1. Manuals
  2. Brands
  3. getemed Manuals
  4. Measuring Instruments
  5. VitaGuard VG3100
  6. Operating instructions manual

getemed VitaGuard VG3100 Operating Instructions Manual

Apnea, heart, and spo2 monitor
Hide thumbs
Table of Contents

Advertisement

Quick Links

Download this manual
VitaGuard® VG 3100
Apnea, heart, and SpO
monitor
2
Operating instructions

Advertisement

Table of Contents
loading
Need help?

Need help?

Do you have a question about the VitaGuard VG3100 and is the answer not in the manual?

Questions and answers

Related Manuals for getemed VitaGuard VG3100

Summary of Contents for getemed VitaGuard VG3100

  • Page 1 VitaGuard® VG 3100 Apnea, heart, and SpO monitor Operating instructions...
  • Page 3 Who should read which sections in these oper- ating instructions? The sections 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.

  • Page 5: Table Of Contents

    Table of contents Table of contents General view and list of accessories ....... 0011 Intended use ................0014 Label on the back of the device0 ............0014 Symbols and warnings0 ................0015 Indications0 ....................0016 2.3.1 and pulse rate monitor0..........0016 2.3.2 Heart rate and apnea monitor0...
  • Page 6 Table of contents Description ................0035 Power supply0 .................... 0036 4.1.1 Power failure with inserted batteries0....... 0037 4.1.2 Power failure without batteries0 ......... 0037 4.1.3 Replacing batteries0 ..............0038 4.1.4 Using the automobile power supply adapter0 ....0039 VitaGuard® connections0 ...............
  • Page 7 Table of contents Why the pulse rate is not displayed0........... 0055 Attaching the SpO sensor to an infant’s foot0 ....... 0055 Attaching the SpO sensor to an adult’s finger0......0056 6.10 Connecting the SpO sensor and patient cable0 ......0058 6.11 Connecting the SpO patient cable to...
  • Page 8 Table of contents 8.10.2 Heart and pulse rate alarms0..........0076 8.10.3 Apnea alarms0 ................0077 8.10.4 Technical heart rate and apnea alarms0 ......0077 8.11 Alarm messages – meanings and other information0 ....0077 8.11.1 Order of equal-priority alarm conditions0 ......
  • Page 9 Table of contents Information for the doctor and qualified medical staff .. 0099 10.1 Safety instructions0 .................. 0099 10.1.1 Preparing for a new patient0..........0099 10.1.2 Connections to the USB and AUX ports0 ......0101 10.1.3 VitaGuard® and other medical devices0 ......
  • Page 10 Table of contents 10.8 storage of operating and device data0 ......0119 Protocol 10.9 Summary of stored signals and data0 ..........0120 10.10 Settings in the SpO menu (Settings protection ....0121 Off)0 10.11 Settings in the Heart rate menu (Settings protection ...
  • Page 11 General view and list of accessories 1 General view and list of accessories The general view shows the monitoring system’s most important components. VitaGuard® monitor sensor patient External cable power adapter electrodes patient cable Fig. 1 General view of the monitoring system...
  • Page 12 The accessories listed 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. Product ................Article no. / REF VitaGuard®...
  • Page 13 General view and list of accessories Masimo LNOP® Adt SpO sensor (PU = 20 pcs) (for one patient use only, adult > 30 kg) .......... 70253 Masimo LNOP® DCI reusable sensor (> 30 kg) ....... 70254 Masimo LNOP® DCIP reusable sensor (10–50 kg) ......70264 Other models are available in addition to the SpO sensors listed here.

  • Page 14: Intended Use

    VitaGuard®. The specific “Information for the doctor and qualified medical staff” can be found on page 99. 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.

  • Page 15: Symbols And Warnings

    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 (TÜV Rheinland Product Safety).
  • Page 16 Intended use Indications VitaGuard® can be used to monitor patients with, for example, the following symptoms or treatment: unstable respiration oxygen therapy life-threatening cardiac dysrhythmia conspicuous sleep laboratory findings facial and/ or cervical and thoracic dysmorphia distinct gastro-esophageal reflux ataxia 2.3.1 SpO and pulse rate monitor The SpO...

  • Page 17: Vitaguard® Modes Of Operation0

    Intended use 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. VitaGuard® modes of operation Depending on the risk group and the latest diagnosis, VitaGuard® allows the treating doctor to combine three monitoring parameters: monitoring heart or pulse rate monitoring...

