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DigiMAP Vital Signs Monitor
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1. CO setup Adult Pediatric Neonatal Alarm switch On Alarm Level Medium Alarm Print Off Limit Display Off Unit mmHg High alarm limit of ECO 50 mmHg 50 mmHg 45 mmHg Low alarm limit of EtCO 20 mmHg 20 mmHg 30 mmHg High alarm limit of FCO 4 mmHg 4 mmHg 4 mmHg High alarm limit of awRR 30 rpm 30 rpm 100 rpm Low alarm limit of awRR 8 rpm 8 rpm 30 rpm Scale 61 mmHg V6 Vital Signs Monitor User s Manual Wave Speed 12 5 mm s Color White Apnea alarm time 20s Appendix C Alarm Messages C 1 Physiological alarm Messages The third line in the cable is Alarm level of factory default the ones with mean that the level can be changed by users O SpO Alarm messages Cause Level SpO High SpO measuring value is above the high alarm limit i S Medium SpO Low SpO measuring value is below the low alarm limit SpO gt Desat SpO measuring value is too low High PR High PR measuring value is above the high alarm limit Medium PR Low PR measuring value is below the low alarm limit SpO No Pulse SpO gt signal is predominantly invalid and High therefore cannot be analyzed O NIBP Alarm messages Cause Level NIBP Sys High NIBP Sys measuring value is above high alarm limit NIBP Sys Low NIBP Sys measuring value is below low alarm limit NIBP Dia High NIBP Dia measuring value is above high alarm limit
2. 6 5 5 Setting Desat Limit Desat Limit means that when the measuring value is lower than the limit high alarm will be triggered Set the Desat Limit as follows 1 Select SpO to enter SpO Setup menu 2 Set Desat Limit to a desired value 6 5 6 Setting Wave Color 1 Select Pleth to enter Pleth Setup menu 2 Set Wave Color to a desired color Digicare Biomedical Technology Chapter 7 NIBP 7 1 Introduction The monitor uses the oscillometric method for measuring NIBP It is applicable for adult pediatric and neonatal patients The method of oscillometry indirectly estimates the systolic and diastolic pressures within the blood vessels by measuring the change of the pressure within blood pressure cuff along with the volume of the arteries and calculates the average pressure The NIBP measurement is suitable for use in the presence of electro surgery and during the discharge of a cardiac defibrillator according to IEC 60601 2 30 1999 EN 60601 2 30 2000 A physician must determine the clinical significance of the NIBP measurement 7 2 Safety Information Warning O Check the patient category before monitoring Incorrect settings may result in some risk for patient safety Higher adult setting is not suitable for pediatric and neonatal patients Do not measure NIBP on patients with sickle cell disease or any condition where skin damage has occurred or is expected O Use clinical judgment to decide whe
3. 1 2 3 Rear View 3 456 Fig 1 3 Grounding terminal AC power input connector Serial port Wired network connector USB Connector Nurse call connector NY Ch WA BW Ne Fan and Sound orifice 1 4 Digicare Biomedical Technology 1 2 4 Bottom View Battery compartment 1 3 Work mode The monitor has two working modes Clinic Mode and Monitor Mode 1 3 1 Clinic Mode Clinic Mode refers to that the monitor is used for monitoring of a number of patients one by one by outpatient doctor Each patient has his her own ID number and the monitoring results of patients are saved according to their ID numbers When a patient with the same ID number appears again the device will automatically find out the previous monitoring data and will add current data to the previous one Clinic mode may be used in one of the following occasions 1 Medical personnel are present e g monitoring of patients by outpatient doctor or house call doctor 2 A number of measurements of many patients e g monitoring of patients by physical checkup doctor 3 Rounds of wards e g doctor or nurse can monitor relevant physiological status of patient by the monitor when checking in ward 1 3 2 Monitor Mode Monitor Mode refers to that the monitor is used to monitor the same patient in ward for long time In this mode the small sized monitor is used to monitor the 1 5 Digicare Biomedical Technology patient s SpO2 NIBP
4. Medium NIBP Dia Low NIBP Dia measuring value is below low alarm limit NIBP Map High NIBP Map measuring value is above high alarm limit NIBP Map Low NIBP Map measuring value is below low alarm limit e CO Alarm messages Cause Level EtCO High ECO measuring value is above high alarm limit EtCO Low EtCO measuring value is below low alarm limit FiCO High FiCO measuring value is above high alarm BAS Medium limit awRR High awRR measuring value is above high alarm limit awRR Low awRR measuring value is above high alarm limit CO Apnea No breath is detected in the set period High C 2 Technical alarm Messages O System Alarm messages Cause Level Battery Failure Battery failure or no battery Low Battery Low Voltage of battery is too low High SD Write Protected SD memory card is writing protect Low SD Unknown part The inserted SD card is unrecognized Low SD Write Error SD card is miswriting SD No Space SD card has no space Medium Flash No Space Interior flash has no space No paper in the recorder when recording Recorder Error or the recorder door is open or recorder is Low absent O SpO Alarm messages Cause Level Sp sensor may be disconnected from the SpO2 Sensor off Pee S Medium patient or the monitor SpO sensor error SpO sensor failure
5. Never use abrasive materials such as steel wool or silver polish or erosive cleaners such as acetone or acetone based cleaners Warning O Be sure to shut down the system and disconnect all power cables from the outlets before cleaning the equipment Caution e If you spill liquid onto the equipment or accessories contact your service personnel or us 12 2 Cleaning of Monitor l Common detergent and non corrosive disinfectant used in hospital can be applied to clean monitor however you must be aware that many kinds of detergents must be diluted prior to utilization and please use it according to the instruction of detergent manufacturer Avoid the use of alcohols amino or acetone detergent The enclosure and screen of monitor shall be free of dust and they can be wiped with lint free soft cloth or sponge soaked in detergent While cleaning Digicare Biomedical Technology be careful and do not spill liquid onto the instrument and keep any liquid out of it When wiping the side panel of monitor you must be especially careful to keep water out of all kinds of cable and outlet on the panel Do not use abrasive material including wire brush or metal brightener during cleaning because this material will damage the panel and monitor screen Do not submerge the monitor in liquid While cable or plug of attachment accidentally gets wet please rinse it with distilled water or deionizer water and dry it in the environ
6. 12 of reading Gas temperature at 25 C Total system response time lt 3s Sample flow rate 50 ml min 10 ml min V6 Vital Signs Monitor User s Manual Appendix B Factory Defaults B 1 Patient messages Patient messages Factory Defaults Type Adult B 2 Alarm Alarm setup Factory defaults ALM Volume 2 Alarm paused time 2min B 3 Interface Setup Interface setup Factory defaults Brightness 3 B 4 SpO SpO setup Adult Pediatric Neonatal Alarm switch On Alarm Level Medium Alarm Print Off Average Time 8s High alarm limit of SpO 100 100 95 Low alarm limit of SpO 90 90 85 Desat Limit 85 Pleth Wave Speed 25mm s Color Y ellow V6 Vital Signs Monitor User s Manual B 5 NIBP NIBP setup Adult Pediatric Neonatal Alarm switch On Alarm Level Medium Alarm Print Off High alarm limit of Sys 160 mmHg 120 mmHg 90 mmHg Low alarm limit of Sys 90 mmHg 70 mmHg 40 mmHg High alarm limit of Map 110 mmHg 90 mmHg 70 mmHg Low alarm limit of Map 60 mmHg 50 mmHg 25 mmHg High alarm limit of Dia 90 mmHg 70 mmHg 60 mmHg Low alarm limit of Dia 50 mmHg 40 mmHg 20 mmHg Measure Mode Manual Unit mmHg Interval 15 min Color red Venipuncture Press 60 mmHg 40 mmHg 30 mmHg Inflation 170 mmHg 130 mmHg 100 mmHg B 6 CO LoFlo
7. bpm Cuff auto deflation The cuff will deflate automatically when power is off or time of measurement is beyond 120 seconds 90 seconds for neonate or the cuff pressure is beyond the overpressure protection set by software and hardware Measurement time Normally it is 20s to 45s depending on HR and moving interference typically V6 Vital Signs Monitor User s Manual Overpressure protection Adult Ae 29743 mmHg Pediatric 25243 mmHg Neonatal 14743 mmHg Sys 0 300 mmHg high low limit can be adjusted continuously Alarm range Dia 0 300 mmHg high low limit can be adjusted continuously Ma 0 300 mmHg high low limit can be adjusted E continuously A 4 3 CO e CO module Measurement way Infrared spectrum Measurement mode micro stream Warm up time Capnogram displayed in less than 15 s at an ambient temperature o 25 C full specifications within 2 minutes Measurement range 0 19 7 0 150 mmHg Resolution 0 1 or ImmHg Short term drift 0 8mmHg over four hours Stability Long term drift Accuracy specification will be maintained over a 120 hour period Unit mmHg kPa 0 mmHg to 40 mmHg 2 mmHg 41 mmHg to 70 mmHg 5 of reading Accuracy 760mmHg 71 mmHg to 100 mmHg 8 of reading temperature is 25 C 101 mmHg to 150 mmHg 10 of reading when RR gt 80 rpm all the range is
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9. 2 2 Safe Operation Conditions cccooooccnnooooncnononnonononnnncnnnnnnnconanonnonon nono nnanonnnnanoss 2 3 Equipment Swvmbols nn nnnnn no noncanonnnnannss SEO RI AAA OT 3 1 Unpacking and Checkmg eiecit bii reisen raai lei Verbraak ikos trennet 3 2 ET EE 3 3 Shutting off the Motor 3 4 Operation Modes asic s 2226 eae sie an eae A eee Aes S ll eet EE ETH ee Ee eege Beemer 3 Default Setups ei A O Eeer 3 9 Viewing the Machine Info Chapter 4 User Interface siti c cccseesis ccossocesdesedetescsssesnescos coddcsssessosecesssssoescesecnssess 4 Display Styles cita da 4 2 Sereen E Beek AA is aA A Ge See A A O AA DEMO A NS 4 5 Machine Mamtenance aiee t Chapter 5 Alar Min Eed add Es E ESE a noss EES E A Sieh hee a hele he ee he eee 5 2 Alarm Level WEE 5 3 A Indicators ennnen aia e a a ao 5 4 Setting Alarm Volume Operators Manual Multi parameter Patient Monitor DigiMAP III Digicare Biomedical Technology 5 5 Parameter ALAIN ri Eegeregie en Eet 5 5 5 6 Pa sing Alarmg eendeitege Eeer 5 5 EEN 5 6 RW OO EEN 6 1 Eer dere A A ei a aea ia A 6 1 6 2 Safety Information ees GEESS 6 1 6 3 Monitoring Procedure oooooocccnnoooccnnnonnncnnoncncnnonnnnononnnnncono nro ncnnn nn ncnnannnnancnnos 6 2 6 4 EEN 6 2 IIS EMILIA Sasol 6 3 Chapter 7 NIBP vicicsscdscccsscsecsensaceccasascdsecsasesescessssssgnsasesceeachcsevgncessseascscensssasandenaveses 7 1 A A A A A Nearer 7 1 SAA O 7 1 7 3 Measurement Limitations EE 7
