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Olympus PSD-30 Скачать руководство пользователя страница 10

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Important Information — Please Read Before Use

ELECTROSURGICAL UNIT PSD-30

• The HF equipment, when applied to a patient with a

pacemaker implanted, may cause malfunctioning or failure of
the pacemaker and may seriously affect the patient. Always
confirm that it is safe to proceed with a cardiologist and the
manufacturer of the pacemaker before proceeding.

• To prevent shock hazards, never apply the PSD-30 to the

heart in combination with TYPE B or TYPE BF applied parts.

• When using the electrosurgical unit on or in the vicinity of the

heart, be sure to use it with the minimum necessary output.
Spark discharge during operation may affect the heart.

• Never install or operate the electrosurgical unit in locations

where:

−

the concentration of oxygen is high.

−

oxidizing agents (such as nitrous oxide (N

2

O)) are present

in the atmosphere.

−

flammable anesthetics are present in the atmosphere.

−

flammable gases are present in the atmosphere.

Otherwise, explosion or fire may result and cause damage to
human body. Because this electrosurgical unit is not
explosion-proof.

• The PSD-30 has been designed for flexible endoscopic

applications. Therefore, do not use it for surgical operations.

• Always use the S-cord when endoscopic treatment is

performed with an endoscope equipped with the S-cord
connector mount. When using an endoscope without the
S-cord connector mount, refer to the instruction manual and
confirm that the electrosurgery is feasible with this
endoscope. If the electrosurgical unit is used in conjunction
with an endoscope that is not feasible with the
electrosurgery, a burn to the patient, the operator or the
assistant may occur.

• If the electrosurgical unit fails and the output is stopped

during treatment, it may be impossible to continue treatment
due to adhesion of the endo-therapy accessory to a mucous
tissue or other accident. Prepare a spare electrosurgical unit
as backup to ensure that the procedure can be completed
without complication in case of a malfunction.

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Содержание PSD-30

Страница 1: ...INSTRUCTIONS ELECTROSURGICAL UNIT PSD 30...

Страница 2: ......

Страница 3: ...17 2 3 Rear panel 21 2 4 Foot switch MAJ 811 22 2 5 S cord MAJ 813 23 2 6 P cord MAJ 814 23 Chapter 3 Installation and Connection 24 3 1 Installation of equipment 24 3 2 Connection to an AC mains powe...

Страница 4: ...urgery 51 5 7 Stand by mode 53 5 8 Adjusting the volume 55 5 9 Procedure after use 56 Chapter 6 Care Storage and Disposal 58 6 1 Care 58 6 2 Storage 59 6 3 Disposal 59 Chapter 7 Troubleshooting 60 7 1...

Страница 5: ...d to the instrument at the location shown below If labels or symbols are missing or illegible contact Olympus Rear side Fuse rating CE marking Potential equalization terminal Foot switch connector Ele...

Страница 6: ...SD 30 Back cover of this instruction manual Manufacturer Authorised representative in the European Community Electrical rating ELECTROSURGICAL UNIT MODEL PSD 30 INPUT 220V 240V 50 60Hz 2A MONOPOLAR 50...

Страница 7: ...e Applicability of endoscopic treatment If there is an official standard on the applicability of endoscopic treatment as defined by a national or local medical administration or other institution such...

Страница 8: ...let An electrical outlet that has a terminal used exclusively for grounding User qualifications If there is an official standard that outlines the qualifications required of medical personnel performi...

Страница 9: ...gnal words The following signal words are used throughout this manual Indicates an imminently hazardous situation which if not avoided will result in death or serious injury Indicates a potentially ha...

Страница 10: ...able gases are present in the atmosphere Otherwise explosion or fire may result and cause damage to human body Because this electrosurgical unit is not explosion proof The PSD 30 has been designed for...

Страница 11: ...nit and ancillary cords A cord P cord S cord should not come in contact with the patient or metal parts of the operating table Furthermore patients should also keep away from metallic parts of the ope...

Страница 12: ...s with air or a non flammable gas before performing the operation to minimize the risk of fire or explosion The endoscopic treatment performed should not include a therapy with which part of the treat...

