#3 ENMIND The solution of the new generation for Smart Intusign. ManademaattinaiensrsPr cen ‘0.0 1mi/h increment ensures infusion accuracy and stability, applicable to high risk drug transfusion. ‘Multiple modes and Applications Multiple infusion modes are available up to 7. modes. Blood Transfusion and Enteral feeding applications meet various treatment demands in ICU, OR, ER, etc. Waterproof Desian Water-proof class up to [P24, 360° splash-proof Ceaeteueresan 9. 9)s1\ 9 eolr touch soreen makes operation easier ano simpler, which can be seen from sistance Make Infusion Simpler and Safer RSs ue tical Electric control and auto-Induction makes operation easy and simple, Visible and graphical alarm display. ‘Alarm details displayed with icon and description makes alarm more clear and vivid. ‘Smart Management af Double bubble detector, Upldown pressure “P>+\? sensors, Stackable, Support workstation ‘and CMS, Long lasting battery, Data record, etc. paxessaratoniamaposem an‘os Housing Material O%PC + 30%ABS Shell and Handle with metal clamp Screen BA D3 4.3" TFT color LCD touch screen (Pixel 480*272) Shows Rate, a4 Volume, Drop, Time, Drug name, etc. Operation System 3% smart Self-Guidance: Touch Screen +6 Buttons (Power, Bolus, Stop, Start, Home, Door open) Infusion Door Design Electric Automatic Anti-free Flow Clamp 8-8 Electric Automatic Working Principle Peristaltic Finger with Spring Pad Applicable IV Set 3.3. Any Sets/Brands/Drops with automatically pops uP Infusion Modes***3.5 7 modes (mi/h (Rate/Time/Volume), body weight, drip, loading dose, sequence, ramp up/down, drug library) Micro Mode Default at 100 ml/h, programmable Relay Mode*** Support Rate Range 36 0,01 - 2000mI/h Step 0.01 ml/h for 0,01 - 99.99 ml/h Step 0.1 ml/h for 100.0 - 999.9 ml/h Step 1 ml/h for 1000 - 2000 ml/h Time Range 0 min -99 hr $9 min Accuracy 3.4 Less than £5% error Titration Support (Change Rate During Running) VBI 3.24 0-9999.99 ml (Minimum step is 0.04 mi} Volume infused 0,03 -9999.99 ml KVO Rate a4 0,01 -5.00 mi/h, programmable Purge SD 400 - 2000 ml/h (Depends on types of infusi Bolus Boy Manual and programmable Bolus Rate 0 - 2000 mi/h Bolus Volume 0 - 9999.99 ml Bolus Time 0 - 99 hr 59 min Anti-bolus Support at Air Detection 3-14 7 levels, 50 - 800 ul (Single) Programable 25 - 1000 ul (Accumulated in 15 mins) Occlusion Level *** S10 12 Levels (150°975mmHg) Voice Volume 314 10 Levels Display Brightness 3d 10 Levels Last Therapy Memory Support “Alarm information 3+U8Silence with 2 mins recall) VIBI near end \VTBI done (infused), (Visible Text, J} Pressure high (Occlusion), Check upstream, Low Battery, Battery, ictures, Sound , empty, No battery inserted, No power supply, Re! 38th Light) Standby time expired, KVO finished, Drop sensor genecti error, Air bubble, Door open, System error, i hg rene auensauunrafiovianngnausennsanbDrug Library *** More than 2000 items Drug Units ug, mg, g) U, Ku, Iu, eu, mmol, mol, kcal Pressure Units mmHg, Kpa, bar, psi Blood Transfusion Support Enteral Feeding Support History Record 3-6 More than 5000 Records (3 Catagories) Drop Control Support (Option) iat? Support (Working Station) (Option) WiFi *** Support (CMS) (Option) Connecting Port $+20. 2 USB type C ports for Drop Control, Transfer data, charging Dynamic Pressure Support (Pressure Meter showing Real Time}s 3-16 Night Mode ‘Support (set start time and end time) Standy Support (24 hrs time setting) Screen Lock 3-16 45s, 30s, Imin, 2min, Smin, 10min, 20min, 30min Keypad Lock 45s, 30s, Lmin, 2min, Smin, 10min, 20min, 30min Password Protect Support Upgrade Support Brand Built-in 3.2. Up to 20 Brands of IV set, Blood set and Feeding set The name is shown when running Languages 14 Languages including English, Thai Battery operating 3.44 Qhours at 25mi/h (Icon Shown on screen) Battery charging time 5 hours under OFF state Battery Rechargable 2-4 11.1 2600mAb Lithium Polymer battery Removable Power Supply a0 DC:15V AC:100/240V, 50/60HZ Waterproof 3% 1P24 Classification dott CE, 15013485, EN 1789, EN60601-1-2, -24, IEC60601-1, IECBOR TTA Weight Approx 1.6 ke a Dimmensions 235(L)*95(W)*120(H) mm. & ee Integrated solutions, more reliab) and more intelligent Hey eenunsaeny9 so AFRINIS Assunsg 3 RUNG BBA) nance Exclusive Distributor Declaration Date: 1st Oct 2019 To whom it may concern, Wo, Shenzhen ENMIND Technology Co., Ltd., Address: 