10. EE 9 Appendix C Alarm Messages ccccsssssssscccssssssssssccssscsssscsscsssccssscscsscsesesssssseeses 11 C 1 Physiological alarm Messanges 11 C 2 Technical alarm Messages cccccssssseeesssceeesseceeeseneeceeesseeeceeseaeeecesseeeesseaeees 12 C3 Prompt EE 14 Operators Manual Multi parameter Patient Monitor DigiMAP VI Digicare Biomedical Technology Chapter 1 General Introduction 1 1 Intended Use The monitor is intended to be used for monitoring of SpO NIBP and CO of patients It can also display review save and print its monitoring information and has built in rechargeable battery ensuring continuous monitoring of patients in the course of operation The monitor is intended for outpatient departments and emergency treatment rooms of hospitals community clinics private clinics and other medical institutions The monitor is suitable for monitoring of vital signs of adults children and infants 1 2 Main Unit 1 2 1 Front View 1 1 Digicare Biomedical Technology Fig 1 1 1 Physiological alarm indicating lamp When a physiological alarm occurs this lamp will light up as defined below e High level alarm the lamp quickly flashes red O Medium level alarm the lamp slowly flashes yellow e Low level alarm the lamp lights yellow without flashing 2 Technical alarm indicating lamp When a technical alarm occurs this lamp will light up as defined below O Medium level alarm the lamp slowl
11. Input device te ni 5 NIBP record suspend silence screen switch and power switch Knob With A 3 7 Connectors Center computer connector RJ 45 10M 100M TCP IP Serial port RS232 serial port Nurse call Nurse call connector Equipotent grounding point 1 USB connector reserved connector Sd card connector reserved connector Wireless network reserved connector A 3 8 Signal Output Nurse call output Drive mode Relay Electric specification lt 60W lt 2A lt 36VDC lt 25VAC Isolated voltage 1500VAC Signal type N C N O A 3 9 Data Storage Clinic Mode Patient quantity 1000 Recording number 16000 Single patient clinic 1 16000 record number Monitor Mode Patient quantity V6 Vital Signs Monitor User s Manual Trend data 3 kind s resolution 1 Min 5Min 10Min 1Min can store 96 hours 5 Min can store 480 hours 10 Min can store 960 hours Alarm events 1000 NIB measurement record 5000 A 4 Measurement Specifications A 4 1 SpO e Digital SpO2 module Measurement technique Digital SpO technique Monitoring parameters SpO2 Measurement Resolution Accuracy PR Measurement range Resolution Accuracy range SpO and PR 0 100 1 t 2 70 100 SpO gt 3 35 69 SpO gt 0 34 unspeci
12. status A new alarm will cancel the silence automatically 5 6 Digicare Biomedical Technology Chapter 6 SpO 6 1 Introduction The measurement of oxygen saturation of arterial blood also known as pulse oxygen saturation usually shortened as SpO adopts the principles of light spectra and volume tracing The LED emits lights with two specific wavelengths which are selectively absorbed by oxygenated hemoglobin and deoxyhemoglobin The optical receptor measures the changes in the light intensity after the light passes the capillary network and estimates the ratio of oxygenated hemoglobin and the total hemoglobin oxygenated hemoglobin SpO ME oxyhemoglobin deoxyhemoglobin x 100 Wavelengths of the light emitted by the pulse oximeter probe are nominally 660nm for red LED and 940nm for infrared LED 6 2 Safety Information Warning Use only SpO2 sensors specified in this manual Follow the SpO2 sensor s instructions for use and adhere to all warnings and cautions When a trend toward patient deoxygenating is indicated blood samples should be analyzed by a laboratory co oximeter to completely understand the patient s conditions O Do not use the monitor and the SpO sensor during magnetic resonance imaging MRI Induced current could cause burns e Prolonged continuous monitoring may increase the risk of unexpected changes in skin characteristics such as irritation reddening blistering or burns Inspect the sens
13. to enter CO Setup menu 2 Set Unit to mmHg KPa and 8 4 Digicare Biomedical Technology 8 4 4 Setting Scan Speed CO Scan Speed Select CO to enter CO Setup menu Set Scan Speed tof 6 25 mm s 12 5 mm s 25 mm s or 50 mm s CO Wave Scan Speed Select CO Wave to enter CO Wave Setup menu Set Scan Speed tof 6 25 mm s 12 5 mm s 25 mm s or 50 mm s 8 4 5 Setting Wave Color iE Select CO Wave to enter CO Wave Setup menu 2 Set Wave Color to a desired value 8 5 Zeroing Zeroing allows the CO2 module to adjust to the optical characteristics in order to obtain accurate readings While zeroing is recommended the first time a CO module is connected to the monitor it is only absolutely necessary when the message Zero Required is displayed Follow these steps l Ensure that the nasal cannula or airway adapter is not connected to the patient or close to any source of CO including the patient s your own exhaled breath and ventilator exhaust valves Select Zero in the CO parameter setting menu this will start zeroing The monitor zeroes the module and displays the message Zero In Progress for about 15 20s on the screen The message disappears upon completion of the zeroing Caution Always ensure that the sampling tube is properly connected to the micro stream CO module before zeroing O Always ensure that the mai
14. 2 View record during a time a Seil Lookup Jto Within a week Within a month 1 Within half a year or TAN b Select Lookup on the right to enter History Review menu 9 1 Digicare Biomedical Technology Chapter 10 Recording 10 1 Recorder This monitor uses the thermal recorder which supports various record types It can output the patient information measurement data review data and two waveforms at most 10 2 Recording Type The records can be divided into the following types according to trigger modes 1 Real time record of manual startup 2 The circular record of automatic startup of the recording meter in line with the given time interval 3 The alarm record triggered by out of limit parameter and so on 4 Record started by manual operation and related to special function 10 3 Starting Stopping Recording Through the following methods you can start and stop recording O Press the button on the front panel of monitor to start real time recording O Press the button again to stop recording 10 4 Setting Recorder e Select Menn System Setup Recorder Setup to enter Recorder Setup menu O Select to enter Recorder Setup menu 10 4 1 Setting Cycle Record 1 Enter Recorder Setup menu through the above methods 2 Set Cycle Record to 5 Min 10 Min 30 Min 1H or 2H Digicare Biomedical Technology 10 4 2 Setting Cycle Record Time You can set a certain time inter
15. Digicare Biomedical Technology Product Information O Product Model DigiMAP DM8x O Product Name DigiMAP DM8x Vital Signs Monitor O Manufacturer Digicare Biomedical Technology Inc Address 107 Commerce Road Boynton Beach FL 33426 USA Fax 561 689 0021 Phone 561 689 0408 Statement Digicare Biomedical Technology Inc holds the copyright of this manual and we are also entitled to deal with this manual as confidential files This manual is only used for operation maintenance and service of product someone else can not publish the manual This manual contains exclusive information protected by copyright laws and we reserve its copyright Without written approval of manufacturer no parts of this manual shall be photocopied Xeroxed or translated into other languages The contents contained in this manual are subject to amendments without notification Manufacturer s Responsibility Only under the following circumstances will Digicare Biomedical Technology Inc be responsible for the safety reliability and performance of the instrument O All the installation expansion readjustment renovation or repairs are conducted by the personnel certified by manufacturer The storage condition operation condition and electrical status of the instrument conform to the product specification The instrument is used in accordance with the user s manual Operators Manual Multi parameter Patient Monitor DigiMAP I Di
16. OGY INC will provide the necessary parts and labor to maintain the monitor s listed on the Warranty Certificate in a usable condition during the covered period DIGICARE BIOMEDICAL TECHNOLOGY INC will at its option repair or replace any product which proves to be defective during the warranty period if returned to the factory with prior authorization transportation prepaid Not covered by this agreement are repairs necessitated by any of the following conditions 1 Inadequate power or power failure 2 Neglect abuse or misuse of equipment 3 Servicing of equipment by person s other than DIGICARE INC 4 Any unit opened or tampered with without prior authorization When returning a monitor for extended warranty repair you must first contact DIGICARE BIOMEDICAL TECHNOLOGY INC to receive a Returned Goods Authorization Number RGA that is to be clearly marked on top of the shipping carton Please make sure that your company name shipping address area code and telephone number and person to contact is located in and or on the box ANY UNIT THAT IS RETURNED TO THE FACTORY WITHOUT AN RGA WILL BE REFUSED Model Serial Dealer Name Date Equip Purch Expiration Date DIGICARE BIOMEDICAL TECHNOLOGY INC 107 Commerce Road Boynton Beach FL 33426
