(IRIS) VITAL SIGNS PATIENT MONITOR Service Manual
Contents
1. Pulse rate Measuring range Alarm setup range 40 255 mmHg 10 195 mmHg 20 215 mmHg 40 200 mmHg 10 150 mmHg 20 165 mmHg 40 135 mmHg 10 110 mmHg 20 125 mmHg 1 mmHg the average error lt t5mmHg the standard error lt t8mmHg software and hardware double protection 290 mmHg 220 mmHg 150 mmHg double length infrared wave 0 100 70 100 1 2 70 100 adult child 3 70 100 neonate 4 40 69 25 250bpm 20 250bpm PMS8210A Service Manual 1 3 Chapter 1 Complete Appliance Introduction Resolution Precision Sweep speed Alarm setup Alarm method 1 4 4 Blood Oxygen Nellcor SpO2 Measuring method Measuring Range Alarm setup range Resolution Precision Pulse rate Measuring Range Alarm setup range Precision Sweep speed Alarm setup Alarm method 1 4 5 Respiration Measuring method Measuring range Resolution Precision Alarm setup Alarm method 1 bpm 3 bpm Geostationary or 5 bpm Campaign 12 5mm s 25mm s SpO2 overruns pulse rate overruns sound light alarm and record the alarm status for review double length infrared wave 0 100 70 100 1 2 70 100 adult child 3 70 100 neonate Unspecified 0 69 20 250bpm 20 250bpm 3 bpm Geostationary or 5 bpm Campaign 12 5mm s 25mm s SpO2 overruns pulse rate overruns sound light alarm and record the alarm status for review the thorax impedance method used with ECG lead 0 10 1202. 6 Make the network connection from a certain aspect disconnect the central station can direct the machine to resume after the networking to connect and work normally the time required see the relevant technical indicators 3 1 6 Clock Instructions correctly walking evenly not mutation non stop 3 1 7 ECG waveform output Connect IRIS to ECG lead and simulator and connect D A output chassis behind to the oscilloscope Universal oscilloscope select the 5V or 1V respectively and compare oscilloscope waveform with the output waveform of IRIS 3 1 8 Long time run After long time run observe the monitor state whether ok 3 1 9 Factory settings The initial values set by software except for the factory settings menu 3 1 10 Safety testing 1 The test of the protective earthing impedance the impedance must not exceed 0 20 between the protective earth terminal in MAINS plug and any accessible MAINS part Please refer to the standard of the clause 18 f of IEC 60601 1 A1 A2 2 Earth leakage current when the MAINS is 250V the current must not exceed 0 5mA under single fault conditions the current must not exceed 1 0mA Please refer to the standard of the clause 19 of IEC 60601 1 A1 A2 3 The patient leakage current when the MAINS is 250V the current must not exceed 10uA Please refer to the standard of the clause 19 of IEC 60601 1 A1 A2 PMS8210A Service Manual 3 3 Chapter 3 Installation and inspection 3 2 The para
3. Buffer amplifier circuit complete the ECG signal s impedance transformation to ensure that ECG has a high input impedance and a low output resistance Right foot drive circuit The mid point of the output buffer amplifier circuit to the RL of the five lead ECG by reversed amplifying to ensure the human body in an equipotential state thereby reducing interference and improve the circuit s common mode rejection ratio Lead off Detection According to lead off caused by a buffer amplifier output level change adjust the lead off via comparing device and converted into TTL level for single chip detection Lead connecting to the circuit In the single chip control enlarge the main release according to the requirements of connecting different lead electrode access to the main circuit Main output circuit By a standard consisting of three op amp instrumentation amplifier PMS8210A Service Manual Chapter 2 Patient Monitor parameters and theory g Post processing circuit The main function is to complete the coupling of ECG signals the size of programmable gain filtering and level shifting and the signals amplification to a certain extent into the mode the digital converters 2 2 1 3 Respiratory RESP parameters IRIS vital sign monitor RESP measurement method is based on the principle of impedance The body chest is up and down when breathe which is equivalent to impedance changes between RL and LL and through the ECG electrode RL and L
4. appropriate government regulations The instrument must be connected to the ground correctly The monitor is used in accordance with the operation manual 3F is not responsible for the effects of safety reliability and performance when Spare Parts have been removed debugged or readjusted The monitor isn t used in accordance with the operation manual Guarantee The range of free service The instrument which is listed in the range of maintenance item can have the free service The range of charged service The monitor which is not on the above free service list and needs the maintenance 3F will charge according to the service If the maintained monitor is man made damaged voltage out of the required range or force majuere by natural calamities even it is within warranty period 3F will charge for the service 3F is not responsible for the direct indirect completely damaging or delay in such condition Using instrument improperly Tearing down maintaining debugging the instrument replacing components or changing electrical wires by the technician without 3F s agreement or commission Essential Guides for the Users Warning All Users must read following warnings and guide before operating the Monitors Any abnormalities or malfunction of the monitor or body harms caused by the violations of the operational guides will not be responsible by our company nor any warranties will be made by us The inst