6th Floor Block A, Detengsheng Bullding, No.41 Dabao Road, Bao'an District 28, Shenzhen BiBIOL, PLR, China, ‘Tel #86-755-23316007, Fax: +86 785-2227 6344, a vliestablished and reputable manufacturer of syringe pump, infusion pump, ‘nfusion workstation, Infusion central station, vein viewer, ete, do hereby authorize World Med Trading Co., Ltd 288/102-103 Phahonyothin Rd, Anusawari, Bang Khen, Bangkok 10220 Tel (+66) 2-551-4515 AAs our distributor for marketing, selling and maintenance of the ENMIND's products, and as our Exclusive Distributor for EN-V7, EN-V7 Smart infusion pumps in All Araa of Thailand. Also EN-S7, EN-S7 smart, EN-VS, EN-V3 a Vein Viewer VV-100. And, we officially claim that we have spare parts for maintenance for at least 7 years from the date of installation to hospitals, our agent World Med Trading Go, Lid -have professional service team to offer technical support, training, adjusting machines, after sales service, supplying related spare parts and accessories during the whole warranty time and afterward. This letter only valid for our exclusive agent, World Med Trading Co., Ute, any siner companies who fas any form of authorization ietet fs Invalid from date st Oct 2019 to 1st Oct 2021, for the selling and after-sales service of these models should only be supplied by World Med Trading. This declaration shalfvooniinue in full force and effect for two year tmnats effective date "ae of andSypnewed by mutual consent of Aas Barley terminated by 18 parties. as hereiefter provides a ‘Add: Sth Floor, Block A, Defengsheng Builging, Not Dabao < Road, Bao'an District 2°44 SHOT RN RIEN RACHA ENA TIA TOT Tel: +86-755-2331 6007 Far gifP:755. 4A EIT, waste, anda...{PABBA S Enintna Tuctinorony Go, Ue Bg wwe ow cna After-Sales Service Training Date: 1st OCT 2019 To whom it may concern, We, Shenzhen ENMIND Technology Co., Ltd., Address: 5th Floor, Block A, Defangsheng Building, No.41 Dabao Road, Bao'an District 23, Shenzhen g18101, P. R. China, Tel: +86-755-23316007, Fax: +86 755-2227 6344, a wall-established and reputable manufacturer of syringe pump, infusion pump, Infusion workstation, infusion central station, ete. do hereby certify that eh World Med Trading Co., Ltd, including the team of § service engineers Has the exclusive After-Sales Service Training from us al Our headquarter. We have conducted a full training to ensure that MR. Thanin Jesadapatrakul ‘and his team are able to provide the excellent service. Therefore, we ‘officially olaim that MR, Thanin Jesadapatrakul and his professional team at World Med Trading Con Lid are certified with ful After-Sales Service including technical support, raining, adjusting machines, supplying related spare parts and accessories during the whole ‘Warranty fine and afterward, We also have spare parts for mainfenanee for at least 7 years from the date of purchase. sum sfiersannamadsemasensinmesind Uses TUNTTNT ASUS ‘Adda: Sth Floor, Block A, Defengsheng Bullding, No4t Dabao Road, Bactan District 23, Shenzhen 518101, P. R.China Tel: 486-755-2331 6007 Fax: +86-755-2227 6344 Peete eet)€ RUBEN RARAA ‘She stier Enid Tectia CO 14 a nceeenncetnonannnciea Declaration Letter November 6, 2019 ‘To: Whom It May Concern, ‘We, Shenzhen Enmind Technology Co.. Ltd located at Sth Floor, Block A, Defengsheng Building, Nol Dabao Road, Bao'an District 23, Shenzhen 518101, PR. China is 2 professional medical devices manufacturer for infusion PUP, syringe pump and docking station, Hereby confirm that EN-V7, EN-V7 Smart infusion pump could perform the blood transfusion(human whole blood and red blood cell) with verified blood transfusion set. Sincerely Yours, General manager/Jack Li : aquunsuunrsfersanmanisusenaaniarsianmsoe na oats. ae iusunssirey want, eo PSSBING en. sense se STUNTS ee Addr: Sth Floor, Block A, Defengsheng Building, No.41 Dabao Road, Bag’ an District 23, Shenzhen S18101, PR. China Fax : +86-0755-2227 6344 woww.enmind-tech.com Zip Code: 51 000€ RUBENRSBAA ‘Shs thes Evan Teton Ga anette Declaration Letter November 6, 2019 ‘To: Whom It May Concern, We, Shenzhen Enmind Technology Co. Ltd located at Sth Floor, Block A, Defenysheng Building, Not Dabao Road, Bao'an District 23, Shenzhen 518101, PR, China is « professional medical devices monufaturer for infsion pump, syinge pump and docking station, Hereby confinn that EN-V7, EN-V7 sinartnfasion pun