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1. Alarms YOU must react to The monitor generates an alarm if the detected pulse rate alarms falls for at least a given period below the lower limit or rises above the upper limit Then the red LED flashes ac companied by a loud acoustic warning The LCD dis plays a message about the actual type of alarm The alarm can be stopped by pressing lt ALARM Stop gt Go to your patient immediately and verify the situation Both the alarm setting and the alarm LED will flash in intervals of 1 second to indicate that an alarm has occurred If no alarm occurs or if no button is pressed for 5 minutes the standard display is deactivated and a message monitoring activated will appear The alarm LED will keep flashing to indicate that an alarm had occurred and will stop once lt ALARM Stop gt is pressed To obtain information about the alarm press lt STATUS Enter gt Should two alarms occur within the period of one minute the alarm will not automatically cease To stop the acous tic alarm press lt ALARM Stop gt System check Alarm generator Approximately 4 seconds after switching on the monitor the monitor generates a short acoustic signal Remember to listen for this tone each time you switch the monitor on Should this signal not occur return the monitor im mediately to the manufacturer for inspection Contact your supplier to get a replacement monitor Never con tinue to use a faulty device Baby phone Important Hint Befo
2. IV Safety and Accuracy Important Intended Use VitaGuard is designed to monitor pulse rate and oxygen saturation Should a bradycardia alarm low pulse rate or a drop in the arterial oxygen saturation occur then artifi cial respiration and cardiopulmonary resuscitation CPR measures may need to be taken Therefore allow a trained person to demonstrate to you how you should per form these measures Safety precautions YOU must act on alarms Stay near your patient Important Operator manual VitaGuard VG 300 Safety precautions Usage e VitaGuard has no therapeutic intentions YOU the caregiver must act in the event of an emergency e Never leave the patient alone until you have veri fied that the monitor is working properly e Never continue operating a damaged or unreliable monitor Immediately check the vital signs of the pa tient Send the monitor back to the manufacturer or agent for inspection Watch the patient yourself until you got another monitor or your handling physician advises you to stop monitoring e Verify that you can hear a possible alarm independent of where you are and what you are doing Make sure that VitaGuard s alarm speaker is not blocked by any thing laid on top of the monitor You cannot act promptly to an alarm if you do not hear it e Make sure you can act on an alarm within a few seconds e VitaGuard must be demonstrated to you by a quali fied person Do
3. The LNOP Neo Neonatal Adhesive Sensor is indicated for single patient use for the continuous non invasive monitoring of arterial oxygen saturation SpO2 and pulse rate for patients weighing lt 10 kg 10 000 grams The LNOP Neo is for use only with instruments containing Masimo SET oximetry or licensed to use LNOP sensors Consult individual oximetry system manufacturer for compatibility of particular instrument and sensor models Each instrument manufacturer is responsible for deter mining whether its instruments are compatible with each sensor model The LNOP Neo is contraindicated for patients who ex hibit allergic reactions to adhesive tape The sensor must be removed and the site inspected at least every eight 8 hours and if indicated by circulatory condition or skin in tegrity reapplied to a different monitoring site INSTRUCTIONS FOR USE A Site Selection e Neonates The preferred site is a foot Alternatively across the palm and back of the hand can be used For 64 e Directions for use of LNOP sensors Operator manual VitaGuard VG 300 Detector on fleshy side of foot hand toe or finger Emitter exactly on the opposite side Wrap both with tape to fix it Connect sensor and ca ble properly and attach it to the child Connecting the patient cable to VitaGuard The skin must be checked regularly Use one of the adhesive sensors for long term monitoring Switch the monitor off before detach
4. Instructions for LNOP Adt SpOz sensors These sensors are intended for multiple use on only one patient weighing gt 30 kg They are non sterile and latex free and can not be sterilised INDICATIONS CONTRAINDICATIONS The LNOP Adt adult Adhesive Sensor is indicated for single patient use for the continuous non invasive moni toring of arterial oxygen saturation SpO2 and pulse rate for patients weighing gt 30 kg The LNOP Adt is or use only with instruments containing Masimo SET oximetry or licensed to use LNOP sensors Consult individual oxi metry system manufacturer for compatibility of particular instrument and sensor models Each instrument manufac turer is responsible for determining whether its instru ments are compatible with each sensor model Operator manual VitaGuard VG 300 Directions for use of LNOP sensors e 55 The LNOP Adr is contraindicated for patients who ex hibit allergic reactions to adhesive tape The sensor must be removed and the s te inspected at least every eight 8 hours and if indicated by circulatory condition or skin in tegrity reapplied to a different monitoring site INSTRUCTIONS A Site Selection e Choose a site that s well perfused and least restricts a conscious patient s movements The ring or middle finger of the non dominate hand is preferred e Alternatively the other digits on the non determinate hand may be used Always choose a site that will completely cover the de
5. Once the installed batteries become weak the monitor displays an appropriate message This message is dis played after the initialisation phase when VitaGuard is switched on and can be checked at any time using lt INFO A gt When the batteries become very weak a message is repeatedly displayed for 2 seconds every 16 seconds informing you to replace them If the external power adapter is not connected and the batteries become weak the SpO module is automatically switched off The monitor generates a technical alarm to warn the clinician and displays an appropriate message Once new batteries have been inserted into the unit or the external power adapter is reconnected the SpO2 module is automatically restarted and monitoring is continued Bear in mind that without monitoring critically situations may not be brought to your attention You should replace the batteries as soon as possible hav ing seen the message on the display GeTeMed recom mends that you always have at least two spare sets of batteries at hand If the batteries are not replaced and are used further the monitor will generate a technical alarm tone forcing you to replace the batteries See Switching VitaGuard on and off on page 11 Remember that the system can only operate in the event of a mains power failure if batteries are inserted There Operating VitaGuard 21 ing of all settings 1s explained in Explanation of the menu settings on page 38
6. 2 If a fault develops in the VitaGuard monitor within the first year after delivery GeTeMed will repair or replace as GeTeMed decides the defective monitor free of charge The customer must to prove that the fault showed up within the first year after delivery 3 To process the guarantee the customer or distributor must send the monitor accompanied with the invoice to GeTeMed GeTeMed will test the monitor If no fault is discovered under the scope of this guarantee than the purchaser takes responsibility for the costs of transport and testing If GeTeMed decides to replace a defective device or part of it then the ownership of the defective device or component is transferred to GeTeMed 4 Intrusions and attempts to repair shall be executed only by GeTeMed or authorised third parties that have been certified to do so by GeTeMed Any warrantee claim is void if such attempts by non authorised per sons have been performed The warrantee is also void if the VitaGuard monitor or its components have been improperly handled Operator manual VitaGuard VG 300 Safety and Accuracy 37 Cleaning Loss of the pulse signal can occur if the patient has hypotension severe vasoconstriction severe anaemia or hypothermia Loss of pulse signal can occur if there is an arterial occlusion proximal to the sensor Loss of pulse signal can occur if the patient is in car diac arrest or is in shock e Disconnect sensors and
7. Complete at least temporary stop of the heart beat BPM Beats per minute of the heart Bradycardia Slow heart rate Event delay This is the minimal duration an event must last to generate an alarm LCD Liquid Crystal Display A special kind of a passive non luminous display VitaGuard employs an LCD to conserve battery power for a longer monitoring period LNOP Low Noise Optical Probe a patented Masimo Corporation sensor type to receive noise reduced optical signals for SpO gt determination low Perfusion here Special SET analysis method employed with patients with low perfusion Oxygen Saturation Ratio of oxygenated haemoglobin to all haemoglobin in arte rial blood Abbr SpO partial saturation of oxygen In this manual this term is always used for partial functional arterial oxygen saturation which is the ratio between oxygen ated to all functional haemoglobin The normal value for adults is about 98 Plethysmograph Plethysmographs primarily measure variations in limb volume or circumference that are caused by blood flow to and from that limb VitaGuard utilises the optical bridge of the LNOP sensor to detect the changes in opacity resulting from the periodic filling and emptying of the blood vessels Plethysmogram Display of the results of a plethysmograph showing the time course of the blood flow in the observed vessel Operator manual VitaGuard VG 300 Operator manual V
8. monitor settings settings system settings time date settings Monitor operation PC interface Power supply Power save Safety Safety and accuracy SET SpO gt sensors placement Technical data general properties heart rate properties memory properties miscellaneous Trend Operator manual VitaGuard VG 300 EMERGENCY SITUATION 9 15 15 13 27 42 44 13 19 25 42 9 12 15 19 20 23 27 12 15 12 15 12 15 12 15 42 44 11 13 14 25 29 43 26 8 11 12 18 21 EN E 53 29 36 43 7 8 10 12 22 24 32 35 37 44 45 53 11 13 L ek 37 12 34 1 16 20 44 46 47 82 83 5 11 16 20 93 33 35 37 38 43 46 50 54 77 82 83 17 56 61 65 69 13 74 25 02 32 33 33 33 9 14 26 43 83 Please ask the handling physician how you should act in the event of an emergency For baby monitoring pur poses we offer an alarm chart with instructions on how to act in an emergency Read those instructions care fully If you do not fully understand them ask your paediatrician or your dealer Make certain you and all other potential caregivers are ready to respond properly to an alarm Every caregiver must be able to perform CPR cardiopulmonary resuscitation alone or be able to instruct a second person to assist in CPR We recom mend to participate in a CPR training course Reca pitulate the necessary actions wit
9. remove the back ing from the sensor Orient the sensor tail so that it is pointed away from the patient Position the detector onto the fleshly part of the sole of the foot aligned with the middle toe Fig 44 Operator manual VitaGuard VG 300 Directions for use of LNOP sensors e 69 Fig 44 Sensor placement detector on the sole of the foot 2 Orient emitter window on top of foot directly opposite the detector Wrap the sponge wrap around the foot with the white detector fitting into the pre punched opening on the foam wrap Be careful to maintain proper alignment of the detector and emitter windows and attach the Velcro strap to secure Fig 45 Check position of sensor to verify correct positioning and re position if necessary Complete coverage of the detec tor window is needed to ensure accurate data Fig 46 Fig 45 Orientation of emitter and detector Fig 46 Correctly attached LNOP Neo Sensor H Fig 47 Connecting patient cable and sensor 70 Directions for use of LNOP sensors Operator manual VitaGuard VG 300 Standard Display 3 power save mode LCD power save Mode Fig 4 Standard Display 3 power save mode Standard Display 3 This mode just indicates that the patient is being moni tored and reverts automatically back to standard display 1 or 2 when an alarm occurs or a button is pressed This mode is recommended for home use To switch between standard display 1 and 2 press l
10. INFO A gt Information about the monitor settings cardio and SpO settings as well as battery and memory information can be viewed by pressing this key Each time it is pressed a new information window appears After displaying all available information the display reverts back to the se lected standard display Graphic lt GRAPHIC V gt By pressing this key you can review the plethysmograph signal curves and some trend curves The trends of pulse rate and SpO are shown for the last 2 5 or 25 minutes or the last 2 5 or 24 hours Pressing lt ALARM Stop gt rewrites the trend display Operating VitaGuard e 13 VitaGuard can only be Always switch the monitor off using the key panel Do switched off using the Not try to switch it off by unplugging the power adapter key panel as this will only cause VitaGuard to switch to battery mode If however batteries are not inserted an acoustic warning will be generated which can only be deactivated by reinserting the power adapter and switching the moni tor back on Once the monitor has been switched off properly you may remove the power adapter Important Self tests After power is applied to the monitor a series of tests are are performed at start performed The monitor type and the battery condition is to ensure functionality displayed Allthe LED s are activated and a short acous tic alarm is generated to verify that the alarm speaker op erates correctly Should th
