Welch Allyn VC-200 User manual

VideoPath
®
VC-2 00
VideoColonoscope
Operating Manual
Endo Menu
Thank you for your purchase of a Welch Allyn Flexible VideoColonoscope. The operating and maintenance instructions
found in this manual should be followed to ensure many years of reliable service. Please read these instructions thoroughly before attempting to use your new Flexible VideoColonoscope.
WARNING: The user of this equipment should be thoroughly trained in the medical procedures appropriate to the equipment. Furthermore, time should be taken to read and understand these instructions before per­forming any procedures. Instructions for other equipment used in conjunc­tion with any VideoEndoscope (e.g., suction machines) should also be read and understood. Failure to do so may result in injury to the patient and/or damage to the instrument.
While this manual describes the recommended protocol for inspecting and operating the equipment, it does not outline procedural techniques. Only physicians trained and versed in flexible endoscopy should use this equipment.
CAUTION: Federal (USA) law restricts this device to sale by/to or on the order of a physician or other appropriately licensed medical professional.

Infection Control Note

This manual includes a current list of disinfecting and sterilizing solutions and processes. However, since infection control procedures involve complex and controversial issues and are constantly changing, it is rec­ommended that the users of this equipment keep informed of the latest information and regulations pertaining to infection control.
The CE mark on this device indicates it has been tested to and conforms with the provisions noted within the 93/42/EEC Medical Devices Directive.
Authorized European Representative Address: European Regulatory Manager Welch Allyn, Ltd. Kells Road, Navan, County Meath, Republic of Ireland Tel.: 353-46-79060 Fax: 353-46-27128

Conventions

WARNING: alerts the user to possible serious injury, death or other
adverse reaction associated with the use or misuse of the device.
CAUTION: indicates a potentially hazardous situation which, if not avoided, may result in minor or moderate injury. It also alerts against unsafe practices.
NOTE
: provides supplemental information to the text and indicates a
potentially hazardous situation, which, if not avoided, may result in property damage. Additionally, it highlights important information on the use of this equipment.
The Welch Allyn 31500 Colonoscope is intended to be used in facilitating colonoscopy procedures.
VC-200 Colonoscope 1
Conventions ....................................................1
Specifications..................................................2
Symbols ..........................................................2
Warnings..........................................................2
Components....................................................3
Nomenclature and Function ..........................6
Flexible VideoColonoscope ..............................6
Light Source ......................................................8
Water Bottle/Cleaning Bottle ............................9
Preparation and Inspection for Use............10
Prior to Initial Use ..........................................10
System Set-up ................................................10
Physical System Inspection............................12
Operations ....................................................15
Procedure ......................................................15
Holding the Instrument....................................16
Preparation Before Insertion of the
VideoEndoscope ............................................16
Insertion and Withdrawal ................................17
Biopsy Passage..............................................18
Electrosurgery ................................................19
Video Printer ..................................................20
Cleaning and Disinfection............................20
Endoscope Internal Schematic ......................20
Semi-Automated Cleaning Method ............23
Cleaning at the Examination Room................23
Leakage Testing..............................................25
Disinfection Procedure (Total Immersion) ......27
Final Rinse......................................................28
Manual Cleaning Method ............................29
Cleaning at the Examination Room................29
Leakage Testing..............................................31
Cleaning the Instrument..................................33
Enzymatic Cleaning Solutions ........................35
Cleaning of Accessories – Biopsy Forceps....35
High-Level Disinfection ..................................36
Disinfecting Solutions......................................36
Sterilization and Aeration ............................37
Ethylene Oxide Gas Sterilization....................37
Cold Sterilization ............................................38
Other Sterilization Methods ............................38
Accessory Sterilization ....................................39
Accessory and Instrument Storage............39
Servicing........................................................40
Care and Maintenance Tips ........................41
Troubleshooting............................................43
Table of Contents
Colonoscope
Parameter (31500)
Angle of View 145° Depth of View 5-100mm Tip Deflection Up: 180° Down: 180°
Right: 160° Left: 160°
Distal Rigid Diameter 13.4mm Insertion Tube Diameter 12.8mm Diameter of Accessory/ 3.8mm
Suction Channel Insertion Tube 1700mm
Working Length Total Length 2020mm
Colonoscope
Parameter (31500)
Function Controls- Freeze, Copy, Video
Communication version Lockable Steering Brakes
Environment Operating +10°C (50°F) to +40°C (104°F)
30 - 75% R.H. 700 hPa - 1060 hPa Altitude
Transport/Storage -20°C to +49°C
95% R.H. Max. 700 hPa - 1060 hPa Altitude
Operating Mode Continuous Compliance UL 2601-1, IEC 60601-1,
IEC 60601-2-18, CAN/CSA C22.2 No. 601.1, EN 60601-1-2, CE

