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1. Appendix B Specifications Specifications English System Cartridge UVC Bulb Dimensions Entry Slot Device Size Weight Integrated system for device disinfection cartridge with ultraviolet C UVC bulbs Two ultraviolet C UVC bulbs UVC sensors transport rollers microcontroller drive stepper motor and fans Wattage 27 Current 800 mA Voltage 34 V UVC Watts 7 5 Height D6000 5 25 in 13 3 cm D7000 23 125 in 60 64 cm Width D6000 15 in 38 1 cm D7000 15 in 38 1 cm Depth D6000 20 in 50 8 cm D7000 14 in 35 56 cm Height maximum 1 0 in 2 5 cm Width maximum 8 0 in 20 3 cm Depth maximum 10 8 in 30 5 cm Less than 44 lbs 18 1 kg Codonics Disinfection Technology User s Manual 79 Power Supply Ballast Noise Environmental Compliance amp Regulatory Classification Internal 100 240 VAC 50 60 Hz Line Current A 0 53 0 45 0 19 Input Power W 54 Maximum Current THD lt 10 Ballast Type Electronic Idle lt 35dBA Operating lt 40dBA Operating Temperature 40 to 86 F 4 to 30 C Humidity 20 to 80 non condensing Shipping and Storage Temperature 30 to 100 F 2 to 38 C Humidity 20 to 85 non condensing Safety IEC61010 1 2nd edition Safety IEC61010 2 040 particular to disinfection equipment and EMC IEC60601 1 2 Class B FDA 880 6890 General Purpose Disinfectants Class 1 equipment Product Code L
2. IEC EN 61000 4 3 Electrical Fast 100 240 VAC Pass Main power quality should be that of a Transient Burst 50 60 HZ typical commercial or hospital environment IEC EN 61000 4 4 Surge 100 240 VAC Pass Main power quality should be that of a 50 60 HZ typical commercial or hospital IEC EN 610000 4 5 environment Conducted Radio Pass Frequency Electromagnetic Field Immunity TEC EN 61000 4 6 Codonics Disinfection Technology User s Manual 28 Immunity Test Test Level Compliance Electromagnetic Environment Level Guidance Power Frequency 50 60 HZ Pass Magnetic Field Immunity Test IEC EN 61000 4 8 Voltage Dips Shot 100 240 VAC Pass Main power quality should be that of a Interruptions and 50 60 HZ typical commercial or hospital Voltage Variations on environment If the user of the CDT Power Supply Input requires continued operation during Lines main power interruptions it is recommended that the CDT be powered TEC EN 61000 4 11 from an uninterruptible power supply or battery Codonics Disinfection Technology User s Manual 29 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 Hazardous Material Information section Conditions et R gles d Utilisation L utilisation de ce pr
3. gt O CODONICS Disinfection Technology User s Manual December 15 2014 Version 1 2 0 Codonics Inc 17991 Englewood Drive Middleburg Heights Ohio 44130 USA 440 243 1198 Phone 440 243 1334 Fax Email info Ecodonics com www codonics com Codonics Disinfection Technology User s Manual Copyright O 2013 2014 by Daylight Medical Inc All rights reserved worldwide Printed in the USA Part Number 905 076 101 Codonics Disinfection Technology CDT manufactured by Daylight Medical Inc for Codonics Inc No part of this document may be copied or reproduced in any form by any means without prior written consent of Daylight Medical Inc 17991 Englewood Drive Suite A Middleburg Heights Ohio 44130 USA Although every effort has been made to ensure the accuracy of this document Daylight Medical Inc assumes no responsibility for any errors that may appear Daylight Medical 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 Codonics Disinfection Technology is a trademark of Codonics Inc iPad and iPhone are registered trademarks of Apple Inc All other registered and unregistered trademarks are the property of their respective owners European Authorized Representative for Daylight Medical Inc CEPartner4U Esdoo
4. travers les ouvertures de l appareil CDT 3 AVERTISSEMENT les lampes UV contiennent du mercure et doivent donc tre correctement limin es comme des d chets dangereux conform ment aux r glementations locales provinciales et nationales ou les lampes doivent tre recycl es 1 AVERTISSEMENT Prenez des pr cautions avec les ampoules UV cass es pour viter l inhalation l ingestion ou le contact avec la peau ou les yeux Voir le Chapitre 4 pour des informations sur les Proc dures d limination des ampoules et les Consignes particuli res de traitement pour les ampoules cass es Safety Warnings and Precautions Pesa WARNING Do not place your hands inside the openings of the CDT before turning off the power Codonics Disinfection Technology Users Manual 14 3 WARNING The CDT should not be operated by children d LT WARNING High Temperature Internal components of CDT may develop temperatures above 110 F WARNING All assembly adjustment modification maintenance and or repair should be performed by qualified personnel authorized by Codonics 1 WARNING Only CDT approved replacement parts should be used when maintaining the device 1 WARNING Do not remove any warnings cautions or descriptive labeling from the CDT cl WARNING Take care when closing the front panel to avoid finger pinching JTION The product must be used in accordance with this User s Guide
5. s Manual 24 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 x The serial number SN which uniquely identifies the unit x The configuration number CN which details the build configuration The modification 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 g The date code in Y Y Y Y MM format is located below the factory date code symbol Serial number Date code e e WN XXXX XX 3 4 5 6 i 8 8 10 11 12 13 14 15 16 29 1 3 20 E Configuration Modification number codes Serial number label Codonics Disinfection Technology Users Manual 25 Potential for Radio Frequency Interference on Device Operation Both portable and mobile RF communications equipment can affect medical electrical equipment including the CDT The CDT is intended for use in the electromagnetic environment specified in the Guidance and Manufacturer s Declaration section Potential for Radio and Television Interference The CDT generates and uses radio frequency energy and if not installed and used properly that is in strict accordance with the manufacturer s instructions may cause interference to radio and television reception It ha
6. 3 PRECAUTION Avoid spilling fluids on any part of the CDT fa PRECAUTION If spills do occur immediately disconnect CDT from the power source and clean the CDT Codonics Disinfection Technology Users Manual 15 7 PRECAUTION Never insert any object not indicated for use with the CDT PRECAUTION Do not use any attachments not recommended by Codonics Conseils de s curit Pda AVERTISSEMENT Ne placez pas vos mains l int rieur des ouvertures de CDT avant la mise hors tension AVERTISSEMENT CDT ne doit pas tre manipul par des enfants AVERTISSEMENT Haute Temp rature certains composants internes de CDT peuvent g n rer des temp ratures sup rieures 45 C 3 AVERTISSEMENT Tout montage r glage modification entretien et ou r paration doivent tre effectu s par du personnel qualifi et autoris par Codonics 1 AVERTISSEMENT Seules les pi ces de rechange approuv es par Codonics peuvent tre utilis es lors de la maintenance de l appareil AVERTISSEMENT Ne pas retirer les avertissements mises en garde et tiquetages descriptifs situ s sur CDT Codonics Disinfection Technology User s Manual 16 fa AVERTISSEMENT Faites attention lors de la fermeture du panneau avant afin d viter tout pincement des doigts 12 PR CAUTION Le produit doit tre utilis conform ment au Guide de l utilisateur 2 PRECAUTION vitez de renverser de
7. Disconnect the power cord from the wall outlet before servicing to avoid the possibility of electric shock ZA WARNING Turn the system off before opening the front panel to avoid the possibility of electric shock WARNING Never look directly through the input and output openings of the CDT SS WARNING Take care when closing the front panel to avoid finger pinching Codonics Disinfection Technology User s Manual 44 CDT Rear Components CDT rear components D6000 shown The Power Input Port is used to connect the Power Cord The Power Input Port allows for either 100 120 volt or 200 240 volt Power Cords e The Power Switch powers the CDT on and off Toggle the Power Switch to the I position for on and to the O position for off Codonics Disinfection Technology User s Manual 45 Pass Through Model D7000 Back Panel Components The Auto Lift Hinge easily raises the Tray after the user starts the lifting process after pushing the Open button on the Front Panel The Mounting Stand vertically positions the D7000 model for pass through processing al CDT D7000 Back Panel components Codonics Disinfection Technology Users Manual 46 Installing the Cartridge The Cartridge for the disinfection process utilizes ultraviolet C UVC bulbs and other perishable items Depending upon utilization of the CDT the Cartridge is typically expected to be replaced annually
