sonosurg-t2l-ge_and_sonosurg-iu_instructions.pdf
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INSTRUCTIONS
Ultrasonic Surgical System SonoSurg
SonoSurg Transducer
SonoSurg-T2L-GE
SonoSurg-T2L-GE-C
SonoSurg Irrigation Unit
SonoSurg-IU
0197
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HHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHH
©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.
HHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHHH
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Manufactured by
2951 Ishikawa-cho, Hachioji-shi, Tokyo 192-8507, Japan
Fax: (0426)46-2429 Telephone: (0426)42-2111
Distributed by
Two Corporate Center Drive, PO Box 9058 Melville, N.Y.
11747-9058, U.S.A.
Fax: (631)844-5442 Telephone: (631)844-5000
One Corporate Drive, Orangeburg, N.Y. 10962, U.S.A.
Fax: (845)398-9444 Telephone: (845)398-9400
6100 Blue Lagoon Drive, Suite 390 Miami, FL 33126-2087, U.S.A.
Fax: (305)261-4421 Telephone: (305)266-2332
(Premises/Goods delivery) Wendenstrasse 14-18, 20097 Hamburg, Germany
(Letters) Postfach 10 49 08, 20034 Hamburg, Germany Telephone: (040)237730
KeyMed House, Stock Road, Southend-on-Sea, Essex SS2 5QH, United Kingdom
Fax: (01702)465677 Telephone: (01702)616333
117071, Moscow, Malaya Kaluzhskaya 19, bld. 1, fl.2, Russia
Fax: (095)958-2277 Telephone: (095)958-2245
Room 1406, E Tower, GongYuan No.6 Royal Palace, No.6 GongYuanXiJie, Jian Guo Men Nei,
DongCheng District, Beijing, 100005, China
Fax: (10)6518-0865 Telephone: (10)6518-8080
8F, Hyundai Marines Bldg., 646-1, Yeoksam-Dong, Kangnam-Gu, Seoul 135-080 Korea
Fax: (02)6255-3499 Telephone: (02)1544-3200
491B, River Valley Road #12-01/04, Valley Point Office Tower, Singapore 248373
Fax: 6834-2438 Telephone: 6834-0010
31 Gilby Road, Mount Waverley, VIC., 3149, Australia
Fax: (03)9543-1350 Telephone: (03)9265-5400
GE2557 03
Printed in Japan 20050531 :0000
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Contents
Contents
Labels and Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1
Important Information – Please Read Before Use . . . . . . . . . . . .
2
Intended use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2
Instruction manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2
User qualifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2
Instrument compatibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3
Reprocessing and storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3
Repair and modification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3
Signal words . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4
Dangers and warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4
Chapter 1
Checking the Package Contents . . . . . . . . . . . . . . .
7
Chapter 2
Instrument Nomenclature . . . . . . . . . . . . . . . . . . . . . .
15
Chapter 3
Preparation and Inspection of the SonoSurg Irrigation
Unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
33
3.1
Preparation of equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
33
3.2
Installation of the SonoSurg irrigation unit . . . . . . . . . . . . . . . . . . . . . .
34
3.3
Power connection for the SonoSurg irrigation unit . . . . . . . . . . . . . . .
35
3.4
Connection of the foot switch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
36
3.5
Connection to the SonoSurg generator
(SonoSurg-G2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
38
3.6
Inspection of the power supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
39
3.7
Inspection of the suction mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
43
Chapter 4
Preparation, Inspection and Connection of the Hand
Piece . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
44
4.1
Preparation of the equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
45
4.2
Inspection and connection of the transducer, probe and sheath . . .
47
4.3
Inspection and connection of the irrigation/suction tube for SonoSurg
(MAJ-1099) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
55
4.4
Connection of the hand piece plug . . . . . . . . . . . . . . . . . . . . . . . . . . . .
66
4.5
Preparation and inspection of the electrosurgical unit . . . . . . . . . . . .
67
4.6
Inspection of compatibility with the trocar tube . . . . . . . . . . . . . . . . . .
72
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Contents
Chapter 5
Inspection of the System . . . . . . . . . . . . . . . . . . . . . .
73
5.1
Inspection of the generator and the irrigation unit . . . . . . . . . . . . . . .
73
5.2
Inspection of the suction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
75
5.3
Inspection of cooling water . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
76
5.4
Inspection of ultrasonic output . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
78
Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
81
6.1
Turning the power ON . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
86
6.2
Setting the suction pressure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
86
6.3
Setting the output level . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
88
6.4
Setting the irrigation level . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
89
6.5
Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
90
6.6
Electrosurgical treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
93
6.7
After use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
95
6.8
Warning indications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
96
Reprocessing and Storage . . . . . . . . . . . . . . . . . . . .
