Video Colposcope Directions for Use
Contents
1. RGB COMPONENT BNC Aduio RCA pin AC IN LINE B composite socket BNC Audio RCA pin 12 Components Printer Welch Allyn Video Colposcope A WARNING f peripheral devices example monitor video printer VCR other do not comply with IEC 60601 1 1 they must be kept out of the patient area 6 feet minimum from patient Note For detailed instructions please refer to the printer operation manual that has been provided by the manufacturer Printer shown is SONY UP 20 this is for reference only Input Connectors To connect the video equipment supplying the source image Connector Connectable Equipment SS Sa __z Q oQz Q e __x_ErRO RHRRVVUTruRYoOQR R R o Y YU O I OI S VIDEO Equipment with a S Video Y C output connector VIDEO Equipment with a composite video signal output connector Output Connectors To connect the video monitor Refer to Important AC IN To connect the printer to a wall outlet with the supplied cord INPUT S VIDEO i __ zACIN ie rs AM safeguards notices for use in the medical environments Connector Connectable Eguipment S VIDEO Video Monitor with a S Video Y C separated input connector VIDEO Video Monitor with a composite video signal input connector NTSC PAL TV Selector Set this selector according to the TV system of the input signal If you change this2. 26 Maintenance Welch Allyn Video Colposcope Tab 2 Pull out and remove the blown fuse from the fuse holder Fo CCC 3 Replace with new fuses T1 00L 250V 1A Time lag Low Breaking Capacity Welch Allyn Part 488307 9 4 Reinsert the fuse holder by pressing until it snaps into place Directions for Use Troubleshooting Maintenance 27 Condition Check Action Power does not come on No image on monitor Lamp will not light Printer does not respond properly to handle buttons Power Cord Attachment of unit to handle Attachment of unit to handle and door to unit Fuses Wall outlet Monitor other peripheral devices Cable connections Monitor input selection Lamp housing Lamp Lamp access door Power cord and printer Printer Check connections at power supply and wall outlet Check colposcope unit s alignment with handle Make sure lamp access door and handle are properly attached Remove fuse panel amp replace blown fuse with T1 00L 250V 1A time lag Welch Allyn part number 488307 9 Plug the power cord into a wall outlet known to work Make sure power is on for all devices o Make sure all video cables are connected properly Make sure correct input selection is made on the front panel Make sure lamp assembly is installed properly Replace lamp Make sure lamp access door is properly closed Unplug power cord from
3. currents To maintain operator and patient safety the User should consider the system leakage current requirements of IEC 60601 1 1 Medical Electrical Equipment Safety Requirements for Medical Electrical Systems The user should measure leakage currents accordingly to confirm that no electric shock hazard exists An isolation transformer that is in compliance with IEC 60601 1 used to power the additional peripherals may be used to control the system leakage current to comply with the requirements of IEC 60601 1 1 Connecting Video Colposcope with Monitor GO q Back Panel of Monitor og _ AAA o o o O SS y oo y S Video Cable to Monitor ED Line A S Video Y C In o Ml 14 Connections and Assembly Welch Allyn Video Colposcope Connecting Video Colposcope with Optional VCR Video Printer WARNING f peripheral devices example monitor video printer VCR other do not comply with IEC 60601 1 1 they must be kept out of the patient area 6 feet minimum from patient Back Panel of Printer S Video Cable Out to Monitor Line A S Video Y C In RS232 Interface Cable S Video Cable to Printer S Video In Back Panel of Monitor Directions for Use Connections and Assembly 15 Assembly General Precautions Make sure the unit is always grounded and secure during use Do not disabl
4. setting turn the printer power off and then back on again Selector position When NTSC NTSC system video eguipment is connected PAL PAL system video eguipment is connected REMOTE O eat ST a L E E pt 1 Equipotential Ground Terminal Connector To connect to the equipotential plug to bring the various parts of a system to the same potential RS 232C Connector To connect the Video Colposcope to control the printer Remote 2 Connector To connect an RM 91 Remove Control Unit not supplied Remote 1 Connector To connect an RM 5500 Remote Control Unit not supplied to be used as a wired remote control unit 13 Connections and Assembly A WARNING f peripheral devices example monitor video printer VCR other do not comply with IEC 60601 1 1 they must be kept out of the patient area 6 feet minimum from patient WARNING All signal input and output I O connectors are intended for connection to only peripheral devices example monitor video printer VCR that are in compliance with IEC 60601 1 General Requirements for Safety Medical Electrical Equipment or other IEC standards for example IEC 60950 Information Technology Equipment Safety as appropriate to the nature of the peripheral device Connecting additional peripherals to the Video Colposcope may increase the risk associated with chassis or patient leakage
