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Olympus EndoTherapy HX-110LR, Instructions Manual, Page: 8 / 64

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Olympus EndoTherapy HX-110LR Instructions Manual Download Page 8

Important Information – Please Read Before Use

Rotatable Clip Fixing Device

4

Reprocessing and Storage

This instrument was not sterilized before shipment. 
Before using this instrument for the first time, reprocess it 
according to the instructions given in Chapter 5, 
“Reprocessing”.

After using this instrument, reprocess and store it 
according to the instructions given in Chapter 5, 
“Reprocessing” and Chapter 6, “Storage”. Improper and/
or incomplete reprocessing or storage can present an 
infection control risk, cause equipment damage or 
reduce performance.

Clips are shipped in a sterile condition. Store them 
following the instructions given in Chapter 6, “Storage”. 
Improper storage can present an infection control risk, 
cause equipment damage or reduce performance. 

All clips are single-use, disposable items that are not to 
be reprocessed after use. Do not reuse or attempt to 
sterilize them after use.

Repair and Modification

This instrument and clip do not contain any 
user-serviceable parts. Do not disassemble, modify or 
attempt to repair them; patient or user injury and/or 
equipment damage can result.

Summary of Contents for EndoTherapy HX-110LR

Page 1: ...AUTOCLAVABLE INSTRUCTIONS Rotatable Clip Fixing Device HX 110LR HX 110QR HX 110UR Clip HX 610 090 HX 610 135 Long Clip HX 610 090L Short Clip HX 610 090S HX 610 135S Colored Short Clip HX 610 090SC...

Page 2: ......

Page 3: ...pter 1 Checking the Package Contents 7 1 1 Checking the Package Contents 7 Chapter 2 Instrument Nomenclature and Specifications 9 2 1 Nomenclature and Functions 9 2 2 Specifications 10 Chapter 3 Prepa...

Page 4: ...Contents Rotatable Clip Fixing Device ii Chapter 6 Storage 57 6 1 Inspection Before Storage 57 6 2 Storage 58...

Page 5: ...n the package the back cover of this instruction manual and or this instrument are as follows Refer to instructions Single use only Use by expiration date Sterilized using irradiation Sterilization lo...

Page 6: ...ndications for use of this instrument should be evaluated by the physician taking into account factors such as the anatomical site histology lesion type and the patient s condition In addition the cau...

Page 7: ...If you have any questions or comments about any information in this manual please contact Olympus User Qualifications The operator of this instrument must be a physician or medical personnel under th...

Page 8: ...essing or storage can present an infection control risk cause equipment damage or reduce performance Clips are shipped in a sterile condition Store them following the instructions given in Chapter 6 S...

Page 9: ...t against unsafe practices or potential equipment damage Indicates additional helpful information Warnings Cautions and Notes Follow the warning cautions and notes described below when handling this i...

Page 10: ...e bleeding after the operation as appropriate Do not use this instrument when hemostasis cannot be verified visually within the endoscopic field of view after application Do not perform MRI procedures...

Page 11: ...patient condition and history A sufficient quantity of clips should be prepared in consideration of all of these factors prior to the procedure Limited studies indicate that the hemostasis clips remai...

Page 12: ...h item for damage If the instrument or clip is damaged a component is missing or you have any questions do not use the instrument or clip immediately contact Olympus This instrument was not sterilized...

Page 13: ...ile single use only 40 pieces Access information sheet Short Clip HX 610 090S or HX 610 135S Short clip Sterile single use only 40 pieces Access information sheet Colored Short Clip HX 610 090SC Color...

Page 14: ...tion wire Insertion portion Working length Hook Lot number Ring Yellow Model reference label Distal portion Extends the hook from the distal end of the coil sheath when pushed Retracts the hook into t...

Page 15: ...s instrument and clip only in combination with products recommended by Olympus If combined with products not recommended by Olympus patient or operator injury malfunction or equipment damage may resul...

Page 16: ...0LR HX 110QR Shape of the distal end of the insertion portion Maximum insertion portion diameter mm 2 75 Working length mm 1650 1950 Compatible Olympus endoscopes All of these parameters should be met...

Page 17: ...2 75 Working length mm 2300 Compatible Olympus endoscopes All of these parameters should be met Length and model Working length less than 1850 mm EF GIF OGF CF PCF SIF SIF 10 only Channel inner diame...