17. ained from SpO Indicator of signal intensity Description id The signal strength is low ee The signal strength is good SEH The signal strength is best 6 5 Setting SpO 6 5 1 Opening the SpO Menu To open the Sp Menu e Select SpO to enter SpO Setup menu O Select Pleth to enter Pleth Setup menu 6 5 2 Setting Beep Volume 1 Select SpO to enter SpO Setup menu 2 Set Beep Volume to Off or 1 5 6 5 3 Setting Scan Speed O Sp Scan Speed 1 Select SpO to enter SpO Setup menu 2 Set Scan Speed to 6 25mm s 12 5mm s1 25 mm s or 50 mm s O Pleth Scan Speed 1 Select Pleth to enter Pleth Setup menu 2 Set Scan Speed to 6 25mm s 12 5mm s 25 mm s or 50 mm s 6 5 4 Setting Average Time The SpO reading shown on the monitor is the average of data collected within a specific time The shorter the averaging time is the quicker the monitor responds to the change in the patient s oxygen saturation level Contrarily the longer the 6 3 Digicare Biomedical Technology averaging time is the slower the monitor responds to the change in the patient s oxygen saturation level but the measurement accuracy will be improved When a critical patient is monitored selecting shorter averaging time will help understanding the patient s state Select SpO to enter SpO Setup menu Set Average Time to a desired value
18. alarm Physiological alarm messages are displayed in the physiological alarm area The system uses different symbols and background colors for the alarm message to match the alarm level as follows Alarm level symbol background color High kk red Medium DE ae S yellow Caution O The monitor won t give physiological alarm under clinic mode e Technical alarm Technical alarm messages are displayed in the technical alarm area The system uses different symbols and blue background color for the alarm message to match the alarm level as follows Alarm level symbol background color Medium D l Low S blue O Prompt messages Prompt messages are displayed in technical alarm area Prompt messages have no color and visual and audible alarm indication 5 4 Setting Alarm Volume You need to set alarm volume only under monitor mode 1 Select Menu Sound Setup 2 Select Alarm Volume choose a desired value 5 4 Digicare Biomedical Technology 5 5 Parameter Alarm You need to set Alarm Setup only under Monitor Mode 5 5 1 Turn on off the Alarm Take SpO2 for example 1 Select Menu Alarm Setup 2 Set Class to any option but Off to turn on the alarm while set Class to Off to turn off the alarm 5 5 2 Setting Alarm Level Take Sp for example 1 Select Menu Alarm Setup 2 Set Class to Medium or High 5 5 3 Setting Alarm Lim
19. and CO Monitor mode may be used in one of the following occasions 1 Monitor of a single patient for a long time e g hospitalized patient 2 Ward without on duty medical personnel 3 Remote monitoring connect to central unit through network 1 3 3 Difference Between two Modes Function Mode Monitor Clinic Silence With With Alarm Pause With Without Technical Alarm With With Physiological Alarm With Without Recording Review With With Alarm Review With With Parameter Storage With With Alarm Messages Storage With Without Nurse Call With Without Communicating with Center With With Computer Multi patient Without With Standby Mode Without With Digicare Biomedical Technology Chapter 2 Safety 2 1 Safety Information Warning O Indicates a potential hazard or unsafe practice that if not avoided will result in death or serious injury Caution O Indicates a potential hazard or unsafe practice that if not avoided could result in minor personal injury or product property damage Note Provides application tips or other useful information to ensure that you get the most from your product 2 1 1 Warning Warning O Before using please check the connecting cables and accessories are in correct working order and operating condition Please connect the monitor to a socket with protective earth If the socket does not have protective earth conductor pleas
20. call Setup to enter nurse call setup menu Set PhyAlarm Trigger and TecAlarm Trigger to Off Low Med or High 3 9 Viewing the Machine Info Select Menu Machine Info 2 View the detail information about this monitor 3 6 Digicare Biomedical Technology Chapter 4 User Interface 4 1 Display Style Display style of user interface can be set according to your need Including Screen brightness Display color of wave and parameter Sweep mode of wave 4 1 1 Adjusting the Screen Brightness 1 Select Menu Display Setup 2 Select Back Light set its value 4 1 2 Selecting the Color 1 Select Menu Display Setup 2 Select Color Setup choose a desired color for the parameter and waveform 3 Select Default Setup set all the parameters and waveforms to default color 4 1 3 Screen Switch You can set the screen layout as required The setting method is as follows 1 Select Menu Display Setup 2 Select Screen Switch choose a desired screens to display There are NIBP Review Trend Screen and Alarm Screen 4 2 Screen Layout The monitor has configured with a color TFT LCD to display parameters and waves of patient s SpO2 NIBP and CO The following figures are screens of the monitor 4 1 Digicare Biomedical Technology 4 2 1 Standard Screen Parameters displayed under the screen are SpO2 CO and SpO Waves displaye
21. d under the screen are SpO and CO 11 1 10 2 3 4 5 6 9 7 8 1 Alarm Pausing Silence Area It is to display alarm pausing icon and time or silence icon 2 NIBP Parameter Area It is to display NIBP parameters Select NIBP to enter NIBP Setup menu 3 CO2 Parameter Area It is to display CO parameters Select CO2 to enter CO Setup menu 4 CO2 Wave Area It is to display CO wave Select CO Wave to enter CO Wave Setup menu 5 SpO2 Parameter Area It is to display Sp parameters Select SpO to enter SpO Setup menu 6 SpO2 Wave Area It is to display SpO wave Select Sp Wave to enter SpO Wave Setup menu 7 Time and Battery Status Displaying Area It is to display system time and battery status 4 2 Digicare Biomedical Technology 8 Prompt Messages Area It is to display the menu s meaning which the cursor is on or prompt messages 9 Icons Area From left to right the icons are Menu Patient Information Recorder Setup Network Setup and SD Card 10 Physiological Alarm Area It shows the physiological alarm messages When multiple alarms of different levels occur at the same time the monitor will give visual and audible alarm indications according to the alarm level 11 Technical Alarm Area It shows technical alarm messages When multiple alarms of different levels occur at the same time the monitor will give visual and audible alarm indications accord
22. d it for 1s to turn off the monitor Caution e Ifthe monitor can t be switched off normally forced close the monitor by pressing and holding the power switch for more than 5s 3 4 Operation Modes 1 Select E or E in the Icons Area after starting the monitor to enter Mode Select menu 2 Select Clinic Mode or Monitor Mode to enter Continue menu 3 If the patient you are going to monitor is the one displayed in Continue menu please select Continue 4 If the patient is a new one please select New Patient 5 Input the new patient s information in New Patient menu 3 5 Using Menu Turn the Trim Knob left or right to select Menu to open the following main menu You can finish most operations and sets through Menu The main menu under Monitor Mode is different from that under Clinic Mode The following figure is main menu under Monitor Mode 3 3 Digicare Biomedical Technology Sound Setup gt Display Setup gt Storage Setup gt System Setup gt Style of other menus is the same as that of the main menu parts of which are as follows 1 Menu title Name of the menu 2 Main display area Area to display options buttons or prompt messages cr Kl Means you can enter its submenu 3 Return Press this button to exit the menu 3 6 General Setup 3 6 1 Changing the Language 1 Select Menu System Setup 2 Select Language choose a desired language 3 Sel
23. different tone O Alarm lamp According to alarm level alarm lamp on monitor flashes in different color and speed Alarm message Alarm messages are displayed on the screen Flashing numeric The numeric of parameter in alarm flashes Caution The concrete presentation of each alarm prompt is related to the alarm level 5 2 Digicare Biomedical Technology 5 3 1 Alarm Tone The different level alarms are indicated by the system in following different audio ways Alarm level Audible prompt High DO DO DO DO DO DO DO DO DO DO Medium DO DO DO Low DO 5 3 2 Alarm Lamp When a physiological alarm occurs the alarm levels are indicated in the following different visual ways Alarm level Visual prompt High Alarm lamp flashes in red with 2 Hz Medium Alarm lamp flashes in yellow with 0 5 Hz Low Alarm lamp lights on in yellow without flashing When a technical alarm occurs the alarm levels are indicated in following different visual ways Alarm level Visual prompt Medium Alarm lamp flashes in blue with 0 5 Hz Low Alarm lamp lights on in blue without flashing Caution When multiple alarms of different levels occur at the same time the monitor will select the alarm of the highest level and give visual and audible alarm indications 5 3 Digicare Biomedical Technology 5 3 3 Alarm Message Physiological
24. displayed in the technical alarm area O Prompt messages As a matter of fact prompt messages are not alarm messages Apart from the physiological and technical alarm messages the monitor will show some message to indicate the system status D Digicare Biomedical Technology 5 2 Alarm Level According to severity of alarm the monitor s physiological alarms are classified into three categories high level alarms medium level alarms and low level alarms e High level alarms Indicate that the patient is in a life threatening situation and an emergency treatment is necessary This is the highest level alarm O Medium level alarms Indicate that the patient s vital signs appear abnormal and an immediate treatment is required e Low level alarm Indicate that the patient s vital signs appear abnormal and an immediate treatment may be required The levels of some physiological alarms are predefined before the monitor leaves the factory and can not be changed by users While some levels of physiological alarms can be changed by users The monitor s technical alarms are classified into two categories medium level and low level The levels of technical alarms are predefined before the monitor leaves the factory and can not be changed by users 5 3 Alarm Indicators When an alarm occurs the monitor will indicate it through the following means O Alarm tone According to alarm level speaker in the monitor gives alarm sound in