11. Immediate data storage Press both lt INFO A gt and lt GRAPHIC V gt simultane ously Data w ll automatically be stored for two minutes The resulting episode will contain data for one minute prior to pressing the buttons and one minute thereafter The following data will be stored e Date and time of the event e Monitor setup at time of the event lower and upper limits e SpO and pulse rate minimal medium and maximal Value in the alarm period e Plethysmogram Compliance log The compliance memory has room for 256 events The oldest events are automatically removed to make room for new ones The following events are registered e Monitor on off e SpO monitoring on off e System reset from key panel e System reset from PC e Episodes removed Number of deleted episodes e Error events from VitaGuard VG 300 s internal Ma simo SpO module MS 3 board The following data is stored with each event e The time and date of the event e Monitoring settings upper and lower limits The log can be examined on the monitor by pressing lt IN FO A gt once followed by pressing lt GRAPHIC V gt twice To scroll press lt INFO A gt The error codes delivered by the SpO module are listed in Error codes on page 45 Explanation of the menu settings 38 e Appendix Following you ll find an explanation of all menu settings in the monitor VitaGuard VG 300 in the menu structures order Explanations t
12. NA 2000 2 provided with the monitor Other mains adapters may not fulfil the necessary safety standards and could cause serious dam age to both the patient and the monitor When Vita Guard is operated from the mains adapter the display backlight is automatically switched on Integrated menus Monitor settings main menu See also Explanation of These settings can be changed using lt MODE Esc gt Re the menu settings on page 38 Operator manual VitaGuard VG 300 fer also to Monitor display structure and Monitor menu structure on pages 12 and 13 The different settings are explained in detail in Explanation of the menu settings on page 38 The factory defaults are shown in large bold font Lower HR limit 30 35 80 175 180 BPM Upper HR limit 100 105 220 255 260 BPM Lower SpO gt limit Silent lower HR Silent upper HR 100 105 255 260 BPM Silent lower SpO2 50 51 88 oo 100 Silent upper SpO2 Bradycardia delay Tachycardia delay Tab 2 Value range for the items in the monitor settings main menu Operating VitaGuard e 23 Important Check bat teries with active SpO gt module Replacing batteries Please pay attention to the polarity of the bat teries as shown on the bottom of the battery compartment GeTeMed recommends ALKALINE Extra Longlife Batteries Hint Operator manual VitaGuard VG 300 fore always insert batteries even if you use
13. SpO gt sensors Place the finger tip Fix it with the T shaped adhesive tape onto the detector Fig 7 Wrap the emitter align it with the detector and fix it too Mate the logos on both Push the grey buttons and pull connectors and connect them the connectors to disconnect For best results place the sensor on a finger tip of the non dominant hand Placing the LNOP Pdt SpO gt sensors detector emitter Remove sensor backing Locate sensor detector amp place detector on fleshy part of the sole of the foot Fig 8 lt Orient emitter window directly opposite the detec tor Loosely wrap bandage to secure vertical alignment Sensor properly applied Insert sensor tab shiny contact side up into patient cable connec tor An audible or tactile click will confirm connection Avoid exces sive bending or creasing of sensor as aggressive folding may dam age sensor integrity For best results place detector on sole of foot aligned with fourth toe Placing the LNOP Neo SpO gt sensors detector emitter Remove sensor backing Locate sensor detector amp place detector on fleshy part of the sole of the foot Fig 9 Orient emitter window directly opposite the detec tor Loosely wrap bandage to secure vertical alignment Sensor properly applied Insert sensor tab shiny contact side up into patient cable connec tor An audible or tactile click will confirm connection Avoi
14. VitaGuard VG 300 lll Technical Data tem Wiem Mains supply External power adapter NA 2000 2 with FRIWO FW1299 5Volt 900 mA DC Display elements LED s and LCD graphical display Patient cable Masimo patient cable PCO8 length 2 44m A maintenance procedure is required every 18 months The end of the maintenance period is marked with a sticker Only with batteries VARTA ALKALINE Extra Longlife Tab 5 General properties of VitaGuard VG 300 Test and mainte nance period Duration Storage mode VitaGuard for Windows Software program for evaluation of stored data Tab Memory properties of VitaGuard VG 300 Technical Data e 29 Monitor log Easy but complex documentation for the patient bulletin In VitaGuard for Windows one can display an Over view over the monitoring period Monitor log Fig 13 Here the monitoring took place only during the n ght with short interrupts around midnight and in the early morning The main screen Fig 14 shows the context of the actual episode for the pulse frequency and the plethysmogram Protocol Graphic Dea aO g pe 03 03 1999 u hin D 04031000 E ees g ii n e 06 031899 a a Ee 07 03 1999 u 08 03 1999 eo era aa 09 03 1999 bn BEER 9 WEE E 10 03 1999 11 03 1999 d 12031903 E BR oF phase Fig 13 VitaGuara for Windows Monitor protocol VitaGuard for Windows supports the documentation of the
15. and distorting the sensor cable be cause this may damage the sensor Hint If the monitor displays pulse rate and SpO not constantly than check the sensor placement and reposition it if necessary If this does not help than change the sen sor Hint Sensors being used for a long period tend to re duced performance A sensor should be replaced if pulse rate and SpO become questionable SPECIFICATIONS When used with Masimo SET pulse oximetry monitors or with licensed Masimo SET pulse oximetry modules us ing PC Series patient cabled during no motion the accu racy of the LNOP Neo from 70 to 100 SpO2 is 3 digits 1 Std Dev Please see also the following section 72 Directions for use of LNOP sensors Operator manual VitaGuard VG 300 Key Explanation Fao Key to enter and exit the menu structure View operating mode View monitor settings View measurements View memory settings Er View plethysmogram and trends View stored episodes Accept new values when changing parameters Alarm stop Controls protection button Change between standard display and 2 Monitor on off This key needs to be pressed for a couple of sec onds Follow the instructions on the LCD display Tab 1 Key function in VitaGuard VG 300 In the following sections keys to be pressed will be written in brackets for example lt MODE Esc gt means that the mode button must be pressed All buttons need to be pressed for approxim
16. and what you are doing for example when house cleaning watching TV listening to radio shopping etc Make sure VitaGuard s alarm speaker is not blocked by anything placed on the monitor You cannot react prop erly to an alarm if you cannot hear it Make sure you can react to an alarm within a few seconds The key panel Fig 1 consists of six keys These keys are explained in Tab 1 below S i FIT VitaGuard SpO Monitor ef SpO gt PC ext mains ext sensor connector adapter alarm unit Fig 1 Frontal view and connectors of VitaGuard VG 300 Operator manual VitaGuard VG 300 Miscellaneous Warnings and Hints INSTRUMENT CAPABILITY LNOP sensors are intended for use only with instru ments containing Masimo SET oximetry or pulse oxi metry monitors licensed to use LNOP sensors Each sensor is designed to operate correctly only on the pulse oximetry systems from the original instrument manufac turer Use of this sensor with other instruments may result in no or improper performance LICENSE Purchase or possession of this sensor confers no ex pressed or implied license to use the sensor with any de vice which is not an authorised device or separately authorised to use LNOP sensors Order of a physician CAUTION FEDERAL LAW U S A RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN Miscellaneous U S A Patient 5 638 818 and international equivalents Other U S A and international
17. arterial blood Fig 3 Standard Display 2 graphic and numbers The measured values for pulse rate and SpO are also shown in this mode The graphical part of the display shows the plethysmograph thus giving a good indication of the condition of the patient and the placement of the SpO sensor Operator manual VitaGuard VG 300 3 Orient the connector tab so that the shiny contacts are facing up Mate the logo D on the sensor tab to the logo on the patient cable Insert the patient cable into the sensor tab until there is a tactile or audible click of connection Fig 47 Gently tug on the connectors to ensure a positive contact C Reattachment The sensor may be reapplied to the same patient if the emitter and detector windows are clear and the adhesive still adheres to the skin NOTE Prior to reattachment or rejuvenation disconnect the sensor from the sensor cable e The adhesive can be partially rejuvenated by wiping with a 70 isopropyl alcohol pad and allowing the sensor to thoroughly air dry prior to replacement on the patient e If the adhesive can not be adequately rejuvenated use a new sensor D Disconnecting Sensor and Patient Cable 1 Place thumb and index finger on grey buttons on ei ther side of the patient cable Fig 48 2 Press firmly on the grey buttons and pull to remove the sensor Fig 48 _Disconnecting patient cable and sensor WARNINGS e The site must be checked and changed a
18. be activated by entering the right password When activated the Monitor Settings menu and the System Settings menu are extended to include functions primarily designed for clinicians e g activation of silent alarms and settings controlling the data memory Silent lower HR Silent upper HR Silent lower SpO2 Silent upper SpO2 Bradycardia delay Tachycardia delay SpO2 lower delay SpO2 upper delay Clear trends SpO perfusion Ditto like lower HR limit but this generates a silent alarm if exceeded Silent alarms save if programmed data like a real alarm but do not generate a user alarm so being silent This kind of alarm can be of interest for the clinician See upper HR limit but generates a silent alarm See lower SpO2 limit but generates a silent alarm See upper SpO2 limit but generates a silent alarm Delay between recognition of a bradycardia pulse rate to low and generation of the appropriate alarm Ditto like tachycardia pulse rate to high Ditto for falling below the lower SpO limit Ditto for exceeding the upper SpO limit System settings Immediately clears the trend memory This cannot be revoked After completion of the command this setting is reset to NO Defines the algorithm to estimate SpO There is a nor mal and a special mode for patients with low Perfusion Operator manual VitaGuard VG 300 Appendix e 39 V Appendix Special function
19. flammable substances in combination with air oxygen enriched environments or nitrous oxide Do not use in extreme temperatures below 10 C or above 40 C Do not place VitaGuard near heat sources such as radiators ventilators ovens etc and do not expose it to direct sunlight Neither the monitor nor any of its accessories may be immersed into liquids Detach the sensor from the pa tient before bathing it Do not expose the monitor to sudden temperature or humidity variations Humidity changes should not re sult in condensation accumulating on the monitor Operator manual VitaGuard VG 300 e Avoid penetration of moisture into the unit Pay also attention to the safety precautions for Vita Guard on page 31ff These precautions are valid for the external alarm also Car adapter NAK 1500 Operation The car adapter NAK 1500 can be used to operate a Vi taGuard monitor from the 12V car supply NAK 1500 is connected instead of the mains adapter NA 2000 2 It is fitted with a safety universal plug DIN ISO 4165 that fits alternatively into the cigarette lighter or the normal car socket outlet A green LED signalises operation from the car power Technical data 12 V car power supplies 500 mA Operational 10 50 C 50 122 F temperature Connectors VitaGuard 2pin socket Car safety universal plug CO Tab 13 Technical data of the Car adapter NAK 1500 Safety with the adapter NAK 15
20. flashing is typically sufficient for about two days Pay attention to the polarity of the new battery Alarm The monitor generated an alarm A loud red flashing flashing tone is generated which volume can be varied within some limits If none of the LEDs are active then the monitor is not switched on or there is no monitor connected at all Technical data Battery 9 V Battery Alkaline Type ol Rol or 6AM6 Connection 7 5 m standard cable Operation On average about two month period Tab 12 Technical data of the external alarm unit EA 1000 Safety with the external alarm unit e Caution Keep the external alarm unit at least 3m away from the patient to prevent damage from the high alarm volume of the EA 1000 e Pay attention to the polarity when replacing the bat tery e Caution Do not puncture the speaker because you could damage it Operator manual VitaGuard VG 300 This can easily happen if operated in a tent If conden sation accumulates wait at least 2 hours before using the monitor e Keep the monitor away from devices that produce strong electromagnetic fields such as televisions walkie talkies radio transmitters as found in cordless telephones and paging transmitters radio controlled toys security equipment in many shops wireless communication links for computers and peripherals etc fluorescent lamps microwave ovens and so on e Do not use VitaGuard near MRI units magnetic r
21. ken ken 82 o W gt Le Q X Fig 15 DST plot of output power vs SpO gt value In reverse The arterial SpO value is always given at the peat with the highest SpQ This entire sequence is repeated every 0 4 seconds on the most recent eight can be varied between six and 16 sec onds of raw data The MS 3 SpO therefore corresponds to a running average of arterial saturation of arterial hae moglobin saturation that is updated every 0 4 seconds Error codes The Masimo SpO module MS 3 board incorporated in VitaGuard VG 300 communicates with VitaGuard via a serial port Should a failure occur on the module an ap propriate error code is passed to VitaGuard These codes are registered in the compliance log Should no commu nication take place between VitaGuard and the MS 3 module then code 31 is registered 31 o communication with MS 3 board 32 Dep Checksum Failure Operator manual VitaGuard VG 300 Appendix e 45 DSP Diag Queue Overrun Per Di Tab 10 Explanation of the error codes used within Vita Guara VG 300 These error codes are intended for maintenance purposes by qualified personnel only Patent information 46 e Appendix The following is a possibly incomplete table of U S is sued Patents and Applications and Patent Markings W Patent 1 15397 7 Low Noise Finger Got Probe U 5 5 638 818hiproved Low Noise Optical Probe 18 5 685 295 signal Process