Page 18: ...odel HX 610 090L Shape of the clip Color of the packages Blue Clip arm length Long General application Hemostasis for large tissue retention Model HX 610 135S Shape of the clip Color of the packages G...

Page 19: ...0SC HX 610 090S Shape of the clip Color of the packages Red White Yellow White Clip arm length Short General application Marking for smaller tissue retention MedicalDevice Directive This device compli...

Page 20: ...ucted in their respective instruction manuals Should the slightest irregularity be suspected do not use the instrument or clip contact Olympus Damage or irregularity may compromise patient or user saf...

Page 21: ...during use follow the instructions given in Chapter 4 Emergency Treatment Before use confirm that the hook is not corroded dented or discolored do not use the instrument if any of these conditions are...

Page 22: ...ve equipment may include eye wear a face mask moisture resistant clothing and chemical resistant gloves Spare Instrument and Clips Always have a spare instrument and clips available Reprocessing Equip...

Page 23: ...lip is detected use a spare instrument or clip inspecting it thoroughly before use Inspection of the Sterile Package The clip is a single use disposable item Do not use or attempt to sterilize it Reus...

Page 24: ...e clip from the coil sheath Do not use the instrument if the coil sheath has any slips the buckling and collapse Using an instrument in this condition may become impossible to move through the endosco...

Page 25: ...n Figure 3 1 2 Gently run your fingertips over the entire length of the insertion portion to check for any slips the bucking and collapse broken areas or other damage see Figure 3 2 3 3 Figure 3 2 Vie...

Page 26: ...that the coil sheath is free from disconnection or looseness 4 Push the slider to extend the hook from the distal end of the coil sheath Confirm that the hook appears exactly as shown in the tables in...

Page 27: ...y and as intended do not use the instrument use a spare instead 1 Holding the instrument as shown in Figure 3 4 form a loop in the insertion portion approximately 20 cm in diameter Figure 3 4 2 Operat...

Page 28: ...eration of this instrument is based on the assumption that open surgery is possible as an emergency measure if the clip cannot be detached from the instrument or if any other unexpected circumstances...

Page 29: ...ion portion is extended from the distal end of the endoscope This could cause patient injury such as perforation bleeding or mucous membrane damage Do not force the distal end of the insertion portion...

Page 30: ...clip is actually going to be used If the clip is extended unnecessarily it may be impossible to insert it into the endoscope Do not disassemble a used cartridge and attempt to reuse the clip in it Ot...

Page 31: ...n Inspection and Operation 3 Place the cartridge on the coil sheath see Figure 3 5 Figure 3 5 4 Hold the coil sheath in position by pinching the grip of the cartridge At this time confirm that the coi...

Page 32: ...y be unable to be mounted 5 Push the slider forward distally until it clicks then pull it toward you proximally until it stops see Figure 3 7 The clip is now attached inside the coil sheath Figure 3 7...

Page 33: ...therwise the clip will open and may extend from the distal end of the endoscope abruptly This could cause patient injury such as perforation bleeding or mucous membrane damage It could also damage the...

Page 34: ...strument is damaged the rotation function will be impaired As the distal end of the coil sheath is thicker than other parts resistance may be felt when it passes through the section near the biopsy va...

Page 35: ...erforation hemorrhage or mucous membrane damage or dropping off of the clip or break up of the clip may result Do not force the clip against body cavity tissue The clip may be deformed and does not cl...

Page 36: ...he endoscope s suction function If a clip or clip connector is accidentally aspirated into the endoscope follow the procedure given in Removal of an Aspirated Clip or Clip Connector on page 39 If the...

Page 37: ...in the endoscopic image as shown in Figure 3 9 b Once the clip of the rotatable clip fixing device is extended from the coil sheath the clip cannot be accommodated in the coil sheath again If it is r...

Page 38: ...the slider slowly towards you to open the clip see Figure 3 10 Figure 3 10 Do not pull the slider quickly This will open and close the clip 3 Hold only the ring yellow and rotate the rotation grip to...

Page 39: ...ate the rotation grip slowly If it is rotated quickly the clip rotation may jump If the endoscope is bent sharply there may be a delay between the rotation of the rotation grip and that of the clip If...

Page 40: ...able Clip Fixing Device 36 5 Pull the slider firmly to close the clip on the target site see Figure 3 13 Figure 3 13 6 Gently pull the slider up to the thumb ring yellow gently to detach the closed cl...

