Bf type evis exera ii ultrasonic bronchofibervideoscope (183 pages)
Summary of Contents for Olympus EVIS EXERA II GIF-Q165
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INSTRUCTIONS EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF TYPE Q165 EVIS EXERA II COLONOVIDEOSCOPE OLYMPUS CF TYPE Q165L/I Refer to the endoscope’s companion manual, the “REPROCESSING MANUAL” whose cover lists the model of your endoscope, for reprocessing information. USA: CAUTION: Federal law restricts this device to sale by or on the order of a...
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Contents Contents EVIS EXERA II GIF/CF TYPE 165 Series OPERATION MANUAL...
Contents Symbols ..................Important Information — Please Read Before Use....Intended use .................... Applicability of endoscopy and endoscopic treatment ......Instruction manual ..................User qualifications ..................Instrument compatibility ................Reprocessing before the first use/reprocessing and storage after use ..Spare equipment ..................Maintenance management ...............
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Contents Appendix ..................System chart .................... EMC information ..................EVIS EXERA II GIF/CF TYPE 165 Series OPERATION MANUAL...
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Contents EVIS EXERA II GIF/CF TYPE 165 Series OPERATION MANUAL...
Symbols Symbols The meaning(s) of the symbol(s) shown on the package with the components, the back cover of this instruction manual and/or this instrument are as follows: Refer to instructions. Caution Endoscope TYPE BF applied part Manufacturer Authorized representative in the European Community Lot number Serial number EVIS EXERA II GIF/CF TYPE 165 Series OPERATION MANUAL...
Important Information — Please Read Before Use Intended use These instruments have been designed to be used with an Olympus video system center, light source, documentation equipment, video monitor, endo-therapy accessories such as a biopsy forceps and other ancillary equipment.
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 If there is an official standard on user qualifications to perform endoscopy and...
Equipment which has been disassembled, repaired, altered, changed or modified by persons other than Olympus’ own authorized service personnel is excluded from Olympus’ limited warranty and is not warranted by Olympus in any manner. EVIS EXERA II GIF/CF TYPE 165 Series OPERATION MANUAL...
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.
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Important Information — Please Read Before Use • Never perform angulation control forcibly or abruptly. Never forcefully pull, twist or rotate the angulated bending section. Patient injury, bleeding and/or perforation can result. It may also become impossible to straighten the bending section during an examination.
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Important Information — Please Read Before Use • Do not coil the insertion tube or universal cord with a diameter of less than 12 cm. Equipment damage can result. • Do not touch the electrical contacts inside the electrical connector. CCD damage may result. •...
Important Information — Please Read Before Use • Electromagnetic interference may occur on this instrument near equipment marked with the following symbol or other portable and mobile RF (Radio Frequency) communications equipment such as cellular phones. If electromagnetic interference occurs, mitigation measures may be necessary, such as reorienting or relocating this instrument, or shielding the location.
Match all items in the package with the components shown below. Inspect each item for damage. If the instrument is damaged, a component is missing or you have any questions, do not use the instrument; immediately contact Olympus. This instrument was not disinfected or sterilized before shipment.
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Chapter 1 Checking the Package Contents Channel cleaning brush (BW-20T) Injection tube (MH-946) Channel plug (MH-944) Water-resistant cap (MH-553) AW channel cleaning Channel-opening cleaning brush adapter (MH-948) (MH-507) Biopsy valve (MB-358, 10 pcs) Mouthpiece Suction cleaning adapter (MB-142 for GIF models (MH-856) only, 2 pcs) Auxiliary water tube...
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Chapter 1 Checking the Package Contents EVIS EXERA II GIF/CF TYPE 165 Series OPERATION MANUAL...
Chapter 2 Instrument Nomenclature and Specifications Chapter 2 Instrument Nomenclature and Specifications Nomenclature GIF-Q165 Universal cord 1. Suction connector 5. Electrical connector Air pipe 2. S-cord connector mount 3. Air supply connector 3. Water supply connector Light guide Product name and serial number Electrical contacts 4.
