Page 1
VideoPath
®
VS-100
VideoSigmoidoscope
Operating
Manual
Endo Menu
Service Manual
Page 2
Thank you for your purchase of a Welch Allyn Flexible
VideoSigmoidoscope.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 VideoSigmoidoscope.
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.
Page 3
Table of Contents
Conventions .......................................................................................................2
Specifications.....................................................................................................2
Components.......................................................................................................3
Nomenclature and Function...........................................................................6
Flexible VideoSigmoidoscope............................................................................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
Cleaning and Disinfection .............................................................................19
Endoscope Internal Schematic........................................................................20
Semi-Automated Cleaning Method...............................................................22
Cleaning at the Examination Room .............................................................22
Leakage T esting...........................................................................................24
Disinfection Procedure #1 (Using Tray)........................................................26
Disinfection Procedure #2 (Total Immersion) ..............................................27
Final Rinse...................................................................................................28
Manual Cleaning Method................................................................................28
Cleaning at the Examination Room .............................................................28
Leak T est Procedure....................................................................................30
Cleaning the Instrument..............................................................................32
Enzymatic Cleaning Solutions..........................................................................34
Cleaning of Accessories – Biopsy Forceps......................................................34
High-Level Disinfection....................................................................................35
Disinfecting Solutions..................................................................................35
Sterilization and Aeration.............................................................................36
Ethylene Oxide Gas Sterilization......................................................................36
Cold Sterilization..............................................................................................37
Other Sterilization Methods.............................................................................37
Accessory Sterilization.....................................................................................38
Accessory and Instrument Storage............................................................38
Servicing ...........................................................................................................39
Care and Maintenance Tips..........................................................................40
Troubleshooting...............................................................................................42
VS-100 Sigmoidoscope 1
Page 4
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.
NO
TE 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.
Specifications
Parameter Sigmoidoscope (30500)
Angle of View 145°
Depth of View 3-100mm
Tip Deflection Up: 180°
Down: 180°
Right: 160°
Left: 160°
Distal Rigid Diameter 213.6mm
Insertion T ube Diameter 212.8mm
Diameter of Accessory 22.8mm
Suction Channel
Insertion T ube 70cm
Working Length
Total Length 103cm
2 VideoPath
Page 5
Components
Flexible VideoSigmoidoscope Set Includes:
30500 Flexible VideoSigmoidoscope
31020 Channel Cleaning Brush (2 each)
31021 Valve Reprocessing Caps
33930 Biopsy Seals (10 each)
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/ET O Vent Cap
31030 Distal Reprocessing Cap (6 each)
VS-100 Sigmoidoscope 3
Page 6
Components (continued)
31038 Suction Reprocessing Adapter
31031 Valve Well Cleaning Brush
31037 Leakage T ester
33918 Valve Lubricant
31028 Soaking Cap
Optional Accessor ies (not included in set):
31032 Air/Water V alv e
31033 Suction Valv e
31035 Instrument Hanger
33902 Disinfection Tray
33950 Biopsy Forceps w/Window and Needle (Sigmoid)
04060 Lamp Replacement Assembly
4 VideoPath
Page 7
Components (continued)
VLX-10 Light Source Includes:
40500 Light Source
45510 Water Bottle
761076-0 Power Cord
45512 S-VHS Video Cable
45520 Cleaning Bottle
VS-100 Sigmoidoscope 5
Page 8
Nomenclature and Function
Flexible VideoSigmoidoscope
VideoSigmoidoscope
6 VideoPath
CONTROL BODY
INSERTION TUBE
BENDING SECTION
DIST AL TIP
ENDOSCOPE CONNECTOR
TERMINAL
Suction Valv e
Air/Water V alv e
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/T op V iew
Front/Bot tom
View
Soaking Cap
ET O/Shipping Vent
Electrical Contacts
Air/Water
Input Ports
Suction Port
Right/Left
Deflection
Control Knob
Light Guide
Light
Guides
Page 9
Nomenclature and Function (continued)
Flexible VideoSigmoidoscope
CONTROL BODY
Suction V alve – Depress to aspirate fluids or air through the biopsy/suction channel.
Air/Wat er V alve – 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.
INSERTION TUBE – Cont ains 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. DIST AL 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 V ent – Vent where ETO/Shipping Vent Cap couples to equalize instrument’s
internal pressure with room pressure during shipping and ETO gas sterilization.
Light Guides – Couple to lamps in light source to provide illumination.
VS-100 Sigmoidoscope 7
Page 10
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 endo-
scope 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
Main
Power
Switch
Air
Pump
Switch
Lamp
Ignition
Lamp
Standby
Indicator
Endoscope
Connector
Port
Air Output
Port
Picture
Brightness
Control
Water
Bottle
Page 11
Composite
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.
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.
NO
TE: 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.
VS-100 Sigmoidoscope 9
Fill Line
Air Input
Terminal
Air Output Terminal
Water Output Terminal
S-Video
Power Supply
Cord Receptacle
Fuse Drawer
Page 12
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 Sigmoidoscope
Insertion T ube – 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 T est – the watertight integrity of the instrument should be verified following the
procedures outlined on page 24.
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 22 and 28.
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 110-120 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
Page 13
Preparation and Inspection f or 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 to the light
source’s air output port and the
VideoSigmoidoscope’s connector
terminal’s 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.
NO
TE: If the Light Source is powered up without having the Video-
Sigmoidoscope 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
VideoSigmoidoscope is removed from the light source, avoid looking
directly into the intense light provided by the light source to prevent
damage to your eyes.
VS-100 Sigmoidoscope 11
Standby LED Light
Standby
LED
Center
LED of the
Picture
Brightness
Indicator
Page 14
Preparation and Inspection f or Use (continued)
8. Activate the Air switch to verify functionality 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.
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 24.
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 T ube, Umbilical T ube, 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 VideoSigmoidoscope with outward signs of damage.
NO
TE: 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
Page 15
Preparation and Inspection f or 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 38.
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.
NO
TE: Do Not attempt to rotate the deflection
knobs past their limits. This can result
in severe damage to the steering
mechanism.
CAUTION: Do Not deflect the bending
section of the VideoSigmoidoscope
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, there may be
internal damage. Do Not use the
VideoSigmoidoscope. Doing so will
result in injury to the patient or further
damage to the VideoSigmoidoscope.
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.
VS-100 Sigmoidoscope 13
Do Not
Wind
Page 16
Preparation and Inspection f or Use (continued)
Inspection of Air Feed Valve
1. Place the tip of the bending section into a container of clear water. Cover the hole in
the top of the air/water feed valve (green ring). Do not depress the valve. Air should
flow freely from the air nozzle in the distal tip of the instrument and the water should
bubble vigorously.
2. Remove your finger from the valve – the bubbling should end immediately.
Inspection of Water Feed Valve
1. Depress the air/water valve completely to initiate the flow of water from the water nozzle
in the distal tip of the instrument. Water should flow in a constant stream over the objective lens and light guides. Upon initial set-up, depress and hold the valve for several
seconds for water to fill the entire line.
