2AVH2EOAIMIElectric Oral Anesthesia Injector

MinI(Smart)UserManual 1 TableofContents 1.Introduction..................................................................................................2 2.ProductDescription.......................................................................................2 3.IndicationsforUse.........................................................................................2 4.PackageContents............................................................................................2 5.FeaturesandBenefits.....................................................................................3 6.Specifications.................................................................................................3 7.OperatingProcedure......................................................................................4 8.ChangingtheO-Ring.......................................................................................7 9.Attention/Caution........................................................................................8 10.FCCCaution..................................................................................................9 11.DeviceLabel.................................................................................................9 12.LabelSymbolsDefined................................................................................9 13.PreventionofCross-Contamination.............................................................10 14.Troubleshooting..........................................................................................10 15.ManufacturerWarranty,ServiceandSupport.............................................10 16.Magneticcompatibilityinformation............................................................11 ShenzhenSogaMedicalEquipmentCo.,Ltd. D906ofYinxingtechnologybuilding,No.1301,GuanGuangRoad,Xinlan community,Guanlanstreet,LonghuaDistrict,ShenZhen,Guangdong,China 0086-755-23776690 [email protected] MinI(Smart)UserManual 2 1.Introduction TheMiniI(SmartI)ElectricOralAnesthesiaInjectorisaprofessionalandpainless localanesthesiainjectiondeviceusedfortheoralcavity. MiniI(SmartI)ElectricOralAnesthesiaInjectorcanplaytheroleofautomatic injectionofanestheticsunderthecircumstancesofblockconductionanesthesia, localinfiltrationanesthesiaandperiodontalmembranelocalanesthesiain stomatologydepartment. Primacaine,Scandonestandothermajoranestheticsfortheoralcavity. 2.ProductDescription TheMiniI(SmartI)ElectricOralAnesthesiaInjectorisadeviceusedforinjectinglocal anestheticpriorto,orinconjunctionwith,dentalprocedures.Themethodusedto delivertheanesthetictothepatientallowstheuseoflessanestheticandtheonset oftheanesthesiaisoftenfaster.Theneedleisnotwhatcausesthediscomfortofan injectiontothepatient,it’stheflowoftheanestheticortherateofdeliverytothe tissue. 3.IndicationsforUse TheMiniI(SmartI)ElectricOralAnesthesiaInjectorisadeviceusedfortheinjection oflocalanestheticsforanesthesiaadministeredpriorto,orinconjunctionwith, dentalprocedures. 4.PackageContents •Onehandpiecewithcontrolsanddisplayscreen •Twoboostpipes;disinfectwithautoclavebeforeuse •Onechargingbase •Onepoweradapter MinI(Smart)UserManual 3 •Onechargingcable •O-ring,10pieces.Settheo-ringinthefrontpartofplunger.Whensuctionedback, theo-ringwillproducesanegativepressureontheanesthetictube. •Disposablesleeve,50pie 5.FeaturesandBenefits 1.Saveonanestheticandlowercosts,withnopipelineorotherconsumables. 2.Simpleoperation,withonefingertouchingthecontrolsofthepen-likehandpiece. Thereisnofootswitch. 3.Lownoisewithmusic. 4.LCDscreenshowstheoperatingprocessanddosage. 5.No-contactbatteryinductioncharging. 6.Audioalarm 6.Specifications 1.Typeclassificationofelectricshockprotection:internalelectricsource.IEC standard60601typeBF. 2.WaterresistancegradeIPX0.Keepdry. 3.Workingsystem:continuousoperation 4.Nosignalinputs 5.Nosignaloutputs 6.Novibrationpreventionorcancellation 7.NonAP/APGtype 8.Workingenvironment:theequipmentisappliedinthegeneralofficeenvironment. 9.Poweradapterinput:AC100-240V50/60HzOutput:5VDC. 10.Workingpower:built-inlithiumbatterycharging. 