22. measurements e Do not use the LNOP Adt during MRI scanning e Avoid placing the LNOP Adt on any extremity with an arterial catheter or blood pressure cuff e The pulsation s from intra aortic balloon support can be additive to the pulse rate on the oximeter pulse rate display Verify pulse rate against an ECG heart rate e Avoid bending and distorting the sensor cable be cause this may damage the sensor Hint If the monitor displays pulse rate and SpO not constantly than check the sensor placement and reposition it if necessary If this does not help than change the sen sor Hint Sensors being used for a long period tend to re duced performance A sensor should be replaced if pulse rate and SpO become questionable SPECIFICATIONS When used with Masimo SET pulse oximetry monitors or with licensed Masimo SET pulse oximetry modules us ing PC Series patient cabled during no motion the accu racy of the LNOP Adt from 70 to 100 SpO2 is 2 digits 1 Std Dev Please see also Miscellaneous Warnings and Hints on page 73ff NOP Pdt Directions for use LNOP Pdt Pesdiatric Slender Digit O Sensor i gt 10 kg lt 50 kg ee Q Single patient use fe LWY i aset Non sterile and latex free Fig 30 Instructions for LNOP Pdt SpO sensors Operator manual VitaGuard VG 300 Directions for use of LNOP sensors e 59 These sensors are intended for multiple use on only one patien
23. monitoring behaviour and results One can gener ate and print many overviews and tables S VitaGuard f r Windows GeTeMed Gmbh Datei Statistiken Protokoll Extras te Hilfe Hebe LIEB TER CHEI v 4 A 1 2 aE 16 0s rat il I it A I it ri Rem rid l BAER I 1 RW U itt it I E Zoom 25mm s 90 eo 70 60 50 40 21 56 51 21 56 55 21 56 59 21 57 03 21 57 07 21 57 11 21 5715 21 57 19 21 57 23 21 57 27 21 57 31 21 57 35 21 57 39 21 57 43 Mi 24 05 95 Atm 28 e Operating VitaGuard 16 mid Herz 75 190 md amp DR D Fig 14 Main screen of VitaGuard for Windows Brady cardia episode Operator manual VitaGuard VG 300 Fig 20 Correctly attached sensor NOTE With smaller digits in order to completely cover the detector window the digit might not need to be pushed all the way to the stop The sensor is not intended for use on the thumb or across a child s hand or foot C Attaching the Sensor to the Patient Cable 1 Orient the connecting tab so that the shiny contacts are facing up and mate the logo to the logo on the pa tient cable Fig 21 Insert the LNOP DC1 connector over the patient cable connector until there is a tactile or audible click of connection Fig 21 Connecting patient cable and sensor 2 Gently tug on the connectors to ensure a positive con tact Tape may be used to secure the cable to the pa tient for ease of m
24. patents pending Masimo SET technology under license from Masimo Corporation Manufactured in the U S A Masimo SET logo LNOP and sensor configuration are trademarks of Masimo Corporation 1998 Masimo Corporation VitaGuard is a trademark of GeTeMed GmbH Licence agreement for end users THIS DOCUMENT IS A LEGAL AGREEMENT BETWEEN YOU THE ePURCHASERe AND GETEMED IF YOU DO NOT AGREE TO THE TERMS OF THIS AGREEMENT PROMPTLY RETURN THE ENTIRE PACKAGE INCLUD ING ALL ACCESSORIES IN THEIR ORIGINAL PACKAGE WITH YOUR SALES RECEIPT TO GETEMED FOR A FULL REFUND 1 Grant of License In consideration of payment of the license fee which is part of the price paid for this product GeTeMed grants to Purchaser a nonexclusive non transferable license Operator manual VitaGuard VG 300 Directions for use of LNOP sensors e 73 74 e Directions for use of LNOP sensors without right to sublicense to use the copy of the incorporated become weak software firmware and documentation in connection with Pur chaser s use of the Products for their labelled purpose GeTeMed reserves all rights not expressly granted to Pur chaser Ownership of Software Firmware Title to ownership of and all rights and interests in any MASIMO software and or firm ware and the documentation and all copies thereof remain in all times vested in MASIMO Corporation licensor to GeTeMed and they do not pass to Purchaser Assignment Purchaser sha
25. rate against an ECG heart rate e High oxygen concentrations may predispose a prema ture infant to retinopathy Therefore the upper alarm limit for the oxygen saturation must be carefully se lected in accordance with accepted clinical standards Configuration of the monitor e Circulation distal to the sensor site should be checked routinely e Avoid bending and distorting the sensor cable be cause this may damage the sensor Hint If the monitor displays pulse rate and SpO not constantly than check the sensor placement and reposition it if necessary If this does not help than change the sen sor Hint Sensors being used for a long period tend to re duced performance A sensor should be replaced if pulse rate and SpO become questionable SPECIFICATIONS When used with Masimo SET pulse oximetry monitors or with licensed Masimo SET pulse oximetry modules us ing PC Series patient cabled during no motion the accu racy of the LNOP Neo from 70 to 100 SpO2 is 3 digits 1 Std Dev e Please see also Miscellaneous Warnings and Hints on page 73ff L 68 e Directions for use of LNOP sensors Operator manual VitaGuard VG 300 NOP NeoPt Directions for use Information about the monitor settings LNOP eNeoPT O Sensor for Neonates DIRECTIONS FOR USE Taa lt ikg GI Single patient use provided non sterile Signal curves and Non Sterile and Latex Free trends Fig 43 Instruct
26. rejuvenated use a new sensor D Disconnecting Sensor and Patient Cable 1 Place thumb and index finger on grey buttons on ei ther side of the patient cable Fig 42 2 Press firmly on the grey buttons and pull to remove the sensor Fig 42 _Disconnecting patient cable and sensor WARNINGS e The site must be checked and changed at least every eight 8 hours NOTE Exercise extreme caution with poorly per fused patients skin erosion and pressure necrosis can be caused when sensors are not frequently moved As sess the site at least every two 2 hours with poorly perfused patients e If the sensor is damaged in any way discontinue use immediately e To prevent damage do not soak or immerse the sensor in any liquid solution Do not attempt to sterilise e Intravascular dyes may lead to inaccurate SpO2 meas urements e Elevated levels of Carboxyhaemoglobin COHb may lead to inaccurate SpO2 measurement e Elevated levels of Methaemoglobin MetHb will lead to inaccurate SpO2 measurements e Failure to apply the LNOP Neo properly may cause incorrect measurements e Do not use the LNOP Neo during MRI scanning e Avoid placing the LNOP Neo on any extremity with an arterial catheter or blood pressure cuff Operator manual VitaGuard VG 300 Directions for use of LNOP sensors e 67 e The pulsation s from intra aortic balloon support can be additive to the pulse rate on the oximeter pulse rate display Verify pulse
27. the Purchaser and may not be transferred to anyone except other end users without the prior written consent of GeTeMed In no event may you transfer assign rent lease sell or otherwise dispose of the software firmware or the products on a tempo rary basis Beneficiary Masimo Corporation is a Beneficiary of this Agreement and has the right to enforce its provisions U S Government Rights If you are acquiring software includ ing the related documentation on behalf of any part of the United States Government the following provisions apply the software is deemed by the commercial software and commer cial computer software documentation respectively pursuant to FAR Section 227 7202 FAR 12 212 as applicable Any use Always have fresh bat teries in the monitor Important Check bat teries with active SpO gt module Operator manual VitaGuard VG 300 Operator manual VitaGuard VG 300 ule will automatically switch off when the batteries be come too weak The monitor generates an appropriate technical alarm to warn the childminder or clinician To reactivate the SpO monitor either replace the batteries or power the device with the external power adapter sup plied Once the batteries have been replaced or the power adapter has been connected the Sp module switches back on automatically Remember that monitoring ceases once the SpO2 module switches off When operating VitaGuard VG 300 with the exter
28. the sensor is not properly connected to the monitor In this case a message is displayed telling the cause of the alarm The SpO value is zeroed out until the problem has been resolved The main causes of technical alarms are e Bad positioning of the sensor emitter and detector not placed across from each other e Sensor has fallen off the patient or the patient cable is not connected to the monitor e Excessive movement e Too much ambient light or electrical interference from an external source e Batteries are too weak for SpO operation The LNOP sensors as well as the SET Technology are specially invented to handle those problematic situations In normal domestic situations the most common source of technical alarms is bad sensor placement Pulse rate The standard pulse rate alarm limit settings are 80 BPM Upper limit 220 BPM Those settings are suitable for children When monitor ing adults consult your clinician for appropriate values Do not change the alarm limits without prior consulta tion Lower limit The selected values are displayed on the monitor LCD If the pulse rate rises above the upper limit or falls below the lower limit then an alarm will be generated The de lays before an alarm is generated are programmable Generally the upper limit needs to be exceeded for at least 15 seconds and the lower limit for at least 6 seconds before an alarm takes place For instructions on how to
29. 00 They are non sterile and latex free and can not be steril ised INDICATIONS CONTRAINDICATIONS The LNOP NeoPt Neonatal Adhesive Sensor is indicated for single patient use for the continuous non invasive monitoring of arterial oxygen saturation SpO2 and pulse rate for patients weighing lt 1 kg 1 000 grams and with poor skin integrity The LNOP NeoPt is for use only with instruments containing Masimo SET oximetry or licensed to use LNOP sensors Consult individual oximetry system manufacturer for compatibility of particular instrument and sensor models Each instrument manufacturer is re sponsible for determining whether its instruments are compatible with each sensor model The LNOP NeoPt is contraindicated for patients who ex hibit allergic reactions foam rubber products and or adhe sive tape The sensor must be removed and the site in spected at least every eight 8 hours and if indicated by circulatory condition or skin integrity reapplied to a dif ferent monitoring site INSTRUCTIONS FOR USE A Site Selection e The preferred site is a foot Alternatively across the palm and back of the hand can be used e Always choose a site that is well perfused and will completely cover the sensor s detector window e Site should be cleaned of debris and dry prior to sen sor placement B Attaching the Sensor to the Patient 1 Open the pouch and remove the sensor Holding the sensor along the length of the Y
30. 00 e Caution Operate only on 12V car power supplies e To avoid condensation do not leave the car adapter in the car overnight e The car adapter can be fixed in the car with the at tached Velcro tape It should not be exposed to direct sunlight or warm air from the cars heating system Operator manual VitaGuard VG 300 Appendix e 49 VI Directions for use of LNOP sen Sors Sensor selection Yi LNOP Neopt amp LNOP Neo LNOP Pdt 50 e Directions for use of LNOP sensors Operator manual VitaGuard VG 300 Following you ll find help in deciding what type of sensor to use Following an adapted copy of the material ac companying every economy sized package of different LNOP sensors is printed GeTeMed offers five different types of LNOP sensors LNOP DC1 LNOP Adt LNOP Pdt LNOP Neo and LNOP NeoPt Selection plan Following you ll find a scheme that might help you to de cide what type of sensor to choose Patient weighing lt 30 kg Yes No Patient weighing long term lt l kg monitoring LNOP Ad Patient weighing lt 10 kg LNOP DC1 No LNOP Adt Yes Fig 16 Plan to choose the optimal sensor type After choosing the right sensor you may read the appro priate sensor instructions You ll find the manuals for the LNOP DC1 hereafter for the LNOP Adt on page 55 for the LNOP Pdt on page 59 for the LNOP Neo on page 64 and for the LNOP NeoPt on page 68
31. CATIONS 1 ecco cc ceesecccseceeesscceeeeees 64 INSTRUCTIONS FOR USE EE 64 WARNINGS E 67 SPECIFIERTIONS 2522 esse 68 LNOP NeoPt Directions for use 68 INDICATIONSCONTRAINDICATIONS 69 INSTRUCTIONS FOR USE a en een 69 WARNINGS te el ae e 71 SPE IEIC AKTION St ee ee ee eek 72 Miscellaneous Warnings and Hints 2 0 0 0 csessssssssssssssecececececececececeeeeeseeeeeees 73 INSEIRUMENT CEAPABIEIT Yes 73 Miscellaneous see ee ee 73 Licence asreement Tor end User I daeas baie 73 Vil Glossary 78 Vill Index 80 4e Operator manual VitaGuard VG 300 Anlage zu Registrier Bericht Nr Hersteller Nr Geltungsbereich K ln den 07 12 1999 A TUV DOC 1 1 Rev 0 T V Rheinland Product Safety GmbH Am Grauen Stein D 51105 K ln HD 9911907 01 C 9912944 E 02 GeTeMed Gesellschaft f r Technische Medizin mbH Oderstra e 59 D 14513 Teltow CardioLink CL 100 CL 1000 11 411 CardioDay 200 300 500 1000 300D 500D 1000D 11 411 Babyguard BS 1000 12 662 VitaGuard VG 300 VG 2000 VG 3000 12 662 Werner amp M ller GmbH RW 300 RW 2000 RW 3000 12 662 Messer Medical GmbH PX 1 SD 1 SD 2 12 662 Fig 50 Covered products of GeTeMeds quality manage ment system Operator manual VitaGuard VG 300 Directions for use of LNOP sensors 77 VII Glossary 78 Glossary Alarm Parameters Limits for monitored data that if exceeded generate alarms Asystolie Asystolea