5. higher the voltage comparator outputs the high level PMS8210A Service Manual 2 5 Chapter 3 Installation and inspection Chapter 3 Installation and Inspection 3 1 Instrument installation Please refer to the PMS8210A operation manual for the usual measurement of IRIS So here we will not describe in detail The following steps are to indicate the main point of the measurement as well as some parts which is not carefully described 3 1 1 The checking for appearance and assembling Take out the instrument from the package carefully Check the aspect first If there are some occurrences due to transportation as that the aspect of monitor is damaged the LCD panel is broken or there is abnormal sound when shaking the instrument mainly caused by fall off of some components please don t plug into the power socket or try to open the instrument to examine or repair Instead contact with the local dealer or the customer service department of 3F as soon as possible If the instrument looks well and buttons operate well put in on the flat desk or fix it on the bracket Please put the electro cardio lead plug blood pressure plug and blood oxygen probe plug in the corresponding socket on the right panel If one of the parameters is not wanted the probe or cable could be taken off from the side panel Connect one side of the power wire to the power socket on the back side of the instrument and the other side to the output of 220V AC pow
6. Complete Appliance Introduction 1 5 Appearance 1 5 1 Front View of IRIS Picture 1 1 IRIS Vital Sign Monitor Switch Power on off Print Switch Start Stop the printer 8 Measure Blood Pressure Start Stop measuring the Blood Pressure 4 Real Time Waveform Recording Freeze unfreeze the current ECG Waveform 5 Mute switch Turn Off On the sound effects Multi function Key SD Card storage and the input of patient data Functional Indicator Display the status of each function Menu Key Adjusting the system parameters and the patient data retrospection 1 6 PMS8210A Service Manual Chapter 1 Complete Appliance Introduction 1 5 2 Back View of IRIS I COS as Indicator light Alarm Indicator Communication port Nurse Call Network interface Standard RJ45 input net connection with 3F Center Station Ground Cable interface Interface for connecting the ground wire Car DC input port 9V 15V Power 100 240VAC 10 50 60Hz 3Hz Lithium battery cabin 6 4V 8 4V Printer Out built printer Q ORS I Channels of temperature sensor Il Channels of NIBP Cuff III SPO2 sensor IV ECG Cable interface PMS8210A Service Manual 1 7 Chapter 2 Patient Monitor parameters and theory Chapter 2 Patient Monitor parameters and theory 2 1 Summary IRIS adopts parameter signal on the base of parameter modules and transmits the result to the main control panel through the
7. Service Manual 6 1 Annex A Electric connect diagram Annex A Electric connect diagram IRIS SYSTEM BOAR Ji LCDBOARD 22 A l A JP2 J1 ALARM LED aia PRINTER J4 MODULE BOARD TEMP Sur prose a PROBE SPO2 J3 P02 PROBE J6 5 DC INLET JS 35 JU ki POWER BOARD J6 CHANGE BOARD Ji J2 a JP1 3 NET BOARD GROUND ULE NINE o IS A NIBP Illumination J7 PROS LINE OF INNER LINE OF MODULE INLET IN MODULE CONNECT BOARD INLET OF SHELL PMS8210A Service Manual A 1 Annex B Electric diagram of modules Annex B Electric diagram of modules 1 Host Assembly Std Code Name amp Spec Qty 1 M10 70 010 Front Housing Component 1 2 M10 07 000 Main Housing Component 1 3 M10 70 040 Rear Housing Component 1 4 GB T 818 2000 Pan Head M3X6 Screws 4 5 GB819 M4 8 Pan Head M4X8 Screws 2 6 GB T 823 1988 Pan Head M4X14 Screws 2 PMS8210A Service Manual Annex B Electric diagram of modules No Std Code Name amp Spec Qty 1 M10 70 011 Front Housing Panel 1 2 M10 06 010 Network Interface Board 1 3 M10 55 000 Printer 1 4 M10 71 020 Rear Housing Cover 1 5 M10 92 020 Li ion Battery 1 6 M10 70 062 Li ion Battery Shell 1 M10 70 063 7 M71 01 020 Foot Pad 4 8 M10 05 010 Power Module 1 9 M10 03 010 Li ion Battery Interface B
8. all set adult model B In the non invasive blood pressure simulator select a group of blood pressure measurement within the scope of value such as NS 90 NM 70 ND 60 C Inspection IRIS portable measuring whether the outcome of the actual simulator set with consistent value D change the simulator set pressure value re measurement 3 2 3 SPO2 parameters test 3 2 3 1 Inspection Tools SPOz2 Simulator 3 2 3 2 Inspection steps A Connect SPO2 Simulator with IRIS B Set SPO2 simulator parameter values are as follows SPO2 98 PR 70 C Inspection IRIS portable SPO2 and PR display value is consistent with the simulator Note To observe PR value must be in the ECG heart rate menu will be selected as the source of PETH D Change in SPO2 Simulator SPO2 and RP settings E Check IRIS display value consistent with the settings F If SPO2 probe is off IRIS shall immediately report 3 2 4 Temperature Parameters Test 3 2 4 1 Inspection Tools Physiological signal simulator 3 2 4 2 Inspection steps A Temperature sensor will take a simulator then an IRIS portable TEMP mouth Through the simulator settings TEMP 34 C B Inspection IRIS portable screen shows the value of the TEMP for 34 C PMS8210A Service Manual 3 5 Chapter 3 Installation and inspection C Change the simulator settings TEMP 40 D Inspection IRIS portable screen shows the value of the TEMP for 40 C 3 6 PMS8210A Service Manual Chapter 4 Maintena
9. be possibilities as follows the power line is not plug in well the fuse is broken the power module is broken or the indicator light is bad 1 blue DC indicator light suitable for the instrument power supplied by the battery The instrument is not plugged in but if there is battery installed in it press the start stop button for about 2 3 seconds when the instrument is off the instruments will be started and the blue indicator light is on the blue DC indicator light is off and it shows that the instrument can work through battery supply If the indicator light isn t on there may be some possibilities as follows the start stop button is loose contact some malfunctions in the charging control board DC indicator light is bad the capacity of the battery is not enough or the battery is damaged gm blue indicator light suitable for the instrument with battery installed supplied by the AC power When AC is supplied the instrument will charge up automatically If the blue light is on it shows that the battery is charged up If the capacity of the battery is full the blue light will be off Generally the battery needs 4 8 hours to be charged up with full capacity If the time for charging up is above 24 hours and the blue light is on yet there may be the possibilities as follows the charging control board has malfunction or the battery is damaged 4 2 2 Instrument malfunctions Malfunction phenomena Pos