11.Workingvoltage:DC3.7V. 12.Workingcurrent:100mA. 13.Workingindication:LEDflickerindicating. MinI(Smart)UserManual 4 7.OperatingProcedure 7.1Productindicationandkeyfunction SerialnumberNameFunctiondescription 1Musicsettingskey Afterlongpresstoenterthesettingstate,clicktoadjustthemusic sound 2 Injectionmodesetting key Afterthelongpresstoenterthesetstate,clicktoswitchtospeed mode 3 ChargeIndicating Lamp Itisusedtoindicatethechargingstate.Greenflasheswhencharging normally 4 OLEDDispalyScreen OLED Usedtodisplayworkingstatusandinstructions 5WorkIndicatingLamp ndicatethatthepushrodisworking,flashingwhenworkingnormally 6 CautionIndicating Lamp Itisusedtoindicatethattheinjectionsiteisperiodontalmembrane ortheinjectionisfinished,anditlightsupwhenprompted 7Power/switchkey Longpressisusedtoswitchonandoffthemachine,shortpressis usedtounlockandlock 8BoostertubeUsedtofixlocalanestheticbottle 9Startworkkey Touchtheareawithyourfingertogetthepushrodtowork,Raise yourhandandsuckback MinI(Smart)UserManual 5 7.2OLEDscreendescription SerialnumberNameScreendescription 1 Injectionmode Displaysthecurrentinjectionmodestatus.Thereare threeinjectionmodes: 1.Periodontalmembranepattern 2.Fastmode 3.Slowmode 2 Anesthesia injectionprogress bar Showcurrentanestheticinjectionprogress 3 Numberof anesthetics injected Displaythenumberofanestheticsthathavebeen injected 4ElectricquantityDisplaycurrentpower 5 Safetylock Displaysthestatusofthecurrentsafetylock.Thereare twomodes: 1.Lockedstatus:lockedmeans"starttotouch"isnot operable. 2.Unlockingstatus:unlockingmeans"starttouch key"canbeoperated. MinI(Smart)UserManual 6 6 Injectionofstate Displaysthecurrentinfusionstatus.Therearetwostatus displays 1.Forwardinjectionstate 2.Suckbackstate 7 Injectionpressure status Displaycurrentinjectionpressure 8 Injectionpressure value Displaythecurrentinjectionpressurevalue 7.3Specificoperationmethod InstallBoostPipeandneedle: Removet…

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Shenzhen Soga Medical Equipment Co., Ltd. Office of Engineering Technology Federal Communications Commission 7435 Oakland Mills Road Columbia, MD 21046 Date: 2020-01-10 Subject; Request for Long Term Confidentiality FCC ID: 2AVH2EOAIMI To Whom It May Concern, Pursuant to the provisions of the Commission’s rules Title 47 Sections §0.457 and §0.459, we are requesting the Commission to withhold the following attachment(s) as confidential documents from public disclosure indefinitely. These documents contain detailed system and equipment descriptions and are considered as proprietary information in operation of the equipment. The public disclosure of these documents might be harmful to our company and would give competitors an unfair advantage in the market. Schematic Diagram Block Diagram Operational Description It is our understanding that all measurement test reports, FCC ID label format and correspondence during the certification review process cannot be granted as confidential documents and this information will be available for public review once the grant of equipment authorization is issued. Sincerely, Signature: Name: Hou Meng Title: Manager

Shenzhen Soga Medical Equipment Co., Ltd. Letter of Authorization Company: Shenzhen Soga Medical Equipment Co., Ltd. Address: D906 of Yinxing technology building, No. 1301, Guan Guang Road, Xinlan community, Guanlan street, Longhua District ,ShenZhen,Guangdong,China Product Name: Electric Oral Anesthesia Injector Model Number: MiniI, SmartI FCC Identifier: 2AVH2EOAIMI We authorize MiCOM Labs Inc, 575 Boulder Court, Pleasanton, California 94566, USA, to act on our behalf on all matters concerning the above named equipment. Any individual within MiCOM Labs is authorized to act on our behalf and take action on the application. We declare that MiCOM Labs Inc, 575 Boulder Court, Pleasanton, California 94566, USA, is allowed to forward all information related to the approval project to the Federal Communication Commission and to discuss any issues concerning the approval application. Any and all acts carried out by MiCOM Labs on our behalf shall have the same effect as acts of our own. Name: Hou Meng Date: 2020-01-10 Title: Manager

PROEXPRESS DISTRIBUTOR LLC Date: 2020-01-10 FCC ID: 2AVH2EOAIMI Model Number: MiniI, SmartI To: Office of Engineering Technology Federal Communications Commission 7435 Oakland Mills Road Columbia, MD 21046 To Whom It May Concern, We, Shenzhen Soga Medical Equipment Co., Ltd., declare that this EUT (FCC ID: 2AVH2EOAIMI) will conduct FCC compliance testing, the SDOC part recognized test lab(Shenzhen Huatongwei International Inspection Co., Ltd.). 1/F,Bldg3, Hongfa Hi-tech Industrial Park, Genyu Road, Tianliao, Gongming Please contact me if you have any question.

