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- Frank`s Hospital Workshop

1. INTERNAL BATTERY a Internal battery Very good This displays the state of the NOES Patient info INTERNAL BATTERY permanently First name Rudolf Mustermann installed in VitaGuard 111i g Oto 4 years Pacer detection Off Auto ID e Date 4 Mar 2005 Time Fig 63 Info General getemed 104 Information for the doctor and qualified medical staff m PATIENT NAME PATIENT ID The patient s name and ID are displayed when VitaWin has trans ferred these from a PC to VitaGuard or when they have been keyed in as explained in the section SYsTEM ADMIT NEW PATIENT restoring factory settings on page 110 AGE This displays the age group that has been set as explained in the section SYSTEM ADMIT NEW PATIENT restoring factory settings on page 110 PACER DETECTION When the patient has a pacemaker set PACER DETECTION in the HEART RATE menu to ON this prevents the monitor from processing stimu lating pacemaker pulses as R waves m AvutTo ID This displays the ID number that is automatically assigned every time the ADMIT NEW PATIENT function is executed DATE TIME This displays the date and time of the internal clock which can be set in the SYSTEM menu 10 2 3 INFO MEASUREMENTS SPO INFO MEASUREMENTS SPO Measurements Spo 3 10 SpO Minute average 98 Yo displays various average values SpO2 Hourly We Ona for SPO gt calculated since the spO 6 hour average 98 o 2 SpO
2. 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 SpO2 and pulse rate monitor with the attached accessories is suitable for the permanent non invasive monitoring of arterial blood oxygen saturation SpO gt and of the pulse rate as measured with the SpO gt sensor The functional blood oxygen saturation displayed as SpO gt is determined exclusively from the measurements of oxygen ated and deoxygenated hemoglobin The SpO gt and pulse rate monitor is suitable for adult pediatric and infant patients in mobile or stationary indoor and outdoor applica tions including patients with weak blood flow and those in hospitals and other institutions 2 3 2 Heart rate and apnea monitor The heart rate and apnea monitor is suitable for adult pediatric and infant patients at home or in rooms used for medical purposes getemed Intended use 17 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 WVitaGuard modes of operation Depending on the risk group and the latest diagnosis VitaGuard allows the treating doctor to combine three monitoring parameters SpO z monitoring heart or pulse rate monitoring ap
3. getemed Information for the doctor and qualified medical staff 121 10 10 Settings in the SPO menu SETTINGS PROTECTION OFF For these settings SETTINGS Status ok nee bap Heart rate min Resp min PROTECTION must be set to OFF as GAR Bif 19 explained under SYSTEM SETTINGS 88 80 PROTECTION ON LIMITED OFF on Lower limit 3S o oe T Upper limit 100 page 91 The possible settings SpO2 Monitor On Lie oe sensitivity standar when SETTINGS PROTECTION is set Factcat Off to LIMITED are explained in the spO average time SS Haan Silent lower limit 50 section SPO menu alarm Silent upper limit 100 settings Settings PROTECTION LIMITED on page 93 Hypoxia alarm delay 10s Hyperoxia alarm delay 10s Averaging interval 60s Trend deviation 5 SpO alarms Limits only Factory settings are shown in bold type Fig 87 Settings in the SpO2 menu SENSITIVITY v ceseeseceseeeteteeeeee The MAXIMUM setting is intended for patients with weak blood flow but its higher sensitivity can hinder the correct detection of a loose SpO gt sensor The MINIMUM setting is intended for patients with good blood flow This set ting utilizes the APOD adaptive probe off detection algorithm from Masimo Inc a method that can correctly detect a loose sensor in almost all situations On the other hand patients with weak blood flow can trigger technical alarms more often In most cases
4. 12 hour average 98 monitor was switched on SpO Average 98 SpO Current deviation 0 o These values are lost when the monitor is switched off Fig 64 Info Measurements SpO getemed Information for the doctor and qualified medical staff 105 SPO gt AVERAGE is calculated over the AVERAGING INTERVAL Set in the SPO gt menu The CURRENT DEVIATION shows how much the current SpO gt deviates from the AVERAGE in percent This deviation is used for reporting deviation alarms when SPO gt ALARMs in the SPOz menu has been set to LIMITS amp TRENDS 10 2 4 INFO MEASUREMENTS PULSE RATE INFO MEASUREMENTS PULSE RATE Measurements Pulse rate 4 10 PR Minute average 120 min displays the various average PR Hourly average 80 min pulse rate values calculated since PR 56 hour average 79 min l l PR 12 hour average 79 fmin the monitor was switched on PR Average 120 fmin PR Current deviation 0 p These values are lost when the monitor is switched off Fig 65 Info Measurements Pulse rate PR AVERAGE is calculated over the AVERAGING INTERVAL set in the HEART RATE menu The CURRENT DEVIATION shows how much the current pulse rate deviates from the AVERAGE in percent 10 2 5 INFO MEASUREMENTS HR amp RESP INFO MEASUREMENTS HR amp RESP Measurements HR amp Resp 5 10 HR Minute average 97 fmin displays the various average HR Hourly average 88 min heart rate values calculated since
5. Also when an alarm has automatically ended because the vital functions have restabilized by themselves the alarm LED and the violated alarm limit continue to flash until you press the lt Esc gt key The alarm LED however flashes slower than during an alarm getemed Description 45 The lt Esc gt key cancels unsaved changes to the monitor settings or moves back to the next higher menu 4 4 Color LEDs Light Emitting Diodes When VitaGuard is switched on all LEDs light up for a short time so that you can see they work properly During this time the alarm LED first lights up red and then yellow 44 1 Alarm LED Inthe event of a higher priority alarm i e a physiological alarm the alarm LED flashes red Inthe event of a medium priority alarm i e a technical alarm the alarm LED flashes yellow Fig 22 Alarm LED 4 4 2 Heart and respiration LEDs The LED with the heart symbol flashes with every heartbeat of the patient In other words this LED flashes as fast as the heart beats The LED with the lungs symbol lights up with every detected breath of the patient when the patient does not move and is not moved In other words this LED flashes as fast as the patient breathes Fig 23 Heart and respiration LEDs These two flashing green LEDs show you even in complete darkness that monitoring is activated getemed 46 Description Also the SySTEM menu lets you switch on and off an acoustic si
6. Safety information when monitoring heart rate and apnea Connecting electrodes the patient cable and VitaGuard Technical alarm from the electrode contact monitor Determining the optimal electrode configuration ECG lead electrode color coding Optimizing the heart and respiration signals signal amplitudes in View 1 Checking the BASAL IMPEDANCE 7 1 Safety information when monitoring heart rate and apnea Observe the following points before monitoring with VitaGuard CAUTION Interference signals can prevent a heart rate alarm from being reported when under certain unfavorable conditions the monitor misinterprets these interference signals as heart signals Interference signals can originate from the power supply or electri cal apparatus in the monitor s environment Observe the instruc tions under Electromagnetic interference on page 26 The doctor can deactivate the APNEA ALARMS as described in the section Settings in the RESPIRATION MENU Settings PROTECTION OFF on page 129 The APNEA ALARMS are then no longer activated and OFF is displayed instead of the respiration rate When a new age getemed 62 Preparing for heart rate and apnea monitoring group is selected under ADMIT NEW PATIENT the APNEA ALARMS are reactivated together with the other factory settings has delivered or approved Other electrodes can in particular when monitoring apnea cause malfunctions and in addition cause
7. Trend deviation TION LIMITED on page 95 Factory settings are shown in bold type SILENT LOWER LIMIT HEART SILENT UPPER LIMIT HEART BRADYCARDIA DELAY eee TACHYCARDIA DELAY ee ASYSTOLE DELAY cccccseeceeeseees getemed Upper limit 220 fmin Silent lower limit 30 min Silent upper limit 255 min Bradycardia delay Tachycardia delay Asystole delay 4s RR averaging 8 beats Averaging interval Trend deviation 50 Hz filter On Lead Nr of electrodes I YE RD 3 Pacer detection Off Heart rate alarms Limits only Heart rate Fig 88 Settings in the Heart rate Pulse rate menu 30 35 50 175 180 min Lower limit for the heart rate when the measured value falls below this limit for longer than the set BRADYCARDIA DELAY a silent alarm is stored 100 105 255 min See SILENT LOWER LIMIT 1 2 3 4 5 6 14 15 seconds Delay between when bradycardia is de tected and the corresponding alarm is triggered 1 2 3 4 5 15 23 24 seconds See BRADYCARDIA DELAY but for tachy Cardia 1 2 3 4 5 14 15 seconds See BRADYCARDIA DELAY but for asystole Information for the doctor and qualified medical staff 125 RR AVERAGING ccccsescesesceeeees AVERAGING INTERVAL 00 TREND DEVIATION wo TREND DEVIATION gt wu 50 HZ FILTER 2 4 6 8 14 16 beats Number of heartbeats used to calculate the heart rate the displayed heart rate
8. 6 14 7 1 7 2 7 3 74 7 5 8 1 8 2 8 3 8 4 8 5 8 6 8 8 8 8 9 8 10 Table of contents Why the pulse rate is not displayed on ee eseseeteteeeeseeeseneeteteees 55 Attaching the SpO sensor to an infant s foot oe eee 55 Attaching the SpO sensor to an adult s finger s sssessessessesssees 56 Connecting the SpO sensor and patient cable oo 58 Connecting the SpO patient cable to VitaGuard oe 58 Disconnecting the SpO sensor from the patient cable 59 Disconnecting the SpO patient cable from VitaGuard 59 Reusing and refastening SPO gt Sensors oo eeeeeeseseseseseteeeteeeeeeseneeeee 59 Preparing for heart rate and apnea monitoring 61 Safety information when monitoring heart rate and apnea 61 Connecting electrodes the patient cable and VitaGuard 64 Technical alarm from the electrode contact monitor uu 64 Determining the optimal electrode configuration oe 65 7 4 1 ECG lead electrode Color coding oo eeeeeeeseseseseeteteeeeeeeesees 65 7 4 2 Optimizing the heart and respiration signals signal amplitudes IN VIEW ab sctsssauseus cssescocomsdese croeessusdere drsccesonsente 66 Checking the BASAL IMPEDANCE seecccccnuscsrececsnnnten nas ancnaance 67 Alarms displays and views during monitoring 69 RATON OSE E E E E E E E 69 HEART RATE values based on age groupS s ssesssssssesssseesessssesseseesesees 69 Alarm message priorities in the status line
9. and transmission gt 5 uses SpO gt 2 digits pulse rate 3 digits The specified tolerances correspond to a standard deviation of 1 This means that within these tolerances the pulse rate and SpO gt can be determined for 68 of the population 13 3 Heart rate monitor Heart rate range oe 20 270 min ACCAC conreen 1 for heartbeats of similar morphol ogy averaged over 4 to 16 beats SeEnSitIVILY saccesceceeseesesegeescesecentest 0 2 mV sin2 signal with 40 ms width Input impedance eee gt 10 MQ at 10 Hz 13 4 Apnea monitor Max respiration rate wee 120 breaths min Min respiration rate oes 4 5 or 10 breaths min depending on AGE GROUP setting ALAM QUIT eeeeeeseeteeeeseeteees 2 breaths within 6 seconds Sensitivity of respiration amplifier approx 0 2 Q 1000 Measuring method impedance pneumography getemed Specifications 147 Measuring current frequency 38 kHz Measuring current ou lt 100 pA 13 5 Intervals for calculating average values in the INFO mask Minute values for SOO 2 HR PR on eeeeeeeees 1s Hour values for SDO2 HR PR ues 30s Six hour values for SOO2 HR PR ween 300s Twelve hour values for SpO2 HR PR ween 300s 13 6 Memory Storage Medium eee 64 MB compact flash memory card memory extendable on request Nr of episodes wee max 200 episodes of two minutes each TEDO scccesscoiesesesstetacsestcoeocreesacesws max 72 hour
10. cable or electrode is defect The set LOWER LIMIT is too high Heart rate The current heart rate When there is no heart rate drop 11 drop falls below the value The heart rate and or the average detected based on the set AVERAG heart rate is incorrectly calculated for when ING INTERVAL by more the reasons given under Heart rate activated than the percentage too low deviation value set under TREND DEVIATION Heart rate A heart rate rise is When there is no heart rate rise 12 rise detected in the same The heart rate and or its average is detected manner as a heart rate incorrectly calculated for the reasons when drop but TREND DEVIA given under Heart rate too high activated TION is used instead getemed 80 Alarms displays and views during monitoring Message _ Meaning Information No Multiple An SpO alarm a heart See the messages and information for 1 alarms rate alarm and an apnea Heart rate too high too low SpO alarm have occurred too low and Apnea detected simultaneously Pulse rate A pulse rate alarm and an See the messages and the information 3 and apnea alarm have for Pulse rate too high too low and apnea occurred simultaneously Apnea detected Pulse rate A pulse rate alarm and an See the messages and information for 2 and SpO SpO alarm have occurred Pulse rate too high too low and SpO simulta
11. ronment When necessary set SETTINGS PROTECTION to LIMITED When necessary train caregivers in the necessary resuscitation measures getemed Information for the doctor and qualified medical staff 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 A device must comply with the regulations under DIN EN 60601 1 for medical devices or under DIN EN 60950 for communication tech nology devices before it is connected to the USB or AUX ports In addition the leakage current from the VitaGuard must be meas ured as stipulated in the standard DIN EN 60601 1 1 This leakage current must not exceed 100 pA Only qualified medical device technicians can check whether the leakage current conforms to the standards When several devices are connected to each other the individual leakage currents can add up and may pose a risk to the patient Do not connect printers cameras scanners or other devices 10 1 3 VitaGuard and other medical devices When VitaGuard is to operate at the same time as a defibrillator the monitoring results may be invalid for a short time In addition defibrillation can damage the cables Check the monitoring system afte
12. sequence acoustic signals for medium priority alarms consist of three pulse bursts Pulse duration 185 mst5ms Rise and fall time 17ms 3ms Time between start of pulse 375 ms 20 ms 1 and start of pulse 2 2 and start of pulse 3 sequence getemed Specifications 145 Characteristics of system monitoring signals pulsating tone of 4 kHz and 1 Hz pulse rate from the sound aperture between the sockets Displays veasestcecctencacesterentestare LEDs and LCD graphic display with 240 x 360 dots Display refresh rate uu 1 Hz Expected service life as per DIN EN ISO 18778 ue 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 13 2 SpO monitor SpO gt display range sses 1 100 Pulse rate range ou 25 240 min Perfusion index oo eee 0 02 20 SpO gt z accuracy calibrated range for all age groups oes when SpO gt gt 70 3 digits when patient moving or still when SpO gt lt 70 unspecified Pulse rate accuracy for all age groups ones 3 min when patient still 5 min when patient moving SpO gt resolution oo 1 getemed 146 Specifications Pulse rate resolution 1 min Heat emission wwe max 50 mW at the LNOP sensor Accuracy with weak perfusion i e pulse amplitude gt 0 02
13. sssessssessesessessssessesees 70 Physiological and technical alarms oe esesesesseseeeeeeecececeeeeeeeseaeeees 70 Differentiating physiological and technical alarm signals 71 ACOUSTIC IAI Orman Signals copsececscnsoucts ceesguerscseneerccenoanere reencaccucseen 72 8 6 1 Information signals from the alarm unit next to TIVO SAY ccpeseceececcaescesccresnet aca E ane 72 8 6 2 Information signals from the sound aperture DETWECIT TIC SOCKEL arrano a A 72 The visual alarm signals s ssssessessssesssssssesssseesesssseesessesesssseeseseeseeseseesesses 73 KUENE AIS PIAVE soe E E E E E 73 SP MONORA ee E EA EE E 74 8 9 1 Physiological SpO alarmMS ssssssssessssessesessessesessesseseesesessessess 74 8 9 2 Technical SOO Alaris oi eecceeseseeseseteeeeseseeeeeeeeseteteeeesees 75 Heart rate ANd apnea monitoring ou eeeeeseteeeteeeeseseeeeeteeeeeeeenenees 75 8 10 1 Differentiating between heart and pulse rate 75 getemed Table of contents 8 11 8 12 Jd 9 2 9 3 9 4 9 5 9 6 9 9 8 8 10 2 Heart and pulse rate alarms ou cceseeseeeseeeeeeteeeeeeeeeeee SOS POCA IAS arao EE O E A EE 8 10 4 Technical heart rate and apnea alarMs ou eee Alarm messages meanings and other information s s s 8 11 1 Order of equal priority alarm conditions eee 8 11 2 Table of physiological alarm messages ou 8 11 3 Table of technical alarm messages ou eeeeeseeteeeteteeees Table of information MESSAGES ou eeececesesese
14. user configurations can be found on page 91 Information for the doctor and qualified medical staff is found on page 99 getemed 22 Safety 3 Safety The doctor decides whether the caregivers are able to use Vita Guard for monitoring and whether they can implement appropri ate measures in the event of an alarm 3 1 Caregivers tasks With caregivers we mean those persons who are responsible during monitoring for the monitored patient s well being for example parents or other members of the family babysitters when they too have been thoroughly prepared for the situation nurses and other medically trained staff Observe in particular the information in those sections of the oper ating instructions that like here address you directly Observe the extensive safety instructions at the beginning of the section Preparing for SpO monitoring on page 51 Observe the extensive safety instructions at the beginning of the section Preparing for heart rate and apnea monitoring on page 61 VitaGuard has no therapeutic effect You may have to implement resuscitation measures in the event of an alarm The potential applications of VitaGuard for high risk patients are so many and diverse that we are unable to give any specific instruc tions on procedure in the event of an alarm It is the doctor s task to inform high risk patients and their caregivers in detail on the correc
15. 1 SpO and pulse rate monitor ssssssssssesessssessssessrsesessesessesess 16 2 3 2 Heart rate and apnea monitor sssssssesessesessessssesessesessesess 16 VitaGuard modes of operation sssessssessessssessesessesssserseseesesseseesesees 17 Intended use and performance eeeesesssseseseseeeeseseseeeeseseseeeeseseeeeeeees 18 Limitations on VitaGuard s intended use s ssessesssssssessesseesesseseese 19 2 6 1 Obstructive apneas are not detected oes 19 2 6 2 Limitations of the heart rate and central apnea monitor 20 2 6 3 Limitations of the SpO and pulse rate monitor 20 Information for the doctor on these operating instructions 21 BUF EE 22 CAFE CIVENS TASKS sssrin nE E cree een aetna nets nemo 22 Allergy risks to patients oe ccesessseseseseseseseseseseeeeeeseseseaeeeeseeteeseaeeees 24 Possible external interference to monitoring oe eee 24 3 3 1 Installation and environment oo eeseteteeeteeeeeeeteeee 25 33 2 NOISE TISKS to MONTONE cecexeapsgeuscaeesceseteerecosmssroganeacareu seen 25 333 Electrostatic interferenc ccpccseteainperene ann sda auecsacepeee 26 3 3 4 Electromagnetic interference ssssssesieisroiseissiisreississsssssesr 26 Safety with approved accessories only oe eeesesssseseseceseseeeeeeeeeeeenees 27 Handling patient cables oe eeeseseseteeseseseseseeeeeteeeeseseaeeeeeteeeeseneeees 28 Power supply reliability eee eeeseseseseeeeeeeeseaeeeseeeeeeseaeaeeeeeteteeseaeeeees 29 3 6 1 Battery voltage indic
16. A E N 148 Selection of applied standards s ssssessssesesssessesessssessrsesersssersesessesesss 149 Table of figures ecceercrserseeterecneans are aveecteeseeetetaternsanedentereaate 151 getemed General view and list of accessories 11 1 General view and list of accessories The general view shows the monitoring system s most important components VitaGuard monitor SpO2 sens 1 External power adapter SpO patient cable ECG patient cable amp Fig 1 General view of the monitoring system getemed 12 General view and list of accessories 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 PROGUGE E E E Article no REF VitaGuard VG 3100 Monitor with Masimo SET COmMmpleteSystENI jeecennseqsaeacecsaeacuearsesesaaseazaccandeseacorapsaneeaneronpcan asarazoes 7311 2012 1 VitaGuard VG 3100 monitor 1 ECG patient cable 9 neonatal electrodes 1 PCO8 SpO patient cable 1 SpO LNOP Neo sensor incl spare adhesive strip 1 NA3000 2 external power adapter 1 rechargeable block battery 1 device bag 1 operating instructions 1 quick reference Transport case NA 3000 2 external power adapter 110 V 240 V 50 6O HZ ooeeeeceecessesesesessesesesesessesesesesseseseetsesseae
17. Amplitude Good 12 5 mmis 5 mmim value every two seconds i Fig 58 Heart rate display The heart rate trend display presents the heart rate over the last three minutes This display varies with the set age group 4 O TO 2 YEARS 2 TO 6 YEARS gt 6 YEARS HEART RATE between 230 and 50 between 180 and 50 between 150 and 45 TREND DISPLAY PER MIN The bottom half of the display presents the ECG A small vertical bar above the ECG indicates every detected heartbeat Under the ECG you can see the evaluated amplitude of the ECG signal known from VIEW 1 9 7 2 HEART RATE menu alarm settings SETTINGS PROTECTION LIMITED The HEART RATE menu lets you view and if necessary change the current heart rate settings You may have to adapt the default age group alarm limits to the current patient These settings can be changed only when SETTINGS PROTECTION has been set to LIMITED in the SYSTEM menu Different heart rate alarm limits can be set as the default values for each age group getemed 96 Alarm and monitor settings Default Lower Hearrrareuimir min 80 60 SS 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 on page 127 The heart rate s LOWER LIMIT can be set from 30 to 180 beats and o A Se the heart rate s UPPER LIMIT from 100 to 255 each