10. switch board and display the data and waveform on the screen The commands of main control panel and module s information are also transmitted through the switch board The switch board can also transfer the power The framework of system is demonstrated as below REIN EEE ged Medical IH eZ N staff Main Control board Net port Respiration CO pets PMS8210A Service Manual 2 1 Chapter 2 Patient Monitor parameters and theory 2 2 Parameters and theory The five parameter modules do the real time monitoring on non invasive blood pressure SpO2 ECG respiration body temperature through the cuff and cables The results are transmitted to the main control panel for processing and displaying and input to print by the thermal recorder 2 2 1 ECG 2 2 1 1 The IRIS main function of ECG a b Qa o gt 0 Lead 3 Lead 5 Lead Lead measurement Il III avR avL avF V CAL Drive by right foot Anti defibrillation Detection of lead off Magnify dual channel ECG while process the ECG signal by any two lead measurement 2 2 1 2 The processing of ECG signals is achieved by circuit of ECG parameter and the circuit is constructed by several parts a b d Input electric circuit ECG electrode is connected to the input circuit with the ECG cable The main function of the circuit is to protect the input port of ECG and signal filter out interference from the outside
11. L s high frequency signal into a high frequency signal The signal is amplified to electric signal output with changes in respiration and sent to mode digital converters Respiratory parameters is combined by the respiration electric board and coupling transformer Circuit is included by oscillometry coupling detection early release high gain amplification and so on 2 2 2 Noninvasive blood pressure NIBP parameters NIBP adopts the theory of pulse oscillometry Puff the cuff around the upper arm until the pressure which generated by the cuff interdict the flow of the brachial artery and then deflated gradually according to a certain algorithm requirements As the pressure reduced with the beat in the pulse the arterial blood will generate a pulse signal Filter out the pulse signal and enlarge it with a high pass filter about 1HZ and convert it into digital signal by the A D The systolic diastolic and the mean blood pressure can measure after the treatment by the single chip microcomputer For neonate pediatric and adult we must choose the correct size of the cuff in order to avoid the measurement error NIBP prevents the excessive pressure with the protection electric circuit Main work mode to NIBP 1 Adult Pediatric Neonate mode choose according to the body figure weight and age 2 Manual Auto Series Manual measurement also means a single measurement Only measured once after choosing the Manual Auto can measure onc
12. PMS8210A IRIS VITAL SIGNS PATIENT MONITOR Service Manual Shanghai 3F Electronics Co Ltd ADDRESS Building 3 No 128 Jiujing Road TEL 86 21 51695200 Shanghai 201615 China FAX 86 21 67696296 POSTALCODE 201615 DATE 2008 09 VERSION V1 0 Intellectual Property Rights Shanghai 3F Electronics Co Ltd has the copyright of this service manual and also can require it as confidential data This manual is only referred to the maintenance and service of IRIS Vital Sign Monitor This manual and intellectual property rights include copyright belong to 3F Electronics Co Ltd Without the written approval of 3F no one can use publish or allowing other people to get the information of this manual at any way Without the advanced permission of 3F no one can take pictures copy print or translate the content into other language Announcement gt 3F reserves the right of final explanation about this service manual gt 3F reserves the right that update this manual without advanced notice gt 3F reserves the right to change the monitor s specifications change without advanced notice gt 3F doesn t guarantee this manual in any form 3F is responsible for the effects of safety reliability and performance only if Assembly operations extensions readjustments modifications or repairing is carried out 3F technical personnel or 3F s authorized agent e The electrical installation complies with the requirements of the
13. ait about 10 minutes the screen will show Initializing the system please wait And pls Wait another 12 minutes the monitoring picture and waveform will appear If the power if off during the working process the power indicator will extinguish and the monitor stops working Check out all the function and confirm the monitor is working normally then put the cable probe to the related body place of the patient The IRIS will start the real time monitoring PMS8210A Service Manual Chapter 6 Cleaning Chapter 6 Cleaning A Warning But can not dip the liquid into the monitor Be forbidden the caustic chemical materials that will make erosion 6 1 Clean Wipe the instrument and the cables by a clean wet cloth if wanted usual cleanser or alcohol is available 6 2 Sterilize After cleaning the ECG leads SPO probe NIBP cuff and TEMP probe can be sterilized sometimes The material of sterilization can use alcohol 70 formaldehyde 35 37 or javelle water the concentration of chloros is 500ppm 5000ppm gt The ECG leads can be sterilized by formaldehyde 35 37 gt The SPO probe and NIBP cuff can be sterilized by alcohol 70 or formaldehyde 35 37 gt The TEMP probe can be sterilized by javelle water the concentration of chloros is 500ppm 5000ppm 6 3 Disinfection After cleaning the disinfection can be done sometimes But the process must be according to the hospital order PMS8210A
