MicroPerc ALL SEEING NEEDLE Operating Manual Rev 003 April 2012

All rights reserved. This operating manual contains information that is protected by the manufacturer. It is prohibited to copy this operating manual and to take sections of the text or duplicates without prior written permission by POLYDIAGNOST GmbH. The manufacturer reserves the right to make changes and updates to the manual. Due to the continued development of our products, it is possible that technical specifications or images in this operating manual do not correspond to the current state of production. As manufacturer of the endoscopes, POLYDIAGNOST GmbH assumes no responsibility whatsoever for any damages to the devices, nor for damages caused by the faulty use of the endoscope and by not adhering to this operating manual. Service and repair work on the devices may only be carried out by the manufacturer or by a maintenance company authorized and appointed by POLYDIAGNOST GmbH. Opening the instruments or having repairs carried out by non-authorized persons will void all safety and warranty claims.

POLYDIAGNOST GmbH POLYDIAGNOST Entwicklungs-, Produktions-, Vertriebs- und Servicegesellschaft für medizinelektronische Diagnostik- und Therapiegeräte mbH

Schäfflerstr. 13 D-85276 Pfaffenhofen / Ilm www.polydiagnost.com info@polydiagnost.com

PH 01.2 Operating Manual PCNL Optic modular PD-PN-0080

Tel.: Fax:

+49 84 41 / 80 60 – 0 +49 84 41 / 80 60 – 60

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Table of Contents

Page

1

Safety... 5

1.1

Intended application ... 5

1.2

Operating manual ... 5

1.3

Compatibility with other devices ... 5

1.4

Important information ... 5

1.5

On receiving the modular PCNL optic ... 5

1.6

Reconditioning and storage... 6

1.7

Sterile packaged products ... 6

1.8

Repair / exchange ... 6

1.9

Compatibility ... 6

2

Specifications ... 7

3

Product description ... 8

4

Technic ... 10

4.1

Camera system ... 10

4.2

Irrigation pump ... 11

4.3

Labeling ... 12

5

Set up of the system ... 13

5.1

Preparation of the MICROPERC® system – All Seeing Needle - ... 13

5.2

Laser stone management through the working shaft of the All Seeing Needle ... 16

5.3

Shock wave Lithotripsy ... 18

5.4

How to proceed with the 8 F or 10.5 F working shaft ... 20

5.5

1

LithoClast® Probe... 21

5.6

1

LithoClast® Master Probe ... 22

6

Preparation for the use of the endoscopy system ... 24

6.1

3-joint arm ... 24

6.2

Exchangeable ocular ... 25

6.3

Connection of ocular and camera ... 26

6.4

Ligth connection ... 27

6.5

The complete installed image transmission system ... 29

7

Operation of the endoscopy system ... 30

7.1

Preparation of the modular endoscope... 30

7.2

Inspection of the modular endoscope ... 30

7.3

Basic equipment ... 30

7.4

Checking the endoscopic image... 30

8

Troubleshooting ... 31

8.1

Occurrence of an error ... 31

8.2

Sending endoscope / instrument in for repair ... 31 PH 01.2 Operating Manual PCNL Optic modular PD-PN-0080

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9

Instructions for reconditioning ... 32

9.1

General statement ... 32

9.2

Safety information ... 32

9.2.1

Basics ... 32

9.2.2

Terminology ... 33

9.2.3

Causes of a faulty reconditioning ... 33

9.3

Cleaning, disinfection and sterilization... 33

9.3.1

Basics ... 33

9.3.2

Precautionary measures ... 34

9.3.3

Reconditioning overview ... 35

9.3.4

Pre-cleaning immediately after the examination ... 35

9.3.5.

Manual cleaning and disinfection ... 36

9.3.6.

Machine cleaning and disinfection (disinfector) ... 38

9.3.7

Sterilization ... 40

9.3.8

Material compatibility ... 41

9.4

Storage of modular optic and accessories... 43

9.5

Service life ... 44

10

Transporting the endoscope ... 44

10.1

Transport inside the hospital ... 44

10.2

Transport outside the hospital ... 44

10.3

Transporting the endoscope by using a shipping company / transport company ... 44

11

Certificates ... 45

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1

Safety

1.1

Intended application

For endoscopic therapy of kidney stones.