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Chapter 2 Instrument Nomenclature and Specifications CF-Q165L/I Universal cord 17. .Auxiliary water inlet 1. Suction connector 5. Electrical connector Auxiliary water inlet cap (MAJ-215) Air pipe 2. S-cord connector mount 3. Air supply connector 3. Water supply connector Light guide Product name and serial number Electrical contacts 4.
Connects the endoscope to the suction tube of the suction pump. 2. S-cord connector mount Connects the endoscope with the Olympus electrosurgical unit via the S-cord. The S-cord conducts leakage current from the endoscope to the electrosurgical unit. To connect the S-cord, refer to the instruction manual for the electrosurgical unit.
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Chapter 2 Instrument Nomenclature and Specifications 11. Insertion tube limit mark This mark shows the maximum point to which the endoscope may be inserted into the patient's body. 12. Bending section This section moves the distal end of the endoscope when the UP/DOWN and RIGHT/LEFT angulation control knobs are operated.
Chapter 2 Instrument Nomenclature and Specifications Specifications Environment Operating Ambient temperature 10 – 40C (50 – 104F) environment Relative humidity 30 – 85% Atmospheric pressure 700 – 1060 hPa (0.7 – 1.1 kgf/cm (10.2 – 15.4 psia) Transportation and Ambient temperature –47 to 70C (–52.6 to 158F) storage Relative humidity...
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Chapter 2 Instrument Nomenclature and Specifications Specifications Endoscope functions Model GIF-Q165 Optical system Field of view 140 Direction of view Forward viewing Depth of field 3 – 100 mm Insertion tube Distal end outer ø 9.2 mm diameter Distal end enlarged 1.
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Chapter 2 Instrument Nomenclature and Specifications Model CF-Q165L/I Optical Field of view 140 system Direction of view Forward viewing Depth of field 3 – 100 mm Insertion tube Distal end outer ø 12.8 mm diameter Distal end enlarged 1. Air/water nozzle 2.
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Chapter 2 Instrument Nomenclature and Specifications Medical This device complies with the requirements Devices of Directive 93/42/EEC concerning medical Directive devices. Classification: Class II a Applied standard; This instrument complies with the IEC 60601-1-2: 2001 standards listed in the left column. CISPR 11 of emission: Group 1, Class B This instrument complies with the EMC...
If any irregularities are suspected after inspection, follow the instructions as described in Chapter 5, “Troubleshooting”. If this instrument malfunctions, do not use it. Return it to Olympus for repair as described in Section 5.3, “Returning the endoscope for repair”.
Chapter 3 Preparation and Inspection Preparation of the equipment Prepare the equipment shown in Figure 3.1 (for compatibility, see the “System chart” in the Appendix) and personal protective equipment, such as eye wear, face mask, moisture-resistant clothing and chemical-resistant gloves, before each use.
Chapter 3 Preparation and Inspection Inspection of the endoscope Clean and disinfect or sterilize the endoscope as described in the “REPROCESSING MANUAL” whose cover lists the model of your endoscope. Then remove the water-resistant cap from the endoscope connector. Inspection of the endoscope Inspect the control section and the endoscope connector for excessive scratching, deformation, loose parts or other irregularities.
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Chapter 3 Preparation and Inspection Using both hands, bend the insertion tube of the endoscope into a semicircle. Then, moving your hands as shown by the arrows in Figure 3.3, confirm that the entire insertion tube can be smoothly bent to form a semicircle and that the insertion tube is pliable.
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Chapter 3 Preparation and Inspection Inspection of the bending mechanisms Perform the following inspections while the bending section is straight. If the movement of the UP/DOWN angulation lock, RIGHT/LEFT angulation lock and their angulation control knobs are loose and/or not smooth, or the bending section does not angulate smoothly, the bending mechanism may be abnormal.
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Chapter 3 Preparation and Inspection Inspection of the UP/DOWN angulation mechanism Move the UP/DOWN angulation lock all the way in the opposite direction of the “F ” mark. Then turn the UP/DOWN angulation control knob in the “ U” or the “D ”...
