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1. Hold the sensor with its opening towards the patient s index finger A The sensor should be oriented in such a way that the sensor side with a finger tip sign 1s positioned on the top Insert the patient s index finger into the sensor until the fingernail tip rests against the stop at the end of the sensor Adjust the finger to be placed evenly on the middle base of the sensor Direct the cable along the top of the patient s hand Apply adhesive tape to secure the cable B If an index finger cannot be positioned correctly or is not available other fingers can be used Plug the sensor into the oximeter and verify proper NY ai Lira Fa operation as described in the My oximeter operator s manual Inspect the monitoring site every 4 hours for skin integrity Cleaning amp Disinfection Unplug the sensor before cleaning or disinfecting Surface clean sensor and cable with a soft gauze pad by saturating it with a solution such as 70 isopropyl alcohol If low level disinfection is required use a 1 10 bleach solution Caution Do not sterilize by irradiation steam or ethylene oxide Warnings 1 This sensor is for use only with compatible patient monitors or pulse oximeter devices Use of this sensor with instruments other than compatibles may result in improper performance 2 Some factors may affect the accuracy of saturation measurements Such factors include excessive patient motion fingernail polish use o
2. SpO Finger clip Sensor reusable 14 User Manual for Vital Signs Monitor 3 If the neonate SpO sensor is used please follow Figure 3 7 to connect High ambient light sources such as surgical lights especially those with a xenon light source bilirubin lamps fluorescent lights infrared heating lamps and direct sunlight can interfere with the performance of an SpO sensor To prevent interference from ambient light ensure that the sensor is properly applied and cover Sensor adapter wrapper Y type sensor Figure 3 7 Neonate SpO sensor placement the sensor site with opaque material Failure to take this action in high ambient light conditions may result in inaccurate measurements If patient movement presents a problem verify that the sensor is properly and securely applied move the sensor to a less active site use an adhesive sensor that tolerates some patient motion or use a new sensor with fresh adhesive backing For reusable sensors follow the sensor directions for use for cleaning and reuse For single patient use sensors use a new sensor for each patient Do not sterilize any sensor by irradiation steam or ethylene oxide Safety Introductions for SpO Monitoring VIZ ee DOLO gt gt TAS gt ANS Continuous use of SpO sensor may result in discomfort or pain especially for those with microcirculatory problem It is recommended that the sensor should NOT be applied to the same place
3. Adult 175 mmHg Infant 135 mmHg Neonate 65 mmHg 8 Overpressure protection limit Adult lt 300 mmHg Infant lt 240mmHg Neonate lt 150 mm 9 NIBP measurement range SYS mmHg 40 255 40 200 40 135 MAP mmHg 20 215 20 165 20 110 10 NIBP accuracy Maximal mean difference 5 mmHg Maximal standard deviation 8 mmHg Measurement mode Manual Auto STAT 38 User Manual for Vital Signs Monitor 6 4 SpO Monitoring 1 Transducer dual wavelength LED Wavelength Red light 660 nm Infrared light 905 nm Maximal optical output power less than 2mW maximum average 2 SpO measuring range 35 100 3 SpO measuring accuracy Arms is not greater than 3 for SpO range from 70 to 100 NOTE Arms is accuracy defined as root mean square value of deviation according to ISO 9919 4 Low perfusion performance the declared accuracy is attained when the pulse amplitude modulation ratio 1s as low as 0 4 6 5 Pulse Rate monitoring 1 Pulse rate measuring range 30bpm 240bpm 2 Pulse rate measuring accuracy 2bpm or 2 whichever is greater 6 6 Data Recording 1 Sensitivity selection tolerance 5 2 Recording speed 25mm s 3 Recording speed accuracy 10 4 Hysteresis lt 0 5mm 5 Frequency response Monitoring mode 0 5 40Hz 6 Time constant Monitoring mode gt 0 3s 6 7 Other Technical Specifications 1 AC power supply voltage 100 240VAC 2 AC power frequency 50 60 Hz 3 Fuse specificat
4. Step 2 Install the paper to the printer properly pull the paper out of the printer for 2 cm as shown in figure 3 10 Step 3 Close the printer cover along the direction of arrow as shown in figure 3 10 Figure 3 10 printing paper 17 User Manual for Vital Signs Monitor 3 3 6 Battery Installation 1 Ensure that the monitor is not connected to AC power supply and the monitor is turned off 2 Open the battery cover and place the battery in the direction as shown in Fig 3 11 to insert the battery into any one of battery compartments Do not insert battery with their polarities reversed 3 Move the battery baffle to secure battery 4 Close the battery cover SI Underside view ne Battery Battery baffle Battery cathode a gt i Rubber gallus Battery cover Figure 3 11 Battery Installation Note e Do not insert battery terminal with its polarities reversed or the monitor can not be started e Please take out the battery before transport or storage 18 User Manual for Vital Signs Monitor Chapter 4 Operations 4 1 Initial Monitoring Screen When the parameter configuration of monitor is ECG SpO NIBP once powered up the LCD will display the initial monitoring screen this 1s the default display screen as well When the parameter configuration of monitor is SpO gt NIBP the screen will not display ECG waveform and data but the operation 1s similar PI 00
5. 0 WAVE CC Title Area T X1 Main Display Area Frobe off 03 11 30 25 Prompt Info Area Figure 4 1 ECG amp SpO monitoring screen Lead off amp Probe off Insert the ECG cable and SpO probe cable into the socket labeled ECG and SpO then attach the ECG leads to the electrodes placed on human body clip the SpO gt probe on patient s finger The LCD will display ECG waveform and plethysmogram at the same time as shown in Figure 4 2 PI 3 o0 WAVE 36 8 L mute C D 90 Figure 4 2 ECG amp SpO monitoring screen Default display screen 4 1 1 Default Display Screen Description Title area IT x1 ECG lead status and ECG waveform scale lt ECG indicate the current monitoring parameter is ECG lt gt 36 8 C temperature numerical value 19 lt gt User Manual for Vital Signs Monitor PI 3 0 the perfusion index is 3 o it displays only when Setup Menu SpO PI Display is set as ON Note PI display function is optional and it needs hardware support Main display area lt gt When ECG leads is attached on the patient and connected to the monitor well ECG waveform will be displayed in the main display area Meanwhile HR value will show on digital LED lt gt When SpO probe is clipped on the patient and connected to the monitor well SpO plethysmogram will be displayed in the main display area Prompt Info lt gt Status or event indica
6. 41 CHAPTER 7 PACKAGING AND ACCESSORIES cccsssscccssscccscscccsccees 45 User Manual for Vital Signs Monitor o EEC MONITORING aaa 46 8 1 1 How to Obtain High Quality ECG and Accurate Heart Rate Value ooooooonnnnnccncnnnnnnncnnnnnnnnnnnos 46 0 1 2 Factors affectine ECG Sinatra nidad adidas 4 0 2 NIBPMONITORING espresso dii 47 Belk Measurino PancpleLa ala 4 0 2 2 Factors affrectine INID PCAs UI aia isia 48 822 5 Clinical LIA A diia 49 SOPO MONITORING i aac 49 rome Messa Pace table 49 8 3 2 SpO Measurement Restrictions interference reason 50 8 3 3 Low SpO measuring value caused by pathology reason 50 Clinical tons rece dates taids 50 9 33 Pomts to be noted n SpO and Pulse Measurin ecco setae A AA AA 51 S4 TEMPERATURE MONITORING tddi OE 51 9 NO DISPLAY ON THE SCREEN dao DI 9 2 EXCESSIVE ECG SIGNAL INTERFERENCE OR TOO THICK BASELINE 0 52 9 3 NO BLOOD PRESSURE AND PULSE OXYGEN MEASURES cccccesecccesecceeeseceeeseceeeeceeeueeceeees 52 O BLANK PRINFINGPEAPPR srl 52 ID S TEM ALARM a 52 CHAPTER 10 MAINTENANCE siena nando 101 SERVICE AND EXAMINATION a collo 53 ADA EOI asa 53 IOE RO me Mantencion 53 TOI Batey Maimenan iea a a tad dent a E eadeeeaSeacdeions 53 A A A A iii 54 10 2 CLEANING STERILIZATION AND DISINFECTION cccocooccnnnnnnconnnnnnconnnnnnnocnnnnanocononoroconananoconanos 54 10 3 CLEANING STER
7. ECG and Accurate Heart Rate Value The electrocardiogram ECG or EKG is primarily a tool for evaluating the electrical events within the heart The action potentials of cardiac muscle cells can be viewed as batteries that cause charge to move throughout the body fluids These currents represent the sum of the action potentials occurring simultaneously in many individual cells and can be detected by recording electrodes at the surface of the skin The figure below shows the system of the heart Sinoatrial Node E _ Left Atrium SANI HIS Bundle Right Atrium HOWE SA TA Left Bundle h 7 ai Branch LBB Atrioventricular Node PF gt i a Left Posterior AVN SI ere a a Fascicle LPS Right Bundle RR ZONE Branch RBB Left Ventricle ___ Left Anterior Fascicle LAF Right Ventricle MR Purkinje Fibera PF First of all the hospital should be equipped with a 100 240V power supply system with a typical grounding wire If big interference in ECG continues connect one end of the grounding wire provided with this equipment to the grounding wire on the back panel of this monitor and the other end to the special grounding wire water pipe or radiator A common ECG plate electrode used together with this monitor has short shelf life Generally the shelf life 1s only one month after the package is opened When outdated plate electrode is used due to skin s contact impedance and big electrode potential the chance
8. No matter what 23 User Manual for Vital Signs Monitor step is as long as you press A or W key towards the other direction the step becomes 1 and towards the other direction 4 Press iP key press this key to shift to next display view Ey key Press it to print the current displayed trend graph se do key start cancel NIBP measurement XK key alarm silence switch press it to enable disable alarm silence 4 4 NIBP List Screen Short pressing iP Display key to shift the screen to NIBP List screen as shown in Figure 4 6 SYS DIA MAP PR 01 2010 04 07 09 15 10073 95 01 2010 04 07 09 16 105 7596 01 2010 04 07 09 17 1027394 01 2010 04 07 09 19 101 7190 mute C D 90 100 16 35 24 Figure 4 6 NIBP List The first column is the date the second column is NIBP measuring time the third column is NIBP value and the fourth column is pulse rate measured by NIBP module Up to 12000 groups of nonvolatile data can be stored in the monitor SYS DIA MAP indicates the value of systolic pressure diastolic pressure mean arterial pressure 4 4 1 Operation Instructions On NIBP List screen if NIBP measurement is more than 8 groups press A key or VW key to turn to previous next page for view other measurement values If NIBP measurement is not more than 8 groups the keys A or Y are not effective lt gt lt gt n m key press this
9. Spia Patient Info NIEP Date Time Nurse Call Default Probe off 01 19 56 07 Figure 4 10 Setup Menu Screen There are 8 functional groups for setting parameters ECG TEMP SpO NIBP Nurse Call System Patient Info Date Time and Default on the Setup Menu Screen 1 Press A key or W key to shift cursor to corresponding functional group setting 2 Pres MW key to confirm and enter into corresponding functional parameter setup screen 3 Pres Ey key under the setup menu will print ECG waveform 26 User Manual for Vital Signs Monitor 4 Press qu to ex1st from Setup Menu Screen Es At Setup Menu Screen or its submenu screen when pressing Ey key the default display screen will be printed The following will cover each functional parameter s setting up Note If you disable Hi and Lo limit alarm function of parameter monitoring all the alarms related to 1ts parameter monitoring will be disabled as well 4 7 1 ECG and Temperature Setup Lead Gain mV Enhancement mode store HR MA mi iso to 40 mola n ia ul Temperature probe Probe off 01 19 30 07 Figure 4 11 ECG TEMP Setup Screen Screen Description lt gt Lead ECG lead selection I H III AVR AVL AVF or V lt Gain ECG waveform scale x1 4 Waveform scaled with 1 4 of the base gain x1 2 Waveform scaled with half of the base gain x1 Waveform scaled with
10. automatic measurement of blood pressure By now automatic blood pressure measuring system based on the principle of oscillating method is mature In practice however various problems are encountered such as why the measures taken by the oscillating method is lower or higher than 47 User Manual for Vital Signs Monitor those taken by Korotkoff Sound Method Why the measures are inclined to decline Why in some cases no result is obtained in spite of the inflation actions Why the measure values have big discreteness and even abnormal data in some cases Why the SpO waveforms may disappear suddenly and so on The following explanations are devised to give the answers The Oscillating method vs the Korotkoff Sound Method Blood pressure measurement by the oscillating method and Korotkoff Sound Method has good correlation with the invasive measurement Notwithstanding any of the non invasive blood pressure measurements has its one sidedness when it is compared to the invasive measurement The oscillating method has its advantages over the Korotkoff Sound Method in less error higher reliability and stability Their differences may be reflected in the following aspects 1 The measures by the Korotkoff Sound Method are liable to effect of human factors For example different people may have different sound judging ability or different reactivity when listening to heart sound and reading mercury meter The air release speed and subjectivity