18. FOUL sceacpsneansacorscacssaraescunssansocassuess Automobile voltage supply at 12 24 V CU aee E E E E 9 Vdc MD CUONG aaan anaa E E R E EE EE EN lt 500 mA OPUNE EMOA IUTE iasa ei 5 to 50 C Connection to VitaGuard s sessssssssssssssssssssersersersessessessessessesens 3 pin plug Connection to automobile supply Universal safety plug DIN ISO 4165 Connecting cable length ee eeeeseseseeeeeseceseseeeeeeeeeeeeeeenees 2m 20cm getemed 40 Description 4 2 VitaGuard connections USB BA NA3000 2 d Fig 11 Overview of VitaGuard connections For safety reasons only those accessories that getemed AG has delivered or approved must be connected to VitaGuard Hold VitaGuard firmly with one hand when connecting and dis connecting plugs insert and remove the plugs parallel to the sockets to prevent dam age to the sensitive contacts Only the doctor in full knowledge of the information under Connections to the USB and AUX ports on page 101 must decide Never use force when connecting and disconnecting cables Always which devices are connected to the USB and AUX ports 4 2 1 Patient cable for SpO sensors Sen Sp02 v i oo O AUX Fig 12 SpO socket The patient cable for the SpO gt sensors is connected to the SpO gt socket getemed Description 41 4 2 2 Patient cable for electrodes apap id USB bind Fig 13 Electrode socket The patient cable for the electrodes f
19. HR 60 hour average 87 fmin l HR 12 hour average 87 min the monitor was switched on HR Average 97 fmin HR Current deviation 23 These values are lost when the z a monitor is switched off Periodic respiration 0 Basal impedance 550 Ohm Fig 66 Info Measurements HR amp Resp getemed 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 amp TRENDS in the HEART RATE Menu and when ON HR ECG i e heart rate and not pulse rate has been selected as the source for heart rate alarms under SPO gt SPO gt MONI ToR This setting is restored as the factory setting when the ADMIT NEW PATIENT function is executed in the SYSTEM menu PERIODIC RESPIRATION displays the time in percent that PERIODIC RESPIRATION has been detected since the monitor was switched on This value is displayed only when the function PERIODIC RESPIRATION is set to ON in the RESPIRATION menu and when AGE GROUP is set to O TO 2 YEARS Under SYSTEM ADMIT NEW PATIENT BASAL IMPEDANCE displays the value measured between the yellow and the red electrode see Checking the BASAL IMPEDANCE on page 67 10 2 6 INFO SETTINGS OXIMETER This wi
20. SpO2 sensor This delay is to prevent false alarms when the physiological parame ters are being recalculated During the alarm mute time the bell symbol in the status line is crossed out 8 5 Differentiating physiological and technical alarm signals The ALARM TONE PITCH can be set in the SYSTEM menu so that alarms are heard over the prevailing background noise The urgency or priority of an acoustic alarm can be recognized by its characteristics described in the following High priority messages emit two sequences of five tones that are repeated every ten seconds getemed 72 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 a toe Tal all Se 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 8 6 Acoustic information signals If wished the alarm unit next to the display can produce a short acoustic signal to accompany each heartbeat or each breath 8 6 1 Information signals from the alarm unit next to the display After the monitor is switched on an acoustic reminder signal is emitted every twenty seconds until all sensors and electrodes are connected and plausible data have been detected 8 6 2 Information signals from the sound aperture between the sockets A pu
21. and 2 simul taneously display the current pulse rate determined via the SpO gt sensor below the abbreviation PR getemed 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 We recommend using the PULSE RATE for monitoring the heart rate only when the electrodes cannot be used e g owing to allergic reactions The heart and pulse rates can differ when irregular heartbeats fail to pump enough blood that can be recognized as a pulse 8 10 2 Heart and pulse rate alarms The currently set alarm limits are always displayed When the displayed HEART or PULSE RATE HR or PR falls below the Lower LIMIT for longer than the set BRADYCARDIA DELAY or exceeds the UPPER LIMIT for longer than the set TACHYCARDIA DELAY or when the ECG signal is not detected for longer than the set ASYSTOLE DELAY VitaGuard emits an acoustic alarm signal and displays the corre sponding message The violated alarm limit and the alarm LED flash Go immediately to the patient when an alarm is reported and check the patient s condition The alarm is ended automatically when the heart rate returns within the permitted limits Deviation alarms can also
22. and from the patient getemed Safety 33 Do not under any circumstances use solvents like ether acetone or benzene These substances can cause malfunctions and attack the housing plastic Also do not use any cleaning agents containing abrasive substances and no coarse brushes or hard objects VitaGuard and accessories can be cleaned any number of times when the recommended cleaning agents are used VitaGuard and accessories must not be sterilized VitaGuard and the cable plugs must not be immersed or otherwise penetrated by liquid 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 Baby oil has proved to be effective in removing residue from adhesive strips The VitaGuard bag can be washed by hand at 30 C It must not be put in the laundry dryer 3 7 2 Checking and cleaning the battery terminals Check the battery compartment every month for traces of leaking and for deposits on the battery terminals indicating leaks Contact your authorized dealer and clarify further procedures when a bat tery starts to leak The battery compartment and how to replace the batteries are explained in the section Replacing batteries on page 38 getemed 34 S
23. contribution to the total alarm report delay is specified as maximum two seconds overall 11 2 Measuring principle for the SpO 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 unoxygenated hemoglobin differ in their absorption of red and infrared light spectrophotometry 2 A heartbeat gives rise to a pulse wave that during its cycle changes the volume of arterial blood and therefore its light ab sorption at the monitoring site plethysmography 3 In particular movements also give rise to blood flows that resem ble pulse waves and generate interference signals Like conventional pulse oximeters SET oximeters determine oxygen saturation by directing red and infrared light through tissue and measuring the absorption of light by the blood flow Light emitting getemed 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 Conventional pulse oximetry then calculates the ratio of the pulsatile to the mean absorption for both wavelengths 660 nm and 940 nm The quotien
24. downwards one after the other around the finger Fig 33 Fig 33 Aligning the sensor and receiver getemed 58 Preparing for SoOz 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 34 Correctly attached LNOP Adt sensor 6 10 Connecting the SpO sensor and patient cable Hold the sensor s contact blade so that the metal contacts are on 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 35 Pull carefully on the contact blade to check that it has engaged properly You can now secure the patient cable to the patient with an adhe sive strip Fig 35 Connecting the patient cable and sensor contact 6 11 Connecting the SpO patient cable to VitaGuard Insert the patient cable s monitor plug into the SpO gt socket on VitaGuard The Masimo inscription on the monitor plug must be on top You should feel the monitor plug engage Fig 36 SpOz socket getemed Preparing for SpO gt monitoring 59 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 pul
25. in steps of five Upper limit 220 min beats per minute Factory settings are shown in bold type Heart rate Fig 59 Heart rate menu for viewing and setting alarm limits LOWER LIMIT heart rate 30 35 80 175 180 min Lower limit for the heart rate an alarm is reported when the heart rate falls be low this limit for longer than the set BRADYCARDIA DELAY UPPER LIMIT heart rate 100 105 220 250 255 min Upper limit for the heart rate an alarm is triggered when the heart rate ex ceeds this limit for longer than the set TACHYCARDIA DELAY 9 8 RESPIRATION display and menu The gt key takes you from View 1 2 or 3 to the RESPIRATION display From here you can open the menu with the A or V key Having highlighted a row press lt Enter gt to change the corresponding value getemed Alarm and monitor settings 97 9 8 1 RESPIRATION display The top half of the display presents 1 1 the status line wap i rate 1min Resp 1min r the set alarm limits m m 3 the current three minute trends that update the last value every two sec onds SpO2 Heart rate Fig 60 Respiration display respiration graph The RESPIRATION trend display presents the respiration rate over the last three minutes This display varies with the set age group O TO 2 YEARS 2 TO 6 YEARS gt 6 YEARS RESPIRATION RATE TREND between 0 and 60 between 0Oand60 between 0 and 30 DISPLAY PE
26. must be operated only with the rechargeable block battery available from getemed AG or new alkaline non rechargeable 1 5 V batteries LR6 or AA e g VARTA UNIVERSAL ALKALINE Bear in mind that cheaper non alkaline non rechargeable batteries can have a considerably reduced operating lifetime in some cases only 10 15 of the brand name batteries we recommend Do not under any circumstances use single rechargeable batteries 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 remove non rechargeable batteries from VitaGuard when it is not used for longer than a week Information on Replacing batteries To prevent leaking batteries from damaging health and property can be found on page 38 3 6 1 Battery voltage indicator When VitaGuard is powered only by non rechargeable batteries check the battery voltage indicator on the display every hour At least one quarter of the battery symbol must be black Fig 3 Battery voltage indicator When VitaGuard is powered from the supply network and com mercially available non rechargeable batteries are inserted check the battery voltage indicator on the display every day Even when the device is powered from the supply network you must replace the non rechargeable batteries as soon as one quarter of the battery symbol on the display is black If necessary a display message will pr
27. receiver Fig 28 Check and if necessary correct the positions 3 The opening in the receiver window must be completely covered by the foot Fig 29 Fig 29 Correctly attached LNOP Neo sensor 6 9 Attaching the SpO sensor to an adult s finger Note that the SpO sensor type LNOP Adt for adults is described here as an example The doctor must decide which SpO sensor type to use in each case getemed Preparing for SpOz monitoring 57 The LNOP Adt sensor designed for LNOP Adt Adult SpO Sensor adults weighing over 30 kg IS identified by the label illustrated 200 E single patient use on t h er i B h t Non Sterile and Latex Free 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 Alternative attachment sites are the other fingers of the non dominant hand On immobilized patients or patients whose hands cannot be used as attachment 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 sor so that the receiver can be attached first Fig 31 2 Now press the receiver on the fingertip and wrap the adhesive T ends around the finger Fig 32 3 Next wrap the sensor with the transmit ter and the finger design around the fin gernail and wrap the flaps
28. row The higher this bar the better the signal from the SpO gt sensor A high SIGNAL IQ indicates that getemed Alarm and monitor settings 93 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 When this value is very low SpO gt and the pulse rate are no longer monitored When the SENSITIVITY in the SpOz menu is set to MAXIMUM the cut off limit is 0 02 when set to STANDARD this limit ranges from 0 5 to 0 02 depending on the signal quality The principal of operation for this calculation can be found in the section Measuring principle for the SpOz monitor on page 135 9 6 2 SPO menu alarm settings SETTINGS PROTECTION LIMITED The SPO menu lets you view and Status ok VS M las change the current SpO gt alarm Spi Heart rate 1min Resp min 100 220 20 settings gH fa IH l Lower limit Go Changes are permitted only Upper limit 100 o SpO Monitor On CHR ECG when SETTINGS PROTECTION is set to LIMITED in the SYSTEM menu Factory settings are shown in bold type Fig 57 SpO2 menu for viewing and setting alarm limits LOWER LIMIT sisscisctesctscracirs 50 51 88 99 100 Lower alarm limit for the measured ar terial oxygen saturation an alarm is re ported when the measured value falls bel
29. switches off and on the apnea monitor In both cases the respiration waveform is displayed and stored When APNEA ALARMS is set to COMBINED an apnea alarm is triggered only when at the same time an apnea is detected shortly before a change in HEART RATE and or SPO see Section 10 14 Information for the doctor and qualified medical staff 99 10 Information for the doctor and qualified medical staff The treating doctor is responsible for monitoring with VitaGuard This also applies to ambulatory monitoring This section contains all safety and settings information that only the treating doctor can make decisions on Remember that all the information and instructions in the sections Intended use on page 14 and Safety on page 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 This certification is awarded only to those persons that have received adequate training from getemed AG for its products 10 1 Safety instructions The safety instructions in this section address special technical and medical issues that are of particular importance to the doctor and qualified medical staff 10 1 1 Preparing for a new patient When more than one VitaGuard monitor with differing settings are used in th
30. the so called output power of the ANC The result is a DST plot Fig 92 that exhibits at least the arterial peak This peak demon strates the particularly effective noise suppression for the affected SpO gt value when a precisely defined source of signal fluctuations the arterial pulse cycle has been identified Other also higher peaks can occur during venous fluctuations Venous blood is saturated less with oxygen so the peak with the maximum SpO value in the right half of the graph always Discrete Saturation Transform corresponds to the arterial oxygen saturation In Fig 92 the right peak corre sponds to an SpO2 of 97 The DST calculation is repeated every two sec onds on the latest raw data over the preceding SpO four seconds Relative Correlation Canceler Energy Output Fig 92 DST plot relative noise cancellation as a function of SpO gt The peak at 80 is caused by venous blood and would with the conventional method have completely corrupted the measurement for a false desaturation The PERFUSION index a percentage value displayed on the monitor is calculated from the electric signal of infrared light captured by the sensors photodiode This signal has a constant and a varying compo nent depending on whether the infrared light is absorbed by bone connective tissue skin or pulsatile blood The ratio of constant to variable signal component is used to calcu late the perfusion index a value betwee
31. used to detect alarm conditions is calculated as an av erage value over the number of heart beats set here The greater the value chosen for RR averaging the slower the system s reaction particularly in the event of bradycardia to report an alarm When the pulse rate is used instead of the heart rate the settings for RR aver aging have no effect on the measure ment 10 20 60 110 120 seconds The average heart rate measured over the set interval yields the reference value for calculating TREND DEVIATION and TREND DEVIATION 5 10 15 20 25 30 35 40 45 50 The current heart rate is compared with the average heart rate measured over the averaging interval and an alarm is reported when the set percentage de viation is exceeded This alarm is re ported only when HEART RATE ALARMS S set to LIMITS amp TRENDS See TREND DEVIATION but the value falls below the set percentage deviation Setting the 50 Hz filter to ON sup presses interference signals but also fil ters out parts of the ECG signal getemed 126 Information for the doctor and qualified medical staff LEAD NR OF ELECTRODES PACER DETECTION HEART RATE ALARMS getemed YE RD 3 yellow red 3 electrodes II BK RD 3 black red 3 electrodes Ill BK YE 3 black yellow 3 electrodes YE RD 2 yellow red 2 electrodes Here you can determine which lead is used with two or three electrodes f
32. 11 Fig 2 Device label on the bottom of the device ou eeeeeeeeeeeeeeees 14 Fig 2 Battery voltageindicatol secnteccrecceeeeareenetenncuateaure 30 Fig 4 Rechargeable block battery xccscceuaivocnsostscacavetsaatanetsncousndenessveienenpinrss 31 Fig 5 VitaGuard and bag with power and patient cables 35 Fig 6 Power adapter socket oon ee esessssseeeesesesesececeseeeseseseaeeeseseeeeteeeeeesees 36 Fig 7 Power adapter for 230 V 50 Hz supply network and a tomobil e POWErSUDDPIY xe nceetirerccosscecigan atines tiered suscacteen 36 Fig 8 Opening the battery compartment ou eeeeteteteteteeeteeeteeeeees 38 Fig 9 Opened battery compartment and polarity uu 38 Fig 10 The arrows show how the block battery is correctly inserted 39 Fig 11 Overview of VitaGuard CONNECTIONS oo eeeceseeeeeeeeeeeeteeeeeeeee 40 FIG LZ SPOZSOCKET sccesarasaesqunseucapeeoseeseenscurapensaresnensnecagavstectauctiqentaxeniesqansanctscesiet 40 Peedo EICCIFOGSSOCKEE cceresedcascocactortsts aeseturctocnscere N EE 41 Fio IA POWeradaplerSOCkEL apsodinti a nese E a 41 Medo SOUNGAPErNUTE sepreisepea uap a ede crete 41 Eo USEDE orerar AA A E E E E AEA E A 42 HOA AVAD aea E E EN E N E E AA 42 PIGS Keysonth topsidE cxcsesesisesp cadccunsesecosqeeaicacqsesorecatentetwnsesenesricadetaeiesnes 43 Pi DIGG CTION REVS morean E E E E 44 fo sO LENER KEY a E E E eee 44 PELL KEC ROY a vere ce esa coerce cee ore eee 44 PU ZZ PIT LED erae E O E 45 Fig 23 Heart and respiration
33. 2 HEART RATE values based on age groups Bear in mind that the HEART PULSE and RESPIRATION RATES drop considerably with increasing age The doctor must check and if necessary adapt the alarm limits for each patient s age group The percentage level of arterial blood oxygenation displayed as SPO normally ranges between 97 and 99 irrespectively of the patient s age group The average heart rate of an infant is much higher than that of an adult Accordingly the alarm limit e g for bradycardia too low a heart rate must be set considerably higher for an infant than for an adult patient As an orientation aid the following table lists some medically getemed 70 Alarms displays and views during monitoring acknowledged approximate heart rates for various age groups and stress situations Age group Heart rate min Stress e g fever 80 160 100 180 1 week to 3 months 80 200 100 220 3 months to 2 years 70 120 80 150 2 to 10 years 60 90 70 110 max 200 10 years and older 50 90 55 90 8 3 Alarm message priorities in the status line do Status ok vo EE fy Fig 44 Status line on the VitaGuard display Physiological alarms have high priority The text messages of physiological alarms end with three exclamation marks S55 Technical alarms have medium priority The text messages of technical alarms end with two exclamation marks ae 8 4 Physiological and technical alarms VitaGuard generates two types of ala
34. ARM and POST ALARM TIMES set here are stored in addition to the duration of the alarm These times can be set from 30 to 180 seconds for PRE ALARM and from 30 to 250 se conds for POST ALARM in steps of ten seconds Also the menu item SYSTEM INTERVAL RECORDING explained on page 113 records data for the duration of the pre alarm and post alarm times 10 3 5 SYSTEM ALARM MUTE TIME In order to allow caregivers to tend to a patient in peace during an alarm the acoustic alarm signal can be temporarily deactivated with the lt Esc gt key Set the ALARM MUTE TIME to 30 60 90 or 120 seconds as required The acoustic alarm signal is automatically reactivated after this time 10 3 6 SYSTEM DATE TIME How to change these values is explained in the section Changing multiple component settings on page 109 This is used to set the current date and the current time e g for summer and winter times getemed Information for the doctor and qualified medical staff 113 10 3 7 SYSTEM LANGUAGE The menu option LANGUAGE is marked with a flag symbol Patt in the event that you do not understand the set language The submenu LANGUAGE lets you choose between the languages supported by your monitor version 10 3 8 SYSTEM ANALOG INPUT 1 2 You can activate and deactivate the two analog inputs separately Both analog inputs have an input range from 0 to 2 5 V An analog signal at input 1 when activated is scanned with 1 Hz and s
35. HR ECG Respira SpO monitor SpO heart rate and tion ON HR ECG apnea without ALWAYS combined alarm Respira SpO2 monitor SpO heart rate and tion ON HR ECG apnea with combined COMBINED alarm Respira SpO2 monitor SpO and pulse rate tion OFF ON PR Masimo 2 Respira SpO monitor SpO pulse rate and tion ON PR Masimo apnea without ALWAYS combined alarm Respira SpO2 monitor SpO pulse rate and tion ON PR Masimo apnea with combined COMBINED alarm getemed Algorithms and measuring principles 133 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 tion of the alarm limits and monitoring parameters The alarm condition delay is the time from the occurrence of a triggering event on the patient or in the monitor to the decision by the alarm system to confirm an alarm condition The alarm report delay is the time between when an alarm condi tion is detected and when it is reported The alarm condition delay and t
