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Getemed VitaGuard VG-2100 Heart Rate Monitor

1. Tachycardia Silent tachycardia Heart rate drop Heart rate rise Manual Interval I Apnea X Silent apnea Periodic respiration P ORS signal amplitude lower than the internal trigger threshold an ORS alarm is reported when the ECG sig nal has not been detected e g ow ing to badly posi tioned electrodes heart rate lower than the set LOWER LIMIT heart rate lower than the set silent LOWER LIMIT heart rate higher than the set UPPER LIMIT heart rate higher than the set silent UPPER LIMIT when activated when activated manual storage see MANUAL DATA STORAGE Or TRANSMIT DATA on page 94 interval storage see SYSTEM INTERVAL RECORDING on page 91 one or more successive apneas one or more short silent apnea phases shorter than the set APNEA DELAY but longer than the SILENT APNEA DELAY periodic respiration see section 9 12 getemed 96 Information for the doctor and qualified medical staff 9 6 TREND storage When an episode is highlighted pressing lt Enter gt once displays HR PR Apnea o Max PET 220 m 20 the details and pressing it a Min A 80 second time the trends Lead Nr of electrodesI YE RD 3 Basal impedance 550 550 Ohm Graphics Press lt Enter gt Trends Fig 66 List of the episodes stored in the trend memory Over a max period of 72 hours 2 Episodes 27 Mayit48 138s Current Episode the TREND memory stores all of rara
2. The switch off command is acknowledged by two short beeps Data must be stored before the device finally switches off For this reason VitaGuard needs about another two seconds after the keys are released until it switches off completely 5 4 Summary of steps after monitoring Switch off VitaGuard as explained in the previous section Carefully detach the ECG electrodes from the patient Disconnect the ECG electrodes from the patient cable lf the procedure concerning stored data has not been clarified dur ing your training then please contact your doctor getemed Preparing for heart rate and apnea monitoring 49 6 Preparing for heart rate and apnea monitoring This section is divided into the following parts Safety information when monitoring heart rate and apnea Connecting electrodes the patient cable and VitaGuard Technical alarm from the electrode contact monitor Determining the optimal electrode configuration ECG lead electrode color coding Optimizing the heart and respiration signals signal amplitudes in View 1 Checking the BASAL IMPEDANCE 6 1 Safety information when monitoring heart rate and apnea Observe the following points before monitoring with VitaGuard CAUTION Interference signals can prevent a heart rate alarm from being reported when under certain unfavorable conditions the monitor misinterprets these interference signals as heart signals Interference sign
3. 7 9 2 Apnea alarms An alarm is reported when apnea i e respiratory arrest is detected for longer than the set APNEA DELAY An alarm message then appears on the display the alarm LED flashes and an acoustic warning is emitted getemed Alarms displays and views during monitoring 63 Go immediately to the patient when an alarm occurs and check the patient s condition When the patient resumes breathing the alarm is switched off automatically Both the delay time and the alarm LED continue to flash to show that apnea has occurred for longer than the set APNEA DELAY Pressing the lt Esc gt key stops the flashing 7 9 3 Technical heart rate and apnea alarms The section Table of technical alarm messages on page 65 can be consulted for the technical alarm signals and the recommended troubleshooting procedure The heart rate and apnea monitors display technical alarms with the corresponding messages Until the problem has been eliminated the heart and respiration rates are replaced by a question mark symbol 7 10 Alarm messages meanings and other information The tables in this section list in alphabetical order all the text mes sages that can appear on the VitaGuard display together with more detailed explanations and troubleshooting hints 7 10 1 Order of equal priority alarm conditions The numbers in the No column on the right indicate the internal priorities that VitaGuard uses to process the respective
4. the signals checked in the TREND column of the table on page 97 HR Resp rate Max 240 23 Min Ca Trends Fig 67 Detailed information on a highlighted trend episode 9 7 LONG TERM Storage over eight hours Independent of alarm events all signals are stored continuously fora maximum total time of eight hours for subsequent evaluation ona PC full disclosure After this period the oldest data are overwritten 9 8 PROTOCOL storage of operating and device data The protocol memory registers e g when monitor settings are changed and when the device has been switched on and off The following changes are stored in protocol memory getemed Information for the doctor and qualified medical staff 97 monitor ON OFF apnea monitor ON OFF admission of a new patient changes to SETTINGS PROTECTION The following data are stored with every change date and time of the change the current monitor settings Protocol memory deletes the oldest data when more than 256 en tries are stored 9 9 Summary of stored signals and data cae 1 m sets aee ee ee Average heart rate for trend deviation Averageheartrateover6h 02 ww MoA E R a Respiration Respiration rate Basal impedance Status graph AUX1 getemed 98 Information for the doctor and qualified medical staff 9 10 Settings in the HEART RATE menu SETTINGS PROTECTION OFF For this setting Settings protec Status ok tion mus
5. Check that the acoustic alarm signal is loud enough to be heard over the prevailing or expected noise levels in the monitor s envi ronment When necessary set SETTINGS PROTECTION to LIMITED When necessary train caregivers in the necessary resuscitation measures getemed Information for the doctor and qualified medical staff 81 9 1 2 Connections to the USB and AUX ports The USB port is designed to transfer data to a PC The AUX port can interface with a modem for remote data transfer Observe the standard DIN EN 60601 1 1 for connections to systems consisting of multiple medical devices and to systems consisting of medical and non medical devices A device must comply with the regulations under DIN EN 60601 1 for medical devices or under DIN EN 60950 for communication tech nology devices before it is connected to the USB or AUX ports In addition the leakage current from the VitaGuard must be meas ured as stipulated in the standard DIN EN 60601 1 1 This leakage current must not exceed 100 pA Only qualified medical device technicians can check whether the leakage current conforms to the standards When several devices are connected to each other the individual leakage currents can add up and may pose a risk to the patient Do not connect printers cameras scanners or other devices 9 1 3 VitaGuard and other medical devices When VitaGuard is to operate at the same time as a defibrillator the monit
6. 2 to 10 years 60 90 70 110 max 200 10 years and older 50 90 55 90 7 3 Alarm message priorities in the status line do Status ok vo EE fy Fig 30 Status line on the VitaGuard display Physiological alarms have high priority The text messages of physiological alarms end with three exclamation marks siete Technical alarms have medium priority The text messages of technical alarms end with two exclamation marks L A 7 4 Physiological and technical alarms VitaGuard generates two types of alarms physiological and techni cal alarms A physiological alarm is generated when VitaGuard detects values that violate one or more of the set alarm limits for longer than the set period There are simple alarm limits e g the LOWER LIMIT for the HEART RATE and there are alarm limits based on the interaction of several monitor settings e g the deviation alarms A technical alarm is generated when monitoring is no longer reliable e g when electrodes have become loose getemed Alarms displays and views during monitoring 59 The reasons for incorrect values can be detached electrodes or other technical defects When a technical alarm condition occurs a life threatening situation may escape detection When for example a technical alarm has occurred yet at the same time a physiological alarm condition has been detected the physio logical alarm condition has priority and the physiological alarm is reported
7. O O Fig 19 lt Enter gt key 4 3 3 lt Esc gt key When an alarm is triggered the lt Esc gt key serves to deactivate the acoustic alarm signal for a set alarm mute time During an alarm condition the red alarm LED and the violated alarm limit flash The acoustic alarm is again emitted if the alarm condition persists af ter the alarm mute time has expired Pressing the lt Esc gt key during the alarm mute time a second time reactivates the acoustic alarm Fig 20 lt Esc gt key Also when an alarm has automatically ended because the vital functions have restabilized by themselves the alarm LED and the violated alarm limit continue to flash until you press the lt Esc gt key The alarm LED however flashes slower than during an alarm getemed Description 43 The lt Esc gt key cancels unsaved changes to the monitor settings or moves back to the next higher menu 4 4 Color LEDs Light Emitting Diodes When VitaGuard is switched on all LEDs light up for a short time so that you can see they work properly During this time the alarm LED first lights up red and then yellow 44 1 Alarm LED Inthe event of a higher priority alarm i e a physiological alarm the alarm LED flashes red Inthe event of a medium priority alarm i e a technical alarm the alarm LED flashes yellow N Fig 21 Alarm LED 4 4 2 Heart and respiration LEDs The LED with the heart symbol flashes with every
8. Switch off the monitor wait for thirty 14 an internal fault seconds and switch it back on if this message persists the monitor is defect The internal software Switch off the monitor wait for thirty 18 monitor has detected a seconds and switch it back on if this data transfer error message persists the monitor is defect The monitor discovers Connect the patient cable that the patient cable is not connected been disconnected or press the lt Esc gt key The battery voltage is too Operate the monitor with the external low the monitor can no power adapter to recharge the block longer operate reliably battery or insert non rechargeable batteries The battery voltage is too Insert new batteries or a new block 33 low the monitor can no battery or operate the monitor with longer operate reliably the external power adapter getemed Alarms displays and views during monitoring 67 7 11 Table of information messages Message Cause Meaning No Calculating The current heart rate The current heart rate is displayed heart rate cannot be displayed after it has been calculated while it is being calculated Internal battery The internal battery for The monitor is defect i e the too low alarms during a power internal battery needs to be replaced failure is depleted by a technician Status ok No messages 40 getemed 68 Alarm and monitor settings 8 Alarm an
9. an apnea monitor can function correctly only when the patient is lying still Here too the measured signals are very weak and must be amplified To prevent false alarms wherever possible it is getemed Algorithms and measuring principles 109 very important that the optimal electrode positions are determined before the start of monitoring The essential advantage of the described method is that the same electrodes can be used for monitoring the heart rate and respiration getemed 110 Evaluating stored data on a PC 11 Evaluating stored data on a PC getemed AG has developed the Windows based software VitaWin for evaluating the recorded monitoring data This software is provided only to doctors and authorized dealers who are or supply VitaGuard users The stored data can be downloaded through the USB universal serial bus port to a PC where they can be stored viewed and evaluated VitaWin presents each alarm s context based on the signals RESPIRA TION RESPIRATION RATE BASAL IMPEDANCE ECG and HEART RATE VitaWin also provides functions for drawing up reports and assessing the patient s monitored data getemed 111 Evaluating stored data on a PC PPE IPE Pt bt ti bid PP hb bb tad PPP PPE EEE ETE EEE PEt tat EEL pausa O xel WMME HS jegy ods suaGunppawenyeys 94 80 h fluaqaGnzuia ejua Wn Aney 2H al Et G20 p t 80 h Ge oe OU b G I wll S90 UW g s
10. is saturated owing to sudden violent movements by the patient directly before the occurrence of apnea the zero line is reached in six seconds From then again in the worst case a period of four beats is needed before any cardiac artifacts can be detected 4 6 6 amplifier s max recovery time in seconds T AC MAX E 10 1 3 Alarm report delays The alarm report delays for bradycardia and tachycardia can be set within certain limits TA max for bradycardia set BRADYCARDIA DELAY 2 5 TA max for tachycardia set TACHYCARDIA DELAY 2 5 getemed Algorithms and measuring principles 107 TA max for asystole set ASYSTOLE DELAY 2 5 TA max for apnea sesse 25 The purpose of these alarm report delays is to prevent alarms from being reported every time the alarm limits are violated for short times only In other words the maximum alarm report delay corresponds to the maximum set delay The monitor outputs measurements e g to the display every second The technology s contribution to the total alarm report delay is specified as maximum two seconds overall 10 2 Measuring principle for the heart rate monitor Every heartbeat i e contraction of the cardiac muscle generates a myopotential that propagates through the body as an electric signal and that can be measured by two sensing electrodes attached to the body The graphical depiction of the measured signal is called an electr
11. oe In the event of persistent false alarms a different lead can be set in the HEART RATE menu as explained in the section Changing the ECG lead for signal optimization on page 100 ao Status ok A gt E Heart rate 1min Resp min The heart rate s LOWER LIMIT can 7 2 290 30 be set from 30 to 180 beats and i J Ib the heart rate s UPPER LIMIT from 100 to 255 each in steps of five beats per minute Factory settings are shown in bold type Heart rate Fig 43 Heart rate menu for viewing and setting alarm limits LOWER LIMIT heart rate 30 35 80 175 180 min Lower limit for the heart rate an alarm is reported when the heart rate falls be low this limit for longer than the set BRADYCARDIA DELAY UPPER LIMIT heart rate 100 105 220 250 255 min Upper limit for the heart rate an alarm is triggered when the heart rate exceeds this limit for longer than the set TACHy CARDIA DELAY getemed Alarm and monitor settings 77 8 7 RESPIRATION display and menu The gt key takes you from View 1 2 or 3 to the RESPIRATION display From here you can open the menu with the A or V key Having highlighted a row press lt Enter gt to change the corresponding value 8 7 1 RESPIRATION display The top half of the display presents li the status line Heart rate 1min Resp 1min 2 the current values with pH A a a the set alarm limits mC 3 the current three minute trends
12. submenu 101 Settings in the Respiration Menu ss ssssessssessesssssssesssseesesseseeseseesesses 103 PETIOGIC MESDILALION onena E E NENE O I EO N 103 VitaWin register Events in graph form s ssssssssessessessessessssess 111 getemed 122 Table of figures getemed Distributed by Manufacturer getemed Medizin und Informationstechnik AG Oderstr 77 D 14513 Teltow tel 49 0 3328 3942 0 fax 49 0 3328 3942 99 e mail info getemed de internet www getemed de getemed REF 73811021 0027H1 LAB Rev B 20 11 2006 16 57
13. yield the ALARM SYSTEM delay The algorithms listed here are based on worst credible cases i e the calculations always return the maximum possible delays 10 1 1 Alarm condition delay for the heart rate The current heart rate used for detecting alarm conditions is calcu lated as the average value over a set number of heartbeats two to sixteen getemed 106 Algorithms and measuring principles The higher the value selected for RR Ni AVERAGING the longer VitaGuard ren ae 60 HR needs before the displayed heart rate nee reflects the patient s actual heart rate When for example a value N 16 is chosen the actual heart rate is not displayed until after sixteen heartbeats whereby N AVERAGING The longest alarm condition delay for the heart rate therefore occurs when it is at its lowest When for example the heart rate suddenly drops to thirty beats a minute a beat is detected every two seconds When RR AVERAGING is set to 16 a heart rate of thirty is not displayed until after thirty two seconds 10 1 2 Alarm condition delay for respiration The impedance pneumography used to monitor apnea must rule out cardiac artifacts as the source of changes to measured impedance When central apnea has occurred the applied algorithm detects cardiac artifacts after max four heartbeats The alarm condition delay for respiration depends in addition on the signal amplifiers recovery time When in the worst case the amplifier
14. Baby oil has proved to be effective in removing residue from adhesive strips The VitaGuard bag can be washed by hand at 30 C It must not be put in the laundry dryer 3 7 2 Checking and cleaning the battery terminals Check the battery compartment every month for traces of leaking and for deposits on the battery terminals indicating leaks Contact your authorized dealer and clarify further procedures when a bat tery starts to leak The battery compartment and how to replace the batteries are explained in the section Replacing batteries on page 36 3 8 Disposing of non rechargeable batteries the device and accessories getemed AG takes back all of the parts it delivers For hygiene reasons these parts do not extend to consumables like electrodes that have been in direct contact with the patient The symbol of the crossed out waste container on the battery pack aging is to remind you that under no circumstances must you dis pose of batteries in normal household waste As the end consumer you are legally obliged to return used batteries or dispose of them properly You can return used batteries to us getemed 32 Safety Place consumables like electrodes in a plastic bag before disposing of them in household waste Please do NOT send us ANY used electrodes Like every electronic device VitaGuard and accessories contain metal and plastic parts that must be disposed of in such a way that they do not pollute t
