Related Manuals for Olympus EndoTherapy HX-110LR
Summary of Contents for Olympus EndoTherapy HX-110LR
- Page 1 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 AUTOCLAVABLE...
-
Page 3: Table Of Contents
Contents Contents Symbols..............Important Information – Please Read Before Use 2 Intended Use ..............Instruction Manual ............. User Qualifications............. Instrument Compatibility ............ Reprocessing and Storage ..........Repair and Modification ............. Signal Words ..............Warnings, Cautions and Notes .......... Chapter 1 Checking the Package Contents.. - Page 4 Contents Chapter 6 Storage ..........57 Inspection Before Storage ........Storage ..............Rotatable Clip Fixing Device...
-
Page 5: Symbols
Symbols Symbols The meaning(s) of the symbol(s) shown on 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 lot number Lot number Manufacturer Authorised representative in... -
Page 6: Important Information - Please Read Before Use
Important Information – Please Read Before Use Intended Use This instrument has been designed to be used with an Olympus endoscope for endoscopic clip placement within the gastrointestinal (GI) tract for the purpose of endoscopic marking, hemostasis for (a) mucosal/sub-mucosal defects < 3 cm, (b) bleeding ulcers, (c) arteries <... -
Page 7: Instruction Manual
Keep this and all related instruction manuals in a safe, accessible location. 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... -
Page 8: Reprocessing And Storage
Important Information – Please Read Before Use 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”... -
Page 9: Signal Words
Important Information – Please Read Before Use Signal Words The following signal words are used throughout this manual: Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury. Indicates a potentially hazardous situation which, if not avoided, may result in minor or moderate injury. - Page 10 Important Information – Please Read Before Use • It might be impossible to stop bleeding depending on the hemorrhage situation because the clip performance for hemostasis is limited. Prepare more than one hemostatic device and select appropriate hemostatic device or use it together to respond to different hemorrhage situations appropriately.
- Page 11 Important Information – Please Read Before Use • Limited studies have shown that the number of clips required for hemostasis may vary depending upon the anatomical site, histology, lesion type and patient condition and history. A sufficient quantity of clips should be prepared in consideration of all of these factors prior to the procedure.
-
Page 12: Chapter 1 Checking The Package Contents
Olympus. This instrument was not sterilized before shipment. Before using this instrument for the first time, reprocess it according to the instructions in Chapter 5, “Reprocessing”. - Page 13 Chapter 1 Checking the Package Contents Clip (HX-610-090 or HX-610-135) Clip (Sterile, single use only, 40 pieces) Access information sheet Long Clip (HX-610-090L) Long clip (Sterile, 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) Colored short clip (Sterile, single use only, 24 pieces)
-
Page 14: Chapter 2 Instrument Nomenclature And Specifications
Chapter 2 Instrument Nomenclature and Specifications Chapter 2 Instrument Nomenclature and Specifications Nomenclature and Functions This instrument must be used in combination with the clip. Rotatable Clip Fixing Device (Reusable) Slider Ring (Yellow) Extends the hook from the The color of the ring distal end of the coil sheath indicates the minimum Handle... - Page 15 Cartridge Grip Insertion port Specifications The compatible Olympus endoscopes are listed in the tables on the following pages. New endoscopes released after the introduction of this instrument and clip may also be compatible for use in combination with this instrument and clip.
- Page 16 Working length length less than 1200 less than 1500 Length and Compatible EF, GIF, OGF, EF, GIF, OGF, model Olympus CF (Exclude I-, CF (Exclude endoscopes L-length), OSF L-length), (All of these PCF (I-length parameters only), OSF should be met.) Channel inner ø...
- Page 17 Working 2300 length (mm) Working length Length and less than 1850 mm; Compatible model EF, GIF, OGF, CF, PCF, Olympus SIF (SIF-10 only) endoscopes (All of these Channel inner parameters diameter ø 2.8, ø 3.2 (Yellow); should be met.) (mm) ø...
- Page 18 Chapter 2 Instrument Nomenclature and Specifications Model 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 Green Clip arm length Short General application Hemostasis (for smaller tissue...
