shockpulse-se_lithotripsy_system_spl-sr__instructio.pdf
Page 1
REF SPL-SR
ShockPulse-SE Lithotripsy System (SPL-SR)
Instructions for Use
FR
IT
ES
EN
DE
Mode d’emploi
Gebrauchsanweisung
Istruzioni per l’uso
Instrucciones de uso
Products and information available from
Gyrus ACMI • 136 Turnpike Road • Southborough, MA 01772 • USA
1-888-524-7266 or 1-763-416-3000 • http://www.olympus-osta.com/
Manufacturer
Cybersonics Inc. • Knowledge Park, 5340 Fryling Road, Suite 101• Erie, PA 16510 • USA
MediTech Strategic Consultants B.V. • Maastrichterlaan 127-129 • 6291 EN Vaals
The Netherlands • Tel: +31.43.306.3320 • Fax: +31.43.306.3338
Rx Only
SPL-IFUR REV AG
2016-04
Page 3
ShockPulse-SE Lithotripsy System • Instructions for Use
Table of Contents
Return/Repair/Warranty................................................................................................... 3
Section 1
Intended Use / Contraindications................................................................ 4
Section 2
Warnings and Cautions............................................................................... 4
Section 3
Symbol Identifications on Labeling and Unit............................................... 6
Section 4
Unpacking and Initial Inspection................................................................. 7
Section 5
Specifications and General Description...................................................... 7
Section 5.1 Specifications......................................................................................... 8
Section 5.2 – Operating and Storage Environment..................................................... 9
Section 5.3 – Safety Specifications.......................................................................... 10
Section 5.4 – General Description of ShockPulse-SE Generator and Accessories... 12
Section 5.5 – Front Panel of Generator.................................................................... 13
Section 5.6 – Back Panel of Generator..................................................................... 14
Section 5.7 – Optional Footswitch (SPL-FS)............................................................. 14
Section 5.8 – Transducer (SPL-T) and Nose Cone (SPL-NC) ................................... 15
Section 5.9 – 3.76 Probe Assembly......................................................................... 15
Section 5.10 – Torque Wrench (SPL-W)................................................................... 16
Section 5.11 – Cleaning Stylet (SPL-CSL)................................................................ 16
Section 6
Assembling the Unit.................................................................................. 17
Section 7
Operating Instructions .............................................................................. 18
Section 7.1 – Tips for Success................................................................................. 18
Section 8
Cleaning and Sterilization......................................................................... 20
Section 8.1 – Generator and Footswitch – Cleaning................................................. 21
Section 8.2 – Probes – Cleaning.............................................................................. 21
Section 8.3 – Transducer and Nose Cone– Cleaning................................................ 22
Section 8.4 – Stylet and Torque Wrench - Cleaning................................................. 23
Section 8.5 – Steam Sterilization............................................................................. 24
Section 8.6 – STERRAD............................................................................................ 24
Section 9
Preventive Maintenance............................................................................ 25
Section 9.1 - General Checks................................................................................... 25
Section 9.2 - Periodic Safety Checks....................................................................... 25
Section 10 Troubleshooting and Fuse Replacement....................................................... 25
Section 10.1 Troubleshooting................................................................................... 25
Section 10.2 – System Operation States– Normal and Error.................................... 26
Section 10.3 – Fuse Replacement............................................................................ 27
Section 11
Disposal of Equipment (WEEE).................................................................. 28
Section 12
Repair....................................................................................................... 28
© 2016 Olympus. All rights reserved. No part of this publication may be reproduced or distributed without the express written
permission of Olympus.
Gyrus ACMI, ShockPulse and Olympus are trademarks of Olympus Corporation (Tokyo, Japan) and/or their
affiliated entities.
STERRAD is a trademark of Johnson & Johnson Medical, Inc.
SPL-IFUR REV AG
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SPL-IFUR REV AG
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ShockPulse-SE Lithotripsy System • Instructions for Use
Return/Repair/Warranty
Return/Repair
All returns must have prior authorization. To comply with OSHA Bloodborne Pathogen Standard 29 CFR
1910.1030 regulations and U.S. Postal and Transportation law, all used medical devices returned for repair or
replacement must be properly cleaned and decontaminated with a chemical germicide that has been cleared
for use as a “Hospital Disinfectant.” To ensure that the product has been properly decontaminated, a signed
Decontamination Certificate should be enclosed in the package.
All medical devices returned to Olympus for any reason must be shipped in accordance with Olympus return
procedures (available upon request) and all applicable regulations. To obtain a return material authorization
(RMA) number, return address, and instructions, please call your Olympus Representative or the related
customer service.
Do not adjust electronic circuitry. Contact your local Olympus representative or call your Olympus customer
service.
Please provide the product part number and lot/serial number. Product should be returned in its original packaging
(when possible) and marked with the RMA number on the exterior of the package.
Limited Express Warranty
SHOULD THE PRODUCT BECOME INOPERABLE DURING NORMAL AND PROPER USE IN ACCORDANCE WITH
THE APPLICABLE INSTRUCTIONS AND WITHIN THE TIME FRAME SPECIFIED BELOW FROM THE DATE OF
SHIPMENT, OLYMPUS WILL REPAIR OR REPLACE THE PRODUCT, AT ITS SOLE OPTION, AT NO CHARGE.
OLYMPUS MAKES NO OTHER WARRANTIES WITH RESPECT TO THE PRODUCT AND EXPRESSLY DISCLAIMS
ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, AS TO MERCHANTABILITY, FITNESS FOR A PARTICULAR
PURPOSE OR ANY OTHER MATTER. IN NO EVENT SHALL OLYMPUS BE LIABLE FOR ANY CONSEQUENTIAL
DAMAGES. IN NO EVENT SHALL OLYMPUS BE LIABLE FOR ANY BREACH OF WARRANTY IN ANY AMOUNT
EXCEEDING THE PURCHASE PRICE OF THE PRODUCT.
This warranty applies only to the original purchase and will be voided if the product(s) are serviced or repaired
by anyone other than Olympus or an organization duly authorized by Olympus for such purpose.
Ultrasonic Generator, Transducer, and Footswitch............................... 1 year
SPL-IFUR REV AG
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Section 1
Intended Use / Contraindications
Intended Use
The ShockPulse-SE Lithotripsy System is intended to be used for fragmentation of urinary tract calculi in the
kidney, ureter, and bladder.
Contraindications
Contraindications directly related to the product are presently unknown. On the basis of the patient’s general
condition, the doctor in charge must decide whether the planned use is possible or not. For further information
please refer to the current medical literature.
Section 2
Warnings and Cautions
The following warnings and cautions apply to the use, care, and/or maintenance of the ShockPulse-SE
Lithotripsy System.
This medical device should be operated only by or under the direct supervision of a physician experienced in
ultrasonic lithotripsy procedures. The user should be thoroughly familiar with this Instruction for Use Manual and
operation of this device prior to use.
This product is a precision device; handle it with care. Avoid rough or violent handling, which may cause
equipment damage.
Warnings
Electrical Safety and Shock Hazards
1. A potential shock hazard exists when the instrument enclosure is opened. Do not attempt to make repairs.
Please contact Olympus Customer Service if any repairs are required.
2. Do not adjust electronic circuitry. Contact your local Olympus representative or call Olympus Customer
Service.
3. Never attempt to service the device when it is connected to a power source. Hazardous voltages inside the
device may cause severe electrical shock. Disconnect the power cord before servicing.
4. As a type BF applied part, this instrument must never be applied directly to the heart and must not be used
in procedures involving cardiac observation or surgery. Do not use electrically active devices, such as
electrosurgical units, on the patient during lithotripsy.
5. To isolate the device from mains power, unplug the device. The plug is used to completely isolate the unit
from the mains.