14. ase be familiar with their definition and meaning Warning Instructions to avoid potential danger and incorrect operation Obey the instructions otherwise death and serious injury may be caused Caution Instructions to avoid potential danger and incorrect operation Obey the instructions otherwise injury and product loss may be caused Note Operational instructions or other useful information to use the instrument fully m Symbols The list of the symbols used in this instrument is as follows N Symbol for caution consult accompanying documents C CE mark when a device has been past CE test we must put the CE mark on the device And the CE number can be after the svmbol a This svmbol shall be accompanied bv the manufacturer s serial number The ISN serial number shall be after or below the symbol adjacent to it b The relative size of the symbol and the serial number are not specified c So far our product serial number is made of seven digits two digits for the year and two digits for the month and three digits for sequence number So the serial number could be show the date of made a The symbol shall be accompanied by the name and the address of the sl manufacturer adjacent to the symbol The address is not required with the symbol on an immediate container as specified in EN375 AND EN376 except when the immediate container is also the outer container b The relative size of the svmbol and the name and addr
15. e in the selected time intervals period can be 1 2 3 4 5 10 15 30 60 90 120 180 200 or 280 minutes Series measurement starts the fast consecutive measurements in five minutes and can be effectively measure the blood pressure changes PMS8210A Service Manual 2 3 Chapter 2 Patient Monitor parameters and theory 2 2 3 SPO2 parameter SPO2 is obtained through describing the pulse wave of fingertip which passing through the specific algorithm and looking up the clinical data table The SO2 probe is the surveying sensor built of two light emitter diodes and an electro optical battery part Two light emitter diodes conclude a red diode and an infrared diode They light alternately according to certain succession When fingertip s blood capillary hyperemia repeatedly along with heart s pump blood the blood vessel and the organization absorb the light of the emitter diode and project on to the solar battery the solar battery may sense luminous intensity along with the pulse blood change and be formed of changed electrical signal The ratio of current and alternating current component is according to the content of oxygen in blood The correct value of oxygen saturation degree is obtained though the specific algorithm simultaneously the arteries rate may be calculated according to the blood oxygen pulse profile The circuit module of SPO2 mainly includes four parts 1 Probe parts Luminescence tubes launch infrared and red radiant t
16. e key board or speaker The printer does not print 1 Printer electric line off or bad connection 2 Printer failure 3 Printer not set 4 Print paper not set 1 Reconnect or replace the printer electric line 2 Replace the printer 3 Add the paper The print record is tilted The installation of printer is not well Adjust the printer The buttons or the knob is invalid 1 the keyboard signal lines is loose contact or damaged 2 malfunction of keyboard PCB 1 re plug the signal line 2 replace the keyboard 4 4 PMS8210A Service Manual Chapter 4 Maintenance 1 offline is set in the menu 2 the net wires are loose contact or damaged 3 the connect board is damaged Not connect to the center station WN set online in the menu rep plug or replace the net wires replace the connect board 4 2 5 Power board malfunction Malfunction phenomena Possible cause Means to dispose The fuse burn when power is on The power or other parts is short Open the instrument to check Cut the load but The fuse burn still The power is damaged Replace the power board The fuse burn when the part connects The part is short Replace the part The LED of power and main board is light but the fan is not work or the LED of trans board is not light The 12VDC power is damaged Replace the power The fa
17. ecially for neonate 1 ECG Measurement Warning Away from the throats of the neonate to avoid asphyxiation The electro cardio cables and the electrode must be used correctly because neonate s body is shorter and tender Avoid the injury of the electrode And check on time and change with the finger 2 Blood Pressure Measurement Warning The pattern of blood pressure measurement for neonate must be selected before the neonate measures otherwise accidents will be caused The cuff that fits neonate must be used to take the measurement of neonate Set correctly the parameters of the air pressure of the cuff and alarm when neonate takes the blood pressure Please select the default Especially note these parameters that neonate fit if you have to adjust parameters 3 Blood Oxygen Measurement Caution Blood oxygen value SpO2 may be not obtained precisely because the neonate moves To measure precisely please keep neonate at rest Use correctly the blood oxygen probe to neonate Do not place the blood oxygen probe on the fingers with skin injury edema or fragile Do not place the probe on the same finger over 2 hours to prevent discomfort of the finger Check on time and change with the finger 4 Temperature Measurement Use the inside temperature probe when taking neonate s temperature Terms for safety and symbols m Terms for safety In this manual warning caution and notice are used to describe the level of danger Ple
