FSE-058-1.0 Reusable Water Bottle Cap and Tubing Set User Manual
Contents
1. BE Ep DL O ke Op Description Consult instructions for use Caution Manufacturer Catalog number Must not be disposed of as unsorted municipal waste but should be collected separately Number of units CE Mark Class Ila European Representative Federal US law restricts this device for sale by or on the order of a physician Non sterile Date of Manufacture Manufactured according to Restriction of Hazardous Substances Directive This product was designed and manufactured to meet all safety requirements applicable to medical ancillary equipment However anyone operating the device must be fully aware of the potential safety hazards It should be operated and maintained in strict compliance with the safety precautions and operating instructions contained herein The device is not to be modified in any way Any attempt to disassemble repair or modify this device by anyone other than an EndoChoice authorized service technician presents 2 ENDCCHOICE FSE 058 EN 1 0 Safety Information Please Read Prior to Use risk to the patient or operator and may result in equipment damage Equipment that has been disassembled repaired altered changed or modified by persons other than EndoChoice s own authorized service personnel is excluded from EndoChoice s warranty and is not warranted by EndoChoice in any way Do not use the device if unsafe conditions exist This device does not contain a2. performance CAUTION Do not bend twist or pull the tube excessively The tube could become damaged which could make air and or water feeding impossible After use reprocess and store according to the instructions given in CHAPTER 6 Reprocessing and CHAPTER 7 Storage Improper and or incomplete reprocessing or Reusable Water Bottle Cap amp Tubing Set User Manual 3 4 Safety Information Please Read Prior to Use storage can create an infection control risk cause equipment damage or reduce performance e Separate reprocessing of the Water Bottle Reprocessing Adaptor EndoChoice Part Number FSR 4368 is not required prior to the reprocessing of the Reusable Water Bottle ENDCCHOICE FSE 058 EN 1 0 Regulatory Information The Reusable Water Bottle is designed to be used with EndoChoice Fuse endoscopes to allow gas insufflation and sterile water feeding during endoscopic procedures The Reusable Water Bottle with CO2 Tubing is designed to be used with EndoChoice Fuse endoscopes to allow CO2 insufflation and sterile water feeding during endoscopic procedures Do not use this device for any purpose other than its intended use CAUTION m Federal U S law restricts this device to sale by or on the order of a physician mal CE cos EC J REP EndoChoice Inc 11810 Wills Road Atlantico Systems Ltd Alpharetta GA 30009 USA 34 Oldfield Tel 888 682 3636 Kingston Galway Ireland Email cus
3. remove contaminated protective clothing before leaving the reprocessing area Reusable Water Bottle Cap amp Tubing Set User Manual 19 Reprocessing Several methods of reprocessing are compatible with EndoChoice endoscopic equipment Certain components and accessories however are incompatible with some methods which can cause equipment damage For appropriate reprocessing methods refer to e the table below e the recommendations of your hospital s infection control committee and e all national and local hospital guidelines and policies Table 2 Water Bottle Reprocessing Type Compatibility Summary Environment Effect Water Bottle Compatibility ke eg al High level disinfection Compatible ETO gas sterilization Sterilization Not Compatible Steam sterilization autoclave Sterilization Compatible Ultrasonic cleaning Cleaning Not Compatible WARNING Do not reuse detergent solution tissue irritation or infection control risk may result Keep detergent foaming to a minimum Excessive detergent foaming can prevent fluid from adequately contacting internal lumens and may limit the effectiveness of subsequent high level disinfection or sterilization Alcohol is not a sterilant or high level disinfectant 20 QENDCCHOICE FSE 058 EN 1 0 Reprocessing The following equipment and materials are required for reprocessing The items listed below including cleaning agents responsible for removal of soil high level disinfe