11. calibration for values determined by the oscillating method 4 The studies have shown that the Korotkoff Sound Method has the worst accuracy when it comes to measurement of hypotension while the oscillating method has worse accuracy when it comes to measurement of controlled hypertension relief 8 2 2 Factors affecting NIBP measuring lt gt Select a cuff of appropriate size according to the age of the subject lt gt Its width should be 2 3 of the length of the upper arm The cuff inflation part should be long enough to permit wrapping 50 80 of the limb concerned Prior to use of the cuff empty the cuff until there is no residual air inside it to ensure accurate measurement Make the cuff mark in the position where artery pulsates obviously the effect will be best The lower part of cuff shall 2cm above the elbow joint lt gt Do not wrap the cuff on too thick clothes especially for cotton padded clothes and sweater to take measurement lt gt The testee shall lie in bed or sit in chair make the cuff and heart at the same level the result will be most accurate other postures may have inaccurate result 48 User Manual for Vital Signs Monitor lt gt During measuring do not move your arm or the cuff lt The measuring interval shall longer than 2 minutes in continuous measurement too short interval may cause arm extrusion blood quantity increases then cause blood pressure increases lt gt Keep the pa
12. key to shift to next display view 5 y key print NIBP list di gt key start cancel measuring NIBP re X key alarm silence switch press it to enable disable alarm silence 24 User Manual for Vital Signs Monitor 4 5 SpO List Screen Short pressing i Display key to shift the screen to SpO List screen as shown in Figure 4 7 01 2012 05 25 09 15 01 2012 05 25 09 16 01 2012 05 25 09 17 01 2012 05 25 09 19 01 16 35 24 Figure 4 7 SpO List The first column is the date the second column is SpO measuring time the third column is SpO value and the fourth column is pulse rate Up to 2000 groups data which are lately measured can be stored in the monitor when it is out of power 4 5 1 Operation Instructions On SpO List screen if SpO value measurement is more than 8 groups press A key or WV key to turn to previous next page for view other measurement values If SpO measurement is not more than 8 groups the keys A or VW are not effective lt gt e cH key short press this key to shift to next display view Long press to enter the screen of Empty history records the user can delete all SpO records according to prompt Sp key print SpO list if the monitor equips with built in printer press this key again to stop printing q e do key start cancel measuring NIBP qo key alarm silence switch press it to enable disable alarm silence 4 6 ECG Recall S
13. new site at least every 4 hours Because individual skin condition affects the ability of the skin to tolerate sensor placement it may be necessary to change the sensor site more frequently with some patients If skin integrity changes move the sensor to another site 4 Do not apply tape to secure the sensor in place or to tape it shut venous pulsation may lead to inaccurate saturation measurements 5 Do not immerse sensor as it causes short 6 Do not use NIBP or other constructing instruments on same appendage as sensor for blood flow interrupted by NIBP cuff or circulatory patient condition will result in no pulse found or loss of pulse 7 Do not use the sensor or other oximetry sensors during MRI scanning 8 Carefully route cables to reduce the possibility of patient entanglement or strangulation 9 Do not alter or modify the sensor Alterations or modifications may affect performance or accuracy 10 Do not use the sensor if the sensor or the sensor cable appears damaged 63 User Manual for Vital Signs Monitor Creative offers a 6 month warranty against manufacturing defects for the SpO sensors mentioned above in its undamaged condition If you have any question regarding any of SpO sensor instructions please contact info creative sz com or your local dealer DI 1141 Budapest Fogarasi Ut 77 1095 Budapest Mester u 34 Tel 220 7940 220 8881 220 7959 Tel 218 5542 215 9771 215 7550 220 7814 364 34
14. of interference will be increased and the ECG baseline will have an unstable inclination Therefore always use valid plate electrodes 46 User Manual for Vital Signs Monitor 8 1 2 Factors affecting ECG signal Interference from Electrosurgical Unit Doesn t filter the interference waveform Poor grounding Electrodes are not placed properly Use expired electrode or use disposable electrode repeatedly The skin placed electrode is unclean or poor contract caused by scurf and hair gt gt gt Electrode long time used 8 2 NIBP Monitoring 8 2 1 Measuring Principle Blood pressure may be measured in an invasive way whereby the sensor will be inserted into blood vessel directly or a non invasive way The non invasive way includes several methodologies such as the Korotkoff Sound Method and oscillating method The Korotkoff Sound Method is used as a conventional way whereby stethoscope is used to measure the blood pressure By the oscillating method an inflation pump will fill the air and release it slowly A computer will record change of the cuff pressure when the air is released With this record the blood pressure value will be determined First of all make sure the signal quality judgment by computer meets the requirements of accurate calculation such as sudden limb movement or cuff being hit during the measurement If the answer is negative give up the calculation If the answer is positive proceed with calcu
15. patient type or rebuilding patients files lt gt unit unit of the blood pressure value mmHg or kPa can be selected Conversion 1kPa 7 5mmHg lt gt gt Page down icon When cursor stays in the unit filed press Y key to enter Tourniquet Setup Tourniquet Setup Screen Description lt gt Pressure when you use Tourniquet function you need to preset a cuff pressure for hemostasia The pressure is adjustable and its adjusting limit is different for different patient category for neonates preset range 70 100mmHg default value 90 mmHg for infants preset range 80 130 mmHg default value 110 mmHg for adults preset range 80 180mmHg default value 140 mmHg If the pressure drops down slowly under 10mmHg compared with the preset value due to little air leakage in the pneumatic system when time passes by the monitor will re inflate to maintain the cuff pressure close to the preset pressure value Note the unit of cuff pressure is the same with the NIBP unit in NIBP Setup lt gt Duration After presetting the cuff pressure you need to set the time period for maintaining the preset pressure after inflation 5 6 7 120 minutes adjustable The default value is 40 minutes If the set value is xx minutes the monitor will count down from xx minutes automatically when starting cuff inflation When time is up it will deflate au
16. pressure alarm is on 2 gt indicates systolic pressure alarm is off DIA Hi high limit of diastolic pressure alarm range 22 230 mmHg DIA Lo low limit of diastolic pressure alarm range 20 228 mmHg MAP amp mean arterial pressure alarm switch 42 indicates mean arterial pressure alarm is on JX indicates mean arterial pressure alarm is off MAP Hi high limit of mean arterial pressure alarm range 28 242 mmHg MAP Lo low limit of mean arterial pressure alarm range 26 240 mmHg Mode NIBP measuring mode manual AUTO 1 AUTO 2 AUTO 240 and STAT etc options AUTO 1 means NIBP measurement takes once every one minute automatically AUTO 60 means NIBP measurement takes once every 60 minutes automatically In AUTO mode 29 User Manual for Vital Signs Monitor the counting down timer 1s displayed in the Prompt Info area lt Initial pressure setup Cuff pre inflation pressure value is default for neonates pre inflation range 60 80mmHg default value 70 mmHg for infants pre inflation range 80 140 mmHg default value 100 mmHg for adults pre inflation range 80 200mmHg default value 150 mmHg Note In order to avoid inappropriate initial pressure value to do harm to patients pre inflation pressure value will resume the default value when measurement mode shifts or changing
17. then according to your need to make the device stay in the power saving mode or exit from power saving mode this function is optional and needs hardware support 26 SpO SpO sensor connector 27 NIBP NIBP hose connector 28 TEMP TEMP probe connector 29 ECG ECG cable connector 3 1 2 Side Panel The built in thermal printer is in the left panel It is easy for user to print waveform and data User Manual for Vital Signs Monitor 3 1 3 Rear Panel Figure 3 2 Rear Panel Introduction to the rear panel 1 Handle 2 Fan 3 Nameplate s A E E Manufacturer including address and date X Disposal of this device according to WEEE regulations EA 4 FUSE T3 15 A Fuse holder Fuse specification T3 15AL 250V 9 5 Xx 20mm 5 AC100 240V AC power supply socket 6 Loudspeaker 7 Mounting hole for hanging the monitor 8 NET serial communication port which is used to network with central monitoring system optional 9 Nurse call connector 10 Y Equipotential ground terminal User Manual for Vital Signs Monitor 3 2 Installation 3 2 1 Opening the Package and Check 1 Open the package take out the monitor accessories from the box carefully and place it in a safe stable and easy to watch position 2 Open the accompanying document to sort the accessories according to the packing list Inspect the monitor for any mechanical damages Check all the accessories for any scratch or deformity espe
18. to interference For those with a substantial amount of staining dilution drug such as methylene blue indigo green and acid indigo blue or carbon monoxide hemoglobin COHb or methionine Me Hb or thiosalicylic hemoglobin and some with icterus problem the SpO determination by this monitor may be inaccurate The drugs such as dopamine procaine prilocaine lidocaine and butacaine may also be a major factor blamed for serious error of SpO measurements As the SpO value serves as a reference value for judgment of anemic anoxia and toxic anoxia the measurement result of some patients with serious anemia may also present as good SpO value 50 User Manual for Vital Signs Monitor 8 3 5 Points to be noted in SpO and Pulse Measuring lt gt The finger should be properly placed see the attached illustration of this instruction manual or else 1t may cause inaccurate measurement result Make sure that capillary arterial vessel beneath the finger is penetrated through by red and infrared lights The SpO sensor should not be used at a location or limb tied with arterial or blood pressure cuff or receiving intravenous injection Do not fix the SpO sensor with adhesive tape or else it may result in venous pulsation and consequential inaccurate measurement result of SpO Make sure the optical path is free from any optical obstacles like adhesive tape Excessive ambient light may affect the measuring result It inc
19. will be effective again DO NOT silence the audible alarm or decrease its volume if patient safety could be compromised User Manual for Vital Signs Monitor 15 Alarm silence indicator When it is on it indicates that the monitor stays in alarm silence status 16 Ey Print the internal printer is optional press this key to print the current measuring data 17 A Up shift cursor forward upward 18 W OK to confirm selection or modification 19 W Down shift cursor backward downward 20 qu Display short time pressing to shift LCD display modes longtime pressing to enter into Setup Menu display screen 21 ok Waveform Freeze freeze the current displayed waveform 22 A ECG Lead Selection select ECG leads among I II III aVR aVL aVF and V 23 AC Power indicator A 24 Ma DC Power indicator AC Power indicator DC Power indicator ON green ON green this device is using mains power supply this device is using mains power supply and ON green ON orange the battery is being recharged Status ON green the battery is being used NS the battery 1s being used but battery voltage OFF ON orange blinking i i 1s low the beeper also gives warning the battery is being recharged while the ON green OFF e device 1s off 25 Power button Press power button for 3 seconds to start the monitor or shut off the monitor Note Short time pressing power button for entering the Power Saving Mode screen
20. 28 Fax 220 7940 216 7017 216 7018 Fax 218 5542 Mobil 30 531 5454 30 939 9989 Mobil 30 940 1970 20 949 2688 E mail delton delton hu Web www delton hu www medipek hu 64
21. 67 Hz 40 Hz i 0 4d A 2 bd BI 37 User Manual for Vital Signs Monitor Additional declarations to conform the particular standard of IEC 60601 2 27 Medical electrical equipment Part 2 27 Particular requirements for the safety including essential performance of electrocardiographic monitoring equipment Direct current for respiration leads off sensing and active noise suppression Applied current less than 0 1 microamperes AI Ventricular bigeminy 80BPM A2 Slow alternating ventricular bigeminy 60BPM rhythm A3 Rapid alternating ventricular bigeminy 120BPM A4 Bidirectional systoles 90BPM Response to irregular Time to ALARM for Waveform B1 Amplitude Average Time to Alarm 0 5 mV lt 8 Sec tachycardia 1 mV lt 8 sec 2mV lt 8 sec Waveform B2 Amplitude Average Time to Alarm lmV lt 8 sec 2mV lt 8 sec 4mV lt 8 sec 6 2 TEMP Monitoring 1 TEMP measuring range 21 0 300 C 2 TEMP measuring accuracy not greater than 0 2 C for TEMP measuring range from 25 0 C 45 0 C 3 TEMP responding time lt 150s 6 3 NIBP Monitoring 1 Measuring method Oscillometric Technique 2 Pneumatic pressure measuring range 0 mmHg 300mmHg 3 Accuracy of pressure measurement 3 mmHg 4 Cuff inflation time lt 10 seconds typical adult cuff 5 Measurement time on the average lt 90 seconds 6 Air release time while the measurement is canceled lt 2 seconds typical adult cuff 7 Initial cuff inflation pressure
22. A ES a 20 4 2 ECO MONITORING SCREEN ut pili ip 22 AD A DIS plays Che Description sra a 22 4 222 Operation LAS ICONS A A AAA AAA AAA A 22 A REND GRAPH DISPLAY ote el e bdo al 29 A AA a a 25 User Manual for Vital Signs Monitor 43 20 Pera con ASTUCIA Sas AAA ASA AA E E 23 AA NIB P LIST SCREEN it 24 4A Operation AS UIC ON a 24 AD SPO LIS TS CREEN ana 25 40 Operation Mmi O aaa ala 25 KOECO RECALLS CREEN aida 25 4 0 1 Operation Miu OSs a ei a anata eas 26 SE EOP MENUS CREEN a T ae 26 A A TCG and Temperature SEP 27 4 12 SPO SEU Pig E EE E E 28 ATONIBO SU ii 29 4 TA Nurse Call A a 32 SS A no caca CTE eT 32 A od One SAA E E AE E Ana 33 4 T7 DateTime re A id 34 A 0 RCCV WCEAUIE Sciimesianeaialeczalenbikalivaliaicslibaleniiai 34 LS POWERSAVING MODE orgenan ar E E AEN 34 CHAPTER SALARM nen 35 ARNO Y ele E ean 35 DZAEARMMODES inline 35 A S EE NOE cet 36 AAA RES IN e et See 36 5 5 VERIFY ADJUSTABLE ALARM FUNCTION cccccsssecccceseccccesecceseuseccecaeecceeaueeecesaueeccesaueeeeeas 36 CHAPTER 6 TECHNICAL SPECIFICATIONS ccsccssscccssccccscccsscceseece 37 ONE CG MONTON Clos ito 37 60 2 TEMP MONITORING gle aa 38 ANIB P MONITORING airline 38 OA SPO MONITORING sar liebe 39 6 3 PULSE RATE MONITORING ii fsi 39 DATARE ORDIN lie 39 6 7 OTHER TECHNICAL SPECIFICATIONS Sai 39 6 8 OPERATING ENVIRONMEN Tesis diia 39 67 CLASSIFICATION sno 40 6 10 GUIDANCE AND MANUFACTURER S DECLARATION ELECTROMAGNETIC COMPATIBILITY
