ShockPulse-SE Lithotripsy System SPL-SR Instructions for Use Rev AG

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

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

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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

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.

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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.

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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

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14

18

15

19

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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

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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

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)

European Competent Authorities

Class III medical device SOR/98-282 – Schedule 1 – Rule 9(2)

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

ShockPulse-SE Lithotripsy System • Instructions for Use

Sterile, Single Use ShockPulse Lithotripsy Probes REF

Description

Color

Outside Diameter

Inside Diameter

Working Length

Provided Sterile

SPL-PD376

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

*Includes Cleaning Stylet - Small ** No suction available

Re-Usable ShockPulse Lithotripsy Probes [five (5) reuses] REF

Description

Color

Outside Diameter

Inside Diameter

Working Length

Provided Sterile

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.

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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

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

150kHz to 80MHz d=1.2√P

(E1)=3 V/m

d=[3.5E ] √P

80 MHz to 800 MHz d=1.2√P

1

1

d=[ E7 ] √P 1

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.

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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.

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SPL-IFUR REV AG

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.

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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. Cable 4. Baseplate 5. Standard Power Label 6. High Power Label

SPL-IFUR REV AG

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. Serial Number 2. Transducer Horn 3. Transducer Housing 4. 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

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SPL-IFUR REV AG

3

2

1. SPL-PD376 or SPL-PR376 Probe 2. Shock Pulsing Free Mass 3. Return Spring 4. Spring Retention Cone/Nose Cone Interface 5. Nose Cone Interface Seal 15

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.

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SPL-IFUR REV AG

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

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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.

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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

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

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