4. torque for screwing will increase when the O ring is engaged From that point screw the cap an additional 180 Figure 3 14 QQENDCCHOICE FSE 058 EN 1 0 Preparation and Inspection CAUTION Hang the Water Bottle on the Water Bottle Holder of the FuseBox or onto the side of the EndoCart using the supplied mounting kit Otherwise the Water Bottle may fall and sterile water could be spilled on surrounding equipment This could result in equipment damage and or malfunction Connect the Tube Connector slowly and carefully Otherwise the Tube Connector could become damaged which could make gas insufflation and water feeding impossible When insufflating with COz turn OFF the AIR FLOW from the FuseBox to stop air feeding If the air feeding is not turned off a gas mixture of nonflammable gas will be insufflated into the body cavity of the patient When insufflating with CO an appropriate insufflator must be used Do not attempt to connect the device directly to a CO tank If using the CO bottle SCT 469 and not insufflating with CO make sure that the CO port cap is securely screwed on the port 1 Hang the Water Bottle on the Water Bottle Holder of the FuseBox 2 Push the Tube Connector gently onto the air water port on the endoscope see Figure 4 Figure 4 1 Unscrew CO port cap 2 Securely connect the CO tube from the CO2 insufflator to the CO2 port on the Water Bottle 3 Turn the Fus
5. 8 EN 1 0 Reprocessing Vv Equipment Description Important Use an autoclave that will operate at the Autoclave conditions specified in Section 6 5 2 Steam Sterilization Autoclave Reusable Water Bottle Cap amp Tubing Set User Manual 23 Reprocessing 6 4 Cleaning AN WARNING e Follow the Water Bottle cleaning instructions provided below Otherwise effective high level disinfection or sterilization cannot be achieved Clean the Water Bottle thoroughly before high level disinfection or sterilization to remove any microorganisms that could impair high level disinfection or sterilization efficiency CAUTION m Never drop or subject the Water Bottle to impacts A damaged Water Bottle may prevent gas insufflation and water feeding m Do not bend twist or pull the tube excessively A damaged tube may prevent gas insufflation and water feeding m Prior to cleaning high level disinfection and sterilization disassemble the Water Bottle as shown in Figure 6 below Do not disassemble the components further A damaged Water Bottle may prevent air and or water feeding m The O ring is an article of consumption Exchange for a new O ring when there is a flaw or a transformation in the O ring A damaged O ring may prevent air and or water feeding 7o remove the O ring pull out the portion of it that lies in the notch along the bottle s rim see Figure 7 Attempting to pry the O ring out of its groove could damage the O ri
6. Do not bend twist or pull the tube excessively The tube could become damaged which could make gas insufflation and water feeding impossible 30 ENDCCHOICE FSE 058 EN 1 0 Storage WARNING Do not store the device in a damaged wet or improperly sealed sterile package An improperly stored device may compromise the sterility of the device pose an infection control risk and or cause tissue irritation Do not store sterile packages containing the device in a place where they will become damaged wet or improperly sealed An improperly stored device may compromise the sterility of the device pose an infection control risk and or cause tissue irritation Prior to storage inspect the sterile packages as follows Confirm that the sterile packages containing the device are free from tears inadequate sealing or water damage If tears inadequate sealing or water damage is detected repackage and sterilize again as described in CHAPTER 6 Reprocessing Store the device in the sterile packages at room temperature in a clean and dry environment Do not store it in direct sunlight or in the presence of X rays Ensure that the packaged devices are not crushed by surrounding objects during storage Consult the sterile package manufacturer for any additional storage instruction e Always store a sterilized Water Bottle in the sterile packaging WARNING These storage parameters are not intended to preserve Water Bottle sterility I
7. ERS Device Components 9 3 1 Packaged Components 9 3 2 SOCAN EA 11 3 2 1 Reusable Water Bottle rrornnrrorrornnnnrrrernnnnrrnnvnnnnnrnennnanervnnnnnnsennennen 11 Jaz EMMI Eire 11 CHAPTER 4 Preparation and INSPe CtiONn cccscscscscscscscsccccccccccccccecscececs 13 4 1 Prepare and Inspect the Water Bottle 14 4 2 Connection to the endoscope ei 15 4 2 1 If insufflating with CO2 15 4 2 2 DISCONNECTION from the scope 16 CHAPTERS Operatlonissiacssnssosasenessncaraassessnnessessunaevseastastessseammneusdatacssneeniane 17 CHAPTER 6 Reprocessing vs 19 ol General NN 19 6 2 Compatible Reprocessing Methods and Chemical Agents 20 6 2 1 Compatibility Summary i 20 6 3 Required Reprocessing Equipment e 21 64 OT 0 EEE 24 6 5 High Level Disinfection and sterilization rrrrrrrnrvrrrnrvrrrnrvrrrnrerrrnrnnrrnvnnnnnn 27 6 5 1 High Level Disinfection 27 Reusable Water Bottle Cap amp Tubing Set User Manual lil Contents 6 5 2 Steam Sterilization Autoclave i 29 CHAPTER SOP 31 7 1 Inspection before StOrage cccccccssseseccccececeeeeeeceeeeeseeeeeeceeeeesseeaeeeeeeeessaaeeeees 31 TE Svane 31 FSE 058 EN 1 0 v QENDOCHOICE Safety Information Please Read Prior to Use This manual provides information require