  • Page 18: Intended Use And Performance0

    Intended use “Settings in the Respiration menu (Settings protection Off)” on page 129, “Combining apnea alarms with heart rate and SpO alarms” on page 130, “Table of operating modes” on page 131. In the event of electrode allergies it may prove convenient, after consultation with the treating doctor, to dispense with the elec- trodes entirely for a time and to operate the device as a pulse oxi- meter.

  • Page 19: Limitations On Vitaguard®'S Intended Use0

    Intended use VitaGuard® features an impedance monitor that triggers a technical alarm 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. When the signal registered by the SpO sensor is inadequate for the reliable measurement of values, a message appears on the display.
  • Page 20 Intended use 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 apneas can be detected only when the patient is sleeping or is lying still, does not move, and is not being moved.

  • Page 21: Information For The Doctor On These Operating Instructions0

    Intended use 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...

  • Page 22: Safety

    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.
  • Page 23 Safety Do not attempt to use VitaGuard® on more than one patient at a time. 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.

  • Page 24: Allergy Risks To Patients0

    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’...

  • Page 25: Installation And Environment0

    Safety 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 69, that you can hear alarms and where you can hear them. Think also of the activities that cause noises, for example showering or vacuuming.

  • Page 26: Electrostatic Interference0

    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®.

  • Page 27: Safety With Approved Accessories Only0

    Electrodes, SpO sensors, cables, and power adapters can be ordered from your authorized dealer or directly from getemed AG. The tele- phone number of your authorized dealer was given to you during...
  • Page 28 Safety your training on how to operate the device, or it is found on a label your authorized 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.
  • Page 29 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. Do not use the external power adapter in sockets that can be switched off or dimmed.

  • Page 30: Battery Voltage Indicator0

    VitaGuard® operates with batteries: either non-rechargeable batter- 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...

  • Page 31: Interruptions To The Power Supply0

    Safety 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.

  • Page 32: Safety With Proper Maintenance Only0

    VitaGuard® for monitoring. Every eighteen months 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.

  • Page 33: Checking And Cleaning The Battery Terminals0

    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.

  • Page 34: Disposing Of Non-Rechargeable Batteries, The Device, And

    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 and sensors that have been in direct contact with the patient.

  • Page 35: Description

    Description 4 Description We recommend placing VitaGuard® in the bag provided. This bag protects the monitor and can be hung from a site where it cannot fall. Fig. 5 VitaGuard® and bag with power and patient cables...

  • Page 36: Power Supply0

    Power supply 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 29. Fig. 6 Power adapter socket VitaGuard®...

  • Page 37: Power Failure With Inserted Batteries0

    VitaGuard® must not be used for 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-...

  • Page 38: Replacing Batteries0

    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. Fig. 8 Opening the battery compartment Make sure that the + sym- bols on the batteries and in the compartment match...

  • Page 39: Using The Automobile Power Supply Adapter0

    Description You will feel a slight pressure from the ter- minal spring connec- tions when inserting the block battery. 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®...

  • Page 40: Vitaguard® Connections0

    Description VitaGuard® connections 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. Never use force when connecting and disconnecting cables. Always insert and remove the plugs parallel to the sockets to prevent dam- age to the sensitive contacts.

  • Page 41: Power Adapter

    Description 4.2.2 Patient cable for electrodes Fig. 13 Electrode socket The patient cable for the electrodes for heart rate and apnea monitor- ing is connected to this socket. 4.2.3 Power adapter Fig. 14 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.

  • Page 42: Usb Port0

    Description 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. 4.2.5 USB port Fig.

  • Page 43: Membrane Key Panel0

    Description 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 69, check each time you switch on the device that an alarm signal is really transferred and the alarm reported. Measure the time it takes for an alarm to be reported and the time needed to reach the patient.

  • Page 44: Direction Keys0

    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 the menu structure. Fig. 19 Direction keys 4.3.2 <Enter> key The <Enter> key switches VitaGuard® on and off. The <Enter>...

  • Page 45: Color Leds (Light Emitting Diodes)0

    Description The <Esc> key cancels unsaved changes to the monitor settings or moves back to the next-higher menu. 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.

  • Page 46: Power Supply And Battery Leds0

    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 lights up, VitaGuard® is being powered from the supply network or an Mains supply active...
  • Page 47 Description Fig. 25 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 For all vital functions, as here SpO [2], the current value for each vital function [2a] is shown in large digits.

