Olympus WA4KL100 ULTRA, Instructions For Use Manual

Page 1: ...INSTRUCTIONS FOR USE TELESCOPE ULTRA WA4KL100 WA4KL130 WA4KL145 WA4KL500 WA4KL530 WA4KL545...

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Page 3: ...l warnings and cautions 8 3 Product description 12 3 1 Scope of delivery 12 3 2 Telescope 12 3 3 Symbols 16 3 4 Warranty 16 4 Preparation 17 4 1 Safety information for preparation 17 4 2 Inspection 17...

Page 4: ...8 Validated sterilization methods 38 7 9 Verified sterilization methods 42 7 10 Storage and handling 44 8 Repair shipment and disposal 45 8 1 Repair 45 8 2 Shipment 46 8 3 Disposal 46 9 Compatible eq...

Page 5: ...tentially hazardous situation which if not avoided could result in death or serious injury CAUTION Indicates a potentially hazardous situation which if not avoided may result in minor or moderate inju...

Page 6: ...for action Dashes indicate the listing of data options or objects 1 Numbers with right parenthesis name elements in illustrations 1 4 Trademarks STERRAD NXTM Cidex OPA are trademarks of their respect...

Page 7: ...cic and abdominal cavities The device is also indicated for visualization of transanal and transvaginal applications as well as transoral applications including but not limited to laryngeal pharyngeal...

Page 8: ...ot be held responsible for the safety and performance of the product 2 4 Environment of use Medical use This product is only intended to be used in hospitals and medical rooms with appropriate endosco...

Page 9: ...nical injury infection and or thermal injury Before each use observe the instructions in the section Inspection on page 17 Do not use a damaged product or a product with improper functioning Replace a...

Page 10: ...sources or light guide cables that meet at least the same requirements of applied part classification For the applied part classification refer to the respective instructions for use WARNING Risk of...

Page 11: ...ipment on page 47 CAUTION Risk of injury to the user There is a risk of injury to the user when using endoscopic equipment in combination with laser equipment Use suitable protection measures e g filt...

Page 12: ...ctions for use 3 2 Telescope A telescope is a rigid endoscope An image relay system of rod lenses transmits the endoscopic image A bundle of optical fibers transmits light from an external light sourc...

Page 13: ...13 Product description 3 2 1 Telescope WA4KL100 WA4KL130 WA4KL145 Entire telescope Main body 1 Insertion tube 2 Light guide connector 3 Eyepiece cup...

Page 14: ...14 Product description 3 2 2 Telescope WA4KL500 WA4KL530 WA4KL545 Entire telescope Main body 1 Insertion tube 2 Light guide connector 3 Eyepiece cup 3 2 3 Distal end 1 Objective cover glass...

Page 15: ...15 Product description 2 Light emission surface 3 2 4 Eyepiece cup 1 Eyepiece cover glass 3 2 5 Direction of view The direction of view is indicated in degree on the main body of the telescope...

Page 16: ...of a physician Manufacturer Consult instructions for use Date of manufacture Storage conditions Indicates a recovery recyclable package or package material Transport conditions Green Dot symbol for du...

Page 17: ...ach use inspect the product as described in the section Inspection on page 17 Do not use a damaged product WARNING Risk of injury to the patient If the light guide cable is not properly connected to t...

Page 18: ...endoscope and the light source is switched on Do not look into the distal end of the endoscope when the light source is switched on Checking the light transmission Hold the distal end of the telescop...

Page 19: ...le system components Refer to the chapter Compatible equipment on page 47 to identify the compatible system components Observe the instructions for use of the compatible system components 4 3 2 Connec...

Page 20: ...escope 2 Screw the light guide cable onto the thread of the light guide connector 4 3 3 Connecting the video adapter and or camera head Refer to the chapter Compatible equipment on page 47 to identify...

Page 21: ...are several risks of injury to the patient Follow the instructions for use of all devices connected to the endoscope for safe application CAUTION Risk of injury to the patient Light sources emit large...

Page 22: ...stal end of the endoscope is placed into close proximity to the tissue If the distal end is soiled and impairs proper visualization remove the endoscope and clean the distal end CAUTION Risk of injury...

Page 23: ...23 Use Only ignite when the laser emission part is visible on the endoscopic image...

Page 24: ...2 Preparation for reprocessing at the point of use WARNING Risk of injury to the patient and or the medical personnel If instruments are left in dry condition for a longer period heavy debris may dry...

Page 25: ...The product can be transported in a wet or dry condition Contain the product during transport to avoid possible environmental or personnel contamination If the product is immersed in detergents or di...

Page 26: ...n contact with all parts of the endoscope Ineffective cleaning and disinfection may lead to infection of the patient Do not use plastic instrument trays for automated cleaning and thermal disinfection...

Page 27: ...of infecting patients users or third parties reprocess the endoscopic instrumentation before each use Contact your local hygiene representative for local standards and regulations Manual cleaning or a...