8. User Manual Water Bottle Water Bottle Cap amp Tubing Set Cap amp Tubing Reusable W CO Set SCT 468 Reusable SCT 469 AUTOCLAVABLE Part Number FSE 058 EN 1 0 Released February 2014 Onl fx y Caution Federal U S law restricts this device to sale by or on the order of a physician EndoChoice Inc 11810 Wills Road Alpharetta GA 30009 Tel 888 682 3636 Fax 866 567 8218 customercare endochoice com www endochoice com IMPORTANT Read this User Manual in its entirety prior to using the Reusable Water Bottle 2014 EndoChoice Inc ALL RIGHTS RESERVED EndoChoice Inc reserves the right to alter the equipment specifications and descriptions in this publication without prior notice No part of this publication shall be deemed to be part of any contract or warranty unless specifically incorporated by reference into such contract or warranty The information contained herein is merely descriptive in nature and does not constitute a binding offer for the sale of the product described herein Neither EndoChoice Inc nor its agents make any representations for fitness for any purpose other than specifically mentioned in this manual DISCLAIMER EndoChoice Inc shall not be obligated in any manner in respect to bodily injury and or property damage arising from the use of the device if such use is not in strict compliance with instructions and safety precautions contained in the relevant ope
9. cting agents responsible for reduction of microbes and rinsing water responsible for removal of agent residuals were validated and demonstrated to be compatible with the device and to meet the predefined reprocessing performance criteria Replace any of the reusable equipment listed below that shows signs of wear prior to reprocessing Table 3 Required Reprocessing Equipment oY Equipment Personal Protective Equipment Clean Lint Free Cloths Sterile Lint Free Cloths Single Use Cleaning Brush Detergent Solution Rinsing Water Sterile Rinsing Water Potable Tap Description Eyewear facemask moisture resistant clothing and long chemical resistant gloves Clean lint free cloth may be used for all reprocessing steps except the final drying step A new sterile lint free cloth MUST be used during final drying step and it may be used for all reprocessing steps A new non metal single use channel Cleaning brush such as EndoChoice s HedgeHog Double End Channel Brush SBD 228 50 Use a medical grade low foaming natural pH or enzymatic detergent indicated for use with flexible endoscopes such as Pure by EndoChoice Follow the manufacturer s recommendations including personal protection to be used dilution temperature immersion duration storage date of expiration disposal etc e Sterile Water MUST be used for final rinsing step following high level disinfectio
10. d to enable you to use the Water Bottle Cap amp Tubing Set reusable SCT 468 or Water Bottle Cap amp Tubing w CO Set reusable SCT 469 Read this manual thoroughly before using the device and ensure that you understand the proper use of and care for the device If you have any questions or comments regarding the use of the device please contact EndoChoice Inc The following conventions are used in this manual Symbol A WARNING CAUTION Outside the United States EndoChoice GmbH Otto Hahn Str 11 25337 Elmshorn Germany 49 0 4121 649390 Phone 49 0 4121 649383 Fax Description A warning is a statement that alerts indicates a potentially hazardous situation associated with the use or misuse of the device which if not avoided could result in serious injury or death A caution is a statement that alerts indicates a potentially hazardous situation associated with its use or misuse which may if not avoided result in minor or moderate injury It may also be used to alert against unsafe practices or potential equipment damage An informational note provides additional information of interest to the user United States EndoChoice Inc 11810 Wills Rd Alpharetta GA 30009 888 682 ENDO 3636 Phone 866 567 8218 Fax Reusable Water Bottle Cap amp Tubing Set User Manual 1 Safety Information Please Read Prior to Use Symbol FEL E gt n I lt N IN 086 xU SE gt
11. e Overview 8 ENDCCHOICE This page intentionally left blank FSE 058 EN 1 0 Device Components CHAPTER3 Device Components 3 1 Packaged Components Match all items in the package with the components shown below Inspect each item for damage If the device is damaged a component is missing or you have any questions do not use the device immediately contact EndoChoice Inc This device was not high level disinfected or sterilized before shipment Before using the device for the first time reprocess it according to the instructions given in CHAPTER 6 Reprocessing 7 4 6 3 5 2 1 CO versions pictured above 14 Item Name of Item 1 Water Bottle 2 O Ring 3 Water Tube 4 Cap 5 Bottle Hanger 6 CE Mark 7 CO Port and Cap 8 Tube Reusable Water Bottle Cap amp Tubing Set User Manual 9 Device Components 10 10 11 12 13 14 ENDCCHOICE Water Bottle Cap Connector Hanger Water Level Marks Lowest Water Level Line Tube Connector Water Bottle Reprocessing Adaptor FSE 058 EN 1 0 Description Capacity Medical Devices Directive Environment Operating Conditions Ambient Temperature Relative Humidity Device Components Details 220 ml filled to marked line This device complies with the requirements of Directive 93 42 EEC concerning medical devices Value 5C 41F 40C 104F 85 Max RH Reusable Water Bottle Cap amp Tubing Set User Manual 11 De