NO
TE: If air or water do not flow from the distal tip, refer to the
Troubleshooting section (page 42).
Inspection of Suction Mechanism
1. Connect the suction tubing from the suction machine to the Suction Port hose barb on
the endoscope connector terminal.
2. Immerse the distal tip of the bending section into clear water and completely depress
the suction valve (orange ring). Make sure biopsy seal is in place.
3. Verify aspiration by viewing water flow into suction receptacle. Releasing valve should
stop suction immediately.
14 VideoPath
Cover
Depress
Depress
Suction Port
Page 17
Preparation and Inspection f or Use (continued)
NOTE: It is import ant that the rubber biopsy seal on the biopsy port is in
good condition. Worn seals will result in poor suction and leakage
and should be replaced.
Inspection of Biopsy/Suction Channel
1. Check for kinks in the flexible shaft of the biopsy forceps.
2. Clean any debris from the biopsy forceps before using them.
3. Make sure the handle mechanism on the forceps works
freely and the jaws open and close freely.
4. Close and inspect the jaws of the forceps to make sure the
cups are in proper alignment. If there is a spike in the forceps, make sure the spike is completely straight and within
the cups.
WARNING: It is important that forceps or accessories not be used if they
show any sign of damage or if they do not operate correctly. If the forceps or an accessory does not work properly during a procedure, serious
injury to the patient could result. Use of damaged forceps or accessories
could also result in damage to the VideoEndoscope.
5. Straighten the VideoSigmoidoscope and insert the forceps through the biopsy port.
If resistance is encountered, contact Welch Allyn Technical Service. Do Not insert
the accessory further. Damage could occur to the instrument. Do Not use the
VideoSigmoidoscope.
Operations
Procedure
The methods and techniques of flexible sigmoidoscopy are well defined and documented.
Endoscopy training seminars and preceptorship programs are also in existence worldwide.
No attempt is made in this manual to outline the medical procedure or techniques of flexible
sigmoidoscopy. The physician should always take care to understand the clinical background
of each patient and the possible contraindications of the procedure.
Before beginning the procedure, make sure the patient is prepared for the examination using
the normal steps required for endoscopy.
WARNING: The light source and connected endoscope should not be
used with electrosurgical generators. The VS-100/VLX-10 Sigmoidoscope
system has not been designed for therapeutic procedures.
VS-100 Sigmoidoscope 15
Page 18
Operations (continued)
Holding the Instrument
The control section is designed for the left hand. The
“V” formed by the left thumb and index finger should
be positioned beneath the area where the umbilical
cord exits the control section. The suction and
air/water valves are controlled by the index finger and
middle finger respectively. The up/down deflection
control is operated by the thumb. The right hand is
used to advance and rotate (torque) the insertion
tube. In some instances, it may be necessary to have
an assistant hold the insertion tube while the right/left
deflection control is rotated by the right hand.
Preparation Before Insertion of the VideoEndoscope
WARNING: Make sure the VideoSigmoidoscope is properly disinfected or
sterilized prior to every use. Current infection control guidelines require
that VideoSigmoidoscopes and their patient contact accessories be subjected to high level disinfection or sterilization.
1. Use a clean gauze to gently wipe the insertion tube.
2. Moisten a cotton-tip swab with alcohol and gently
clean the objective lens on the distal tip. If a lens
cleaner (anti-fogging agent) is used, apply it first to
gauze or other applicator. Make sure to wipe off all
excess cleaner.
3. Apply a medical grade water soluble lubricant
(e.g., KY Jelly) to the bending section and
insertion tube. Do Not use petroleum based
lubricants. Do Not contaminate the lens with
lubricant.
16 VideoPath
Lens
Bending
Section
Page 19
Operations (continued)
Insertion and Withdrawal
1. Slowly insert the lubricated instrument.
2. Use the deflection controls to guide the instrument through the lumen. The deflection
of the tip should be done under direct vision in a gentle and deliberate manner.
WARNING: If resistance is encountered, Do Not force the deflection
controls. Doing so may result in serious injury to the patient and/or
damage the instrument.
Do Not advance the instrument if the lumen is not visible. Blind advancement could result in perforation of the patient’s colon.
If during the procedure, the deflection controls cease to function or the
image is lost due to a power shortage, lamp or processor failure, etc.,
terminate the examination. Return one (or both) of the deflection controls
to the neutral position. Slowly withdraw the VideoSigmoidoscope from
the patient. Do Not operate the controls during withdrawal.
3. A collapsed lumen can be opened by insufflation. Cover the hole on the top of
the air/water valve to inflate the colon. Adequate insufflation can be maintained by
insufflation and periodic aspiration of air. Use the suction control to decrease the
level of insufflation.
WARNING: It must be recognized that variations in air flow (pressure
and volume) for patient insufflation may exist from one manufacturer’s
equipment (light source and/or endoscope) to another. It is, therefore,
important to closely monitor the patient at all times and to aspirate
excessive air to prevent over insufflation and patient discomfort.
4. Fluid, secretions, and liquid stool can be aspirated by depressing the suction valve,
thus improving visualization. Do Not try to aspirate solid material since this will clog
the suction channel.
CAUTION: Care should be taken to avoid sucking mucosa into the suction channel. This phenomena can result in a “suction polyp” that can be
mistaken for a lesion.
5. Lubricant, mucous and fecal materials can cloud or fog the objective lens. Use the
air/water and suction control valves alternately to clean the objective lens.
NO
TE: Water drops retained on the lens can be removed by covering
the hole on top of the air/water valve, pushing air through the
scope and over the lens.
6. Before removing the VideoSigmoidoscope, aspirate any remaining air to reduce any
patient discomfort.
7. Before withdrawing the scope, return the bending section to the neutral position.
Always withdraw the VideoSigmoidoscope under direct visualization.
VS-100 Sigmoidoscope 17
Page 20
Operations (continued)
Biopsy Passage
1. Biopsy forceps and accessories should be inserted through
the biopsy seal and into the channel. Hold the forceps handle so that the jaws are fully closed during insertion.
NO
TE: Failure to insert the forceps in the fully closed
position may cause serious damage to the
biopsy/suction line.
Temporary resistance will be experienced when the cups
are first passed through the seal. Advance the forceps using
short strokes, started by grasping the forceps sheath tightly
at about 5cm from the cups.
WARNING: If resistance is encountered during the passage through the
bending section, relax the deflection angle until the passage is smooth
and easy. Wetting the forceps with water or a medical grade silicone
lubricant will promote easier passage. Never apply excessive pressure
when inserting any accessory into the biopsy channel, since the channel
may be damaged, resulting in malfunction of the VideoEndoscope and
costly repairs.
If the biopsy seal “Splits” or leaks while the VideoSigmoidoscope is in place, remove
the defective seal and replace it.
NO
TE: When replacing the biopsy seal, rotate the
seal one full turn clockwise after pushing on
the luer lock fitting to insure a proper seal.
NO
TE: Always flush the biopsy/suction channel
immediately after a procedure by aspirating
clear water through the channel (see the
Cleaning instructions). This flushing will
assist passage of instruments in
subsequent procedures.
