User`s Manual
Contents
1. Intended use The MDSCOPE video otoscope is as an assistive tool to observe the health condition of the ear Indications for use include Inspection of the outer ear canal and tympanic membrane and detection of hearing aid devices The device may also be coupled a flexible camera module to monitor the health condition of the mouth Indications for use include inspection of palate tongue and anterior of oropharynx The MDSCOPE video otoscope should not be used for any other purposes MS101 features Screen Power indicator ON OFF button Image Freeze button video out port amera module button Symbols Safety Symbols ul A Manufacturer Caution SN IPXO Serial number Not protected against the ingress of water m 49 C my 4 Type BF Temperature limits Symbol for AUTHORIZED CE mark has been identified according REPRESENTATIVE IN THE to Article 17 of the MDD 93 42 EEC EUROPEAN COMMUNITY Bl Consult instructions for use Button Symbols Power Saftey and Cautions The MDSCOPE video otoscope should be operated under supervision of a trained ENT doctor or health professionals with sufficient knowl edge of otoscopy ih Do not use this device in the presence of inflammable anesthetics Please follow local rules and regulations regarding disposal or recycling of the device and its components The Video signal output RCA Port connector is intended for connect2. MDSCOPE Video Otoscope User s Manual UM AP1005 08 A When there is a need to immediately report an adverse effect in connection with operation of the MDSCOPE Video Otoscope please contact the authorized representative or the agent You may also contact the customer service at 886 2 2999 5505 or MDSCOPE appleBMI com U S Agent Harvest Consulting Corp Medical Device Safety Service GmbH 2904 N Boldt Drive Flagstaff Schiffgraben 41 30175 Hannover Arizona 86001 U S A Germany Thank you for choosing the MDSCOPE Video Otoscope the Video Otoscope choice for health care professionals The operating and maintenance instructions found in this manual should be followed to ensure product reliability Please read this manual carefully before using the product If you experience a technical problem related to operation of the MDSCOPE Video Otoscope please contact your local dealer for the after sales support You may also contact the customer service at 886 2 2999 5505 or MDSCOPE appleBMI com FDA listed D083901 D119968 D150295 IEC 60601 1 IEC 60601 1 2 The manufacturer declares on his her sole responsibility that the product is in conformity with the essential requirements of the 93 42 EEC Medical Device Directive and that the relevant conformity assessment procedures have been fulfilled 2012 by Apple Biomedical Inc All Rights reserved Reproduction or reprinting of any part of this manua
3. and manufacture s declaration electomagnetic immunity The MDSCOPE video otoscope is intended for use in the electromag netic environment specified below The customer or the user of the device should assure that it is such an environment Immunity test EC 60601 Complianc Electromagnetic environment guidance test level e level Conducted RF 13 Vms Portable and mobile RF communications IEC61000 46 150kHzto80 Applicable equipment should be used no closer to any part of the device including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance d 1 2 P d 1 2 P 80MHz to 800 MHz d 2 3 P 800 MHz to 2 5 GHz Radiated RF 13 V m where Pis the maximum output power rating of IEC61000 4 3 80 MHz to 25 the transmitter in watt W according to the transmitter manufacturer and dis the recommended separation distance in meters m Field strength 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 9 NOTE 1 At 80 Hz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorptions and reflections from structures objects and people Field strength fro
4. e image 1 Restart the device and try the freeze function again 2 Check and confirm the button can be depressed with ease and repeat at least 10 times 3 The main unit may be defective if the freeze function does not work after repeating the above steps for several times Please contact your local dealer for technical supports 13 6 Parts List Parts Basic Parts ltem Number Description Quantity 1 MS101 001 Main device 1 MS101 002 Camera module 45mm MS101 003 Protective cover MS101 005 Video cable MS101 006 User manual MS101 007 Warranty card MS101 008 AA Alkaline batteries MS101 016 Disposable Specula MS101 017 Cotton Swab 2 3 4 5 6 8 9 Number Description Quantity MS101 011 Image Dongle With USB cable MS101 012 Long camear module 75mm MS101 013 Flexible camera module 150mm MS101 014 Flexible camera module 300mm MS101 015 Disposable Specula MS101 018 Cable Set f Limited Warranty Appendix Each of the MDSCOPE video otoscope comes with a one year Table 201 warranty starting on the purchase date to cover repair and or if Guidance and manufacture s declaration electomagnetic emissions necessary replacement of any product failure due to defects in The MDSCOPE video otoscope is intended for use in the electromag materials and workmanship Within the limited range of the warranty netic environment specified below The customer or the users of the defective products shall be repaired or rep