98
7.1
Reprocessing: General policy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
98
7.2
Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
99
7.3
Compatible reprocessing methods and chemical agents . . . . . . . . . 101
7.4
Cleaning and sterilization procedures . . . . . . . . . . . . . . . . . . . . . . . . . 110
7.5
Care . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 116
7.6
Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 117
7.7
Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 117
Chapter 6
Chapter 7
Chapter 8
Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 118
8.1
Troubleshooting guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 119
8.2
When the ultrasonic output warning lamp is lit . . . . . . . . . . . . . . . . . . 125
8.3
Returning the equipment for repair . . . . . . . . . . . . . . . . . . . . . . . . . . . . 126
Appendix . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 128
System chart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 128
Operating environment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 130
Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 130
EMC compliance information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 136
Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 140
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Labels and Symbols
Labels and Symbols
Safety-related labels and symbols are attached to the instrument at the
locations shown below. If labels are missing or illegible, contact Olympus.
Electrical rating plate
The product name and rated
voltage are displayed.
Caution Plate
Shows the proper tubing connection.
Serial number plate
Electrical rating plate
SonoSurg
Irrigation Unit
MODEL: SonoSurg-IU
INPUT
120V
1A
50/60Hz
(120 V)
SonoSurg
Irrigation Unit
MODEL: SonoSurg-IU
INPUT
Caution Plate
220--240V
0.5A
50/60Hz
(220 -- 240 V)
SonoSurg Transducer SonoSurg-T2L-GE/SonoSurg-T2L-GE-C
SonoSurg Irrigation Unit SonoSurg-IU
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Important Information -- Please Read Before Use
Important Information – Please Read
Before Use
Intended use
These devices have been designed to be used with the SonoSurg generator
(SonoSurg-G2) and a separate surgical suction device to dissect, fragment,
emulsify and aspirate tissue for general surgery, laparoscopic surgery, plastic
and reconstructive surgery and urologic surgery. These devices may also be
combined with electrosurgery using Olympus electrosurgical Units. Do not use
these instrument for any purpose other than its intended use.
Instruction manual
This instruction manual contains essential information on using this instrument
safely and effectively. Before use, thoroughly review this manual and the
manuals of all equipment which will be used during the procedure and use the
instruments as instructed.
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 medical personnel under
the supervision of a physician and must have received sufficient training in
clinical techniques. This manual, therefore, does not explain or discuss these
techniques.
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Important Information -- Please Read Before Use
Instrument compatibility
Refer to the “System chart” in the Appendix to confirm that this instrument is
compatible with the ancillary equipment being used. Using incompatible
equipment can result in patient injury and/or equipment damage.
If this instrument is used in combination with equipment manufactured by other
companies, confirm their compatibility before use.
This instrument complies with the EMC standard for medical electrical
equipment; edition 2 (IEC 60601-1-2 : 2001). However, when connecting to an
instrument that complies with medical electrical equipment edition 1 (IEC
60601-1-2:1993), the whole system complies with edition 1. (See “EMC
compliance information” on page 136 for EMC compliance level.)
Reprocessing and storage
The transducer and ancillary components (e.g. probes and sheaths, which are
sold separately) were not sterilized before shipment. Before using them for the
first time, reprocess them according to the instructions given in Chapter 7,
“Reprocessing and Storage”.
After using the instruments, reprocess and store them according to the
instructions given in Chapter 7, “Reprocessing and Storage”.
Improper and/or incomplete reprocessing or storage can present an infection
control risk, cause equipment damage or reduce performance.
Repair and modification
This instrument does not contain any user-serviceable parts. Do not
disassemble, modify or attempt to repair it. Otherwise, patient or user injury
and/or equipment damage can result.
Problems that appear to be malfunctions may be correctable by referring to
Chapter 8, “Troubleshooting”. If the problem cannot be resolved using the
information in Chapter 8, contact Olympus.
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SonoSurg Irrigation Unit SonoSurg-IU
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Important Information -- Please Read Before Use
Signal 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 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. It may also
be used to alert against unsafe practices or potential
equipment damage.
Indicates additional helpful information.
Dangers and warnings
Follow the dangers and warnings given below when handling this instrument.
This information is to be supplemented by the dangers, warnings and cautions
given in each chapter.
S These devices are not explosion-proof. Do not use them
where flammable gases or liquids or high concentrations of
oxygen may be present. Otherwise, an explosion or fire may
occur.
S These devices are not intended to be used for dissection,
fragmentation, emulsification, or aspiration of fatty cells for
liposuction.