2. Collect a tissue sample by opening the forceps and advancing the open cups up
against the mucosa. Carefully close the cups until resistance is felt, and then hold.
Gently pull back on the forceps until a small tissue sample is removed. Always keep
the accessory in view during advancement.
3. Withdraw the forceps with the cups closed. Opening the cups during withdrawal may
damage the biopsy channel.
18 VideoPath
Page 21
Operations (continued)
NOTE: If the forceps fail to close during a procedure,
close the cups by winding the proximal portion of the forceps cable around your index
finger. If the forceps still do not close, retract
the cups as close as possible to the distal tip
and slowly withdraw the instrument under
direct visualization.
Because of the effect that accessories
used in the biopsy/suction channel of the
VideoSigmoidoscope can have on the performance of the VideoSigmoidoscope itself, it is
strongly recommended that only Welch Allyn
accessories be used with Welch Allyn instruments. If a unique or highly specialized
accessory is available from another source,
please contact Welch Allyn to arrange for a
test of its compatibility before using it
through the W elc h Allyn VideoSigmoidoscope.
Cleaning and Disinfection
Endoscope Internal Schematics
These schematic illustrations are intended to provide the user with a better understanding of
how the Welch Allyn VideoSigmoidoscope works. All the internal channels are indicated to
better show their relationship to one another. This understanding should assist the user in
caring for and reprocessing the VideoSigmoidoscope.
The design of VideoSigmoidoscopes and its components allows for efficient and effective
cleaning and disinfecting by either manual methods or automated processes prior to
patient use.
Standard size luer lock and/or luer-slip fittings are used on the connectors on all cleaning/
disinfecting adapters and scope inlet ports. These locks and fittings easily accommodate
reprocessing devices or systems available from other manufacturers.
As illustrated in the schematics, the cleaning system promotes efficient unidirectional flow of
solution beginning from connections at the endoscope connector terminal, traveling up channels in the umbilical cord to the valve cylinders in the control section, passing through the
channels in the insertion tube and finally exiting nozzles or channel openings at the distal tip
of the scope.
The elimination of multiple branching channels, combined with a direct and straightforward
pathway for solutions to travel maximizes flow efficiency and ensures contact of disinfectant/sterilant with all internally exposed channel surfaces.
VS-100 Sigmoidoscope 19
Page 22
Cleaning and Disinfection (continued)
WARNING: It is imperative that flexible VideoEndoscopes and other
semi-critical devices be reprocessed such that high level disinfection is
achieved with an EPA registered sterilant/disinfectant. It should be noted
that any endoscope automated reprocessing device or system* must be
cleared for marketing by the FDA via the 510 (k) premarket notification or
PMA approval process.
Only reprocessing solutions/systems satisfying the above conditions and tested and found to
be compatible by Welch Allyn should be used with Welch Allyn products.
*Liquid chemical germicides (disinfectants/sterilants) to reprocess medical devices come under FDA regulation and new products must, therefore, undergo a 510 (k) premarket notification submission prior to introduction into interstate commerce.
Internal Schematic
NO
TE: Endoscopic instruments should be meticulously cleaned
immediately after each use prior to disinfection or sterilization.
Endoscopes are delicate and will degrade, if not cleaned properly,
due to the effects of digestive contents (e.g., blood, mucous).
The methods outlined on the following pages have been tested
and verified to have no damaging effects. Therefore, it is important to adhere to these procedures.
20 VideoPath
Valve Reprocessing Cap
Valve Reprocessing Cap
Biopsy Port
From Syringe (under vacuum)
Insertion T ube
Distal Head
Distal Reprocessing Cap
(fluid collects in cap from air and
water lines and is then pulled
through suction line)
Endoscope Connector
Terminal
Cleaning Fluid
Cleaning Bottle
To Suction Container
(suction pump pulls vacuum
on closed system)
Umbilical T ube
Suction Line
Water
Air
Page 23
Cleaning and Disinfection (continued)
Required Equipment (for cleaning and disinfection):
Basin of Clean Water
Basin of Enzymatic Solution
Gauze Pads
Disposable Gloves
31020 Channel Cleaning Brush
31021 Valve Reprocessing Caps
31023 60cc Syringes (2 each)
33924 Air/Water Nozzle Cleaning Brush
31027 Reprocessing Adapter
31030 Distal Reprocessing Cap
(semi-automated cleaning only)
31028 Soaking Cap
31037 Leak T ester
33918 Valve Lubricant
31038 Suction Reprocessing Adapter
31031 Valve Well Cleaning Brush
VS-100 Sigmoidoscope 21
Page 24
Cleaning and Disinfection (continued)
WARNING: The importance of meticulous mechanical cleaning of Video
Endoscopes cannot be overemphasized. Prior to disinfection or sterilization, all instruments must be scrupulously cleaned. Failure to do so could
result in incomplete or ineffective disinfection and/or sterilization.
The bending section of the instrument should be handled with care during the cleaning process. The most common failure that results in an
instrument being returned for repair is a leak in the bending section rubber due to a pin hole leak. Do Not strike the bending section against any
hard surface or use abrasive material to wipe clean.
Semi-Automated Cleaning Method
(Utilizing the #45520 Cleaning Bottle)
The following steps should be performed immediately after removal of the instrument from a
patient. For further clarification of the channels affected by this process, please refer to the
internal schematic on page 20.
NO
TE: Protective garments (i.e., gloves, gowns, face masks or shields)
should always be worn during the cleaning process to minimize
the risk of cross contamination.
Cleaning at the Examination Room
Power-off and Wipedown
Remove scope from patient. Turn off suction pump and light source. Leave the scope
plugged into light source and suction tubing attached.
Wipe off insertion tube with enzymatic cleaner and gauze to remove any debris.
Perform Semi-Automated Cleaning Process using enzymatic cleaner.
Note: If for some reason the Semi-Automated Cleaning Process cannot
be performed, refer to the Manual Cleaning Process outlined
later in this section.
Semi-Automated Cleaning Process
Enzymatic Cleaner
See list of approved enzymatic cleaners on page 34.
Remove Water Bottle (45510) from light source. Locate the
Cleaning Bottle (45520) and fill it to the line with enzymatic
cleaner. Dry excess fluid from the exterior of the bottle and
insert it into the light source.
Remove valve plungers and biopsy seal from the scope and
place them in a small container of enzymatic cleaner.
22 VideoPath
Page 25
Cleaning and Disinfection (continued)
Replace the plungers with the corresponding color-coded Valve Reprocessing Caps (31021).
Attach Distal Reprocessing Cap (31030).
Load a 60cc (31023) syringe with enzymatic cleaner.
Attach to the biopsy port.
Turn on suction
pump. Power up
the light source
and turn on the air
pump. Run until
no enzymatic
cleaner remains in
the cleaning bottle. Empty the suction pump collection bottle periodically throughout the procedure.
When completed, turn off the light source and then
the suction pump.
Disconnect the suction pump tubing from the suction port. Remove the syringe, valve
reprocessing caps and the distal reprocessing cap.
