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DirectVision® Instruction Manual

Page ii


Page iii

Table of Contents

GENERAL GUIDANCE .......................................................................... 1

INTRODUCTION ...................................................................................... 1

INDICATIONS FOR USE ............................................................................. 1

PRODUCT OVERVIEW ......................................................................... 2

DIRECTVISION® SYSTEM ........................................................................... 2

DIRECTVISION® GUIDE ............................................................................ 2

DIRECTVISION® CATHETER ....................................................................... 2

WARNINGS & CAUTIONS ................................................................... 3

DOCUMENTATION CONVENTIONS .............................................................. 3

GENERAL WARNINGS .............................................................................. 3

GENERAL CAUTIONS ............................................................................... 5

CATHETERIZATION INSERTION PROCEDURE ....................................... 6

SPECIFIC WARNINGS ............................................................................... 6

SPECIFIC CAUTIONS ................................................................................ 7

SPECIFIC NOTES ..................................................................................... 8

USER & ASSISTANT RESPONSIBILITIES ......................................................... 9

QUICK START INSTRUCTIONS FOR DIRECTVISION® ....................................... 14

Setup DirectVision® System ......................................................... 14

Setup DirectVision® Catheter and Guide ..................................... 14

Catheterize Patient ..................................................................... 15

Post Catheterization Procedure .................................................. 15

DETAIL INSTRUCTIONS FOR DIRECTVISION® ................................................ 16

CATHETER REMOVAL PROCEDURE ................................................... 37

WARNINGS AND CAUTIONS .................................................................... 37

PROCEDURAL STEPS .............................................................................. 37

CLEANING, DISINFECTING & STERILIZING ......................................... 39

INTRODUCTION .................................................................................... 39

GENERAL WARNINGS AND CAUTIONS ....................................................... 39

DIRECTVISION® GUIDE ........................................................................... 40

Specific Warnings ........................................................................ 40

Specific Cautions ......................................................................... 41


Page iv

Specific Note ................................................................................ 41

Cleaning Procedure ..................................................................... 42

Disinfecting Procedure ................................................................ 43

Sterilization Recommendations ................................................... 43

Sterilizing Procedure .................................................................... 43

Additional Warnings .................................................................... 44

CAMERA HANDPIECE ............................................................................. 44

Specific Warning .......................................................................... 44

Specific Cautions.......................................................................... 45




CAMERA CONTROL UNIT ........................................................................ 47





DISPLAY MONITOR ............................................................................... 49


Cleaning Plastic Enclosure Procedure .......................................... 50

Cleaning Color LCD Display Procedure ........................................ 50



CART .................................................................................................. 51

Specific Caution ........................................................................... 51




DEFINITIONS .................................................................................... 52

REFERENCES .................................................................................... 53


Page 1 of 53

General Guidance

Introduction Thank you for purchasing the PercuVision® DirectVision® System. This manual is intended to serve as a guide for assembling, preparing components for use, operating and handling, maintaining, cleaning, disinfecting and sterilizing the DirectVision® System and reusables. All of these guidances are explained in this manual. It is imperative that you read and understand the contents of this manual prior to use. Keep this instruction guide for reference.

Indications for Use The DirectVision® Catheter is indicated for use in the drainage and/or collection and/or measurement of urine. It is intended to be used as a urological catheter inserted through the urethra for the purpose of draining urine and other fluids from the urinary tract. However, drainage is sometimes accomplished by suprapubic or other placement of the catheter, such as the nephrostomy tract.

The DirectVision® Guide is indicated for use in the visual examination of the urethra and bladder when placing the DirectVision® Catheter.

Warning: Federal (USA) Law restricts this device to use by or on the order of a physician.

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Product Overview

DirectVision® System

Compact camera with integrated LED light source

Custom designed optics

Control features for image optimization

Cart with LCD color monitor

DirectVision® Guide Endoscopic quality image

Fiber-optic bundle to transport light and images

1.5mm flexible design for easy insertion into the

DirectVision® Catheter

Quick, easy and secure connection to the camera and

catheter

DirectVision® Catheter 3-way / tri-lumen Foley design: vision, voiding and balloon

inflation

Irrigation enabled

100% silicone

1cm insertion markers

Multiple French sizes for various voiding capacities

10cc balloon


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Warnings & Cautions

Documentation Conventions Please read this manual and follow its instructions carefully. The words: Warning, Caution, and Note carry special meaning and should be reviewed carefully:

Warning: The personal safety of the patient or user may be involved. Disregarding this information could result in injury to the patient or user.

Caution: Special service procedures or precautions must be followed to avoid damage to the equipment.

Note: Special information to make maintenance easier and important information more clear.

An exclamation point within a triangle alerts the user of risk of danger; attention, consult company documents.

General Warnings It is important to read and understand this instruction manual. Failure to follow these instructions may cause damage to the product or harm to the patient and/or the user. The user should do the following:

1. Warning: Read this instruction manual thoroughly before

assembling and using the product.

2. Warning: Be a qualified user and properly trained in

DirectVision® catheterization placement procedure.

3. Warning: Federal (USA) Law restricts this device to use by

or on the order of a physician.

4. Warning: Keep the distal tip of DirectVision® Guide and DirectVision® Catheter in your field of vision at all times during the procedure (Create & maintain the sterile field).

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5. Warning: Read and understand the care, cleaning, disinfecting, and sterilizing instructions in this manual. Failure to follow these instructions may cause damage to the product or harm to the patient and/or user.