25. e Mean arterial blood pressure Pulse Rate obtained from NIBP Diastolic blood pressure nA A U N rz 7 7 Setting NIBP Select NIBP to enter NIBP Setup menu 7 7 1 Setting Unit In NIBP Setup menu set Unit to mmHg or kPa 7 4 Digicare Biomedical Technology 7 7 2 Setting Initial Press In NIBP Setup menu set Init Press to a desired value 7 8 Setting Venipuncture Press You can use the NIBP cuff to cause sub diastolic pressure and block the venous blood vessel to assist venous puncture 1 Select NIBP to enter NIBP Setup menu Set Veni Press to a desired value Select Venipuncture Puncture vein and draw blood sample A Select Venipuncture again to deflate the cuff The cuff deflates automatically after a set time if you do not deflate it 7 9 NIBP Resetting Select Reset in NIBP Setup menu to restore the inflation value of blood pressure pumps to the initial value In case the blood pressure pump doesn t work as normal but without any prompt the blood pressure pump can be checked by reset thus the blood pressure pump in abnormal condition due to unexpected reason will automatically restore 7 10 Air Leakage Testing Air Leakage Testing is to test the status of air way s air leaking If no error information displays on NIBP parameter area it indicates that the airway is in good situation and no air leaks exist However if the airway may have air leaks the prompt
26. e do not use the socket and use battery to provide power to the monitor O To avoid explosion hazard do not use the monitor in the presence of flammable anesthetics vapors or liquids O Do not open the monitor housings electric shock hazard may exist All servicing and future upgrades must be carried out by the personnel 2 1 Digicare Biomedical Technology trained and authorized by manufacturer only When using the monitor with electrosurgical units ESU make sure the patient is safe Do not come into contact with the patient during defibrillation Otherwise serious injury or death could result Do not rely exclusively on the audible alarm system for patient monitoring Adjustment of alarm volume to a low level or off may result in hazard to the patient Remember that alarm settings should be customized according to different patient situations and always keeping the patient under close surveillance is the most reliable way for safe patient monitoring The physiological data and alarm messages displayed on the monitor are for reference only and cannot be directly used for diagnostic interpretation To avoid inadvertent disconnection route all cables in a way to prevent a stumbling hazard Wrap and secure excess cabling to avoid risk of entanglement or strangulation by patient or personnel 2 1 2 Caution Caution To ensure patient safety use only parts and accessories specified in this manual At the end of its service
27. e g patient has severe tremor 3 Irregular pulse rate e g arrhythmia Overpressure Sensed Cuff pressure exceeds the specified high safety limit Could be due to rapid squeezing or bumping of cuff Signal Saturated Large motion artifact that saturates the BP amplifier s amplitude handing capability Pneumatic Leak Module reports Air Leakage failure while in the Pneumatic Test mode System Failure Module experiences abnormal processor event Time Out Measurement took more than 120 seconds in adult 90 seconds in neonate mode Cuff Type Err Neonate cuff is used in adult mode Low SpO gt signal weak SpO signal is weak O NIBP Alarm messages Cause Level Self test Failed Transducer or other hardware failure 1 Cuff is completely unwrapped Loose Cuff 2 The cuff is not connected 3 Adult cuff used in neonate mode Air Leak Air leak in pneumatics hose or cuff Unable to maintain stable cuff pressure Air Pressure Error e g kinked hose Very weak patient signal due to a loosely Weak Signal wrapped cuff The pulse of patient is too weak Measurement range exceeds module Range Exceeded specification 1 Too many retries due to interference of motion artifact Excessive Motion 2 Signal is too noisy during measurement Low e CO Alarm messages Cause Level CO sensor is of
28. e sample pump off To remove the sampling tube from the sampling tube receptacle press down on the locking tab and pull the sampling tube from the receptacle 3 Ifthe sampling pump fails to turn on or runs intermittently perform a Zero procedure 4 Ensure that the CO module exhaust tube vents gases away from the module environment 5 Wait for the CO module to warm up The monitor will display the Sensor Warm Up message for approximately lminute while the module warms up to operating temperature The message disappears when the module is ready for use 6 Apply Micro stream airway adapter or cannula 1 For intubated patients requiring an airway adapter Install the airway adapter at the proximal end of the circuit between the elbow and the ventilator Y section Shown as follows 2 For intubated patients with an integrated airway adapter in the breathing circuit Connect the male connector on the straight sample line to the female port on the airway adapter Shown as follows 0 8 2 Digicare Biomedical Technology 3 For non intubated patients Place the nasal cannula onto the patient Shown as follows DA yr 4 For patients prone to mouth breathing use an oral nasal cannula Trim the oral sampling tip if necessary to fit the patient It should extend down past the teeth and be positioned in the mouth opening Remove the cannula from the patient if the tip needs to be trimmed Shown as follow
29. earing Jam Paper While the sound of recorder operation or printing of recording meter is abnormal please first check whether there is paper jam in the recording meter If so please clear it as per following steps 1 Open the recorder door 2 Pull out the recording paper and cut off the wrinkle part 3 Load recording paper once again and close the recording meter door 10 7 Cleaning Recorder After long time service some paper scrap and impurity will accumulate on the printing head and affect printing quality as well as the service life of printing head and roll shaft The recorder can be cleaned according to the following methods 1 Before cleaning the measures such as wearing anti static wrist strap shall be adopted to avoid the damage to recording meter resulting from static 2 Open the recorder door and pull out recording paper 3 Use a tampon with some alcohol to sweep slightly the surface of thermo sensitive parts of printing head 4 After the alcohol entirely vaporizes load recording paper once again and close the recorder s door Caution e Don t use any article that can damage the thermo sensitive parts of recorder during cleaning e Don t heavily press the printing head of recorder 10 3 Digicare Biomedical Technology Chapter 11 Battery 11 1 Introduction The monitor can be fitted with rechargeable battery to ensure its continuous work after the failure of alternating current power supply and it
30. ect Return gt exit the current menu 3 6 2 Setting the Screen Saver Under the Clinic Mode 1 Select Menu Display Setup 2 Select Screen Save Time choose a desired setup 3 6 3 Setting the Date and Time 1 Select Menu System Setup Datetime Setup 2 Set Year Month Day Hour Min and Sec to a desired value 3 Select Modify Yes to finish setting 3 6 4 Adjusting the Volume O Alarm Volume Under the Monitor Mode 3 4 Digicare Biomedical Technology 1 Select Menu Sound Setup 2 Select Alarm Volume choose a desired value Oo Beep Volume 1 Select Menu Sound Setup 2 Select Beep Volume choose a desired value 3 7 Default Setups Caution O In case of power failure after restart the system will restore the setup before power failure automatically It is possible that you change some setup during operation but these changes are not always appropriate or correct Therefore you may restore some setup to factory default setup during actual operation to ensure that various setup of the monitor is applicable to the monitored patient 1 Select Menu System Setup to open System Setup menu 2 Select Default Config to enter Default Config menu 3 Select one config from AdultConfig 1 ChildConfig Jandl NewbornConfig to restore setups to factory defaults 4 Select Return to exit Default Config menu 3 8 Nur
31. ediatric cuff and adult cuff Including arm cuff and thigh cuff 7 5 2 Starting Stopping Measuring Press the button on the front panel of monitor to start NIBP measuring while press the button a 1 to stop NIBP measuring 7 5 3 Auto Measurement 1 Select NIBP to enter NIBP Setup menu 2 Set Interval to any option but Manual 3 Start the Auto measurement manually for the first time and then enter the Auto mode The the monitor will start the measurement continually repeated in the set interval after the first measurement If you press Lo button during the auto measurement the measuring will be paused You should press the but 4 again to start the auto measurement 7 3 Digicare Biomedical Technology Warning Prolonged NIBP measurements in Auto mode are associated with purport ischemia and neuropathy in the limb wearing the cuff When monitoring a patient examine the extremities of the limb frequently for normal color warmth and sensitivity If any abnormality is observed stop the NIBP measurements 7 5 4 STAT Measurement 1 Select NIBP to enter NIBP Setup menu 2 Select STAT to start the STAT Measurement 7 6 NIBP Display There is no waveform displayed for NIBP measurement the NIBP readings are displayed in the parameter area The following figure shows the NIBP display screen the display on your monitor may be looked slightly different Pressure unit Systolic blood pressur
32. f patient or off the CO sensor off y monitor CO airway adapter is disconnected with Check airway adapter CO sensor CO measurement over CO measurement is over range and need range verify zero Zero Required Sensor or module is not initialized Low Check CO Sampling Line Sampling tube is occluded or damaged Sampling tube is kinked or pinched Exhaust tube is blocked CO sensor error CO sensor is error Sensor no initialized Sensor or module is not initialized C 3 Prompt Messages O System Messages Cause Level Recording Recorder is in printing operation No level O SpO Messages Cause Level Search pulse SpO module is searching for pulse SE i No level Motion interference Patient movement is too much NIBP Messages Cause Level Software Over press NIBP is testing Software Over Pressure No level Hardware Over press NIBP is testing Hardware Over Pressure Manometer NIBP is testing Manometer Air Leakage Testing NIBP is testing Air Leakage No level Venipuncture NIBP is in venipuncture e CO Messages Cause Level Zero in Progress Zeroing is in progress No level CO Sensor Warm Up Module is warming up WARRANTY TERMS amp CONDITIONS DIGICARE BIOMEDICAL TECHNOLOGY INC covers all of their monitors with a 1 year warranty Monitors 1 year parts and labor Accessories 90 days on accessories only DIGICARE BIOMEDICAL TECHNOL