5. should be that of a typical commercial or hospital environment If the user of the REF 880 and 890 Series Video Colposcope reguires continued operation during power mains interruptions it is recommended that the REF 880 and 890 Series Video Colposcope be powered from an uninterruptible power supply or battery Power frequency magnetic fields should be at levels 50 60Hz magnetic field IEC 61000 4 8 characteristic of a typical location in a typical commercial or hospital environment 34 Specifications Welch Allyn Video Colposcope Electromagnetic Immunity The REF 880 and 890 Series Video Colposcope is intended for use in the electromagnetic environment specified below The customer or user of the REF 880 and 890 Series Video Colposcope should assure that it is used in such an environment Immunity Test IEC 60601 Compliance Electromagnetic Environment Guidance Test Level Level Portable and mobile RF communications equipment should be used no closer to any part of the Video Colposcope including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance Conducted RF 3 Vrms 3 Vrms d 1 17 P IEC 61000 4 6 150 kHz to 80 MHz Radiated RF 3 V m 3 V m d 1 17 P 80 MHz to 800 MHz IEC 61000 4 3 80 MHz to 2 5 GHz d 2 33 P 800 MHz to 2 5 GHz where Pis the maximum output power rating of the transmitt
6. 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 20 Operation Welch Allyn Video Colposcope Mag Index Control Note Pressing the scan button on the monitor or activating this menu option sets the display size to 3 under image scan size and alters the size of the image on the screen making the magnification index displayed inaccurate Activating the button or mem option briefly displays the word under on the monitor screen and a red light displays on the scan button To change the scan size back to normal press the scan button again and the word over briefly appears on the monitor screen This is the normal setting Activate the magnification index button by pressing the blue button located on the
7. 880 and 890 Series Video Colposcope is inte the REF 880 and 890 Series Video Colposcope should Specifications 3 Electromagnetic Immunity nded for use in the electromagnetic environment specified below The customer or user of assure that it is used in such an environment Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment Guidance Electrostatic discharge ESD IEC 61000 4 2 6 kV contact 8 kV air 6 kV contact 8 kV air Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Electrical fast transient burst 2 kV for power supply lines 2 kV for power supply lines Mains power quality should be that of a typical commercial or hospital environment IEC 61000 4 4 1 kV for input output 1 kV for input output lines lines Surge 1 kV differential mode 1 kV differential mode Mains power quality should be that of a typical commercial or hospital environment IEC 61000 4 5 2 kV common mode 2 kV common mode Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 Power frequency gt 95 dip in 0 5 cycle 60 dip in 5 cycles 30 dip for 25 cycles gt 95 dip in 5 seconds 3 A m gt 95 dip in 0 5 cycle 60 dip in 5 cycles 30 dip for 25 cycles gt 95 dip in 5 seconds 3 A m Mains power quality
8. Use o wm o ao 11 Connections and Assembly 17 Locking caster 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 Place the base on the floor with casters down Lock the two locking casters Place the vertical pole section of the assembly into the base aligning the pin on the flange with the pin hole in the base Hex Bot Allen Wrench Align pin with hole Locate the packaged bolt Place the bolt through the bottom of the pole The assembly may need to be tilted Tighten securely with the enclosed Allen wrench Remove the bolt from the arm of the colposcope assembly and insert it through the hole near the top of the pole Position the pole and the arm of the remaining colposcope assembly in close proximity Connect the two wire harnesses via their connectors This may require assistance for proper assembly Bring the colposcope swing arm assembly to the pole while at the same time pushing the electrical connectors into the colposcope arm 18 Connections and Assembly Welch Allyn Video Colposcope 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 4 13 Before using the Video Colposcope refer to Setting Up Video Colposcope section of
