use manual milli
Contents
1. Table 7 Range of alarms values pcc Alarm Min value Max value Factory enabled Factory minimum value Factory maximum value WOO cata bctahastte Sed MeN E EIN CNN tnt sol o SAREE OR SOOT SSO ena RUBUS SSIES RODS BONN LATTES e afe Mn Ar m SpO2 0 100 Yes 85 100 a SARTO P LUE EE S DE ERES SERRE NANI RETE Ld an Nu _ UC o USCC Rac ITE a rtd ne Gree ee ee mE PORE RITE EE Deen cc ae NEN o o MMMEMERH Variability of perfusion index 0 100 No 40 100 06 6 0 6 9 9 0 06 0 9 O0 0 0 0 9 0 0 0 eee eee 9 0 0 0 0 0 0 0 9 0 O 0 9 0 0 0 O 0 GO 0 0 9 GO 0 9 9 0 0 0 O0 0 GO GO 0 9 6 9 0 6 9 0 O0 0 GO 6 0 0 0 0 0 0 6 0 0 GO 0 0 O 9 6 0 9 O 9 0 O 0 GO 0 O 0 0 9 0 0 0 0 0 0 0 0 0 0 GO 0 0 GO 9 0 0 9 O 9 O 0 O 0 9 9 9 0 6 0 0 0 9 0 9 GO 9 HOE 6 6 6 OES Patient Data T a W Glenn Allan Patient s data may be registered using the Patient s application in the menu screen If no patients are registered a form will appear automatically Touching in any field enables a virtual keyboard The keyboard can be used by touching the touchscreen When the patient is registered the user may choose to Release remove all patient data including trend charts or Edit allows data editing Mala B Edit Figure 19 Figure 20 Patient data Editing Display of Patient data T q E X2. Browse in Internet MONITORING IHE Batteries This icons sequence shows the battery charge When the charge level decreases the blue color becomes yellow followed by red when the charge is finishing When the battery is empty the icon is black While the battery is charging icon color goes from red to blue passing through yellow To charge the handheld battery is neces sary to connect it to docking station and connect this to power grid The average battery charge time is 10 hours Figure 21 Sequence of battery charge PATIENT Trends The patient s vital signals are stored in pulse oximeter and can be seen as trend charts The access to this screen is trough the Trend shortcut in the main menu D Go to Menu screen 9 Click on Trends shortcut D Click on Applications shortcut O Analyze the charts Figure 22 Trends charts T cD E X q gt QA D GENERAL GUIDELINESS Essential Care Biocompatibility AN AN All parts of the equipment that remains in contact with the patient sensors are produced with biocompatible materials The manufacturer has the documents that certify the sensors biocompatibility and it should be delivered signing a confidentiality agreement According to the kind of contact with patient ISO 10993 1 itis classified as external communication equipment According to the duration of contact with the patient
3. q gt Q MONITORING THE Settings PAT BACKGR IENT OUND m Select your preferred The user can set up the oximeter in the image Define it as background Settings screen of the main menu follo wing the next steps Password of Settings Screen KIRK CD Go to Menu screen e Click on Settings Danaa shortcut Choose one of the options to set Cu E Wallpaper Date amp tire P Select language TP Wireless amp networks Af Openivida Network o DATE AND TIME Define desired date and time do necessary adjustments SELECT LANGUAGE Choose one of preinstalled languages Portu guese English and Spanish WIRELESS NETWORKS AND OTHERS Enable or disable the desired connections e Do necessary adjustments Tare um Fey OPENVIDA NETWORK Milli pulse oximeter may be used in telemedicine applications using OpenVida Network For more information acquire OpenVida Central Monitoring APPLICATIONS Applications installed in the device can be removed To do this select one application and check available options Internet The user may browse in Internet using the Internet application from main menu screen It is necessary to setup and enable a Wi Fi connection before browsing The Ses are 5 Go to Menu screen o9 Click on Applications shortcut Click on Internet option
4. CD Go to MENU screen Enable audible alarms Click the Application shortcut Hold the button to lock the Click the Security and Lock medical functions of the VITAL SIGNALS SYMBOLS shornc t device Maintain the red button pressed IP to lock medical functions of the Perfusion index equipment The land appears in Status Bar while the device is 96 i IVP in this state i Variabillity perfusion index SPO2 06 Functional saturation of oxygen v Note Functions may be temporarily unlocked with individual ap PULSE Patient s cardiac password while equipment is locked frequency T q E X q gt QA MONITORING THE Security Locks UNLOCK OF MEDICAL FUNCTIONS To unlock proceed as follows To unlock temporarily individual functions or general lock enter the password AMOR Select a letter by dragging the column up or down until to reach to the correct letter If the password is correct the red button cancel becomes green proceed Clicking on it unlocking is done and disappear of Status Bar PATIENT Enter the password to proceed cancel TECHNICAL FUNCTIONS Technical functions of device e g settings appli cations are protected by the password KIRK MONITORING THE PATIENT Alarms In the alarms screen the user can set the alarm limits Touching the desired alarm the window with the limits will appear The sounds can be
5. done in situations where the calculated saturation is stable for the duration of collecting blood for testing Commercial 2t ttt Code Name Quantity Presentation NT C TNNT i IA m S FOCA DM 001 Pulse Oximeter 1 i cm l EEI ee ee AEL TSEN ee ce ate a ee E E E This product consists of the following devices FOCA BA 001 Dckinc station e andaccessories 00000000000 EV CO NNT eR I aa a 5 See sensors table Oximetry Sensor 1 Er NOTICE All parts accessories and sensors are RITTER OR ELT SORTER TUR Hanna t for EXCLUSIVE USE of Milli Pulse Oximeter FOCA CA 001 Power Cord O T BR rr R SBBRBBBBBB M i Tr 1 y FOCA MU 001 User Manual 1 9 9 9 9 6 6 9 6 9 6 6 9 9 9 9 9 06 6 06 06 9 9 9 6 9 0 9 09 9 9 9 9 9 06 9 06 6 GO 9 9 06 9 06 6 9 06 9 9 9 9 96 9 9 6 9 9 9 9 9 Table 1 Figure 4 Milli Pulse Oximeter horizontal position Figure 3 Milli Pulse Oximeter vertical position Figure 5 Milli Pulse Oximeter detached from docking station a a ff i mm omm e9 q E X O q gt Q OVERVIEW Compatible Sensors Table 2 shows th
6. 2 8 2 8 2 0 8 8 8 2 29 89 0 28 8 3 Fe E Ter Teer 01 0 37 0 37 074 D esa NIAN SSIES SNR aah NRN S INITIA Steere te VET ee Bee cere ence rece hh hh nese hh heh hh he nnn Bee n hh hehehe hh heh e ehh Hh ehh hn dee hl ehh hh ehe ehe heh ehe nn 12 12 23 RURLBU8 8 8 8 8 8 9 8 9 8 9 8 8 8 9 8 8 8 9 8 9 2 8 9 0 2 0 0 0 8 8 8 9 2 8 0 8 9 8 0 0 9 9 8 8 9 2 8 2 08080 8 8 4 00 4 8 2 8 9 9 9 i 8 8 0 8 8 8 8 8 8 9 8 8 8 8 9 8 9 8 8 8 0 8 8 0 8 8 8 0 0 0 8 8 9 9 0 8 0 8 8 9 8 0 8 9 8 9 9 8 9 8 8 8 8 9 2 9 8 0 8 8 0 8 8 8 0 8 8 0 8 9 8 0 9 8 9 8 9 9 9 8 8 8 8 9 8 8 8 8 8 8 8 8 8 8 8 8 8 0 8 8 8 0 8 8 8 9 8 9 8 4 9 9 8 8 9 8 0 8 0 0 8 8 0 2 8 8 0 8 8 9 0 0 8 0 9 8 8 2 0 8 8 8 0 8 8 2 0 8 9 8 0 8 9 8 8 0 9 8 0 9 9 i 8 8 8 8 8 8 8 8 8 8 8 0 8 8 8 9 8 8 8 A 0 8 8 8 0 8 9 2 0 0 8 8 2 0 8 8 8 0 8 9 8 8 9 0 09 8 9 8 9 9 0 8 8 0 8 9 0 8 4 0 2 9 8 9 8 8 8 8 0 8 9 10 27 137 74 ee ee eee eee v sse v6 Ve v4 Vet es v se ev ee er e qe Va Ves ee 6 e eV PPS See eee e v Q V v be a v9 de V eee ee 4 9 qe dev vie Qe e 9d VG Viviq e d VG 0 v ded o V e vis e d v i9 vie eq Vie tiu ews Vie eiut e v 9e e ve qq e qu eed d e Ve Vue e q gv e e viviu Gd GV a e 4 G V o V vivis e Qiu q Oed eer Vua qvi q e d u qr e oy O Qd e Veg H 94 e ee Vivis Q qd 9 viv e d d QV Ge vq Q V V V V Vgie QV e QU o e vq qq GG 9 Qu 99 d o V6 Uv d 9 9 V d v9 qe DIU 100 12 ae 23 For transmitters with a nominal maximum output power not listed in this table recommended separatio