8. User s Manual 69 fiA WARNING Disconnect the power cord from the wall outlet before servicing to avoid the possibility of electric shock 4 WARNING Turn the system off before opening the front panel to avoid the possibility of electric shock Checking the Software Version The software version may be checked following these steps 1 Toggle the Power Switch to the O position on the rear of the CDT to power off the system 2 Toggle the Power Switch to the I position on the rear of the CDT to power on the system 3 While the system is starting up press the Cancel button one time 4 Observe the LED lights System and Cartridge and count the number of green flashes from each one For example System light flashing 2 times and Cartridge light flashing 8 times indicates software version 2 8 Codonics Disinfection Technology User s Manual 70 Chapter 5 Troubleshooting Status Indicators The front panel includes LED style indicator lights to provide overall status of the CDT The front panel LED lights will flash to signify the status of the system Each light has multiple states Green indicates proper operation yellow indicates that an action will be required soon such as replacing the UVC cartridge and red indicates an error condition The system will be inoperable if any of the lights are red and action must be taken to restore proper function Here is a summary of the LED lighting
9. With the raised numerals on the Voltage Selector Plug showing the voltage range 100 120 or 220 240 appropriate for your region closest to the Applied Voltage Arrow on the Electrical Socket insert the Voltage Selector Plug in to the recess until fully seated 4 Verify that the Applied Voltage Arrow points to the voltage range appropriate for your region see figure on following page NOTE In the D7000 model it is recommended to view the Applied Voltage Arrow when the Tray is released and in the upward most position and with an open Receiving Area Door A portable light source may be required for ideal viewing Codonics Disinfection Technology Users Manual 50 This product is in conformity with the the laws of the Member States relati A SKY Disinfection Tech Dayl Ig ht mec Made in U S A Patents F All Rights Reserved EC REP CEpartner4U BV Esdoornlaan 3951 DB Maarn The Netherlan Phone 31 6 516 536 26 sl Daylight Medical Inc 17991 Er Middleburg Heights OH 44130 CDT electrical socket D6000 shown 5 Locate the Power Cord included with your CDT 6 Plug the Power Cord into the Power Input Port either 100 120 volts or 200 240 volts on the Rear Panel of the CDT NOTE In the D7000 model the Power Cord is factory connected Codonics Disinfection Technology User s Manual 51 NOTE In the D7000 model it is recommended to insert the Power Cord when the Tray is released and in the upwa
10. or replacing the Cartridge 6 Install the Cartridge by aligning it with the two metal vertical pins and pushing it down to interlock with the white electronics connector Hold the Cartridge by its handles which are yellow in color 7 Close the Front Panel by pushing it into the unit and push the Open button until it locks CDT cartridge loading Codonics Disinfection Technology User s Manual 48 8 Upon the Cartridge being detected in the system the Cartridge LED light on the Front Panel will be illuminated in green 1 WARNING Only CDT approved replacement parts should be used when maintaining the device 2 WARNING Disconnect the power cord from the wall outlet before servicing to avoid the possibility of electric shock cl WARNING Turn the system off before opening the front panel to avoid the possibility of electric shock A WARNING Never look directly through the input and output openings of the CDT Codonics Disinfection Technology Users Manual 49 Connecting the Power Cord 1 Locate the Voltage Selector Plug included with your CDT noting the side of the plug with raised numerals showing the voltage range appropriate for your region NOTE The Voltage Selector Plug will be factory set for your region 2 Locate the Electrical Socket on the rear of the CDT noting the location of the recess for the Voltage Selector Plug and Applied Voltage Arrow on the right hand side of the electrical socket 3
11. sp cifiques sont r pertori es Des pr cautions suppl mentaires peuvent tre trouv es dans ce manuel lorsque des op rations sp cifiques sont r pertori es Post Disinfection Warnings cl WARNING The Codonics Disinfection Technology is intended to disinfect non critical medical devices The subsequent utilization of the non critical medical devices disinfected by the CDT is the sole responsibility of the user Avertissements post d sinfection AA AVERTISSEMENT La technologie de d sinfection de CDT est destin e d sinfecter les dispositifs m dicaux non critiques L utilisation ult rieure des dispositifs m dicaux non critiques d sinfect s par CDT est de la seule responsabilit de l utilisateur Ultraviolet Light Bulb Warnings and Precautions cl WARNING Never look directly through the input and output openings of the CDT WARNING Ultraviolet bulbs contain mercury and therefore must be properly disposed of as a hazardous waste in accordance with local state and federal regulations or the lamps should be recycled Codonics Disinfection Technology User s Manual DER ZA WARNING Take precaution with broken UV bulbs to avoid inhalation ingestion or contact with skin or eye See Chapter 4 for information about Procedures for Disposal of Bulbs and Special Handling Information for Broken Bulbs Mises en garde et pr cautions concernant les lampes UV 1 AVERTISSEMENT Ne jamais regarder directement
12. 1 2 Classe B FDA 880 6890 d sinfectants 4 usage g n ral Classification Equipement de classe 1 code produit LRJ produits d sinfectants dispositifs m dicaux Codonics Disinfection Technology User s Manual 82
13. 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 and effectiveness 2 WARNING Failure to insert the Voltage Selector Plug in the proper voltage orientation will cause the fuses in the Voltage Selector Plug to blow and will require the user to replace the fuses prior to restore operation Fuses are not covered under warranty Codonics Disinfection Technology Users Manual 18 Pida PRECAUTION Never operate CDT if it has a damaged power cord power supply or plug If the power cord power supply or plug is worn or damaged contact Codonics at 1 440 243 1198 Fa PRECAUTION The electrical installation of the room in which CDT will be operated must comply with the local electrical wiring standards Mises en garde et pr cautions concernant la tension Fa AVERTISSEMENT Cet appareil doit tre reli lectriquement la terre 2 AVERTISSEMENT Pour viter un incendie ou un choc lectrique n exposez pas cet appareil la pluie ou l humidit cl AVERTISSEMENT Risque d explosion Ne pas faire fonctionner CDT en pr sence de vapeurs inflammables AVERTISSEMENT D branchez le cordon d alimentation de la prise murale avant de r parer CDT afin d viter tout risque de choc lectrique AVERTISSEMENT teignez le syst me avant d ouvrir le p
14. Codonics Disinfection Technology User s Manual Guidance and Manufacturer s Declaration Electromagnetic Immunity nana nos 28 Ree EE 30 Conditions et R gles d Utilisation rra 30 Europear Disposal Requirements sata dla ei ten ne enema teens 30 INDICATIONS or US ren rain inner An ent el taa 32 Jmend d USO ici nan oR ASA A SH ea A elo 32 Device Indications for Use Gtatement seen 32 Chapter 1 Introduction 33 Malta ii A deel EA aa 33 Product Features A A n 35 System Feature Si eet eege ETA ba A E REA E E AAA AAA IA e 35 Operational RE 36 Chapter 2 Setting Up the System 37 Finding a Location for the System sise 37 Shipped Ree 37 Identifying the Components sise 39 CDTFr nt ee e 39 Pass Through Model D7000 Receiving Area Components 42 Components Inside CDT Front Panel 43 CDT R le TT 45 Pass Through Model D7000 Back Panel Components 46 Installing the Cartridge seen 47 Connecting the Power COR sica arde 50 Pow ring th SVSt mM NO 53 Chapter 3 Disinfection Operations usines 56 Double Pass CDT D6000 Processing Technique sr 56 Pass Through CDT D7000 Processing Technioue 59 Chapter4 Maintenance nr A A A adas 63 Ordering Supplies and Parts ici Ad a iE ASEE 63 Procedures for Disposal Of UVC Puibes sienne 64 Special Handling Information for Broken UVC Bulbs nsssnsssnennnennnenenennnenenennnnennnennnennnnennnennnennnnnnnnnnennnsnenenenn