32. ECTIONS FOR USE 1 A Reusabel Q gt 30 kg Non sterile and latex free Fig 17 Instructions for LNOP DC1 SpO gt sensors These sensors are intended for multiple use on different patients weighing gt 30 kg They are non sterile and latex free and can not be sterilised INDICATIONS CONTRAINDICATIONS The LNOP DC1 Reusable Adult Sensor is indicated for either spot check or continuous non invasive monitor ing of arterial oxygen saturation SpO2 and pulse rate for patients weighing gt 30 kg It is for use only with instru ments containing Masimo SET oximetry or licensed to use LNOP sensors Consult individual instrument manu facturer for compatibility of particular instrument and sensor models Each instrument manufacturer is respon sible for determining whether its instruments are com patible with each sensor model The LNOP DCI1 is contraindicated for use on mobile pa tients or for prolonged periods of use It is not intended for long term monitoring It must be removed and reposi tioned to a different monitoring site at least every four 4 hours If extended monitoring is required use of a LNOP Adt adhesive sensor is recommended INSTRUCTIONS A Site Selection e Choose a site that is well perfused and least restricts a conscious patient s movements The ring finger of the non dominate hand is preferred e Alternatively the other digits on the non dominate hand may be used Always choose a site tha
33. NOP DC properly may cause incorrect measurements e Do not use the LNOP DC1 during MRI scanning e Avoid placing the LNOP DC1 on any extremity with an arterial catheter or blood pressure cuff e The pulsation s from intra aortic balloon support can be additive to the pulse rate on the oximeter pulse rate display Verify pulse rate against an ECG heart rate e Avoid bending and distorting the sensor cable be cause this may damage the sensor Hint If the monitor displays pulse rate and SpO not constantly than check the sensor placement and reposition 54 e Directions for use of LNOP sensors Operator manual VitaGuard VG 300 Episode memory and PC interface Integrated memory for VitaGuard is fitted with a solid state memory for storing 100 alarm episodes alarm episodes The pulse rate SpO and plethysmograph are stored as a function of time Up to approx 7 hours of data or 200 episodes can be stored with the standard memory There are two storage modes possible event mode or permanent mode When in event mode an alarm occurs both time and date as well as the signal curves for a pro grammable period prior to the alarm usually 50s during the alarm phase and for a programmable period after the alarm usually 20s are stored together as an alarm epi sode In the permanent mode of operation all the signals are continuously stored in blocks of approx 2 5 minutes regardless of whether an alarm occurs or not Ev
34. RAPHIC V gt Once the episode of interest is selected the information about the episode can be viewed with lt STATUS Enter gt Each time it is pressed a new page of information is dis played Once the last page is reached the plethys mograph curves can be viewed Changing parameters Select the parameter that needs to be modified using the arrow buttons lt INFO A gt or lt GRAPHIC V gt Enter the selected parameter by pressing lt STATUS Enter gt By keeping lt ALARM Stop gt pressed use the arrow buttons to move the cursor to the required position Once selec ted accept the value by pressing lt STATUS Enter gt To leave the menu structure and reject any changes made press lt MODE Esc gt Note that parameters can only be changed by simulta neously pressing lt ALARM Stop gt This is necessary to avoid any parameters from being unintentionally changed by siblings or small children or due to lightly touching or rubbing the monitor Also remember that the buttons need to be held pressed for approximately 1 2 a second be fore they react If any button is pressed for gt 120 seconds depending on the button an acoustic warning is gener ated This feature ensures that the alarm function cannot be deactivated by placing a heavy object on the monitor or if a key becomes defect Operator manual VitaGuard VG 300 sensor to thoroughly air dry prior to replacement on the patient e If the adhesive can not be adequately
35. SpO average LCD power save LCD brightness Defines the period for SpO Measurement The algo rithm uses a data block from the LNOP sensor of a length defined here The data block is organised as a ring memory where the oldest data is overwritten by the actual data Enables the message LCD power save Mode see Fig 4 on page 11 to be displayed Defines the brightness of the LCD display only available in expert mode Wave display Buzzer frequency Delete memory Pre alarm time Post alarm time Memory mode Overwrite mode Factory setting Day num Month Year Hour Minute Expert mode GeTeMed mode 40 e Appendix Defines if graphs can be displayed or not Defines the frequency tone of the monitor buzzer Immediately deletes the alarm episode memory This cannot be revoked You should consider transferring the data to a PC before selecting this option After completion of the command this setting is reset to NO Defines the duration of the pre alarm period to be stored Defines the post alarm period See Pre alarm period Defines if data is stored only on alarms Event or per manent The permanent storage mode might be of inter est for physicians In permanent mode the monitor stores episodes of 2 5 minutes one after the other Defines how the monitor handles an out of memory problem It can overwrite the oldest episodes or stop writing At every start up this i
36. TION 1 IMPORTANT Telephone numbers in an emergencx 1 I General Information 5 DAO GUC e NEE 5 Intendeduse 01 VGO rate 5 Compliance with the legally relevant requirements ccccececcceeeeeeeeeees 5 SOU OT EE 6 EE Appeal Een 6 POW CE SUD Oly eie er ae a duet rid 6 Dispi sneen a E 7 Operio E 8 IR CY DANG NEE 8 Connectors of VitaGuard VG 200 9 Monitor displays i aussehen nee 9 ll Operating VitaGuard 11 EE 11 Switching VitaGuard on and oft 11 Monitor display Sucita eg 12 Monitor REDER EA e 13 Chansine BETEN EE ESE 14 der eer E O WEE 15 SID ee esse ee 15 Handling LNOP senge 15 Monlt rnes u she 18 Seltins alar n pa amele ls sca ernennen 18 SPO5 Daranleleisasensa meer 18 eet 19 SY SICH Check E 20 Alarm generator isn 20 BaD EE 20 Ballet OP Ta EE 21 Battery Supervision 21 tee 22 Mams adapter ie ine 22 ett ACTS E 23 Monitor selungs Main ment unseren 23 System settmss MAIN MENU as 24 Time Date man menden 24 Exper mode man ment a 24 2 Table of Content Operator manual VitaGuard VG 300 Fig 51 Example of a plethysmogram as displayed on the VitaGuard VG 300 SET Signal Extraction Technology A patented Masimo Corpora tion procedure to determine the arterial Sp value in noisy environments e g due to motion and low perfusion Silent Alarms Special internal alarm limits that cause episodes to be stored without actually generating an acoustic alarm For example a silen
37. ant levels of dysfunctional haemoglobin e g Car boxyhaemoglobin or Methaemoglobin Carboxy haemoglobin may erroneously increase SpO readings The level of increase is approximately equal to the amount of Carboxyhaemoglobin present Dyes e g Indocyanine green or methylene blue or any substance containing dyes that change the usual arterial pigmentation may cause erroneous readings or inaccurate measurements Inaccurate measurements may be caused by venous pulsation Operator manual VitaGuard VG 300 Safety and Accuracy 35 34 e Safety and Accuracy e Electrical shock hazard Never open or tamper with the power adapter Do not use the power adapter if it has fallen e Do not operate the power adapter from an electrical outlet controlled by a wall switch or dimmer e The mains power adapter should not be operated in damp environments e g bathroom or utility room e Remove the batteries when storing the monitor for longer periods e You can check the battery status by pressing lt INFO A gt multiple times Please follow the proce dure explained in Battery replacement on page 22 Safety precautions Sensor and cable e Only use the SpO patient cable delivered with the monitor e Connect the SpO sensor to the SpO patient cable PCO8 or PC12 only e Only use Masimo SpO sensors that have been veri fied and delivered by GeTeMed or its agents Care fully read the sensors Directions for Usel informa
38. ately Lo a second before they react Connectors of VitaGuard VG 300 Important Use only the external power adapters delivered by GeTeMed Monitor displays Operator manual VitaGuard VG 300 VitaGuard VG 300 Fig 1 has connectors to accom modate an external power adapter the SpO sensor ca ble and the external alarm amplifier EA 1000 A PC connector is also available to download data Only use cables and sensors delivered by GeTeMed or an authorised distributor For safety reasons only use the mains adapter delivered with the monitor or the car power adapter NAK 1500 Under no circumstances should you connect any other mains adapter or connect the monitor with the 220V mains supply directly Failure to comply with the above advice may result in serious health damage or even death VitaGuard offers three standard display modes as fol lows General Information 9 Particularly easy op eration VitaGuard is just a tool YOU must react Caution Do not cover the speaker Key panel 8 e General Information Operation Operation of VitaGuard can be learned within minutes Allow your doctor to demonstrate the monitor to you and to set the alarm limits to suit the patient being monitored Remember that YOU the caregiver must act in the event of emergencies Refer to Emergency situation on page 1 In the home environment verify that you can hear the alarm independent of where you are
39. ates lt 1kg Masimo LNOP Pdt sensor paediatric sensor 70252 10 50kg User manual English Alarm chart English User manual German Alarm chart German Alarm chart Turkish VitaGuard packaging External alarm unit EA1000 External alarm connector cable 10m 70004 Car adapter NAK1500 72127 Tab 9 Ordering information for accessories to Vita Guard VG 300 Operator manual VitaGuard VG 300 Appendix e 41 42 e Appendix Ordering address Place your order at your local dealer or contact GeTe Med GeTeMed GmbH Oderstr 59 D 14513 Teltow Germany Telephone 49 3328 3942 0 Fax 49 3328 3942 99 E Mail info getemed de Web www getemed de Operator manual VitaGuard VG 300 Lower HR limit Upper HR limit Tone Pulse Lower SpO2 limit Upper SpO2 limit play structure on page 12ff the values and factory de faults are given in Integrated menus on page 23ff and in Tab 2 to Tab 4 The following explanations are given in the order of their appearance in the menu Monitor settings Lower limit for the pulse rate that if fallen below gen erates an alarm Upper limit for the pulse rate that if exceeded gener ates an alarm Defines if an acoustic signal is given at every recog nised pulse Lower limit for SpO that if fallen below generates an alarm Upper limit for SpO that if exceeded generates an alarm only available in expert mode The so called Expert mode can
40. ayed Using the arrow buttons other episodes Settings at the alarm tain more information about a particular epi Enter gt again After the and SpO2 limits alpha numerical at the alarm Using lt STATUS En Standard E ge ata 1 Standard display 2 chronological order By i f Dat d ti to choose last stored episode is dis DEE can be addressed To ob sode press lt STATUS Pulse oximeter settings information you will see lt Status gt the stored signals Press SER Cart rate intorma lt MODE Esc gt to exit the episode information lt Status gt mode Plethysmogram at the alarm Fig 12 Scheme on how to review stored data Remember that you need to wait for the programmed Operator manual VitaGuard VG 300 Operating VitaGuard e 25 System settings main menu See also Explanation of These settings can be changed using lt MODE Esc gt Re the menu settings on page 38 fer also to Monitor display structure and Monitor menu structure on pages 12 and 13 The different settings are explained in detail in Explanation of the menu settings on page 38 The factory defaults are shown in large bold font tem Valuerange Low_Perfusion Off LCD power save Off On LCD brightness Level 1 2 3 4 Only available in expert mode Tab 3 Value range for the items in the system settings main menu Expert mode main menu See also Explanation of The expert mode can be activated using lt MODE Es
41. c gt the menu settings on page 38 24 e Operating VitaGuard Refer also to Monitor display structure and Monitor menu structure on pages 12 and 13 Operator manual VitaGuard VG 300 2 Next wrap the sensor with the emitter and finger design over the fingernail and secure the wings down one at a time around finger Fig 26 When properly applied the emitter and the detector should be verti cally aligned as shown Fig 27 Check position of sensor to verify correct positioning and reposition if necessary Complete coverage of the detector window is needed to ensure accurate measurements Fig 26 Fixing of the emitter Fig 27 Correctly attached sensor emitter and detector are aligned 3 The connector tab is now oriented on the top side of the patient s finger so that the shiny contacts are facing up Mate the logo on the sensor to the logo on the patient cable Insert the patient cable into the sen sor tab until there is a tactile or audible click of con nection Fig 28 Gently tug on the connectors to en sure a positive contact If required tape may be used to secure the cable to the patient 5 GE ALP ZZ Fig 28 Connecting patient cable and sensor Operator manual VitaGuard VG 300 Directions for use of LNOP sensors 57 C Reattachment The sensor may be reapplied to the same patient if the emitter and detector windows are clear and the adhesive still adh
42. cables from the patient and the monitor before cleaning them Use a damp cloth to clean both the monitor and the cables Use cleaning solution sparingly Excessive solution can flow into the monitor and cause damage to internal components e Do not use aggressive solvents or cleaning agents such as petroleum based or acetone solutions to clean the monitor These substances attack the device s materi als and device failure may result e Do not use alcohol to clean the monitor or cables as this hardens the cables e Do not touch press or rub the display panel or casing with abrasive cleaning compounds instruments brushes rough surfaced materials or bring them into contact with anything that could scratch them e Do not autoclave pressure sterilise or gas sterilise the monitor or any of its components Regulatory information 36 e Safety and Accuracy e VitaGuard VG 300 complies with the requirements of the Medical Device Directive 93 42 EEC e VitaGuard VG 300 fulfils the EMC requirements laid out under the directive 89 336 EWG and EN60601 1 2 1 May 1993 part 1 2 EN55011 class B 1991 DIN VDE 0875 part 11 07 92 e VitaGuard VG 300 is a class Ia devices according to the Medical Device Directive 93 42 EEC MDD Operator manual VitaGuard VG 300 blood or tissue has ALWAYS a lower SpO level these peaks are always at lower SpO values Discrete Saturation Transform ken E Q 5 LUS T 25 so 25