23. Alarm Priority High Priority TOUR C D XXX seconds PR Over limit SpO over limit SYS over limit DIA Over limit MAP Over limit NIBP error 1 NIBP error 2 NIBP error 3 NIBP error 4 NIBP error 5 Air leak Cuff error NIBP over range Over motion Over pressure NIBP timeout Medium Priority Probe Off 5 2 Alarm modes When an alarm occurs the monitor responds with visual alarm indications which are shown by two ways alarm indicator and alarm message description and audible alarm indications Visual Alarm Indicators The flashing rates for the three categories of alarms are shown in the table below Indicator Color Alarm Category Flashing Rate Yellow flashing Medium priority alarm Yellow light Low priority alarm Constant on non flashing Table 5 1 Refer to Chapter 11 2 Alarm Information for detailed alarm message descriptions 35 User Manual for Vital Signs Monitor Audible Alarm Indications The audible alarm has different tone pitch and on off beep patterns for each priority category These are summarized in the Table below Alarm Category Tone Pitch Beep Chain High priority alarm 400Hz 10 beeps pause 3 sec Medium priority alarm 500Hz 3 beeps pause 5 sec Low priority alarm 500Hz Single beep Table 5 2 Note Visual alarm indicators can not be suspended or removed Audible alarms may be decreased in volume or silenced as described 5 3 Alarm Silence Press XK key to set or ac
24. ILIZATION AND DISINFECTION OF ACCESSORIES 0 55 IOASTORAGE oscar 55 10 5 TRANSPORTATION iia 55 CHAPLERILAPPENDE rari OO VI User Manual for Vital Signs Monitor 11 1 PROMPT INFORMATION EXPLANATIONS said 56 11 2 DEFAULT ALARMING VALUES AND SETUP RANGE erre 57 II SABBREVIATION OF ARRAY HIM A E ea 58 TANCES SORTES ST or 59 US TNS TRUCTIONS FOR SPO PROBE cuida 60 VII Chapter 1 Overview 1 1 Features n x A gt gt Blood Pressure SpO and Pulse Rate are displayed by big bright digital LEDs ECG waveform SpO plethysmogram and system parameters are displayed on color LCD Accurate NIBP measurement with hardware and software over pressure protection Unique SpO measuring technique ensures sensitive and accurate SpO Pulse Rate and Perfusion Index measurement HR and SpO trend curve display for last 12 24 or 96 hours 12000 groups of NIBP measurements nonvolatile can be stored and reviewed by list Up to 120 hour ECG waveform can be stored and recalled Audible amp visible alarm with 3 levels of alarm events Nurse call output 1s available With tourniquet function NIBP measurement 1s applicable to adult pediatric and neonate by patient selection Built in printer is optional to print out waveforms and text information 1 2 Product Name and Model Name Vital Signs Monitor Model PC 900 1 3 Intended Use This Monitor is a multi functio
25. Notes Attach the TEMP transducer to the patient generally if the TEMP transducer and skin doesn t contact closely the measured value becomes lower so for those who have requirement for temperature add a proper martial to transducer and fix it with adhesive tape to make them contact firmly Especially for pediatric patient they like sports pay more attention to the transducer fixing 51 C 37 C inside body cavity 36 5 C 37 7 C User Manual for Vital Signs Monitor Chapter 9 Troubleshooting 9 1 No Display on the Screen Shut down the machine and unplug the power Use a universal meter to check if the outlet has proper voltage if the power cable is in good condition and if the power cable is properly connected with this apparatus or outlet Remove the fuse from the back cover of this machine and make sure it is in good condition 9 2 Excessive ECG Signal Interference or Too Thick Baseline 1 Check if the plate electrodes are properly located and if valid plate electrodes are used 2 Check whether the lead wires are inserted properly If no ECG curve is displayed check if the ECG lead wires are broken 3 Make sure the mains outlet has standard grounding wire 4 Check if the grounding wire of the apparatus is properly grounded 9 3 No Blood Pressure and Pulse Oxygen Measures 1 Check if the blood pressure cuff is properly wrapped around the arm according to the operating instructions if the cuff leaks and
26. R alarm is on ZA gt indicates PR alarm is off PR Hr high limit of PR alarm range 22 250 gt gt PR Lo low limit of SpO alarm range 0 248 lt gt PI display on means PI display is enabled off means PI display is disabled Operation Instructions 1 Press A key or W key to move cursor to select parameter 2 Press MW key to confirm and active this parameter setting 3 Press A key or W again to adjust or modify parameter value 4 Press II key again to confirm and save the setting 5 Press qu key to return to upper level screen 28 User Manual for Vital Signs Monitor 4 7 3 NIBP Setup SY A Hi 100 Lo pressure duration DIA J Hi 180 Lo Alert T MAP M Hi 180 Initial Pressure NIBP Mode Probe off O1 19 44 50 Figure 4 13A NIBP Setup Figure 4 13B Tourniquet Setup Adjust Setup NIBP Call Mode 1 NIBP Call Mode 2 Gas Leak Cuff Error Figure 4 13C Adjust Setup NIBP Setup Screen Description lt gt lt gt lt gt SYS Q systolic pressure alarm switch 4 indicates systolic pressure alarm is on RK indicates systolic pressure alarm is off SYS Hi high limit of systolic pressure alarm range 32 250 mmHg SYS Lo low limit of systolic pressure alarm range 30 248 mmHg DIA 2 diastolic pressure alarm switch amp indicates diastolic
27. Signs Monitor should assure that it is used in such an electromagnetic environment Compliance IMMUNITY test IEC 60601 test level level Electromagnetic environment guidance Portable and mobile communications equipment should be used no to any part of PC 900 Vital Signs Monitor including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance d 124P d 12 JP MHzw 800 MHz Conducted RF 3 Vrms d 234P 300 MHz 2 5 GHz ice PORZIO SOIL Where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in metres m j Field strengths from fixed RF transmitters as Radiated RF 3Vim determined by an electromagnetic site survey should be less than the compliance level in each IEC 61000 4 3 80 MHz to 2 5 GHz frequency range Interference may occur in the vicinity of equipment marked with the following symbol x NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV bro
28. T CREATIVE MEDICAL Vital Signs Monitor PC 900 User Manual User Manual for Vital Signs Monitor This Manual is written and compiled in accordance with the IEC 60601 1 Medical electrical equipment Partl General requirements for safety and MDD 93 42 EEC It complies with both international and enterprise standards and is also approved by State Technological Supervision Bureau The Manual is written for the current PC 900 Vital Signs Monitor The Manual describes in accordance with the Vital Signs Monitor s features and requirements main structure functions specifications correct methods for transportation installation usage operation repair maintenance and storage etc as well as the safety procedures to protect both the user and equipment Refer to the respective chapters for details The Manual is published in English and we have the ultimate right to explain the Manual No part of this manual may be photocopied reproduced or translated into another language without the prior written consent We reserve the right to improve and amend it any time without prior notice Amendments will however be published in a new edition of this manual Version of This Manual Ver 1 6 January 24 2013 All rights reserved Marks in the Manual 6 Warning must be followed to avoid endangering the operator and the patient A Attention must be followed to avoid causing damage to the monitor gt Note some important informati
29. adcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters and electromagnetic site survey should be considered If the measured field strength in the location in which PC 900 Vital Signs Monitor 1s used exceeds the applicable RF compliance level above PC 900 Vital Signs Monitor should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating PC 900 Vital Signs Monitor b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3V m 43 User Manual for Vital Signs Monitor Table 4 Recommended separation distances between portable and mobile RF communications equipment and The equipment or system for EQUIPMENT and SYSTEM that are not LIFE SUPPORTING PC 900 Vital Signs Monitor is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the equipment or system can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the equipment or system as recommended below according to the maximum output power of the communications equipment Separation distance according to frequency of transmitter Rated maximum output power of SOMHz to 2 5GHz transmitter For transmitters rated at a maximum out
30. against the stop so that it is over the sensor window A If an index finger cannot be positioned correctly or 1s not available other fingers can be used 2 Note When selecting a sensor site priority should be given to an extremity free of an arterial catheter blood pressure cuff or intravascular infusion line 3 Spread open the rear tabs of the sensor to provide even force over the length of the pads B 4 The sensor should be oriented in such a way gt 5 that the cable is ia 5A El A positioned along the fe top of the hand C AQ Bb E 5 Plug the sensor into the oximeter and verify proper operation as described in the oximeter operator s manual 6 Inspectthe monitoring site every 4 hours for skin Integrity 7 Before each use surface clean sensor and cable with a soft gauze pad by saturating it with a solution such as 70 isopropyl alcohol If low level disinfection is required use a 1 10 bleach solution Caution Do not sterilize by irradiation steam or ethylene oxide Warnings 1 Some factors may affect the accuracy of saturation measurements Such factors include excessive patient motion fingernail polish use of intravascular dyes excessive light poorly perfused finger extreme finger sizes or improper placement of the sensor 2 Using the sensor in the presence of bright lights may result in inaccurate measurements In such cases cover the sensor site with an opaque material 3 The sensor must be moved to a
31. ases Storage environment ambient temperature 20 60 C relative humidity 10 95 atmosphere 50kPa 107 4kPa 10 5 Transportation This monitor should be transported by land vehicle or railway or air in accordance with the contractual terms Do not hit or drop it with force 55 User Manual for Vital Signs Monitor Chapter 11 Appendix 11 1 Prompt information explanations The repeated measurement due to moving excessive noise during the Over motion stepping inflation and measuring pressure and pulse e g during patient shaking motion Cuff press exceeds the safety limit value of software Limit value for adult Over pressure 290mmHg Limit value for pediatric 145mmHg Or caused by cuff extrusion or flapping cuff with force Adult measurement is more than 120 seconds neonate measurement is more NIBP timeout than 90 seconds 56 User Manual for Vital Signs Monitor 11 2 Default Alarming Values and Setup Range The default alarming value e Adult Pediatric Neonate Parameter High limit 130mmHg 110mmHg Low limit SOmmHg High limit 120mmHg 90mmHg 90mmHg DIA Low limit 50mmHg High limit 160mmHg Low limit 50mmHg 40mmHg 30mmHg High limit 100 SpO 2 Lowlimi The high and low limits setting range eee Adult Parameter 1 350 bpm 0 349 bpm 30 280 mmHg 29 279 mmHg 11 232 mmHg 1 350 bpm 1 350 bpm 0 349 bpm 0 349 bpm 30 200 mmHg 30 135 mmHg 29 199 mmHg 29 134 m
32. base gain x2 Waveform scaled with twice of the base gain lt ImV generating internal 1mV calibration signal This signal is used to test the function of the machine It 1s not used during normal operation The default set 1s off lt gt Enhancement mode the switch of ECG enhancement mode lt gt HR 2 HR alarm switch A indicates HR alarm is on XA indicates HR alarm is off lt gt HR Hi Lo high low limit of HR alarm lt gt TEMP amp temperature alarm switch indicates temperature alarm is on XA indicates temperature alarm is off lt gt TEMP Hi Lo high low limit of temperature alarm lt gt Unit body temperature unit Two options C or F Conversion relation 1 F CX1 8 32 27 User Manual for Vital Signs Monitor lt Store decide whether to store ECG data or not If your selection is off thereafter the ECG data measured will not be stored lt gt T probe the type of temperature probe KRR 4 7 2 SpO Setup Probe off O1 19 30 07 Figure 4 12 SpO Setup Screen Screen Description lt gt SpO 2 SpO alarm switch amp indicates SpO alarm is on XA indicates SpO alarm is off SpO Hi high limit of SpO alarm range 1 100 SpO Lo low limit of SpO alarm range 0 99 PR 22 pulse rate alarm switch amp indicates P
33. bout 1 second to turn on or turn off the alarm sound temporarily Long time press it to enter into the alarm setup shortcut menu as shown in figure 4 3 If not turn off ECG Lead off and SpO Probe off manually after alarm lasts for 5 minutes system will resume alarm silence status Setup Alarm ECG Lead Off SPO Probe Off SpO Probe Off 03 11 30 25 Figure 4 3 Alarm setup shortcut screen Alarm setup operation description 1 Press A key or W key to move cursor to select parameter 2 Press MW key to confirm and enter into corresponding alarm parameter setup screen Press A key or Y key again to turn off corresponding lead off alarm 3 Press qu to ex1st from Setup Menu Screen 21 User Manual for Vital Signs Monitor 4 2 ECG Monitoring Screen Short pressing iP Display key to shift the screen view to ECG monitoring screen as shown in Figure 4 4 ECG 36 80 Probe off Figure 4 4 ECG Monitoring Screen Note if you need to store the measuring data please set the option of store as on on ECG TEMP setting screen 4 2 1 Display Screen Description Title area lt gt Il X1 ECG lead status and ECG waveform scale lt ECG indicate the current monitoring parameter is ECG lt gt 36 8 C temperature numerical value Main display area lt gt When ECG leads is attached on the patient and connected t