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Important Information -- Please Read Before Use
S Do not prepare or operate this instrument with wet hands.
Otherwise, the user may receive an electric shock.
S Always have a defibrillator ready in case of a cardiac
emergency. Before operating the defibrillator, remove the
instrument and endoscope from the patient. Also make
preparations for an abdominal operation if necessary.
S Use this instrument in an environment equipped to
accommodate open surgery and have the hospitalization
plan prepared in case any problem occurs that may not be
resolved by form of endoscopic surgery.
S To ensure electrical safety, this instrument should not be
used in conjunction with:
-- Electromedical equipment whose safety in combined use
is not guaranteed.
-- Electromedical equipment whose safety against leakage
current is not guaranteed.
When performing electrosurgery, special attention should be paid to the
following:
S Never apply this instrument directly to the heart in
combination with a TYPE B/BF electrosurgical unit. Doing so
may cause ventricular fibrillation, which could be fatal to the
patient.
S 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.
Before proceeding, confirm with a cardiologist or the
manufacturer of the pacemaker that it is safe to do so.
S Be sure not to bring and/or pile up this instrument too close
to other instruments to avoid an electromagnetic
interference from them.
S Electromagnetic interference may occur on this instrument
near a portable device and a mobile RF communications
equipment such as a cellphone marked with the following
symbol:
SonoSurg Transducer SonoSurg-T2L-GE/SonoSurg-T2L-GE-C
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Important Information -- Please Read Before Use
S Never loop the A-cord or bundle it together with the cords
belonging to other medical equipment (e.g.
electrocardiograph, video camera for endoscopes, etc.).
Otherwise, the high-frequency signals or spark discharge
noise generated may interfere with the operation of the
medical equipment during electrosurgery.
S If the intestines contain a flammable gas, replace this gas
with a nonflammable gas such as CO2 before the procedure
to minimize the risk of fire or explosion.
S The safety standard for electromedical equipment (IEC
60601-1) classifies equipment into TYPE CF (applicable to
the whole human body including the heart) and TYPE B/BF
(applicable to organs other than the heart). As the applicable
region of the instruments varies depending on the
classification of connected equipment, it is necessary that
this classification first be checked by referring to the
instruction manual of the electromedical equipment in use.
Symbol
Classification
TYPE CF applied part
TYPE BF applied part
TYPE B applied part
S Exercise special care when electrosurgical output is applied
in the vicinity of the heart. Current flowing through the heart
or the low-frequency current generated by rectification
during spark discharge may cause ventricular fibrillation,
even when this instrument is used in combination with a
TYPE CF electrosurgical unit.
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Chapter 1 Checking the Package Contents
Chapter 1 Checking the Package
Contents
Match all items in the package with the components shown below. Inspect each
item for damage. If these instruments are damaged, a component is missing or
you have any questions, do not use these instruments; immediately contact
Olympus.
The transducer and ancillary components (e.g. probes and sheaths) were not
sterilized before shipment. Before using them for the first time, reprocess them
according to the instructions given in Chapter 7, “Reprocessing and Storage”.
This instruction manual is shipped with the SonoSurg Transducer
(SonoSurg-T2L-GE/SonoSurg-T2L-GE-C) and the SonoSurg Irrigation Unit
(SonoSurg-IU).
