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Summary of Contents for VitaGuard VG310

Page 1: ...VitaGuard VG310 Pulse oximeter Operating instructions...

Page 2: ......

Page 3: ...dical staff 1 General view and list of accessories 2 Intended use 3 Safety 4 Description 5 Steps before and after monitoring 6 Preparing for SpO2 monitoring 7 Alarms displays and views during monitori...

Page 4: ......

Page 5: ...3 3 3 Electrostatic interference 21 3 3 4 Electromagnetic interference 21 3 4 Safety with approved accessories only 23 3 5 Handling patient cables 23 3 6 Power supply reliability 24 3 6 1 Battery volt...

Page 6: ...s after monitoring 45 6 Preparing for SpO2 monitoring 46 6 1 Safety instructions for SpO2 monitoring 46 6 2 Operation of SpO2 sensors 47 6 3 SpO2 sensor adapted to the patient s size and weight 48 6 4...

Page 7: ...larms 60 7 9 1 Physiological SpO2 alarms 60 7 9 2 Technical SpO2 alarms 61 7 10 Pulse rate alarms 61 7 11 Alarm messages meanings and other information 62 7 11 1 Order of equal priority alarm conditio...

Page 8: ...1 3 VitaGuard and other medical devices 80 9 1 4 Safety instructions for the doctor SpO2 monitor 81 9 2 Info display 81 9 2 1 Last status messages 82 9 2 2 General 82 9 2 3 Measurements SpO2 83 9 2 4...

Page 9: ...menu Settings protection Off 97 9 11 Settings in the Pulse rate menu Settings protection Off 99 10 Algorithms and measuring principles 102 10 1 Alarm condition and report delays 102 10 2 Alarm report...

Page 10: ...Table of contents...

Page 11: ...eneral view of the monitoring system 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 dea...

Page 12: ...utomobile power supply adapter 7344 1201 Rechargeable block battery 7344 2201 Masimo SpO2 patient cable PC08 2 44 m 70257 Masimo LNOP NeoPt SpO2 sensor PU 20 pcs for one patient use only infants 1 kg...

Page 13: ...001 AUX 01 RS232 cable for connecting VitaGuard to a serial PC port 7341 2002 AUX 02 modem cable for connecting a modem to VitaGuard 7341 3001 AUX 03 cable for connecting an external alarm unit to Vit...

Page 14: ...act and the resuscitation of babies and infants require particu lar know how that the treating doctor should communicate to the caregivers 2 1 Label on the back of the device The device label serves a...

Page 15: ...tected against the effects of defibrillation The factory symbol shows the year of manufacture Like every electronic device VitaGuard and accessories contain metal and plastic parts that must be dispos...

Page 16: ...tic effect VitaGuard emits an acoustic and visual alarm when the measured pulse rate and or oxygen saturation values violate the set alarm limits for a period set by the operator The alarm limits can...

Page 17: ...terial The monitor operates properly only when the SpO2 sensor is correctly attached 2 6 Information for the doctor on these operating instructions In full knowledge of these operating instructions th...

Page 18: ...serve the extensive safety instructions at the beginning of the section Preparing for SpO2 monitoring on page 46 VitaGuard has no therapeutic effect You may have to implement resuscitation measures in...

Page 19: ...ter 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 operability of your device Test the aco...

Page 20: ...Think before you raise the volume of your television or stereo Also the VitaGuard s alarm outlet should not be obstructed by any objects that absorb sound Never place VitaGuard or the power adapter su...

Page 21: ...m VitaGuard Information on the alarm signal types and volumes can be found in Alarms displays and views during monitoring on page 56 The alarm pitch is set as explained in the section System menu gene...

Page 22: ...ent 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 displayed When y...

Page 23: ...r 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 The modem used to transfe...

Page 24: ...e 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 Do n...

Page 25: ...s use single rechargeable batteries 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 To prevent leakin...

Page 26: ...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...

Page 27: ...pensation charging 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 dam...

Page 28: ...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...

Page 29: ...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 consum...

Page 30: ...ription 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...

Page 31: ...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...

Page 32: ...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...