12. eBox ON and set the AIR FLOW on the FuseBox to OFF Confirm that no air is being fed from the FuseBox 4 Operate COz insufflation per manufacturer instructions Reusable Water Bottle Cap amp Tubing Set User Manual 15 Preparation and Inspection 4 2 2 Disconnection from the scope 1 Pull the connector from its connection to the air water port on the endoscope 2 Hang the connector on the connector hanger on the cap see Figure 5 Figure 5 16 QENDOCHOICE FSE 058 EN 1 0 Operation The operator of this device must be a physician or a physician supervised clinician who is well trained and capable of performing the planned endoscopic procedure This manual describes only basic procedures and precautions related to the operation of the Water Bottle This manual does not explain or discuss clinical endoscopic procedures WARNING e Ata minimum clean and high level disinfect or sterilize the Water Bottle once per day Failure to do so can result in increased patient infection risk tissue irritation device contamination degraded performance or loss of functionality Using Water Bottles that have either been improperly or incompletely reprocessed or stored may cause cross contamination or infection If insufflating with CO2 and using a CO bottle the gas is normally emitted through the small hole in the endoscope s air water valve To prevent oxygen deficiency ensure adequate ventilation CAUTION Befo
13. f necessary reprocess the Water Bottle again prior to use Reusable Water Bottle Cap amp Tubing Set User Manual 31 EndoChoice Inc 11810 Wills Road Alpharetta GA 30009 USA Tel 888 682 3636 Email customercare EndoChoice com Atlantico Systems Ltd 34 Oldfield Kingston Galway Ireland Tel 35391443609 Email info atlanticosystems com
14. ing Adaptor 7 Flushing with air a Thoroughly wipe dry the bottle s interior exterior cap tube s exterior O ring and Tube Connector using a sterile dry lint free cloth b Attach the Water Bottle Reprocessing Adaptor to the Tube Connector as shown in the picture above c Attach a 30 cc 30 mL syringe filled with air and inject a total of 120 cc 120 mL of air d Disconnect the Water Bottle Reprocessing Adaptor 28 QENDCCHOICE FSE 058 EN 1 0 Reprocessing Use biological indicators as recommended by your hospital s policy and follow the manufacturer s instructions all national and local hospital guidelines and policies WARNING Always leave space between the packages in the autoclave Packages placed too close together will not achieve effective sterilization Do not handle wet packages Allow the packages to dry within the autoclave using the autoclave s drying cycle if applicable or by opening the door of the autoclave and allowing the packages to air dry Handling a wet package can compromise its sterility Put the O Ring in position i e on the Water Bottle Cap BEFORE sterilization to avoid contamination during reassembly prior to usage 1 Before sterilization the device must be thoroughly cleaned and dried Residual moisture inhibits sterilization 2 Wear the protective equipment as specified in the Table in Section 6 3 Required Reprocessing Equipment 3 Remove the Water Bottle Reprocess
15. ing Adaptor from the Tube Connector 4 Assemble the O ring on the Water Bottle Cap prior to steam sterilizing to avoid contamination during reassembly 5 If using a CO bottle unscrew CO port cap 6 Wrap all components together in sterilization wrap 7 Place the sterilization wrap containing the Water Bottle components in the autoclave and steam sterilize at the conditions given below e For details on operation of the autoclave refer to the instruction manual for the autoclave 8 Allow the sterilization wrap to dry within the autoclave using the autoclave s drying cycle at the conditions given below Steam Sterilization Sterilizer Type Pre vacuum Min Temperature 132 C 270 F Min Exposure time 4 Min Min Dry time 30Min The following Steam Sterilization parameters are mandatory in some European countries Sterilizer Type Pre vacuum Min Temperature 134 C 270 F Min Exposure time 4 Min Min Dry time 30Min Reusable Water Bottle Cap amp Tubing Set User Manual 29 Reprocessing The following Steam Sterilization parameters are mandatory in some European countries Sterilizer Type Pre vacuum Min Temperature 134 C 270 F Min Exposure time 18 Min Min Dry time 30Min Do not exceed 140 284 F during sterilization CAUTION Never drop the Water Bottle or subject it to impacts The bottle could become damaged which could make gas insufflation and water feeding impossible
