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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 monitoring

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:

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Содержание VitaGuard VG2100

Страница 1: ...VitaGuard VG2100 Apnea and Heart Rate Monitor Operating instructions...

Страница 2: ......

Страница 3: ...aff 1 General view and list of accessories 2 Intended use 3 Safety 4 Description 5 Steps before and after monitoring 6 Preparing for heart rate and apnea monitoring 7 Alarms displays and views during...

Страница 4: ......

Страница 5: ...regivers tasks 20 3 2 Allergy risks to patients 22 3 3 Possible external interference to monitoring 22 3 3 1 Installation and environment 22 3 3 2 Noise risks to monitoring 23 3 3 3 Electrostatic inte...

Страница 6: ...Diodes 43 4 4 1 Alarm LED 43 4 4 2 Heart and respiration LEDs 43 4 4 3 Power supply and battery LEDs 44 4 5 The display 44 5 Steps before and after monitoring 46 5 1 Summary of steps before monitoring...

Страница 7: ...te and apnea monitoring 62 7 9 1 Heart rate alarms 62 7 9 2 Apnea alarms 62 7 9 3 Technical heart rate and apnea alarms 63 7 10 Alarm messages meanings and other information 63 7 10 1 Order of equal p...

Страница 8: ...w patient 79 9 1 2 Connections to the USB and AUX ports 81 9 1 3 VitaGuard and other medical devices 81 9 2 Info display 82 9 2 1 Last status messages 82 9 2 2 General 83 9 2 3 Measurements HR Resp 84...

Страница 9: ...ettings protection Off 103 10 Algorithms and measuring principles 105 10 1 Alarm condition and report delays 105 10 1 1 Alarm condition delay for the heart rate 105 10 1 3 Alarm condition delay for re...

Страница 10: ...Table of contents...

Страница 11: ...ccessories 11 1 General view and list of accessories The general view shows the monitoring system s most important components Fig 1 General view of the monitoring system External power adapter ECG pat...

Страница 12: ...external power adapter 1 rechargeable block battery 1 device bag 1 operating instructions 1 quick reference Transport case NA3000 2 external power adapter 110V 240V 50 60Hz 7344 1101 NAK3000 2 automo...

Страница 13: ...X 03 cable for connecting an external alarm unit to VitaGuard 7341 5001 AUX 04 cable for connecting VitaGuard to a nurse call system with 4 kV isolation 7341 5011 AUX 06 cable for connecting two exter...

Страница 14: ...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 trac...

Страница 15: ...e ments in Annex I of the Medical Devices Directive 93 42 EWG and that this has been approved by a noti fied body T V Rheinland Product Safety This symbol means that the VitaGuard s ECG socket is a ty...

Страница 16: ...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...

Страница 17: ...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 elect...

Страница 18: ...rt 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 a...

Страница 19: ...ained 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 b...

Страница 20: ...ectly 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 r...

Страница 21: ...ed dealer Stop using VitaGuard after the servicing interval of eighteen months has expired Before the end of this period make an ap pointment with your authorized dealer to check the safety and operab...

Страница 22: ...r 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...

Страница 23: ...elow 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 nob...

Страница 24: ...waves 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 com...

Страница 25: ...systems stipulated 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...

Страница 26: ...the one 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...

Страница 27: ...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 VitaGuard operates with batteries either...

Страница 28: ...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 di...

Страница 29: ...e recycled when its service life 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...

Страница 30: ...sonnel 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 VitaGu...

Страница 31: ...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 explain...

Страница 32: ...ry electronic device VitaGuard and accessories contain metal and plastic parts that must be disposed of in such a way that they do not pollute the environment after their service live For this reason...

Страница 33: ...tion 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 Fig 5 VitaGuard and bag with power and patient...

Страница 34: ...g 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...

Страница 35: ...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 failu...

Страница 36: ...e 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 r...

Страница 37: ...erwise 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 IS...

Страница 38: ...force when connecting and disconnecting cables Always insert and remove the plugs parallel to the sockets to prevent dam age to the sensitive contacts Only the doctor in full knowledge of the informat...

Страница 39: ...2 3 Sound outlet no socket 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...

Страница 40: ...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...

Страница 41: ...ds 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 t...

Страница 42: ...activate 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 p...

Страница 43: ...LED flashes red In the event of a medium priority alarm i e a technical alarm the alarm LED flashes yellow Fig 21 Alarm LED 4 4 2 Heart and respiration LEDs The LED with the heart symbol flashes with...

Страница 44: ...n 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...

Страница 45: ...he 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...

Страница 46: ...y 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...

Страница 47: ...ve 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...

Страница 48: ...d 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...