Chapter 3 Preparation and Inspection Preparation and inspection of accessories Clean and disinfect or sterilize the air/water valve, suction valve and biopsy valve as described in the endoscope’s companion reprocessing manual. Inspection of the air/water and suction valves Confirm that the top hole of the air/water valve is not blocked (see Figure 3.5).
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Chapter 3 Preparation and Inspection The air/water and suction valves are consumables. If the inspection of the air/water or suction valve reveals any irregularities, use new valves. Inspection of the biopsy valve The biopsy valve is a consumable that should be inspected before each use.
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Chapter 3 Preparation and Inspection Inspection of the auxiliary water inlet cap (for endoscopes with auxiliary water feeding only) Confirm that the auxiliary water inlet cap attached to the endoscope connector has no dents, cracks or other irregularities (see Figure 3.9). If irregularities are observed, replace it with a new one as described in “Attaching the auxiliary water inlet cap (for endoscopes with auxiliary water feeding only)”...
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Chapter 3 Preparation and Inspection Inspection of the mouthpiece (for GIF models only) Do not use a mouthpiece that is damaged, deformed or reveals other irregularities. Doing so may cause patient injury and/or equipment damage. Placing the mouthpiece in the patient’s mouth before the procedure prevents the patient from biting and/or damaging the endoscope’s insertion tube.
Chapter 3 Preparation and Inspection Attaching accessories to the endoscope The air/water valve and the suction valve do not require lubrication. Lubricants can cause swelling of the valves' seals, which will impair valve function. Attaching the suction valve Align the two metal ridges on the underside of the suction valve with the two holes in the suction cylinder.
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Chapter 3 Preparation and Inspection Attaching the air/water valve Attach the air/water valve to the air/water cylinder of the endoscope (see Figure 3.13). Confirm that the valve fits properly without any bulging of the skirt. Air/water valve Suction valve Skirt Suction cylinder Air/water cylinder Figure 3.13...
Chapter 3 Preparation and Inspection Attaching the auxiliary water inlet cap (for endoscopes with auxiliary water feeding only) If the auxiliary water inlet cap is not attached, attach the fitting ring to the auxiliary water inlet on the endoscope connector (see Figure 3.15). Fitting ring Auxiliary water inlet cap Auxiliary water inlet...
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Chapter 3 Preparation and Inspection Connection of the endoscope and ancillary equipment Firmly connect the suction tube from the suction pump to the suction connector on the endoscope connector. If the suction tube is not attached properly, debris may drip from the tube and can present an infection-control risk, damage and/or reduce suction capability.
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Chapter 3 Preparation and Inspection Align the mark on the videoscope cable EXERA or the videoscope cable 100 with mark 1 on the endoscope connector and push it in until it stops (see Figure 3.17). Mark 2 (yellow) Mark (yellow) Mark 1 (yellow) Figure 3.17 Turn the connector of the videoscope cable clockwise until it stops (see...
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Chapter 3 Preparation and Inspection Open the auxiliary water inlet cap (for endoscopes with auxiliary water feeding only, see Figure 3.19). Connect the auxiliary water tube to the auxiliary water inlet on the endoscope connector and turn it clockwise until it stops (for endoscopes with auxiliary water feeding only, see Figure 3.19).
Chapter 3 Preparation and Inspection Inspection of the endoscopic system Inspection of the endoscopic image Do not stare directly at the distal end of the endoscope while the examination light is ON. Otherwise, eye injury may result. Turn the video system center, light source, video monitor ON and inspect the endoscopic image as described in their respective instruction manuals.
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If this fails to stop air bubbles from being emitted, do not use the endoscope, as there may be a malfunction. Contact Olympus. When the distal end of the insertion tube is immersed less...
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If the reattached or replaced suction valve fails to operate smoothly, the endoscope may be malfunctioning; stop using it and contact Olympus. • If the biopsy valve leaks, replace it with a new one. A leaking biopsy valve can reduce the efficacy of the endoscope’s...
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Chapter 3 Preparation and Inspection Depress the suction valve and aspirate water for one second. Then, release the suction valve for one second. Repeat this several times and confirm that no water leaks from the biopsy valve. Remove the distal end of the endoscope from the water. Depress the suction valve and aspirate air for a few seconds to remove any water from the instrument channel.