could perform te blood transfusion leukoeyte-removed te blood cells and apheresis, platelets) with verified blood transfusion set ood transfusion of human whole blood or human red Blood cell with peristaltic infusion pump is a widely used and well-established mecical tshnology. An inwtto lab lst bss ‘been authorized and goings ‘conducted al authoritative clinical organiégtion to velit neo and effectiveness of blood transfusion by peristaltic infusion pump, ie 5 -the test was based on human red blood cell(RBC) and human blood platelt(PL1), an 10 verify the result of red blood cal hemolysis rte, haematoeti(HHCT), hemoglobin content ofthe experimental group, which the data was collected after passing the infusion pump. with gif rate(RBC) ae possng the infison pump. th ren Sas SRG eH MAg ead wnocn maximum low rte of 200m and PLT is based on a 00H ssernessees VIVO VST anes oy “Test sonelustont Da analysis and evaluation, the leukoeyle-removed red blood eels were» ata flow rate of 2000 ml/h before and after the test. The data index met the" ta fens Blood ‘i Quality Requirements" (GBIS4 169-2012) standard ‘Addr: Sth Floor, Block A, Defengsheng Building, No.1 Debao Road, Bao! an District 23, Shenzhen 518101, PR. China Fax : 486-075-2227 6344 www.enmind-tech.com-the test indicators before and ae the pump is squeezed a low rate of 400 ralfh are in compliance with the "Blood and Component Blood Quality Requirements" (GB18469-2012) standard. ‘tye pretest and post-test paired test was used to analyze te sigieant differences between the paired items, and the P values were all >0.05.The results showed that there was ne significant difference in the shverved indexes of leukocyte-suspended re blood cells before and alter being squeezed by the infusion ump at 2000 mVtThere was no signifieant difference in the ‘observed indexes between the apheresis platelets and the infusion pump a the How rate of 400 ml/h- “The test result showed that the result has no static difference between the experimental group and the cconrolgroup, And the result ofthe RBC hemolysis me, HT, and temoglobin content after passing the infusion pump meets the clinical requirement. Therefore, to conclude that the EN-V7, EN-V7 Smart potistaltic infusion pump could perform blood transfusion safely and effectively in clinical practice by following te loca/regional clinical recommendations/guidelines “the reference used for the experiment are as follows: 1. Quantitative assessment of haemolysis secondary to modern infusion PARP: Vox Sanguinis, April 2017, Vol, 112(3), pp-201-209 Sincerely Yours, General managers Addr: Sth Floor, Block A, Defengsheng Building, No Dabao Road, Bao’ an District 23, Shenzhen 518101, PR. China Fax ; +86-0755-2227 6344 wnenmind-tech.comZig Bill OB Soon RAISE Exclusive Distributor Declaration Date: 1st Oct 2019 ‘To whom it may concern, We, Shenzhen ENMIND Technology Co., Ltd., Address: Sth Floor, Block A, Defengsheng Building, No.41 Dabao Road, Bao'an District 23, Shenzhen 518101, P, R. China, Tel: +88-755-23316007, Fax: +86 756-2227 6344, a well-established and reputable manufacturer of syringe pump, infusion pump, infusion workstation, infusion central station, vein viewer, etc. do hereby authorize World Med Trading Co., Ltd 298/102-103 Phahonyothin Rd, Anusawari, Bang Khen, Bangkok 40220 Tel (+66) 2-651-4515 fas our distributor for marketing, selling ac maintenance of the ENMIND's: products, and as our Exelusive Distributor for EN-V7, EN-V7 Smart infusion pumps in All Area of Thailand. Also EN-S7, EN-S7 smert EN-V6, EN-V3 and Vein Viewer VV-100. And, we officially claim that we have spare parts for maintenance for atleast 7 years from the date of installation to hospitals, our agent World Med Trading ee Lid. have professional service tearm to offer technical suppor’ training, adjusting machines, after sales service, supplying related spare parts and accessories during the whole warranty time and afterward, ‘this letter only valid for our exclusive agent, World Med Trading Co.,Ltd, ary ther companies who has any form of authorization letir is invalid from cate {st Oct 2019 to 1st Oct 2021, for the selling and after-sales servic of thase madels should only be supplied by World Med Trading. —e Uist, - erg Fas This declaration shalhsaiijpue in full force and effect for two yea/$om thi 2x offective date /Me¥e of and renewed by mutual consent of tha Gertie *\ terminated by tH parties as hersihafter provided. 