6. The housing of the generator must be properly grounded to ensure safe operation. To reduce the risk of
electric shock, be sure to connect the power cord to a properly grounded 3-pin receptacle of the proper
rating. Do not use a 3-pin/2-pin adapter. Do not position the generator so that it is difficult to connect and
disconnect the power cord.
7. In the case where running equipment in rooms which do not have a 3 pin protectively earthed electrical
socket, the ShockPulse-SE System must be joined to the central potential equalization of the operating
theater or of the equipment trolley by means of a grounding cable.
NOTE: The potential equalization conductor is a conductor providing a connection between the
equipment and the potential equalization busbar. The purpose for the additional potential equalization
is to equalize potentials between different metal parts that can be touched simultaneously, or to
reduce the differences of potential which can occur during operation between the bodies of medical
electrical devices and conductive parts of other objects.
8. The receptacle and circuit to which this product is connected should have enough power capacity to fulfill
the total power requirements of all equipment connected to it. If the capacity is insufficient, the circuit
breaker of the medical facility may be tripped, cutting off the power supply to all equipment connected to
the same power source.
9. To minimize the risk of electric shock and generator damage, keep all liquids away from the generator. If
liquid is spilled into this product, immediately stop the procedure and contact Olympus. If the power cord
gets wet, fully dry it before use. Otherwise the user may receive an electric shock.
10. This equipment has been tested and found to comply with the EMC limits for medical devices. The
equipment generates and can radiate radio frequency energy and if not installed and used in accordance
with these instructions may cause harmful interference to other devices in the vicinity. Please refer to
section 5.3 for additional information.
Fire and Explosion Hazards
1. When used in an environment containing flammable gasses and high oxygen concentrations, be aware of
the potential for a flammable event. Take routine cautions to prevent this kind of event. The product is not
explosion proof.
2. This product is provided with cooling fan intake on the back panel and air vents for heat release on the side
panels. Do not block the fan intake or the air vents. Allow at least 5 cm of space between generator and
any other objects.
4
SPL-IFUR REV AG
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ShockPulse-SE Lithotripsy System • Instructions for Use
Health Hazards
Health Risks:
Potential elevated health risks in patients with the following:
• Active bleeding disorder.
• During pregnancy.
• With an electrical stimulator implanted e.g. pacemaker.
• Untreated urinary tract infection.
On the basis of the patient’s general condition, the doctor in charge must decide whether the planned use is
possible or not.
General
1. Only ShockPulse-SE probes and accessories should be used with ShockPulse-SE generators. The use of
other probes with the ShockPulse-SE system may lead to patient injury or failure of the device to perform
as intended.
2. Perform the prescribed inspections prior to first use and regularly thereafter to ensure continued
satisfactory performance. Thoroughly inspect all electrical cables and probes before each use. Do not use
if there is any evidence of deterioration. Replace if any damage or excessive wear is observed. Inspect the
transducer plug pins, cord, and transducer body for mechanical damage (bent pins, cracks, etc.). After
each use or prior to cleaning and sterilizing, carefully inspect the transducer and cable for tears, cracks,
or other signs of damage. Do not use a ShockPulse-SE System that fails to meet the criteria stated in the
labeling or that has been damaged. Otherwise, injury to the patient, personnel and/or an adverse effect on
the procedure could result.
3. A continuous outflow of irrigation from the body cavity (operative site) is necessary to prevent excessive
pressure buildup.
4. As a Type BF applied part, this instrument must never be applied directly to the heart and must not be used
in procedures involving cardiac observation or surgery. Do not use electrically active devices, such as
electrosurgical units, on the patient during lithotripsy.
5. Keep the tip of probe in the field of view at all times when the ShockPulse-SE System is activated.
6. As with any lithotripter device, adverse events may occur, such as, bleeding and/or damage in the bladder,
ureter, or kidney, and other potential events associated with endoscopy.
Probes
7. If a probe breaks during a procedure, use a grasping device to remove it. Always have a spare probe set
available to finish the procedure.
8. The user must ensure that the endoscope will accommodate the following ShockPulse-SE probes:
Sterile, Single Use ShockPulse Lithotripsy Probes
Min. Working Channel
SPL-PD376
ShockPulse Lithotripsy Probe, Sterile Single Use, 3.76mm
4 mm (12 Fr)
SPL-PD340
ShockPulse Lithotripsy Probe, Sterile Single Use, 3.40mm
3.5 mm (10.5 Fr)
SPL-PD183
ShockPulse Lithotripsy Probe, Sterile Single Use, 1.83mm
2 mm (6 Fr)
SPL-PD150
ShockPulse Lithotripsy Probe, Sterile Single Use, 1.50mm
2 mm (6 Fr)
SPL-PD097**
ShockPulse Lithotripsy Probe, Sterile Single Use, 0.97mm
1 mm (3 Fr)
Reusable ShockPulse Lithotripsy Probes [five (5) reuses]
Min. Working Channel
SPL-PR376
ShockPulse Lithotripsy Probe, Reusable, 3.76mm
4 mm (12 Fr)
SPL-PR340
ShockPulse Lithotripsy Probe, Reusable, 3.40mm
3.5 mm (10.5 Fr)
SPL-PR183
ShockPulse Lithotripsy Probe, Reusable, 1.83mm
2 mm (6 Fr)
SPL-PR150
ShockPulse Lithotripsy Probe, Reusable, 1.50mm
2 mm (6 Fr)
SPL-PR097**
ShockPulse Lithotripsy Probe, Reusable, 0.97mm
1 mm (3 Fr)
**No Suction Available.
9. The sterile ShockPulse-SE probes are single-use devices, as indicated by the label, once they are used
they should not be reused.
10. Do not contact mucosal tissue with the tip of the activated probe as tissue damage may occur.
11. Do not apply the tip of the probe within 15 cm of a pacemaker. Patients with implanted pacemakers should be
monitored via ECG during treatment to verify normal intrinsic rhythms and pacemaker operation.
SPL-IFUR REV AG
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Cautions
1. Damage (mechanical and electrical) may result if the unit is dropped or struck against another object.
2. Thoroughly inspect all electrical cables and probes before each use. Do not use if there is any evidence
of deterioration. Replace if any damage or excessive wear is observed.
3. Before attaching, be sure the probe and transducer threads are clean. The probe must be secured
tightly to the transducer using the torque wrench (SPL-W) to assure good coupling. If the probe is not
properly assembled, seated, or tightened onto the transducer, it will not perform properly. Loosening of
the probe during operation will decrease or halt performance and may cause damage.
4. Do not allow fluids to enter the generator cabinet. Damage can result.
5. Continuous irrigation and suction must be applied whenever the ultrasonic energy is activated to
prevent overheating of the transducer and probe. If the aspiration becomes interrupted, first ensure
that the hand operated valve on the transducer is closed and that the suction tubing is not kinked or
clogged, and then use the cleaning stylet to unclog the transducer and probe.
6. Do not allow the probe to press against the scope during the procedure. Pressure on the probe may
stall the transducer and heat the probe within the scope’s working channel.
7. Verify proper operation by setting up the generator, transducer, and probe and running the system as
outlined in section 6.
8. A back-up transducer and probe should be sterilized and available prior to beginning a procedure.
9. Do not twist or turn the transducer or footswitch plugs when connecting them to the generator;
equipment damage may result.
10. The Nose Cone must be disassembled from the transducer, the probe removed and the cleaning stylet
removed from within the probe or transducer prior to cleaning and sterilization.
1
2
3
4
11. Never rinse the ShockPulse-SE components with cooled water for faster cooling after sterilization; sudden
changes in temperature may damage the components.
