeat Set Loading for Container 2 4 13 4 6 Begin Illumination Process 4 14 4 7 Illumination Interruption 4 15 4 8 Unload the Processing Set s 4 16 4 9 Optional Printi...

Страница 86: ...Chapter 4 How to Use the Illuminator 4 2 This page intentionally left blank MAN EN 00601 v3 0...

Страница 87: ...iven in the Appendix Illumination is one step in the INTERCEPT Blood System process Refer to the Directions for Use included with the INTERCEPT Processing Set and follow the instructions for the prepa...

Страница 88: ...switch under the screen to turn the illuminator on The illuminator will run several self tests When the self tests are complete the Enter function button will appear NOTE Once this step is complete c...

Страница 89: ...the keypad to delete the wrong username Then re enter the correct username using the keypad If the identification is correct press the Enter button A confirmation screen will appear Press OK to confir...

Страница 90: ...tment button This will remove any information that you have entered and you will go back to the Select a function screen 3 Use the arrow buttons to select the number of containers to illuminate 4 Pres...

Страница 91: ...en the front door of the illuminator NOTE If the door is not opened then an information screen will appear to remind you to open the door 6 Pull out the drawer 7 Open the cover of the tray by sliding...

Страница 92: ...hamber 1 is the front compartment Chamber 2 is the rear compartment The left hand side of each chamber is the illumination side marked by a sun symbol 8 Place the illumination container marked with th...

Страница 93: ...containers into the right hand side of the front chamber 1 so that the final storage container label is facing up NOTE Ensure that the containers in the right hand side of the chamber remain secure 1...

Страница 94: ...4 10 NOTE If you are treating two blood products you may load the second processing set into the rear chamber 2 at this time or after scanning the barcodes for the first set Refer to Section 4 5 Repea...

Страница 95: ...INTERCEPT manufacturing lot number The barcode symbol on the screen is dark before the barcode has been entered After the barcode has been entered the symbol will change to gray with a check mark acro...

Страница 96: ...n to delete the wrong barcode Then re enter the correct barcode using the keypad Press the Enter button The Confirm Barcode screen will appear If the barcode is correct press the OK button to confirm...

Страница 97: ...load the second set into the illuminator tray and scan barcodes placing second container in the rear chamber 2 CAUTION Make sure all tubing is in the tray before closing the cover and drawer 1 Close t...

Страница 98: ...tion 4 6 Begin Illumination Process The Running screen will automatically appear NOTE The blue bar moves to the right as the illumination progresses and is based on the target dose The numbers beside...

Страница 99: ...you that the treatment has been stopped by the operator Press OK NOTE If the treatment has stopped the record for any blood product in the illuminator will be marked as Incomplete WARNING Partial ill...

Страница 100: ...ete WARNING Partial illumination has not been validated for pathogen inactivation Do not attempt to re treat a partially treated unit Do not treat a blood product more than once No claim of pathogen i...

Страница 101: ...k The Unload containers screen will appear 3 Open the front door of the illuminator 4 Pull out the drawer and open the cover 5 Check the screen for the treatment status symbol Follow your facility s p...

Страница 102: ...xt steps in the process Process Additional Blood Products 1 Press the Treatment button The Enter username screen will appear 2 Repeat the steps described earlier beginning with Section 4 2 to enter us...

Страница 103: ...report Print treatments in a date range Print labels The following paragraphs describe how to create these reports once the printer is connected and the illuminator is configured Refer to Section 3 7...

Страница 104: ...int screen will appear Use these steps to access the report printing options or press the Back button to get back to the previous screen or the Select a report to print screen while you are printing r...

Страница 105: ...ow 4 If the Print the last treatment report screen is correct press the Print button The Printing Last Treatment Report information screen will appear to confirm that printing is occurring 5 When the...

Страница 106: ...atment to print screen will appear 3 Use the arrow buttons to choose the desired treatment If the treatment is not listed on the screen press the advance or backspace buttons on the keypad to display...

Страница 107: ...ing 7 When the report has been printed the Select a report to print screen will appear Shift Report The Shift Report option refers to a specific 24 hour day in which treatments were performed on the i...

Страница 108: ...order 6 Press the Print button to select the desired date The Printing shift report screen will appear 7 When the report has been printed the Select a report to print screen will appear Treatments in...