Mechanically Cleaning the Channels
The Channel Cleaning Brush (31020) can now be used to clean the various channels. Insert
the brush into the suction valve well, directing it towards the opening in the
side of the wall which is furthest away from the deflection knobs. Advance
the brush until it exits the suction port on the endoscope connection terminal. Clean away any debris with a soft, lint-free gauze pad moistened with
enzymatic cleaner and repeat until debris no longer
appears on the brush.
Next, insert the channel cleaning brush into the
open suction valve well and direct it towards the
bottom of the channel. Feed the brush through the
opening until resistance is felt (approx. 15 cm). Do
not use excessive force. Withdraw the brush and
clean away any debris using a gauze pad moistened with enzymatic
cleaner. Repeat the process until debris no longer appears on the
brush.
Insert the brush into the open biopsy port and advance
it until it exits from the distal tip of the instrument. Remove debris from the
brush with a gauze pad and withdraw it from the channel. Repeat until no
debris appears on the brush.
Insert the Suction Valve Well Cleaning Brush (31031)
into the suction valve well and clean the surface of the
well by rotating the brush while inserting and removing.
Using the Air/Water Nozzle Cleaning Brush (33924),
clean the nozzles at the distal tip of the instrument.
VS-100 Sigmoidoscope 23
Suction T ube
Distal
Reprocessing Cap
Distal
Reprocessing
Cap
Page 26
Cleaning and Disinfection (continued)
Leakage Testing
Stage 1
Remove the cleaning bottle and scope from the light source.
After making sure that the Leakage Tester (31037) and the ETO vent on the endoscope
connector terminal are dry, attach the leakage tester to the ETO vent. They should be
screwed together until snug to insure a watertight seal.
After making sure that the pressure release valve on the back of the gauge is closed,
(turn fully counter-clockwise) pressurize the inside of the instrument by pumping the
hand bulb until the indicator needle is within the TEST zone. Do not overpressurize
or the scope may be damaged.
Observe the gauge indicator needle. It should remain in the TEST zone for at least one
minute. If it does not remain in the TEST zone, the scope has a leak. Contact the Welch Allyn
Service Dept. immediately before any further processing so that proper steps can be taken
to prevent any damage to the endoscope.
Leakage Testing
Stage 2
If no leaks are determined during the Stage 1 test,
the instrument should now be tested for loss of
integrity in the watertight construction due to small
pinholes.
Attach the Soaking Cap (31028) to the endoscope
connector terminal to seal off the electrical contacts. Make sure the leakage tester is securely
attached to the ETO Vent port and that the gauge
indicator needle is still in the TEST zone.
24 VideoPath
Page 27
Cleaning and Disinfection (continued)
Immerse the entire instrument, with all
valves and biopsy seals removed, into enzymatic cleaner. Immerse only a small part of
the leakage tester tubing. Never immerse
the entire leakage tester.
Carefully observe the instrument for bubbles
while deflecting the distal tip in all 4 directions. Observe for at least one minute. A
few bubbles may initially rise from the biopsy channel or recessed areas of the scope.
This is normal. If bubbles continue to rise
from the same location, a leak is indicated.
Remove the scope immediately from the
basin and contact the Welch Allyn Service
Dept. before any further processing so that
proper steps can be taken to prevent any
damage to the endoscope.
Mechanically Cleaning the Exterior of the Instrument
If the scope has successfully passed the leakage test it should now be cleaned.
Make sure
that the leakage tester remains securely attached to the endoscope light source connector.
While still immersed in the enzymatic cleaner, gently but thoroughly wash the entire exterior
surface of the endoscope with a gauze pad moistened with enzymatic cleaner. In addition,
wash the valves plungers, biopsy seal and reprocessing cap with enzymatic solution.
Clean Wat er Rinse
Remove the endoscope and accessories from the enzymatic solution and immerse it in a
container of clean water. Rinse all components thoroughly.
After removing the instrument from the water,
open the pressure release valve on the leak-
age tester to release the air pressure. Remove the leakage tester
. Never connect or discon-
nect the leakage tester under water. The instrument will be severely damaged.
Remove the soaking cap from the light source connector.
Semi-Automated Cleaning Process
Clean Wat er
Refill the cleaning bottle and 60cc syringe with clean water and repeat the Semi-Automated
Cleaning Process as previously described to remove enzymatic cleaner from the channels.
Remove the syringe and the distal reprocessing cap. Leave the valve reprocessing caps in
place. Remove the cleaning bottle and the scope from the light source.
Now proceed with disinfection of the instrument by using
either
Disinfection Procedure #1
(Using Tray) or #2 (Tot al Immersion).
VS-100 Sigmoidoscope 25
Page 28
Cleaning and Disinfection (continued)
Disinfection Procedure #1 (Using Tray)
See the list of approved disinfectants on page 35.
Fill the tube of the Disinfection Tray (33902) to the black dot with an approved
glutaraldehyde-based disinfection solution. Solution should also be added to the basin
in the center of the tray.
Advance the endoscope insertion tube completely into the disinfection tray tube.
Place the air/water valves, suction valves and biopsy seal into the basin for soaking.
Attach the Suction Reprocessing Adapter (31038) to the
suction port on the endoscope light source connector.
Connect an empty 60cc syringe to the adapter.
Connect another empty 60cc syringe to the biopsy port
on the control section of the endoscope.
Attach the Air/Water Reprocessing Adapter (31027) to the
endoscope light source connector. Drawing from the
basin, fill another 60cc syringe with disinfectant and
connect it to the adapter.
Draw 30cc’s of fluid into the syringe connected to the suction reprocessing adapter. Leave
the syringe attached.
Draw 30cc’s of fluid into the syringe on the biopsy port. Leave the syringe attached.
Inject all fluid from the prefilled 60cc syringe until the syringe is empty. If necessary, let any
trapped air vent through the disinfection tray tube. Leave the syringe attached. All the
channels have now been filled with disinfectant.
Following the solution manufacturer’s recommendations for high level disinfection, allow the
instrument to soak for the proper time period.
Following the disinfection soak cycle ....
Disconnect the empty 60cc syringe from the air/water reprocessing adapter, fill it with air
and reattach it.
Draw an additional 30cc’s of fluid into the syringe connected to the biopsy port, then remove
it and purge the disinfectant into the soak basin. Fill the syringe with air and reattach it.
Disconnect the remaining syringe and purge the disinfectant into the soak basin. Fill it with
air and reattach it to the suction reprocessing adapter.
Slowly inject air into all channels. Allow air to purge through the soaking tube.
Remove all syringes and adapters.
Slowly withdraw the endoscope from the disinfection tray. Rinse the insertion tube with
clean water and wipe it with a gauze pad to remove any residual disinfectant. Remove all
accessories from the basin and rinse them thoroughly with clean water.
Proceed to Final Rinse.
26 VideoPath
Air/Water
Reprocessing
Adapter
Page 29
Cleaning and Disinfection (continued)
Disinfection Procedure #2 (Total Immersion)
See the list of approved disinfectants on page 35.
Fill a covered basin with activated disinfectant to a level that will allow the entire instrument
to be immersed in solution.
Connect the Air/Water Reprocessing Adapter (31027) to the air and water ports on the
endoscope connector.