18. er supply Complete marks with correct content And standard configuration and fixed socket is ok Now the instrument can be used If there is battery supply the instrument can work relying on the internal power when it isn t connected to the 220V AC When the AC220V is connected the instrument uses the AC power supply and the internal battery is charged by the AC power A Warning 1 Can t be put under direct sunlight to avoid damages by the high temperature in the machine box 2 Don t use the instrument in the environment with poisonous flammable or caustic gas 3 Pay attention to the unsteady of the local voltage if the voltage is over the permitted range we advise to add voltage stabilizing device PMS8210A Service Manual 3 1 Chapter 3 Installation and inspection 4 Don t use keyboard in order to avoid damage to internal information and procedures 3 1 2 Power on Before power on you should check 1 The power voltage meets the requirement of the instrument 2 The three wire power cable is necessary and the power inlet must match three wire Do not use the two wire AC power supply 3 When IRIS is used together with other medical devices the protective ground should be reliably connected to other device 4 Do not put monitor below the perfusion bag or some other places with the liquids leakage to avoid the liquids enter into the monitor When the power is on check whether the patient monitor can f
19. ess is not specified a The svmbol shall be accompanied bv the name and the address of the m o authorized representative in the European Community adjacent to the symbol The address is not required with the symbol on an immediate container as VI specified in EN375 AND EN376 except when the immediate container is also the outer container b The relative size of the symbol and the name and address is not specified Q Smbol for do not reuse single use use only once X Symbol for temperature limitation D BA Symbol for consult instructions for use consult operating instructions ad Symbol for biological risks 0 Defibrillation proof type CF applied part on medical equipment to identify a defibrillation proof type CF applied part Equipotentiality to identify the terminals which when connected together bring the various parts of an equipment or of a system to the same potential Not necessarily being the earth ground potential e g for local bonding The symbol indicating separate collection for electrical and electronic equipment consists of the crossed out wheeled bin The symbol must be printed visibly legibly and indelibly m The interface of networking CONTENT Chapter 1 Complete Appliance Introduction 1 1 el ON CL VICW TEE i a a T E 1 1 O CS HEUER EEE 1 1 1 3 Tag SUCCES ee Be ee i a 1 1 1 4 Parameters cesenseesssensssenennsnnnennnnennnenennonnnenenne
20. he value of Cuff is tied outside the clothes Tie the cuff after taking off the clothe blood pressure cannot be read or the value is incorrect Air leakage for the cuff Change the new cuff The connection between the cuff tube and the plug is not tight Connect again and ensure its tightness Rubber tube of the cuff twisting Release the tube to keep the airway smooth Patients belongs to the one who is not allowed to measure blood pressure Take the value repeatedly Blood pressure measurement error code contrast table Error Code Description 00 No error 06 Wrong cuff Cuff not connected or not tied 07 Air leakage 08 Air pressure wrong unstable pressure 09 Signal weak 10 Upper measurement 11 Too much motion 12 Over pressure tested 13 Signal saturated 19 Over time testing 4 2 4 Operation record displayed and network malfunction Malfunction B phenomena Possible cause Means to dispose 1 Malfunction of parameter modules t Replace tne module Initialization 2 The communicational signal line or zus PIO or I a i 9 communicational signal lines or connect board is loose or damaged module The parameters probe or electrode is Lead off damaged or the electrode is BOP La en Pepe BIELLSSE OT A electrode invalidation The speaker is 1 The key board is damaged hoarse or invalid 2 Speaker or the line is damaged Replace th
21. ion monitor lead standard lead Gain 5mm mv 10mm mv Sweep speed 12 5mm s 25mm s 50mm s Wave gain 5 Range of heart rate monitoring 0 20 350 bpm Resolution 1 bpm Precision 5 Alarm setting the limit of alarm setup range 20 350 bpm and leads off alarm display Aalarm mode audible and visual alarm and record the data during alarm for the retrospection Input resistance 5 MO CMRR 89 dB S T detecting range 1 00 1 00mv Heart disorder analysis NO Anti polarized voltage 500 mV Baseline renewing time lt 5 s after the defibrillation ECG mode mode 1 mode 2 mode 3 mode 4 Frequency characteristic 0 5Hz 40Hz Safeguard 4000V high voltage isolation anti defibrillation anti high frequency electrical bistoury 1 4 2 Blood Pressure NIBP Method Oscillometric Mode Manual Auto Continuous Measuring Interval in auto mode 0 480 min Data unit mmHg kPa optional Data storage review 4000 blood pressure value at most Alarm setup SYS DIA MAP the range is the same as parameter measurement range Alarm method sound light alarm and record the alarm status for review 1 2 PMS8210A Service Manual Chapter 1 Complete Appliance Introduction Measuring range Adult Mode SYS DIA MAP Child Mode SYS DIA MAP Neonate Mode SYS DIA MAP Resolution Precision Overpressure Protection Adult Mode Child Mode Neonate Mode 1 4 3 Blood Oxygen 3F SpO2 Measuring method Measuring range Alarm setup range Resolution Precision
22. m left to the right when viewing from IRIS front panel 1 START STOP Power on off button 2 RECORDER Start stop printing 3 Y NIBP Start stop the NIBP measurement 4 O MENU enter the system menu the main set up button for the system function 5 bid FREEZE Freeze unfreeze the current waveform 6 X MUTE Mute turn on suspended the alarm sound 5 1 2 Screen Displaying There are three parts on the screen indication waveform and parameters field Indication field It is on the top side of the screen can display the bed number system time date indication information and alarm information Waveform field This field can show 2 waveforms at most On each waveform s top left there is a name When select these names by the knob users can control the name gain and monitoring type All these control is limited to ECG waveform Parameter field It is on the upper half of the front panel Users can select the parameters by the knob and enter into related menu and operate each item on the menu to reach the demand PMS8210A Service Manual 5 1 Chapter 5 Basic instruction 5 2 Monitor Usage Users should take the steps as below when take measurement 1 2 5 2 Read carefully the user s Operation Manual Check carefully the possible damages caused by transportation and bad connection of power cable ECG cable NIBP cuff SpO2 probe slots sockets and ports Press the power on button w
