Photodynamic Diagnosis (PDD)

DETECTION Equipment Overview

Blue Light Flexible Cystoscopy with Cysview®

Detection: Flexible Blue Light Cystoscopy with Cysview®

1) Equipment Overview

• PDD Flexible Video Cystoscope

• Suction Assembly

• PDD CCU – TELECAM SL II FI

• PDD Light Source – D-Light C

• Suction Pump – ENDOMAT® LC

2) Procedure

• Equipment Start-Up Sequence

• Troubleshooting

3) Reprocessing: Cleaning and Sterilization

Detection with Flexible PDD: Equipment Overview

Component Name Part # Notes

Flexible

Cystoscope

Flexible

PDD Video

Cystoscope

11272VNIUAK/

11272VNIAK

Can be used in-office without

general anesthesia. Connecting

cable 20213070 is needed and

sold separately.

Camera

Control Unit

(CCU)

TELECAM

SL II FI

20213011U1 Flexible PDD-specific sensitivity

and image brightness

Light Source D-LIGHT C 20133620-134 Same light source used for both

Detection and Resection

Suction Pump ENDOMAT®

LC

20330320-1 Used to provide a clear surgical

view during procedures. Cysview

combined with urine can cause a

murky green effect. Wall suction

can be used as an alternative

Documentation

Unit

AIDATM HD

Connect

20205501-140 Record clinical images and

videos of each Blue Light case.

Flexible PDD Cystoscope

Light Source

Connection Leakage Tester

Connection

Deflection

Lever Handle

Suction

Assembly

Video Adapter

Cable (20213070)

Video connection

from Flexible PDD

Cystoscope to CCU

Flexible

Sheath

Working Channel

Flexible PDD Cystoscope

Working Channel Instruments

• 27425ZG Forceps, Biopsy, Flexible,

Double, 5Fr, 60cm

• 27425FG Forceps, Grasping,

F/Stone (Stent Removal), 5Fr,

60cm

• 27723T Electrode, Bugbee,

Monopolar, Ball, 73cm, 4Fr

• 26006M HF Cord, Monopolar,

Bugbee, 8mm plug, 300cm

Best Practice: When using a bugbee,

plug generator into a different outlet

from the Flex PDD tower to minimize

risk of video interference

Video Adapter Cable (20213070)

1. Unscrew the protection cap on PDD Flexible Cystoscope and plug in the Video Adapter Cable (20213070) by aligning white dots

2. Next, insert the PDD Video Cystoscope into the Light Source Connection of the D-Light C until it clicks.

3. Plug the other end of the Video Adapter Cable into the CCU. The top of the video adapter cable connector is labeled “UP”.

Flexible PDD Cystoscope

Button 3

• Quick Press: Menu

• Long Press: N/A

Button 1

• Quick Press: Toggle Blue Light On/Off

• Long Press: Brightness (“PEAK” setting is recommended)

Button 2

• Quick Press: Image Capture

• Long Press: Image Archive

Flexible PDD Cystoscope – Suction Assembly

Suction Valve 27100MV

(Single-Use)

Valve Intake 11900VA

Connecting Tube 27100MS

(Single-Use)

Forceps Unit/ Luer Lock 11272AZK

Luer Connector w/Stopcock 27502

Flexible PDD Cystoscope – Suction Assembly

1) Attach the Forceps Unit and Valve Intake to each end of the Connecting Tube.

2) Insert the Valve Intake into the channel in the scope handle

3) Attach the Forceps Unit to the instrument channel port in scope handle.

4) Screw the Suction Valve onto the Valve Intake.

Flexible PDD CCU – TELECAM SLII FI

Power

Switch

White Balance

Required before each

procedure

Video Adapter

Cable (20213070)

Video connection

from Flexible PDD

Cystoscope to

CCU

Connection for PDD

Flexible Cystoscope

Use connecting cable

(20213070) from scope

to CCU

Flexible PDD CCU – TELECAM SLII FI

SCB Cable Connection

Ensure the SCB cable is

connected between CCU

and light source

Flexible PDD Light Source – D-Light C

Power

Switch

Standby

Avoid thermal

damage when

cystoscope is not

in use

Brightness

Adjustment

Set to 100%

Blue Light On/Off

Toggle between White

Light and Blue Light.

Function duplicated on

Cystoscope Button #1

Light Cable

Connection

Mode

Always use MANUAL setting

Flexible PDD Light Source – D-Light C

Lamp Life

Warning Light

Turns on at 350

hours of service.