Symbols

Type BF IPX7 Protected against the effects of immersion

Warnings

WARNING: Total system risk current should not exceed 50µA. An isolation
transformer is required if the total system risk current exceeds 50µA when accessories are interconnected.
WARNING: If the endoscope is removed from the light source, the lamps will remain lit. DO NOT look directly into the lights. The intensity of the illumination may damage your eyes. If the instrument is removed from the light source, either turn off the main power switch or press the Lamp Ignition/Standby switch to turn off the lamps and put them in a standby mode.
WARNING: High energy radiated light may be transmitted from the light emission window of the endoscope, giving rise to high temperatures in front of the light emission window. To minimize hazards, avoid prolonged exposure or contact.
WARNING: DO NOT use this equipment in the presence of any flammable anesthetics.

Specifications

2 VideoPath
NOTE: This device complies with current required standards for electromag-
netic interference and should not present problems to other equipment or be affected by other devices. As a precaution, avoid using this device in close proximity to other equipment.

Components

Flexible VideoColonoscope Set Includes:

31500 Flexible VideoColonoscope

31020 Channel Cleaning Brush (2 each)

31021 Valve Reprocessing Caps

31039 (Biopsy Seals) Procedure Scope

31023 60cc Syringes (2 each)

33924 Air/Water Nozzle Cleaning Brush

31024 Air/Water Valve “O” Ring Kit

31025 Suction Valve “O” Ring Kit

31027 Air/Water Reprocessing Adapter

31029 Shipping/ETO Vent Cap

31030 Distal Reprocessing Cap (6 each)
VC-200 Colonoscope 3
ETO Vent Cap
Components (continued)

31038 Suction Reprocessing Adapter

31031 Valve Well Cleaning Brush

31037 Leakage Tester

33918 Valve Lubricant

31028 Soaking Cap

Optional Accessories (not included in set):

31032 Air/Water Valve

31033 Suction Valve

31035 Instrument Hanger

4 VideoPath
Components (continued)

04060 Lamp Replacement Assembly

33915 Electrosurgical Ground Kit

VLX-20 Light Source Includes:

45500 Light Source

45510 Water Bottle

761076-0 Power Cord

45512 S-Video Cable

45520 Cleaning Bottle

VC-200 Colonoscope 5
POWER AIR
!
STANDBY
LAMP
IGNITION
LAMP
SERVICE
PICTURE
BRIGHTNESS
2

Nomenclature and Function

Flexible VideoEndoscope (200 Series)
VideoEndoscope
6 VideoPath
CONTROL BODY
INSERTION TUBE
BENDING SECTION
DISTAL TIP
ENDOSCOPE CONNECTOR
TERMINAL
Suction Valve Air/Water Valve
Biopsy Seal
Biopsy Port
Up/Down Deflection Control Knob
Air Nozzle
Light Guides
Biopsy/Suction
Channel
Objective Lens
Water Nozzle
Suction Port
Side View
Rear/Top View
Front/Bottom
View
Soaking Cap
ETO/Shipping Vent
Electrical Contacts
Air/Water Input Ports
Suction Port
Right/Left Deflection Control Knob
Light Guide
Light Guides
Function Control Switches
Right/Left Deflection Control Brake
Up/Down Deflection Control Brake
Nomenclature and Function (continued)