1.2

Operating manual

Before using the endoscope, please thoroughly read the operating manual as well as the operating manuals of all other necessary devices that are to be used during the examination. The different endoscopic procedures and the medical aspects of endoscopy are not a part of these instructions. Keep the operating manual in a safe, easily accessible place. If you have questions or suggestions about the content of this operating manual, please contact the company POLYDIAGNOST or its distribution partners.

1.3

Compatibility with other devices

The safe operation of endoscopy devices depends in large part on the correct selection of other devices. The combination with any devices other than the recommended ones can lead to an impairment of safety and performance.

1.4

Important information

The user has to check and decide whether the endoscope is the right model for the intended examination. A prerequisite for the safety of patients is the proper handling of the endoscope by the doctor and the medical personnel. Examples of improper behavior: Using insufficiently prepared or wrongly stored devices increases the risk of infection of the patient and personnel. Forcing the endoscope forwards or backwards without a clear endoscopic view can lead to injury to the patient. The insertion and / or use of endoscopic accessories without a clear endoscopic view can lead to injury to the patient.

1.5

On receiving the modular PCNL optic

Check the modular endoscope for damages and for proper functionality. Do not use the modular endoscope if there are any visible damages and / or if the functionality is not guaranteed. If you notice any irregularities, please contact your POLYDIAGNOST customer representative. WARNING: The endoscope was not sterilized or disinfected before delivery. It must be cleaned and disinfected / sterilized before every use, as described in the corresponding chapter of the manual.

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1.6

Reconditioning and storage

After use, recondition the endoscope and store it according to the general guidelines. (See chapter “Instructions for reconditioning”.) Insufficient reconditioning can create an infection risk and cause damage to the device. Attention: The optic is not autoclavable. Autoclaving will damage the optic.

1.7

Sterile packaged products

When using sterile packaged products, make sure that the sterile packaging is undamaged. If the packaging is damaged, the products may not be used.

1.8

Repair / exchange

This endoscope contains no parts to be serviced by the user. Do not make any changes to the endoscope or attempt to repair it, as this can lead to putting the patient at risk or can damage the device. (See chapter “Troubleshooting”.)

1.9

Compatibility

Our products may contain nickel and / or latex. Care must be taken in case of relevant allergies. In such cases, the use of the device is up to the doctor’s judgment.

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Specifications

Figure 1 - PCNL optic with protective tube for optic

10,000 pixel optic, 120°  Article number:

PD-PN-0080

 Exterior diameter:

0.9 mm

 Image control system:

10,000 pixel

 Viewing direction:

0°, direct view

 Field of vision:

120°

 Optic length:  Standard light connection:

272 mm ACMI adapter Integrated fiber-optic lighting Reinforced nitinol optic

Operating conditions

Room temperature Rel. humidity Air pressure

PH 01.2 Operating Manual PCNL Optic modular PD-PN-0080

10 – 40 C (50 – 104 F) 30 – 85% 700 – 1060 mbar

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Product description

3.1

The needed parts

The system consists out of 13 parts, which all have to be placed at the table before examination. 10,000 pixel Optic (PD-PN-0080) reusable

Figure 2

Shifter 26 mm (PD-DS-1210) autoclavable Figure 3

All Seeing Needle 5 F (PD-PN-0015) exterior diameter: 1.65 mm sterile (single-use)

Figure 4

T-Piece 3-port (PD-CA-0205) for All Seeing Needle sterile (single-use) Figure 5

3–way Stopcock sterile (single-use) Figure 6

Perfusion Tube (PD-CA-0201) sterile (single-use) Figure 7

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3-port LuerLock (PD-CA-0607) for the shaft of All Seeing Needle and 8 F working shaft sterile (single-use) Figure 8

Touhy Borst Adapter (PD-CA-0112) for fixation of the laser fiber sterile (single-use) Figure 9

8 F Working Shaft (PD-PN-0005) exterior diameter: 2.65 mm autoclavable Figure 10

10.5 F Working Shaft (PD-PN-0020) exterior diameter: 3.47 mm autoclavable Figure 11

2-port Adapter for 10.5 F working shaft (PD-PN-0030) autoclavable Figure 12

Lunderquist Guide Wire (PD-PN-0010) sterile (single-use)

Figure 13

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4

Technic

4.1

Camera system EndoGnost RA 100 The compact version of the POLYDIAGNOST endoscopy tower includes: Camera Xenon Ligthsource 15” Monitor Digital USB-Stick Recorder (video and pictures)

Figure 14

POLYDIAGNOST 3-Joint-Arm It holds the camera outside the sterile area.