Attach the color-coded valve reprocessing caps.
Attach the soaking cap to the endoscope connector terminal.
Place the entire endoscope into the basin making sure that all surfaces are immersed in
the disinfectant. Place the air/water and suction valves and the biopsy seal into the
solution as well.
Fill a 60cc syringe with disinfectant and attach it to the
air/water reprocessing
adapter. Fill another
60cc syringe and attach
it to the
biopsy port.
Depress the plungers
of both syringes to
fill all channels with
disinfectant.
Following the solution manufacturer’s recommendations, allow the instrument to soak for the
proper time period.
Following the disinfection soak cycle ....
Remove the endoscope connector terminal from the disinfectant and uncouple the syringe from
the adapter. Also remove the other syringe. Fill both syringes with air and reattach.
Inject air from both syringes to purge the lines of disinfectant. Repeat until bubbles appear indicating that all solution has been removed.
Remove the instrument from the solution and uncouple the syringes and the adapter.
Place the entire instrument into a basin or sink of clean water. Thoroughly wipe down the exteri-
or of the instrument to remove any residual solution. Remove all accessories from the basin and
rinse them thoroughly with clean water.
Proceed to Final Rinse.
VS-100 Sigmoidoscope 27
Air/Water
Reprocessing Adapter
Air/Water
Reprocessing Cap
Suction Reprocessing
Cap
Page 30
Cleaning and Disinfection (continued)
Final Rinse
Perform the
Semi-Automated Cleaning Process
, this time using
Clean Water
. Attach the light
guide connector to the light source and follow the steps in the Semi-Automated Cleaning
Process section above, this time using
Clean Water
instead of enzymatic solution.
The Semi-Automated Cleaning Process may be repeated with alcohol, if desired, to promote
drying. Use only 70% Isopropyl alcohol.
Apply a thin coating of Welch Allyn Valve Lubricant (33918) to the Air/Water Valve “O” Rings
(31024) and Suction Valve “O” Rings (31025). Remove air/water and suction caps and insert
the valves into the open valve wells. Reattach the Biopsy Seal (33930) to the biopsy port.
Disconnect the endoscope from the light source and hang it on the Instrument Hanger
(31035) to dry.
Manual Cleaning Method
(Alternative to the Semi-Automated Cleaning Process described above)
Cleaning at the Examination Room
The following steps should be performed immediately after
removal of the instrument from a patient.
NO
TE: Protective garments (i.e., gloves, gowns,
face masks or shields) should always be
worn during the cleaning process to minimize the risk of cross contamination.
Immediately after the instrument is removed from the
patient, put the lamps on stand-by by pressing the lamp
ignition switch. Next, wipe off all debris from the insertion tube with a soft, lint-free cloth
moistened with enzymatic cleaner. See page 34 for a list of compatible cleaners.
28 VideoPath
Page 31
Cleaning and Disinfection (continued)
With the instrument still coupled to the suction machine, insert the distal tip into
the enzymatic solution and depress the suction valve. Aspirate solution through the
biopsy/suction channel until the solution exiting from the suction port is clean and
free of debris. Alternate aspiration of solution and air for 5-10 seconds.
Keeping the distal tip in the container of solution (air switch is still “on”), depress the
air/water feed valve (green valve) for 5-10 seconds. Release the valve and cover the hole on
top for 5-10 seconds. This will expel any mucous, debris, etc. which may have entered the air
and water nozzles during the procedure.
Turn off the light source and then the suction pump, and remove the suction line from the
endoscope suction port.
Grasp the water bottle handle and pull back
gently to disconnect the bottle from the
light source.
Detach the endoscope connector terminal
from the light source by grasping the
umbilical cord strain relief and pulling
back gently. The instrument is now ready
to be transported to the cleaning room for
further processing.
Mechanically Cleaning the Channels
Remove the valve plungers and biopsy seal from the scope and place them in a small container of enzymatic cleaner. The Channel Cleaning Brush (31020) can now be used to clean
the various channels. Insert the brush into the suction valve well, directing it towards the
VS-100 Sigmoidoscope 29
Cover
Cover
Depress
Page 32
Cleaning and Disinfection (continued)
opening in the side of the wall which is furthest away from the deflection
knobs. Advance the brush until it exits the suction port on the endoscope
connection terminal. Clean away any debris with a soft, lint-free gauze pad
moistened with enzymatic cleaner and repeat until debris no longer appears
on the brush.
Next, insert the channel cleaning brush into the open suction valve well and
direct it towards the bottom of the channel.
Feed the brush through the opening until resistance is felt (approx. 15 cm). Do not use excessive force. Withdraw the brush and clean away
any debris using a gauze pad moistened with
enzymatic cleaner. Repeat the process until debris no longer
appears on the brush.
Insert the brush into the open biopsy port and advance it until it
exits from the distal tip of the instrument.
Remove debris from the brush with a gauze
pad and withdraw it from the channel. Repeat
until no debris appears on the brush.
Insert the Suction Valve Well Cleaning Brush
(31031) into the suction valve well and clean the
surface of the well by rotating the brush while
inserting and removing.
Using the Air/Water Nozzle Cleaning Brush
(33924), clean the nozzles at the distal tip of
the instrument.
Leakage Testing
Stage 1
Remove the cleaning bottle and scope from the light source.
After making sure that the Leakage Tester (31037) and the ETO vent on the endoscope
connector terminal are dry, attach the leakage tester to the ETO vent. They should be
screwed together until snug to insure a watertight seal.
After making sure that the pressure release valve on the back of the gauge is closed,
(turn fully counter-clockwise) pressurize the inside of the instrument by pumping the
hand bulb until the indicator needle is within the TEST zone. Do not overpressurize
or the scope may be damaged.
30 VideoPath
Page 33
Cleaning and Disinfection (continued)
Observe the gauge indicator needle. It should remain in the TEST zone for at least one
minute. If it does not remain in the TEST zone, the scope has a leak. Contact the Welch Allyn
Service Dept. immediately before any further processing so that proper steps can be taken
to prevent any damage to the endoscope.
Leakage Testing
Stage 2
If no leaks are determined during the
Stage 1 test, the instrument should
now be tested for loss of integrity in
the watertight construction due to
small pinholes.
Attach the Soaking Cap (31028) to
the endoscope connector terminal to
seal off the electrical contacts. Make
sure the leakage tester is securely
attached to the ETO Vent port and
that the gauge indicator needle is still
in the TEST zone.
Immerse the entire instrument, with
all valves and biopsy seals removed,
into enzymatic cleaner. Immerse
only a small part of the leakage tester
tubing. Never immerse the entire leakage tester.
VS-100 Sigmoidoscope 31
Page 34
Cleaning and Disinfection (continued)
Carefully observe the instrument for bubbles while
deflecting the distal tip in all 4 directions. Observe for
at least one minute. A few bubbles may initially rise
from the biopsy channel or recessed areas of the
scope. This is normal. If bubbles continue to rise from
the same location, a leak is indicated. Remove the
scope immediately from the basin and contact the
Welch Allyn Service Dept. before any further processing so that proper steps can be taken to prevent any
damage to the endoscope.