7. 8 0 0 8 0 8 0 0 8 0 8 8 0 8 0 8 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 8 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 8 0 0 0 0 0 0 8 0 80 0 0 0 0 0 2 0 0 8 0 0 20 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 8 0 0 0 9 NOU DINNER A Bias at ARCET REN CM OUT INS OIE TEESE LIT GRRE NOR SID RC CANTER ORELL HSN EL UNCTE TUNE UE SARI ft A EC OR PR OI EAA CEST SEE UNE AP EPUM RS j Keep pressed to turn on off the device Menu Turn on Turn Off Touching quickly activate the menu if the equipment is in vital signals monitoring screen Return Returns to the previous screen Do RL Sn EC EP yA ESD Le Eg eS PE SNe EN Turn off the audible alarms by 25 seconds sil n Turn on the audible alarms if they are temporarily disabled dS ME one alarm SpO2 or Pulse is permanently disabled it displays alarm settings screen T q E X q gt Q FQUIPMENT OPERATION Light Indicators Docking station has blue light indicators When lit this indicates some states of the equipment Meaning Meaning when lit when off Handheld is connected to Handheld is not connected to Handheld connection l l l l docking station docking station tacit c REESE RR NEREREEIRERRERRO c EL eR ETT ae ee er eT en LEER eT aaa ROR ER TC Te ee EE Docking station is connected Docking station is not co
8. ICAL SPECIFICATIONS Milli pulse oximeter is intended for use in the electromagnetic environment specified in this table It is recommended the user or consumer to ensure that the equipment is used in such an environment Electrostatic discharge ESD IEC 61000 4 2 6 kV by contact 8 kV by air 6 kV by contact 8 kV by air Floors should be of wood concrete or ceramic If floors gt are covered with synthetic material the relative humidity should be at least 3096 b Rsntniettnttitnee theses nnne nts hstetesntste ttn testet detstttestttttnttettititet ttt tti ttittitetstti tette ttt ttittttittstitetttitetttiteen dnte ntt ttti ttt ttt ntstettitetsttitets titt ETPPTTPEECTPEPEEECPEEPPEETPTETPPEPPCPERPPURTPPEPPPEPPETPEPPPPPPPPPPPPPEPPPEUPPEPPPPPOPPPPPPPOPPEPPPPPPPPPPEP P P Testing and measurement techniques Ea MON 2 kV in power supply lines Electrical fast transient burst immu 1 Kin input output lines nity test IEC 61000 4 4 2 kV in power supply lines Not applicable The quality of power supply should be that ofa typical com mercial or hospital environment Bree e eee eee reece reece etree rete eee teen erent ee BLLLGG LEAL LLL LL So cy Decree eee e eee eee ee eee e rece eee eee RLLLRGGUGu LLLRGGULLRRG LLLLLLGIB LG LLLA RLLLILLELLRGGL LLLLLGULLLLGUGGULUG LLLZ Testing and measurement techniques 4 1 KV line to line s 2 KV line
9. ISO 10993 1 it is classified as limited or prolonged exposure equipment AN gt bee Maintain the equipment in a dry environment protected of direct solar rays Avoid places where liquid spillage may occur Do not use the equipment if it is wet or with humidity excess Do not use if it shows external damage or in case of suspec ted fall Install the equipment always in places where the electrical installation corresponds to the conditions established on the equipment voltage current power Essential Care AN AN AN AN AN AN Never sterilize or immerse it in liquids Do not apply mechanical stress to the cables Do not expose the device to temperatures upper 131F 55 C or lower 14F 10 C Do not operate the device in temperatures upper 104F 40 C or lower 32F 0 C Calibration is not required Functional measurers may not be used to determine the accuracy of the oximetry sensor battery Care AN AN AN Batteries may have longer lifetime if kept whenever possi ble its maximum load Constant discharges decrease their lifetime It must also be considered that elderly batteries have lower operating time The equipment s batteries docking station and handheld should not be changed and do not require maintenance In case of problems send the equipment to an Authorized Technical Support Batteries charging temperature varies between 32F 0 C and 117F 47 C and batteries dischargi
10. O0 O0 9 96 9 GO O 9 6 06 6 6 69 6 e Supply of Sensors and Accessories The company provides sensors and accessories that can be connected to the Milli pulse oximeter If necessary the sensors for replacement may be purchased directly from Hi Technologies omm EN omm wx q 4 cD E X O q JA Q Connectoximetertothe power grid Connect sensor in the oximeter Turn the equipment on Wait the start up Theequipmentshouldplayanalarmduring start up Usethecapacitivebuttonsandtouchscreento browse in menus Checkifbuttonsandscreenrespondto commands Turntheoximeterinthe4possiblepositions to check screen rotation Oximeter Manual Test 9 Thescreenwouldrotateautomaticallyafter a few seconds a Ifscreendoesnotrotate tapitandwait 5 seconds until the rotation 10 Connectthesensorinapatientorsimulator 11 12 13 andcheckifthevitalsignalsareonscreen Browsetoalarmsettingsscreenandsetupthe upperSpO limittoavaluelowerthancurrent vital signal Check if the alarm is triggered Browsetoalarmsettingsscreenandsetupthe lowerSpO2limittoavalueupperthancurrent vital signal 14 Check if the alarm is triggered 15 TurntheSpO2alarmoffandcheckifthealarm is triggered 16 Repeat steps 11 to 15 for a Cardiac frequency b Perfusion index c Perfusion variability 17 Returntotheinitialsettingsforalarmlimits m T cD x lt e9 D
11. gt QA 4 f Test Method for Accuracy Verification Some models of functional testers or patient simulators available on the market may be used to check the functionality of the oximeter cables and sensors Read the specific operation manual of these equipments to perform the tests Even being useful for checking the oximeter cables and sensors these testers ARE NOT CAPABLE of evaluate the accuracy of oximeter measurements The full evaluation of the accuracy of Milli pulse oximeter requires at least a full reproduction of the optical interaction between the sensor and the patient This level of technology is beyond the ability of the testers and simulators on the market even those that say they have those resources Therefore the Milli pulse oximeter accuracy may be evaluated with in vivo experiments through direct comparison with the values simultaneously measured with a lab co oximeter The accuracy limits of the oximeter were established with a clinical study realized with healthy adult volunteers SpO2 scale between 7096 and 100 The measured SpO2 values were statis tically compared with the simultaneous results obtained with a certified and calibrated lab co oximeter Pulse measurements were statistically compared with simultaneous results obtained with a certified and calibrated cardiac monitor Validation of accuracy of measured values is the sole responsibi lity of the manufacturer and may only be guarant
