Welch Allyn Video Colposcope Model 88000A and 89000A Operating Instruction Manual

Table of Contents Conventions... 2 General Precautions...2 Symbols...3 Summary of Warnings and Cautions...4

Components... 5 Video Colposcope...5 Optional Accessories...5

Nomenclature... 7 Video Colposcope Front View...7 Video Colposcope Side Views...7 Video Colposcope Back View...8 Video Colposcope Bottom View...8 Vertical Pole Stand...9 Swing Arm Stand...9 Monitor...10 Front Panel of Monitor...10 Back Panel of Monitor...10

Connection Diagrams... 11 Connecting Video Colposcope with Monitor...11 Connecting Video Colposcope with VCR/Video Printer...12

Preparation for Use... 13 General Precautions...13 Assembly of Video Colposcope...13 Vertical Pole Stand Assembly...13 Swing Arm Stand Assembly...14 Setting Up Video Colposcope...15

Operation... 16 Power Switch... 16 Lamp Ignition... 16 Focus and Zoom Controls... 16 Mag Index Control... 16 Green Filter Control... 16 Polarization Filter Control... 16 Illumination Beam Director... 16 Vertical Height Adjustment Ring (Vertical Colposcope Model Only)... 16 Swing Arm Height Adjustment (Swing Arm Colposcope Model Only)... 16 Positioning Video Colposcope... 17 Remote Video Functions... 17

Maintenance... 17 Video Colposcope Cleaning... 17 Disinfecting Solutions... 17 Illumination Lens Cleaning... 17 Camera Lens Cleaning... 18 Replacing Lamp... 18 Replacing Fuses... 20

Service Information... 21 Troubleshooting... 22 Specifications... 23

Thank you for purchasing the Welch Allyn Video Colposcope. Follow the operation and maintenance instructions found in this manual and your video colposcope will provide you with many years of reliable service. Please read these instructions thoroughly before attempting to use your new video colposcope. CAUTION: Federal law restricts sale of this device to, or to the order of, a physician or other appropriately licensed medical professional.

WARNING: Users of this equipment should be thoroughly trained in the appropriate medical procedures. Furthermore, they should take the time to read and understand these instructions before performing any procedure. They should also read and understand the instructions for any other equipment used in conjunction with the video colposcope (i.e. electrosurgical generators). Failure to do so may result in injury to the patient and/or damage to the video colposcope.

IMPORTANT: The material outlined in this manual should be reviewed and understood prior to operation of the equipment. NOTE:

This equipment has been tested and complies with emissions standard EN60601-1-2: 1993, CISPR Publication 11:1990/EN55011: 1991 for Radiated and Conducted Emissions, Group 1, Class B.

This equipment also has been tested and complies with susceptibility standards to electrostatic discharge (ESD), radiated electromagnetic fields, fast transient bursts, and conducted surge interference. The procedures and criteria for conformance are contained in IEC801-2, 801-3, 801-4, 801-5, and EN60601-1-2: 1993. In addition, this equipment has been tested and complies with EN6000-3-2 (1st Edition) covering harmonic disturbances in supply systems caused by household appliances and similar electrical equipment, Part 2, and EN 6000-3-3 (1st Edition) covering voltage fluctuation disturbances in supply systems caused by household appliances and similar electrical equipment Part 3. INDICATIONS FOR USE: For examination of the tissues of the vagina, cervix, and external genitalia, to investigate, by means of magnification, abnormal cervical cytology or suspicious lesions of the lower female genital tract. Also used for corresponding biopsy and treatment, when indicated. NOTE:

This device complies with the guidelines of the American Conference of Governmental Industrial Hygienists threshold limits values for ultraviolet radiation for exposure time and distance consistent with the intended use of this device.

1

Conventions WARNING: Warnings alert the user to the possibility of serious injury, death, or other adverse reaction associated with the use or misuse of the device.

CAUTION: Cautions indicate a potentially hazardous situation that, if not avoided, may result in minor or moderate injury and/or damage to the equipment. They also alert against unsafe practices.