43. change the alarm parameters refer to Monitor display structure on page 12 The mean Operating VitaGuard e 19 Monitoring If problems arise you may reposition the sen sor Having connected the SpO sensor and ensured that all connections are secure switch on the monitor using the lt ON OFF gt button If false alarms occur you must check the sensor place ment and the quality of the used sensor Do not change any alarm limits to combat alarms without prior consultation with your clinician Setting alarm parameters Important SpO alarm limits YOU must act on alarms 18 e Operating VitaGuard Ask your doctor to set the alarm limits that suit the patient Do not change the alarm limits without prior consultation SpO parameters The standard SpO alarm limits are Lower limit 88 Upper limit 100 To change the alarm limits press lt MODE gt to enter the main menu structure Select the Monitor settings menu using lt STATUS Enter gt Move to the SpO alarm limit menus with the arrow keys and select the required menu using lt STATUS Enter gt Remember to hold lt ALARM Stop gt when selecting the new value Press lt STATUS Enter gt to accept the new value or lt MODE Esc gt to reject The limits may be adjusted be tween 50 and 100 Refer to Monitor display struc ture on page 12 The meaning of all settings is explained in Explanation of the menu settings on page 38 Should excessi
44. d by the terms of this agreement Note In the event that any of the provisions of this agreement shall be held by a court or other tribunal of competent jurisdic tion to be unenforceable or unlawful such provisions shall be deleted from this agreement and the remaining portions of this agreement shall remain in full force and effect except where the economic equity of both parties hereto is martially affected by such unenforceability Directions for use of LNOP sensors e 75 TUV Genehmigung Richtlinie 93 42 EWG Anhang Il Artikel 3 vollst ndiges Qualit tsmanagementsystem Medizinprodukte HD 9911907 01 C 9912944 E 02 Registrier Nr Bericht Nr Hersteller GeTeMed Gesellschaft f r Technische Medizin mbH Oderstra e 59 D 14513 Teltow Geltungsbereich Entwicklung Herstellung Vertrieb und Service von EKG und Atmungs Monitoring Systemen Produkte siehe Anlage G ltig bis 12 08 2003 Hiermit genehmigt die Benannte Stelle das vom Hersteller eingef hrte und angewandte Qualit ts managementsystem Die Anforderungen des Anhanges Il Artikel 3 der Richtlinie werden erf llt Der Hersteller unterliegt der EG berwachung nach Anhang Il Artikel 5 der Richtlinie Der Inhaber ist berechtigt diese Bescheinigung im Rahmen seiner Herstellerkonformit tserkl rung zu verwenden K ln den 06 12 1999 Akkreditiert von der Zentralstelle der L nder f r Sicherheitstec nik ZLS u und der Zentralstelle der Lander f r Ges
45. d exces sive bending or creasing of sensor as aggressive folding may dam age sensor integrity em L x For best results place detector on sole of foot aligned with middle toe Fig 10 16 Operating VitaGuard Placing the LNOP NeoPt SpO gt sensors Operator manual VitaGuard VG 300 neonates with poor skin integrity use of the LNOP NeoPt is recommended e Infants For infants between 3 and 10 kg or with fat or oedematous feet use of the LNOP Neo sensor on the big toe is recommended Follow instructions shown with sensor detector on fleshy part underside of big toe Alternative site would be the thumb e Paediatric patients For infants or paediatric patients above 10 kg use of the LNOP Pdt is recommended e Always choose a site that is well perfused and will completely cover the sensor s detector window e Site should be cleaned of debris and dry prior to sen sor placement B Attaching the Sensor to the Patient 1 Open the pouch and remove the sensor Holding the sensor along the length of the Y remove the back ing from the sensor and bandage Orient the sensor tail so that it is pointed away from the patient Position the detector onto the fleshly part of the sole of the foot aligned with the fourth toe Fig 38 E Fig 38 Sensor placement detector on the sole of the foot 2 Orient emitter window on top of foot directly opposite the detector Wrap the bandage around the foot to
46. des LED s allow visual control of the monitor Acoustic signals synchronous with the pulse rate may be activated using the key panel General Information 7 LNOP Neo Sensors for pulse oximetry e g monitoring of pulse and SpO gt Important The optimal SpO gt sensor position depends on the sensor type and the patients weight Important Cable rout ing Automatic switching be tween battery and mains supply Alarm when batteries 6 General Information Sensors The LNOP Neo sensor delivered with the VitaGuard VG 300 monitor is a single patient disposable sensor in tended to measure the functional oxygen saturation of ar terial haemoglobin SpO of neonatal patients weighing less than 10 kg To monitor premature born babies with very fragile skin use the LNOP NeoPt sensor with re duced adhesive area For larger children between 10 and 50 kg use the LNOP Padt sensor and for patients weigh ing more than 30 kg use the LNOP Adt sensor Patients exhibiting allergic reactions to adhesive tape may not be able to use these sensors The sensor must be removed and the site inspected at least every eight 8 hours every four 4 hours with DCI sensor every two 2 hours on children with poor skin integrity and if indicated by circulatory condition or skin integrity reapplied to a different monitoring site Sensor application The sensors delivered with VitaGuard can be placed on the feet or ha
47. e LNOP Pdt on any extremity with an arterial catheter or blood pressure cuff e The pulsation s from intra aortic balloon support can be additive to the pulse rate on the oximeter pulse rate display Verify pulse rate against an ECG heart rate e Avoid bending and distorting the sensor cable be cause this may damage the sensor Hint If the monitor displays pulse rate and SpO not constantly than check the sensor placement and reposition it if necessary If this does not help than change the sen sor Hint Sensors being used for a long period tend to re duced performance A sensor should be replaced if pulse rate and SpO become questionable SPECIFICATIONS When used with Masimo SET pulse oximetry monitors or with licensed Masimo SET pulse oximetry modules us ing PC Series patient cabled during no motion the accu Operator manual VitaGuard VG 300 Directions for use of LNOP sensors e 63 racy of the LNOP Pdt from 70 to 100 SpO2 is 2 digits 1 Std Dev Please see also Miscellaneous Warnings and Hints on page 73ff NOP Neo Directions for use LNOP Neo O Sensor for Neonates DIRECTIONS FOR USE ta lt 10kg Q One Patient use Non sterile and latex free Fig 37 Instructions for LNOP Pdt SpO gt sensors These sensors are intended for multiple use on only one patient weighing lt 10 kg They are non sterile and latex free and can not be sterilised INDICATIONS CONTRAINDICATIONS
48. e cleaned of debris and dry prior to sensor placement B Attaching the Sensor to the Patient 1 Open the pouch and remove the sensor Holding the sensor with the tan printed side downward bend the sensor backward and remove the backing from the sensor Orient the sensor so the detector can be placed first Fig 31 Press the detector onto the fleshly part of the finger near the tip of the finger Press down the T shaped adhesive ends of the sensor onto the finger Fig 32 60 e Directions for use of LNOP sensors Operator manual VitaGuard VG 300 Bear in mind that you should be able to reach your patient within 10 seconds in order to react promptly to a critical situation Battery operation Important Hint Attention Monitoring is aborted when batter ies are weak With low batteries you should firstly restore power supply Operator manual VitaGuard VG 300 VitaGuard can be operated either with four LR6 alkaline batteries or with an external power adapter NA 2000 2 or NAK 1500 see Power supply on page 6 The moni tor also has an internal battery that always powers the in ternal memory and clock chip Should the power adapter be suddenly removed from the monitor during operation and no batteries are installed then the internal battery is used to generate a warn tone This should be avoided The monitor must be returned to the manufacturer if the internal battery becomes weak Battery supervision
49. ent mode is default When the monitor is switched on it always assumes event mode storage To change to permanent storage mode enter the expert mode and change the memory mode option under the System settings menu Refer also to System settings main menu on page 24 In both modes the memory operates as a loop memory Le when the memory is full 200 episodes the oldest episodes are automatically deleted to make room for new ones This ensures that the most actual stored episodes are available The actual memory usage is displayed during start up of the monitor It can be reviewed by pressing lt INFO A gt multiple times Stored data can be re The data from the monitor can be transferred to a stan viewed ona PC dard PC over the serial RS232 interface and evaluated with a Windows based programme developed by GeTe Med The PC programme can also be used to set the monitor internal clock GeTeMed developed the Software VitaGuard for Windows to support the evaluation of the saved protocols and alarm episodes VitaGuard for Windows runs on Windows 95 98 NT 4 0 or higher It 1s sold only to authorised dealers and to physicians that supervise users of VitaGuard Operator manual VitaGuard VG 300 Operating VitaGuard e 27 Bradycardia Tachycardia SpO low SpO high SpO2 Silent Silent Brady Silent Tachy Permanent Manual Combination 26 Operating VitaGuard post alarm period usually 20s to elapse befo
50. eres to the skin NOTE Prior to reattachment or rejuvenation disconnect the sensor from the sensor cable e The adhesive can be partially rejuvenated by wiping with a 70 isopropyl alcohol pad and allowing the sensor to thoroughly air dry prior to replacement on the patient e If the adhesive can not be adequately rejuvenated use a new sensor D Disconnecting Sensor and Patient Cable 1 Place thumb and index finger on grey buttons on ei ther side of the patient cable Fig 29 Fig 29 Disconnecting patient cable and sensor 2 Press firmly on the grey buttons and pull to remove the sensor WARNINGS e The site must be checked and changed at least every eight 8 hours NOTE Exercise extreme caution with poorly per fused patients skin erosion and pressure necrosis can be caused when sensors are not frequently moved As sess the site at least every two 2 hours with poorly perfused patients e If the sensor is damaged in any way discontinue use immediately e To prevent damage do not soak or immerse the sensor in any liquid solution Do not attempt to sterilise e Intravascular dyes may lead to inaccurate SpO2 meas urements 58 Directions for use of LNOP sensors Operator manual VitaGuard VG 300 The monitor settings and stored alarm episodes are not lost when changing the batteries Refer also to Technical Data on page 29 for battery operation lifetime Mains adapter Only use the mains adapter
51. ery two 2 hours to en sure proper adhesion skin integrity and alignment The LNOP DC1 sensor is not intended for long term monitoring On patients with poor perfusion or when monitoring is needed for more than 8 hours don t use the DCI sensor but the appropriate adhesive sensor instead Disconnecting the sensor Before you detach the sensor from the patient you should switch the monitor off and disconnect the sensor and the patient cable Press firmly on the grey buttons on either side of the patient cable connector and pull to remove the sensor connector Now you may detach the sensor from the patient Operating VitaGuard 17 Press the hinge tabs to open the sensor Place the leshy part of the finger on the detector window Fig 6 D d Wen ar No NS The sensor cable should run Mate the logos on both cable connectors over the top of the hand r u oo ra NW Ma N A N ch pm Cao Insert the DC1 connector in the patient cable connector until a click is sensed Placing the LNOP DC1 SpO sensors Sender ae Place the finger tip Fix it with the T shaped adhesive tape onto the detector Wrap the emitter align it with the detector and fix it too Mate the logos on both Push the grey buttons and pul connectors and connect them the connectors to disconnect For best results place the sensor on a finger tip of the non dominant hand Placing the LNOP Adt
52. esonance imaging Induced currents could poten tially cause burns Also VitaGuard may affect the MRI image and the MRI unit may affect the accuracy of the VitaGuard readings e Do not operate in connection with HF surgical equip ment defibrillators TENS units or pacemakers Should however the monitor still be connected to the patient during defibrillation the readings may be inac curate for a short period afterwards e While monitoring patients do not connect VitaGuard to any devices e g evaluating PC other than those delivered with the monitor Other devices may not have the required isolation and cause excessive leak age currents gt 100uA to flow through the patient This may damage the patient and or the monitor e Static electricity from fabrics e g curtains or rugs may cause damage to the patient and the monitor or may reduce the reliability of the monitoring function Always touch the patient s bed or a wall before touch ing the patient or the monitor Try to use fabric sof tener when washing the patient s clothes to reduce static electricity e Do not operate VitaGuard when travelling by air Switch the monitor off and remove the batteries before packing the monitor into your luggage Pressure due to other luggage my otherwise switch the monitor on during the flight causing the monitor to generate a technical alarm Safety precautions Power supply e Only use the mains power adapter NA 2000 2