12. only to con energy to the equipment 110V to nect accessories approved by the 220V company Po e uon pins Cconneci The oximetry sensor should be con nected in this port Only certified E sensors tested and approved by the 9 B 2 company should be connected in z this entry IEC60601 X O 2 y Connections pins used to connect the handheld to Q laA docking station z A No other equipment should be connected here ta 3 EQUIPMENT OPERATION Installing the Oximeter Connect the power cord to docking station Connect the handheld to docking station The connection is electromagnetic mechanical fittings are not needed Connect the sensor to the handheld To turn on the equipment press the MENU button by 3 seconds The same procedure will be done to turn it off o 8 8 8 8 After turning on register the patient according to Patient section then accompany the monitoring NOTICE When the equipment is turned on it emits a sound that indicates whether the speaker is operating properly and whether the alarm will sound normally FQUIPMENT OPERATION Equipment Controls Milli pulse oximeter can be controlled by two ways 1 Touch buttons buttons are lit when the device is on but they are turned off momentarily during touch to indicate they are being activated 2 Touch screen press the buttons on the screen to activate functions 4
13. to the product must specify product name model and serial number as described in the equipment Certifications of the Company and Product Good manufacturing practice GMP Issued 07 13 2010 Renewed every 2 years Health License Certificado em 04 19 2011 Renewed annually INMETRO Certification Issued 03 10 2011 Validity 03 10 2016 NBR IEC 60601 1 4 2004 Electro medical equipment Parts 1 4 General safety requirements Collateral Standard Programmable electro medical systems Issued 10 03 2011 Validity 10 03 16 NBR IEC 60601 1 1994 Amendment 1997 Electro medical equipment Part 1 General safety requirements Issued 03 10 2011 Validity 03 10 2016 NBR IEC 60601 1 2 2006 Electro medical equipment Parts 1 2 General safety requirements Collateral Standard Electromagnetic Compatibility Requirements and testing Issued 03 10 2011 Validity 03 10 2016 NBR ISO 9919 1997 Pulse oximeter for medical use Prescriptions Issued 03 10 2011 Validity 03 10 2016 57 Lm T cD E x lt q gt Q WARRANTY Manufacturer Data Register in ANVISA MINISTRY OF HEALTH Brazil 80583710002 Product manufactured by HIT Tecnologia em Saude Ltda Rua Prof Algacyr Munhoz Mader 3775 CIC CEP 81350 010 Curitiba PR Brazil Phone number 55 41 3022 3291 Fax 55 41 3022 3271 CNPJ National Register of Legal Entities 07 111 023 0001 12 Business license U776
14. 03 04 05 06 07 08 10 12 15 16 17 18 19 20 21 23 25 26 27 AA AN INTRODUCTION Symbols Introduction Intellectual Property OVERVIEW Intended Use Operating Priciples Commercial Presentation Compatible Sensors Equipment Connections EQUIPMENT OPERATION Installing the Oximeter Equipment Controls Light Indicators MONITORING THE PATIENT Main Menu Buttons and Widgets Security Locks Alarms Patient Data Settings Internet Batteries Trends 28 29 30 32 33 35 38 41 42 43 44 45 GENERAL GUIDELINES Biocompatibility Essential Care Battery care Packaging Transportation and Storage Electrostatic Discharge Precautions Restrictions Warnings MAINTENANCE Cleaning and Disinfection Preventive Maintenance Corrective Maintenance Problems and Solutions Supply of Sensors and Accessories Oximeter Manual Test Test Method for Accuracy Verification Fuse Substitution 46 47 49 50 56 57 TECHNICAL SPECIFICATIONS Equipment Classification Equipment Accuracy Calibration and Resolution Power Supply External Power Supply Batteries Conectivity Electromagnetic Compatibility WARRANTY Certifications of the Company and Product INDEX INSTALLING THE EQUIPMENT Device and accessories 08 Compatible Sensors 10 Equipment connections us 12 Installation Steps csset rs 15 Equipment BUTTONS 16 ALARMS AN
15. 206020206029029290290292920290602920209020290902902920602920292929062992920202920902929209020292092020292922090292920602020292022290209020902060029229292022929229692929209202929020202929290292092909290292020206020202902902902060209290920902902929202920602902929029092029020296029029220029292029292929060292029029002900290029029292929999 TECHNICAL SPECIFICATIONS Table 14 Separation distances Milli pulse oximeter is intended for use in the electromagnetic environment where radiated RF disturbances are controlled The customer or user of the oximeter can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communication devices transmitters and the oximeter as recommended in this table according to the maximum power output of communication equipment From 150 kHz to 80 MHz From 80 MHz to 800 MHz From 800 MHz to 2 5 GHz d 1 17VP d 1 17yP d2233JP 999592909990229499499009494 900904030498909040594959 69042809 0909999 65909009599900 999999959 e hh eh Hehe hh Ih m hh III hh hh hh e I tm 0 01 012 012 0 23 P RUE SUB BL SLR B R 8 08 82 0 2 2 8 28 8 2 0 2 0 2 8 0 2 8 0 2 2 0 ee 8 9 9 8 0 1 85858 858 952 8 8 9 2 8 8 2 2 2 9 9 8 8 2 2 2 2 8 8 9 9 8 2 2 2 8 8 2 8 2 0 9 8 8 2 8 2 3 9 8 2 2 8 2 2 2 2 9 8 0 2 9 20 2 2 0 2 9 8 9 2 0 2 2 9 2 9 8 8 2 9 2 8 i 8585858 8 2 8 8 8 2 8 8 0 2 28 8 8 2 2 8 8 9 28 8 28 4 2 8 99 22 8 2 8 8 8 2 2 2 8 0 88 2 0 2 8 2 0 2 9
16. D SOUNDS Device sounds when TUN On isinen 18 Alarms screen naasser 23 Turning off the alarms 24 Understanding the priority O ala Vax ce Dio dun Uta Dio 24 BATTERY How to charge batteries 27 Charge vela uniti piano 27 Taking care of battery 29 Battery typ IU s 49 VITAL SIGNALS MONITORING THE PATIENT Basic monitoring TVG IOS RP PM 18 Basic Information about vital signals 19 How to register patient s Xa d aee pistrinum 25 How to analyze trends Chat setas dte 27 SCREEN INTERFACE Touchscreen 16 Screen of monitoring of patient s vital signal 19 Menu Screen naisen 19 Security and Lock screen 2 Alarms Screen 23 Patient data screen 25 SETTE S SEP esae suites 26 Internet Screen 2d ICONS BUTTONS AND WIDGETS 20 MAINTENANCE Preventive and corrective 4 How to verify equipment COE Ole ch oa ar ate E 44 How to replace fuses 45 PROBLEMS AND SOLUTIONS Frequent problems and SOLUTIONS uacscsveyuim cucekes 42 How t clean seii rtt etn i 40 How to discard parts of equipment sesser 37 How to perform oximeter Manual testerenin 43 WARRANTY es 56 CONSUMER SERVICE 58 Symbols i C max A C min Fragile handle Protect of humidity with c
17. MM9X03XM CTO Eng S rgio Renato Rogal Jr CREA PR 83470 D Legal Person Eng Marcus Vinicius Mazega Figueredo CREA PR 83468 D Manual translated by Eng Viviana Raquel Zurro MSc Consumer Assistance Technical Support 55 41 3022 3195 SAC 55 41 3022 3461 E mail suporteghitechnologies com br Website www hitechnologies com br Annotations Annotations