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Chapter 3 Preparation and Inspection Disconnect the water tube from the water pump or the syringe from the luer port of the auxiliary water tube. Make sure that no water leaks from the luer port of the auxiliary water tube and/or the distal end of the insertion tube. If the auxiliary water channel is used for feeding water, never disconnect the auxiliary water tube during an examination;...
Chapter 4 Operation Chapter 4 Operation The operator of this instrument 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.
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Chapter 4 Operation Insertion or withdrawal with excessive force, or forcible insertion or withdrawal. • If any of the following phenomena occur during an examination, immediately stop the examination and withdraw the endoscope from the patient as described in Section 5.2, “Withdrawal of the endoscope with an abnormality”.
Chapter 4 Operation Insertion Holding and manipulating the endoscope The control section of the endoscope is designed to be held in the left hand. The air/water and suction valves can be operated using the left index finger. The UP/DOWN angulation control knob can be operated using the left thumb. The right hand is free to manipulate the insertion tube and the RIGHT/LEFT angulation control knob (see Figure 4.1).
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Chapter 4 Operation • Do not allow the insertion tube to be bent within a distance of 10 cm or less from the junction of the boot. Insertion tube damage can occur (see Figure 4.2). > 10 cm Figure 4.2 ...
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Chapter 4 Operation Angulation of the distal end Avoid forcible or excessive angulation, as this imposes load on the wire controlling the bending section. This may cause stretching or tearing of the wire, which could impair the movement of the bending section. Operate the angulation control knobs as necessary to guide the distal end for insertion and observation.
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Chapter 4 Operation • If the biopsy valve is left uncapped during the procedure, debris or fluids could leak or spray from it, posing an infection-control risk. When the valve is uncapped, place a piece of sterile gauze over it to prevent leakage. If the endoscope is cold, dew condensation may form on the surface of the objective lens, and the endoscopic image may appear “cloudy”.
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“Inspection of the suction function” on page 40, before using the endoscope again. If the thick fluid or solid matter cannot be discharged, stop using the suction function and contact Olympus. • When aspirating, maintain the suction pressure at the lowest level necessary to perform the procedure.
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Chapter 4 Operation Auxiliary water feeding (for endoscopes with auxiliary water feeding only) Use sterile water only. Non-sterile water may cause patient infection. • Never disconnect the auxiliary water tube from the auxiliary water inlet during an examination; leave it attached until the endoscope is precleaned.
Chapter 4 Operation Using endo-therapy accessories For more information on combining the endoscope with particular endo-therapy accessories, refer to the “System chart” in the Appendix and the instruction manuals of the accessories. Refer to the accessories’ instruction manuals for operating instructions. •...
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Chapter 4 Operation • When using a biopsy forceps with a needle, confirm that the needle is not bent excessively. A bent needle could protrude from the closed cups of the biopsy forceps. Using such a biopsy forceps could damage the instrument channel and/or cause patient injury.
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Chapter 4 Operation • When inserting an endo-therapy accessory, hold it close to the biopsy valve and insert it slowly and straight into the biopsy valve. Otherwise, the endo-therapy accessory and/or biopsy valve could be damaged. This can reduce the efficacy of the endoscope’s suction system, and may leak or spray patient debris or fluids, posing an infection-control risk.
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Chapter 4 Operation Withdrawal of endo-therapy accessories • Patient debris might spray when the endo-therapy accessories are withdrawn from the biopsy valve. To prevent this, hold a piece of gauze around the accessory and the biopsy valve. • Do not withdraw the endo-therapy accessory if the tip is open or extended from its sheath;...
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Chapter 4 Operation High frequency cauterization treatment • If the intestines contains a flammable gas, replace it with air or a non-flammable gas such as CO before performing high frequency cauterization treatment. Otherwise, fire or explosion could result. • Not all parts of the endoscope are electrically insulated. When applying high frequency current, there is a danger of unintentional diathermy burns.
Chapter 4 Operation Withdrawal of the endoscope If blood unexpectedly adheres to the surface of the insertion tube of the withdrawn endoscope, carefully check the condition of the patient. Aspirate accumulated air, blood, mucus or other debris by depressing the suction valve.