Flexible VideoEndoscope

CONTROL BODY

Suction Valve – Depress to aspirate fluids or air through the biopsy/suction channel. Air/Water Valve – Covering the vent hole in the top of the valve delivers pressurized air
through the air nozzle in the distal tip. Covering the hole and fully depressing the valve delivers pressurized water through the water nozzle in the distal tip.
Biopsy Seal – Allows passage of accessories while preventing escape of fluids and air. Biopsy Port – For introduction of biopsy forceps and other accessories.
Up/Down Deflection Control Knob – Rotation of the knob toward the operator will deflect
the bending section up. Rotation away will deflect the bending section down. Right/Left Deflection Control Knob – Rotation of the knob toward the operator will
deflect bending section left. Rotation away will deflect the bending section right. Up/Down Deflection Lock – When this lever is in the “F” (Free) position (rotated fully clock-
wise) the bending section moves freely. When the brake lever is rotated counterclockwise, deflection of the bending section becomes progressively more stabilized. When the lever is rotated fully counterclockwise, the bending section is locked into position. Note that when the lock is engaged, deflection can still be accomplished by rotating the deflection lever.
Right/Left Deflection Lock – Function similarly to Up/Down lock.
ELECTRONIC FUNCTION CONTROLS (when connected to video printer with built-in memory).
F (Freeze) Button – Push to freeze an image. C (Copy) Button – Push to activate the remote video printer. V (Video) Button – Push to switch between “frozen” image (stored in printer memory) and
“live” image.
INSERTION TUBE – Contains random light guides, biopsy/suction channel, air and water lines, steering cables and wires from CCD (Charge Coupled Device).
BENDING SECTION – Contains articulating vertebra that allows deflection in two planes. DISTAL TIP
Air Nozzle – Directs pressurized air across objective lens to remove moisture and to
distend cavity being examined.
Light Guides – Provide illumination of examination area. Biopsy/Suction Channel – Opening from which biopsy forceps and other accessories exit
and where fluid/debris is aspirated when the suction valve is depressed.
Objective Lens – Contains the lens system that provides depth of field and field of view. Water Nozzle – Directs pressurized water, via the water nozzle, across objective lens to
remove debris.
ENDOSCOPE CONNECTOR TERMINAL
Air/Water Input Ports – Couples with the air/water bottle to allow the introduction of
pressurized air and water to the instrument. Suction Port – Port where the auxiliary suction machine hose is attached to the
instrument.
Soaking Cap – Covers electrical contacts during immersion (cleaning/disinfection). Electrical Contacts – Provides power to the endoscope and provides pathway for video
signal input into the light source. ETO/Shipping Vent – Vent where ETO/Shipping Vent Cap couples to equalize instru-
ment’s internal pressure with room pressure during shipping and ETO gas sterilization.
Light Guides – Couple to lamps in light source to provide illumination.
VC-200 Colonoscope 7
Nomenclature and Function (continued)

Light Source

Front Panel

Main Power Switch – Primary power control for the light source. If not activated, other
controls will not function. Air Pump Switch – Activates flow of air at air output connector in light source’s endoscope
connector port. Lamp Ignition – Activates the lamps when switch is depressed and main power switch
is on. Lamp Standby Indicator – When LED blinks, lamps cannot be ignited even if lamp igni-
tion switch is depressed. Endoscope Connector Port – Accepts VideoEndoscope connector terminal to transmit
light, electrical signals, water, and air through the endoscope. Water Bottle – Couples to endoscope connector terminal’s air and water input ports and
light source’s air output port.
Air Output Port – Couples to water bottle to provide air and water to the endoscope. Picture Brightness Control – Pressing up or down arrows adjusts image on monitor to
desired average brightness level (level indicated by illuminated green LED).
8 VideoPath
POWER AIR
!
STANDBY
LAMP
IGNITION
LAMP
SERVICE
PICTURE
BRIGHTNESS
2
Main Power Switch
Air
Pump
Switch
Lamp
Ignition
Lamp Standby Indicator
Endoscope
Connector
Port
Air Output
Port
Picture
Brightness
Control
Water Bottle
Nomenclature and Function (continued)