6. Warning: To minimize the risk of patient infection, the DirectVision® Guide must be cleaned and sterilized prior to the first use and every subsequent use. See the Cleaning, Disinfecting & Sterilizing Section in this manual for details.

7. Warning: Do not use this product until you have sterilized the necessary components.

8. Warning: Never look directly at the light emitted from the light source of the camera handpiece or the DirectVision® Guide. Eye damage may result.

9. Warning: Never leave the DirectVision® System powered and unattended. Heat from the light source could ignite drapes or other materials.

10. Warning: Do not store or use the DirectVision® System in an environment that contains flammable gases which can result in an explosion.

11. Warning: The DirectVision® System must only be repaired by personnel authorized by PercuVision®. Unauthorized repairs could compromise the safety and integrity of the product and voids the warranty.

Failure to follow the instructions in this manual could void the warranty.

PercuVision® reserves the right to improve our product. As a result, product may not conform in detail to published design or specifications. Improvements are subject to change without notice. Please contact PercuVision® customer care department for information on improvements and new products.


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General Cautions 1. Caution: Carefully unpack the shipment and check for

physical damage. If damage is observed or suspected, please refer to the Warranty, Service and Claims Section in DirectVision® Technical Reference Manual (PL000072) for resolution.

2. Caution: Do not use the DirectVision® System until you have verified that it is properly assembled, setup and functioning correctly.

3. Caution: Use only in conjunction with other Type BF or CF rated medical electrical equipment approved to IEC 60601-1 or equivalent standard.

4. Caution: The DirectVision® System has been designed and tested to comply with IEC 60601-1(ed. 3.1)including requirements for electromagnetic compatibility with other devices. Make sure that all devices operated in the vicinity comply with the relevant EMC requirements. Radio systems, mobile telephones, etc. are possible sources of interference as they may emit higher levels of electromagnetic energy.

5. Caution: Never attempt repairs or maintenance to the DirectVision® System before reviewing the Warranty, Service and Claims Section of DirectVision®Technical Reference Manual (PL000072).

6. Caution: To prevent damage to the DirectVision® Guide and camera handpiece, always handle with care. Do not drop, crush, cut, or bend any portion of the visual guide beyond a 2” radius. Although the visual guide is flexible, bending beyond the specified radius could cause breakage in the fiber optic bundle, which reduces its useful life. Kinking the visual guide could break the entire fiber optic bundle which can render it non-operational.

7. Caution: Do not expose the DirectVision® System to excessive heat which can cause damage.


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8. Caution: Never place heavy objects on the DirectVision® System.

9. Caution: The DirectVision® System and accessories must be disposed of according to local regulations, ordinances and hospital practices.

Catheterization Insertion Procedure

Specific Warnings 1. Warning: A user should stop catheterization upon observing

pelvic trauma. The system is not recommended if in the opinion of a qualified physician, use would endanger the patient, e.g. due to the patient’s general condition.

2. Warning: This information is not a substitute for proper training. Use of this product without proper training could result in patient or user injury.

3. Warning: Always remove visual guide before balloon

inflation.

4. Warning: Before any catheterization procedures and

sterilization processes, inspect the DirectVision® System for

damage. Do not use damaged DirectVision® products in a

catheterization procedure.

5. Warning: Always inspect the visual guide before a

procedure. Never use a visual guide that has burs, sharp

edges, cracked or disconnected jacket and/or strain

relief(s), or is kinked.

6. Warning: Never insert the DirectVision® Guide into a

patient without first placing it into a PercuVision® catheter.

7. Warning: Only use a DirectVision® Guide with a

DirectVision® Catheter. Failure to do so can result in patient

injury.

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.

8. Warning: After each use, remove any observable body

fluids and/or mucus or incrustations from the DirectVision®

Guide with 70% isopropyl alcohol, place it in the sterilization

container and send it to the sterilization department for

immediate cleaning and sterilization.

9. Warning: To minimize the risk of patient infection, the

DirectVision® Guide must be sterilized by your facility prior

to the first use and after every subsequent use. See the

Cleaning, Disinfecting & Sterilizing Section of this manual

for sterilization details. Always use a new sterile

DirectVision® Catheter with each catheterization.

10. Warning: Be sure to remove the DirectVision® Guide from

the patient prior to discharge of a defibrillator. Failure to

follow this warning could result in patient injury or damage

to the DirectVision® Guide.

11. Warning: Do not use ointments or petroleum based

lubricants. They will damage the silicone catheter and may

cause balloon rupture.

Specific Cautions 1. Caution: To prevent damage to the DirectVision® System,

always handle the visual element and camera with care. Do not drop, crush, cut, or bend any portion of the visual element beyond a 2” radius. Although the visual guide is flexible, bending beyond the specified radius could cause breakage in the fiber optic bundle, which reduces its useful life. Kinking the visual guide could break the entire fiber optic bundle which can render it non-operational.

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2. Caution: Be sure to either irrigate the visual guide lumen of

the DirectVision® Catheter with sterile irrigation water (not

saline solution) or lubricate the visual guide directly with

surgical lubricant prior to inserting the DirectVision® Guide.

This will lubricate the catheter’s visual guide lumen and

facilitate placement of the visual guide. Failure to do so

can cause damage to the visual guide and/or catheter.

Specific Notes 1. Note: Once the powerbutton for the Monitor is turned ON,

it remains ON even when the power cord is not plugged into a wall receptacle.