Страница 13: ...ere with the operation of an electrocardiograph or other physiological monitoring equipment Needle monitoring electrodes should not be used as they may cause patient burns Physiological monitoring equ...

Страница 14: ...th power from separate breakers During operation temporarily unused electrodes should be stored in an electrically insulated container Unused electrodes should never be placed on the patient otherwise...

Страница 15: ...atient otherwise it may cause operator and or patient burns Do not use the electrosurgical unit in a location exposed to strong electromagnetic radiation microwave medical treatment equipment short wa...

Страница 16: ...nents shown below Inspect each item for damage If the electrosurgical unit is damaged a component is missing or you have any questions do not use the electrosurgical unit immediately contact Olympus P...

Страница 17: ...A cord MA 255 MH 969 P plate MB 574 P cord MAJ 3 P adapter MAJ 812 For other combinations refer to the System chart in the Appendix Place the instruction manual next to the electrosurgical unit or in...

Страница 18: ...unctions ELECTROSURGICAL UNIT PSD 30 Chapter 2 Nomenclature and Functions 2 1 Symbols and descriptions Warning section Coag section Refer to instructions Patient plate S cord High frequency output Out...

Страница 19: ...er 2 Nomenclature and Functions 15 ELECTROSURGICAL UNIT PSD 30 Cut section Power switch Front panel Pure Blend1 Blend2 Power ON OFF Type CF applied parts defibrillation protected equipment STAND BY Pr...

Страница 20: ...GICAL UNIT PSD 30 Connector section Rear panel Active S cord Patient plate Refer to instructions Connection for neutral electrode isolated from earth at high frequency Potential equalization terminal...

Страница 21: ...s 17 ELECTROSURGICAL UNIT PSD 30 2 2 Front panel 1 Stand by switch 2 Program switch 3 Cut mode selector 4 Output control buttons 5 Coagulation mode selector 6 S cord connector 7 Active connector 8 Pat...

Страница 22: ...cord warning indicator 11 Output indicators 12 High frequency output warning indicator 13 Output time warning indicator 14 Coagulation output setting indicator 15 Coagulation mode indicators 16 Cut ou...

Страница 23: ...or connects the electrosurgical unit to the active electrode via the A cord 8 Patient plate connector This connector connects the electrosurgical unit to the patient plate via the P cord 9 Power switc...

Страница 24: ...buttons 17 Cut mode indicators These indicators light when the corresponding cut mode selector is pressed 18 CQM indicator When a split type patient plate is connected the CQM indicator lights to indi...

Страница 25: ...power inlet This inlet accepts the power cord 3 Foot switch connector This connector connects the foot switch MAJ 811 to the electrosurgical unit 4 Potential equalization terminal To be equipotential...

Страница 26: ...t switch MAJ 811 1 Cut pedal This pedal starts and stops the cut output 2 Coagulation pedal This pedal starts and stops the coagulation output 3 Foot switch plug This plug connects the foot switch to...

Страница 27: ...the electrosurgical unit via the S cord 2 6 P cord MAJ 814 1 Plug on the unit side This plug connects the patient plate to the electrosurgical unit via the P cord 2 Clamp This clamp connects the pati...

Страница 28: ...d fall causing equipment damage and or injury to the operator or patient If the electrosurgical unit is placed on a cart the cart must be of adequate strength and size to hold the unit securely Never...

Страница 29: ...le wall mains outlet Always plug the power cord into a 3 pin outlet Do not use a 3 pin 2 pin adapter as it can impair the safe operation of the unit Do not allow the power cord to become wet Electric...

Страница 30: ...to the PSD 30 Otherwise high frequency output may not activated In this case the electrosurgical accessory could cut the tissue mechanically which could cause bleeding and or perforation to the patie...

Страница 31: ...ient plate in the vicinity of a metal implant The tissue in the vicinity of the metal implant may get burned Body hair will impede proper contact with the patient plate Improper contact between the pa...