9. Video Colposcope Directions for Use REF 88000A 88001A 89000A 88007 89001A 88007 88002A 88004A 88006A 89006A WelchAllyn Advancing Frontline Care Video Colposcope Directions for Use REF 88000A 88001A 89000A 88007 89001A 88007 88002A 88004A 88006A 89006A Welch Allyn Advancing Frontline Care ii Welch Allyn Video Colposcope Copyright 2005 Welch Allyn All rights are reserved No one is permitted to reproduce or duplicate in any form this manual or any part thereof without permission from Welch Allyn Welch Allyn assumes no responsibility for any injury to anyone or for any illegal or improper use of the product that may result from failure to use this product in accordance with the instructions cautions warnings or statement of intended use published in this manual Welch Allyn is a registered trademark of Welch Allyn For information about any Welch Allyn product call Welch Allyn Technical Support USA 1 800 535 6663 Australia 61 2 9638 3000 1 315 685 4560 Canada 1 800 561 8797 China 86 21 6327 9631 European Call Center 353 46 90 67790 France 33 1 60 09 33 66 Germany 49 7477 9271 70 Japan 81 3 3219 0071 Latin America 1 305 669 9003 Netherlands 31 157 505 000 Singapore 65 6419 8100 South Africa 27 11 777 7555 United Kingdom 44 207 365 6780 Sweden 46 85 853 6551 Manual Part Number 880324 Ver C Welch Allyn 4341 State Street Road Skaneateles Falls NY 13153 USA ww
10. cation Technical Data Color system Color mosaic CCD Video output S Video Y C Remote Control RS 232 9 Pin D Female Connector Transport Storage Ambient temperature 40 F 40 C to 120 F 50 C environment Relative humidity 95 max Fuses T1 00L 250V 1 Amp time lag Welch Allyn part 488307 9 low breaking capacity Classification Electro medical equipment FDA Class equipment Patents This product is covered by the following patents 5 083 059 5 117 154 5 138 228 5 144 201 5 291 100 D391 360 D395 084 5 840 012 5 879 286 D416 088 6 068 593 6 147 705 Patents pending Video Monitor Item Specification Technical Data Color Video Monitor Resolution 640 x 480 pixels or greater minimum specifications Video Interface S video input User Controls Color brightness contrast Display Aspect Ratio 4 3 Color Video Monitor Product safety Conformance to local reguirements regulatory compliance examples UL 6500 CE 60065 IEC 60065 CAN CSA E60065 00 other Electromagnetic compatibility EMC Conformance to local reguirements examples USA FCC Part 15 Canada ICES 003 CE EN55103 1 amp EN55013 2 Japan VCCI AS NZS CISPR22 other Directions For Use Agency Approvals j C 15169 f m E US 74227 Specifications 31 Conforms to UL 2601 1 Certified to CAN CSA C22 2 No 601 1 M90 IEC 601 1 EN60601 1 EN IEC 60601 1 2 The CE mark on this prod
11. e dad Weal ANY yd Ad du O Rte dU A y 19 LA al MEIC TA eM Pw ud ee Y o LO NR GT 19 FOeus aridZoom CONTIOIS eeni eee eee oe oe eee hk Rd GWD GEO Pare DR 19 Mag ndexiCGontrolu eu a A Bn tee O a y Mi Rds ok A 20 Green Filter Control ue Na New wd Sti Dilek WD OD dw DE DU o n 20 Polarization Filter Control 2 0 ooo 20 Illumination Beam Directors soi ee eu y bl ee eC be DWL AD 20 Vertical Height Adjustment Ring Vertical Colposcope Model Only 21 Swing Arm Height Adjustment Swing Arm Colposcope Model Only 21 Positioning Video Colposcope 6 eee eae 21 iv Contents Welch Allyn Video Colposcope Remote Video FunctionS FI eee 21 6 Maintenance 22102 ein dae dae dees cd bord eben pais weed dea 23 Disintecting solutions a sesh we ey Medel eee other GYD Showa wool oes 23 Video Colposcope Cleaning ss gees ey ded clea Db YD Dowd WYDD ok 4 23 Lens Cleaning Aresia a enu o da Ll o ined dd Ne AT ot Oks aen 23 Camera LENS se ei idad da GN Ad Ghd had deadline Abd FUD 23 Illumination Beam Director Lens 0 0 0 0 000 0c ee 24 Replacing Lamp yu eu gu oe pete le atte Ge eb jen Beate ab GAF caer de nay 24 Replacing FUSES en AUS tu Sold A e 0N A rd nnd de gtd IA e de 25 TROUBIESHOOTING see Pu Poe oH eco ea tdi SG Se Bede oe Bans eos 27 9 Spectator ot ec Y eed sewers GODAU DY 29 Mideo GolposcoDp su eu ta a eee eed eee oad A eee dr 29 Video Monitor Zen Ae te cam eaters dd he ah AY LO ata YN AI AIG 30 Age
12. e 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 Caution Do not sterilize Caution Do not spray or allow solution to drip into the air vents Caution Do not immerse any part of the unit in cleaning solutions Lens Cleaning Camera Lens Clean the camera lens with isopropyl alcohol or any commercial lens cleaner 24 Maintenance Welch Allyn Video Colposcope Illumination Beam Director Lens A Caution DO NOT clean illumination beam director lens with alcohol DO NOT touch the camera or illumination lenses except as described in Maintenance section of this manual Clean the illumiantion beam director lens with a cloth dampened slightly with warm water and mild detergent Replacing Lamp 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 U only 1 Turn the power switch off and unplug the power cord from the electrical outlet 2 Holding the video colposcope as shown turn the knob located at the back of the handle counterclockwise and unscrew and remove the video colposcope from the handle 3 Place the unit on a suitable work surface Slide the lamp access door away from the housing as shown until t