2. Note: The DirectVision® catheterization procedure involves two people (i.e. User and assistant).

3. Note: The DirectVision® catheterization procedure requires double gloving or a glove change.

4. Note: PercuVision® does not recommend inflating the balloon prior to catheter insertion.

5. Note: For the balloon volume 10cc = 10ml.


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User & Assistant Responsibilities

User’s Responsibilities Assistant’s

Responsibilities

Setup DirectVision® System

Lock cart wheels

Plug power plug of cart into wall

receptacle

Connect camera handpiece to

CCU

Turn on CCU & monitor

Place an IV pole next to the

DirectVision® System

Hang irrigation bag on the IV

pole

Setup DirectVision® Catheter and Guide

Receive wrapped DirectVision®

Guide

Unwrap DirectVision® Guide

Prep patient and create a sterile

field

Spike the irrigation bag

Present sterile catheter package


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Remove DirectVision® Catheter from package

Turn on irrigation

Lubricate the visual guide lumen with sterile irrigant OR Lubricate the visual guide directly with surgical lubricant

Turn off irrigation


Responsibilities

Connect irrigation tubing to center port of catheter

Lubricate the catheter (with sterile gel) except for the very tip (visual guide opening)

Remove lid of sterilization box which contains sterile

DirectVision® Guide

Retrieve DirectVision® Guide from sterilization box

Present visual guide connector to camera handpiece connector

Present camera handpiece connector to visual guide connector

Connect camera handpiece to visual guide

Lock visual guide to camera handpiece

Insert DirectVision® Guide into catheter

Lock visual guide to catheter


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Confirm system operation (light at tip of visual guide and image on monitor)

Perform white balance Press white balance button

Perform focus adjustment Adjust focus ring on camera handpiece

Orient the catheter curve tip and the visual guide alignment “dot” to the 12:00 o’clock position (curved tip up)


Responsibilities

Catheterize Patient

Start irrigation

Insert the catheter Hold connected camera handpiece-visual guide

Stop irrigation

Unlock visual guide from catheter

Remove visual guide from catheter

Present connected visual guide-camera handpiece to assistant

Receive connected visual guide-camera handpiece

Cap visual guide lumen


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Advanced catheter hub to meatus

Inflate balloon

Disconnect irrigation tubing

Connect urine collection bag & verify urine flow


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Responsibilities

Post Catheterization Procedure

Unlock & separate visual guide from camera handpiece

Clean camera handpiece and cable

Place camera handpiece in the camera holder.

Wipe off used visual guide and place in sterilization box

Close lid of sterilization box

Send visual guide to sterilization department

Dispose of waste

Turn off power

Unplug power cord

Clean DirectVision® System

Unlock cart wheels & transport cart to holding area


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Quick Start Instructions for DirectVision®

Setup DirectVision® System

1. Lock cart wheels and plug in power cord

2. Connect camera handpiece to CCU and turn on CCU & monitor

3. Locate and place an IV pole next to the DirectVision System

4. Hang catheter irrigation solution bag on the IV pole

Setup DirectVision® Catheter and Guide

5. Open visual guide sterile box wrap

6. Prep patient and create a sterile field

7. Connect irrigation tubing to IV bag

8. Remove DirectVision® Catheter from package

9. Instill 1-2ml of sterile irrigant into the visual guide lumen (via irrigation tubing) OR lubricate visual guide directly with surgical lubricant

10. Stop irrigation and connect irrigation tubing to center port of catheter

11. Lubricate the catheter (with sterile gel) except for the very tip (visual guide opening)

12. Connect DirectVision® Guide to camera handpiece and lock into place

13. Insert the DirectVision® Guide into visual guide port of DirectVision® Catheter and lock into place. Focus

14. Inspect the visual guide image for brightness and clarity prior to each use. Discontinue use of any visual guide which has an unacceptable image after troubleshooting

15. Orient the catheter curve tip and the visual guide alignment “dot” to the 12:00 o’clock position (curved tip up)


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Catheterize Patient

16. Start irrigation and insert the catheter into meatus

17. Advance the catheter while viewing the video image on the monitor

Note: If a DirectVision® Guide fails to provide an adequate visual representation of the urethra to the clinician, the catheterization procedure should be discontinued

18. Steer the catheter by rotating the catheter and manipulating the penis (to keep full image of urethra whenever possible)

19. Advance the catheter until the tip enters the bladder (the video image will go dark or yellow)

20. Stop irrigation. Unlock and remove the DirectVision® Guide and cap the lumen

21. Advance the hub of the catheter to meatus before inflating balloon with no more than 10ml of sterile water

Note: Inflating the balloon should not cause pain to the patient

22. Disconnect irrigation tubing and connect the urine collection bag

Post Catheterization Procedure

23. Unlock and detach the DirectVision® Guide from the camera handpiece

24. Place visual guide in its tray for immediate cleaning and re-sterilization by sterile processing

25. Power down the equipment, remove camera handpiece from CCU, unplug power and unlock wheel casters. Move system to holding location (restock as needed)

26. Properly dispose of waste materials


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Detail Instructions for DirectVision® 1. Setup the DirectVision® System

Position DirectVision® System in room to perform catheterization procedure near a 110/120 VAC wall socket.

Lock the cart wheels.

Warning: Failure to lock the wheels could result in cart movement during the catheterization procedure. Injury to the patient could result.

Unwind the power cord, and plug it into an approved medical grade 110/120 VAC wall receptacle, keeping the cord away from traffic areas to prevent tripping.

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Connect camera handpiece to the CCU. o Retrieve the camera handpiece from the camera

holder.

o Remove the Plug Cap (metal cover) from Camera Handpiece Plug end.