15. Fig 42 Fig 43 Fig 44 Fig 45 Fig 46 Fig 47 Fig 48 Fig 49 Fig 50 Fig 51 Fig 52 Fig 53 Fig 54 Fig 55 Fig 56 Fig 57 Fig 58 Fig 59 Fig 60 Fig 61 Fig 62 Fig 63 Fig 64 Table of figures Characteristics of the high priority acoustic alarm signal 59 The status line displayed in all views ou eeeeseeeeeeeeseseseteeeteees 60 VION 2 excep E E ot ee occa eget sta E ete Gate tse 70 VION D aires etcetera E eect osetia eet eee eed 70 Menu system LCD brightness 80 highlighted oe 71 System LCD brightness highlighted in the change WIDOOWN naea stecoteases EAE E E E EE E E 71 System accept change to LCD brightness highlighted 71 System menu general settings scscsccccrscsecsesessscnesnsntvocensidenacaneesesaexs 12 System submenu Signal beep tone oo eeeseseseeeteteteteteteee 73 System submenu Alarm tone pitch oo eeseseeeeeeeeeeeeeeeeeeeeeees 73 System RS232 format sescciausetscresachsonassencatvespeasucaneesasenneasaincansesdenieeienes 73 POA EAS DIAY moeren E a R ER 75 Heart rate menu for viewing and setting alarm limits 76 Respiration display respiration graph s sssssssesssessssssesssseesesseseeses 77 Respiration menu for viewing and setting alarm limits 78 Info Last status messages dccestsnsecssscaranttieevess seornesieyeacoewoseveediusneasaeeandas 82 NTON GEAGIAL ccscosessseecsnersnsesrensnentenmsacrsqe aaeripacstactanenancajanssaciz
16. Make sure when laying and securing patient cables that these can not kink kinking causes damage patient Disinfect patient cables before using them on a new patient When more than one monitor is used in the one environment each monitor should always be connected to the same patient cables and the same power adapter Faults can therefore be located and reme For hygiene reasons always use the same patient cable on the one died faster 3 6 Power supply reliability Before first using VitaGuard for monitoring familiarize yourself with the section Power supply on page 34 Monitoring is safe guarded only when the power supply is in perfect operating order CAUTION Danger of electric shock Never open the external power adapter or the connecting cable Exclusively the NA 3000 2 approved for VitaGuard must be used as the external power adapter VitaGuard is usually delivered with the external power adapter for European supply networks For other supply networks use only the plug adapters available from getemed AG getemed Safety 27 Do not use the external power adapter in sockets that can be switched off or dimmed When the VitaGuard external power adapter is plugged into a multiple socket outlet only the modem may be connected to this outlet simultaneously When an extension cable is used with a multiple socket outlet this outlet must not lie on the floor Otherwise water may penetrate the out
17. Operating temperature 5 40 C Operating humidity 5 95 non condensing Ambient pressure height above sea level 1060 500 mbar 304 to 5486 m x Storage and transport CONCITIONS eeseseesecessreesresn 40 to 70 C humidity 15 95 non condensing EMC classification CISPR 11 class B Observe the information on the electrodes packaging for the stor age temperature of electrodes getemed Specifications 117 12 8 Selection of applied standards HEC GOI acoso sepiceresepsteresoeaseustces Medical electrical equipment Part 1 General requirements for safety incl A 13 IEC 60601 1 1 ee Medical electrical equipment Part 1 1 General requirements for safety Colla teral standard Safety requirements for medical electrical systems HEC GOGOL l 2 ienr Medical electrical equipment Part 1 2 General requirements for safety Col lateral standard Electromagnetic com patibility Requirements and tests IEC 60601 1 4 eee Medical electrical equipment Part 1 4 General requirements for safety Col lateral standard Programmable electri cal medical systems IEC 62A 422 CDV 2003 prEN 60601 1 6 2003 Medical electrical equipment Part 1 6 General requirements for safety Col lateral standard Usability IEC 60601 1 8 eee Medical electrical equipment Part 1 8 General requirements for safety Col lateral standard Genera
18. RATE ALARMS getemed Ill BK YE 3 black yellow 3 electrodes YE RD 2 yellow red 2 electrodes Here you can determine which lead is used with two or three electrodes for detecting the ECG signal explanations in the following Activate this for pacemaker patients so that stimulating pacemaker pulses are not mistakenly processed as R waves explanations can be found under VitaGuard and other medical devices on page 81 When HEART RATE ALARMS is set to LIMITS ONLY acoustic alarms are re ported when the measured values vio late the set alarm limits When HEART RATE ALARMS is set to LIMITS amp TRENDS acoustic alarms are re ported when the measured values vio late the set alarm limits AND when there is a positive or negative deviation from the average heart rate measured over the set interval Information for the doctor and qualified medical staff 101 9 11 Changing the ECG lead for signal optimization When the used lead frequently causes false heart rate alarms an other lead can be chosen The default is lead YE RD 3 yellow red 3 electrodes Signals can be optimized only when the patient is stil or sleeping Bear in mind when optimizing the ECG lead that there must be no changes to the optimized positions of the red and yellow electrodes for detecting the respiration signal When optimization becomes necessary only the black electrode must be repositioned When replacing the electrod
19. a A E EE 37 Fig 11 Overview of VitaGuard CONNECTIONS oo eeeeeeeseceeeeeeeeeeeeeeeeteee 38 PE EICCRROC SC SOC CE sarniprie renon N EEE 38 Figs 2S POWeEradaplEr SOCKEL srcour E E aE E 39 eA Ound aper UG san E A E eee eee 39 E NOTA arenaer AE AAA AT E E A E AA E I 40 HOLO AVA TON aea E A E E E E eee eee 40 Pipa KEYVSOM TMC TOD SIGE sscsesesecespzcat csnsececesaseeiencacessucasesnctuseesecesriendetasiesiess 41 Peto DE UOK eoan E A E N gaeacnanseres 42 oD me to 1 KEY ea a E E R E E 42 E20 KEC KY a E A EA E E E ee ee 42 PU 2g ALED p E E N 43 Fig 22 Heartand respiration LEDS s sssssessssessesssssesseseesessessessessessesresreseesesses 43 Fig 23 Powersupply LEDS cccceucssseceoscrdaceuseesncnsacneretapeateesednstasngensbeneaseusewasanndvens 44 Fig 24 Current values and alarm limits in View 1 ssssssssssssssesessessessse 45 Fig 25 Color coded sockets on the ECG patient cable s distributor 52 FIG ZO EICCUROCS SOG arpian E E nena ace nares ONE 52 Fig 27 Recommended electrode configuration oo eeseeeeeeeeeteteteteeee 54 Fig 28 Alternative electrode configuration for optimizing the heart ANd respiration signals oo eeseseseceseeeeeeeeeeeseseeeeteeseseseeeeeeeeees 54 Fig 29 Electrode signal amplitude in View 1 oie eeseteteteeeeseeeeeeeeeeees 54 Fig 30 Status line on the VitaGuard display on eeeeseeeeeeeeeeeeeeeeeeee 58 getemed 120 Fig 31 Fig 32 Fig 33 Fig 34 Fig 35 Fig 36 Fig 37 Fig 38 Fig 39 Fig 40 Fig 41
20. a vehicle s dashboard Do not leave the automobile power supply adapter overnight in the vehicle particularly during the cold season Otherwise condensa tion may form on and in the device The NAK 3000 2 automobile power supply adapter is connected to the VitaGuard power adapter socket NAK 3000 2 features a univer sal safety plug DIN ISO 4165 for the dashboard lighter Automobile power supply mode is indicated on VitaGuard by the green LED beside the power adapter symbol The specifications of the automobile power supply adapter are as follows HUE coteoeconsasa esacesa eacsensserscescoeeeauer Automobile voltage supply at 12 24 V CU aee E E E E 9 Vdc Ep eel Ud ol qe eee ERE EREN lt 500 mA OPUNE EMOA IUTE iasa ner neers renee etree etree 5 to 50 C CONNECTION to VitaGuard Lee eceeeteteteeseeeeeeeseseseseeeteeeeeens 3 pin plug Connection to automobile supply Universal safety plug DIN ISO 4165 Connecting cable length ee eeeeseseseeeeeseceseseeeeeeeeeeeeeeenees 2m 20cm getemed 38 Description 4 2 VitaGuard connections 9 NA3000 2 Mj Usp Rin v f m 9V w n a Gt Fig 11 Overview of VitaGuard connections For safety reasons only those accessories that getemed AG has delivered or approved must be connected to VitaGuard Hold VitaGuard firmly with one hand when connecting and dis connecting plugs insert and remove the plugs parallel to the sockets to prevent dam age to the sen
21. acoustic reminder signal is emitted as a short tone every twenty seconds after the monitor is switched on The technical alarms for cable and electrode monitoring are not activated until the patient cable is connected and the first plausible data have been calculated A text message in the status line reports from the beginning that the cables are being checked After the device has been switched on the following displays and signals show you that the monitoring system is fully operable All indicator LEDs light up briefly During this time the alarm LED first lights up red and then yellow A brief tone is emitted to indicate that the acoustic alarm buzzer is Tully operable If the alarm buzzer does not emit the acoustic signal after the device has been switched on you must immediately send VitaGuard to getemed AG or your authorized dealer for inspection Please consult your authorized dealer for a replacement device Observe the patient carefully until the replacement device arrives Bear in mind that the patient is not being monitored at this time and that no alarm will be reported in an emergency getemed 48 Steps before and after monitoring 5 3 Switching off Always switch off VitaGuard in the manner described here 1 Press the lt Enter gt key and keep this pressed the message PRESS ESC KEY appears 2 Briefly press the lt Esc gt key still keeping the lt Enter gt key pressed and then release both keys
22. all times in the event that the power supply from the external power adapter fails 4 5 The display Each of the Alarms displays and views during monitoring are ex plained on page 57 Pressing the lt key in View 1 takes you to the INFO screen with the current information for the doctor Pressing it again takes you to the System menu for the basic VitaGuard settings After the monitor is switched on it can take up to twenty seconds before the first values are displayed getemed Description 45 qn Status ok 2 Heart rate 1 min 2a 2c Amplitude Good 3 Resp 1 min 3a Amplitude Good 3C 3b Basal imp Ohm 550 20 Fig 24 Current values and alarm limits in View 1 1 The status line at the top of the display shows messages on the left and symbols on the right for the external power supply and alarm activation 2 Forall vital functions as here HEART RATE 2 the current value for each vital function 2a is shown in large digits Smaller digits to the right show the set alarm limits 2b In the HEART RATE line the quality of the signal amplitude 2c is shown on the left 3 RESPIRATION 3 shows in addition on the left the quality of the amplitude 3a and the basal impedance in ohms 3b This term is explained in the section Checking the BASAL IMPEDANCE on page 55 A respiration bar 3c moves up and down synchroneously with the patient s breathing getemed 46 Steps befor
23. e g cellular phones radio equipment walkie talkies etc can inter fere with the monitor and influence its operability interference and reduce the device s immunity Do not place the monitor directly next to other electrical equipment and do not stack monitors on top of each other When the monitor has to be placed next to or on other equipment check that the monitor operates as designed in this environment We recommend you to check at regular intervals that the displayed signals are not disrupted when the patient is not moving whether the same technical alarm messages are repeatedly dis Bear in mind that non approved accessories can amplify emitted played getemed Safety 25 When you discover disruptions if possible switch off the interfering equipment or move this equipment to another site VitaGuard uses high frequency signals exclusively for its internal functions As a result its emitted interference is very low and dis ruption to neighboring electronic equipment is unlikely False diagnoses are possible when monitored values are corrupted by interference from electric or electromagnetic fields and this escapes the doctor s attention Every time you analyze stored data consider the possibility of interference from electric or electromag netic fields VitaGuard s emitted interference and immunity to external interfer ence are within the limits for life supporting systems stipulat
24. in the following can be used together with VitaGuard and can be ordered with the specified article numbers from getemed AG or authorized dealers Please consult getemed AG or your authorized dealer for other approved accessories PROGUGE E E E Article no REF VitaGuard VG 2100 Monitor COmMpleteSystENI seecenseqseacecsacacucurzenensapestacsesdeseacornesaneeanerenpcansasacatoes 7311 1022 1 VitaGuard VG 2100 monitor 1 ECG patient cable 9 neonatal electrodes 1 NA3000 2 external power adapter 1 rechargeable block battery 1 device bag 1 operating instructions 1 quick reference Transport case NA 3000 2 external power adapter 110 V 240 V 50 GOHZ ccssecssscsssecesscssssseressessceeerensesseaconees 73441101 NAK 3000 2 automobile power supply adapter ee 73441201 Nala acl gedete 6 oa DOCK DALOY naene terrae peer ter eee ert iee 7344 2201 PK1 8P ECG patient cable oc ccsseesseseseseeesseeteeeeseeeeseesees 7341 1001 Kitty Cat neonatal electrodes PU 30 pcs wv eeseeeseseeteseeee 70222 Operating instructions English oe seseseeseseeeeteseseeeeseeee 73811021 Alarm chart English scsssscssssssesssssessesscessessesrersesssersessees 7383 1021 DEVICE DAE aes seceseaceesoueageecasessspcoticest EE 7345 1001 VitaGuard transport case for the complete system 7391 0001 AUX 01 RS232 cable for connecting VitaGuard to a serial PC port pecsicesssaniseetadcerusciebertcadetetuels cass easaenesotenece
25. in the section Changing the ECG lead for signal optimization on page 100 getemed Alarms displays and views during monitoring 57 7 Alarms displays and views during monitoring Immediately call the emergency services when a patient remains unconscious after being shaken or addressed 7 1 Alarm test CAUTION When beginning monitoring at a new site make sure that you can clearly hear the alarm signal and quickly reach the patient For this purpose deliberately trigger a technical alarm When a patient is connected you can deliberately trigger an alarm Pull the red electrode plug out of the distributor on the ECG patient cable 7 2 HEART RATE values based on age groups Bear in mind that the HEART and RESPIRATION RATES drop considera bly with increasing age The doctor must check and if necessary adapt the alarm limits for each patient s age group The average heart rate of an infant is much higher than that of an adult Accordingly the alarm limit e g for bradycardia too low a heart rate must be set considerably higher for an infant than for an adult patient As an orientation aid the following table lists some medically acknowledged approximate heart rates for various age groups and stress situations getemed 58 Alarms displays and views during monitoring Age group Heart rate min stress e g fever 80 160 100 180 1 week to 3 months 80 200 100 220 3 months to 2 years 70 120 80 150
26. is powered only by non rechargeable batteries check the battery voltage indicator on the display every hour At least one quarter of the battery symbol must be black Fig 3 Battery voltage indicator When VitaGuard is powered from the supply network and com mercially available non rechargeable batteries are inserted check the battery voltage indicator on the display every day Even when the device is powered from the supply network you must replace the non rechargeable batteries as soon as one quarter of the battery symbol on the display is black If necessary a display message will prompt you to insert new non rechargeable batteries or to recharge the block battery 3 6 2 Interruptions to the power supply When the external power adapter is connected VitaGuard operates automatically in supply network mode When the supply network fails VitaGuard switches automatically to battery mode when batteries are inserted As long as VitaGuard is powered from the external power adapter or the automobile power supply the green LED next to the power adapter symbol lights up Normal voltage fluctuations in the supply network do not adversely affect monitoring with VitaGuard Following a power supply failure getemed Safety 29 the current alarm settings are retained for at least thirty days and are again available when the device is switched back on 3 6 3 Using the rechargeable block battery Note the warnings
