Products, Inc. AL-106 and AL-106SA Digital Video Colposcope User Manual English Version 3.0 MedGyn AL-106 Digital Video Colposcope User Manual Table of Content 1. Introduction 2 1.1 Scope 2 1.2 Indication 2 1.3 Features 3 1.4 System Introduction 3 1.4.1Main parts 3 1.5 Installation preparation 5 1.5.1Environment 5 1.5.2Unpacking and Inspection 6 1.6 Further information 6 2. Safety 7 2.1 Markings 7 2.2 Classification 7 2.3 Support and maintenance 8 2.3.1Warranty 8 2.4 Terminology 8 2.5 Safety Note 9 2.5.1Warnings 9 2.5.2Precautions 9 2.6 Contraindication 10 3. Camera 11 3.1 Composition 11 3.2 Installation 11 3.3 Disassembly 12 4. Stand 13 4.1 Vertical Stand 13 4.1.1Vertical Stand Composition 13 4.1.2Assembly 13 4.2 Swing arm stand 17 4.2.1Swing arm stand composition 17 4.2.2Assembly 17 4.3 Precautions 25 5. Camera Operation 26 5.1 Button Function 26 5.2 Camera Adjustment 28 1 I MedGyn AL-106 Digital Video Colposcope User Manual 1. Introduction Welcome to use AL- 106 digital video colposcope! Clinical application of colposcope has a history of more than eighty years. With the rapid development of medical diagnosis technology and digital imaging technology, the design and function of the colposcope is becoming better day by day. The new type of colposcope achieves much improvement in the advancement of the imaging module, image clarity and personalized design. AL-106 digital video colposcope adopts high - resolution electronic imaging technology. This technique is different from traditional optical colposcopy for it does not have eyepieces so that the doctors could observe the lesion on the monitor. The high quality light source and continuously magnified image could present very subtle details. In addition, AL - 106 is easy to operate, and can be used both for diagnosis and guiding treatment. Such innovative and non - invasive technique could provide fast and safe screening, and it is an advanced method for education and research. 1.1 Scope Cervix, vulva and vaginal examination, treatment and data management 1.2 Indication MedGyn's Digital Video Colposcope is intended for magnified viewing of the tissues of the vagina, cervix and external genitalia in order to assist doctors in diagnosing abnormalities such as lesions or cancer, and selecting areas for biopsy. The images from the Digital Video Colposcope are to be viewed on a color monitor. The Digital Video Colpscope is intended for use in hospitals, clinics, and doctors' offices. 2 MedGyn AL-106 Digital Video Colposcope User Manual 1.3 Features AL-106 digital video colposcope adopts high resolution color CCD video image capture technology and advanced control technology, thus can not only satisfy big - screen display requirement, but also realize image ca pture, display, process, save and print through computer and software. High-resolution color CCD, double circular LED group light source, control circuit all integrated in one handheld camera. Button control provides convenience for operation such as zo om in/out, focus, freeze, green filter, and timing and magnification factor display. Digital video colposcope check is dual-visual that both doctors and patients can observe, thus it could help doctor explain cervix lesion and suggest treatment to patient directly. 1.4 System Introduction AL-106 digital video colposcope is composed of camera and stand. Composition and type Diagram 1 -1 composition Colposcope Model AL-106 AL-106SA Camera Conversion box Vertical stand Camera Conversion box Swing arm stand 1.4.1 Main parts Camera Camera is composed of high- resolution color CCD , circular LED group light source, control circuit, it mainly used to control zoom in, zoom out, green filter, timing and freeze function. 3 MedGyn AL-106 Digital Video Colposcope User Manual Diagram 1 -2 AL-106 Camera name Camera Description 1/4" SONY Exview IIAD CCD imaging module Fast auto focus magnification: 1~40 optical magnification: 1~36 double circular LED group light source 3 grade green filter function S-Video output Image freeze control Working distance: 200~300mm Field of view: At 1X≥Φ60mm; At 40 X≥Φ6mm Depth of view: 5mm ~ 120mm Magnification and acetic acid reaction timing display Multifunction board (direct control magnification, focus, freeze and green filter)) Stand Vertical and swing arm stand is used to support the camera and connect with the video cable Diagram 1 -3 AL-106 Stand name Vertical stand Swing arm stand Description S-Video interface Maximum height:≤900 mm adjustable:≥150mm movable 5 leg caster (with brake) Vertical swing arm rotation:>180° ; Left to right rotation :0-180°; Up and down rotation:±30° ; Stand height:800mm Movable five legs base (three brake) 4 MedGyn AL-106 Digital Video Colposcope User Manual Conversion box Name description Conversion box 1.5 S-Video output ; Signal interface (camera out/in) 90~240V Power in Installation preparation 1.5.1 Environment To ensure electric assembly safety, the environment shall be reasonably dust free, no corrosive or combustible gas, or extreme temperatur e or humidity. Keep