Страница 32: ...s sufficient In this case use the non split type patient plate MB 574 3M 1149 7149 P cord MAJ 3 and P adapter MAJ 812 are required when using MB 574 When using the patient plate MAJ 897 3M 1149 1180 7...

Страница 33: ...the unit side plug of the P cord into the patient plate connector on the front panel of the electrosurgical unit see Figure 3 4 Figure 3 4 4 When a split type patient plate is connected verify that t...

Страница 34: ...ter are free of cracks and other damage 4 Insert the plug on the patient plate inside of the P cord into the terminal of the P plate and turn the Clamping ring clockwise to tighten it securely Figure...

Страница 35: ...it side of the P cord Figure 3 8 When using the PSD 30 with the endoscope that is capable of high frequency cauterization and do not have the S cord connector mount use the non split type patient plat...

Страница 36: ...al tissue cutting by the electrosurgical accessory may occur and cause bleeding or perforation of the patient 1 Confirm that the S cord is free of scratches and cracks 2 With the arrow mark on the S c...

Страница 37: ...f other combinations are used the full responsibility is assumed by the medical treatment facility For details refer to the instruction manual for the accessory If you have any questions concerning th...

Страница 38: ...is free of scratches and cracks and is not buckled damaged or bent Insert the A cord plug into the active connector on the electrosurgical unit s front panel until it clicks see Figure 3 11 Figure 3...

Страница 39: ...wn in the System chart in the Appendix to be used with this electrosurgical unit for each particular case Refer to the respective instruction manual for each piece of equipment 4 1 Inspection of the p...

Страница 40: ...n the electrosurgical unit Turn the electrosurgical unit OFF and remove the power cord from the AC power inlet on the electrosurgical unit before removing the fuse box Otherwise fire or electric shock...

Страница 41: ...an result 5 Even if only one fuse has blown always replace both of them see Figure 4 4 If both fuses have not blown contact Olympus 6 Insert the fuse box into the electrosurgical until it clicks into...

Страница 42: ...ld cause injury to the patient and or operator Also high frequency output may not activated In this case the electrosurgical accessory could cut the tissue mechanically which could cause bleeding and...

Страница 43: ...g alarm is heard and the indicators shown in Figure 4 6 light Figure 4 6 3 Re insert the patient plate plug into the patient plate connector on the front panel and confirm that the warning indicator a...

Страница 44: ...alarm stops 4 4 Inspection of the cut mode and output 1 Confirm that each time the cut mode selector is pressed the cut mode indicators are changed and the corresponding indicators the PURE BLEND1 or...

Страница 45: ...nges the output level to 5 W After 5 W setting the output level can be changed in 5 W sequences and increased to 50 W To decrease the output press the button with the arrow pointing down 4 5 Inspectio...

Страница 46: ...se Figure 4 11 3 Confirm that the output level can be changed in sequences by pressing the button The output level starts at 0 W Pressing the button once will change the output level to 2 W Pressing i...

Страница 47: ...responsibility is assumed by the medical treatment facility For details refer to the instruction manual for the accessory If you have any questions concerning the applicability of your accessory plea...

Страница 48: ...electricity may result in perforation and or bleeding Use only the cutting mode Using the coagulation mode may result in perforation and or damage to the accessory Precautions for hot biopsy Set the...

Страница 49: ...re 5 1 shows the display with the pure mode selected Figure 5 1 The PURE BLEND1 and BLEND2 modes have the following characteristics Output is disabled until both cut and coagulation modes are selected...

Страница 50: ...d FORCED coagulation modes have the following characteristics Output is disabled until both cut and coagulation modes are selected The coagulation mode selecting cannot be changed while output is acti...

Страница 51: ...ve the desired effect Inappropriate output can cause burns to the patient and or operator patient bleeding and or perforation It is recommended to do appropriate examination before using to human body...

Страница 52: ...output level is 50 W in all output modes 5 5 Program mode This electrosurgical unit is capable of storing the output setting cut mode and coagulation mode in memory When the stored output setting and...

Страница 53: ...s the program switch A short beep is generated and the output setting cut mode and coagulation mode set in step 1 will be stored in memory see Figure 5 6 Figure 5 6 The above operation erases the prev...

