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1. M 4 1 Formulary Database irrito t etn rn tede nan nent EREE EEEE nac 4 1 Container IDs Outside the USA enne nennen nennen nnne nnnenn 4 2 Container IDs and Master IDs USA Only iii 4 2 Matching CGontalpnerlez m eeben bees 4 2 Mapping Container IDs to Master IDs USA Only ss 4 3 Mns P 4 3 Printing a Syringe Label 4 4 Scanning the Drug Container Barcode sessssssssssseseeseeeeeeeneeeee nennen nennen 4 5 Selecting from Matching Container IDs ennemis 4 7 Learning a Drug USA On 4 8 V rifying a Drug E D tee den 4 10 Specifying th RL TEE 4 12 Confirming the Syringe Label Before Printing It 4 14 Confirming the Printed Syringe Label 4 16 Custom Labele 4 18 Custom LEabel Categories 2 dep En pee i E ea EAR EE e RR XR ERE a nd dXX RO ux 4 18 s e 4 19 BL ric E 4 20 j u M E 4 21 ul rt 4 22 Printing Custom Ee EE 4 23 Contents Chapter 5 Maintenance Ordering Supplies and Parts issues 5 1 Cleaning the Enclosure 5 2 Cleaning Precautions iii 5 3 Disinfecting the Enclosure ettet recueil ENEE br E Ya ane ta vanas ae RR RESCH Rr eeu SE 5 4
2. SLS500i Components inside SLS front cover Pressing the Load Button feeds the label media through the SLS and advances the labels Pressing the Ink Button positions the ink cartridge carriage for easy ink cartridge replacement Codonics SLS 500i User s Manual 2 7 e Pressing the Unload Button unloads the installed label media by reversing it through the SLS TheInk Cartridge Carriage holds the ink cartridge The Label Cutter cuts the label after it is printed WARNING When the front cover is open avoid contact with the label cutter SLS Rear Components The following illustrations show the input output ports and the power switch located at the rear of the SLS USB port 2 USB port 2 behind touch screen rear panel door Setting Up the System Power input port Ethernet port Power switch not used SLS rear panel power input port and Power switch e USB Port2 behind the rear panel door is used to mount the SmartDrive flash drive The external power supply connects to the Power Input Port The external power supply is a switching 100 V 240 V power supply The Power Switch powers the SLS on and off P NOTE The system includes an Ethernet port that is not currently supported and should not be used 5 Codonics SLS 500i User s Manual 2 9 Touch Screen The following illustration shows the touch screen Power LED the Reset button an
3. 1 440 243 1198 Insert a valid SmartDrive and restart the system If the problem persists with a SmartDrive that you believe to be valid contact Codonics Technical Support 1 440 243 1198 Delete files on the flash drive to provide enough storage space for the log files Try using another flash drive Insert the SmartDrive in USB port 2 inside the touch screen rear panel door and copy the log files again Update the SLS application software or create a compatible version of the configuration update package and install that package For more information refer to the SLS Administration Tool User s Manual Codonics SLS 500i User s Manual 6 9 6 10 Table 6 1 Troubleshooting Continued Problem Touch Screen Problems The touch screen does not respond properly when touched The touch screen calibration failed error code 19 Formulary Problems The formulary fails to load error code 60 The system indicates that the updated formulary is invalid error code 81 Troubleshooting Possible Causes The touch screen is not properly calibrated After running the Calibrate Screen utility the user pressed the No button when prompted whether to save the calibration settings The user session timed out while the Calibrate Screen utility was running The formulary database is corrupt The formulary update package that was installed is damaged or the version of the formulary update
4. 3 12 Basic Operations Adjusting the Audio Volume Cas Press the Volume Up or Volume Down button Press Volume Up or To adjust the Volume Down audio volume Clean Nozzles Print My Badge Copy Logs Adjust Label Calibrate Screen Clear Errors Utilities Dark Print Off Manage Features Ocoponics QQ ms OU am The current volume level is indicated by an audible beep and in the volume level display If you turn the volume down until it is muted and a Muted icon displays in the Dashboard Clean Nozzles Print My Badge Copy Logs Adjust Label Calibrate Screen Clear m Dark Print Off Manage Features Utilities SYRINGE BLANK LINES Domen Muted icon Codonics SLS 500i User s Manual 3 13 Adjusting the Touch Screen Brightness Cas Press the Brightness Up or Brightness Down button To adjust the Press Brightness Up brightness or Brightness Down Clean Nozzles Print My Badge Copy Logs Adjust Label Calibrate Screen Clear Errors Utilities Dark Print Off Manage Features Qcoponics QQ m TET The current brightness level is indicated by the brightness level display 3 14 Basic Operations Printing a User Badge Nu Press the Print My Badge button To print a user Press Print My Badge badge Clean Nozzles Print My Badge Copy Logs Adjust Label Calibrate Screen Clear Errors Utilities Dark Print Off Manage Features The user badge is displayed and
5. The system cannot print labels The following actions may resolve the problem Print the test label again Clean the ink cartridge nozzles using the Utilities screen Replace the ink cartridge or labels Cycle power on the system If problems persist contact your system administrator LT e TE To print another test label press the Try Again button Another test label prints and you are prompted again to confirm the test label To attempt to resolve the printing problem press the Continue button The Utilities screen displays and the SLS is put into an out of service state To troubleshoot the printing problem and perform the recommended solution refer to Table 6 1 on page 6 7 The system cannot leave the out of service state until you press the Yes button in response to the prompt to confirm that the test label printed correctly So after each solution you try print another test label If the utility you use does not do this automatically you can log out and log in again to have the system print a test label If the test label still does not print correctly after trying the suggested solutions contact your SLS system administrator Codonics SLS 500i User s Manual 6 25 QAdiusting fhe Media Path If the label is not properly centered on the printed labels or the labels are not being cut at the proper location on the media you might need to adjust the media path Ne 1 Unload the label media as described in
6. Clearing a Label Media Jam on page 6 21 To adjustthe 2 Press the Utilities button at the top of the user interface media path Utilities button 2 gl BLANK LINES PATIENT EJ The Utilities screen displays 6 26 Troubleshooting 3 Press the Adjust Label button Press Adjust Label Clean Nozzles Print My Badge Copy Logs Adjust Label Calibrate Screen Clear Errors Utilities Dark Print Off Manage Features Ocoponics QQ OB ew The Adjust Label dialog box displays 4 Use the adjustment buttons as described in the following figure 4 Adjust Label Bl Label mi Position mm 0 Use these buttons to adjust the position of the printed content on the label SS Var CETA Cut Location 5 Use these buttons to adjust the out e gel location between labels on the media For example if the label content is correctly centered horizontally but is too low on the label vertically use the up arrow button to move the print area up on the label 5 After making the appropriate adjustments press the OK button 6 Close the Utilities screen codonies SLS 500i User s Manual 6 27 7 Reload the label media as described in Loading or Replacing the Label Media on page 2 20 8 Print a custom label to see if the label prints correctly and use the Adjust Label utility again to make additional adjustments if needed QAdivsting the Label Black Levels You can a
7. Disintecting Pr cautions c 5 4 Installing Update Packages or System Goftware eee 5 5 Removing the Rear Cover 5 8 Calibrating the Touch Screen nennen nennen nennen trennen enne nenas 5 9 Backing Up Log Files i i tet en e hc eer n i eed en di rh rus 5 12 Adding a cic ort bete e tta EE uda e Epod eve Rv ore av Rae RR rv dev ERE Eel 5 15 Swapping Systems iii 5 17 Preparing the System for Ghipping nennen enne nnne nnne nnns 5 18 Chapter 6 Troubleshooting Status Indcetors eee 6 1 Displaying System Information sise 6 2 CUM M 6 3 Silent p 6 4 User TaD n 6 5 ICI ote 6 6 Troubleshooting Common Problems eene eene nennen enne en nnne en nnne n nnne nns 6 7 Idiegeno P aii ai neh a A deen ae 6 18 Clearing a Label Media Jam 6 21 Cleaning the Ink Cartridge Nozzles enne nnne nnne nennt nnne nen 6 23 Adjusting the Modia E 6 26 Codonics SLS 500i User s Manual vii Adjusting the Label Black Levels AAA 6 28 Cleaning M LRO EE I 6 30 Appendix A Hazardous Material Information Mat rials of Constr ctiOn 25225er886 ta ceto traer RER a cedes nad Con ae aspere eaa mess A 1 Mat riaux de Construction ics EE A 2 NUES IU Lett Ile pen A 3 Lic lee te EET A 3 Appendix B Specifications Sp citications ENGISH
8. package is not compatible with the current SLS software Solutions Run the Calibrate Screen utility Refer to Calibrating the Touch Screen on page 5 9 Run the Calibrate Screen utility again Refer to Calibrating the Touch Screen on page 5 9 Log in and run the Calibrate Screen utility Clear the error refer to Clearing Errors on page 6 30 Create and load a new formulary update package For information about how to create a formulary update package refer to the SLS Administration Tool User s Manual Create and load a new formulary update package For information about how to create a formulary update package refer to the SLS Administration Tool User s Manual If the problem persists with a new formulary update package contact Codonics Technical Support 1 440 243 1198 Table 6 1 Troubleshooting Continued Problem Possible Causes Solutions The system indicates that the The formulary update package did Reinstall the formulary update package formulary update is incomplete not install correctly error code 82 If the problem occurs again create and load a new formulary update package For information about how to create a formulary update package refer to the SLS Administration Tool User s Manual If the problem persists when installing the new formulary update package contact Codonics Technical Support 1 440 243 1198 Drug Container Barcode Verification Problems A drug container
9. Ce devis mit CDRH IEC Class 2 laser et IEC Class 1 M lumi re Ne regarde pas dans le rayon Preface Serial Number Configuration Date Code and Modification Codes The serial number label is placed onto the safety and compliance label The serial number label includes the following information The serial number SN which uniquely identifies the unit The configuration number CN which details the build configuration The modifications codes which are to the right of the CN number and are a series of 20 numbers When any of these numbers are blocked out that identifies a modification that was made to the unit The date code in YYYY MM format below the factory date code symbol Serial number Date code a R SN e XXXXXXXXC XXX XX CN T ae MEM Ge XXX EM V Configuration Modification number codes Serial number label Codonics SLS 500i User s Manual xvii xviii Potential for Radio Frequency Interference on Device Operation Both portable and mobile RF communications equipment can affect medical electrical equipment including the SLS The SLS is intended for use in the electromagnetic environment specified in the guidance and manufacturer s declaration section Potential for Radio and Television Interference The SLS generates and uses radio frequency energy and if not installed and used properly that is in strict accordance with the manufacturer s instructions
10. Label 6 26 Calibrate Screen 5 9 Clean Nozzles 6 23 Clear Errors 6 30 closing the Utilities screen 3 16 Dark Print setting 6 28 displaying Utilities screen 3 12 Manage Features 5 15 Utilities button 3 10 Index v verification 4 3 4 10 voltage warning xiv volume adjusting 3 13 Muted icon 3 13 6 1 w warnings laser xvi WEEE Waste Electrical and Electronic Equipment disposal directive Xxx
11. Printing Labels gt gt If the label is correct press the Print button to confirm it and print the label After the label has been printed retrieve it from the output bin WARNING To avoid mislabeling syringes make sure that you immediately remove each label from the output bin after it is printed confirm the label and then affix it to the appropriate syringe before attempting to print another syringe label WARNING Unwanted labels should be destroyed or disposed of to ensure that incorrect labels are not used Next you need to confirm that the label printed correctly Go to Confirming the Printed Syringe Label below Codonics SLS 500i User s Manual 4 15 Confirming the Printed Syringe Label If the system is configured to require confirmation of the printed syringe label you are prompted to scan the label s barcode to confirm that it printed correctly Confirm Did the label print correctly Scan printed label to confirm L Unable to Scan P NOTE Labels as presented on the touch screen and in print form might not be an absolute match to how your SLS system administrator viewed them in the Administration Tool After reviewing the printed label and the label displayed on the touch screen you have the following options e Scan the label s barcode If the barcode is correct the system plays an audible beep briefly displays a confirmation message and then displays the main
12. Setting Up the System 6 Insert the ink cartridge into its carriage copper end first Hold the cartridge at a 45 angle as you slide it into its carriage then tilt the cartridge down until it fully drops into place Loading the ink cartridge 7 Close the carriage cover until it snaps into place and is secured by the purple hold down clip Carriage cover closed Codonics SLS 500i User s Manual 2 19 8 Press the Ink button Ink button 9 Close the front cover QLoading or Replacing the Label Media L L I To load or replace label media 2 20 NOTE Use only Codonics labels to ensure proper operation of the device and proper labeling of syringes Using unapproved labels could lead to unacceptable results including poor print quality and poor label adhesion to the syringe NOTE Unwanted labels should be destroyed or disposed of to ensure that improper labels are not used 1 Open the rear cover 2 Optionally remove the rear cover For more information refer to Removing the Rear Cover on page 5 8 Setting Up the System 3 Remove the loaded label media and hubs from the media guides Removing the loaded label media 4 Remove any shipping tape or rubber bands from the new label media to ensure that it can unroll freely making certain that no adhesive portion is exposed P NOTE Any exposed adhesive surface can attach itself to the inner workings of the print mechanism and cause a l
13. Tel 31 343 442 524 Contents Preface Conventions Used in This Manual ix SIIICOESE E ix Numbered Steps A ix Dorf x Cautions and WathinigS s reseau eee ru re ne rates ent dre ex uu ae dva ne lens x Important Information and Filenames essen x Purpose and Scope xi Product Information zs isstess c xii Warnings and Limitations of Use ss xiii Location of Safety and Compliance Labele eene xiii Molle A ru E xiv I fe og m aeeas XV IK IT TAA Ia UL PE TTE IE xvi Danger du Faisceau Laser sise xvi Serial Number Configuration Date Code and Modification Codes c ccccccessseeeesesteeeeeseee xvii Potential for Radio Frequency Interference on Device Operation xviii Potential for Radio and Television Interference seeeeeennnenn xviii Guidance and Manufacturers Declaration Electromagnetic Emissions xix Guidance and Manufacturers Declaration Electromagnetic Immunity sssssss XX Safety PreCAUtlONs E Eai xxii Precaution d EMPIO p ERASE xxiii Location Precautions seen xxiv Environnement de Fonctionnement AA XXV Clea
14. amended by Directive 2003 108 EC The EN 50419 symbol indicates separate collection and return required EN 50419 symbol Preface indications for Use Device Description Drug preparation and administration in the perioperative environment are integral aspects of anesthesiologist s patient care responsibilities The Codonics Safe Label System SLS is a simple integrated system utilizing a barcode scanner to read and confirm drug identity from FDA NDC National Drug Code and other drug ID Barcodes from drug containers and automatically print labels for prepared drugs and other items in use on patients during surgical procedures The labels are compliant with national regulations focused on improving medication safety in the perioperative environment The software components provide functions for scanning container barcodes creating reviewing and approving the hospital managed promotion of a formulary database displaying on screen and audibly confirming drug type and printing ISO ASTM and TJC The Joint Commission content and color compliant labels with 2D barcodes The system reads drug container barcodes and produces water resistant color labels The system can be integrated to function with an Anesthesia Information Management System AIMS workflow to provide real time documentation of drug administration when the syringe 2D barcode is read Device Characteristics The use of drug class specific pattern and color per AS