23. meters of testing and calibration At least once a year the following parameters are tested and calibrated in order to guarantee the accuracy of IRIS After repair the various parameters shall re calibration 3 2 1 ECG and respiratory parameters testing 3 2 1 1 Tools Simulator of human body physiology parameter 3 2 1 2 Test steps A Connect IRIS to ECG simulator B Confirm the number of ECG waveforms on the screen and accord with the selection of EC menu C Configure the default values of ECG1 and ECG2 when ECG2 exist Ensure the waveform of ECG and RESP to be ok E Set parameter values of simulator are as follows HR 30 gain 4 RR 15 F Check to the waveform or values of ECG RESP HR and RR are correct G To change the simulator s configuration HR 240 RR 120 H Check the ECG RESP HR RR values set with the simulator parameter values consistent If ECG leads is off IRIS should be reported immediately U 3 2 2 Non invasive blood pressure parameter test 3 2 2 1 Inspection Tools Non invasive blood pressure simulator 3 2 2 2 Test steps Calibration function with the use of non invasive blood pressure simulator in accordance with the user manual give the calibration method and calibrated to determine the accuracy of measurement of blood pressure pump lf the calibration 3 4 PMS8210A Service Manual Chapter 3 Installation and inspection passes the following tests are performed A Simulator and monitor
24. n is work and the LED of trans board is light but the LED of power and main board is not light The 5VDC power is damaged Replace the power 4 2 6 Parameters malfunction Malfunction Possible cause Means to dispose phenomena 1 Electrode patch is bad contact 2 CAL self check does not detect 1 Stock the good electrode patch No ECG waveform square wave 2 Replace the ECG RESP module 3 RL electrode hangs in the air 3 Re plug RL electrode 4 ECG RESP module is damaged 1 The electrode connects error 1 Connect the electrode right 5 2 The AC does not connect the 2 Adopt the three wire power ECG waveform is abnormality or ground IRB interter d 3 The electrode mav hang 3 Movethe free electrode patch 4 Filter mode of ECG is error 4 Select the right filter mode 5 ECG RESP module is damaged 5 Replace ECG RESP module No RESP waveform or 1 The electrode connects error 1 Connect the electrode right abnormity 2 The patient move frequent 2 Keep patient still 3 ECG RESP module is damaged 3 Replace ECG RESP module ER er oh se not The measurement bad connect Adjust the ECG electrode correct The value of TEMP is 1 The probe connects badly 1 Re fix the probe error 2 The performance of probe is bad 2 Replace the probe NIBP is not puff Air windpipe may be twisted Adjust the windpipe Sometimes NIBP can be not measured The cuff is loose or the
25. nce Chapter 4 Maintenance 4 1 The assembly parts drawing 4 1 1 The front assembly view 4 1 2 The front frame view Inlet module NIBP Pump N f 4 i i modules HA T Main Control board l Battery back board PMS8210A Service Manual Chapter 4 Maintenance 4 1 3 The back assembly view 4 1 4 The back frame view 4 2 Malfunction guide On the process of transport storage and usage IRIS may produce some malfunctions If the instrument has malfunctions in use the problems can be disposed as shown in the table below If the malfunction is not debugged please contact with our dealer or service department 4 2 1 Simple and apparent malfunction checking When you check the malfunctions of the monitor two problems must be checked first 1 Whether the battery is full if the monitor own the re changeable battery 2 If it is supplied by the AC check if the monitor is plugged in and if the power line is connected to the monitor If there is no problem with power supply observe the three power indictor lights on 4 2 PMS8210A Service Manual 1 2 Chapter 4 Maintenance the front panel to judge where the malfunction exits blue indicator light for AC If AC power is supplied press the start stop button for about 2 3 seconds when the instrument is off the instruments will be started and the blue indicator light is on the blue DC indicator light is off If the light is not on there may
26. nnennnennnenennennennensnenennensnenensenennensnensnsnensnenenseensnsnensnn 1 2 IS Appeatatiet iii e e a ees l 6 Chapter 2 Patient Monitor parameters and theory sssssesenzenzenzinzinnzanzinzinzznnznnzznzznzzzzzanrznzzzzzanznnzrnzzzzza 2 1 2 1 Summary O AE 2 1 2 2 Parameters and theory iii e Meere 2 2 Chapter 3 Installation and Inspection 3 1 3 1 Instrument installation cc Mb ms 3 1 3 2 The parameters of testing and calibration 3 4 Chapter 4 Maintenance iii 4 1 CES NI RA ss 4 1 4 2 Malfunction guide cooooconococononcnoonnonnnnnononononnnonnnononrn ono nn non cnn nro cnn nn nn nro nn nn nan rr nn nr nan rr none rca nn rnann rr nanrninnss 4 2 4 3 P nodic Checa O Nic 4 6 Chapter 5 Basic instruction ico cette ells MM lg Vescssssssensesscsscensenscsaces 5 1 MEE TEE en one re 5 1 5 2 Monitor Usage 47 2 AS AA 5 2 Chapter 6 Cleaning EE encres snreneenesnsenennennsensenrenneensee 6 1 AME EP SAS 7 RA A A CE RRR RE T RER 6 1 AS ii sissa 6 1 ASI A 2 AA RT 6 1 Annex A Electric connect diagram ss A 1 Annex B Electric diagram of modules ooocoocccononicocococanononncononnonnnnnonannnnonnonnnnnonnnon non nonannn non nonnna non nonncnnnnos B 1 VIII Chapter 1 Complete Appliance Introduction Chapter 1 Complete Appliance Introduction 1 1 Overview IRIS Vital Sign Patient monitor is one of the PMS8 monitor series products of the 3F Medical Company and is born on