27. monitoring when the internal battery is depleted This status appears on the display A new internal battery can be installed at getemed AG only so you must continue monitoring with a replacement device until the inter nal battery has been displaced getemed 36 Description 4 1 3 Replacing batteries Switch off VitaGuard before replacing batteries Push back the catch and lift off the battery cover to open the battery com partment Insert either four non rechargeable batteries or the recharge able block battery Make sure that the symbols on the batteries and in the compartment match before inserting non rechargeable batter ies Fig 9 Opened battery compartment and polarity Observe the following instructions when you use the rechargeable block battery Never use force to insert the block battery The bottom of the block battery has a guide groove that prevents the battery from being inserted the wrong way Make sure when inserting the block battery that the labeled side is on the top and the metal terminals point to the device label getemed Description 37 You will feel a slight pressure from the ter minal spring connec tions when inserting the block battery o x gelemey Fig 10 The arrows show how the block battery is correctly inserted 4 1 4 Using the automobile power supply adapter Use only the NAK 3000 2 automobile power supply adapter to oper ate VitaGuard from
28. of pages are dis played in the top right For example 1 10 means the first of ten pages 9 2 1 INFO LAST STATUS MESSAGES The last status messages provide Status ok morman omine directly Aa cstectadl preceding monitoring period 24 Heart rate and apneal Heart rate too lowi Here you can see when and why 23 Status ok Apnea detected a message appeared Fig 46 Info Last status messages getemed Information for the doctor and qualified medical staff 83 9 2 2 INFO GENERAL INTERNAL BATTERY Internal battery Very good This displays the state of the Memory used 13 Patient info INTERNAL BATTERY permanently First name Emil surname Mustermann installed in VitaGuard ID 11232244 Age Oto 2 years g Pacer detection Off Auto ID 0 Date 7 May 2005 Time 11 34 Fig 47 Info General PATIENT NAME PATIENT ID The patient s name and ID are displayed when VitaWin has trans ferred these from a PC to VitaGuard or when they have been keyed in as explained in the section SYsTEM ADMIT NEW PATIENT restoring factory settings on page 88 AGE This displays the age group that has been set as explained in the section SYSTEM ADMIT NEW PATIENT restoring factory settings on page 88 PACER DETECTION When the patient has a pacemaker set PACER DETECTION in the HEART RATE menu to ON this prevents the monitor from processing stimu lating pacemaker pulses a
29. on page 53 The electrode arrangement as depicted in Fig 27 b on page 54 is the standard Einthoven arrangement and normally yields good results for heart rate monitoring with the yellow red lead 1 Select the HEART RATE display and note the amplitude of the displayed ECG signal Press A to open the menu and note the set ting for the ECG LEAD e g I YE RD 3 2 Select a different ECG LEAD e g Il BK RD 3 Press lt Esc gt to return to the HEART RATE display and again note the displayed ECG am plitude 3 Repeat the procedure for the last setting i e III BK YE 3 4 Select from all three leads the one that produces the greatest deflection It is not important here whether this deflection is negative or positive Select the lead I YE RD 3 when this is one of two leads that have produced approximately equal amplitudes When none of the leads produces a particularly large amplitude you should change the position of the black electrode and repeat the procedure Carefully reapply the black electrode until you obtain the best signal amplitude When you reposition the electrodes e g as depicted in Fig 27 a you must again check the ECG amplitude and by repeating these steps select the best lead for this new electrode configuration getemed Information for the doctor and qualified medical staff 103 9 12 Settings in the RESPIRATION menu SETTINGS PROTECTION OFF For these settings SETTI
30. on the rechargeable block battery s label Do not open or short circuit Do not throw into a fire Avoid temperatures over 50 C The charging time for the block battery is at most six hours Fig 4 Rechargeable block battery Also note the recycling symbol on the label This means ON that the block battery must be recycled when its service life AA has expired Do not expose the block battery to direct sunlight For example temperatures greater than 50 C can easily occur on a vehicle s dashboard or rear shelf When you intend to use VitaGuard powered from the rechargeable battery block and disconnected from the supply network you must first make sure that the block battery is fully charged For this rea son check the Battery charging LED The battery is being charged as long as this LED light is continuously a on When the LED flashes every second the battery is full and compensation charging is activated Sometimes the LED will go out for a short time in the interval be tween battery and compensation charging getemed 30 Safety 3 7 Safety with proper maintenance only VitaGuard can operate safely and reliably over the long term only when it is subject to proper maintenance and use Check visually for any damage on VitaGuard the patient cables including the connections the external power adapter and the electrodes every time you use VitaGuard for monitoring Every eighteen mont
31. rate can be measured only when the amplitude of the measured ECG signal itself is large enough to be detected by the monitor Normally the amplitude of the ECG signal detected on the body surface cannot be influenced and varies from person to person The monitor measures the potential difference between the two sens ing electrodes Depending on where the electrodes are attached the measured signal is strong weak positive or negative It is even poss ible that a signal cannot be seen at all This is the case when the elec trodes are inadvertently placed on the same potential line The pro pagating signal from a heartbeat can be pictured as contour lines around a hillon a map When two persons are standing on the same line the difference in height between these persons is zero Accordingly no ECG signal can be measured when the sensing electrodes are placed on such a line on the body surface To prevent too weak ECG signals from triggering false alarms it is therefore important that the optimal electrode positions are determined before the start of monitoring 10 3 Measuring principle for the apnea monitor Unlike the heartbeat respiration is not accompanied by its own electric signal A different principle must therefore be adopted for measuring respiration The most common method is the so called impedance pneumography Fluctuations in impedance are caused by both respiratory movements of the thorax and other movements For this reason
32. rate too high activated TION is used instead 7 10 3 Table of technical alarm messages Message Meaning Cause or elimination No Check ECG The monitor discovers Check the ECG cable cable that the ECG cable is not connected Check The monitor discovers that Check the electrodes If this message 23 electrodes one or more electrodes persists use new electrodes or replace are not connected the ECG cable Check The measured voltage Check that the stipulated power 16 power from the power adapter adapter is being used adapter is less than 8 V or greater Check and if necessary replace the than 10 V NA3000 2 power adapter getemed 66 Alarms displays and views during monitoring Message Conflicting HR limits Corrupted ECG signal Hardware fault Internal data error No cables connected No power adapter Recharge battery Replace batteries Meaning Cause or elimination No The heart rate s LOWER Correct the heart rate limits LIMIT has been set higher than the UPPER LIMIT The ECG signal is Attach the electrodes as symmetrically 24 corrupted too strongly by as possible 50 Hz interference Replace the electrodes signals fromthe supply Select the I YE RD 3 lead network Proceed in accordance with the section Electromagnetic interference on page 24 The monitor has detected
33. that update the last value every two sec onds Fig 44 Respiration display respiration graph The RESPIRATION trend display presents the respiration rate over the last three minutes This display varies with the set age group oo O TO 2 YEARS 2 TO 6 YEARS gt 6 YEARS RESPIRATION RATE TREND between 0 and 60 between 0Oand60 between 0 and 30 DISPLAY PER MIN The bottom half of the RESPIRATION display presents the respiration wave form A small vertical bar above the respiration waveform indicates every detected respiration signal Under the respiration curve you can see the respiration signal s BASAL IMPEDANCE in ohms as in VIEW 1 The displayed respiration rate is not used in the alarm assessment and is calculated and displayed only when the respiration signal exhibits an adequate amplitude and is relatively free of movement artefacts Otherwise a question mark is displayed This has no negative effects on either the alarm function or the detection of central apneas getemed 78 Alarm and monitor settings 8 7 2 RESPIRATION menu alarm settings SETTINGS PROTECTION LIMITED dh Status ok ao a These settings can be changed Heart rate 1min Resp Tmin only when SETTINGS PROTECTION J is set to LIMITED in the SYSTEM menu Apnea alarms Always Factory settings are shown in bold type Fig 45 Respiration menu for viewing and setting alarm limits APNEA DELAY uu ccssccecescceeeeeceees 8 10
34. 20 32 34 seconds VitaGuard interprets apnea and trig gers an alarm when a respiration signal or movement is not detected and APNEA DELAY is exceeded The doctor must have set APNEA ALARMS to ALWAYS APNEA ALARMS nasses OFF ALWAYS CAUTION A deactivated apnea monitor can no longer detect apnea OFF and ALways switches off and on the apnea monitor In both cases the respiration waveform is displayed and stored getemed Information for the doctor and qualified medical staff 79 9 Information for the doctor and qualified medical staff The treating doctor is responsible for monitoring with VitaGuard This also applies to ambulatory monitoring This section contains all safety and settings information that only the treating doctor can make decisions on Remember that all the information and instructions in the sections Intended use on page 14 and Safety on page 20 must also be observed Only getemed AG personnel or authorized dealers certified by getemed AG as medical product advisers in accordance with 31 MPG German Medical Products Act may instruct the doctor and the qualified medical staff on how to handle and use VitaGuard This certification is awarded only to those persons that have received adequate training from getemed AG for its products 9 1 Safety instructions The safety instructions in this section address special technical and medical issues that are of particular importance to the doctor
35. 55 Alarms displays and views during monitoring 57 Alarm TES sagisnscescuasersssmnaessacentarsecenssnigarstensnananenspenibeasnenstenepntheetnuepaeenjaratnens 57 HEART RATE values based on age groups sessessssssssssesseseesesssseeseseesesees 57 Alarm message priorities in the status line ssssssssseesessesseesesseseess 58 Physiological and technical alarms searcssvsesnsnrqssosssssduausnsicticnenensteneaussaesosss 58 Differentiating physiological and technical alarm signals 59 ACOUSTIC information signals oo eeseseseseeeeeeeeseceseseseeeeeeseseaeeeeeseteeeesees 60 7 6 1 Information signals from the alarm unit next to the ISDA serces sch tate tes A A E E E E E ES 60 7 6 2 Information signals from the sound aperture DENCE TIS SOCKET paro R 60 The visual alarm signals ssssssssssessssssessessssessesseseessseesesseseesesseseesesseseeseeses 60 Stat s line displays cssseccsespaccnarcecnsnatvedexescuntacesceoteciaansaensstsoieatecenseannnsatenieeses 60 Heart rate and apnea monitoring e ssssesssssssesssssesessesesseseeseseeseeseseeseeses 62 FON FCA ACS GANG E T E I I IEE 62 192 APET Aa oE E A E EE 62 7 9 3 Technical heart rate and apnea alarMs ou eeeeeeeseeeeees 63 Alarm messages meanings and other information eee 63 7 10 1 Order of equal priority alarm conditions oo eee 63 7 10 2 Table of physiological alarm messages ou eeeeeeteeeee 63 7 10 3 Table of technical alarm messages ou ee eeteteteteeeeeeeee
36. Cer USB AUX Fig 16 AUX port The AUX auxiliary port can take the following connections Two analog inputs Modem for communicating data Nurse call unit External alarm unit VitaGuard cannot confirm whether an alarm signal has been re ported by a nurse call unit As explained in the section Alarm test on page 57 check each time you switch on the device that an alarm signal is really transferred and the alarm reported getemed Description 41 Measure the time it takes for an alarm to be reported and the time needed to reach the patient No more than ten seconds must pass between these times Observe the operating instructions for the nurse call unit 4 3 Membrane key panel Do not apply excess pressure to the keys VitaGuard recognizes key presses only when the keys have been pressed for about one second There are six membrane keys on the top side of VitaGuard VitaGuard VG 2100 a5 Status ok AEG Atmung wr incl Fig 17 Keys on the top side getemed 42 Description 4 3 1 Direction keys With the direction keys you navigate from one window to the next The direction keys also allow you to navigate within K O the menu structure Fig 18 Direction keys 4 3 2 lt Enter gt key The lt Enter gt key switches VitaGuard on and off O Enen The lt Enter gt key also lets you confirm changes to the monitor settings
37. GOOD Or MEDIUM there should be no deterioration in the detected heart rate when the patient moves normally Observe the LED with the lungs symbol and the respi ration bar on the VitaGuard display Carefully change the positions of the red and yellow electrodes When ever possible try to obtain the largest possible deflections in the respiration bar Also the respiration bar must move and the LED flash synchronously with the respiration 6 5 Checking the BASAL IMPEDANCE The basal impedance is displayed in View 1 the respiration display and the display INFO MEASUREMENTS HR amp RESP The basal impedance is the sum of all impedances in the measuring circuit skin and tissue impedance between the red and the yellow electrode impedance of the electrode skin interface impedance of the electrodes themselves and the patient cable getemed 56 Preparing for heart rate and apnea monitoring The basal impedance slowly falls for the first few hours after the electrodes have been attached This is caused by a reduction in the impedance at the electrode skin interface The displayed basal impedance should be less than 1000 If not wait for about fifteen minutes When the basal impedance has still not fallen you should use new electrodes When the displayed basal impedance does not lie within the specified range or when false alarms frequently occur the doctor or the medi cal caregivers should observe the instructions
38. NGS PROTECTION must be set to OFF as ex plained under SYSTEM SETTINGS PROTECTION ON LIMITED OFF on page 74 The possible set tings when SETTINGS PROTEC Heart rate 1min Resp min TION is set to LIMITED are full 220 a explained in the section RESPIRATION menu alarm Apnea alarms Always settings SETTINGS PROTECTI e j ON LIMITED on page 78 Period T1 Resp Hs Period T2 Resp 2085 Factory settings are shown in elder al e r Amin bold type Resnir Fig 70 Settings in the Respiration menu SILENT APNEA DELAY 8 10 22 34 seconds Same as APNEA DELAY but a silent alarm is stored when exceeded PERIODIC RESPIRATION Yes No This activates the detection of periodic respiration NOTE Activating the monitor for periodic respiration only operates if the age group 0 2 years has been previously selected a Erste Periode pa Zweite Periode p Fig 71 Periodic respiration PERIOD T1 DELAY oo 6 8 10 18 20 seconds For the detection of periodic respiration apnea must be longer than T1 but shorter than the set APNEA DELAY getemed 104 Information for the doctor and qualified medical staff PERIOD T2 RESP v ceeeeseeeees 4 6 8 20 28 30 seconds When resumed respiration lasts longer than T2 periodicity is no longer assumed NUMBER OF PERIODS 000 2 3 5 6 periods When the set number of periodic cycles has been reached the data are stored as a s
39. NOTE An alarm mute time of ten seconds follows a technical alarm triggered by problems with the ECG electrodes This delay is to prevent false alarms when the physiological parameters are being recalculated During the alarm mute time the bell symbol in the status line is crossed out 7 5 Differentiating physiological and technical alarm signals The ALARM TONE PITCH can be set in the SYSTEM menu so that alarms are heard over the prevailing background noise The urgency or priority of an acoustic alarm can be recognized by its characteristics described in the following High priority messages emit two sequences of five tones that are repeated every ten seconds The interval between each tone packet is two seconds Also there is a slightly longer interval between the third and 1 f2 laf Ja fs fourth tone of each sequence Fig 31 Characteristics of the high priority acoustic alarm signal Medium priority messages emit a sequence of three tones which is repeated every 5 2 seconds getemed 60 Alarms displays and views during monitoring 7 6 Acoustic information signals If wished the alarm unit next to the display can produce a short acoustic signal to accompany each heartbeat or each breath 7 6 1 Information signals from the alarm unit next to the display After the monitor is switched on an acoustic reminder signal is emitted every twenty seconds until all electrodes are connected and plausible data have been de