8! if partieg ap here} g} OW. Add: Sth Floor, Block A, Defengsheng Building, No.4t Dabao Road, Bao'an Distict 23, Shenzl@nsnaisin RREMHgN EVIE Tel: 486-755-2331 6007 Fax: +86-755-2P27 6344 >} o.O8b8. SY) AFTRA STUNTBoy RNB RASS After-Sales Service Training Date: 1st OCT 2019 To whom it may concern, We, Shenzhen ENMIND Technology Co., Ltd., Address: 5th Floor, Block A, Defengsheng Building, No.41 Dabao Road, Bao'an District 23, Shenzhen 518101, P. R. China, Tel: +86-755-23316007, Fax: +86 755-2227 6344, a welkestablished and reputable manufacturer of syringe pump, infusion pump, jnfusion workstation, infusion central station, etc. do hereby certify that MR. Thanin Jesadapatrakul, who is the chief technician of World Med Trading Co., Ltd. including the team of 5 service engineers Has the exclusive After-Sales Service Training from us at our headquarter. We have conducted a full training to ensure that MR. ‘Thanin Jesadapatrakul ‘and his team are able to provide the excellent service. Therefore, we officially claim that MR. Thanin Jesadapatrakul and his professional team at World Med Trading Cow Lid are certified with full After-Sales Service including technical support, tralning, adjusting van chines, supplying related spare parts and accessories during the whole vvarranty time and afterward. We also have spare parts for maintenance for at least 7 years from the date of purchase. Aerating eS oY 4. aati. Aden sean NTN ‘Add. Sth Floor, Block A, Defengsheng Building, Not Dabao Road, Bao'an District 23, Shenziven $1810, & RChina Tel: 496-755-2331 6007 Fax: ¥86-755-2227 6344 Post Code: 518401HUE N ARS niTestubiegz Ot Declaration Letter November 6, 2019 ‘To: Whom It May Concer, We, Shenzhen Enmind Technology Co., Ltd located at Sth Floor, Block A, Defengsheng puilding, No} Dabao Road, Bao'an District 23, Shenzhen 518101, PR. China is a professional medical devices manufacture for infosion pump, syringe PurnP and docking station, Hereby confirm that EN-V7, EN-V7 Smart infusion parap could perform the blood transfusion( human whole blood and red blood cell) with verified blood transfusion set. Sincerely Yours,’ General manager/Jack Li Ae nssunay pee eee ‘Addr: 5th Floor, Block A, Defengsheng Building, No.41 Dabao Road, Bao’ an District 23, Shenzhen 518101, PR. China Fax | +86.0755-2227 6344 wavyenmind-tech.com Zip Code: 518009@ RUMBA RSA Shean Ean Tshno959 69.4 ——— Declaration Letter Noveniber 6, 2019 ‘To: Whom It May Concern, ‘We, Shenzhen Enmind Technology Co. Ltd located et Sth Floor, Block A, Defengshens Building, Nol Davao Roed, Bao'an District 23, Shenzhen SIBIO1, PR, China is » professional medical devices manufacturer for infsion pump, syringe pump and docking steton. Hereby confi hat EN-V7, ENV7 smart infusion pump could perfor the blood transfusion, leukocyte-remaved red blood cells and apheresis platelets) with verified blood transfusion set. Blood trensfusion of humnan whole blood or human red Blood cell with peristaltic infusion pum isa widely used and well-established medical technology. An in-vitro lab test has been authorized and Zoning. conducted at authoritative clinieal organjéation to vetity tu@Spfety and effectiveness of blood transfusion by peristaltic infusion pump. “The test was based on himan re blood ee(RBC) and human blood platele(PLT), and to verify the result of red blood cel hemolysis rate, haematoesi(HCT), hemoglobin content of the experimental grouP, which the data was collected ater possng the infusion pump with different flow rate(RBC is, base oa mum flow rate of 2000mlk and PLT is based on a 400mth test) ‘Test gonelusion: ‘Data analysis and evaluation, the leukoeyte-removed red blood cells were waa, Qe oy Resin pump a ‘ata flow rate of 2000 mish before and after the test, The data index met (NS “Blood Quality Requirements" (GB18469-2012) standard Addr: 5th Floor, Block A, Defengsheng Building, No41 Dabao Road, Bao’ an District 23, Shenae BUHIOT HA Cena IU IEMIATIANE Fax : +86-0755-2227 6344, augyvenmind-tech, & sysqunsaunt Assn nssuens‘te tet indestors before and afer the pump is squeeze ata low rate oF 400 nll are in compliance with the "Blood and Component Blood Quulity Requirements” (GB 18469-2012) standard. “The pretest and posttest paired test was used 10 analyze the rificant