16. n e Temperature 22 30 C 71 6 80 6 F e Minimum required volume 10 Liters e Clean potable tap water may be used for all other cleaning steps e Temperature 22 30 C 71 6 80 6 F e Minimum required volume 10 Liters Important Ensure the reprocessing room is adequately ventilated and lighted DO NOT REUSE DETERGENT SOLUTION Solution should be replaced after being used to reprocess one Water Bottle DO NOT REUSE RINSING WATER Water should be replaced after being used to reprocess one Water Bottle DO NOT REUSE RINSING WATER Water should be replaced after being used to reprocess one Water Bottle Reusable Water Bottle Cap amp Tubing Set User Manual 21 Reprocessing Vv Equipment Water Bottle Reprocessing Adaptor Syringe Luer Lock High Level Disinfectant Solution 70 alcohol Basins Transportation Containers or Pads Sterilization Wrap 22 ENDCCHOICE Description Reusable adaptor that connects to the Tube Connector allows connection of a Syringe Luer Lock Available from EndoChoice Part FSR 4368 Single use sterile 30 mL syringe at least 7 units Use an FDA cleared CE marked high level disinfectant like Cidex OPA by Advanced Sterilization Products which has been validated for use in the reprocessing of this device Follow the manufacturer s recommendations including personal protection to be used dilution temperature immersio
17. n duration storage date of expiration disposal etc Isopropyl should be stored in closed container to avoid evaporation Containers sinks and basins should be large enough to contain the Water Bottle Minimum recommended basin dimension is 40 cm X 30 cm x 15 cm 16 x 12 x 6 The basin should have a tight fitting lid if it is also used for high level disinfection Number of basins required is four 4 1 Used during Manual Cleaning Detergent 1 Used during Manual Cleaning Water 1 Used during High level Disinfection High Level disinfectant 1 Used during Rinsing Sterile Water It is recommended that the Water Bottle is transported in a closed container or closed transport pad such as the EndoChoice CinchPad to prevent contamination or equipment damage during transport A 40 cm X 30 cm x 15 cm 16 x 12 x 6 container may be used Use a sterilization wrap that is compatible with pre vacuum steam sterilization with a minimal size of 30 cm x 30 cm 12 x 12 Important If the high level disinfectant solutions are reused routinely check their efficiency with test strips according to the manufacturer recommendations Do not use solutions beyond their expiration date Test high level disinfectant MEC Minimal Effective Concentration routinely Alcohol is not a sterilant or high level disinfectant DO NOT REUSE ALCOHOL DO NOT USE A SMALLER STERILIZATION WRAP FSE 05
18. ng and or the bottle m Do not bend pull or twist the water tube on the underside of the cap with excessive force A damaged water tube may prevent water feeding m Never detach the water tube from the cap Doing so could damage the water tube preventing water feeding O Ring Notch Figure 6 Bottle 24 QENDCCHOICE FSE 058 EN 1 0 Reprocessing Wear the protective equipment specified in Section 6 3 Required reprocessing equipment Washing under running water a Place the complete unopened contaminated Water Bottle in a sink b Rinse the bottle s external surfaces under running tap water 22 30 C using a lint free cloth to remove gross soil for at least 60 seconds Fill a basin with detergent solution at the temperature and concentration recommended by the detergent manufacturer Disassemble the bottle components Bottle Bottle tubing O ring and if using a CO bottle unscrew the CO port cap Cleaning and flushing with detergent solution a Completely submerge all components in the prepared detergent basin b Thoroughly scrub for at least 30 seconds each of the following Water Bottle s parts locations interior exterior cap tube s exterior O ring and Tube Connector using a Clean lint free cloth c Thoroughly brush for at least 30 seconds each of the following locations e the threads of the bottle and cap and e atthe Tube Connector d If using a COz Water Bottle thoroughly brush CO p
19. ntative to order a replacement To remove the O ring pull out the portion that lies in the notch along the bottle s rim see Figure 1 Attempting to pry the O ring out of its groove could damage the O ring Figure 1 Reusable Water Bottle Cap amp Tubing Set User Manual 13 Preparation and Inspection 1 Referring to Section 3 1 Packaged Components inspect the Water Bottle and all of its components Confirm that all components are free of damage or irregularities 2 When insufflating with COz prepare medical grade CO insufflation system suitable for GI endoscopic procedures in accordance with their respective instruction manuals WARNING e Never fill in the bottle with sterile water while holding it over electrical equipment If water is spilled on or into the equipment electrical shock or damage can result e Use sterile water only Using non sterile water can result in growth of bacteria or channels clogging this could pose an infection control risk and tissue irritation 3 Fill the bottle with sterile water until the water level is within the water level lines specified on the outside of the bottle to ensure adequate water feeding to the scope Water level lines Figure 2 CAUTION m Ifthe O ring is not correctly attached and the cap is not closed properly gas insufflation and water feeding may not be possible see Figure 3 4 Attach the cap to the bottle Screwing the cap onto the boitle the