  • Page 48: Steps Before And After Monitoring

    Steps before 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”...

  • Page 49: Switching On0

    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.

  • Page 50: Switching Off

    Steps before and after monitoring Switching off Always switch off VitaGuard® in the manner described here. 1 Press the <Enter> key and keep this pressed: the message Press Esc key appears. 2 Briefly press the <Esc> key, still keeping the <Enter> key pressed, and then release both keys.
  • Page 51 Preparing for SpO monitoring 6 Preparing for SpO monitoring The information in this section refers primarily to the use of adhe- sive strip sensors. Also available, however, are SpO sensors that can be disinfected and reused (permanent sensors) for brief examina- tions and for monitoring patients with allergies.

  • Page 52: Preparing For Spo Monitoring Monitoring0

    Preparing for SpO monitoring Connect the SpO sensors only to the corresponding patient cable and this only to the corresponding socket on VitaGuard®. Do not use adhesive strip SpO sensors on patients exhibiting aller- gic reactions to adhesive strips or similar. Securing sensors incorrectly, e.g.

  • Page 53: Spo 2 Sensor Adapted To The Patient's Size And Weight0

    The sensor LNOP® Pdt can be used on children weighing between 10 and 50 kg. The sensor LNOP® Adt is suitable for patients over 30 kg. Information on other sensors can be obtained from getemed AG or your authorized dealer. Choosing the sensor site Always choose a site that is intact, has good blood flow, and covers completely the receiver window.

  • Page 54: Repositioning Or Replacing The Sensor0

    Preparing for SpO monitoring On infants with thick or swollen feet, the big toe is often better than the whole foot. Clean and dry the attachment site. Choose a site where the sensor and patient cable can least restrict the patient’s freedom of movement. Repositioning or replacing the sensor Sensors used for a long time do not adhere as well as new ones.
  • Page 55 Preparing for SpO monitoring the blood exhibits appreciable quantities of dysfunctional hemo- globin, e.g. carboxyhemoglobin or methemoglobin, blood dyes have been used such as indocyanine green, methylene blue, or other substances that contain coloring agents and there- fore affect the blood color. Why the pulse rate is not displayed Clarify with the doctor whether one of the following situations may have arisen:...

  • Page 56: Attaching The Spo 2 Sensor To An Adult's Finger0

    Preparing for SpO monitoring On infants weighing between 3 and 10 kg with thick or swollen feet, the LNOP® Neo sensor can be secured to the big toe. In this case, the following information for the sensor’s receiver does not refer to the sole of the foot, but to the underside of the big toe.
  • Page 57 Preparing for SpO monitoring The LNOP® Adt sensor designed for adults weighing over 30 kg is identified by the label illustrated on the right. Fig. 30 Label on the LNOP® Adt SpO sensor The preferred attachment sites on adults are the ring and middle fingers of the non-dominant hand.

  • Page 58: Connecting The Spo

    Preparing for SpO monitoring 4 When the transmitter and receiver are correctly attached, they should be exactly opposite each other (Fig. 34). Check and if necessary correct the sensor’s position. The receiver window must be completely covered by the tissue. Fig.

  • Page 59: Disconnecting The Spo Sensor From The Patient Cable0

    Preparing for SpO monitoring 6.12 Disconnecting the SpO sensor from the patient cable Use the thumb and index finger of one hand to carefully press the two buttons on the side of the patient cable’s socket (Fig. 37). Carefully pull the end of the sensor to withdraw it.
  • Page 60 Preparing for SpO monitoring When sensors have been in use for a short time only, you can refresh the adhesive surfaces with a cotton swab saturated with a 70% isopropanol solution. Leave the sensor to dry thoroughly in air before reattaching it. A sensor can be secured with an adhesive strip on less sensitive patients.

  • Page 61: Preparing For Heart Rate And Apnea Monitoring

    Preparing for heart rate and apnea monitoring 7 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 –...
  • Page 62 Admit new patient, the Apnea alarms are reactivated together with the other factory settings. Use only those electrodes that getemed AG or an authorized dealer 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.
  • Page 63 Preparing for heart rate and apnea monitoring 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.

