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Appendix

VISERA RHINO-LARYNGO VIDEOSCOPE ENF-V2

Appendix

System chart

The recommended combinations of equipment and accessories that can be
used with this instrument are listed below. Some items may not be available in
some areas. 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.

Regarding electromagnetic compatibility (EMC), this device
complies with IEC 60601-1-2: 2001 (second edition).
However, the system complies with IEC 60601-1-2: 1993
(first edition) when this device is used with the equipment
that complies only with the first edition.

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Содержание VISERA ENF-V2

Страница 1: ...For PAL type only INSTRUCTIONS VISERA RHINO LARYNGO VIDEOSCOPE OLYMPUS ENF TYPE V2...

Страница 2: ......

Страница 3: ...sappeared or frozen endoscopic image 10 Examples of inappropriate handling 11 Chapter 1 Checking the Package Contents 13 Chapter 2 Instrument Nomenclature and Specifications 14 2 1 Nomenclature 14 2 2...

Страница 4: ...nt 47 7 2 Cleaning disinfection and sterilization procedures 51 7 3 Precleaning 52 7 4 Transportation of the endoscope 54 7 5 Leakage testing 55 7 6 Manual cleaning 60 7 7 Disinfection 63 7 8 Rinsing...

Страница 5: ...ymbol 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 Type BF applied part Endoscope Manufactur...

Страница 6: ...tent and probability Perform endoscopy and endoscopic treatment only when its potential benefits are greater than its risks Fully explain to the patient the potential benefits and risks of the endosco...

Страница 7: ...to confirm that this instrument is compatible with the ancillary equipment being used Using incompatible equipment can result in patient and operator injury and or equipment damage This instrument com...

Страница 8: ...de on page 73 If the irregularity is still suspected after inspection contact Olympus Prohibition of improper repair and modification This instrument does not contain any user serviceable parts Do not...

Страница 9: ...ult Never operate the bending section perform suction insert or withdraw the endoscope s insertion tube without viewing the endoscopic image Patient injury can result Never operate the bending section...

Страница 10: ...ed carefully If resistance to insertion is felt or the patient reports pain stop insertion immediately Otherwise operator and or patient injury can result or the endoscope could become lodged and be d...

Страница 11: ...not illuminated unnecessarily If the endoscopic image becomes dimmer during the procedure it may indicate that blood or mucus is adhering to the light guide on the distal end of the endoscope Careful...

Страница 12: ...rom the output socket of the light source and the endoscopic image will not be visible Do not pull the video cable during an examination The endoscopic image may not be visible anymore Do not coil the...

Страница 13: ...and or may cause water leaks Do not attempt to bend the endoscope s insertion tube with excessive force Otherwise the insertion tube may be damaged To check the electromagnetic influence from other eq...

Страница 14: ...e faulty contact can result Do not bend hit or twist the insertion section control section universal cord video connector and light guide connector The endoscope may be damaged and water leaks and or...

Страница 15: ...d endoscopic treatment can be ensured through appropriate handling by the physician and the medical facility Examples of inappropriate handling are given below Inserting or withdrawing the endoscope a...

Страница 16: ...12 Important Information Please Read Before Use VISERA RHINO LARYNGO VIDEOSCOPE ENF V2...

Страница 17: ...onent is missing or you have any questions do not use the instrument immediately contact Olympus This instrument was not cleaned disinfected or sterilized before shipment Before using this instrument...

Страница 18: ...RA RHINO LARYNGO VIDEOSCOPE ENF V2 Chapter 2 Instrument Nomenclature and Specifications 2 1 Nomenclature 4 Light guide connector 7 Venting connector Light guide Serial number Video cable Universal cor...

Страница 19: ...VISERA RHINO LARYNGO VIDEOSCOPE ENF V2 1 Bending section 2 UP DOWN angulation control lever 3 Remote switches 3 Remote switches Control section Boot Insertion tube working length Distal end 9 Identif...

Страница 20: ...t of the light source and transmits light from the light source to the endoscope 5 Video connector The video connector connects the endoscope to the output socket of the video system center and makes...

Страница 21: ...idity 10 95 Atmospheric pressure 700 1060 hPa 0 7 1 1 kgf cm2 10 2 15 4 psia Transportation environment conditions during transportation and short term storage Ambient temperature 47 to 70 C 52 6 to 1...