a proper space for the monitor at least 5cm from the wall to ensure good air ventilation. Keep the room clean, avoid shock, noise interference, and avoid direct sun. Extreme temperature can affect the accuracy of the monitor and damage accessory or circuit. Please ensure that there is no water condensing in the device before use. When the device is transferred between buildings, water condensing happens because of exposure to humidity and temperature difference. Operating room should be ventilated, anti -shock, noise, strong power and avoid direct sunlight. To ensure safe use, user must provide standard three- prong power socket and ensure proper connection of earth protection especially when used together with microwave machine or high frequency device. 5 MedGyn AL-106 Digital Video Colposcope User Manual 1.5.2 Unpacking and Inspection Do not bottom up when unpacking. After unpacking the camera and accessories, keep the packing materials properly for return service when necessary. Check carefully the device and the accessories against the packing list supplied by the manufacturer and see if there is any damage. Any damage or missed please contact the agent or manufacturer. 1.6 Further information This manual explains the performance, operation and maintenance of the colposcope. If schematic diagram, key component list or any other materials needed by technical personnel, please contact the manufacturer. Note: This manual should be put around the device for user. Read the manual thoroughly before use to ensure proper operation, and safety. 6 MedGyn AL-106 Digital Video Colposcope User Manual 2. Safety 2.1 Markings mark description mark Note: check accompany files Fuse description ○ disconnect power │ connect power AC current USB interface Signal input/output Electronics pollution control mark high voltage Outer packing is recyclable recycle Maximum stacking Protect against water Fragile contents Manufacturing date up Footswitch enclosure IP code series number 2.2 Classification Classification information is as flowed: Classification principle According to the type of protection against electric shock According to the degree of protection against electric shock Classification Class I Type B According to the mode of operati on continuous operation According to t he degree of protection against Normal device, but footswitch is ingress of water IP68。 7 MedGyn AL-106 Digital Video Colposcope User Manual According to the degree of safety in the presence of a flammable anesthetic mixture Non AP or APG equipment with air or with oxygen or nitrous oxide According to the methods of sterilization or disinfection recommended by the Recommend by manufacturer manufacturer According the type of management Type Ⅱ,classification code 6822 2.3 Support and maintenance 2.3.1 Warranty We provide warranty for this product within warranty period. And please keep the packages for further transportation and storage. We will assume the following responsibilities: The device is assembled, adjusted, improved by authorized personnel. Operation environment is in accordance with the electrical standard specified in this manual. Operate strictly according to this manual. The warranty shall be assumed except: Damage due to improper operation, improper connection to other device, and accident. The device is modified by user without the written authorization of the manufacturer. The serial number has been removed or unrecognizable. 2.4 Terminology The terms danger, warning, and caution are used throughout this manual to point out hazards and to designate a degree or level of seriousness. Familiarize yourself with their definitions and significance. 8 MedGyn AL-106 Digital Video Colposcope User Manual Note : Provide application tips or other useful information to assure maximum function Caution : Indicates a potential hazard or unsafe practice which, if not avoided,ld cou result in minor personal injury or product damage. Warning : Indicates a potential hazard or unsafe practice which, if not avoided, could result in death or serious injury. Danger : Is defined as a source of potential injury to a person. 2.5 Safety Note 2.5.1 Warnings Please confirm the colposcope is in normal working condition before operation. Keep the camera away from extreme humidity. During operation, avoid liquid splashing. Otherwise, it may result in failure. Never place the camera under a temperature of higher than 60C or direct high temperature radiation of sensors of thermal therapeutic or microwave devices. This is a non-contact type of examination device. Avoid contacting patient during use. To ensure safety use, user must provide standard three -prong power socket and ensure proper connection of earth protection. Before turn off power supply of the colposcope, never plug or unplug the video cable. Never stare at the illumination lens because it is extremely bright. 