2AZ8H-6120-K01LXFingertip Pulse Oximeter

Fingertip Pulse Oximeter Instructions for use P/N: 1.28 .0600-10 Version: 1.0 Release/Revision date: 2021-03 Jiangsu Kon sung Bio-Medica l Scienc e A nd Technology Co., Ltd NO.8, She ngcha ng Wes t R oad , Da nyang Develo pmen t Zone, Jian gsu Province, 21 230 0, P.R.China Tel: +86-511-8 637 596 8 Fax: +86-511-863 716 68 E-mail: in fo@ konsun g.com Website: www.ko nsung .com Statement Hereby, Jiangsu Kon sung Bio-Medica l Scien ce A nd Technology Co.,Ltd., dec lares th a t this Fingertip Pulse Oximeter is in complia nce with the esse n tial re qu iremen ts a nd other re levan t provis ions o f D irec tive 201 4/5 3/EU. Thanks for your purchasing fin ger tip p ulse oxime ter o f Jia ngsu Konsung Bio-M edical Science An d Tech nology Co ., L td., (herein a fter ca lled “Kon sung"). Be fore usin g th e pu lse oxime ter, p le ase rea d th is manua l care fully for u nders ta nd ing th e o pera tion an d main ten ance o f th e oxime ter. Konsung o wns th e righ ts to modify, upd a te, an d u ltima tely expla in this man ual. Konsun g ow ns th e copyrig h ts o f this manual. With ou t prior written conse n t o f Konsun g, a ny ma terials con tained in th is manua l sha ll no t be pho tocop ied , repro duced or tr ansla ted in to o ther lan gua ges. This manua l w ill help you und erstand the op era tion and main te nance o f the pro duc t be tter. I t is remind ed tha t the produc t sh all be used s tr ictly complying with th is manua l. User’s opera tion fa iling to comp ly with th is manu al may resu lt in malfunc tion or accid en t for wh ich Konsu ng can no t be he ld lia bl e. This manua l is base d on the maximum con figura tion an d th ere for e some con ten ts may no t ap ply to your pro duc t. All illus tra tions a nd se ttin gs in th is manua l are for re ference only, and the ac tua l pro duc t sha ll preva il. Finger tip Pu lse Oxime ter is C lass 1 LEDs pro duc t. I t mus t be serviced by a sp ecified tr ained person nel. Responsibility of the Manufacturer Konsung is respons ible for the e ffec ts o n sa fe ty, relia bility a nd per formance o f th is prod uc t, o nly if:  All ins talla tio n op era tions, expans ions, ch ang es, modifica tio ns an d rep airs o f this produc t are con duc te d by Konsung a u th orized person nel;  The e lec trica l ins talla tio n o f the relevan t ro om complies with th e a pp licab le na tion al an d local re qu iremen ts;  The pro duc t is used in accordance w ith th e instr uctio ns for use. Upon r equ est, Konsun g may provide, w ith compensa tio n, necessary circuit d ia grams, and o ther in forma tio n to he lp qua lified techn ician to main tain a nd re pair some par ts, w hich Konsung may de fin e as user serviceab le. Part 1 Safety precautions 1.1 Safe ty Informa tion T he user should pay attention to and abide by the basic safety information which was referred to in this Part. Warning  Indicates a potential hazard or uns afe practic e that, if not avoided, wi ll result in d eath or se rious inju ry. Caution  Indicates a potential hazard or uns afe practic e that, if not avoided, could result in minor personal injury or product/property damage. NOTE  Provid es application tips or other useful information to ensure that you get the most fro m your p roduct. Warning 1 The oxi mete r i s not intended as a devi ce us ed for treat ment purpo ses. En sure that th e equip ment is in normal working condition and operating environ ment before using . 2 Do not use the measu ring data displayed on the pulse oxi meter as th e only b asis for cl inica l diagnos is. The oxi meter is int ended only as an adjunct in patient asse ss ment. It must be u sed with othe r methods of asse ssing clinic al s igns and sy mpto ms o r phy sici an's diagnosis. 3 Do not open the she ll of inst ru ment; otherwis e you may damage the equip ment. All servicing and future upgrades must be carried out b y the personnel train ed and authorized by our co mp any only. 4 Misapplication of the o xi mete r with e xce ssi ve pressu re for prolonged periods can indu ce p res sure injury , che ck and change th e applied site according to the different circu mstance s of the us er whil e using o xi met er for prolonged periods. It is reco mmended to ch eck and change the applied site e ve ry 2 hours. 5 C heck the integrit y of the subj ect’s skin, circulatory conditions and ch ange the applied site. 6 The oximeter is not intended to use of infant and neonate. 7 High ambient light sources such as su rgical lights (especially those with a xenon light source), bilirubin la mps, fluo res cent lights, infrared heating lamp s, and direct sunlight can interfe re with the p erformance of a SpO 2 sensor. 8 Do not use the o xi mete r in situations whe re alarms required. The o ximeter does not support alarms. 9 FUNCTIONAL TESTER cannot be used to assess AC C URA CY. 10 The skin te mperature is initi ally at 35°C for ea ch PULSE OXIMETER, the APPL IED PART temperature cannot exce ed 41°C . 11 The material that the pulse o xi mete r conta cted to body is Non-toxic sili ca gel which meet the ISO 1 099 3 require ments, so c an be safety u sed. U sers who a re allerg ic to natural rubber l atex cannot us e this p roduct. Caution 1 To ensure use r saf ety, only use acc esso rie s and p arts produced or reco mmended by Kon sung. Otherwise, damage to the pul se o xi mete r c an occu r. 2 Do not use the o xi mete r near by the source of interference, such as mobil e phones , radio tran s mitter, radiant he ater, nebuli ser o r ste a m k ettle. 3 Do not use deg raded o r loosened sensor, which can degrade p erformance of the oxi meter o r c ause othe r problems. 4 Keep the o xi mete r su rface dry and cl ean. Keep the oxi meter away fro m co rro sive che mi cal s, lint, du st, high temp erature and hu midity en viron ment. 5 The operating t emperature of the oximeter is 5°C to 40°C . If the a mbient te mp erature e xce eds the op erating temp erature range, the oxi met er shall b e left for at l…