Страница 109: ...From date Then use the arrow buttons to advance to the To date Use the keypad to enter the To date 6 Press the Enter button to confirm the desired date range The Confirm date range screen will appear...

Страница 110: ...int Labels option 4 Press the Enter button to select this option The Select a treatment to print screen will appear 5 Use the arrow buttons to choose the desired treatment If the treatment is not list...

Страница 111: ...red treatment The Print the selected treatment labels screen will appear 7 Press the Print button to select this option A confirmation screen will appear NOTE The number of labels that print will be d...

Страница 112: ...e following 1 Press the Function button on the Unload containers screen The Select a function screen will appear 2 To enter credentials repeat the steps in Section 4 2 to enter credentials NOTE When t...

Страница 113: ...Function button on the Unload containers screen The Select a function screen will appear 2 Press the Back button The Power On screen will appear 3 Press the power switch 4 The illuminator will transi...

Страница 114: ...not scan into the illuminator If your operator badge will not scan into the illuminator use the keypad to manually enter your operator username into the illuminator Q A How will you know if only one o...

Страница 115: ...or refer to Section 4 9 Optional Printing Treatment Reports and Additional Labels See Specific Record for details on how to find a treatment record If you cannot locate a record for a given product fo...

Страница 116: ...apter 5 Troubleshooting SECTIONS PAGE 5 1 Introduction 5 3 5 2 Summary of 5 4 Questions and Answers 5 3 Error Messages 5 8 5 4 System Issue Messages 5 23 5 5 Confirmation Messages 5 24 5 6 Information...

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Страница 118: ...ese screens are used to confirm that the entered data is correct Information The information messages will be indicated by a blue bordered pop up screen with a lowercase i in a circle These screens in...

Страница 119: ...As a secondary check the illuminator software checks the treatment time to make sure that it is within the appropriate range set by the authorized service representative The bulbs will need changing...

Страница 120: ...ditional instructions are not helpful turn the illuminator off wait until the screen darkens then turn it back on If this does not resolve the issue contact your authorized service representative for...

Страница 121: ...r refer to Section 4 9 Optional Printing Treatment Reports and Additional Labels See Specific Record for details on how to find a treatment record If you cannot locate a record for a given product fol...

Страница 122: ...e the issue and select the OK button If you have tried to resolve the issue and cannot select the Cancel button This button should only be selected if there is a problem and it cannot be resolved as i...

Страница 123: ...o subcategories These subcategories will make it easier to rapidly locate pertinent information The subcategories are Agitator Bulbs Data Entry Drawer Fan Front Door Integrity Check Issues Self tests...

Страница 124: ...tance The agitator is stopped or is moving slowly Contact your authorized service representative for assistance On after Cancel is selected Hold time exceeded The Unlock door button on the Treatment C...

Страница 125: ...tact your authorized service representative for assistance On after Cancel is selected A Treatment Issue has occurred T1004 Replace bulbs X and Y Refer to the Operator s Manual for assistance The list...

Страница 126: ...int The number entered for labels to be printed was greater than 6 Off The entered date is invalid Touch Edit to re enter the date The date was not entered in the correct format You must enter 2 numbe...

Страница 127: ...logy scanned is not allowed for this field Please press Cancel to re enter the data The barcode scanner sends a symbology code that is not allowed for the field being read Upon canceling the pop up me...

Страница 128: ...illuminator and should not be Remove the processing set s and continue If this message continues to occur contact your authorized service representative On after Cancel is selected Close the drawer T...

Страница 129: ...ot blocked and that the air filter is clean Touch OK to continue or Cancel to quit The fan is not working properly or the air filter is blocked or missing Ensure the air filter is clean and present Se...

Страница 130: ...continue or Cancel to quit Processing set s are in the illuminator and should not be Remove the processing set s and continue If this message continues to occur contact your authorized service represe...

Страница 131: ...ce A problem is detected during the self tests Ensure the side access panel is closed Turn the illuminator off wait until the screen darkens then turn on to restart the illuminator If this message con...

Страница 132: ...representative for assistance On An Integrity Check Issue has occurred C0009 Contact service for assistance A problem is detected during the self tests Turn off the illuminator Open and close the door...

Страница 133: ...m is detected during the self tests Turn off the illuminator Ensure the tray is clean and present then turn on the illuminator If this message continues to occur contact your authorized service repres...

Страница 134: ...et s have not been properly placed in the illuminator Treatment must be canceled The processing sets are in the wrong chambers or there is an issue with the placement sensor Ensure the processing sets...