13. e 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 A WARNING f peripheral devices example monitor video printer VCR other do not comply with IEC 60601 1 1 they must be kept out of the patient area 6 feet minimum from patient 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 A 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 To avoid overheating verify that the unit is no less than 6 from a wall Caution The colposcope can be damaged if the unit is transported while holding the handle The unit should be transported by grasping the pole Video Colposcope Before initial set up of the Video Colposcope check a
14. er in watts W according to the transmitter manufacturer and d is the recommended separation distance in metres m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol 5 Note 1 At 80 MHz and 800 MHz the higher frequency range app les Note 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the REF 880 and 890 Series Video Colposcope is used exceeds the applicable RF compliance level above the Video Colposcope should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the Video Colposcope b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m Directions For Use Specifications 35 Recomme
15. et or could be exposed to any environmental conditions like extreme temperature or humidity direct sunlight dust etc Caution All service to the Video Colposcope must be performed by Welch Allyn or by an authorized repair center Caution 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 Caution The Video Colposcope is cooled via a 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 To avoid overheating verify that the unit is no less than 6 from a wall Caution Do not clean illumination lens with alcohol Do not touch optical or illumination lenses except as described in Maintenance section of this manual Caution The colposcope can be damaged if the unit is transported while holding the handle The unit should be transported by grasping the pole Caution Do not sterilize Caution Do not spray or allow solution to drip into the air vents Caution Do not immerse any part of the unit in cleaning solutions 3 4 Introduction Welch Allyn Video Colposcope 2 Components Video Colposcope 88000A 89000A Video Colposcope and vertical stand Video Colposcope and swing arm with vertical stand hardware kit stand with swing arm hardware kit e Allen wrench e Allen wrench e Allen bo
16. he door is completely removed Directions for Use 5 11 Maintenance 25 Push the retainer spring toward the back ofthe colposcope and remove the lamp from its housing Remove a Welch Allyn replacement lamp 09800 U from its package Do not touch the lamp itself or the interior reflective surface of the lamp Skin oils will cause premature lamp failure Hold lamp by the outside of the reflector or the connector only Remove any grease or fingerprints with a clean cotton swab moistened with alcohol Do not leave any lint on the lamp Holding the retainer spring as in Step 5 slide the new lamp into the lamp housing so that the lamp s alignment pin engages the alignment slot in the lamp holder Make sure lamp is properly seated and snaps into place Plug the electrical connector onto the new lamp Slide the lamp access door securely back into place reversing the process described in Step 3 above Place the video colposcope back into the handle making sure the power connector is engaged Rotate the knob clockwise until snug 12 Plug the power cord back into the electrical outlet Replacing Fuses Two fuses are located in slots adjacent to the power supply cord receptacle on the side of the power supply housing This housing is attached to the pole of the video colposcope stand 1 To replace a blown fuse remove the fuse holder by pressing the tab and pulling the holder out of the power supply
17. hold it securely in the desired position The center position can be recovered by returning the director to the detent position Directions for Use Operation 21 Ve rtical 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 H eig ht Adjustme nt 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 or Welch All