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FCC ID: 2AVH2EOAIMI RF Exposure Considerations 1. Measuring Standard KDB 680106 D01 RF Exposure Wireless Charging Apps v03 2. Requirements According to the item 5.2 of KDB 680106 D01v03: Inductive wireless power transfer applications that meet all of the following requirements are excluded from submitting an RF exposure evaluation. a) Power transfer frequency is less than 1 MHz. Yes, the device operate in the frequency range from 400-490KHz b) Output power from each primary coil is less than or equal to 15 watts. YES, the maximum output power of the primary coil is 5W. c) The transfer system includes only single primary and secondary coils. This includes charging systems that may have multiple primary coils and clients that are able to detect and allow coupling only between individual pairs of coils Yes, the transfer system includes only single primary and secondary coils . d) Client device is placed directly in contact with the transmitter. Yes, client device is placed directly in contact with the transmitter. e) Mobile exposure conditions only (portable exposure conditions are not covered by this exclusion). Yes, the EUT just work as a mobile device. f) The aggregate H-field strengths at 15 cm surrounding the device and 20 cm above the top surface from all simultaneous transmitting coils are demonstrated to be less than 50% of the MPE limit. Yes, the EUT field strength levels are 50% X MPE limit. FCC ID: 2AVH2EOAIMI 3. Test Equipment List Test Equipment Manufacturer Model No. Serial No. Last Cal. (mm-dd-yy) Next Cal. (mm-dd-yy) Exposure LeveI Tester Narda ELT-400 F-0010 2019/10/12 2020/10/11 4. EUT configuration The following peripheral devices and interface cables were connected during the measurement: ● - supplied by the manufacturer ○ - supplied by the lab 1 Adapter Manufacturer : LISTED Model No. : GAT-0501000U FCC ID: 2AVH2EOAIMI 5. Test Setup Note: Measurements should be made from all sides and the top of the primary/client pair, with the 10cm measured from the center of the probe(s) to the edge of the device. 6. Test Procedure 1) The RF exposure test was performed in anechoic chamber. 2) The measurement probe was placed at test distance (15cm) which is between the edge of the charger and the geometric center of probe. 3) The highest emission level was recorded and compared with limit as soon as measurement of each points (A, B, C, D, E, F) were completed. 4) The EUT was measured according to the dictates of KDB 680106 D01 v03. Remark: The EUT’s test position A, B, C, D, E and F is valid for the E and H field measurements FCC ID: 2AVH2EOAIMI 7. Test Result 1.No load： Magnetic Field Emissions Test Position H-field (μT) Measure Value (A/m) 50% of the MPE limit (A/m) Limit(A/m) Result Top 0.045 0.0360 0.815 1.63 Pass Bottom 0.038 0.0304 0.815 1.63 Pass Front 0.036 0.0288 0.815 1.63 Pass Rear 0.048 0.0384 0.815 1.63 Pass Left 0.039 0.0312 0.815 1.63 Pass Right 0.035 0.0304 0.815 1.63 Pass 2.Half load： Magnetic Field Emissions Test Position H-field (μT) Measure Value (A/m) 50% of the MPE limit (A/m) Limit(A/m) Result Top 0.043 0.0344 0.815 1.63 Pass Bottom 0.039 0.0312 0.815 1.63 Pass Front 0.037 0.0296 0.815 1.63 Pass Rear 0.045 0.0360 0.815 1.63 Pass Left 0.036 0.0288 0.815 1.63 Pass Right 0.033 0.0264 