40. OTECTION LIMITED nsasesssssssesesesessseseseseseerosererersrsrsrsrsrsrsrsrsrsrsrss 75 RESPIRATION display and Menu aciarecsd seseratennsyodeesnsysadersenntdereatatienerendduens 77 8 L RESPIRATION display cseascucteaseesutcneceesecccuet necenetncsneearpnseaeaee 77 8 7 2 RESPIRATION menu alarm settings SETTINGS PROTECTION LIMITED ccecececccssccsscsscscsscsccscsscssescsscssescsscsssecseees 78 Information for the doctor and qualified medical staff 79 Safety INSUUCUONS shcseezecteuescrasstarnetoremeneyconetecceversuetatanncbsnenssegeeeveearemnarceee 79 9 1 1 Preparing for a new patient s ssssessssessessssesseseeseesessesesseseesesss 79 9 1 2 Connections to the USB and AUX ports oe eeeeeeeeeeees 81 9 1 3 VitaGuard and other medical devices oo eeeeeeeeees 81 INTO GI DIIY ai E E aaece es eoeeiec 82 Jak ALAST STATUS MESSAGES grca e E ee 82 J2 EIN ER Seen AE NE E EAE O E EE 83 9 23 IVIEASUREMENTS AR amp RESP scasseintonincacosaniexsavcccouasiaunceeses 84 Jat NET TINGS FEART RATE sacccecoescetyccsantoctcrensivacncessctennees izececacossere 85 92 9 NOETIINGSSAPNEAIMONITOR scscecccssccesoreesececsressseqemeseeusomseuie 85 dA AMEMORY INTERNET geqsecet as cateescaceeceteras sues ca aseerenceeen se eees ancien 86 sd NERS IONS spectre cece cence cece ee cece ca sce ce te cece cece tcc seme 86 Settings in the SYSTEM menu SETTINGS PROTECTION OFF seseseees 87 9 3 1 Changing multiple component settings oo eee 87 9 3 2 OPE
41. P TONE You can configure the monitor to emit a brief signal tone with every detected respiration RESPIRATION or with every detected heartbeat HEART PULSE BEAT Signal beep tone When this tone disturbs the patient 7 eart beat or caregivers choose the setting OFF Respiration The factory setting is OFF Fig 39 System submenu Signal beep tone 8 5 5 SYSTEM ALARM TONE PITCH You can set the pitch of the acoustic alarm signals to Low MEDIUM or HIGH so that they can be heard over the expected background noise The DIN settings DIN match the alarm tone characteristics as described from page 59 on in the section Differentiating physiologi cal and technical alarm signals As AEn an alternative you can set the alarm Medium DIN tone characteristic gtm as familiar High DIN from other getemed devices Medium gtm The factory setting is MEDIUM Fig 40 System submenu Alarm tone pitch 8 5 6 SYSTEM RS232 FORMAT This submenu lets you assign the RS format format for online data output from the AUX serial port gtm Format Fig 41 System RS232 format getemed 74 Alarm and monitor settings 8 5 7 SYSTEM SETTINGS PROTECTION ON LIMITED OFF The codes that protect the alarm defaults from unauthorized changes must be given by the doctor to those persons only whom the doctor judges to be adequately informed about monitoring and their responsibility for the patient The doctor sho
42. RATING AREA HOME OF CLINIC ou eeeeeeeeceeeeeeeeeeeeeeeeeeeees 88 9 3 3 ADMIT NEW PATIENT restoring factory settings 88 9 3 4 PRE and POST ALARM TIME ccessccssssessecscssescsssssesecserssnsscscorsesens 90 Jaa ARI UT UNE specs 90 DY A TU eae eer ere ees eee eee eye eet ee emia 90 Seo A 051 610 6 Saree enter E renter reer errr rr srt rr ete rere er 91 D0 AANALOGINPUT IFZ cecpeccacececeeactcaceussccpatuacececensvecasavecranennyees 91 O59 NANTERVALRECORDING carnin E seat 91 Data Storage TUNCUONS sisien aine e EE OEN E 91 getemed 9 5 9 6 9 7 9 8 9 9 9 10 9 11 9 12 10 10 1 10 2 10 3 11 12 12 1 12 2 12 3 12 4 12 5 12 6 12 7 12 8 13 Table of contents EVENT OIO ren A E E E E eensegneseeee eran 92 Foa SILENT ALAR IMIS ar E AE N E 94 9 5 2 MANUAL DATA STORAGE Or TRANSMIT DATA ou eeeeeeeeseeeeeees 94 9 5 3 Summary of stored EVENTS sss ssssssssssesessessesessesseseesessesesseseesesss 95 TRENDET OR nee E A E I E EE AN 96 LONG TERM storage over eight hours oo eeeeeeseseseseseseseeteeeeseseneeeeeeeees 96 PROTOCOL storage of operating and device data ou 96 Summary of stored signals and data sssssssssessesssssssessessssesseseesesseses 97 Settings in the HEART RATE menu SETTINGS PROTECTION OFF 98 Changing the ECG lead for signal optimization oo eeeeeeeeeeeeeees 101 Settings in the RESPIRATION menu SETTINGS PROTECTION OFF 103 Algorithms and measuring princi
43. VitaGuard VG 2100 Apnea and Heart Rate Monitor Operating instructions getemed Who should read which sections in these oper ating instructions The sections 3 to 7 colored blue at the top of the page and in the table of contents are intended specifically for caregivers without medical background knowledge The other sections are intended in particular for doctors and qualified medical staff Oo oOo N WW WN BP W N FF RP H N e O 13 General view and list of accessories Intended use Safety Description Steps before and after monitoring Preparing for heart rate and apnea monitoring Alarms displays and views during monitoring Alarm and monitor settings Information for the doctor and qualified medical staff Algorithms and measuring principles Evaluating stored data on a PC Specifications Table of figures NOTE Words and passages in SMALL CAPITALS in these operating instructions also appear on the display getemed Table of contents Table of contents 1 2 2 1 2 2 2 3 2 4 2 5 2 6 2 3 1 3 2 3 3 3 4 3 5 3 6 3 3 8 General view and list Of accessories ooi eeeccccsteeccesseeeeeeee 11 Intended use oeeeeeeeccsssesesssssssssneescccssnteeescessssnessceessssnsesceessnteesseessnnnesseeee 14 Label on the back of the device ssussssessessssesssssssessesesseseesessssesseseeseeses 14 Symbols and warnings s sss sssssssesssssssessesessesseseesessesesseseesesseseesessests
44. alarm signals getemed 22 Safety 3 2 Allergy risks to patients Attach ECG electrodes to intact areas of skin only So that the permanent contact with the electrodes does not put too much of a strain on the patient s skin the electrodes can be placed in the vicinity of the optimal site All materials that are used with VitaGuard and can come into con tact with patient or caregivers during normal operations are free of latex and are non toxic in accordance with the standard ISO 10993 1 getemed AG recommends replacing the adhesive electrodes used to monitor heart rate and apnea as soon as they start to lose their adherence The special gel for the electrodes has been developed to avoid skin irritation even after several months monitoring on new borns Nevertheless patients with sensitive skin may suffer allergic reac tions in the form of reddened skin and blistering that in serious cases may look like burns When the skin exhibits such changes you must immediately inform the doctor A change of electrode type may help 3 3 Possible external interference to monitoring Please bear in mind the possibility of other risks that are not listed here that can be caused by your specific monitoring environment 3 3 1 Installation and environment We recommend hanging VitaGuard in the delivered bag at a place where the display can be easily viewed Check as described in the section Alarm test on page 57 that you c
45. all other patients as depicted in Fig 27 b getemed 54 Preparing for heart rate and apnea monitoring a or b Fig 27 Recommended electrode configuration If the electrode configuration depicted in Fig 27 does not yield a good signal quality you can also try the Da yellow amp a A alternative electrode configuration red d AA black depicted in Fig 28 Fig 28 Alternative electrode configuration for optimizing the heart and respiration signals 6 4 2 Optimizing the heart and respiration signals signal amplitudes in View 1 The amplitudes of the heart and respiration signals are displayed Heart rate 1 min under the headings HEART RATE _ Amplitude Good 220 and RESPIRATION respectively in 80 VIEW 1 Basal imp Ohm 550 C 20 5 System Info View Fig 29 Electrode signal amplitude in View 1 getemed Preparing for heart rate and apnea monitoring 55 CAUTION When AMPLITUDE POOR is displayed the values for the monitored heart rate and apnea may be imprecise AMplitude on ee eeeeeeeees Meaning POOR rean E sonst the signal is not or only sporadically detected MEDIUM us cccccsccceesscceessceceecceees the signal is detected but interference e g due to movement can cause false alarms GOOD ecco cree eet a Clear signal is detected A correct HEART RATE is detected when the heart LED flashes synchro nously with the patient s heartbeat When the signal amplitude is
46. als can originate from the power supply or electri cal apparatus in the monitor s environment Observe the instruc tions under Electromagnetic interference on page 24 The doctor can deactivate the APNEA ALARMS as described in the section Settings in the RESPIRATION MENU Settings PROTECTION OFF on page 103 The APNEA ALARMS are then no longer activated and OFF is displayed instead of the respiration rate When a new age getemed 50 Preparing for heart rate and apnea monitoring group is selected under ADMIT NEW PATIENT the APNEA ALARMS are reactivated together with the other factory settings has delivered or approved Other electrodes can in particular when monitoring apnea cause malfunctions and in addition cause dam age to the patient s skin Read and observe the operating instruc tions for the electrodes Do not continue using damaged electrodes or cables Do not immerse Use only those electrodes that getemed AG or an authorized dealer electrodes or cables in water solvents or liquid cleaning agents Store the electrodes in a cool dry place Observe the storage instruc tions on the packaging Do not use electrodes after their expiration dates this date is printed on the packaging e g FEB2006 or 2006 02 February 2006 The electrodes provided are designed for short term applications Using the same electrodes several times can lead to malfunctions when the adhesive surface fails to adher
47. an hear alarms and where you can hear them Think also of the activities that cause noises for example showering or vacuuming Think before you raise the volume of your television or stereo Also getemed Safety 23 the VitaGuard s alarm outlet should not be obstructed by any objects that absorb sound Never place VitaGuard or the power adapter such that they could fall on the patient For example the power adapter could become detached from an overhead socket when the cable is pulled Do not immerse either VitaGuard or the accessories in liquids Variations in temperature and air humidity could lead to condensation forming in and on VitaGuard Wait for at least two hours after Vita Guard has visibly dried on the outside before using it for monitoring Do not operate VitaGuard in environments containing explosive gases flammable substances nitrous gases or highly oxygen en riched atmospheres Do not use VitaGuard at extreme temperatures below 5 C or above 40 C Do not place VitaGuard near heat sources such as radiators ovens etc Do not expose it to direct sunlight Always lay all cables and in particular any extension cables so that nobody can trip over them Do not place VitaGuard directly next to the patient s head risk of hearing damage 3 3 2 Noise risks to monitoring When the alarm cannot be set to a volume that is sufficiently above the prevailing ambient noise levels you must ke
48. and qualified medical staff 9 1 1 Preparing for a new patient When more than one VitaGuard monitor with differing settings are used in the same environment there is a risk of mixing monitors and a particular patient may be monitored with unsuitable settings For this reason check the currently set alarm limits every time the monitor is switched on getemed 80 Information for the doctor and qualified medical staff It is important that VitaGuard is configured so that false alarms are avoided to the greatest possible extent Frequent false alarms can prove detrimental to the alertness of caregivers When VitaGuard is to be used for a new patient the doctor or the qualified medical staff are obliged to take the following important precautionary measures Place used consumables such as electrodes in a plastic bag before disposing of them in household or medical waste Clean the device and disinfect all cables e g as described in the guidelines from the Robert Koch Institute Insert new batteries or a fully charged block battery Select the age group in SYSTEM ADMIT NEW PATIENT as explained under SYSTEM ADMIT NEW PATIENT restoring factory settings on page 88 Check that the monitor settings are suitable for the patient and if necessary adapt them Consider that the monitor settings may need to be changed ata future date and as appropriate arrange appointments to change these settings
49. anging the date and time in the SYSTEM menu is intended to explain how you can change system settings consisting of several components Use the V key to highlight the entry DATE TIME RS 232 format Off Press lt Enter gt A window appears Settings protection ff i Operating area Home for cha teu the ola entry Admit new patient Mustermann l Alarm mute time 60s Use the keys lt and gt to high pe He light the component you want to mg lineata change amp 05 16 48 The highlighted value is changed with the keys A and V Fig 54 System Date time getemed 88 Information for the doctor and qualified medical staff After changing a value pressing the lt Enter gt key a second time causes a prompt to appear with Accept No highlighted Press the lt key to highlight Accept Yes Confirming the prompt Accept Yes with the lt Enter gt key displays the changed value in the list To exit the menu press the lt Esc gt key 9 3 2 SYSTEM OPERATING AREA HOME or CLINIC OPERATING AREA lets you decide whether the value you have entered for SETTINGS PROTECTION is retained the next time VitaGuard is switched on When you select HOME SETTINGS PROTECTION is ON when the device is next switched on Operating area When you select CLINIC SETTINGS PROTECTION is set to the selected value when the device is next switched on Fig 55 Operating area Home or Clinic 9 3 3 SySTEM ADMIT NEW PATIENT restor
50. arameter a erae amp amp F XP Events Fig 60 List of the stored events M I marks the episodes that have been stored via MANUAL STORAGE or INTERVAL RECORDING Set in the SYSTEM menu The minimum and maximum values of the respective physiological parameters are seen at the bottom of the window getemed Information for the doctor and qualified medical staff 93 Highlighting an alarm event with the direction keys A and V and pressing the lt Enter gt key opensa Min mask with initial detailed infor Lead Nr of electrodesI YE RD 3 Basal impedance 550 550 Ohm HR FPR Apnea Max 220 20 80 mation on this event Highlight ing WAVEFORMS and pressing the j Graphics lt Enter gt key displays ine wave forms recorded with this event Trends Fig 61 Detailed information on a highlighted event The black symbol between the displayed times for the start and end of the event marks the section of the stored event currently displayed The two small vertical bars mark the start and end of the alarm event itself Events Fig 62 Stored waveforms Highlighting TRENDS and press Duration 04 19 0 36 mm s Screen 3 min ing the lt Enter gt key displays the TRENDS recorded with this alarm Fig 63 Stored trends getemed 94 Information for the doctor and qualified medical staff 9 5 1 SILENT ALARM LIMITS The monitor also lets you store signal sequences that are important for evaluating
51. as can be detected only when the patient is sleeping or is lying still does not move and is not being moved The heart rate can be monitored with electrodes also when the patient is moving but sudden vigorous movements can adversely affect the measuring accuracy A false heart rate is displayed during ventricular fibrillation or when the heart rate exceeds 270 beats per minute getemed Intended use 19 2 7 Information for the doctor on these operating instructions In full knowledge of these operating instructions the treating doc tor must decide whether the caregivers have to be trained in the performance of resuscitation measures how the caregivers can be best prepared for monitoring and above all for the measures that must be taken in the event of an alarm which View should be displayed Information on SETTINGS PROTECTION that sets the display modes and user configurations can be found on page 73 Information for the doctor and qualified medical staff is found on page 9 getemed 20 Safety 3 Safety The responsible doctor decides whether the caregivers are able to use VitaGuard for monitoring and whether they can implement appropriate measures in the event of an alarm 3 1 Caregivers tasks With caregivers we mean those persons who are responsible during monitoring for the monitored patient s well being for example parents or other members of the family babysitter
52. ber must be loaded by the evaluation software VitaWin and cannot be edited directly in the monitor Here you can also view the details for transferring data as an e mail attachment 9 2 7 INFO VERSIONS INFO VERSIONS displays the software and hardware version numbers followed by the moni tor s serial number SN getemed Memory Internet 6 7 Memory used 13 o Memory size 8 MB Modem type Land line Telephone ATDTO1L929 E mail address yitaguard getemed de Fig 51 Info Memory Versions getemed SW DAQ 0 0 0 1 SW IO 1 0 6 0 Hardware 1 0 0 0 Shl 803 04 0000 Fig 52 Info Versions Information for the doctor and qualified medical staff 87 9 3 Settings in the SysTEM menu SETTINGS PROTECTION OFF When SETTINGS PROTECTION is LCD brightness 95 o switched off in the SYSTEM Menu LCD contrast 70 Signal beep tone Off the doctor can configure Vita Pare tone pitch Medium DIN fi RS 23 Tormat O Guard for specific monitoring Settings protection Off requ irements Operating area Home cual new patient Mustermann Alarm mute time Os Use the direction keys to high Pre alarm time light an entry When you want to Say A a change the entry press the lt Enter gt key Pressing the lt Esc gt key discards any changes with out saving Fig 53 Separately protected settings in the System menu 9 3 1 Changing multiple component settings The following example for ch