SN
5
6
7
8
10
Rx Only
11
12
QTY
9
Distributed
by
13
17
14
18
15
19
16
20
Section 3
Symbol Identifications on Labeling and Unit
1. Tested by Intertek
18. Do Not Reuse
2. Tested by TUV
19. Non Sterile
3. Consult Instructions for Use
20. Catalogue Number
4. Power ON/OFF
21. Sterilized Using Ethylene Oxide
5. Caution
22. Use By
6. Suction Control
7. Alternating Current
23. Authorized Representative in the European
Community
8. Serial Number
24 Equipotential
9. Quantity
25. CE Mark to Medical Device Directive via TUV
(Notified Body)
10. Fuse
21
25
22
H
26
23
S
27
24
28
11. Caution: Federal (US) Law restricts this device
to sale by or on the order of a physician.
28. Do not use if package is damaged
13. Distributed by
29. Not made with natural rubber latex
14. Refer to instruction manual/booklet
30. Waste Electrical And Electronic Directive
(WEEE) Recommendations
16. Date of Manufacture
29
6
30
32
27. Standard Power
12. Footswitch
15. Manufacturer
31
26. High Power
17. Lot Number
31. Fragile, handle with care
32. Type BF Applied Part
SPL-IFUR REV AG
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ShockPulse-SE Lithotripsy System • Instructions for Use
Section 4
Unpacking and Initial Inspection
Proper care and maintenance are critical for safe and effective operation of the ShockPulse-SE System. We
recommend careful inspection of all equipment upon receipt and prior to each use as a safeguard against
possible injury to patient or operator.
1. To avoid inadvertent damage, study this manual thoroughly before handling, assembling, testing, using
or cleaning the ShockPulse-SE unit.
2. Examine the shipping carton and instrument for signs of damage. Any breakage or other apparent
damage should be noted, the evidence retained, and Olympus Customer Service (1-888-524-7266 or
1-763-416-3000) and the shipping agency notified.
3. Verify that the shipping carton for a ShockPulse-SE System contains the items listed below:
ShockPulse-SE (Stone Eliminator) Lithotripsy System
ShockPulse-SE Lithotripsy System
1 x ShockPulse Lithotripsy Transducer (SPL-T)
1 x ShockPulse Lithotripsy Cleaning Stylet - Large (SPL-CSL)
1 x ShockPulse Lithotripsy Wrench (SPL-W)
1 x ShockPulse Lithotripsy Power Cord (SPL-PC)
1 x ShockPulse Lithotripsy Generator (SPL-G)
1 x ShockPulse Lithotripsy Nose Cone (SPL-NC)
1 x ShockPulse Lithotripsy IFU (SPL-IFUR)
SPL-SR
NOTE: ShockPulse-SE Optional Footswitch and Probes are sold separately. See Section 5 below.
Section 5
Specifications and General Description
The ShockPulse-SE Lithotripsy System is an electromechanical device capable of fragmenting calculi
and aspirating stone debris. The novel technology in the ShockPulse-SE Lithotripsy System uses a single
transducer and proprietary ShockPulse technology to generate both low-frequency mechanical impacts and
high-frequency ultrasonic energy which quickly disintegrates stones.
Classification
Applicable Regulation/Directive/Standard
Regulatory Authority
Class 1 Equipment with
a Type BF applied Part
IEC 60601-1 - Medical electrical equipment - Part 1: General
requirements for basic safety and essential performance
Intertek
Class II medical device
21 CFR §876.4480 electrohydraulic lithotriptor 21 CFR §820
Quality System Regulation (Good Manufacturing Practices)
Food and Drug
Administration
Class IIb medical device Medical Device Directive (93/42/EEC as amended by
2007/47/EC)
Class III medical device SOR/98-282 – Schedule 1 – Rule 9(2)
European Competent
Authorities
Health Canada
Sterile, Single Use ShockPulse Lithotripsy Probes (Box of 3)
SPL-PDBX376
ShockPulse Lithotripsy Probe, Sterile Single Use, 3.76mm (3/Box)
SPL-PDBX340
ShockPulse Lithotripsy Probe, Sterile Single Use, 3.40mm (3/Box)
SPL-PDBX183
ShockPulse Lithotripsy Probe, Sterile Single Use, 1.83mm (3/Box)*
SPL-PDBX150
ShockPulse Lithotripsy Probe, Sterile Single Use, 1.50mm (3/Box)*
SPL-PDBX097** ShockPulse Lithotripsy Probe, Sterile Single Use, 0.97mm (3/Box)
Reusable ShockPulse Lithotripsy Probes (1 Each; 5 reuses)
SPL-PR376
ShockPulse Lithotripsy Probe, Reusable, 3.76mm (1/ea)
SPL-PR340
ShockPulse Lithotripsy Probe, Reusable, 3.40mm (1/ea)
SPL-PR183
ShockPulse Lithotripsy Probe, Reusable, 1.83mm (1/ea)*
SPL-PR150
ShockPulse Lithotripsy Probe, Reusable, 1.50mm (1/ea)*
SPL-PR097**
ShockPulse Lithotripsy Probe, Reusable, 0.97mm (1/ea)
*Includes Cleaning Stylet - Small
**No Suction Available.
SPL-IFUR REV AG
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The following accessories may be ordered individually from Olympus:
ShockPulse Lithotripsy Accessories (1/ea)
SPL-T
ShockPulse Lithotripsy Transducer
SPL-FS
ShockPulse Lithotripsy Footswitch
SPL- PC
ShockPulse Lithotripsy Power Cord
SPL-W
ShockPulse Lithotripsy Torque Wrench
SPL-CSL
ShockPulse Lithotripsy Cleaning Stylet - Large
SPL-NC
ShockPulse Lithotripsy Nose Cone
SPL-IFUR
ShockPulse Lithotripsy IFU
Section 5.1 Specifications
Generator (SPL-G)
Power Supply
Physical
Classification (Electro-Medical)
Ultrasonic Energy
Voltage
90 - 264 VAC
Frequency
50/60 Hz
Dimensions
14.57 x 15.89 x 4.58 in / 37 x 40 x 11.5 cm
Weight
13.7 lbs / 6.2 kg
Protection Against Electric Shock
Class I
Type of Applied Part
Type BF
Frequency
19,500 Hz - 21,500 Hz
Maximum Output
100 Watts
Dimension
9 X 2.2 X 6.5 IN / 23 X 5.5 x 16.5 CM
Weight
4.2 lbs / 1.9 kg
Length of Cord
10 ft. / 3 meters
Degree of Water Resistance
IPX6 except for plug
Footswitch (SPL-FS)
Physical Specifications
Classification
Transducer (SPL-T) with Nose Cone (SPL-NC)
Housing Dimensions
8
Maximum Diameter
2” / 4.8 cm
Length
7.7” / 19.6 cm
Weight
0.99 lbs / 0.45 kg
Color
Black, Blue, and Silver
Cable
Length
10 ft. / 3 meters
Sterilization
Steam and Sterrad
Refer to Section 8 for reprocessing
instructions.
Validated Lifetime
100 Reuses
Refer to Section 8 for reprocessing
instructions.