5. ion to devices that comply with IEC 60601 1 or other IEC standards for example IEC 60950 as appropriate to the device Do not apply alcohol chemicals or water to clean the lenses Solution entering the optical assembly can cause short circuits for electrical components Portable and mobile wireless communications device which transmits radiofrequency RF may affect the performance of the medical electrical device Please remove the batteries if the device is stored for a long time Some patients may feel warm and uncomfortable at the probe during the diagnosis when the device is left switched ON for a long period of time The operator of the device should first discuss the possible discomfort with the patient and when necessary withdraw the device from the patient and switch it off until the probe no longer feels warm WARNING No modification of this equipment is allowed Under an extreme laboratory test condition at 40 C the applied part of the device may be measured at a temperature of no higher than 60 C and its enclosure at 49 C if it is turned on continuously for more than 2 hours Suggested Use of Long Flexible Camera module For User purchasing the long flexible camera modules The long camera module is selected when it is difficult to get near to the target using the standard camera module As the MDSCOPE video otoscope is operated with the long camera module the user needs to ensure that the tip of the ca
6. l by any means without written authorization from Apple Biomedical Inc is strictly prohibited Printed in Taiwan Contents Chapter 1 Introduction Features Symbols Saftey and Cautions Use of Long Flexible Camera Module Chapter 2 Operations Setting up the Otoscope Loading the Batteries Power ON OFF Batteries Condition Image Freeze Release Function Video Out Function Chapter 3 Specifications Chapter 4 Cleaning and Storage Chapter 5 Troubleshooting Chapter 6 Parts Chapter 7 Limited Warranty Appendix EMC Guidance and Manufacturer s declaration Tables 201 202 204 206 1 Introduction The MDSCOPE Video Otoscope is a hand held medical device that includes a video camera for capturing a video image of the outer ear canal and or tympanic membrane The image is displayed directly on a built in screen or displayed on an external display device via connec tion to a video out port The MDSCOPE video otoscope is preset for its focus brightness level and white balance It is powered by two AA batteries for a continuous operation of about 4 hours Video imaging provides several advantages over direct visualization The MDSCOPE video otoscope may be operated with an image dongle to record the otoscopic images which are used to create medical history for each patient By using the MDSCOPE video otoscope health professionals can review and discuss the clinical findings with patients to enhance the doctor patient interaction
7. laced by the Manufacturer device should assure that it is used in the such an environment or authorized technical and service groups at their options and to the Fisciromannciie envionment guidance extent permitted by law RF emissions CISPR11 Group 1 The device uses RF energy only for its internal function Therefore its RF emissions are very This warranty is non transferable Damages due to negligence low and are not likely to cause any interference accident abuse misapplication modification or repairs not made by EO Se SCE Pen the Manufacturer or authorized technical and service groups are not covered by the warranty Within the coverage of the warranty the The device is suitable for use in all establish RF emissions CISPR11 Class B ments including domestic establishments and those directly to the public low voltage delivery fee for mailing to the local dealer or the direct store is not covered within the scope of the warranty adu asus used for domestic purposes EU Representative Medical Device Safety Service Harmonic emissions Not Applicable GmbH Schiffgraben 41 30175 IEC 61000 3 2 Hannover Germany Manufacturer APPLE BioMedical Inc Voltage fluctuations Not Applicable flicker emissions 8th Floor No 12 Lane 609 Chong Shin Road Sec 5 New Taipei IEC 61000 3 3 24159 Taiwan Table 202 Guidance and manufacture s declaration electomagnetic immunity The MDSCOPE video otoscope is intended for u
8. m transmitters such as base stations for radio celluar cordes telephones and mobile radio amateur radio AM and FM radio 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 device is used exceeds the applicable RF compliance above the device should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the device P Over the frequency range 150 kHz to 80 MHz field strength should be less than 3 V m Table 206 Recommended separation distances between portable and mobile RF communications equipment and the MDSCOPE Video Otoscope The device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The user of the device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communication equipment transmitters and the device as recommended below according to the maximum output power of the communications equipment Separation distance according to the frequency of transmitter Rated maximum m output power of 150 kHz to 80 MHz 150 kHz to 80 MHz 150 kHz to 80 MHz transmitter For transmitters rated at a maximum output power not listed above the rec