Страница 49: ...itoring 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 unfavorabl...

Страница 50: ...d are designed for short term applications Using the same electrodes several times can lead to malfunctions when the adhesive surface fails to adhere properly Do not open the electrode s packaging unt...

Страница 51: ...ample lay the patient 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...

Страница 52: ...the socket marked with the heart and lungs symbol Fig 26 Electrode socket 6 3 Technical alarm from the electrode contact monitor The electrode contact monitor reports an alarm when the electrodes have...

Страница 53: ...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 o...

Страница 54: ...nfiguration 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...

Страница 55: ...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...

Страница 56: ...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 impeda...

Страница 57: ...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 in...

Страница 58: ...three exclamation marks Technical alarms have medium priority The text messages of technical alarms end with two exclamation marks 7 4 Physiological and technical alarms VitaGuard generates two types...

Страница 59: ...ical 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 c...

Страница 60: ...il all electrodes are connected and plausible data have been detected 7 6 2 Information signals from the sound aperture between the sockets A pulsating tone is emitted if the external power adapter is...

Страница 61: ...battery voltage indicator depicts the voltage from the batteries When the block battery is being recharged this symbol is animated i e a filling animation is displayed Alarm indicator When you interr...

Страница 62: ...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...

Страница 63: ...cedure 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...

Страница 64: ...d The ECG signal is too small to be detected The monitor cable or electrode is defect 5 Heart rate and apnea A heart rate alarm and an apnea alarm have occurred simultaneously See the messages and inf...

Страница 65: ...ctly calculated for the reasons given under Heart rate too low 11 Heart rate rise detected when activated A heart rate rise is detected in the same manner as a heart rate drop but Trend devia tion is...

Страница 66: ...monitor is defect 14 Internal data error The internal software monitor has detected a data transfer error Switch off the monitor wait for thirty seconds and switch it back on if this message persists...

Страница 67: ...rent heart rate cannot be displayed while it is being calculated The current heart rate is displayed after it has been calculated 37 Internal battery too low The internal battery for alarms during a p...

Страница 68: ...or 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 a...

Страница 69: ...Info display The U or 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 SpO2 Heart rate and Respiration...

Страница 70: ...unction 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 the alarm limits The bottom half of View 3 displays the wavef...

Страница 71: ...ed Press the Enter key A window appears where you can change the old value Use the U and V keys to change the highlighted value Fig 36 System LCD brightness highlighted in the change window Pressing t...

Страница 72: ...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...

Страница 73: ...e 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 pag...

Страница 74: ...esents 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 Setti...

Страница 75: ...rt rate display The heart rate trend display presents the heart rate over the last three minutes This display varies with the set age group 0 to 2 years 2 to 6 years 6 years Heart rate trend display p...

Страница 76: ...the section Changing the ECG lead for signal optimization on page 100 The heart rate s Lower limit can be set from 30 to 180 beats and the heart rate s Upper limit from 100 to 255 each in steps of fi...

Страница 77: ...s This display varies with the set age group 0 to 2 years 2 to 6 years 6 years Respiration rate trend display per min between 0 and 60 between 0 and 60 between 0 and 30 The bottom half of the Respirat...

Страница 78: ...u for viewing and setting alarm limits Apnea delay 8 10 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 exce...

Страница 79: ...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...

Страница 80: ...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 Syste...

Страница 81: ...ce 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 pa...

Страница 82: ...lectrodes 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...

Страница 83: ...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 det...

Страница 84: ...s deviation is used for triggering deviation alarms when Heart rate alarms has been set to Limits trends in the Heart rate menu This setting is restored as the factory setting when the Admit new patie...

Страница 85: ...s window presents all the sett ings for heart rate monitoring that are not shown in Views 1 to 3 Fig 49 Info Settings Heart rate 9 2 5 Info Settings Apnea monitor This window presents all the sett ing...

Страница 86: ...r automatically dials for remote data transfer This telephone number must be loaded by the evaluation software VitaWin and cannot be edited directly in the monitor Here you can also view the details f...

Страница 87: ...e Esc 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 changing the date and time i...

Страница 88: ...is switched on When you select Home Settings protection is On when the device is next switched on When you select Clinic Settings protection is set to the selected value when the device is next switc...

Страница 89: ...to confirm your entry in the Surname menu opens the submenu for setting the age group Here too press the Enter key to confirm your age group settings Fig 58 System Age group Use the Y key to highligh...

Страница 90: ...tion 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...

Страница 91: ...ed 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...

Страница 92: ...e 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 b...

Страница 93: ...ey displays the wave forms recorded with this event 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...