Chapter 4 Operation Transportation of the endoscope Transporting within the hospital When carrying the endoscope with the auxiliary water tube connected to the auxiliary water inlet, attach the clip of the auxiliary water tube to the universal cord (for endoscopes with auxiliary water feeding only, see Figure 4.4).
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Chapter 4 Operation Transporting outside the hospital Transport the endoscope in the carrying case. Always clean, disinfect or sterilize the endoscope after removing it from the carrying case. If the endoscope is not cleaned, disinfected or sterilized, it could pose an infection-control risk.
Some problems that appear to be malfunctions may be correctable by referring to Section 5.1, “Troubleshooting guide”. If the problem cannot be resolved by the described remedial action, stop using the endoscope and send it to Olympus for repair. Olympus does not repair accessory parts. If an accessory part becomes damaged, contact Olympus to purchase a replacement.
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Chapter 5 Troubleshooting Endoscope functions Angulation Irregularity Possible cause Solution description Resistance is The angulation lock(s) Rotate angulation lock(s) in the “F ” encountered is (are) engaged. direction. when rotating angulation control knob(s). Air/water feeding Irregularity Possible cause Solution description No air feeding.
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Chapter 5 Troubleshooting Suction Irregularity Possible cause Solution description The suction is The biopsy valve is not Attach it correctly. absent or attached properly. insufficient. The biopsy valve is Replace it with a new one. damaged. The suction pump is Adjust the suction pump's setting as not set properly.
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Chapter 5 Troubleshooting Auxiliary water feeding (for endoscopes with auxiliary water feeding only) Irregularity Possible cause Solution description The auxiliary The auxiliary water Replace it with a new one. water inlet cap inlet cap is worn out. is leaking. The auxiliary water Install the auxiliary water inlet cap correctly.
If the endoscope or endo-therapy accessory cannot be withdrawn from the patient smoothly, do not attempt to forcibly withdraw it. If any irregularities are suspected, immediately contact Olympus. Forcibly withdrawing the endoscope or endo-therapy accessory may cause patient injury, bleeding and/or perforation.
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Chapter 5 Troubleshooting When the endoscopic image does not appear on the monitor or a frozen image cannot be restored Turn all equipment OFF except the video system center, the light source and the monitor. Turn the video system center and light source OFF and then ON again. If the endoscopic image appears or the frozen image restored, follow the procedure given in “When the endoscopic image appears on the monitor”...
Olympus. Before returning the endoscope for repair, contact Olympus. With the endoscope, include a description of the malfunction or damage and the name and telephone number of the individual at your location who is most familiar with the problem.
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EVIS EXERA II GIF/CF TYPE 165 Series OPERATION MANUAL...
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New products released after the introduction of this instrument may also be compatible for use in combination with this instrument. For further details, contact Olympus. If combinations of equipment other than those shown below are used, the full responsibility is assumed by the medical treatment facility.
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Appendix Suction pumps Auxiliary water tube (MAJ-855 for endoscopes Water pump (OFP) with auxiliary water feeding only) GIF-Q165 CF-Q165L/I SSU-2 KV-4/5 Sclerotherapy tube (for GIF models) Videoscope cable EXERA Videoscope cable 100 (MAJ-843) (MH-976) Sclerotherapy balloon (for GIF models) EVIS EXERA video system EVIS video system center center (CV-145/160) (CV-140)
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Appendix Endoscope position detecting unit (UPD) Biopsy valve (MB-358) Electrosurgical units Position detecting probe (MAJ-1300, for CF models only) UES-20/30 PSD-30 Electrosurgical unit Endo-therapy accessories See the following pages. Electrosurgical accessories PSD-60 See the following pages. Argon plasma coagulation unit APC probe (MAJ-1011/1012) ENDOPLASMA...