2.5.2 Precautions Without the written ap proval of the manufacturer, user shall not remove, modify or use accessories which do not comply with the manufacturer’s requirements. When connecting the CABLE, handle it carefully. Align the connectors, do not to plug or unplug with strong force, otherw ise, the cable and connectors may be damaged, which will impact the image quality or camera power supply or even the equipment. 9 MedGyn AL-106 Digital Video Colposcope User Manual When not in use, the power supply shall be turned off, and the camera shall be covered to prevent dust. To prevent accidental power failure and other potential accidents, use UPS power system with the colposcope. Before cleaning or sterilizing the colposcope, make sure to disconnect the power cable. Clean and sterilize according to the items specified. Do not use the device with other electrical devices. Keep cellular phones away from the device. When use diskette, CD, or other device to copy data, please be aware of virus. Packing materials should be put away from children reach or handled according to related regulations. In case any doubt arises, please consult as soon as possible. Please comply with the items stipulated in this manual. This manual is not the replacement of medical regulations. Notes indicate points of particular interest for more efficient and convenient operati on. Always take particular notice of the warnings, cautions and notes provided throughout this manual. Note :Digital video colposcope is not a treatment device, and it is only a non- contact examination device. 2.6 Contraindication No contraindication 10 MedGyn AL-106 Digital Video Colposcope User Manual 3. Camera This chapter explains the camera composition and installation. 3.1 Composition AL-106 includes high-resolution color CCD, double circular LED group light source, control circuit and enclosure. The outer view is as following: Fig.3 -1 ① Fig. 3-1: ① ① — Enclosure ② — LED group light ③ — Switch ④ — Button ③ ② ③ ④ ④ ② ⑤ — Handgrip ⑤ ⑤ Fig. 3-1 camera composition 3.2 Installation Thread the camera output cable through the hinge fixed block ② then fix the camera on the hinge ③ with 2PCS M4 black round head screws. Fig. 2-2:① — Stand fixing knob ② — Hinge fixed block ③ — Hinge ④ — Fixed block knob ③ ③ ② ② ④ ④ ① ① Fig.3-2 camera installation 11 MedGyn AL-106 Digital Video Colposcope User Manual 3.3 Disassembly 1) Screw off the 2pcs M4 screws to disassembly the camera. Fig. 3-3 Camera disassembly 2) Take off the fixing base with the screw driver; Fixing base Lock Fig.3-4 lock 3) Then the camera can be took off from the pole. Note: Camera case can only be opened by professionals/trained personnel. 12 MedGyn AL-106 Digital Video Colposcope User Manual 4. Stand This chapter explains the composition of the stand and installation 4.1 Vertical Stand 4.1.1 Vertical Stand Composition Vertical stand is used to support the camera, the stand height could be adjusted, and adjustable range is within 180mm. ① ② Fig. 3-1: ① — ②— ③— ④— ⑤— ⑥— 4.1.2 Inner pole Upper stand Lower stand Stand base Fixing nut Caster ③ ④ ⑥ Fig. 4-1 Vertical stand ⑤ Assembly 1) Screw off the nut from the lower pole; Fig. 4-2 2) Put the lower pole through the hole of the stand base, and then fasten the stand and the base with the nut. Fig 4-3 13 MedGyn AL-106 Digital Video Colposcope User Manual 3) Put the camera connection cable through the upper pole. (Align gap a with the screw hole b) a b Fig 4-4 4) Fix the camera and stand with one M3 flat screw . M3 screw Fig 4-5 5) Get out the spring wire (c) with the hook (d) from the lower pole, and connect it with camera output cable(e): e c d Fig 4-6 14 MedGyn AL-106 Digital Video Colposcope User Manual 6) Loosen the knob (f), pull up the inner pole (g) to the highest position and hold it, then rotate the upper stand to connect the upper stand with the lower stand. (Make sure the inner tube does not rotate along with the upper pole): g f Fig 4-7 7) For the purpose of better cable management, please mount the power box cover) with M3 screw, the cable will get out through the outlet (h). h M3 screw Fig 4-8 15 MedGyn AL-106 Digital Video Colposcope User Manual 8) Then the installation is completed. Press the power switch to start work. Switch Fig 4-9 16 MedGyn AL-106 Digital Video Colposcope User Manual 4.2 Swing Arm Stand 4.2.1 Swing arm stand composition 17 MedGyn AL-106 Digital Video Colposcope User Manual 4.2.2 Installation steps 1) Unscrew nut from bottom of pole, place pole in hole of rolling base and tighten nut. 2) Connect horizontal arm to bottom pole. Turn the top sleeve on the vertical pole counter clockwise to locate screw placement lock. Insert screw labeled M4x6 in the horizontal arm and tighten. Tighten the sleeve clockwise. 18 MedGyn AL-106 Digital Video Colposcope User Manual 3) Connect swing arm to horizontal arm. Unscrew the cap on the underside of the horizontal arm and insert a screw to tighten the swing arm in place. Replace cap. 4) Connect camera support arm to swing arm. Unscrew cap on upper side of camera support arm. Place one step screw in hole and tighten to hold camera support arm in place. Replace the cap. 19 MedGyn AL-106 Digital Video Colposcope User Manual 5) Put camera cable through hole of support arm. Release knob, put camera in support, and rotate knob to fasten camera. 