User's Manual - Doctorshop.it
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1. User Manual 20120509 24page final pdf 1 2012 5 9 F 04 14 53 MDSCOPE Video Otoscope User s Manual UM AP0902 01 B User Manual 20120509 24page final pdf 2 2012 5 9 FF 04 15 03 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 Ec REP Harvest Consulting Corp Medical Device Safety Service GmbH 2904 N Boldt Drive Flagstaff Schiffgraben 41 30175 Hannover Arizona 86001 U S A Germany Ti hank 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 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 releva2. T less than 1cm away from the target in the ear canal 2 Operations Loading the Batteries Setting up the Video Otoscope 1 Push the release button 2 Slide down to open the battery cover 1 Remove the fastening ring 2 Align the camera module to the mounting base 2 1 Remove the protective cover Insert the camera module to the mounting base via the mating parts 3 Screw on the fastening ring 4 Put on new speculum before using 3 1 Align the Ses fastening ring 4 1 CAPPING 3 2 Screw it down 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 Press and hold the power button for 2 seconds to switch the device on Image Freeze Release Function When the power is turned 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 Battery Conditions MDSCOPE cE When the light switches from green to red it indicates that the batteries are low In this case please change batteries Video Out Function Video out port E A 1 Remove the battery cover 2 Remove the video out cover 3 Connect one end of the video out cable to the video out port and the other end to the monitor video p
3. ase Function Video Out Function Chapter 3 Specifications 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 Inspection of the tympanic membrane Inspection of hearing aid devices Chapter 4 Cleaning and Storage Chapter 5 Troubleshooting Chapter 6 CHAPIEEE CINE Waranty The MDSCOPE video otoscope should not be used for any other Appendix EMC Guidance and Manufacturer s declaration purposes Tables 201 202 204 206 MS101 features Symbols Safety Symbols ull Manufacturer Caution IPX Serial number Not protected against the ingress of water 49 C 20 C Temperature limits Screen Camera module Fastening Power indicator Ring ON OFF button Image Freeze button symbol for AUTHORIZED CE mark has been identified according REPRESENTATIVE IN THE to Article 17 of the MDD 93 42 EEC EUROPEAN COMMUNITY Consult instructions for use video out port Button Symbols Video out User Manual 20120509 24page final pdf 5 2012 5 9 F 04 15 03 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 A Do not use this device in the presence of inflammable anesthetics Please follow local rules and regulations regarding disposal or
4. ction does not work after repeating the above steps for several times Please contact your local dealer for technical supports 6 Parts Basic Parts Item 1 2 3 4 9 6 8 9 Number MS 101 001 MS101 002 MS101 003 MS101 005 MS101 006 MS101 007 MS 101 008 MS101 016 MS101 017 Optional Parts Item 10 11 12 13 14 15 Number MS101 011 MS101 012 MS101 013 MS101 014 MS101 015 MS101 018 NIG User Manual 20120509 24page final pdf 9 2012 5 9 F 04 15 05 Description Quantity Main device Camera module 45mm Protective cover Video cable User manual Warranty card AA Alkaline batteries Disposable Specula Cotton Swab Description Quantity Image Dongle With USB cable Long camear module 75mm Camera module 150mm Camera module 300mm Disposable Specula Cable Set EEEE Parts List NIG User Manual 20120509 24page final pdf 10 2012 5 9 FF 04 15 06 7 Limited Warranty Each of the MDSCOPE video otoscope comes with a one year warranty starting on the purchase date to cover repair and or if necessary replacement of any product failure due to defects in materials and workmanship Within the limited range of the warranty defective products shall be repaired or replaced by the Manufacturer or authorized technical and service groups at their options and to the extent permitted by law This warranty is non transferable Damage
5. ments including domestic establishments and those directly to the public low voltage power supply network that supplies building used for domestic purposes NIG User Manual 20120509 24page final pdf 11 2012 5 9 FF 04 15 06 Table 202 Guidance 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 IEC 60601 Compliance Electromagnetic environment test level level guidance Electrostatic 6 kV contact 6 kV Floors should be of wood concrete or discharge 8 kV air contact ceramic tiles If the floor is tiled with ESD 8 kV air synthetic material the relative air humidity IEC must have 30 at least 61000 4 2 Electrical fast 2 kV for power Not transient bursts supply lines Applicable IEC 61000 4 4 1 kV for input output lines Surge 1 kV line s to line s Not A 4 5 2 kV line s to earth pppleable Voltage dips lt 5 UT gt 95 dip Not short in UT for 0 5 cycle Applicable nteruptions 40 UT 60 dip in and voltage UT for 5 cycle s variations on power supply 70 UT 30 dip in input lines UT for 25 cycles IEC 61000 4 1 1 lt 5 UT gt 95 dip in UT for 5 s Power If image distortion occurs it may be frequency necessary to position the device image magnetic field intensifier f
6. ng 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 output m power of oo 150 kHz to80MHz 150kHzto80MHz 150 kHz to 80 MHz d 1 2 P d 1 2 P d 1 2 P 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 For transmitters rated at a maximum output power not listed above the recommended 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 User Manual 20120509 24page final pdf 13 2012 5 9 FF 04 15 06 www MDSCOPE net ae