15. RJ Disinfectant medical devices Codonics Disinfection Technology User s Manual Specifications French Syst me Cartouche Ampoule UVC Dimensions Dimension de la fente d entr e de l appareil Poids Alimentation Ballast Syst me int gr pour la d sinfection de l appareil avec cartouche d ampoules ultraviolets C UVC Deux ampoules ultraviolets C UVC capteurs UVC rouleaux de transport microcontr leur moteur d entra nement pas pas et ventilateurs Puissance 27 Watts Courant 800 mA Tension 34 V UVC 7 5 Watts Hauteur D6000 13 3 cm D7000 60 64 cm Largeur D6000 38 1 cm D7000 38 1 cm Profondeur D6000 50 8 cm D7000 35 56 cm Hauteur maximale 2 5 cm Largeur maximale 20 3 cm Profondeur maximale 30 5 cm Moins de 18 kg Interne 100 240 VAC 50 60 Hz Courant de ligne 0 53 0 45 0 19 A Puissance d entr e 54 W THD actuelle maximale lt 10 Type de ballast lectronique Codonics Disinfection Technology Users Manual Bruit En veille lt 35 dBA En fonctionnement lt 40 dBA Conservation En fonctionnement Temp rature entre 4 et 30 C Humidit 20 a 80 sans condensation Transport et de stockage Temp rature entre 2 et 38 C Humidit 20 85 sans condensation Conformit et r glementation S curit IEC61010 1 2 dition s curit IEC61010 2 040 notamment pour l quipement de d sinfection et EMC IEC60601
16. Refer to the CDT Front Panel section regarding the LED indicators about the life cycle status for the installed Cartridge The following steps may be performed to install a new Cartridge NOTE The CDT D6000 unit must be in a horizontal position to replace the Cartridge The CDT D7000 unit may be in a vertical position to replace the cartridge NOTE The CDT D7000 unit includes an Auto Lift Hinge that easily raises the Tray after the user starts the lifting process 1 Locate the Cartridge included with your CDT or future replacement Cartridges purchased separately NOTE The use of unapproved parts including the Cartridge will void the Codonics warranty for the CDT unit See the Ordering Supplies and Parts section 2 Toggle the Power Switch to the O position on the rear of the CDT to power off the system 3 Disconnect the Power Cord from the wall outlet 4 Press the Open button on the Front Panel of the CDT 5 Pull forward on the CDT D6000 Front Panel to expose the device Tray or on the D7000 first push down on the front panel and then pull up on the knob to expose the device Tray The downward pushing motion is required to release the safety interlock in the knob to allow the tray to be lifted Codonics Disinfection Technology User s Manual 47 NOTE The CDT D7000 model includes a louver which is used to block UVC light when the Receiving Area Door is raised This louver may need to be held down when installing and
17. anneau avant afin d viter tout risque de choc lectrique Codonics Disinfection Technology User s Manual 19 AVERTISSEMENT CDT doit tre connect a une prise de terre lectrique afin de maintenir la fiabilit lectrique E AVERTISSEMENT Toujours teindre le syst me avant de le nettoyer Si le syst me est sous tension lorsque du liquide est renvers l int rieur un choc lectrique peut se produire cl AVERTISSEMENT L quipement ne doit pas tre consid r comme composant d un respirateur artificiel Les respirateurs artificiels sont des dispositifs ou des syst mes destin s 4 maintenir la vie et dont le mauvais fonctionnement peut conduire une blessure s v re voire la mort d une personne Un composant essentiel est un composant provenant d un respirateur artificiel dont le mauvais fonctionnement peut provoquer la panne du respirateur artificiel ou porter atteinte sa s curit et son efficacit cl AVERTISSEMENT Brancher le s lecteur de tension dans le mauvais sens de tension provoque l explosion des fusibles dans le s lecteur de tension L utilisateur devra alors remplacer les fusibles avant de r tablir le fonctionnement Les fusibles ne sont pas couverts par la garantie PR CAUTION Ne faites jamais fonctionner CDT lorsque l alimentation le cordon d alimentation et ou la prise sont endommag s Si le cordon d alimentation l alimentation ou la prise sont us s ou e
18. ariot ou un support pr voir un espace de s paration d au moins 15 cm entre le panneau arri re de CDT et le mur 3 PRECAUTION Ne pas poser d objet de plus de 18 00 kg 40 Ibs sur le dessus du mod le Double Pass Consultez le Chapitre 3 pour plus d informations PRECAUTION Tenez CDT loign des surfaces chauff es Cleaning Precautions 2 PRECAUTION Refer to the Cleaning the Enclosure section for recommended cleaning of the el PRECAUTION 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 and cause damage Use extra caution when cleaning around the front panel display E PRECAUTION Allow the device to completely dry before operating again 2 PRECAUTION Never use abrasive materials Codonics Disinfection Technology User s Manual 22 PRECAUTION Never use any disinfecting agents that corrode PRECAUTION Always dilute cleaning agents according to the manufacturer s instructions or use the lowest possible concentration PRECAUTION Do not allow the cleaning agent to remain on the device surface Wipe off immediately with a lint free cloth moistened with water Failure to do so may result in discoloration of the surface 1 WARNING Codonics makes no claims regarding the efficacy of the listed chemicals or methods as a means of controlling infection Consult your hospital s in
19. cal assure notamment n avoir ajout ou avoir t inform que soit ajout les composants suivants dans son produit et son emballage e Mercure sauf dans le cas de syst mes d clairage lampe balayage r tro clairage LCD e Cadmium l exception des encres de couche paisse sur les circuits imprim s e 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 e Des thers de diph nyl polybrom ou des biph nyls polybrom s Codonics Disinfection Technology Users Manual 77 e Arsenic de tres 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 e Biphenyls polychlor s e Amiante e Mati res organiques e Substances portant atteinte la couche d ozone tels que des carbones chlorofluor s du chloroforme et des t trachlorures de carbone Manufacturing During manufacturing operations that produce Daylight Medical 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 Daylight Medical Codonics Disinfection Technology User s Manual 78
20. chnology User s Manual 56 NOTE Using any sleeve other than Codonics Disinfection Sleeves is prohibited Do not use CDT Sleeves in any other disinfection device or without first enclosing your device in a CDT Sleeve and processing it in CDT The item is fed into the Entry Slot on the Front Panel of the CDT A sensor detects the feeding of an item into the Entry Slot which activates the transport mechanism for the disinfection process to be started The item is processed and automatically returned to the user at the Entry Slot in the Front Panel The System LED will flash in green with a two second interval indicating that the system is processing a device for disinfection The flashing is displayed during the entire process from entry to exit NOTE When the Open button on the Front Panel is pressed and the drawer is moved the power to the system is immediately turned off as a safety mechanism It is recommended to fully power off the system prior to opening the Front Panel by toggling the Power Switch to the O position on the rear of the CDT unit NOTE A multi stage UVC blocking mechanism is employed to automatically block UVC light from being emitted from the system and these safeguards must remain in place Do not bypass or remove these safeguards The Check Mark light on the Front Panel flashes in green indicating that the process was completed successfully and the disinfected item will quickly be returned to the user at the E
21. complies with Canadian ICES 003 Cet appareil numerique de la Classe B est conform a la norme NMB 003 du Canada This product is in conformity with the requirements of EC Council directive MDD93 42 EEC on the approximation of the laws of the Member States relating to medical devices This product satisfies the Class B limits of IEC60601 1 CODONICS DISINFECTION TECHNOLOGY d C MODEL D6000 Codonics Disinfection Technology Manufactured by Daylight Medical Inc for Codonics Inc Daylight meaicai Made in U S A Patents Pendi AIRights Reserved El 100 120V 1 6A 50 60Hz c US ECIREP CEpartner4U BV Esdoornlaan 13 200 240V 1 2A 50 60Hz 3951 DB Maarn The Netheriands Liste Phone 31 6 516 536 26 Conforms to UL Std 61010 1 amp Daylight Medical Inc 17991 Englewood Drive Ste IEC Std 61010 2 040 e Middleburg Heights OH 44130 USA A Intertek Certified to CAN CSA Std C22 2 MODEL MODELE SKY 6Xi 4009181 Nos 61010 1 amp 61010 2 040 CDT D6000 safety and compliance label Codonics Disinfection Technology User s Manual 10 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 B digital apparatus complies with Canadian ICES 003 Cet appareil numeriq