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FCC ID: 2AZ8H-6120-K01LX

1 Safety Human Exposure 1.1 Radio Frequency Exposure Compliance 1.1.1 Electromagnetic Fields RESULT: Pass Test Specification Test standard : CFR47 FCC Part 2: Section 2.1093 CFR47 FCC Part 1: Section 1.1310 FCC KDB Publication 447498 v06, section 7  FCC requirements a) EUT RF Exposure Evaluation operations, Worst Case mode Test Mode Measured conducted Power Threshold power @5mm Verdict dBm mW dBm mW BLE(GFSK) -0.9 0.813 10 10 Compliant

Prüfbericht - Produkte Test Report - Products Prüfbericht-Nr.: Test report no.: CN21MM6F 001 Auftrags-Nr.: Order no.: 168315612 Seite 1 von 51 Page 1 of 51 Kunden-Referenz-Nr.: Client reference no.: N/A Auftragsdatum: Order date: 2021-05-06 Auftraggeber: Client: Jiangsu Konsung Bio-Medical Science And Technology Co.,Ltd. NO.8, Shengchang West Road, Danyang Development Zone, Jiangsu Province, 212300 P.R.China. Prüfgegenstand: Test item: Fingertip Pulse Oximeter Bezeichnung / Typ-Nr.: Identification / Type no.: SONOSAT-K01LP, SONOSAT-K02LP, SONOSAT-K01LT, SONOSAT-K02LT (Trademark: konsung) Auftrags-Inhalt: Order content: Test Report Prüfgrundlage: Test specification: FCC CFR Title 47, Part 15, Subpart C, Section 15.247 Wareneingangsdatum: Date of sample receipt: 2021-05-06 Please refer to Photo Document Prüfmuster-Nr.: Test sample no: A003040772-002~003 Prüfzeitraum: Testing period: 2021-05-06 – 2021-06-02 Ort der Prüfung: Place of testing: TÜV Rheinland (Shenzhen) Co., Ltd. Prüflaboratorium: Testing laboratory: TÜV Rheinland (Shenzhen) Co., Ltd. Prüfergebnis*: Test result*: Pass geprüft von: tested by: Recoverable Signature X Signed by: [email protected] genehmigt von: authorized by: X Signed by: Winnie Hou Datum: Date: 2021-06-08 Ausstellungsdatum: Issue date: 2021-06-08 Stellung / Position: Senior Project Manager Stellung / Position: Technical Certifier Sonstiges / Other: FCC ID: 2AZ8H-6120-K01LX Zustand des Prüfgegenstandes bei Anlieferung: Condition of the test item at delivery: Prüfmuster vollständig und unbeschädigt Test item complete and undamaged * Legende: 1 = sehr gut 2 = gut 3 = bef riedigend 4 = ausreichend 5 = mangelhaf t P(ass) = entspricht o.g. Prüfgrundlage(n) F(ail) = entspricht nicht o.g. Prüfgrundlage(n) N/A = nicht anwendbar N/T = nicht getestet * Legend: 1 = very good 2 = good 3 = satisfactory 4 = sufficient 5 = poor P(ass) = passed a.m. test specification(s) F(ail) = failed a.m. test specification(s) N/A = not applicable N/T = not tested Dieser Prüfbericht bezieht sich nur auf das o.g. Prüfm uster und darf ohne Genehm igung der Prüfstelle nicht auszugsw eise vervielfältigt w erden. Dieser Bericht berechtigt nicht zur Verwendung eines Prüfzeichens. This test report only relates to the a. m. test sample. Without permission of the test center this test report is not permitted to be duplicated in extracts. This test report does not entitle to carry any test mark. T ÜV Rheinland (Shenzhen) Co., Ltd. 1601 R&D Room, 1602-1604, 17-18F, Building 7 Site C, Vanke Cloud City Phase I, Xingke First Street, Xili Street, Xili Community, Nanshan District, Shenzhen 518052, P.R. China Mail: [email protected] · Web: www.tuv.com Prüfbericht - Produkte Test Report - Products Prüfbericht - Nr.: Test Report No. CN21MM6F 001 Seite 2 von 51 Page 2 of 51 Test Summary 5.1.1 ANTENNA REQUIREMENT RESULT: Pass 5.1.2 MAXIMUM PEAK CONDUCTED OUTPUT POWER RESULT: Pass 5.1.3 CONDUCTED POWER SPECTRAL DENSITY RESULT: Pass 5.1.4 6DB BANDWIDTH RESULT: Pass 5.1.5 99% BANDWIDTH RESULT: Pass 5.1.6 CONDUCTED SPURIOUS EMISSIONS MEASURED IN 100 KHZ BANDWIDTH RESULT: Pass 5.1.7 RADIATED SPURIOUS EMISSION RESULT: Pass Prüfbericht - Produkte Test Report - Products Prüfbericht - Nr.: Test Report No. CN21MM6F 001 Seite 3 von 51 Page 3 of 51 Contents 1 General Remarks........................................................................................................... 