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

ShockPulse-SE Lithotripsy System (SPL-SR) Instructions for Use Table of Contents

6.1 Tips for Success... 21

7 Cleaning and Sterilization ...23 7.1 Generator and Footswitch - Cleaning ... 23 7.2 Probes - Cleaning ... 24 7.2.1

Manual Cleaning ... 24

7.2.2 Automated Cleaning Using a Washer Disinfector ... 25

7.3 Transducer and Nose Cone - Cleaning ... 25 7.3.1

Manual Cleaning ... 26

7.4 Stylet and Torque Wrench - Cleaning ... 26 7.4.1

Manual Cleaning ...27

7.4.2

Automated Cleaning Using A Washer Disinfector... 28

7.5 Steam Sterilization ... 28

8 Preventive Maintenance ... 29 8.1 General Checks ... 29 8.2 Periodic Safety Checks ... 29

9 Troubleshooting and Fuse Replacement ... 30 9.1 Troubleshooting ... 30 9.2 System Operation States - Normal and Error ... 31 9.3 Fuse Replacement... 32

10 Safe Disposal of Hazardous Waste...33 10.1 Safe Disposal of Waste Electrical and Electronic Equipment (WEEE) ... 33 10.1.1

Waste Electrical and Electronic Equipment ...33

10.1.2 Safe Disposal of Waste Electrical Equipment ...33 10.1.3 User Responsibility and Applicable Standards ...33

10.2 Disposable, Single Use Products ... 34 10.3 Reusable Products ... 34

11 Repair ... 35 12 Symbols... 36 13 Return/Repair/Warranty ... 39 14 Sterilization Log... 40

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ShockPulse-SE Lithotripsy System (SPL-SR) Instructions for Use List of Figures

List of Figures Figure 1

Front Panel of Generator ...14

Figure 2

Rear Panel of Generator ... 15

Figure 3

Optional Footswitch (SPL-FS) ... 16

Figure 4

Transducer (SPL-T) and Nose Cone (SPL-NC)...17

Figure 5

Probe Assembly ... 18

Figure 6

Torque Wrench (SPL-W) ... 18

Figure 7

Cleaning Stylet... 19

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ShockPulse-SE Lithotripsy System (SPL-SR) Instructions for Use List of Tables

List of Tables Table 1

Sterile, Single Use ShockPulse™ Lithotripsy Probes ... 3

Table 2

Reusable ShockPulse Lithotripsy Probes [Five (5) reuses] ... 3

Table 3

ShockPulse-SE (Stone Eliminator) Lithotripsy System...5

Table 4

Applicable Directives ...5

Table 5

Sterile, Single Use ShockPulse Lithotripsy Probes (Box of 3) ...6

Table 6

Reusable ShockPulse Lithotripsy Probes (1 Each; 5 reuses) ...6

Table 7

ShockPulse Lithotripsy Accessories (1 Each) ...6

Table 8

Generator (SPL-G) Specifications... 7

Table 9

Footswitch (SPL-FS) Specifications ... 7

Table 10 Transducer (SPL-T) with Nose Cone (SPL-NC) ... 7 Table 11 Sterile, Single Use ShockPulse Lithotripsy Probes ...8 Table 12 Reusable ShockPulse Lithotripsy Probes - five (5) reuses... 8 Table 13 Operating and Storage Environment...9 Table 14 Electromagnetic Emission Declarations...9 Table 15 Electromagnetic Immunity Declaration ... 10 Table 16 Guidance and Manufacturer’s Declaration – Immunity ... 11 Table 17 Proximity Field from Wireless Transmitters (61000-4-3) ... 12 Table 18 Recommended Separation Distances between Portable and Mobile RF Communications Equipment and the ShockPulse-SE System...13 Table 19 Probes ... 24 Table 20 Stream Sterilization Cleaning Cycles... 29 Table 21 Troubleshooting ... 30 Table 22 Error ...31 Table 23 Normal... 32 Table 24 Waste Electrical and Electronic Equipment ...33 Table 25 Sterile, Single Use ShockPulse Lithotripsy Probes ...34 Table 26 Reusable ShockPulse Lithotripsy Probes (1 Each; 5 reuses) ...34 Table 27 ShockPulse Lithotripsy Accessories (1 Each) ...34 Table 28 Symbols ... 36 Table 26 Sterilization Log... 40

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ShockPulse-SE Lithotripsy System (SPL-SR) Instructions for Use Intended Use / Contraindications

1

Intended Use / Contraindications

1.1

Intended Use

The ShockPulse-SE™ Lithotripsy System is intended to be used for fragmentation of urinary tract calculi in the kidney, ureter, and bladder.