22. e Receiving Area is gently disinfected by low level UVC light to protect the area from any possible contamination by users retrieving their devices The Receiving Area Door blocks UVC light from emitting from the Receiving Area and lifting the Receiving Area Door automatically deflects UVC away from the Receiving Area until the door is again lowered completely In the Pass Through model items can be processed without sleeves or they can optionally be placed into either one single or two nested ultraviolet C UVC transmissive sleeves each with a photochromic marker if that option is present before being placed into the system For the greatest infection defense possible we recommend using the nested sleeve option discarding the outer sleeve after processing and using the device while inside the remaining sleeve Both the sleeve and the device are being disinfected but using the device in the sleeve acts to minimize the accumulation of pathogens in device recesses Placement into the Entry Slot requires that the item is face screen toward the back of the CDT Optionally if sleeves are utilized for processing the sleeve closure zip or flap is required to be entered first leading edge NOTE Not all device cases may be processed through CDT due to the surface area presented NOTE Using any sleeve other than Codonics Disinfection Technology Sleeves is prohibited Do not use CDT Sleeves in any other disinfection device or without first
23. e 64 Codonics Disinfection Technology User s Manual Cleaning TNeENCIOS EE 65 Cleaning Re 66 Installing TEE 67 Software NS TEMA ti id dido 67 Checking the Software Version ta 70 Chapter 5 Troubleshooting sirsiran a daa 71 Status Indicators EE 71 Troubleshooting Common Problems sise 73 Appendix A Hazardous Material Information ss 76 Materials of CONSTITUCION A bites hee a belies nine 76 Mat riaux de CONSTTUCUON EE 77 Mani ACUN EE 78 FDTICAUON EE 78 Appendix B SPOCIICANONS EE 79 ee Ee EE 79 SD CITICATIONS de WEE 81 Codonics Disinfection Technology Users Manual Preface Conventions Used in This Manual Bulleted Lists Bullets are used to display a list of nonprocedural items For example Codonics Disinfection Technology is shipped in cartons that contain the following system components Codonics Disinfection Technology Unit Power Cord Cartridge in separate internal carton Numbered Steps Numbered items indicate steps that are to be followed in a procedure For example ep 1 Toggle the Power Switch to the start up the system position on the Rear Panel of the CDT unit to power on and 2 For the initial 5 seconds of power up there is no Front Panel LED illumination Once 5 seconds is reached the System light begins to flash green and system activation is audible 3 After the 30 second system warm up process has been completed the System light on the Front Panel will be illuminated in solid g
24. en pulled out to perform servicing and cartridge replacement WARNING Disconnect the power cord from the wall outlet before servicing to avoid the possibility of electric shock A WARNING Turn the system off before opening the front panel to avoid the possibility of electric shock Codonics Disinfection Technology User s Manual 41 Pass Through Model D7000 Receiving Area Components CDT D7000 Receiving Area components e The Receiving Area provides access to the user for items that have been processed through the disinfection cycle Codonics Disinfection Technology User s Manual 42 The Receiving Area Pad allows items to be gently released after disinfection processing has been completed The Receiving Area Door blocks the low level UVC light that is gently disinfecting the Receiving Area and enables user access to processed items Components Inside CDT Front Panel Components inside CDT front panel Codonics Disinfection Technology User s Manual 43 The Cartridge contains ultraviolet C UVC bulbs and other perishable items Refer to the Installing the Cartridge section The secure digital SD Card Slot provides a port to update or reload software Refer to the Installing Software section The Hide Track the disinfection route behind the Cartridge provides for user access to remove a jammed item This is utilized for the Double Pass style models 3 WARNING
25. enclosing your device in a CDT Sleeve and processing it in CDT The item is fed into the Entry Slot on the Front Panel of the CDT The user should optimally place the item in the center most position left to right of the Entry Slot A sensor detects the feeding of an item into the Entry Slot which activates the transport mechanism for the disinfection process to be started The item is processed through CDT and gently released onto the Receiving Area Pad in the Receiving Area To access the processed item the user simply raises the Receiving Area Door to retrieve it Larger items such as tablets are intended to be retrieved from the lower edge by the user while gripping it through the notches of the Receiving Area Pad Codonics Disinfection Technology User s Manual 60 The System LED will flash in green with a two second interval indicating that the system is processing a device for disinfection The flashing is displayed during the entire process from entry to exit NOTE When the Open button on the Front Panel is pressed and the drawer is moved the power to the system is immediately turned off as a safety mechanism NOTE A multi stage UVC blocking mechanism is employed to automatically block UVC light from being emitted from the system and these safeguards must remain in place Do not bypass or remove these safeguards The Check Mark light on the Front Panel flashes in green indicating that the process was completed successfully a
26. evices used in a healthcare environment CDT is not intended to be used to pre clean or decontaminate critical or semi critical medical devices prior to terminal sterilization or high level disinfection Device Indications for Use Statement The CDT disinfection function is achieved through the application of high intensity germicidal UVC light applied at a known intensity and for a known duration The intention is to allow the user to insert the NCD into the system for disinfection The user may also elect to place the NCD into a specially designed and manufactured sleeve before processing The benefit of using the sleeve is to minimize to the extent possible any accumulated soil on the NCD and reduce reliance on user diligence for the best possible outcome Operation of the system is to take place outside of sterile fields and by personnel performing their duties outside of sterile fields Typical operating personnel are nurses and physicians Codonics Disinfection Technology User s Manual 32 Chapter 1 Introduction Welcome Thank you for your purchase of Codonics Disinfection Technology CDT D6000 Double Pass Model Codonics Disinfection Technology Users Manual 33 CDT D7000 Pass Through Model Codonics Disinfection Technology User s Manual 34 We are pleased that you chose Codonics Disinfection Technology We are confident that it will provide safe and effective disinfection for your portable electron
27. fection control officer or epidemiologist Pr cautions de nettoyage A E PRECAUTION Reportez vous la section Nettoyage du bo tier recommand e pour le nettoyage de CDT 2 PRECAUTION Appliquez le nettoyant sur un chiffon propre et non pelucheux puis nettoyez l appareil Tout liquide appliqu directement sur l appareil pourrait couler l int rieur et causer des d g ts Faites preuve de prudence lors du nettoyage autour de l afficheur du panneau frontal 3 PRECAUTION Laissez l appareil s cher compl tement avant de le r utiliser Codonics Disinfection Technology User s Manual 23 gt PRECAUTION Ne jamais utiliser de produits abrasifs PRECAUTION Ne jamais utiliser de produits de d sinfection corrosifs 3 PRECAUTION Toujours diluer les produits de nettoyage selon les instructions du fabricant ou eme la concentration la plus faible possible PR CAUTION Ne pas laisser agir le produit de nettoyage sur la surface du dispositif Essuyez le imm diatement avec un chiffon non pelucheux et humidifi avec de l eau Ne pas le faire pourrait entra ner une d coloration de la surface AVERTISSEMENT Codonics n met aucun jugement quant a l efficacit des produits chimiques ou d autres m thodes num r es comme un moyen de contr le des infections Consultez l hygi niste ou l pid miologiste de contr le de votre h pital Codonics Disinfection Technology User