NOTE:

Notes provide supplemental information to the text and indicate a potentially hazardous situation, which, if not avoided, may result in property damage. They also highlight important information on the use of this equipment.

General Precautions •

For safety, the video colposcope should only be coupled to a grounded 110-120 VAC hospital-grade outlet (220 - 240 volt, 50 cycle international).

•

The video colposcope should not be operated in the presence of flammable or explosive gases or chemicals, or installed in areas where these materials are commonly used.

•

To avoid overheating, the video colposcope should not be positioned closer than 6” to any wall.

•

Keep all liquids away from electrical equipment to avoid the possibility of shock and instrument damage.

•

Occasionally inspect the power cord for signs of cuts, abrasions or dents.

•

The video colposcope should never be stored or operated in areas where it could get wet or could be exposed to any environmental conditions like extreme temperature or humidity, direct sunlight, dust, etc.

•

The lamp is extremely bright. DO NOT stare directly into illumination lens when the lamp is lit.

•

All service to the video colposcope must be performed by Welch Allyn or by an authorized repair center.

•

Video colposcope user should adhere to the operating conditions found in this manual. Otherwise, instrument damage may occur and/or operator/patient safety may be compromised.

•

There are no user servicable parts (other than the lamp and fuses) in this unit or in its accessories. Any attempt to disassemble and/or repair this unit will result in voiding of the warranty.

2

Symbols

On: Power: Connects to the low voltage supply.

Off: Power: Disconnects from the low voltage supply.

Caution: Consult user's manual for additional information.

Warning: Consult user's manual for additional information.

Warning: High temperatures

Type B Equipment

Risk of fire. Replace fuses as marked.

Warning: High-intensity light

Warning: Power supply of unit is energized whenever power cord is plugged in.

The CE mark on this product indicates it has been tested to and conforms with the provisions noted in the 93/ 42/EEC Medical Device Directive. Authorized European Representative: European Regulatory Manager Welch Allyn, Ltd. Kells Road, Navan, County Meath, Republic of Ireland Tel 353 46 79060 Fax 353 46 27128

3

Summary of Warnings and Cautions WARNING: All video monitors and peripheral equipment used with this instrument must be IEC 601-1 (or UL 2601) listed to comply with medical electrical safety guidelines. If not IEC 601-1(UL-2601) listed, the monitor/peripheral equipment should be positioned outside of the 6-foot patient contact area.Please contact Welch Allyn for more information.

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.

CAUTION: The video colposcope is cooled via a vent fan located in the back of the unit. The fan draws air in from beneath the video colposcope and exhausts the air out the back of the video colposcope. Verify that the unit is no less than 6" from a wall.

WARNING: DO NOT use a converter adapter that will convert the three-prong AC plug to a two-prong line plug. The power supply in the video colposcope will not be properly grounded and electric shock might result. CAUTION: DO NOT clean illumination lens with alcohol. DO NOT touch optical or illumination lenses except as described in Maintenance section of this manual. WARNING: The lamp operates at a high temperature. DO NOT attempt to remove the lamp before allowing it to cool. Allow at least five minutes for the lamp to cool before replacing. Replace with Welch Allyn lamp #09800 only.

CAUTION: The colposcope can be damaged if the unit is transported while holding the handle. The unit should be transported by grasping the pole.

4

Components Video Colposcope

88000A Video colposcope and vertical stand with vertical stand hardware kit:

89000A Video colposcope and swing arm stand with swing arm hardware kit:

•

Allen wrench

•

Allen wrench

•

Allen bolt

•

Bolt

•

Mounting washer

•

Spacer

88600

S-Video Cable

761076-0

Power Cord

Optional Accessories

09800

Replacement Lamp

88500

RS-232 Interface Cable

5

NOTE:

488307-9

Replacement Fuse (2 required)

88010

Cervical Model

88040

Dust Cover for Vertical Stand

89040

Dust Cover for Swing Arm

88030

Vertical Stand with Base Only

89030

Swing Arm Stand with Base Only

Only accessories and components indicated in this manual are to be used with the Welch Allyn Video Colposcope system.

