ShockPulse-SE Lithotripsy System SPL-SR Instructions for Use Rev AG April 2016

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 4

2

SPL-IFUR REV AG

Page 5

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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Page 6

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

Page 7

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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Page 8

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

Page 9

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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Page 10

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

Page 11

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

9

Page 12

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.

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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.

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

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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

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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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Page 20

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

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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

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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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Page 24

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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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