- Page 19 Chapter 2 Instrument Nomenclature and Specifications Model HX-610-090SC HX-610-090S Shape of the clip Color of the packages White White Yellow Clip arm length Short General application Marking (for smaller tissue retention) Medical Device This device complies with Directive the requirements of Directive 93/42/EEC concerning medical devices.
-
Page 20: Chapter 3 Preparation, Inspection And Operation
Should the slightest irregularity be suspected, do not use the instrument or clip; contact Olympus. Damage or irregularity may compromise patient or user safety by, for example: posing an infection control risk, causing tissue irritation, perforation, bleeding or mucous membrane damage. - Page 21 Chapter 3 Preparation, Inspection and Operation • Before use, inspect several coil sheaths as instructed and make sure they are not crushed, bent or deformed. Do not use the clip fixing device if the coil sheath is damaged. • Do not strike or crush the coil sheath during operation or reprocessing.
-
Page 22: Preparation
Chapter 3 Preparation, Inspection and Operation Preparation Equipment and Personal Protective Equipment Prepare all equipment and personal protective equipment which will be used with the instrument and clip in accordance with their respective instruction manuals. Appropriate personal protective equipment may include: eye wear, a face mask, moisture-resistant clothing and chemical-resistant gloves. -
Page 23: Inspection
Chapter 3 Preparation, Inspection and Operation Inspection Wear the personal protective equipment as specified in the table on page 50. Before each case, always inspect the instrument and clip according to the following procedures. If an abnormality in the instrument or clip is detected, use a spare instrument or clip, inspecting it thoroughly before use. - Page 24 Chapter 3 Preparation, Inspection and Operation Appearance Inspection If any of the following steps reveals irregularities, do not use the instrument or clip; use a spare instead. • Do not use the instrument if the distal end of the coil sheath is deformed. Using an instrument in this condition may result in the clip catching on the rim of the coil sheath after clipping and make it...
- Page 25 Chapter 3 Preparation, Inspection and Operation Coil sheath Viewing direction. Perfectly round Crushed, deformed Figure 3.1 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).
- Page 26 Chapter 3 Preparation, Inspection and Operation Coil sheath buckling Figure 3.3 Move the slider back and forth. Confirm that the coil sheath is free from disconnection or looseness. 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 Section 2.2, “Specifications”...
- Page 27 Chapter 3 Preparation, Inspection and Operation Inspection of Operation If the instrument does not operate smoothly and as intended, do not use the instrument; use a spare instead. Holding the instrument as shown in Figure 3.4, form a loop in the insertion portion approximately 20 cm in diameter.
-
Page 28: Operation
Chapter 3 Preparation, Inspection and Operation Operation The operator of the instrument and clip 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. - Page 29 Chapter 3 Preparation, Inspection and Operation • Do not insert the instrument into the endoscope unless you have a clear endoscopic field of view. If you cannot see the distal end of the insertion portion in the endoscopic field of view, do not use it.
- Page 30 Chapter 3 Preparation, Inspection and Operation Attaching the Clip • Do not use a clip that has not been properly attached. Otherwise, the clip may not operate correctly or it could be damaged. • After attaching the clip, dispose of the cartridge properly.
- Page 31 Chapter 3 Preparation, Inspection and Operation Place the cartridge on the coil sheath (see Figure 3.5). Figure 3.5 Hold the coil sheath in position by pinching the grip of the cartridge. At this time, confirm that the coil sheath can be suspended (see Figure 3.6). Figure 3.6 Rotatable Clip Fixing Device...
- Page 32 Chapter 3 Preparation, Inspection and Operation Keep pinching the grip of the cartridge until the clip has been attached completely. Otherwise, the positioning between the coil sheath and cartridge may be deviated and the clip may be unable to be mounted. Push the slider forward (distally) until it clicks, then pull it toward you (proximally) until it stops (see Figure 3.7 ).
- Page 33 Chapter 3 Preparation, Inspection and Operation Insertion Into the Endoscope • Do not force the instrument if resistance to insertion is encountered. Reduce the angulation of the endoscope until the instrument passes smoothly. Attempting to force the instrument could cause patient injury, such as perforation, bleeding or mucous membrane damage.