36. LEDS oo eeeeseeeseseseseseseeeeeeeeeeseeeeeeeetens 45 Fig 24 Power supply LEDS oo es eseseseseseeeesecesesesceeseseseseseeeeeeeeeaeaeeesesees 46 Fig 25 Current values and alarm limits in View 1 oe eeeeeeeeeeeeees 47 Fig 26 Label on the LNOP Neo SpO gt z Sensor ou eeeeeeeeeseseeeeeeeeeeeeeeeeee 55 Pigs POSIGONINE LMG SENSO aeccnreeanrtete etapa 56 Fig 28 Aligning the sensor and receiver oo eeseseseseceseseeeeeeeeteeeeeteeeeeeeees 56 Fig 29 Correctly attached LNOP Neo sensor ou eeeseseseeeeeeeeeeeeeeeeeeee 56 Fig 30 Label on the LNOP Adt SpO5 Sensor ou ee eeeeceeeseseeeeeeteeeeeeeee 57 Fig POSON CSEND OT saranin EE gt Fig 32 Positioning the receiver on the fingertip e ssesssssssssseesessessesses 57 getemed 152 Fig 33 Fig 34 Fig 35 Fig 36 Fig 37 Fig 38 Fig 39 Fig 40 Fig 41 Fig 42 Fig 43 Fig 44 Fig 45 Fig 46 Fig 47 Fig 48 Fig 49 Fig 50 Fig 51 Fig 52 Fig 53 Fig 54 Fig 55 Fig 56 Fig 57 Fig 58 Fig 59 Fig 60 Fig 61 Fig 62 Fig 63 Fig 64 Fig 65 Fig 66 Fig 67 Table of figures Aligning the sensor and receiver ou eeceeseseseceeteeseceseseeseeeeeeees 57 Correctly attached LNOP Adt sensor ou eeceseseseeeeeeeeeeseeteeeeeeees 58 Connecting the patient cable and sensor contact 58 SPOR socket espasercivnriuessconenevegevivesieentnesesertuesooannersnesscepaniney oreuecepacies 58 Disconnecting the sensor from the patient cable ow 59 Two levers for securin
37. NGS PROTECTION appears as OFF When the wrong code has been entered three times SETTINGS PRO TECTION cannot be so easily deactivated In this case consult your authorized dealer getemed 92 Alarm and monitor settings 9 6 SPO display and menu The gt key takes you from View 1 2 or 3 to the SPO display Here you can open the menu with the A or V key Having highlighted a row press the lt Enter gt key to change its contents 9 6 1 SPO view The top half of the display presents 1 the status line E Status ok fy wap Heart rate 1min Resp min 100 220 20 2 the current value with the OH 30 5 100 230 60 set alarm limits 3 the current three minute trend views that update the last value every two seconds Fig 56 SpO gt 2 view plethysmogram perfusion index and signal IQ The SpOz trend displays the SpO z values between 70 and 100 over the last three minutes The first row under the trend view is the SIGNAL IO as vertical bars the second the PLETHYSMOGRAMME At the bottom perfusion index PI and pulse rate PR are displayed When 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 for example indicates that the SpO gt sensor is correctly secured Every time the SpOz monitor detects a pulse beat a vertical bar appears in the SIGNAL IQ
38. R MIN The bottom half of the RESPIRATION display presents the respiration waveform A small vertical bar above the respiration waveform indicates every detected respiration signal Under the respiration curve you can see the respiration signal s BASAL IMPEDANCE in ohms as in VIEW 1 The displayed respiration rate is not used in the alarm assessment and is calculated and displayed only when the respiration signal exhibits an adequate amplitude and is relatively free of movement artefacts Otherwise a question mark is displayed This has no nega tive effects on either the alarm function or the detection of central apneas getemed 98 Alarm and monitor settings 9 8 2 RESPIRATION menu alarm settings SETTINGS PROTECTION LIMITED These settings can be changed tapi Heart rate 1min Resp 1min only when SETTINGS PROTECTION Op 4 iei 7 iH Apnea delay 205 Apnea alarms Always 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 _ cccccseccccescecesceee APNEA ALARMS ese 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 exceeded The doctor must have set APNEA ALARMS to ALWAYS OFF ALWAYS COMBINED CAUTION A deactivated apnea monitor can no longer detect apnea getemed OFF and ALways
39. Safety requirements for medical electrical systems HEC GOGOL l 2 ienr Medical electrical equipment Part 1 2 General requirements for safety Col lateral standard Electromagnetic com patibility Requirements and tests IEC 60601 1 4 eee Medical electrical equipment Part 1 4 General requirements for safety Col lateral standard Programmable electri cal medical systems IEC 62A 422 CDV 2003 prEN 60601 1 6 2003 Medical electrical equipment Part 1 6 General requirements for safety Col lateral standard Usability IEC 60601 1 8 eee Medical electrical equipment Part 1 8 General requirements for safety Col lateral standard General requirements tests and guidance for alarm systems in medical electrical equipment and medi cal electrical systems IEC 601 2 27 i eeceeeeteeees Medical electrical equipment Part 2 27 Particular requirements for the safety including essential performance of electrocardiographic monitoring equip ment getemed 150 Specifications DIN EN 60601 2 49 ow Medical electrical equipment Part 2 49 Particular requirements for the safety of multifunctional patient monitoring equipment DIN EN 865 oo eseteeeeeeeees Pulse oximeters Particular requirements prEN ISO 18778 wo eee Infant Monitors Particular requirements getemed Table of figures 151 14 Table of figures Fig 1 General view of the Monitoring system oo eeeeeeeeteteeeeeeees
40. TEC Sp02 Heart rate Tmin Resp 1min 100 270 20 TION is set to LIMITED are 90 20 Painea nE CEREN RESPIRATION menu alarm Apnea alarms Always Silent apnea delay 34s settings SETTINGS PROTECTI Periodic respiration No ON LIMITED on page 98 Period T1 Apnea Hs Period T2 Resp 2085 Factory settings are shown in Mumber of periods So bold t Min respiration rate 10 fmin ae RE Respir Fig 90 Settings in the Respiration menu SILENT APNEA DELAY 8 10 22 34 seconds Same as APNEA DELAY but a silent alarm is stored when exceeded PERIODIC RESPIRATION Yes No This activates the detection of periodic respiration NOTE Activating the monitor for periodic respiration only operates if the age group 0 2 years has been previously selected a Erste Periode pa Zweite Periode p Fig 91 Periodic respiration PERIOD T1 DELAY oo 6 8 10 18 20 seconds For the detection of periodic respiration apnea must be longer than T1 but shorter than the set APNEA DELAY getemed 130 Information for the doctor and qualified medical staff PERIOD T2 RESP v ceeeeseeeees 4 6 8 20 28 30 seconds When resumed respiration lasts longer than T2 periodicity is no longer as sumed NUMBER OF PERIODS 000 2 3 5 6 periods When the set number of periodic cycles has been reached the data are stored as a silent alarm MIN RESPIRATION RATE 4 5 6 9 10 min VitaGuard disca
41. TEM menu SETTINGS PROTECTION OFF 109 10 3 1 Changing multiple component settings oe 109 10 3 2 OPERATING AREA HOME OF CLINIC uu eeeeesccesecereeereeseeeees 110 10 3 3 ADMIT NEW PATIENT restoring factory settings 110 10 3 4 PRE ANG POST ALARM TIME cccsscccssesesssseseeseseeseseeseseeeeseeeeees 112 LOUS PUA IT TI oeeie a sacen net E E 112 LOS O YDA TIME moreen ce cccace seek cate ce era sechagenoecearasieeec aneee 112 1037 ARNG ayes an scrapes E into ves tneden as E E 113 10 3 8 ANALOG INPUT 14 2 wu ccccsssccsecesccsecssccsecssccsecssccsecsseeees 113 10 3 9 INTERVAL RECORDING o i ecscesecsscessceeceseeseeeseeeseceneeeseeeeeseeenes 113 TOO SHOW PR TAR sorori o N E E E OEE T 113 Dara SLOG CS TUCO S oae E E S 113 EVENT SOF gpa ee E E A 114 10 5 1 SILENT ALARM LIMITS eesessssssssssssssessesrssessessesseseeseesessesseseeseeseeses 116 10 5 2 MANUAL DATA STORAGE OF TRANSMIT DATA uu ceeeeceeeteeeees 116 10 5 3 Summary of stored EVENTS s ssssssssssssessssessesseseeseseeseeseseesesees 117 TREND STONIO eenn e E E E E 118 LONG TERM storage over eight hours oo eeeseeeeeesececeseeteeeeeeeeeeneeees 119 getemed Table of contents 10 8 10 9 10 10 10 11 10 12 10 13 10 14 10 15 11 11 1 11 2 11 3 11 4 12 13 13 1 13 2 13 3 13 4 13 5 13 6 13 7 13 8 13 9 14 PROTOCOL storage of operating and device data eee 119 Summary of stored signals and data s ssessssessessssessesseses
42. TNESS You can set the 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 9 5 3 SYSTEM LCD CONTRAST You can set the display s contrast from 0 to 100 in steps of 5 The factory setting is 70 getemed 90 Alarm and monitor settings 9 5 4 SYSTEM SIGNAL BEEP TONE You can configure the monitor to emit a brief signal tone with every detected respiration RESPIRATION or with every detected heartbeat HEART PULSE BEAT Signal beep tone When this tone disturbs the patient 7 eart beat or caregivers choose the setting OFF Respiration The factory setting is OFF Fig 53 System submenu Signal beep tone 9 5 5 SYSTEM ALARM TONE PITCH You can set the pitch of the acoustic alarm signals to Low MEDIUM or HIGH so that they can be heard over the expected background noise The DIN settings DIN match the alarm tone characteristics as described from page 71 on in the section Differentiating physiologi cal and technical alarm signals As AGRuuEOne Dich an alternative you can set the alarm Medium DIN tone characteristic gtm as familiar High DIN from other getemed devices Medium gtm The factory setting is MEDIUM Fig 54 System submenu Alarm tone pitch 9 5 6 SYSTEM RS232 FORMAT This submenu lets you assign the RS format format for online data output from the AUX serial port gtm Form
43. VitaGuard VG 3100 Apnea heart and SpO2 monitor Operating instructions getemed Who should read which sections in these oper ating instructions The sections 3 to 8 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 iO Co N WW WN BP W N FF PP FP H WN F O 14 General view and list of accessories Intended use Safety Description Steps before and after monitoring Preparing for SpO2 monitoring Preparing for heart rate and apnea monitoring Alarms displays and views during monitoring Alarm and monitor settings Information for the doctor and qualified medical staff Algorithms and measuring principles Evaluating stored data on a PC Specifications Table of figures NOTE Words and passages in SMALL CAPITALS in these operating instructions also appear on the display getemed Table of contents Table of contents 1 2 2 1 2 2 2 3 2 4 2 5 2 6 2 7 3 1 3 2 3 3 3 4 3 5 3 6 3 3 8 General view and list Of accessories oo eeseeteseeeeseeeees 11 M ENOC USS enprene E E E 14 Label on the back of the device sssessesessessssessesessesseseesesseseeseseesesses 14 Symbols and warnings ssssessessssessesessesseseesesseseeseseeseeseseesesseseesesseseesess 15 MAIC ONS snra NEE NOE EEE EE 16 2 3
44. 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 The heart rate can be monitored with electrodes also when the patient is moving but sudden vigorous movements can adversely affect the measuring accuracy A false heart rate is displayed during ventricular fibrillation or when the heart rate exceeds 270 beats per minute 2 6 3 Limitations of the SpO and pulse rate monitor The monitoring of SpO2 and pulse rate is adversely affected when the patient moves vigorously or is vigorously moved When the sensor is not attached correctly ambient light can falsify measurements One remedy is to cover the sensor with a dark or Opaque material The monitor operates properly only when the SpO gt sensor is correctly attached getemed Intended use 21 2 7 Information for the doctor on these operating instructions In full knowledge of these operating instructions the treating doc tor must decide whether the caregivers have to be trained in the performance of resuscitation measures how the caregivers can be best prepared for monitoring and above all for the measures that must be taken in the event of an alarm which view should be displayed Information on SETTINGS PROTECTION that sets the display modes and
45. afety 3 8 Disposing of non rechargeable batteries the device and accessories getemed AG takes back all of the parts it delivers For hygiene reasons these parts do not extend to consumables like electrodes and sensors that have been in direct contact with the patient The symbol of the crossed out waste container on the battery pack aging is to remind you that under no circumstances must you dis pose of batteries in normal household waste As the end consumer you are legally obliged to return used batteries or dispose of them properly You can return used batteries to us Place consumables like electrodes and sensors in a plastic bag before disposing of them in household waste Please do NOT send us ANY used electrodes or sensors Like every electronic device VitaGuard and accessories contain metal and plastic parts that must be disposed of in such a way that they do not pollute the environment after their service live For this reason the device and accessories may be sent to getemed AG in an adequately stamped package when possible in the original packag ing for free and proper disposal getemed Description 35 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 getemed 36 Description 4 1 Powersupply VitaGuard is usually delivered with the
46. and infants require particu lar know how that the treating doctor should communicate to the caregivers 2 1 Label onthe back of the device The device label serves as a getemed a E unique identifier for VitaGuard an Eon sji Af 0197 In addition the label bears im Product VitaGuard Model VG 3100 E A ortant cautionary information p y SN 803 04 0022 wooo On the device label you will Ingress protection class IP21 Do not use in explosive atmospheres find the manufacturer s name Use only power adapter NA 3000 2 e Do not use with plug in socket which can be switched off and address as well as the In battery mode use only fresh LRG batteries Check polarity p rod U ct ad n d m od n ad m s T h s This device is covered under one or more of the following U S A patents 5 482 036 5 490 505 5 632 272 5 685 299 5 759 644 5 769 785 6 002 952 6 036 642 6 067 462 6 206 830 S e r j a n u m be r of yo u r d evice j S 6 157 850 6 002 952 and international equivalents U S A and international patents pending NO IMPLIED LICENSE Possession or purchase of this device does not convey any express or implied license to use the d h which id alone bination with this device fall given ne xt to SN AAA a EDE A DAEN DDIR l TA Fig 2 Device label on the bottom of the device getemed Intended use 15 2 2 Symbols and warnings This symbol warns you that failure to o
47. aring for heart rate and apnea monitoring 7 2 Connecting electrodes the patient cable and VitaGuard Insert the electrode s plug into the ECG patient cable s see distributor Note the color coding of the electrodes and the distributor s sockets 7 _ _ E ull eer i MM al ee 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 Fig 40 Electrode socket 7 3 Technical alarm from the electrode contact monitor The electrode contact monitor reports an alarm when the electrodes have become detached the electrodes are too dry e g the expiration date has been ex ceeded or the electrodes have been used several times giving rise to too high a value of basal impedance When electrodes have become detached or when the electrical resistance between the electrode and skin is too high the respira tion and ECG signals are displayed as a zero line getemed Preparing for heart rate and apnea monitoring 65 When new electrodes have become detached you can reattach these by pressing them gently You must replace electrodes that have become detached more than once or that exhibit too high a resistance between the electrode and skin Further explanations can be found in the section Checking the BASAL IMPEDANCE on page 67 7 4 Determining the optimal electrode configuration The
48. at Fig 55 System RS232 format getemed Alarm and monitor settings 91 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 The doctor should point out that the code must be treated as confidential that settings should be changed at the doctor s request only and that all changes must be confirmed by the doctor VitaGuard provides the following three settings for SETTINGS PRO TECTION SETTINGS PROTECTION ON deactivates all options to change moni tor settings The display presents only View 1 the INFo display and the SYSTEM menu SETTINGS PROTECTION LIMITED enables access to all views and menus Of all the monitor settings however only the alarm limits can be changed SETTINGS PROTECTION OFF enables all views and menus and allows changes to all monitor settings The factory setting is SETTINGS PROTECTION LIMITED After highlighting the function SETTINGS PROTECTION press the lt En ter gt key to open a submenu This submenu always displays SETTINGS PROTECTION as 00 irre spectively of the current setting Pressing the lt Enter gt key acti vates SETTINGS PROTECTION When you enter a code SETTINGS PROTECTION appears as LIMITED When you enter a different code SETTI
49. ator wie eeseeseeeeeseseseeeeeeeeeeeseneeeee 30 3 6 2 Interruptions to the power supply oe eeeeeeeeeeeeeteeee 31 3 6 3 Using the rechargeable block battery oes 31 Safety with proper maintenance only s sssssssssessessesessesssseesessesessess 32 3 7 1 Cleaning VitaGuard and accessories 0 32 3 7 2 Checking and cleaning the battery terminals 33 Disposing of non rechargeable batteries the device and IC EESO ol ree een ee E E ee ee ee 34 getemed Table of contents 4 2 4 3 4 4 4 5 5 5 1 5 2 5 3 5 4 6 6 1 6 2 6 3 6 4 6 5 6 6 Deae e d E E E 35 POWeET SUD DIY copresoscssacedcccnsscicsnatcntudseneae censanse teseesis onteas E E ES 36 4 1 1 Power failure with inserted batteries oes 37 4 1 2 Power failure without batteries ose 37 Ado REDIACING DAU CTICS enan 38 4 1 4 Using the automobile power supply adapter 39 VitaGuard CONNECTIONS sesessessesssssesesseeseesessesssseeseestesesseseeseestesesseseesss 40 4 2 1 Patient cable for SPO gt Sensors eesssssssssessssesessesessesessssesersess 40 4 2 2 Patient cable for electrodes s ssnssssesssessessssessessesesseseesesees 41 Belo POWE adip oriai ERE 41 4 2 4 Sound outlet no socket ssssssssssssessssssssssssesssssssssssssrersss 41 La WD OU saecca ee ce ceee ce eeeteue E anced openness 42 ALO AUA 910 Gee Serene eee E rere ee eet rr ere ere 42 Membrane key panel scisiectecscsesscscssscdacassenssesedeagecenensiancadsndpass
50. batteries and in the compartment match before inserting non re chargeable batteries O getemey Mad oa Ow ie Fig 9 Opened battery compartment and polarity Observe the following instructions when you use the rechargeable block battery Never use force to insert the block battery The bottom of the block battery has a guide groove that prevents the battery from being inserted the wrong way Make sure when inserting the block battery that the labeled side is on the top and the metal terminals point to the device label getemed Description 39 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 from a vehicle s dashboard Do not leave the automobile power supply adapter overnight in the vehicle particularly during the cold season Otherwise condensa tion may form on and in the device The NAK 3000 2 automobile power supply adapter is connected to the VitaGuard power adapter socket NAK 3000 2 features a univer sal safety plug DIN ISO 4165 for the dashboard lighter Automobile power supply mode is indicated on VitaGuard by the green LED beside the power adapter symbol The specifications of the automobile power supply adapter are as follows
51. be activated in addition to the alarms based on permanently set limits getemed Alarms displays and views during monitoring 77 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 Go immediately to the patient when an alarm occurs and check the patient s condition When the patient resumes breathing the alarm is switched off automatically Both the delay time and the alarm LED continue to flash to show that apnea has occurred for longer than the set APNEA DELAY Pressing the lt Esc gt key stops the flashing 8 10 4 Technical heart rate and apnea alarms The section Table of technical alarm messages on page 81 can be consulted for the technical alarm signals and the recommended troubleshooting procedure The heart rate and apnea monitors display technical alarms with the corresponding messages Until the problem has been eliminated the heart and respiration rates are replaced by a question mark symbol When VitaGuard is to be used as a pulse oximeter only the ab sence of an ECG patient cable would normally generate a technical alarm To prevent this technical alarm the doctor can deactivate the apnea monitor and switch to PULSE RATE instead of HEART RATE as the source for heart related alarms 8 11 Alarm messages meanings and other in
52. bserve these op erating instructions can cause death or injury to the pa tient The book symbol means that you must not use the de vice when you are not familiar with the information con tained in these operating instructions C Eor With this CE label and the CE approval number 0197 getemed AG confirms that VitaGuard complies with all the pertinent regulations and in particular the require ments in Annex I of the Medical Devices Directive 93 42 EWG and that this has been approved by a noti fied body TUV Rheinland Product Safety This symbol means that the VitaGuard s ECG socket is a type CF cardio floating application part and that it is protected against the effects of defibrillation s This symbol means that the VitaGuard s SpO gt socket is ENI a type BF body floating application part that is pro tected against the effects of defibrillation The factory symbol shows the year of manufacture Note the warnings on the device label Do not use in explosive atmospheres Use the NA 3000 2 power adapter only Warning Do not connect to an electrical socket controlled by a wall switch Only new alkaline batteries LR6 or AA must be used when the device is powered by non rechargeable batteries Note the polarity getemed 16 Intended use 2 3 Indications VitaGuard can be used to monitor patients with for example the following symptoms or treatment unstable respiration