SPL-IFUR REV AG
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ShockPulse-SE Lithotripsy System • Instructions for Use
Sterile, Single Use ShockPulse Lithotripsy Probes
Color
Outside
Diameter
Inside
Diameter
Working
Length
Provided
Sterile
ShockPulse Lithotripsy
Probe, Sterile Single
Use, 3.76mm
Silver
3.76 mm
3.15 mm
396 mm
Yes;
ETO
SPL-PD340
ShockPulse Lithotripsy
Probe, Sterile Single
Use, 3.40mm
Blue
3.4 mm
2.9 mm
396 mm
Yes;
ETO
SPL-PD183*
ShockPulse Lithotripsy
Probe, Sterile Single
Use, 1.83mm
Red
1.83 mm
1.37 mm
418 mm
Yes;
ETO
SPL-PD150*
ShockPulse Lithotripsy
Probe, Sterile Single
Use, 1.50mm
Green
1.50 mm
1.04 mm
564 mm
Yes;
ETO
SPL-PD097**
ShockPulse Lithotripsy
Probe, Sterile Single
Use, 0.97mm
Gold
0.97 mm
N/A
578 mm
Yes;
ETO
Inside
Diameter
Working
Length
Provided
Sterile
REF
SPL-PD376
Description
*Includes Cleaning Stylet - Small
** No suction available
Re-Usable ShockPulse Lithotripsy Probes [five (5) reuses]
REF
Description
Color
Outside
Diameter
SPL-PR376
ShockPulse Lithotripsy
Probe, Reusable,
3.76mm
Silver
3.76 mm
3.15 mm
396 mm
No;
Non-Sterile
SPL-PR340
ShockPulse Lithotripsy
Probe, Reusable,
3.40mm
Blue
3.4 mm
2.9 mm
396 mm
No;
Non-Sterile
SPL-PR183*
ShockPulse Lithotripsy
Probe, Reusable,
1.83mm
Red
1.83 mm
1.37 mm
418 mm
No;
Non-Sterile
SPL-PR150*
ShockPulse Lithotripsy
Probe, Reusable,
1.50mm
Green
1.50 mm
1.04 mm
564 mm
No;
Non-Sterile
SPL-PR097**
ShockPulse Lithotripsy
Probe, Reusable,
0.97mm
Gold
0.97 mm
N/A
578 mm
No;
Non-Sterile
*Includes Cleaning Stylet - Small
** No suction available
Section 5.2 – Operating and Storage Environment
Operating Environment
Storage Environment
SPL-IFUR REV AG
Ambient Temperature
10 - 40 °C, 50-104 °F
Relative Humidity
10 - 70% RH
Air Pressure
70 - 106 kPa, 21-31” Hg
Ambient Temperature
-25 - +55 °C, -13 - +131 °F
Relative Humidity
10 - 85% RH
Air Pressure
70 - 106 kPa, 21-31” Hg
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Section 5.3 – Safety Specifications
The ShockPulse-SE Lithotripsy System meets IEC 60601-1 - 3rd Edition, EN 61000-3-2 and EN 61000-3-3, EN 60601-12, EN55011, IECS-003 and FCC Part 15 subpart B.
Electromagnetic Emission Declaration
The ShockPulse-SE Lithotripsy System is intended for use in the electromagnetic environment specified below. The
customer or user of the ShockPulse-SE Lithotripsy System should assure that it is used in such an environment.
Emission Test
Compliance
Electromagnetic Environment
RF emission CISPR 11
Group 1
RF emissions are very low and are not likely to cause any
interference in nearby electrical equipment.
RF emission CISPR 11
Class A
Harmonic emission IEC
61000-3-2
Complies
The ShockPulse-SE Lithotripsy System is suitable for use in all
establishments, other than domestic establishments and those
directly connected to a low voltage power supply network that
supplies buildings used for domestic purposes.
Electromagnetic Immunity Declaration
The ShockPulse-SE System is intended for use in the electromagnetic environment specified below. The customer or user
of the ShockPulse-SE System should assure that it is used in such an environment.
10
Immunity Test
IEC 60601 test level
Electrostatic discharge (ESD)
IEC 61000-4-4
± 6 kV contact
± 8 kV air
Floors should be wood, concrete, or tiled
(ceramic). If the floor is covered with
synthetic material, the relative humidity must
be at least 30%.
Electrical fast transient/ burst
IEC 61000-4-4
± 2 kV for power supply line
Power quality should be that of a typical
commercial or hospital environment.
Surge IEC 61000-4-5
± 1 kV differential
±2 kV common mode
Power quality should be that of a typical
commercial or hospital environment.
<5% UT (>95% dip in UT) for 0.5 cycle
Voltage dip, short interruptions 40% UT (60% dip in UT) for 5 cycle
and voltage variations on
70% UT (30% dip in UT) for 25 cycle
power supply input lines IEC
<5% UT (95% dip in UT) for 5 sec
61000-4-11
Power quality should be that of a typical
commercial or hospital environment. If
the user requires continued operation
during power mains interruptions, it is
recommended that the ShockPulse-SE
System be powered from an uninterrupted
power supply.
Power frequency (50/60 Hz)
magnetic field IEC 61000-4-8
Magnetic fields in the network frequency
should correspond to the typical values found
in business and hospital environments.
3 A/m
SPL-IFUR REV AG
Page 13
ShockPulse-SE Lithotripsy System • Instructions for Use
Guidance and Manufacturer’s Declaration – Immunity
The ShockPulse-SE system is intended for use in the electromagnetic environment specified below.
The customer or user of the ShockPulse-SE system should ensure that it is used in such an environment.
Immunity Test
IEC 60601 Test Level
Compliance
Level
Electromagnetic Environment – Guidance
Portable and mobile communications equipment
should be separated from the ShockPulse-SE system
by no less than the distances calculated/listed below:
Conducted RF
3 Vrms
IEC 61000-4-6
150 kHz to 80 MHz
Radiated RF
3 V/m
IEC 61000-4-3
80 MHz to 2.5 GHz
(V1)=3 Vrms
d =[ 3.5V ] √P
(E1)=3 V/m
d=[3.5E ] √P
1
1
d=[ E7 ] √P
1
150kHz to 80MHz
d=1.2√P
80 MHz to 800 MHz
d=1.2√P
800 MHz to 2.5 GHz
d=2.3√P
Where P is the max power in watts and d is the
recommended separation distance in meters.
Field strengths from fixed transmitters, as determined
by an electromagnetic site surveya, should be less
than the compliance levels (V1 and E1) in each
frequency range.b
Interference may occur in the vicinity of equipment
containing a transmitter.
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects, and people.
Field strengths 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.
To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be
considered. If the measured field strength in the location in which the ShockPulse-SE System is used exceeds the
applicable RF compliance level above, the ShockPulse-SE System should be observed to verify normal operation. If
abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the
ShockPulse-SE System.
a
b
SPL-IFUR REV AG
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
11
Page 14
Recommended separation distances between portable and mobile RF communications equipment and the
ShockPulse-SE System
The ShockPulse-SE System is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the ShockPulse-SE System can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications
equipment (transmitters) and the ShockPulse-SE System as recommended below, according to the maximum
output power of the communications equipment.
Separation distance according to frequency of transmitter (m)
Rated maximum
output power of
transmitter (W)
150 kHz to 80 MHz
80 MHz to 800 MHz
800 MHz to 2.5 GHz
d=1.2√P
d=1.2√P
d=2.3√P
0.01
0.11667
0.11667
0.23333
0.1
0.36894
0.36894
0.73785
1
1.1667
1.1667
2.3333
10
3.6894
3.6894
7.3785
100
11.667
11.667
23.333
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in
meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the
maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects, and people.
Section 5.4 – General Description of ShockPulse-SE Generator and Accessories
The generator has no adjustable settings with a simple user interface that informs the user of error states and
ultrasonic output mode. The generator is a plug and play device that does not require a tuning cycle. A phase lock loop
continuously auto-tunes the system during use while automatic gain control maintains probe tip excursion in various
loading conditions. The generator has a useful life of seven years.
Information regarding the unique identification of the software such as revision level or date of release/issue is available
from Olympus.
12
SPL-IFUR REV AG
Page 15
ShockPulse-SE Lithotripsy System • Instructions for Use
Section 5.5 – Front Panel of Generator
2
3
5
1
7
6
4
1. Power Indicator
•
Power Switch LED is illuminated when power is applied to the system.
2. Transducer Receptacle
•
Connect the transducer to the generator by pressing the plug straight in. CAUTION: Do not
twist or turn the plug.