  • Page 64: Connecting Electrodes, The Patient Cable, And Vitaguard®0

    Preparing for heart rate and apnea monitoring Connecting electrodes, the patient cable, and VitaGuard® Insert the electrode’s plug into the ECG patient cable’s distributor. Note the color coding of the electrodes and the distributor’s sockets. Fig. 39 Color-coded sockets on the ECG patient cable’s distributor Insert the plug from the ECG patient cable into the socket marked with the heart and lungs symbol.
  • Page 65 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.
  • Page 66 Preparing for heart rate and apnea monitoring black yellow yellow black Fig. 41 Recommended electrode configuration If the electrode configuration depicted in Fig. 41 does not yield a yellow good signal quality, you can also try the alternative electrode configura- tion depicted in Fig.

  • Page 67: Checking The Basal Impedance0

    Preparing for heart rate and apnea monitoring CAUTION When Amplitude: poor is displayed, the values for the monitored heart rate and apnea may be imprecise. Amplitude ......Meaning poor .......... the signal is not or only sporadically detected medium ........the signal is detected, but interference, e.g.
  • Page 68 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 Ý. If not, wait for about fifteen minutes.

  • Page 69: Alarm Test

    Alarms, displays, and views during monitoring 8 Alarms, displays, and views during monitoring Immediately call the emergency services when a patient remains unconscious after being shaken or addressed. 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.

  • Page 70: Alarms, Displays, And Views During Monitoring 0

    Alarms, displays, and views during monitoring acknowledged approximate heart rates for various age groups and stress situations. Age group Heart rate / min Sleep Rest Stress (e.g. fever) Newborns 80–160 100–180 max 220 1 week to 3 months 80–200 100–220 max 220 3 months to 2 years 70–120...
  • Page 71 Alarms, displays, and views during monitoring A technical alarm is generated when monitoring is no longer reliable, e.g. when electrodes have become loose. 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.

  • Page 72: Acoustic Information Signals0

    Alarms, displays, and views during monitoring The interval between each tone packet is two seconds. Also, there is a slightly longer interval between the third and fourth tone of each sequence. Fig. 45 Characteristics of the high-priority acoustic alarm signal Medium-priority messages emit a sequence of three tones which is repeated every 5.2 seconds.

  • Page 73: The Visual Alarm Signals0

    Alarms, displays, and views during monitoring The visual alarm signals A high-priority alarm, i. e. physiological alarm, causes the alarm LED to flash red. A medium-priority alarm, i. e. technical alarm, causes the alarm LED to flash yellow. Status line displays During monitoring the status line is displayed in all views.
  • Page 74 Alarms, displays, and views during monitoring When a new alarm condition is detected, the acoustic alarm is emit- ted before the alarm mute time has expired. Pressing the <Esc> key a second time immediately ends the Alarm mute time. The alarm bell outline indicates that all acoustic alarm signals are enabled.
  • Page 75 Alarms, displays, and views during monitoring In addition to the alarms based on permanently set limits, deviation alarms can also be activated as explained in the section “Combining apnea alarms with heart rate and SpO alarms” on page 130. 8.9.2 Technical SpO alarms The section “Table of technical alarm messages”...
  • Page 76 Alarms, displays, and views during monitoring When the SpO sensor is set as the source for monitoring the heart rate, the word Pulse rate appears as the heading in various views. In addition – when this option has been activated – Views 1 and 2 display the current heart rate determined via the ECG elec- trodes below the abbreviation HR.
  • Page 77 Alarms, displays, and views during monitoring 8.10.3 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.
  • Page 78 Alarms, displays, and views during monitoring 8.11.1 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 messages. This is of importance to the doctor only. 8.11.2 Table of physiological alarm messages Physiological alarms are reported with high priority.
  • Page 79 Alarms, displays, and views during monitoring Message Meaning Information Heart rate The calculated heart rate When there is no tachycardia: too high!!! exceeds the set Upper T wave peaks are interpreted as R limit for longer than the waves so that the calculated heart rate set Tachycardia delay.
  • Page 80 Alarms, displays, and views during monitoring Message Meaning Information Multiple An SpO alarm, a heart See the messages and information for alarms!!! rate alarm, and an apnea “Heart rate too high/ too low”, “SpO alarm have occurred too low”, and “Apnea detected”. simultaneously.
  • Page 81 Alarms, displays, and views during monitoring Message Meaning Information The calculated SpO When SpO is not too high: high!!! exceeds the set Upper The sensor is incorrectly attached, e.g. limit for longer than the it is too loose or too tight, the trans- set Hyperoxia alarm mitter and receiver are too far apart, or they are not exactly opposite each other.
  • Page 82 Alarms, displays, and views during monitoring Message Meaning Cause or elimination Check The measured voltage Check that the stipulated power 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.
  • Page 83 Alarms, displays, and views during monitoring Message Meaning Cause or elimination : Check The SpO module reports Connect the SpO cable. cable!! that the SpO cable is not Replace the SpO cable, if this message connected. persists. The SpO module reports Replace the SpO sensor.
  • Page 84 Alarms, displays, and views during monitoring 8.12 Table of information messages Message Cause Meaning 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. Heart and pulse The heart rate deter- Check the ECG electrodes and the...
  • Page 85 Alarm and monitor settings 9 Alarm and 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.
  • Page 86 Alarm and monitor settings 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 The keys let you access more detailed information and enter menus for changing monitor settings.