Страница 54: ...Figure 5 7 The stored cut mode coagulation mode and output setting will be displayed and a short beep is generated see Figure 5 8 Figure 5 7 Figure 5 8 2 If the program switch is pressed and no settin...

Страница 55: ...d operator and or patient burns Do not increase the unit s output if a function is not working as expected doing so could cause patient injury burns bleeding and or perforation In this case inspect th...

Страница 56: ...rect before activating the output 2 By pressing the CUT pedal cut output will occur By pressing the COAG pedal coagulation output will occur 3 Output will take place while the foot switch is pressed D...

Страница 57: ...e stand by mode To operate the electrosurgical unit release the stand by mode as described in Section 5 7 Stand by mode When using the PSD 30 with the endoscope that is capable of high frequency caute...

Страница 58: ...ure 5 12 In the stand by mode all output adjustments and change of settings are disabled The output tone volume can be adjusted only in the stand by mode The stand by mode can only be activated after...

Страница 59: ...in the stand by mode as described in Section 5 7 Stand by mode 2 Confirm that the numbers 1 to 4 are displayed on the coagulation output setting indicator The larger the number the larger the output...

Страница 60: ...e patient plate plug from the patient connector on the front panel 3 Disconnect the A cord s plug on the accessory side from the accessory for the endoscope Disconnect the A cord s plug on the unit si...

Страница 61: ...nt panel 5 Disconnect the A cord s plug on the accessory side from the accessory for the endoscope Disconnect the A cord s plug on the unit side from the Active connector on the front panel 6 Followin...

Страница 62: ...priate personal protective equipment such as eye wear face mask moisture resistant clothing and chemical resistant waterproof gloves that fit properly and long enough so that your skin is not exposed...

Страница 63: ...an infection control risk Do not store the electrosurgical unit in a location exposed to direct sunlight X ray radioactivity liquids or strong electromagnetic radiation e g near microwave medical trea...

Страница 64: ...by the described remedial action stop using the electrosurgical unit and send it to Olympus for repair Olympus does not repair accessory parts If an accessory part becomes damaged contact Olympus to p...

Страница 65: ...short circuited Replace the foot switch with a new one The cut mode is not selected The coagulation mode is not selected Select the cut mode or coagulation mode as described in Section 5 2 Selection...

Страница 66: ...tion of the patient plate The patient plate is not in proper contact with the patient s skin Reattach the patient plate or replace it with designated patient plate as described in Section 3 4 Connecti...

Страница 67: ...tact with the patient s skin and the S cord is connected incorrectly Reattach the patient plate or replace it with designated patient plate as described in Section 3 4 Connection of the patient plate...

Страница 68: ...an endoscope is used any metal portion of the endoscope s distal end has come into contact with tissue Position the accessory in the vicinity of the target area and move the endoscope away to the exte...

Страница 69: ...th the lesion Keep the tip in contact with the lesion Both of the two pedals of the foot switch are pressed simultaneously Be sure to press only the required pedal of the foot switch The internal temp...

Страница 70: ...l unit is not turned ON Turn the electrosurgical unit ON The fuses have blown Replace fuses with new ones as described in Section 4 1 Inspection of the power supply No output The output level is set t...

Страница 71: ...w one When the S cord is used the tip of the accessory is not in contact with lesion during output Keep the tip in contact with the lesion The alarm sounds and output is inhibited The A cord is not co...

Страница 72: ...roper contact with the patient s skin Reattach the patient plate as described in Section 3 4 Connection of the patient plate The wires of the P cord are broken Replace the P cord with a new one The pa...

Страница 73: ...d in Section 3 4 Connection of the patient plate The wires of the S cord are broken The S cord is connected incorrectly Connect the S cord correctly as described in Section 3 5 Connection of the S cor...

Страница 74: ...used any metal portion of the endoscope s distal end has come into contact with tissue via bridging fluids Lift the distal end of the endoscope away from the tissue Suction fluids around the target ar...