Страница 94: ...in the Heart rate menu silent bradycardia alarms are stored 9 5 2 Manual data storage or Transmit data The U or V key takes you from View 1 2 or 3 to the Manual data storage or Transmit data menu In a...

Страница 95: ...lower than the set Lower limit Silent bradycardia heart rate lower than the set silent Lower limit Tachycardia heart rate higher than the set Upper limit Silent tachycardia heart rate higher than the...

Страница 96: ...of the table on page 97 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 for a maximum...

Страница 97: ...a when more than 256 en tries are stored 9 9 Summary of stored signals and data Data type Sample rate Hz Alarms Long term Trend ECG waveform 256 D D Current heart rate 1 D D D Average heart rate for t...

Страница 98: ...protec tion Limited on page 75 Factory settings are shown in bold type Fig 68 Settings in the Heart rate menu Silent lower limit Heart 30 35 50 175 180 min Lower limit for the heart rate when the mea...

Страница 99: ...nds The average heart rate measured over the set interval yields the reference value for calculating Trend deviation and Trend deviation Trend deviation 5 10 15 20 25 30 35 40 45 50 The current heart...

Страница 100: ...ing pacemaker pulses are not mistakenly processed as R waves explanations can be found under VitaGuard and other medical devices on page 81 Heart rate alarms When Heart rate alarms is set to Limits on...

Страница 101: ...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 th...

Страница 102: ...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 II BK RD 3 Press Esc to return to the Heart rate display and again note the displayed ECG am plitu...

Страница 103: ...protecti on Limited on page 78 Factory settings are shown in bold type 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 wh...

Страница 104: ...ched the data are stored as a silent alarm Min respiration rate 4 5 6 9 10 min VitaGuard discards signals with a lower rate of occurrence NOTE Changing the min respiration rate to 5 min has an effect...

Страница 105: ...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...

Страница 106: ...pedance 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 artifact...

Страница 107: ...he measured signal is called an electrocardiogram ECG The amplitude and the polarity positive or negative of the measured signal depend on both the arrangement of the sensing electrodes and the indivi...

Страница 108: ...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 hill on a map When two...

Страница 109: ...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 monito...

Страница 110: ...rs 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 pr...

Страница 111: ...Evaluating stored data on a PC 111 Fig 72 VitaWin register Events in graph form...

Страница 112: ...R6 AA alkaline Chargeable block battery NiMH 4 8 V 2000 mAh Charging time 6 hours Battery life e g VARTA UNIVERSAL ALKALINE minimum 2 days Keys 6 membrane keys Battery change displayed message Deplete...

Страница 113: ...Time between start of pulse 3 and start of pulse 4 T2 440 ms 20 ms Time between start of pulse 4 and start of pulse 5 T1 215 ms 20 ms Time between start of burst 1 and start of burst 2 T3 2 s 0 1 s Re...

Страница 114: ...vicing 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 monit...

Страница 115: ...current 100 A 12 4 Intervals for calculating average values in the Info mask Minute value HR 1 s Hour value HR 30 s Six hour value HR 300 s Twelve hour value HR 300 s 12 5 Memory Storage medium 64 MB...

Страница 116: ...b Device protection class II as per DIN EN 60601 1 Application part type CF Ingress protection IP 21 Operating temperature 5 40 C Operating humidity 5 95 non condensing Ambient pressure height above s...

Страница 117: ...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 equipme...

Страница 118: ...fications DIN EN 60601 2 49 Medical electrical equipment Part 2 49 Particular requirements for the safety of multifunctional patient monitoring equipment prEN ISO 18778 Infant Monitors Particular requ...

Страница 119: ...ed 37 Fig 11 Overview of VitaGuard connections 38 Fig 12 Electrode socket 38 Fig 13 Power adapter socket 39 Fig 14 Sound aperture 39 Fig 15 USB port 40 Fig 16 AUX port 40 Fig 17 Keys on the top side 4...

Страница 120: ...44 Respiration display respiration graph 77 Fig 45 Respiration menu for viewing and setting alarm limits 78 Fig 46 Info Last status messages 82 Fig 47 Info General 83 Fig 48 Info Measurements HR Resp...

Страница 121: ...memory 96 Fig 67 Detailed information on a highlighted trend episode 96 Fig 68 Settings in the Heart rate menu 98 Fig 69 Heart rate menu Lead Nr of electrodes submenu 101 Fig 70 Settings in the Respi...

Страница 122: ...122 Table of figures...

Страница 123: ......

Страница 124: ...ufacturer getemed Medizin und Informationstechnik AG Oderstr 77 D 14513 Teltow tel 49 0 3328 3942 00 fax 49 0 3328 3942 99 e mail info getemed de internet www getemed de REF 7381 1021 0027H1 LAB Rev B...

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