9. mera module is held a distance NOT less than 1cm away from the target in the ear canal The flexible camera module is selected when it is difficult to get near to the target using the long camera module As the MDSCOPE video otoscope is operated with the flexible camera module the user needs to ensure that the tip of the camera module is held a distance NOT less than 1cm away from the target in the oral cavity Loading the Batteries 2 Operations Setting up the Video Otoscope 1 Push the release button 1 Remove the fastening ring 2 Align the camera module to the mounting base iH 2 1 Remove the protective cover Insert the camera module to the mounting base via the mating parts 3 Load in the batteries 3 Screw on the fastening ring 4 Put on new speculum before using 3 1 Align the er fastening ring pe j 4 1 CAPPING f G 3 2 Screw it down i Push the flanged end onto the to tighten camera module until it clicks into Do not overtighten a lock position 4 2 REMOVE Press the flanged end of the rigid speculum to remove and discard after use 2 Slide down to open the battery cover Power ON OFF Battery Conditions When the light switches from green to red it indicates that the batteries are low Press and hold the power In this case please change batteries button for 2 seconds to switch the device on Video Out Function Video out port Image Freeze Release Functi
10. ommended separation distance d in the meters m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacture NOTE 1 At 80 Hz and 800 MHz the separation distance for the frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorptions and reflections from structures objects and people
11. on 1 Remove the battery cover 2 Remove the video out cover 4 Connect one end of the video out cable to the video out port and the other end l to the monitor video port When the power is turned p ON Press the image freeze button for less than 1 second to freeze the image and press the same button again to return to preview mode 3 Specifications Item Specifications Dimensions Length 7 5 cm 3 approximate Width 6 3 cm 2 1 2 Height 21 2 cm 8 3 8 Focal length distance 1 to 4 cm away from target Weight Approximately 180 g Batteries 2 x AA Alkaline batteries Display size 2 4 TFT LCD Video out NTSC system Operating conditions Temperature 10 C to 40 C 509 F to 104 Relative humidity F 30 to 75 non condensing Shipping Storage conditions Temperature 20 C to 49 C 4 F to 120 Relative humidity F 95 non condensing max Predicted product life 2 years 4 Cleaning and Storage For cleaning of the camera probe 1s Step Take out the alcoholized prep pad 2nd Step Clean and wipe the stainless steel part of the standard long camera module or the outer sheath of the flexible camera module with the alcoholized prep pad 3rd Step Gently clean the camera lens with the cotton swab Care should be taken not to scratch the lens of the camera module For cleaning of the main unit The housing of the main unit can be cleaned with a cloth dampened with water alcohol or a non
12. se in the electromag netic environment specified below The customer or the user of the device should assure assure that it is such an environment Immunity test 1EC60601 60601 Compliance Electromagnetic environment environment test level level guidance 6 kV contact Floors should be of wood concrete or rea 8kV air ceramic tiles If the floor is tiled with ESD synthetic material the relative air IEC i humidity must have 30 at least 61000 4 2 Electrical fast 2 kV for power Not transient oursts supply lines Applicable IEC 61000 4 4 mm input output lines Surge 1 kV line s to line s Not IEC Applicable 61000 4 5 2 kV line s to earth Voltage dips K5 lt 5 UT 295 dip gt 95 dip Not o short in UT for 0 5 cycle Applicable mteruptions UT 60 dip in ane vole UT for 5 cycle s variations on power supply 70 UT 30 dip in input lines UT for 25 cycles IEC 61000 4 11 lt 5 UT gt 95 dip in inUT forss for5s Power 3 A m 0 3 A m If image distortion occurs it may be frequency necessary to position the device image magnetic field intensifier further from sources of power IEC 61000 4 frequency magnetic fields or to install 8 magnetic shielding The power frequency magnetic field should be measured in the intended installation location to assure that it is sufficiently low NOTE UT is the ac mains voltage prior to application of test level 18 Table 204 Guidance
13. staining disinfectant Liquids should not be dripped or spilled over the surfaces of the LCD module pogo pins or handle as they are not watertight Storage The camera module and main unit should be placed in the storage compartment of the carrying case Unnecessary exposure to extremes in temperature and humidity should be avoided LZ 5 Troubleshooting 1 Why is the MDSCOPE video otoscope not switched ON 1 Please confirm the batteries have power and reload the batteries in the battery compartment 2 Check and confirm the batteries are positioned in correct orientation 3 Check and confirm the button can be depressed with ease and repeat at least 10 times 4 Ifthe device is NOT switched ON by repeating the above steps please contact your local dealer for technical supports 2 After the device is switched ON the power indicator light is ON but no image is displayed or the image is fuzzy and unstable 1 Confirm if the LED light in front of the camera module is switched ON 2 Confirm if camera module is mounted properly 3 Confirm if the fastening ring is tightened up 4 Confirm if there is any foreign substance stuck on the metal contact and clean the surface of metal contact with alcoholized prep pad 5 If the image is still NOT displayed properly after carrying out steps 1 4 above please contact your local dealer for technical supports 3 The device is switched ON with image displayed but can t freeze th
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