Back View

Power Supply Cord Receptacle – Couples with power cord which should be plugged into
an 115V hospital grade outlet.
S-Video – Outputs S-Video or Y/C, 4 pin DIN. Composite – Outputs NTSC (composite video), BNC connector. Earth Ground Terminal Connector – Provides a terminal which is connected to earth
ground through the VLX-20 line cord (1/4-36 UNS-2A thread). Equipotentiality Terminal Connector – Accepts ground connector from electrosurgery
equipment to provide a secondary or redundant ground path.
RS-232 Communication Connector Port – Communication port for use with video printers. Aux(illiary) Port – No function. Future capability.

Water Bottle/Cleaning Bottle

Water Bottle
Air Input Terminal – Couples to light source air output port. Air Output Terminal – Couples to VideoEndoscope air input port. Water Output Terminal – Couples to VideoEndoscope water input port. Fill Line – Indicates maximum water level bottle should be filled to.
NOTE
: The Cleaning bottle is identical to water bottle with the
exception that it allows fluid to be introduced into the air input port of the endoscope. The Cleaning bottle can be easily identi­fied via the red caution label on the front of the bottle.
VC-200 Colonoscope 9
Fill Line
Air Input Terminal
Air Output Terminal
Water Output Terminal
S-Video
Power Supply
Cord Receptacle
Composite
Earth Ground Terminal Connector
Equipotentiality Terminal Connector
RS-232 Communication Connector Port
Fuse Drawer
Auxilliary Port

Preparation and Inspection for Use

Prior to Initial Use

Before preparation or set up of the equipment, check all components received against the list of components (see components section) to verify a complete set. If parts are missing, please notify Welch Allyn. Review the nomenclature, set-up, operation, and cleaning/disinfection sections to become familiar with the equipment.
Specifically, inspect:
Video Endoscope
Insertion Tube – for tears, cuts, dents, bubbles, bumps Control Section – depress valves and test bending section deflection to assure smooth
rotation of controls. Biopsy Port – pass cleaning brush through biopsy/suction channel to verify
smooth passage Leak Test – the watertight integrity of the instrument should be verified following the
procedures outlined on page 25.
Light Source
Cabinet – for any dents, scratches or other abnormalities Water Bottle – for any cracks, leaks, etc.