4 1.1 Complementary Materials .............................................................................................. 4 2 Test Sites...................................................................................................................... 5 2.1 Test Facilities................................................................................................................ 5 2.2 List of Test and Measurement Instruments...................................................................... 5 2.3 Traceability ................................................................................................................... 6 2.4 Calibration .................................................................................................................... 6 2.5 Measurement Uncertainty .............................................................................................. 6 2.6 Location of Original Data ............................................................................................... 7 2.7 Status of Facility Used for Testing .................................................................................. 7 3 General Product Information .......................................................................................... 8 3.1 Product Function and Intended Use................................................................................ 8 3.2 Ratings and System Details ........................................................................................... 8 3.3 Independent Operation Modes ....................................................................................... 8 3.4 Noise Generating and Noise Suppressing Parts .............................................................. 9 3.5 Submitted Documents ................................................................................................... 9 4 Test Set-up and Operation Modes................................................................................. 10 4.1 Principle of Configuration Selection ............................................................................. 10 4.2 Test Operation and Test Software................................................................................. 10 4.3 Special Accessories and Auxiliary Equipment............................................................... 10 4.4 Countermeasures to Achieve EMC Compliance............................................................. 10 4.5 Test Setup Diagram .............................................................................................…

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Prüfbericht - Produkte Test Report - Products Appendix A CN21MM6F 001 Page 1 of 2 Appendix A: Photographs of the Test Set-Up Appendix A: Photographs of the Test Set-Up ........................................................................................................................... 1 Photograph 1: Set-up photo for Radiated Spuri ous Emission, Below 1GHz ........................................................................ 2 Photograph 2: Set-up photo for Radiated Spuri ous Emission, Above 1GHz ........................................................................ 2 Prüfbericht - Produkte Test Report - Products Appendix A CN21MM6F 001 Page 2 of 2 Photograph 1: Set-up photo for Radiated Spurious Emission, Below 1GHz Photograph 2: Set-up photo for Radiated Spurious Emission, Above 1GHz