34. cially on connector wire and probe parts You can customize the module configuration by choosing necessary modules to meet your own needs Therefore your monitor may not have all the monitoring functions and accessories If in doubt please contact the local dealer or our company in case of any problems We are to offer you the best solution for your satisfaction 3 2 2 Connecting the Power Supply 1 When powered by AC mains power supply Make sure that the AC power supply is 100 240VAC 50 60Hz Use the power cable prepared by the manufacturer Insert one end of it to the power port of the monitor and the other end to the grounded three phase power jack To eliminate potential differences the monitor has a separate connection to the equipotential grounding system Connect one end of the provided ground cable to equipotential grounding port on the rear of the monitor and connect the other end to one point of the equipotential grounding system Caution ensure that the monitor is grounded correctly After the supply mains has been interrupted when power switch remains in the on position and is restored after a period of time that is longer than 30 seconds the monitor will run by the last settings when restarting the monitor 2 When powered by built in battery Caution it s better to recharge the battery after it is used up the charging time should be 13 15 hours long The provided battery of the monitor must b
35. creen Short pressing i Display key to shift the screen to Default ECG Recall screen as shown in Figure 4 8 On this screen the latest 120 hour ECG data stored in monitor can be reviewed recall PID stsrt end 03 2010 01 14 16 00 34 16 01 54 view 03 2010 01 14 10 35 12 11 14 42 03 11 30 25 Figure 4 8 Default ECG Recall Screen 23 User Manual for Vital Signs Monitor 4 6 1 Operation Instructions 1 Press MW key to confirm view 2 Then press A gt key or W key to shift yellow selecting box to choose a record After pressing I key to confirm its recorded ECG waveform will display on screen recall I x1 65 16 00 34 PID stsrt end 03 2010 01 14 16 00 34 16 01 54 META 03 2010 01 14 10 35 12 11 14 42 03 11 30 25 Figure 4 9 Recalled ECG Waveform 3 Press A key or W key to turn to the previous next page to view recalled ECG waveform 4 Press MW to back to Default ECG Recall screen Note If the setting of store on ECG TEMP setting screen 1s off thereafter the ECG data measured will not be stored 4 7 Setup Menu Screen At any display view screen long time press O Display key to shift the screen to Setup Menu screen as shown in Figure 4 10 All the functional parameters of the system can be set through Setup Menu Setup Menu ECG TEMP System
36. d to the limb Continuous use of SpO sensor may result in discomfort or pain especially for those with microcirculatory problem It is recommended that the sensor should NOT be applied to the same place for over two hours change the measuring site periodically if necessary SpO measuring position must be examined more carefully for some special patient Do NOT install the SpO sensor on the finger with edema or vulnerable tissue To prevent the risk of the short circuit and to ensure the ECG signal quality the equipment must be properly grounded Although biocompatibility tests have been performed on all the applied parts some exceptional allergic patients may still have anaphylaxis Do NOT apply to those who have anaphylaxis All the connecting cables and rubber tubes of the applying parts should be kept away from the patient s cervix to prevent any possible suffocation of the patient All the parts of the monitor should NOT be replaced at will If necessary please use the components provided by the manufacturer or those that are of the same model and standards as the accessories along with the monitor which are provided by the same factory otherwise negative effects concerning safety and biocompatibility etc may be caused DO NOT stare at the infrared light of SpO sensor when switch it on for the infrared may do harm to the eye If the monitor falls off accidentally please do NOT operate it before its safety and technical i
37. e is HR measuring value Display HR or PR value when the set of Setup Menu System priority is HR it shows HR value here preferentially 1f the set is PR PR value will be shown preferentially PR priority indicator if PR indicator is on it indicates that the numerical value beside is pulse rate value Unit bpm beats per minute If SpO and NIBP are monitoring at the same time only the PR value measured through SpO probe is displayed here and the PR measuring by NIBP measurement is undergoing and recorded in NIBP list SpO Display SpO gt value Unit Bar graph of pulse intensity LCD panel Pulse sync indicator patient category indicator M for adult If for pediatric fs for neonate Patient category is selected under sub menu Patient Info within the setup menu Pulse sync indicator Cardio pulse pulse sync indicator When HR priority indicator is on its flashing is synchronized with heart beat When PR priority indicator is on its flashing 1s synchronized with pulse NIBP start cancel NIBP measurement XK Alarm silence key Enable disable alarm silence function When the alarm silence indicator on the left of keys is on it means the system is in alarm silence status and it lasts this status for 2 minutes When finishing counting down the system will resume normal alarm status automatically if alarm event occurs at this time the alarm sound
38. e recharged after transportation or storage So if the monitor is switch on without being connected to the AC power socket it may not work properly due to insufficient power supply 3 2 3 Starting the Monitor The system performs self test and enters initial display after switching on the monitor and the orange alarm indicator blinks to inform that the user can begin operating it 9 Check all the applicable functions to make sure that the monitor works normally 0 If the battery is applied please recharge it after using the monitor to ensure sufficient power storage It will take minimal 8 hours to charge battery from depletion to 90 charge User Manual for Vital Signs Monitor Do not use the device to monitor the patient if there are indications of damage or reminders of error Please contact the local dealer or our company A It s recommended to delay 1 minute to start it again 3 3 Sensor Placement and Connection 3 3 1 ECG Cable Connection ECG measurement is to collect the ECG signal via the ECG electrodes Electrode connects the patient and the lead The lead connects the monitor The locations of the electrodes are very important for obtaining accurate ECG signals 1 Connect the cable to the right panel connector marked with the ECG icon 2 Select electrodes to be used Use only one type of electrode on the same patient to avoid variations in electrical resistance For ECG monitoring it is strongly recommended to use sil
39. e the cursor to inspect the SpO value at the given time lt gt SpO indicate that the trend graph beside it is SpO trend Let the cursor stay here and press W key to confirm then press A key or W key again to select trend graph type SpO SpO trend graph HRP HR trend graph 4 3 2 Operation Instructions 1 Press A key or W key to highlight trend length or cursor on selection 2 Press MW key to confirm 3 Press A key or W key again to select value of trend length 12 24 96 hours if the selecting box stays in trend length option or to move the cursor if the selecting box stays in cursor on option Instructions for viewing the trend curve e Select cursor on and press MW key to confirm and cursor on becomes cursor off then you can press A key or W key to move the vertical cursor the list box below will display SpO HR value and the time value at the point where the cursor stays Move cursor back and forth this way you can view the SpO HR trend 12 24 96 hours long Press MW key again to exit trend viewing e When pressing A key or Y key to move cursor the moving step is variable The rule is that the initial step is 1 point after pressing A or W key towards the same direction for 5 times the step becomes 5 points and with 5 more pressing the step becomes 10 then 20
40. ement Restrictions interference reason lt gt Intravascular dyes such as indocyanine green or methylene blue Exposure to excessive illumination such as surgical lamps bilirubin lamps fluorescent lights infrared heating lamps or direct sunlight Vascular dyes or external used color up product such as nail enamel or color skin care Excessive patient movement Placement of a sensor on an extremity with a blood pressure cuff arterial catheter or intravascular line Exposure to the chamber with high pressure oxygen There 1s an arterial occlusion proximal to the sensor Blood vessel contraction caused by peripheral vessel hyperkinesias or body temperature decreasing 8 3 3 Low SpO measuring value caused by pathology reason gt Hypoxemia disease functional lack of HbO Pigmentation or abnormal oxyhemoglobin level Abnormal oxyhemoglobin variation Methemoglobin disease Sulfhemoglobinemia or arterial occlusion exists near sensor Obvious venous pulsations Peripheral arterial pulsation becomes weak Peripheral blood supply 1s not enough 3 3 4 Clinical Limitations lt gt As the measure is taken on the basis of arteriole pulse substantial pulsating blood stream of subject 1s required For a subject with weak pulse due to shock low ambient body temperature major bleeding or use of vascular contracting drug the SpO waveform PLETH will decrease In this case the measurement will be more sensitive
41. eonate 140mmHg Table B After the verification do press the button again to return to normal working mode then continue other operation or the NIBP key will be invalid Pressure accuracy verification must be operated by technician or equipment manager Doctor or nurse is not allowed to do the verification it is very dangerous especially when the pressure cuff is still on patients gt Air Leakage Check In order to avoid significant error of blood pressure measurement or even no measurement result caused by air leakage in the pneumatic system including the cuff during measuring it is recommended to check if there is leak in the pneumatic system as well Please remove the cuff from patient while performing the leakage check Safety Instructions for NIBP Monitoring VIZ When taking the measurement of a pediatric or an infant or neonate s less than 10 years old blood pressure do NOT operate in the adult mode The high inflation pressure may cause lesion or even body putrescence It is recommended to take the blood pressure measurement manually Automatic measurement should be used at the presence of a doctor nurse NIBP monitoring is prohibited to those who have severe hemorrhagic tendency or with sickle cell disease or partial bleeding will appear Pay attention to the color and sensitivity of the limb when measuring NIBP make sure the blood circulation is not blocked If blocked the limb will discolor p
42. equipment like a mercury pressure meter 191911 310559104 poog Amat NIBP cuff with dual air tube E Air tube Agr vent Manual valve ay module testing Increase the pressure manually software Inflatable balloon through the inflatable balloon inside of this monitor Figure 3 5 Connection of Pressure calibration fixture Mode 1 The inflation can be activated by Monitor so the pressure will increase automatically until it exceeds the limit value specified in table A This pressure limit value depends on the patient type selection as shown in table A Child 200mmHg Neonate 120mmHg Table A During the inflation the Monitor will close the deflating valve and the pressure value will be shown during the process If there 1s no manual deflation operation the pressure will persist until deflation by manual operation so it is necessary to use a manual valve for doing adequate deflation in several steps to verify the pressure accuracy in the full scale of measurement range Mode 2 No automatic inflation by Monitor during the pressure accuracy verification Increase the pressure manually by the pumping balloon and the verification can be done by applying different pressure value manually If the increased pressure exceeds the given limit as shown in table B the Monitor will deflate automatically because of over pressure protection 12 LA LA User Manual for Vital Signs Monitor 0m Child 240mmHg N
43. f intravascular dyes excessive light poorly perfused finger extreme finger sizes or improper placement of the sensor 3 The sensor site must be checked for skin integrity at least every 4 hours Because individual skin condition affects the ability of the skin to tolerate sensor placement it may be necessary to change the sensor to another finger 4 Do not use NIBP or other constructing instruments on same appendage as sensor for blood flow interrupted by NIBP cuff or circulatory patient condition will result in no pulse found or loss of pulse Do not use the sensor during MRI scanning 5 Carefully route cables to reduce the possibility of patient entanglement or strangulation 6 Do not alter or modify the sensor Alterations or modifications may affect performance or accuracy 7 Do not use the sensor if the sensor or the sensor cable appears damaged Instructions for Adult SpO Finger Clip Sensor 62 User Manual for Vital Signs Monitor Intended Use When used with a compatible patient monitor or a pulse oximeter device the sensor is intended to be used for continuous non invasive functional arterial oxygen saturation SpO and pulse rate monitoring for patients weighing greater than 40kg Contraindications This sensor is contraindicated for use on active patients or for prolonged use Instructions for Use 1 With the upper and lower jaws open place an index finger evenly on the base of the clip Push the finger tip