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Nomenclature Video Colposcope Front View

1

2

Name

Function

1.

Objective Lens

The lens that establishes the magnification and field of view.

2.

Illumination beam director

Directs lamp beam.

Video Colposcope Side Views 6

5

9

5 3

8

4

4 3

10

7

Name

Function

3.

Ventilation slots

Allow air to enter and leave unit, cooling internal components.

4.

Zoom control button

Pressing + or - increases or decreases magnification accordingly.

5.

Fine Focus control button

Pressing < or > adjusts the focus.

6.

Green filter button

Pressing turns the electronic green filter on or off.

7.

Green filter LED indicator

Illuminates if the electronic green filter is on.

8.

Polarization filter control

Adjusts the proportion of glare removed from the image.

9.

Mag button

Displays magnification index on screen.

10. Mag LED indicator

Illuminates if Mag Index is on.

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Video Colposcope Back View 11 12

14

15

13

Name

Function

11. Power switch

Power control for the video colposcope.

12. Ventilation slots

Allow air to enter and leave unit, cooling internal components.

13. Video colposcope handle

For positioning the colposcope in the proper up/down, left/right position.

14. Attachment knob

Fastens handle to video colposcope.

15. Remote video function buttons

Allow use of remote video printer functions.

Video Colposcope Bottom View 17

16

18

Name

Function

16. Lamp access door

Removes for lamp replacement. (Note: If door is not properly closed, interlock power switches will not activate and the lamp will not start.)

17. Ventilation slots

Allow air to enter and leave unit, cooling internal components.

18. Mounting piece

Allows the video colposcope to attach to the stand. On the swing arm model, the mounting piece is located at the top of the colposcope. On the vertical stand model, the mounting piece is located at the bottom of the colposcope.

8

Vertical Pole Stand

24

23 22 20

21

19

Name

Function

19. Vertical rolling base stand

Allows mobility with 5-caster base, including two locking casters.

20. Fuse drawer

Opens for replacement of fuses.

21. Power supply cord receptacle

Couples with power cord, which should be plugged into a 110-120 VAC hospital-grade outlet (220-240 volt, 50 cycle international).

22. S-Video output

Outputs Y/C (S-Video).

23. RS232 interface cable output

Couples with RS232 interface cable.

24. Height adjustment ring

Allows vertical movement and locking of stand at desired height;vertical height adjustment 36”-46” (91.4cm to 116.8cm).

Swing Arm Stand

27

26

25

Name

Function

25. Swing arm rolling base stand

Allows overhead positioning of the instrument with 5-caster weighted base, including two locking casters; vertical height 29.5” to 49.5” (74.9cm to 125.7cm).

26. Power supply cord receptacle

Couples with power cord, which should be plugged into a 110-120 VAC hospital-grade outlet (220-240 volt, 50 cycle international).

27. Fuse drawer

Opens for replacement of fuses.

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Monitor NOTE:

The following is a brief overview of the nomenclature of the Sony PVM-14N1U Video Monitor. For detailed instructions, please refer to the operation manual that has been provided by the manufacturer

Front Panel of Monitor

Back Panel of Monitor

34

28 30 29

31

32

36

33

35

PLEASE REFERENCE YOUR SONY MONITOR MANUAL FOR FURTHER INFORMATION.

Name

Function

28. Power Switch

Press to turn the monitor on. The indicator lights in green. To turn the monitor power off, press again.

29. Line A/Line B

Press Line A if the signal is fed through a Line A connector on the back of (input select) the monitor. Press Line B if the signal is fed through a Line B connector on the back of the monitor.