Call your KARL

STORZ Rep if

warning light

appears

Total Hours of Usage

Appears for 3 seconds

when unit is powered up

Note: The model number for

D-Light C is the same for Rigid

PDD and Flex PDD

Units with “-E” at the end of

the serial number are

compatible with both

Rigid and Flex PDD

Units without “-E” in the

serial number are compatible

with Rigid PDD only

Power

Switch Suction Rate

Recommended setting:

400 mL/min

Suction

Start/Stop

Mode

Select “Normal”

(0-1000mL/min)

Pump Head

Connection for

Suction Tubing

(031247-10)

ENDOMAT® LC

ENDOMAT ® LC

Inflow

Outflow

Pump Reel

Lever

1) Lower the Pump Reel Lever until it is horizontal

2) Insert the tubing into the pump head with the inflow on

the bottom and outflow on the top

– Note: The suction tubing is directional and will only fit

properly when inserted in the correct direction

3) Raise pump reel lever back to the vertical position

4) Connect the free end of the inflow tube to the Valve

Intake (11900VA) of the Suction Assembly on the PDD

Flexible Cystoscope.

5) Connect the free end of the outflow tube to the

collection container for suction waste.

Flexible PDD Cystoscope – ENDOMAT ® LC Setup

Luer Connector 27500/3

Suction Tubing 031247-10

(Single-Use)

Inflow Outflow

Inflow

Outflow

NOTE: The shorter piece of

tubing included with the suction

tubing set is not needed for the

Flex PDD procedure and can be

discarded.

Discard

Procedure: Flexible Blue Light Cystoscopy

1) Cysview® is instilled directly into the patient’s bladder via catheter one hour before Blue Light Cystoscopy, which should be performed within 1-3 hours after instillation.

2) Flexible PDD Cystoscope is inserted

3) Bladder is completely emptied using the suction feature on the Flexible PDD Video Cystoscope and refilled again.

4) Bladder is examined and mapped using both white light and blue light

Start-Up Sequence

1) Plug the PDD Video Cystoscope into the Camera Control Unit (CCU) and the D-Light C

2) Start Up Sequence:

3) Power up remaining components (ENDOMAT® LC, etc.)

Monitor CCU D-Light C AIDATM

Troubleshooting Problem: No Light at distal end of the scope

Solution:

1) Check the SCB cable connection between CCU and D-Light C

2) Check the connection between Video Adapter Cable (20213070) and the PDD Video Cystoscope

3) Check connection between Video Adapter Cable and CCU

4) Shut down the system and reboot according to Start-Up Sequence:

Monitor CCU D-Light C AIDATM

Reprocessing

Sterilization

Flexible PDD Video Cystoscope

• STERIS System 1E (SS1E) sterilization is validated for the PDD Video Cystoscope

• For High Level Disinfection (HLD), Resert XL HLD (2.0% Hydrogen Peroxide) is approved

Suction Assembly

• Steam Sterilization is approved for reusable components

• The Suction Valve and Connecting Tube are single-use and should be discarded

Suction Assembly

• Disassemble the Suction Assembly

• Discard Suction Valve and Connecting Tube

• The Valve Intake and Forceps Unit can be reused after they have been cleaned and steam sterilized.

• Important: Double check that the base and double luer lock of the Forceps Unit remain screwed in tightly together after steam sterilization. If not, leakage can occur during a case.

Reprocessing

Reprocessing Post-Procedure

1) Wipe down the Flexible PDD Cystoscope with a lint free, disposable cloth, moistened with water

2) Detach the Video Adapter Cable

3) Close the cap on the Flexible PDD Cystoscope for the video cable connector and ensure it is screwed on tightly.

Leakage Test

1) Ensure that the Leakage Tester Connecting Tube and Leakage Tester Connection on the scope are completely dry

2) Follow directions in IFU

3) Use the grey button on Leakage Tester to release remaining pressure and detach from scope

Reprocessing

PDD Flexible Video Cystoscope

• Immerse in cleaning solution

• Rinse and brush working channel using Cleaning Brush (110910-50) and Irrigation Adapter (11900RA)

• Attach Irrigation Adapter by pressing and twisting simultaneously to ensure a tight fit

• Attach syringe to proximal end of Irrigation Adapter to rinse working channel

• Clean distal lens

• Inspect for visual damages

Reprocessing

STERIS System 1E (SS1E)

For SS1E parts, order directly from Steris: (800) 548-4873

STERIS Quick Connect

QKC1734E

STERIS Universal Flexible Processing Tray

C1160E

In case of technical difficulties please call:

• Contact: (800) 421-0837; Press 2

• Support email: KSEATechnicalServices@karlstorz.com

• Hours of Operation : 6:00am to 3:00pm PST Monday-Friday

• Medical Emergency After Hour Support 24/7/365

Technical Support & Repair

Cysview Risk & Safety Information