18. S to ground Surge immunity test IEC 61000 4 5 1 kV line s to line s Not applicable The quality of power supply should be that of a typical com l mercial or hospital environment ooc562c606c96ce906cc6 2990 09 2 292 092 0 900292929299 55550620002 eres eee ee eee eee see ese See reese er reece eee ee eee ee eee seee Serer reese eee ese ere see ee ee eee eee eee eee eee eee sees eee eeeee Li TECHNICAL SPECIFICATIONS Table 11 Electromagnetic immunity general lt 5 UT gt 95 voltage drop in UT for 0 5 cycle 40 UT Testing and measurement tech 60 voltage drop in UT for 5 cycles Milli pulse oximeter is always operated niques Voltage dips short 70 UT Mcxepsllesibre with a backup battery The user must interruptions and voltage variations 3096 voltage drop in UTfor25 cycles ensure that the equipment battery is immunity tests IEC 61000 4 11 lt 5 UT fully charged gt 9596 voltage drop in UT for 5 seconds RR EAA PA EA EEE a ee c i t Testing and measurement techni ques Power frequency magnetic Milli pulse oximeter cannot be used near a Magnetic field immunity test 50 60Hz IEC SAND SAID Resonance Unit MRI one O 1 2 2 Ou TECHNICAL SPECIFICATIONS Table 12 Electromagnetic immunity equipment that is not for life support Milli pulse oximeter is intended for use in the el
19. are SB This side up Handle with care Temperature limits Indicates the temperature NL Alternating current AC range for transportation and storage Maximum stacking where the number n in the Consult accompanying information about N central square indicates the maximum quantity of necessary information boxes that can be stacked ia J I its e Direct current DC A Non ionizing radiation Equipment class Il Equipment with applied part type BF protec ted against defibrillator discharge Electrostatic discharge sensibility INTRODUCTION Milli pulse oximeter is an electro medical device manufactured by HI Technologies Brazil that indirectly monitors the oxygen functional saturation of patient s blood and cardiac frequency in patients who are in medical and hospital environment With a completely new design this device has unique characteristics Itcan be used as a table oximeter when connected to the docking station or as a hand oximeter when separated of the base e It has its own operating system created by the company that permits the installation of medical applications increasing the unit features e t can transmit patient s vital signals via Internet or through a wireless connection e t offers Internet and Intranet access with a browser like a computer e t has an integrated video camera e t allows that approved accessories are installed via USB or wireless connec
20. bout the equipment and its operation contact the manufacturer The validity of the warranty and veracity of monitoring is only guaranteed when the corrective maintenance is performed in an Authorized Technical Support MAINTENANCE Problems and Solutions This section shows possible solutions for some problems that may occur and can be solved by the operator If the problem persists and the system does not work properly after the indicated verification contact Hi Technologies or an Authorized Technical Support to solve the problem as soon as possible l 1 Lack of energy 1 Verify the energy cable The equipment does not turn on 2 Energy cable broken 2 Change the energy cable 3 Battery discharged 3 Connect the equipment in the power grid i O e e TNO 1 Sensor disconnected from the equipment 1 Connect the sensor to the equipment zn 2 Sensor disconnected from the patient 2 Place the sensor in the patient Signals lores nok epprpemirioi scien 3 Patient with very low perfusion 3 Change sensor position 4 Faulty sensor 4 Substitute the sensor 6 6 6 6 6 6 9 06 6 9 0 6 0 6 96 0 0 6 6 96 0 0 6 6 6 0 6 06 O0 6 0 6 0 O0 6 0 0 6 GO 0 0 O 6 0 O 6 O0 O 0 GO 9 0 6 9 O0 6 O0 6 9 0 O 9 O O 6 9 O0 0 0 O0 O 0 0 O 6 9 O 6 G6 O 9 6 O O0 9 O0 6 9 O 60 6 O9 GO 0 09 O 6 9 0 0 O O0 0 0 0 O0 6 9 6 0 O O0 6 0 O0 O0 9 6 90
21. curacy In the range of 70 to 100 there is an error of 2 and during movement 3 The measurements done by the equipment related to patient s pulse have an error of 2 bpm between 20 and 100 beats per minute and 296 between 101 and 250 beats per minute Table 8 Oximeter accuracy 6 0 9 6 06 0 9 0 06 9 9 0 0 9 9 0 O 9 0 0 O 9 9 0 O 0 0 0 O 9 0 O 9 9 O 9 9 9 O GO 9 0 0 O 0 0 O0 0 0 O0 9 0 O GO 0 0 0 GO 9 0 0 09 0 9 O 0 O 0 0 9 0 0 9000009 000900002020290202290202920208292290220202902092029029902020929290209202902929202922902020422249202920290290202029292029002902990292929029929299 SpO2 70 1009 2 SpO2 70 100 in movement 4 306 SpO2 lt 70 Undefined Pulse frequency 20 100 bpm 2 bpm Pulse frequency 101 250 bpm 2 TECHNICAL SPECIFICATIONS Table 9 Equipment resolution 062020626202902060060202640602020600202060602029200202600202960602060206006290220600600290206002028406020060200290220600602085900202802020602060202902060020280020208020206020209229090202G600020602002920029080020208020200202060020206002020020900080202060009202020060202020600920020600202002900290600029202020000600200600629292029299 6 SpO2 1 00 o M M OG RAE IDE ETERS M A REET PROC Pulse frequency 1 bpm 10 seconds Conditions Oximeter powered looking for the pulse and with the clip adult sensor 2 seconds Conditions Oximeter powered
22. e sensors compatible with the equipment FOCA LC 001 Adult LED FOCA IN 001 Pediatric Intermediate Table 2 NOTICE The manufacturer recommends its disposal and replacement every 12 months OVERVIEW Compatible Sensors Table 3 shows the sensors compatible with the equipment i T cD x lt q D gt QA NOTICE The sensors are identified with a label that holds infor F q U D ment C onnect Ons mation about lot and expiry date as follows ae T m Made in Brazil by Hi Technologies HT EurRbag gi err Sale Lekal FOCA AE5 001 Sow v MU p MER mm Figure 6 Sensor identification label NOTICE Every sensors use the same connector as follows Figure 7 Figure 8 Sensor Connector Sensor Connector lateral view front view ta Connection pins Connection pins used to connect the docking station with handheld No other equipment should be connec ted here V p 2 7 z F R TT External batteries input USB input It should be used only to connect external batteries Just certified batteries tested and approved by the company can be used IEC 60601 This port should be used only to connect accessories approved by the company CT n m mih pu Connection DINS AIEBAT UR DI 823 a LJ m Cy eot Power supply it supplies electrical It should be used