Страница 22: ...on Group 1 Class B This instrument complies with the EMC standard for medical electrical equipment edition 4 IEC 60601 1 2 2014 When connecting to an instrument that complies with a previous edition o...

Страница 23: ...shooting If this instrument malfunctions do not use it Return it to Olympus for repair as described in Section 10 3 Returning the endoscope for repair on page 75 Using an endoscope that is not functio...

Страница 24: ...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 Refer to the respective instruc...

Страница 25: ...nd light guide connector section for excessive scratching deformation or other irregularities 2 Inspect the boot and the insertion tube near the boot for bends twists or other irregularities 3 Inspect...

Страница 26: ...t a point 10 cm from the distal end Push and pull gently to confirm that the angle between the bending section and the distal end is not loose 8 Inspect the objective lens at the distal end of the end...

Страница 27: ...ystem center and display monitor as described in their respective instruction manuals Connection of the endoscope and ancillary equipment If the video connector and video system center are not connect...

Страница 28: ...ly reprocessing agents 1 are aggressive and might effect the distal end of the endoscope When the effect progresses fogging of the inner lenses might appear which result in a foggy video image Any fur...

Страница 29: ...endoscopic image is free from noise blur fog or other irregularities 5 Angulate the bending section and confirm that the endoscopic image is free from momentary disappearing or other irregularities In...

Страница 30: ...system center OFF then without touching the angulation control lever slowly withdraw the endoscope from the patient If the angulation control mechanism or any other part of the system is not functioni...

Страница 31: ...image on the video monitor disappears or freezes unexpectedly If the endoscopic image on the video monitor appears blurry of foggy unexpectedly If the angulation control mechanism is not functioning p...

Страница 32: ...rikes the distal end Be sure to contact Olympus for repair 4 1 Insertion Holding and manipulating the endoscope The control section of the endoscope is designed to be held in the left hand The UP DOWN...

Страница 33: ...an result or the endoscope could become lodged and be difficult to withdraw Transnasal insertion of the endoscope should be performed carefully If resistance to insertion is felt or the patient report...

Страница 34: ...ndoscopic image Refer to the light source s instruction manual for instructions to adjust the brightness Observation of the NBI image All mucosal areas are to be viewed using traditional white light N...

Страница 35: ...chemicals For the types and conditions of the means of cleaning disinfection and sterilization to be adopted please make judgments from your professional viewpoints Refer to the American National Stan...

Страница 36: ...ope reprocessor follow their instruction manual Olympus does not assure the effect of cleaning disinfection and sterilization in endoscope reprocessors Contact the manufacturers of those disinfection...

Страница 37: ...adequately ventilated Adequate ventilation protects against the buildup of toxic chemical fumes Store alcohol in an air tight container Alcohol stored in an open container may cause fires and will los...

Страница 38: ...each method please contact Olympus If cleaning disinfection and sterilization methods not stated in this instruction manual are performed Olympus cannot guarantee the effectiveness safety and durabil...

Страница 39: ...of material durability it means that the method can be adopted as a repetitive reprocessing procedure Just because the material durability is confirmed it does not mean a certain degree of microbiolo...

Страница 40: ...lists those cleaning disinfection and sterilization procedures and agents that have been thoroughly tested on components of endoscopes and their accessories Methods validated in terms of biological ef...

Страница 41: ...hout an identification mark for STERRAD 200 NX material compatibility on the control section is not compatible with STERRAD 200 NX When STERRAD 200 NX is used instrument damage and patient injury may...

Страница 42: ...ral pH detergent or enzymatic detergent and follow the manufacturer s dilution and temperature recommendations Do not reuse detergent solutions Excessive detergent foaming can prevent fluid from adequ...

Страница 43: ...be cleaned at room temperature Vapor generated by the ultrasonic cleaning device may contain infectious agents such as aerosol Always use a face screen and air exhaust during ultrasonic cleaning Exces...

Страница 44: ...endoscopic instruments is certified by manufacturers and are approved by a competent authority Incompatible disinfectant solutions may considerably damage Olympus endoscopes and accessories For furth...

Страница 45: ...l instruments have been securely fixed to the baskets Make sure that instruments do not touch each other Instruments with lumens must be attached to special tubes with rinsing devices Make sure that a...

Страница 46: ...ment in the sterilization device Please verify the sterilization effects by using biological or chemical indicators Also follow the guidelines for sterilization issued by medical administrative author...