Page 33: ...sym bols on the batteries and in the compartment match before inserting non re chargeable batteries Fig 9 Opened battery compartment and polarity Observe the following instructions when you use the r...

Page 34: ...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...

Page 35: ...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 Only the doctor in full knowledg...

Page 36: ...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...

Page 37: ...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...

Page 38: ...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...

Page 39: ...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...

Page 40: ...of a higher priority alarm i e a physiological alarm the alarm 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...

Page 41: ...lock 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 b...

Page 42: ...t 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 both vital functions as here SpO2 2 the current value for each vit...

Page 43: ...dapter to connect VitaGuard to the supply network do not switch on yet Attach the SpO2 sensor to the patient Connect the SpO2 patient cable to VitaGuard Connect the SpO2 sensor to the patient cable Sw...

Page 44: ...p 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 fully operable If the alarm buzzer does not emit the...

Page 45: ...ds 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 Detach the SpO2 sensor carefully removin...

Page 46: ...the SpO2 patient cable to VitaGuard 6 1 Safety instructions for SpO2 monitoring For hygiene reasons check that there is no damage to the sensor s packaging before opening it Use adhesive strip sensors...

Page 47: ...lowed 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...

Page 48: ...arterial blood oxygen satura tion SpO2 of infants weighing up to 10 kg Sensors of the type LNOP NeoPt are available for monitoring premature infants with sensitive skin The sensor LNOP Pdt can be used...

Page 49: ...perly secured Check the sensor s position and if necessary move the sensor to a different site Always replace a sensor when the displayed pulse rate and the displayed percentage level of oxygen satura...

Page 50: ...light Inflated blood pressure cuff on the same limb as the sensor Arterial occlusion near the sensor Low blood pressure serious vasoconstriction anemia hypother mia cardiac arrest or shock 6 8 Attachi...

Page 51: ...ntacts point away from the patient Align the receiver along the fourth toe and press it against the sole of the foot Fig 26 Fig 26 Positioning the sensor 2 Align the transmitter window along the top o...

Page 52: ...ment sites the big or middle toe can be used 1 Open the packaging and remove the sensor Hold the sensor with the printed beige side downwards and bend it back to draw off the rear side Align the sen s...

Page 53: ...n the top and the two Masimo symbols on the blade and patient cable are opposite each other Insert the contact blade into the patient cable until it engages Fig 34 Pull carefully on the contact blade...

Page 54: ...index finger carefully press the two levers in the patient cable s monitor plug and carefully pull out the plug Fig 37 Two levers for securing and releasing the patient cable plug 6 14 Reusing and ref...

Page 55: ...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 Ve...

Page 56: ...ent cable 7 2 Pulse rate values based on age groups Bear in mind that the Pulse rate drops considerably with increasing age The doctor must check and if necessary adapt the alarm limits for each patie...

Page 57: ...arms have medium priority The text messages of technical alarms end with two exclamation marks 7 4 Physiological and technical alarms VitaGuard generates two types of alarms physiological and techni c...

Page 58: ...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...

Page 59: ...discon nected and no batteries are installed 7 7 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 c...

Page 60: ...symbol is crossed out To the left of 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 ac...

Page 61: ...t an alarm has occurred The SpO2 Upper limit is deactivated when it is set to 100 factory setting We recommend setting an upper limit when the patient is undergoing oxygen therapy 7 9 2 Technical SpO2...

Page 62: ...n the permitted limits Deviation alarms can also be activated in addition to the alarms based on permanently set limits 7 11 Alarm messages meanings and other information The tables in this section li...

Page 63: ...ected when activated The current pulse rate has fallen below the value based on the set Averaging interval by more than the percent age deviation value set under Trend deviation When there is no pulse...

Page 64: ...for the reasons given under SpO2 too high 13 7 11 3 Table of technical alarm messages Message Meaning Cause or elimination No Check power adapter The measured voltage from the power adapter is less t...

Page 65: ...pO2 cable Replace the SpO2 cable if this message persists 26 SpO2 Defective sensor The SpO2 module reports that the SpO2 sensor is defect Replace the SpO2 sensor 27 SpO2 Hardware fault The SpO2 module...