  • Page 87: Changing The Settings

    Alarm and monitor settings 9.3.1 View 2 – Large data presentation and waveforms View 2 displays in large digits the current values for the monitored vital functions and, on the right in smaller digits, the set alarm limits. Also, each section on the left presents a waveform of the monitored vital function.
  • Page 88 Alarm and monitor settings key takes you to the menus. The first entry in the list is high- lighted. Use the key to high- light the setting LCD brightness (“Changing multiple-component settings” is explained on page 109 for the doctor and qualified medical staff).

  • Page 89: System Menu - General Settings

    Alarm and monitor settings System menu – general settings NOTE You can familiarize your- self with the menus without changing values. Simply press the <Esc> key to exit each menu and submenu without saving changes. Fig. 52 System menu – general settings 9.5.1 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.
  • Page 90 71 on in the section “Differentiating physiologi- cal and technical alarm signals”. As an alternative, you can set the alarm tone characteristic (gtm) as familiar from other getemed devices. The factory setting is Medium. Fig. 54 System\ submenu “Alarm tone pitch” 9.5.6 System\ RS232 format...
  • Page 91 Alarm and monitor settings 9.5.7 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.
  • Page 92 Alarm and monitor settings display and menu key takes you from View 1, 2, or 3 to the SpO display. Here you can open the menu with the key. Having highlighted a row, press the <Enter> key to change its contents. 9.6.1 SpO view The top half of the display presents:...

  • Page 93: Spo

    Alarm and monitor settings the sensor is correctly attached, an adequately strong signal is detected for the arterial blood flow, the patient does not move or is not moved too vigorously. The calculated percentage value for Perfusion (PI) can vary between 0 and 20%.
  • Page 94 Alarm and monitor settings Upper limit ......50, 51 ... 88 ... 99, 100 % Upper alarm limit for the measured ar- terial oxygen saturation; an alarm is re- ported when the measured value ex- ceeds this limit for longer than the set Hyperoxia alarm delay monitor ......

  • Page 95: Heart Rate Display

    Alarm and monitor settings 9.7.1 Heart rate display The top half of the display presents: 1 the status line 2 the current values with the set alarm limits 3 the current three-minute trends that update the last value every two seconds Fig.
  • Page 96 Alarm and monitor settings Default > 6 years 0 to 2 years 2 to 6 years Lower heart rate limit [/min] Upper heart rate limit [/min] 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”...

  • Page 97: Respiration Display

    Alarm and monitor settings 9.8.1 Respiration display The top half of the display presents: the status line 2 the current values with the set alarm limits 3 the current three-minute trends that update the last value every two sec- onds Fig.
  • Page 98 Alarm and monitor settings 9.8.2 Respiration menu – alarm settings (Settings protection Limited) These settings can be changed only when Settings protection is set to Limited in the System menu. Factory settings are shown in bold type. Fig. 61 Respiration menu for viewing and setting alarm limits Apnea delay ......

  • Page 99: Safety Instructions

    14 and “Safety” on page 22 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®.
  • Page 100 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.
  • Page 101 Information for the doctor and qualified medical staff 101 10.1.2 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.
  • Page 102 Information for the doctor and qualified medical staff VitaGuard® correctly interprets pacer pulses with amplitudes greater than 5 mV, so VitaGuard® can be used on patients with pace makers. 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.