18. imum from patient WARNING All signal input and output I O connectors are intended for connection to only peripheral devices example monitor video printer VCR that are in compliance with IEC 60601 1 General Requirements for Safety Medical Electrical Equipment or other IEC standards for example IEC 60950 Information Technology Equipment Safety as appropriate to the nature of the peripheral device Connecting additional peripherals to the Video Colposcope may increase the risk associated with chassis or patient leakage currents To maintain operator and patient safety the User should consider the system leakage current requirements of IEC 60601 1 1 Medical Electrical Equipment Safety Requirements for Medical Electrical Systems The user should measure leakage currents accordingly to confirm that no electric shock hazard exists An isolation transformer that is in compliance with IEC 60601 1 used to power the additional peripherals may be used to control the system leakage current to comply with the requirements of IEC 60601 1 1 Image is for reference only Actual monitor may vary Monitor shown is SONY LMD 1410 Use the video monitor provided by Welch Allyn or any video monitor that meets the specifications listed on page 30 For detailed instructions please refer to the provided manufacturer s operation manual LINE A S Video composite modular connector RCA pin
19. is affected by absorption and reflection from structures objects and people 36 Specifications Welch Allyn Video Colposcope 3 Service A Caution Unauthorized repairs will void the warranty A Welch Allyn Service Center must perform all repairs on products under warranty Qualified electronics personnel or a Welch Allyn Service Center should repair products out of warranty Technical Assistance If you have an equipment problem that you cannot resolve call the Welch Allyn Technical Support center nearest you page ii on normal business days If you are advised to return a product to Welch Allyn for repair or routine maintenance schedule the repair with the service center nearest you The part and serial numbers are located on the housing of the colposcope near the fan Remove the colposcope from the handle to locate these numbers Before returning a product for repair you must obtain authorization from Welch Allyn Service personnel will give you a Service Notification number Please note this number on the outside of your shipping box Returns without a Service Notification number will not be accepted for delivery Service Manual Spare Parts The Service Manual is a comprehensive guide to troubleshooting service and repair available by request to qualified electronics personnel Also included with the Service Manual is a complete spare parts list Order spare parts from your local Welch Allyn Service Center 38 Se
20. ll 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 16 Connections and Assembly Welch Allyn Video Colposcope Vertical Stand Assembly The Video Colposcope stand is shipped unassembled Minimal assembly is reguired 1 Remove the stand and base parts from their 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 Locking caster 3 Place the base on the floor with casters down Lock the two locking casters 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 Wrenc Align pin with hole 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 Directions for
21. lled in areas where these materials are commonly used WARNING Keep all liguids away from electrical eguipment to avoid the possibility of shock and instrument damage WARNING The lamp is extremely bright DO NOT stare directly into illumination lens when the lamp is lit WARNING 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 WARNING All signal input and output I O connectors are intended for connection to only peripheral devices example monitor video printer VCR PC DV Converter that are in compliance with IEC 60601 1 General Reguirements for Safety Medical Electrical Eguipment or other IEC standards for example IEC 60950 Information Technology Equipment Safety as appropriate to the nature of the peripheral device Connecting additional peripherals to the Video Colposcope may increase the risk associated with chassis or patient leakage currents To maintain operator and patient safety the User should consider the system leakage current requirements of IEC 60601 1 1 Medical Electrical Equipment Safety Requirements for Medical Electrical Systems The user should measure leakage currents accordingly to confirm that no electric shock hazard exists An isolation transformer that is in compliance with IEC 60601 1 used to power the additional peripherals may be used to control the system leakage current t