15. and will not vibrate or shake when the system is operating The device has mounting holes designed to be compatible with VESA mounting capabilities Refer to www vesa org for mounting options and instructions Codonics SLS 500i User s Manual 2 1 Q Shipped Components The SLS is shipped in cartons that contain the following system components e SIS e Supporting documentation package including the SLS Quick Reference Warranty and support documents The following items are found in the Accessory Kit box e Label media hubs e External power supply and cord e SmartDrive USB flash drive Ethernet cable not currently used Reference Guide and other printed documentation e Software and User s Manuals disc Setting Up the System Some configurations also include a Starter Kit that has one ink cartridge and one label media Safe Label System gt External power supply and cord SmartDrive and USB flash drive with system eS software Label media hubs Reference Guide cable and other documentation Software and User s Manuals discs Unpacked components codonies SLS 500i User s Manual 2 3 Inspect the cartons for damage that might have occurred during shipping Report any damage to the shipping company Save the cartons and packing materials in case you ever need to transport the SLS later CAUTION When removing the SLS hold under the front and rear of the sy
16. are prompted to confirm that it printed correctly the prompt is shown in step 3 Go to step 4 Enter PIN Reeg pem mcd cmi ben nins enin Codonics SLS 500i User s Manual 3 5 3 Enter your PIN and then press the Enter button To ensure that labels print properly the test print screen displays and a test label is printed Ocoponics GAY mm GH Tu lal TL Y DOES Test Print Cyan Magenta Yellow Prepared On 03 09 2011 12 47 By ADN 03 09 2011 12 47 f NOTE The system will ensure that a test print is performed at least once a day 3 6 Basic Operations You are then prompted to confirm the test label printed correctly Confirm Did the label print correctly Test Print Cyan Magenta Yellow Prepared On 03 09 2011 12 47 By ADN Review the following to ensure that the test label printed correctly The colors are correct e The label content is correctly centered The print is not faded There is no horizontal banding The date and time are correct e The user s initials are correct If the test label has printed correctly press the Yes button Codonics SLS 500i User s Manual 3 7 The main screen displays and the system is ready for use 03 09 2011 13 02 If the test label prints incorrectly press the No button A Test Print Failed Verification message displays ERROR CODE 2 Test print failed verification The system cannot print
17. be verified on each of the SLSs on which the formulary is installed Verifying a drug record in one SLS does not change its verification state in the other SLSs Codonics SLS 500i User s Manual 4 11 Specifying the Dilution and Diluent If you turned the Dilute switch on and the drug can be diluted or if the drug must be diluted you are prompted to specify the dilution and diluent Succinylcholine Choose a dilution Concentration Diluent Other Normal Saline 10 mg mL D5W 5 mg mL Ringers Lactate M mecs ez Press and or drag the lists until the appropriate concentration dilution and diluent are selected that is they are displayed under the blue highlighted bars You can also select Other for the concentration to print a label with a blank line so that you can enter the dilution on the label by hand You can also select Other for the diluent NOTE Additional dilutions can be added using the SLS Administration Tool For more information refer to the SLS WARNING SLS users are responsible for calculating the correct dilution concentration Administration Tool User s Manual 4 12 Printing Labels gt E After selecting the concentration and diluent press the OK button One of the following occurs e You are prompted to confirm the label before it is printed if this option has been configured Go to Confirming the Syringe Label Before Printing It on page 4 14 The l
18. external power supply is connected the SLS can be powered on and off using the Power switch on the rear panel 2 12 Setting Up the System nserting the SmartDrive TS Insert the SmartDrive in USB port2 inside the touch screen rear panel door To insert the SmartDrive Inserting the SmartDrive into USB port 2 inside the touch screen rear panel door P NOTE The rear panel door is not intended to be removed 5 Codonics SLS 500i User s Manual 2 13 Starting Up the System Ne 1 Press the Power switch on the rear of the SLS to power on and start up the system To start up the Power switch system Power switch on the rear panel When the SLS has completed its startup successfully you are prompted to verify that the date and time are correct A Are the date and time correct 03 09 2011 12 09 2 14 Setting Up the System 2 Press Yes if the date or time is correct The Login screen displays Scan User Badge or Enter User ID to Log In Press No if the date or time is incorrect Controls for changing the date and time display 3 Use the controls to correct the date and time then press the OK button The Login screen displays Codonics SLS 500i User s Manual 2 15 an update package you will be prompted to install the update For more information refer to Installing Update Packages P NOTE If the system detects that the SmartDrive contains a newer ver
19. failed verification The user indicated that the drug in Make sure the barcode on the drug when the barcode was scanned to the formulary that matched the container is of good quality print a syringe label error Container ID in the scanned drug code 20 container barcode is not the same Use the Administration Tool to correct drug as that in the drug container the drug information in the Master Drug To prevent a syringe being Database MDD create a new version improperly labeled that drug of the formulary update package and record is assigned a verification load the new version into the SLS For status of Failed and a label will not more information refer to the SLS be printed anytime this drug Administration Tool User s Manual container s barcode is scanned Codonics SLS 500i User s Manual 6 11 6 12 Table 6 1 Troubleshooting Continued Problem When a drug containers barcode is scanned to print a syringe label the system indicates that the barcode previously failed drug verification error code 21 Possible Causes The first time this drug container barcode was scanned the user indicated that the drug in the drug container did not match the drug found in the formulary with the same Container ID To prevent a syringe being improperly labeled the drug record s verification status was set to Failed and a label will not be printed anytime this drug container s barcode is scanned Printed Syringe Label Confirmat
20. may cause interference to radio and television reception It has been type tested and found to comply with Class A emission limits for a computing device in accordance with the specifications in Subpart J of Part 15 of FCC Rules which are designed to provide reasonable protection against such interference when operating in a commercial environment The SLS is not intended for use in a residential Class A environment The SLS requires a medical power ground If your SLS does cause interference to radio or television reception you are encouraged to try to correct the interference by one or more of the following measures Reorient the receiving antenna e Relocate the SLS with respect to the receiver If necessary you should consult Codonics Technical Support or an experienced radio television technician for additional suggestions You may find the following booklet prepared by the Federal Communications Commission helpful How to Identify and Resolve Radio TV Interference Problems This booklet is available from the U S Government Printing Office Washington D C 20402 Stock No 004 000 00345 4 Preface Le pr sent appareil num rique n met pas de bruits radio lectriques d passant les limites applicables aux appareils num riques de la Classe B prescrites dans le R glement sur le brouillage radio lectrique dict par le minist re des Communications du Canada This product is in conformity with the protection requirements of
21. of device Voltage Warning The exclamation point within a triangle is intended to alert the user to the presence of important operating and maintenance servicing instructions in the literature accompanying this device A REFER SERVICING TO QUALIFIED SERVICE PERSONNEL REMOVAL OF LABELS COVERS OR ENCASEMENT FASTENERS MAY VOID THE WARRANTY THIS APPARATUS MUST BE ELECTRICALLY GROUNDED TO PREVENT FIRE OR SHOCK HAZARD DO NOT EXPOSE THIS DEVICE TO RAIN OR MOISTURE Preface GE EQUIPMENT IS NOT TO BE USED AS A COMPONENT OF A LIFE SUPPORT SYSTEM Life support devices or systems are devices or systems that support or sustain life and whose failure to perform can be reasonably expected to result in a significant injury or death to a person A critical component is any component of a life support device or system whose failure to perform can be reasonably expected to cause the failure of the life support device or system or to affect its safety or effectiveness WARNING Grounding reliability can be achieved only when the SLS is connected to a receptacle marked Hospital Only that is Hospital Grade WARNING The power cord connected to the SLS is the main disconnect for the system WARNING To disconnect overall power to the SLS prior to servicing it power off the system refer to Powering Off the System on page 3 20 Dangers lectriques Le point d exclamation situ l int rieur d un triangle repr sente
22. or abrasive cleansers e Never use abrasive material e Always dilute cleaning agents according to the manufacturer s instructions or use the lowest possible concentration Do not allow the cleaning agent to remain on the device surfaces Wipe it off immediately with a lint free cloth moistened with water Codonics SLS 500i User s Manual 5 3 Qbisinfecting the Enclosure 5 4 It is recommended that you disinfect the product only when necessary as determined by your hospital s policy to avoid long term damage to the product The device must be cleaned first as described in Cleaning the Enclosure on page 5 2 before using a general disinfecting agent Recommended disinfecting agents include e 1 part household bleach and 5 parts water solution e A 456 N e Virex II 256 e PDI Sani Cloth WARNING Codonics makes no claims regarding the efficacy of the listed chemicals or methods as a means of controlling infection Consult your hospital s infection control officer or epidemiologist Disinfecting Precautions To avoid damage to the device observe the following general precautions for disinfecting the device e Do not use Povodine Sagrotan or Mucocit disinfecting agents or strong solvents for example acetone Do not use any disinfecting agents that corrode or damage polycarbonate Maintenance Cinstalling Update Packages or System Software DD The SLS formulary configuration and system softw
23. screen 4 16 Printing Labels If the scanned barcode is incorrect the system displays a message explaining the actions that can be taken WARNING Incorrect syringe labels should be destroyed or disposed of to ensure that they are not used CAUTION A failed label content confirmation is a serious issue It means that the formulary is wrong An SLS system administrator should be consulted immediately to review the logs and correct the formulary e If by visual inspection you can see that the label did not print correctly press the No button You are prompted to indicate whether there was a label content error or a problem printing the label WARNING CODE 37 t CN Label failed visual inspection Press Content Error if the contents of the label is incorrect Examples include drug name drug concentration or label color differing from what was displayed Press Printing Error if the label was damaged while printing Examples include label smudging improper cut off fading etc Press Cancel to go back to the previous dialog ans zm Ke OC After clicking either of the Error buttons the system displays a message explaining the appropriate action to take WARNING Incorrect syringe labels should be destroyed or disposed of to ensure that they are not used Codonics SLS 500i User s Manual 4 17 A A A WARNING If the barcode scan or you indicate that the label content was not correct or
24. that the label was not printed correctly contact the SLS system administrator or Codonics Technical Support 1 440 243 1198 to resolve the problem before attempting to print a syringe label again CAUTION A failed label content confirmation is a serious issue It means that the formulary is wrong An SLS system administrator should be consulted immediately to review the logs and correct the formulary If you are unable to scan the barcode press the Unable to Scan button You are prompted to discard the label and to try scanning the drug container barcode and printing the label again Correct the scanning problem before attempting to print any more labels WARNING Unconfirmed syringe labels should be destroyed or disposed of to ensure that they are not used Custom Labels 4 18 In addition to printing syringe labels the SLS can print custom labels that are configured for your site The next topic describes the custom label categories For instructions about how to print custom labels refer to Printing Custom Labels on page 4 23 Custom Label Categories By default the system includes pre defined categories for Blank Lines I V and Patient labels These categories are described in the following topics Printing Labels NOTE Custom labels can be added using the SLS Administration Tool For more information refer to the SLS Administration Tool User s Manual Blank These blank syringe labels no drug na
25. then printed Ocoponies QQ mm OO x i SLS User Badge Name Admin ID 1111 03 09 2011 14 00 Codonics SLS 500i User s Manual 3 15 Closing the Utilities screen Cas Press the Utilities button To close the Press the Utilities button Utilities screen Clean Nozzles Print My Badge Copy Logs Adjust Label Calibrate Screen Clear Errors Dark Print Off Manage Features The Utilities screen closes 3 16 Basic Operations ogging Out Ne 1 Press the Logout button To log out Logout button The Log Out or Shut Down dialog box displays 2 Press the Log Out button Logout button Log Out or Shut Down System En Sn The Login prompt displays Codonics SLS 500i User s Manual 3 17 3 18 Being Logged Out Automatically Due to Inactivity The system includes a preconfigured timeout period by default 15 minutes to help ensure the security of system operations If a user is logged in but the user session is idle for the timeout period a notification message displays and a countdown begins l Y System is about to timeout due to inactivity 19 seconds remaining D To cancel the automatic logout and continue with your session press the Continue button The system resets the inactivity timer Screen Blanking Due to Inactivity If the system is inactive for a preconfigured timeout period 20 minutes the touch screen becomes blank To reactive the system press any
26. un point d instruction important dans l utilisation ou l entretien de cette appareil A POUR SOUTIEN ADRESSEZ VOUS AU PERSONNEL QUALIFIE LE RETRAIT DE LES ETIQUETTES LES COUVERTURES OU LES ATTACHES PEUT ANNULENT LA GARANTIE CET APPAREIL DOIT ETRE ELECTRIQEMENT RELIE A LA TERRE Codonics SLS 500i User s Manual xv GE N EXPOSEZ PAS CET APPAREIL LA PLUIE OU L HUMIDIT EN RAISON DU RISQUE DE FEU OU DE D CHARGES LECTRIQUES Cet appareil ne doit pas tre utilis comme composant d un syst me d assistance vitale Les devis ou les syst mes vitale sont quelque devis ou syst me qui assistent ou soutiennent la vie et si les devis ou syst mes chouent on peut attend raisonnablement la mort ou la blessure Cet appareil ne doit pas tre utilis dans des conditions o la d faillance de l appareil pourrait entrainer la blessure ou la mort de quelqu un ATTENTION Une mise la terre fiable est possible seulement pendant que le SLS est connect aux appareils marqu Hospital Only de qualit hositali re ATTENTION Le fil lectrique connect le SLS sont le syst me de coupure principal de l appareil ATTENTION Pour d brancher le fil lectrique avant le soutien se d connecter et puis teint le syst me renvoyer Powering Off the System sur la page 3 20 Laser Warning This device emits CDRH IEC Class 2 laser and IEC Class 1M light Do not stare into beam Danger du Faisceau Laser