7. nt conformity assessment procedures have been fulfilled 2012 by Apple Biomedical Inc All Rights reserved Reproduction or reprinting of any part of this manual by any means without written authorization from Apple Biomedical Inc is strictly prohibited Printed in Taiwan NIG User Manual 20120509 24page final pdf 3 2012 5 9 F 04 15 03 Contents 1 Introduction Chapter 1 Introduction Features Symbols Saftey and Cautions Use of Long Flexible Camera Module 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 Chapter 2 Operations batteries for a continuous operation of about 4 hours Setting up the Otoscope Loading the Batteries Power ON OFF Batteries Condition 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 Image Freeze Rele
8. ort 3 Specifications Item Dimensions approximate Focal length distance Weight Batteries Display size Video out Operating Temperature Shipping Storage Temperature Relative humidity Predicted product life Specifications Length 7 5 cm 3 Width 6 3 cm 2 1 2 Height 21 2 cm 8 3 8 1 to 4 cm away from target Approximately 180 g 2 x AA Alkaline batteries 2 4 TFT LCD NTSC system 10 C to 40 C 50 F to 104 F 20 C to 49 C 4 F to 120 F 50 to 75 non condensing 2 years User Manual 20120509 24page final pdf 8 2012 5 9 F 04 15 05 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 4 Cleaning and Storage For cleaning of the camera probe 15 Step Take out the alcoholized pre pad 24 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 pre pad 311 Step Gently clean the camera lens with the cotton swab Care should be taken not to scratch the lens of the camera module _ 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 If the device is NOT switched ON by repeating the ab
9. ove steps please contact your local dealer for technical supports 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 staining disinfectant Liquids should not be dripped or spilled over the surfaces of the LCD module or handle as they are not watertight 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 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 _ 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 pre 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 the 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 fun
10. range Interference may occur in the vicinity of equipment marked with the following symbol D 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 a Field strength from 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 gt Over the frequency range 150 kHz to 80 MHZ field strength should be less than 3 V m User Manual 20120509 24page final pdf 12 2012 5 9 FF 04 15 06 lt amp 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 maintaini
11. recycling of the device and its components The Video signal output RCA Port connector is intended for connection to devices that comply with IEC 60601 1 or other IEC standards for example IEC 60950 as appropriate to the device To minimize external otoscope housing temperatures the device is suggested to turn on for no more than 3 minutes The device must then be turned off for a minimum of 3 minutes before turning it back on again 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 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 camera 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 NO
12. s due to negligence accident abuse misapplication modification or repairs not made by the Manufacturer or authorized technical and service groups are not covered by the warranty Within the coverage of the warranty the delivery fee for mailing to the local dealer or the direct store is not covered within the scope of the warranty EU Representative Medical Device Safety Service GmbH schifigraben 41 30175 Hannover Germany Manufacturer APPLE BioMedical Inc 8th Floor No 12 Lane 609 Chong Shin Road Sec 5 New Taipei 24159 Taiwan TEL 886 2 2999 5505 FAX 886 2 2999 6605 E mail MDSCOPE appleBMI com Website www MDSCOPE net Appendix Table 201 Guidance and manufacture s declaration electomagnetic emissions The MDSCOPE video otoscope is intended for use in the electromag netic environment specified below The customer or the users of the device should assure that it is used in the such an environment Emissions test RF emissions CISPR1 1 RF emissions CISPR1 1 Harmonic emissions IEC 61000 3 2 Voltage fluctuations flicker emissions IEC 61000 3 3 Compliance Group 1 Class B Not Applicable Not Applicable Electromagnetic environment guidance The device uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment The device is suitable for use in all establish
13. urther from sources of power IEC 61000 4 8 frequency magnetic fields or to install 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 a c mains voltage prior to application of test level amp 1 Table 204 Guidance 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 IEC 60601 Compliance Electromagnetic environment guidance test level level Conducted RF Portable and mobile RF communications IEC61000 4 6 150 kHz to 80 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 2V P 80MHz to 800 MHz d 2 3 P 800 MHz to 2 5 GHz Radiated RF 3 V m where P is the maximum output power rating of IEC61000 4 3 80 MHz to 2 5 the transmitter in watt W according to the GHz transmitter manufacturer and d is 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
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