Страница 135: ...tor was off for more than 10 minutes The treatment must be canceled OR The treatment has been interrupted several times for an accumulated time over 10 minutes The treatment must be canceled Off A Tre...

Страница 136: ...printer Turn off the illuminator after treatment Check the cable connection to port 4 Check the printer for adequate paper and supplies Turn on the illuminator and try to reprint the report If this me...

Страница 137: ...rs if Service Light Close the side access panel Touch OK to continue or Cancel to quit The side access panel is open and should be closed Close the panel to continue If the message continues to occur...

Страница 138: ...occurred S1007 Contact service for assistance The bulbs are on when they should be off Contact your authorized service representative for assistance On A Safety Issue has occurred S1010 Contact servic...

Страница 139: ...racy of data In general these screens will contain Edit and OK function buttons If the information is incorrect press the Edit button to change the data If the information is correct press the OK butt...

Страница 140: ...t Open the door and drawer to continue Off Open the door and drawer Place the container s to be treated into the illuminator s tray and then scan or manually enter the required data The door and drawe...

Страница 141: ...sername The username entered does not correspond to an existing account OR The username is already in use and cannot be used to create a new account Off Invalid password Touch Edit to enter a new pass...

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Страница 143: ...Warranty and Service SECTIONS PAGE 6 1 Installation What to Expect When 6 3 the Illuminator Arrives 6 2 Selecting a Place for the Illuminator 6 4 6 3 Cleaning the Illuminator 6 6 6 4 Transportation an...

Страница 144: ...Chapter 6 Maintenance Transportation and Storage Warranty and Service 6 2 This page intentionally left blank MAN EN 00601 v3 0...

Страница 145: ...Illuminator Arrives The illuminator will be unpacked and installed by your authorized service representative The shipping container will include 1 Illuminator INT100 1 Tray 2 Glass filter plates 1 Ba...

Страница 146: ...8 cm 3 inches away from anything that will block the air filter on the bottom left hand side of the illuminator NOTE Place the illuminator so that there is enough space to open the left side access p...

Страница 147: ...tors may be stacked two high as shown below WARNING Do not stack illuminators more than two high WARNING If the blood product leaks into the tray tilting the drawer could cause the blood product to sp...

Страница 148: ...forming any maintenance on the illuminator WARNING Blood products containing amotosalen should be treated like all other blood products that is as biohazardous material Follow the guidelines for use o...

Страница 149: ...dy to use Bode Germany NO YES YES YES CaviCide ready to use Metrex USA YES YES YES YES DAX 70 ready to use OpusHealth Care Sweden YES YES YES YES Gigasept FF New 5 Schulke Meyr Germany YES YES YES YES...

Страница 150: ...er 4 Clean the plastic container tray including the corners gently but thoroughly with an approved solution using a soft cloth You may lift the tray out of the illuminator drawer optional 5 Use a soft...

Страница 151: ...t may be used include a mild detergent solution The air filter can be found under the bottom left hand corner of the illuminator 1 Pull the ring towards you and slide out the air filter 2 Wash the air...

Страница 152: ...r carrying the illuminator should be done by a minimum of two people or by using a mechanical lifting device If the illuminator needs to be shipped contact your authorized service representative to re...

Страница 153: ...copy of the specific written warranty information applicable to your region A list of authorized service representatives is available at the front of this manual Service Instructions Contact your aut...

Страница 154: ...p and bottom surfaces that are dispersed over the surface such that the external radiometers sample the same light field seen by the illumination container During use the external radiometer is placed...

Страница 155: ...ll be performed 6 months after each major PM Major PM consists of tests and verifications of the illuminator systems and settings and implementation of any updates or corrections as required In additi...

Страница 156: ...apter 7 Specifications SECTIONS PAGE 7 1 Illuminator Dimensions 7 3 7 2 Illuminator Compliance 7 4 with Standards 7 3 Illuminator Requirements 7 6 7 4 Barcode Compatibility 7 8 7 5 Connecting External...

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Страница 158: ...7 3 Section 7 1 Illuminator Dimensions Illuminator height approximate 37 cm 14 5 inches Illuminator width approximate 115 cm 45 inches Illuminator depth approximate 74 cm 29 inches Power cord length E...