27. 01 Test Level Electromagnetic Environment Guidance Compliance Level 6 kV contact 8 KV air Electrostatic discharge ESD IEC 61000 4 2 Electrical fast transient burst 2 kV for power supply lines IEC 61000 4 4 1 KV for input output lines Surge x 1 kV line s to line s IEC 61000 4 5 x 2 kV lines s to earth Voltage dips shot interruptions lt 5 Uy and voltage variations on power lt 95 dip in Ur supply input lines for 0 5 cycle IEC 61000 4 11 40 Ur 60 dip in Ur for 5 cycles 70 Ur 30 dip in Ur for 25 cycles lt 5 Ur 95 dip in Ur or bs Power frequency 50 65 Hz 3 A m magnetic field IEC 61000 4 8 NOTE U is the AC main voltage prior to application of the test level Preface Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 x 6 kV contact x 8 kV air Main power quality should be that of a typical commercial or hospital environment x 2 kV for power supply lines 1 KV for input output lines Main power quality should be that of a typical commercial or hospital environment 1 KV line s to line s x 2 kV lines s to earth lt 5 Ur Main power quality should be that of a typical commercial or hospital 9576 dip in Ur environment If the user of the SLS requires continued operation for 0 5 cycle during main power interruptions it is recommended that the SLS be 40 Ur powered f
28. 0i User s Manual 5 9 2 Press the Calibrate Screen button Press Calibrate Screen Clean Nozzles Print My Badge Copy Logs Adjust Label Calibrate Screen Clear Errors Utilities Dark Print Off Manage Features Qcoponics QQ amp 4 49 mm P NOTE If pressing the button does not start the Calibrate Screen utility the touch screen calibration might be very far off Try pressing the area around the button until the button activates The system displays a message with instructions about how to perform the calibration 3 Press the OK button to dismiss the message 5 10 Maintenance The Calibration screen displays 4 Four targets will display sequentially on the Calibration screen Carefully press the center of each target and hold your finger there until the next target displays When the last target is calibrated a calibration confirmation dialog box is displayed Confirm Save these calibration settings codonics SLS 500i User s Manual 5 11 5 Press the Yes button to confirm the calibration After confirming the calibration the Utilities screen displays again Press the No button to cancel this calibration and redisplay the Utilities screen Q Backing Up Log Files A I To copy logs and other system files to a USB flash drive To prevent loss of the system logs stored on the SLS it is strongly recommended that this data be backed up to another storage device on a
29. 18 Table 6 1 Troubleshooting Continued Problem Possible Causes Solutions The system indicates that the There is a problem with the Cycle power to the system scanner is not responding error barcode scanner code 18 If the problem persists contact Codonics Technical Support 1 440 243 1198 Error Codes The following table lists the error codes that could be displayed in system messages Table 6 2 Error Codes Error Code 01 02 12 18 Description The system detected an error while printing the test print The user indicated that the test print failed The ink cartridge is not installed The ink cartridge is out of ink The ink cartridge is low on ink There is no label media loaded The printer front or rear cover is open The printer is not responding to the system The ink cartridge carrier cannot move The printer is not responding to the system or has an error The scanner is not responding to the system Troubleshooting Table 6 2 Error Codes Continued Error Code Description 19 The Calibrate Screen utility timed out before being completed or the user has indicated that the touch screen calibration failed 20 The user has indicated that the drug verification failed 21 The scanned drug container barcode previously failed a drug verification 25 On the syringe label pre print confirmation dialog box the user has pressed the Cancel button 30 The scanned barcode is n
30. 3 6 1 o output bin 2 6 P parts ordering 5 1 Patient labels 4 22 PIN user 3 2 entering 3 5 power cord ordering 5 1 power input port 2 9 Power LED front cover 2 6 touchscreen 2 10 power supply connecting 2 11 ordering 5 1 Power switch 2 9 power applying 2 11 powering off the system 3 20 precautions Codonics SLS 500i User s Manual 1 3 I 4 cleaning xxvi to xxvii 5 3 disinfecting xxvii to xxviii 5 4 location xxiv to xxv media xxviii safety xxii to xxiii prescription for use device xxxiii printer firmware version 6 6 information about 6 4 printing custom labels 4 23 purpose of User s Manual xi radio frequency interference xviii rear cover 2 6 removing 5 8 Reset button touch screen 2 10 restart 3 19 sS Safe Label System applying power 2 11 cleaning 5 2 cleaning precautions xxvi to xxvii 5 3 components inside front cover 2 7 components front 2 5 components rear 2 8 components touch screen 2 10 configuration number xvii configuration settings 2 24 configuration version 6 6 date code xvii device characteristics xxxi device description xxxi Index Safe Label System cont device indications for use statement xxxiii disinfecting 5 4 disinfecting precautions xxvii to xxviii 5 4 disposal requirements xxix electromagnetic emissions xix electromagnetic immunity xx formulary version 6 6 hazardous material information A 1 to A
31. 3 indications for use xxxi information about displaying 6 2 laser warning xvi License Code 2 24 location precautions xxiv to xxv location finding 2 1 log files 2 25 log files backing up 5 12 media precautions xxviii modification codes xvii parts ordering 5 1 powering off 3 20 printer firmware version 6 6 product features 1 2 to 1 3 radio frequency interference xviii restart 3 19 safety and compliance label locations xiii safety precautions xxii to xxiii serial number 6 6 serial number label xvii shipped components 2 2 to 2 4 shipping preparing for 5 18 shutdown 3 19 software version 6 6 software installing 5 5 specifications B 1 to B 3 starting up 2 14 status indicators 6 1 supplies ordering 5 1 swapping 5 17 Safe Label System cont system status 3 10 television frequency interference xviii troubleshooting 6 7 to 6 18 utilities 3 11 voltage warning xiv website xii safety location of labels xiii precautions xxii to xxiii scanner problems troubleshooting 6 17 serial number label xvii serial number of system 6 6 shipping the device preparing for 5 18 shutdown 3 19 SLS See Safe Label System SmartDrive information stored on 2 24 inserting 2 13 overview 2 24 software version 6 6 specifications B 1 to B 3 starting up the system 2 14 status indicators 6 1 status messages 6 1 status information about 6 3 supplies ordering 5 1 syring
32. 3 02 Dilute switch urrent date and time 3 10 Basic Operations as Utilities You can perform the following operations from the Utilities screen Adjusting the audio volume Adjusting the touch screen brightness Printing another copy of your user badge There are other utilities that are used to maintain the SLS and that are described in other chapters in this User s Manual Cleaning the ink cartridge nozzles Refer to Cleaning the Ink Cartridge Nozzles on page 6 23 Adjusting the label media path Refer to Adjusting the Media Path on page 6 26 Setting the black levels of a printed label Refer to Adjusting the Label Black Levels on page 6 28 Calibrating the touch screen Refer to Calibrating the Touch Screen on page 5 9 Copying system log files to a USB flash drive Refer to Backing Up Log Files on page 5 12 Clearing system errors Refer to Clearing Errors on page 6 30 Adding SLS features Refer to Adding a Feature on page 5 15 Codonics SLS 500i User s Manual 3 11 Displaying the Utilities Screen Ne Press the Utilities button To display the Utilities button Utilities screen Ocoponies c EX m DI e The Utilities screen displays Clean Nozzles Print My Badge Copy Logs Adjust Label Calibrate Screen Clear Errors Dark Print Off Manage Features Utilities Geseems OGG TE Cm Lam Le Le on 03 09 2011 13 46
33. 7 CODONICS We bring the future into focus SLS 500i Safe Label System User s Manual Codonics Catalog Number SLS500 MNLU April 20 2011 Version 1 2 0 042011 Codonics Inc 17991 Englewood Drive Middleburg Heights OH 44130 USA 440 243 1198 Phone 440 243 1334 Fax Email info codonics com www codonics com Copyright 2010 2011 by Codonics Inc All rights reserved worldwide Printed in the USA Part Number 905 062 020 No part of this document may be copied or reproduced in any form by any means without prior written consent of Codonics Inc 17991 Englewood Dr Middleburg Heights Ohio 44130 USA Although every effort has been made to ensure the accuracy of this document Codonics Inc assumes no responsibility for any errors that may appear Codonics Inc makes no commitment to update nor to keep current the information contained in this document Patents Pending All Rights Reserved Codonics the Codonics logo and We bring the future into focus are registered trademarks and Safe Label System is a trademark of Codonics Inc Sani Cloth is a registered trademark of Professional Disposables International Inc All other registered and unregistered trademarks are the property of their respective owners CAUTION Federal law restricts this device to be sold for use by or on the order of a physician European Authorized Representative CEpartner4U Esdoornlaan 13 3951DB Maarn The Netherlands
34. EC Council directive 89 336 EEC on the approximation of the laws of the Member States relating to electromagnetic compatibility This product satisfies the Class A limits of EN 55011 A declaration of conformity with the requirements of the Directive has been signed by a Codonics vice president Guidance and Manvfacturer s Declaration Electromagnetic Emissions The SLS is intended for use in the electromagnetic environment specified below The customer or the user of the SLS should assure that it is used in such an environment Emissions Test Compliance Electromagnetic Environment Guidance RF emissions Group 1 The SLS uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to CISPR 11 cause any interference in nearby electronic equipment RF emissions Class A The SLS is suitable for use in all establishments other than CISPR 11 domestic and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes Harmonic emission Class A IEC 61000 3 2 Voltage fluctuations Flicker Complies emissions IEC 61000 3 3 Codonics SLS 500i User s Manual xix Guidance and Manufacturer s Declaration Electromagnetic Immunity The SLS is intended for use in the electromagnetic environment specified below The customer or the user of the SLS should assure that it is used in such an environment Immunity Test IEC 606
35. LS for extended periods of time will cause damage Never use petroleum based solutions or abrasive cleansers e Never use abrasive material e Always dilute cleaning agents according to the manufacturer s instructions or use the lowest possible concentration Do not allow the cleaning agent to remain on the device surfaces Wipe it off immediately with a lint free cloth moistened with water For cleaning instructions refer to Cleaning the Enclosure on page 5 2 Preface Pr cautions d Entretien e Pour vit les dommages appareil regardez les pr cautions d entretien e Appliquez le nettoyeur sur un tissu propre et puis nettoyez l appareil Liquide qui est applique directement sur le appareil peut causer les dommages Utilisez beaucoup de pr cautions sur le conduit d a ration en bas de la cran et l baut parleur _ L appareil doit s cher compl tement avant marcher encore Ilya beaucoup des choses plastiques utilisant avec la fabrication du SLS L emploi des chiffons chimiques de benzene des diluants des insecticides ou des autres solvants peuvent causer les dommages l ext rieur ou les d formations Le caoutchouc ou le PVC qui ont beaucoup de contact avec le SLS causeront les dommages N utilisez jamais les nettoyeuses avec p trole ou les nettoyeuses abrasives e N utilisez jamais les mat rielles abrasive Toujours dilatez les nettoyeuses par les instructions du fabricant ou utilisez la conce
36. Media 5 80 noncondensing Codonics SLS 500i User s Manual B 1 Medical Compliance and Regulatory Classification FDA cleared to market per 510 k K101439 Class II MDD CE GMP QSR 8013485 2003 Safety IEC EN 60601 1 and EMC EMI EN 55011 A amp EN 60601 1 2 for Healthcare facilities Class 2 equipment Product Code BSZ Anesthesiology Device CAUTION Federal law restricts this device to be sold for use by or on the order of a physician Q Specifications French Syst me Cartouches Smart Drive Bar codes livrable Bar codes inscriptible Dimensions Poids Puissance B 2 Q Specifications Ordinateur avec cran tactile int gr 2d bar code scanner imprimante jet d encre feed back audio et prestation d un network interface Une cartouche coleur CMY USB flash drive pour garder data du configuration database de formulaire dossiers du registre RSS UPC A B C Data Matrix GS1 DataBar Limited RSS Limited GS1 DataBar Stacked RSS 14 Stacked UPC A Data Matrix Hauteur 41 9 cm 16 5 in Largeur 26 5 cm 10 43 in Profondeur 39 8 cm 15 67 in 14 5 Ibs 6 6 kg Universel Input 100 240 VAC 50 60 Hz Conditions du travail Op ration Temp rature 15 30 C 59 86 F Humidit 2096 8096 non condensation Transport et Stockage Altitude Niveau de la mer to 5790 m Temp rature appareil 22 2 51 C 8 123 8 F Temp rature les cartouches et les
37. SA Outside the USA Container IDs are used to identify drugs A drug s Container ID is included in its container barcode When you scan a drug container to initiate the printing of a syringe label the SLS uses the Container ID to find the correct drug information in the formulary database Container IDs and Master IDs USA Only In the USA 11 digit Master IDs and 10 digit Container IDs are used to identify drugs A drug s Container ID is included in its container barcode Master IDs always uniquely identify a drug However in rare cases the same Container ID could be used for up to three different drugs When you scan a drug container barcode to initiate the printing of a syringe label the SLS uses the Container ID to find the correct drug information in the formulary database The SLS looks for drugs with the same Container ID and for Master IDs that map to the Container ID The Master ID can be used to help locate the correct drug record when the Container ID is not in the formulary database Matching Container IDs Matching is the process that occurs when a drug container barcode is scanned on an SLS and the SLS determines that the Container ID in the barcode equals that is matches the Container ID for one or more drug records in the formulary database Printing Labels Mapping Container IDs to Master IDs USA Only Mapping is the process that occurs when a drug container barcode is scanned and there are 11 digit Maste
38. TM D4774 and ISO 28625 Specifications for User Applied Drug Labels in Anesthesiology is configurable by site and dataset Formularies datasets are uniquely named configurations that may differ in drugs colors dilutions and comments to accommodate different practices within a single site or hospital for example pediatric versus cardiac Codonics SLS 500i User s Manual xxxi xxxii Additional uses include producing labels for IVs and other artifacts used during a surgical procedure The Codonics SLS is generally placed in however not limited to the perioperative environment to identify syringes prepared for anesthesiology use during surgery Typical users of this system are trained professionals including but not limited to physicians nurses and technicians The major characteristics and functions of the family of devices include Scanning the drug container barcode directly from a vial or other type of container Decoding the manufacturer issued barcode into the required FDA National Drug Code NDO or Unique Drug Identifier UDI number Referring the NDC UDI number to a site managed formulary lookup database Providing audio and ISO compliant visual readback of the drug name Providing an alert if the drug container is listed as recalled obsolete in the site s formulary Printing an easy to read water resistant ISO 26825 compliant color label meeting The Joint Commission medication management standards and th
39. abel jam 5 Insert the hubs into the label media A ENN J Inserting the hubs into the label media Codonics SLS 500i User s Manual 2 21 6 Place the label media with hubs into the media guides Placing the label media with hubs into the media guides 7 Adjust the media guides into position to securely hold the label media while allowing it to turn freely 8 Place the leading edge of the label media below the two top media guides and into the feeder slot Placing the label media leading edge into the feeder slot 2 22 Setting Up the System Label media fed beneath media guides 9 Feed the label media leading edge further into the feeder slot until the SLS senses the labels and automatically feeds them through You might need to hold the label media in place for a few seconds P NOTE If the SLS fails to feed the label media open the front cover press the Unload button shown below remove the media from the media path wait until the media path rollers stop spinning and try loading the media again Unload button Codonics SLS 500i User s Manual 2 23 QSmarmrive and Stored Information 2 24 A The SLS SmartDrive is a USB flash drive that holds critical SLS information including configuration data and log files CAUTION The SmartDrive must be inserted for the system to operate If the SmartDrive is not inserted the system can start up but will not be a