Страница 47: ...re 20 EtO 80 CO2 Process Parameters Ethylene oxide gas sterilization Temperature 57 C Pressure 0 1 0 17 MPa Humidity 55 Exposure time 1 75 hours Ethylene oxide gas concentration 0 6 0 7 mg cm3 600 700...

Страница 48: ...ave equipment let it cool down to room temperature Otherwise it may cause burns to the people handling the instrument Effective sterilization will not be possible if items are packed tightly together...

Страница 49: ...on in a prevacuum sterilizer This method has been validated for its germicidal effectiveness with most of the Olympus instruments Olympus recommends that the instruments are autoclaved for 5 minutes a...

Страница 50: ...kg 10 mg l SiO2 0 1 mg kg 1 mg l Fe 0 1 mg kg 0 2 mg l Cd 0 005 mg kg 0 005 mg l Pb 0 05 mg kg 0 05 mg l Traces of heavy metals except Fe Cd Pb 0 1 mg kg 0 1 mg l Cl 0 1 mg kg 2 mg l P2O5 0 1 mg kg 0...

Страница 51: ...cleaning disinfection and sterilization procedures for the endoscopic instruments that are related to the safety and health of patients Regarding the maintenance procedure of equipments for reprocessi...

Страница 52: ...500 cm3 500 ml containers Detergent solution Clean lint free cloths Large non metallic basins with a tight fitting lid for detergent and disinfectant solution Disinfectant solution Sterile lint free...

Страница 53: ...6 When performing gas sterilization ethylene oxide gas STERRAD 50 100S etc the ETO cap must be attached to the venting connector to equalise the outer and inner pressure see Figure 7 2 Figure 7 2 Leak...

Страница 54: ...are subject to wear Should any irregularity be observed use a new one Using defective equipment may result in ineffectual reprocessing and cause equipment damage Inspection of the ETO cap Confirm tha...

Страница 55: ...e endoscope Section 7 4 on page 54 Withdrawal of the endoscope Precleaning Section 7 3 on page 52 Leakage testing Section 7 5 on page 55 Manual cleaning Section 7 6 on page 60 Rinsing and drying Autom...

Страница 56: ...the procedure of Section 6 6 Automatic cleaning disinfection on page 41 or Section 7 7 Disinfection on page 63 7 3 Precleaning Preclean the endoscope immediately after the procedure The following step...

Страница 57: ...stretch or severely damage the insertion tube and the covering of the bending section Gently wipe off debris on the insertion tube with a clean lint free cloth soaked in detergent solution Wipe from...

Страница 58: ...e insertion tube securely but gently without squeezing with the video connector in the other hand see Figure 7 6 Figure 7 6 Transport reusable products except endoscope from the point of use to the re...

Страница 59: ...d wear appropriate personal protective equipment Leakage testing when using MB 155 prepare the following equipment Never connect or disconnect the leakage tester s connector cap while immersed Doing s...

Страница 60: ...emaining on either component could cause endoscope malfunction When the leakage tester connector WA23070A MB 155 is in place the covering of the bending section will expand as the air pressure inside...

Страница 61: ...ale area press the pressure release lever to let the air escape Otherwise equipment damage may result 1 Fill a basin with clean water Use a basin which is at least 25 W 10 H 50 D cm in size and deep e...

Страница 62: ...us water leakage or the leakage tester may be damaged Stop leakage testing immediately Water may enter the endoscope with no pressure inside if it is still immersed in water As a result problems other...

Страница 63: ...the leakage tester s connector cap 4 Attach the leakage tester to the venting connector on the light guide connector see Figure 7 9 5 With the leakage tester connected immerse the endoscope in water a...

Страница 64: ...sive force when cleaning the endoscope Regarding the detergent solution refer to Section 6 2 Detergent solution on page 38 After completing the leakage test perform manual cleaning according to the pr...

Страница 65: ...ternal surface 1 Immerse the endoscope in the detergent solution 2 With the endoscope immersed use a soft brush or lint free cloth to thoroughly brush and wipe all external surfaces of the endoscope C...

Страница 66: ...t free cloth gently wipe off and dry the external surfaces of the endoscope 2 Inspect the endoscope for residual debris Should debris remain repeat the procedures given in this Section Presoak for exc...

Страница 67: ...ge 63 or Section 7 10 Sterilization on page 67 7 7 Disinfection All disinfection steps should be performed with the endoscope completely immersed Otherwise disinfectant solution may not adequately con...