differences between the pred items, and the P values were all >0.05:The results showed that there was ro significant difference io the peered indexes of levkocyte-soqpended ted blood cells before and after being squeszed by the infusion pump at 2000 mivh:There was no significant difference in the observed indexes between the apheresis platelets an the infusion pump at the flow rate of 40 mil ste text result showed that the result bas no state diffrence between the experimental group and the contol group. And the rel of the RBC bemolysi rate, HCT, and hemoglobin content after passing the infusion pump meets the clinieal requirement, "Therefoe, o conelode that the EN-V7, EN-V7 Smart portale infosion pump could perform blood Wansfsion sally ‘and effectively in clinical practice by following the locaVtegional clinical recommendations/guidelines ‘the reference used for the experiment are as follows: 1. Quantitative assesient of haemalysis sezondary to modem infusion PUMP- Vox Sanguinis, April 2017, ‘Vol, 112), pp.201-209 is le 8 “thy ” mec Bh Singetely Yours, aaah ae 4 4 eneral manager AND ses TUNTUN ‘Adair Sth Floor, Block A, Defengsheng Building, No.41 Dabo Zip Code: 518000 Road, Bao’ an District 23, Shenzhen 518101, PR. China Fax ; +86-0755-2227 6344 wwwenmind-tech.comuuu van 1 Susosviemin vatloah en din ot 5 isfofusonisenounaiuctodiaunnd AriinsruneunssNIsaWINALE? NsMTNES WIAD weisfowerfl CHN 6300403 46 unvien! 2563 ie nantdot nommmne/nidelusounsneunemibfetuseseuugaamnmsanin gndowrunismensens nena Tsnlgy (otal 34) 8, 2549 uakomsesreyeluetasiionnmé mF, 2531 dofpindn : adn Badia insane Sila lj: SHENZHEN ENMIND TECHNOLOGY CO.LTD. wa 4 widofuroansmeayl snideatulllivsenouity 20191213, sein People’s Republic of China Cl ihdofuroeeuugmnmmsnaina® erunstliidsenoumabebietedtouméentichul 31 nngnest ala actos uaeriouNar® adtovsingrinlsawveradnitodsenatroosstatoniiionne sdosimnunitnnnsivrosmannaumnnrtavoenostnunndremiians exlihumidothnnsathil Wormnsturoustostioundiindtuduanin 2. Sunhuonthnelahveerelemin 23. duilauonsntthumsfusoeindihenessnsaymsawnana 4. fiulauerwito stowed naautiurouvestsinsnnassnsaan aera echrasensnmnranaiqen eoaenayéfecnsintinsoitifeoniinaueatshsstoeméatul ynglatinyse Hratihtrangrannatemundinasos uno rmemestausonateneumaietareonnt Foonmasnenatlt eostonnnd vat 2551 iangosermnahasatiy dunia is “ngoildaroumstusind arniannodhuernt vo wonseneurs E \%, aausnsaumafieriansanrsUzenansrenaviniiteded o.titeinn .AUsestunssunia | 4 wavta. snee SSIS 4 oasite., .ASBINITgadnounnusn sano TINSEL naserauquirtasiiownns . aa anaeadion 4 crommhutandindantidodieurend eunniiesusoasty CHN 6300403 Suflowili 16/1/2563 Auflunery 31/7/2564 arnamuneassi¥a Owner 1 aia 30588 doxSrmos/fudinsinedsevne SHENZHEN ENMIND TECHNOLOGY CO.,LTD. avananwvassiid manucd vsemna China ‘Useun China 1 wa 34588 doitruas/fidinghnad tein SHENZHEN ENMIND TECHNOLOGY CO.LTD. ‘Owner |manucd| — gmpno catno offname patname dese [pageno| umdn ase | 54588 ENNS Infusion pump Infusion pump 5 | 16495 (6334588000001 3506 | 30588 ENS Infusion pump infusion purnp 5 | 16095 (6334588000002 34588 | 30588 ENT Smart | Infusion pump infusion pump 5 | 16995 (6334588000003 sasa8 | 39588 ENV? infusion pump infusion pump 5 | 16495 6334588000004 34588 | 34588 EN-S7 Srnart ‘Syringe Pump ‘Syringe Pump 5 | 13217 653a5dep00g05 34508 | 34588 ENST Syringe Pump Syringe Purp 5 | 13217 Gesasshoe06 34588 | 34588 EN-D7 Smart | Infusion work station Infusion work station 5 | 16495 6334588000807 : 3 ANUBATRINISAT TN WAN ITUTENIAT 0938 nssunsPRIS CHEE 19073089 1900042189 ena 1 fs (swe ROME AR AT IA RITE aE AGES iE CERTIFICATE wanralenraninadrnsatin USESTUNGIUNT mh eee el el Bes iid td id be BE A HE EB : s China Chamber of Inter ational CO ret Trade is China Chamber of Int rn teow China Couneil for the Promotion of InternationalPHAR KRZRRARS China Council for the Promotion of International Trade China Chamber of International Commerce ie AA BESS 19440348/000786 CERTIFICATE 5 No. RAE: Ze FS SS ee BH RH 20191213 BIT a a ‘ARSE WE Af PAR 8B FH THIS IS TO CERTIFY THAT: the electronic seal of GUANGDONG PROVINCE DRUG ADMINISTRATION on the CERTIFICATE FOR EXPORTATION OF MEDICAL PRODUCTS NO. ) YSYJXC20191213 is genuine. China Council, for the Promotion of Interfational Trade, UES: ce fowng ae 2 Authorized gc" fis Be Sea el ai Sbgnaiture: seo NID LOSF 12 208, agaitPate: Dec. 25, 2019) Mepis nnusnsiunish aad NaN y: (Jue, veeepit. eon/vatidate. ital 4 el loaito.. Boot verifying the cert iticater Nt Ai: tensive foriA #1 9073089 ae DE A TST SUD Gk BA Bw ME OL eH He copit (86) ty er Me mH ho FABRE OBER. fds A IG SUEAITEL I 2 fs (440) a =O MErTASta il (ee — UNE UI DU e002 JAN 2020 Certiied genuine signature of Aln,,.