20. ny user serviceable parts Do not disassemble modify or attempt to repair it patient or user injury and or equipment damage can result This device is compatible with the Fuse Endoscope system Using incompatible equipment can result in patient injury and or equipment damage The operator of this device must be a physician or medical personnel under the supervision of a physician and must have received sufficient training in clinical endoscopic technique This manual therefore does not explain or discuss clinical endoscopic procedures The manufacturer or vendor of the equipment makes no claim that the act of reading this manual renders the reader qualified to operate the device It is important that this manual remain available studied carefully and reviewed periodically by the authorized operators Follow the warnings and cautions given below when handling this device This information is to be supplemented by the warnings and cautions provided in each chapter WARNING This device was not high level disinfected or sterilized before shipment Before using this device for the first time reprocess it according to the instructions given in CHAPTER 6 Reprocessing After using this device reprocess and store it according to the instructions given in CHAPTER 6 Reprocessing and CHAPTER 7 Storage Improper and or incomplete reprocessing or storage can present an infection control risk cause equipment damage or reduce
21. ort and port cap for at least 30 seconds e Attach the Water Bottle Reprocessing Adaptor to the Tube Connector as shown in the picture below f Attach a 30 cc 30 mL syringe filled with the prepared detergent and inject a total of 120 cc 120 mL of detergent through the tube g Disconnect the Water Bottle Reprocessing Adaptor h Allow the Water Bottle to soak in the detergent solution for a minimum of 1 minute at room temperature 22 30 C Rinsing with water following manual cleaning a Fill a clean basin with clean potable water b Completely submerge all components in the water basin c Thoroughly scrub for at least 30 seconds the following Water Bottle s parts locations interior exterior cap tube s exterior O ring and Tube Connector using clean lint free cloth Reusable Water Bottle Cap amp Tubing Set User Manual 25 Reprocessing i Attach the Water Bottle Reprocessing Adaptor to the Tube Connector as shown in the above picture Attach a 30 cc 30 mL syringe filled with clean potable water and inject a total of 120 cc 120 mL of water through the tube Disconnect the Water Bottle Reprocessing Adaptor Rinsing with air a b Remove all components from the water basin Thoroughly wipe until dry each of the following Water Bottle s parts locations interior exterior cap tube s exterior O ring and Tube Connector using a clean dry lint free cloth Attach the Water Bottle Reprocessing Adapto
22. per hour will help reduce chemical vapors 1 Wear the protective equipment specified in Section 6 3 Required Reprocessing Equipment 2 Fill a basin with high level disinfectant solution at the temperature and concentration recommended by the high level disinfectant manufacturer 3 High level disinfecting and flushing with high level disinfectant solution a Completely submerge all components in the high level disinfectant basin b Thoroughly scrub for at least 30 seconds each of the following Water Bottle s parts locations interior exterior cap tube s exterior O ring and Tube Connector using clean lint free cloth c Attach the Water Bottle Reprocessing Adaptor to the Tube Connector as shown below Reusable Water Bottle Cap amp Tubing Set User Manual 2 Reprocessing d Attach a 30 cc 30 mL syringe filled with high level disinfectant and inject a total of 120 cc 120 mL of high level disinfectant through the tube e Disconnect the Water Bottle Reprocessing Adaptor f Allow the Water Bottle to soak in the high level disinfectant solution for the time recommended by the HLD manufacturer g Empty the Water Bottle and remove from the high level disinfectant solution 4 Rinsing with sterile water following High Level Disinfection a Fill a clean basin with a minimum of 2 gallons of sterile water b Completely submerge all components in the water basin for at least 1 minute c Thoroughly scrub for at leas