28. g User s Manual Quick Set Up Reference Guide Warranty 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 CDT later ZA PRECAUTION When removing the CDT hold under the front and rear of the system Do not lift the system by the foam packaging 2 PRECAUTION The CDT weighs 35 to 44 Ibs 15 to 19 kg To avoid injury use two people to unpack and position the device NOTE Electronic copies of the CDT software and user documentation may be downloaded from www codonics com Codonics Disinfection Technology User s Manual 38 Identifying the Components CDT Front Components D6000 system gt cartridge bl Insert Device ee In Sleeve J Screen Side Down Zip Flap First Disinfection Technology CDT front components D6000 shown The System LED indicates the state of the CDT The following LED lighting conditions will be presented e Slow flashing green indicates that the system is in stand by mode The Cartridge LED light will be illuminated with its current status Codonics Disinfection Technology User s Manual 39 Flashing green System LED indicates that the system is starting up or warming up from a stand by mode session Flashing green System LED at two second interval indicates that the system is processing a dev
29. i Cloth HB PDI Sani Cloth PLUS PDI Super Sani Cloth Cleaning Precautions To avoid damage to the device observe the following general precautions for cleaning the device PRECAUTION 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 and cause damage Use extra caution when cleaning around the front panel display JTION Allow the device to completely dry before operating again H PRECAUTION Never use abrasive materials PRECAUTION Never use any disinfecting agents that corrode A L In PRECAUTION Always dilute cleaning agents according to the manufacturer s instructions or use the lowest possible concentration Codonics Disinfection Technology Users Manual 66 3 PRECAUTION Do not allow the cleaning agent to remain on the device surface Wipe off immediately with a lint free cloth moistened with water 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 Installing Software Software Installation The software installation process may be performed with a secure digital SD card following these steps L Toggle the Power Switch to the O position on the rear of the CDT to power off the system Unplug the Power Cord from
30. ic devices NOTE CDT models have various face plates and encasements rounded or square corners and all use the same disinfection technology and share functionality Product Features The Codonics Disinfection Technology is a simple device utilizing ultraviolet C spectrum light to disinfect non critical devices such as smart phones iPads tablet PCs and other thin format touch display devices Note CDT is intended for flat surface devices only and should not be used with any devices that have protrusions System Features The system enables medical personnel to safely use a portable electronic device for example an iPad iPhone smart phone or tablet PC in the medical environment where disinfection is appropriate The system uses a disposable user replaceable cartridge that contains the ultraviolet C UVC bulbs and perishable items The geometry and proximity of the ultraviolet C UVC bulbs to the object being processed allows 100 coverage of the device Codonics Disinfection Technology User s Manual 35 The object being processed is unobstructed in the region the disinfecting action 1s taking place allowing maximum exposure to be applied to the device The transport rollers act both to convey the object and block ultraviolet C UVC from escaping the system The system allows for the use of specially designed ultraviolet C UVC transmissive sleeves to allow the broadest use of the device in acco
31. ice for disinfection The flashing is displayed during the entire process from entry to exit Green System LED indicates system is functional and ready for use Red and flashing red System LED indicate a fault error condition NOTE If the red System LED is illuminated the CDT should be powered down and troubleshooting steps should be taken as described in the Troubleshooting section The Cartridge LED indicates the remaining life of the cartridge which contains the ultraviolet C UVC bulbs and other components which will wear out with system usage The following Cartridge LED lighting conditions will be presented Green indicates 100 to 25 of cycles remaining Yellow indicates 25 to 1 of cycles remaining prepare to replace cartridge Red indicates that the cartridge needs to be replaced Codonics Disinfection Technology User s Manual 40 NOTE If the red Cartridge LED is illuminated the CDT should be powered down for a Cartridge replacement as described in the Installing the Cartridge section The Entry Slot is the location in which an item will be placed to process in the system The Check Mark Light is flashed to notify the user that the disinfection process is completed The Cancel Button is pressed by the user once to reverse the transport direction or twice in succession to fully stop the disinfection process due to a jammed condition or other problems e The Open Button is pressed by the user th
32. ion is unavailable use respirators as specified below Respiratory Protection Use appropriate NIOSH approved respirator if airborne dust concentrations exceed the PEL or TLV limits All appropriate requirements set forth in 29 CFR 1910 134 should be met Eye Protection OSHA specified safety glasses goggles or face shield are recommended if bulbs are broken Hygienic Practices After handling broken bulbs wash thoroughly before eating smoking or using toilet facilities Codonics Disinfection Technology User s Manual 64 Cleaning the Enclosure el PRECAUTION Avoid spilling fluids on any part of the CDT E PRECAUTION If spills do occur immediately disconnect CDT from the power source and clean the CDT e O Always power off the system before cleaning An electrical shock could occur if the system is powered on and liquid is spilled into it NOTE Refer to the Powering the System section To clean the system s enclosure without physical or cosmetic degradation use a clean lint free cloth moistened with one of the following Phenolic Disinfectant Cleaner meets VII d 4 of AORN recommendation 1 part household bleach and 5 parts water meets VII e 2 of AORN recommendation A 456 N Disinfectant Virex256 Disinfectant Isopropyl Alcohol 70 solution The following pre moistened disposable cloths may also be used for cleaning the enclosure Codonics Disinfection Technology Users Manual 65 PDI San
33. nd off using the Power Switch on the Rear Panel Powering the System 1 Toggle the Power Switch to the I position on the Rear Panel of the CDT to power on and start up the system NOTE In the D7000 model it is recommended to access the Power Switch when the Tray is released and in the upward most position The Power Switch may be accessed from the front of the unit through the Receiving Area Door Codonics Disinfection Technology Users Manual 53 IL 6A Canadian Ee se are NUBA FUSE S 250V 1 1e ares Lee ses This produc the laws of the Member ACE SKY Disinfection Technology g Daylight macs KI lents Pending inte 400 CDT power switch D6000 shown 2 For the initial 5 seconds of power up there is no Front Panel LED illumination Once 5 seconds is reached the System light begins to flash green and system activation is audible 3 After the 30 second system warm up process has been completed the System light on the Front Panel will be illuminated in solid green Additionally the UVC bulbs will warm up and the Cartridge LED will be illuminated in green With those indications the CDT is available for utilization Codonics Disinfection Technology User s Manual 54 4 To power off the system toggle the Power Switch to the O position on the rear of the CDT to power off the system NOTE If there is no system utilization for a period of 30 minutes the system will start a
34. nd the disinfected item will be presented in the Receiving Area for removal 2 WARNING The Codonics Disinfection Technology is intended to disinfect non critical medical devices The subsequent utilization of the non critical medical devices disinfected by the CDT is the sole responsibility of the user WARNING Do not place your hands inside the openings of the CDT before turning off the power A WARNING The CDT should not be operated by children WARNING High Temperature Internal components of CDT may develop temperatures above 110 F Codonics Disinfection Technology User s Manual 61 PRECAUTION The product must be used in accordance with this User s Guide ZA PRECAUTION Avoid spilling fluids on any part of the CDT 2 PRECAUTION If spills do occur immediately disconnect CDT from the power source and clean the CDT PRECAUTION Never insert any object not indicated for use with the CDT 3 PRECAUTION Do not use any attachments not recommended by Codonics Codonics Disinfection Technology User s Manual 62 Chapter 4 Maintenance Ordering Supplies and Parts The following table lists the supplies and parts that can be ordered from Codonics Catalog Number Sleeves Various sizes and styles available from smart phones to tablet PCs Please contact your Codonics Customer Service Representative Cartridge CDT CARTRIDGE To order supplies and parts con