0.815 1.63 Pass 3.Full load： Magnetic Field Emissions Test Position H-field (μT) Measure Value (A/m) 50% of the MPE limit (A/m) Limit(A/m) Result Top 0.044 0.0352 0.815 1.63 Pass Bottom 0.040 0.0320 0.815 1.63 Pass Front 0.039 0.0312 0.815 1.63 Pass Rear 0.047 0.0376 0.815 1.63 Pass Left 0.037 0.0296 0.815 1.63 Pass Right 0.036 0.0288 0.815 1.63 Pass Remark: 1. H-field strength(A/m)=H-field(μT)/1.25 2. According to October 2018 TCB workshop. Only H-field required. FCC ID: 2AVH2EOAIMI 8. Test Set-up Photo 15cm 20cm

Page: 1 of 25 TEST REPORT Report No. ...................................... : CHTEW20010037 Report Verification: Project No.................................： SHT1912068003EW FCC ID ............................................. : 2AVH2EOAIMI Applicant’s name ........................... : Shenzhen Soga Medical Equipment Co., Ltd. Address ............................................. : D906 of Yinxing technology building, No. 1301, Guan Guang Road, Xinlan community, Guanlan street, Longhua District ,ShenZhen,Guangdong,China Manufacturer.....................................: Shenzhen Soga Medical Equipment Co., Ltd. Address..............................................: D906 of Yinxing technology building, No. 1301, Guan Guang Road, Xinlan community, Guanlan street, Longhua District ,ShenZhen,Guangdong,China Test item description .................... : Electric Oral Anesthesia Injector Trade Mark ....................................... : - Model/Type reference ....................... : MiniI Listed Model(s) ................................. : SmartI Standard ......................................... : FCC CFR Title 47 Part 15 Subpart C Date of receipt of test sample..........: Dec.25,2019 Date of testing.............................: Dec.25,2019 ~ Jan.02,2020 Date of issue...............................: Jan.03,2020 Result .................. ........................: PASS Compiled by ( Position+Printed name+Signature): File administrator Yueming Li Supervised by (Position+Printed name+Signature): Project Engineer Kiki Kong Approved by (Position+Printed name+Signature): RF Manager Hans Hu Testing Laboratory Name ............. : Shenzhen Huatongwei International Inspection Co., Ltd. Address ............................................. : 1/F, Bldg 3, Hongfa Hi-tech Industrial Park, Genyu Road, Tianliao, Gongming, Shenzhen, China Shenzhen Huatongwei International Inspection Co., Ltd. All rights reserved. This publication may be reproduced in whole or in part for non-commercial purposes as long as the Shenzhen Huatongwei International Inspection Co., Ltd. is acknowledged as copyright owner and source of the material. Shenzhen Huatongwei International Inspection Co., Ltd. takes no responsibility for and will not assume liability for damages resulting from the reader's interpretation of the reproduced material due to its placement and context. The test report merely correspond to the test sample. Report No : CHTEW20010037 Page 2 of 25 Issued: 2020-01-03 Shenzhen Huatongwei International Inspection Co., Ltd. Report Template Version: V02 (2019-10) Contents 1. TEST STANDARDS AND REPORT VERSION 3 1.1. Test Standards 3 1.2. Report version information 3 2. TEST DESCRIPTION 4 3. SUMMARY 5 3.1. Client Information 5 3.2. Product Description 5 3.3. Radio Specification Description 5 3.4. Testing Laboratory Information 5 4. TEST CONFIGURATION 6 4.1. Test frequency list 6 4.2. EUT operation mode 6 4.3. EUT configuration 6 4.4. Environmental conditions 6 4.5. Statement of the measurement uncertainty 7 4.6. Modifications 7 4.7. Equipments Used during the Test 8 5. TEST CONDITIONS AND RESULTS 10 5.1. Antenna requirement 10 5.2. AC Power Conducted Emissions 11 5.3. 