23. r to the Tube Connector as shown in the picture above Attach a 30 cc 30 mL syringe filled with air and inject a total of 120 cc 120 mL of air through the tube Disconnect the Water Bottle Reprocessing Adaptor When the Water Bottle is thoroughly dry after cleaning continue with high level disinfection or sterilization 26 QENDCCHOICE FSE 058 EN 1 0 Reprocessing 6 5 High Level Disinfection and Sterilization A WARNING Disassemble the Water Bottle to its parts the bottle cap and O ring Otherwise effective high level disinfection or sterilization might not be achieved which would pose an infection control risk or could cause tissue irritation CAUTION Never drop the Water Bottle or subject it to impacts The bottle could become damaged which could make gas insufflation and water feeding impossible Do not bend twist or pull the tube excessively The tube could become damaged which could make gas insufflation and water feeding impossible 6 5 1 High Level Disinfection WARNING Rinse the Water Bottle thoroughly and carefully The Water Bottle must be free of high level disinfectant and thoroughly flushed with sterile water to avoid the possibility of exposing the next patient to residual high level disinfectant Make sure that the reprocessing area is adequately ventilated as dictated by hospital policy or national occupational health regulation Adequate ventilation at least eight to ten air exchanges
24. rating manuals and in all supplements thereto in all product labels and according to all terms of warranty and sale of this device or in any change not authorized by EndoChoice Inc WARNING e User provided ancillary equipment and or accessories are NOT validated or warranted by EndoChoice Inc The use of such user provided items is the sole responsibility of the party using such items EndoChoice Inc Atlantico Systems Ltd 34 OldfieldKingston Galway IrelandTel 35391443609Email info atlanticosystems com 11810 Wills Rd Alpharetta GA 30009 Tel 770 682 8700 Fax 866 567 8218 Email customercare EndoChoice com ENDOCHOICE FSE 058 EN 1 0 Contents CONTEN hhv iii Safety Information Please Read Prior to USe ssesessesessssesssoessssessssesessecssseo 1 NN Ne 1 SUPPO ze EE EN EN 1 Summary of device SYmbols 2 Safety Guidelines please read prior tO USC ccceeeeeeeeeeeeeeeeeeeeeeeeeeeeeeaaaaaeeeeeeeeees 2 User Qualification please read prior tO USE rnnr nn 3 Warnings and CAO eccccecccncttcnecuatenncdauidssconetweinedatectanesieenebueimecassetnnsceaniediqcesiecietaetente 3 POOP OC eS SING anale 3 CHAPTER 1 Regulatory Information ccsccccscscsccccscsccccccscsceccecscscscecccceces 5 l 65 gt RE EE ERRE REENER 5 2 VEME 5 GEN 5 CHAPTER 2 Device Overview ssssssesesssscsessssssosososososososososososososososesesesessse 7 CHAPT
25. re insufflating with CO turn OFF the FuseBox Air Flow to disable air feeding If the air flow remains ON an air and gas mixture will continue to insufflate into the patient s body cavity Monitor the water level carefully during the procedure and fill the Water Bottle with sterile water as necessary Water feeding will stop when the water level falls below the lowest water level line 1 Perform gas insufflation and water feeding as described in the respective instruction manuals for the gas water valve and Fuse endoscope being used with this Water Bottle If the water level falls below the lowest water level line during use disconnect the Water Bottle s Tube Connector from the endoscope as described in Section 4 2 2 Disconnection from the scope Then refer to CHAPTER 4 Preparation and inspection to learn how to refill the Water Bottle with sterile water Reusable Water Bottle Cap amp Tubing Set User Manual 1 Operation This page intentionally left blank 18 JENDCCHOICE FSE 058 EN 1 0 Reprocessing WARNING The Water Bottle was not high level disinfected or sterilized before shipment Before first time use reprocess the Water Bottle according to the instructions given in this Chapter e Itis strongly recommended that reprocessing personnel e have a thorough understanding of patient cross contamination resulting from improper cleaning and disinfection or sterilization and e follow the official s
26. t 30 seconds each of the following Water Bottle s parts locations the bottle s interior exterior cap tube s exterior O ring and Tube Connector using a sterile lint free cloth d Attach the Water Bottle Reprocessing Adaptor to the Tube Connector as shown in the picture above e Attach a 30 cc 30 mL syringe filled with sterile water and inject a total of 120 cc 120 mL of sterile water through the tube f Discard rinse water and repeat steps a e two more times for a total of 3 rinse cycles g Disconnect the Water Bottle Reprocessing Adaptor 5 Flushing with air a Remove all components from the water basin b Thoroughly wipe the bottle s interior exterior cap tube s exterior O ring and Tube Connector using a sterile dry lint free cloth c Attach the Water Bottle Reprocessing Adaptor to the Tube Connector as shown in the picture above d Attach a 30 cc 30 mL syringe filled with air and inject a total of 120 cm 120 mL of air e Disconnect the Water Bottle Reprocessing Adaptor 6 Rinsing with alcohol a Thoroughly scrub the bottle s interior exterior cap tube s exterior O ring and Tube Connector using a sterile lint free cloth soaked with alcohol b Attach the Water Bottle Reprocessing Adaptor to the Tube Connector as shown in the picture above c Attach a 30 cc 30 mL syringe filled with alcohol and inject a total of 120 cc 120 mL of alcohol d Disconnect the Water Bottle Reprocess