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Appendix Cleaning and disinfection equipment Auxiliary water tube (MAJ-855 for endoscopes with auxiliary water feeding only) Ultrasonic cleaner (KS-2/ENDOSONIC) Leakage tester (MB-155) ** Endoscope washer Channel plug Channel (EW-30) (MH-944) cleaning brush ** Endoscope reprocessor Maintenance unit (BW-20T) (OER/OER-A) (MU-1) AW channel cleaning Single use adapter (MH-948)
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Appendix Endo-therapy accessories BIOPSY FORCEPS BIOPSY FORCEPS (Fenestrated) Single side open With needle Alligator jaws Standard GIF-Q165 FB-11K-1 – FB-15K-1 FB-25K-1 CF-Q165L FB-7U-1 FB-13U-1 – FB-28U-1 CF-Q165I FB-7U-1 FB-13Q-1 – FB-28R-1 BIOPSY FORCEPS (Fenestrated) Elongated cups with With needle Rat tooth Alligator jaws needle...
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Appendix ROTATABLE BIOPSY FORCEPS (Fenestrated) Alligator jaws and Alligator jaws and Alligator jaws and Elongated cups with rat tooth (Swinging rat tooth with needle rat tooth (Swinging needle type/ Elongated (Swinging type/ type) cups) Elongated cups) GIF-Q165 FB-24KR-1 FB-53KR-1 FB-54KR-1 FB-55KR-1 CF-Q165L –...
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Appendix GRASPING FORCEPS Rat tooth with W shape jaw Basket type Tripod type alligator jaws FG-42L-1/47L-1/ GIF-Q165 FG-4L-1 FG-16L-1 FG-45L-1 49L-1 CF-Q165L – – FG-16U-1 FG-45U-1 CF-Q165I – – FG-16U-1 FG-45U-1 SINGLE USE GRASPING GRASPING SURGICAL FORCEPS LOOP CUTTER FORCEPS SCISSORS Pentapod type Tripod type...
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Appendix SINGLE USE CLIP FIXING ROTATABLE CLIP LIGATING DEVICE DEVICE FIXING DEVICE GIF-Q165 HX-5LR-1 HX-201LR-135 HX-20L-1 HX-21L-1 CF-Q165L HX-6UR-1 HX-201UR-135 HX-20U-1 – CF-Q165I HX-5QR-1 HX-201UR-135 HX-20Q-1 – : These accessories may not be available in some areas DISPOSABLE LIGATING DEVICE INJECTION NEEDLE HEAT PROBE INJECTION NEEDLE...
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Appendix DISTAL DISPOSABLE DISTAL ATTACHMENT ATTACHMENT GIF-Q165 MAJ-295 D-201-10704 D-206-02 CF-Q165L – D-201-14304 – CF-Q165I – D-201-14304 – : These accessories may not be available in some areas. EVIS EXERA II GIF/CF TYPE 165 Series OPERATION MANUAL...
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Appendix DIATHERMIC DISPOSABLE HOT BIOPSY FORCEPS HOT BIOPSY CUTTER FORCEPS Alligator jaws-step Oval Needle type GIF-Q165 FD-1L-1 FD-210U FD-230U KD-1L-1 CF-Q165L FD-2U-1 FD-210U FD-230U – CF-Q165I FD-2U-1 FD-210U FD-230U – EVIS EXERA II GIF/CF TYPE 165 Series OPERATION MANUAL...
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Appendix EMC information Guidance and manufacturer’s declaration — Electromagnetic emissions This model is intended for use in the electromagnetic environment specified below. The customer or the user of this model should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment —...
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Appendix Guidance and manufacturer’s declaration — Electromagnetic immunity This model is intended for use in the electromagnetic environment specified below. The customer or the user of this model should assure that it is used in such an environment. Immunity test IEC 60601 test level Compliance level Electromagnetic environment —...
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Appendix Guidance and manufacturer’s declaration — Electromagnetic immunity This model is intended for use in the electromagnetic environment specified below. The customer or the user of this model should assure that it is used in such an environment. Portable and mobile RF communications equipment should be used no closer to any part of this model, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
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Appendix • Field strength from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Field strength from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy.
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Appendix Recommended separation distances between portable and mobile RF communications equipment and this model This model is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of this model can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and this model as recommended below, according to the maximum output power of the communications equipment.
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