System Set-up

NOTE: The instrument should be cleaned and disinfected prior to initial
use, following the steps starting on page 23 and 29.
1. Connect the power cord to the power cord receptacle on the back of the light source.
2. Plug the remaining end of the power cord into a properly grounded 100-240 volt AC outlet.
3. Fill the water bottle to the fill line with clean, distilled water and replace the sealing cap.
10 VideoPath
Fill Line
Sealing Cap
Preparation and Inspection for Use (continued)
4. Plug the endoscope connector terminal into the endoscope connector port of the light source. The endoscope connector terminal should fully engage and “click” into place.
5. Plug the water bottle into the recessed area on the front panel of the light source. This will couple the water bottle both to the light source air output port and the VideoSigmoidoscope connector terminal air/water input ports.
6. Activate the Power switch on the front panel. The green Lamp Ignition/Stand-By light will blink for approximately 11 seconds. Once the LED stops blinking, the lamps are ready to be ignited.
7. Once the green Lamp Ignition/Standby light remains lit, press the Lamp Ignition Switch. The lamps will ignite and the Lamp Ignition/Standby light will go out. The lamps require 11 seconds to warm up. This length of time will be indicated by the center LED of the Picture Brightness Indicator, which blinks until the lamps reach full intensity. Once the Picture Brightness Indicator remains constant, the lamps are fully warmed up, and the system is ready for use.
NOTE
: If the Light Source is powered up without having the Video-
Endoscope attached, the lamp ignition Standby LED will remain blinking and lamp ignition cannot occur.
WARNING: Once lamps have been lit, do not remove the instrument from the light source without turning the main power switch off or putting the lamps on Stand-By by pressing the Lamp Ignition switch. If the VideoEndoscope is removed from the light source, avoid looking directly into the intense light provided by the light source to prevent damage to your eyes.
VC-200 Colonoscope 11
Standby LED Light
Standby LED
Center LED of the Picture Brightness Indicator
VLX-20
LAMP
IGNITION
STANDBY
PICTURE
BRIGHTNESS
LAMP
SERVICE
2
LAMP
IGNITION
PICTURE
BRIGHTNESS
LAMP
SERVICE
LAMP IGNITION
POWER AIR
STANDBY
LAMP SERVICE
PICTURE BRIGHTNESS
LAMP IGNITION
STANDBY
LAMP IGNITION
STANDBY
LAMP SERVICE
POWER AIR
PICTURE BRIGHTNESS
LAMP IGNITION
LAMP SERVICE
2
PICTURE BRIGHTNESS
Preparation and Inspection for Use (continued)
8. Activate the Air switch to verify function of the pump. Air should begin to flow immediately out of the top hole in the air/water valve on the control section of the instrument.
WARNING: It is essential that the instruction manual for the VLX-20 Light Source be reviewed in detail prior to using the system.

Physical System Inspection

Before inspecting the system, the VideoEndoscope should be tested to verify that it is water­tight. Refer to the Leak Test procedures on page 25.
The following steps should be repeated prior to every procedure to verify that the system is working properly. If any problem is encountered, immediately consult the troubleshooting sec­tion of this manual or contact Welch Allyn Customer Service (1-800-535-6663) for assistance.
Insertion Tube, Umbilical Tube, and Bending Section
N
OTE: The insertion tube may have a slight curve when first removed
from the package due to product settling. This can be eliminated by storing the instrument with the insertion tube in a straight position.
1. Inspect the insertion tube and bending section for tears, cuts, dents, bubbles, bumps or other abnormalities on the surface.
2. Run your fingers carefully over the entire length of the insertion tube and bending section to check for protruding braid.
3. Inspect the umbilical cord for outward indications of damage (e.g., dents, cuts).
CAUTION: To avoid harm to the patient and further damage to the equip­ment, Do Not use a VideoEndoscope with outward signs of damage.
NOTE
: Make sure the distal end of the instrument is not damaged. The
distal end has an atraumatic non-removable tip. Do Not try to remove the distal tip. Doing so will result in damage to the distal portion of the instrument.
12 VideoPath
Preparation and Inspection for Use (continued)
CAUTION: Do Not wind the insertion
tube into a tight radius. Serious internal damage could result. Proper storage procedures are outlined on page 39.
Deflection Controls
1. Rotate the up/down and right/left deflection control knobs to the limit in each direction. The knobs should rotate without excess friction or grinding.
NOTE
: Do Not attempt to rotate the deflection
knobs past their limits. This can result in severe damage to the steering mechanism.
2. Make sure the bending section can be locked into position by engaging the deflec­tion brakes. The brakes are disengaged when the brake levers are rotated fully clockwise (looking at the steering knobs straight on). The bending section will move freely. As the brake levers are rotated counterclock­wise, the bending section becomes progressively stiffer. When the brake levers are rotated fully counterclockwise, the bending section is locked into position.
CAUTION: Do Not deflect the bending section of the VideoEndoscope by hand. This applies excess force to the deflection mechanism and may result in steering cable failure. If the deflec­tion controls do not operate smoothly do not use the VideoEndoscope. Doing so may result in injury to the patient or further damage to the instrument.
Inspection of Light Guides and Optics
1. With the lamps on, hold the distal tip approximately 40mm from any surface.
2. Verify light is being emitted from both light guides.
VC-200 Colonoscope 13
Do Not Wind
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