44. for over two hours change the measuring site periodically if necessary SpO measuring position must be examined more carefully for some special patient Do NOT place the SpO sensor on the finger with edema or fragile tissue If sterile packaging of SpO sensor is damaged do not use it any more Check the SpO sensor and cable before use Do NOT use the damaged SpO sensor When the temperature of SpO sensor is abnormal do not use it any more Please do not allow the cable to be twisted or bended Do NOT put the SpO2 sensor and pressure cuff on the same limb otherwise the NIBP measuring will affect SpO2 measuring and cause the alarm error Using nail polisher or other cosmetic product on the nail may affect the accuracy of measurement The fingernail should be of normal length The SpO2 sensor can not be immerged into water liquor or cleanser completely because the sensor has no capability to resist the harmful ingress of water 15 User Manual for Vital Signs Monitor 3 3 4 TEMP Transducer Connection Connecting methods 1 Attach the transducers to the patient firmly 2 Connect the cable to TEMP probe connector in the front panel Note When unplugging the probe be sure to hold the head of the connector and pull it out 3 3 5 Loading printing paper Operation procedures for loading printing paper 1 Press both OPEN notches with force on printer shield with two thumbs to open it 2 Move the tab of rubber r
45. graph will become empty 33 User Manual for Vital Signs Monitor 4 7 7 Date Time yy 07 mm os da 21 hh 10 mm 15 ss 20 Probe off OL 12 17 50 Figure 4 17 Data Time Setup Screen Screen Description lt gt yy 07 mm09 dd 21 date setting 07 09 21 shows the date is September 21 2007 lt hh10 mmil5 ss 20 time setting 09 20 21 shows the time is10 15 20 4 7 8 Recover Default Settings On Setup Menu screen press A button or W button to shift cursor to Default and then press W button all the setting parameters will be reset to factory default setting value 4 8 Power Saving Mode On the initial display screen you can make the monitor stay in power saving mode for power saving Short time press power button to shift screen to Power Saving Mode display screen as shown in Figure 4 18 Power Saving Mode Enter into power saving mode Probe off O1 20 14 57 Figure 4 18 Power Saving Mode Press A button or Y button to shift cursor to yes or no and press mM button to confirm If your selection is yes all the numerical values displayed on digital LEDs display become darker and the monitor stays in power saving mode Short time press power button again to shift screen to Power Saving Mode display screen for exiting the sleeping mode 34 User Manual for Vital Signs Monitor Chapter 5 Alarm 5 1
46. hours Because individual skin condition affects the ability of the skin to tolerate sensor placement it may be necessary to change the sensor site more frequently with some patients If skin integrity changes move the sensor to another site Do not apply tape to secure the sensor in place or to tape it shut venous pulsation may lead to inaccurate saturation measurements Do not immerse sensor as it causes short Do not use NIBP or other constructing instruments on same appendage as sensor for blood flow interrupted by NIBP cuff or circulatory patient condition will result in no pulse found or loss of pulse Do not use the sensor or other oximetry sensors during MRI scanning Carefully route cables to reduce the possibility of patient entanglement or strangulation Do not alter or modify the sensor Alterations or modifications may affect performance or accuracy 10 Do notuse the sensor if the sensor or the sensor cable appears damaged 61 User Manual for Vital Signs Monitor Instructions for Adult SpO Finger Rubber Sensor Intended Use When used with a compatible patient monitor or a pulse oximeter device this SpO sensor is intended to be used for continuous non invasive functional arterial oxygen saturation SpO and pulse rate monitoring for patients weighing greater than 50kg Contraindications This sensor is contraindicated for use on active patients or for prolonged use Instructions for Use 1 2 3 4
47. if the infant mode 1s selected Prior to use of the cuff empty the cuff until there is no residual air inside it to ensure accurate measurement Do NOT twist the cuff tube or put heavy things on it When unplugging the cuff hold the head of the connector and pull it out The symbol indicates that the cable and accessories are designed to have special protection against electric shocks and is defibrillator proof 3 3 3 SpO Sensor Connection SpO gt sensor is a very delicate part Please follow the steps and procedures in operating it Failure to operate it correctly can cause damage to the SpO sensor Operation procedure 1 Connect the SpO sensor to the connector labeled SpO When unplugging the probe be sure to hold the head of the connector and pull it out 2 If the finger clip SpO sensor is used insert one finger into the sensor index finger middle finger or ring finger with short nail length as shown in the figure below Figure 3 6 Finger clip SpO sensor placement When selecting a sensor consider the patient s category adequacy of perfusion availability of probe site and anticipated monitoring duration Use only SpO probes provided by our company with this monitor Read the following table for SpO probe information Refer to Chapter 11 5 for the detailed instructions of each SpO probe SpO Probe Patient Category SpO Finger clip Sensor reusable SpO Finger rubber Sensor reusable
48. if the inlet is closely connected with the NIBP jack on the side panel Check if the indicator of the pulse oxygen probe flashes and if the pulse oxygen probe is properly connected to the SpO jack on the side panel 2 If the problems still exist please contact the local dealer 9 4 Blank Printing Paper 1 Check whether the printing paper is installed with its face reversed Please reinstall it and let the sensitive page face upward 2 Ifthe problems still exist please contact the local dealer 9 5 System Alarm 1 When the parameter value is higher or lower than the alarm limits the alarm will ring Please check whether the alarm limit value is proper or the condition of the patient 2 Probe off Please check the connection of the probes Note In case of trouble of this machine in the service follow the instructions below to eliminate the problem first If the attempt fails contact the dealer in your local area or the manufacturer Do not open the cabinet without permission a2 User Manual for Vital Signs Monitor Chapter 10 Maintenance 10 1 Service and Examination 10 1 1 Daily Examination Before using the monitor the checks below should be carried out Check the monitor for any mechanical damage Inspect the exposed parts and the inserted parts of all the leads and the accessories Examine all the functions of the monitor that are likely to be used for patient monitoring and ensure that it is in good
49. in current inside battery so it is suggested that user should press the power button again to cut off the power supply If battery keeps in a state of small drain current battery will be damaged and can t be repaired because of excessive discharged s recommended to use the battery once a month to ensure its strong power supply capacity and long service life and recharge it after running out of the power a If battery is damaged please replace with same type and specification battery marked by CCC or CE in time or contact the company directly 10 1 4 Service If the monitor has functional malfunction or is not working please contact the local dealer or our company and we are to offer the best solution as soon as possible for your satisfaction Only qualified service engineer specified by the manufacture can perform the service Users are not permitted to repair 1t by themselves 10 2 Cleaning Sterilization and Disinfection E Kept the monitor from dust m It is recommended to clean the outer shell and screen of the monitor to keep it clean Only non corrosive cleanser such as clear water is permitted NW Use the cloth with alcohol to wipe the surface of the monitor and transducers and dry it with dry and clean cloth or simply air dry E The monitor can be sterilized and disinfected please clean it first Switch off the monitor and disconnect the power cable before cleaning Do not let the liquid clea
50. ion T3 15AL 250V 5 X 20mm 4 Internal power supply 12VDC rechargeable 5 Battery specification 12V 2 3AH sealed lead acid battery 6 8 Operating Environment Working Environment Ambient temperature range 5 C 40 C Relative humidity 30 80 Atmospheric pressure 70kPa 106kPa Transport and Storage Environment Ambient temperature range 20 C 60 C 39 User Manual for Vital Signs Monitor Relative humidity 10 95 Atmospheric pressure 50 0kPa 107 4kPa 6 9 Classification Safety standard IEC 60601 1 The type of protection against electric shock Class equipment The degree of protection against electric shock Type BE CF applied parts Electro Magnetic Compatibility Group I Class A 40 User Manual for Vital Signs Monitor 6 10 Guidance and manufacturer s declaration Electromagnetic compatibility Table 1 Guidance and manufacturer s declaration electromagnetic emission for all EQUIPMENT AND SYSTEM PC 900 Vital Signs Monitor is intended for use in the electromagnetic environment specified below The customer or the user of the equipment or system should assure that it is used in such an environment Emissions test Compliance Electromagnetic environment guidance RF emissions Group PC 900 Vital Signs Monitor uses RF energy only for its CISPR 11 internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF em
51. issions Class A PC 900 Vital Signs Monitor is suitable for use in all CISPR 11 establishments other than domestic and those directly connected to the public low voltage power supply network Harmonic emissions Class A A that supplies buildings used for domestic purposes IEC61000 3 2 Voltage Complies fluctuations flicker emissions IEC61000 3 3 41 User Manual for Vital Signs Monitor Table 2 Guidance and manufacturer s declaration electromagnetic immunity for all EQUIPMENT AND SYSTEMS PC 900 Vital Signs Monitor 1s intended for use in the electromagnetic environment specified below The customer or the user of the equipment or system should assure that it is used in such an environment Immunity test Electrostatic discharge ESD IEC61000 4 2 Electrical transient burst IEC61000 4 4 Surge IEC 61000 4 5 Voltage dips variations on supply input lines IEC61000 4 11 Power frequency 50Hz 60Hz magnetic field IEC61000 4 8 short interruptions and voltage power IEC60601 test level 6 kV contact 8kV air 2kV for power Supply lines 1 kV for input output lines 1kV line s to line s 2kV line s to earth lt 5 Ur gt 95 dip in LU for 0 5 cycle 40 Ur 60 dip in Uv for 5 cycles 70 Ur 30 dip in Uv for 25 cycles lt 5 Ur gt 95 dip in UT for 5 5 Compliance level 6 kV contact 8kV air 2kV for power Supply lines kV for input
52. lation of the blood pressure value As change of the blood pressure is recorded by electric sensor which sensitivity is much higher than that of human ears the oscillating method uses different definitions for measurement of diastolic pressure mean arterial pressure and systolic pressure from the Korotkoff Sound Method When the oscillating method is used the circuit in the measuring apparatus will separate the amplitude of the cuff pressure from its change with pulsation With the oscillating method the blood pressure at the maximum amplitude of cuff pressure 1s defined as the mean arterial pressure The blood pressure at amplitude of cuff pressure forward reduced according to proper proportion is defined as systolic pressure while the blood pressure at amplitude of cuff pressure backward reduced according to proper proportion is defined as diastolic pressure The maximum change of pulse pressure occurs at these two points They are equivalent to the point with pulse sound and the point without pulse sound respectively in the Korotkoff Sound Method When the risk of invasive monitoring method outweighs its advantage of accuracy non invasive monitoring method shall be used Comparison between blood pressure measuring methods To overcome the effect of human hearing variation and air release speed on measurement accuracy when the conventional Korotkoff Sound Method is used to take measure of blood pressure people have been dedicated to study of
53. lease stop measuring or remove the cuff to other positions Doctor should examine this timely Confirm your patient category adult pediatric or neonate before measurement Do NOT bind NIBP cuff on limbs with transfusion tube or intubations or skin lesion area otherwise damages may be caused to the limbs If the time of the automatic pattern noninvasive blood pressure measurement is too long the body connected with the cuff will possibly occur the purpura lack the blood and the neuralgia In order to protect patient it is requested to inspect the luster the warmth and the sensitivity of the body far end frequently Once observes any abnormity please immediately stop the blood pressure measurement The patient should lie on the back so that the cuff and the heart are in a horizontal position and the most accurate measure is taken Other postures may lead to inaccurate measurement Do not speak or move before or during the measurement Ensure that the cuff will not be hit or touched by other objects 13 User Manual for Vital Signs Monitor The measures should be taken at appropriate intervals Continuous measurement at too short intervals may lead to pressed arm reduced blood flow and lower blood pressure and resulting inaccurate measure of blood pressure It is recommended to take measurement at intervals of more than two minutes When an adult is monitored the machine may fail in giving the blood pressure measure
54. ludes fluorescent lamp dual ruby light infrared heater and direct sunlight etc Strenuous action of the subject or extreme electrosurgical interference may also affect the accuracy Please do not use the SpO sensor when having the MRI or burn may be caused by faradism Always observe the plethysmogram waveform which is auto scaled within the range of 100 The SpO reading may be unlikely true when the waveform is not smooth or irregular If in doubt rely on your clinical judgment rather than the monitor readout A functional tester cannot be used to assess the accuracy of the pulse oximeter monitor or a SpO sensor However a functional tester such as SpO simulator can be used to check how accurately a particular pulse oximeter is reproducing the given calibration curve Before testing the oximeter by a functional tester please firstly ask the manufacturer which calibration curve is used if necessary request the manufacturer for its dedicated calibration curve and download it into the tester 8 4 Temperature Monitoring The sensor is thermo resistor type 25 temperature of measured part through measuring the voltage There is a period responding time so the accurate temperature value display after a while The temperature monitoring can be divided into two measuring method measure through body surface temperature and through the temperature inside the body cavity placed in mouth or anus Normal value body surface 36 5