23. ectromagnetic environment specified in this table tis recommended the user or consumer must ensure that the equipment is used in such an environment RF communication equipment portable or not should not be used near any part of the Milli Pulse Oximeter including cables with a separation distance less than recommended his distance is calculated from the equation applicable to the 3V transmitter frequency Testing and measurementtech niques Immunity to conducted 3Vrms disturbances induced by radio fre 150 kHz until 80 MHz sae MA Recommended separation distance quency fields 4 d 1 17VP d 1 17 from JP 80 MHz at 800 MHz d 2 33 from VP 800 MHz at 2 5 GHz Table 13 Electromagnetic immunity equipment that is not for life support Immunity test Test level Conformity level Electromagnetic environment Guidelines ABNT NBR IEC 60601 ee eee eheu hh EEE 1 eee e heh hh he vh he heh e nnn T Mese hh hh eh hh ht yh hh hh hh un T Mee eere eee i ci cc hehehe hehe tet 9 rs rs svn 1 Where P is the maximum nominal output power of the transmitter in Watts W according to the transmitter manufacturer and d the sepa ration distance in meters m It is recommended that the field strength established by the RF transmitter and the field strength determined 3V m through an electromagnetic inspection in the place is less than the compliance level in each frequ
24. eed when the equipment is used according to the instructions in this manual Fuse Substitution The docking station has 2 fuses that can be located in the Figure 23 which shows radial fuse 3 15A 250VAC retarded on the power circuit board The fuse 1 blue one is visible without removing the cover of power supply To see fuse 2 yellow one cover removal is necessary el oe Ba ee Figure 23 Fuse localization inside the power supply of the Milli docking station om omm pa cB 4 q E X O q A gt Q 7 TECHNICAL SPECIFICATIONS Equipment Classification IPXO COMMON EQUIPMENT closed equipment Protection against harmful water penetration mb l i without protection against water penetration a ee EEEE LANSE eee ee ee TT Senn ae ETN RO TTT TTT TORT ioa i Equipment operation mode CONTINUOUS OPERATION p U DRE REINS ITS a J CLASSI Protection degree against electric shock esee hhhh hh hh hh hh hh hh hh hh hh hh h t hh hh hh hh hh hh hh hh hh hh hh hh hh hh hh hh hh hh he e hh hh Equipment Accuracy Calibration and Resolution Milli pulse oximeter is calibrated after the end of fabrication process Therefore a new calibration is not necessary during oximeter lifetime It was calibrated between 70 and 10096 being that for lower values is not possible to ensure the calibration ac
25. ency range Interference may occur around the equipment with the following symbol e Ge seehhhhhhhhhhhhhhh rr hr rr rrr rrr rrr rmn Testing and measurement techni ques Radiated radio frequency 3V m electromagnetic field immunity test 80 MHz until 2 5 GHz IEC 61000 4 3 NOTE 1 In 80 MHz and 800 MHz apply a higher frequency range NOTE 2 These guidelines may be not applicable in every situation Electromagnetic propagation is affected by absorption and reflection of structures objects and people Field intensity established by fixed transmitters as radio base stations telephone cell and wireless and land mobile radios amateurs transmission radio AM and FM and TV transmission theoretically cannot be predicted accurately To evaluate the electromagnetic environment due to fixed RF transmitters it is recommended an electro magnetic inspection of the place If the measurement of the field strength where Milli pulse oximeter is used exceeds the level of conformity cited above it should be observed to verify if the equipment is in normal operation If it is observed an abnormal operation some additional procedures such as reorientation or repositioning of the Milli pulse oximeter may be necessaries T q E x q gt Q Above frequency range of 150KHz until 80MHz field strength should be lesser than 3V m 9092909062092020606296292029 9
26. epresentative check failures during normal use This warranty will be null and void if the product is damaged by accidents natural agents if it is operated in disagreement with the Operation Manual use of accessories not approved by HIT Tecnologia em Sa de LTDA not suitable electrical installations or excessive fluctuations of electricity supply and if shows signs of having been violated adjusted or repaired by people not autho rized by HIT Tecnologia em Sa de LTDA Potential losses and damages of the buyer by the malfunctioning or standstill of product under any circumstances will not be manufacturer s liability HIT Tecnologia em sa de LTDA undertakes to provide both free and paid services only in localities which maintain its own workshops or authorized representatives Freight expenses transportation lodging and packaging are responsibility of the consumer purchaser except in cases covered by the warranty If the property of product is transferred during the warranty period this will be transferred with all rights and will continue in force until the end of the period counting from the date of purchase by the first consumer purchaser This warranty certificate is the only responsibility statement for HIT Tecnologia em Saude LTDA no representative is authorized to open exceptions on their behalf Claims for damage during transportation must be registered immediately with the carrier company All correspondence relating
27. lation N VENOUS CONGESTION Increased blood volume may produce capillaries pulses and promote reading errors in some equipment N MOVEMENTS The location for sensor placement should be analyzed according to patient s mobility to avoid compromising their anatomophysiology and reliability of sensor readings GENERAL UlL DELI N E N Significant rates of dysfunctional hemoglobin as carbo xyhemoglobin may affect the accuracy of SpO2 measure N ANOMALOUS HEMOGLOBIN Genetic diseases like falciform anemia in acute condi tions lower than 5mg dl may have the value decreased N INTOXICATIONS e g carbon dioxide may alter the values N SKIN PIGMENTATION Darker skins may interfere in the readings N LIGHT INTERFERENCE When two or more sensors are placed near mistakes may happen due to the exchange of light among them Cover each of the sensors with opaque material to prevent light leakage T cD E X q gt QA GENERAL GUIDELINES Restrictions AN AN A AN A ARTIFACTS For example cell phones may interfere in the correct opera tion of some electronic equipment causing reading mistakes AMBIENT LIGHT Intense solar light xenon light fluorescent and infrared light may decrease the presented values BAD POSITIONING OF THE SENSOR May have unrealistic values regarding the patient s general condition Obstructions or dirt on the LEDs or photodiode may cau
28. lean or use of not recommended products result in optical deterioration of the panel or functionality damage It is recommended B Usea moistened cloth not wet In case the display has W Gently wipe the screen without pressing grease stains use three drops of neutral soap B immediately dry with a dry cloth NOTE the majority of products have 1 396 of isopropyl alcohol per volume which is in the acceptable limits for cleaning resistive touch screens CAUTION many products contain ammonia phosphates and or ethylene glycol and they are NOT RECOMMENDED Carefully verify the content of the product in the label omm EN omm wx cB 4 cD E X O q JA Q Preventive Maintenance Every three months the operator should check all equipment if there is no breaks in cables drying of connections and metal parts oxidation Oximetry sensor should be inspected monthly for life because handling may damage the LEDs and the internal wires of the cable To ensure the proper operation of the oximeter is recommended to send the equipment to an Authorized Technical Support annually Corrective Maintenance Milli Pulse Oximeter corrective maintenance requires specific technical knowledge and software that only authorized people have There are no internal parts that can be repaired by users Therefore if any repairs to the equipment are required only Authorized Technical Support can do it In case on doubts a