27. nt all other parts can t be connected with patients except the defibrillation ECG cable supplied by pacemaker of 3F The high frequency electrical bistoury can t be touched the electrode when use it together with the monitor in order to avoid of burning the patients Forbidden to place the electrode onto the injured or edematous site to prevent infection Blood pressure measurement mode are forbidden to use in the blood pressure monitoring or test for neonates to prevent injuries Do not measure the blood pressure on the limbs with catheter or infusion Do not put on the cuff at or near the wounded position Local bleeding may be caused when using the blood pressure monitoring in the patients with severe bleeding tendency Be careful to use on the patients with sickle cell disease Forbidden to place the blood oxygen sensor onto the injured skin edematous or fragile tissues Discomfort or pain may be caused by the continuous use of the clip type of blood oxygen sensor especially in patients with micro circulation disorder Better not to place the sensor over 2 hours at the same place Non disposable accessories should be sterilized before it is used on next patient to prevent cross infection Opening the apparatus by the unauthorized personnel of our company is forbidden Don t need to note the user when the types of the accessories are changed To the disposal of package waste please deal with by the local waste law Note esp
28. o measured position alternately phototubes will receive the light into electrical signals 2 Signal processing parts The electric signal is amplified by the measuring amplifier and after high pass filter and program controlled amplification by A D conversion to digit It is through D A switch to control signal baseline and amplify to the communication signal to get an appropriate pulse wave A D conversion for the digital quantity is processed by SCM 3 Light emitting diode drivers control parts led transferring and light degree is controlled by the sequential circuits and DAC SCM control the size of the electric current according to algorithm requirements 4 SCM parts conclude by CPU RAM ROM and interface circuit 2 2 4 Temperature TEMP parameters Temperature measurement is to convert the temperature to the electrical signal by a sensor enlarge it by the amplifier and process into data The circuit is made of proportional amplifier which is constituted by operational amplifier Turned into voltage signal by the thermistor probe the temperature is magnified and sent to the A D converter 1 4 PMS8210A Service Manual Chapter 2 Patient Monitor parameters and theory Probe examination electric circuit is constituted to voltage comparator by operational amplifier When probe off the input voltage is lower than the comparison voltage and the voltage comparator outputs the low level when insert the probe the input voltage is
29. oard 1 10 M10 55 001 Print Paper 1 11 M10 92 050 Printer Slot 1 12 M10 71 032 AC DC Input 1 1 M10 45 020 13 GB T 845 1985 Self Tapping M3X8 Screws 1 14 M10 92 040 Name Plate 1 15 UL F002 Functional Ground Port 1 B 2 PMS8210A Service Manual Annex B Electric diagram of modules Sos No Std Code Name amp Spec Qty 1 M10 70 011 Front Housing Facing 1 2 M10 70 010 Front Housing Cover 1 3 M10 04 010 1 Alarm and Optic sense Eye Board 1 4 M10 04 010 2 Speaker Board 1 5 M10 70 050 Alarm Window 1 6 M10 01 010 Display and Key Board 1 7 M10 02 010 LCD Driver Board 1 8 G240320LTSW LCD 1 9 M10 70 030 Knob 1 10 M10 70 020 Key 1 11 M10 45 010 Knob Head 1 12 GB41 M3 Screws amp Nuts 9 13 7SEG3 0 8 3 8 LED Digital Tube 7 14 SMDLED LED Indicator Light 8 PMS8210A Service Manual B 3 Annex B Electric diagram of modules No Std Code Name amp Spec Qty 1 M10 71 010 SD Card Interface Panel 1 2 SD 1GDB SD Card 1 3 M10 55 001 Printer Interface 1 4 M10 07 010 Signals Process Board 1 5 M10 71 020 Signals Interface Panel 1 6 M10 92 013 ECG SpO2 NIBP TEMP interface 1 7 M00 06 020 Pump 1 8 M00 06 050 SD Card Slots 1 9 GB T9074 5 2004 Screws 2 10 M10 92 010 Right Name Plate 1 B 4 PMS8210A Service Manual
30. patient moves Keep patient still and adjust the cuff The measurement 1 The size of cuff is not fit error is large 2 NIBP module is bad 1 Select the correct size 2 Replace the NIBP module No SPO waveform The probe or module of SPO is damaged Replace the probe or module PMS8210A Service Manual 4 5 Chapter 4 Maintenance The SPO wave is ia Tie Dane ee 1 Keep patient still A 2 The ray of ambience is too A interfered strong 2 Weaken the rav of ambience Measurement of SPO The patient may be injected staining Before measuring exclude the is not correct material factor of the staining material 4 3 Periodic Check 1 The using life of the instrument is designed at 5 years 2 Clean the instrument and accessories often 3 Check the instrument once a year in its using life 4 Calibrate all kind of parameters once a year in its using life 5 Check the accessories once half a year in its using life 6 If the instrument with battery hasn t been used for a long time then it needs to be charged up once half a year at least Otherwise the battery performance will be affected or invalid The means to charge up is that plug into the power socket for about 4 8 hours at least 4 6 PMS8210A Service Manual Chapter 5 Basic instruction Chapter 5 Basic instruction 5 1 Basic instruction 5 1 1 Functional Button There are such below buttons fro
31. rpm 1 rpm the bigger one between 2 rpm or 2 Resp rate overruns asphyxiation sound light alarm and record the alarm status for review PMS8210A Service Manual Chapter 1 Complete Appliance Introduction 1 4 6 Temp Channel Measuring mode Measuring and Alarm Range Resolution Precision Actualization interval Average Time Constant Data unit 1 4 7 Others Power supply Ambulance power supply Internal battery input Power consumption 1 Thermal 0 50 C 32 122 F 0 1 C 0 1 C 25 45 C 0 2 C Others 1 Sec lt 10 Sec Cie 100 240VAC 10 50 60Hz 3Hz 40VA 9V 15V 6 4V 8 4V lt AOVA Display LED 3 2 colorful TFT LCD 320x240 Input NIBP ECG Temperature SpO2 Output Printer and internet CLASS According to the type of protection against electric shock Class internal power supply According to the degree of protection against electric shock Anti defibrillation CF type According to the degree of protection against ingress of water as detailed in the current edition of IEC 529 Ordinary equipment sealed equipment without liquid proof According to the degree of safety of application in the presence of a FLAMMABLE ANAESTHETIC MIXTURE WITH AIR or WITH OXYGEN OR NITROUS OXIDE not suitable for use in the presence of a FLAMMABLE ANAESTHETIC MIXTUREWITH AIR or WITH OXYGEN OR NITROUS OXIDE According to the mode of operation Continuous PMS8210A Service Manual 1 5 Chapter 1