•
The transducer receptacle light turns from flashing green to solid green when the transducer
is plugged in.
•
The transducer receptacle light is red when the transducer is malfunctioning and should be
replaced.
3. Check Probe Indicator
•
The check probe indicator is illuminated red when the probe is causing a malfunction.
•
The probe should be checked for proper attachment to the transducer using the wrench.
•
The probe should also be checked for any signs of failure such as tip wear or cracks.
4. Error Indicator
•
The error indicator illuminates red when there is a general system malfunction.
•
The generator power should be cycled off and then back on after waiting a few seconds to reset
the system.
5. Footswitch Enabled Indicator
•
The footswitch enabled indicator illuminates green when the optional footswitch is plugged in.
•
When the footswitch is plugged in and the indicator is illuminated green, the hand switches on the
transducer are disabled. If you want to use the hand switches on the transducer, the footswitch must
be unplugged.
6. High Power Indicator
•
The high power indicator is illuminated green when the transducer is activated in High Power mode.
7. Standard Power Indicator
•
SPL-IFUR REV AG
The standard power indicator is illuminated green when the transducer is activated in Standard
Power mode.
13
Page 16
Section 5.6 – Back Panel of Generator
12
9
10
8
15
11
13
14
8. Footswitch Receptacle
•
Align the colored dots to connect the optional dual footswitch to the generator.
CAUTION: Do not twist or turn the plug.
9. Power Receptacle
•
UL listed 3-prong hospital grade plug.
10. Fuse Holder
•
2 x T5A – 250V.
11. Cooling Fan with Finger Guard
•
CAUTION: Do not block the fan during operation or the generator will overheat.
12. Generator Label / Serial Number
13. Equipotential Label
14. Grounding Plug
15. Footswitch Symbol Label
Section 5.7 – Optional Footswitch (SPL-FS)
3
1. HIGH POWER Pedal Mode (Gray)
6
5
Depressing the HIGH POWER pedal causes the ShockPulse-SE System to produce
maximum energy to fragment large stones into smaller stone pieces.
2. STANDARD POWER Pedal Mode (Black)
2
14
a.
4
1
a.
Depressing the STANDARD POWER pedal causes the ShockPulse-SE system to
produce an energy level that keeps the probe in contact with the smaller stone
fragments allowing greater fragmentation. Small stones are repulsed less when the
STANDARD POWER pedal is used.
b.
Standard Power is recommended when the 1.50 or 1.83 probes are being used.
c.
Standard Power is required when the 0.97 probes are being used.
3.
4.
5.
6.
Cable
Baseplate
Standard Power Label
High Power Label
SPL-IFUR REV AG
Page 17
ShockPulse-SE Lithotripsy System • Instructions for Use
Section 5.8 – Transducer (SPL-T) and Nose Cone (SPL-NC)
3
4
5
7
6
8
12
2
Rear View
10
1
11
9
1.
2.
3.
4.
Serial Number
Transducer Horn
Transducer Housing
High Power Activation Button
a. Depressing the HIGH POWER button causes the ShockPulse-SE System to produce
maximum energy to fragment large stones into smaller stone pieces.
5. Standard Power Activation Button
a. Depressing the STANDARD POWER button causes the ShockPulse-SE system to
produce an energy level that keeps the probe in contact with the smaller stone
fragments allowing greater fragmentation. Small stones are repulsed less when the
STANDARD POWER button is used.
b. Standard Power is recommended when the 1.50 or 1.83 probes are being used.
c. Standard Power is required when the 0.97 probes are being used.
6. Suction Control Symbol
7. Suction Control Ring
8. Suction Outlet
9. Nose Cone
10. O-ring
11. Transducer Plug
12. Cable
1
4
Section 5.9 – 3.76 Probe Assembly
Order of Assembly
1.
2.
3.
4.
5
SPL-IFUR REV AG
3
2
SPL-PD376 or SPL-PR376 Probe
Shock Pulsing Free Mass
Return Spring
Spring Retention Cone/Nose Cone
Interface
5. Nose Cone Interface Seal
15
Page 18
Section 5.10 – Torque Wrench (SPL-W)
Cam Housing
Wrench Head
Spring Housing
Handle
Cam Head
Section 5.11 – Cleaning Stylet (SPL-CSL) for 3.76mm and 3.40mm probes and
SPL- CSS for 1.83, and 1.50 mm probes.
The cleaning stylet (SPL-CSL) is very important for every case using the 3.76 mm and 3.40 mm probes.
Should a blockage of the fluid path occur within the suction pathway, the stylet is used to clear the blockage.
16
SPL-IFUR REV AG
Page 19
ShockPulse-SE Lithotripsy System • Instructions for Use
Section 6
Assembling the Unit
CAUTION: Check the integrity of the packaging. Do not use the device if the packaging is open or damaged.
1. Make sure that the following ShockPulse-SE system equipment is present for the procedure.
The operator should ensure that the generator (SPL-G) and all cables and all components on
transducer are undamaged prior to beginning any procedure.
a.
ShockPulse-SE Generator (SPL-G)
b.
ShockPulse-SE Transducer (SPL-T)
c.
ShockPulse-SE Nose Cone (SPL-NC)
d.
ShockPulse-SE Wrench (SPL-W)
e.
ShockPulse-SE Footswitch (SPL-FS) (Optional)
f.
ShockPulse-SE Cleaning Stylet (SPL-CSL) or (SPL-CSS) – as per the probe size used
g.
ShockPulse-SE Probes
h.
ShockPulse-SE Power Cord (SPL-PC)
2. All sterile packaged devices (i.e. probes), should be opened just prior to the procedure.
3. It is always recommended that a spare transducer and probe assembly be available.
4. Clean and sterilize transducer, non-sterile probes, cleaning stylet and wrench according to the
instructions in Sections 8
5. Firmly wipe the threads in the transducer and the mating screw end of the probe with a sterile gauze
pad to remove any moisture and to permit a firm seating.
a.
Inspect the plug pins, cord, and transducer body for mechanical damage (bent pins,
cracks, etc.). If repair is necessary, please contact Olympus Customer Service.
6. Check to ensure that the probe set parts are in the correct order, concentrically aligned, and in close
contact with each other before attaching probe to transducer.
CAUTION: Probe must be secured tightly to the transducer to assure good coupling. Loosening
of the probe during operation will decrease or halt lithotripsy action of the probe and may cause
damage. With the side of the torque wrench that has the Olympus brand in the palm of the
hand, turn the torque wrench until “it” clicks to ensure adequate coupling.
CAUTION: If the probe is not properly seated or tightened into the transducer, it will not perform
properly. Check to ensure that the probe is seated and tightened correctly prior to use.
7. Screw on Nose Cone. Ensure there is no visible space between Nose Cone and transducer before
continuing.
8. Connect the transducer to generator by aligning key way of the transducer connector with the key way
slot on the transducer receptacle on the front panel. Push straight in.
CAUTION: Do not twist or turn the plug.
9. Connect sterile aspiration tubing (OD 9 mm, ID 6 mm) to the port at the rear of the transducer and
connect the other end of the tubing to an appropriate suction source. It is recommended to start
with a vacuum pressure of 150mmHg or lower and increase as needed for the probe type and the
procedure being conducted.
10. If preferred, connect the optional footswitch to the generator by aligning the red dot on the footswitch
connector with the red dot on the footswitch receptacle on the rear panel. Push straight in.
CAUTION: Do not twist or turn the plug.
NOTE: It is recommended that the footswitch be protected from contamination by containing it in a
plastic bag.
NOTE: When footswitch is connected, the buttons on the transducer are disabled.
11. Turn the ShockPulse-SE system power ON by pressing the power on button and verify that the green
power and LEDs on the front panel are illuminated.
12. If the probe does not appear to work effectively, verify proper seating with transducer, then use a
cleaning stylet to make sure it is not obstructed by debris.