33. fications A 1 Safety Specifications A 1 1 Classification Classification of Protection against electric shock Degree of protection against electric CF shock Degree of protection against hazards y er P 5 Not suitable of explosion e of protection against ingress Ordinary equipment of liquid Mode of operation Continuous Note I Class I internally and externally powered equipment CF Type CF applied part Not suitable Equipment is not suitable for use in the presence of flammable anesthetic mixture with air or with oxygen or nitrous oxide Ordinary equipment Without protection against ingress of water A 1 2 Environmental Specifications Operating 5 40 C Temperature Transportation and Storage 20 55 C Operating lt 85 no condensing Humidity Transportation and Storage lt 93 no condensing Operating 860 1060 hPa Transportation and Storage 500 1060 hPa Atmospheric Pressure V6 Vital Signs Monitor User s Manual A 1 3 Power Specifications Input voltage AC 100 240 V 50 60 Hz Input power TOVA Fuse TI1 6AL 250V 2 05x20mm A 2 Physical Specifications Part Weight kg Size WxHxD mm Mainframe About 2 5 Including a lithium battery lt 160x130x260 A 3 Hardware Specifications A 3 1 Display Type Color TFT LCD Size diagonal 7 inch Resolution 234x480 pixe
34. fied 25 250 bpm 1 bpm 1 or 1 bpm whichever is the greater Sp alarm range 0 100 high low limit can be adjusted continuously PR alarm range Nellcor SpO module 0 300 bpm high low limit can be adjusted continuously M t EEN Nellcor SpO technique technique Monitoring parameters SpO and PR SpO2 Measurement range i ES 0 100 Resolution 1 Accuracy V6 Vital Signs Monitor User s Manual 2 70 100 SpOs adult 3 70 100 SpO2 neonate 2 70 100 SpO gt Clow perfusion unspecified 0 69 PR Measurement range 20 250 bpm Resolution 1 bpm Accuracy 1 or 1 bpm whichever is the greater Sp alarm range 0 100 high low limit can be adjusted continuously PR alarm range 0 300 bpm high low limit can be adjusted continuously A 4 2 NIBP Measurement way Automatic oscillometry Measurement range Sys 30 270 mmHg Adult Dia 10 220 mmHg Map 20 235 mmHg Sys 30 235 mmHg Pediatric Dia 10 220 mmHg Map Q0 225 mmHg Sys 30 135 mmHg Neonatal Dia 10 110 mmHg Map Q0 125 mmHg Cuff pressure range 0 280 mmHg Resolution 1 mmHg Pressure accuracy Static 3 mmHg Clinic Average error 5 mmHg standard deviation lt 8 mmHg Unit mmHg kPa PR range 40 240
35. g or have recently received anesthetics connect the outlet to a scavenging system or to the anesthesia machine ventilator to avoid exposing medical staff to anesthetics Use an exhaust tube to remove the sample gas to a scavenging system Attach it to the outlet connector of micro stream CO module 8 7 Digicare Biomedical Technology Chapter 9 Reviewing Review means reviewing the patients relevant data that have been saved by the monitor previously Review function is available in Clinic Mode only In Monitor Mode you may review the trend data NIBP measurement data and alarm events of the monitored patient by use of screen changing key 9 1 Entering the Reviewing Menu You can enter the reviewing menu by the following two methods e Select Menu History Review to enter the reviewing window O Select Menu Data Manage to enter Data Manage window 9 2 Reviewing Details O Through History Review window 1 Select History Review to enter History Review menu 2 Turn the Trim Knob to select a patient in the window then select LookUp to view patient s Detail Record 3 Select Record or press the button F on the front panel of monitor to print out the current page e Through Data Manage window 1 View one patient s ID record a Input the patient s ID number in Lookup ID Record b Select the button Lookup ID Record on the right to view patient s Detail Record
36. ge At last select OK to keep the setting of new patient 4 5 Digicare Biomedical Technology 4 3 3 Patient ID e Clinic Mode In Patient Info menu when selecting New Patient Patient ID will be created according to ID Name automatically You can also input Patient ID manually Through Patient Info menu you can change the patient info After amending the patient info selecting Return to save the changes e Clinic Mode In Patient Info menu when selecting New Patient You need to input Patient ID manually Through Patient Info menu you can change the patient info After amending the patient info selecting Return to save the changes 4 4 Demo 4 4 1 Turn on Demo 1 Select Menu System Setup to enter the system setup menu 2 Set Demo to On a password entering window will pop up 3 Input the desired password and then select OK to enter the demo mode 4 4 2 Turn off Demo 1 Select Menu System Setup to enter the system setup menu 2 Set Demo to Off 4 5 Machine Maintenance Select Menu System Setup Machine Mainte input the required passwords to enter the following menu From left to right are Clinic Mode and Monitor Mode 4 6 Digicare Biomedical Technology Machine Mainte Machine Mainte si Return Return NIBP Test Select NIBP Test to test NIBP CO Mainte Select CO Mainte to maintain CO Touch Adjust Selec
37. gicare Biomedical Technology About this manual This manual contains the instructions necessary to operate the product safely and in accordance with its function and intended use Observance of this manual is a prerequisite for proper product performance and correct operation and ensures patient and operator safety This manual is based on the maximum configuration and therefore some contents may not apply to your product If you have any question please contact us This manual is an integral part of the product It should always be kept close to the equipment so that it can be obtained conveniently when needed The manual is geared for clinical professionals who are expected to have a working knowledge of medical procedures practiced and terminology as required for monitoring patients All illustrations in this manual serve as examples only They may not necessarily reflect the setup or data displayed on your product Conventions e Bold Italic text is used in this manual to quote the referenced chapter or sections e is used to enclose screen texts O is used to indicate operational procedures Revision 0 January 2011 Operators Manual Multi parameter Patient Monitor DigiMAP II Digicare Biomedical Technology Contents Chapter 1 General Introduction cccccsssssssseccssssssscssccccsccscscsscscsecesscssssceees IA AA A A T E a 12 M in Et ee ee ee NEE eeneg td Chapter AS EE 271 Satety ee E e EE
38. harger stand and connect the AC mains Allow the battery to be charged uninterruptedly for above 6 hours 3 Disconnect AC mains and allow the monitor to run on the battery until it shuts off 4 The operating time of a battery reflects its performance directly Caution O The operating time of a battery depends on the configuration and operation of the monitor NIBP measurement SpO measurement and using of recorder will deplete the battery faster than other parameters measurement 11 5 Disposing Batteries Batteries that are damaged or depleted should be replaced and discarded properly Dispose of used batteries according to local regulations Caution The service life of battery depends on the service time and frequency This monitor battery can be charged and discharged for 300 times generally Warning O Do not disassemble batteries dispose of them in fire or cause them to short circuit They may ignite explode or leak causing personal injury 11 3 Digicare Biomedical Technology Chapter 12 Maintenance and Cleaning 12 1 Introduction Keep your equipment and accessories free of dust and dirt To avoid damage to the equipment follow these rules l AUS lS Always dilute according the manufacturer s instructions or use lowest possible concentration Do not immerse part of the equipment in the liquid Do not pour liquid onto the equipment or accessories Do not allow liquid to enter the case
39. ilization level is required please choose disposal cuff One disposal cuff can only be used for one patient Carefully keep water and cleaning solution out of the connecting parts of cuff and monitor 12 3 3 CO Sensor and Reusable Airway Adapter The outside of the module or sensor may be cleaned and disinfected by wiping with 70 isopropyl alcohol a 10 bleach solution or mild soap After cleaning wipe with a clean water dampened cloth to rinse Dry before use Reusable airway adapters may be cleaned by rinsing in a warm soapy solution followed by soaking in a liquid disinfectant such as 70 isopropyl alcohol a 10 bleach solution Cidex or System 1 refer to the disinfectant manufacturer s instructions for use Adapters should then be rinsed with sterile water and dried Reusable airway adapters may also be pasteurized or autoclaved Autoclave at 121 C 250 F for 20 minutes unwrapped Before reusing the adapter ensure the windows are dry and residue free and that the adapter has not been damaged during handling or by the cleaning process 12 3 Digicare Biomedical Technology Chapter 13 Accessories Warning Use only accessories specified in this manual Using other accessories may cause damage to the monitor Disposable accessories are designed for single patient use only Reuse of them may cause a risk of contamination and affect the measurement accuracy Check the accessories and their packages for any sig
40. ing to the alarm level 4 2 2 Alarm Screen Alarm Screen Page 1 1 pe Alarm Event 113 Recorder Error p Low Under the screen you can view each alarm event including its data time and the parameters leading the alarm 4 3 Digicare Biomedical Technology 4 2 3 NIBP Review Under the screen you can view the measurement of NIBP 4 2 4 Trend Screen 4 4 Digicare Biomedical Technology The screen is called Trend Screen under Monitor Mode while called Clinic Review under Clinic Mode Under the screen you can view the measurement of each parameter O Storage Setup 1 Select Menu Storage Setup to enter Storage Setup menu 2 Set Trend StorInter to a desired value between 1 Min 1 Min and 10 Min 4 3 Patient Information Select Patient Information icon to center Patient Info menu In the menu you can view patient s ID Name Type Gender and Age which are shown as follows PatientID FC Name Type emily adult Sex Age Female E E 4 3 1 Continuous the same patient When the patient to be monitored is the one displayed in Patient Info menu please select Return The monitor will continuous the monitoring of the same patient and add current data to the previous one 4 3 2 Admitting a new patient When the patient to be monitored is a new one please select New Patient to enter New Patient menu Input new patient s ID Name Type Gender and A