53. creen saver On LCD brightness S0 Oo LCD contrast 0 Yo Signal beep tone Off Alarm tone pitch Medium DIN 5 LCD brightness fete o Fig 50 System LCD brightness highlighted in the change window Pressing the lt Enter gt key after changing a value causes a prompt to appear with ACCEPT No highlighted Press the lt key to highlight ACCEPT YES Screen saver On LCD brightness BO Fp LCD contrast J0 Yo Signal beep tone Off Alarm tone pitch Medium DIN R di gd LCD brightness Accept Yes Fig 51 System accept change to LCD brightness highlighted Confirming the prompt Accept Yes with the lt Enter gt key displays the changed value in the list To exit the menu press the lt Esc gt key getemed Alarm and monitor settings 89 9 5 SYSTEM menu general settings iar 7 Screen sayer On NOTE 7 can farailarize your PED brightness SE ap self with the menus without LCD contrast 70 i Signal beep tone Off changing values Simply press Alarm tone pitch Medium DIN RS 232 format Off the lt Esc gt key to exit each menu Settings protection Limited and submenu without saving changes Fig 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 When you press a key or an alarm is triggered the previous mask is displayed again 9 5 2 SYSTEM LCD BRIGH
54. cted and SpO too low When there is no asystole cardiac arrest 5 or delay The electrodes are badly placed The ECG signal is too small to be detected The monitor cable or electrode is defect See the messages and information for 3 Heart rate too high too low and Apnea detected See the messages and information for 2 Heart rate too high too low and SpO too low getemed Alarms displays and views during monitoring 79 Message _ Meaning Information No Heart rate The calculated heart rate When there is no tachycardia 7 too high exceeds the set UPPER T wave peaks are interpreted as R LIMIT for longerthanthe waves so that the calculated heart rate set TACHYCARDIA DELAY is too high The electrodes are badly placed Artifacts caused by excessive move ment trigger false alarms 50 Hz or other sources of electromag netic interference trigger false alarms suspected interference sources must be removed The electrode has become detached The monitor cable or electrode is defect The set UPPER LIMIT is too low Heart rate The calculated heart rate When there is no bradycardia 6 too low falls below the set Lower Heartbeats are not detected LIMIT for longer thanthe The electrodes are badly positioned set BRADYCARDIA DELAY Abnormal beats e g extrasystoles are not detected The electrode has become detached The monitor
55. d SpO When SpO j is not too high 9 high exceeds the set UPPER The sensor is incorrectly attached e g LIMIT for longer than the itis too loose or too tight the trans set HYPEROXIA ALARM mitter and receiver are too far apart or DELAY they are not exactly opposite each other The sensor has become detached The blood flow is weak or obstructed e g by a pressure cuff Strong artifacts caused by movements corrupt the signal The monitor cable or sensor is defect The set UPPER LIMIT is too low SpO too The calculated SpO has See SpO too high 8 low fallen below the set LOWER LIMIT for longer than the set HYPOXIA ALARM DELAY SpO drop The currently measured When there is no SpO drop 13 detected SpO has fallen below the The present SpO or the value based on when value based on the set the set averaging interval is incorrect activated AVERAGING INTERVAL by for the reasons given under SpO too more than the percent high age deviation value set under TREND DEVIATION 8 11 3 Table of technical alarm messages Message Meaning Cause or elimination No Check ECG The monitor discovers Check the ECG cable cable that the ECG cable is not connected Check The monitor discovers that Check the electrodes If this message 23 electrodes one or more electrodes persists use new electrodes or replace are not connected the ECG cable get
56. d from the rechargeable battery block and disconnected from the supply network you must first make sure that the block battery is fully charged For this rea son check the Battery charging LED The battery is being charged as long as this LED light is continuously on When the LED flashes every second the battery is full and com O map pensation charging is activated Sometimes the light will go out for a short time in the interval be tween battery and compensation 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 damage on VitaGuard the patient cables including the connections the external power adapter the elec trodes and the SpO sensor every time you use 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 For the protection of our service personnel disinfect VitaGuard and the patient cables with Virkon available as a spray or wiping solu tion before sending them to getemed AG 3 7 1 Cleaning VitaGuard and accessories Before cleaning VitaGuard remove the batteries Before cleaning VitaGuard detach the electrodes and cables from the monitor
57. d properly ing for the pulse SpO gt The SpO gt sensor is defect Check whether the SpO sensor is Sensor off or not connected correctly connected to the cable if necessary replace the sensor SpOz Too The SpO module reports Protect the SpO sensor from light much that there is too much sources e g by covering it light light SpO gt The SpO module reports Replace the SpO sensor 29 Unrecog that an unrecognized use only the sensors from Masimo Inc nized sensor is connected sensor getemed 84 Alarms displays and views during monitoring 8 12 Table of information messages Message Cause Calculating The current heart rate heart rate cannot be displayed while it is being calculated The heart rate deter mined via the ECG electrodes differs from Heart and pulse rates diverge the pulse rate by more than 40 Internal battery The internal battery for too low alarms during a power failure is depleted SpO gt Low The SpOz module perfusion reports that the blood flow is too weak The SpO z module lO reports that the signal SpO2 Low signal quality is low Status ok No messages Meaning No The current heart rate is displayed after it has been calculated Check the ECG electrodes and the SpO gt sensor See also the messages for Heart 2 rate too high Heart rate too low 2 Pulse rate too high Pulse rat
58. d sample rates for the respective memory The currently utilized memory capacity is shown on the INFO display The installed memory can store up to 200 events of two minutes each 10 5 EveENT storage Please bear in mind that you must wait for the PosT ALARM TIME to expire after an alarm has ended before the current alarm event can be completely stored The time of occurrence and the Episodes SpO2 HR Apnea Mil length of the stored data are d Mar 17 06 10s X 4 Mar 16 55 128s x stored for every alarm event The section Summary of stored EVENTS on page 117 explains the symbols in the columns for each physiological parameter SpO2 HR PR Resp rate e tt 4 XP Max 99 120 i6 Min Se c Events Fig 79 List of the stored events getemed 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 Highlighting an alarm event with the direction keys A and V and SpO2 HR PR Apnea Max 99 100 120 220 20 pressing the lt Enter gt key opensa Min 88 80 mask with initial detailed infor Lead Nr of electrodes YE RD 3 Basal impedance 550 550 Ohm mation on this event Highlight ing WAVEFORMS and pressing the E Graphics lt Enter gt key displays the wave forms recorde
59. d with this event Trends Events Fig 80 Detailed information on a highlighted event The black symbol between the Bt 0 03 52 30 20 mmis Screen 9 s displayed times for the start and end of the event marks the section of the stored event currently displayed The two Small vertical bars mark the start and end of the alarm event itself Events Fig 81 Stored waveforms Highlighting TRENDS and press oe 03 52 0 36 mmis Screen 3 min ing the lt Enter gt key displays the TRENDS for SpO2 and heart rate recorded with this alarm Fig 82 Stored trends getemed 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 When measurements violate the SILENT ALARM LIMITS the current episode is stored without triggering an acoustic or visual alarm For example when the SILENT LOWER LIMIT is set higher than the LOWER LIMIT in the HEART RATE menu silent bradycardia alarms are stored 10 5 2 MANUAL DATA STORAGE or TRANSMIT DATA The A or V key takes you from View 1 2 or 3 to the MANUAL mon Gata DATA STORAGE Or TRANSMIT DATA menu In addition to the auto matic storage of alarm events you can also store current data manually MANUAL DATA STORAGE stores data for the
60. dam age to the patient s skin Read and observe the operating instruc tions for the electrodes Do not continue using damaged electrodes or cables Do not immerse Use only those electrodes that getemed AG or an authorized dealer electrodes or cables in water solvents or liquid cleaning agents Store the electrodes in a cool dry place Observe the storage instruc tions on the packaging Do not use electrodes after their expiration dates this date is printed on the packaging e g FEB2006 or 2006 02 February 2006 The electrodes provided are designed for short term applications Using the same electrodes several times can lead to malfunctions when the adhesive surface fails to adhere properly Do not open the electrode s packaging until shortly before the elec trode is to be used Open the packaging and remove the electrodes Hold the sides of the electrode and peel off the transparent film Do not pull on the electrode s cable Avoid finger contact with the elec trode s gel coated surface as much as possible reattach them to the transparent film This helps to prevent the electrode from drying out or becoming soiled Use exclusively the ECG patient cable delivered by getemed AG Connect the ECG electrodes only to the ECG patient cable and this only to the corresponding VitaGuard socket CAUTION Make sure when attaching electrodes that neither the electrodes nor their plug connectors come into contact with ot
61. de their clothing so that it exits at the foot On larger children and adults you can for example lay the patient cable so that it exits between the trousers and pullover To prevent damage avoid all kinks folds and any other unnecessary bends in the sensor cable 6 2 Operation of SpO sensors SpO gt sensors consist of a transmitter diode referred to as transmit ter in the following and a receiver The transmitter is identified by the red star symbol on the adhesive strip The receiver is identified by its round window and the white plastic part on the adhesive strip behind it The transmitter emits light the receiver detects this light When this light penetrates arterial blood vessels the composition and intensity of the light picked up by the receiver change getemed Preparing for SpO gt monitoring 53 The SpO gt z monitor can calculate the percentage level of blood oxy genation from the composition of the light picked up by the receiver However it is important that no other light whether daylight or ambient light can reach the receiver More detailed explanations can be found in the section Measuring principle for the SoOz monitor on page 135 6 3 SpO sensor adapted to the patient s size and weight The following lists a number of SpO gt sensors that are also available The LNOP Neo delivered with VitaGuard is an adhesive strip sensor for measuring the functional arterial blood oxygen satu
62. different site Always replace a sensor when the displayed pulse rate and the displayed percentage level of oxygen saturation remain uncon vincing despite the sensor s new site 6 6 Reasons for unconvincing SpO values Clarify with the doctor whether one of the following situations may have arisen the sensor is improperly secured or used e g when the transmit ter and receiver do not lie exactly opposite each other the patient moves vigorously the sensor picks up bright ambient light e g from powerful lamps IR heater lamps direct sunlight etc venous pulsation a catheter or pressure cuff has been applied to the same limb as the sensor getemed Preparing for SpO gt monitoring 55 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 6 7 Whythe pulse rate is not displayed Clarify with the doctor whether one of the following situations may have arisen The sensor is secured too tightly dangerous for the patient Bright ambient 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 Attaching the SpO sensor to an
63. doctor and qualified medical staff 123 TREND DEVIATION wee 3 4 10 24 25 The current SpO gt 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 SPO2 ALARMS is Set to LIMITS amp TRENDS an alarm is triggered SPO gt ALARMS ou eccssecssseeeseeees When SPO ALARMS is set to LIMITS ONLY alarms are reported only when the measured values violate the set alarm limits When SPO gt ALARMS is set to LIMITS amp TRENDS alarms are reported when the measured values violate the set alarm limits AND when they deviate from the average SPO measured over the set interval 10 11 Settings in the HEART RATE menu SETTINGS PROTECTION OFF This menu can refer to PULSE RATE or HEART RATE depending on the settings under SPO27 SPO2 MONITOR In the example the heart rate is determined with ECG electrodes the menu bears the caption HEART RATE getemed 124 Information for the doctor and qualified medical staff For this setting SETTINGS PROTEC Status ok wap Heart rate 1min Resp 1min 482 Ieis 145 plained under SYSTEM SETTINGS 88 80 5 i PROTECTION ON LIMITED OFF on ower init SO TION must be set to OFF as ex page 91 The possible settings when SETTINGS PROTECTION is set to LIMITED are explained in the section HEART RATE menu alarm settings Settings PROTEC
64. e data transfer This telephone number must be loaded by the evaluation software VitaWin and cannot be edited directly in the monitor getemed 108 Here you can also view the details for transferring data as an e mail attachment 10 2 10 INFO VERSIONS INFO VERSIONS displays the software and hardware version numbers The software and hardware from Masimo for monitoring SpO gt are also displayed followed by the monitor s serial number SN getemed Information for the doctor and qualified medical staff Memory Internet 9 10 Memory used Memory size 41 o S MB Land line ATDT 01929 E mail address yitaguard getemedde Fig 70 Info Memory Versions 10 10 getemed SW DAQ 1 0 4 0 SW IO 1 0 3 16 Hardware 1 0 0 0 Masimo 4 3 2 1 43 21 Asad 4 3 2 1 S035 04 0000 Product ID DSP MCU Hardware Fig 71 Info Versions Information for the doctor and qualified medical staff 109 10 3 Settings in the SysTEM menu SETTINGS PROTECTION OFF When SETTINGS PROTECTION is LCD brightness 95 o switched off in the SYSTEM Menu LCD contrast 70 Signal beep tone Off the doctor can configure Vita Pare tone pitch Medium DIN ifi i RS 23 7 format O Guard for specific monitoring Settings protection Off requirements Operating area Home cual new patient Mustermann Alarm mute time 60s Use the direction keys to high Pre alarm time 60s Post alarm time 60 s light an en
65. e same environment there is a risk of mixing monitors and a particular patient may be monitored with unsuitable settings For this reason check the currently set alarm limits every time the monitor is switched on getemed 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 Place used consumables such as electrodes or sensors in a plastic bag before disposing of them in household or medical waste Clean the device and disinfect all cables e g as described in the guidelines from the Robert Koch Institute Insert new batteries or a fully charged block battery Select the age group in SYSTEM ADMIT NEW PATIENT as explained under SYSTEM ADMIT NEW PATIENT restoring factory settings on page 110 Check that the monitor settings are suitable for the patient and if necessary adapt them Consider that the monitor settings may need to be changed ata future date and as appropriate arrange appointments to change these settings Check that the acoustic alarm signal is loud enough to be heard over the prevailing or expected noise levels in the monitor s envi
66. e too The monitor is defect i e the internal battery needs to be replaced by a technician Either use a different attachment site or set SENSITIVITY tO MAXIMUM in the SpOz menu Use a different attachment site or check for the presence of light or electromagnetic interference sources in the vicinity Whenever possible prevent vigorous movements by the patient 40 getemed Alarm and monitor settings 85 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 The set alarm limits and other monitor parameters are stored and retained when the monitor is switched back on after a battery change 9 1 Safety instructions for the alarm settings It is important that the doctor responsible sets new alarm limits and monitor parameters for each patient and for each new medical situation Never change alarm limits without consulting the treating doctor Never set the alarm limits to extreme values that render the moni toring system useless When you have been given a code for changing alarm limits it is important that you treat this code as confidential Life is in danger when alarm limits are not adapted specifically to each and every patient getemed 86 Alarm and monitor settin
67. ead to condensation forming in and on VitaGuard Wait for at least two hours after Vita Guard has visibly dried on the outside before using it for monitoring Do not operate VitaGuard in environments containing explosive gases flammable substances nitrous gases or highly oxygen en riched atmospheres Do not use VitaGuard at extreme temperatures below 5 C or above 40 C Do not place VitaGuard near heat sources such as radiators ovens etc Do not expose it to direct sunlight Always lay all cables and in particular any extension cables so that nobody can trip over them Do not place VitaGuard directly next to the patient s head risk of hearing damage 3 3 2 Noise risks to monitoring When the alarm cannot be set to a volume that is sufficiently above the prevailing ambient noise levels you must keep VitaGuard and getemed 26 Safety its display within view The visual signals from the alarm LED and display must then be relied upon to recognize critical situations You can also use the external alarm unit available from getemed AG that raises the volume of the alarm signals from VitaGuard Information on the alarm signal types and volumes can be found in Alarms displays and views during monitoring on page 69 The alarm pitch is set as explained in the section System menu general settings on page 89 3 3 3 Electrostatic interference Electrostatic build up that for example a per
68. emed 82 Alarms displays and views during monitoring Message Meaning Cause or elimination No 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 NA3000 2 power adapter Conflicting The heart rate s LOWER Correct the heart rate limits HR limits Limit has been set higher than the UPPER LIMIT Conflicting The SpO LOWER LIMIT has Correct the SpO limits SpO gt been set higher than the limits UPPER LIMIT Corrupted The ECG signal is Attach the electrodes as symmetrically ECG signal corrupted too strongly by as possible 50 Hz interference Replace the electrodes signals from the supply Select the I YE RD 3 lead network Proceed in accordance with the section Electromagnetic interference on page 26 Hardware The monitor has detected Switch off the monitor wait for thirty fault an internal fault seconds and switch it back on if this message persists the monitor is defect Internal The internal software Switch off the monitor wait for thirty data error monitor has detected a seconds and switch it back on if this data transfer error message persists the monitor is defect No cables The monitor discovers Connect the patient cables for SpO connected that both patient cables and ECG are not connec
69. er than every eight hours and permanent sensors no later than every four hours so that you can inspect and if necessary clean the attachment sites on the patient s skin When the blood flow or attachment site is not satisfactory attach the sensor to a different site and inspect this site more often Be particularly careful with patients exhibiting weak blood flow failing to check the sensors frequently may lead to skin damage and pressure induced necrosis Check no later than every two hours in these cases getemed 52 Preparing for SoOz 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 too tightly can damage tissue Do not use damaged sensors Replace sensors immediately if they exhibit any damage Do not immerse the sensors in liquids and do not attempt to sterilize them An improperly attached sensor can falsify measurements Do not attach the SpO sensor to a limb that has or will have a catheter or pressure cuff during monitoring Secure the sensors and cables so that they cannot harm strangle or be swallowed by the patient Always lay the patient cable at a safe distance from the patient s head and neck Lay the patient cable when monitoring small children insi
70. es to measured impedance When central apnea has occurred the applied algorithm detects cardiac artifacts after max four heartbeats The alarm condition delay for respiration depends in addition on the signal amplifiers recovery time When in the worst case the amplifier is saturated owing to sudden violent movements by the patient directly before the occurrence of apnea the zero line is reached in six seconds From then again in the worst case a period of four beats is needed before any cardiac artifacts can be detected T AC MAX 4 6 6 amplifier s max recovery time in seconds apnea 11 1 4 Alarm report delays The alarm report delays for bradycardia tachycardia hypoxia and hyperoxia can be set within certain limits getemed Algorithms and measuring principles 135 TA max for bradycardia Set BRADYCARDIA DELAY 2 S TA max for tachycardia set TACHYCARDIA DELAY 2 5 TA max for asystole set ASYSTOLE DELAY 2 5 TA max for hypoxia set HYPOXIA ALARM DELAY 2 5 TA max fur hyperoxia set HYPEROXIA ALARM DELAY 25 TA max TOF apnea sses 25 The purpose of these alarm report delays is to prevent alarms from being reported every time the alarm limits are violated for short times only In other words the maximum alarm report delay corresponds to the maximum set delay The monitor outputs measurements e g to the display every second The technology s