6) Place cable into clips as shown in Fig 4-15: 20 MedGyn AL-106 Digital Video Colposcope User Manual 7) Install fixing plate onto swing arm with M4x8 flat head screws, and install power and signal conversion box onto fixing plate with 4 M3x8 screws. Fig.4-16 Install power and signal conversion box 8) Connect DB9 end of DB9-MD6 extension cable to interface marked "SIG NAL", then tighten. Connect MD6 end to camera cable, (carefully align the arrows before connecting). Place remainder of cable in buckle of swing arm if necessary. 21 MedGyn AL-106 Digital Video Colposcope User Manual 9) If Video signal out is needed, connect composite video cable to interface marked "Video", and other side to output device. If S-Video signal out is needed, connect S-Video to interface marked "S-Video" (arrow should face upward) and other end to output device. 10) Unplug power cable; connect one end to power socket of conversion box, and other side to power socket. Then lock power cable with anti-slip clip. 22 MedGyn AL-106 Digital Video Colposcope User Manual 11) Installation is complete. Press switch to start. 4.3 Precautions If swing arm needs adjusting, adjust it as follows: a) When camera is moved to certain positions, but still drops, use special wrench (an accessory) to rotate weight adjustment nut counter-clockwise. b) When camera is moved to certain positions, but still goes up, use the special wrench (an accessory) to rotate weight adjustment nut clockwise. 23 MedGyn AL-106 Digital Video Colposcope User Manual 5. Camera Operation This chapter explains the function of the camera and its operation 5.1 Button Function 1. Power indicator ①: When the switch turns on, the indicator ① flash and then becomes green. 2. “Zoom out” ② : Under auto focus, this button could control the magnification of observed image, equivalent to local size reduction . Under manual focus, press this button to decrease the focal distance 3. “Zoom in” ③ : Under auto focus, this button could control the magnification of observed image, equivalent to local enlargement. Under manual focus, press this button to increase the focal distance. 24 MedGyn AL-106 Digital Video Colposcope User Manual 4. “White” ④: 1) Under green filter function, press this button to return to normal white light display. 2) Press it again, exposure way change to aperture- priority, with screen display “FA”; press it once again, aperture increase one grade, with screen display ”FB” press it again to return to auto status. 3) The default value is normal white light, green filter is off. 5. “Green” ⑤: 1) Press this button to activate green filter function, camera will automatically filtrate the redness and present the morphology of the vascular. 2) There are three grades of filter, press this button once, screen will display light green filter result; press it ag ain, screen will display normal green filter image; press it the third time, screen will display dark green filter image. 3) When start up the camera, white light display is set as default, while green filter function is off. 6. AF/MF ⑥: 1) This button is used to control auto focus and manual focus 2) Press this button, auto focus turns to manual focus. And then, “zoom out” button is used to manually adjust the far focus. “Zoom in” is used to manually adjust the near focus, until clear imaged is obtained. Press “focus” return to auto focus, and then “zoom in” and “zoom out” function returns to normal. 3) When start up the camera, auto focus is set as default. 7. Display ⑦: 1) Press this button, screen could display magnification information 2) Press it again, the information disappears 3) When start up the camera, no information display is set as default. 8. Time ⑧: 1) Press this button, display “acetic acid reaction timing” mark 2) Press it again, timing mark will disappear 3) When start up the camera, no timing mark is set as default 9. Still ⑨: Press this button to freeze the image with “Still” mark display on the screen; press it again, display will return to normal 10. Camera switch ⑩: Camera switch is used to turn on and turn off the camera power 25 MedGyn AL-106 Digital Video Colposcope User Manual 5.2 Camera Adjustment Camera direction and height can be adjusted accords to the doctor’s height during examination. Method is as following: Fig. 4-2: ① — ② — ③ — ④ — Stand fixing knob Hinge fixed block Hinge Fixed block knob ③ ② ③ ② ④ ① ④ ① Fig 5-2 Camera Adjustment 1) Counterclockwise loosen the standing fixing knob ① to adjust the stand to a proper height, then fix the knob ①; 2) Rotate the camera back and forward through the hinge ③; 3) Counterclockwise loosen the fixed block knob ④ to adjust the camera left-right, then fix the knob. 26 TRUSTED PRODUCTS FOR PREMIER WOMEN’S HEALTHCARE MEDGYN PRODUCTS, INC. 100 W. Industrial Rd. Addison, IL 60101 USA t: +1 630.627.4105 toll-free: 800.451.9667 f: +1 630.627.0127 e: info@medgyn.com w: medgyn.com