27. tandards defined by the hospital s administrators or other national or local official institutions e A specific individual or individuals in the endoscopy unit should be responsible for reprocessing endoscopic equipment It is highly desirable that a trained backup be available should the primary reprocessing individual s be absent e All individuals responsible for reprocessing should thoroughly understand Your institution s reprocessing procedures Occupational health and safety regulations All national and local hospital guidelines and policies The instructions in this manual The mechanical aspects of endoscopic equipment O O O O Oo 9 Pertinent germicide labeling WARNING At a minimum clean and high level disinfect or sterilize the Water Bottle once per day Failure to do so can result in increased patient infection risk tissue irritation device contamination degraded performance or loss of functionality Using Water Bottles that have either been improperly or incompletely reprocessed or stored may cause cross contamination or infection Wear personal protective equipment to guard against dangerous reprocessing chemicals and potentially infectious material such as patient debris During cleaning high level disinfection and sterilization protect your skin by wearing personal protective equipment such as properly fitted protective chemical resistant gloves eyewear face mask and moisture resistant clothing Always
28. tomercare EndoChoice com Tel 35391443609 Email info atlanticosystems com This device complies with the requirements of Directive 93 42 EEC concerning medical devices Classification Class Ila In the European Union the following symbol indicates that when the last user wishes to discard this product it must be sent to appropriate facilities for recovery and recycling Contact your local EndoChoice representative for additional information on the collection and recovery programs available for this product Reusable Water Bottle Cap amp Tubing Set User Manual 5 Regulatory Information 6 ENDCCHOICE This page intentionally left blank FSE 058 EN 1 0 Device Overview The following table provides catalog and model numbers for the Reusable Water Bottle Sets and a separately available adaptor Table 1 Reusable Water Bottle Catalog Numbers Catalog Number Description Water Bottle Cap and Tubing Set Reusable SCT 468 Water Bottle O Ring Water Tube Water Bottle Cap Tube with Tube Connector Water Bottle Reprocessing Adaptor Water Bottle Cap and Tubing Set with CO Reusable SCT 469 FSR 4368 Water Bottle O Ring Water Tube Water Bottle Cap Tube with Tube Connector Water Bottle Reprocessing Adaptor CO Port and Cap Water Bottle Reprocessing Adaptor Also available separately EndoChoice Part Number FSR 4368 Reusable Water Bottle Cap amp Tubing Set User Manual 7 Devic
29. vice Components This page intentionally left blank 12 QQENDCCHOICE FSE 058 EN 1 0 Preparation and Inspection This chapter provides an overview of the system s setup and instructions for system preparation and inspection WARNING Before each procedure prepare and inspect this device as instructed below Inspect other equipment to be used with this device as described in the respective instruction manuals Should the slightest irregularity be suspected do not use this device contact EndoChoice Damage or irregularity may compromise patient or user safety and may result in more severe equipment damage This device was not high level disinfected or sterilized before shipment Before using this device for the first time reprocess it according to the instructions given in CHAPTER 6 Reprocessing Failure to do so could pose an infection control risk and cause tissue irritation CAUTION Never drop the Water Bottle or subject it to impacts The bottle could become damaged which could make air and or water feeding impossible The Water Bottle is a consumable item If inspection of the Water Bottle reveals any irregularities use a new Water Bottle Do not bend twist or pull the tube excessively The tube could become damaged which could make air and or water feeding impossible The water bottle O ring HPG 4002 is subject to wear over time If damage or deformation is detected please contact EndoChoice or its represe
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