SonoSurg Transducer (SonoSurg-T2L-GE)
Instruction manual
SonoSurg Transducer
(SonoSurg-T2L-GE)
SonoSurg Transducer (SonoSurg-T2L-GE-C)
Instruction manual
SonoSurg Transducer
(SonoSurg-T2L-GE-C)
SonoSurg Transducer SonoSurg-T2L-GE/SonoSurg-T2L-GE-C
SonoSurg Irrigation Unit SonoSurg-IU
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Chapter 1 Checking the Package Contents
SonoSurg Irrigation Unit (SonoSurg-IU)
SonoSurg Communication Cable
(MAJ-1103)
SonoSurg Irrigation Unit
(SonoSurg-IU)
Instruction manual
Power cord
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Chapter 1 Checking the Package Contents
The following Olympus items are optional and may be purchased separately:
Foot Switch for SonoSurg Irrigation Unit (MAJ-1102)
Foot Switch for SonoSurg Irrigation
Unit (MAJ-1102)
SonoSurg Connection Cable (MAJ-1121)
SonoSurg Connection Cable
(MAJ-1121)
Probe (Straight) (MH-112)
Probe (Straight)
(MH-112)
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Chapter 1 Checking the Package Contents
The following Olympus items are optional and may be purchased separately:
Probe (15° Angled) (MH-113)
Probe (15° Angled)
(MH-113)
Probe (Tapered, Long) (MH-125)
Probe (Tapered, Long)
(MH-125)
SonoSurg GE Straight Sheath (T3310)
SonoSurg GE Sheath
Attachment (T3300), × 3
SonoSurg GE Straight Sheath
(T3310)
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Chapter 1 Checking the Package Contents
The following Olympus items are optional and may be purchased separately:
SonoSurg GE Sheath (15° Angled) (T3320)
SonoSurg GE Sheath
Attachment (T3300), × 3
SonoSurg GE Sheath
(15° Angled) (T3320)
SonoSurg GE Tapered Sheath (T3330)
SonoSurg GE Tapered Sheath
(T3330)
SonoSurg GE Sheath
Attachment (T3300), × 3
SonoSurg GE Sheath Attachment (T3300)
SonoSurg GE Sheath
Attachment (T3300), × 3
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Chapter 1 Checking the Package Contents
The following Olympus items are optional and may be purchased separately:
Irrigation/Suction Tube for SonoSurg (MAJ-1099)
(disposable, sterile)
SonoSurg Irrigation/Suction Tube for SonoSurg
(MAJ-1099), × 6
SonoSurg GE Hand Switch (MAJ-1100)
SonoSurg GE hand switch (MAJ-1100)
Cleaning Rod (MAJ-1178)
Cleaning Rod (MAJ-1178)
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Chapter 1 Checking the Package Contents
The following Olympus items are optional and may be purchased separately:
Cleaning Brush (MH-140)
Cleaning Brush (MH-140)
Cleaning Brush (NSG-BW)
Cleaning Brush (NSG-BW)
Brush (MH-507)
Brush (MH-507)
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Chapter 1 Checking the Package Contents
The following Olympus items are optional and may be purchased separately:
6mm Torque Wrench (MAJ-1117)
6mm Torque Wrench (MAJ-1117)
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Chapter 2 Instrument Nomenclature
Chapter 2 Instrument Nomenclature
Symbols and Descriptions
` Warning section
COMM.
Communication error
` Power switch
Power OFF
Power ON
` Front panel
Flush
Irrigation
Suction mode select
Normal suction
Laparoscopic suction
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Chapter 2 Instrument Nomenclature
` Rear panel
SN
Serial number
Fuse
Potential equalization terminal
Foot Switch
` Foot switch
Ultrasonic output
Variable steps
Maximum output level
Irrigation
Suction
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Chapter 2 Instrument Nomenclature
` Irrigation/suction tube package
Refer to instructions.
Single use only
Use by (expiration date)
STERILE EO
Sterilized using ethylene oxide
STERILE LOT
Sterilization lot number
LOT
Lot number
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Chapter 2 Instrument Nomenclature
SonoSurg Transducer (SonoSurg-T2L-GE)
8. Suction fitting
Handpiece cord
7. A-cord mounting pin
Model name
(back side)
Red mark
Serial number
6. Seal
TYPE CF symbol
5. Sheath connecting section
4. Probe connecting section
3. Suction channel
2. Hand piece plug
1. Water-proof cap
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Chapter 2 Instrument Nomenclature
1. Water-proof cap
When cleaning, the hand piece plug is covered with the water-proof cap to
prevent water from entering the plug.
2. Hand piece plug
The hand piece plug is connected to the hand piece connector of the
SonoSurg generator (SonoSurg-G2).
3. Suction channel
Emulsified tissue is aspirated through the channel.
4. Probe connecting section
The probe connecting section is connected to the probe.
5. Sheath connecting section
The sheath connecting section is connected to the sheath.
6. Seal
Prevents leakage of irrigation fluid.
7. A-cord mounting pin
The A-cord mounting pin is connected to the active cord (A-cord), which is
connected to the electrosurgical unit.
8. Suction fitting
Connects to the suction tube of the irrigation/suction tube for SonoSurg
(MAJ-1099).
SonoSurg Transducer SonoSurg-T2L-GE/SonoSurg-T2L-GE-C
SonoSurg Irrigation Unit SonoSurg-IU
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Page 27
Chapter 2 Instrument Nomenclature
SonoSurg Transducer (SonoSurg-T2L-GE-C)
Handpiece cord
8. Suction fitting
7. A-cord mounting pin
Model name
(back side)
Serial number
(back side)
6. Seal
Red triangle
5. Sheath connecting section
4. Probe connecting section
3. Suction channel
20
2. Contacts
SonoSurg Transducer SonoSurg-T2L-GE/SonoSurg-T2L-GE-C
SonoSurg Irrigation Unit SonoSurg-IU
1. Plug