Page 41: ...the hook is not completely retracted into the coil sheath This could damage the endoscope and or instrument Do not withdraw the instrument abruptly from the endoscope Otherwise damage to the endoscop...

Page 42: ...After removing the clip connector dispose of it properly Otherwise infection may result 1 Push the slider so that the hook is extended from the coil sheath Now bend the clip connector with respect to...

Page 43: ...low to remove it 1 Withdraw the endoscope from the body cavity keeping the insertion portion and bending section straight Leave the biopsy valve mounted on the endoscope 2 Remove the suction tube and...

Page 44: ...xing Device 40 Figure 3 17 4 Irrigation should discharge the clip or clip connector from the endoscope If one injection is not enough to discharge the clip or clip connector repeat steps 2 and 3 until...

Page 45: ...p cannot be detached from the instrument Forcibly withdrawing the instrument could cause patient injury such as perforation bleeding or mucous membrane damage If the clip cannot be detached from the i...

Page 46: ...the endoscope that extends from the patient Keep as straight as possible Confirm that the slider has been pulled out as far as possible When the clip cannot be detached from the instrument Straighten...

Page 47: ...ook from coil sheath 2 While adjusting the endoscope angle push the coil sheath to bend the clip with respect to the hook When the clip cannot be detached from the instrument 3 Pull the slider to with...

Page 48: ...the clip in place until tissue necrosis occurs and the clip comes free This may take some time Carry out open surgery or other possible treatment A certain amount of force is sometimes required to wit...

Page 49: ...ation resulting from improper cleaning or sterilization It is strongly recommended that reprocessing personnel have a thorough understanding of and follow all national and local hospital guidelines an...

Page 50: ...be biologically monitored such as steam sterilization Failure to properly clean and sterilize the instrument after each examination can compromise patient safety During use the instrument normally co...

Page 51: ...ing before leaving the reprocessing area The reprocessing procedures described in this manual should be completed the same day the instrument has been used If reprocessing is delayed residual organic...

Page 52: ...riate manner For methods to handle CJD please follow the respective guidelines in your country This instrument is not durable or does not have sufficient durability against the respective methods stat...

Page 53: ...and fill a second immersion basin with lubricant at the temperatures and concentrations recommended by the manufacturers Also fill the ultrasonic cleaner with a detergent solution appropriate for ult...

Page 54: ...e enough to allow complete immersion of the instrument when the insertion portion is coiled with a diameter of not less than 20 cm Compatible ultrasonic cleaners include OLYMPUS ULTRASONIC CLEANER KS...

Page 55: ...e to operate the instrument This could damage the instrument Immersion Immerse the instrument in detergent solution immediately after use If the instrument is not cleaned immediately it may be difficu...

Page 56: ...on operation of the ultrasonic cleaner refer to the instruction manual of the ultrasonic cleaner 3 Remove the instrument from the detergent solution Rinsing After ultrasonic cleaning rinse the instrum...

Page 57: ...This could damage the insertion portion Never use excessive force to operate the instrument This could damage the instrument 1 Immerse the insertion portion in the lubricant for 2 to 3 seconds 2 Remo...

Page 58: ...isk or cause tissue irritation Do not coil the insertion portion with a diameter of less than 20 cm This could damage the insertion portion Never use excessive force to operate the instrument This cou...

Page 59: ...compromise its sterility The results of sterilization depend on various factors such as how the sterilized instrument was packed or the positioning method of placing and loading of the instrument in...

Page 60: ...m temperature Sudden changes in temperature may damage the instrument Autoclavable products have a green reference label Products that do not have green reference labels are not autoclavable Table 5 1...

Page 61: ...d wet or improperly sealed Otherwise the sterility of the instrument may be compromised and pose an infection control risk or cause tissue irritation Do not coil the insertion portion with a diameter...

Page 62: ...e sterile package at room temperature in a clean and dry environment Do not store it in direct sunlight Ensure that the packaged instrument is not crushed by surrounding objects during storage Follow...

Page 63: ...SYSTEMS CORP All rights reserved No part of this publication may be reproduced or distributed without the express written permission of OLYMPUS MEDICAL SYSTEMS CORP OLYMPUS is a registered trademark o...

Page 64: ...lley Road 12 01 04 Valley Point Office Tower Singapore 248373 Fax 6834 2438 Telephone 6834 0010 Room 1202 NCI Tower A21 Jianguomenwai Avenue Chaoyang District Beijing 100022 PRC Fax 10 6569 3545 Telep...

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