29. n a nuisance to people it may damage electronics circuits as Milli s circuits Therefore it is important to take certain precautions to avoid these episodes Electrostatic Discharge AN All professional who use Milli pulse oximeter should know the explanations contained in this manual about electros tatic discharge protection so that e They can recognize the warning symbol ESD e hey are trained in procedures to prevent electrostatic discharge Connection pins identified with the ESD warning should not be touched To connect these pins it is necessary to follow procedures against ESD GENERAL GUIDELINES N Follow these precaution procedures e Connect to a grounding point to take the equipment Increase the air relative humidity e Install specific protection items against ESD as floors bracelets and antistatic heel straps N Avoid conditions that promote the accumulation of static electricity in the environment e ow relative humidity e Materials that accumulate static charge e g synthetic materials accumulate more static energy than natural fiber as cotton e Touch or connect the equipment quickly T cD E x lt q gt QA GENERAL GUIDELINES Precautions A A gt The equipment should be used by trained professionals The operator should know the information contained in this user manual before proceeding to use it with the patient The operatio
30. n distance d in meters m may be determined by the equation applicable to the frequency of the transmitter where P is the maximum power output of the transmitter in Watts W according to the transmitter s manufacturer NOTE 1 In 80 MHz and 800 MHz separation distance for the higher frequency range is applied NOTE 2 These guidelines may not be applicable in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people 6 6 9 6 6 6 0 9 0 0 0 0 0 0 0 9 0 O 6 O0 0 0 6 6 0 0 6 0 0 0 O 9 0 0 0 O 9 0 6 9 O0 0 0 O0 0 6 GO 0 0 O 0 06 O 9 0 9 9 0 0 0 0 0 0 O 9 0 O 0 0 0 9 0 O 9 0 0 0 O 0 9 0 6 0 O0 0 9 0 0 O0 O 0 9 6 0 0 O 0 0 0 0 O 9 9 O 9 6 0 0 O GO 9 9 9 9 6 O 0 O0 0 9 O0 9 6 9 O0 9 0 O 0 O0 0 09 0 9 6 0 0 6 6 0 06 6 9 0 9 6 9 6 T cD E x lt q gt Q amp WARRANTY HIT Tecnologia em Saude LTDA within the limits specified in this certificate assures the consumer purchaser of this product warran ty against manufacturing defects materials if presented within one year for the equipment and 90 ninety days on accessories cables and sensors counting from the date of invoice issuance of the product The responsibility of HIT Tecnologia em Sa de LTDA is limited to repair replace defective parts or at the discretion of the company replace the products equipments since technical department or authorized r
31. n of this equipment may be affected by presen ce of strong magnetic fields as electro surgery devices computed tomography magnetic resonance images MRI and others Always disconnect the equipment of power supply and remove the accessories before cleaning and disinfecting to avoid damaging and ensure the biosafety guidelines Always use sensors approved by the company The use of other sensors can generate inaccurate measures or damage the equipment A A A A A The results obtained with this device are a complement of the evaluation patient client and should be used with a clinical evaluation of a qualified professional Hi Technologies s sensors do not contain latex in its compo sition protecting patient and operator of possible allergic tissue reactions due to toxicity Do not use the sensor in temperatures above 106F 41 C in children under one year This equipment requires special precautions related to electromagnetic compatibility for that it must be instal led and operated in accordance with the electromagnetic compatibility information available in this manual Mobile and portable radio frequency devices may affect this equipment Hestrictions JIN Any condition that restricts the peripheral blood flow as non invasive pressure cuffs may prevent accurate measu rement of vital signals N HYPOPERFUSION The result of readings for low values may be altered due to the difficulty of the peripheral circu
32. ng temperature is estimated between 4F 20 C and 149F 65 C There is a protection circuitry that disables it partially in temperatures out of limits During device operation batteries may have temperatures varying between 4F 20 C and 167F 75 C T cD E x lt q gt Q GENERAL GUIDELINES Packaging Transportation and Storage N The equipment is packaged in a Kraft box reinforced with AN A internal polyurethane protector During transportation handle with care to avoid damage During transportation or storage the equipment should be maintained in temperatures between 40F 40 C and 158F 70 C protected against liquid spillage with relative air humidity between 10 and 90 and atmospheric pressure between 500hPa and 1060hPa 375mmHg and 795mmHg Electrostatic Discharge N Electrostatic discharge ESD may cause damage to the Milli pulse oximeter if it happens inside of it Because of the accumulation of electrons on the material surface it may occur in many ways For example after dragging feet on carpet floor what causes electrons accumulation on your body you may feel an electric shock while touching the metallic knob door This shock is due to the static electricity accumulated on your body is discharged to ground through knob door Eventually the discharge may occur touching the car bodywork after it was driven for some time Even these shocks are nothing more tha
33. nnected Power grid connection tothe power grid tothe power grid Table 5 T cD E X cD QA 4 MONITORING THE PATIENT Milli pulse oximeter starts with the patient s monitoring screen The user has access to 1 Patient s name 2 Functional oxygen saturation in blood SpO2 measured in 96 3 Heartbeat measured in beats per minute 4 Perfusion Index IP and Perfusion Variability IVP measu red in 96 If user presses the MENU button the MENU screen will be displayed If SILENCE ALARMS button is pressed the alarms will be tempo rarily disabled by 25 seconds If the button is pressed again during this period the alarms will be enabled But in case of alarms being permanently disabled the SILENCE ALARMS button displays the alarm settings 5 Plethysmographic curve proportional to the patient s heartbeat 6 Heartbeats indicator The quality of heartbeats signals can be verified by the size of the circumference Bigger is better signal quality SQ To access to Alarm settings the device request for a password See page 21 Security Locks for more information Alarms can be disabled with a quick tap on the screen MONITORING THE PATIENT Pulse Glenn Allan Ss Patient s name Plethysmographic curve SP02 IP IVP Main Menu P Heartbeats Figure 16 Patient s vital signals monitoring Touch the menu button in the monitoring screen to access t