Mechanically Cleaning the Exterior of the Instrument
If the scope has successfully passed the leakage test it should now be cleaned.
Make sure
that the leakage tester remains securely attached to the endoscope light source connector.
While still immersed in the enzymatic cleaner, gently but thoroughly wash the entire exterior
surface of the endoscope with a gauze pad moistened with enzymatic cleaner. In addition,
wash the valves plungers, biopsy seal and reprocessing cap with enzymatic solution.
Enzyme Cleaning the Channels of the Instrument
Connect the Air/Water Reprocessing Adapter (31027) to the air and water ports on the
endoscope connector.
Attach the color-coded valve reprocessing caps.
Attach the soaking cap to the endoscope connector terminal.
Fill a 60cc syringe with enzymatic cleaner and attach it to the air/water reprocessing adapter.
Fill another 60cc syringe and attach it to the biopsy port.
Depress the plungers of both syringes to fill all channels.
Following the solution manufacturer’s recommendations, allow the instrument to soak for
the proper time period.
32 VideoPath
Air/Water
Reprocessing Adapter
Air/Water
Reprocessing Cap
Suction Reprocessing
Cap
Page 35
Cleaning and Disinfection (continued)
Following the soak cycle, remove the instrument from the solution and place into a sink or
basin filled with clean water, along with the air/water, suction valves and biopsy seal.
Rinse the exterior of the instrument (including valves and seal) thoroughly to remove any
residual solution.
Lift the endoscope connector terminal out of the basin and remove the syringe coupled to
the air/water reprocessing adapter. Refill the syringe with clean water and reattach. Inject
clean water into the air and water lines to rinse. Continue until the water exiting from the
air and water nozzles is clear.
Remove the syringe connected to the biopsy port and fill with clean water. Reconnect and
inject water until it sprays from the open biopsy/suction channel and the suction port.
Continue until the water exiting from channel and port is clear.
WARNING: Make sure that ALL internal channels (e.g., air, water,
suction), the outside of the instrument, and components are thoroughly
rinsed with clean water to remove any remaining enzymatic detergent
solution.
Uncouple both syringes. Fill with air, recouple and inject air through the lines to dry.
Repeat until water does not exit from the channels.
Lift the entire instrument out of the clean water and place on a clean, dry towel to dry
(valves and biopsy seal, as well).
Gently dry the outside surfaces of the instrument with a soft, clean, lint-free cloth. Dry the
objective lens with a cotton-tipped applicator. Open the pressure release valve on the
leakage tester to release the air pressure. Remove the leakage tester. Never connect or
disconnect the leakage tester under water. The instrument will be severely damaged.
NO
TE: 70% alcohol, followed by air may be introduced through the
channels to promote drying.
The instrument is now ready to be disinfected.
VS-100 Sigmoidoscope 33
Page 36
Cleaning and Disinfection (continued)
Enzymatic Cleaning Solutions
NOTE: Specific references to brand name is not an endorsement of
efficacy as a cleaning solution. Tests have shown these solutions
to be compatible with Welch Allyn endoscopes, providing the
manufacturer’s directions are followed.
The materials listed below are considered safe for use with the Welch Allyn
VideoSigmoidoscope if used according to the manufacturer’s instructions for cleaning
and in accordance with procedures detailed in the cleaning section of this manual.
Brand Name Source Usage
Endozime The Ruhof Corp.
Klenzyme Calgon Vestal Labs Follow
Enzy-Clean Burnishine Products Manufacturer’s
Metrizyme Metrex Research Corp. Instructions
Enzol J & J Medical
These solutions must be enzymatic detergents or other cleaning agents specially
formulated to clean endoscopes.
WARNING: Before disinfection or sterilization, be sure that any enzymatic
cleaning solution is thoroughly rinsed off all surfaces. Cleaning solutions
should not be combined with disinfecting or sterilizing solutions since
they can alter the germicidal effectiveness.
Cleaning of Accessories – Biopsy Forceps
1. Clean reusable forceps immediately after each use since dried blood, mucous, or other
debris may cause damage and make it impossible to use the forceps. If forceps are not
clean prior to sterilization, the user may not be able to reprocess them properly.
2. Place the forceps in a container of warm water and enzymatic detergent. Do Not tightly
coil or kink the flexible shaft.
3. Clean the handle and flexible shaft with a soft, clean cloth. Carefully and gently clean the
biopsy cups, pivot pin, and needle with a soft brush.
4. Rinse any remaining detergent from the forceps by rinsing the entire forceps with clean
water while manipulating the handle and biopsy cups mechanism.
34 VideoPath
Page 37
Cleaning and Disinfection (continued)
NOTE: Make certain all detergent is removed from the inner mecha-
nism of the forceps. Any remaining detergent after the water
evaporated causes increased friction that may cause the mechanism not to work. Any remaining detergent also may interfere in
the subsequent sterilization process.
5. After the forceps are cleaned and thoroughly rinsed, dry them gently with a soft, clean
lint free cloth. Do not tightly coil or kink or put tension on the flexible shaft of the forceps.
NO
TE: Clean all other reusable accessories (e.g., channel cleaning
accessories, cleaning brushes) and scope components (e.g.,
rubber biopsy seals, air/water and suction control valves) in the
same way as the forceps were cleaned.
High-Level Disinfection
The Welch Allyn VideoEndoscopes are manufactured from a variety of special materials
which optimize the instrument’s performance, but may not withstand some disinfection
solutions and methods.
Prior to disinfection, the instrument should be thoroughly cleaned and dried following the
methods previously discussed. Incomplete or improper cleaning will decrease the effectiveness of the disinfection process.
CAUTION: Before complete immersion in any disinfecting solution,
make sure the instrument has been leak tested. Refer to instructions
on page 24.
Disinfecting Solutions
NOTE: Specific references to brand name is not an endorsement of
efficacy as a disinfecting solution. Tests have shown these solutions to be compatible with Welch Allyn endoscopes, providing
the manufacturer’s directions are followed.
The materials listed below are considered safe for use with the Welch Allyn flexible Video
Endoscope if used according to the manufacturer’s instructions for cleaning and in accordance with procedures explained in the disinfecting section of this manual.
Solution Brand Name Source Usage
Cidex (14 day) (2.4%) J & J Medical
Follow
Glutaraldehyde Wavicide-01 (2.5%) Wave Energy System Inc.
Manufacturer’s
Metricide (14 day) (2.6%) Metrex Research Corp.
Instructions
VS-100 Sigmoidoscope 35
Page 38
Cleaning and Disinfection (continued)
NOTE: Do not use any other solutions until a sample has been sent to
Welch Allyn for compatibility testing.
Refer to the infection control note located on the inside cover of
the manual.
CAUTION: Before immersing the scope, remove the ETO/Shipping vent
and place the soaking cap on the electrical contacts located on the endoscope connector terminal.
For clarity the reader may wish to refer to the internal schematic on
page 20 showing the pathways involve d during the disinfection process.