40. abel is properly printed confirmed and adhered to the proper syringe NOTE It is recommended that syringes smaller than 5 cc ml have the printed label wrapped around the barrel of the syringe with the ends adhered together in a flag fashion Printing Labels Scanning the Drug Container Barcode 1 Press the Syringe label button L Syringe label To scan the DUNS drug container barcode ne Q IFZ MEN RC UE P RE 03 09 2011 13 02 Dilute switch 2 To include dilution information on the label for drugs that can be diluted press the Dilute switch to on This must be done prior to scanning the drug container barcode NOTE The dilution setting for each drug in the formulary has precedence over the Dilute switch setting Therefore the Dilute switch will be ignored if the drug is not allowed to be diluted or if it is required to be diluted For more information about determining a drug s dilution setting in the formulary refer to the SLS Administration Tool User s Manual Codonics SLS 500i User s Manual 4 5 4 6 VA A NOTE The Dilute switch is set to off at the completion of the label printing 3 Scan the drug container barcode by aligning the barcode with the barcode scanner located below the touch screen Scanning a barcode on a drug container NOTE Place the container below the scanner so that the red cross hair lines up on the barcode Placing the container closer to the cover
41. abel is printed Retrieve the label and go to Confirming the Printed Syringe Label on page 4 16 WARNING To avoid mislabeling syringes make sure that you immediately remove each label from the output bin after it is printed confirm the label and then affix it to the appropriate syringe before attempting to print another syringe label WARNING Unwanted labels should be destroyed or disposed of to ensure that incorrect labels are not used Codonics SLS 500i User s Manual 4 13 4 14 f A Confirming the Syringe Label Before Printing It If the system is configured to require visual confirmation of the label before printing it you are prompted to confirm the displayed label NOTE If a sound file has been configured for the scanned drug the system also announces the drug name and if specified the concentration when the label to be printed is displayed on the main screen GO Krees aum ST geht 03 24 2011 14 47 NOTE Labels as presented on the touch screen and in print form might not be an absolute match to how your SLS system administrator viewed them in the Administration Tool If the label is not correct or you do not want to print the label at this time press the Cancel button CAUTION A failed visual label confirmation is a serious issue It means that the formulary is wrong An SLS system administrator should be consulted immediately to review the logs and correct the formulary
42. age the time this status message first appeared is indicated The LED status indicator severity states are e Green Normal operation No issues Yellow Alert condition The system can still process jobs but requires user attention for example low ink Codonics SLS 500i User s Manual 6 3 6 4 Red Critical or fault condition The system might not be able to process jobs The system requires immediate user attention for example out of labels Printer Tab System Information Status Printer User System Contact Codonics to order media Labels part number 005 001 001 Ink Cartridges part number 004 003 001 Phone 1 440 243 1198 Email support codonics com Website www codonics com 10096 10096 10096 e Percent of ink remaining in the ink cartridge for all three colors e Codonics part numbers for ordering ink cartridges and label media e Codonics contact information for ordering ink cartridges and label media Troubleshooting User Tab System Information Status Printer User System User Name Admin User Initials ADN User ID 1111 Log In Time 03 09 2011 18 50 Previous Log In 03 09 2011 17 28 Name of the currently logged in user along with their initials ID current login time and previous login time Codonics SLS 500i User s Manual 6 5 System Tab System Information Status Printer User SIN 140C00017C Software Version 1 2 0 Printer Firmw
43. age did not install correctly 84 The USB flash drive that is inserted in USB port 1 on the side of the touch screen is either full not valid or has been removed in the middle of a log file copy operation 85 The installed version of the configuration is not compatible with the installed version of the SLS software 6 20 Troubleshooting CCiearing a Label Media Jam I2 1 Open the rear cover and tear the label media to separate the label roll from the portion of the label media that is jammed in the media path To clear a label media am 2 Open the front cover 3 Gently remove the label media from under the front guide Press the Load button to advance any portion of the label media that is still in the media path Remove the damaged labels Load button Codonics SLS 500i User s Manual 6 21 5 Press the Unload button to reverse any portion of the label media that is still in the media path Remove the damaged labels Unload button 6 If portions of the label media are still jammed in the media path power off the system refer to Powering Off the System on page 3 20 Then carefully remove the jammed portions of the label media with non metallic tweezers Do not try to pick the labels out with your fingers CAUTION If a label is peeled up in the media path do not press the adhesive side of the label against the sheet metal guides WARNING Re glove in the event of a cut or pinch to prevent
44. almost resting it on the cover instead of placing it closer to the scanner will also provide better results Printing Labels Selecting from Matching Container IDs Matching is the process that occurs when a drug container barcode is scanned on an SLS and the SLS determines that the Container ID in the barcode equals that is matches the Container ID for one or more drug records in the formulary database For single matches the matching drug record is automatically selected by the system In very rare instances if more than one match is found the matching drugs are listed in the Choose a drug to PRINT dialog box as shown below NOTE If there are multiple matches for a Container ID this dialog box will be displayed every time a drug container barcode with that Container ID is scanned Choose a drug to PRINT Naloxone 0 4 mg mL Ondansetron 2 mg mL Propofol 10 mg mL ln bell da ow You have three options e If none of the choices are correct press the Not Found button The system indicates that no drugs were selected and a syringe label is not printed Or in the USA if mappings are then found after pressing the Not Found button then the Choose a drug to LEARN dialog box displays Refer to Learning a Drug USA Only on page 4 8 codonies SLS 500i User s Manual 4 7 4 8 To cancel the print operation press the Cancel button The main screen displays If one of the
45. alog box displays The drug has now been learned Please scan container again to verify drug and print label The drug has been learned by the system The next time this drug container barcode is scanned the system will remember the correct drug information to use CAUTION SLS users can have an SLS learn drug containers Please contact your SLS system administrator for proper training and usage NOTE Learned drugs are added only to the individual SLS Global updates should be made in the Master Drug Database MDD and formulary using the Administration Tool For more information refer to the SLS Administration Tool User s Manual Codonics SLS 500i User s Manual 4 9 Verifying a Drug Verification is the process of scanning a drug container s barcode and verifying that the drug name and concentration that is in the formulary database match the drug name and concentration of the drug container By default each SLS requires that all scanned drug containers be verified the first time that each SLS sees them Refer to the SLS Administration Tool User s Manual for more information about verification configuration If a drug s verification status is Not Verified then the verification prompt displays SN Is this the correct drug Lorazepam 2 mg mL ne ES You have three options e If the displayed information does not match the drug container press the No button The system prompts you to confirm your deci
46. are 216 Formulary Version 2 03 10 2011 11 37 Configuration Version 2 03 07 2011 12 57 Serial number of the system e Current software version Current printer firmware version Current formulary version e Current configuration version Troubleshooting Crroubleshooting Common Problems The following table lists common problems their possible causes and how to solve them Table 6 1 Troubleshooting Problem Possible Causes System Problems The system fails to power on The system does not have power connected The external power supply has failed The system has lost power The system does not have power connected There is an internal power problem The SmartDrive is not inserted in USB port 2 inside the touch screen rear panel door During startup the system indicates that the SmartDrive is missing error codes 70 71 During startup the system The version number on the indicates that the SmartDrive is not SmartDrive does not match the compatible with the SLS version number of the SLS application error code 73 application The system is not responding A variety of conditions Solutions Check the power cables Check the power supply switch on the rear panel Replace the external power supply Check the power cables Check the power switch on the rear panel Cycle power to the system Contact Codonics Technical Support 1 440 243 1198 Insert the SmartDrive Refe
47. are can be updated A formulary update package includes the formulary database which contains drug records and associated content such as drug specific label templates sound files watermark images and localization files A configuration package includes the configuration settings for the SLS WARNING The formulary or configuration should be updated only when the SLS is not in use CAUTION Installing system software should only be performed as directed by Codonics Technical Support Do not attempt to install system software without the assistance of Codonics Technical Support An administrator uses the SLS Administration Tool to create these update packages and store them on a USB flash drive for installation in an SLS For more information about creating update packages refer to the SLS Administration Tool User s Manual You might also need to update system software which will be stored on a USB flash drive NOTE If the formulary update package contains a formulary in Test Review mode the yellow LED on the Dashboard will be on and a system message will indicate that the system is in Test Review mode Any syringe label that is printed while in this mode will have a watermark indicating that it is a test label and for demo use only NOTE It is strongly recommended that each SLS customer create and set up a process and audit plan to check that the latest approved versions of the formulary and configuration are correctly deployed on
48. be replaced replace it only with another Codonics power cord or Codonics external power supply Alternatively replace it with a power cord or external power supply manufactured specifically for your power configuration If the device is smoking or making unusual sounds power off and unplug the device immediately Do not insert foreign objects of any kind into the device doing so can constitute a safety hazard and cause extensive damage Do not place any liquid containers on the device If for some reason liquid seeps into the device power off the device and unplug the power cord from the source outlet If used without taking corrective measures the device may be damaged Do not expose the device to flammable gases in concentrations high enough to cause fire or explosion Preface Pr caution d Emploi Ne jamais brancher cet appareil sur une source d alimentation lectrique dont la tension ou la fr quence different des valeurs indiqu es 100 240 VAC 50 60 Hz Utiliser uniquement l alimentation lectrique fourni avec l appareil numero de pi ce Codonics SLS PS Avant de remplacer le appareil veuillez toujours teindre l appareil et n oubliez pas de d brancher le c ble secteur Un fil lectrique endommag est une cause d incendie ou de d charge lectrique En d connectant le fil lectrique tenez le seulement par la prise et retirez la prise soigneusement e Sile fil lectrique ou l alimentatio
49. ble to process jobs A message at the touch screen will prompt you to insert the SmartDrive The SmartDrive also allows you to move the configuration files of one SLS to another SLS thus allowing the second SLS to operate exactly like the first This feature is especially helpful when swapping an SLS for service purposes NOTE A SmartDrive cannot be duplicated That is it cannot be used in two SLS units at the same time Information Stored on the SmartDrive The SLS SmartDrive stores the following information The SLS Software License Code This is the serial number for the SLS software All keyed features are keyed from the License Code The SLS Configuration This includes all of the system s configuration settings e Formulary database This is a backup copy of the formulary database that is stored in the SLS Tracking database This is the database that is used to track user events for example when a user logs on or off the system or when a user prints a label Setting Up the System Log files These include installation logs system logs and event audit logs The SLS configuration formulary database tracking database and log files that are stored on the SmartDrive are encrypted to ensure the security of the data Events That Synchronize Data to the SmartDrive The following events trigger a synchronization of the SLS data with that stored on the SmartDrive e Automatically every 15 minutes e Shutting
50. choices is correct select it and press the OK button A confirmation dialog box displays Learning a Drug USA Only Mapping is the process that occurs when a drug container barcode is scanned and there are 11 digit Master IDs that could potentially map to the scanned 10 digit Container ID For example a pharmacist enters only a drug s 11 digit Master ID when adding the drug to the formulary When a user scans that drug s container barcode for the first time and there are no 10 digit Container ID matches the SLS will look for all 11 digit Master IDs that could potentially map to the drug s Container ID Learning is the process of associating the 10 digit Container ID from a scanned drug container barcode with a mapped 11 digit Master ID If the Container ID has mappings in the formulary database then any Master ID mappings that are found for the Container ID are displayed in the Choose a drug to LEARN dialog box Choose a drug to LEARN Ketorolac 30 mg mL Propofol 10 mg mL eee acum ez cm Printing Labels D You have three options If none of the choices are correct press the Not Found button The system indicates that no drugs were selected and a syringe label is not printed A custom label can then be selected for printing To cancel the print operation press the Cancel button The main screen displays If one of the choices is correct select it and press the OK button A confirmation di
51. d USB port 1 at the left side of the touch screen p ASS Reset button and USB port 1 at left side of touch screen The Power LED lights when the touch screen is powered on The Reset button is used to reboot the system software in the event of a critical failure If required use a pen or other pointed tool to press the Reset button P NOTE Do not use the Reset button unless directed to do so by Codonics Technical Support 5 e USB porti is used for connecting USB flash drives that contain software and formulary updates 2 10 Setting Up the System QU Connecting the External Power Supply Ne 1 Locate the external power supply included with your SLS To connectthe 2 Plug the external power supply into the Power Input port on the rear panel of the SLS external power supply Connecting the external power supply Codonics SLS 500i User s Manual 2 11 3 Connect the power cord from the external power supply to a grounded power outlet that supplies the appropriate voltage for the applicable country WARNING The power cord plug is the main disconnect for the device The power outlet should be near the device and be easily accessible WARNING Remove the power cord plug from the power outlet to disconnect overall power to the device WARNING Grounding reliability can be achieved only when the SLS is connected to a receptacle marked Hospital Only that is Hospital Grade GE Once the