22. lt e Bolt e Mounting washer e Spacer 6 Components Welch Allyn Video Colposcope All illustrations are for reference only 88600 S Video Cable 761076 0 NE Power Cord Optional Accessories D 09800 U Replacement Lamp 88500 RS 232 Interface Cable 488307 9 hm Replacement Fuse 2 required 88010 A a Cervical Model 88040 inl Dust Cover for Vertical Stand gt 89040 Dust Cover for Swing Arm WelchAllyn Directions for Use Components 88030 Vertical Stand with Base Only 89030 Swing Arm Stand with Base Only Monitor For specifications see Video Monitor on page 30 Contact Welch Allyn for details VCR Printer Contact Welch Allyn for details Image Capture System Contact Welch Allyn for details Note Only accessories and components indicated in this manual are to be used with the Welch Allyn Video Colposcope system Front View lllumination Beam Director Lens Provides light for the examination Camera Lens The lens that establishes the magnification and field of view lllumination Beam Director Directs lamp beam 7 8 Components Welch Allyn Video Colposcope Side Views Green filter LED indicator llluminates if the electronic green filter is on button Pressing lt or gt adjusts the focus Polarization filter Er a Green filter button Pressing control Adjusts the turns the electronic gree
23. n filter proportion of glare on or off removed from the image Ventilation slots Allow air to enter and leave unit cooling internal components Ventilation slots Allow air to enter and leave unit cooling internal components Zoom control button Pressing or increases or decreases magnification accordingly Fine Focus control button Pressing lt or gt adjusts the focus Mag button Displays magnification index on screen eo LC Pressing or increases or decreases magnification accordingly Mag LED indicator llluminates if Mag Index is on Directions for Use Components Back View Ventilation slots Allow air to enter and leave unit cooling internal components Power switch Power control for the Video Colposcope Attachment knob Fastens handle to Video Colposcope Remote video function buttons Allows use of remote printing and saving functions with appropriate accessory device Video Colposcope handle For positioning the colposcope in the proper up down left right position Bottom View Ventilation slots Allow Lamp access door Removes for lamp air to enter and leave unit replacement Note If door is not properly closed cooling internal interlock power switches will not activate and the components lamp will not start Mounting piece Allows the Video Colposco
24. ncy Approvals se ey ap ANO GAR YO Y AG A yd Pie eee 31 Guidance and Manufacturer s Declaration Y ua 32 Emissions and Immunity Information 0 0 0 0 cee 32 a o ae hee theses Oe E A ee ante e 37 Technical ASSISTANCE ss oes Fe Pad ele ae BERG GE ea Bh A DOR 37 Service Manual Spare PartS 2 0 eee 37 Warranty a cet othe 05 8 ee ae ee PROS Be Se ek eh eee ee 39 Introduction 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 IMPORTANT The material outlined in this manual should be reviewed and understood prior to operation of the eguipment 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 Symbols female genital tract On Power Connects to the low voltage supply Attention Consult user s manual for additional information gt 6 High temperatures Risk of fire Replace fuses as marked Power supply of unit is energized whenever power cord is plugged in gt C Also used for corresponding biopsy and treatment when indicated Off Power Disconnects from the low vol
25. nded Separation Distances Between Portable and Mobile RF Communications Eguipment and the Video Colposcope The REF 880 and 890 Series Video Colposcope is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or user of the REF 880 and 890 Series Video Colposcope can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications eguipment transmitters and the REF 880 and 890 Series Video Colposcope as recommended below according to the maximum output power of the communications eguipment Separation Distance According to Freguency of Transmitter m Rated Max Output 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz Power of Transmitter W d 1 17 P d 1 17 P d 2 33 P 0 01 0 11667 0 11667 0 23333 0 1 0 36894 0 36894 0 73785 1 1 1667 1 1667 2 3333 10 3 6894 3 6894 7 3785 100 11 667 11 667 23 3333 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter where Pis the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer Note 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies Note 2 These guidelines may not apply in all situations Electromagnetic propagation
26. o comply with the requirements of IEC 60601 1 1 WARNING f peripheral devices example monitor video printer VCR other do not comply with IEC 60601 1 1 Medical Electrical Equipment Safety Requirements for Medical Electrical systems they must be kept out of the patient area 6 feet minimum from patient 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 Directions for Use Cautions Introduction WARNING For safety the Video Colposcope should only be coupled to a grounded 110 120 VAC hospital grade outlet 220 240 volt 50 cycle international 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 U only A caution statement in this manual identifies a condition or practice which if not corrected or discontinued immediately could lead to equipment failure equipment damage or data loss A Caution Federal law restricts sale of this device to or to the order of a physician or other appropriately licensed medical professional Caution Occasionally inspect the power cord for signs of cuts abrasions or dents Caution The Video Colposcope should never be stored or operated in areas where it could get w