55. mHg 11 150 mmHg 11 100 mmHg 10 149 mmHg 10 99 mmHg 21 165 mmHg 21 110 mmHg 20 164 mmHg 20 109 mmHg PA ZA m i i PO NP a a __ n ae AS NAS 10 231 mn High limit 21 242 mmHg 20 241 mmHg MAS AS A A High limit 1 100 1 100 1 100 SpO d 0 99 0 99 0 99 High limit 1 300 bpm 1 350 bpm 1 350 bpm Pulse rate 0 299 bpm 0 349 bpm 0 349 bpm High limit 0 1 60 C 0 1 60 C 0 1 60 C TEMP 0 59 9 C 0 59 9 C 0 59 9 C ala 57 User Manual for Vital Signs Monitor 11 3 Abbreviation of arrhythmia 1 ECGTACHY ECG BRADY ECG VPCEST MISS BEAT VE EARLY SVE EARLY VE COUPLET SVE COUPLET 0 di DIE E DI DI VE RUN na SVE RUN ind ind VE SHORT RUN pa NO SVE SHORT RUN pa DI VE BIGEMINY nd SS SVE BIGEMINY na N VE TRIGEMINY pl ON SVE TRIGEMINY pa VE INSERT pl 00 SVE INSERT pa NO VE RONT N SVE RONT 58 User Manual for Vital Signs Monitor 11 4 Accessories List soros ECG ele o O S 1504051 Adu SpO Finger ip amor omoa anneres SiS osmo smem O soo power TO 201 0003032 Grandi wie SSS For more information regarding the accessories please contact your local sales representative or the manufacturer Note Part no is subject to change without prior notice please refer to the label of parts or packlist 59 User Manual for Vital Sig
56. may also affect the judgment By the oscillating method the computation is accomplished by the computer thus relieving the possibility of effect due to human factor 2 With the Korotkoff Sound Method the measure 1s taken on the basis of appearance and disappearance of heart sound The air release speed and heart rate may have direct effect on the measurement accuracy It also has the disadvantages of rapid air release and poor accuracy In the contrast with the oscillating method the determination is calculated on the basis of cuff pressure oscillatory waveform envelope and the air release speed and heart rate has little effect on the measurement accuracy 3 Statistics show that when measuring the hypertension the measure taken by the oscillating method is likely to be lower than that taken by the Korotkoff Sound Method When measuring the hypotension the measure taken by the oscillating method is likely to be higher than that by the Korotkoff Sound Method But it doesn t mean the advantages or disadvantages between the oscillating method and the Korotkoff Sound Method Comparison with the results taken by more accurate method let s say comparison of the invasive pressure result with the output value by the blood pressure measuring simulator will show which method has more accurate results In addition higher or lower value should be a statistical concept It is recommended those used to adopt the Korotkoff Sound Method use different physiological
57. mmunication j part s power Central Processing Electrocardiogram 4 Non invasive Blood Pulse Ci yen Module Pressure Module Saturation Module ECG TEMP NIBP SpO2 PR ES A gt ECG leads Temperature Figure 2 1 2 2 Conformation PC 900 Vital Signs Monitor is module designed product it consists of ECG TEMP module optional NIBP module optional SpO module optional main control unit printer module optional display panel and power supply block etc and the related accessories for ECG NIBP SpO and Temperature measurement gt According to different needs you can customize the module configuration by choosing necessary modules Therefore your monitor may not have all the monitoring functions and accessories L ECG TEMP module measures ECG signal and detects heart rate with ECG lead wires and electrodes it also measures temperature with temperature probe The SpO module detects and calculates pulse rate and oxygen saturation SpO and provides plethysmogram and perfusion index as well The NIBP module performs the measurement of blood pressure by non invasive way of oscillometric technology including the diastolic systolic and mean arterial pressure The cuffs are designed for adult pediatric and neonate respectively The main control unit is in charge of LED and LCD display keyboard input data storage printing and networking function User Manual for Vital Signs Monit
58. n t be adjusted lower than the factory default value unless the nursing personnel keeps close attention and surveillance on the patients and the device at all times lt gt key beep to turn on off key beep lt gt Language language selection ENG for English lt gt priority priority of PR value or HR value display The default set is HR lt gt care mode Demo shows the demo waveforms and data In the demo state all the signals and data are generated from the monitor for demonstration and testing purpose When the mode Demo is selected the user can test whether the visual and audible alarm system runs normally by raising or lowering the alarm limit to trigger the monitor to alarm Real shows the real time waveform 1 e normal monitoring status lt gt BT sound adjust the volume of pulse beeping sound 0 7 level adjustable 0 means switching off the sound 4 7 6 Patient Info Patient Info m ctoger 01 12 14 50 Figure 4 16 Patient Info Screen Screen Description lt gt lt gt ID change or set current patient s ID number 0 100 adjustable category change or set the category of current patient three options adult pediatric and neonate the default is adult Note If the patient ID is changed the history data except NIBP list will be cleared that means SpO trend graph and HR trend
59. n the NIBP calibration Meanwhile the Start shifts to Stop after the calibration the Stop shifts to Start Gas leak Move the cursor to Gas leak Start button click the OK button the pump inflates to certain pressure and then the valve will be closed for leak detection for ten seconds then the blood pressure module will deflate automatically and the screen displays measurements The NIBP calibration and Gas leak detection can only be carried on when the NIBP measurement is set to mode Manual Other buttons are disabled except m OK button and TOL Power button during NIBP calibration and Gas leak detection Make sure the m OK button is off after the test or the user could not do other operations NIBP Mode Setup Shortcut Screen Descriptions In waveform display screen or trend graphic screen or NIBP list screen longtime press key about 3 seconds can enter into the screen shown in Figure 4 13D Please refer to NIBP Setup Screen Description for more detailed information NIBP Mode Setup NIBP Mode Figure 4 13D NIBP Mode Setup Shortcut Screen 31 User Manual for Vital Signs Monitor 4 7 4 Nurse Call Qutput level Source ALM H M L Duration Probe off Dl 20 14 50 Figure 4 14 Nurse Call Setup Screen Screen Description lt gt Output level two options low or high output levels are available When the calli
60. nal instrument designed for monitoring the vital physiological signs of adult and pediatric patients With the functions of real time recording and displaying parameters such as ECG heart rate non invasive blood pressure functional oxygen saturation body temperature and so on it allows comprehensive analysis of patient s physiological conditions This instrument is applicable for use in hospitals and clinical institutions The operation should be performed by qualified professionals only 1 4 Safety a b c d This device conforms to IEC60601 1 electric safety classification Class I with Type BF and CF applied parts This device can resist against the discharge of defibrillator and the interference of electro surgical unit This device can monitor the patients with pace maker DO NOT use this device while the patient is under MRI scanning User Manual for Vital Signs Monitor 1 5 Symbols on the Monitor Da o peee ip Pediatric Patient appled part with defibrillator protection CEE AN Warning refer to User Manual yo Down Equal potential terminal Pa A ECG Lead Selection Nurse call output User Manual for Vital Signs Monitor Chapter 2 Operating Principle 2 1 Overall Structure The overall structure of the monitor is shown in Fig 2 1 Built in printer AC100 240 Operation buttons etna Power Supply including Buttons LOD Display a battery supports each Navigation knob Co
61. ndexes have been tested minutely and positive testing results obtained It is recommended to take the blood pressure measurement manually The automatic or continuous mode should be used at the presence of a doctor nurse Please peruse the relative content about the clinical restrictions and contraindication When disposing of the monitor and its accessories the local law should be followed III User Manual for Vital Signs Monitor Table of Contents A ble 12 PRODUCT NAME AND MODEL sale aaa l LON TENDED OUN Ec a OAA l KASAR iia LS YMBOLS ON THE MONITOR lalla 2 CHAPIERZOPERAFINGPERINCIPLE aio AO a O Lai a 3 A AMAS AA A A AAA II 3 CHAPTER 3 INSTALLATION AND CONNECTION oncmciccccccccccocsissiiiiiiiciccconos Y APPEAR ANC E liebe 4 ron ran eaa 4 Dabs OIE Bane A sce na nice audeauduatwenicenadeadsuatwedenadeadduatwe nce nudeadcuandentcenedteusuandentceneceads 6 SAS AM Re E O E OE OE TO IE 7 724 NIIBENI ENER E TR ER 8 321 Opening the Packase and Cheeki rcruia iia 8 32 2 Commnecune he Power SUP A aa 8 DS ATA MS MONOT A ian 8 3 3 SENSOR PEACEMENTAND CONNECTION illa 9 Done Cre do le COMME Odd dc 9 555 2 B lood Pressure CUE COACCI N A A ii 11 PPS 14 30 TEMP Transducer COMECUON dista 16 0 beading PANA PAPA A A A dala 16 9 050 Battery IAS talla A alia alia ico dolo ia 18 CHAPTER 4 OPERATIONS onda tii iia 17 A INTA MONITORING SCREEN aii io iaa biota 19 Al Default Display Sereen Descrip Ii aaa 19 Aled Pera non ASTUCI
62. ng system in hospital works in Normal Open mode low level should be selected When the calling system in hospital works in Normal Close mode high level should be selected lt Source three kinds of alarm sources can trig the nurse call high level alarm medium level alarm and low level alarm multi optional If you don t make choice nurse call signal will not be sent out lt gt Duration two options pulse or continuous output modes are available continuous the continuous mode of output means the nurse call signal will keep until the selected alarm source es disappear 1 e the signal will last from starting alarm to stopping alarm pulse the output nurse call signal is pulse signal which lasts for 1 second When several alarms occur at the same time only one pulse signal will be sent out Note Nurse Call function can not be regarded as main alarm notice method please do not entirely relay on it You should combine parameter values with alarm level and patient s clinical behavior and symptom to determine patient s status 4 7 5 System Setup Volume key beep language ENG priority care mode BT sound 01 20 14 50 Figure 4 15 System Setup Screen 32 User Manual for Vital Signs Monitor Screen Description lt gt Volume set beeper volume 1 7 level adjustable the factory default is 03 It is recommended that the alarm volume should
63. ns Monitor 11 5 Instructions for SpO Probe Instructions for Neonate SpO Y type Sensor Intended Use When used with a compatible patient monitor or a pulse oximeter device this sensor is intended to be used for continuous non invasive functional arterial oxygen saturation SpO2 and pulse rate monitoring for neonates 1 3 kg Contraindications This sensor 1s contraindicated for use on active patients or for prolonged use Instructions for Use 1 Insert the two sensor tips into the slots on the rubber wrap A place the sensor on the neonate s foot B wrap the rubber belt around the foot and tighten accordingly C 2 Plug the sensor into the oximeter and verify proper operation as described in the oximeter operator s manual 3 Inspect the monitoring site every 4 hours for skin integrity ff y f A l SS gt S An EY la A j Cleaning amp Disinfection Unplug the sensor before cleaning or disinfecting Surface clean sensor and cable with a soft gauze pad by saturating it with a solution such as 70 isopropyl alcohol If low level disinfection is required use a 1 10 bleach solution Warnings 1 Some factors may affect the accuracy of saturation measurements Such factors include excessive 2 patient motion fingernail polish use of intravascular dyes excessive light poorly perfused finger extreme finger sizes or improper placement of the sensor 3 The sensor must be checked for skin integ
64. nser flow into the connector jack of the monitor to avoid damage 54 User Manual for Vital Signs Monitor Clean the exterior of the connector only Dilute the cleanser Do not let any liquid flow into the shell or any parts of the monitor Do not let the cleanser and disinfectant stay on its surface Do not perform high pressure sterilization to the monitor Do not put any parts of the monitor or its accessories in the liquid D bb bb Db e If the monitor is accidentally wetted it should be thoroughly dried before use The rear cover can be removed by qualified service technician to verify absence of water amp Do not pour the disinfector on its surface while sterilization 10 3 Cleaning Sterilization and Disinfection of Accessories It is recommended to clean the accessories including sensor leads and plugs with a piece of gauze which has been soaked in 75 Alcohol or 70 Ispropanol before use Do not use damaged accessories Accessories can not be entirely immerged into water liquor or cleanser Do not use radial steam or epoxyethane to disinfect accessories Do wipe off the remained alcohol or ispropanol on the accessories after disinfection for good maintenance can extend the life of accessories 10 4 Storage If the equipment will not be used for long period of time wipe it clean and keep it in the packaging which shall be kept in a dry and good ventilation place free from dust and corrosive g