35. ndommag s contactez Codonics au 1 440 243 1198 PR CAUTION L installation lectrique de la pi ce dans laquelle CDT sera utilis doit tre conforme aux normes locales de c blage lectrique Codonics Disinfection Technology User s Manual 20 Location Warnings and Precautions da PRECAUTION When removing the CDT hold under the front and rear of the system Do not lift the system by the foam packaging 3 PRECAUTION The CDT weighs 35 to 44 lbs 15 to 19 kg To avoid injury use two people to unpack and position the device Za PRECAUTION Placement of the CDT on a cart or stand must have at least 4 inches separation between the CDT back panel and the wall behind it PRECAUTION Do not place any objects over 40 lbs 18 18 kg on the top lid of the Double Pass model See Chapter 3 for information about Double Pass Processing Technique Model 2 PRECAUTION Keep the CDT away from heated surfaces Mises en garde et pr cautions concernant la mise en place de l appareil fa PR CAUTION Lors du retrait de CDT de son emballage tenir sous l avant et l arri re du syst me Ne soulevez pas le syst me par l emballage en mousse Codonics Disinfection Technology User s Manual 21 pos 1 PRECAUTION CDT p se 15 to 19 kg 35 to 44 Ibs Afin d viter toute blessure deux personnes sont n cessaires pour d baller et installer l appareil PRECAUTION Lorsque CDT est plac sur un ch
36. ntended for use in the electromagnetic environment specified below The customer or the user of the CDT should assure that it is used in such an environment CDT is third party tested and verified compliant with UL 61010 1 CSA 61010 1 IEC 61010 2 040 EN 60601 1 2 2007 3 Edition IEC 60601 1 2 207 3 Edition Class B Emissions and Immunity for non life supporting equipment JIS T 0601 1 2012 as follows Emissions Test RF Emissions Class B Electromagnetic Environment Guidance Emissions IEC EN 61000 3 3 Electromagnetic compatibility Generic standards Emission standard for residential CISPR 11 EN 55011 commercial and light industrial environments Harmonic Emission Class A IEC EN 61000 3 2 Voltage Fluctuations Flicker Complies Codonics Disinfection Technology User s Manual 27 Guidance and Manufacturer s Declaration Electromagnetic Immunity The CDT is intended for use in the electromagnetic environment specified below The customer or the user of the CDT should assure that it is used in such an environment Immunity Test Test Level Compliance Electromagnetic Environment Level Guidance Electrostatic Discharge Contact 6 KV Pass Floors should be wood concrete or ESD ceramic tile If floors are covered with Air 8 KV Pass synthetic material the relative humidity IEC EN 61000 4 2 should be at least 30 Radiated Radio Pass Frequency Electromagnetic Field Immunity
37. ntry Slot for removal Codonics Disinfection Technology User s Manual 57 D6000 system cartridge NO Insert Device CANCEL In sieeve F Screen Side Down Disinfection Technology Zip Flap First TO OPEN press and pull CDT s check mark illuminated in green showing completed disinfection The photochromic marker on the sleeves will change in color revealing a check mark indicating that the process was completed successfully Double sleeved iPad before disinfection Codonics Disinfection Technology User s Manual 58 Double sleeved iPad after disinfection Once run through the CDT the sleeved item can be taken into medical settings where infection prevention is desirable In practice the outer sleeve is removed once the device has been processed and taken to the use location The device is then used while remaining in the interior sleeve After use the interior sleeve is discarded Pass Through CDT D7000 Processing Technique The Pass Through model is a variation of the Double Pass model which provides additional options including the following e Option to process items without CDT sleeves e Faster processing by eliminating the return cycle e Smaller footprint by vertical mounting the unit to a base Codonics Disinfection Technology User s Manual 59 The Pass Through model includes a Receiving Area for easy access by the user to processed items Th
38. oduit doit tre conforme toutes les lois et r glements applicables sur le lieu d utilisation European Disposal Requirements Codonics Disinfection Technology and accessories are not to be discarded or recycled rather they are to be returned to the manufacturer Contact Codonics directly or by the email link provided for the latest information concerning Identification of the country specific Importer Distributor Producer Product return and treatment of our electronic products Codonics Incorporated 17991 Englewood Drive Middleburg Heights Ohio 44130 USA Phone 1 440 243 1198 Fax 1 440 243 1334 Email WEEE codonics com Web Site www codonics com Codonics Disinfection Technology User s Manual 30 Codonics electronic products and accessories bearing the following symbol are subject to European Directive of Waste Electrical and Electronic Equipment WEEE 2002 96 EC amended by Directive 2003 108 EC The EN 50419 symbol indicates separate collection and return required EN 50419 symbol Codonics Disinfection Technology User s Manual 31 Indications for Use Intended Use The CDT disinfection system is intended to allow authorized trained personnel within the hospital the ability to disinfect a non critical device NCD on demand Non critical medical devices make only topical contact with intact skin Devices suitable for CDT application are smart phones iPads tablet PCs and other thin format touch display d
39. of Construction Daylight Medical 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 e Mercury except as used in lamp applications for example scanning lamps backlit LCDs e Cadmium except as used as thick film inks on printed circuit boards e 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 e Polybrominated diphenyl ethers and polybrominated biphenyls Codonics Disinfection Technology User s Manual 76 e Bioavailable arsenic small amounts of arsenic used in glass LEDs and semiconductors are not considered to be bioavailable e Bioavailable crystalline silica small amounts of crystalline silica are used in certain paints coatings and filler materials e Polychlorinated biphenyls PCBs e Asbestos e Organic tin not used in tin lead solder applications e 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 Daylight Medical utilise les standards d valuation les plus contraignants pour tester ses produits Daylight Medi
40. on the front panel showing indicator status for the System and Cartridge The System LED indicates the state of the CDT The following LED lighting conditions will be presented e Slow flashing green color indicates that the system is in stand by mode The Cartridge LED light will be illuminated with its current status Codonics Disinfection Technology User s Manual 71 e Flashing green indicates that the system is starting up or warming up from a stand by mode session e Green indicates system is functional and ready for use e Red and flashing red indicate a fault error condition NOTE If the red System LED is illuminated the CDT should be powered down and troubleshooting steps should be taken as described in the Troubleshooting section The Cartridge LED indicates the remaining life of the cartridge which contains the ultraviolet C UVC bulbs and other perishable items The following LED lighting conditions will be presented e Green indicates 100 to 25 of cycles remaining e Yellow indicates 25 to 1 of cycles remaining e Red indicates that the cartridge needs to be replaced NOTE A Cartridge nearing the end of its life may flash the Cartridge LED yellow and return to green due to reduced output 25 to 1 range and or heat levels NOTE If the red Cartridge LED is illuminated the CDT should be powered down for a Cartridge replacement as described in the Installing the Cartridge section Codonics Disinfec
41. r technical assistance with the Codonics Disinfection Technology call Codonics Technical Support at the following number Phone 1 440 243 1198 Toll Free 800 444 1198 USA only Technical Support is available weekdays from 8 30 AM to 5 30 PM EST U S holidays excluded Technical Support is also available online via email and the Codonics web site Email support codonics com Web Site www codonics com General product information can also be requested by sending an email to Email info 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 Codonics Disinfection Technology User s Manual Warnings Precautions and Limitations for Use Location of Safety and Compliance Labels Codonics Disinfection Technology manufactured by Daylight Medical Inc for Codonics Inc Daylight Medical Inc is in compliance with various regulations details of which are listed in the Specifications section The CDT safety and compliance labels shown below are located on the rear panel D6000 or back panel D7000 of the device 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 B digital apparatus