52. ding USB and an integrated speaker Touch screen display with an intuitive easy to use interface System operation and status information is easily accessible from the touch screen interface Introduction Barcode scanner identifies medications High quality Codonics SLS inkjet cartridge and labels provide reliable printing and adhesion for syringe labeling Convenient label media and ink cartridge access is provided for ease of replacing labels and ink Operational Features Easy to service with Codonics Return to Factory Warranty An optional Express Warranty program is also available which provides a replacement SLS if the problem cannot be solved by our Technical Support team Also the SmartDrive allows all configurations settings to be quickly transferred to a replacement SLS This minimizes downtime and reconfiguration effort Codonics SLS 500i User s Manual 1 3 Setting Up the System G Finding a Location for the System When finding a suitable location for the system use the following guidelines Place the system in a location with adequate air circulation to prevent internal heat build up Do not place the system near heat sources such as radiators or air ducts or in a location subject to direct sunlight excessive dust mechanical vibration or shock Do not block air ventilation at the rear of the system Make sure that the countertop or work surface supporting the system is level can support the weight
53. djust the black levels of printed labels to improve their print contrast If ink bleeding or barcode printing issues occur the black levels adjustment should be turned off Ne 1 Press the Utilities button at the top of the user interface To adjust the Utilities button label black levels SYRINGE BLANK PATIENT eel The Utilities screen displays 6 28 Troubleshooting 2 Press the Dark Print Off button the button is in the Dark Print Off state by default Press Dark Print Off Clean Nozzles Print My Badge Copy Logs Calibrate Screen Clear Errors Utilities Manage Features Q coponics TJQQ re 2 ADN O The button label changes to Dark Print On which indicates that the black levels adjustment has been turned on and the black levels for labels increased 3 To turn off the black levels adjustment press the Dark Print On button Codonics SLS 500i User s Manual 6 29 EElearing Errors Sometimes a permanent error state needs to be cleared in the SLS software P NOTE This function should only be performed by a qualified and trained SLS system administrator or in coordination with Codonics Technical Support Ne 1 Press the Utilities button at the top of the user interface To clear errors Utilities button The Utilities screen displays 6 30 Troubleshooting 2 Press the Clear Errors button Press Clear Errors Clean Nozzle
54. down the system e Formulary updates Codonics SLS 500i User s Manual 2 25 Basic Operations CAUTION Users should read and understand all safety warnings and operating instructions prior to using the system Making a User Badge At the Login prompt you can choose to make and print a user badge for yourself You can then log in to any SLS by scanning the barcode on the badge If you have already made a badge and just need to reprint it refer to Printing a User Badge on page 3 15 Us 1 At the Login prompt press the Make User Badge button r 1 To make a user Scan User Badge or Enter User ID to Log In badge Make User Badge Press Make User Badge Codonics SLS 500i User s Manual 3 1 You are prompted to enter your user information Enter User Badge Information Full Name Employee ID Initials PIN Confirm PIN Please enter Full Name iwi sai a cud cun can jaa jul uc can pmi rui ico ici jc pcm ac kees 2 Enter user information by pressing each field and using the on screen keyboard NOTE The PIN can be up to ten digits long If the system is not configured to require a PIN then you will not be prompted to enter one 3 When you have entered your user information press the Print button The badge is printed and placed in the output bin The Login prompt is displayed Your user information is stored in the system You can now u
55. e American Society of Anesthesiologists guidelines for labeling Providing the basic information by which the printed label barcode can be read to document medication administration in an AIMS Printing labels with insertion and expiration date and time for IV lines Preface Device Indications for Use Statement Prescription Use Device The Codonics SLS device and SLS software provides a simple computer based barcode scanning and printing system to automatically verify drug identity from NDC and other drug container UDI barcodes and to print labels for prepared drugs and other items in use on patients during surgical procedures The Codonics SLS is generally placed in however not limited to the perioperative environment to identify syringes prepared for anesthesiology use during surgery Additional uses include producing labels for IVs and other artifacts used during a surgical procedure SLS can also be used to print non surgical environment color and text labels as required Typical users of this system are trained professionals including but not limited to physicians nurses and technicians Codonics SLS 500i User s Manual xxxiii Introduction Welcome and Congratulations Congratulations on your purchase of the Codonics Safe Label System SLS medication labeling system We are pleased that you chose the SLS We are confident that it will provide safe compliant fast medication labeling Codonic
56. e labels confirmation problems troubleshooting 6 12 confirming after printing 4 16 confirming before printing 4 14 printing 4 4 System Information button 3 10 6 2 System Information screen 6 2 Printer tab 6 4 Status tab 6 3 System tab 6 6 User tab 6 5 system information displaying 6 2 system log files 2 25 backing up 5 12 System problems troubleshooting 6 7 system serial number 6 6 System software installing 5 5 version 6 6 system information about 6 6 T television frequency interference xviii test label printing 3 6 verifying 3 7 Test Review mode 5 5 touch screen 2 6 blanking due to system inactivity 3 18 brightness adjusting 3 14 calibrating 5 9 components 2 10 main screen elements 3 10 problems troubleshooting 6 10 rear panel door 2 13 USB port 1 2 6 5 6 tracking database 2 24 troubleshooting 6 7 to 6 18 barcode scanner problems 6 17 drug container barcode problems 6 11 formulary problems 6 10 ink cartridge problems 6 16 label printing problems 6 14 syringe label confirmation problems 6 12 System problems 6 7 touch screen problems 6 10 Codonics SLS 500i User s Manual I 5 Unload button 2 8 5 18 6 22 USB port 1 touch screen 2 6 2 10 5 6 USB port 2 behind rear panel door 2 8 rear panel door 2 13 user information about 6 5 logging in 3 3 user badge making 3 1 printing 3 15 scanning barcode 3 3 User s Manual purpose xi utilities 3 11 Adjust
57. e session and all print jobs have completed before shutting down or restarting the system software Make sure that the device is properly powered off to allow the ink cartridge to be sufficiently capped codonies SLS 500i User s Manual 3 21 lt gt Printing Labels Overview The SLS allows you to scan a drug s barcode and easily print a label containing information about the drug the preparer the time of preparation and other information for example concentration dilution notice user defined warnings expiration times to be affixed to a syringe It also allows you to print custom labels that have been configured for your site Formulary Database Information about scanned drugs is contained in the formulary database that was installed on the SLS The formulary database is managed by an administrator using the SLS Administration Tool For more information about the Administration Tool refer to the SLS Administration Tool User s Manual Each drug record in the formulary database contains use and labeling information audio announcements that are played when the drug record is found whether the dilution should be forced or not allowed for the drug and a choice of concentrations and diluents To ensure safety no changes are ever written to the formulary database in the SLS and all formulary updates are handled by a full overwrite of the database Codonics SLS 500i User s Manual 4 1 Container IDs Outside the U
58. each SLS Codonics SLS 500i User s Manual 5 5 L To update packages or system software 5 6 1 Log in to the SLS as described in Logging In on page 3 3 2 Insert the USB flash drive into USB port1 on the left side of the touch screen a Inserting the USB flash drive into the touch screen USB port 1 You are prompted to confirm installation of the packages or software on the USB flash drive 3 Press the Yes button to continue with the installation After copying the installation files to internal memory the system displays a message indicating that the installation process is beginning and that the USB flash drive can be removed 4 Remove the USB flash drive The system displays status of the installation process During installation the system is not usable and cannot be interrupted Maintenance pb When installation is complete the system displays a completion message 5 Press the OK button to dismiss the message The system then either restarts the software or restarts the entire system depending on the specifics of the update Formulary package updates do not require a full system restart Configuration package updates require a full system restart Software updates might require a full system restart depending on the details of the software update CAUTION The SLS customer is responsible for ensuring that the correct formulary is being installed in the SLS CAUTION Practice standa
59. els of debris Do not locate the SLS in hot springs areas where hydrogen sulfide and acidic ions are likely to be generated Do not locate the SLS where there are oily fumes and vapors Do not locate the SLS in direct sunlight Do not locate the SLS near sources of high RF energy Do not locate the SLS where it might be subject to jarring or vibrations such as a table or desk in a high traffic area Jarring and vibrations can affect the print quality of labels If using a VESA mount to mount the device on a wall stand or anesthesia supply cart refer to the VESA Mounting Interface Standard MIS available at www vesa org for proper location and installation information Preface Environnement de Fonctionnement e Les conditions normales d utilisation de l appareil sont une temp rature de 15 30 C et une bumidit relative de 20 80 96 En cas de variation rapide de la temp rature de la condensation peut se former En ce cas la n utilisez pas l appareil attendez que la condensation se soit vapor e Vous pouvez acc l re cette vaporation en d placent l appareil dans un endroit sec Toujours placez l appareil dans une zone propre et non bumide Des particules de poussi res peuvent causer des disfonctionnements de la qualit d imprimante vitez de placer l appareil proximit d une bouche de ventilation d une porte ou d un endroit tr s fr quent car cela pourrait exposer l appareil ainsi que les
60. et tiquettes 1 43 C 34 110 F Humidit appareil 5 85 non condensation Humidit les cartouches et les et tiquettes 596 8096 non condensation Conformit M dical Conformit M dicale R glementaire approuv par la FDA num ro 510 k K101439 R glementaire Class I MDD CE GMP QSR ISO13485 2003 Conformit IEC EN 60601 1 et EMC EMI EN 55011 A amp EN 60601 1 2 pour les tablissements m dicaux Equipement de Classe 2 code de produit BSZ appareil d anesth siologie Classification Class 2 quipement code de produit BSZ appareil d anesth siologie CAUTION Conform ment la loi il est interdit de vendre cet appareil par l ordre d un m decin Codonics SLS 500i User s Manual B 3 Index A Accessory Kit box 2 2 Adjust Label utility 6 26 associating a Master ID with a Container ID 4 3 4 8 audio speaker 2 6 audio volume adjusting 3 13 barcode scanner 2 6 problems troubleshooting 6 17 barcodes drug container troubleshooting problems 6 11 scanning from drug container 4 5 verification 4 3 4 10 black levels of labels adjusting 6 28 Blank labels 4 19 brightness adjusting 3 14 c Calibrate Screen utility 5 9 calibrating the touch screen 5 9 cartridges See ink cartridges Clean Nozzles utility 6 23 cleaning precautions xxvi to xxvii 5 8 cleaning the enclosure 5 2 Clear Errors utility 6 30 CN configuration label xvii Codonics email address xii
61. et des t trachlorures de carbone Manufacturing During manufacturing operations that produce Codonics products including packaging no ozone depleting substances such as chlorofluorocarbons methyl chloroform and carbon tetrachloride are used Fabrication Aucun composant susceptible de d truire la couche d ozone ne sont utilis s lors de la fabrication emballage inclus des produits Codonics Codonics SLS 500i User s Manual 3 A 3 Specifications Q Specifications English System Ink Cartridges SmartDrive Readable Barcodes Writable Barcodes Dimensions Weight Power Environmental Integrated touch screen computer 2D barcode scanner color ink jet printer audio feedback and provision for a network interface One color cartridge CMY USB flash drive for storing configuration data formulary database log files GS1 DataBar Limited RSS Limited GS1 DataBar Stacked RSS 14 Stacked UPC A Data Matrix Data Matrix Height 16 5 in 41 9 cm Width 10 43 in 26 5 cm Depth 15 67 in 39 8 cm 14 5 Ibs 6 6 kg Universal Input 100 240 VAC 50 60 Hz Operating Temperature 15 30 C 59 86 F Humidity 20926 8096 noncondensing Shipping and Storage Altitude Sea Level to 5790 m Temperature Hardware 22 2 51 C 8 123 8 F Temperature Ink Cartridge and Label Media 1 43 C 34 110 F Humidity Hardware 596 8596 noncondensing Humidity Ink Cartridge and Label
62. f and a status message area Alert condition The system can Critical or fault condition The still process jobs but requires user System might not be able to process attention for example low ink jobs The system requires immediate user attention for example out of labels Normal The system is ready to process or is processing a job for example printing Muted icon Displays when the volume is muted Status messages Ready OO ww 3 CENA ENT EH Codonics SLS 500i User s Manual 6 1 I To display system information isplaying System Information You can display information about the SLS configuration and its current status Press the System Information button System Information button The System Information screen displays System Information Status Printer User 04 07 2011 13 26 Press the OK button to dismiss the System Information screen 6 2 Troubleshooting The four tabs in the System Information screen include the information described in the following topics Status Tab System Information Status Printer User System 04 07 2011 13 26 e A list of active system status messages Fach line of the list has a descriptive message about the status To the left of each message there is an LED status indicator that displays the color coded severity of the system state To the right of each mess
63. g approved cleaning agents Ammonia Dilution of Ammonia lt 3 Alcohol Ethanol 70 Isopropanol 70 Over time ink overspray might gather at the base of the device The device uses a vacuum system to gather most of this ink on a series of saturation pads Eventually these pads might need to be replaced Contact Codonics Technical Support to determine if pad replacement is necessary If ink has gotten onto the system s enclosure it can be cleaned with an ammonia based window cleaner and a lint free cloth If scanning barcodes is inconsistent or the device is having difficulty scanning clean the scanner s glass window Maintenance Cleaning Precautions To avoid damage to the device observe the following general precautions for cleaning the device e Apply the cleaner to a clean lint free cloth first and then clean the device Liquid applied directly to the device could possibly leak inside the device and cause damage Use extra caution when cleaning around the vents on the back of the touch screen and rear panel e Allow the device to completely dry before operating it again Many plastic components are used in the SLS construction Coat flecking and deformation is likely to occur if the device is wiped with chemical dusters benzene thinners insecticides or other solvents Rubber and PVC materials left in contact with the SLS for extended periods of time will cause damage Never use petroleum based solutions
64. g a not being dropped into the output path Label Media Jam on page 6 21 bin A label is jammed in the discharge Place your finger on the leading edge of slot above the output bin the label and pull it forward to pull the label from the discharge slot Labels are not being printed The software scanner or printer is Follow on screen resolution prompts to correctly For example after not operating properly correct issues scanning a barcode to confirm a printed label the system displays an error message indicating that the scanned barcode is not correct Poor print quality Saturation Adjust the label black levels Refer to Adjusting the Label Black Levels on page 6 28 The wrong labels are loaded Load the correct labels for an SLS The ink cartridge is not functioning Replace the ink cartridge with a proper properly SLS ink cartridge from Codonics Refer to Installing the Ink Cartridge on page 2 16 The ink cartridge has been refilled Use only new ink cartridges from Codonics Ink Cartridge Problems The system indicates that the ink The ink cartridge is about to Install a new ink cartridge Refer to cartridge is low error code 5 on become empty or is empty Installing the Ink Cartridge on ink or out of ink error code 4 page 2 16 6 16 Troubleshooting Table 6 1 Troubleshooting Continued Problem The system indicates that the ink cartridge is not installed error code 3 The ink cartridge ca