71. eseeeeseseens 7381 2081 Alarm chart Turkish wee ccccscscsscscsscscsecscscscsscsssscsseseens 7383 1081 DEVICE DAE erpe e a ene asprsoevaeee eae Geeevess 7345 1001 VitaGuard transport case for the complete system 7391 0001 AUX 01 RS232 cable for connecting VitaGuard Casera PEDOT eraa E i 7341 2002 AUX 02 modem cable for connecting a Moden LO VACAGUAGO a E E A EA 7341 3001 AUX 03 cable for connecting an external alarm unit COVO dA eE tea a 7341 5001 AUX 04 cable for connecting VitaGuard to a nurse call system with 4 kV isolation sssssssessssessesssseses 7341 5011 AUX 06 cable for connecting two external signal sources COVIC ea E E E 7341 6001 getemed 14 Intended use 2 Intended use This section provides information on the intended use of VitaGuard and the limitations of this intended use CAUTION Do not attempt to use VitaGuard for detecting obstruc tive apneas Obstructive apneas i e respiratory arrest following an occluded respiratory tract are not detected by VitaGuard Food debris or vomit for example can occlude the respiratory tract The doctor treating the patient is responsible for the application of VitaGuard The specific Information for the doctor and qualified medical staff can be found on page 99 getemed AG recommends qualified training for the caregivers in potentially necessary resuscitation techniques Clearing the respira tory tract and the resuscitation of babies
72. essssessess 120 Settings in the SPO menu SETTINGS PROTECTION OFF ou 121 Settings in the HEART RATE Menu SETTINGS PROTECTION OFF 123 Changing the ECG lead for signal optimization on eeeeeeeeees 127 Settings in the RESPIRATION menu SETTINGS PROTECTION OFF 129 Combining apnea alarms with heart rate and SpO alarms 130 TADC OT OPElAUN eS MOES arn R casement sen O 131 Algorithms and measuring principles ou eee 133 Alarm condition and report delays ssssessessssessssessesssseesessesesseseesesees 133 11 1 1 Alarm condition delay for the heart rate oo 133 11 1 2 Alarm condition delay for oxygen saturation 134 11 1 3 Alarm condition delay for respiration oes 134 11 1 4 Alarm report delays on ecesesesssseseseseseeeeseseseseseeeeeeeeeeeeeees 134 Measuring principle for the SpO monitor oe eee eeeeeeeeeteteeeeeeees 135 Measuring principle for the heart rate monitor oo eects 138 Measuring principle for the apnea monitor oo eeeeeeeeteteteteeees 139 Evaluating Stored data on aPC oieeeeceeeccssssseesssessneessesen 141 SPECIFICATIONS o eeeeccccceeeeessssssssneesssecssseeescccssnsesesceessnnnecsesssnnnesseeesnnee 143 GENETAL ssie E E E E tans EE E S 143 PONOT ae E E E E E E E E E E 145 Pedri PARC INONOL sie E E E 146 POCA TRONTON arerp ena E acc 146 Intervals for calculating average values in the INFO mask 147 MEMO meie E E E 147 PONIO sacar asec E nea estas scenic see ants ences E E E ae 147 WNISCETIANICOUS eroe E
73. et UPPER LIMIT Silent tachycardia heart rate higher than the set silent UPPER LIMIT Heart rate drop 00000 when activated Heart rate rise 00 00 when activated getemed 118 Information for the doctor and qualified medical staff Manual Mocs manual storage see MANUAL DATA STORAGE Or TRANSMIT DATA On page 116 Interval E sessies INTERVAL storage see SYSTEM INTERVAL RECORDING on page 113 Apnea X essees one or more successive apneas Silentapnea X uu one or more short silent apnea phases shorter than the set APNEA DELAY but longer than the SILENT APNEA DELAY Periodic respiration P_ periodic respiration see section 10 13 10 6 TREND storage When an episode is highlighted 5 Episodes i Mar 17 11 194s Current Episode pressing lt Enter gt once displays a har i708 2S the details and pressing ita A Mar 17 02 261s 4 Mar 16 57 266 s second time the trends A Mar 1653 265 s Spo HR PR Resp rate Max 99 120 16 Min ae Oe Trends Fig 85 List of the episodes stored in the trend memory Over a max period of 72 hours 4 Mar 17 06 262 s Spo HR PR Apnea the TREND memory stores all of ax 199 100 126 220 BS 20 the signals checked inthe TREND Min 88 80 column of the table on page 120 Lead Nr of electrodesI YE RD 3 Basal impedance 550 550 Ohm Graphics Press lt Enter gt Trends Fig 86 Detailed information on a highlighted t
74. for evaluating the recorded monitoring data This software is pro vided only to doctors and authorized dealers who are or supply VitaGuard users The stored data can be downloaded through the USB universal serial bus port to a PC where they can be stored viewed and evaluated VitaWin presents each alarm s context based on the signals RESPIRA TION RESPIRATION RATE BASAL IMPEDANCE ECG HEART RATE PULSE RATE SPO 7 PLETHYSMOGRAMME SIGNAL IO and PERFUSION VitaWin also provides functions for drawing up reports and assess ing the patient s monitored data getemed Evaluating stored data on a PC 142 YitaWin 2 99 Testversion geb 0 0 0 0 Jahre Messung 19 3 2000 21 10 2004 laj x Datei YitaWin Hilfe amp a getemed I l l I l l l 1 l T ol I ela nun Atm Atm fr 138 1 Amin 38 300 250 Pm 200 a aL ae eae Dein iiie i 150 1 Amin 100 50 0 EKG mm JI 5 29 mm s 100 Spo2 75 Pleth IQ Perf 41 08 25 1 08 28 8 ms F 397 1 391 Ho 393 lO 402 416 435 463 479 481 496 497 l 508 l 505 l EKG m 50 00 mmis IQ 1 0 4 08 11 4 08 12 1 08 13 4 08 14 4 08 15 44 08 16 I 150 7225 4 gt Alarme Trends Langzeit Statistiken Statusmeldungen p02 Abfall erkannt 20 10 2004 1 07 25 131s SpO2 88 100 Cardio 80 220 min Atm 20 s 5 29 50 00 mms 1 min 00s O min 06s fox Hier Mausklick
75. formation The tables in this section list in alphabetical order all the text mes sages that can appear on the VitaGuard display together with more detailed explanations and troubleshooting hints getemed 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 Message Meaning Apnea A respiration signal has detected not been detected for longer than the set APNEA DELAY Apnea and An SpO and apnea alarm SpO have occurred simulta neously ECG The monitor could not amplitude detect the ECG signal for low longer than the set ASYSTOLE DELAY Heart rate A heart rate alarm and an and apnea alarm have apnea occurred simultaneously Heart rate A heart rate alarm and an and SpO SpO alarm have occurred simultaneously Information No When there is no apnea 10 The electrodes are badly placed i e the signal is too small to be detected Cardiogenic artifacts are superim posed on the respiration signal so that it is rejected The monitor cable or electrode is defect The set APNEA DELAY is too short See messages and information for 4 Apnea dete
76. g and releasing the patient cable plug 59 Color coded sockets on the ECG patient cable s distributor 64 EICCUFOUSSOCKEE arcscecassceced pecraryuereethcoeesteeperecos AE ER 64 Recommended electrode configuration oe eeeeseseseseteteteteeees 66 Alternative electrode configuration for optimizing the Neart ANd respiration SIGNAIS oo eesecesesescssesececeseeeteeeeeeeeseseeeeeeeeees 66 Electrode signal amplitude in View 1 oo eeeeeeseeeeeseeteeeeeeees 66 Status line on the VitaGuard display oe eeeeeteeeeeeeeeeeeeeeeees 70 Characteristics of the high priority acoustic alarm signal 72 The status line displayed in all views oo eeeseseeseseeeseeteeeteeees 73 VION Gamer rere A E E rere rr sere T entre E 87 SV A E A A E A 87 Menu system LCD brightness 80 highlighted esses 88 System LCD brightness highlighted in the change window 88 System accept change to LCD brightness highlighted 88 System menu general settings e ssessssessessssessesssseeseseesessesesesses 89 System submenu Signal beep tone ssssessessessssessesseesessessesees 90 System submenu Alarm tone pitch essssssessessesssssssseseesesseseesees 90 SYSTEMA RS232 TOMAT seiceanna eise eiieeii 90 SpO view plethysmogram perfusion index andsignallQ 92 SpO menu for viewing and setting alarm limits oe 93 FH AUC FACS AISOIA oeren E E ms ccesateeearmeans 95 Heart rate menu for viewing and setting alarm limits 96 Respiratio
77. gnal 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 gt gt being powered from the supply network or an automobile power supply Mains supply active Block battery charging Fig 24 Power supply LEDs When the LED with the power adapter symbol does not light up but the usual monitor displays are visible VitaGuard is being supplied by batteries four non rechargeable batteries or the re chargeable block battery The light from the LED with the battery symbol is permanently on when the block battery is being charged in VitaGuard A depleted block battery takes up to six hours to recharge When the block battery is fully charged the LED with the battery symbol flashes every second to indicate that compensation charging is active The block battery must therefore be fully charged at all times in the event that the power supply from the external power adapter fails 4 5 The display Each of the Alarms displays and views during monitoring are ex plained on page 69 Pressing the lt key in View 1 takes you to the INFO screen with the current information for the doctor Pressing it again takes you to the System menu for the basic VitaGuard settings After the monitor is switched on it can take up to twenty seconds before the first values are displayed getemed Descripti
78. gs 9 2 Summary of views and menus The views presented here are intended to provide extensive informa tion on the monitoring situation When SETTINGS PROTECTION is Set to LIMITED they can be accessed with the direction keys lt and gt System Info View 1 View 2 View 3 spo Heart rate Respir Events Trend The keys A and V let you access more detailed information and enter menus for changing monitor settings The Aor V key takes you from the System view to the SYSTEM menu The first setting is highlighted The Aor V key leafs through pages on the Info display The Aor V key takes you from View 1 2 or 3 to the menu MANUAL DATA STORAGE Or TRANSMIT DATA This is explained in the corresponding section on page 116 The SPO 2 HEART RATE and RESPIRATION displays each feature a menu for adjusting the respective settings and can be accessed with the A or V key The first setting is highlighted The Aor V key takes you from the EVENTS or TRENDS views to detailed views WAVEFORMS and TRENDS 9 3 Additional views When the doctor has configured VitaGuard so that also the caregiv ers can change settings i e SETTINGS PROTECTION is set to LIMITED Views 2 and 3 are also activated in addition to VIEW 1 VIEW 1 is explained in the section The display on page 46 getemed Alarm and monitor settings 87 9 3 1 View 2 Large data presentation and waveforms View 2 displays in large digits the current va
79. he yellow red lead 1 Select the HEART RATE display and note the amplitude of the displayed ECG signal Press A to open the menu and note the set ting for the ECG LEAD e g I YE RD 3 2 Select a different ECG LEAD e g Il BK RD 3 Press lt Esc gt to return to the HEART RATE display and again note the displayed ECG am plitude 3 Repeat the procedure for the last setting i e III BK YE 3 4 Select from all three leads the one that produces the greatest deflection It is not important here whether this deflection is negative or positive Select the lead I YE RD 3 when this is one of two leads that have produced approximately equal amplitudes When none of the leads produces a particularly large amplitude you should change the position of the black electrode and repeat the procedure Carefully reapply the black electrode until you obtain the best signal amplitude When you reposition the electrodes e g as depicted in Fig 41 a you must again check the ECG amplitude and by repeating these steps select the best lead for this new electrode configuration getemed Information for the doctor and qualified medical staff 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 Status ok a tings when SETTINGS PRO
80. he alarm report delay are added to yield the ALARM SYSTEM delay The algorithms listed here are based on worst credible cases i e the calculations always return the maximum possible delays 11 1 1 Alarm condition delay for the heart rate The current heart rate used for detecting alarm conditions is calcu lated as the average value over a set number of heartbeats two to sixteen N l jl The higher the value selected for RR rn 60 L AR AVERAGING the longer VitaGuard n h N AVERAGIN needs before the displayed heart rate deat gt GING getemed 134 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 When for example the heart rate suddenly drops to thirty beats a minute a beat is detected every two seconds When RR AVERAGING is set to 16 a heart rate of thirty is not displayed until after thirty two seconds 11 1 2 Alarm condition delay for oxygen saturation An alarm condition delay as defined in the standard does not occur when oxygen saturation is monitored Please observe though the information on alarm report delays below 11 1 3 Alarm condition delay for respiration The impedance pneumography used to monitor apnea must rule out cardiac artifacts as the source of chang
81. her If you intend to reuse the same electrode a short time later carefully electrically conducting parts There must also be no contact with getemed Preparing for heart rate and apnea monitoring 63 other electrically conducting parts when electrodes become de tached during monitoring Attach the electrodes only to intact areas of skin Secure the electrodes and cables so that they cannot harm strangle or be swallowed by the patient Always lay the patient cable at a safe distance from the patient s head and neck Lay the patient cable when monitoring small children inside their clothing so that it exits at the foot On larger children and adults you can for example lay the patient cable so that it exits between the trousers and pullover Place the gel coated side of the electrode on the chosen site and carefully press it several times for a good contact New electrodes may be reattached several times Peel them gently from the skin starting at the edge When disconnecting the electrodes from the patient cable do not pull on the electrode s cable Pull the plug only If necessary secure the cable with an adhesive strip The skin should be dry and free of oil and grease Make sure when attaching and securing the patient cable that it cannot kink Kinking can cause damage Do not pull on the cable this is unpleasant for the patient and in addition can damage the electrodes getemed 64 Prep
82. hese sixty seconds neither the heart rate nor SpO experi ences a negative trend the monitor assumes a false apnea alarm and does not report it 10 15 Table of operating modes In the following table the heading Menu settings is divided into two columns one for the settings in the RESPIRATION menu and one for the settings in the SPO menu The HEART RATE menu cannot be used to set any values relevant to operating modes Which of the four vital parameters are monitored and whether apnea monitoring is COM BINED with HEART RATE and SPO gt depend on how the settings are combined The operating mode marked with 1 is the standard monitoring mode for heart rate and respiration as provided by Vita Guard VG 2100 The operating mode marked with 2 is the pulse oximetry monitoring mode as provided by VitaGuard VG 310 The setting Respiration COMBINED takes effect only when the SpOz monitor is activated getemed 132 Information for the doctor and qualified medical staff Menu settings Monitored vital parameters Operating modes Apnea SpO 7 monitor SpOz Pulse Heart Apnea Monitored vital alarms rate rate parameters Respira SpO2z monitor Heart rate tion OFF OFF Respira SpO2z monitor Heart rate and apnea tion OFF without combined ALWAYS alarm 1 Respira SpO2 monitor Heart rate and apnea tion OFF without combined COMBINED alarm Respira SpO2 monitor SpO and heart rate tion OFF ON
83. infant s foot Note that the SpO sensor type LNOP Neo for infants is described here as an example The doctor must decide which SpO sensor type to use in each case LNOP Neo is anSpO sensor for LNOP Neo Neonatal SpO Sensor a ern Secor Ee ee ee meee recrensronuse less than 10 kg fa 10 E Single patient use Non Sterile and Latex Free Fig 26 Label on the LNOP Neo SpO sensor LNOP Neo is free of latex is not sterile and cannot be sterilized The foot is the preferred attachment site on newborns Alternative sites are also the palms and backs of the hands getemed 56 Preparing for SoOz 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 An alternative attachment site is also the thumb 1 Open the packaging and remove the sensor Hold the sensor at the stem of the Y and remove the protective cover from both the sensor and the adhesive strip Align the end of the sensor so that the contacts point away from the patient Align the receiver along the fourth toe and press it against the sole of the foot Fig 27 2 Align the transmitter window along the top of the foot directly opposite the receiver Wrap the adhesive strip around the foot to secure the transmitter and
84. ing an upper limit when the patient is undergoing oxygen therapy getemed Alarms displays and views during monitoring 75 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 gt alarms on page 130 8 9 2 Technical SpO alarms The section Table of technical alarm messages on page 81 can be consulted for the technical alarm signals and the recommended troubleshooting procedures The SpO gt z monitor displays technical alarms with the corresponding messages Until the problem has been eliminated the SpO gt value and the pulse rate are replaced by a question mark symbol Perfusion and signal IQ are set to zero 8 10 Heart rate and apnea monitoring After the monitor is switched on it may take up to twenty seconds before the first values are displayed 8 10 1 Differentiating between heart and pulse rate In the menu SPO submenu SPO MONITOR the doctor can set the source for monitoring the heart rate when activating the SpO module Menu setting SpO2 monitor Source for monitoring heart rate switched off ECG signal heart rate ON HR ECG ECG signal heart rate ON PR Masimo SpO2 sensor pulse rate When the ECG signal is set as the source for monitoring the heart rate HEART RATE appears as the heading in various views In addi tion when this option has been activated Views 1
85. ith proper operation This is the case for example when an electrode has become detached When the signal registered by the SpO2 sensor is inadequate for the reliable measurement of values a message appears on the display Physiological data measured for a set period before and after an alarm are stored and can afterwards be evaluated and documented VitaGuard can be operated with the NA3000 2 power adapter 9 V the NAK3000 2 automobile power adapter e g in the cigarette lighter four non rechargeable batteries or a rechargeable block battery Non rechargeable batteries or the rechargeable block battery serve above all to safeguard the monitor s functions during a power failure and to continue monitoring the heart rate and oxygen satura tion when patients are in transit 2 6 Limitations on VitaGuard s intended use Even when operated in accordance with its intended use VitaGuard cannot detect all life threatening situations under certain unfavor able conditions 2 6 1 Obstructive apneas are not detected Obstructive apneas are not detected by VitaGuard The caregiver may have to remove food debris from the patient s oral cavity When an obstructive apnea at the same time triggers a bradycardia alarm heart rate too low or an oxygen saturation alarm SpO gt value too low resuscitation measures may need to be taken getemed 20 Intended use 2 6 2 Limitations of the heart rate and central apnea monitor
86. l the end of the sensor to withdraw it Fig 37 Disconnecting the sensor from the patient cable 6 13 Disconnecting the SpO patient cable from VitaGuard Using your thumb and index finger carefully press the two levers in the patient cable s monitor plug and carefully pull out the plug Fig 38 Two levers for securing and releasing the patient cable plug 6 14 Reusing and refastening SpO sensors When the SpO sensors are treated with care they can be used several times on the same patient as long as the adhesive surfaces still adhere and the transmitter and receiver windows are cleaned at regular intervals Disconnect the sensor from the patient cable before you reattach or refresh it There are replacement adhesive strips available for the LNOP Neo sensor used on infants getemed 60 Preparing for SoOz 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 Velcro strips are available for more sensitive patients Use a new sensor when the old one can no longer be properly se cured getemed Preparing for heart rate and apnea monitoring 61 7 Preparing for heart rate and apnea monitoring This section is divided into the following parts
87. lsating tone is emitted if the external power adapter is discon nected and no batteries are installed getemed Alarms displays and views during monitoring 73 8 7 The visual alarm signals A high priority alarm i e physiological alarm causes NO the alarm LED to flash red Amedium priority alarm i e technical alarm causes the alarm LED to flash yellow 8 8 Status line displays During monitoring the status line is displayed in all views a Status ok gt i Fig 46 The status line displayed in all views The monitor s text messages appearing on the left are explained in detail in the section Alarm messages meanings and other informa tion on page 77 On the right of the status line are three symbols Power supply The power supply symbol indicates whether the NA3000 2 external power adapter or the automobile power supply adapter is connected When a power adapter is connected rw the symbol appears as illustrated on the right Otherwise the symbol is crossed out Battery voltage indicator The battery voltage indicator depicts the voltage from the batteries When the block battery is being recharged this a symbol is animated i e a filling animation is displayed Alarm indicator When you interrupt an acoustic alarm by pressing the lt Esc gt key the bell symbol is crossed out To the left of 16 E the bell the remaining alarm mute time is displayed in seconds This