34. o MENU screen Many functions of the oximeter are available in this screen by touching the icons shortcuts on screen surface touch screen Patient Widget Applications icons Status Bar Alarm Monitoring Figure 17 Main menu MONITORING IHE PATIENT Open Folder Helps in applications organization Buttons and Widgets Shortcuts Allows the creation of shortcuts for applications Applications Hints Access the applications Shows safety hints and use hints the first time the device is turned on i L Settings Access to personal settings Patient s Avatar Identifies the patient if not yet been Add widgets Helps in widget settings Au ue sy Internet set whether male or female T Internet access E Remove widgets e Helps in widgets settings e Trends i x Access to monitoring trends charts CONNECTIVITY SYMBOL E D Organizational folder Helps in applications organization D i Bluetooth activated Er Patient E e Register and access to patient s J Edit information Edit patient data Bluetooth in activity E a Y Al e gt Wi Ficonnection activated 5 Alarm information Release i gt Delete the patient MONITORING THE PATIENT OTHERS BUTTONS Security Locks de screen details LOCK OF MEDICAL FUNCTIONS To lock the access to all the medical functions of the device Zoom out Decreases screen details
35. of the sensor every 4 hours or as patient s needs N When connecting the equipment in any instrument verify proper operation before clinical use See instrument manual for complete information Accessories connected to the interface of the monitor should be certified in accordance with the respective standards Any connection of additional equipment in the input or output of signal will be classified as a medical system so it should be in accordance with applicable technical standards Sensors used incorrectly may cause inaccurate readings See manual for instructions about proper application T cD E x lt q gt Q GENERAL GUIDELINES Warnings A A Damaged cables and sensors may cause incorrect readings with possible injury or death of patient Inspect each sensor and each cable and immediately discard if damaged It is recommended to use another cable or sensor and contact the Technical Support for assistance Chemical products petroleum based substances or substan ces used for disinfection e g alcohol for removing skin glue e g benzine removers e g thinner and other may damage the material protection of the sensor altering the reading results Do not connect USB devices not approved by the company because the use of other devices may cause irreparable damage to the equipment AN A Do not insert any object into the docking station s power input connector Connecto
36. ples the pulse oximeter determines functional oxygen saturation in blood SpO2 with a sensor with two light emitting diodes LEDs red and infrared and a photodiode light receptor This sensor is placed in a pulsating arterial vascular bed e g fingers and toes ears and nose The LEDs emit infrared light wavelength 905nm and red light wavelength 660nm through a patient s arterial vascular bed The light is converted in electronic signals by the photodiode These signals are used to calculate the vital signals OVERVIEW The calculus of functional saturation of blood oxygen SpO2 is obtained using the equation figure 1 where A and B are calibration values and R is obtained by the equation figure 2 where AC and DC are the AC and DC components of red light and AC and DC are the components AC and DC of infrared light It is very Figure 1 important to remark that the equipment is enabled to measure the functional saturation which means the percentage of oxygenated hemoglobin related to total hemoglobin able to carry oxygen It is also important to report that comparing the calculated saturation obtained with pulse oximeter with the measured saturation obtained with a gas sample of arterial blood it may be different These discrepancies are due to the calculated saturation is not properly corrected with some variables as pH carbon dioxide partial pressure temperature and fetal hemoglobin Moreover a comparison can only be
37. pulse detected and with the clip adult sensor 6 6 9 0 6 9 09 06 9 9 09 0 9 0 0 0 0 0 9 0 GO 0 9 0 GO 9 0 0 0 9 0 0 0 0 9 9 0 O 9 0 0 0 09 GO 9 0 GO 0 9 0 9 0 0 9 0 9 0 0 9 9 9 O9 O0 0 9 0 0 9 O 9 0 O 0 0 GO 0 9 GO 0 0 O0 0 9 GO 9 9 GO 9 0 O 9 O0 0 9 0 GO 9 9 O0 0 9 0 O 9 0 0 9 0 O 9 0 O 9 0 O 0 6 9 9 9 O 9 0 0 0 0 GO O 9 O 9 9 0 O 9 6 0 9 0 9 6 6 omm mm omm Vv cD E X O q gt a Power Supply Electric grid 110 to 220 V AC Frequency 60 Hz 50 Hz Connector 2 Pins Power 44 VA Fuses 2 units type of Radial T3 15A 250V retarded External Power Supply Connected to the docking station 12 to 15Vcc CO Current 3 5A Batteries Docking station battery 2 x Li Polymer 2000mAh 3 7V Handheld battery 2 x Li Polymer 2000mAh 3 7V Connectivity Bluetooth Operating frequency 2 4 2 4835 GHz Power 1 1 mW Modulation Frequency Hopping Spread Spectrum FHSS IEEE 802 11 b g Operating frequency 2 4 2 4835 GHz Power 500 mW Modulation Orthogonal Frequency Division Multiplexing OFDM TECHNICAL SPECIFICATIONS Electromagnetic Compatibility Table 10 Electromagnetic emissions Milli pulse oximeter is intended for use in the electromagnetic environment specified in this table It is recommended the user or consumer to ensure that the equipment is used in such an environment RF emis
38. rs identified with warning ESD symbol should not may not be touched directly neither with manual tools N The equipment may generate imprecise results if operated out of amplitudes specified in this manual N The use of accessories transducers or cables not speci fied approved and recommended by the manufacturer may adversely affect equipment operation increasing the electromagnetic emissions or decreasing the electromag netic immunity of the equipment N The device may not be used near or stacked over other equipments PAN This equipment is susceptible to other equipments even being in conformity with CISPR emission prescription N All discarded parts such as sensors batteries etc should be sent to the manufacturer or delivered to one of the Technical Support Network duly sterilized for proper disposal N The equipment should be sent to the manufacturer or delivered to one of the Technical Support Network duly sterilized for proper disposal m T cD x q D gt Q 6 MAINTENANCE Cleaning and Disinfection The instructions for cleaning and disinfection of the equipment and accessories should be strictly followed as follows e Do not drop liquids onto the equipment mainly in ventilation areas to prevent it from entering in the electronic components e f it happens disconnect the equipment and call the Technical Support Never immerse the equipment in any liquid e Do not