1.2 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.

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 and Cautions CAUTION A Caution alerts the operator to the possibility of a problem with the device associated with its use or misuse. These types of problems may include device malfunction, device failure, and damage to the device or other property. The cautionary statement includes the precaution that should be taken to avoid the hazard. WARNING A Warning alerts the operator to the possibility of injury, serious adverse reactions or death associated with the use or misuse of the device. DANGER Danger alerts the operator to a hazard with a high level of risk which, if not avoided, will result in death or serious injury associated with the use or misuse of the device. NOTE

A Note alerts the operator to particularly important information.

2.1 Warnings 2.1.1

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.

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ShockPulse-SE Lithotripsy System (SPL-SR) Instructions for Use Warnings and Cautions 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 4.3 Safety Specifications on Page 9 for additional information. 11. Avoid placing this equipment adjacent to or stacked with other equipment because it could malfunction. If such placement is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. 12. The use of accessories, transducers, and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation. 13. Do not place portable RF communications equipment (including peripherals such as antenna cables and external antennas) closer than 30 cm (12 inches) to any part of the ShockPulse-SE System, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.

2.2 Fire and Explosion Hazards 1.

When used in an environment containing flammable gases 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.

2.3 Health Hazards 2.3.1

Health Risks

Potential elevated health risks in patients with the following: • Active bleeding disorder. • During pregnancy.

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ShockPulse-SE Lithotripsy System (SPL-SR) Instructions for Use Warnings and Cautions

• 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.

2.3.2 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.

2.3.3 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: Table 1 Sterile, Single Use ShockPulse™ Lithotripsy 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)

**No Suction Available

Table 2 Reusable ShockPulse Lithotripsy Probes [Five (5) reuses] Reusable ShockPulse Lithotripsy Probes

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 Use, 1.50mm

2 mm (6 Fr)

SPL-PR097**

ShockPulse Lithotripsy Probe, Reusable, 0.97mm

1 mm (3 Fr)

**No Suction Available

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ShockPulse-SE Lithotripsy System (SPL-SR) Instructions for Use Warnings and Cautions 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.

2.4 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 Chapter 5 Assembling the Unit on Page 20. 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. 11. Never rinse the ShockPulse-SE components with cooled water for faster cooling after sterilization; sudden changes in temperature may damage the components.

2.5 Serious Incident Reporting CAUTION Report any serious incident relating to the use of this product to Olympus and to the health authority of the country in which it occurred. This applies to any incident where a shortcoming in the performance, usability, or labeling of this product has led, might have led, or could lead to the death or a permanent or temporary deterioration in the state of health of the patient, user, or others. It also applies to any incident that indicates that a serious public health threat exists

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ShockPulse-SE Lithotripsy System (SPL-SR) Instructions for Use Unpacking and Initial Inspection

3

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: Table 3 ShockPulse-SE (Stone Eliminator) Lithotripsy System Part No.

ShockPulse-SE Lithotripsy System

SPL-SR

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)

NOTE: ShockPulse-SE Optional Footswitch and Probes are sold separately. See Section 5 below.

4

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 that quickly disintegrates stones. Table 4 Applicable Directives 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 TÜV

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

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ShockPulse-SE Lithotripsy System (SPL-SR) Instructions for Use Specifications and General Description

Table 5 Sterile, Single Use ShockPulse Lithotripsy Probes (Box of 3) REF

Description

SPL-PDBX376

ShockPulse Lithotripsy Probe, Sterile Single Use, 3.76 mm (3/Box)

SPL-PDBX340

ShockPulse Lithotripsy Probe, Sterile Single Use, 3.40 mm (3/Box)

SPL-PDBX183

ShockPulse Lithotripsy Probe, Sterile Single Use, 1.83 mm (3/Box)*

SPL-PDBX150

ShockPulse Lithotripsy Probe, Sterile Single Use, 1.50 mm (3/Box)*

SPL-PDBX097**

ShockPulse Lithotripsy Probe, Sterile Single Use, 0.97 mm (3/Box)

*Includes Cleaning Stylet - Small **No Suction Available.