Страница 68: ...l disinfection steps should be performed with the endoscope and all equipment completely immersed If the equipment is not completely immersed disinfectant solution may not adequately contact all surfa...

Страница 69: ...d water Aq Dest Do not use tap water for rinsing because it might be chlorinated Regarding the rinsing water quality refer to Section 6 5 Rinsing water on page 40 After disinfection rinse the endoscop...

Страница 70: ...mmerse the endoscope in de ionized water Aq Dest Using a clean lint free cloth thoroughly rinse and wipe all outer surfaces 2 Remove the endoscope from water 3 Use a sterile lint free cloth moistened...

Страница 71: ...covering of the bending section Regarding the condition of ethylene oxide gas sterilization refer to Section 6 7 Ethylene oxide gas sterilization on page 42 1 Dry the endoscope before ethylene oxide...

Страница 72: ...0 steam sterilize autoclave according to the procedures given below 1 Seal the individual parts or equipment separately in packages appropriate for steam sterilization autoclave according to your hosp...

Страница 73: ...RHINO LARYNGO VIDEOSCOPE ENF V2 Chapter 8 Maintenance Procedures of Equipments for Reprocessing Clean and decontaminate the equipment after use If necessary perform ultrasonic cleaning For compatible...

Страница 74: ...g case Use the carrying case only for shipping the endoscope Routinely storing the endoscope in a humid non ventilated environment such as the carrying case may present an infection control risk 1 Bef...

Страница 75: ...the carrying case again before use If the endoscope is not cleaned disinfected or sterilized the patient might be infected The carrying case cannot be cleaned disinfected or sterilized Clean and disin...

Страница 76: ...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 replacem...

Страница 77: ...3 Returning the endoscope for repair on page 75 Image quality or brightness Other Irregularity description Possible cause Solution There is no video image Not all the power switches are ON Turn ON all...

Страница 78: ...eeding and or perforation When the endoscopic image appears on the monitor 1 Turn OFF all equipment except the video system center light source and video monitor 2 Carefully withdraw the endoscope whi...

Страница 79: ...l or at Olympus Olympus is not liable for any injury or damage which occurs as a result of repairs attempted by non Olympus personnel Before returning the endoscope for repair contact Olympus With the...

Страница 80: ...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 as...

Страница 81: ...center OTV S7V Video system OTV SI Endoscope ENF V2 Video monitor OEV141 OEV142 OEV143 OEV201 OEV202 OEV203 OEV181H OEV191 EVIS EXERA II xenon light source CLV 180 EVIS EXERA II video system center C...

Страница 82: ...eaning and disinfection equipment Maintenance unit MU 1 ETO cap MB 156 Leakage tester MB 155 Leakage tester WA23070A Ultrasonic cleaner KS 2 Sterilization tray WA05991A ETD series 1 1 For any other de...

Страница 83: ...y for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment Radiated emissions CISPR 11 Class B This instrument s RF...

Страница 84: ...2 4 6 kV Air 2 4 8 kV Same as left Floors should be made of wood concrete or ceramic tile that hardly produces static If floors are covered with synthetic material that tends to produce static the rel...

Страница 85: ...UT is the a c mains voltage prior to application of the test level Power frequency 50 60 Hz magnetic field IEC 61000 4 8 30 A m 50 Hz 60 Hz 3 A m 50 Hz 60 Hz Same as left It is recommended to use this...

Страница 86: ...ation distance in meters m Proximity magnetic field from RF communication equipment IEC 61000 4 3 Refer to the table of the next page Same as left a Field strength from fixed transmitters such as base...

Страница 87: ...sed for EMC compliance testing Refer to the instruction manuals for each piece of equipment Test frequency MHz Band MHz Modulation 1 Maximum power W Immunity test level V m 385 380 390 Pulse modulatio...

Страница 88: ......

Страница 89: ...reproduced or distributed without the express written permission of OLYMPUS MEDICAL SYSTEMS CORP OLYMPUS is a registered trademark of OLYMPUS CORPORATION Trademarks product names logos or trade names...

Страница 90: ...Valley Road 12 01 04 Valley Point Office Tower Singapore 248373 Fax 6834 2438 Telephone 6834 0010 A8F Ping An International Financial Center No 1 3 Xinyuan South Road Chaoyang District Beijing 100027...

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