£ue fom Aprnis of the Foreign Affaies office of Guangdong rovincal People's Government, ‘Mr. Kanehitpon Chitilostvifin rousnsainasfiarsanwamalemanaenmaint | Uses UnsHRA BSEAI PEOPLE’S REPUBLIC OF CHINA By ey wh FA AED CERTIFICATE FOR EXPORTATION OF MEDICAL PRODUCTS TERMS: eds MARY 20191213 Cortificate NO: (cH MAR 201912135 Pee UT Product(s): See Attachment Raga: UT Model: See Attachment FRR ARIES: MAT Rogistxation certificate(s): See Attachsent AP oa: RBA RA Manufacturer: Shenzhen Eomind Technology CooLtd, AP DEBT: I MEME Ate AT BE 1 AE 201 BART ARH AAR; Bee: ZR 23 CARHAL BRERAM ABE) Lidross of masufacturer: tn2-tnel tne! tenanerencmntnnins ts Scene APPR: PACE MRE PE 20162868 & Maoufacturing License (s): 6-425 WetRee FF 20162868 SeEELLAR PB BREE BL aa ‘This is to certify that the above products have been register manufactured and. sold in China, SEMA INS: 2001 4607 ABE ‘This cortification valid until: 31/07/2021 artis / Remark: /ereaetne ahs TL BIE ATTACHMENT OF CERTIFIC EXPORTATION OF MEDIC. st PR ts ORME EB RZ Certificate No. etry) 20191218 g ne Piet ies Ce ones Model cortificate(s) es EN-V5, EN-250, EN-V3, EN-Z30 ' wy asa Ins po nev, BLDSO, EN ZI a TNT Sar ENVT 2 sno 010254957 Inst up ENT Smat, BVT AER EN-S7 Smart, EN-ST 3 oye 01csioss Sings P op ENSTSnat, SST eT ES EN-D7 Smart ‘ sree 206250936 nisin wo ton ERDT Sma f i i YA FEB Blank below rey ‘i % puenasunyai UENSSUNaHaTIONWANALIEMATIMBLAMsAtNA oartia, Asgavunssunis| | WMienufacturer: | | | Products: Expiry Date: “The Notified Body hereby dectares that the requirements of Annox 1 ‘excluding section 4 of Directive 93/42/EEC Annex Ii, exeluding Section 4 LEX EC Certificate ‘TOvRheinland Full Guality Assurance System Medical Devices Registration No.: HD 60144003 0001 Report No.: 17055844 008 Shenzhen Enmind Technology Co., Ltd. Room 201, Block A No. 1, Qianhai Road 1 Qianhaishen Port Cooperative District Shenzhen 518000 Guangdong China Tnfusion Pumps, Syringe Fumps (see attachment for site included) peplaces Approval, Registration No.; Dp 60109366 0002 2024-05-27 the directive yee SGEEG have been met for the listed products. The above named manwsncrer hhas established ‘and applies a quality assurance system, wh is subject to periodic surveillance, defined by Annex Tl, ae eer of the aforementioned directive. For placing on the market of Fass il devices covered by section ineate an EO design-examinetion certificate according to Annex ths Effective Date: Dato: ion 4 is required. 2019-12-02 2019-12-02 Vals TOV Rheinland LGA Products GmbH - Tillystrabe 290834, Marabers ‘TOV Rheinland LGA Products GmbH is @ Notified Body sccording sea BIEEC ie voerning medical devices with the identification nuriDer one, oN fo . & es anwnsmunnafiarsnmansdsemanentidnnating Ss, 2 a se ron * “% 8)UvRheinland TUV Rheinland pap alee LGA Products GmbH TillystraBe 2, 90431 Nurnberg Attachment to Certificate Registration No: HD 60144003 0001 Report No. 17055844 008 Manufacturer: Shenzhen Enmind Technology Go., Ltd. Room 201, Block A No. 1, Qianhai Road 1 Qianhaishen Port Cooperative District Shenzhen 518000 Guangdong China Site included sth Floor, Bleck A, Defengsheng Building, WNo.41 Dabao Road, Bao'an District 23, Shenzhen, 518101, P.R.China Date: eter aangK hea ‘TOVRheinland Certificate The Certification Body of TOV Rheinland LGA Products GmbH hereby certifies that the organization Shenzhen Enmind Technology Co., Ltd. Room 201, Block A No. 1, Qianhai Road 1 Qianhaishen Port Cooperative District Shenzhen 518000 Guangdong China has established and applies a quality management system fer medical devices for the following Scope: Design and Development, Manufacture and Distribution of Pfogon Pumps, Syringe Pumps, and Infusion Workstations (see attachment for additional site included) Proof has been furnished that the requirements specified in EN ISO 13485:2016 are fulfled, The quaity management system is subject to yeatly Effective Date: 2019-08-28 Certificate Registration No. 8X 60191044 0004 ‘An audit was performed, Report No.: 17055844 003 ‘This