20dB Bandwidth 14 5.4. Radiated Emission 16 6. TEST SETUP PHOTOS OF THE EUT 19 7. EXTERNAL AND INTERNAL PHOTOS OF THE EUT 20 Report No : CHTEW20010037 Page 3 of 25 Issued: 2020-01-03 Shenzhen Huatongwei International Inspection Co., Ltd. Report Template Version: V02 (2019-10) 1. TEST STANDARDS AND REPORT VERSION 1.1. Test Standards The tests were performed according to following standards: FCC Rules Part 15C: Intentional Radiators ANSI C63.10-2013: American National Standard for Testing Unlicensed Wireless Devices. 1.2. Report version information Revision No. Date of issue Description N/A 2020-01-03 Original Report No : CHTEW20010037 Page 4 of 25 Issued: 2020-01-03 Shenzhen Huatongwei International Inspection Co., Ltd. Report Template Version: V02 (2019-10) 2. TEST DESCRIPTION Report clause Test Item Section in CFR 47 Result Test Engineer 5.1 Antenna requirement 15.203 PASS Jianquan Wu 5.2 AC Power Line Conducted Emissions 15.207 PASS Jianquan Wu 5.3 20dB Occupied Bandwidth 15.215(c) PASS Jian Li 5.4 Spurious Emissions 15.209 PASS Jian Li Remark: The measurement uncertainty is not included in the test result. Report No : CHTEW20010037 Page 5 of 25 Issued: 2020-01-03 Shenzhen Huatongwei International Inspection Co., Ltd. Report Template Version: V02 (2019-10) 3. SUMMARY 3.1. Client Information Applicant: Shenzhen Soga Medical Equipment Co., Ltd. Address: D906 of Yinxing technology building, No. 1301, Guan Guang Road, Xinlan community, Guanlan street, Longhua District ,ShenZhen,Guangdong,China Manufacturer: Shenzhen Soga Medical Equipment Co., Ltd. Address: D906 of Yinxing technology building, No. 1301, Guan Guang Road, Xinlan community, Guanlan street, Longhua District ,ShenZhen,Guangdong,China 3.2. Product Description Name of EUT: Electric Oral Anesthesia Injector Trade Mark: - Model No.: MiniI Listed Model(s): SmartI Power supply: DC 3.7V Adapter information: Model:GAT-0501000U Input:AC100-240V 0.4A 50/60Hz Output:5.0Vd.c.1000mA Hardware Version: 1.0 Software Version: 1.0 3.3. Radio Specification Description Operation frequency: 400KHz-490KHz Antenna type: Coil antenna 3.4. Testing Laboratory Information Laboratory Name Shenzhen Huatongwei International Inspection Co., Ltd. Laboratory Location 1/F, Bldg 3, Hongfa Hi-tech Industrial Park, Genyu Road, Tianliao, Gongming, Shenzhen, China Qualifications Type Accreditation Number CNAS L1225 A2LA 3902.01 FCC 762235 Canada 5377A Report No : CHTEW20010037 Page 6 of 25 Issued: 2020-01-03 Shenzhen Huatongwei International Inspection Co., Ltd. Report Template Version: V02 (2019-10) 4. TEST CONFIGURATION 4.1. Test frequency list Channel Frequency (KHz) 00 489 4.2. EUT operation mode TEST MODE For RF test items The EUT was programmed to be in continuously transmitting mode with rating output(5V) for charging For AC…

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Conducted Emissions (AC Mains) Radiated Emissions

15cm 20cm