- Page 34 Chapter 3 Preparation, Inspection and Operation • When inserting the instrument into the endoscope, hold it close to the biopsy valve and keep it as straight as possible relative to the biopsy valve. Otherwise, the insertion portion could be damaged. •...
- Page 35 Chapter 3 Preparation, Inspection and Operation Advance the instrument until the distal end of the insertion portion appears within the endoscopic field of view. Clipping Tissue • Do not extend the clip abruptly from the distal end of the coil sheath. Also, when pushing the clip out of the coil sheath, keep a sufficient distance between the distal end of the coil sheath and the...
- Page 36 Chapter 3 Preparation, Inspection and Operation • When clipping tissue, do not change the angulation of the endoscope before the clip is detached from the instrument. Doing so may result in patient injury, such as perforation, bleeding or mucous membrane damage. •...
- Page 37 Chapter 3 Preparation, Inspection and Operation Gently push the slider so that the clip projects from the coil sheath until the white part of the clip is visible. At this time, the clip should appear 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...
- Page 38 Chapter 3 Preparation, Inspection and Operation Pull 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. Hold only the ring (yellow) and rotate the rotation grip to orient the clip so that it may be applied to the tissue (see Figure 3.11).
- Page 39 Chapter 3 Preparation, Inspection and Operation • Rotating the rotation grip also causes the slider to rotate together. Therefore, be sure to remove your finger from the slider when rotating the rotation grip. • Rotate the rotation grip slowly. If it is rotated quickly, the clip rotation may jump.
- Page 40 Chapter 3 Preparation, Inspection and Operation Pull the slider firmly to close the clip on the target site (see Figure 3.13). Figure 3.13 Gently pull the slider up to the thumb ring (yellow) gently to detach the closed clip from the coil sheath (see Figure 3.14).
- Page 41 Chapter 3 Preparation, Inspection and Operation Withdrawing the Instrument From the Endoscope Do not withdraw the instrument from the endoscope quickly. This could scatter blood, mucus or other patient debris and pose an infection control risk. • Do not withdraw the instrument from the endoscope if the forceps elevator is up.
- Page 42 Chapter 3 Preparation, Inspection and Operation Detaching the Clip Connector After removing the clip connector, dispose of it properly. Otherwise, infection may result. Push the slider so that the hook is extended from the coil sheath. Now bend the clip connector with respect to the hook and remove (see Figure 3.15).
- Page 43 Chapter 3 Preparation, Inspection and Operation Removal of an Aspirated Clip or Clip Connector If a clip or clip connector is accidentally aspirated into the endoscope, follow the procedure below to remove it. Withdraw the endoscope from the body cavity, keeping the insertion portion and bending section straight.
- Page 44 Chapter 3 Preparation, Inspection and Operation Push the suction valve. Figure 3.17 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 the clip or clip connector is discharged. Rotatable Clip Fixing Device...
-
Page 45: Chapter 4 Emergency Treatment
Chapter 4 Emergency Treatment Chapter 4 Emergency Treatment Emergency Treatment Do not try to forcibly withdraw the instrument from the endoscope if the clip cannot be detached from the instrument. Forcibly withdrawing the instrument could cause patient injury such as perforation, bleeding or mucous membrane damage. - Page 46 Chapter 4 Emergency Treatment Keep as straight as possible. Straighten out the portion of the endoscope that extends from the patient. Keep as straight as possible. When the clip cannot be detached from the Straighten out the portion of instrument. the instrument that extends Confirm that the slider has been from the biopsy valve.
- Page 47 Chapter 4 Emergency Treatment 1. Push the slider to extend 2. While adjusting the the hook from coil endoscope angle, push sheath. the coil sheath to bend the clip with respect to the hook. When the clip cannot be detached from the instrument.
- Page 48 Chapter 4 Emergency Treatment Cut the coil sheath and operation wire using pliers and/or wire cutters. Withdraw the endoscope. Leave the clip in place until tissue necrosis occurs and the clip comes free. This may take some time. A certain amount of force is sometimes Carry out open surgery or required to withdraw the endoscope.