30. Menu/Exit

Press to make the on-screen menu appear. Press again to leave the on- screen menu. The following parameters can be modified using the on- screen menu system:

Volume - No function. Contrast - Adjust the contrast of the screen using the arrow buttons. Brightness - Adjust the brightness of the screen using the arrow buttons. Chroma - Adjust the color intensity of the video signal using the arrow buttons. Phase - Adjust the phase of the video signals using the arrow buttons. Color Select - Select the color system of the current input signals. Language - Select the menu language. User memory - Select options for storing and recalling menu settings. 31. Down Arrow

In item selection menus, moves the cursor downward. In adjustment and setting menus, decreases the value of the selected item or moves downward through item selections.

32. Up Arrow

In item selection menus, moves the cursor upward. In adjustment and setting menus, increases the value of the selected item or moves upward through item selections.

33. Enter

Chooses the selected item. Is active only during the first level of on-screen selections.

34. Power supply

Couples with power cord, which should be plugged into a 110-120 VAC hospital grade cord receptacle outlet (220-240 volt, 50 cycles for international).

35. Line A/Line B Video In

Input connectors for composite video.

36. Line A/Line B Y/C In

Input connectors for high resolution S-Video

NOTE:

This monitor is shipped with default picture settings. Any change of the on-screen controls may result in poor picture quality.

10

Connection Diagrams Connecting Video Colposcope with Monitor Back Panel of Monitor

S-Video Cable Line A Y/C In

Connecting Video Colposcope with VCR/Video Printer RS232 Interface Cable S-Video In

S-Video Out

S-Video Cable Line A Y/C In Back Panel of Monitor

WARNING: All video monitors and peripheral equipment used with this instrument must be IEC 601-1 (or UL 2601) listed to comply with medical electrical safety guidelines. If not IEC 601-1(UL-2601) listed, the monitor/ peripheral equipment should be positioned outside of the 6-foot patient contact area. Please contact Welch Allyn for more information.

11

Preparation for Use General Precautions Make sure the unit is always grounded and secure during use. Do not disable power cord ground connection. Grounding reliability is achieved only when power cord is connected to a hospital-grade receptacle. Inspect the electrical plug and cord routinely. Do not use if damaged. Do not use the video colposcope in the presence of any flammable anesthetics. Do not open the video colposcope housing. An electrical shock hazard exists due to high voltage. There are no user serviceable parts inside the video colposcope, except the lamp. NOTE:

Opening of the video colposcope housing by an unauthorized repair facility will void the product warranty.

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.. CAUTION: The video colposcope is cooled via a vent fan located in the back of the unit. The fan draws air in from beneath the video colposcope and exhausts the air out the back of the video colposcope. Verify that the unit is no less than 6" from a wall. WARNING: DO NOT use a converter adapter that will convert the three-prong AC plug to a two-prong line plug. The power supply in the video colposcope will not be properly grounded and electric shock might result. CAUTION: The colposcope can be damaged if the unit is transported while holding the handle. The unit should be transported by grasping the pole.

Assembly of Video Colposcope Before initial set up of the video colposcope, check all components received against the parts list of components (see Components section of this manual) to verify a complete set. If parts are missing, please notify Welch Allyn. Review the Nomenclature, Preparation for Use, Operation, and Maintenance sections to become familiar with the equipment.

Vertical Pole Stand Assembly The video colposcope stand is shipped unassembled. Minimal assembly is required. 1.

To assemble the stand, remove the stand and base parts from their cartons. Locking caster

2.

Place base upside down on the floor and insert casters into holes on the bottom of the base. (Do not place two locking casters next to each other.)

3.

Place the base on the floor with casters down. Lock the two locking casters.

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4.

Place pole into the base, aligning the pin on the flange with the pin hole in the base. Place bolt, spacer, and washer, oriented as shown, into the pole. Tighten securely with the enclosed Allen wrench. (The assembly may need to be tilted.)

Washer Spacer Hex Bolt Allen Wrench Align pin with hole 5.

Before using the video colposcope, refer to “Setting Up Video Colposcope” section of this manual.