88. lues for the monitored sSpO2 n vital functions and on the right A VVV in smaller digits the set alarm Heart rate a son limits l E 2 Also each section on the left Resp 1 min presents a waveform of the monitored vital function Fig 47 View 2 9 3 2 View 3 Smaller data presentation and waveforms The top half of View 3 displays Statusok mm the current measured values and the alarm limits The bottom half of View 3 displays the waveforms over a longer interval than VIEW 2 Fig 48 View 3 9 4 Changing the settings Use the direction keys to highlight a menu option or an entry in this option Once you have highlighted the option you want press the lt Enter gt key to change it When you do not want to keep your changes press the lt Esc gt key getemed 88 Alarm and monitor settings The A key takes you to the menus The first entry in the list is high lighted Use the V key to high light the setting LCD BRIGHTNESS Changing multiple component settings is explained on page 109 for the doctor and qualified medical staff Screen saver LCD brightness LCD contrast Signal beep tone Alarm tone pitch RS 23 format settings protection Off Medium DIM Off Limited Fig 49 Menu system LCD brightness 80 highlighted Press the lt Enter gt key A window appears where you can change the old value Use the A and V keys to change the highlighted value S
89. moglobin COHb and methemoglobin MetHb levels can lead to imprecise Sp0 measurements An intra aortic balloon pump can distort these values For this rea son check the pulse rate against the ECG heart rate 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 monitored SpO gt values Circulatory centrali zation can arise when e g patients are anesthetized suffer from shock or are under great physical strain Ear sensors for example are available for short term applications A pulse oximeter may not be used as an apnea monitor getemed 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 A and V The current page number and the total number of pages are dis played in the top right For example 1 10 means the first of ten pages 10 2 1 INFO LAST STATUS MESSAGES The last status messages provide Last status messages 1 10 Status ok information on the directly 18 Apnea detected receding monitoring period 18 Status o p 5 8 P Apnea detectedll Here you can see when and why 17 Status ok Heart rate too lowll a message appea red Status ok Apnea detectedll Status ok Calculating heart rate 10 2 2 INFO GENERAL
90. monitor displays VitaGuard is being supplied by the batteries 4 1 2 Power failure without batteries VitaGuard is fitted with an internal battery This provides the volt age for an acoustic signal that is emitted when monitoring cannot be continued during a power failure The acoustic alarm from the internal battery does not stop until VitaGuard has been switched back on after the power adapter has been reconnected or batteries have been inserted A power failure jeopardizes monitoring when the batteries in the VitaGuard are nearly depleted or no batteries have been inserted and VitaGuard is disconnected from the external power adapter To stop the power draw on the internal battery it is important that non rechargeable batteries are inserted as quickly as possible or better the power adapter is reconnected VitaGuard must not be used for monitoring when the internal battery is depleted This status appears on the display A new internal battery can be installed at getemed AG only so you must continue monitoring with a replacement device until the inter nal battery has been displaced getemed 38 Description 4 1 3 Replacing batteries Switch off VitaGuard before replacing batteries Push back the catch and lift off the battery cover to open the battery com partment Insert either four non rechargeable batteries or the recharge able block battery Make sure that the sym bols on the
91. mute time applies only to the current alarm type getemed 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 lt Esc gt key a second time immediately ends the ALARM MUTE TIME The alarm bell outline indicates that all acoustic alarm signals ey are enabled In the event of an alarm the alarm bell is filled out and flashes ss 8 9 SpO monitor alarms After the monitor has been switched on it can take up to twenty seconds before the first values are displayed 8 9 1 Physiological SpO alarms The currently set alarm limits are always displayed When the dis played SpO gt value falls below the SpOz Lower LIMIT for longer than the period set under HYPOXIA ALARM DELAY or exceeds the SpOz UPPER LIMIT for longer than the period set under HYPEROXIA ALARM DELAY an acoustic alarm signal is emitted and the corresponding message is displayed The affected alarm limit and the alarm LED flash Go immediately to the patient when an alarm occurs and check the patient s condition When the SpO value returns within the permitted range the alarm is ended automatically In this case the affected alarm limit and the alarm LED continue to flash until the lt Esc gt key is pressed to indicate that an alarm has occurred The SpO UPPER LIMIT is deactivated when it is set to 100 factory setting We recommend sett
92. n 0 and 20 When the PERFUSION index is very small SoOz and the pulse rate are no longer monitored When the SENsITIvITy in the SoOz menu is set to MAXI getemed 138 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 11 3 Measuring principle for the heart rate monitor Every heartbeat i e contraction of the cardiac muscle generates a myopotential that propagates through the body as an electric signal and that can be measured by two sensing electrodes attached to the body The graphical depiction of the measured signal is called an 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 individual location of the heart The signal is very weak typically one millivolt so it must be ampli fied before it can be used to calculate the heart rate For this purpose an instrumention amplifier is used in conjunction with filter circuitry This amplifies the ECG signal and reduces all other unwanted secondary signals e g movement induced artifacts and electromagnetic interference Interference signals can be optimally suppressed when a third so called
93. n display respiration graph oo eeeeseeseseeeseseteteeeeeeees 97 Respiration menu for viewing and setting alarm limits 98 INTO LAST STALUS MESSAGES ceccecsnsscasscrescincessesenevsanceniensecausdasarsuswnsensy 103 AMO GCHCU AN spi E E EE E 103 Info Measurements SpO3 esessssessssessssesessesersesessesessrsesersesersesersesenss 104 Info Measurements Pulse rate s esssssssssssessesessesssseesesseseesessesessess 105 Info Measurements HR amp ReSp essssessessssessssessessssersessrsessesersesssss 105 Info Settings Oximeter s sssessssessesssseesesssseesessesteseseesesseseesesseseesess 106 getemed Fig 68 Fig 69 Fig 70 Fig 71 Fig 72 Fig 73 Fig 74 Fig 75 Fig 76 Fig 77 Fig 78 Fig 79 Fig 80 Fig 81 Fig 82 Fig 83 Fig 84 Fig 85 Fig 86 Fig 87 Fig 88 Fig 89 Fig 90 Fig 91 Fig 92 Fig 93 Table of figures Info Settings Heart rate Info Settings Apnea monitor occ eeecececececeeeeeeeeeeeteeseeeeteeees TON IWNGINOUY arae E E MOLVE IONS onra E E S Separately protected settings in the System menu VENA D O TING aeeie E E Operating area Home or CINIC esssssssssessesessesessesseseesessesesseseesesses Warning before changes under System Admit new patient System ID First name and Surname DY SECU ACS SROU oaen E eater E A E E E AEE Confirming the age group setting ss sssesssessessesessesseseesesseseesesss List of the stored events c cscscsasstsciesnessasseseoeatesdae
94. ndow presents all the sett Settings Oximeter 6 10 i or SpO Monitor On HR ECG ings for gt pO2 monitoring that are Sensitivity Standard not shown in Views 1 to 3 FastSat Off SpO average time os Silent lower limit 50 o Silent upper limit 100 o Hypoxia alarm delay 10s Hyperoxia alarm delay 10s Averaging interval 60s Trend deviation 5 SpO alarms Limits only Fig 67 Info Settings Oximeter getemed 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 Lead Nr of electrodes I YE RD 3 Silent lower limit 30 mi Silent upper limit Bradycardia delay Tachycardia delay Asystole delay RR averaging Averaging interval Trend deviation Trend deviation Heart rate alarms 50 Hz filter Fig 68 Info Settings Heart rate 10 2 8 INFO SETTINGS APNEA MONITOR This window presents all the sett ings for apnea monitoring that are not shown in Views 1 to 3 Settings Apnea monitor 8 10 Silent apnea delay Periodic respiration Period T1 Apnea Period T Resp Number of periods Min respiration rate Apnea alarms Fig 69 Info Settings Apnea monitor 10 2 9 INFO MEMORY INTERNET This displays the current MEMORY USED and the total MEMORY SIZE Also displayed is TELEPHONE i e the modem number that the monitor automatically dials for remot
95. nea monitoring The doctor can deactivate the apnea monitor in the RESPIRATION menu or combine the apnea monitor alarms with the heart rate and oxygen saturation monitor In this case apnea alarms are triggered only when after detecting apnea the device also detects deviations from particular average values in the monitored heart rate and or the monitored SpO gt This combination helps to reduce false apnea alarms When VitaGuard is to be used to monitor heart rate and respiration only the doctor can deactivate the SpO gt monitor in the SpOz menu In addition to the fixed alarm limits for the heart or pulse rate moni tor and the SpO 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 Settings in the SPO menu SETTINGS PROTECTION OFF on page 121 Settings in the HEART RATE menu SETTINGS PROTECTION OFF on page 123 getemed 18 Intended use Settings in the RESPIRATION menu SETTINGS PROTECTION OFF on page 129 Combining apnea alarms with heart rate and SpO gt 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 de
96. neaneesonennentes 43 4 3 1 Direction KEYS e ssessssessessssessesessesseseseseesesseseesesseseseseeseseeseeses 44 AOD LEMEK aea E IE E E 44 da ESCO a E E E E E ery 44 Color LEDs Light Emitting Diodes se ssssssesssossosseessesseosseessesseesses 45 4 4 1 Alarm LED seeseveuesecesonenseacsvesases ven coeveyeianesswewsvesepsoquedenenaveseeneseseres 45 4 4 2 Heartand respiration LEDS oe eeseeeeseeseeeeseeteseeeees 45 4 4 3 Power supply and battery LEDS s ssssssssssssessssessessesesseseesesees 46 TACA O e A E E cna unernas E EE E E 46 Steps before and after monitoring s sssssssssssssssseeessesssees 48 Summary of steps before monitoring ssssessssessesssseesessseesesseseesess 48 NICE O ie E E E A EE NE 49 SNU ANE OI ae E E 50 Summary of steps after monitoring s esssssssessssessessssesesseseesesseseesess 50 Preparing for SpOz monitoring essssssssssssssssssssesssesssseesseees 51 Safety instructions for SpO monitoring ssss sessessssessesseseesesseseesess 51 Operation of SPO gt SENSOMS sesssssssssesessesessesessssessrsesersesersesessrsessrseseeses 52 SpO sensor adapted to the patient s size and weight 53 Choosing the sensor site sccisasnsscscssssdccasoenssesoneeg cenensdensadondpananeaneasonendeates 53 Repositioning or replacing the Sensor es ssessessssessssessessesessesseseeseses 54 Reasons for unconvincing SPO gt values s s ssssessessssessesseseesesseseeseses 54 getemed 6 6 8 6 9 6 10 6 11 6 12 6 13
97. neously too low Pulse rate The calculated pulse rate When there is no tachycardia 7 too high exceeds the set UPPER Strong artifacts caused by excessive LIMIT for longerthanthe movement trigger false alarms set TACHYCARDIA DELAY The monitor cable or sensor is defect The set UPPER LIMIT is too low Pulse rate The calculated pulse rate When there is no bradycardia 6 too low has fallen below the set No pulse is detected LOWER LIMIT for longer There are abnormal beats than the set BRADYCARDIA The monitor cable or sensor is defect DELAY The set LOWER LIMIT is too high Pulse rate The current pulse rate When there is no pulse rate drop 11 drop has fallen below the The pulse rate and or the average detected value based on the set pulse rate is incorrectly calculated for when AVERAGING INTERVAL by the reasons given under Pulse rate activated more than the percent too low age deviation value set under TREND DEVIATION Pulse rate A pulse rate rise is When there is no pulse rate rise 12 rise detected in the same The pulse rate and or the average detected manner as a pulse rate pulse rate is incorrectly calculated for when drop but TREND DEVIA the reasons given under Pulse rate activated TION is used instead too high getemed Alarms displays and views during monitoring 81 Message _ Meaning Information No SpO too The calculate
98. nsaenescsndondensaanesnsoaaees Detailed information on a highlighted event Stored waveforms AOA TENOS oan E EEE A E E S View Manual data storage ssssessssessessesessesseseeseseesesseseesesseseesess View Transmit data List of the episodes stored in the trend memory Detailed information on a highlighted trend episode SENE MAE PO MEU eoe E E E Settings in the Heart rate Pulse rate menu ou eeeeeeeeeeeeeees Heart rate menu Lead Nr of electrodes submenu Settings in the Respiration menu Periodic respiration DST plot relative noise cancellation as a function of SpO VitaWin register Events in graph form 153 107 107 108 108 109 109 110 110 111 111 111 114 115 115 115 116 116 118 118 121 124 127 129 129 137 getemed 154 Table of figures Distributed by Manufacturer getemed Medizin und Informationstechnik AG Oderstr 77 D 14513 Teltow tel 49 0 3328 3942 0 fax 49 0 3328 3942 99 e mail info getemed de internet www getemed de getemed REF 7381 2021 O0027H1 LAB Rev B 08 06 2005 15 27
99. odes make sure that the plugs do not touch any other electrically conducting parts Make sure that there can also be no contact with other electrically conducting parts when the electrodes become detached during monitoring Treat all leads and connections with particular care and never use the connecting cables to lift VitaGuard Switch off VitaGuard before boarding an aircraft When you want to transport VitaGuard in your luggage you should remove the Stop using VitaGuard after the servicing interval of eighteen batteries This prevents other pieces of luggage from switching on getemed 24 Safety the device by accident An activated but disconnected VitaGuard will generate acoustic alarm signals 3 2 Allergy risks to patients Attach ECG electrodes and SpO gt sensors to intact areas of skin only So that the permanent contact with the electrodes does not put too much of a strain on the patient s skin the electrodes can be placed in the vicinity of the optimal site All materials that are used with VitaGuard and can come into contact with patient or caregivers during normal operations are free of latex and are non toxic in accordance with the standard ISO 10993 1 getemed AG recommends replacing the adhesive electrodes used to monitor heart rate and apnea as soon as they start to lose their adherence The special gel for the electrodes has been developed to avoid skin irritation even after several months monit
100. ompt you to insert new non rechargeable batteries or to recharge the block battery getemed Safety 31 3 6 2 Interruptions to the power supply When the external power adapter is connected VitaGuard operates automatically in supply network mode When the supply network fails VitaGuard switches automatically to battery mode when batteries are inserted As long as VitaGuard is powered from the external power adapter or the automobile power supply the green LED next to the power adapter symbol lights up Normal voltage fluctuations in the supply network do not adversely affect monitoring with VitaGuard Following a power supply failure the current alarm settings are retained for at least thirty days and are again available when the device is switched back on 3 6 3 Using the rechargeable block battery Note the warnings on the rechargeable block battery s label Do not open or short circuit Do not throw into a fire Avoid temperatures over 50 C The charging time for the block battery is at most six hours Fig 4 Rechargeable block battery Also note the recycling symbol on the label This means aX that the block battery must be recycled when its service life AA has expired Do not expose the block battery to direct sunlight For example temperatures greater than 50 C can easily occur on a vehicle s dashboard or rear shelf getemed 32 Safety When you intend to use VitaGuard powere
101. on 47 ta Status ok SpPO2 Heart rate 1 min Amplitude Good Amplitude Good Basal imp Ohm 550 Fig 25 Current values and alarm limits in View 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 For all vital functions as here SpO gt 2 the current value for each vital function 2a is shown in large digits Smaller digits to the right show the set alarm limits 2b In addition to the The HEART RATE 3 the quality of the signal am plitude 3a is shown on the left PULSE RATE will be displayed instead of HEART RATE 3 and PR 3b instead of HR if the pulse oxi meter is selected as the source for the heart rate alarms rather than the ECG electrodes The System menu lets you deactivate the simultaneous display of PR or HR 3b Pulse rate 1 min 20 RESPIRATION 4 shows in addition on the left the quality of the amplitude 4a and the basal impedance in ohms 4b This term is explained in the section Checking the BASAL IMPEDANCE On page 67 A respiration bar 4c moves up and down synchroneously with the patient s breathing getemed 48 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 q
102. optimal position By changing the ECG lead you can Lead Nr oe optimize separately the detection II BK RD 3 of respiration and heart signals for ENE VitaGuard Fig 89 Heart rate menu Lead Nr of electrodes submenu YE RD 3 yellow red 3 electrodes Both signals the heart and the respiration signal are measured between lt yellow gt and lt red gt BK RD 3 black red 3 electrodes Like lead I the respiration signal is measured between lt red gt and lt yellow gt the heart signal on the other hand between lt black gt and lt red gt I BK YE 3 black yellow 3 electrodes Like lead I the respiration signal is measured between lt yellow gt and lt red gt the heart signal on the other hand between lt black gt and lt yellow gt getemed 128 Information for the doctor and qualified medical staff YE RD 2 yellow red 2 electrodes This lead is used when only two electrodes are to be attached Test the quality of the signal from the heart rate monitor with all leads When View 1 displays the quality level Goon for at least one of these leads further optimization is not necessary The following explanations follow from the section Determining the optimal electrode configuration on page 65 The electrode arrangement as depicted in Fig 41 b on page 66 is the standard Einthoven arrangement and normally yields good results for heart rate monitoring with t
103. or detecting the ECG signal explanations in the following Activate this for pacemaker patients so that stimulating pacemaker pulses are not mistakenly processed as R waves explanations can be found under VitaGuard and other medical devices on page 101 When HEART RATE ALARMS Is set to LIMITS ONLY acoustic alarms are re ported when the measured values vio late the set alarm limits When HEART RATE ALARMS Is set to LIMITS amp TRENDS acoustic alarms are re ported when the measured values vio late the set alarm limits AND when there is a positive or negative deviation from the average heart rate measured over the set interval Information for the doctor and qualified medical staff 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 YE RD 3 yellow red 3 electrodes Signals can be optimized only when the patient is stil or sleeping Bear in mind when optimizing the ECG lead that there must be no changes to the optimized positions of the red and yellow electrodes for detecting the respiration signal When optimization becomes necessary only the black electrode must be repositioned When replacing the electrodes 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
104. or 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 4 2 4 Sound outlet no socket C NA3000 2 w fr 9V i Fig 15 Sound aperture The outlet in the figure is not a socket but a sound hole for the internal system monitor buzzer getemed 42 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 Ta NA3000 2 d USB Fig 16 USB port The USB universal serial bus port serves to read out stored data and to modify the VitaGuard settings via a PC 4 2 6 AUX port ol NA3000 2 lj v i ay USB me AUX port The AUX auxiliary port can take the following connections Two analog inputs Modem for communicating data Nurse call unit External alarm unit getemed Description 43 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 i
105. oring can continue without interruption only as long as the required consumables are available In emergen cies of this nature you can call your authorized dealer who provides 24 hour emergency services Please try however to avoid unneces sary stress for both yourself and your authorized dealer and order your consumables in good time The modem used to transfer monitoring data must comply with the requirements under the German and European standard DIN EN 60950 Safety of IT Equipment with the amendments A1 A4 These details are found in the modem s operating instructions 3 5 Handling patient cables Always lay patient cables at a good distance from the patient s head and neck Lay each patient cable inside the clothing and secure it in place in such a way that no harm can come to the patient or cable strangulation twisting Make sure when laying and securing patient cables that these can not kink kinking causes damage For hygiene reasons always use the same patient cable on the one patient Disinfect patient cables before using them on a new pa tient monitor should always be connected to the same patient cables and the same power adapter Faults can therefore be located and reme When more than one monitor is used in the one environment each died faster getemed Safety 29 3 6 Power supply reliability Before first using VitaGuard for monitoring familiarize yourself with the section Power su