39. se sensor failures Always verify if the sensor is free and clean EXCESSIVE SECRETIONS Interfere in the sensor reading allowing the reading of a lower value than reality The problem is solved by cleaning the verification area mechanical removal or by changing the sensor position AN AN EPITHELIAL LESIONS Skin problems e g dermatitis lesions onicomycosis and necroses may block the light input in the sensor altering the reading result NAIL POLISH May prevent the propagation of light sensor altering the reading mainly dark colors It is not significant but for complementary observation it is preferable to remove using nail polish remover FALSE NAILS May interfere in the propagation of light sensor altering the reading It is preferable to remove them to perform complementary examination Warnings AN AN Never use this device in presence of flammable anesthetic because of the risk of ignition that may result in an explosion Never use this device in the presence o Magnetic Resonance devices MRI MRI scanners can generate induced currents in the sensor resulting in injuries and severe burns in the patient N The autoclave use ethylene oxide sterilization or immersion of the sensors in liquids may cause incorrect readings or irreversible damage to the equipment N The prolonged use of the sensor may cause blisters skin deterioration and discomfort It is recommended to change the location
40. sions ABNT NBR IEC CISPR 11 Group 1 Milli pulse oximeter uses RF energy only for internal functions Its RF emissions are very low and it is not pro i bable to cause any interference in near electronic equipments rni OXIDE ILI e RF emissions ABNT NBR IEC CISPR 11 Class A Milli pulse oximeter is suitable for use in all establishments other than domestic and can be used in homes M M ELLE and establishments connected to the public power grid low voltage for domestic use whenever it has Limits for harmonics emissions IEC 61000 3 2 Not applicable A a B X ID OP eee Eee eee Warning Thisdevice systemisintendedforuseonlybyhealthprofessionals Thisdevice systemmaycauseradio Y x interferenceordisruptoperationsofnearbyequipmentltmaybenecessarytoadoptcertainproceduressuchasreo 5 Voltage fluctuations and flicker in public rientationandrepositioningoftheMilli pulseoximeterorlocalshieldingtoreducetheeffects a Not applicable low voltage supply systems IEC 61000 3 3 E e0906029902020929029 0292990292920902990 692990202090292929029090060292929092999 ooc5coecooc0c0ccc6cc565cscc 9c2902220902 0292920 622729290292922020292029292290202929092902999029298292992902929906029020902090290202920e602920620290294902929092029299029202029299029090202902900299069029002090296099 62 6292990292999 Table 11 Electromagnetic immunity general TECHN
41. sterilize with autoclave or any disinfectant immer sion technique Turn it off and disconnect from the power grid before start cleaning Clean the external part with a smooth lint free cloth moistened with mild soap and water Do not use chemical petroleum based products as thinner benzine and other derivatives to clean the accessories and modules Never wet connectors LCD Touch Screen In case of splashing or spilling liquids directly over LCD screen clean immediately with a dry cloth and proceed to disinfection Remember any more fluid substance may enter in screen edges and damage the internal circuits Use a lint free cloth The cloth should be used dry or moistened with a mild cleanser Make sure the cloth is slightly damp not wet Never apply the cleaner directly on the surface of the panel If the cleaner is spilled on the touch panel dry immediately with an absorbent cloth Never use cleaning products with acid or alkaline base use products with neutral pH When using the cleaner avoid the contact with the edges of the film or glass and flexible parts Wipe the surface gently if it has directional texture wipe in the direction of texture Never use chemical organic products as thinner acetone propyl or isopropyl alcohol toluene xylene or kerosene Appropriate cleaning products are commercially available MAINTENANCE Cleaning and Disinfection e LCD Touch Screen The wrong way to c
42. tion Bluetooth om omm S VY ep E X e q a EO Q Intellectual Property IP The information contained in this manual is exclusive property of HI Technologies and may not be copied in part or whole without the prior written permission of the company The company doesn t measure efforts to maintain the information provided in this manual free of errors In order to update the informa tion provided and correct some mistakes HI Technologies reserves the right to alter any portion of this document without prior notice Circuit diagrams component lists descriptions and other information are available by signing in a confidentiality agreement NDA with the company 2 OVERVIEW Intended Use This device is indicated to monitor the oxygen functional saturation of patient s blood and cardiac frequency in patients who are in medical and hospital environment N This equipment should not be used during Magnetic Resonance Exam MRI due to severe burns hazard N This equipment should not be used to continuous monitoring if the audible alarms are permanently disabled N The validity period of this equipment is UNDETERMINED but its lifetime is 3 year average since the manufacture date and it may vary with the adequate use and preventive maintenance T cD E x lt q gt QA OVERVIEW Operating Principles Pulse oximetry is based on two main principles Based on mentioned princi
43. turned off permanently for each vital signal with alarm sounds controls on the right side of the screen When SpO2 or pulse audible alarm is disabled a visual notice will appear SPO2 Pulse Audible Alarm Disabled Audible Alarm Enabled Perfusion Index Variabilityofperfusionindex Figure 18 Alarms settings screen MONITORING IHE PATIENT Alarms are categorized into high medium and low priority Each priority has a different visual identification 1 HIGH MEDIUM LOW etter x indicates that any audible alarm SpO2 or pulse is permanently disabled d e The clock indicates that the audible alarms are disabled by 25 seconds Table 6 Description of the alarm sounds 0 0 0 8 0 0 5 080 080 8 0 0 0 0 6 0 0 0 0 0 0 0 0 0 0 8 0 0 0 0 0 0 0 0 0 0 0 8 0 0 0 0 0 0 0 8 0 0 0 0 0 6 0 0 0 0 0 0 0 0 0 0 2 0 0 0 2 0 0 0 0 0 0 2 0 6 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 2 0 0 0 0 0 DESIREN e NEN and Sensor disconnected of the equipment Medium C4 CA C4 Finger disconnected of the sensor Medium C4 C4 C4 Weak signal Low E4 C4 Errors inthe oximetry module Medium CACA CA Seem 000 Mm a S SpO2 out of limits High C5 B4 A4 G4 F4 creer SL Se ARS REST sn ee er ee Ee ee E E i EAI E Pe eer ee s n Ane EEREN Wenn ppe 5 j pey T 7 ee ame eee eres ene ere ues PE eee rte p PEST EE
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