53. cable so that it exits between the trousers and pullover Place the gel coated side of the electrode on the chosen site and carefully press it several times for a good contact New electrodes may be reattached several times Peel them gently from the skin starting at the edge When disconnecting the electrodes from the patient cable do not pull on the electrode s cable Pull the plug only If necessary secure the cable with an adhesive strip The skin should be dry and free of oil and grease Make sure when attaching and securing the patient cable that it cannot kink Kinking can cause damage Do not pull on the cable this is unpleasant for the patient and in addition can damage the electrodes getemed 52 Preparing for heart rate and apnea monitoring 6 2 Connecting electrodes the patient cable and VitaGuard Insert the electrode s plug into the ECG patient cable s ee distributor Note the color coding of the electrodes and the distributor s sockets eee Fig 25 Color coded sockets on the ECG patient cable s distributor Insert the plug from the ECG patient cable into the wv socket marked with the heart and lungs symbol V A Fig 26 Electrode socket 6 3 Technical alarm from the electrode contact monitor The electrode contact monitor reports an alarm when the electrodes have become detached the electrodes are too dry e g the expiration date has been exceeded or the electrode
54. d by excessive move ment trigger false alarms 50 Hz or other sources of electromag netic interference trigger false alarms suspected interference sources must be removed The electrode has become detached The monitor cable or electrode is defect The set UPPER LIMIT is too low getemed Alarms displays and views during monitoring 65 Message _ Meaning Information No Heart rate The calculated heart rate When there is no bradycardia 6 too low falls below the set Lower Heartbeats are not detected LIMIT for longer than the The electrodes are badly positioned set BRADYCARDIA DELAY Abnormal beats e g extrasystoles are not detected The electrode has become detached The monitor cable or electrode is defect The set LOWER LIMIT is too high Heart rate The current heart rate When there is no heart rate drop 11 drop falls below the value The heart rate and or the average detected based on the set AVERAG heart rate is incorrectly calculated for when ING INTERVAL by more the reasons given under Heart rate activated than the percentage too low deviation value set under TREND DEVIATION Heart rate A heart rate rise is When there is no heart rate rise 12 rise detected in the same The heart rate and or its average is detected manner as a heart rate incorrectly calculated for the reasons when drop but TREND DEVIA given under Heart
55. d monitor settings The functions described in this section can be accessed only when the doctor has set SETTINGS PROTECTION to LIMITED in the SYSTEM menu This setting requires a code The function ADMIT NEW PATIENT in the SYSTEM menu overwrites all earlier settings The set alarm limits and other monitor parameters are stored and retained when the monitor is switched back on after a battery change 8 1 Safety instructions for the alarm settings It is important that the doctor responsible sets new alarm limits and monitor parameters for each patient and for each new medical situation Never change alarm limits without consulting the treating doctor Never set the alarm limits to extreme values that render the moni toring system useless When you have been given a code for changing alarm limits it is important that you treat this code as confidential Life is in danger when alarm limits are not adapted specifically to each and every patient getemed Alarm and monitor settings 69 8 2 Summary of views and menus The views presented here are intended to provide extensive informa tion on the monitoring situation When SETTINGS PROTECTION is Set to LIMITED they can be accessed with the direction keys lt and P system Info View 1 View 2 View 3 Heart rate Respir Events Trend The keys A and V let you access more detailed information and enter menus for changing monitor settings The Aor V key takes you from the Syste
56. e alarm limits lj 1 eb s The bottom half of View 3 displays the waveforms over a longer interval than VIEW 2 _View 1 View View 3 Heart rate gt 4 Fig 34 View 3 8 4 Changing the settings Use the direction keys to highlight a menu option or an entry in this option Once you have highlighted the option you want press the lt Enter gt key to change it When you do not want to keep your changes press the lt Esc gt key getemed The A key takes you to the menus The first entry in the list is highlighted Use the V key to highlight the setting LCD BRIGHT NESS Changing multiple com ponent settings is explained on page 87 for the doctor and quali fied medical staff Alarm and monitor settings 71 Screen saver LCD brightness LCD contrast Signal beep tone Alarm tone pitch RS 23 format settings protection Off Medium DIN Off Limited Fig 35 Menu system LCD brightness 80 highlighted Press the lt Enter gt key A window appears where you can change the old value Use the A and V keys to change the highlighted value Screen saver On LCD brightness SO vo LCD contrast JO Signal beep tone Off Alarm tone pitch Medium DIN i LCD brightness iTe 2o Fig 36 System LCD brightness highlighted in the change window Pressing the lt Enter gt key after changing a value causes a prompt to appear with ACCEPT No highlighted Press the lt key to highlig
57. e and after monitoring 5 Steps before and after monitoring The following summary shows you all the necessary measures that need to be taken before monitoring Also read information on how VitaGuard is switched on and off The doctor and the qualified medical staff are responsible for all other important activities when Preparing for a new patient see page 79 5 1 Summary of steps before monitoring Insert the battery or batteries do not switch on yet Use the external power adapter to connect VitaGuard to the supply network do not switch on yet Connect the ECG patient cable to VitaGuard Attach the ECG electrodes to the patient Connect the ECG electrodes to the patient cable Switch on VitaGuard as explained in the next section Make sure that after the monitor is switched on the indicator lamps light up briefly and a short sound is emitted by the alarm buzzers Check that the alarm limits displayed are the same as those recommended by the doctor getemed Steps before and after monitoring 47 5 2 Switching on Press the lt Enter gt key for several seconds to switch on VitaGuard In the first minute of operation no acoustic signals are emitted so that you have time to check all cables The alarm bell is crossed out for this time and the remaining time is shown next to it Text mes sages on the other hand are shown from the beginning When no patient cable is connected an
58. e device label serves as a unique identifier for Vita Guard In addition the label bears important cautionary information On the device label you will find the manufacturer s name and address as well as the product and model name The serial number of your device is given next to SN getemed getemed Label on the back of the device Medizin und Informationstechnik AG Odersirasse 59 14513 Tetew GERMANY Product VitaGuard Model VG 2100 SN 02 04 0025 WL ALANYA UOUN OOIUIAU ONTO IINI MN MN Ingress protection class IP21 Do not use in explosive atmospheres Use only power adapter NA 3000 2 Do not use with plug in socket which can be switched off In battery mode use only fresh LRG batteries Check polarity 2004 Made in Germany Fig 2 Device label on the bottom of the device Intended use 15 2 2 Symbols and warnings This symbol warns you that failure to observe these op erating instructions can cause death or injury to the pa tient The book symbol means that you must not use the de vice when you are not familiar with the information con tained in these operating instructions C TE With this CE label and the CE approval number 0197 getemed AG confirms that VitaGuard complies with all the pertinent regulations and in particular the require ments in Annex I of the Medical Devices Directive 93 42 EWG and that this has been approved by a noti fied body TUV Rhein
59. e properly Do not open the electrode s packaging until shortly before the elec trode is to be used Open the packaging and remove the electrodes Hold the sides of the electrode and peel off the transparent film Do not pull on the electrode s cable Avoid finger contact with the elec trode s gel coated surface as much as possible reattach them to the transparent film This helps to prevent the electrode from drying out or becoming soiled Use exclusively the ECG patient cable delivered by getemed AG Connect the ECG electrodes only to the ECG patient cable and this only to the corresponding VitaGuard socket CAUTION Make sure when attaching electrodes that neither the electrodes nor their plug connectors come into contact with other If you intend to reuse the same electrode a short time later carefully electrically conducting parts There must also be no contact with getemed Preparing for heart rate and apnea monitoring 51 other electrically conducting parts when electrodes become de tached during monitoring Attach the electrodes only to intact areas of skin Secure the electrodes and cables so that they cannot harm strangle or be swallowed by the patient Always lay the patient cable at a safe distance from the patient s head and neck Lay the patient cable when monitoring small children inside their clothing so that it exits at the foot On larger children and adults you can for example lay the patient
60. ecseaeoparenecatens 83 Info Measurements HR amp ReSp csectcnucsmanmenatenteden 84 MO eE RETE o E E 85 Info Settings Apnea Monitor s ss ssssessssessessesesseseeseseesesseseesesseseesess 85 Info Memory cocsesncocueyesceasesevererapecenounee evavepeoesevornntonsyetcoressereveessannearse 86 OSVETIO cerei e E I E A nde oaageersees 86 Separately protected settings in the System Menu eee 87 NEED EA UNIE aree a E E E ruse dee 87 Operating area HOME OF CINIC wee eceseseseseseeceeeeeseseneeeeeteeeeeenees 88 Warning before changes under System Admit HAON Dae sorn a E eer freer terre te ereee eee re reece eer 88 System ID First name and Surname oo eeesetseeeeeeeeeseeeeeteeeeeenees 89 DY SUI OS COUN eree e e A A EEE 89 Confirming the age group setting ss sessessssessesessessseesesseseeseseesesses 89 ISRO CIS S LOCC EVES eri E E ERE 92 Detailed information on a highlighted event oe eeeeeeeees 93 ACU WAVE TONIS arren E E ere E S 93 HOCA NS saraa E E ES 93 View Manual data storage ssessssessssessessssesssssseesesersesseseeseseeseesess 94 getemed Fig 65 Fig 66 Fig 67 Fig 68 Fig 69 Fig 70 Fig 71 Fig 72 Table of figures 121 VIEW aAA n E S 94 List of the episodes stored in the trend Memory eee 96 Detailed information on a highlighted trend episode 96 Settings in the Heart rate menu s ssssssssssessssessesssesssseesessesessseeseeses 98 Heart rate menu Lead Nr of electrodes
61. ed in the standard EN 60601 1 2 3 4 Safety with approved accessories only Use VitaGuard only with the delivered or approved accessories and in accordance with the information contained in these and the accessories operating instructions Electrodes cables and power adapters can be ordered from your authorized dealer or directly from getemed AG The telephone num ber of your authorized dealer was given to you during your training on how to operate the device or it is found on a label your author ized dealer has attached to VitaGuard Bear in mind that monitoring can continue without interruption only as long as the required consumables are available In emergen cies of this nature you can call your authorized dealer who provides 24 hour emergency services Please try however to avoid unneces sary stress for both yourself and your authorized dealer and order your consumables in good time getemed 26 Safety The modem used to transfer monitoring data must comply with the requirements under the German and European standard DIN EN 60950 Safety of IT Equipment with the amendments A1 A4 These details are found in the modem s operating instructions 3 5 Handling patient cables Always lay patient cables at a good distance from the patient s head and neck Lay each patient cable inside the clothing and secure it in place in such a way that no harm can come to the patient or cable strangulation twisting
62. eeeee 65 Table of information messages oun eeeeseeseseseseseseseeeeeeeeeeseseseseeeeeteeseaeaees 67 Alarm and monitor settings occ eeeccsssssseescesssnnesseeesnnneesees 68 Safety instructions for the alarm settings ssessessssessesessessesersessesess 68 Ss ummary OF views and inenUS gets scetsdescesnetrnseeanescsestecseatsseeenceteoore eee 69 AGAIONAL VIEWS cucecsestoescanctoseaseseceraceincessestaacarectenayearsron ceacieansncuseeynaiearueses 69 8 3 1 View 2 Large data presentation and waveforms 70 8 3 2 View 3 Smaller data presentation and waveforms 70 Changing TASSELS ccescossantces ccsereeenosesmssensstesansecanseunscmsesacseminteessesigacne 70 SYSTEM MENU general settings oe eeeseeseteeeeeeseeeseseseeteteteeeeneeees 12 8 5 1 SCREEN SAVER OFF ON sessssssssssssesesesesssesssssssrsrersrsrersrsrsrses 72 Oa NLCD BRIGEI INES yeresete rea E E EEE EE 72 CONT RAS spree eats tet ett 72 Bo SIGNAL BEEP TONE cecscrcacccscsut crsctescccateutscrateuscteacsutvesacensvonsesatoanes 73 getemed Table of contents 8 6 8 9 2 9 3 9 4 Ge JALAR M TONE PITCH saioa E 73 OO NRL FORA seria E eee E eee 73 8 5 7 SETTINGS PROTECTION ON LIMITED OFF eeessssssssessseeseee 14 HEART RATE display and MENU nsssssssssssssssessessesesssseesessesesseseesesseseeseseeseeses 75 8 6 1 HEART RATE display esesssssssessssessessssessesseseesessesessessesesseseesesseseesess 75 8 6 2 HEART RATE menu alarm settings SETTINGS PR
63. enveensens 7341 2002 AUX 02 modem cable for connecting a modem to VitaGuard gious cate papte de sesinettie ve svsescuasessnseaesaaunenesiaeccaceees 7341 3001 getemed General view and list of accessories 13 AUX 03 cable for connecting an external alarm unit EOR ETO E seaecesoeasseneesees E E E 7341 5001 AUX 04 cable for connecting VitaGuard to a nurse call system with 4 kV isolation ssssessessesessesesseses 7341 5011 AUX 06 cable for connecting two external signal sources OVRI UIO E secetacnaveste vaversndeven seavivtetores 7341 6001 getemed 14 Intended use 2 Intended use This section provides information on the intended use of VitaGuard and the limitations of this intended use CAUTION Do not attempt to use VitaGuard for detecting obstruc tive apneas Obstructive apneas i e respiratory arrest following an occluded respiratory tract are not detected by VitaGuard Food debris or vomit for example can occlude the respiratory tract The doctor treating the patient is responsible for the application of VitaGuard The specific Information for the doctor and qualified medical staff can be found on page 79 getemed AG recommends qualified training for the caregivers in potentially necessary resuscitation techniques Clearing the respira tory tract and the resuscitation of babies and infants require particu lar know how that the treating doctor should communicate to the caregivers 2 1 Th
64. ep VitaGuard and its display within view The visual signals from the alarm LED and display must then be relied upon to recognize critical situations You can also use the external alarm unit available from getemed AG that raises the volume of the alarm signals from VitaGuard Information on the alarm signal types and volumes can be found in Alarms displays and views during monitoring on page 57 The alarm pitch is set as explained in the section System menu general settings on page 72 getemed 24 Safety 3 3 3 Electrostatic interference Electrostatic build up that for example a person can pick up on certain carpets must not discharge through the VitaGuard connec tor sockets or the electrodes electrically conducting parts For this reason avoid touching the electrically conducting parts or discharge any electrostatic build up beforehand by for example touching an earthed water pipe or heater 3 3 4 Electromagnetic interference VitaGuard is not designed for applications near strong electromag netic fields These interference fields are frequently emitted by devices with large electric power consumptions Keep a good dis tance from e g washing machines computers microwaves vacuum cleaners power tools etc The device and the system can be used in the home and in all other environments that public utilities supply directly Bear in mind that portable and mobile HF communication devices
65. ert batteries When VitaGuard is supplied by the power adapter charging of the inserted rechargeable block battery is activated The LED next to the battery symbol illuminates getemed Description 35 4 1 1 Power failure with inserted batteries VitaGuard automatically switches to battery mode when the exter nal power supply fails or the power adapter is disconnected In this event a technical alarm is permanently emitted until the power supply has been reinstated or the lt Esc gt key pressed When the supply network LED is off but you can still see the usual monitor displays VitaGuard is being supplied by the batteries 4 1 2 Power failure without batteries VitaGuard is fitted with an internal battery This provides the volt age for an acoustic signal that is emitted when monitoring cannot be continued during a power failure The acoustic alarm from the internal battery does not stop until VitaGuard has been switched back on after the power adapter has been reconnected or batteries have been inserted A power failure jeopardizes monitoring when the batteries in the VitaGuard are nearly depleted or no batteries have been inserted and VitaGuard is disconnected from the external power adapter To stop the power draw on the internal battery it is important that non rechargeable batteries are inserted as quickly as possible or better the power adapter is reconnected VitaGuard must not be used for