41. ioxide CO2 concentration in the breathing airway of patient Because CO molecule can absorb infrared light of special wavelength and the amount of absorbed infrared light directly relates to the concentration of CO therefore while the infrared light radiated from the infrared light source passing through the gas sample containing CO3 part of energy will be absorbed by CO in the gas At another side of infrared light source a photo detector is used to measure the remaining infrared energy and convert it to electric signal which will be compared with the energy of infrared light source and adjusted so as to correctly reflect the CO concentration in the gas sample The method to measure carbon dioxide in the patient s airway for this monitor is micro stream That is taking a sample of the respiratory gas with a constant sample flow from the patient s airway and analyzes it with the CO2 sensor 8 2 Monitoring Procedure 1 Attaching the CO Module Cable Plug the cable into the CO connector on the monitor 2 Attaching the Sampling Tube Insert the sampling tube into the sampling tube receptacle Shown as follows Exhaust Tube _ S d p Receptac1 N DS Sampling Tube er A Module Cable Receptacle ae il y CO2 Module Sampling Tube 8 1 Digicare Biomedical Technology Note e Inserting the sampling tube into the receptacle automatically starts the sampling pump Removal of the sampling tube turns th
42. it Take Sp for example 1 Select Menu Alarm Setup 2 Set High Lim and Low Lim to a desired value 5 6 Pausing Alarms Press the button AX on the front panel of monitor you can suspend all alarm indicators of the monitor O The visual alarm and audible alarm are all suspended O The parameters of physiological alarm stop flashing O The alarm message in the physiological alarm area will not be displayed O The remaining time and the icon ZX will be shown in the physiological alarm area O The technical alarm message will still be shown in the technical alarm area After the alarm paused time or when a new medium level technical alarm occurs during the alarm pausing the monitor will automatically Aincel the alarm pausing Press again the button ZX the alarm pausing can be cancelled by manual operation O Setting Alarm Pausing time Set the silence time only under Monitor Mode 5 5 Digicare Biomedical Technology 1 Select Menu System Setup 1 gt Machine Mainte gt enter the required password 2 Set Alarm suspend Time to 1Min 2Min or 3Min 5 7 Silence Press and hold the button 4 on the front panel of monitor for 1 second to set the system silent That is all the sound of system is shut off And the icon IS will be displayed in the upper right corner of the screen When in the silence status the alarm indicators are valid except audible alarm Press the button again to exit the silence
43. life the monitor as well as its accessories must be disposed of in compliance with the guidelines regulating the disposal of such products If you have any questions concerning disposal of the monitor please contact us Magnetic and electrical fields are capable of interfering with the proper performance of the monitor For this reason make sure that all external devices operated in the vicinity of the monitor comply with the relevant EMC requirements Mobile phone X ray equipment or MRI devices are a possible source of interference as they may emit higher levels of electromagnetic radiation 2 2 Digicare Biomedical Technology O Before connecting the monitor to the power line check that the voltage and frequency ratings of the power line are the same as those indicated on the monitor s label or in this manual Always install or carry the monitor properly to avoid damage caused by drop impact strong vibration or other mechanical force 2 1 3 Note Note Put the monitor in a location where you can easily see the screen and access the operating controls O Keep this manual in the vicinity of the monitor so that it can be obtained conveniently when needed The software was developed in compliance with IEC 60601 1 4 The possibility of hazards arising from software errors is minimized This manual describes all features and options Your monitor may not have all of them 2 2 Safe Operation Conditions Meth
44. ls Anti glare screen With LCD switch With A 3 2 Recorder Paper width 50 mm Recording width 40 mm Recording speed Recording waveform double tracks A 3 3 Battery Type Rechargeable lithium ion battery Size 105mmx78mmx20mm V6 Vital Signs Monitor User s Manual Operating time Weight lt 360 g Quantity 1 Rated voltage 11 1 VDC Capability 4000 mAh 8 hours Using a new and fully charged battery at 25 C ambient temperature connecting Sp sensor and NIBP work on AUTO mode for 15 minutes interval Charge time 6h to 100 Standby Turn off delay 5 min 15 min after the low battery alarm first occurs Indicator of battery f CN With capability A 3 4 Mainframe LED Physiological alarm indicating lamp 1 Yellow Red Technical alarm indicating lamp 1 Blue Power indicating lamp 1 Green Orange Green When powered with AC it lights green while turn on and off the monitor Orange When powered with battery it lights orange only while turn on the monitor Battery charging indicating lamp 1 Orange A 3 5 Audio indicating Speaker Gives audible alarm QRS tone Supports Pitch Tone and multi level volume Alarm tones meet the requirement of IEC 60601 1 8 Alarm pressure 45 dB to 85 dB Testing place is 1 meter from the tone V6 Vital Signs Monitor User s Manual A 3 6
45. ment of temperature 40 C to 80 C for at least one hour 12 3 Cleaning of and Sterilizing Accessories 12 3 1 SpO Sensor The recommended disinfector include isopropyl alcohol 70 10 decolourant solution can be used for sterilization at lower standard Don t use undiluted decolourant 5 5 25 sodium hypochlorite or other non recommended disinfector in order to avoid damage to sensor The method of cleaning and sterilization can refer to the corresponding method of ECG cable Attention Do not sterilize sensor by ray steam or epoxy ethane Do not directly submerge sensor in liquid To avoid long time harm to sensor it is suggested that sterilization to the product be conducted only when necessary according to the regulation of your hospital 12 3 2 NIBP Cuff Please regularly clean the product Remove cuff from connector and pull out airbag from sheath Submerge clean and soft medical gauze pad or other soft cleaning tools into fresh water or neutral soapy water and wring out surplus water from the submerged gauze then wipe airbag and pipe Wash the cuff sheath in the clean neutral soapy water After the sheath and airbag intensive drying enclose airbag with cuff sheath 12 2 Digicare Biomedical Technology and put into operation Attention Excessive or frequent cleaning may damage airbag so don t clean airbag unless necessary Do not dry airbag and sheath in high temperature If higher ster
46. message appears in NIBP displaying area NIBP Air Leakage Testing should be done every two years or when you feel the reading is incorrect Before testing please get ready the following things O One adult cuff O One inflate hose One Cylinder Metal Vessel Procedure of the air leakage test 1 Enter Patient Info menu set Type to Adult 2 Connect the cuff securely with the socket for NIBP air hole 7 5 Digicare Biomedical Technology 3 Connect the cuff to a suitable Cylinder Metal Vessel shown as follows Cylinder Metal Monitor NIBP Hose 4 Enter NIBP Setup menu select Leakage Cuff 5 After 20 seconds or so the system will automatically open the deflating valve which marks the completion of an air leakage test 6 If no error information displays on NIBP parameter area it indicates that the airway is in good situation and no air leaks exist However if the prompt Air Leak appears in the place it indicates that the airway may have air leaks In this case the user should check for loose connection After confirming secure connections the user should re perform the air leakage test If the failure prompt still appears please contact the manufacturer for repair If the leakage still exists after all the above operations please contact us 7 6 Digicare Biomedical Technology Chapter 8 CO 8 1 Introduction The monitor adopts infrared absorption technology to measure the carbon d
47. n of damage Do not use them if any damage is detected 13 1 SpO e SpO Sensor Nellcor SpO Type Model Patient category MAX A Adult finger patient size gt 30kg MAX P Pediatric foot hand patient size 10 50kg Disposable MAX I Infant foot hand patient size 3 20kg EN Adult finger or neonatal foot hand patient size gt 40 kg or lt 3 kg DS 100A Adult Reusable OXI A N Adult neonatal OXI P I Pediatric infant Digicare SpO Type Patient category PN Adult PO732 Reusable Pediatric PO723 Neonatal PO723 Digicare Biomedical Technology SpO Extension cable Accessories PN Extension cable PO736 13 2 NIBP Disposable cuffs Model Patient category Limb circumference cm BP006 3 A 5 7 BP007 4 3 8 0 BP008 Neonatal 5 8 10 9 BP009 7 0 13 0 BP010 8 0 15 0 O Reusable cuffs Patient category Limb circumference cm PN Large adult 45 65 BP000 Adult 28 40 BP002 Pediatric 17 25 BP004 Infant 12 19 BP003 Neonatal 8 13 BP005 13 3 CO Accessories PN Sidestream Sampling line high humidity Adult CAP 120 Sidestream Sampling line low humidity Adult CAP121 Sidestream Sampling line high humidity Neonatal CAP 122 Sidestream Sampling line low humidity Neonatal CAP123 13 2 V6 Vital Signs Monitor User s Manual Appendix A Product Speci