53. h all potential caregiv ers regularly at least once every month In the event of an alarm follow the instructions on page il IMPORTANT Telephone numbers in an emergency Please note the telephone numbers of your doctors in the spaces provided below Emergency Family doctor Your address Name Street Postal code Telephone Keep this manual in a place where it can easily be found by every potential caregiver Operator manual VitaGuard VG 300 el Operator Manual VitaGuard Serial number 0199701 or greater VG 300 Pulse oximeter incorporating Masimo SET Technology GeTeMed V p Gesellschaft f r Technische Medizin mbH BEER SpO Monitor Glaf Oderstra e 59 14513 Teltow Telefon 0 33 28 39 42 0 Telefax 0 33 28 39 42 99 Email Info getemed de Internet www getemed de Po ALARM Stop ALARM NETZ ENN e ap 5 C O HighTech made easy GeTeMed GmbH Operator manual VG 300 Version of 25 02 2000 Subject to changes
54. ich is the same relationship for TPO The equation for the noise reference N is based on the value of R the value being seeked to determine the SpO The MS 3 software sweeps through possible values of R that correspond to SpO values between 1 and 100 and generate an N value for each of these R values The S 660 and S 940 signals are processed with each possi ble N noise reference through an adaptive correlation canceller ACC which yields an output power for each possible value of R 1 e each possible SpO from 1 to 100 The result is a Discrete Saturation Transform DST plot as shown in Fig 15 where R corresponds to SpO 97 The DST plot has at least one peak caused by the arterial pulse This peak shows that at the associated SpO value the effective noise cancellation was especially effective because a well defined source of noise the arterial pulse variation was identified The DST plot may show more peaks with even higher peak values caused by other sources of noise e g ve nous variations of light absorbance But because venous Operator manual VitaGuard VG 300 Guarantee conditions We provide the following guarantee for VitaGuard 1 GeTeMed guarantees that all VitaGuard devices with the exception of all consumables such as SpO sensors batteries and packaging material are free from faults for one year after delivery This guarantee is provided in addition to the statutory warrantee
55. ing Apparatus o 15758 644Manual and Automatic Probe Calibration 17 pending Signal Processing Apparatus Operator manual VitaGuard VG 300 Accuracy and factors effecting the SoO2 measurement e If you doubt the accuracy of any measurement first check the patient s vital signs by alternate means and check that the monitor is functioning correctly e Inaccurate measurements may be caused by incorrect sensor application or use e Inaccurate measurements or loss of the pulse signal may be caused by exposure to excessive illumination such as surgical lamps especially ones with Xenon light sources bilirubine lamps fluorescent lights in frared heating lamps or direct sunlight Expose to excessive illumination can be corrected by covering the sensor with a dark or opaque material e Inaccurate measurements may be caused by placing the sensor on an extremity with a blood pressure cuff arterial catheter or intravascular line e Loss of the pulse signal can occur if the LNOP sen sor is too tight e Use only Masimo LNOP sensors for SpO measure ments Other sensors may cause improper perform ance Information for the handling paediatrician e A pulse oximeter should be considered an early warn ing device As a trend towards patient deoxygenation is indicated blood samples should be analysed by a laboratory co oximeter to completely understand the patients condition Inaccurate measurements may be caused by signifi c
56. ing the sensor Operator manual VitaGuard VG 300 Attaching the sensor to the patient e Open the sensor package and remove the sensor Hold the sensor along the length of the Y and remove the backing from sensor and bandage Orient the sensor tail so that it is pointed away from the patient Position the detector onto the fleshy part of the sole of the foot aligned with the fourth toe e Orient the emitter window on top of the extremity di rectly opposite to the detector Wrap the bandage or plaster around to maintain proper alignment of detec tor and emitter windows Check position of sensor to verify correct positioning and reposition if necessary Complete coverage of the detector window is needed to ensure accurate data e Orient the connector tab to match the logos D on the sensor tab and the patient cable Insert the patient ca ble to the sensor tab until there is a tactile or audible click of connection Gently tug on the connectors to ensure a positive contact Tape may be used to secure the cable to the patient for ease of movement By holding the connector of the patient cable so that the logo is pointing up connect it to the VitaGuard monitor Again an audible or tactile click will con firm connection Gently tug on the connector to ensure a positive contact with the monitor Avoid excessive bending of the patient cable The site should be checked at least every eight 8 on in fants with poor skin integrity ev
57. ingle Patient LNOP Neo Sensors must be handled prop erly to achieve their full performance Operator manual VitaGuard VG 300 The alarm is always deactivated for 20 seconds after pressing a button All monitor settings are stored and reappear automati cally when the monitor is switched back on again This 1s also true when replacing the batteries Alarm information When an alarm occurs a message related to the cause of the alarm appears on the display lt STATUS Enter gt can be used to obtain more information about the alarm This information is available approx minute after the alarm has stopped Handling LNOP sensors The LNOP sensors offered with VitaGuard are dispos able ones intended for single patient use and only with instruments containing Masimo SET oximetry They can be used several times but prolonged use of the same sensor may lead to reduced performance if the sensor be comes dirty or the plaster no longer sticks properly The only exception is the LNOP DC1 sensor that can be used with different patients If you are not sure what type of sensor to choose than read Sensor selection on page 50 In the subsequent sec tions of Directions for use of LNOP sensors on page SOff you ll find detailed instructions on how to use the different sensor types Here the descriptions are limited to global instructions Before using a particular type of sensor refer to the de tailed inst
58. ions for LNOP NeoPt SpOz sensors These sensors are intended for multiple use on only one patient weighing lt 1 kg and having poor skin integrity Operator manual VitaGuard VG 300 Monitor menu structure The monitor possesses three menu levels The first menu level is activated with lt MODE Esc gt Use lt INFO A gt or lt GRAPHIC V gt to highlight the required selection To enter the selected menu press lt STATUS Enter gt Settings lt Modus gt There are four submenus available that can be selected with lt INFO A gt or lt GRAPHIC V gt and activated with lt STATUS Enter gt Monitor settings All parameters governing alarm limits settings and signals are grouped here System settings These include parameters such as scaling the displayed waves power save mode and settings for the SpO monitor Time Date The time and date of the internal clock can be adjusted using this menu Expert mode The expert mode can be activated upon entering a password When activated the Monitor Settings menu and the System Settings menu are ex tended to include functions primarily designed for cli nicians e g activation of silent alarms and settings controlling the data memory Upon entering one of these menus the parameter of in terest can be selected using lt INFO A gt or lt GRAPHIC V gt Once highlighted the individual menu can be entered by pressing lt STATUS Enter gt Info lt
59. is acoustic signal not be gen erated send the monitor for inspection to the manu facturer immediately Monitor display structure Monitor information can be viewed using the four buttons lt MODE Esc gt lt INFO A gt lt GRAPHIC V gt and lt STATUS Enter gt as shown in Fig 5 The four main menu paths will be explained next For information on the individual monitor settings refer to Explanation of the menu settings on page 38ff lt ALARM Stop gt Standard Display 1 Standard Display 2 lt Mode gt lt Info gt Graphic gt lt Status gt Monitor settings Graphic gt Episode number count System settings Information display Graphic display Type of episode lt A gt lt V gt Datum Uhrzeit Date and time to choose Expert mode browse Duration lt hfo gt lt Graphic with lt Info gt lt Graphic gt es lt Enter gt Monitor O ti d Monitoring lo Plethysmogram EE Sr SE Settings at the alarm lt Graphic gt ui lt Status gt lt Enter gt System Pulse oximeter Trends Pulse oximeter settings lt A gt lt V gt settings settings at the alarm to choose SpO2 limits at the lt Info gt alarm lt Enter gt lt Status gt Date time common settings Heart rate informa lt Info gt tion at the alarm lt Status gt lt Enter gt Expert Memory settings mode Plethysmogram at the alarm lt Info gt Version information Fig 5 Menu structure of VitaGuard VG 300 12 e Operating VitaGuard Operator manual VitaGuard VG 3
60. itaGuard VG 300 Staus memor y ee Eet 25 PRN AU MACY Be Ee Ee 26 Episode memory and PC interface uueeeeeseeeseseseeesesesnennnnnnnnnnnnnnnnnnnnnnnnnnnnen nn 27 Technical Data 29 Genera ee 29 leede eegen 29 NETTO nee ee ee 29 Ok Ee Ee EE 30 Safety and Accuracy 31 Salely PLCC AULIONS eccaneste rents eisernen ee 31 Salely precautions Eeer tele 31 Safety precautions Environment cccccccccccccceeeceeseeeeseseeeseeeeeeeeeeeeeeeees 32 Safety precautions Power supply eeeeeeeeeeeeeseseneeeeeeesennnnnnnnnnnnnnnnnnnnnnnnnnn nn 33 Safety precautions Sensor and cable nn 34 Accuracy and factors effecting the SpO measurement 35 Clean ae inet an 36 Regulatory informalion ae na EE eases 36 Guarantee COMCIN eebe 37 Appendix 38 Special function Immediate data gtorage 38 Compliance EG 38 Explanation of the menu settings eeeeeeeeeeesesesesenenenesnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnn 38 le nterne 39 Sy SECM EE 39 Date INS SOU OS ost sain ca lias sia Rear Bee 40 Expedia ee 40 HEIEREN ee 41 EE 41 ACCE SONS ee elle 41 Biere e EE 42 Masimo SET Ree 43 Principle Of OPCratlON a AEN 43 Eeer eeh 45 Patent Nom atl n nn ern 46 External alarm unit BA1000 nen ae deed 47 Hints TOP operati ON EE 47 eier ru 48 Techmica da E 48 Safety with the external alarm unt 48 Caradapier NAK T300 EE 49 FHAS FOr perat OM eege 49 dE e ee en ee EA 49 Table of Content 3 Table of Content EMERGENCY SITUA
61. ll not assign or transfer this license in whole or in part by operation of law or otherwise without GeTeMed s prior written consent any attempt without such consent to assign any rights duties or obligations arising here under shall be void Copy Restriction The software firmware and the accompany ing materials are copyrighted Unauthorised copying of the software including software that has been modified merged or included with other software or other written materials is ex pressly forbidden You may be held legally responsible for any infringement that is caused or incurred by your failure to abide by the terms of this license Nothing in this license provides any rights beyond those provided by 17 U S C 117 Use Restriction As the Purchaser you may physically transfer the products from one location to another provided that the software firmware is not copied You may not electronically transfer the software firmware from the product to any other device You may not disclose publish translate release or dis tribute copies of the software firmware or accompanying mate rials to others You may not modify adapt translate reverse engineer decompile disassemble or create derivative works based on the software firmware You may not modify adapt translate or create derivative works based on the written materi als without the prior written consent of GeTeMed Transfer Restrictions The software firmware is licensed to
62. maintain proper alignment of the detector and emitter windows Fig 39 Check position of sensor to verify correct positioning and reposition if necessary Com plete coverage of the detector window is needed to en sure accurate data Fig 40 Operator manual VitaGuard VG 300 Directions for use of LNOP sensors e 65 Fig 39 Orientation of emitter and detector E Fig A0 Correctly attached LNOP Neo Sensor 3 Orient the LNOP Neo s connector tab so that the top site of the shiny contacts are facing up Mate the logo D on the sensor tab to the logo on the patient ca ble Insert the patient cable to the sensor tab until there is a tactile or audible click of connection Fig 41 Gently tug on the connectors to ensure a positive con tact Tape may be used to secure the cable to the pa tient for ease of movement E Fig Ai Connecting patient cable and sensor C Reattachment The sensor may be reapplied to the same patient if the emitter and detector windows are clear and the adhesive still adheres to the skin NOTE Prior to reattachment or rejuvenation disconnect the sensor from the sensor cable e The adhesive can be partially rejuvenated by wiping with a 70 isopropyl alcohol pad and allowing the 66 Directions for use of LNOP sensors Operator manual VitaGuard VG 300 Important Automatic storage of all parameters Alarms are shown in the display Sensors Attention Most sen sors are S
63. n the event of an emergency The LNOP Neo and NeoPt sensors are especially de signed for neonates to allow monitoring over a period of months without causing irritation of the skin In seldom cases allergic reactions can occur Should this happen consult your clinician for advise Compliance with the legal requirements The product VitaGuard complies with all legal re quirements listed in the appendix I basic requirements on medical products of the EEC directive on medical products When applied according to the intended use and observing all the stated warnings there are no safety risks known to be caused by the product The monitor must be returned for inspection to the manufacturer if the operation period printed on the monitor is expired General Information 5 Safety with the adapter NAK LEE 49 VI Directions for use of LNOP sensors 50 SENSOR SEIECHON ze ee ee 50 Ser 50 LNOP DC1 Directions for use 51 INDICATIONSCONTRAINDICATIONS eecccceseccccceeeeeseeeeees 51 INSTRUCTION S cas u se nee De el 51 CLEANING see re Se 53 WARNING S 2223320 ernst 54 SPECIFICATIONS us esse 55 LNOP Adt Directions for use 55 INDICATIONSCONTRAINDICATIONS 55 EE 56 WARNING Saena en essen lan 58 SPECIFICATION Sennaa aa A 59 LNOP Pdt Directions for use anna 59 INDICATIONSCONTRAINDICATIONS 60 INSTRUCTIONS FOR USE E 60 WARNINGS EE 63 SPECIFIE ATIONS EE 63 LNOP Neo Directions for use 64 INDICATIONS CONTRAINDI