Swing Arm Stand Assembly The video colposcope stand is shipped unassembled. Minimal assembly is required. NOTE:

BASE WEIGHS 58 LBS. YOU MAY REQUIRE ASSISTANCE TO LIFT IT.

1.

To assemble the stand, remove the stand and base parts from the cartons.

2.

Place base upside down on the floor and insert casters into holes on the bottom of the base. (Do not place two locking casters next to each other.)

3.

Place the base on the floor with casters down. Lock the two locking casters.

4.

Place the vertical pole section of the assembly into the base, aligning the pin on the flange with the pin hole in the base.

5.

Locate the packaged bolt.

6.

Place the bolt through the bottom of the pole. (The assembly may need to be tilted.)

7.

Tighten securely with the enclosed Allen wrench.

Locking caster

Hex Bolt

Allen Wrench Align pin with hole

8.

Remove the bolt from the arm of the colposcope assembly and insert it through the hole near the top of the pole.

9.

Position the pole and the arm of the remaining colposcope assembly in close proximity. 10. Connect the two wire harnesses via their connectors. (This may require assistance for proper assembly.)

13

11. Bring the colposcope swing arm assembly to the pole while at the same time pushing the electrical connectors into the colposcope arm.

12. Tighten the bolt securely with the enclosed Allen wrench. Be sure not to pinch any of the electrical wires between the vertical pole and arm of the colposcope assembly.

13. Before using the video colposcope, refer to Setting Up Video Colposcope section of this manual.

Setting Up Video Colposcope 1.

Connect the power cord to the power cord receptacle in the power supply located on the video colposcope stand.

2.

Plug the other end of the power cord into a properly grounded 110-120 volt AC outlet (220-240 volt, 50 cycle for international).

3.

Connect the S-Video cable to the S-Video output on the side of the power supply located on the video colposcope stand.

4.

Connect the other end of the S-Video cable into the Line C connector Y/C (S-Video) on the back of the monitor.

5.

Plug the monitor into a properly grounded 110-120 volt AC outlet (220-240 volt, 50 cycle for international).

RS232 output

S-Video output

14

Operation Power Switch With the power cord connected to a properly grounded outlet, and the S-video cable connected to the video colposcope and monitor, activate the power switch on the handle of the video colposcope.

Lamp Ignition Once the video colposcope's power switch has been activated, the lamp will ignite. The lamp requires approximately 11 seconds to warm up.

Focus and Zoom Controls Once the power switch has been activated, the video colposcope will execute a setup procedure, ending in the low magnification setting, or 4.5x. To obtain coarse focus, position the distal end of the video colposcope approximately 300mm (12”) from the target. Adjust the video colposcope by moving the stand (for vertical stand), or the arm (for the swing arm stand), until the picture is in focus. Press the + on one of the zoom controls until maximum magnification is obtained, and readjust the position of the stand or the swing arm until the picture is in focus. Fine focus, in either direction, is provided by the focus controls once coarse focus has been achieved. After coarse focus is achieved at maximum magnification, zoom control can be set to a desired lower magnification by pressing either zoom control. Focus will be maintained throughout the entire magnification range once these steps have been completed if the video colposcope or target is not moved. NOTE:

The setup (nominal) setting of the focus controls can be recovered by pressing one of the zoom + controls for 4 seconds after maximum magnification has been achieved.

Mag Index Control Activate the magnification index button by pressing the blue button located on the right side of the colposcope (see Video Colposcope Side Views). The Mag Index refers to magnification relative to a 14” monitor. Deactivate the magnification index by pressing the mag index control again. To determine the magnification*, multiply the mag index by the number in the table below.

NUMBER BY WHICH TO MULTIPLY MAG INDEX

EXAMPLE: Mag. Index on screen

EXAMPLE: Magnification

Sony 14” Monitor, model PVM-14M2U

1.0

5

5

Sony video printer, model UP2100 & model UP2300

0.37

5

1.85

Sony 20” Monitor, model PVM-20N5U

1.44

5

7.2

DISPLAY DEVICE

*Magnification is the size of an object displayed on a display device (monitor, video print, etc.) divided by the actual size of the object.