42. rd most position and then the Power Input Port may be accessed from the front of the unit through the Receiving Area Door The Power Switch is also most easily accessed in this manner Te Connect the Power Cord to a grounded power outlet that supplies the appropriate voltage for the applicable country CC Rules Operation is sube s F This device complies with part 15 of the e e may not cause harmful interference ang 2 that may cause undesired operation n ICES 003 lanorme N E FUSE S 250V 1 6A pre is prod formi Thie Pie ofthe Member Sites relating y Disinfection Technology Daylight medical Made in USA Patents Pending inte is Reserved All Rights an CDT power cord connection D6000 shown Codonics Disinfection Technology User s Manual 52 ZA WARNING The power cord is the main disconnect for the device The power outlet should be near the device and be easily accessible A G The CDT must be connected to a grounded electrical outlet to maintain grounding reliability WARNING Remove the power cord from the power outlet to disconnect overall power to the device WARNING Failure to insert the Voltage Selector Plug in the proper voltage orientation will cause the fuses in the Voltage Selector Plug to blow and will require the user to replace the fuses prior to restore operation Fuses are not covered under warranty Once the Power Cord is connected the CDT can be powered on a
43. rd with customer requests for speed ease of use and use location The system continuously monitors ultraviolet C UVC output to ensure at least a given UVC exposure occurs or the system becomes disabled and alerts the user Operational Features Easy to service with Codonics Return to Factory Warranty An optional Express Warranty program is also available which provides a replacement CDT if the problem cannot be solved by our technical support team Codonics Disinfection Technology User s Manual 36 Chapter 2 Setting Up the System Finding a Location for the System When finding a suitable location for the system use the following guidelines along with the information in the Location Warnings and Precautions section 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 Make sure that the countertop or work surface supporting the system is level can support the weight and will not vibrate or shake when the system is operating Shipped Components The CDT is shipped in cartons that contain the following system components Codonics Disinfection Technology Unit Codonics Disinfection Technology Users Manual 37 Power Cord Cartridge in separate internal carton Literature includin
44. reen Additionally the UVC bulbs will warm up and the Codonics Disinfection Technology Users Manual Cartridge LED will be illuminated in green With those indications the CDT unit is available for utilization Notes Notes contain additional information related to a topic or procedure For example NOTE If there is no system utilization for a period of 30 minutes the system will start a stand by mode Cautions and Warnings Cautions alert you to actions or situations that could cause harm to equipment For example 2 PRECAUTION Never insert any object not indicated for use with the CDT Warnings alert you to actions or situations that could result in personal injury For example eS WARNING Do not place your hands inside the openings of the CDT before turning off the power Important Information Bold type is used for emphasis For example The System LED indicates the state of the CDT unit Codonics Disinfection Technology User s Manual Purpose and Scope Refer to this User s Manual for procedures on how to perform the Codonics Disinfection Technology Operations including e Unpacking the hardware e Setting up the hardware and software e Performing device disinfection e Utilizing device sleeves for disinfection e Maintaining the system and replacing the cartridge e Monitoring the system and troubleshooting common problems Codonics Disinfection Technology User s Manual Product Information Fo
45. rnlaan 13 3951DB Maarn The Netherlands Tel 31 6 516 536 26 Codonics Disinfection Technology Users Manual Table of Contents Preface Conventions Used in This Manual 6 Bulleted Lists entame le Ad ame lente 6 Numbered Steps si ii tt ee an mdr bs mn mire dame mue de AAA ee 6 NOS cc attenante Pratt idee le alien sd dete decay dul abet net A et ile nier e tire er he 7 Cautions and Warning tere ege a A AAA RNA at i ada 7 Important Information A ati 7 elle Ee Bee 8 Product deelen Ee Ee 9 Warnings Precautions and Limitations for Use sise 10 Location of Safety and Compliance Labels sie 10 Warnings ANd Pr cautions EE 11 Post Disinfection War UDS iii A at ce goed RA A TA dada Dada apes 13 Avertissements post d sinfection es 13 Ultraviolet Light Bulb Warnings and Precautions is 13 Mises en garde et pr cautions concernant les lampes UV 14 Safety Warnings and Precautions usines 14 EE 16 Voltage Warnings and Precautions is 17 Mises en garde et pr cautions concernant la tension 19 Location Warnings and Precautions sise 21 Mises en garde et pr cautions concernant la mise en place de l appareil 21 Cl anihg EE 22 Pr cautions de NCUOV AGO acicate AA Aia ro a 23 Serial Number Configuration Date Code and Modification Codes 25 Potential for Radio Frequency Interference on Device Operation 26 Potential for Radio and Television Jnterterence 26 Guidance and Manufacturer s Declaration Electromagnetic Emiseions 27
46. s been type tested and found to comply with Class B emission limits for a computing device in accordance with the specifications in Subpart B of Part 15 of FCC rules which are designed to provide reasonable protection against such interference when operating in a commercial environment The CDT is not intended for use in a residential Class A environment The CDT requires a medical power ground If your CDT 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 e Reorient the receiving antenna e Relocate the CDT 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 Codonics Disinfection Technology User s Manual 26 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 Guidance and Manufacturer s Declaration Electromagnetic Emissions The CDT is i
47. s enclosure that may be of sufficient magnitude to constitute a risk of electrical shock The thermometer within the equilateral triangle is intended to alert the user to presence of internal components that may reach high temperatures within the device s enclosure that may be of sufficient temperature to cause a burn Warnings and precautions may be found throughout this manual when specific operations are listed Additional precautions may be found throughout this manual when specific operations are listed Mises en garde et pr cautions Le point d exclamation dans un triangle quilat ral est destin alerter l utilisateur de la pr sence d instructions importantes de fonctionnement et d entretien dans la documentation accompagnant l appareil L clair avec le symbole de fl che dans un triangle quilat ral est destin alerter l utilisateur de la pr sence d une tension dangereuse dans le bo tier de l appareil qui peut tre d une ampleur suffisante pour constituer un risque de choc lectrique Le thermom tre dans le triangle quilat ral est destin alerter l utilisateur de la pr sence de composants internes pouvant atteindre des temp ratures lev es l int rieur de l enceinte de l appareil qui peuvent tre suffisantes pour provoquer une br lure Codonics Disinfection Technology User s Manual DER Mises en garde et pr cautions peuvent tre trouv es dans ce manuel lorsque des op rations
48. s liquides sur n importe quelle partie de CDT JTION Si des projections se produisent d branchez imm diatement CDT de la source d alimentation et nettoyez l appareil PRECAUTION Ne jamais ins rer un objet non indiqu pour une utilisation avec CDT JPR CAUTION Ne pas utiliser d accessoires non recommand s par Codonics Voltage Warnings and Precautions St WARNING This device must be electrically grounded cl WARNING To prevent fire or shock hazard do not expose this device to rain or moisture Codonics Disinfection Technology Users Manual 17 WARNING Explosion Hazard Do not operate the CDT in the presence of flammable vapors WARNING Disconnect the power cord from the wall outlet before servicing to avoid the possibility of electric shock 2 WARNING Turn the system off before opening the front panel to avoid the possibility of electric shock WARNING The CDT must be connected to a grounded electrical outlet to maintain grounding reliability A 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 gt WARNING 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