Страница 159: ...42 EEC Directive 2002 96 EC WEEE EN 1041 EN 50419 EN 55011 EN 61000 3 2 EN 61000 3 3 EN 61000 4 1 EN 61000 4 2 EN 61000 4 3 EN 61000 4 4 EN 61000 4 5 EN 61000 4 6 EN 61000 4 8 EN 61000 4 11 EN 61010...

Страница 160: ...evice s are connected Consult the manufacturer or field technical service representative for help CAUTION The illuminators need special precautions regarding electromagnetic compliance EMC and need to...

Страница 161: ...h the lights and shaker off Power Cord Power cords are provided by the technical service representative as part of the installation kit for the INT100 illuminator Battery Requirements Each illuminator...

Страница 162: ...ator There is a fifth port located inside the front door of the illuminator for service personnel only Port Label Type Location Function 1 RS 232 Front Barcode Scanner 2 RJ 45 Rear Data Management 3 R...

Страница 163: ...the human readable portion of the barcode contains lower case letters manually enter the data using upper case letters During illuminator installation assist the authorized service representative in c...

Страница 164: ...and control characters accepted The manually entered characters are printed only in human readable form on the printed label if label printing is selected CAUTION If using Codabar excluding Monarch 1...

Страница 165: ...imary Data Identifier a 1 character secondary data identifier and part of the Country Collection Facility Code A N P Z 1 9 pppp 4 digits of the Country Collection Facility Code 0 9 yy 2 digit year of...

Страница 166: ...ptionally displayed in the human readable portion if they are not a checksum When displayed human readable these two characters are rotated ninety degrees k This character is printed enclosed in a box...

Страница 167: ...dable form on the printed label if label printing is selected 2 Codabar Code128 Scanned Data Input not allowed Codabar Scanned Data Input All legal Codabar numeric and control characters accepted If s...

Страница 168: ...ned to Product Codes by UKBTS nnnn Label ID Number m Version Number 4 ISBT 128 Code128 Scanned Data Must be in the following format Data Identifier a One alphanumeric character used to describe the bl...

Страница 169: ...g the type of donation or intended use d Character that provides information about divisions of the blood product s Character that provides information about divisions of the blood product 5 Eurocode...

Страница 170: ...with the illuminator Label Printer Treatment Printer Zebra printer model T402 Any Hewlett Packard laser printer with a USB connector Zebra printer model GK420T Zebra printer model TLP 2844 Z If using...

Страница 171: ...Chapter 7 Specifications 7 16 This page intentionally left blank MAN EN 00601 v3 0...

Страница 172: ...Chapter 8 Appendix 8 1 Chapter 8 Appendix SECTIONS PAGE 8 1 Glossary 8 3 8 2 Summary of Operator Steps 8 4 MAN EN 00601 v3 0...

Страница 173: ...Chapter 8 Appendix 8 2 This page intentionally left blank MAN EN 00601 v3 0...

Страница 174: ...e processing set reduces levels of residual amotosalen as a step in the INTERCEPT Blood System Cover Crosslink To form a permanent link Donation Number The donation number from a blood product or the...

Страница 175: ...ress the Enter button The Enter username screen will appear Enter Credentials Refer to Section 4 2 for details Step Action 1 If you have a barcode for username scan it If a barcode is not available en...

Страница 176: ...cover of the tray by sliding the black latch to the right The cover will open to the right 6 Place the illumination container marked with number 1 into the front illumination chamber 1 in the left han...

Страница 177: ...ation manually by performing the following Use the keypad to enter the barcode Press the Enter button The Confirm Barcode screen will appear If the barcode is incorrect press the Edit button The Enter...

Страница 178: ...ose drawer and door screen will appear Step Action 1 Make sure that all tubings are in the tray and the containers are flat 2 Close the tray cover and ensure that it is secured by the black latch 3 Pu...

Страница 179: ...and open the cover 5 Check the screen for the treatment status symbol Follow your facility s procedures for handling product recorded as Incomplete 6 When the label had printed place the label on the...

Страница 180: ...Chapter 8 Appendix 8 9 This page intentionally left blank MAN EN 00601 v3 0...

Страница 181: ...This page intentionally left blank MAN EN 00601 v3 0...

Страница 182: ...rporation Cerus and INTERCEPT Blood System are trademarks of Cerus Corporation MAN EN 00601 v3 0 Global Headquarters www interceptbloodsystem com Cerus Corporation www cerus com 2550 Stanwell Drive Co...

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