13. Verify that the fan in the back of the generator is running and that nothing is blocking/interfering with
air intake.
14. Aspiration is on when the ring is rotated counterclockwise when viewed from the back.
SPL-IFUR REV AG
17
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Section 7
Operating Instructions
This section is intended to provide the operator with instructions on the use of the ShockPulse-SE Lithotripsy
System, not provide detailed instructions on how to perform ultrasonic lithotripsy procedures.
Once the physician visualizes the stone with the endoscope, the appropriate ShockPulse-SE probe is
to slide carefully through the working channel of the nephroscope. See Section 2 which identifies the
minimum required work channel of the endoscope for each probe. The aspiration suction control ring
should be on and have a starting vacuum pressure of 150 mmHg. Aspiration is on when the ring is rotated
counterclockwise when viewed from the back. The physician should depress and hold down the foot pedal
or transducer button and then move to contact the stone. The ShockPulse-SE system will break up the
stone and the fragments will be quickly evacuated through the aspiration tubing.
Section 7.1 – Tips for Success
Probe Pressure
a.
The ShockPulse-SE should be placed in light contact with the stone. It is not necessary to
press down on the stone with a lot of pressure.
NOTE:
•
While the Probe is activated, torquing the Probe may increase the likelihood of friction
between the Probe and endoscope producing visible particles that can be aspirated normally.
Probe Bending Torque
b.
The Probe is fragile. It is critical that the surgeon does not bend or torque the probes
against the endoscope during the procedure. There is no need to rotate the probe or
transducer; it will not improve fragmentation or stone clearance.
Activating the Transducer
c.
d.
Activate the ultrasonic energy by depressing the footswitch or using the buttons on the
transducer.
The contact hand switches function as follows: One switch activates Standard Power while
the other activates High Power. Activation will either require momentary pushing of the
button or a double click to latch activation on; a single click of either button would then turn
activation off. The High Power button is toward the Nose Cone and is a lighter color. The
Standard Power button is toward the suction guide and is darker in color.
Aspiration/Suction Control
e.
The ShockPulse-SE System does not have any means to automatically regulate suction
pressure because every case has different requirements. Suction control can be adjusted
manually from no suction to full suction by rotating the suction ring to allow for adequate
visualization while the surgeon locates the stones. It is recommended to start with a
vacuum pressure of 150mmHg while the probe is active to maximize stone removal
efficiency and allow adequate cooling of the probe and the transducer.
NOTE:
•
0.97 Probe does not allow suction.
Cleaning Stylet
f.
Cleaning stylets are provided to clear the probe should obstructions occur, but first check to
make sure that the suction control is rotated fully counter clockwise when viewed from the
rear; this may resolve the problem. Should the ultrasonic action lessen during use, remove
the probe from the endoscope and remove the suction tubing from the transducer. Pass the
cleaning stylet through the transducer to the probe tip to dislodge any obstruction. Less
effort is required if the ultrasonic action is briefly activated while using the cleaning stylet.
Additional Tips
g.
h.
i.
18
The tip of the probe should be visible at all times while in use.
Position the probe gently against the stone for best fragmentation.
When the ultrasound is activated, do not contact tissue with the tip or sides of the probe;
tissue damage could result.
SPL-IFUR REV AG
Page 21
ShockPulse-SE Lithotripsy System • Instructions for Use
j.
k.
l.
m.
n.
If using optional footswitches, depending on the stone size, select High Power mode or
Standard Power mode by depressing the right or left foot pedal.
Depressing High Power Mode causes the ShockPulse-SE system to produce maximum
energy to fragment large stones into smaller stone pieces.
Depressing Standard Power Mode causes the ShockPulse-SE system to produce an
energy level that keeps the probe in contact with the smaller stone fragments allowing
greater fragmentation. Small stones are repulsed less when the Standard Power mode is
used.
Continuous irrigation and suction should be used when ultrasonic energy is activated to
avoid overheating the probe and transducer.
Continue fragmentation and suctioning of stone debris until remaining pieces are deemed
small enough to pass, or patient is stone free.
NOTES
• Normal physiological saline is the recommended irrigation for ultrasonic lithotripsy.
• The SPL-PD097 or SPL-PR097 probe should only be used with the Standard Power setting. Use
of the High Power setting with the SPL-PD097 or SPL-PR097 probes may result in premature
probe failure.
• 0.97 Probe does not allow suction.
• While the Probe is activated, torquing the Probe may increase the likelihood of friction
between the Probe and endoscope producing visible particles that can be aspirated normally.
WARNINGS AND CAUTIONS
• The tip of the probe must be kept visible at all times when the transducer is activated.
• Do not contact mucosal tissue with the tip of the activated probe as tissue damage may occur.
• A back-up transducer and probe should be sterilized and available prior to beginning a
procedure.
• Continuous irrigation and suction is necessary for proper operation and cooling of transducers
and probes. If the aspiration becomes interrupted, first ensure that the suction tubing is not
kinked or clogged, that the suction control is rotated fully counter clockwise when viewed
from the rear (follow indicator), and then, if necessary, use the cleaning stylet to unclog the
transducer and probe.
SPL-IFUR REV AG
19
Page 22
Section 8
Cleaning and Sterilization
The following cleaning and sterilization procedures are recommended by Olympus. Use of any procedures
not expressly recommended by Olympus may adversely affect or damage Olympus devices and may void
Olympus’ Limited Express Warranty.
Follow all applicable bloodborne pathogen procedures as indicated by OSHA and/or your hospital
requirements when cleaning and sterilizing instruments and accessories.
WARNING: Failure to properly clean and sterilize devices prior to use can compromise patient safety.
If devices are not cleaned meticulously, effective sterilization cannot be obtained.
CAUTION: Clean and sterilize the reusable devices immediately after each use.
CAUTION: Maintain the instruments in a moist environment in the event that it cannot be cleaned
immediately after patient contact.
Identification of Devices
Sterile, Single-Use Devices
Sterile, Single Use ShockPulse Lithotripsy Probes
SPL-PD376
ShockPulse Lithotripsy Probe, Sterile Single Use, 3.76mm
SPL-PD340
ShockPulse Lithotripsy Probe, Sterile Single Use, 3.40mm
SPL-PD183
ShockPulse Lithotripsy Probe, Sterile Single Use, 1.83mm
SPL-PD150
ShockPulse Lithotripsy Probe, Sterile Single Use, 1.50mm
SPL-PD097
ShockPulse Lithotripsy Probe, Sterile Single Use, 0.97mm
Non-Sterile, Reusable Devices (to be cleaned and sterilized)
Reusable ShockPulse Lithotripsy Probes [five (5) reuses]
SPL-PR376
ShockPulse Lithotripsy Probe, Reusable, 3.76mm
SPL-PR340
ShockPulse Lithotripsy Probe, Reusable, 3.40mm
SPL-PR183
ShockPulse Lithotripsy Probe, Reusable, 1.83mm
SPL-PR150
ShockPulse Lithotripsy Probe, Reusable, 1.50mm
SPL-PR097
ShockPulse Lithotripsy Probe, Reusable, 0.97mm
ShockPulse Lithotripsy Accessories (Non-Sterile – to be cleaned and sterilized)
•
•
•
•
•
Transducer – SPL-T
Cleaning Stylet (Large)– SPL-CSL
Cleaning Stylet (Small) – SPL-CSS
Torque Wrench – SPL-W
Nose Cone – SPL-NC
Equipment and Consumable Supplies Needed
•
Personal Protective Equipment including eye wear, face mask, moisture-resistant clothing
and chemical resistant gloves
•
Sponge or Towel
•
Soft Bristled Brush (M16)
•
Pipe Cleaner (4.76 mm diameter)
•
Lumen Brush (depending on size of lumen)
o Olympus Brush WA90214A (3.5 mm diameter - 3.4 and 3.76 mm Probes or equivalent)
o Olympus Brush BW-7B (1.0 mm diameter - 1.83 and 1.5 mm Probes or equivalent)
•
Lint free cloth
•
Cleaning agents:
o Mild soap solution (use medical-grade, low foaming and neutral pH detergent)
o Enzol prepared according to the manufacturer’s recommendations (1oz/gal) using
lukewarm tap water
20
SPL-IFUR REV AG
Page 23
ShockPulse-SE Lithotripsy System • Instructions for Use
Section 8.1 – Generator and Footswitch – Cleaning
1. Turn off power to the unit and remove the power cord before cleaning.
2. Wipe generator cabinet, front panel, power cord and footswitch with a sponge (or towel) lightly
moistened with a mild soap solution (use medical-grade, low foaming and neutral pH detergent).