Sterilization and Aeration
Before sterilizing the instrument make certain to thoroughly follow the cleaning instructions in
the cleaning section of this manual. It is up to the user to determine if the sterilization procedures described in this section meet the requirements of the facility.
CAUTION: NEVER put the instrument in a steam autoclave.
Ethylene Oxide Gas Sterilization
If Ethylene Oxide (ETO) Gas sterilization is performed on this instrument, make sure to follow
the steps below. This is an acceptable method of sterilization for this instrument, however
the steps are different from those used for other endoscopes.
1. Properly clean and dry the instrument according to the instructions presented previously
in this manual. Remove all component parts (e.g., air/water valve, suction valve, biopsy
seal, etc.).
36 VideoPath
Page 39
Cleaning and Disinfection (continued)
WARNING: If all surface areas are not completely dried, the ETO gas may
not make contact with the contaminated surfaces, causing incomplete or
ineffective sterilization.
Important: Before placing the instrument in a gas sterilizer or aeration chamber, be sure to:
• Couple the Shipping/ETO vent to the ETO vent on the endoscope connector terminal.
• The soaking cap (Part No. 31028) should not be attached and must be OFF of the electrical contacts.
WARNING: Failure to attach the Shipping/ETO Vent Cap will result in
severe damage to the instrument.
NO
TE: This is the opposite procedure from the immersion instructions.
• Make sure the temperature does not exceed 55°C (131°F).
• Make certain the pressure does not exceed 24 psi.
• Make sure the humidity does not exceed 50%.
• Make certain the sterilization procedure does not exceed
4 hours.
2. After ETO Gas sterilization, 72 hours of aeration at room temperature must follow. The
aeration time may be shortened to 12 hours if an aeration chamber is used. The temperature must not exceed 55°C (131°F).
Cold Sterilization
If Ethylene Oxide (ETO) Gas sterilization is not available, the Welch Allyn VideoSigmoidoscope
can withstand immersion in glutaraldehyde solution for a maximum of 12 hours to achieve
cold sterilization. Before fully immersing the instrument, perform the leakage test described
in the Leakage Testing section.
CAUTION: NEVER IMMERSE THE ENDOSCOPE FOR MORE THAN 12
HOURS. After the 12 hours, thoroughly rinse the instrument to remove all
of the glutaraldehyde solution.
After rinsing the instrument, attach the Shipping/ETO Vent to balance the internal and external
humidity.
Other Sterilization Methods
In addition to the ETO and Cold Sterilization methods, Welch Allyn VideoEndoscopes are also
compatible with the Steris Sterilization System/Process. Call Welch Allyn Customer Service at
1-800-535-6333 for additional information.
CAUTION: While there are other types of cleaning and/or sterilization systems or processes available, these types may have damaging effects on
the instrument because of the heat sensitive nature and/or the specific
biocompatible materials used in construction of the endoscopes.
VS-100 Sigmoidoscope 37
Page 40
Cleaning and Disinfection (continued)
To avoid damage to the instrument, check the compatibility of reprocessing systems/
processes other than described in this manual with your Welch Allyn representative.
Accessory Sterilization
WARNING: According to current infection control guidelines all acces-
sories that break the mucosal barrier (e.g., biopsy forceps), must be
sterilized.
Before sterilizing the accessories, make certain to thoroughly follow the cleaning instructions
in the Cleaning Section of this manual. It is up to the user to determine if the sterilization
procedures described in this section meet the requirements of the facility.
1. Once the accessories have been cleaned and thoroughly dried, Ethylene Oxide (ETO) Gas
sterilization can be performed.
2. Aeration is necessary after the accessories have been subjected to ETO sterilization.
Accessory and Instrument Storage
1. Make sure all water is removed from the instrument and accessories.
2. Store the instrument with the insertion tube and umbilical cable as straight as possible. If
coiling is necessary, the insertion tube and umbilical cable should not be wound in more
than one loop.
3. Do Not store the instrument in an area exposed to temperature extremes, high humidity, or
direct sunlight. The storage area should be dr y and clean.
4. Apply silicone oil to the cups of the biopsy forceps to prevent rust.
5. Couple the Shipping/ETO vent to the instrument to balance the internal and external
humidity. Before storing, remove all valves, biopsy seals, soaking caps, etc. to allow
thorough drying of internal parts.
WARNING: Prior to storage, it is important that no residual water be left
within any internal channels/lumens of the instrument or accessories.
Thoroughly dry all instrument surfaces to reduce the potential for bacteria
colonization during storage.
6. Use optional Welch Allyn wall hanger to store instrument securely (#31035).
38 VideoPath
Page 41
Servicing
Prior to returning any instrument for repair to Welch Allyn, the instrument should first undergo
appropriate reprocessing/decontamination procedures for the purpose of infection control.
1. All instruments requiring repair should be shipped in the original shipping package with
appropriate packing along with comments describing the instrument damage and complaint.
2. A repair/return authorization number, contact name and phone number of the individual
responsible for authorizing repairs, as well as shipping address should be included.
3. The ETO/Shipping vent should be attached to the instrument if it will be shipped by air
freight.
4. Any accessories potentially related to the scope damage or complaint also should be
included with the VideoSigmoidoscope.
5. Soaking caps (if applicable) also should be returned with the VideoEndoscope to
check/confirm the integrity of their watertight seal.
NO
TE: Instrument repairs should only be performed by an authorized
Welch Allyn service facility. Welch Allyn assumes no liability for
any patient/user injury, instrument damage or malfunction, or
reprocessing failure due to repairs made by unauthorized
personnel.
Customer Service Telephone Assistance: 1-800-535-6663
For repairs, ship to:
Welch Allyn Repair Department
4341 State Street Road
Skaneateles Falls, NY 13153
VS-100 Sigmoidoscope 39
Page 42
Care and Maintenance Tips
Flexible endoscopes have been an invaluable tool in the medical community’s armamentarium
to successfully diagnose and treat a wide variety of illnesses in patients for several decades.
Perhaps due to their longevity and progressive design changes over the years which have simplified their use, flexible endoscopes have been somewhat taken for granted and have erroneously not been considered highly technological medical devices.
In fact, current generation flexible endoscopes, although easier to clinically use, are more
sophisticated than ever. Special reprocessing instructions must be followed to make sure the
instruments are patient ready and patient safe. Special care and handling must be exercised
and practiced to prevent instrument malfunction and prolong the reliability of the endoscope.
The burden of responsibility to make sure of safe and reliably functioning instruments is left
in the hands of the healthcare professionals who actually care for and reprocess flexible
endoscopes.
Naturally, equipment manufacturers share this responsibility and tremendous efforts have been
spent in designing instruments which could be reprocessed and maintained as easily as possible. However, due to the nature of their use and application, flexible endoscopes must be subjected to special cleaning procedures, followed by a disinfection or sterilization process after
each and every patient use.
To highlight and simplify what may appear to some as being complicated maintenance
and reprocessing instructions, Welch Allyn strongly recommends that users review the
following suggestions and advice on the care and maintenance of your Welch Allyn flexible
VideoEndoscope.