  • Page 103: Info Display

    Information for the doctor and qualified medical staff 103 10.2 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 The current page number and the total number of pages are dis- played in the top right.
  • Page 104 Information for the doctor and qualified medical staff 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”...
  • Page 105 Information for the doctor and qualified medical staff 105 : Average is calculated over the Averaging interval set in the menu. The Current deviation shows how much the current deviates from the Average in percent. This deviation is used for reporting deviation alarms when SpO Alarms in the SpO menu has...
  • Page 106 Information for the doctor and qualified medical staff 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 &...
  • Page 107 Information for the doctor and qualified medical staff 107 10.2.7 Info\ Settings: Heart rate This window presents all the sett- ings for heart rate monitoring that are not shown in Views 1 to 3. Fig. 68 Info\ Settings: Heart rate 10.2.8 Info\ Settings: Apnea monitor This window presents all the sett- ings for apnea monitoring that...
  • Page 108 Information for the doctor and qualified medical staff Here you can also view the details for transferring data as an e-mail attachment. Fig. 70 Info\ Memory 10.2.10 Info\ Versions Info\ Versions displays the software and hardware version numbers. The software and hardware from Masimo for monitoring SpO also displayed, followed by the monitor’s serial number (SN).
  • Page 109 Information for the doctor and qualified medical staff 109 10.3 Settings in the System menu (Settings protection Off) When Settings protection is switched off in the System menu, the doctor can configure Vita- Guard® for specific monitoring requirements. Use the direction keys to high- light an entry.
  • Page 110 Information for the doctor and qualified medical staff After changing a value, pressing the <Enter> key a second time causes a prompt to appear with Accept: No highlighted. Press the key to highlight Accept: Yes. Confirming the prompt Accept: Yes with the <Enter>...
  • Page 111 Information for the doctor and qualified medical staff 111 The submenus for ID, First name, and Surname are displayed one after the other. Use the keys to position the cursor. Use the keys to enter letters and numbers. Press the <Enter> key after you have entered your data in each submenu.

  • Page 112: System\ Date/ Time

    Information for the doctor and qualified medical staff the Lower limit and the Upper limit in the Heart rate menu The table lists the factory settings for each age group: 0 to 2 years 2 to 6 years > 6 years Min.

  • Page 113: Data Storage Functions

    Information for the doctor and qualified medical staff 113 10.3.7 System\ Language The menu option Language is marked with a flag symbol 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.

  • Page 114: Event Storage

    Information for the doctor and qualified medical staff The memory contents of VitaGuard® are also retained when the power adapter or batteries fail. VitaGuard® features the following data storage functions: Event storage (automatic storage of Alarms and Silent Alarms or Manual storage) Trend storage (automatically for max 72 hours) Interval storage (set in the System menu)
  • Page 115 Information for the doctor and qualified medical staff 115 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.
  • Page 116 Information for the doctor and qualified medical staff 10.5.1 Silent alarm limits The monitor also lets you store signal sequences that are important for evaluating the selected alarm limits. To store these so-called “silent alarms”, activate Silent Alarm limits in the corresponding monitoring menu.
  • Page 117 Information for the doctor and qualified medical staff 117 10.5.3 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......

  • Page 118: Trend Storage

    Information for the doctor and qualified medical staff Manual M ......manual storage (see “Manual data storage or Transmit data” on page 116) Interval I ......Interval storage (see “System\ Interval recording” on page 113) Apnea X ......one or more successive apneas Silent apnea (X) ....
  • Page 119 Information for the doctor and qualified medical staff 119 10.7 Long term storage over eight hours Independent of alarm events, all signals are stored continuously for a maximum total time of eight hours for subsequent evaluation on a PC (full disclosure). After this period, the oldest data are overwritten. 10.8 Protocol storage of operating and device data The Protocol memory registers e.g.
  • Page 120 Information for the doctor and qualified medical staff 10.9 Summary of stored signals and data Data type Sample rate [Hz] Alarms Long term Trend ECG waveform Current heart rate Average heart rate for trend deviation Average heart rate over 1 min Average heart rate over 1 h Average heart rate over 6 h Average heart rate over 12 h...

  • Page 121: Settings In The Spo 2 Menu

    Information for the doctor and qualified medical staff 121 10.10 Settings in the SpO menu (Settings protection Off) For these settings, Settings protection must be set to Off as explained under “System\ Settings protection On, Limited, Off” on page 91. The possible settings when Settings protection is set to Limited are explained in the section “SpO...
  • Page 122 Information for the doctor and qualified medical staff suitable for detecting sudden, short de- saturations. When the Average time is set to 4 or 6, FastSAT™ is automatically activated, even when it has been deactivated in this submenu. Average time ......4, 6, 8, 10, 12 , 14, 16 seconds Here you can view or set the period dur- ing which the SpO module uses the...