106. oring on new borns Nevertheless patients with sensitive skin may suffer allergic reac tions in the form of reddened skin and blistering that in serious cases may look like burns When the skin exhibits such changes you must immediately inform the doctor A change of electrode type may help The use of SpO gt sensors with adhesive materials may cause problems when the patient develops an allergy to adhesive tape or similar 3 3 Possible external interference to monitoring Please bear in mind the possibility of other risks that are not listed here that can be caused by your specific monitoring environment getemed Safety 25 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 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 such that they could fall on the patient For example the power adapter could become detached from an overhead socket when the cable is pulled Do not immerse either VitaGuard or the accessories in liquids Variations in temperature and air humidity could l
107. ow this limit for longer than the set HYPOXIA ALARM DELAY getemed 94 Alarm and monitor settings UPPER LIMIT ccccccsecccsesccescees SPO MONITOR ceesecesseeeseeees 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 OFF ON HR ECG ON PR MASIMO Here you can view or set the following whether the SpOz monitor is deacti vated or when it is activated whether the heart rate derived from the ECG electrode signals or the pulse rate de rived from the SpO gt sensor is used as the alarm criterion 9 7 HEART RATE display and menu Depending on the setting in the SPO menu you can decide whether the heart rate derived from the ECG electrode signals or the pulse rate derived from the SpO gt sensor is used as the alarm criterion The gt key takes you from View 1 2 or 3 to the heart rate display From here you can open the menu with the A or V key When a row is highlighted press lt Enter gt to change the corresponding value getemed Alarm and monitor settings 95 9 7 1 HEART RATE display The top half of the display presents 1 bop g i rate aa i 1min Hee 220 ay 2 1 thestatus line _ D me eee 3 2 the current values with the set alarm limits let 3 the current three minute ALLELE trends that update the last
108. pedance of the electrode skin interface impedance of the electrodes themselves and the patient cable getemed 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 If not wait for about fifteen minutes When the basal impedance has still not fallen you should use new electrodes When the displayed basal impedance does not lie within the specified range or when false alarms frequently occur the doctor or the medi cal caregivers should observe the instructions in the section Changing the ECG lead for signal optimization on page 127 getemed Alarms displays and views during monitoring 69 8 Alarms displays and views during monitoring Immediately call the emergency services when a patient remains unconscious after being shaken or addressed 8 1 Alarm test CAUTION When beginning monitoring at a new site make sure that you can clearly hear the alarm signal and quickly reach the patient For this purpose deliberately trigger a technical alarm When a patient is connected there are two ways you can deliberately trigger an alarm 1 pull the red electrode plug out of the distributor on the ECG patient cable or 2 disconnect the SpO sensor from the SpO patient cable 8
109. power adapter EESTE for European supply networks For other supply net cA works contact getemed for the appropriate plug adapter Observe the information in Power supply reliability on page 29 Fig 6 Power adapter socket VitaGuard is normally supplied by the power adapter Fig 7 left in the 230 V 50 Hz supply net work The NAK 3000 2 automo bile power supply adapter Fig 7 right for vehicle dashboards can be inserted in this socket Fig 7 Power adapter for 230 V 50 Hz supply network and automobile power supply When VitaGuard is supplied by the external power adapter the green LED lights up next to the power adapter symbol In addition the display backlight is activated when VitaGuard is switched on When VitaGuard is supplied by the power adapter only without in serted batteries a display message will prompt you to insert batteries When VitaGuard is supplied by the power adapter charging of the inserted rechargeable block battery is activated The LED next to the battery symbol illuminates getemed Description 37 4 1 1 Power failure with inserted batteries VitaGuard automatically switches to battery mode when the exter nal power supply fails or the power adapter is disconnected In this event a technical alarm is permanently emitted until the power supply has been reinstated or the lt Esc gt key pressed When the supply network LED is off but you can still see the usual
110. pply on page 36 Monitoring is safe guarded only when the power supply is in perfect operating order CAUTION Danger of electric shock Never open the external power adapter or the connecting cable Exclusively the NA 3000 2 approved for VitaGuard must be used as the external power adapter VitaGuard is usually delivered with the external power adapter for European supply networks For other supply networks use only the plug adapters available from getemed AG Do not use the external power adapter in sockets that can be switched off or dimmed multiple socket outlet only the modem may be connected to this outlet simultaneously When an extension cable is used with a multiple socket outlet this outlet must not lie on the floor Otherwise water may penetrate the When the VitaGuard external power adapter is plugged into a outlet and damage the monitor The external power adapter and the power outlet must be free of damage Never use the external power adapter s cable to lift VitaGuard Stop using the external power adapter when it has fallen or been dropped Do not operate the external power adapter in a damp environment e g in the bathroom Always leave the batteries in VitaGuard even when this is oper ated through the external power adapter getemed 30 Safety VitaGuard operates with batteries either non rechargeable batter ies or a rechargeable block battery VitaGuard
111. r defibrillation Bear in mind that an external defibrillation pulse can be attenuated A test in accordance with DIN EN 60601 2 49 showed that defibrilla tion pulses emitted during monitoring with electrodes and SpO gt sensors are attenuated by less than 10 Do not use VitaGuard in conjunction with HF surgical equipment TENS devices or nerve stimulators getemed 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 Do not operate VitaGuard near MRI devices magnetic resonance imaging or other systems that generate strong electromagnetic fields The electrode leads for example can heat up by induction causing burns under the electrodes and fire in the cables The strong magnetic fields generated by magnetic resonance image devices can cause permanent damage to VitaGuard 10 1 4 Safety instructions for the doctor SpO2 monitor Regard the SpO gt monitor as an early warning device When the SpO gt monitor tends towards too low blood oxygen saturation blood samples should be analyzed to clarify the situation Intravascular coloring agents and the associated possible rise in carboxyhe
112. ra tion SpO gt 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 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 6 4 Choosing the sensor site Always choose a site that is intact has good blood flow and covers completely the receiver window Information on choosing the right attachment site can be found on the sensor s packaging Choose a site such that the sensor s transmitter and receiver can lie exactly opposite each other The distance between the transmitter and the receiver should not be greater than two centimeters getemed 54 Preparing for SoOz 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 6 5 Repositioning or replacing the sensor Sensors used for a long time do not adhere as well as new ones When VitaGuard does not display plausible values for the pulse rate and oxygen saturation the sensor may not be attached to the opti mal site or may not be properly secured Check the sensor s position and if necessary move the sensor to a
113. rds signals witha lower rate of occurrence NOTE Changing the min respiration rate to 5 min has an effect only when the age group has been set to O To 2 YEARS under Sys TEM ADMIT NEW PATIENT see SYSTEM ADMIT NEW PATIENT restor ing factory settings on page 110 For the age group 2 To 6 YEARS the min respiration rate is fixed at 5 min for the age group gt 6 YEARS at 4 min 10 14 Combining apnea alarms with heart rate and SpO alarms When APNOE ALARMS is set to COMBINED it is important before monitoring that the AVERAGING INTERVAL and the TREND limit s are set in the SPO and HEART RATE menus A threatening central apnea causes changes to the heart rate and oxygen saturation Setting APNEA ALARMS to ALWAYS however fre quently reports an apnea alarm when in fact only the signal ampli tudes are too low Setting APNEA ALARMS to COMBINED helps prevent these false alarms Setting APNEA ALARMS to COMBINED starts an observation period of at least 60 s when no respiration has been detected getemed Information for the doctor and qualified medical staff 131 for at least 8 s for the age group O 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 gt 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 When in t
114. red as contour lines around a hill on a map When two persons are standing on the same line the difference in height between these persons is zero Accord ingly no ECG signal can be measured when the sensing electrodes are placed on such a line on the body surface To prevent too weak ECG signals from triggering false alarms it is therefore important that the optimal electrode positions are determined before the start of moni toring 11 4 Measuring principle for the apnea monitor Unlike the heartbeat respiration is not accompanied by its own electric signal A different principle must therefore be adopted for measuring respiration The most common method is the so called impedance pneumography Fluctuations in impedance are caused by both respiratory movements of the thorax and other movements For this reason an apnea monitor can function correctly only when the patient is lying still Here too the measured signals are very weak and must be amplified To prevent false alarms wherever possible it is getemed 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 getemed Evaluating stored data on a PC 141 12 Evaluating stored data on a PC getemed AG has developed the Windows based software VitaWin
115. reference electrode is used Without this reference electrode the ECG measuring circuitry must suppress interference signals solely with the aid of filters When however interference signals exceed a certain limit suppression is no longer possible and the ECG signal can no longer be measured false alarms are the consequence The use of a reference electrode is the most common method for effecting an essentially greater suppression of interference getemed Algorithms and measuring principles 139 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 Normally the amplitude of the ECG signal detected on the body surface cannot be influenced and varies from person to person The monitor measures the potential difference between the two sensing electrodes Depending on where the electrodes are attached the measured signal is strong weak positive or negative It is even possible that a signal cannot be seen at all This is the case when the electrodes are inadvertently placed on the same potential line The propagating signal from a heartbeat can be pictu
116. rend episode getemed 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 when monitor settings are changed and when the device has been switched on and off The following changes are stored in PROTOCOL memory Monitor ON OFF SpO monitor ON OFF Apnea monitor ON OFF Admission of a new patient Changes to SETTINGS PROTECTION The following data are stored with every change Date and time of the change The current monitor settings Protocol memory deletes the oldest data when more than 256 entries are stored getemed 120 Information for the doctor and qualified medical staff 10 9 Summary of stored signals and data masa a Pe Te Currentheartrate J oo oo o o o o cam deviation Respiration ww Respiration rate ww Basalimpedance o o 1 o o ov o a Average SpOafor trend deviations 1 v v a ENE Average pulse rate for trend deviation Averagepulserateovertmin 02 v xv v Average pulserateover6h 02 v ox v Average pulserateover32h 02 J v o v Jy Plethysmogam aa Perfusion we Signalo aw we Statusgrph tw Fe a a ax ooo d a e me e tt H
117. respiration and heart signals are detected using the same elec trodes The optimal electrode configuration involves finding good signal amplitudes for both the respiration and the heart signals simultaneously getemed AG recommends that the responsible doctor determine the optimal electrode configuration In most cases this configuration can be retained for the whole period of monitoring 7 4 1 ECG lead electrode color coding Start with the electrode configuration depicted in Fig 41 see next page First arrange the electrodes on infants as depicted in Fig 41 a this electrode configuration has often proved successful because the abdominal wall of infants clearly moves synchronously with the respiration the electrodes on all other patients as depicted in Fig 41 b getemed 66 Preparing for heart rate and apnea monitoring a or b Fig 41 Recommended electrode configuration If the electrode configuration 7 depicted in Fig 41 does not yielda Sai scien good signal quality you can also try the alternative electrode configura red tion depicted in Fig 42 AS f KA black 3 Fig 42 Alternative electrode configuration for optimizing the heart and respiration signals 7 4 2 Optimizing the heart and respiration signals signal amplitudes in View 1 The amplitudes of the heart and respiration signals are displayed under the headings HEART RATE and RESPIRATION respectively in VIEW 1 go Stat
118. rms physiological and techni cal alarms A physiological alarm is generated when VitaGuard detects values that violate one or more of the set alarm limits for longer than the set period There are simple alarm limits e g the LOWER LIMIT for the HEART RATE and there are alarm limits based on the interaction of several monitor settings e g the deviation alarms Combining apnea alarms with heart rate and SpO gt alarms is ex plained on page 130 getemed Alarms displays and views during monitoring 71 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 When for example a technical alarm condition relevant to SpO gt has occurred yet at the same time a physiological alarm condition has been detected by the heart rate and apnea monitor the physiological alarm condition has priority and the physiological alarm is reported When on the other hand a technical alarm condition has been detected by the heart rate and apnea monitor and at the same time the SpOz monitor detects a physiological alarm condition again the physiological alarm condition takes priority NOTE An alarm mute time of ten seconds follows a technical alarm triggered by problems with the ECG electrodes or the
119. s Long term full disclosure max 8 hours 13 7 Ports LYONS E E mini USB port getemed 148 Specifications AUX vicccccescscssccsscscsscsesscsssssseeseees modem port RS232 socket for a nurse call system socket for an external alarm unit socket for two analog inputs from 0 to 2 5Vatilor 32 Hz 13 8 Miscellaneous German Hilfsmittel NUMMET cacnsnaterststatensecacteacnennss 21 24 02 5005 Calibrating time after ACTIVATION woe eeeeeeeeeteeeeeeees lt 605 MPG device class oo IIb Device protection class Il as per DIN EN 60601 1 Application part on BF for SpO3 CF for heart rate and respiration Ingress protection seses IP 21 Operating temperature 5 40 C Operating humidity 5 95 non condensing Ambient pressure height above sea level 1060 500 mbar 304 to 5486 m x Storage and transport CONCITIONS eesesesscesseesren 40 to 70 C humidity 15 95 non condensing EMC classification CISPR 11 class B Observe the information on the electrodes packaging for the stor age temperature of electrodes getemed Specifications 149 13 9 Selection of applied standards HEC GOI acoso sepiceresepsteresoeaseustces Medical electrical equipment Part 1 General requirements for safety incl A 13 IEC 60601 1 1 ee Medical electrical equipment Part 1 1 General requirements for safety Colla teral standard
120. s 73441101 NAK 3000 2 automobile power supply adapter 73441201 Rechargeable block battery eee eeeseseeseeeseseseceseseeeteteeseeeeeeeees 7344 2201 PK1 8P ECG patient cable occ eeseseeseseseseeeeseseseeeseeseesseesees 7341 1001 Kitty Cat neonatal electrodes PU 30 pcs w eeeeeeseseeteseeee 70222 Masimo PC08 SpO patient cable 2 44 M ween 70257 Masimo LNOP NeoPt SpO sensor PU 20 pcs for one patient use only infants lt 1 kg we eeeeeeeteeeeeeeeee 70250 Masimo LNOP Neo SpO sensor PU 20 pcs for one patient use only infants lt 10 Kg oo eeeeeeeeeeeeeeee 70251 Masimo LNOP Pdt SpO sensor PU 20 pcs for one patient use only pediatric slender finger 10 50 kg 70252 getemed General view and list of accessories 13 Masimo LNOP Adt SpO gt sensor PU 20 pcs for one patient use only adult gt 30 kg we eesesseseeeeteseeteeeees 70253 Masimo LNOP DCI reusable sensor gt 30 Kg wee eeeeeseeeeteeteteeee 70254 Masimo LNOP DCIP reusable sensor 10 50 kg oes 70264 Other models are available in addition to the SpO sensors listed here Operating instructions English oe eesesseeseeeseeeeeeseeteeees 7381 2021 Alarm chart English sacticiceties stich nenieeeeeneeie 7383 1021 Operating instructions German o eeeseseseeeeseeeeeeseseeteseseees 7381 2011 Alarm chart German wicccccccsccssccsssscsscscsscscsscsssscsssscsssscsseees 7383 1011 Operating instructions Turkish oo eeeseseseseseeeceeees
121. sages are repeatedly dis played When you discover disruptions if possible switch off the interfering equipment or move this equipment to another site VitaGuard uses high frequency signals exclusively for its internal functions As a result its emitted interference is very low and dis When the monitor has to be placed next to or on other equipment ruption to neighboring electronic equipment is unlikely False diagnoses are possible when monitored values are corrupted by interference from electric or electromagnetic fields and this escapes the doctor s attention Every time you analyze stored data consider the possibility of interference from electric or electromag netic fields VitaGuard s emitted interference and immunity to external interfer ence are within the limits for life supporting systems 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 in these and the accessories operating instructions 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 getemed 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 monit
122. seseteeeeeeceseneeeeeteeeeeeseaeeees Alarm ANd monitor settings oie eeccccceeteeccesssseeesseessnneeseeeen Safety instructions for the alarm Settings oe eeeeseseeteeeeeeeeees Summary of VIEWS and MENUS ascasessncssessncsssnseosensitsnecnnedsreseontraosssberaasss ACON ONAT VICWS ae E E E E EE EEEE 9 3 1 V ew 2 Large data presentation and waveforms 9 3 2 View 3 Smaller data presentation and waveforms Changing the settings ssssssessssessesessesssssesesssseeseseeseesrstestseseesesseseesess SYSTEM menu general settings cesscsssenessanscousstussstcsunscarasceseatsrsuseresdye 9 5 1 SCREEN SAVER OFF ON esssssesssesssesesesesesesesesesesesssessssssreese Loe ALCO BRUGES mer cae neteneepat ce doteurentateat oe onset Do LCE CONTA T a EAEE AEE Do VAC NALEERT TONE pa E AE EN 93 3 MALARM TONE PITCH seressiniiseipiriieorsiniosoiriei meira rinisin i iin LIO ERAL TFORMAT a E AE ene 9 5 7 SETTINGS PROTECTION ON LIMITED OFF esssessssssssesee SPO CISPIAV AMG IMCL aa E E E 96A PO VICW siooni 9 6 2 SPO menu alarm settings SETTINGS PROTECTION LIMITED ievececeeccscscescsscseescsscsseseeees HEART RATE display and Menu sccicsaessvessnnsarenes ousiacessucwateccxtdasossesateests Ol FEART RATE OIS DIY sonce E 9 7 2 HEART RATE menu alarm settings SETTINGS PROTECTION LIMITED nasssssssssssesssesessesesesererersrsrsen RESPIRATION display and MENU nessssssesssssssesssseesesssseeseseesesseseesesseseesesss 9 8 1 RESPIRATION display sss
123. sessssessessssessesssseesssessesssseesesssseesesseseesess 9 8 2 RESPIRATION menu alarm settings SETTINGS PROTECTION LIMITED uuvecececscssescssccescsseseeseeees getemed 10 10 1 10 2 10 3 10 4 10 5 10 6 10 7 Table of contents Information for the doctor and qualified medical staff 99 Safely iNSUUCHONS lt ccricscetsesecsesaiengqsnedeseeanicegeteaesonasatends En EE e SEN 99 10 1 1 Preparing for a new patient oe eeeeeteteeeeeeeeeeeteees 99 10 1 2 Connections to the USB and AUX ports oo eeeeees 101 10 1 3 VitaGuard and other medical devices wu 101 10 1 4 Safety instructions for the doctor SpO monitor 102 INFO display oe seereven go msayaner asenenererepes enevaueeseesepeteoesensoevesep ange msarencemeoanensomeres 103 10 2 1 LAST STATUS MESSAGES oe eececescesccssecesceseeeseeeseeeneeeneeeeeeseeeees 103 LOZA AGENERAL ceee E E E 103 10 2 3 AMEASUREMENTS SPO 5 sanioris 104 10 2 4 MEASUREMENTS PULSE RATE cescesesseesseeseceseeeseeseeeseeenes 105 10 2 5 MEASUREMENTS HR amp RESP neesssssesssessesseseesessessessesseseses 105 10 2 6 SETTINGS OXIMETER nssssssssssssessesrsseesesseseeseeseesessesseseesseseeses 106 10 2 A SETTINGS HEART RATE sssccsscccccrastssctcsacesvecsetesscuceteacsqnteanseceetee 107 10 2 8 SETTINGS APNEA MONITOR ccesscescessceseeteeseeeseesseeseesenseees 107 10 29 NAVVEIWORY INTERNET sarprvegnan oro 107 LOZ LO NNER SIONS a E E E E 108 Settings in the SYS