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Note: The camera cord may be controlled by threading it through one loop of an IV pole.

o Connect the Camera Handpiece Plug to the camera connector receptacle on the CCU’s front panel. Red alignment dot on camera connector plug should align to the red dot on the CCU receptacle.

Caution: Be careful how you align the Camera Handpiece Plug into the CCU Connector Receptacle. Failure to align pins with the corresponding pin hole could cause damage to the pins.

Turn on the CCU by pressing the power ON button. CCU LED should illuminate.


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Note: The display monitor’s power switch should be ON. If this is not the case, the display monitor must be turned ON. Turn on the Monitor power by pressing the Power Button on the back of the monitor. The monitor LED Indicator should illuminate GREEN.

Hang an irrigation bag on an IV pole placed next to the DirectVision® System.

2. Prepare DirectVision® Guide

Receive wrapped visual guide.

Verify visual guide was sterilized (color of external sterilization indicator)

Unwrap DirectVision® Guide box using sterile technique.

3. Prep the patient for procedure (create and maintain a sterile field).

Note: PercuVision® recommends double gloving, put on a mask, apply antiseptic such as Betadine to genitalia, instill

Wrapped sterilization tray

Closed sterilization tray

Visual Guide in an open sterilization tray

Preparing the DirectVision® Guide for Use


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lidocaine gel into urethra, apply a penile clamp, open a fenestrated sterile drape and properly position it on the patient. These steps should be performed in accordance to standard hospital protocol. Details for this step are not presented in this document.

4. Connect irrigation tubing to IV bag.

Assistant connects irrigation tubing to the irrigation bag (i.e. Spike the irrigation bag).

Assistant removes the DirectVision® Catheter by peeling back the outer, unsterile packaging and presents the sterile catheter to user.


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Remove the catheter from the packaging.

Note: The uncoated catheter does not have inner packaging.

Instill 1-2ml of sterile irrigation water from irrigation

tubing into the visual guide lumen of the DirectVision®

Catheter. Water will lubricate the catheter’s visual

guide lumen and facilitate the passage of visual guide.

The visual guide may also be lubricanted directly using

surgical lubricant.


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Stop irrigation. Connect irrigation tube to the irrigation/drainage lumen of the DirectVision® catheter.

5. Lubricate the catheter shaft with sterile gel.

Note: Lubricate about 8 inches (20 cm) of the catheter

shaft with a lubricant approved by your healthcare facility

for 100% silicone catheters. Do not lubricate the first 0.25

inches of the tip in order to avoid obscuring the visual guide

tip.

6. Connect DirectVision® Guide to the camera handpiece.

Remove lid of sterilization box which contains sterile DirectVision® Guide

Retrieve Directvision® Guide from Sterilization box

Assistant removes the camera handpiece from the camera handpiece holder on the cart's upper column


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Assistant removes Protection Cap from camera handpiece and places it on the top shelf of cart.

Align the DirectVision® Guide with the camera handpiece. Open the lock. Connect the visual guide with camera handpiece making sure that the lock remains open.


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Assistant closes the lock on camera handpiece once the visual guide and camera handpiece are engaged.

The camera handpiece and visual guide are now securely coupled and ready for use.

7. Confirm System Operation.

Turn the illumination knob to maximum brightness.

Confirm that the tip of the visual guide is illuminated and an image appears on the monitor. If the tip of the visual guide is not illuminated or an image does not appear on the monitor, go to the Troubleshooting Section of the DirectVision® Technical Reference Manual (PL000072) to resolve the problem.


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8. Insert DirectVision® Guide into the visual guide lumen of DirectVision® Catheter.

Warning: The DirectVision® Guide must only be inserted

into the visual guide lumen of the DirectVision® Catheter.

Grasp the catheter and if the visual guide lumen cap is affixed, remove it to be able to insert the DirectVision® Guide.

Insert the DirectVision® Guide into visual guide lumen of the DirectVision® Catheter. Line-up the visual guide with the guide port.

Caution: When inserting the DirectVision® Guide into

catheter’s visual guide lumen, advance slowly and carefully,

rotating the silicone visual guide port. If the visual guide

encounters resistance, withdraw the visual guide about an

inch then resume insertion. Straighten catheter tip as

needed either by resting the catheter on the sterile field or

by manually straightening the tip.

Caution: The visual guide can be damaged by kinking the

polyimide tubing when inserting the visual guide into the

catheter’s visual guide lumen. While holding the catheter

manifold with one hand, always apply the insertion force

with your other hand less than 1 inch from the catheter’s

visual guide lumen.

Silicone visual guide port


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Note: Use the image on the monitor display to thread the

visual guide through the retaining ring located about 1.75

inches from the end of the catheter tip.

Continue inserting the DirectVision® Guide into the visual guide lumen until the end of visual guide touches the luer-lock on the end of the manifold. The tip of the DirectVision® Guide should be positioned at the tip of the catheter.

Lock the DirectVision® Guide in place by holding the

catheter luer-lock stable and twisting the metal fitting

of the visual guide into catheter's plastic luer-lock.

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Inspect the visual guide image for brightness and clarity

prior to each use. Discontinue use of any visual guide

which has an unacceptable image.

Warning: Inspect the tip of the catheter once the visual guide is inserted into the catheter and locked into place. Make sure it is not protruding 1mm or more beyond the catheter tip.