65. o the monitor well ECG waveform will be displayed in the main display area Prompt Info lt gt Probe off the SpO sensor is disconnected from the monitor or off from the patient lt 03 Patient ID number lt gt 11 30 25 the current time 4 2 2 Operation Instructions x PIA VE key select ECG lead When ECG 1s monitored press this key to switch the ECG lead among II III aVR aVL aVF and V LR key freeze ECG waveform or Plethysmogram on the screen lt gt a qu key shift display mode lt gt 66 B key print ECG waveform Press it again to stop printing gt amp key start cancel NIBP measurement vo XK key Alarm silence switch press it to enable disable alarm silence A W key change ECG waveform scale 22 User Manual for Vital Signs Monitor 4 3 Trend Graph Display Short pressing qu Display key to shift the screen view to trend graph display screen as shown in Figure 4 5 Trend graph 01 50 05 50 Trend length Probe off 01 1 44 39 Figure 4 5 Trend Graph 4 3 1 Screen Description lt gt 12 hours the trend length of trend graph three options 12 24 or 96 hours when the selection is 12 hours the upper trend graph will display SpO trend curve for last 12 hours cursor on enable the display of cursor on trend graph i e the vertical cursor line displayed in trend graph so the user can mov
66. of the limb concerned See the table below for the dimensions Note The size of the cuff selected should suit the subjects while measuring Cuff Model Cuff Width Small sized Pediatrie Cuff Middle sized Pediatric Cuff 10cm 19cm Large sized Pediatric Cuff 18cm 26cm Adult Cuff 25cm 35cm 14cm Table 3 2 A When putting on the cuff unveil and wrap it around the upper arm evenly to appropriate tightness 2 Remember to empty the residual air in the cuff before the measurement is commenced 66 99 3 Locate the cuff in such a way that the mark 1s at a location where the clearest pulsation of brachial artery 1s observed 4 The cuff should be tightened to a degree where insertion of one finger 1s allowed 5 The lower end of the cuff should be 2cm above the elbow joint Figure 3 4 Cuff Placement 11 User Manual for Vital Signs Monitor gt Pressure Accuracy Verification Pressure Accuracy Verification 1s a function to inspect the accuracy of pressure measurement by the NIBP module inside the device Technician or equipment manager should do pressure accuracy verification every half year or year in order to check if the pressure measurement still conforms to the requirement of product performance If the deviation is beyond the declared specification it is permitted to return it to factory for repair or calibration Before verification please connect the monitor to a standard pressure meter as the reference
67. oid damaging the battery do NOT use other power supply device to charge the battery 53 User Manual for Vital Signs Monitor i AS After battery ageing phenomenon occurring to avoid explosion risk do NOT throw the battery into fire Do not hit or strike it with force Do not use this battery on other devices Do not use this battery below 10 Cor above 40 Dispose of the battery the local law should be followed D d Ly Ly de 7S AS 7 AS In order to maintain battery supply time and prolong battery lifetime please charge the battery every one or two months if don t use battery for a long time And do charge battery at least 12 15 hours every time Before connect to AC do start monitor with battery s power supply until battery power is used up and monitor turn off automatically then connect monitor to AC and have it charged for 12 15 hours continuously The speed of charge will be the same no matter whether the monitor is working or not The reason why discharge the battery before charge is to avoid the decrease of capacity caused by battery s memory effect If the monitor won t be used for a long time do have it charged fully before conservation a When starting the monitor by battery power only which is short of supply monitor will turn off automatically In order to avoid the damage to battery caused by excessive discharge please pay attention to following After monitor turns off automatically there is still small dra
68. oller lock at the left 90 upwards to unlock it refer to the following figure with mark 1 3 Cut one end of the paper into triangle and load the paper from the underside of the rubber roller 4 Turn the roller clockwise to get the paper rolled and put the paper roll into the compartment 5 Pull the paper out of paper slot on the shield 6 Move the tab of the rubber roller lock 90 downwards to lock it 7 Put the shield back in position and secure it Operation procedures for taking out printing paper roll 1 2 steps are the same with the 1 2 steps mentioned above for loading printing paper 3 Roll the loading roller anti clockwise and pull the paper out 4 5 steps are the same with the 6 7 steps mentioned above for loading printing paper cilea A Figure 3 8 Loading and taking out printing paper PS printer may be used due to the different configuration PS printer operation instruction Power indicator green light shows the power is on while the monitor is out of power the green light 1s off Error indicator red light is constant which shows the printer is out of paper or the printing paper does not install well When the printer installs normally the red light 1s off 16 User Manual for Vital Signs Monitor Power Indicator Open button Error Indicator Paper cartridge Figure 3 9 P8 printer Loading printing paper Step 1 press and hold down the cartridge button to open the paper cartridge
69. on and tips about operations and application 3502 2530004 User Manual for Vital Signs Monitor Instructions to User Dear Users Thank you very much for purchasing our product Please read the following information very carefully before using this device Read these instructions carefully before using this monitor These instructions describe the operating procedures to be followed strictly Failure to follow these instructions can cause monitoring abnormity equipment damage and personal injury The manufacturer is NOT responsible for the safety reliability and performance issues and any monitoring abnormality personal injury and equipment damage due to user s negligence of the operation instructions The manufacturer s warranty service does not cover such faults VIZ WARNING PACEMAKER PATIENTS This monitor may continue to count the pacemaker rate during occurrences of cardiac arrest or some arrhythmias Do not rely entirely upon this monitor ALARMS Keep pacemaker patients under close surveillance Monitoring a single person at a time The monitor is defibrillator proof Verify that the accessories can function safely and normally and the monitor is grounded properly before conducting defibrillation Disconnect the monitor and sensors before MRI scanning Use during MRI could cause burns or adversely affect the MRI image or the monitor s accuracy If you have any doubt to the grounding layout and its performance yo
70. or Chapter 3 Installation and Connection 3 1 Appearance 3 1 1 Front Panel 1 2 4 11 3 12 5 13 i 14 f 15 8 9 16 17 10 18 B 19 21 22 20 27 23 s 24 29 25 26 Figure 3 1 Front panel illustration Description 1 Alarm indicator Alarm Level Alarm Event Red flashing High priority alarm Exceeding the limits low battery voltage Orange flashing Medium priority alarm Leads or probe off Green light 2 3 4 User Manual for Vital Signs Monitor SYS display systolic pressure value DIA display diastolic pressure value MAP When NIBP measurement mode is set to manual and STAT Display mean arterial pressure or measuring time of the latest group of NIBP measurement they will be displayed alternately The format of NIBP measuring time is hh mm If the tourniquet is in use the cuff pressure will be displayed here When NIBP measurement mode is set to AUTO Display real time pressure value during measurement Countdown time will be displayed in the MAP when the measurement finishes Countdown time has two formats gt 1 hour HH mm lt 1 hour mm ss Note two formats to display NIBP value xxxmmHg and xx xkPa Refer to section 4 4 2 NIBP 10 11 12 13 14 Setup to set the unit of NIBP value the conversion relation between mmHg and kPa ImmHg 0 133kPa HR priority indicator if HR indicator is on it indicates that the numerical value besid
71. output lines 1kV mode 2kV mode lt 5 Ur gt 95 dip in Ur for 0 5 cycle 40 Ur 60 dip in Uv for 5 cycles 70 Ur 30 dip in Uv for 25 cycles differential common lt 5 UF gt 95 dip in Ur for amp s Electromagnetic environment guidance Floors should be wood concrete or ceramic tile if floors are covered with synthetic material the relative humidity should be at least 30 Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment If the user of the requires equipment or system continued operation during power mains interruptions it is recommended that the equipment or system be powered from an uninterruptible power supply or a battery Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment NOTE Uris the a c mains voltage prior to application of the test level 42 User Manual for Vital Signs Monitor Table 3 Guidance and manufacturer s declaration electromagnetic immunity for EQUIPMENT and SYSTEM that are not LIFE SUPPORTING PC 900 Vital Signs Monitor is intended for use in the electromagnetic environment specified below The customer or the user of PC 900 Vital
72. put power not listed above the recommended separation distance d in meters m can be determined using the equation applicable to the frequency of the transmitter where p is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE I At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people 44 User Manual for Vital Signs Monitor Chapter 7 Packaging and Accessories 7 1 Packaging The product is packed in high quality corrugated cartons with foam inside to protect the equipment against damage in the shipping and handling process Weight Details see the indication on the outer package Dimension 360 L x320 W x410 H mm 7 2 Accessories 1 ECG cable with lead wire One set 2 ECG electrodes Twenty five pieces 3 NIBP cuff One piece 4 SpO probe One piece 5 Temperature probe One piece 6 Power cord One piece 7 Grounding wire One piece 8 User manual One copy 9 Quality Certificate One copy 10 Warranty Two copies 11 Packing list Two copies Note The accessories are subject to change Detailed items and quantity see the Packing List 45 User Manual for Vital Signs Monitor Chapter 8 Monitoring Parameter 8 1 ECG Monitoring 8 1 1 How to Obtain High Quality
73. rding to this manual s instructions and the instructions for using electrode the chance of this transient occurring will be decreased Besides the improper connection with electrosurgical unit may cause burns the monitor may be damaged or arouse deviations of measurement You can take some steps to avoid this situation such as do NOT use small ECG electrodes choosing the position which is far away from the estimated Hertzian waves route using larger electrosurgical return electrodes and connecting with the patient properly ECG leads may be damaged while using defibrillator If the leads are used again please do the 10 User Manual for Vital Signs Monitor functional check first 5 When removing the ECG cable hold the head of the connector and pull it out When the monitor is inoperable due to an overload or saturation of any part of the amplifier it will prompt Lead off to remind operator lt No predictable hazard will be caused by the summation of leakage currents when several item of monitor are interconnected 3 3 2 Blood Pressure Cuff Connection 1 Connect the cable to the right panel connector marked with the NIBP icon 2 Unveil and wrap the cuff around patient s upper arm Requirements of the cuff 1 Appropriate cuff should be selected according to the age of the subject Its width should be 2 3 of the length of the upper arm The cuff inflation part should be long enough to permit wrapping 50 80
74. re as follows Position Symbol The intersection between the centerline of the right RA clavicle and Rib 2 The intersection between the centerline of the left clavicle LA and Rib 2 LL Left part of the upper abdomen RL Right part of the upper abdomen C1 V1 C2 V2 C V C3 V3 The electrodes are placed in different places the different Chest C4 V4 lead forms will display electrode C5 V5 C6 V6 Table 3 1 Safety Instructions for ECG Monitoring VIZ Use the same type electrode on a patient If skin rash or other unusual symptom occurs remove electrodes from patient Do not attach electrodes on the patient with an inflammation of the skin or scores on skin PC 900 Vital Signs Monitor can only be equipped with ECG leads provided by our company using ECG leads supplied by other companies may cause improper performance or poor protection while using defibrillator Electric parts of electrodes leads and cable are forbidden to contact any other conductive parts including ground PC 900 Vital Signs Monitor can resist against defibrillator and electrosurgical unit Readings may be inaccurate for a short time after or during using defibrillator or electrosurgical unit Transient caused by cable circuitry blocks while monitoring may be similar to the real heartbeat waveform as a result resistance heart rate alarm rings If you put the electrodes and cable in proper places acco
75. rity at least every 4 hours Because individual skin condition affects the ability of the skin to tolerate sensor placement it may be necessary to change the sensor site 4 Do not use NIBP or other constructing instruments on same appendage as sensor for blood flow inter rupted by NIBP cuff or circulatory patient condition will result in no pulse found or loss of pulse 5 Do not use the sensor during MRI scanning Carefully route cables to reduce the possibility of patient entanglement or strangulation 6 Donotalter or modify the sensor Alterations or modifications may affect performance or accuracy 7 Do not use the sensor if the sensor or the sensor cable appears damaged Caution Do not sterilize by irradiation steam or ethylene oxide 60 User Manual for Vital Signs Monitor Instructions for Pediatric SpO Finger Clip Sensor Intended Use When used with a compatible patient monitor or a pulse oximeter device the sensor 1s intended to be used for continuous non invasive functional arterial oxygen saturation SpO2 and pulse rate monitoring for pediatric patients weighing between 10 40kg Contraindications This sensor is contraindicated for use on active patients or for prolonged use Instructions for Use 1 2 3 4 5 6 1 With the upper and lower jaws open place an index finger evenly on the base of the clip Push the finger tip against the stop so that 1t 1s over the sensor window A If an inde