65. he label is affixed to it Print another label or a blank label If the problem persists contact your SLS system administrator Codonics SLS 500i User s Manual 6 13 Table 6 1 Troubleshooting Continued Problem Possible Causes Solutions Label Printing Problems The test label fails to print error A variety of printer conditions Print the label again code 1 Check to make sure that there are labels on the label media and that the label media is properly loaded Check the ink cartridge Cycle power to the system The test label did not print correctly A variety of printer conditions Refer to the appropriate problem in this error code 2 table for a solution The system indicates that the The user cancelled the print If the content of the preview syringe printing of a syringe label was operation at the pre print label did not match the drug container cancelled confirmation whose barcode was scanned contact your SLS system administrator to correct the drug record problem in the formulary The system indicates that itis out The label media is empty Install new label media Refer to of label media error code 6 Loading or Replacing the Label Media on page 2 20 6 14 Troubleshooting Table 6 1 Troubleshooting Continued Problem Print is light there is banding or gaps or there is no printed image Printed content is not properly centered on the label Labels are incorrectly cut Pr
66. inted labels are not being cut Possible Causes The ink cartridge is low or out of ink The ink cartridge is clogged The ink cartridge still has the protective seal on it Low quality labels are being used The ink cartridge has been refilled The media path is out of alignment The cutter is out of adjustment Labels are not being advanced correctly The label offset is not set correctly The cutter is not properly positioned Solutions Replace the ink cartridge Refer to Installing the Ink Cartridge on page 2 16 Purge the ink cartridge refer to Cleaning the Ink Cartridge Nozzles on page 6 23 Remove the ink cartridge and wipe the copper contacts with an alcohol based wipe Remove the ink cartridge and peel the protective seal from the cartridge Use only Codonics labels For ordering information refer to Ordering Supplies and Parts on page 5 1 Use only new ink cartridges from Codonics Adjust the media path Refer to Adjusting the Media Path on page 6 26 Contact Codonics Technical Support 1 440 243 1198 Reload the labels Adjust the media path Refer to Adjusting the Media Path on page 6 26 Contact Codonics Technical Support 41 440 243 1198 Codonics SLS 500i User s Manual 6 15 Table 6 1 Troubleshooting Continued Problem Possible Causes Solutions Labels are being printed but are Labels are jammed in the media Clear the label jam Refer to Clearin
67. ion Problems The displayed label in the pre print confirmation screen was incorrect so the user pressed the Cancel button error code 25 The confirmation scan of a printed syringe label s barcode failed error codes 30 31 32 Troubleshooting There is an error in the formulary unless the user just decided that they did not want to print the label The barcode that was scanned was not a syringe barcode error code 30 The barcode that was scanned was not the syringe barcode of the label that was just printed error codes 31 32 Solutions Make sure the barcode on the drug container is of good quality Use the Administration Tool to correct the drug information in the MDD create a new version of the formulary update package and load the new version into the SLS For more information refer to the SLS Administration Tool User s Manual If the label content or label color are incorrect discard the label or the syringe if the label is affixed to it and contact your SLS system administrator Scan the barcode on the syringe label that was just printed Make sure that the label whose barcode you are scanning is the label that was just printed e fitisnot then scan the correct label e If it is then the label did not print correctly Do not use the label or the syringe if the label is affixed to it Contact your SLS system administrator and Codonics Technical Support 1 440 243 1198 t
68. ion from structures objects and people a Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TB broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength is the location in which the SLS that is used exceeds the applicable RF compliance level above the SLS should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the SLS P Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m Codonics SLS 500i User s Manual xxi xxii Safety Precautions Never connect the device s external power supply to any outlet or power supply that has a voltage or frequency different than that specified 100 240 VAC 50 60 Hz Use only the external power supply provided with the device Codonics part number SLS PS When replacing the device always power it down refer to Powering Off the System on page 3 20 and disconnect the AC power cord prior to servicing it Damage to a power cord is a fire and shock hazard When unplugging a power cord hold it by the plug only and remove the plug carefully If a power cord or external power supply needs to
69. labels The following actions may resolve the problem Print the test label again Clean the ink cartridge nozzles using the Utilities screen Replace the ink cartridge or labels Cycle power on the system If problems persist contact your system administrator DE Basic Operations 6 To print another test label press the Try Again button Another test label prints and you are prompted again to confirm the test label To attempt to resolve the printing problem press the Continue button The Utilities screen displays and the SLS is put into an out of service state 7 To troubleshoot the printing problem and perform the recommended solution refer to Table 6 1 on page 6 7 The system cannot leave the out of service state until you press the Yes button in response to the prompt to confirm that the test label printed correctly So after each solution you try print another test label If the utility you use does not do this automatically you can log out and log in again to have the system print a test label 8 If the test label still does not print correctly after trying the suggested solutions contact your SLS system administrator Codonics SLS 500i User s Manual 3 9 uch Screen User Interface The elements of the main screen are identified in the following figure LED status indicators System status System Information button Wer User initials Label type buttons Utilities button Logout button 03 09 2011 1
70. m B 1 Specifications FrenclT u E B 2 Index viii Contents Preface conventions Used in This Manual La To install an ink cartridge Bulleted Lists Bullets are used to display a list of nonprocedural items For example The following events trigger a synchronization of the Safe Label System data to that stored on the SmartDrive e Automatically every 15 minutes e Formulary updates Numbered Steps The Cas icon indicates the beginning of a procedure The steps in a procedure are numbered For example 1 Open the front cover 2 Press the Ink button Codonics SLS 500i User s Manual ix gt D Notes Notes contain additional information related to a topic or procedure For example NOTE The system will ensure that a test print is performed at least once a day Cautions and Warnings Cautions alert you to actions or situations that could cause harm to equipment or data For example CAUTION Do not touch the copper area of the cartridge print head Warnings alert you to actions or situations that could result in personal injury For example WARNING When the front cover is open avoid contact with the label cutter Important Information and Filenames Bold type is used for emphasis user interface object names and paths or filenames For example The Barcode Scanner scans drug container barcodes for identity and verification e Use the controls to correct the date and time then
71. me or concentration are provided for the labeling of drugs that do not have an NDC barcode on them are not in the formulary or cannot be read by the barcode scanner One copy of the Blank label will be printed when it is selected Ocoponics QQ Sen OO O SYRINGE E3 Tre 03 09 2011 16 15 Codonics SLS 500i User s Manual 4 19 4 20 Lines These labels are provided for the labeling of invasive monitoring lines used commonly in anesthesia One copy of the Lines label will be printed when it is selected me OE CC RZ HR se A ns e be ve UVP er Ka eon 99 Ocoponics 09 SYRINGE 03 09 2011 16 15 Printing Labels IV These labels are provided for the labeling of the general IV line and catheter Two copies of the IV label will be printed when it is selected 03 09 2011 16 17 codonies SLS 500i User s Manual 4 21 Patient These labels are provided for the labeling of the reports and specimens Two copies of the Patient label will be printed when it is selected 03 09 2011 16 21 4 22 Printing Labels Printing Custom Labels T 1 Press one of the custom label buttons To print a Custom label buttons custom label 03 09 2011 13 02 Codonics SLS 500i User s Manual 4 23 4 24 The system displays a selection of the custom labels that are available for that category Scroll buttons m ME Available labels 2 If
72. n lectrique doit tre remplac utilisez un fil lectrique ou un alimentation lectrique Codonics fabriqu sp cifiquement pour votre appareil e Sil appareil fume ou met des bruits inbabituels arr tez le imm diatement et d branchez le fil lectrique e Nintroduisez aucun objet tranger dans l appareil cela peut tre une source de danger et peut causer de graves dommages Ne d posez aucun r cipient cot de l appareil Si pour quelque raison un liquide filtre l int rieur arr tez imm diatement l appareil et d branchez le fil lectrique Toute nouvelle utilisation de l appareil sans intervention peut causer de graves dommages Ne pas utiliser l appareil cot d une source de gaz inflammable Codonics SLS 500i User s Manual xxi xxiv Location Precautions The operating ambient temperature range of the SLS is 15 30 C 59 86 F with a relative humidity of 2096 8096 If the SLS is moved quickly from an extremely cold location to a warmer one condensation is likely to form Do not use the SLS if condensation has formed Wait until the condensation has evaporated You can speed up the evaporation time by moving the SLS to a dryer location Do not place the SLS in a location with high humidity or high dust Airborne dirt particles can cause print quality problems Avoid placing the SLS in locations where ventilation ducts open doors or frequent passers by might expose the SLS and labels to high lev
73. nics Technical Support so that they can direct you through the required steps Codonics SLS 500i User s Manual 5 17 La To prepare the SLS for shipping CPreparing the System for Shipping If you have to ship the SLS for any reason for example to return it to Codonics for service you must use the original boxes and packing materials If you do not have the original box and packing materials contact your Codonics representative for instructions on how to return the SLS 1 With the SLS powered on open the front cover and press the Unload button to back out the label media so that it can be removed Unload button 2 Open the rear cover remove the label media and close the rear cover 3 Shut down the SLS Refer to Shutting Down or Restarting the System on page 3 19 5 18 Maintenance Press the Ink button Ink button The ink cartridge carriage moves to a position that allows you access to the ink cartridge 5 Remove the ink cartridge and close the front cover For information about how to remove the ink cartridge refer to Installing the Ink Cartridge on page 2 16 6 Set the Power switch on the rear panel to Off Power switch Power switch on the rear panel Codonics SLS 500i User s Manual 5 19 Troubleshooting fatus Indicators The Dashboard includes three LED style lights that indicate the overall status of the SLS a Muted icon if the volume has been turned of
74. ning Pr cautions m xxvi Pr cautions d Entretien iii iiiiiuiiiiiiicceeesscrcrceneansececeecenanseeeceeennseeeeeses xxvii DISINTECHING Pr cautions te trae n Est b elvis rte erede bad dee bue re xxvii Pr cautions de D sinfection sise xxviii Media Hrecautong T xxviii Pr cautions de M dia et Consommables nennen nennen xxviii Disposal Ee UH E LC XXix Conditions et R gles d U lteatton ennemis Xxix European Disposal Requirements nennen XXix Indications for E M xxxi D vice Description Re xxxi Device Characteristics sise xxxi Device Indications for Use Statement Prescription Use Device xxxiii Chapter 1 Introduction Welcome and Congratulations usines 1 1 Product e TE 1 2 Hardware F AtUrSS c 1 2 Operational Features 1 3 Chapter 2 Setting Up the System Finding a Location for the System sise 2 1 Shipped Components suisses 2 2 Identifying the Components sise 2 5 SES Front Combponehlts orte te eer tea reda tux ea ater aaa dE ped ane inst 2 5 Components Inside SLS Front Cover 2 7 SLS Rear Components idet aii avin sa Du d Bue cp Ea aar cei died ve Ed EEEN 2 8 elle 2 10 Contents Connecting the External Power Supply iii 2 11 Inserting the SmanDiVE m mana Den at een a enter tele ee enr ee rite 2 13 Star
75. ntration le plus faible Ne laissez pas les nettoyeuses la surface de l appareil pour longtemps Donnez un coup d ponge propre Pour instructions d entretien regardez Cleaning tbe Enclosure sur la page 5 2 Disinfecting Precautions To avoid damage to the device observe the following general precautions for disinfecting the device Do not use Povodine Sagrotan or Mucocit disinfecting agents or strong solvents for example acetone Do not use any disinfecting agents that corrode or damage polycarbonate Codonics SLS 500i User s Manual xxvii Pr cautions de D sinfection Pour vit les dommages appareil regardez les pr cautions de d sinfection e N ulilisez pas de Provodine du Sagrotan ou de Mucocit d sinfectant ou les solvents fortes e N utilisez pas les d sinfectants qui corroder polycarbonate Media Precautions e Unwanted labels should be destroyed or disposed of to ensure that improper labels are not used Only use Codonics ink cartridges and labels to ensure proper operation of the device and proper labeling of syringes Using unapproved ink cartridges and labels could lead to unacceptable results including poor print quality and poor label adhesion to syringes e Never refill ink cartridges as this can result in incorrect color usage Pr cautions de M dia et Consommables Les tiquettes inutilis es doivent tre dispos ou d truit donc les tiquettes mauvais ne sont
76. o notify them of the problem Table 6 1 Troubleshooting Continued Problem Possible Causes The visual confirmation of a printed The wrong drug information was syringe label failed that is on the post printing confirmation dialog box the user has pressed the No button error code 37 and then pressed the Content Error error code 35 or the Printing Error error code 36 button The confirmation of a printed syringe label is not able to be performed error code 33 printed on the syringe label error code 35 The label print quality is not satisfactory error code 36 The user pressed the Unable to Scan button Solutions Discard the label or the syringe if the label is affixed to it try printing the syringe label again and contact your SLS system administrator to notify them of the problem If the wrong drug information is printed again then the match between the Container ID in the scanned barcode and the Container ID in the drug record in the formulary is incorrect The drug record in the formulary needs to be corrected For more information refer to the SLS Administration Tool User s Manual Discard the label or the syringe if the label is affixed to it try printing another one and contact your SLS system administrator to notify them of the problem If the problem continues refer to the label problems and solutions described below in this table Discard the label or the syringe if t