66. es always choose the same electrode position and color To avoid too much of a strain on the patient s skin you can also arrange the electrodes in a small circle around the optimal position By changing the ECG lead you can Lead Nr oe optimize separately the detection II BK RD 3 of respiration and heart signals for ENE VitaGuard Fig 69 Heart rate menu Lead Nr of electrodes submenu YE RD 3 yellow red 3 electrodes Both signals the heart and the respiration signal are measured between lt yellow gt and lt red gt BK RD 3 black red 3 electrodes Like lead I the respiration signal is measured between lt red gt and lt yellow gt the heart signal on the other hand between lt black gt and lt red gt I BK YE 3 black yellow 3 electrodes Like lead I the respiration signal is measured between lt yellow gt and lt red gt the heart signal on the other hand between lt black gt and lt yellow gt getemed 102 Information for the doctor and qualified medical staff YE RD 2 yellow red 2 electrodes This lead is used when only two electrodes are to be attached Test the quality of the signal from the heart rate monitor with all leads When View 1 displays the quality level Goon for at least one of these leads further optimization is not necessary The following explanations follow from the section Determining the optimal electrode configuration
67. ese RR AVERAGING esee AVERAGING INTERVAL TREND DEVIATION TREND DEVIATION 5O HZ FILTER eessen LEAD NR OF ELECTRODES 1 2 3 4 5 14 15 seconds See BRADYCARDIA DELAY but for asystole 2 4 6 8 14 16 beats Number of heartbeats used to calculate the heart rate the displayed heart rate used to detect alarm conditions is calculated as an av erage value over the number of heart beats set here The greater the value chosen for RR averaging the slower the system s reaction particularly in the event of bradycardia to report an alarm 10 20 60 110 120 seconds The average heart rate measured over the set interval yields the reference value for calculating TREND DEVIATION and TREND DEVIATION 5 10 15 20 25 30 35 40 45 50 The current heart rate is compared with the average heart rate measured over the averaging interval and an alarm is reported when the set percentage de viation is exceeded This alarm is re ported only when HEART RATE ALARMS is set to LIMITS amp TRENDS See TREND DEVIATION but the value falls below the set percentage deviation Setting the 50 Hz filter to ON sup presses interference signals but also fil ters out parts of the ECG signal YE RD 3 yellow red 3 electrodes II BK RD 3 black red 3 electrodes getemed 100 Information for the doctor and qualified medical staff PACER DETECTION eeens HEART
68. fety with proper maintenance ONLY ou eeeeseeeeeeeececeseteteeeeeeeeeeeees 30 3 7 1 Cleaning VitaGuard and accessories on 30 3 7 2 Checking and cleaning the battery terminals 0 31 Disposing of non rechargeable batteries the device and CCS SOS asset hace ease cee areca ck cate E E E 31 getemed Table of contents 4 2 4 3 4 4 4 5 5 1 5 2 5 3 5 4 6 1 6 2 6 3 6 4 Boag 0 d o aiara RE A S erie Ome rcv mtr nen ere 33 POVVES SUDDIY sscjesestsnacasetcaascan cpicadscaniete oceseetasaceeasueseiess a E 34 4 1 1 Power failure with inserted batteries oo eects 35 4 1 2 Power failure Without batteries oo eeeseeeeeeeteeeeeeeeees 35 Ad Replacing DA ETIES seinere ar N E eE EESE EEEE 36 4 1 4 Using the automobile power supply adapter 37 VitaGUard CONNECTIONS o eeeeeceseseseseseseeeeeteeeteeseeeseseseseseseseaeeeeeeeeeees 38 4 2 1 Patient cable for electrodes oe ecceeseseeeseteeeeseeeeeseseeeeeeeeees 38 4 2 2 Power adapter cavsieccassoasdseiosaescsnanasdsesandearsieane susdeugeassencaosastcustentets 39 4 2 3 Sound outlet no socket ssssssessssssssssesssssssssrsesesesesesesesesese 39 a ES e 2 810 E E E A E E 40 mLa AYVA DPO ee E E E E E E 40 Membrane key panel ssssssssssessssesssssssesssssssesssseesessssesseseesessestesessesesssseesesss 41 43 1 Direction KEYS sapiesnearssacaasceseaescserssescencecancsacns tsodesgecsneassnncatvoswensacce 42 43 2 KENTE KEY ccecrarensecesqenssarapevateciauctanenserstacoqanss
69. gg uw g siuu Oo OS 62 S amp L B0 co Sc 80 1 S02 Way UU O22 08 HIMES 00T 98 zods cb 80 S TEL Gev0 T bOOe O10 Lesher weebueq spuai SUlely GEZ OSL LL B0 b ob 5l apuu g g au 2Ha 96 Had il Uld suu GE G If AW TH PEEP Lid rte uty dd JH uyo oppg SM uy Ad UP kiiin tte S 2 SYIIH UNE lege FOOZ OT Tz 0002 E 6T Dunssa ayer g ogg qab w0Is494959 662 UMEJAA amp Fig 72 VitaWin register Events in graph form getemed 112 Specifications 12 Specifications 12 1 General Welo nE seene e approx 650 g with non rechargeable batteries approx 700 g with rechargeable block battery DIMENSIONS neessssesesesssesssesessse 13 5 x 20 3 x 4 5 cm Non rechargeable batteries 4x 1 5 V type LR6 AA alkaline Chargeable block battery NiMH 4 8 V 2000 mAh Charging time oes 6 hours Battery life cxestatcssdecemosteoansdeeves e g VARTA UNIVERSAL ALKALINE minimum 2 days KEYS cecceesescesssesesesceeeseeeseseeeeesees 6 membrane keys Battery change ou eee displayed message Depleted battery acoustic alarm Power consumption lt 10 W Power adapter ou NA3000 2 power adapter Manufacturer FRIWO Geratebau GmbH Type FW 7555MM 09 Output 9V 1500 mA DC Input 100 240 V 50 60 Hz 400 mA AC Ingress of protection IP 40 getemed Specifications 113 Characteristics of acou
70. he currently stored data and restores the factory settings If neces sary transfer the data beforehand to a PC The memory contents of VitaGuard are also retained when the power adapter or batteries fail VitaGuard features the following data storage functions EveENT storage automatic storage of ALARMS and SILENT ALARMS or MANUAL STORAGE getemed 92 Information for the doctor and qualified medical staff TREND Storage automatically for max 72 hours INTERVAL storage set in the SYSTEM menu LONG TERM Storage automatically for max eight hours PROTOCOL storage automatic The VitaGuard display lets you view stored EVENTS and stored TRENDS LONG TERM and PROTOCOL storage can be evaluated on a PC only The Summary of stored signals and data on page 97 presents the signals and sample rates for the respective memory The currently utilized memory capacity is shown on the INFO display The installed memory can store up to 200 events of two minutes each 9 5 EVENT storage Please bear in mind that you must wait for the POST ALARM TIME to expire after an alarm has ended before the current alarm event can be completely stored 3 Episodes HR Apnea Mil The time of occurrence and the 2i May 1 43 485 length of the stored data are 27 Mav it34 56s stored for every alarm event The 27 May t23 TS section Summary of stored EVENTS on page 95 explains the symbols in the columns for each physiological p
71. he environment after their service live For this reason the device and accessories may be sent to getemed AG in an adequately stamped package when possible in the original packag ing for free and proper disposal getemed Description 33 4 Description We recommend placing VitaGuard in the bag provided This bag pro tects the monitor and can be hung from a site where it cannot fall z E T a Fig 5 VitaGuard and bag with power and patient cables getemed 34 Description 4 1 Powersupply NA3000 2 9V VitaGuard is usually delivered with the power adapter for European supply networks For other supply net works contact getemed for the appropriate plug adapter Observe the information in Power supply reliability on page 26 Fig 6 Power adapter socket VitaGuard is normally supplied by the power adapter Fig 7 left in the 230 V 50 Hz supply net work The NAK3000 2 automo bile power supply adapter Fig 7 right for vehicle dashboards can be inserted in this socket Fig 7 Power adapter for 230 V 50 Hz supply network and automobile power supply When VitaGuard is supplied by the external power adapter the green LED lights up next to the power adapter symbol In addition the display backlight is activated when VitaGuard is switched on When VitaGuard is supplied by the power adapter only without in serted batteries a display message will prompt you to ins
72. heartbeat of the patient In other words this LED flashes as fast as the heart beats The LED with the lungs symbol lights up with every detected breath of the patient when the patient does not move and is not moved In other words this LED flashes as fast as the patient breathes Fig 22 Heart and respiration LEDs These two flashing green LEDs show you even in complete darkness that monitoring is activated getemed 44 Description Also the SySTEM menu lets you switch on and off an acoustic signal that is emitted synchronously with the heartbeat or respiration 4 4 3 Power supply and battery LEDs When the LED with the power adapter symbol AE gt lights up VitaGuard is be ing powered from the sup ply network or an automo Mains supply active Block battery charging bile power supply Fig 23 Power supply LEDs When the LED with the power adapter symbol does not light up but the usual monitor displays are visible VitaGuard is being supplied by batteries four non rechargeable batteries or the re chargeable block battery The light from the LED with the battery symbol is permanently on when the block battery is being charged in VitaGuard A depleted block battery takes up to six hours to recharge When the block battery is fully charged the LED with the battery symbol flashes every second to indicate that compensation charging is active The block battery must therefore be fully charged at
73. hs at the latest VitaGuard and accessories must be serviced by getemed AG to comply with safety regulations Repairs must be performed by getemed AG only Clarify the neces sary procedure with your authorized dealer For the protection of our service personnel disinfect VitaGuard and the patient cables with Virkon available as a spray or wiping solu tion before sending them to getemed AG 3 7 1 Cleaning VitaGuard and accessories Before cleaning VitaGuard remove the batteries Before cleaning VitaGuard detach the electrodes and cables from the monitor and from the patient Do not under any circumstances use solvents like ether acetone or benzene These substances can cause malfunctions and attack the housing plastic Also do not use any cleaning agents containing abrasive substances and no coarse brushes or hard objects VitaGuard and accessories can be cleaned any number of times when the recommended cleaning agents are used VitaGuard and accessories must not be sterilized VitaGuard and the cable plugs must not be immersed or otherwise penetrated by liquid getemed Safety 31 Cleaning the exterior is best done with a non linting cloth moistened slightly with water or a mild soap solution getemed AG recommends disinfecting the device with Virkon available as a spray or wiping solution Patient cables can be cleaned with liquid Cable Care or with a 70 alcohol solution
74. ht ACCEPT YES Screen saver On LCD brightness BO Fp LCD contrast J0 Yo Signal beep tone Off Alarm tone pitch Medium DIN R di gd LCD brightness Accept Yes Fig 37 System accept change to LCD brightness highlighted Confirming the prompt Accept Yes with the lt Enter gt key displays the changed value in the list To exit the menu press the lt Esc gt key getemed 72 Alarm and monitor settings 8 5 SYSTEM menu general settings iar p Screen saver On NOTE You can ranae your PED brightness eae self with the menus without LCD contrast 70 Signal beep tone Off changing values Simply press Alarm tone pitch Medium DIN RS 232 format off the lt Esc gt key to exit each menu settings protection Limited and submenu without saving changes Fig 38 System menu general settings 8 5 1 SYSTEM SCREEN SAVER OFF ON When SCREEN SAVER is set to ON an animation appears on the display when no key has been pressed for five minutes When you press a key or an alarm is triggered the previous mask is displayed again 8 5 2 SYSTEM LCD BRIGHTNESS You can set the LCD BRIGHTNESS from 0 to 100 in steps of 5 When 0 the displays backlight illumination is switched off The factory setting is 95 8 5 3 SYSTEM LCD CONTRAST You can set the display s contrast from 0 to 100 in steps of 5 The factory setting is 70 getemed Alarm and monitor settings 73 8 5 4 SYSTEM SIGNAL BEE
75. ilent alarm MIN RESPIRATION RATE 4 5 6 9 10 min VitaGuard discards signals witha lower rate of occurrence NOTE Changing the min respiration rate to 5 min has an effect only when the age group has been set to O To 2 YEARS under SYsTEM AD MIT NEW PATIENT See SYSTEM ADMIT NEW PATIENT restoring factory settings on page 88 For the age group 2 To 6 YEARS the min respir ation rate is fixed at 5 min for the age group gt 6 YEARS at 4 min getemed Algorithms and measuring principles 105 10 Algorithms and measuring principles Knowledge of the following calculation bases is essential if VitaGuard is to be properly configured 10 1 Alarm condition and report delays As prescribed in the standard IEC 60601 1 8 General requirements for safety Collateral standard General requirements tests and guidance for alarm systems in medical electrical equipment and medical electrical systems this section allows the doctor to become familiar with the set and inherent delays for the correct configura tion of the alarm limits and monitoring parameters The alarm condition delay is the time from the occurrence of a triggering event on the patient or in the monitor to the decision by the alarm system to confirm an alarm condition The alarm report delay is the time between when an alarm condi tion is detected and when it is reported The alarm condition delay and the alarm report delay are added to
76. ing factory settings IMPORTANT This deletes all stored data and all monitor settings for a specific patient Check that the new monitor settings are suitable for the patient All data are deleted and all user settings are restored to the factory values So you are prompted Attention whether you want to CONTINUE Data and settings will be deleted Continue Press the lt key to highlight ACCEPT Yes and then the lt Enter gt key Accept Yes Fig 56 Warning before changes under System Admit new patient getemed Information for the doctor and qualified medical staff 89 The submenus for ID FIRST NAME and SURNAME are displayed one gs ID Use the lt and gt keys to position the cursor Admit new patient ID Use the A and V keys to enter 0123 E letters and numbers Admit new patient First name Press the lt Enter gt key after you have entered your data in each Admit new patient submenu paname These inputs are optional and can be Skipped by pressing the lt Enter gt key Fig 57 System ID First name and Surname Pressing the lt Enter gt key to confirm your entry in the SURNAME menu opens the submenu for setting the age group Here too press the lt Enter gt key to confirm your age group settings Admit new patient to 6 years gt 6 years Fig 58 System Age group Use the lt key to highlight Accept Admit new patient Yes and then press the lt Enter gt key your sett
77. ings for the new patient are stored Oto 4 years Accept Yes Fig 59 Confirming the age group setting The ADMIT NEW PATIENT function restores the factory settings VitaGuard is delivered with alarm limits for patients in the O To 2 YEARS age group The following settings vary with the age group m the minimum RESPIRATION RATE in the RESPIRATION menu m the LOWER LIMIT and the UPPER LIMIT in the HEART RATE Menu getemed 90 Information for the doctor and qualified medical staff The table lists the factory settings for each age group tro 2 vemrs 2TOGYEARS gt 6vEARS Min respiration rare min dO S MIN RESPIRATION RATE MIN 10 LOWERHEARTRATELIMIT MIN 80 SO S UPPER HEART RATE LIMIT MIN 150 120 All other settings are not specific to age groups The values set last are retained when VitaGuard is switched off and when the supply network or batteries fail to provide power 9 3 4 SYSTEM PRE and POST ALARM TIME In the event of an alarm data for the pre alarm and post alarm times set here are stored in addition to the duration of the alarm These times can be set from 30 to 180 seconds in steps of ten seconds Also the menu item SYSTEM INTERVAL RECORDING explained on page 91 records data for the duration of the pre alarm and post alarm times 9 3 5 SYSTEM ALARM MUTE TIME In order to allow caregivers to tend to a patient in peace during an alarm the acoustic alarm sig
78. l requirements tests and guidance for alarm systems in medical electrical equipment and medi cal electrical systems IEC 601 2 27 i eeceeeeteeees Medical electrical equipment Part 2 27 Particular requirements for the safety including essential performance of electrocardiographic monitoring equip ment getemed 118 Specifications DIN EN 60601 2 49 aiina prEN ISO 18778 oes getemed Medical electrical equipment Part 2 49 Particular requirements for the safety of multifunctional patient monitoring equipment Infant Monitors Particular require ments Table of figures 119 13 Table of figures Fig 1 General view of the Monitoring system oo eeeeeeeeeeeeteteeeeeeees 11 Fig 2 Device label on the bottom of the device oe eeeeeeeteteteeeee 14 Fig Battery voltageindicalor ecccsseeeserceereenieteersseconseeemacecsanreacom secs 28 Fig 4 Rechargeable block battery acacia rs cu ater caaree taper crenseeeansieeenneaes 29 Fig 5 VitaGuard and bag with power and patient cables 33 Fig 6 Power adapter socket oo eeesssssesseseseseseseceseeeseceseacaeaeaescseeceeeeeeeeeeens 34 Fig 7 Power adapter for 230 V 50 Hz supply network and AULOTMODUE DOWEFSUDOIY scnrarctiemsectonscectieandisese tieerdtnacrenne ee 34 Fig 8 Opening the battery compartment ou eeeeeeeeeeeeeeeeeeeeteteteeeee 36 Fig 9 Opened battery compartment and polarity eee 36 Fig 10 The arrows show how the block battery is correctly PESOS ha acs eect cece