Figure 15

The ocular fix-focus (PD-FS-4001) has to be fixed on the upper side of the 3-Joint-Arm.

Figure 16

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4.2

Irrigation pump POLYDIAGNOST Irrigation Pump IP 200 (PD-IP-0100 / 230 V) (PD-IP-0110 / 110 V)

Figure 17

Irrigation Tube for IP 200 (PD-IP-0120) sterile (single-use)

Figure 18

Spike for the Irrigation Solution Bag (PD-IP-0121) sterile (single-use)

Figure 19

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4.3

Labeling

The respective serial number, manufacturer and CE-label are indicated on the body of the optic and the exchangeable oculars. Serial number Manufacturer CE-label

Figure 20

Serial number and CE-label

Figure 21

Manufacturer

Figure 22

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5

Set up of the system

5.1

Preparation of the MICROPERC® system – All Seeing Needle – remove protection tube from the optic

Figure 23

provide the shifter

Figure 24

and move it with open screw over the optic

Figure 25

The needle has to be placed in the shaft (cone-shaped connection)

Figure 26

and connected with slight twisting.

Figure 27

connect T-piece (a)

a Figure 28

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adapt stopcock (b) on T-piece b

Figure 29

now insert the optic into the needle

Figure 30

connect shifter with T-piece with gentle twisting

Figure 31

adapt irrigation tube at the stopcock

Figure 32

Finally adjust the distal end of the optic to the cone end of the needle by using the shifter.

Figure 33a

optic

Figure 33b PH 01.2 Operating Manual PCNL Optic modular PD-PN-0080

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the stopcock allows irrigation

Figure 34

and injection of contrast medium

Figure 35

Important: a)

Adjust „up – down” position of the endoscopic picture on screen through rotating the camera head at the ocular.

b)

Irrigate the All Seeing Needle completely before placing into the patient.

Figure 36 - Insertion of the All Seeing Needle under US-Control

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5.2

Laser stone management through the working shaft of the All Seeing Needle remove stilett including optic out of the working shaft (The working shaft remains inside the patient.)

Figure 37

remove the optic out of the stilett

Figure 38

now move the optic through the side-port of the 3-port adapter

Figure 39

Very, very important: move finally the optic as far as possible out of the shifter and fix the optic with the screw (a).

Figure 40a

a

Figure 40b

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place the optic with the 3-port adapter in the working shaft (which is inside in the patient) and connect it with the rotating LuerLock

Figure 41

stopcock for irrigation has to be connected

Figure 42

Finally the Touhy Borst adapter has to be connected to the middle port, then insert the laser fiber and keep the Touhy Borst adapter so much closed that no irrigation solution flows out of it and the laser fiber can still become shiftet smoothly.

Figure 43

Laser fibers up to an outer diameter of 350µm can be used.

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5.3

Shock wave Lithotripsy

If the use of 1LithoClast® or a similar product is scheduled the 8 F working shaft must be used: LithoClast® Probe exterior diameter: 1 mm

Figure 44

8 F Working Shaft (PD-PN-0005) exterior diameter: 2.65 mm

Figure 45

Stopcock

Figure 46

3-port LuerLock (PD-CA-0607) for the shaft of All Seeing Needle and 8 F working shaft

Figure 47

Touhy Borst Adapter (PD-CA-0112) for fixation of the LithoClast® Probe

Figure 48

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If the use of 1LithoClast® Master or a similar product is scheduled the 10.5 F working shaft must be used: LithoClast® Master Probe exterior diameter: 1.9 mm

Figure 49

10.5 F Working Shaft (PD-PN-0020) exterior diameter: 3.47 mm

Figure 50

2-port Adapter for PCNL 10.5 F working shaft (PD-PN-0030)

Figure 51

T-Piece 3-port (PD-CA-0205) for All Seeing Needle

Figure 52

Touhy Borst Adapter (PD-CA-0112) for fixation of the LithoClast® Master Probe

Figure 53

1

LithoClast® and LithoClast® Master are registered tradenames of EMS Switzerland.

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5.4

How to proceed with the 8 F or 10.5 F working shaft Take the Lunderquist Guide Wire and move it under X-ray control into the working shaft of the All Seeing Needle which is placed inside the patient.

Figure 54

move then the needle out

Figure 55

and move careful the 8 F or 10.5 F working shaft over the guide wire

Figure 56

remove finally the obturator and guide wire

Figure 57a

Figure 57b

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