Used olympus tjfq180v duodenoscope for sale dotmed. Olympus validates new reprocessing instructions for model tjf. Water resistant cap mh553 chain for waterresistant cap maj1119. Federal law restricts this device to sale by or on the order of a physician. Instructions provided in the tjfq180v reprocessing manual are not valid for olympus devices repaired by a nonolympus facility. The food and drug administration fda announces that olympus has issued new, validated manual reprocessing instructions for the tjfq180v duodenoscope to replace those provided in the original labeling. Olympus tjf q180v instructions manual 118 pages duodenovideoscope. Cleaning brush maj1534 instructions evis exera duodenovideoscope olympus tjf type 160vf olympus tjf type 160f. Digital platform with online tutorials, training videos and elearnings. New tjf q180v duodenoscopes manufactured with the new forceps elevator design will have a serial number which has a 1 as the third digit and are not included in this corrective action. Professional education olympus professional education. Implement the new tjfq180v manual cleaning procedure as soon as possible. The food and drug administration fda has announced that new, validated manual reprocessing instructions have been issued by.
Infections associated with reprocessed duodenoscopes fda. The reprocessing manual includes updated reprocessing instructions, including information on the use of acecidec highlevel disinfectant when disinfecting the tjfq180v in the oerpro and a new chapter chapter 6 regarding annual inspections by olympus service personnel. Olympus duodenoscope model tjfq180volympus has issued new, validated manual reprocessing instructions for the tjfq180v duodenoscope to replace those provided in the original labeling. Elevator mechanism replacement, updated operation manual, and new reprocessing instructions for the olympus tjfq180v duodenoscope. Olympus corporationurgent medical device removal and corrective action. Olympus duodenoscope model tjfq180v olympus has issued new, validated manual reprocessing instructions for the tjfq180v duodenoscope to replace those provided in the original labeling. This instruction manual contains essential information on using this instrument safely and effectively.
The updated instruction manual describes the necessity for an annual inspection of the tjf q180v by olympus service personnel. Challenges following duodenoscope reprocessing instructions as. More olympus duodenoscopes get validated reprocessing. This page contains information about infections associated with reprocessed duodenoscopes. We have 1 olympus tjf q180v manual available for free pdf download. In collaboration with the american society for gastrointestinal endoscopy asge our diagnostic eus training course is focused. This instruction manual contains essential information on reprocessing. Page 111 aer so that the forceps elevator recess can be sufficiently cleaned and disinfected. Olympus tjfq180vwith a new, highly innovative forceps elevator design. View online or download olympus tjfq180v instructions manual. Our service teams will be glad to help you with technical and other supporting questions regarding olympus products. Boasting a beautiful fullscreen, highresolution image and support for narrow band imaging, the tjf q180v also brings unmatched image quality to ercp procedures. The updated tjfq180v operation manual contains new information on the required inspection of the tjfq180v before and after patient procedures that must be performed by the user facility, and the annual inspection of the forceps elevator mechanism, to be performed by olympus.
Mar 26, 2015 implement the new tjfq180v manual cleaning procedure as soon as possible. The device evaluation into the performance of the accessory equipment was conducted as part of our investigation associated with the olympus tjfq180v duodenoscope, serial number b4. Olympus tjf q180v manuals manuals and user guides for olympus tjf q180v. Olympus is replacing previously distributed tjfq180v operation manuals with a new operation manual. The first inspection will become necessary 12 months after purchase of a new tjf q180v endoscope, or 12 months after the exchange of the elevator forceps mechanism as described above. Safety communications olympus validates new reprocessing. Olympus receives 510k clearance for tjfq180v duodenoscope. The mu1 is utilized during leak testing of flexible endoscopes.
Olympus was informed that the 14 patients developed esbl ecoli infections after undergoing ercp procedures using the tjf q180v duodenovideoscope. After getting a redesigned scope approved by the fda in january, olympus issued the voluntary recall for the tjfq180v and will be replacing the defective component. Boasting a beautiful fullscreen, highresolution image and support for narrow band imaging, the tjfq180v also brings unmatched image quality to ercp procedures. The tjf q180v offers two locking mechanisms that enable truly secure guidewire locking in a wide range of positions relative to the papilla, even for smaller guidewires. Olympus evis exera iii medical equipment instructions manual. If anything is missing or damaged, contact the dealer from whom you. Manufacturer narrative the subject device has not been returned to olympus medical systems corp. Customer duodenoscope guidance olympus america medical. Evis exera tjf type 160vr operation manual 3 instruction manual this instruction manual contains essential information on using this instrument safely and effectively. Arjo loeve, delft u niversity of technology, investigation olympus tjf q180v scope. Instructions provided in the tjf160fvf reprocessing manual are not valid for olympus devices repaired by a nonolympus facility. Take full advantage of the diverse educational resources that olympus has developed with your particular needs in mind. Mar 26, 2015 the food and drug administration fda has announced that new, validated manual reprocessing instructions have been issued by olympus for the tjfq180v endoscopic retrograde.