Follow with a sponge (or towel) lightly moistened with clear warm (42 °C-52 °C, 107 °F-125 °F) tap
water. Dry immediately.
3. Avoid using chemical or abrasive cleaning agents, which damage the finish.
Section 8.2 – Probes – Cleaning
NOTE: Please see cross reference Table (at the end of section 8.2.1) to identify the associated cleaning
brush and color to each probe reference number and sizes.
8.2.1 Manual Cleaning
1. Remove stylet from the probe.
2. Spread out the O-ring, Nose Cone spring retention cone, spring, and free mass along the probe so that
they can be cleaned (approximately a 1/8” gap between components).
3. Fully immerse the probe and other components in an enzymatic cleaning solution that is formulated to
dissolve proteinaceous material. Follow the manufacturer’s instructions for dilution, temperature and
time. DO NOT USE dishwashing detergents, skin cleansers or any other cleaning agents not designed
to dissolve protein.
4. While probe is fully immersed, carefully insert a soft brush or pipe cleaner configured to clean the
lumen to ensure the lumen is free of air pockets. For the smaller lumen ureteral probes such as the
SPL-PR150, use the cleaning stylet in place of a soft brush or pipe cleaner. Run the cleaning stylet in
and out of the lumen while the probe is immersed to ensure the lumen is free of air pockets.
5. Let the probe and other components soak for at least 5 minutes.
6. Scrub the probe set components with a soft brush. Run a soft-bristled brush or pipe cleaner through
the lumen until the lumen is cleaned. For smaller lumen ureteral probes such as the SPL-PR150, use
the cleaning stylet in place of a soft brush or pipe cleaner.
7. Rinse the parts thoroughly in clean warm (42 °C-52 °C, 107 °F-125 °F) tap water to remove all traces
of cleaning solution; visually inspect exterior and lumen to ensure no visible contamination is present.
8. If visible contamination is present repeat cleaning steps 1-7.
9. Once adequately clean, dry the components with a lint-free towel.
10. Then the cleaned probe is to be sterilized immediately per the requirements set forth in Section 8.5.
REF
Description
Color
Outside
Diameter
Inside
Diameter
Working
Length
Cleaning
Brush
SPL-PR376
ShockPulse Lithotripsy
Silver
Probe, Reusable, 3.76mm
3.76 mm
3.15 mm
396 mm
WA90214A
or 3/16" Pipe
Cleaner
SPL-PR340
ShockPulse Lithotripsy
Blue
Probe, Reusable, 3.40mm
3.4 mm
2.9 mm
396 mm
WA90214A
or 3/16" Pipe
Cleaner
SPL-PR183
ShockPulse Lithotripsy
Red
Probe, Reusable, 1.83mm
1.83 mm
1.37 mm
418 mm
BW-7B or
Cleaning
Stylet
SPL-PR150
ShockPulse Lithotripsy
Green
Probe, Reusable, 1.50mm
1.50 mm
1.04 mm
564 mm
BW-7B or
Cleaning
Stylet
SPL-PR097
ShockPulse Lithotripsy
Gold
Probe, Reusable, 0.97mm
0.97 mm
N/A
578 mm
NOTE: The Sterile, Single-Use Probes are intended for single use only. Reuse may result in weak
performance or breakage of the probe and patient harm. Single use devices, as indicated by the
label, should NOT be re-sterilized and reused because the device may not perform as intended by the
manufacturer if it is reused.
SPL-IFUR REV AG
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8.2.2 Automated Cleaning Using A Washer Disinfector
Automated cleaning should be performed in an Automatic Washer Disinfector in the following conditions:
• With the SPL-PR376 or SPL-PR340 lying loose in the washer rack [Spread out the O-ring,
spring retention cone, spring, and free mass along the probe so that they can be cleaned
(approximately a 1/8” gap between components)].
NOTE: The tray/rack must contain only one of either type of device.
NOTE: Only the SPL-PR376 and SPL-PR340 can be used in an automatic Washer Disinfector.
• Use alkaline or neutral pH detergent recommended by washer/disinfector manufacturers.
An example of an approved detergent is MediClean Forte detergent.
The Automatic Washer Disinfector can be set to these parameters:
Cycle Parameters:
Pre-Cleaning : Cold water for 2 minutes
Wash: Cold water with detergent heated to 55 °C for 5 minutes
Rinse 1: Hot water for 2 minutes
Rinse 2: Hot water for 2 minutes
Final Rinse: Deionized Water at 90°C for 1 minute
Dry Phase: 20 minute dry period at 90 °C
• After Automated Cleaning, visibly inspect all components for any adherent soil. Repeat cleaning
procedure if needed.
Section 8.3 – Transducer and Nose Cone– Cleaning
CAUTION: The Nose Cone and any probes must be disassembled from the transducer and the cleaning
stylet removed from within the transducer prior to cleaning and sterilization.
CAUTION: After each use or prior to cleaning and sterilizing, carefully inspect transducer and cable for
tears, cracks or other signs of damage.
CAUTION: Never use damaged equipment.
CAUTION: This product is not validated for high-level disinfection (HLD).
NOTE: Residue from the probe operation may be visible upon removal of the nose cone. This is an expected
by-product of the ultrasonic energy on the probe materials during operation. Rinse the residue during
the cleaning and continue to clean in accordance with these instructions.
8.3.1 Manual Cleaning
1. Remove the transducer connector from the generator, if it is attached.
2. Remove the cover (Nose Cone) of the transducer by turning the Nose Cone counterclockwise as
viewed from front of the transducer.
3. Open the suction control orifice by rotating the suction control ring; the suction control orifice is open
when the ring is rotated clockwise when viewed from the back.
4. Fully immerse the transducer and Nose Cone in an enzymatic cleaning solution that is formulated to dissolve
proteinaceous material. Follow the manufacturer’s instructions for dilution, temperature and time. DO NOT
USE dishwashing detergents, skin cleansers or any other cleaning agents not designed to dissolve protein.
5. Let the transducer and Nose Cone soak for a minimum of 5 minutes.
6. While the transducer and Nose Cone are fully immersed, use a lumen brush to clean down the lumen
and to ensure the lumen is free of air pockets and debris. Also, brush down the suction control orifice to
remove any air pockets and debris. Actuate the suction control ring 10 times while immersed.
7. Scrub the transducer and Nose Cone thoroughly with a soft bristled brush and pipe cleaner (3/16 inch
diameter). Pay attention to any crevices, entry and exit ports, lumens and hard to clean areas until all
visible soil has been removed.
8. Pay special attention to brushing around the transducer buttons.
9. Pay special attention to brushing around the clearance space between the transducer horn and black housing.
10. Pay special attention to brushing around the area where the cable comes out of the transducer housing.
11 . Ultrasonicate the Nose Cone only for 5-10 minutes.