77. of the device shown on the following page This device complies with part 15 of the FCC Rules Operation is subject to the following two conditions 1 This device may not cause harmful interference and 2 this device must accept any interference received including interference that may cause undesired operation This Class A digital apparatus complies with Canadian ICES 003 Cet appareil numerique de la Classe A est conform a la norme NMB 003 du Canada This product is in conformity with the requirements of EC Council directive 93 42 EEC on the approximation of the laws of the Member States relating to medical devices This product satisfies the Class A limits of EN 60601 1 and CISPR 11 CODONICS Gir NEA US SLS Safe Label System CONFORMS TO Made in US A wwe Mm Ce Patents Pending CAN CSA STD C22 2 NO 601 1 All Rights Reserved e CEpartner4U BV Esdoomlaan 13 PER oo DG Maam Tho Netherlands MODEL MODELE Phone 31 6 516 536 26 SLS 1 Codonics Inc 17991 Englewood Dr Middleburg Heights OH 44130 USA E SLS safety and compliance label Codonics SLS 500i User s Manual e e Safety and compliance s label location O e fe HM A Em Hl Ex J SLS safety and compliance label on bottom
78. ot a drug container barcode 31 On the failed syringe label scan dialog box the user has pressed the Try Again button 32 On the failed syringe label scan dialog box the user has pressed the Cancel button 33 On the syringe label post print confirmation dialog box the user has pressed the Unable to Scan button 35 On the syringe label failed visual confirmation dialog box the user has pressed the Content Error button 36 On the syringe label failed visual confirmation dialog box the user has pressed the Printing Error button 37 On the syringe label post print confirmation dialog box the user has pressed the No button 60 The formulary database is corrupted or cannot be loaded 61 The system disk space is low 62 The system disk is full Codonics SLS 500i User s Manual 6 19 Table 6 2 Error Codes Continued Error Code Description 70 The SmartDrive has been removed from USB port 2 behind the touch screen rear panel door 71 The SmartDrive is not inserted in USB port 2 behind the touch screen rear panel door 72 The SmartDrive content is corrupt 73 The version number on the SmartDrive does not match the version number of the SLS software 74 The SmartDrive does not have the necessary files 80 An unknown error was detected 81 The formulary update package that was installed is damaged or the version of the formulary update package is not compatible with the current SLS software 82 The formulary update pack
79. pas utiliser e Utilisez seulement les cartouches et tiquettes Codonics pour faire certain que le SLS fonctionner comme il faut e Nerecbargez jamais les cartouches Ca peut avoir pour r sulte les couleurs incorrects Preface Disposal Requirements Disposal of this product and consumables shall be in accordance with all applicable laws and regulations in effect at the locality at the time of disposal For additional information refer to Appendix A Hazardous Material Information Conditions et R gles d Utilisation L utilisation de ce produit doit tre conforme toutes les lois et r glements applicables sur le lieu d utilisation European Disposal Requirements Codonics imagers and electronic accessory devices are not to be discarded or recycled rather they are to be returned to the manufacturer Contact Codonics directly or by the link provided for the latest information concerning Identification of the country specific Importer Distributor Producer e Product return and treatment of our electronic products Manufacturer Codonics Inc 17991 Englewood Drive Middleburg Heights OH 44130 USA Phone 1 440 243 1198 Fax 1 440 243 1334 E mail WEEE codonics com www codonics com and www safelabel com Codonics SLS 500i User s Manual xxix Codonics electronic products and accessories bearing the following symbol are subject to European Directive on Waste Electrical and Electronic Equipment WEEE 2002 96 EC
80. phone numbers xii product information xii website xii compliance label location xiii components shipped 2 2 to 2 4 configuration number xvii configuration settings 2 24 configuration update package installing 5 5 configuration version 6 6 container barcodes problems troubleshooting 6 11 scanning 4 5 verification 4 3 4 10 Container ID 4 2 associating with a Master ID 4 3 4 8 mapping to Master IDs 4 3 4 8 matching 4 2 multiple matches 4 7 cover removing rear 5 8 Codonics SLS 500i User s Manual I 1 custom labels 4 18 to 4 24 categories 4 18 printing 4 23 Dark Print setting 6 28 Dashboard 6 1 database formulary 2 24 4 1 tracking 2 24 date code xvii Date Time prompt 2 14 device characteristics xxxi device description xxxi device indications for use statement xxxiii Dilute switch 3 10 4 5 disinfecting precautions xxvii to xxviii 5 4 disinfecting the enclosure 5 4 disposal requirements xxix drug container barcodes problems troubleshooting 6 11 scanning 4 5 verification 4 3 4 10 drug records verification 4 3 4 10 electromagnetic emissions xix electromagnetic immunity xx errors clearing 6 30 European disposal requirements xxix external power supply connecting 2 11 ordering 5 1 Index F feature keys 5 15 features adding 5 15 formulary database 2 24 4 1 installing update package 5 5 problems troubleshooting 6 10 version 6 6 formulary upda
81. press the OK button Preface Purpose and Scope Refer to this User s Manual for procedures on how to perform the SLS user operations including Setting up the hardware and software Performing basic functions such as logging in and out and configuring some system settings for example sound volume brightness Printing and confirming syringe labels Checking drug syringes by scanning their barcodes Maintaining the system Monitoring system status and troubleshooting common problems Codonics SLS 500i User s Manual xi Product Information For technical assistance with the SLS call Codonics Technical Support at the following number Phone 1 440 243 1198 Toll Free 800 444 1198 USA only Technical Support is available 24 7 365 Technical Support is also available online via email and the Codonics web site Email support codonics com Web Sites www codonics com and www safelabel com General product information can also be requested by sending email to Email infoG codonics com Please include your postal mailing address and telephone number in the email message Basic product information is returned via email unless otherwise requested Preface QWarnings and Limitations of Use Location of Safety and Compliance Labels Codonics is in compliance with various regulations details of which are listed in Appendix B The SLS safety and compliance label shown below is located on the bottom
82. r IDs that could potentially map to the scanned 10 digit Container ID Learning is the process of associating the 10 digit Container ID with one of the mapped 11 digit Master IDs For more information about mapping and learning refer to Learning a Drug USA Only on page 4 8 Verification Verification is the process of scanning a drug container s barcode and verifying that the drug name and concentration that is in the formulary database matches the drug name and concentration of the scanned drug container For more information refer to Verifying a Drug on page 4 10 Codonics SLS 500i User s Manual 4 3 Q Printing a Syringe Label 4 4 A A f The general workflow for printing a syringe label is If you want to specify the drug s dilution set the Dilution switch to on Scan the drug container barcode Specify the dilution and diluent if necessary es Ee bes s Confirm the label displayed on the touch screen before printing it if this confirmation step has been configured A Retrieve the printed syringe label from the output bin Confirm whether the syringe label printed correctly if this confirmation step has been configured Details for these steps are covered in the following topics CAUTION The formulary used on the SLS should be one that was created by the system administrator and approved for use CAUTION When preparing syringes always keep control of the drug container and syringe until the l
83. r to Inserting the SmartDrive on page 2 13 Contact Codonics Technical Support 1 440 243 1198 Cycle power to the system Codonics SLS 500i User s Manual 6 7 Table 6 1 Troubleshooting Continued Problem Possible Causes The system starts in an error state A variety of software and or The user cannot log in The system indicates that it is in Test Review mode The system indicates that a cover is open error code 7 The system indicates that the printer is not responding error code 8 or has an error error codes 9 12 Troubleshooting hardware conditions The PIN has been forgotten or misplaced The most recent formulary update package that was installed contains a formulary in Test Review mode This mode is used to test formularies before they are actually deployed on SLSs The installed localization pack is in Test Review mode and has not been validated yet by Codonics The front or rear cover is open While it is open the printer cannot print labels There is a problem with the label printer Solutions Follow on screen resolution prompts to correct issues Refer to the on screen information section about error codes Contact Codonics Technical Support 1 440 243 1198 Create a new badge for the user with a new user ID To return the SLS to the normal mode a formulary update package at the Approved level must be installed For more information abo
84. rd information technology IT precautions to protect data associated with the formulary for example securing the content of the USB flash drive on which the formulary update package is stored CAUTION The SLS customer is responsible for the accuracy of the data in the formulary including drug data that has been copied from third party sources such as drug databases Codonics SLS 500i User s Manual 5 7 Q Removing the Rear Cover You might need to remove the rear cover for cleaning purposes to clear a label jam or to load labels in a restricted space TS 1 Partially open the rear cover do not fully open the cover Toremovethe 2 Hold the cover on both sides and gently lift it up until the hinges separate rear cover 3 Carefully pull the cover away from the SLS Removing the rear cover WARNING Re glove in the event of a cut or pinch to prevent using a possible torn glove 5 8 Maintenance Calibrating the Touch Screen The Calibrate Screen utility can be run when necessary to ensure that your finger will select the proper object on the touch screen Run the Calibrate Screen utility if you notice that press points are out of alignment with the target object on the screen Ne 1 Press the Utilities button at the top of the user interface To calibrate the Utilities button touch screen c Sc The Utilities screen displays Codonics SLS 50
85. regular basis Also if the SLS is experiencing problems Codonics Technical Support might ask you to copy the system files to a USB flash drive and send them the drive Use the following procedure to copy the system files to a USB flash drive You can then copy these files to another storage device for backup purposes CAUTION The system files copied to the USB flash drive are not encrypted 1 Log in to the SLS as described in Logging In on page 3 3 2 Insert the USB flash drive into USB port 1 on the left side of the touch screen 5 12 Maintenance Inserting the USB flash drive into the touch screen USB port 1 3 Press the Utilities button at the top of the user interface Utilities button as The Utilities screen displays codonics SLS 500i User s Manual 5 13 4 Press the Copy Logs button Press Copy Logs to start the copy operation Clean Nozzles Print My Badge Copy Logs Adjust Label Calibrate Screen Clear Errors Utilities Dark Print Off Manage Features Ocoponics TJG OB Ta The system prompts you to confirm the copy operation E Confirm Copy the log files to an attached USB drive 5 Press the Yes button to continue The system displays the progress of the copy operation 6 When the copy operation is complete press the Utilities button to close the Utilities screen 7 Remove the USB flash drive 5 14 Maintenance adding a Feature Feature ke
86. rom an uninterruptible power supply or a battery 60 dip in Ur for 5 cycles 70 Ur 30 dip in Ur for 25 cycles lt 5 Ur 95 dip in Ur for5s 3 A m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment Guidance Portable and mobile RF communications equipment should be used no closer to any part of the SLS including cables than the recommended separation distance calculated from the equation applicable to the frequency to the transmitter Recommended separation distance d 1 17 P Conducted RF 3 Vrms 3V prs 1 17 P 80 MHz to 800 MHz IEC 61000 4 6 150 kHz to 80 MHz Fia Ie SECH SVM d 233 JP 800 MHz to 2 5 GHz IEC 61000 4 3 80 MHz to 2 5 GHz where P is the maximum output power rating of the transmitter in Watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol E NOTE At 80 MHz and 800 MHz the higher frequency range applies NOTE These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflect
87. rriage is not moving error code 9 Barcode Scanner Problems The barcode scanner is not scanning Possible Causes There is no ink cartridge in the carriage An obstruction is preventing the ink cartridge carriage from moving The scanners glass window is dirty The low light red light is on but the scanner laser cross hairs are not on The barcode symbology is not supported The barcode on the printed syringe label has poor quality The barcode is incorrectly positioned Solutions Install an ink cartridge Refer to Installing the Ink Cartridge on page 2 16 Open the front cover and remove the obstruction Press the Ink button to reset the position of the ink cartridge carriage Clean the scanner s glass window Refer to Cleaning the Enclosure on page 5 2 Shutdown the system from the touch screen and then cycle power to the system Contact Codonics Technical Support 41 440 243 1198 Follow the on screen resolution prompt to fail the post confirmation and try printing the label again If the barcode quality is still poor contact Codonics Technical Support 1 440 243 1198 Place the container or syringe below the scanner so that the red cross hair lines up on the barcode Placing the container or syringe closer to the cover almost resting it on the cover instead of placing it closer to the scanner will also provide better results Codonics SLS 500i User s Manual 6 17 6
88. rtain paints coatings and filler materials Polychlorinated biphenyls PCBs Codonics SLS 500i User s Manual A 1 Asbestos Organic tin not used in tin lead solder applications Ozone depleting substances such as chlorofluorocarbons methyl chloroform and carbon tetrachloride Mat riaux de Construction Afin d obtenir les certificats de conformit de ses produits dans le monde entier Codonics utilise les standards d valuation les plus contraignants pour tester ses produits Codonics assure notamment n avoir ajout ou avoir t inform que soit ajout les composants suivants dans son produit et son emballage Mercure sauf dans le cas de syst mes d clairage lampe balayage r tro clairage LCD Cadmium l exception des encres de couche paisse sur les circuits imprim s Chrome hexavalent l exception des encres de couche paisse sur les circuits imprim s des protection de surface m tallique et des photo r sistances de tubes cathodiques Des thers de diph nyl polybrom ou des biph nyls polybrom s e Arsenic de tr s faible quantit d ars nic sont pr sents dans le verre les leds et les semi conducteurs sans port e atteinte l organisme e Cristaux de silicium Bipbenyls polychlor s e Amiante Mati res organiques A 2 Hazardous Material Information e Substances portant atteinte la couche d ozone tels que des carbones chlorofluor s du chloroforme
89. s Print My Badge Adjust Label Calibrate Screen Clear Errors Utilities Dark Print Off Manage Features A Warning This operation clears error and C warning conditions requiring system administrator attention Only a system administrator should perform this operation Confirm Clear errors 3 To continue with clearing the errors and restarting the system press the Yes button The SLS shuts down restarts and returns to the Login prompt Codonics SLS 500i User s Manual 6 31 X Hazardous Material Information Materials of Construction Codonics has set very stringent standards for evaluating products to ensure the marketing of regulatory compliant products worldwide We do not intentionally add nor are we aware that the products or packaging contain the following materials Mercury except as used in lamp applications for example scanning lamps backlit LCDs Cadmium except as used as thick film inks on printed circuit boards Hexavalent Chromium except as used as thick film inks on printed circuit boards as chromate conversion coatings on metal surfaces and as a photoresist on glass panels of cathode ray tubes Polybrominated diphenyl ethers and polybrominated biphenyls Bioavailable arsenic small amounts of arsenic used in glass LEDs and semiconductors are not considered to be bioavailable Bioavailable crystalline silica small amounts of crystalline silica are used in ce