System 83 plus 2 single chamber ultrasonic washerdisinfector for reprocessing one to two flexible endoscopes duodenoscopes validated for reprocessing in the system 83 plusolympus model tjfq180v and pentax model ed3490tk. Strictly following the manufacturers instructions regarding reprocessing does not. The updated tjfq180v and tjf160fvf reprocessing manuals include a new warning requiring users to conduct all duodenoscope precleaning and manual cleaning, even when using an automated endoscope reprocessor aer that may indicate a user can forego certain steps in precleaning and manual cleaning of the endoscopes. Jan 15, 2016 the reprocessing manual includes updated reprocessing instructions, including information on the use of acecidec highlevel disinfectant when disinfecting the tjfq180v in the oerpro and a new chapter chapter 6 regarding annual inspections by olympus service personnel. Olympus has issued new, validated manual reprocessing instructions for the tjfq180v duodenoscope to replace those provided in the original labeling. Refer to the endoscopes companion manual, the operation manual with your endoscope model listed on the cover, for operation information. View and download olympus evis exera ii instructions manual online. Unique dual locking mechanism for efficient short guide wire exchange in combination with a dedicated vsystem ercp devices superb image quality with exceptional sharp, crisp details and large display size. The new reprocessing measures should be implemented as soon as possible. Olympus sent letters dated march 26, 2015 disclaimer icon to healthcare facilities and other users of the tjfq180v outlining the new, validated reprocessing instructions, and will soon be distributing revised user manuals. When using olympus aer oerpro or oeraw for reprocessing this endoscope, you can conduct precleaning and manual cleaning by either of the following a or b.
The updated instruction manual describes the necessity for an annual inspection of the tjfq180v by olympus service personnel. Almost a year after new reprocessing instructions for its tjfq180v duodenoscope, olympus is back with updated, validated protocols for more. Tjfq180v reprocessing manual olympus america medical. Evis exera ii medical equipment pdf manual download. User manuals, guides and specifications for your olympus gifh190 medical equipment.
The probability of failure of the endoscope and ancillary. Following detected contamination after cleaning and disinfection. It involves the use of a new, smaller bristle cleaning brush model maj1888 which olympus anticipates shipping to. Olympus tjfq180v duodenoscope receives 510k clearance. Olympus tjfq180v duodenoscope iec innovative endoscopy. As mentioned above, the updated instruction manual describes the necessity for an annual inspection of the tjfq180v by olympus service personnel. Olympus celonlab ent instructions for use manual user manual manual 6 pages olympus quickclip pro hx202lr quick reference manual quick reference manual 2 pages olympus bfp190. Superb treatment capability with exceptionally large 4. Olympus also has dedicated field personnel, called endoscopy support specialists, who visit customer sites to access and observe customer reprocessing methods and to provide reprocessing training and education. To date above 70 patients have been notified due to their exposure to the device. Olympus evis exera ii instructions manual pdf download. Olympus exera ii tjfq180v video duodenoscope global.
Cv180 evis exera ii video system center instruction manual. You might have a duodenoscope tjfq180v not making the angulation, or some puzzling insertion tube problem like blistering, buckling or discoloration, or you have a foggy image on an image guide. Tjfq180v cleaning and disinfection checklist olympus america. By continuing to browse the site you are agreeing to our use of cookies. The first inspection will become necessary 12 months after purchase of a new tjfq180v endoscope, or 12 months after the exchange of the elevator forceps mechanism as described above. Olympus shall not be liable for any delay in the delivery of any products resulting from any cause or circumstance which is not within the control of olympus, including but not limited to acts of god, acts of the third party delivery service, acts or orders of governmental authorities having or asserting jurisdiction, fires, floods, inclement. Database contains 1 olympus gifh190 manuals available for free online viewing or downloading in pdf. See a list of olympus support numbers for your country.
Olympus celonlab ent instructions for use manual user manual manual 6 pages olympus quickclip pro hx202lr quick. The tjfq180v offers two locking mechanisms that enable truly secure guidewire locking in a wide range of positions relative to the papilla, even for smaller guidewires. Evis exera ii video system center cv180 5 user qualifications if there is an official standard on user qualifications to perform endoscopy and endoscopic treatment that is defined by the medical administration or other official institutions, such as academic societies on endoscopy, follow that standard. Olympus tough tg5 is waterproof to 50ft 15m, shockproof from 7ft 2. Olympus exera tjf160f video duodenoscope global endoscopy. Evis exera ii tjf type q180v reprocessing manual 1 chapter 1 general policy 1. Olympus vscope tjf160vf change product information.
Tjf q180v specifications, design, and accessories are subject to change without any notice or obligation on the part of the manufacturer. The system 83 plus aers may now be used to reprocess only the olympus tjfq180v duodenoscope and the pentax ed3490tk duodenoscope. May 15, 2017 you might have a duodenoscope tjf q180v not making the angulation, or some puzzling insertion tube problem like blistering, buckling or discoloration, or you have a foggy image on an image guide. Olympus exera tjf160f video duodenoscope endoscope. Tjfq180v specifications, design, and accessories are subject to change without any notice or obligation on the part of the manufacturer.
Oai has updated the existing tjf q180v operation manual and reprocessing manual with a new. The updated tjfq180v operation manual contains new information on the required inspection of the tjfq180v before and after patient procedures that must be performed by the user. Compatible with cv180, cv160, cv140 and cv100 video processors. Olympus tjfq180v community, manuals and specifications. Olympus exera tjf160f video duodenoscope endoscope endoscopy. Olympus validates new reprocessing instructions for model. Free download olympus tough tg5 pdf user manual, user guide, instructions, olympus tough tg5 owners manual. The following are key changes to the reprocessing procedure for olympus tjfq180v duodenoscope. Welcome to olympus global professional education website.