-
Page 49: Chapter 5 Reprocessing
Chapter 5 Reprocessing Chapter 5 Reprocessing This instrument was not sterilized before shipment. Before using this instrument for the first time, reprocess it according to the instructions in this Chapter. Do not use an instrument that has not been cleaned and sterilized. This poses an infection control risk or can cause tissue irritation. - Page 50 • pertinent germicide labeling Olympus endo-therapy accessories are compatible with 2.0% to 3.2% glutaraldehyde solution. However, routine biological monitoring is not feasible with glutaraldehyde and, therefore, it should not be used to sterilize reusable...
- Page 51 Chapter 5 Reprocessing • Patient debris and reprocessing chemicals are hazardous. Wear personal protective equipment to guard against dangerous chemicals and infectious material. During cleaning and sterilization, always wear appropriate personal protective equipment, such as eye wear, a face mask, moisture-resistant clothing and chemical-resistant gloves that fit properly and are long enough so that your skin is...
- Page 52 For information on the durability against each method, please contact Olympus. If cleaning and sterilization methods not stated in this instruction manual are performed, Olympus cannot guarantee the effectiveness, safety and durability of this instrument.
-
Page 53: Required Reprocessing Equipment
For details on preparation and directions for use of the following equipment, refer to the respective instruction manuals or contact the equipment manufacturer. Contact Olympus for the names of specific brands of detergent solutions and lubricants. Rotatable Clip Fixing Device... - Page 54 20 cm. Compatible ultrasonic cleaners include OLYMPUS ULTRASONIC CLEANER KS-2. Detergent solution Use a neutral pH, low-foaming, medical for ultrasonic grade detergent solution with no abrasive.
-
Page 55: Cleaning
Chapter 5 Reprocessing Sealing device for Sealing the packages may require a device packages such as a heat sealer. Prepare an appropriate sealing device according to the packages to be used. Autoclave Use an autoclave that will operate at the conditions specified in Section 5.5, “Sterilization”. - Page 56 Chapter 5 Reprocessing Immerse the entire instrument in the detergent solution for the time specified in manufacturer’s instructions. If no time is specified, immerse for between 5 minutes and 3 hours. Remove the instrument from the detergent solution. Ultrasonic Cleaning Immerse the entire instrument in the ultrasonic cleaner containing detergent solution.
-
Page 57: Lubrication
Chapter 5 Reprocessing Lubrication When lubricating, avoid exposure to the lubricant. It may pose an infection control risk or cause skin irritation. • Do not coil the insertion portion with a diameter of less than 20 cm. This could damage the insertion portion. •... -
Page 58: Sterilization
Chapter 5 Reprocessing Sterilization Sealing the Package Before placing the instrument in the package, always retract the hook into the coil sheath. Otherwise, they could tear the package during sterilization or storage and compromise its sterility, which could pose an infection control risk or cause tissue irritation. - Page 59 Chapter 5 Reprocessing Steam Sterilization (Autoclaving) • Use biological indicators as recommended by your hospital’s policy and follow the manufacturer’s instructions, all national and local hospital guidelines and policies. • Always leave space between the packages in the autoclave. If the packages are placed too close together, effective sterilization will not be possible.
- Page 60 Chapter 5 Reprocessing After steam sterilization, let the instrument gradually cool down to room 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.
-
Page 61: Storage
Chapter 6 Storage Chapter 6 Storage • Do not store the instrument in a sterile package that is damaged, wet or improperly sealed. Otherwise, the sterility of the instrument may be compromised and could pose an infection control risk or cause tissue irritation. - Page 62 Chapter 6 Storage Storage Store the instrument in the 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 any additional storage instructions provided by the manufacturer of the sterile package.
- Page 63 ©2004 OLYMPUS MEDICAL 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 of OLYMPUS CORPORATION.
- Page 64 Manufactured by 2951 Ishikawa-cho, Hachioji-shi, Tokyo 192-8507, Japan Fax: (042)646-2429 Telephone: (042)642-2111 Distributed by 3500 Corporate Parkway, P.O. Box 610 Center Valley, PA 18034-0610, U.S.A. Fax: (484)896-7128 Telephone: (484)896-5000 One Corporate Drive, Orangeburg, N.Y. 10962, U.S.A. Fax: (845)398-9444 Telephone: (845)398-9400 5301 Blue Lagoon Drive, Suite 290 Miami, FL 33126-2097, U.S.A.