48. needs no special maintenance under the normal condition While the monitor connecting with alternating current power no matter whether the monitor is operating or not the battery always can be charged In the case of sudden power off the monitor will automatically get power supply from battery without interruption of monitoring work Indicative message under the screen will display battery states HE The icon indicates that the battery is fully charged HEE The icon indicates that the battery is four grids left JIM The icon indicates that the battery is three grids left e BR The icon indicates that the battery is two grids left WN The icon indicates that the battery is one grid left WW The icon indicates that the battery is almost depleted and need to be charged immediately Warning e Use only batteries specified in this manual e Keep the batteries out of children s reach Caution Remove the batteries prior to shipping or if the monitor is not likely to be used for an extended period Digicare Biomedical Technology 11 2 Installing a Battery The battery compartment is in the bottom part of the monitor please refer to the following steps when installing or charging the batteries 1 o E ire a Turn off power of the monitor and disconnect the power wire and other connected wires Open the battery door towards the direction labeled on it Take out the old battery Insert the new battery toward
49. nstream CO sensor is properly connected to the airway adapter before zeroing O Do not attempt zeroing for 20s after removing the adapter or cannula 8 5 Digicare Biomedical Technology from the patient s airway This time allows any CO remaining in the adapter or cannula to dissipate before zeroing e Do not attempt to zero the module while the adapter or cannula is in the patient s airway e Do not attempt zeroing if the temperature is not stable Zeroing with CO in the adapter or cannula can lead to inaccurate measurements or other error conditions If you attempt zeroing while CO remains in the adapter or cannula the time required to zero the module may be increased 8 6 Calibrating The monitor has been calibrated before leaving factory You can use the monitor directly except the following three situations When one of the following situations happens please calibrate the CO2 module The CO module has been used for half a year or a whole year The therapeutics doubt about the reading of measurement The atmospheric pressure or height above sea level has changed a lot after last calibrating Caution Please calibrate the monitor under the direction of the technician authorized by manufacturer Incorrect calibrating process should lead incorrect reading 8 6 Digicare Biomedical Technology 8 7 Removing Exhaust Gases Warning O When using the CO measurement on patients who are receivin
50. ods of sterilization or Sterilization not applicable disinfection recommended by the Disinfection Refer to Maintenance and Cleaning chapter manufacturer Electromagnetic interference No mobile telephone nearby Electrosurgical interference damage No damage Diathermy instruments influence Displayed values and prints may be disturbed or erroneous during diathermy 2 3 Digicare Biomedical Technology 2 3 Equipment Symbols Symbol Symbol Note Type CF applied part defibrillation protected The unit displaying this symbol contains an F Type isolated floating applied part providing a high degree of protection against shock and is defibrillator proof Attention Consult accompanying documents this manual Equipotent grounding 100V 240V Alternating current input range 100V 240V USB socket Network connector Nurse call connector SpO Short for Pulse Oxygen Saturation NIBP Short for Non invasive Blood Pressure CO Short for Carbon dioxide 2 4 Digicare Biomedical Technology Chapter 3 Operations 3 1 Unpacking and Checking 1 Unpacking Before unpacking examine the packing case carefully for signs of damage If any damage is detected contact the carrier If the packing case is intact open the package 2 Remove the monitor and accessories carefully 3 Keep all the packaging materials for future use in transportation or st
51. or site every two hours and move the sensor if the skin quality changes For neonates or patients with poor peripheral blood circulation or sensitive skin inspect the sensor site more frequently O Check the Sp sensor and its package for any sign of damage before use Do not use the sensor if any damage is detected Digicare Biomedical Technology O Before use the operator must ensure the compatibilityies of the monitor SpO sensor and extension cables otherwise this may lead to the burning of patients do not use damaged sensor or extension cable Do not soak the sensor into water or make it wet otherwise it may be damaged O When disposing the disposable SpO probe or useless SpO probe please observe all local state and federal regulations that relate to the disposal of this products or similar products 6 3 Monitoring Procedure 1 Depending on the patient category weight and application site you can select the SpOz sensor as required 2 Clean the application site such as colored nail polish 3 Apply the sensor to the patient 4 Select the extension cable according to the SpO connector 5 Plug the Sp sensor into the extension cable 6 4 SpO Display Oo Waveform Display Pleth 1 5 1 Pleth waveform 2 indicates SpO unit while indicates signal intensity Details are as 6 2 Digicare Biomedical Technology the following table 3 SpO value 4 Pleth bar 5 Pulse Rate obt
52. orage 4 Check the monitor and accessories Check the monitor and its accessories one by one in accordance with the packing list Check to see if the parts have any mechanical damages In case of problems please contact us or our agent Warning Keep the packing materials out of children s reach Disposal of the packing materials should observer the applicable waste control regulations O The monitor might be contaminated during storage and transport Before use please verify whether the packages especially the package of disposable accessories are intact In case of any damage do not apply it to the patient Please ensure the monitor is working under specified conditions otherwise the technical specifications mentioned in this manual will not be met thus possibly leading to damage of equipment and other unexpected results Caution Please put the monitor onto a horizontal and stable supporting plane Avoid putting the monitor in the locations where it easily shakes or wobbles Enough space shall be left around the monitor so as to guarantee normal ventilation 3 1 Digicare Biomedical Technology 3 2 Getting Started 3 2 1 Inspecting the Monitor 1 Before you start to make measurements carry out the following checks on the monitor including all connected modules Check for any mechanical damage Check for any incorrect connection of all the external cables and accessories 2 Plug the power cord in
53. ous mode Use only on supervised patients 7 5 Monitoring Procedure 7 5 1 Preparing to Measure NIBP 1 Check the patient category if you want to change the patient category Select D To enter Patient Info menu And select the patient category as required 2 Select the appropriate cuff according to patient category O Check the limb circumference of patient O Select the appropriate cuff The applicable limb circumference for cuff is marked on the cuff The width of the cuff should be about 40 of the limb circumference 50 for neonate or 2 3 of the upper arm s length The inflatable part of the cuff should be long enough to encircle 50 80 of the limb 1 2 Digicare Biomedical Technology Note The accuracy of measurement of BP depends on the suitability of the cuff 3 Confirm the cuff has been entirely deflated 4 Plug the air pipe plug of cuff into the connector NIBP of monitor until the plug and socket contact well Attention you shall nip the part of air pipe plug of cuff close to socket with fingers before pulling it out 5 Tie the cuff to the upper arm or thigh of the patient Ensure the mark on the cuff shall lie above artery while the air pipe shall be under the cuff ensuring the air pipe outside the cuff does not knot and the white line on the cuff shall be within the range lt gt otherwise the cuff shall be replaced The monitor is applicable for standard neonatal cuff p
54. s 5 For nasal or oral nasal cannulas with oxygen delivery place the cannula on the patient as shown then attach the oxygen supply tubing to the oxygen delivery system and set the prescribed oxygen flow Caution e Always connect the airway adapter to the sensor before inserting the airway adapter into the breathing circuit In reverse always remove the airway adapter from the breathing circuit before removing the sensor e Always disconnect the cannula airway adapter or sampling tube from the CO sensor when not in use e Do not insert the things other than sampling tube into receptacle of sampling tube e The sampling tubes are disposable Please keep the sampling tube clean and prevent the tube from clogging by dust It is advised to replace the sampling tube every 12h up to 120h of use with filter tip the sampling tube leaks or has been damaged and contaminated 8 3 Digicare Biomedical Technology 8 3 CO Display e Waveform Display CO waveform Unit of CO Inspired minimum CO FiCO2 Airway respiration rate awRR End tidal CO value EtCO2 AR WN 8 4 Setting CO 8 4 1 Entering CO Menu O Select CO to enter CO Setup menu e Select CO Wave to enter CO Wave Setup menu 8 4 2 Setting Apnea Alarm 1 Select CO to enter CO Setup menu 2 Set Apnea Alarm to 10 Sec 15 Sec 20 Sec 30 Sec 45 Sec or 60 Sec 8 4 3 Setting Unit 1 Select CO
55. s the direction labeled Close the battery door 11 3 Optimizing Battery Performance A battery needs at least two optimizing cycles when it is put into use for the first time A battery cycle is one complete uninterrupted charge of the battery followed by a complete uninterrupted discharge of the battery A battery should be conditioned regularly to maintain its useful life Condition a battery once when it is used or stored for two months or when its run time becomes noticeably shorter To optimize a battery follow this procedure l 6 Disconnect the monitor from the patient and stop all monitoring and measuring procedures Place the battery in need of optimizing into the battery compartment to the monitor Place the monitor in the charger stand and connect the AC mains Allow the battery to be charged uninterruptedly for above 6 hours Remove the AC mains and allow the monitor to run from the battery until it shuts off Replace the monitor in the charger stand and connect the AC mains Allow the battery to be charged uninterruptedly for above 6 hours The optimizing of the battery is over 11 4 Checking Battery Performance The performance of a battery may deteriorate over time To check the performance of a battery follow this procedure l Disconnect the monitor from the patient and stop all monitoring and measuring procedures 11 2 Digicare Biomedical Technology 2 Place the monitor in the c