Страница 75: ...requency output is stopped The output continues for more than 30 sec Immediately stop the output If the indicator remains light turn the power OFF More than 15 seconds More than 30 seconds Output time...

Страница 76: ...the electrosurgical unit is turned ON until all output settings are completed It does not work during output Figure 7 4 Irregularity description Possible cause Solution The alarm sounds and the output...

Страница 77: ...ith the electrosurgical unit include a description of malfunction or damage and the name and telephone number of the individual at your location who is most familiar with the problem Also include a re...

Страница 78: ...74 Appendix ELECTROSURGICAL UNIT PSD 30 Appendix Construction Schematic Monopolar I Accessory Operator Electrode Patient Patient plate Bed P cord PSD 30 S cord I High frequency current I I A cord...

Страница 79: ...ical unit are listed below New products released after the introduction of this electrosurgical unit may also be compatible for use in combination with this electrosurgical unit For further details co...

Страница 80: ...mount Fiberscope without the S cord connector mount Foot switch MAJ 811 Videoscope equipped with the S cord connector mount Fiberscope equipped with the S cord connector PSD 30 S cord MAJ 813 A cord M...

Страница 81: ...perating environment Operating environment Ambient temperature 10 40 C 50 104 F Relative humidity 30 85 Air pressure 700 1060 hPa 0 7 1 1 kgf cm2 10 2 15 4 psia Storage environment Ambient temperature...

Страница 82: ...odes PURE BLEND1 BLEND2 Coagulation modes 3 modes SOFT AUTO STOP FORCED The AUTO STOP output uses an identical waveform to SOFT and is provided with the auto stop function Fundamental frequency 350 kH...

Страница 83: ...50 W BLEND2 50 W SOFT 50 W AUTO STOP 50 W FORCED 50 W Rated load resistance 300 SOFT AUTO STOP 100 Adjustment steps 5 W increments below 5 W can be set on 2 W 0 500 1000 1500 2000 2500 3000 RESISTANC...

Страница 84: ...t control Control by foot switch Output time 10 seconds ON and 30 seconds OFF output to continue the output keep the output time below 10 seconds Output power vs setting Rated load resistance 300 25 5...

Страница 85: ...GICAL UNIT PSD 30 Item Specification High frequency output Output power vs setting Rated load resistance 300 SOFT AUTO STOP 100 25 50 SETTING W 0 25 50 SOFT 25 50 SETTING W 0 25 50 AUTO STOP 25 50 SET...

Страница 86: ...ll light An alarm will sound Output will be prevented Output time monitor The function detects the high frequency output time It activates the following functions if continuous output time exceeds the...

Страница 87: ...the irregularities are detected the following functions are triggered High frequency output warning indicator will light If the above condition continues for a while an alarm will sound and high freq...

Страница 88: ...rgery may affect the cardiac function of the patient refer to dangers warnings and cautions and EN standard EN60601 1 Degree of protection against explosion Never use the electrosurgical unit where th...

Страница 89: ...e disposed of as unsorted municipal waste but should be collected separately Refer to your local Olympus distributor for return and or collection systems available in your country EMC Applied standard...

Страница 90: ...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 emissions are very low and are not li...

Страница 91: ...nal condition feeding the facilities or hospital environment Surge IEC 61000 4 5 Differential mode 0 5 1 kV Common mode 0 5 1 2 kV Same as left Mains power quality should be that of a typical commerci...

Страница 92: ...However under electromagnetic environment that exceeds its noise level electromagnetic interference may occur on this instrument Electromagnetic interference may occur on this instrument near a high f...

Страница 93: ...ommunications equipment such as cellular phones should be used no closer to any part of this instrument including cables than the recommended separation distance calculated from the equation applicabl...

Страница 94: ......

Страница 95: ...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...

Страница 96: ...wer Singapore 248373 Fax 6834 2438 Telephone 6834 0010 Room 1202 NCI Tower A21 Jianguomenwai Avenue Chaoyang District Beijing 100022 PRC Fax 10 6569 3545 Telephone 10 6569 3535 117071 Moscow Malaya Ka...

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