27. pe 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 9 10 Components Welch Allyn Video Colposcope Vertical Stand RS232 interface cable i connector Couples with RS Height adjustment ring Allows 237 interface cable vertical movement and locking of stand at desired height vertical height adjustment 36 46 91 4cm to S Video output Outputs S Video il Vertical rolling base stand Fuse drawer Opens for Allows mobility with 5 caster replacement of fuses base including two locking 116 8cm casters 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 Swing Arm Stand Height adjustment knob Allows adjustment of arm tension and vertical height adjustment 26 5 to 45 5 67 3 cm to 115 6 cm 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 Directions for Use Monitor A Note Components 11 WARNING f peripheral devices example monitor video printer VCR other do not comply with IEC 60601 1 1 they must be kept out of the patient area 6 feet min
28. right side of the colposcope See Side Views on page 8 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 DISPLAY DEVICE Sony 14 Monitor model LMD1410 NUMBER BY WHICH TO MULTIPLY MAG INDEX 1 0 EXAMPLE Mag Index on screen 5 EXAMPLE Magnification 5 Magnification is the approximate size of an object displayed on a display device monitor video print etc divided by the actual size of the object Green Filter Control Press the green filter button on the left side of the video colposcope Figure on page 8 to activate the electronic green filter Press the green filter button again to deactive the filter 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 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
29. rvice Welch Allyn Video Colposcope 39 Warranty Welch Allyn warrants Video Colposcope when new to be free of defects in material and workmanship and to perform in accordance with manufacturer s specifications for a period of one year from the date of purchase from Welch Allyn or its authorized distributors or agents Welch Allyn will either repair or replace any components found to be defective or at variance from manufacturer s specifications within this time at no cost to the customer It shall be the purchaser s responsibility to return Video Colposcope to Welch Allyn or an authorized distributor agent or service representative This warranty does not include the lamp breakage or failure due to tampering misuse neglect accidents modification or shipping This warranty is also void if the instrument is not used in accordance with manufacturer s recommendations or if repaired by other than Welch Allyn or an authorized agent Purchase date determines warranty reguirements No other express warranty is given Remember to submit the instrument registration warranty card for warranty validation Complete the information and mail the pre addressed card to Welch Allyn 40 Warranty Welch Allyn Video Colposcope WelchAllyn 4341 State Street Road Skaneateles Falls NY 13153 U S A Tel 1 800 535 6663 Fax 1 315 685 3361 www welchallyn com Printed in the USA 880324 Ver C
30. tage supply Warning A warning statement in this manual identifies a condition or practice which if not corrected or discontinued immediately could lead to patient injury illness or death Caution A caution statement in this manual identifies a condition or practice which if not corrected or discontinued immediately could lead to equipment failure equipment damage or data loss High intensity light Type B Equipment 2 Introduction Welch Allyn Video Colposcope Warnings and Cautions Familiarize all operating personnel with the general safety information in this summary Specific warnings and cautions are also found throughout this manual Warnings A waming statement in this manual identifies a condition or practice which if not corrected or discontinued immediately could lead to patient injury illness or death A 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 eguipment 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 WARNING The Video Colposcope should not be operated in the presence of flammable or explosive gases i e anesthetics or chemicals or insta
31. 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 A connector S Video Y C 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 Power Cord 19 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 reguires 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