64. nal power adapter always ensure that fresh batteries are in stalled If no batteries are installed the monitor displays a message every 16 seconds informing you to do so The batteries are important to ensure that the device can automatically switch to battery mode in the event of a mains power failure or when somebody abruptly removes the power connector Should either of these events hap pen and no batteries are inserted the monitor generates a permanent alarm tone This can only be deactivated by inserting batteries into the device or reapplying the power connector and switching the monitor back on You should react promptly in the event of such an alarm because your child is no longer being moni tored This alarm tone is generated by an internal buffer battery If this battery becomes weak the monitor must be returned to the manufacturer for replacement To test that the batteries in the battery compartment are charged enough for SpO operation carry out the follow steps Remove the external power adapter so that the de vice is powered from batteries Wait 30 seconds and then press lt INFO A gt a number of times until you reach the battery information If the batteries are weak replace them immediately with good quality alkaline batteries such as VARTA alkaline Extra Longlife It is recommended that you always keep at least two spare sets handy Display The large surfaced LCD display and the light emitting dio
65. nds of smaller children on the big toe or thumb of larger children or on a finger of adult or paedi atric patients In choosing the actual site you have to consider the necessity of obtaining a good signal and the comfort of the child See also Directions for use of LNOP sensors and Sensor selection on page 5Off The sensor must be fixed at its site without obstructing the blood flow Carefully route the patient cable to prevent strangulation If necessary route the cable within the clothing and fix it with a plaster Power supply VitaGuard offers a high level of electrical safety and flexibility and operates with batteries the car power adapter NAK 1500 or with the mains supply adapter NA 2000 2 provided When an external power adapter is connected the LCD backlight is automatically switched on The monitor switches automatically to battery mode in the event of an external power failure It is therefore strongly recommended that you always keep batteries in the monitor even when using external power adapters When operating the device with batteries the SpO gt mod Operator manual VitaGuard VG 300 Operator manual VitaGuard VG 300 modification reproduction release performance display or disclosure of the software including the related documentation by the U S Government or any of its agencies shall be govered solely by the terms of this Agreement and shall be prohibited except to the extend permitte
66. nm and 940 nm S 660 AC 660 DC 660 S 940 AC 940 DC 940 The oximeter then calculates the ratio of these two arte rial pulse added signals R S 660 S 940 This value of R is used to find the saturation SpO in a look up table build into the oximeter s software The val ues in the look up table are based upon human blood studies against a laboratory co oximeter on healthy adult volunteers in induced hypoxia studies Operator manual VitaGuard VG 300 Appendix e 43 44 e Appendix Masimo SET pulse oximeter The Masimo SET pulse oximeter assumes that the arte rio venous shunting is highly variable and that fluctuating absorbance by venous blood is the major component of the noise during the pulse The SpO module MS 3 board decomposes S 660 and S 940 into an arterial signal plus a noise component and calculates the ratio of the arterial signals without the noise S 660 S1 NI1 S 940 S2 N2 R S1 S2 Again R is the ratio of two arterial pulse added absorb ance signals and its value is used to find the saturation SpO in an empirically derived equation in the oximeter s software The values in the empirically derived equation are based upon human blood studies against a laboratory co oximeter on healthy adult volunteers in induced hy poxia studies The above equations are combined and a noise reference N is determined N S 660 R S 940 If there is no noise N 0 then S 660 R S 940 wh
67. not operate the monitor until you have been made familiar with its usage by a trained person and have read and understood this manual and all other documentation provided e Allow your doctor to set the alarm limits and monitor ing parameters suitable for your patient e VitaGuard may not be used for other purposes other than the intended purpose laid out in Intended use of VG 300 on page 5 Safety and Accuracy 31 Pulse oximetry Miscellaneous 30 e Technical Data om ess SSCS 25 30 35 175 180 BPM Upper alarm limit 100 105 110 235 240 BPM Pulse rate accuracy 3 digits during no motion condi 1 Std Dev tions 5 digits during motion condi tions SpO range 1 100 SpO accuracy Range above 70 3 digits on 1 Std Dev neonates during motion Range 0 69 unspecified Testing based on adult volunteers in induced hypoxia stud ies with LNOP Adt sensors in the range 70 100 SpO against a laboratory co oximeter and ECG monitor Tab 7 Pulse rate monitor properties of VitaGuard VG 300 tem Valuerange Safety classification BF IEC 601 2 25 IP41 IEC 601 1 Operating tempera 10 40 Celsius ture Humidity D 90 non condensing Tab 8 Miscellaneous properties of VitaGuard VG 300 Operator manual VitaGuard VG 300 LNOP DC1 Directions for use Paisi aain Ai a 2 ee wif Wi S mu Si eg I ee En O Sensor for adults DIR
68. o the menu structure itself and on how to operate the menus can be found in Monitor dis Operator manual VitaGuard VG 300 Masimo SET technology Principle of operation Masimo s SET SET Signal Extraction Technology pulse oximeter is based on three principles 1 Oxyhaemoglobin and deoxyhaemoglobin have differ ent red and infrared light absorption spectrophotome try 2 The arterial blood volume in tissue and the light ab sorbed by the blood changes during the pulse ple thysmography 3 Arterio venous shunting is highly variable and fluctu ating absorbency by venous blood is a major compo nent of noise during the pulse The Masimo SET pulse oximeter as well as traditional pulse oximetry determine SpO by passing red and infra red light into a capillary bed and measure changes in light absorption during the pulsatile cycle Red and infrared light emitting diodes LEDs in oximetry sensors serve as light sources a photodiode serves as the photodetector Traditional pulse oximeters TPO Traditional pulse oximetry assumes that all pulsations in the light absorbance signal are caused by oscillations in the arterial blood volume This assumes that the blood flow in the sensor region passes entirely through the cap illary bed rather than through any arterio venous shunts The traditional pulse oximeter calculates the ratio of pul satile absorbance AC to the mean absorbance DC at each of two wavelength 660
69. or the car power adapter NAK1500 Operator manual VitaGuard VG 300 Safety and Accuracy 33 VitaGuard s MDD ap proval is bound to ap proved accessories 32 e Safety and Accuracy Electrical shock hazard Never open or dismantle the monitor or any other items delivered with the monitor e g mains power adapter cable connectors etc Do not lift VitaGuard by the power supply cord or any of the patient cables Do not place VitaGuard or its power adapter in a po sition that might cause it to fall onto the patient Do not press heavily on the monitor press buttons lightly Do not use damaged components sensors or cables Do not immerse VitaGuard or any of its components in liquids Detach all sensors from the patient before bathing VitaGuard and the authorised accessories can only be purchased through authorised agents Order new sen sors before you run out Never use accessories from other sources Maintenance repairs may only be carried out by authorised persons Check the acoustic alarm on a weekly basis If an alarm condition occurs while the alarm silence period is activated e g after pressing a button the only alarm indication is the visual red alarm LED Send the monitor back to the manufacturer or agent for environmental friendly disposal Safety precautions Environment Do not operate in the vicinity of explosive gases Do not use in the presence of flammable anaesthetics or other
70. ovement D Disconnecting sensor and patient cable 1 Place thumb and index finger on grey buttons on ei ther side of the patient cable connector Fig 22 2 Press firmly on the grey buttons and pull to remove the sensor CLEANING To clean the sensor first remove it from the patient and disconnect it from the patient cable You my then clean the LNOP DC1 by wiping it with a 70 isopropyl alco hol pad Allow the sensor to dry prior to placement on a patient Operator manual VitaGuard VG 300 Directions for use of LNOP sensors 53 Caution Do not soak or immerse the cable in any liquid solution Do not attempt to sterilise E Fig 22 Disconnecting patient cable and sensor WARNINGS e The site must be checked and changed at least every four 4 hours NOTE Exercise extreme caution with poorly per fused patients skin erosion and pressure necrosis can be caused when sensors are not frequently moved As sess the site at least every two 2 hours with poorly perfused patients e If the sensor is damaged in any way discontinue use immediately e To prevent damage do not soak or immerse the sensor in any liquid solution Do not attempt to sterilise e Intravascular dyes may lead to inaccurate SpO2 meas urements e Elevated levels of Carboxyhaemoglobin COHb may lead to inaccurate SpO2 measurement e Elevated levels of Methaemoglobin MetHb will lead to inaccurate SpO2 measurements e Failure to apply the L
71. re relying on any form of external system for trans mitting the alarm tone to another room e g Baby phone ensure that the VitaGuard alarm tone is transmitted clearly To amplify the alarm signal over a greater distance we recommend that you use the external alarm unit EA 1000 This unit also checks that the monitor is switched on 20 e Operating VitaGuard Operator manual VitaGuard VG 300 Fig 31 Sensor placement detector on the finger tip Fig 32 Fixing of the detector 2 Next wrap the sensor with the emitter and finger design over the fingernail and secure the wings down one at a time around finger Fig 33 When properly applied the emitter and the detector should be verti cally aligned as shown in Fig 34 Check position of sensor to verify correct positioning and reposition if necessary Complete coverage of the detector window is needed to ensure accurate measurements Fig 33 Fixing of the emitter Fig 34 Correctly attached sensor emitter and detector are aligned Operator manual VitaGuard VG 300 Directions for use of LNOP sensors e 61 62 e Directions for use of LNOP sensors 3 The connector tab is now oriented on the top side of the patient s finger so that the shiny contacts are facing up Mate the logo on the sensor to the logo on the patient cable Insert the patient cable into the sen sor tab until there is a tactile or audible click of con nection Fig 35 Gentl
72. re you can view the information about an alarm that has just oc curred The actual process of saving is displayed Alarm types The following alarm types can be displayed under status information Pulse rate below the set alarm limit Pulse rate above the set alarm limit SpO below the set alarm limit SpO above the set alarm limit Episode with an overrun of both SpO limits Silent alarm where the SpO lay outside either of the si lent alarm limits Pulse rate below the silent alarm limit Pulse rate above the silent alarm limit Episode without an alarm stored in permanent mode Episode manually initiated Episode with more than one alarm cause e g SpO and bradycardia together Operator manual VitaGuard VG 300 it if necessary If this does not help than change the sen sor Hint Sensors being used for a long period tend to re duced performance A sensor should be replaced if pulse rate and SpO become questionable SPECIFICATIONS When used with Masimo SET pulse oximetry monitors or with licensed Masimo SET pulse oximetry modules us ing PC Series patient cabled during no motion the accu racy of the LNOP DC1 from 70 to 100 SpO2 is 2 digits 1 Std Dev Please see also Miscellaneous Warnings and Hints on page 73ff LNOP Adt Directions for use LNOP Adt O Sensor f r for adults H DIRECTIONS FOR USE I gt 30 kg Single patient use Non sterile and latex free Fig 23
73. ructions starting on page 50 Always choose a site that is well perfused and will completely cover the sensor s detector window The skin should be dry and clean prior to sensor placement For infants with poor skin integrity use of the LNOP NeoPt is recommended Place the actual LNOP sensor as shown in the appropri ate figure Use only sensors provided by GeTeMed or its authorised dealers Operating VitaGuard e 15 Interrupted monitoring result in a vertical line in the trend curve Important Clear the old trend curves when changing the patient Information about stored episodes Important Controls protection Safety measure 14 e Operating VitaGuard The trend display shows a horizontal line if monitoring was interrupted Such interrupts are typically caused by switching off the monitor To display trend curves VitaGuard stores older data When changing the patient this could cause wrong data being used in the trend curves Clear the trend curves whenever you finally finish monitoring a specific pa tient More information on how to clear the trend curves can be found in System settings main menu on page 24 After displaying the last signal curve the display reverts back to the selected standard display Status lt STATUS Enter gt lt STATUS Enter gt is used to view information on stored episodes Once activated the actual episode of interest can be selected with lt INFO A gt and lt G