Table 6 Reusable ShockPulse Lithotripsy Probes (1 Each; 5 reuses) REF

Description

SPL-PR376

ShockPulse Lithotripsy Probe, Reusable, 3.76 mm (1/Box)

SPL-PR340

ShockPulse Lithotripsy Probe, Reusable, 3.40 mm (1/Box)

SPL-PR183

ShockPulse Lithotripsy Probe, Reusable, 1.83 mm (1/Box)*

SPL-PR150

ShockPulse Lithotripsy Probe, Reusable, 1.50 mm (1/Box)*

SPL-PR097**

ShockPulse Lithotripsy Probe, Reusable, 0.97 mm (1/Box)

*Includes Cleaning Stylet - Small **No Suction Available.

The following accessories may be ordered individually from Olympus: Table 7 ShockPulse Lithotripsy Accessories (1 Each) REF

Description

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-IFU

ShockPulse Lithotripsy IFU

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ShockPulse-SE Lithotripsy System (SPL-SR) Instructions for Use Specifications and General Description

4.1 Specifications Table 8 Generator (SPL-G) Specifications Item

Measurement

Value

Power Supply

Voltage

100 – 240 VAC

Frequency

50/60 Hz

Dimensions

37 cm x 40 cm x 11.5 cm (14.57 in. x 15.89 in. x 4.58 in.)

Weight

6.2 kg (13.7 lb)

Physical Classification (Electro-Medical)

Ultrasonic Energy

Protection Against Electric Shock Class I Type of Applied Part

Type BF

Frequency

19,500 – 21,500 Hz

Maximum Output

100 Watts

Table 9 Footswitch (SPL-FS) Specifications Item

Measurement

Value

Physical Specifications

Dimension

23 cm x 5.5 cm x 16.5 cm (9 in.x 2.2 in. x 6.5 in.)

Weight

1.9 kg (4.2 lb)

Length of Cord

3 m (10 ft)

Degree of Water Resistance

IPX6 except for plug

Classification

Table 10 Transducer (SPL-T) with Nose Cone (SPL-NC) Item

Measurement

Value

Housing Dimensions

Maximum Diameter

4.8 cm (2 in.)

Length

19.6 cm (7.7 in.)

Weight

0.45 kg (0.99 lb)

Color

Black, Blue, and Silver

Cable

Length

3 m (10 ft)

Sterilization

Steam

Refer to Chapter 7 Cleaning and Sterilization on Page 23 for reprocessing instructions.

Validated Lifetime

100 Reuses

Refer to Chapter 7 Cleaning and Sterilization on Page 23 for reprocessing instructions.

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ShockPulse-SE Lithotripsy System (SPL-SR) Instructions for Use Specifications and General Description

Table 11 Sterile, Single Use ShockPulse Lithotripsy Probes

REF

Description

Color

Outside Diameter (mm)

Inside Diameter (mm)

Working Length (mm)

Provided Sterile

SPL-PD376

ShockPulse Lithotripsy Probe, Sterile Single Use (3.76 mm)

Silver

3.76

3.15

396

Yes; ETO

SPL-PD340

ShockPulse Lithotripsy Probe, Sterile Single Use (3.40 mm)

Blue

3.40

2.90

396

Yes; ETO

SPL-PD183*

ShockPulse Lithotripsy Probe, Sterile Single Use (1.83 mm)

Red

1.83

1.37

418

Yes; ETO

SPL-PD150*

ShockPulse Lithotripsy Probe, Sterile Single Use (1.50 mm)

Green

1.50

1.04

564

Yes; ETO

SPL-PD097** ShockPulse Lithotripsy Probe, Sterile Single Use (0.97 mm)

Gold

0.97

N/A

578

Yes; ETO

Inside Diameter (mm)

Working Length (mm)

Provided Sterile

*Includes Cleaning Stylet - Small **No Suction Available.