  • Page 123: Settings In The Heart Rate Menu

    Information for the doctor and qualified medical staff 123 Trend deviation (-) ....-3, -4 …-10 … -24, -25% The current SpO is compared every sec- ond with the average SpO measured over the averaging interval. When the current value falls below the average by more than the value set here and when alarms is set to Limits &...
  • Page 124 Information for the doctor and qualified medical staff For this setting, Settings protec- tion must be set to Off as ex- plained under “System\ Settings protection On, Limited, Off” on page 91. The possible settings when Settings protection is set to Limited are explained in the section “Heart rate menu –...
  • Page 125 Information for the doctor and qualified medical staff 125 RR averaging ......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.
  • Page 126 Information for the doctor and qualified medical staff Lead, Nr. of electrodes ..I YE-RD, 3 (yellow–red, 3 electrodes) II BK-RD, 3 (black–red, 3 electrodes) III BK-YE, 3 (black–yellow, 3 electrodes) I 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).

  • Page 127: Changing The Ecg Lead For Signal Optimization0

    Information for the doctor and qualified medical staff 127 10.12 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 I YE-RD, 3 (yellow–red, 3 electrodes).
  • Page 128 Information for the doctor and qualified medical staff I 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 Good for at least one of these leads, further optimization is not necessary.

  • Page 129: Settings In The Respiration Menu

    Information for the doctor and qualified medical staff 129 10.13 Settings in the Respiration menu (Settings protection Off) For these settings, Settings protection must be set to Off as ex- plained under “System\ Settings protection On, Limited, Off” on page 91. The possible set- tings when Settings protec- tion is set to Limited are explained in the section...

  • Page 130: Combining Apnea Alarms With Heart Rate And Spo

    Information for the doctor and qualified medical staff Period T2 (Resp.) ....4, 6, 8 ... 20 ... 28, 30 seconds When resumed respiration lasts longer than T2, periodicity is no longer as- sumed. Number of periods ....2, 3 ... 5, 6 periods When the set number of periodic cycles has been reached, the data are stored as a silent alarm.
  • Page 131 Information for the doctor and qualified medical staff 131 – for at least 8 s for the age group 0 to 2 years, – for at least 12 s for the age group 2 to 6 years, – for at least 15 s for the age group > 6 years. During this observation period the currently measured values for heart rate and oxygen saturation are compared with the average values measured over the set Averaging interval before the event.
  • Page 132 Information for the doctor and qualified medical staff Menu settings Monitored vital parameters Operating modes Apnea SpO 2 monitor SpO 2 Pulse Heart Apnea Monitored vital alarms rate rate parameters Respira- monitor = Heart rate tion = OFF Respira- monitor = Heart rate and apnea tion = without combined...

  • Page 133: Algorithms And Measuring Principles

    Algorithms and measuring principles 11 Algorithms and measuring principles Knowledge of the following calculation bases is essential if VitaGuard® is to be properly configured. 11.1 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-...

  • Page 134: Alarm Condition Delay For Respiration0

    Algorithms and measuring principles 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. The longest alarm condition delay for the heart rate therefore occurs when it is at its lowest.
  • Page 135 Algorithms and measuring principles for bradycardia: ..set Bradycardia delay + 2 s (max) for tachycardia: ..set Tachycardia delay + 2 s (max) for asystole: ..... set Asystole delay + 2 s (max) for hypoxia: ..... set Hypoxia alarm delay + 2 s (max) für hyperoxia: ..
  • Page 136 Algorithms and measuring principles diodes (LEDs) serve as light sources and a photodiode as the receiver attached opposite. Conventional pulse oximetry assumes that all pulsations in the light absorption are caused by the arterial pulse cycle. For this to work, the venous blood in the sensor area must flow completely and therefore constantly through the capillary bed.
  • Page 137 Algorithms and measuring principles The SET® software goes through all the possible values for R (corre- sponding to SpO between 1 and 100%) and calculates the associated interference components. An adaptive noise canceller, or ANC, then takes this value N’(R) to calculate the amplitude of the noise energy, or the so-called output power of the ANC.

  • Page 138: Measuring Principle For The Heart Rate Monitor0

    Algorithms and measuring principles mum, the cut-off limit is 0.02%; when set to Standard, the limit varies from 0.5 to 0.02% depending on the signal quality. Further information about FastSat™, APOD™ (adaptive probe off detection), perfusion index, and signal IQ can be found in the white papers at www.masimo.com.