76. rm limits to ensure that they are appropriate for the patient being monitored 5 5 Verify Adjustable Alarm Function To verify adjustable alarm function select Demo for the item of Mode in system parameter settings menu and adjust alarm limits or change alarm setting then pay a close attention to the alarm If the alarm 1s sent out according to your setting 1t means the alarm function 1s effective 36 User Manual for Vital Signs Monitor Chapter 6 Technical Specifications 6 1 ECG Monitoring 1 Input signals range in amplitude 0 5 mVp 5 mVp 2 Heart rate display range 15 bpm 350 bpm 3 Heart rate display accuracy 1 or 2 bpm whichever 1s greater 4 Heart rate averaging Averages the recent eight beats having RR intervals falling within the acceptable limits 5 Heart rate alarm delay time lt 10s 6 Response time to change in heart rate Change from 80 bpm to 120 bpm lt 8 sec Change from 80 bpm to 40 bpm lt 8 sec 7 Tall T wave rejection Rejects all T wave less than or equal to 120 of 1ImV QRS 8 Sensitivity selection x1 4 2 5mm mV tolerance 5 x1 2 5mm mV tolerance 5 xl 10mm mV tolerance 5 x2 20mm mV tolerance 5 9 Sweeping speed 25mm s tolerance 10 10 ECG noise level lt 30uVp p 11 ECG input loop current lt 0 1uA 12 Differential input impedance gt S5MQ 13 Common mode rejection ratio CMRR gt 105dB 14 Time constant gt 0 3s 15 Frequency response 0
77. tatistical significance of mass data Abnormal data may be observed in some individual cases It is normal in the scientific experiments It may be caused by an apparent reason or by an unknown factor in some cases Such individual doubtful experimental data may be identified and eliminated using the special statistical technique It is not a part of this manual The practitioner may eliminate the apparently unreasonable data according to the experience 8 3 SpO Monitoring 8 3 1 Measuring Principle Based on Lamber Beer law the light absorbance of a given substance 1s directly proportional with its density or concentration When the light with certain wavelength emits on human tissue the measured intensity of light after absorption reflecting and attenuation in tissue can reflect the structure character of the tissue by which the light passes Due to that oxygenated hemoglobin HbO and deoxygenated hemoglobin Hb have different absorption character in the spectrum range from red to infrared light 600nm 1000nm wavelength by using these characteristics SpO can be determined SpO measured by this monitor is the functional oxygen saturation a percentage of the hemoglobin that can transport oxygen In contrast hemoximeters report fractional oxygen saturation a percentage of all measured hemoglobin including dysfunctional hemoglobin such as carboxyhemoglobin or metahemoglobin 49 User Manual for Vital Signs Monitor 8 3 2 SpO Measur
78. tient still and stop talking before and during measuring lt gt The patients mood also can affect the measuring result when exciting the blood pressure goes up lt gt The measuring result also affected by time lower in the morning and higher in the evening 3 2 3 Clinical Limitations 1 Serious angiospasm vasoconstriction or too weak pulse 2 When extremely low or high heart rate or serious arrhythmia of the subject occurs Especially auricular fibrillation will lead to unreliable or impossible measurement 3 Do not take the measurement when the subject is connected with an artificial heart lung machine 4 Do not take the measurement when the subject uses diuresis or vasodilator 5 When the subject is suffering from major hemorrhage hypovolemic shock and other conditions with rapid blood pressure change or when the subject has too low body temperature the reading will not be reliable for reduced peripheral blood flow will lead to reduced arterial pulsation 6 Subject with hyperadiposis In addition statistics show that 37 people report blood pressure difference of no less than 0 80kPa 6mmHg between the left and right arms and 13 people report difference of no less than 1 47kPa 11mmHg Note Some practitioners may report big discreteness or abnormal value of the blood pressure measures when the oscillating method is used As a matter of fact the so called big discreteness must be a term in the sense of s
79. tion segment This segment will display the ECG leads status probe status alarm silence counting down timer automatic NIBP measurement counting down timer over limit warning and other error messages for technical warning If more than one event occurs or more status appears the indication message will be displayed alternately at this segment NIBP C D XXX the counting down timer of NIBP measurement is XXX seconds This prompt message appears only when the NIBP measuring mode is set as AUTO X mute C D XXX the counting down timer of alarm silence is XXX seconds This prompt message appears only when the alarm silence 1s enabled lt gt Patient ID segment 03 Patient ID number lt gt Real time clock segment 11 30 25 the current time 4 1 2 Operation Instructions lt gt e key select ECG lead When ECG is monitored press this key to switch the ECG lead among II III aVR aVL aVF and V OR key freeze ECG waveform or Plethysmogram on the screen di ql key shift display mode among 5 display views ECG amp SpO monitoring screen default screen ECG monitoring screen trend graph screen NIBP list screen and ECG waveform recall screen ce Es key print ECG waveform Press it again to stop printing se do key start cancel NIBP measurement A W key change ECG waveform scale 20 User Manual for Vital Signs Monitor x key short press this key a
80. tivate the system alarm In the monitoring screen press Alarm to set the alarm timer There are four options of alarm silent time 2 minutes 5 minutes 10 minutes and 20 minutes The time shows up on the upper left corner of the screen When the alarm timer is activated the system begins to count down If alarm occurs during that period the system alarm will be activated automatically and the monitor will give alarm If there is no alarm during that period when the set time has passed the system alarm will be activated as well When the monitor alarms press X key to suspend the alarm and set the alarm silence time DO NOT silence the audible alarm or decrease its volume if patient safety could be compromised zero value alarm occurs must be on the condition of probe not off If SpO value is zero displayed on the screen instead of normal value the zero value alarm will be automatically activated 1f the state lasts for about 7 seconds 5 4 Alarm Setting In the Mode Selection screen move the cursor to the SETUP and press it to enter system setup screen Es Limits setup Move the gray cursor to the High or Low limits of the alarm settings and press the Alarm key to turn ON or OFF the alarm for the setting Yellow color shows ON status and gray color shows the OFF status Refer to Chapter 11 2 for detailed Default Alarming Values of All Parameters and Setup Range Whenever the monitor is used check the ala
81. tomatically lt gt Alert T the alert time for reminding user that the operation of tourniquet is going to be end after this time period 1 to 60 minutes adjusting range with 1 minute step the default value is 5 minutes If the set value is xx minutes the monitor will produce alarm sound until ending deflation when counting down time reaches to xx minutes The alarm type is high priority alarm For example the duration is 40 minutes the alert time is 5 minutes the alarm will ring for prompt when the duration counting down to 5 minutes The Prompt Info area starts to prompt TOUR C D 300 seconds lt gt Start shift cursor to Start and press m key Start becomes Stop and meanwhile the blood cuff starts being inflated Pressing Stop button can stop using this function After deflation it will change to Start again NIBP Calibration Setup Descriptions NIBP Cali Mode 1 Inflating the Pump Move the cursor to NIBP Cali Mode 1 Start button click the OK button to begin the NIBP calibration Meanwhile the Start shifts to Stop after the 30 User Manual for Vital Signs Monitor calibration the Stop shifts to Start NIBP Cali Mode 2 Receiving the exterior pressure The exterior pressure source pressurize to the module to proceed the pressure calibration Move the cursor to NIBP calibration mode 2 Start button click the OK button to begi
82. u must use the built in battery to power the monitor All combinations of equipment must be in compliance with standard of IEC 60601 1 1 for medical electric system requirements Check SpO probe application site periodically every 30 minutes to determine circulation positioning and skin sensitivity The SpO measurement of this monitor may not work for all testees If stable readings can not be obtained at any time discontinue use Do not immerse the monitor or its accessories in liquid to clean Do not use accessories other than those provided recommended by the manufacturer Each time the monitor is used check the alarm limits to ensure that they are appropriate for the patient being monitored The monitor is intended only as an adjunct in patient assessment It must be used in conjunction with clinical signs and symptoms When taking the measure of an infant or neonate s less than 10 years old blood pressure do NOT operate in the adult mode The high inflation pressure may cause lesion or even body putrescence The monitor is prohibited from applying to those who have severe hemorrhagic tendency or who are with sickle cell disease for they may develop partial bleeding when this monitor is used to take II User Manual for Vital Signs Monitor the blood pressure measurement DO NOT take blood pressure measurement from a limb receiving ongoing transfusion or intubations or skin lesion area otherwise damages may be cause
83. ver silver chloride electrodes When dissimilar metals are used for different electrodes the electrodes may be subject to large offset potentials due to polarization Using dissimilar metals may also increase recovery time after defibrillation 3 Prepare the electrode sites according to the electrode manufacturer s instructions 4 Skin clean gt Clean and dry abrade skin to ensure low sensor impedance Mild soap and Water is recommended as a skin cleanser Note Alcohol is not recommended as a skin cleanser it leaves a film layer that may cause high sensor impedance If alcohol is used ensure 30 second dry time gt Dry abrading the skin gently with a dry wash cloth gauze or skin preparation product is helpful e The locations of the electrode are in the following Figure to remove the non conductive skin layer The symbol indicates that the cable accessories are designed to have special protection against electric shocks and is defibrillator proof Figure 3 3 Electrode Location Note If skin rash or other unusual symptoms develop remove electrodes from patient 5 After starting the monitor if the electrodes become loose or disconnected during monitoring the system will display LEAD OFF on the screen to alarm the operator Tt might not display ECG wave with 3 leads The 5 leads should be used to have ECG wave User Manual for Vital Signs Monitor 6 The ECG leads and their corresponding locations a
84. working condition Make sure that the monitor is grounded properly Pay close attention to the fluctuation of the local power supply voltage A manostat is recommended when necessary In case any indication of damage about the function of the monitor is detected and proven it is not allowed to apply it to the patient for any monitoring 10 1 2 Routine Maintenance After each maintenance or the yearly maintenance the monitor can be thoroughly inspected by qualified personnel including function and safety examinations The designed life of this monitor is 5 years In order to ensure its long service life please pay attention to the maintenance NA NZ If the hospital fails to carry out a satisfactory maintenance program about the monitor it may get disabled and harm the patient s safety and health In case of ECG leads damage or aging please replace the lead If there is any indication of cable and transducer damage or they deteriorate they are prohibited from any further use The adjustable units in the monitor such as potentiometer are not allowed to adjust without permission to avoid unnecessary failures that affect normal application 10 1 3 Battery Maintenance NZA Please pay attention to the polarity of battery do NOT insert it into battery compartment with reversed polarities Do NOT use the batteries manufactured by other companies if being inserted the device will may be damaged In order to av
85. x finger cannot be positioned correctly or 1s not available other fingers can be used Note When selecting a sensor site priority should be given to an extremity free of an arterial catheter blood pressure cuff or intravascular infusion line Spread open the rear tabs of the sensor to provide even force over the length of the pads B The sensor should be oriented in such a way that the cable is positioned along the top of the hand C Plug the sensor into the wpe oximeter and verify proper a AS operation as described in Tei da A the oximeter operator s manual A By ei Inspect the monitoring site every 4 hours for skin integrity Before each use surface clean sensor and cable with a soft gauze pad by saturating it with a solution such as 70 isopropyl alcohol If low level disinfection is required use a 1 10 bleach solution Caution Do not sterilize by irradiation steam or ethylene oxide Warnings 1 2 3 4 5 6 1 8 9 Some factors may affect the accuracy of saturation measurements Such factors include excessive patient motion fingernail polish use of intravascular dyes excessive light poor blood perfusion in the finger extreme finger sizes or improper placement of the sensor Using the sensor in the presence of bright lights may result in inaccurate measurements In such cases cover the sensor site with an opaque material The sensor must be moved to a new site at least every 4

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