49. stand by mode NOTE When the Open button on the Front Panel is pressed and the tray begins to move forward the power to the system is immediately turned off as a safety mechanism Codonics Disinfection Technology Users Manual 55 Chapter 3 Disinfection Operations There are two models Double Pass D6000 and Pass Through D7000 of the Codonics Disinfection Technology which are utilized for disinfecting non critical devices The processing technique for both models is described below Double Pass CDT D6000 Processing Technique In the Double Pass model all items to be processed are placed into either one single or two nested ultraviolet C UVC transmissive sleeves each with a photochromic marker if that option is present before being placed into the system In this model the use of at least one sleeve is required For the greatest infection defense possible we recommend using the nested sleeve option discarding the outer sleeve after processing and using the device while inside the remaining sleeve Both the sleeve and the device are being disinfected but using the device in the sleeve acts to minimize the accumulation of pathogens in device recesses Placement into the Entry Slot requires that the item is face screen down with the sleeve closure zip or flap entered first leading edge NOTE Not all device cases may be processed through CDT due to the surface area presented Codonics Disinfection Te
50. tact Codonics Customer Service at Phone 1 440 243 1198 non US customers Toll Free 1 800 444 1198 Fax 1 440 243 1334 Email info codonics com Web Site www codonics com NOTE The use of unapproved parts will void the Codonics warranty for the CDT unit NOTE There are no user serviceable parts inside the CDT unit Codonics Disinfection Technology User s Manual 63 NOTE Using any sleeve other than Codonics Disinfection Technology Sleeve is prohibited Do not use CDT Sleeves in any other disinfection device or without first enclosing your device in a CDT Sleeve and processing it in CDT Procedures for Disposal of UVC Bulbs If bulbs are broken ventilate the area where breakage occurred Clean up with mercury vacuum cleaner or other suitable means that avoid dust and mercury vapor generation Take usual precautions for collection of broken glass Clean up requires special care due to mercury droplet proliferation Place materials in closed containers to avoid generating dust It is the responsibility of the generator to ensure proper classification of waste products To that end TCLP tests should be conducted on all waste products to determine the ultimate disposition in accordance with all applicable federal state and local regulations Special Handling Information for Broken UVC Bulbs Ventilation Use adequate general and local exhaust ventilation to maintain exposure levels below the PEL or TLV limits If such ventilat
51. the wall outlet Press the Open button on the Front Panel of the CDT Pull forward on the Front Panel to expose the device Tray Insert the SD card into the SD Card Slot on the left side Codonics Disinfection Technology Users Manual 67 SD Card Insertion for Software Installation 6 Close the Front Panel by pushing it into the unit and push the Open button until it locks 7 Plug the Power Cord into the wall outlet 8 Toggle the Power Switch to the I position on the rear of the CDT to power on the system Codonics Disinfection Technology User s Manual 68 Upon completion of the software update the System LED light on the Front Panel will flash green NOTE If the software upgrade fails the System LED light on the Front Panel will flash red 10 11 12 13 14 15 16 17 18 Toggle the Power Switch to the O position on the rear of the CDT to power off the system Unplug the Power Cord from the wall outlet Press the Open button on the Front Panel of the CDT Pull forward on the Front Panel to expose the device Tray Remove the SD card from the SD Card Slot on the left side Close the Front Panel by pushing it into the unit and push the Open button until it locks Plug the Power Cord into the wall outlet ep Toggle the Power Switch to the system position on the rear of the CDT to power on the The CDT is now ready for use Codonics Disinfection Technology
52. tion Technology User s Manual BW CR Troubleshooting Common Problems The following table lists common problems their possible causes and how to solve them The Cartridge is not seated properly Cartridge needs replaced as it reached its life span There is a device or something in the rollers of the Cartridge Problem Possible Causes Solutions The System LED flashes There is a device jammed in the Check the Cartridge for any items devices red System stuck in the cartridge Power off the System prior to opening the Front Panel Try installing the Cartridge again or There is a problem with the Cartridge replace it with a new Cartridge The software has become corrupted Reinstall software The Cartridge LED is A Cartridge is not installed Install a Cartridge red Remove the Cartridge and try reseating in the System Install a new Cartridge Open the System and remove any devices or other items in the rollers of the Cartridge Power off the System prior to opening the Front Panel Codonics Disinfection Technology Users Manual 73 Problem Possible Causes Solutions The Cartridge LED is yellow The Cartridge is nearing end of life Order a new Cartridge and prepare to replace the consumed Cartridge when the Cartridge LED turns red The LED lights are not illuminated on front of the System The power cord is disconnected The Front Panel is not full
53. ue de la Classe B est conform a la norme NMB 003 du Canada This product is in conformity with the requirements of EC Council directive MDD93 42 EEC on the approximation of the laws of the Member States relating to medical devices This product satisfies the Class B limits of IEC60601 1 CODONICS DISINFECTION TECHNOLOGY d C MODEL D7000 Codonics Disinfection Technology Manufactured by Daylight Medical Inc for Codonics Inc Dayl 19 ht medica Made in U S A Patents Pending ae All Rights Reserved ECIREP CEpartner4U BV Esdoornlaan 13 C US 3951 DB Maarn The Netherlands LISTES Phone 31 6 516 536 26 AZAR mal D2yight Medical Inc 17991 Englewood Drive Ste Intertek Middleburg Heights OH 44130 USA MODEL MODELE SKY 7xi 4009181 100 120V 1 6A 50 60Hz 200 240V 1 2A 50 60Hz Conforms to UL Std 61010 1 amp IEC Std 61010 2 040 Certified to CAN CSA Std C22 2 Nos 61010 1 amp 61010 2 040 CDT D7000 safety and compliance label Warnings and Precautions Codonics Disinfection Technology User s Manual The exclamation point within an equilateral triangle is intended to alert the user to the presence of important operating and maintenance instructions in the literature accompanying the device The lightning flash with the arrowhead symbol within an equilateral triangle is intended to alert the user to the presence of uninsulated dangerous voltage within the device
54. y closed A fuse may be blown Check the power cables Check the power supply switch on the rear panel Depress the Open button until it is flush with the System face Then slide the tray in firmly until it locks into place Contact Technical Support for replacement fuse information The System flashed the red Cancel button A device is left in the System Switch off and unplug the System prior to opening the Front Panel Open the unit and remove any jammed or left behind devices The knurled knobs on the side of the Cartridge may assist in rolling back the jammed device Codonics Disinfection Technology User s Manual 74 Problem Possible Causes Solutions There is a chattering noise in the System The Cartridge is not installed properly The Cartridge drive belt is worn The device being disinfected is not supported at this time A jam has occurred in the feed system Remove the Cartridge and try reseating in the unit Install a new Cartridge Try disinfecting a different type of device Press the Open button slide the tray forward and remove any jammed object and re process Continued jamming may reflect that the device cannot be disinfected in the System Switch off and unplug the System prior to opening the Front Panel Codonics Disinfection Technology Users Manual 75 Appendix A Hazardous Material Information Materials

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