56. se Call Nurse Call is a function that the monitor will send signal to call nurse when the alarm conditions destined occur The monitor has a nurse call output connector connect the connector to the nurse call system of the hospital by the nurse call cable the nurse call function can be realized The nurse call function is valid when the following conditions are concurrent The nurse call function is open An alarm condition destined occurs The monitor is not in the state of alarm paused or system silence 3 5 Digicare Biomedical Technology Warning The nurse call function should not be used as the primary patient alarm inform source It is necessary for combining the auditory and visual alarm signal and the patient clinical feature and symptom as the primary information to medical and nursing staff about the physiological condition of the patient 3 8 1 Turning on off Nurse Call Select Menu System Setup Machine Mainte gt enter the required password Select Nursecall Setup to enter nurse call setup menu Set Nursecall Type to Normally Closed or Normally Open 3 8 2 Setting Call Time Select Menu System Setup Machine Mainte gt enter the required password Select Nursecall Setup to enter nurse call setup menu Set Call Time to 1 Sec or Continuous 3 8 3 Triggering Nurse Call Select Menu System Setup to enter system setup menu Select Nurse
57. ssooccssasesssevessosdess 11 1 KENE ONT AAA A E O 11 1 11 2 Installing a Batter eege Saisie ean 11 2 11 3 Optimizing Battery Bertormanee essee tesssressssessseeresseee 11 2 11 4 Checking Battery Performance ccoooooccnnoocccnnoncnnnnonnnncncnnnnoncnnnnoncnnanonnnnnns 11 2 11 Disposing Batteries oi a eas oes 11 3 Chapter 12 Maintenance and Cleaning ommocononccocononononacacnnnonnononanacncnconcnacanacocos 12 1 RRE E EE 12 1 12 2 Cleaning ene EE 12 1 12 3 Cleaning of and Sterilizing Accessories oooooooooccccooooncononannnncnnnnononconcnnonnno 12 2 Chapter 13 Accessories sscsssscccsssscsscsssssscssssccessscccessessssessssccsesssscseeesseseee 13 1 Lt eebe EE EE 13 1 TBD INTIS a A ao da 13 2 TE E ee 13 2 Appendix A Product Specifications ccccccsssssssscsccssssssssseccsessscscsseeescosssoeees 1 Axl Safety Specifications od sas 1 A Z Physical Specifications 2 A 3 Hardware Specifications cccccccccessseecssseceeeeeseeceeseneeeceeseeeeecesseeeeneeteeseeneas 2 AA Measurement Specifications 0 ccccccccccccssecceeeeseeceeseseeeceeseeeecsnsaesesesseeeeeeas 5 Appendix B Factory Defaullts cssscccssscssccsssssecessssseessssccsscsscsceessssseeesssoseeees 8 Bil Patient messages cli aeieea Ee edd ee 8 B2 Alai ii aii 8 Operators Manual Multi parameter Patient Monitor DigiMAP V Digicare Biomedical Technology ES Interface SetUP ud Seed clave ended bate faceted ST 8 EE EEN 8 EE 9 EE
58. t Touch Adjust to adjust touch screen Nurse Call Select Nurse Call to set nurse call ID Name Select ID Name to set the rule of ID naming Desat limit Set SpO2 desat value Alarms suspend Time Set the value of Alarm suspend Time Factory Mainte Used for factory maintenance Digicare Biomedical Technology Chapter 5 Alarm Alarm refers to a prompt that is given by the monitor for medical personnel through visual audible and other means when a vital sign appears abnormal or technical problem occurs Note O The monitor generates all the audible and visual alarms through speaker alarm lamp and screen When the monitor powers on the alarm lamp will be lighted one time and the speaker will give a beep voice which indicates the alarm system of the monitor is working order 5 1 Alarm Category According to character of alarm the monitor s alarms can be classified into three categories physiological alarms technical alarms and prompt messages e Physiological alarms Physiological alarms are triggered by a monitored parameter value that violates set alarm limits or an abnormal patient condition Physiological alarm message are displayed in the physiological alarm area e Technical alarms Technical alarms are triggered by a device malfunction due to improper operation or system problems The problems may result in system abnormal operation or irresponsible monitoring parameters Technical alarm message are
59. ther to perform frequent Auto BP measurements on patients with severe blood clotting disorders because of the risk of hematoma in the limb fitted with the cuff O Use clinical judgment to decide whether to perform Auto BP measurement on the patients of thrombasthemia e Do not use the NIBP cuff on a limb with an intravenous infusion or arterial catheter in place This could cause tissue damage around the catheter when the infusion is slowed or blocked during cuff inflation O If you doubt the NIBP measurements check the patient s vital signs by other device and then check the monitor bal Digicare Biomedical Technology 7 3 Measurement Limitations NIBP measurements are impossible with heart rate extremes of less than 40 bpm or greater than 240 bpm or if the patient is on a heart lung machine The measurement may be inaccurate or impossible with excessive and continuous patient movement such as shivering or convulsions if a regular arterial pressure pulse is hard to detect with cardiac arrhythmias with rapid blood pressure changes with severe shock or hypothermia that reduces blood flow to the peripheries on an edematous extremity 7 4 Measurement Mode There are three modes of measuring NIBP O Manual measurement on demand O Auto continually repeated measurements in the set interval STAT rapid series of measurements over a five minutes period then the monitor returns to the previ
60. to the AC power source If you are using battery power ensure that the battery has sufficient power for monitoring When you use a battery for the first time you must charge it following the instructions given in Battery chapter 3 2 2 Starting the Monitor Press the power switch the technical alarm lamp will light up in blue and then the physiology alarm lamp lights up in yellow and red and then goes out Meanwhile the system clanks and enters main screen Warning e If the monitor is mechanically damaged or if it is not working properly do not use it for any monitoring procedure on a patient Contact your service personnel Caution e The monitor does not have mains switch The monitor is switched completely only by unplugging the power cable from the AC power source 3 2 3 Starting Monitoring 1 Decide which parameter should be monitored or measured 2 Install required modules or sensors 3 2 Digicare Biomedical Technology 3 Check whether the installation of modules or sensors is correct 4 Check whether all kinds of settings are correct 5 Start monitoring on a patient Detailed information refers to the related chapters 3 3 Shutting off the Monitor Please follow the below steps to shut off the monitor Confirm that the patient monitoring is finished Disconnect the cables and sensors form the monitor Confirm that the monitoring data is stored or cleared A L N n Press the power switch and hol
61. val and the recorder will automatically start recording in line with the given time interval 1 Enter Recorder Setup menu through the above methods 2 Set Cycle Record Time to 5 Sec 10 Sec or 30 Sec 10 4 3 Setting Alarm Record 1 Enter Recorder Setup menu through the above methods 2 Set Alarm Record to On or Off 10 4 3 Setting Alarm Record Time 1 Enter Recorder Setup menu through the above methods 2 Set Alarm Record Time to 5 Sec 10 Sec or 30 Sec 10 4 3 Setting Alarm Record Time 1 Enter Recorder Setup menu through the above methods 2 Set Open Grid to On or Off 10 5 Installing Recording Paper If the record paper runs out please install the record paper as the following step 1 Press both sides of the recorder door with one hand and pull outwards to open the recorder door 2 Put the recording paper into the recorder with the thermal side which is smoother up 3 Close the door of the recorder and pull some recording paper outside of the paper out port Caution e Must use the thermo sensitive record paper otherwise it will lead to recording failure bad quality record or damage of thermo sensitive printing head e Do not pull out the recording paper during recorder printing otherwise 10 2 Digicare Biomedical Technology the recording meter may be damaged Unless for paper replacement or fault remedy do not keep the recorder door open 10 6 Cl
62. y flashes blue e Low level alarm the lamp lights blue without flashing 3 Display screen 4 42 NIBP press this button to start or stop NIBP measurement 5 RECORD press this button to start or stop recording 6 28 SOUND SILENCE O Press this button to pause or reactive the alarms O Press and hold this button for 1 second to silence the system sound 7 mm Press this button to O Change the screen O Return to the main screen when a menu is opened 8 Trim Knob The Trim Knob is used for e Turn left or turn right to move the cursor O Press down to perform an operation such as open a menu dialog or select one option 9 NIBP connector Digicare Biomedical Technology 10 CO connector 11 Spo connector 12 oe Power button Press this button to turn on the monitor after AC power is connected or the battery is installed Press and hold it for 2 seconds to turn the monitor off 13 Power indicating lamp It is a LED that lights green and orange the status of the LED is specified as follows O Green When the AC mains is connected O Orange When the AC mains are not connected and monitor is powered by battery e Off When the AC mains is not connected 14 Battery charging indicating lamp Light up When the battery is being charged e Off When the battery is fully charged or no battery in monitor 15 Handle 1 2 2 Side View SD Card Record 1 3 Digicare Biomedical Technology Fig 1 2
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