Confirm that the tip of the visual guide is illuminated and an image appears on the monitor. If the tip of the visual guide is not illuminated or an image does not appear on the monitor, go to the Troubleshooting Section of the DirectVision® Technical Reference Manual (PL000072) to resolve the problem.

Aim the illuminated tip of the visual guide to within approximately 5mm of a white object. If the white light requires color correction, perform White Balance Adjustment summarized in the Camera Control Unit Calibration Procedures Section of DirectVision® Technical Reference Manual (PL000072).

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Confirm image quality and camera orientation. If the focus is not sharp, perform Focus summarized in the Camera Control Unit Calibration Procedures Section of DirectVision® Technical Reference Manual.

9. Warning: Do not use the DirectVision® System if the video image is not displayed on the monitor or if the video image is not sharp.

10. Orient the catheter tip to the 12:00 o’clock position.

Note: The alignment “dot” on the catheter manifold (irrigation/drainage port) is on the same plane as the angled catheter tip. When the catheter tip is positioned to the 12:00 o’clock position, the catheter tip is curved up and the “dot” on the catheter manifold is also in the 12:00 o’clock position.


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Catheter Manifold

Tip of catheter is curved up

Catheter dotaligned to 12 O’clock


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11. Catheterize the patient.

Turn on irrigation water and verify flow.

Carefully insert the catheter tip into the patient’s meatus. Observe the image of the urethra on the display monitor.

Note: When initially inserting the catheter, the “dot” on the visual guide luer fitting and the “dot” on catheter irrigation/drainage port should both be aligned to 12:00 o’clock position. This alignment orientation ensures the tip of the catheter is pointing up and orientates the relative position of the image displayed on the monitor to the 12:00 o’clock position.

Note: If a DirectVision® Guide fails to provide an adequate visual representation of the urethra to the clinician, the catheterization procedure use should be discontinued.

Steer the catheter by manipulating the penis or rotating the catheter. Advance the catheter carefully while viewing the video image on the monitor. As you advance, try to maintain a “bull’s-eye” view of the urethra.


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View in sequence 5 basic urethral landmarks:

o Upward angulation of Bulbous urethra o External sphincter o 6:00 o’clock verumontanum o Upward angulation of prostate o Bladder opening

Continue advancing the catheter until the tip enters the bladder (the video image will go dark or yellow).

Stop irrigation.

12. Remove visual guide from catheter.

Unlock the DirectVision® Guide by rotating the luer-lock on the catheter clockwise until it becomes loose. Detach from the catheter.

Warning: Once the luer-lock is unlocked and while the catheter is in the patient, do not advance or reinsert the DirectVision® Guide in the visual guide lumen.

While holding on to the visual guide’s connector, gently pull the visual guide out of the catheter, about one inch, while holding the manifold with other hand to prevent catheter removal.

Change hand position from grasping the visual guide connector to grasping the one inch of exposed visual guide shaft.

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Continue removing the visual guide by grasping the exposed visual guide shaft and gently pulling until the entire shaft is removed from the catheter.

Affix the visual guide lumen cap to the open visual guide lumen.

Pass the visual guide attached to the camera to the assistant.

13. Inflate the balloon.

Continue advancing the catheter until the catheter hub reaches the meatus.

Verify that the catheter hub is touching patient’s meatus.

Insert 10ml syringe with sterile water into balloon port.


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Inflate balloon with 10ml sterile water.

Warning: Only use sterile water to inflate balloon. Do not exceed 10ml of liquid volume for balloon inflation.

Remove the syringe from the balloon port. Dispose of

the empty syringe.

Gently pull catheter until inflation balloon is snug against bladder neck.

14. Disconnect irrigation tubing.

Disconnect irrigation tubing from the catheter.

Connect urine collection bag and verify urine flow.

15. Place camera handpiece into camera holder.

Assistant unlocks the camera handpiece and gently pulls the camera handpiece apart from the visual guide.


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Assistant retrieves the Protection Cap from top shelf of cart, places it on the front of the camera handpiece and locks into place.


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Assistant attaches Plug Cap to Camera Handpiece Plug.

Clean the camera handpiece as described in the Cleaning, Disinfecting & Sterilizing Procedures Section of this manual.

Place camera handpiece into camera holder.

16. Send visual guide to sterilization department.

Clean the visual guide as described in the Cleaning, Disinfecting & Sterilizing Procedures Section of this manual.

Place the DirectVision® Guide into an approved sterilization tray. See Table 1 in the Cleaning, Disinfecting & Sterilizing Procedures Section for list of recommended sterilization trays.


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Send the DirectVision® Guide in its sterilization tray to

sterilization services for immediate cleaning and

sterilization.

17. Return the DirectVision® System to its holding area.

Remove and properly dispose of waste.

Press OFF Button on CCU.

Note: The display monitor is not turned off.

Unplug cart’s power plug from 110/120 VAC wall receptacle. Wind power cord around hooks on the neck of the cart.

Clean CCU, monitor and cart as described in the Cleaning, Disinfecting & Sterilizing Section of this manual.

Unlock cart wheels and transport cart to its holding area.


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Catheter Removal Procedure

Warnings and Cautions Warning: Should balloon rupture occur, care should be taken to assure that all balloon fragments are removed from the patient.

Warning: Do not resterilize the DirectVision® Catheter.

Note: A catheter that is removed from a patient may be a potential biohazard. Handle and dispose of the catheter in accordance with accepted medical practice and applicable laws and regulations.

Procedural Steps 1. Setup for procedure.

Put on clean gloves in accordance to hospital protocol.

Retrieve 10cc syringe.