79. land Product Safety This symbol means that the VitaGuard s ECG socket is a 1 type CF cardio floating application part and that it is protected against the effects of defibrillation The factory symbol shows the year of manufacture Note the warnings on the device label Do not use in explosive atmospheres Use the NA 3000 2 power adapter only Warning Do not connect to an electrical socket controlled by a wall switch Only new alkaline batteries LR6 or AA must be used when the device is powered by non rechargeable batteries Note the polarity getemed 16 Intended use 2 3 Indications VitaGuard can be used to monitor patients with for example the following symptoms or treatment unstable respiration life threatening cardiac dysrhythmia conspicuous sleep laboratory findings facial and or cervical and thoracic dysmorphia distinct gastro esophageal reflux ataxia The heart rate and apnea monitor is suitable for adult pediatric and infant patients at home or in rooms used for medical purposes The apnea monitor is specifically intended for monitoring central apneas Successful apnea monitoring requires a stable underground and a patient that lies quietly without moving 2 4 VitaGuard modes of operation Depending on the risk group and the latest diagnosis VitaGuard allows the treating doctor to combine two monitoring parameters heart rate monitoring apnea monit
80. let and damage the monitor The external power adapter and the power outlet must be free of damage Never use the external power adapter s cable to lift VitaGuard Stop using the external power adapter when it has fallen or been dropped Do not operate the external power adapter in a damp environment e g in the bathroom Always leave the batteries in VitaGuard even when this is oper ated through the external power adapter ies or a rechargeable block battery VitaGuard must be operated only with the rechargeable block battery available from getemed AG or new alkaline non rechargeable 1 5 V batteries LR6 or AA e g VARTA UNIVERSAL ALKALINE Bear in mind that cheaper non alkaline non rechargeable batteries can have a considerably reduced operating lifetime in some cases only 10 15 of the brand name batteries we recommend Do not under any circumstances use single rechargeable batteries VitaGuard operates with batteries either non rechargeable batter available on the market Never use a non rechargeable battery and a rechargeable battery together in the device and never mix old and new batteries getemed 28 Safety To prevent leaking batteries from damaging health and property remove non rechargeable batteries from VitaGuard when it is not used for longer than a week Information on Replacing batteries can be found on page 36 3 6 1 Battery voltage indicator When VitaGuard
81. m view to the SYSTEM menu The first setting is highlighted The Aor V key leafs through pages on the Info display The Aor V key takes you from View 1 2 or 3 to the menu MANUAL DATA STORAGE Or TRANSMIT DATA This is explained in the corresponding section on page 94 The SPO 2 HEART RATE and RESPIRATION displays each feature a menu for adjusting the respective settings and can be accessed with the A or V key The first setting is highlighted The Aor V key takes you from the EVENTS or TRENDS views to detailed views WAVEFORMS and TRENDS 8 3 Additional views When the doctor has configured VitaGuard so that also the caregiv ers can change settings i e SETTINGS PROTECTION is set to LIMITED Views 2 and 3 are also activated in addition to VIEW 1 VIEW 1 is explained in the section The display on page 44 getemed 70 Alarm and monitor settings 8 3 1 View 2 Large data presentation and waveforms View 2 displays in large digits the Status ok Heart rate 1 min MUL Te current values for the monitored vital functions and on the right in smaller digits the set alarm limits Resp 1 min Also each section on the left H presents a waveform of the Info View 1 View 3 monitored vital function Fig 33 View 2 8 3 2 View 3 Smaller data presentation and waveforms The top half of View 3 displays the current measured values and Feat rate fmin Resp min 220 th
82. m when an electrode exhibits impedance values that are not compatible with proper operation This is the case for example when an electrode has become detached Physiological data measured for a set period before and after an alarm are stored and can afterwards be evaluated and documented VitaGuard can be operated with the NA3000 2 power adapter 9 V the NAK3000 2 automobile power adapter e g in the cigarette lighter four non rechargeable batteries or a rechargeable block battery Non rechargeable batteries or the rechargeable block battery serve above all to safeguard the monitor s functions during a power failure and to continue monitoring when patients are in transit getemed 18 Intended use 2 6 Limitations on VitaGuard s intended use Even when operated in accordance with its intended use Vita Guard cannot detect all life threatening situations under certain unfavorable conditions 2 6 1 Obstructive apneas are not detected Obstructive apneas are not detected by VitaGuard The caregiver may have to remove food debris from the patient s oral cavity When an obstructive apnea at the same time triggers a bradycardia alarm heart rate too low resuscitation measures may need to be taken 2 6 2 Limitations of the heart rate and central apnea monitor VitaGuard could misinterpret movements as respiration e g in ambulances cars and prams or when a child is held in the arms For this reason central apne
83. messages This is of importance to the doctor only 7 10 2 Table of physiological alarm messages Physiological alarms are reported with high priority getemed 64 Alarms displays and views during monitoring Message Meaning Apnea A respiration signal has detected not been detected for longer than the set APNEA DELAY ECG The monitor could not amplitude detect the ECG signal for low longer than the set ASYSTOLE DELAY Heart rate A heart rate alarm and an and apnea alarm have apnea occurred simultaneously Heart rate The calculated heart rate too high exceeds the set UPPER LIMIT for longer than the set TACHYCARDIA DELAY Information No When there is no apnea 10 The electrodes are badly placed i e the signal is too small to be detected Cardiogenic artifacts are superim posed on the respiration signal so that it is rejected The monitor cable or electrode is defect The set APNEA DELAY is too short When there is no asystole cardiac arrest 5 or delay The electrodes are badly placed The ECG signal is too small to be detected The monitor cable or electrode is defect See the messages and information for 3 Heart rate too high too low and Apnea detected When there is no tachycardia 7 T wave peaks are interpreted as R waves so that the calculated heart rate is too high The electrodes are badly placed Artifacts cause
84. nal can be temporarily deactivated with the lt Esc gt key Set the ALARM MUTE TIME to 30 60 90 or 120 seconds as required The acoustic alarm signal is automatically reactivated after this time 9 3 6 SYSTEM DATE TIME How to change these values is explained in the section Changing multiple component settings on page 87 This is used to set the current date and the current time e g for summer and winter times getemed Information for the doctor and qualified medical staff 91 9 3 7 SYSTEM LANGUAGE The menu option LANGUAGE is marked with a flag symbol Patt in the event that you do not understand the set language The submenu LANGUAGE lets you choose between the languages supported by your monitor version 9 3 8 SYSTEM ANALOG INPUT 1 2 You can activate and deactivate the two analog inputs separately Both analog inputs have an input range from 0 to 2 5 V An analog signal at input 1 when activated is scanned with 1 Hz and stored a signal at input 2 is scanned with 32 Hz and stored 9 3 9 SYSTEM INTERVAL RECORDING The doctor can use INTERVAL RECORDING for specific situations and can set an interval in steps of ten minutes after which monitored data are again stored After each of these intervals the monitor stores data for the PRE ALARM and POST ALARM TIMES The setting O MIN deactivates interval recording 9 4 Data storage functions The function ADMIT NEW PATIENT in the SYSTEM menu overwrites all t
85. ncdscesneraneranensnensecetaenss 42 ADS KESK y eri E EEE 42 Color LEDs Light Emitting Diodes wescentenecagncnencecaentie 43 TAL ALED rone aE EA A E cates 43 4 4 2 Heart and respiration LEDS s sssssssssesssessesessesersssessesesseseseesess 43 4 4 3 Power supply and battery LEDS oo eeeeeeeeseseeeneeeeeeeees 44 TAE dISPIaAy seezerecesccotensesccneaccsaestntensn iaceso tanacededeasesesiget ene tuniateseesnetteecnteereeaees 44 Steps before and after monitoring oe eeecccceeeesceeeeeeeeee 46 Summary of steps before monitoring oon eeeseteteeeeeeceseeeeeeeeeeenees 46 SVVILCH CON saree E E E E E E 47 SWIECIE OT Saan E E E E A A AEE E A A 48 Summary of steps after monitoring ssssessssessesssseesesseseesessesesseseesesss 48 Preparing for heart rate and apnea monitoring 49 Safety information when monitoring heart rate and apnea 49 Connecting electrodes the patient cable and VitaGuard 52 Technical alarm from the electrode contact monitor 0 0 52 Determining the optimal electrode configuration oo eee 53 6 4 1 ECG lead electrode color coding oe eseseseseseeteteeeeeeeesees 53 6 4 2 Optimizing the heart and respiration signals Signal amplitudes in VIEW Loe eeeeseseseceseeteeeteeeeseneseeeteees 54 getemed 6 5 7 1 7 2 7 3 74 7 5 7 6 7 1 7 8 7 9 7 10 7 11 8 1 8 2 8 3 8 4 8 5 Table of contents Checking the BASAL IMPEDANCE wicseconcencecsameceseasoncesnastacstenenscaner ae
86. ocardiogram ECG The amplitude and the polarity positive or negative of the measured signal depend on both the arrangement of the sensing electrodes and the individual location of the heart The signal is very weak typically one millivolt so it must be ampli fied before it can be used to calculate the heart rate For this purpose an instrumention amplifier is used in conjunction with filter circuitry This amplifies the ECG signal and reduces all other unwanted secondary signals e g movement induced artifacts and electromagnetic interference Interference signals can be optimally suppressed when a third so called reference electrode is used Without this reference electrode the ECG measuring circuitry must suppress interference signals solely with the aid of filters When however interference signals exceed a certain limit suppression is no longer possible and the ECG signal can no longer be measured false alarms are the consequence The use of getemed 108 Algorithms and measuring principles a reference electrode is the most common method for effecting an essentially greater suppression of interference The adhesive quality and the composition of the gel applied to the elec trodes have an additional important effect on ECG measurements The best results are obtained when the electrodes adhere well Electrodes that have dried out or adhere badly are unsuitable Irrespectively of all interference signals the heart
87. om patients only so far that you can reach them within ten seconds When you are not sure that VitaGuard is in perfect operating order check the patient s vital functions Under no circumstances should you use VitaGuard when you suspect a device defect In the event of ANY suspected VitaGuard malfunction continue to observe the patient until you can use a replacement monitor or VitaGuard has been examined by the doctor or authorized dealer months has expired Before the end of this period make an ap pointment with your authorized dealer to check the safety and operability of your device Test the acoustic alarm unit every time you switch on VitaGuard This is explained in the section Alarm test on page 57 CAUTION When attaching the electrodes make sure that the plugs do not touch any other electrically conducting parts Make sure that there can also be no contact with other electrically conducting parts when the electrodes become detached during monitoring Treat all leads and connections with particular care and never use the connecting cables to lift VitaGuard Switch off VitaGuard before boarding an aircraft When you want to transport VitaGuard in your luggage you should remove the batteries This prevents other pieces of luggage from switching on the device by accident An activated but disconnected VitaGuard Stop using VitaGuard after the servicing interval of eighteen will generate acoustic
88. oring The doctor can deactivate the apnea monitor in the RESPIRATION menu In addition to the fixed alarm limits for the heart rate monitor the doctor or the qualified medical staff can also configure percentage deviations as alarm conditions The doctor or the qualified medical staff can find all other explana tions they may need in the following sections getemed Intended use 17 Settings in the HEART RATE Menu SETTINGS PROTECTION OFF on page 98 Settings in the RESPIRATION menu SETTINGS PROTECTION OFF on page 103 2 5 Intended use and performance The intended use of VitaGuard is to detect central apneas when the patient is completely immobile on a stable underground and to moni tor the heart VitaGuard is designed for applications at home and in rooms used for medical purposes VitaGuard has no therapeutic effect VitaGuard emits an acoustic and visual alarm when no respiration or movement is detected within a set period when the measured heart rate values violate the set alarm limits for a period also set by the operator and or when no heartbeat has been detected for a set period The alarm limits can be set within particular values specified by VitaGuard Respiration and heart rate are monitored with adhesive ECG elec trodes VitaGuard determines the heart rate from the ECG signal detected by the electrodes VitaGuard features an impedance monitor that triggers a technical alar
89. oring results may be invalid for a short time In addition defibrillation can damage the cables Check the monitoring system after defibrillation A test in accordance with DIN EN 60601 2 49 showed that defibrilla tion pulses emitted during monitoring are attenuated by less than 10 Do not use VitaGuard in conjunction with HF surgical equipment Bear in mind that an external defibrillation pulse can be attenuated TENS devices or nerve stimulators VitaGuard correctly interprets pacer pulses with amplitudes greater than 5 mV so VitaGuard can be used on patients with pace makers getemed 82 Information for the doctor and qualified medical staff Warn your pacemaker patients that the displayed heart rate may possibly be affected by stimulating pulses Point out to the caregiv ers that they must carefully observe pacemaker patients Do not operate VitaGuard near MRI devices magnetic resonance imaging or other systems that generate strong electromagnetic fields The electrode leads for example can heat up by induction causing burns under the electrodes and fire in the cables The strong magnetic fields generated by magnetic resonance image devices can cause permanent damage to VitaGuard 9 2 INFO display The INFO display quickly presents the doctor with a summary of the monitor settings and data Other INFO windows can be accessed with the direction keys A and V The current page number and the total number
90. ples oes 105 Alarm condition and report delays ss ssssesssssssessesessesseseeseseeseeseseesesses 105 10 1 1 Alarm condition delay for the heart rate eee 105 10 1 3 Alarm condition delay for respiration essssessesseseesesessesses 106 10 1 4 Alarm report delays s ssessssessessssessesessesessessssesesessesseseeseseeseesess 106 Measuring principle for the heart rate monitor oo eee eeeeeeeteeeee 107 Measuring principle for the apnea monitor ou eee eeeeteteeeeeeeeeeeeeeee 108 Evaluating Stored data on aPC a eeccecseesssssssseesssessnneeseeeen 110 PECANS oee ae E E EE 112 ES A E E E 112 ple ain I ALE ae qi te queen scenes ere ern ee ere ree ee 114 PACA MIONIEON enie a eee ee eee ee E 114 Intervals for calculating average values in the INFO mask 115 MERO aeee A E E A E 115 FOS eaa E E E E E E EA 115 PWS EA OU e E E A E E aneesee saree sinseate ar 116 SEICC HOMO aD ONCE Standarde sea nE T 117 Table of figures ane ee eer nee enn nee ene 119 getemed Table of contents getemed General view and list of accessories 11 1 General view and list of accessories The general view shows the monitoring system s most important components g Go ao pol ar id External power adapter i P i J F f pi ir if ECG ECG jjj electrodes Fig 1 General view of the monitoring system getemed 12 General view and list of accessories The accessories listed
91. s when they too have been thoroughly prepared for the situation nurses and other medically trained staff Observe in particular the information in those sections of the oper ating instructions that like here address you directly Observe the extensive safety instructions at the beginning of the section Preparing for heart rate and apnea monitoring on page 49 VitaGuard has no therapeutic effect You may have to implement resuscitation measures in the event of an alarm The potential applications of VitaGuard for high risk patients are so many and diverse that we are unable to give any specific instruc tions on procedure in the event of an alarm It is the doctor s task to inform high risk patients and their caregivers in detail on the correct procedure in this case An alarm chart is available from getemed AG when monitoring children This alarm chart presents a sequence of activities that are considered suitable by many medical specialists and pediatricians Do not attempt to use VitaGuard on more than one patient at a time getemed Safety 21 Never modify settings without consulting the responsible doctor Only the doctor knows the correct alarm limits and monitor configu ration for each patient Never leave the patient s room without first making sure that the LEDs for heart and respiration are flashing Make absolutely sure that you can react to an alarm within a few seconds Move away fr