Table 12 Reusable ShockPulse Lithotripsy Probes - five (5) reuses

REF

Description

Color

Outside Diameter (mm)

SPL-PR376

ShockPulse Lithotripsy Probe, Reusable (3.76 mm)

Silver

3.76

3.15

396

No; Non-Sterile

SPL-PR340

ShockPulse Lithotripsy Probe, Reusable (3.40 mm)

Blue

3.40

2.90

396

No; Non-Sterile

SPL-PR183*

ShockPulse Lithotripsy Probe, Reusable, (1.83 mm)

Red

1.83

1.37

418

No; Non-Sterile

SPL-PR150*

ShockPulse Lithotripsy Probe, Reusable, (1.50 mm)

Green

1.50

1.04

564

No; Non-Sterile

SPL-PR097**

ShockPulse Lithotripsy Probe, Reusable, (0.97 mm)

Gold

0.97

N/A

578

No; Non-Sterile

*Includes Cleaning Stylet - Small **No Suction Available.

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ShockPulse-SE Lithotripsy System (SPL-SR) Instructions for Use Specifications and General Description

4.2 Operating and Storage Environment Table 13 Operating and Storage Environment Operating Environment

Storage Environment

Ambient Temperature

10 °C to 40 °C (50 °F to 104 °F)

Relative Humidity

10% – 70% RH

Air Pressure

70 kPa – 106 kPa (21 – 31 in.) Hg

Ambient Temperature

-25 °C to 55 °C (-13 °F to 131 °F)

Relative Humidity

10 – 85% RH

Air Pressure

70 – 106 kPa (21 – 31 in.) Hg

If there are any issues related to EM DISTURBANCES, the user can recover from any EUT error, indicated by a signal on the front panel, by either releasing and reengaging the foot pedal or restarting the device, after which the device will resume normal function.

4.3 Safety Specifications The ShockPulse-SE Lithotripsy System meets IEC 60601-1 - 3rd Edition, EN 61000-3-2 and EN 61000-3-3, EN 60601-1-2, EN55011, IECS-003 and FCC Part 15 subpart B. The ShockPulse-SE Lithotripsy System is intended for use in the electromagnetic environment specified in Table 14. The customer or user of the ShockPulse-SE Lithotripsy System should assure that it is used in such an environment. Table 14 Electromagnetic Emission Declarations 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

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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.

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ShockPulse-SE Lithotripsy System (SPL-SR) Instructions for Use Specifications and General Description

The ShockPulse-SE System is intended for use in the electromagnetic environment specified in Table 15. The customer or user of the ShockPulse-SE System should assure that it is used in such an environment. Table 15 Electromagnetic Immunity Declaration Immunity Test

IEC 60601 Test Level

Note

Electrostatic discharge (ESD) IEC 61000-4-2

±2 kV, ±4 kV, ±6 kV, ±8 kV contact ±2 kV, ±4 kV, ±8 kV, ±15 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

AC Mains or DC Input: ±2 kV, 100 kHz PRF Input/Output Ports: ±1 kV, 100 kHz PRF

Power quality should be that of a typical commercial or hospital environment.

Surges Line-to-line IEC 61000-4-5 ± 0.5 kV, ± 1 kV

Power quality should be that of a typical commercial or hospital environment.

Surges Line-to-ground IEC 61000-4-5

Power quality should be that of a typical commercial or hospital environment.

± 0.5 kV, ± 1 kV, ± 2 kV

Voltage dip, short interruptions 100% of VNOM for 8.3 mSec and voltage variations on power (0.5 Line Cycles) at 0°, 45°, 90°, supply input lines IEC 61000-4-11 135°, 180°, 225°, 270°, 315° 100% of VNOM for 16.67 mSec (1 Line Cycle) at 0° 60% of VNOM for 100 mSec (6 Line Cycle) at 0° 30% of VNOM for 500 mSec (30 Line Cycles) at 0° Interruptions: 100% of VNOM for 5000 mSec (300 Line Cycles) at 0°

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.

10

30 A/m at 50 Hz or 60 Hz

SPL-IFUR_AR

ShockPulse-SE Lithotripsy System (SPL-SR) Instructions for Use Specifications and General Description

The ShockPulse-SE system is intended for use in the electromagnetic environment specified in Table 16. The customer or user of the ShockPulse-SE system should ensure that it is used in such an environment. Table 16 Guidance and Manufacturer’s Declaration – Immunity Immunity Test

IEC 60601 Test Level

Conducted RF IEC 61000-4-6

0.15 MHz – 80 MHz 6 V in (V1) = 3 Vrms ISM bands between 0.15 MHz and 80 MHz 80% AM at 1 kHz

Radiated RF IEC 61000-4-3

3 V/m 80 MHz – 2.7 GHz 80% AM at 1 kHz

Compliance Level

(E1) = 3 V/m

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: 150 kHz to 80 MHz d = 1.2√P

80 MHz to 800 MHz d = 1.2√P 800 MHz to 2.7 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 survey,a 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. a. 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. b. Over the frequency range 0.15 MHz to 80 MHz, field strengths should be less than 3 V/m.