These tips, particularly those involving scope reprocessing, should not be construed as “shortcuts” and are not intended as substitute directions for complete instructions found elsewhere
in the owner’s manual.
• Avoid soaking of the instrument with accessories (e.g., forceps, injection or aspiration needles) or any sharp-edged objects which could inadvertently scratch or cut the distal bending
section sheath. (Subsequent flexing back and forth of the rubber sheath could eventually
stretch the scratched rubber until a pinhole appears and leak develops.)
• Exposure to a compatible enzymatic detergent is essential to thorough cleaning of all surfaces of the instrument. Rinsing and drying after cleaning is imperative to prevent dilution of
the disinfectant/sterilant.
• Do not reuse disposable accessories intended for single patient or one-time use.
• Do not expose the instrument or accessories to harsh chemical solutions. Strictly adhere to
exposure times recommended by the manufacturers of compatible solutions.
• Avoid contact of any flexible portion of the instrument with any sharp objects (e.g., bed
frames, table top corners, sink drains, accessories hanging in storage cabinets) at any time
during the handling, reprocessing, or storage of the instrument.
• Avoid stretching of the bending section rubber sheath at the distal portion of the scope.
During mechanical cleaning of the instrument with a dampened gauze, do not use excessive force. A gentle back and forth wiping motion should be sufficient to remove gross
debris. Subsequent soaking in an enzymatic detergent will clean the remainder of the
debris.
• Disinfectants and sterilants are toxic substances by nature. All residual solution must be
thoroughly rinsed and dried prior to each patient use.
• The key to preventing clogged air or water channels/nozzles is to immediately flush the
channels upon removal from the patient. This should be followed by soaking with an enzymatic detergent.
40 VideoPath
Page 43
Care and Maintenance Tips (continued)
• Avoid attempting to remove or unscrew the instrument’s components which should not be
removed. Parts such as the distal portion on the end of the bending section and any rubber
strain reliefs on either the insertion tube or umbilical cord are essential to the watertight
integrity of the instrument. Removal or loosening of these components and subsequent
immersion could lead to fluid invasion into the instrument.
• Avoid excessive and/or tight bends in the insertion tube and umbilical cord. Tight curling of
these portions of the instrument can result in serious internal damage.
• Never articulate the bending section by applying force directly to the bending section. This
can cause serious damage to the internal steering cables.
• If resistance is felt during rotation of the deflection control knobs, do not apply excess
force.
• Check for any sharp edges on all surfaces of an automated cleaning/reprocessing unit
which may come in contact with an endoscope. Some units may have sharp edged wire
mesh filters and baskets or inlet/outlet ports which could damage the instrument.
• The air/water and suction control valves must be screwed down onto their respective
cylinders on the instrument’s control body to function properly. This is unlike other
manufacturer’s semi-disposable valves with a rubber base which do not have threads to
secure attachment.
• Do NOT overtighten the cap to the water bottle assembly. Overtightening could cause the
cap to crack.
• Do NOT introduce air bubbles into the instrument’s internal channels during flushing of
cleaning and/or disinfecting/sterilizing solutions since the bubbles could interfere in the
effectiveness of the disinfection/sterilization process.
• Do NOT store the instrument and accessories in the carrying case since this type of dark,
humid, and unventilated environment is conducive to bacteria colonization which increases
the risk of cross-contamination.
• Prior to each use, check the condition of all accessories.
Do NOT use any accessories with kinked or bent flexible shafts.
Do NOT use forceps with misaligned cups and/or bent needles/spikes.
Do NOT use aspiration or injection needles which are not retractable or whose sharp tips
cannot be protected.
DO NOT use cleaning brushes without smooth or rounded distal tips.
Use of any of the above accessories could result in channel damage and costly repairs.
• Verification of the effective concentration of glutaraldehyde (via test strips or similar methods) is recommended to ensure potency of glutaraldehyde to achieve high-level disinfection.
• Instrument repairs should be performed by an authorized Welch Allyn service facility.
Welch Allyn assumes no liability for any patient/user injury, instrument damage or malfunction, or reprocessing failure due to repairs made by unauthorized personnel.
VS-100 Sigmoidoscope 41
Page 44
Troubleshooting
Symptom Possible Cause Solution
No image. Endoscope not properly Advance endoscope connector
plugged in. terminal into light source until it
“clicks” into place.
Image is not clear. Distal objective lens obscured. Rinse lens by injecting water
through auxiliary water inlet.
Lenses dirty. Remove endoscope and clean
distal objective lens with cotton
swab and alcohol.
Water damage to lens. Return to Welch Allyn for evalu-
ation/repair.
Inadequate suction. Suction valve blocked. Remove valve, clean valve and
housing with a cleaning brush.
Lubricate “O” rings with valve
lubricant and replace.
Biopsy seal is worn. Replace biopsy seal.
Suction channel blocked. Call Welch Allyn Service
Department for instructions.
Suction pump not on or tubing Verify good connection
between
disconnected. suction pump and endoscope.
Turn pump on.
No insufflation. Air pump not turned on. Turn air pump on. Test endo-
scope for air flow.
Water bottle not connected Verify water bottle is properly
properly to light source or plugged into light source.
endo connector plug.
Air nozzle blocked. Soak tip of endoscope in warm
soapy water for 2-3 minutes.
Gently brush with air/water noz-
zle cleaning brush. Gently inject
warm water through the endo-
scope by depressing the
air/water feed valve. If the noz-
zle remains blocked, contact
Welch Allyn Customer Service.
Water bottle cap not Tighten cap.
secured tightly.
Cannot irrigate. Water bottle empty. Fill water bottle to fill line.
Water bottle not connected Verify water bottle is properly
properly to light source or plugged into light source.
endo connector plug.
Water bottle cap not Tighten cap.
secured tightly.
42 VideoPath
Page 45
Troubleshooting (continued)
Symptom Possible Cause Solution
Suction or Air/Water Dirty valve stem. Remove valve; clean valve and valve sticks housing with cotton swab and
alcohol; lubricate “O” rings with
valve lubricant and replace.
Bad “O ” rings. R eplace “O” rings.
Biopsy seal “spitting” Biopsy seal is worn. Replace biopsy seal. or leaking.
Insufficient articulation Loose articulation knob. Return endoscope to of tip. Welch Allyn for adjustment.
Degree of articulation is less Return endoscope to
than specified. Welch Allyn for adjustment.
Inadequate illumination. Light source not turned on. Turn of power to light source.
Damage to light transmitting Return endoscope to
fibers. Welch Allyn for
evaluation/repair.
Light source not working. Not plugged into electrical Plug light source into 120 volt
outlet. grounded outlet.
Lamps burned out. Replace lamps according to
instructions.
Fuse is blown. Call Welch Allyn Service
Department.
Lamp access plate not
properly re-installed.
No illumination. Endoscope connector plug not
properly engaged.
VS-100 Sigmoidoscope 43
Page 46
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Page 48
Welch Allyn, Inc.
4341 State Street Road
P.O. Box 2 20
Skaneateles Falls, NY 13153-0220
Telephone: 315-685-4560
1-800-535-6663
Printed in the U.S.A. Part # 305199-1 Rev. A
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