32. uct indicates it has been tested to and conforms with the provisions noted in the 93 42 EEC Medical Device Directive Authorized EC Representative European Regulatory Manager Welch Allyn Ltd Navan Business Park Dublin Road Navan County Meath Republic of Ireland Tel 353 46 90 67700 Fax 353 46 90 67756 32 Specifications Welch Allyn Video Colposcope Guidance and Manufacturer s Declaration Emissions and Immunity Information Electromagnetic Emissions The REF 880 and 890 Series Video Colposcope is intended for use in the electromagnetic environment specified below The customer or user of the REF 880 and 890 Series Video Colposcope should assure that it is used in such an environment Emissions Test Compliance Electromagnetic Environment Guidance RF emissions Group 1 The REF 880 and 890 Series Video Colposcope uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any CISPR 11 interference in nearby electronic equipment RF emissions Class B The REF 880 and 890 Series Video Colposcope is suitable for use in all establishments including domestic establishments and those directly connected to the public CISPR 11 low voltage power supply network that supplies buildings used for domestic purposes Harmonic emissions Class A IEC 61000 3 2 Voltage fluctuations Complies flicker emissions IEC 61000 3 3 Directions For Use The REF
33. w welchallyn com Printed in USA CE WelchAllyn Contents TINTO duction aes 2 sie A ada een AAA Gy SA Ed UG 1 Indications For Use a ua ed gd A Aa 1 lA i 4 E Ear CR OST RY NAC GR FR 1 Warnings and Cautions G see eb ed A wb Yd Bd A Dd o mu Yd GR 2 UNAS Yd DG Y DG WYD 2 CAUTIONS A RW mle ek YD TD WAD a 3 2 COMPONENTS sec oe ad GG RAN CEN oe ome eee 5 Mideo Colposcop amp u ie yd y tn Dele gsi dean AR EDD DW one Ff 5 FROME AE AS DIR DN ae eu nd A thea cal dd AN an 7 SIJE VIEWS one bu l amp n FI che ead Y FWY EU Y dd saan UR YDA DL DAN A 8 Back VIGW 3a ee mu MY wnn a aha Mie en SS o a YG FRS NG No 9 Bottom VICW inc y WW Be DG Wty eet Senne A dod A FD 9 Mire Esla ueu ie A fla ERA nd BL an tinh A adda te EA 10 SWIRGATR Stand cun AS DAR hae UE GR YNA hoe Y ada Y 10 MONITO fat rs A ele FA FON liar it a de 11 BH So otal E Glud FAD DN A wd hanes 12 3 Connectionsand Assembly A 13 Connecting Video Colposcope with Monitor LL Y eee 13 Connecting Video Colposcope with Optional VCR Video Printer 14 eT an e n AM O Ee ee ord Y e REN FE DNA 15 General PrecautlOnSu Ae bu A o Dod hag EB ydy dl my pda BYR 15 Nideo ColDoscop6ey sus YN YD Td DG DIN GY YU OU WG 15 Vertical tandsAssembl as ne RY da eee ade 16 Swing Arm Stand Assembly V FF FF Ya 16 Setting Up Video Colposcope LL FFF ae 18 AS Operas aca Lu AS i a RR Eg 19 POWER SWIT sit ain Sn d
34. wall outlet then plug cord back in to outlet At the same time turn printer off and then on again Make sure printer is on and is properly connected 28 Maintenance Welch Allyn Video Colposcope 6 Specifications 29 Video Colposcope Item Specification Technical Data Power requirements Voltage 115VAC domestic 220 240VAC international Frequency 50 60Hz Current 1 0 Amp Dimensions Vertical Stand Low 36 0 high 46 0 91 4 cm to 116 8 cm Swing arm stand Low 29 5 high 49 5 74 9 cm to 125 7 cm Optical centerline to swing arm bottom 15 0 38 1 cm Colposcope HxWxD excluding handles 8 25 x 5 75 x 3 37 21 0 cm x 14 6 cm x 8 6 cm Weight Colposcope 3 1 lbs 1 4 kg Vertical Stand 25 lbs 11 3 kg Swing arm stand 80 Ibs 36 3 kg Video Colposcope Focal length 300 mm 12 Specifications Magnification relative to a 14 monitor 4 5x 30x typ Field of view 66mm 14mm Depth of field 112mm 5mm Operating environment Ambient temperature Relative humidity Atmospheric pressure 509 F 10 C to 1049F 40 C 9596 max 70kPa to 110kPa lllumination Lamp type Lamp life Brightness adjustment Lamp Lamp voltage 21 Watt metal halide arc 750 hrs 1 hr per start Automatic electronic shutter Welch Allyn part no 09800 U 60 volts Cooling method Forced air via fan 30 Specifications Welch Allyn Video Colposcope Item Specifi
35. yn software program are Freeze Print and Toggle See Operation on page 19 of this manual for connecting the printer to the video colposcope e Pressing the freeze F button stores a new image in memory The frozen image is displayed on the monitor or PC e Pressing the copy C button prints saves the image displayed on the monitor If live video is displayed the image visible when the button was pressed will be printed saved e 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 2 Operation Welch Allyn Video Colposcope 23 s Maintenance 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 e 70 isopropyl alcohol e 10 mild bleach solution e 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 Video Colposcope Cleaning Turn the power switch off and unplug the power cord from the electrical outlet prior to cleaning The video colposcop
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