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ShockPulse-SE Lithotripsy System (SPL-SR) Instructions for Use Specifications and General Description

Table 17 Proximity Field from Wireless Transmitters (61000-4-3) Test Frequency (MHz)

Band a MHz

Service a

Modulation b

385

380 – 390

TETRA 400

450

430 – 470

710 745 780

NOTE

Maximum Power (W)

Distance (m)

Immunity Test Level (V/m)

Pulse modulation b 18 Hz

1.8

0.3

27

GMRS 460 FRS 460

FM c ± 5 kHz deviation 1 kHz sine

2

0.3

28

704 – 787

LTE Band 13, 17

Pulse modulation b 217 Hz

0.2

0.3

9

810 870 930

800 – 960

GSM 800/900 TETRA 800 iDEN 820 CDMA 50 LTE Band 5

Pulse modulation b 18 Hz

2

0.3

28

1720 1845 1970

1700 – 1990

GSM 1800 GSM 1900 CDMA 1900 LTE Band 1, 3, 4, 25 DECT UMTS

Pulse modulation b 217 Hz

2

0.3

28

2450

2400 – 2570

Bluetooth WLAN 802.11 b/g/n RFID 2450 LTE Band 7

Pulse modulation b 217 Hz

2

0.3

28

5240 5500 5785

5100 – 5800

WLAN 802.11 a/n

Pulse modulation b 217 Hz

0.2

0.3

9

If necessary to achieve the IMMUNITY TEST LEVEL, the distance between the transmitting antenna and the ME EQUIPMENT or ME SYSTEM may be reduced to 1m, The 1 M test distance is permitted by IEC 61000-4-3.

a. For some services, only the uplink frequencies are included. b. The carrier shall be modulated using a 50% duty cycle square wave signal. c. As an alternative to FM modulation, 50 pulse modulation at 18 Hz may be used because while it does not constitute actual modulation, it would be worst case.

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ShockPulse-SE Lithotripsy System (SPL-SR) Instructions for Use Specifications and General Description

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 in Table 18, according to the maximum output power of the communications equipment. Table 18 Recommended Separation Distances between Portable and Mobile RF Communications Equipment and the ShockPulse-SE System Separation distance according to frequency of transmitter (m) Rated maximum output power of transmitter (W)

150 kHz to 80 MHz d=1.2√P

80 MHz to 800 MHz d=1.2√P

800 MHz to 2.7 GHz 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.

4.4 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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ShockPulse-SE Lithotripsy System (SPL-SR) Instructions for Use Specifications and General Description

4.5 Front Panel of Generator Figure 1

Front Panel of Generator

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.

3.

4.

5.

6. 7.

14

• 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. 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. 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. 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. High Power Indicator • The high power indicator is illuminated green when the transducer is activated in High Power mode. Standard Power Indicator • The standard power indicator is illuminated green when the transducer is activated in Standard Power mode.

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ShockPulse-SE Lithotripsy System (SPL-SR) Instructions for Use Specifications and General Description

Figure 2

Rear Panel of Generator

4.6 Back Panel of Generator 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

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ShockPulse-SE Lithotripsy System (SPL-SR) Instructions for Use Specifications and General Description

4.7 Optional Footswitch (SPL-FS) Figure 3

1. 2.

3. 4. 5. 6.

16

Optional Footswitch (SPL-FS)

HIGH POWER Pedal Mode (Gray) a. Depressing the HIGH POWER pedal causes the ShockPulse-SE System to produce maximum energy to fragment large stones into smaller stone pieces. STANDARD POWER Pedal Mode (Black) 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 mm or 1.83 mm probes are being used. c. Standard Power is required when the 0.97 mm probe is being used. Cable Baseplate Standard Power Label High Power Label

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