Certiticate is valid unt 2021-09-25 ___catigation Body nsannaniasemiasieaiainnsating 4 4 Si Uses TUNTTIMNT res Dewsshe 2 RibredaaGaaste.. LRN / 3 Saminasstie nate np Date 2018-05-28 MO! Ne. ia ‘ / op pa. |-Munker swings TUV Rheinland LGA Products GmbH - TillystraBe 2 - fest Nargherg) we , 5 JV Rin aii Favs edo 221 t0-2095 eatcerivelsty coven ep wan gaeTe 2\ 7 es c s/w im, PY meniA bes TUVRheinland TUV Rheinland Dee eelemeey LGA Products GmbH TillystraBe 2, 90431 Nurnberg Attachment to Certificate Registration No.: SX 60131044 0001 Roport No.: 17055844 003 Organization: Shenzhen Enmind Technology Co., Ltd. Room 201, Block A No. 1, Qianhai Road 1 Qianhaishen Port Cooperative District Shenzhen. 518000 Guangdong China Scope: site included: sth Floor, Block A, Defengsheng Building, No.4i Dabao Road, Bao'an District 23, shenzhen, 518103, P-R.China pesiga and Development, Manufacture and Distribution of tafueion Punps, syringe Pumps and Infusion Workstations ALILNTTIMTAD IN WAN UIENIAT akieky, 4 OBS Dearee ((DAkks Ee oaate Sunsets Date: 2019-05-28ATTACHMENT 1 Page 3of 17 [clause _ [Requirement + Test 7a ihe maximum volume that may be infused TEC 60601-2-24 inder SINGLE FAULT CONDITIONS _ ‘alist ofthe allowed ADMINISTRATION 'SET(S) with their stated accuracy in accordance with the test methods ‘mentioned in 201.124 A Repo Result Remark TOVRheintand® 1 Non 17053863 001 Verdict | = if changing between different allowed ADMINISTRATION SETS can result in an Unacceptable RISK if no changes are made to the ME EQUIPMENT, a statement regarding the procedure to be followed to | guarantee the stated accuracy = the range of infusion rates and the ‘conditions for which the stated accuracy is valid a list of ACCESSORIES which are necessary to maintain the accuracy stated in 7 Secordance with the test methods | _|imentioned in 201,12.1 and safe use _ _ : applicable, description of how the ME NA EQUIPMENT operates if communication is - fost with the remote control device ~ For PROFILE PUMPS the programmed WA Sequence of delivery rates. | Jo17 aSA01 | Technical description includes the required Information: P =the sensitivity ofthe air detector, it T P included to comply with 201.12.44,407, over the specified range of rates fora single [ube __ _ zl | i applicable, the PROCESS for calibration P | [of me ME EQUIPMENT _ | arp description of any batery charging P system =a functional description of the means provided to protect the PATIENT from over infusion and, where applicable, under infusion resulting from ME EQUIPMENT error of partial or total blockage of the MINISTRATION SET identification of ADMINISTRATION 'SET(S) used forall the tests in this standard = ifthe ME EQUIPMENT cannot be programmed in volume per unit time, and Goes not display the rato in volume per unit time, the formula for calculating volume per unit time (201.0.3.104 ABBLIED BARTS are TYPE BF or TYPE CF [CF 201.14.6.3 201.41.6.5 Me Ranaling of Uquids in NORMAL USE are Constructed so that spillage does not wet ore that could tesult in @ HAZARDOUS |SruaTion SYSTEMS iE EGUIPHENT and ME SYSTEMS requling | See appended Table 201.11 IP Code = 1P24 sngese of watororpariouato water ive NE EGUIPHENT ane TRF I TEGE0O1_2_24C be — Reena TANT aa ANaaUSEZS, TOvRheinland® Page 14 of 148, Report No. 17053563 001 IEC 60601-1 [Clause _ [Requirement + Test Result Remark Verdict ‘ll additional parts that became accessible NA checked using standard test finger and by inspection 5923 [Conductive parts of actuating mechanisms of NIA electrical controls accessible after removal of handles, knobs, levers and the like regarded as ACCESSIBLE PARTS ‘Conductive parts of actuating mechanisms not NA considered ACCESSIBLE PARTS when removal of handles, knobs, etc. required use of 8 TOOL: 6 CLASSIFIOATION OF ME EQUIPMENT AND ME SYSTEMS P 62 CLASS Ime EQUIPMENT, externally powered P CLASS HME EQUPNENT, externally powered NA INTERNALLY POWERED ME EQUIPMENT P [EQUIPMENT with means of connection fo a SUPPLY P ‘was complied with CLASS 1 oF CLASS IME EQUIPMENT requirements when so connected, dnd when nit connected to SUPPLY MANS with INTERNALLY POWERED ME EQUIPMENT requirements [TYPE 8 APPLIED PART NA, Tyee BF APPLIED PART NA. [TPE GF APPLIED PART DEFIBRILLATION-PROOF APPLIED PARTS P 63 ENcLosuRES classified according to degree of | |IP_X4 P protection against ingress of water and [See RM Results Table 11.6.5. particulate matter (Nits) as per IEC 60529 6a Me equiPnenT or its parts intended to be NIA sterilized classified according to methodts) of sterilization in instructions for use... : 65 ‘ME EQUPWENT and ME SYSTEMS intended for use NIA in an OXYGEN Rich ENVIRONMENT classified for such use and complied with 11.22 66 ‘CONTINUOUS oF Non-CONTINUGUS OPERATION jGoniwuous | 7 ME EQUIPMENT IDENTIFICATION, MARKING, AND DOCUMENTS P 742 |Legibility of Markings Test for Markings [See Appended:Table 7, P [specified in Clause 7.2-7.6 nm _ See APS EAS atutiag FAS [Required markings can be removed only with a is BS 3 8 Fear py appreciable force, are durable and) (SEB 2B remain CLEARLY LEGIBLE during EXPECTED 2 EN =| SERVICE LIFE of ME EOUIPWENT in NORMAL USE Va al ‘TRF No, IEC60601_1H anit. asia ast ons ATT cunt pawnsnunrafiansannanyaUsenins e faengsRN soe UETTUNTTINGFrode A Prowucts Z-d, SUVHheiniand® Priifbericht-Nr.: 17053563 001 Auftrags-Nrwt 464046505 Seite 1 von 145| Test Fleport No. Order No: Page 1 of 146 ‘Kunden-Raferene Nis ‘uftragedatam: Stosteterence nos NS Order dae: 2016-020 Thenzhen Enmind Technology Co.,Ltd, auteggsbor FN Er ne Roa, lenhaanen Port Cooperative Disc, si ‘Shenzhen, 518000, P.R. China Prligogenstand Prifgeae Intuston Pump GersiomnangTOPNE ey : Identification | Type No. EN-V7 Smart, EN-V7 Seach asad eS Sider canton Prdfgrundlage: TEC SURO ZOOS SA Did oF EN 600011 2O0BFAT2073 Peele peatoton: HEC 60601-2-24: 2012 Wareneingangsdatum: Date of receipt 2015-10-28 (AG00273478 Test sample No.: sf | Tesling period. 201611.0210 2015-11-90 a TOV Rheinland (Shenzhen) Co., Prifmuster-Nr. Lita. East of F/, F/2-F/4, Building 1, Cybio Technology Building, No. 6 Langshan No. 2 Road, North Hi-tech industry Park, Nanshan District, Shenzhen, China ort der Priifung: Place of testing: See photo documentation TOV Rheinland (Shenzhen) Co., Ltd. ‘Same as place of testin Priiflaboratorium: Testing laboratory: Prafergebnis’: Pase Test result opritt von 7 isled By Tonivolvert van reviewed by Slur te emis stra mangi Sea Prilctenmes: 201818 Loren Scania aiecess —_Sievesaiang ures Reet Ae eStong Unesat ase Nemec Sgrase Ba Nimes Spnaie Sonstiges/ Other. Fao tectsepor consists of IEGEN 0601-1 test report including tis cover page (148 pages) and atachmen's: ‘Machment { -£C 60601_2.24 Test Report (17 pages), }itecirnent 2 -IEC6060%_1_B Test Report (15 pages), ‘tachment 2- Photo Docuirentaton (3 pages) Tustand des Prifgegenstandes bel Antisferung: _Proffmuster volsténdig und unbeschciat ‘Condition of the tas tem at delivery. ‘Test tem complete and undamaged iggunde Tsang Pep ba = sineiend Sg Tae sacvon paingenin) os nemel ae oo.Petomenen) WAS seamen WT tones tegen: Womnypood nn Bugoed Staeucory ‘Feeutoent Spear Fe eeedam, Fla nles a4 not appeals eerie Fetaposicaton(s) fst spacstons) -piaser Prdtbericht bezieht sich nur auf das og. Priffmuster und darf ohne Genel reset raswolse vervielfatigl werden. Dieser Bericht berechtigt nicht zur Ve ‘This tat apart only relates 1 the a, m test sample. Without permission ofthe tes, the duptcated in extract, This test report does not entie 1 “TIN Wratten Shen) Co, 6, sv oF FT, H.-FN, Bulg 1, Cyto Tesinokogy Bf ‘Moth Hitch nds Pack, Nanshun Distt, Sheen, ie arate * \ aauunsaunrsfiarsnnannaurenaasienbudintsatin gs .vavenunssunsProdukte « TUVRheinland® Products Priifbericht-Nr 47087623 004 ‘Auftrags-Nri 164046505 Seite 1 von 38 Test Report No. Order No. Page 1 of 29 Kunden-Referenz-Nr.: NIA Auftragsdatum: — 30,09,2015 7 Gliont Reference No. Ordor dats: ‘Shenzhen Enmind Technology Co.,Ltd ‘ustagebor Shenzhen En el Roa 1, Gianhalshen Port Cooperative Distt, Spethhen’ste000, PR. Cana 7 : Prigogenstand efi Pump Tat toe - ENAV7 San ENV exin} rufagelnhait ‘Type Tet Gor onto Prifgrndlage: EN 60601-4-2 2007AC Test specification: IEC 60601-1-2: 2007, 1EC 60604 2-24: 2012 (Clause 202) Wareneingangsdatum: 05.11.2015 Date of receipt Priifmustor-Nrs ‘A000273476-004 Test sample No. Prifeltraum: 95112015 -0503.2016 Testing prio: vt dor Pritu Tearate Technology Co, Ld Place of testing Acasa Toon Oo vatolgy end Quay Inapedton EMC Laboratory Priiflaboratorium: ‘TOV Rhelniand (Shenzhen) Co., Ld. Testing abort: Prifergebrio" Pass Tostroeut geprittvontesedy. Ii (ontraller von revues by-— ‘dl a 25.04.2016 a ie (25042018 Oven! 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