90. s SLS 500i User s Manual 1 1 Product Features Drug preparation and administration in the perioperative environment are integral aspects of anesthesiologist s patient care responsibilities The SLS is a simple integrated system utilizing a barcode scanner to read and confirm drug identity from FDA NDC National Drug Code and other drug ID barcodes from drug containers and automatically print labels for prepared drugs and other items in use on patients during surgical procedures The labels are compliant with national regulations focused on improving medication safety in the perioperative environment The software components provide functions for scanning container barcodes creating reviewing and approving the hospital managed promotion of a formulary database displaying on screen and audibly confirming drug type and printing ISO ASTM and TJC The Joint Commission content and color compliant labels with 2D barcodes The system reads drug container barcodes and produces water resistant color labels The system can be integrated to function with an Anesthesia Information Management System AIMS workflow to provide real time documentation of drug administration when the syringe 2D barcode is read Hardware Features Integrated printer produces syringe labels that include medication name and concentration dilutions and diluents preparation time and date preparer and expiration time and date Embedded computer inclu
91. se this badge to log in to any SLS by scanning its barcode NOTE If you make a badge and had previously made one your user information is overwritten with the most recent entry NOTE The SLS system administrator needs to ensure that unique user IDs are assigned to each user Basic Operations Qegging In You log in by entering your user ID or by scanning the barcode on your user badge For information about making a user badge refer to Making a User Badge on page 3 1 TS 1 With the Login prompt displayed enter your user ID using one of the following methods To log in Scan User Badge or Enter User ID to Log In DM Enter user e Method 1 Press the Enter User ID field Then go to step 2 e Method 2 Scan the barcode on your user badge Codonics SLS 500i User s Manual 3 3 3 4 Scanning a user badge If the SLS has been configured to require a PIN you are prompted to enter your PIN which can be up to ten digits long Go to step 3 Otherwise a test label is printed and you are prompted to confirm that it printed correctly the prompt is shown in step 3 Go to step 4 Basic Operations 2 Use the keypad to enter your user ID and then press the Enter button Scan User Badge or Enter User ID to Log In If the SLS has been configured to require a PIN you are prompted to enter your PIN which can be up to ten digits long Otherwise a test label is printed and you
92. sion If you confirm it then the system indicates that the drug failed verification and you are given the option of printing a custom label You could then enter the syringe drug information on the custom label by hand If this drug container barcode is scanned again at this SLS the system will indicate that the drug has a Verification Failed status and will only allow the option of printing a custom blank label For more information about custom labels refer to Custom Labels on page 4 18 CAUTION A failed verification is a serious issue It means that the formulary is wrong An SLS system administrator should be consulted immediately to review the logs and correct the formulary 4 10 Printing Labels To cancel the print operation press the Cancel button The main screen displays If the displayed information matches the drug container press the Yes button The system prompts you to confirm your decision Confirm Drug is correct Lorazepam 2 mg mL To confirm your decision press the Yes button By default each SLS requires that all scanned drug containers are to be verified the first time that each SLS sees them Refer to the SLS Administration Tool User s Manual for more information about verification configuration CAUTION SLS users can verify drug containers Please contact your SLS system administrator for proper training and usage NOTE If a drug record in a formulary is Not Verified that drug will have to
93. sion of software or that a USB flash drive contains 2 or System Software on page 5 5 Cinstalling the Ink Cartridge The dashboard on the SLS touch screen indicates when there is a low ink condition The System status light is yellow and the status message text reports that the system is low on ink If there is no ink the System status light will be red During setup this will be the condition until the ink cartridge is installed NOTE The SLS is designed to work only with Codonics ink cartridges To order ink cartridges refer to Ordering Supplies and Parts on page 5 1 Using unapproved ink cartridges could lead to poor print quality and incorrect label colors Ki P NOTE Never refill ink cartridges as this can result in incorrect color usage and cause improperly printed labels 5 2 16 Setting Up the System 1 Open the front cover TS d RTE EL 2 Press the Ink button cartridge Ink button 3 Open the carriage cover by pulling out on the purple hold down clip The cover is spring loaded and will pop open Opening the ink cartridge carriage cover Codonics SLS 500i User s Manual 2 17 4 Remove the ink cartridge from its packaging Once the ink cartridge is removed from its package hold it by its sides 5 Slowly remove the tape covering the cartridge s print head Removing ink cartridge print head tape CAUTION Do not touch the copper area of the cartridge print head 2 18
94. stem Do not lift the system by the foam packaging Setting Up the System dentifying the Components SLS Front Components Touch screen USB port 1 Audio speaker NS Touch screen E Barcode scanner Rear cover System Ut m Y Output bin ss SLS500 X coponics _ SLS front components Front cover Codonics SLS 500i User s Manual 2 5 The Touch Screen displays the user interface to the system e The Touch Screen USB Port1 is used to install formulary update packages configuration update packages and software updates stored on USB flash drives The Audio Speaker is used to announce drug names when a drug container s barcode is scanned system messages and other audio sounds The Barcode Scanner scans drug container barcodes for identity and verification The Rear Cover provides access to the label rolls The System Power LED indicates when the system is powered on The Front Cover is a durable plastic cover that protects the SLS from dust and accidental user interference while operating WARNING When the front cover is open avoid contact with the label cutter e Printed labels are placed in the Output Bin Setting Up the System Components Inside SLS Front Cover Load button Unload button Ink cartridge carriage
95. te package installing 5 5 front cover 2 6 hazardous material information A 1 to A 3 inactivity logout 3 18 inactivity touch screen blanking 3 18 indications for use xxxi information displaying 6 2 Ink button 2 7 ink cartridge cleaning nozzles 6 23 installing ix 2 16 ordering 5 1 problems troubleshooting 6 16 ink cartridge carriage 2 8 IV labels 4 21 L label cutter 2 8 label media hubs 2 21 Load button 6 21 loading 2 20 ordering 5 1 replacing 2 20 Unload button 5 18 6 22 label media guides 2 22 label type buttons 3 10 labels black levels adjusting 6 28 Blank 4 19 confirming syringe labels after printing 4 16 confirming syringe labels before printing 4 14 custom 4 18 to 4 24 custom printing 4 23 IV 4 21 Lines 4 20 Patient 4 22 printing problems troubleshooting 6 14 printing syringe labels 4 4 laser warning xvi learning 4 3 4 8 LED status indicators 6 1 system status 3 10 License Code 2 24 Lines labels 4 20 Load button 2 7 6 21 location for the device 2 1 location precautions xxiv to xxv log files 2 25 backing up 5 12 logging in 3 3 logging out 3 17 Logout button 3 10 Manage Features utility 5 15 mapping 4 3 4 8 Master ID 4 2 associating with a Container ID 4 3 4 8 mapping to Container ID 4 3 4 8 matching Container IDs 4 2 media guides 2 22 media path adjusting 6 26 media precautions xxviii modification codes xvii Muted volume icon 3 1
96. there are more custom labels than can be displayed at one time click the left or right arrow buttons to scroll to the other labels 3 Press the desired custom label to print it The system prints the label There is no pre print or post print confirmation of custom labels Printing Labels Maintenance Ordering Supplies and Parts The following table lists the label and print supplies that can be ordered from Codonics Supplies Catalog Number Ink cartridge 1SCT LR833 Label media 1SCA SLX33 The following table lists the replacement parts that can be ordered from Codonics Safe Label System external power supply SLS PS Power cord North America Medical Grade SP 00417 Power cord Europe Medical Grade SP 00418 To order parts in the USA contact Codonics Customer Service at Phone 1 440 243 1198 Fax 1 440 243 1334 Toll Free 800 444 1198 USA only Web www codonics com or www safelabel com Codonics SLS 500i User s Manual 5 1 To order parts outside of the USA contact your Codonics Customer Support Representative Q Cleaning the Enclosure WARNING Always power off the system before cleaning An electrical shock could occur if the system is powered on and liquid is spilled into it Refer to Powering Off the System on page 3 20 To clean the system s enclosure use a clean lint free cloth moistened with either warm water and mild soap a diluted non caustic detergent or one of the followin
97. ting Up the System exer aeo a a be per rate uu bees zer cou la e BER EXE Go e n tenue 2 14 Installing the Ink Cartridge tocando aea dieser etae sane Yo SE cae aaa E Lec X MPa Gd 2 16 Loading or Replacing the Label Media 2 20 SmartDrive and Stored Information nennen nnne nnne enne nnn 2 24 Information Stored on the Gmarttirive nennen nnne 2 24 Events That Synchronize Data to the Gmartfrive 2 25 Chapter 3 Basic Operations Making a User Badge iet e EENEG be re d taa c epa cia epa aav v La a diu Ea BV a aat 3 1 LOG GUNG I m RAR 3 3 Touch Screen User Interface e ee ORE ERR e ERE HR GXX EXER RE XXER EEN ERR ERR sacs 3 10 SLS Utilitie ce E E 3 11 Displaying the Utilities Gcreen sisi 3 12 Adjusting the Audio Volume eeeeeeeeeeeeneniinenin nennen nnne tentant nbn enata aane anda 3 13 Adjusting the Touch Screen Brightness iii 3 14 Printing a User Badge ss 3 15 Closing the Utilities screen 3 16 Logging 18 c 3 17 Being Logged Out Automatically Due to Inactivity sssssseeeeneennn 3 18 Screen Blanking Due to Inactivity iii 3 18 Shutting Down or Restarting the Gvstem is 3 19 Powering Off the Systems teen pieces ede der bn agen ER E EXE WEE a rar alerte DEXKNE RID dock 3 20 Codonics SLS 500i User s Manual v Chapter 4 Printing Labels SU
98. tiquettes la poussi re Ne placez pas l appareil proximit d une source de chaleur ou de substances acides Ne placez pas l appareil dans une endroit o il y a des vapeurs huileuses et grasses N xposez pas l appareil la lumi re directe du soleil Ne placez pas l appareil pr s d une source baute fr quence Ne placez pas l appareil dans un lieu o il pourrait tre expos des vibrations car cela peut nuire l impression des m dia e Si vous utilisez un bras de montage VESA pour monter l appareil sur un mur une potence ou un charriot d anestb sie veuillez vous r ferrer aux instructions de montage VESA MIS sur www vesa org pour de plus amples informations Codonics SLS 500i User s Manual xxv xxvi Cleaning Precautions To avoid damage to the device observe the following general precautions for cleaning the device e Apply the cleaner to a clean lint free cloth first and then clean the device Liquid applied directly to the device could possibly leak inside the device and cause damage Use extra caution when cleaning around the vents on the back of the touch screen and speaker e Allow the device to completely dry before operating it again Many plastic components are used in the SLS construction Coat flecking and deformation is likely to occur if the device is wiped with chemical dusters benzene thinners insecticides or other solvents Rubber and PVC materials left in contact with the S
99. using a possible torn glove 6 22 Troubleshooting CCiecning the Ink Cartridge Nozzles If label print quality is poor you might need to clean the ink cartridge nozzles Ne 1 Press the Utilities button at the top of the user interface To clean the ink Utilities button cartridge nozzles Get BLANK LINES PATIENT The Utilities screen displays 2 Press the Clean Nozzles button Press Clean Nozzles Clean Nozzles Print My Badge Copy Logs Adjust Label Calibrate Screen Clear Errors Utilities Dark Print Off Manage Features Codonics SLS 500i User s Manual 6 23 The system cleans the ink cartridge nozzles and then prints a test label You are then prompted to confirm that the test label printed correctly Confirm Did the label print correctly Test Print Cyan Magenta Yellow Prepared On 03 09 2011 12 47 By ADN 3 Review the following to ensure that the test label printed correctly The colors are correct The label content is correctly centered The print is not faded There is no horizontal banding The date and time are correct The user s initials are correct 4 If the test label has printed correctly press the Yes button The main screen displays If the test label prints incorrectly press the No button 6 24 Troubleshooting A Test Print Failed Verification message displays ERROR CODE 2 Test print failed verification
100. ut formulary levels refer to the SLS Administration Tool User s Manual Install a localization pack that has been validated by Codonics For more information refer to the SLS Localization Reference Guide and the SLS Administration Tool User s Manual Close the front or rear cover Cycle power to the system If the problem persists contact Codonics Technical Support 1 440 243 1198 Table 6 1 Troubleshooting Continued Problem The system indicates that disk space is low error code 61 The system indicates that disk space is full error code 62 Possible Causes Storage capacity is at or below 10 Storage capacity is below 1 The system indicates that the data The SmartDrive is corrupted on the SmartDrive is damaged error code 72 The system indicates that the SmartDrive is not valid error code 74 Copying log files failed error code 84 The SmartDrive does not have the necessary files The USB flash drive is full The USB flash drive is damaged The USB flash drive was removed while the copy operation was still being performed The system indicates that a system The installed version of the setting was not found error code 85 configuration is not compatible with the installed version of the SLS application Solutions Contact Codonics Technical Support 41 440 243 1198 Contact Codonics Technical Support 1 440 243 1198 Contact Codonics Technical Support
101. where on the touch screen and the display will activate again Basic Operations QGhutting Down or Restarting the System You should always shut down the system software before powering down the system CAUTION Always make sure that all print jobs have completed before shutting down or restarting the system software Before attempting to shut down or restart the system make sure that all print jobs have finished TS 1 Make sure all print jobs have completed Toshutdownor 2 Press the Logout button restart the system Logout button software passen 29 ns Codonics SLS 500i User s Manual 3 19 The Log Out or Shut Down dialog box displays Log Out or Shut Down System lt 2 a STELLA 3 Press the Shut Down or Restart button The system shuts down or restarts owering Off the System Ne 1 Make sure all print jobs have completed To power oft he 2 Press the Logout button system Logout button BLANK LINES PATIENT Nn n wee 3 20 Basic Operations The Log Out or Shut Down dialog box displays Log Out or Shut Down System La Kaz Ret En 3 Press the Shut Down button The system shuts down and displays a message indicating that it is now safe to power off the system 4 Set the Power switch on the rear panel to off Power switch Power switch on the rear panel CAUTION Always make sure that the user is logged out of th
102. ys enable specific features of the SLS Each feature key is associated with an integer value that identifies the name of the feature If you have purchased new feature for SLS Codonics will provide you with the feature key Ne 1 Press the Utilities button at the top of the user interface To add a feature Utilities button LINES PATIENT tiii The Utilities screen displays Codonics SLS 500i User s Manual 5 15 2 Press the Manage Features button Press Manage Features Clean Nozzles Print My Badge Adjust Label Calibrate Screen Clear Errors Utilities Dark Print Off Manage Features Manage Features Permanent Clinical Use Permanent Admin Tool Permanent Led SS Add Key Delete Key eee 3 Press the Add Key button 5 16 Maintenance The Add Feature Key dialog box displays Add Feature Key Feature Key pmo kl ja jar incu ks kel cui et jao IE IE ICH ICM E C ICH jo CN CN pr klen bal jud kl emt pci ema Ss CE en cL Enter the feature key and then press the OK button to install the feature You are prompted to confirm the feature installation QSwapping Systems You can move the SmartDrive from one SLS to another to move the system s configuration and formulary database thus allowing the second SLS to operate exactly like the first This feature is helpful when swapping an SLS for service purposes To swap systems contact Codo

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