2. Deflate balloon.

Gently insert a syringe in the catheter valve. Never use more force than is required to make the syringe “stick” in the valve.

Allow the pressure within the balloon to force the plunger back and fill the syringe with water.

If you notice slow or no balloon deflation, gently reseat the syringe. Use only gentle aspiration to encourage deflation as needed. Vigorous aspiration may collapse the inflation lumen, preventing balloon deflation.

If the balloon does not deflate, resolve the problem by following hospital procedures and/or calling a physician.

Remove all 10ml sterile water from inflated balloon.

Disconnect syringe from balloon port.

3. Withdraw the catheter slowly from patient. If the catheter does not gently withdraw from the patient, follow hospital guidelines and/or notify a physician.


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4. Dispose of the catheter and urine bag following facility guidelines.


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Cleaning, Disinfecting & Sterilizing

Introduction Medical equipment devices are essential for the care of patients. Some are typically designed for reuse, but can transmit pathogens if any steps in reprocessing, cleaning, disinfecting, or sterilizing fail. The vast majority of pathogens are present in organic matter, e.g. visible soil. The first step in reprocessing is cleaning. It is the most important. Failure to remove soil creates the potential to transmit infection and can compromise the efficacy of subsequent disinfection or sterilization. Decontamination is the process in which microorganisms are removed or destroyed in order to render an object safe. Decontamination includes:

• Cleaning

• Disinfecting

• Sterilizing

General Warnings and Cautions 1. Warning: Read these instructions thoroughly before

cleaning, disinfecting and/or sterilizing the product. Failure to follow these instructions may cause damage to the product or harm to the patient and/or user.

2. Caution: Ultrasonic cleaning should not be used to clean any part of the DirectVision® System.

3. Caution: The cleaning, disinfecting and sterilizing methods presented in this document are validated. Any deviation is not validated and is not recommended.


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DirectVision® Guide

Table 1: Recommended Cleaning and Sterilizing Conditions for the DirectVision® Guide

Specific Warnings

1. Warning: Always inspect the DirectVision® Guide before performing a cleaning and/or sterilization procedure. Reject a visual guide that has burs, sharp edges, cracked or disconnected jacket and/or strain relief(s), or is kinked.

Catheter Hub Lock

Camera Connector

Internal Stop

Camera Channel

LightChannel

Sterilization System or

Method

Cycle(s)/Paramenters Tray or Pouch

ASP Sterrad 100s Full Cycle

APTIMAX®

Instrument Tray

(13835) or equivalent

ASP Sterrad 200 Full Cycle

APTIMAX®

Instrument Tray


ASP Sterrad 100 NX Duo Cycle

APTIMAX®

Instrument Tray


Steris Amsco V Pro-1 Lumen CycleSteris Tray (VP0003)

or equivalent

Lumen Cycle

Non-Lumen Cycle

Lumen Cycle

Non-Lumen Cycle

Flexible Cycle

Steris System 1E Standard Operating CycleStaris C1140E, C1200E,

or C1220E

Staris Tray (VP0003)

or equivalent

Sterilization EnvironmentDevice Name Cleaning

Solutions

Disinfecting

Solution

DirectVision

® GuideEnzol™ ---

Steris Amsco V Pro-1PlusSteris Tray (VP0003)

or equivalent

Steris Amsco V-Pro maX


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2. Warning: Only clean or sterilize the DirectVision® Guide as specified in this manual. Failure to follow the instructions provided in this manual could result in infection or damage to the DirectVision® Guide.

Specific Cautions

1. Caution: To prevent damage to the DirectVision® Guide always handle with care. Do not drop, crush, cut, or bend any portion of the visual guide beyond a 2” radius.

2. Caution: Machine washing is not recommended. It increases likelihood of damage to the DirectVision® Guide.

3. Caution: When cleaning the DirectVision® Guide, use a soft sponge and/or soft bristle brush to clean surfaces and crevices.

4. Caution: Inspect the DirectVision® Guide for damage following each use.

5. Caution: The DirectVision® Guide should never be exposed to temperatures greater than 55o C (131o F). It can cause damage.

6. Caution: Never place heavy objects on the DirectVision® System.

7. Caution: The DirectVision® Guide must be disposed of according to local regulations, ordinances and hospital practices.

Specific Note

1. Note: The cleaning and sterilization procedure can affect performance of the DirectVision® Guide. If a DirectVision® Guide ceases to provide adequate illumination or a clear image of the urethra, discontinue use of that DirectVision® Guide.


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Cleaning Procedure

1. Prior to cleaning, disassemble the DirectVision® Guide from camera handpiece.

2. Prepare an enzymatic detergent, such as Enzol™ (1 oz detergent/gallon water), using warm tap water and following the manufacturers instructions.

3. Note: The enzyme solution should be changed when it becomes grossly contaminated (bloody and/or turbid).

4. Immerse the DirectVision® Guide in an enzymatic solution for at least one minute.

5. Soak a clean soft cloth in the detergent and wipe entire DirectVision® Guide to remove any visible evidence of soil or debris.

6. Using a soft bristled brush (such as M-16 BRUSH-DBL END),

scrub the DirectVision® Guide for a minimum of 30 seconds,

paying particular attention to the visual guide coupler’s two

lenses.

7. Use only a soft cloth to clean the tip of the DirectVision® Guide lens.

8. Remove the DirectVision® Guide from the detergent and wipe with a clean soft cloth that is dipped in ambient sterile water to remove any evidence of detergent.