12. Rinse the transducer (including through the lumen and suction control orifice) and Nose Cone thoroughly
in running warm (42 °C-52 °C, 107 °F-125 °F) tap water to remove all traces of cleaning solution; visually
inspect the exterior and lumens to ensure no visible contamination is present. Actuate the suction control
ring 10 times while being rinsed in running warm tap water.
13. If visible contamination is present, repeat cleaning steps 4-12.
14. Once adequately clean, dry the transducer and Nose Cone with a lint-free towel.
15. The cleaned transducer and Nose Cone is to be sterilized immediately per the requirements in Sections
8.5 and 8.6.
22
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Page 25
ShockPulse-SE Lithotripsy System • Instructions for Use
8.3.2 Automated Cleaning Using A Washer Disinfector
Automated cleaning should be performed in an Automatic Washer Disinfector in the following conditions:
• With the hand piece, Nosecone, and Torque Wrench lying loose in the washer rack
• Use alkaline or neutral pH detergent recommended by washer/disinfector manufacturers.
An example of an approved detergent is MediClean Forte detergent.
The Automatic Washer Disinfector can be set to these parameters:
Cycle Parameters:
Pre-Cleaning : Cold water for 2 minutes
Wash: Cold water with detergent heated to 55 °C for 5 minutes
Rinse 1: Hot water for 2 minutes
Rinse 2: Hot water for 2 minutes
Final Rinse: Deionized Water at 90 °C for 1 minute
Dry Phase: 20 minute dry period at 90 °C
• After Automated Cleaning, visibly inspect all components for any adherent soil. Repeat cleaning
procedure if needed.
Section 8.4 – Stylet and Torque Wrench - Cleaning
CAUTION: After each use or prior to cleaning and sterilizing, carefully inspect stylet and wrench for
tears, cracks or other signs of damage.
CAUTION: Never use damaged equipment.
8.4.1 Manual Cleaning
Cleaning Stylet
1. Fully immerse the cleaning stylet in an enzymatic cleaning solution that is formulated to dissolve
proteinaceous material. Follow the manufacturer’s instructions for dilution, temperature and time. DO
NOT USE dishwashing detergents, skin cleansers or any other cleaning agents not designed to dissolve
protein. Avoid using chemical or abrasive cleaners that could damage the surface finish.
2. Let the cleaning stylet soak for at least 1 minute.
3. Scrub the cleaning stylet with a soft brush.
4. Rinse the cleaning stylet thoroughly in running warm (42 °C-52 °C, 107 °F-125 °F) tap water to
remove all traces of cleaning solution; visually inspect to ensure no visible contamination is present.
5. If visible contamination is present, repeat cleaning steps 1-4.
6. Once adequately clean, dry the cleaning stylet with a lint-free towel.
7. The cleaning stylet is to be sterilized immediately after cleaning.
CAUTION: After each use or prior to cleaning and sterilizing, carefully inspect stylet and wrench for
tears, cracks or other signs of damage.
CAUTION: Never use damaged equipment.
Torque Wrench
After each use or prior to placing in a disinfectant or sterilizer, carefully inspect the wrench for cracks or
other signs of damage. Do not use damaged equipment.
1. Fully immerse the wrench in an enzymatic cleaning solution that is formulated to dissolve
proteinaceous material. Follow the manufacturer’s instructions for dilution, temperature and time. DO
NOT USE dishwashing detergents, skin cleansers or any other cleaning agents not designed to dissolve
protein. Avoid using chemical or abrasive cleaners that could damage the surface finish.
2. Let the torque wrench soak for at least 5 minutes.
3. Scrub the torque wrench with a soft brush.
4. Pay special attention to openings in the wrench handle where contamination can build up.
5. Ultrasonicate the wrench for 5-10 minutes.
6. Rinse the torque wrench thoroughly in running warm (42 °C-52 °C, 107 °F-125 °F) tap water to
remove all traces of cleaning solution; visually inspect the exterior and openings to ensure no visible
contamination is present.
7. If visible contamination is present, repeat cleaning steps 1-6.
8. Once adequately clean, dry the torque wrench with a lint-free towel.
9. The torque wrench is to be sterilized immediately after cleaning.
SPL-IFUR REV AG
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8.4.2 Automated Cleaning Using A Washer Disinfector
Automated cleaning should be performed in an Automatic Washer Disinfector in the following conditions:
• With the hand piece, Nosecone, and Torque Wrench lying loose in the washer rack
• Use alkaline or neutral pH detergent recommended by washer/disinfector manufacturers.
An example of an approved detergent is MediClean Forte detergent.
The Automatic Washer Disinfector can be set to these parameters:
Cycle Parameters:
Pre-Cleaning : Cold water for 2 minutes
Wash: Cold water with detergent heated to 55 °C for 5 minutes
Rinse 1: Hot water for 2 minutes
Rinse 2: Hot water for 2 minutes
Final Rinse: Deionized Water at 90 °C for 1 minute
Dry Phase: 20 minute dry period at 90 °C
• After Automated Cleaning, visibly inspect all components for any adherent soil. Repeat cleaning
procedure if needed.
Section 8.5 – Steam Sterilization
CAUTION: Never rinse the ShockPulse-SE components with cooled water for faster cooling after
sterilization; sudden changes in temperature may damage the components.
Thoroughly clean, rinse, and dry transducers, probes, Nose Cone, cleaning stylet, and wrench prior to sterilization.
The ShockPulse-SE transducer and Nose Cone, probe, probe parts, cleaning stylet, and wrench have been
validated and can be reprocessed as follows in a legally marketed Prevacuum Steam Sterilizer controlled
within the following parameters:
NOTE:
•
Disassemble the Nose Cone from the Transducer, but leave the O Ring on the transducer.
Double wrap separately and as follows: A). Transducer and Nose Cone. B). Two probes and
two Stylets and C). Torque Wrench alone.
NOTE:
•
•
Sterile probes can be steam sterilized with the same method as non-sterile probes if their
package has been opened and the probes unused.
The ShockPulse-SE transducer and Nose Cone, probe, cleaning stylet, and wrench should
be processed in a legally marketed Prevacuum Steam Sterilizer
Cycle
Name
Load Description
Temperature
Conditioning
Pulses
Vacuum
Pressure
Sterilization
Time
Dry Time
Prevac
Cycle
Double-Wrapped
132 °C
(270 °F)
3 pulses
minimum
required
20-28” Hg
25-28 psi
4 minutes
20 minutes
60-95 kPa
172-193 kPa
134 °C
(273 °F)
3 pulses
minimum
required
20-28” Hg
25-28 psi
3 minutes
20 minutes
60-95 kPa
172-193 kPa
132 °C
(270 °F)
3 pulses
minimum
required
20-28” Hg
25-28 psi
3 minutes
None
60-95 kPa
172-193 kPa
137 °C
(279 °F)
3 pulses
minimum
required
20-28” Hg
25-28 psi
18 minutes
20 minutes
60-95 kPa
172-193 kPa
134 °C
(273 °F)
3 pulses
minimum
required
20-28” Hg
33 psi
5 minutes
20 minutes
60-95 kPa
230 kPa
(USA)
Prevac
Cycle (UK)
Prevac Flash
Cycle
Double-Wrapped
No Wrapping
Prevac
Cycle
French
Double-Wrapped
Prevac
Cycle
German
Double-Wrapped
Section 8.6 – STERRAD
CAUTION: Probes have only been validated for STEAM STERILIZATION (See Section 8.5).
The ShockPulse-SE transducer, Nose Cone and wrench have been validated for efficacy sterilization with the
STERRAD 100S (Full SHORT Cycle), STERRAD 100NX (Full STANDARD Cycle) and STERRAD NX (Full ADVANCED
Cycle) systems by Advanced Sterilization Products. The ShockPulse-SE transducer, Nose Cone and wrench have
been validated for material compatibility.
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SPL-IFUR REV AG