Page 66: ...been calculated 37 Internal battery too low The internal battery for alarms during a power failure is depleted The monitor is defect i e the internal battery needs to be replaced by a technician 39 Sp...

Page 67: ...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...

Page 68: ...s on the Info display The U or V key takes you from View 1 or 2 to the menu Manual data storage or Transmit data This is explained in the corre sponding section on page 93 The SpO2 and Pulse rate disp...

Page 69: ...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 Enter key to change it When you do not want t...

Page 70: ...o appear with Accept No highlighted Press the Y key to highlight Accept Yes Fig 44 System accept change to LCD brightness highlighted Confirming the prompt Accept Yes with the Enter key displays the c...

Page 71: ...he LCD brightness from 0 to 100 in steps of 5 When 0 the display s 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...

Page 72: ...m submenu Alarm tone pitch 8 5 6 System RS232 format This submenu lets you assign the format for online data output from the AUX serial port Fig 48 System RS232 format 8 5 7 System Settings protection...

Page 73: ...nction Settings protection press the En ter key to open a submenu This submenu always displays Settings protection as 00 irre spectively of the current setting Pressing the Enter key acti vates Settin...

Page 74: ...n the monitor is switched on it can take up to twenty seconds before the first values are displayed Bear in mind that the plethysmogram is NOT proportional to the pulse volume A regular plethysmogram...

Page 75: ...w and change the current SpO2 alarm settings Changes are permitted only when Settings protection is set to Limited in the System menu Factory settings are shown in bold type Fig 50 SpO2 menu for viewi...

Page 76: ...e the last value every two seconds Fig 51 Pulse rate display The pulse rate trend display presents the pulse rate over the last three minutes This display varies with the set age group 0 to 2 years 2...

Page 77: ...Lower limit can be set from 30 to 180 beats and the pulse rate s Upper limit from 100 to 255 each in steps of five beats per minute Factory settings are shown in bold type Fig 52 Pulse rate menu for v...

Page 78: ...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...

Page 79: ...87 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 at a future date and as appropriate arrange appoin...

Page 80: ...as a defibrillator the monitoring results may be invalid for a short time In addition defibrillation can damage the cables Check the monitoring system after defibrillation Bear in mind that an extern...

Page 81: ...c balloon pump can distort these values Circulatory centralization i e when the organism contracts the vessels to reduce the flow of blood to the extremities can suppress or otherwise distort the moni...

Page 82: ...ery This displays the state of the Internal battery permanently installed in VitaGuard Fig 54 Info General Patient name Patient ID The patient s name and ID are displayed when VitaWin has trans ferred...

Page 83: ...surements SpO2 Info Measurements SpO2 displays various average values for SpO2 calculated since the monitor was switched on These values are lost when the monitor is switched off Fig 55 Info Measureme...

Page 84: ...se values are lost when the monitor is switched off Fig 56 Info Measurements Pulse rate PR Average is calculated over the Averaging interval set in the Pulse rate menu The Current deviation shows how...

Page 85: ...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 number must be loaded by...

Page 86: ...n configure Vita Guard for specific monitoring requirements Use the direction keys to high light an entry When you want to change the entry press the Enter key Pressing the Esc key discards any change...

Page 87: ...anged value in the list To exit the menu press the Esc 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 retai...

Page 88: ...ys to position the cursor Use the U and V keys to enter letters and numbers Press the Enter key after you have entered your data in each submenu These inputs are optional and can be skipped by pressin...

Page 89: ...n 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...

Page 90: ...ctivate 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 scanne...

Page 91: ...term and Protocol storage can be evaluated on a PC only The Summary of stored signals and data on page 96 presents the signals and sample rates for the respective memory The currently utilized memory...

Page 92: ...with initial detailed infor mation on this event Highlight ing Waveforms and pressing the Enter key displays the wave forms recorded with this event Fig 69 Detailed information on a highlighted event...

Page 93: ...in the Pulse 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 or 2 to the Manual data storage or Transmit data menu In ad...

Page 94: ...en saturation higher than the set Upper limit Silent SpO2 high measurement higher than the set silent alarm limit SpO2 drop when activated Bradycardia pulse rate lower than the set Lower limit Silent...