  • Page 139: Measuring Principle For The Apnea Monitor0

    Algorithms and measuring principles The adhesive quality and the composition of the gel applied to the electrodes have an additional important effect on ECG measure- ments. 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 rate can be meas- ured only when the amplitude of the measured ECG signal itself is large enough to be detected by the monitor.
  • Page 140 Algorithms and measuring principles 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.

  • Page 141: Evaluating Stored Data On A Pc

    Evaluating stored data on a PC 12 Evaluating stored data on a PC getemed AG has developed the Windows®-based software VitaWin® for evaluating the recorded monitoring data. This software is pro- vided only to doctors and authorized dealers who are or supply VitaGuard®...
  • Page 142 Evaluating stored data on a PC Fig. 93 VitaWin®\ register “Events in graph form”...

  • Page 143: Specifications

    Specifications 13 Specifications 13.1 General Weight ........approx. 650 g with non-rechargeable batteries approx. 700 g with rechargeable block battery Dimensions ......13.5 x 20.3 x 4.5 cm Non-rechargeable batteries 4 x 1.5 V (type LR6, AA), alkaline Chargeable block battery ... NiMH/4.8 V/2000 mAh Charging time ......
  • Page 144 Specifications Characteristics of acoustic alarm signals ..acoustic signals for higher-priority alarms consist of two acoustic se- quences of five tones each: 155 ms ± 5 ms Pulse duration 17 ms ± 3 ms Rise and fall time 215 ms ± 20 ms Time between start of pulse 1 and start of pulse 2 215 ms ±...

  • Page 145: Spo

    Expected service life (as per DIN EN ISO 18778) ....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.

  • Page 146: Heart Rate Monitor0

    Specifications Pulse rate resolution .... 1/min Heat emission ......max 50 mW (at the LNOP® sensor) Accuracy with weak perfusion (i.e. pulse amplitude > 0.02 % and ± 2 digits ansmission > 5 %) ....SpO pulse rate ± 3 digits * The specified tolerances correspond to a standard deviation of ±...
  • Page 147 Specifications Measuring current frequency 38 kHz Measuring current ....< 100 µA 13.5 Intervals for calculating average values in the Info mask Minute values for SpO , HR, PR ..... 1 s Hour values for SpO , HR, PR ..... 30 s Six-hour values for SpO , HR, PR .....
  • Page 148 Specifications AUX ..........– 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 13.8 Miscellaneous German “Hilfsmittel- nummer”...

  • Page 149: Selection Of Applied Standards0

    Specifications 13.9 Selection of applied standards IEC 601-1 ......... Medical electrical equipment – Part 1: General requirements for safety, incl. A 13 IEC 60601-1-1 ......Medical electrical equipment – Part 1-1: General requirements for safety – Colla- teral standard: Safety requirements for medical electrical systems IEC 60601-1-2 ......
  • Page 150 Specifications DIN EN 60601-2-49 ....Medical electrical equipment – Part 2-49: Particular requirements for the safety of multifunctional patient monitoring equipment DIN EN 865 ......Pulse oximeters – Particular requirements prEN ISO 18778 ...... Infant Monitors – Particular requirements...

  • Page 151: Table Of Figures

    Table of figures 14 Table of figures Fig. 1 General view of the monitoring system0 ........0011 Fig. 2 Device label on the bottom of the device0........0014 Fig. 3 Battery voltage indicator0..............0030 Fig. 4 Rechargeable block battery0 ............. 0031 Fig.
  • Page 152 Table of figures Fig. 33 Aligning the sensor and receiver0 ........... 0057 Fig. 34 Correctly attached LNOP® Adt sensor0 .......... 0058 Fig. 35 Connecting the patient cable and sensor contact0....0058 Fig. 36 socket0 ..................0058 Fig. 37 Disconnecting the sensor from the patient cable0 ....
  • Page 153 Table of figures Fig. 68 Info\ Settings: Heart rate0 ..............0107 Fig. 69 Info\ Settings: Apnea monitor0 ............0107 Fig. 70 Info\ Memory0 ..................0108 Fig. 71 Info\ Versions0..................0108 Fig. 72 Separately protected settings in the System menu0 ....0109 Fig.
  • Page 154 Table of figures...
  • Page 156 Distributed by: Manufacturer: getemed Medizin- und Informationstechnik AG Oderstr. 77 D-14513 Teltow tel. +49 (0)3328 3942-00 +49 (0)3328 3942-99 e-mail info@getemed.de internet www.getemed.de...

Table of Contents