9. Dry the DirectVision® Guide with a clean soft cloth. Use filtered pressurized air (no more than 40psi) to dry crevices and hard to reach areas.

10. Visually examine each DirectVision® Guide to ensure cleanliness.


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Disinfecting Procedure

Not required.

Sterilization Recommendations

During reprocessing ensure the following:

1. Comply with labeling and instructions for use for the STERRAD®, Steris Amsco® V-PRO®, or Steris Systems 1E system and parameters (listed in Table 1).

2. Use only the recommended cycles listed in Table 1 for

respective sterilization systems listed in Table 1.

3. Use only recommended trays listed in Table 1 for respective

sterilization systems listed in Table 1.

Sterilizing Procedure

1. The DirectVision® Guide is sterilized with vapor hydrogen peroxide sterilization. See Table 1 for recommended sterilization systems and conditions.

2. Warning: To ensure proper sterilization of the DirectVision® Guide, follow the sterilization procedure provided by the manufacturer for the respective system listed in Table 1. Failure to follow the sterilization procedure defined by the manufacturer could result in infection or damage to the DirectVision® Guide.

3. Warning: Use of sterilization systems or conditions not listed in Table 1 may result in shortened useful life for the DirectVision® Guide.

4. Warning: Always sterilize the DirectVision® Guide in a tray/container listed in Table 1. Failure to use the correct container could result in patient infection or damage to the DirectVision® Guide.


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Additional Warnings

1. Warning: To minimize the risk of patient infection, the

DirectVision® Guide must be sterilized prior to the first use

and after every subsequent use.

2. Warning: Clean the DirectVision® Guide immediately after

use to prevent incrustation. Failing to do so could

compromise future sterility and possibly cause damage to

the visual guide.

3. Warning: During cleaning, immerse the DirectVision®

Guide in an enzymatic solution for at least 1 minute while

cleaning or patient infection may result.

Camera Handpiece

Table 2: Recommended cleaning and disinfecting conditions for the camera handpiece

Specific Warning

1. Warning: To minimize the risk of bioburden contamination,

take caution to not contaminate the camera handpiece

LED Output

Camera Input

Camera Handpiece

Focus

Sterilization System Cycle(s) Tray

Camera

HandpieceEnzol® CIDEX® OPA --- --- ---

Component

Name

Cleaning

Solution

Disinfecting

Solution

Sterilization Environment


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after the sterile drape (if applicable) has been removed or

before processing.

Specific Cautions

1. Caution: The Plug Cap, which may be wired to the Camera

Handpiece Plug , should be locked into place during cleaning

and disinfecting procedures. Failing to cover the Camera

Handpiece Plug while soaking will damage the wiring.

2. Caution: Machine washing is not recommended. It increases likelihood of damage to the camera.

3. Caution: The camera handpiece shall not be cleaned in an

ultrasonic bath.

4. Caution: Ensure that detergent and disinfectant are

compatible with each other. Avoid constantly changing the

selected detergent-disinfectants.

Cleaning Procedure

Cleaning the camera handpiece is necessary for hygienic reasons. It can be done manually or by soaking.

Use only mild cleaning substances for dissolving the impurities. These cleaning agents must have been approved by PercuVision® for such use. While using the different substances, pay attention to the details provided by PercuVision® with respect to concentration and soaking time.

Plug Cap

Camera Handpiece Plug


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1. Prepare the cleaning bath solution using the Enzol™

enzymatic solution.

2. Lock Plug Cap on Camera Handpiece Plug to protect cable

from damage.

3. Remove the Protection Cap from the camera handpiece if it

is locked to the camera handpiece. This will expose the

protective optical surfaces of the illumination and camera

ports for cleaning.

4. For mechanical cleaning, use soft cloth, cotton swabs and

special brushes. For channels and cavities, it is especially

advisable to use suitable brushes.

5. Clean dirt off the optical surface with a cotton swab soaked

in 70% isopropyl alcohol or neutral cleanser.

6. After cleaning, rinse all parts with distilled water. Ensure

that all residues of cleaning agents have been washed away.

7. Dry the camera with a tissue or soft absorbent cloth.


The necessity for disinfection of the camera handpiece is to be determined by the user based upon facility policy for equipment.

1. Prepare the disinfecting bath solution using CIDEX® OPA.

Note: In order to ensure the entire camera is properly disinfected, all surfaces must be exposed to CIDEX®.

Protection Cap

Camera Handpiece

Lock OPEN


Page 47 of 53

2. Completely immerse the camera handpiece in the disinfecting solution.

3. Soak in bath according to bath manufacturer’s instructions.

4. After soaking, thoroughly rinse camera handpiece with sterile water.

5. Dry camera handpiece appropriately, with compressed air, for its next use. Ensure lens is free of residue.

6. Lock the Protection Cap to the Camera Handpiece if the Protective Cap is available.


1. Caution: The camera handpiece is never sterilized.

Camera Control Unit

Table 3: Recommended cleaning condition for the Camera Control Unit (CCU)

Protection Cap

Camera Handpiece

Lock OPEN


CCUIsopropyl

Alcohol (IPA)--- --- --- ---

Component

Name

Cleaning

Solution

Disinfecting

Solution



Page 48 of 53

Specific Cautions

1. Caution: Do not immerse the CCU into liquids.

2. Caution: Machine washing is not recommended. It increases likelihood of damage to the CCU.

2. Caution: Do not use scouring agents or solvents since they could damage the paint or labels on the CCU housing.

3. Caution: Do not use wet sponges or clothes since this could lead to liquid reaching the electrical parts which could cause damage.