32. rument is not therapeutic instrument The instrument must be operated under the direction of the professional medical staff All of the monitoring parameters are used as a reference and should not be used as the clinical diagnosis For abnormalities occurred clinical methods should be used to check out the reasons The instrument should not be operated in the circumstance with flammable gas or corrosive gas Prevent the liquid or electrical conductive substance entering into the instrument The instrument must be grounded correctly and the power supply must be in accordance with the specified requirement Delete all the previous data when monitoring a new patient Only one patient once If monitor connects to the other instrument the leakage circuit must be tested by qualified biological technician before use and must accord to IEC 60601 1 It can be used on many parts of this monitor together and the security meets the demand of IEC 60601 1 Make sure the connection is not dangerous to the patient or circumstance before the monitor connects to the other instrument Must use the defibrillation ECG cable supplied by 3F or the monitor can t be use together with defibrillator Checkout the alarm system periodically Do not touch the patient in defibrillation Otherwise it may lead to serious injury or death III All cables must be away from patient s throat to avoid asphyxia When using together with pacemaker or other electric equipme
33. sible causes Means to dispose The screen is black and power is not on the fuse is damaged the power is damaged Other components are short 1 Replace the fuse 2 Replace power 3 Confirm the component and replace The screen is black when power on 1 2 3 1 2 LCD or mainboard is damaged The lines of LCD is loose contact or damaged 1 Replace the LCD or mainboard 2 Re plug or replace the lines The word is ok but the waveform is not continuous Mainboard or parameters module is loose contact or damaged Base on the error display replace the module The operation or measurement is fault Mainboard or parameters module is damaged Base on the error display replace the module 1 The MAINS fluctuates 1 Check the MAINS and GROUND ine performance pl power gt Replace the power board or main Halt on sometime board or main board is not well board 3 The connector of power board or main board is not well 3 Replace or repair the connector PMS8210A Service Manual 4 3 Chapter 4 Maintenance 4 2 3 Error code displayed on the Screen The error code is only used in blood pressure measurement in this monitor Malfunction phenomena Possible cause Means to dispose Cuff tied incorrectly Tie the cuff again according to 2 3 The patient s arm with cuff is moving Keep the patient quiet when taking the blood pressure T
34. the base of the 3F PMS series multi parameter monitor Fully considered the increasing need of clinical applications 3F develops IRIS with the latest technology making it as a new generated medical electronic product IRIS monitor can monitor the patient s vital physiology signals including ECG RESP NIBP SPO2 and TEMP It can be used for adults pediatric and neonatal IRIS uses 50HZ 100V or 220V main power supply displaying real time data and waveform with 3 2 inches high definition color LCD and LED It can display one waveform or two and all monitor parameters can be connected to the central network monitoring system It equips with a 50mm thermal sensitive recorder and optional with a 8V built in replaceable amp rechargeable lithium battery It has many advantages full parameters compact size clear observation convenient usage and can be used for emergency monitoring 1 2 Model MODEL TRADE NAME SPECIFICATION CONFIGURATION l B NIBP TEMP Nellcor SpO l A NIBP TEMP 3F SpO PMS8210A IRIS g a II B NIBP TEMP Nellcor SpO2 ECG RESP II A NIBP TEMP 3F SpO gt ECG RESP 1 3 Tag Structure PMS8210A II II Product configuration code Without ECG Il With ECG RESP rate Product type code Vital Signs Patient Monitor LCD LED IRIS PMS8210A s trade name PMS8210A Service Manual 1 1 Chapter 1 Complete Appliance Introduction 1 4 Parameters 1 4 1 ECG Lead 3 lead RA LA LL 5lead RA RL LA LL V Lead opt
35. unction properly the screen display is OK and no error message the two waveforms can show correctly the parameters are refreshed every second the tracking time is precise too 3 1 3 Configuration Users can setup related function in MENU including the switch of the recorder ECG type of the lead network bed number setting and the switch of arrhythmia 3 1 4 Running Normally 1 When operate any key the patient monitor can run according to the operation manual s guidelines 2 When rotate or press the knob the patient monitor can run according to the operation manual s guidelines 3 Operate the patient monitor as the user s manual and check sound and audio alarm normal or not alarm mute and turn off alarm is working or not 4 Check the machine to make sure that the memory function is OK 3 1 5 Network function 1 Start Central Station and the bedside monitor make sure the net is connected and the bed number shows correctly 2 The transfer of data between IRIS and central station normally 3 Central Station receives waveform parameters alarm level alarm limits and the 3 2 PMS8210A Service Manual Chapter 3 Installation and inspection patient information correctly 4 Waveform parameters alarm level alarm limits and the patient information correctly turned to the central station 5 IRIS portable shutdown correctly after the Central Station response time required see the relevant technical indicators
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