92. s R waves m AvutTo ID This displays the ID number that is automatically assigned every time the ADMIT NEW PATIENT function is executed DATE TIME This displays the date and time of the internal clock which can be set in the SYSTEM menu getemed 84 Information for the doctor and qualified medical staff 9 2 3 INFO MEASUREMENTS HR amp RESP INFO MEASUREMENTS HR amp RESP HR Minute average 120 min displays the various average HR Hourly average 126 fmin HR 6 hour average 126 min heart rate values calculated since yR 12 hour average 126 qd HR Average 119 min the monitor was switched on HR Current deviation 0 These values are lost when the Periodic respiration 0 Yo monitor is switched off Basal impedance 550 Ohm Fig 48 Info Measurements HR amp Resp HR AVERAGE is calculated over of the AVERAGING INTERVAL set in the HEART RATE menu HR CURRENT DEVIATION shows how much the current heart rate deviates from the AVERAGE in percent This DEVIATION is used for triggering deviation alarms when HEART RATE ALARMS has been set to LIMITS amp TRENDS in the HEART RATE Menu This setting is restored as the factory setting when the ADMIT NEw PATIENT function is executed in the SYSTEM menu PERIODIC RESPIRATION displays the time in percent that PERIODIC RESPIRATION has been detected since the monitor was switched on This value is displayed only when the function PERIODIC RESPIRATION Is set
93. s have been used several times giving rise to too high a value of basal impedance When electrodes have become detached or when the electrical resistance between the electrode and skin is too high the respira tion and ECG signals are displayed as a zero line getemed Preparing for heart rate and apnea monitoring 53 When new electrodes have become detached you can reattach these by pressing them gently You must replace electrodes that have become detached more than once or that exhibit too high a resistance between the electrode and skin Further explanations can be found in the section Checking the BASAL IMPEDANCE on page 55 6 4 Determining the optimal electrode configuration The respiration and heart signals are detected using the same elec trodes The optimal electrode configuration involves finding good signal amplitudes for both the respiration and the heart signals simultaneously getemed AG recommends that the responsible doctor determine the optimal electrode configuration In most cases this configuration can be retained for the whole period of monitoring 6 4 1 ECG lead electrode color coding Start with the electrode configuration depicted in Fig 27 see next page First arrange the electrodes on infants as depicted in Fig 27 a this electrode configuration has often proved successful because the abdominal wall of infants clearly moves synchronously with the respiration the electrodes on
94. seseesesss 15 MACAO eese E A E ENE OE EEE 16 VitaGuard modes of operation s sssssessssesssessessesesessssesesersessesersesses 16 Intended use and performance snesssesnecssseneuancssoncayorseecavederonsmbinacespeaesines 17 Limitations on VitaGuard s intended use ou eects 18 2 6 1 Obstructive apneas are not detected ones 18 2 6 2 Limitations of the heart rate and central apnea MOITO Gamer y te E eee rer ener rere ey ee 18 Information for the doctor on these operating instructions 19 T E EEA eee EEE 20 CACO CNS TASKS aae ren E I E E IEE E A 20 Alera y TISKG tO PI UENTS siras EE E 22 Possible external interference to monitoring sssessssessessssessssessesees 22 3 3 1 Installation and environment ss sessessssessessssessesesseesesessesees 22 3 3 2 NOISE risks to monitoring e ssssessssessessssssseesesseseesesesseseseesesses 23 3 3 3 Electrostatic interference s ssessesessessssesseseeseseesesseseeseseeseesess 24 3 3 4 Electromagnetic interference sssssessssessesessesersesseseeseseeseesess 24 Safety with approved accessories only ou eeeeseeeeseseseceeteteeeeeeeeseeeees 25 Mandine paucntCaDiES seriineeri 26 Power supply reliability eee eee es eseseseseeeeeeeeseseneseeeeeeeeseaeaeseeeseeeeeeeaees 26 3 6 1 Battery voltage indicator oe eeeseeeeseseceseseeeeeeeeeeseseeteeeees 28 3 6 2 Interruptions to the power supply ou eee eeeeeeeeseeeteteeeeeeees 28 3 6 3 Using the rechargeable block battery 0 eeeeeeeeeeeees 29 Sa
95. sitive contacts Only the doctor in full knowledge of the information under Connections to the USB and AUX ports on page 81 must decide Never use force when connecting and disconnecting cables Always which devices are connected to the USB and AUX ports 4 2 1 Patient cable for electrodes EA pistia USB AUX ii Fig 12 Electrode socket The patient cable for the electrodes for heart rate and apnea monitor ing is connected to this socket getemed Description 39 4 2 2 Power adapter 9 NA3000 2 USB AUX vn v O me 0 Fig 13 Power adapter socket The external power adapter socket is for connecting the NA 3000 2 exter nal power adapter or the NAK 3000 2 automobile power supply adapter 4 2 3 Sound outlet no socket en NA3000 2 d m on so USB AUX Fig 14 Sound aperture The outlet in the figure is not a socket but a sound hole for the internal system monitor buzzer This outlet emits a pulsating sound when the external power ad apter is disconnected from the monitor and no batteries are inserted The sound outlet is located between the cable sockets so that it cannot be covered by objects such as cushions or curtains getemed 40 Description 4 2 4 USB port USB AUX a wedi AD mon Fig 15 USB port The USB universal serial bus port serves to read out stored data and to modify the VitaGuard settings via a PC 4 2 5 AUX port on ew W B a
96. stic alarm signals acoustic signals for higher priority alarms consist of two acoustic se quences of five tones each Burst 1 Burst 2 ai O ee 1 e d3 4 14 ee lt gt Pulse duration i 155mst5ms Rise and fall time o a7mst3ms OO O 1 and start of pulse 2 2 and start of pulse 3 3 and start of pulse 4 4 and start of pulse 5 1 and start of burst 2 aspe sequence acoustic signals for medium priority alarms consist of three pulse bursts Pulse duration 185 mst 5 ms Rise and fall time 17ms 3ms Time between start of pulse 375 ms 20 ms 1 and start of pulse 2 2 and start of pulse 3 sequence getemed 114 Specifications Characteristics of system monitoring signals pulsating tone of 4 kHz and 1 Hz pulse rate from the sound aperture between the sockets DISD IAW S sercccersscenescenntaracetasnsieoeet LEDs and LCD graphic display with 240 x 360 dots Display refresh rate 1 Hz Expected service life as per DIN EN ISO 18778 ou eee min seven years Inspection and servicing intervals getemed AG prescribes safety checks function checks and servicing every eighteen months The next appoint ment is specified on a label in the bat tery compartment 12 2 Heart rate monitor Heart rate range wee 20 270 min ACCUILACY ceeeecesessseseseseseseeeeteteees 1 for heartbeats of similar morphol ogy averaged over 4 to 16 beats Sensitivity oe eeeeeeeeeteeeeeesee 0 2 mV sin2 signal
97. t To the left of 16 ES the bell the remaining alarm mute time is displayed in seconds This mute time applies only to the current alarm type When a new alarm condition is detected the acoustic alarm is emit ted before the alarm mute time has expired Pressing the lt Esc gt key a second time immediately ends the ALARM MUTE TIME The alarm bell outline indicates that all acoustic alarm signals ry are enabled In the event of an alarm the alarm bell is filled out and flashes r getemed 62 Alarms displays and views during monitoring 7 9 Heart rate and apnea monitoring After the monitor is switched on it may take up to twenty seconds before the first values are displayed 7 9 1 Heart rate alarms The currently set alarm limits are always displayed When the displayed HEART RATE falls below the Lower Limit for longer than the set BRADYCARDIA DELAY or exceeds the UPPER LIMIT for longer than the set TACHYCARDIA DELAY or when the ECG signal is not detected for longer than the set ASYSTOLE DELAY VitaGuard emits an acoustic alarm signal and displays the corre sponding message The violated alarm limit and the alarm LED flash Go immediately to the patient when an alarm is reported and check the patient s condition The alarm is ended automatically when the heart rate returns within the permitted limits Deviation alarms can also be activated in addition to the alarms based on permanently set limits
98. t be set to Off as ex Heart rate min Resp 1min i plained under System Settings 2 H 30 iB T protection On Limited Off on page 3 The possible settings when SETTINGS PROTECTION is set to LIMITED are explained in the section HEART RATE menu alarm settings Settings PROTEC Trend deviation TION LIMITED on page 75 Factory settings are shown in bold type SILENT LOWER LIMIT HEART SILENT UPPER LIMIT HEART BRADYCARDIA DELAY eee TACHYCARDIA DELAY esee getemed Lower limit 80 Upper limit 220 fmin Silent lower limit 30 min Silent upper limit 255 min Bradycardia delay Tachycardia delay Asystole delay RR averaging 8 beats Heart rate Averaging interval 60s Trend deviation 25 Vo 25 0 50 Hz filter On Lead Nr of electrodes I YE RD 3 Pacer detection Off Heart rate alarms Limits only Heart rate Fig 68 Settings in the Heart rate menu 30 35 50 175 180 min Lower limit for the heart rate when the measured value falls below this limit for longer than the set BRADYCARDIA DELAY a silent alarm is stored 100 105 255 min See SILENT LOWER LIMIT 1 2 3 4 5 6 14 15 seconds Delay between when bradycardia is de tected and the corresponding alarm is triggered 1 2 3 4 5 15 23 24 seconds See BRADYCARDIA DELAY but for tachy cardia Information for the doctor and qualified medical staff 99 ASYSTOLE DELAY ese
99. tected 7 6 2 Information signals from the sound aperture between the sockets A pulsating tone is emitted if the external power adapter is discon nected and no batteries are installed 7 7 The visual alarm signals A high priority alarm i e physiological alarm uN causes the alarm LED to flash red Amedium priority alarm i e technical alarm causes the alarm LED to flash yellow N 7 8 Status line displays During monitoring the status line is displayed in all views a Status ok ATI fy Fig 32 The status line displayed in all views getemed Alarms displays and views during monitoring 61 The monitor s text messages appearing on the left are explained in detail in the section Alarm messages meanings and other informa tion on page 63 On the right of the status line are three symbols Power supply The power supply symbol indicates whether the NA3000 2 external power adapter or the automobile power supply Mh adapter is connected When a power adapter is connected ae the symbol appears as illustrated on the right Otherwise the symbol is crossed out Battery voltage indicator The battery voltage indicator depicts the voltage from the batteries When the block battery is being recharged this a symbol is animated i e a filling animation is displayed Alarm indicator When you interrupt an acoustic alarm by pressing the lt Esc gt key the bell symbol is crossed ou
100. the A or V key When a row is highlighted press lt Enter gt to change the corresponding value 8 6 1 HEART RATE display The top half of the display a Status ok gt a presents Heart rate Tmin Resp 1min 220 20 2 1 the status line JH 80 IS S i 2 the current values with E EEE 3 the set alarm limits 3 the current three minute trends that update the last value every two seconds Fig 42 Heart rate display The heart rate trend display presents the heart rate over the last three minutes This display varies with the set age group OTORNEARS 2TO6YEARS gt 6YEARS HEART RATE TREND DISPLAY between between between PER MIN 230 and 50 180 and 50 150 and 45 The bottom half of the display presents the ECG A small vertical bar above the ECG indicates every detected heartbeat Under the ECG you can see the evaluated amplitude of the ECG signal known from VIEW 1 8 6 2 HEART RATE menu alarm settings SETTINGS PROTECTION LIMITED The HEART RATE menu lets you view and if necessary change the current heart rate settings You may have to adapt the default age getemed 76 Alarm and monitor settings group alarm limits to the current patient These settings can be changed only when SETTINGS PROTECTION has been set to LIMITED in the SYSTEM menu Different heart rate alarm limits can be set as the default values for each age group Default LOWER HEART RATE LIMIT MIN 80 UPPER HEART RATE LIMIT MIN
101. the selected alarm limits To store these so called silent alarms activate SILENT ALARM LIMITS in the corresponding monitoring menu When measurements violate the SILENT ALARM LIMITS the current episode is stored without triggering an acoustic or visual alarm For example when the SILENT LOWER LIMIT is set higher than the LOWER LIMIT in the HEART RATE menu silent bradycardia alarms are stored 9 5 2 MANUAL DATA STORAGE Or TRANSMIT DATA The A or V key takes you from View 1 2 or 3 to the MANUAL mon Gata DATA STORAGE Or TRANSMIT DATA menu In addition to the auto matic storage of alarm events you can also store current data manually MANUAL DATA STORAGE stores data for the set PRE and A eE POST ALARM TIMES just like in an alarm situation Fig 64 View Manual data storage The AUX socket is used to trans Manual data storage mit data via a modem The setting SINCE LAST TRANSMISSION transfers only those new epi aa ere sodes stored since the last trans Last 20 episodes fer but no more than twenty The setting LAST 20 EPISODES always transfers the last twenty episodes Fig 65 View Transmit data getemed Information for the doctor and qualified medical staff 95 9 5 3 Summary of stored EVENTS The symbols next to the name of each event appear on the EVENTS display in the columns for each physiological parameter following the time and duration of the event Bradycardia Silent bradycardia
102. to ON in the RESPIRATION menu and when AGE GROUP is set to O TO 2 YEARS Under SYSTEM ADMIT NEW PATIENT BASAL IMPEDANCE displays the value measured between the yellow and the red electrode see Checking the BASAL IMPEDANCE On page 55 getemed Information for the doctor and qualified medical staff 85 9 2 4 INFO SETTINGS HEART RATE This window presents all the sett Settings Heart rate 4 7 i al Lead Nr of electrodes I YE RD 3 ings for heart rate monitoring that Silent lower limit 30 min are not shown in Views 1 to 3 Silent upper limit 255 fmin Bradycardia delay Tachycardia delay Asystole delay RR averaging Averaging interval Trend deyiation a Trend deviation Heart rate alarms 50 Hz filter Fig 49 Info Settings Heart rate 9 2 5 INFO SETTINGS APNEA MONITOR This window presents all the sett Settings Apnea monitor 5 7 tari Silent apnea delay 34s ings for apnea Menihorinig that Periodic respiration No are not shown in VIEWS 1 to 3 Period T1 Apnea 6s Period T Resp 20s Number of periods 3 Min respiration rate 10 min Apnea alarms Fig 50 Info Settings Apnea monitor getemed 86 Information for the doctor and qualified medical staff 9 2 6 INFO MEMORY INTERNET This displays the current MEMORY USED and the total MEMORY SIZE Also displayed is TELEPHONE i e the modem number that the monitor automatically dials for remote data transfer This telephone num
103. uld point out that the code must be treated as confidential that settings should be changed at the doctor s request only and that all changes must be confirmed by the doctor VitaGuard provides the following three settings for SETTINGS PRO TECTION SETTINGS PROTECTION ON deactivates all options to change moni tor settings The display presents only View 1 the INFo display and the SYSTEM menu SETTINGS PROTECTION LIMITED enables access to all views and menus Of all the monitor settings however only the alarm limits can be changed SETTINGS PROTECTION OFF enables all views and menus and allows changes to all monitor settings The factory setting is SETTINGS PROTECTION LIMITED After highlighting the function SETTINGS PROTECTION press the lt En ter gt key to open a submenu This submenu always displays SETTINGS PROTECTION as 00 irre spectively of the current setting Pressing the lt Enter gt key acti vates SETTINGS PROTECTION When you enter a code SETTINGS PROTECTION appears as LIMITED When you enter a different code SETTINGS PROTECTION appears as OFF When the wrong code has been entered three times SETTINGS PRO TECTION cannot be so easily deactivated In this case consult your authorized dealer getemed Alarm and monitor settings 75 8 6 HEART RATE display and menu The gt key takes you from View 1 2 or 3 to the heart rate display From here you can open the menu with
104. with 40 ms width Input impedance gt 10 MQ at 10 Hz 12 3 Apnea monitor Max respiration rate wees 120 breaths min Min respiration rate wees 4 5 or 10 breaths min depending on AGE GROUP setting getemed Specifications 115 Alarm quit wee eeeceseseseteteeeeeees 2 breaths within 6 seconds Sensitivity of respiration amplifier approx 0 2 Q 1000 Q Measuring method impedance pneumography Measuring current frequency 38 kHz Measuring current ou lt 100 pA 12 4 Intervals for calculating average values in the INFO mask Minute value HR 1s Hour value HR ocean 30s Six hour value HR 300s Twelve hour value HR 300s 12 5 Memory Storage medium eee 64 MB compact flash memory card memory extendable on request Nr of episodes wee max 200 episodes of two minutes each TONO serene ai max 72 hours Long term full disclosure max 8 hours 12 6 Ports Ue o T E A T mini USB port getemed 116 Specifications AUX vicccccescscssccsscscsscsesscsssssseeseees modem port RS232 socket for a nurse call system socket for an external alarm unit socket for two analog inputs from 0 to 2 5 V at 1 or 32 Hz 12 7 Miscellaneous Calibrating time after activation essssssssesesesssesesesses lt 605 MPG device Class oo IIb Device protection class Il as per DIN EN 60601 1 Application part ou type CF Ingress protection seses IP 21

Getemed VitaGuard VG-2100 Heart Rate Monitor

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