Page 95: ...of the table on page 96 Fig 75 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...

Page 96: ...ample rate Hz Alarms Long term Trend Current SpO2 1 D D D Average SpO2 for trend deviations 1 D D D Average SpO2 over 1 min 0 2 D D D Average SpO2 over 1 h 0 2 D D D Average SpO2 over 6 h 0 2 D D D Av...

Page 97: ...menu Sensitivity The Maximum setting is intended for patients with weak blood flow but its higher sensitivity can hinder the correct detection of a loose SpO2 sensor The Minimum setting is intended f...

Page 98: ...s limit for longer than the set Hypoxia alarm de lay a silent alarm is stored Silent upper limit SpO2 50 51 99 100 As Silent lower limit SpO2 but with the Hyperoxia alarm delay Hypoxia alarm delay 1 2...

Page 99: ...e reported when the measured values violate the set alarm limits AND when they deviate from the average SpO2 measured over the set interval 9 11 Settings in the Pulse rate menu Settings protection Off...

Page 100: ...hycardia Averaging interval 10 20 60 110 120 seconds The average pulse rate measured over the set interval yields the reference value for calculating Trend deviation and Trend deviation Trend deviatio...

Page 101: ...aff 101 When Pulse rate alarms is set to Lim its 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...

Page 102: ...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...

Page 103: ...or the SpO2 monitor The pulse oximeter with Masimo SET SET Signal Extraction Tech nology is based on the following three principles 1 Oxyhemoglobin oxygenated hemoglobin and deoxyhemoglobin unoxygenat...

Page 104: ...ls with volunteers who underwent temporary induced hypoxia During these trials a conventional pulse oximeter was used for the measurements at the same time arterial blood was extracted and examined fo...

Page 105: ...ys cor responds to the arterial oxygen saturation In Fig 78 the right peak cor responds to an SpO2 of 97 The DST calculation is repeated every two seconds on the latest raw data over the preceding fou...

Page 106: ...ff 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 I...

Page 107: ...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 contex...

Page 108: ...108 Evaluating stored data on a PC Fig 79 VitaWin register Events in graph form...

Page 109: ...LR6 AA alkaline Chargeable block battery NiMH 4 8 V 2000 mAh Charging time 6 hours Battery life e g VARTA UNIVERSAL ALKALINE min 8 hours Keys 6 membrane keys Battery change displayed message Depleted...

Page 110: ...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...

Page 111: ...ing 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 SpO2 and pulse rate...

Page 112: ...ithin these tolerances the pulse rate and SpO2 can be determined for 68 of the population 12 3 Intervals for calculating average values in the Info mask Minute values for SpO2 PR 1 s Hour values for S...

Page 113: ...nummer 21 24 02 5005 Calibrating time after activation 60 s MPG device class IIb Device protection class II as per DIN EN 60601 1 Type of application part BF Ingress protection IP 21 Operating temper...

Page 114: ...t Part 1 4 General requirements for safety Col lateral standard Programmable electri cal medical systems IEC 62A 422 CDV 2003 Medical electrical equipment Part 1 6 General requirements for safety Col...

Page 115: ...y inserted 34 Fig 11 Overview of VitaGuard connections 35 Fig 12 SpO2 socket 35 Fig 13 Power adapter socket 36 Fig 14 Sound aperture 36 Fig 15 USB port 37 Fig 16 AUX port 37 Fig 17 Keys on the top sid...

Page 116: ...Fig 46 System submenu Signal beep tone 71 Fig 47 System submenu Alarm tone pitch 72 Fig 48 System RS232 format 72 Fig 49 SpO2 view plethysmogram perfusion index and signal IQ 74 Fig 50 SpO2 menu for v...

Page 117: ...ew Manual data storage 93 Fig 73 View Transmit data 93 Fig 74 List of the episodes stored in the trend memory 95 Fig 75 Detailed information on a highlighted trend episode 95 Fig 76 Settings in the Sp...

Page 118: ...emed 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 3021 0027H1 LAB Rev A VitaGuard VG...

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