Green Filter Control Activate the electronic green filter by pressing the green button located on the left side of the video colposcope (see Video Colposcope Side Views). Deactivate the filter by pressing the green filter button again.

Polarization Filter Control The Polarization Filter control can be rotated to reduce glare from the image as desired. The filter is completely engaged (minimum glare) when the control is fully rotated to the left. The filter can be disengaged by returning the Polarization Filter control to the full right hand position.

15

Illumination Beam Director The illumination beam director can be rotated up to 45° clockwise or counterclockwise to better illuminate the examination area. To rotate the director, grasp the flat sides and twist in either direction as desired. The illumination beam director moves with some resistance. This helps to hold it securely in the desired position. The center position can be recovered by returning the director to the detent position.

Vertical Height Adjustment Ring (Vertical Colposcope Model Only) The height of the vertical stand can be adjusted by rotating the black height adjustment ring, located on the pole of the stand, counterclockwise. Once the ring has been loosened, adjust the pole to the desired height and then tighten the ring again by rotating it clockwise.

Swing Arm Height Adjustment (Swing Arm Colposcope Model Only) Adjust the height of the swing arm stand by loosening the height adjustment knob located on the arm of the stand. The swing arm can then be moved to the desired position. After moving the arm, tighten knob securely by rotating clockwise. The desired drag can be obtained by adjusting this knob either clockwise or counterclockwise.

Positioning Video Colposcope The video colposcope can be angled up and down and left and right. To change the up/down tilt angle, loosen the knob located on the tilt axis. The video colposcope can then be tilted as necessary. To change the horizontal angle, loosen the knob located on the support shaft. The drag of either knob can be set by loosening or tightening as necessary.

Remote Video Functions The handle of the video colposcope contains three buttons that control three video functions. These functions, provided by a remote video printer, are Freeze, Print, and Toggle. (See “Connection Diagrams” on page 11. of this manual for connecting the printer to the video colposcope.) 1. 2. 3.

Pressing the freeze (“F”) button stores a new image in printer memory. The frozen image is displayed on the monitor. Pressing the copy (“C”) button prints the image displayed on the monitor. If live video is displayed, the image visible when the button was pressed will be printed. Pressing the video (“V”) button changes the display from printer memory (frozen image) to live video, or from live video to printer memory (frozen image), depending on the current mode.

16

Maintenance Video Colposcope Cleaning Turn the power switch off and unplug the power cord from the electrical outlet prior to cleaning. The video colposcope housing can be wiped down with a cloth dampened slightly with a mild solution of disinfectant. Be careful not to allow the plug prongs to get wet. Also be careful not to allow the camera lens or lamp lens to get wet.

Disinfecting Solutions The disinfecting solutions listed below are safe for cleaning the housing of the video colposcope if used according to the manufacturer’s instructions for cleaning and disinfecting, and in accordance with procedures detailed in the cleaning section of this manual. •

70% isopropyl alcohol

•

10% mild bleach solution

•

10% Wescodyne

NOTE:

References to brand names are not endorsements of their efficacy as disinfecting solutions. However, tests have shown these solutions to be compatible with Welch Allyn colposcopes, providing the manufacturers' directions are followed. Do not use any other solutions unless a sample has been sent to Welch Allyn for compatibility testing.

IMPORTANT Be careful not to allow solution to drip into the air vents. DO NOT spray solution into the air vents. DO NOT sterilize any part of the unit. DO NOT IMMERSE any part of the unit in cleaning solutions.

Illumination Lens Cleaning The lamp lens may be cleaned with a cloth dampened slightly with warm water and mild detergent. CAUTION: DO NOT clean illumination lens with alcohol. DO NOT touch optical or illumination lenses except as described in Maintenance section of this manual.

Camera Lens Cleaning The camera lens may be cleaned with isopropyl alcohol or any commercial lens cleaner.

17