4. Caution: Only clean front bezel of the CCU.

5. Caution: Do not clean the back of CCU which has video and power connections. There is danger of electric shock.

Cleaning Procedure

1. The CCU front panel can be cleaned by wiping with a moist cloth.

2. Prepare a pH neutral cleanser or isopropyl alcohol

3. All exterior surfaces of the CCU can be wiped by a soft cloth which has been moistened with water and soft soap suds or isopropyl alcohol. Difficult to remove stains can be removed using a soft cleaner of ammoniac basis.


1. Caution: The CCU is never disinfected.


1. Caution: The CCU is never sterilized.


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Display Monitor

Table 4: Recommended cleaning conditions for the MonitorEnclosure and the LCD Display Panel components of the Display Monitor

Specific Cautions

1. Caution: Do not use thinner, benzene, alcohol or such on the monitorenclosure. These solvents can damage the enclosure.

2. Caution: Do not use organic solvents such as acetone and toluene to clean the color LCD panel. These solvents can damage the LCD panel.

3. Caution: Do not apply insecticides and other volatile items to the monitor enclosure. Do not leave rubber and vinyl products or such in contact with the enclosure for long hours. This can damage the enclosure and cause paint to peel.

4. Caution: Treat the color LCD panel with care. Do not rub the


Plastic

(Enclosure)pH=7 Solution --- --- --- ---

LCD Display

Panel

Isopropyl

Alcohol (IPA)--- --- --- ---

Component

Name

Cleaning

Solution

Disinfecting

Solution



Page 50 of 53

LCD panel surface with a rough item or hit it on the surface. Do not strongly press the LCD panel surface. This can lead to unevenness in the screen and also to failure of the product.

Cleaning Monitor Enclosure Procedure

1. Remove the power plug from the monitor and AC wall receptacle for security.

2. Lightly wipe off dirt on the monitor enclosure with a hard-

wrung soft cloth soaked in a neutral cleaning solution.

3. Allow wet surfaces to completely dry before reconnecting power plugs.

Cleaning Color LCD Display Procedure

Recommended cleaners for the color LCD panel are: isopropyl alcohol (without abrasive), non-ammonic glass cleaner and watered-down neutral cleaning solution.

1. Remove the power plug from the monitor and AC wall

receptacle for security.

2. When the screen has dust on the color LCD panel surface,

wipe it off with soft moist cloth.

3. Lightly wipe-off dirt on the monitor enclosure with a hard-

wrung soft cloth soaked in a neutral cleaning solution.

4. Allow wet surfaces to completely dry before reconnecting power plugs.


1. Caution: The monitor is never disinfected.


1. Caution: The monitor is never sterilized.


Page 51 of 53

Cart

Table 5: Recommended cleaning condition for the Cart

Specific Caution

1. Caution: Do NOT use the following chemicals to clean your cart: acetone, mineral spirits, abrasive cleaners, paint thinner or any other harsh or toxic chemicals.

Cleaning Procedure

1. Verify that your cart is unplugged from the wall outlet before cleaning.

2. Use a soft, clean cloth to clean the cart.

3. Use a cleaner of 80% denatured alcohol and 20% water.

4. Allow the cart to dry completely before plugging the power plug into a wall outlet.


CartIsopropyl

Alcohol (IPA)--- --- --- ---

Component

Name

Cleaning

Solution

Disinfecting

Solution



Page 52 of 53


1. Caution: The Cart is never disinfected.


1. Caution: The Cart is never sterilized.

Definitions cc: Cubic Centimeters (volume, i.e. cm3; equivalence 1cc = 1ml )

CCU: Camera Control Unit

Cleaning: Cleaning is a process, usually involving detergent or enzymatic presoak, that removes foreign material (e.g. dirt, mucus, blood stains or microorganisms) from an object. Cleaning is the most essential step in reprocessing medical instruments and equipment.

Disinfecting: Any process, chemical or physical, that destroys pathogens such that an item is safe to handle for its intended use.

Disinfectant: A disinfectant is a chemical agent that destroys most pathogens but may not kill bacterial spores. Chemical disinfection should only be used if heat treatment is impractical or if it may cause damage to the equipment. There is a broad spectrum of chemical disinfectants that have different antimicrobial activities. Most of them do not necessarily kill all microorganisms or spores that are present on an inanimate object but instead reduce the number of microorganisms to a level that is not harmful to health. Disinfectants are used on inanimate objects only and not on living tissue. Chemicals used to kill microorganisms on skin or living tissue are known as antiseptics.

IPA: Isopropyl Alcohol

ml: milliliters (volume; equivalence 1ml = 1cc )

mm: millimeter

Sterilant: An agent that destroys all viable forms of microbial life to achieve sterilization.


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Sterilization: Sterilization methods remove or destroy all forms of microbial life, including bacterial spores, by either physical or chemical processes. It is recommended that any instrument or equipment that comes in contact with the blood stream or with subdermal tissues is cleaned and sterilized in between each use. Sterilization is accomplished principally by steam under pressure, by dry heat, or by chemical sterilants. The choice of the method for sterilization depends on a number of factors including the type of material to be sterilized is made of, the number and type of microorganisms involved, the classification of the item, and availability of sterilization methods.

References DirectVision®Technical Reference Manual, PL000072.

PercuVision® LLC

2030 Dividend Drive

Columbus, Ohio 43228

(877) 913-6333

www.percuvision.com

PL000070 Rev 01

http://www.percuvision.com/

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