124. set PRE and A eE POST ALARM TIMES just like in an alarm situation Fig 83 View Manual data storage The AUX socket is used to trans Manual data storage mit data via a modem The setting SINCE LAST TRANSMISSION transfers only those new epi aa ere sodes stored since the last trans Last 20 episodes fer but no more than twenty The setting LAST 20 EPISODES always transfers the last twenty episodes Fig 84 View Transmit data getemed 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 SpOz low HF eee oxygen saturation lower than the set LOWER LIMIT Silent SpOz low _ measurement lower than the set silent alarm limit SpOz high Boe oxygen saturation higher than the set UPPER LIMIT Silent SpOz high f _ measurement higher than the set silent alarm limit SpO7 drop Fee when activated ORS S aerer ORS signal amplitude lower than the internal trigger threshold an ORS alarm is reported when the ECG sig i T nal has not been 7 N detected e g ow ing to badly posi tioned electrodes Bradycardia wo heart rate lower than the set LOWER LIMIT Silent bradycardia heart rate lower than the set silent LOWER LIMIT Tachycardia ow heart rate higher than the s
125. son can pick up on certain carpets must not discharge through the VitaGuard connec tor sockets or the electrodes electrically conducting parts For this reason avoid touching the electrically conducting parts or discharge any electrostatic build up beforehand by for example touching an earthed water pipe or heater 3 3 4 Electromagnetic interference VitaGuard is not designed for applications near strong electromag netic fields These interference fields are frequently emitted by devices with large electric power consumptions Keep a good dis tance from e g washing machines computers microwaves vacuum cleaners power tools etc The device and the system can be used in the home and in all other environments that public utilities supply directly Bear in mind that portable and mobile HF communication devices e g cellular phones radio equipment walkie talkies etc can inter fere with the monitor and influence its operability Bear in mind that non approved accessories can amplify emitted interference and reduce the device s immunity getemed Safety 27 Do not place the monitor directly next to other electrical equipment and do not stack monitors on top of each other check that the monitor operates as designed in this environment We recommend you to check at regular intervals that the displayed signals are not disrupted when the patient is not moving whether the same technical alarm mes
126. t procedure in this case An alarm chart is available from getemed AG when monitoring children This alarm chart presents a sequence of activities that are considered suitable by many medical specialists and pediatricians getemed Safety 23 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 Make absolutely sure that you can react to an alarm within a few seconds Move away from patients only so far that you can reach them within ten seconds When you are not sure that VitaGuard is in perfect operating order check the patient s vital functions Under no circumstances should you use VitaGuard when you suspect a device defect In the event of ANY suspected VitaGuard malfunction continue to observe the patient until you can use a replacement monitor or VitaGuard has been examined by the doctor or authorized dealer months has expired Before the end of this period make an ap pointment with your authorized dealer to check the safety and operability of your device Test the acoustic alarm unit every time you switch on VitaGuard This is explained in the section Alarm test on page 69 CAUTION When attaching the electr
127. t of the two signals is then formed as follows R 660 S 940 The result R is used to read the corresponding SpO gt value out of an empirically calibrated table mapped in the oximeter software These tables were drawn up in trials 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 for its oxygen content Unlike conventional pulse oximeters Masimo SET pulse oximeters assume that not only the arterial also the venous blood flow varies greatly Changes to venous light absorption are regarded as a signifi cant source of interference to the pulse signal The SoOz module separates the signals for both wavelengths S 660 and S 940 into an arterial signal Sand a noise component N that are then used to calculate the ratio R S 660 S1 N1 S 940 S2 N2 R S1 N1 S2 N2 N1 and N2 are the noise components generated by venous blood The DST method discrete saturation transform isolates and there fore compensates for venous interference components getemed Algorithms and measuring principles 137 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
128. t takes for an alarm to be reported and the time needed to reach the patient No more than ten seconds must pass between these times Observe the operating instructions for the nurse call unit 4 3 Membrane key panel Do not apply excess pressure to the keys VitaGuard recognizes key presses only when the keys have been pressed for about one second There are six membrane keys on the top side of VitaGuard VitaGuard VG 3100 fcr Status ok SpO2 D WWV Herzrate me A o D som Fig 18 Keys on the top side getemed 44 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 ae the menu structure Fig 19 Direction keys 4 3 2 lt Enter gt key The lt Enter gt key switches VitaGuard on and off ea Enter The lt Enter gt key also lets you confirm changes to the monitor settings O O Fig 20 lt Enter gt key 4 3 3 lt Esc gt key When an alarm is triggered the lt Esc gt key serves to deactivate the acoustic alarm signal for a set alarm mute time During an alarm condition the red alarm LED and the violated alarm limit flash The acoustic alarm is again emitted if the alarm condition persists af ter the alarm mute time has expired Pressing the lt Esc gt key during the alarm mute time a second time reactivates the acoustic alarm Fig 21 lt Esc gt key
129. tched on The technical alarms for cable and electrode monitoring are not activated until the patient cable is connected and the first plausible data have been calculated A text message in the status line reports from the beginning that the cables are being checked After the device has been switched on the following displays and signals show you that the monitoring system is fully operable All indicator LEDs light up briefly During this time the alarm LED first lights up red and then yellow A brief tone is emitted to indicate that the acoustic alarm buzzer is Tully operable If the alarm buzzer does not emit the acoustic signal after the device has been switched on you must immediately send VitaGuard to getemed AG or your authorized dealer for inspection Please consult your authorized dealer for a replacement device Observe the patient carefully until the replacement device arrives Bear in mind that the patient is not being monitored at this time and that no alarm will be reported in an emergency getemed 50 Steps before and after monitoring 5 3 Switching off Always switch off VitaGuard in the manner described here 1 Press the lt Enter gt key and keep this pressed the message PRESS ESC KEY appears 2 Briefly press the lt Esc gt key still keeping the lt Enter gt key pressed and then release both keys The switch off command is acknowledged by two short beeps Data must be stored before the de
130. ted adapter been disconnected or press the lt Esc gt key Recharge The battery voltage is too Operate the monitor with the external battery low the monitor can no power adapter to recharge the block longer operate reliably battery or insert non rechargeable batteries Replace The battery voltage is too Insert new batteries or a new block 33 batteries low the monitor can no battery or operate the monitor with longer operate reliably the external power adapter getemed Alarms displays and views during monitoring 83 Message Meaning Cause or elimination No SpO gt Check The SpOz module reports Connect the SpO cable 26 cable that the SpO cable is not Replace the SpO cable if this message connected persists SpO gt The SpO module reports Replace the SpO sensor Defective that the SpO gt sensor is sensor defect SpO gt The SpO module is not Switch off the monitor wait for thirty Hardware __ supplying data seconds and switch it back on if this fault message persists the monitor is defect SpO gt The SpO module detects Locate any interference sources in the Interfer electromagnetic interfer direct vicinity and if necessary remove ence ence them SpO Pulse When switched on at When this message is displayed during search first the SpO module monitoring check whether the sensors reports that it is search are secured and positione
131. the lt Enter gt key Fig 76 System ID First name and Surname Pressing the lt Enter gt key to confirm your entry in the SURNAME menu opens the submenu for setting the age group Here too press the lt Enter gt key to confirm your age group settings Admit new patient to 6 years gt 6 years Fig 77 System Age group Use the lt key to highlight Accept Admit new patient Yes and then press the lt Enter gt key to 2 years your settings for the new patient are stored Accept Yes Fig 78 Confirming the age group setting The ADMIT NEW PATIENT function restores the factory settings VitaGuard is delivered with alarm limits for patients in the O To 2 YEARS age group The following settings vary with the age group m the minimum RESPIRATION RATE in the RESPIRATION menu getemed 112 Information for the doctor and qualified medical staff m the LOWER LIMIT and the UPPER LIMIT in the HEART RATE Menu The table lists the factory settings for each age group tro 2 vers 2106 EARS gt 6 veaRs Lower HEART RATE LiMT min 80 o 60o O55 UPPER HEART RATE LIMIT min All other settings are not specific to age groups MIN RESPIRATION RATE MIN 55 120 The values set last are retained when VitaGuard is switched off and when the supply network or batteries fail to provide power 10 3 4 SYSTEM PRE and POST ALARM TIME In the event of an alarm data for the PRE AL
132. the factory setting STAN DARD is recommended PASTORAL R ETR When FastSAT is On this effectively takes a pulse to pulse measurement getemed 122 Information for the doctor and qualified medical staff AVERAGE TIME essensen SILENT LOWER LIMIT SpO gt SILENT UPPER LIMIT SPO3 HYPOXIA ALARM DELAY HYPEROXIA ALARM DELAY AVERAGING INTERVAL 00 getemed 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 4 6 8 10 12 14 16 seconds Here you can view or set the period dur ing which the SpO module uses the sensor data to determine each SpO gt and pulse rate value 50 51 99 100 Lower alarm limit for the measured ar terial oxygen saturation when the measured value falls below this limit for longer than the set HYPOXIA ALARM DE LAY a silent alarm is stored 50 51 99 100 As SILENT LOWER LIMIT SPO gt but with the HYPEROXIA ALARM DELAY 1 2 10 19 20 seconds Time between when desaturation is de tected SpO gt too low and the corre sponding alarm is triggered 1 2 10 19 20 seconds As above but with the UPPER LIMIT for SpO2 10 20 60 110 120 seconds The average SpO measured over the set interval yields the reference value for calculating the TREND DEVIATION Information for the
133. tored a signal at input 2 is scanned with 32 Hz and stored 10 3 9 SYSTEM INTERVAL RECORDING The doctor can use INTERVAL RECORDING for specific situations and can set an interval in steps of ten minutes after which monitored data are again stored After each of these intervals the monitor stores data for the PRE ALARM and POST ALARM TIMES The setting O MIN deactivates interval recording 10 3 10 SYSTEM SHOW PR HR This lets you set whether the HEART RATE HR and the PULSE RATE PR are displayed simultaneously in View 1 and 2 10 4 Data storage functions The function ADMIT NEW PATIENT in the SYSTEM menu overwrites all the currently stored data and restores the factory settings If neces sary transfer the data beforehand to a PC getemed 114 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 EveENT 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 LONG TERM Storage automatically for max eight hours PROTOCOL storage automatic The VitaGuard display lets you view stored EVENTS and stored TRENDS LONG TERM and PROTOCOL storage can be evaluated on a PC only The Summary of stored signals and data on page 120 presents the signals an
134. try When you want to Date time Change 4 change the entry press the lt Enter gt key Pressing the lt Esc gt es Language English I 6 Analog input 1 Hz Off key discards any changes with Analog input 2 32 Hz Off Interval recordin O min Out saving Show PRAHR Yes System Fig 72 Separately protected settings in the System menu 10 3 1 Changing multiple component settings The following example for changing the date and time in the SYSTEM menu is intended to explain how you can change system settings consisting of several components Use the V key to highlight the entry DATE TIME RS 232 format Off Press lt Enter gt A window appears Settings protection Off Operating area Home for chan SIN the old ent y Admit new patient Mustermann Alarm mute time Use the keys lt and to high light the component you want to d yyy hh mm change amp 05 16 48 The highlighted value is changed with the keys A and V Fig 73 System Date time getemed 110 Information for the doctor and qualified medical staff After changing a value pressing the lt Enter gt key a second time causes a prompt to appear with Accept No highlighted Press the lt key to highlight Accept Yes Confirming the prompt Accept Yes with the lt Enter gt key displays the changed value in the list To exit the menu press the lt Esc gt key 10 3 2 SYSTEM OPERATING AREA HOME or CLINIC OPERATING AREA lets you decide
135. ualified medical staff are responsible for all other important activities when Preparing for a new patient see page 99 5 1 Summary of steps before monitoring Insert the battery or batteries do not switch on yet Use the external power adapter to connect VitaGuard to the supply network do not switch on yet Attach the SpO gt sensor to the patient Connect the SpO gt patient cable to VitaGuard Connect the SpO gt sensor to the patient cable Connect the ECG patient cable to VitaGuard Attach the ECG electrodes to the patient Connect the ECG electrodes to the patient cable Switch on VitaGuard as explained in the next section Make sure that after the monitor is switched on the indicator lamps light up briefly and a short sound is emitted by the alarm buzzers Check that the alarm limits displayed are the same as those recommended by the doctor getemed Steps before and after monitoring 49 5 2 Switching on Press the lt Enter gt key for several seconds to switch on VitaGuard In the first minute of operation no acoustic signals are emitted so that you have time to check all cables The alarm bell is crossed out for this time and the remaining time is shown next to it Text mes sages on the other hand are shown from the beginning When no patient cable is connected an acoustic reminder signal is emitted as a short tone every twenty seconds after the monitor is swi
136. um Kommentar einzugeben a aii io Ef i C O Fig 93 VitaWin register Events in graph form getemed Specifications 143 13 Specifications 13 1 General Ween seceseccectceestsisecereteaeeensea approx 650 g with non rechargeable batteries approx 700 g with rechargeable block battery DIMENSIONS ou eeeeeeeeeteeeeeees 13 5 x 20 3 x 4 5 cm Non rechargeable batteries 4x 1 5 V type LR6 AA alkaline Chargeable block battery NiMH 4 8 V 2000 mAh Charging time eee 6 hours Battery life ccsestucansnansesavenavaveed e g VARTA UNIVERSAL ALKALINE min 8 hours with SpOz monitor min 2 days without SpO z monitor KEYS oreson AEAEE EE 6 membrane keys Battery change ou displayed message Depleted battery acoustic alarm Power consumption lt 10 W Power adapter eseeeeeee NA3000 2 power adapter Manufacturer FRIWO Geratebau GmbH Type FW 7555MM 09 Output 9V 1500 mA DC Input 100 240 V 50 60 Hz 400 mA AC Ingress of protection IP 40 getemed 144 Specifications Characteristics of acoustic alarm signals acoustic signals for higher priority alarms consist of two acoustic se quences of five tones each Burst 1 Burst 2 O q E Y 1al d3 4 d5 lt r lt gt Pulse duration P 155 ms t5 ms Rise and fall time o a7mst3ms OO O 1 and start of pulse 2 2 and start of pulse 3 3 and start of pulse 4 4 and start of pulse 5 1 and start of burst 2 aspe
137. us ok Amplitude Good Basal imp Ohm 550 Fig 43 Electrode signal amplitude in View 1 getemed Preparing for heart rate and apnea monitoring 67 CAUTION When AMPLITUDE POOR is displayed the values for the monitored heart rate and apnea may be imprecise AMplitude on ee eeeeeeeees Meaning POOR rean E sonst the signal is not or only sporadically detected MEDIUM us cccccsccceesscceessceceecceees the signal is detected but interference e g due to movement can cause false alarms GOOD ecco cree eet a Clear signal is detected A correct HEART RATE is detected when the heart LED flashes synchronously with the patient s heartbeat O When the signal amplitude is GOOD or MEDIUM there should be no deterioration in the detected heart rate when the patient moves normally Observe the LED with the lungs symbol and the respi ration bar on the VitaGuard display Carefully change O bh the positions of the red and yellow electrodes When ever possible try to obtain the largest possible deflec tions in the respiration bar Also the respiration bar must move and the LED flash synchronously with the respiration 7 5 Checking the BASAL IMPEDANCE The basal impedance is displayed in View 1 the respiration display and the display INFO MEASUREMENTS HR amp RESP The basal impedance is the sum of all impedances in the measuring circuit skin and tissue impedance between the red and the yellow electrode im
138. vice as a pulse oxi meter The display then shows the PULSE RATE monitored by the SpO gt sensor instead of the HEART RATE 2 5 Intended use and performance The intended use of VitaGuard is to detect central apneas when the patient is completely immobile on a stable underground and to monitor the heart or the pulse rate as well as the oxygen saturation VitaGuard is designed for applications at home and in rooms used for medical purposes VitaGuard has no therapeutic effect VitaGuard emits an acoustic and visual alarm when no respiration or movement is detected within a set period when the measured heart rate and or oxygen saturation values violate the set alarm limits for a period also set by the operator and or when no heartbeat has been detected for a set period The alarm limits can be set within particular values specified by VitaGuard Respiration and heart rate are monitored with adhesive ECG elec trodes and blood oxygen saturation and pulse rate with an SpO gt sensor Suitable to the patient s age and weight VitaGuard determines the heart rate from the ECG signal detected by the electrodes and the pulse rate from the signal detected by the SpO gt sensor The doctor can choose whether the pulse or the heart rate is used for alarm triggering getemed Intended use 19 VitaGuard features an impedance monitor that triggers a technical alarm when an electrode exhibits impedance values that are not compatible w
139. vice finally switches off For this reason VitaGuard needs about another two seconds after the keys are released until it switches off completely 5 4 Summary of steps after monitoring Switch off VitaGuard as explained in the previous section Carefully detach the ECG electrodes from the patient Disconnect the ECG electrodes from the patient cable Detach the SpO sensor carefully removing the adhesive strip from the skin If the procedure concerning stored data has not been clarified dur ing your training then please contact your doctor getemed Preparing for SpOz monitoring 51 6 Preparing for SpO2 monitoring The information in this section refers primarily to the use of adhe sive strip sensors Also available however are SpO gt sensors that can be disinfected and reused permanent sensors for brief examina tions and for monitoring patients with allergies LNOP Neo will be explained as an example SpO gt sensor for children LNOP Adt will be explained as an example SpO gt sensor for adults Preparing for SpO monitoring involves attaching the sensors to the patient laying and securing the patient cable connecting the SpO patient cable to VitaGuard 6 1 Safety instructions for SpO monitoring For hygiene reasons check that there is no damage to the sensor s packaging before opening it Use adhesive strip sensors on the one patient only Remove the adhesive sensors no lat
140. whether the value you have entered for SETTINGS PROTECTION is retained the next time VitaGuard is switched on When you select HOME SETTINGS PROTECTION is ON when the device is next switched on Operating area When you select CLINIC SETTINGS PROTECTION is set to the selected value when the device is next switched on Fig 74 Operating area Home or Clinic 10 3 3 SYSTEM ADMIT NEW PATIENT restoring factory settings IMPORTANT This deletes all stored data and all monitor settings for a specific patient Check that the new monitor settings are suitable for the patient All data are deleted and all user settings are restored to the factory values So you are prompted Attention whether you want to CONTINUE Data and settings will be deleted Continue Press the lt key to highlight Accept Yes and then the lt Enter gt key Accept Yes Fig 75 Warning before changes under System Admit new patient getemed Information for the doctor and qualified medical staff 111 The submenus for ID FIRST NAME and SURNAME are displayed one after the other Admit new patient Use the lt and gt keys to position the cursor Admit new patient ID Use the A and V keys to enter 0123 F e letters and numbers Admit new patient First name Press the lt Enter gt key after you g have entered your data in each Admit new patient submenu Surname These inputs are optional and can be skipped by pressing

- Frank`s Hospital Workshop

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