Page 28: ...ompatible reprocessing methods according to ISO 17664 The microbiological efficacy and or material compatibility of the reprocessing methods listed in the table have been validated or verified with th...

Page 29: ...hine Alkaline detergent Acidic detergent o Neutral detergent Rinsing Disinfection Manual Machine Chemical o Thermal Drying dry heat Tmax 95 C 203 F max 10 min Maintenance Sterilization Moist heat pref...

Page 30: ...in the detergent Select the immersion time and the concentration of the solution in accordance with the instructions given by the manufacturer of the detergent Make sure that there are no air bubbles...

Page 31: ...rious aggressive compounds which can damage the product To remove residues rinse the product thoroughly with deionized water as described by the manufacturer of the detergent Do not use tap water for...

Page 32: ...Manual disinfection NOTICE Risk of damage to the product Incompatible disinfectants may considerably damage Olympus endoscopes and accessories Use only solutions that are approved and verified for ex...

Page 33: ...anufacturer of the solution 2 Completely immerse the product in Cidex OPA Solution by Johnson Johnson Ensure that all parts are covered 3 Soak the product in Cidex OPA Solution for as long as recommen...

Page 34: ...protein fixation caused by detergents or disinfectants Make sure that the first water inflow into the washer disinfector during automated cleaning and thermal disinfection starts with cold temperatur...

Page 35: ...ing because it might be chlorinated 7 5 1 Preparation for automatic cleaning and thermal disinfection Use adequate instrument trays to fix the product Make sure that the product has been securely fixe...

Page 36: ...re that the program does not include any sudden changes in temperature Example for a program cycle 1 Pre rinse 2 Cleaning 3 Rinsing 4 Heating 5 Disinfection 6 Drying 7 5 3 After automated cleaning and...

Page 37: ...ilization Precondition for sterilization The product must be cleaned thoroughly before sterilization Thorough cleaning removes both micro organisms and organic material Failure to remove organic mater...

Page 38: ...e section Steam sterilization on page 38 For STERRAD sterilization refer to the section STERRAD sterilization on page 41 7 8 1 Steam sterilization Preparing the telescope for steam sterilization Using...

Page 39: ...e instrument trays or load them on their side edges during steam sterilization Steam sterilization conditions Steam sterilization of the product has been validated with fractionated prevacuum at 132 C...

Page 40: ...tion Olympus recommends a drying time of at least 15 30 minutes Choose an appropriate drying time depending on the autoclave Refer to the autoclave s instructions for use Be careful when unloading the...

Page 41: ...n 2x 3 Heating 4 Sterilization 5 Evacuation 6 Drying 7 Aeration 7 8 2 STERRAD sterilization CAUTION Risk of injury to the patient Performing a STERRAD sterilization with the endoscope in the plastic i...

Page 42: ...ket The information provided on STERRAD sterilization in this document applies to the following STERRAD systems and cycles STERRAD 50 only 1 cycle STERRAD 100S short cycle and long cycle STERRAD 200 s...

Page 43: ...move toxic gasses aerate the product sufficiently after sterilization Gas sterilization of the product has been verified with the following sterilization procedures 100 ethylene oxide gas sterilizatio...

Page 44: ...instrument trays to store or transport the product Load instruments separately into instrument trays Only remove instruments from the instrument tray directly before use NOTICE Risk of damage to the p...

Page 45: ...d servicing personnel that has been authorized by Olympus Contact an Olympus representative or an authorized service center for repair and warranty information Otherwise Olympus can not be held respon...

Page 46: ...ghly as possible and mark it accordingly When sending products to an authorized service center for repair and or warranty claims note the following Use the original cardboard packaging for the transpo...

Page 47: ...ber bundle diameter the connectors may become hot Only use endoscopes and light guide cables with the appropriate combination of the maximum insertion portion width and fiber bundle diameter For the a...

Page 48: ...ription Article number Instrument trays and wire baskets e g WA05990A A5940 Light guide cable e g WA03310A High resolution camera head e g CH S190 XZ E OTV S7 ProH HD 10E OTV S7 ProH HD 12E 5 5 mm tro...

Page 49: ...ription Article number Instrument trays and wire baskets e g WA05990A A5940 Light guide cable e g WA03310A High resolution camera head e g CH S190 XZ E OTV S7 ProH HD 10E OTV S7 ProH HD 12E 11 mm troc...

Page 50: ...tion portion width WA4KL100 WA4KL130 WA4KL145 10 2 mm WA4KL500 WA4KL530 WA4KL545 5 45 mm 10 2 Specifications Direction of view WA4KL100 WA4KL500 0 WA4KL130 WA4KL530 30 WA4KL145 WA4KL545 45 Field of vi...

Page 51: ...51 Technical data Storage conditions Temperature 10 to 40 C 50 to 104 F Relative humidity 30 to 85 Transport conditions Temperature 40 to 70 C 40 to 158 F Relative humidity 10 to 95...

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Page 56: ...W7510750_06 2018 06 07 en Copyright 2018 Olympus Winter Ibe GmbH...