74. s set to Overwrite Reactivates the factory default settings Caution All individual settings will be overwritten Date time settings Correction of the day in the internal clock Correction of the month in the internal clock Correction of the year in the internal clock Correction of the hour in the internal clock Correction of the minute in the internal clock Expert mode Activates the expert mode after entering the correct password When activated the menus Monitor Settings and System Settings are extended to include functions primarily designed for clinicians e g activation of silent alarms and settings controlling the data memory Only for internal purposes of GeTeMed Operator manual VitaGuard VG 300 Ordering information Complete system The complete system consists of the following items e 1 VitaGuard VG300 monitor e 1 SpO patient cable PCO8 1 LNOP SpO sensor e mains power adapter NA2000 2 1 set of batteries e 1 pouch with straps e 1 user manual license agreement Accessories Please quote the following order numbers when ordering replacements Item Order number VitaGuard Monitor VG 300 complete system 72022 with Masimo SET Power adapter NA2000 2 72126 Pouch with straps 72186 Masimo SpO2 patient cable PCO8 2 44m 70257 Masimo SpO2 patient cable PC12 3 66m 70258 Masimo LNOP Neo sensor neonates lt 10kg 70251 Masimo LNOP NeoPt sensor pre term neo 70250 n
75. t ALARM Stop gt Display 3 appears automatically after 5 minutes if no button is pressed and the power save setting is activated See also System settings on page 39 ll Operating VitaGuard Operation Attention Read Safety Before using VitaGuard for the first time read and un and Accuracy on page derstand this manual carefully Pay particular attention to 31 Safety precautions on page 31ff If you have questions about monitoring handling VitaGuard or how to react in the event of an emergency ask your clinician or moni tor dealer Switching VitaGuard on and off VitaGuard is switched on using lt ON OFF gt To switch the monitor off press lt ON OFF gt for a couple of seconds and follow the instructions on the monitor display After switching the monitor off wait at least two seconds be fore switching it back on again Operator manual VitaGuard VG 300 Operating VitaGuard e 11 Standard Display 1 Standard Display 2 10 e General Information Standard Display 1 numbers and alarm limits Oxygen saturation Heart rate Status of the arterial blood SpO2 Heart rate Alarm activated SpO2 Trend 97 HR Trend 88 100 80 220 120 Trends Fig 2 Standard Display 1 only numbers This display mode gives an overview of the measured values along with the associated alarm limits Standard Display 2 graphic and numbers Heart rate Plethysmogram Oxygen saturation of the
76. t least every eight 8 hours NOTE Exercise extreme caution with poorly per fused patients skin erosion and pressure necrosis can be caused when sensors are not frequently moved As sess the site at least every two 2 hours with poorly perfused patients e If the sensor is damaged in any way discontinue use immediately Operator manual VitaGuard VG 300 Directions for use of LNOP sensors 71 e To prevent damage do not soak or immerse the sensor in any liquid solution Do not attempt to sterilise e Intravascular dyes may lead to inaccurate SpO2 meas urements e Elevated levels of Carboxyhaemoglobin COHb may lead to inaccurate SpO2 measurement e Elevated levels of Methaemoglobin MetHb will lead to inaccurate SpO2 measurements e Failure to apply the LNOP Neo properly may cause incorrect measurements e Do not use the LNOP Neo during MRI scanning e Avoid placing the LNOP Neo on any extremity with an arterial catheter or blood pressure cuff e The pulsation s from intra aortic balloon support can be additive to the pulse rate on the oximeter pulse rate display Verify pulse rate against an ECG heart rate e High oxygen concentrations may predispose a prema ture infant to retinopathy Therefore the upper alarm limit for the oxygen saturation must be carefully se lected in accordance with accepted clinical standards e Circulation distal to the sensor site should be checked routinely e Avoid bending
77. t lower bradycardia limit of 100 BPM may be set If the pulse rate falls below 100 BPM then a silent alarm will be stored If the real alarm limit is set to 80 BPM and the pulse rate falls below this value then a real alarm with warn tone is generated SpO See oxygen saturation Tachycardia Rapid heart rate Technical Alarm A technical alarm is a slow sequence of warning tones that are generated when a technical irregularity is detected for exam ple when the SpO sensor is not properly connected Trend In this manual Displaying average values to show and review a longer period of data Operator manual VitaGuard VG 300 Glossary e 79 Vill Index Accessories 44 Accuracy 12 38 Alarm 1 5 7 15 18 21 23 25 29 32 34 35 42 44 51 52 72 76 82 83 limits 8 10 13 18 19 20 25 28 32 34 42 72 76 83 parameter 82 technical 7 8 19 20 22 23 36 83 test 21 Allergies 5 6 60 64 68 73 Batteries 7 8 12 14 15 20 24 32 36 37 44 51 52 82 Display 8 9 10 13 14 15 19 20 22 24 26 29 32 43 51 58 63 67 72 76 79 82 Emergency How to act 1 51 Telephone numbers 1 Expert mode Handling Intended Use Key panel Memory what is stored Menu 80 e Index 13 25 26 29 42 43 44 16 34 8 9 12 14 15 27 43 9 14 15 23 27 28 29 33 42 43 83 13 changing parameters controls protection Expert mode
78. t weighing between 10 and 50 kg They are non sterile and latex free and can not be sterilised INDICATIONS CONTRAINDICATIONS The LNOP Pdt Paediatric Slender Digit Adhesive Sensor is indicated for single patient use for the continuous non invasive monitoring of arterial oxygen saturation SpO2 and pulse rate for patients weighing between 10 and 50 kg It is for use only with instruments containing Masimo SET oximetry or licensed to use LNOP sensors Consult individual instrument manufacturer for compatibility of particular instrument and sensor models Each instrument manufacturer is responsible for determining whether its instruments are compatible with each sensor model The LNOP Pdt is contraindicated for patients who exhibit allergic reactions to adhesive tape The sensor must be removed and site inspected at least every eight 8 hours and if indicated by circulatory condition or skin integrity reapplied to a different monitoring site INSTRUCTIONS FOR USE A Site Selection e Choose a site that is well perfused and least restricts a conscious patient s movements The ring or middle finger of the non dominate hand is preferred e Alternatively the other digits on the non dominate hand may be used Always choose a site that will completely cover the sensor s detector window The great toe or second toe next to the great toe may be used on restrained patients or patients whose hands are unavailable e The site should b
79. t will completely cover the sensor s detector window The great toe or long toe next to the great toe may be Operator manual VitaGuard VG 300 Directions for use of LNOP sensors 51 used on restrained patients or patients whose hands are unavailable Site should be cleaned of debris prior to sensor place ment General B Attaching the Sensor to the Patient l Open the sensor by pressing on hinge tabs Place the selected digit over the sensor window of the LNOP DC1 The fleshiest part of the digit should be covering the detector window in the lower half of the sensor The top half of the sensor is identified by the cable On finger sites the tip of the finger should touch the raised digit stop inside the sensor If the fingernail is long it may extend over and pass the finger stop Fig 18 Fig 18 DCT sensor placement 2 The hinged tabs of the sensor should open to evenly distribute the grip of the sensor along the length of the finger Fig 19 Check position of sensor to verify correct positioning Complete coverage of the detector window s needed to ensure accurate data e Memory Fig 19 Orientation of emitter and detector 2 52 e Directions for use of LNOP sensors Orient the sensor so that the cable will be running to wards the top of the patient s hand as shown in Fig 20 Connect the LNOP DC1 connector to a patient cable Operator manual VitaGuard VG 300 Operator manual
80. tector window The great toe or long toe next to the great toe may be used on re strained patients whose hands are unavailable e The site should be cleaned of debris and dry prior to sensor placement B Attaching the Sensor to the Patient 1 Open the pouch and remove the sensor Holding the sensor with the printed side down bend the sensor backward and remove the backing Orient the sensor so the detector can be placed first Fig 24 Press the detector onto the fleshly part of the finger near the tip of the finger Press down the T shaped adhesive ends of the sensor onto the finger Fig 25 Fig 24 Sensor placement detector on the finger tip Fig 25 Fixing of the detector 56 Directions for use of LNOP sensors Operator manual VitaGuard VG 300 Time Date main menu See also Explanation of These settings can be changed using lt MODE Esc gt Re the menu settings on fer also to Monitor display structure and Monitor menu page 38 structure on pages 12 and 13 The different settings are explained in detail in Explanation of the menu settings on page 38 tem Valuerange 7 Day num 1 2 29 30 31 Month January February March etc Tab 4 Value range for the time settings main menu lt Status gt Status memory function ter gt the stored episodes can be examined in pressing the key once Episode number count information about the Type ot episode N Duration pl
81. the mains adapter supplied with the monitor Battery replacement Switch the monitor off before replacing the batteries To test that the batteries in the battery compartment are charged enough for SpO operation carry out the follow Steps Remove the external power adapter so that the device is powered from batteries Wait 30 seconds and then press lt INFO A gt a number of times until you reach the battery information Ifthe state of the batteries is not good replace them immediately with good quality alkaline batteries such as VARTA alkaline Extra Longlife It is recommen ded that you always keep at least two spare sets handy Slide open the battery compartment at the back of the monitor Pay attention to the polarity of the batteries when inserting the new ones Fig 11 Fig 11 Bottom of the monitor with partially opened Battery compartment Only use new good quality alkaline LR6 AA 1 5V bat teries Change the whole set of batteries Never use new and old batteries together Cheap non alkaline batteries may lead to a drastic reduc tion in the battery operation time Some batteries only have 10 15 of the capacity of good batteries 22 e Operating VitaGuard e Elevated levels of Carboxyhaemoglobin COHb may lead to inaccurate SpO2 measurement e Elevated levels of Methaemoglobin MetHb will lead to inaccurate SpO2 measurements e Failure to apply the LNOP Adt properly may cause in correct
82. tion e Carefully route the cables to reduce the risk of patient entanglement or strangulation If necessary affix the cables with a plaster or tape e Tissue damage can be caused by incorrect application or use of an LNOP sensor for example by wrapping the sensor too tightly Inspect the sensor site as di rected in Directions for use of LNOP sensors on page 50 to ensure skin integrity and correct position ing and adhesion of the sensor Detailed instructions for the different sensor types are given for the LNOP sensors DC1 on page 51 Adt on page 55 Pdt on page 59 Neo on page 64 and NeoPt on page 68 e Do not use damaged LNOP sensors or cables Do not immerse in water solvents or cleaning agents Detach the sensor from the patient before bathing it e Do not attempt to sterilise by any means Do not use alcohol to clean the cables as this may harden the ca ble isolation Operator manual VitaGuard VG 300 Patent Marking ee Patent The Masimo Device incorporated in VitaGuard 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 5 758 644 5 769 785 and int equivalents U S A and international patents pending Tab 11 The most important patents on pulse oximetry is sued in the U S for Masimo Corp External alarm unit EA1000 Do not cover the speaker Caution Due to the ex treme volume of EA 1000 you should leave it at least 3 m off yo
83. undheitsschutz bei Medizinprodukten ZLG Notifiziert unter der Nr 0197 bei der Kommission der Europ ischen Gemeinschaft C Das CE Kennzeichen darf bei Einhaltung aller zutreffenden EG Richtlinien angebracht werden Fig 49 Approval of the quality management system of GeTeMed 76 Directions for use of LNOP sensors Operator manual VitaGuard VG 300 L General Information Introduction Alarm generation when pulse rate or SpO are outside of the allowed limits Responsibility Allergies Operator manual VitaGuard VG 300 In this chapter you will find information on the intended purpose of VitaGuard and some general information on its usage Intended use of VG 300 VitaGuard VG 300 is intended to be used for continu ous non invasive monitoring of oxygen saturation and pulse rate of adult paediatric and neonate patients in hospitals hospital type facilities intra hospital transport and the home An alarm is generated if the pulse rate or the oxygen saturation falls below or exceeds preset limits The delay times before alarms are generated can be indi vidually programmed VitaGuard VG 300 is a warning device that gener ates an alarm YOU the caregiver must act in the event of an emergency The manufacturer takes no responsibility for any damages resulting from using the monitor in any way other than the intended use Remember that Vita Guard is a warning device and that YOU must act i
84. ur patient Operator manual VitaGuard VG 300 Operation The external alarm unit can be connected to VitaGuard to amplify the integrated alarm generator It is intended for situations where your home is such that you may not hear the integrated alarm generator reliably Verify in your actual situation if you can hear a possible alarm independently of what you are doing Think of ac tivities like housecleaning watching TV etc Make sure the alarm speakers of VitaGuard or EA 1000 are not blocked by anything placed on them You cannot react properly to an alarm if you cannot hear it Make sure you can react to an alarm within a few seconds Remember YOU the caretaker must react on an alarm The monitor cannot react for you Refer also to EMERGENCY SITUATION on page 1 and Operation on page 8 Appendix e 47 48 e Appendix Function elements The unit has a trimmer to regulate the alarm volume Once it is connected to VitaGuard using the cable sup plied it is automatically activated The three light emit ting diodes LED s on the unit have the following func tions LED Meaning Monitoring VitaGuard is activated and the EA 1000 is active green ready Green flashing system status flashing OK The flashing frequency is independent from the rhythm of the LEDs on Vita Guard Change bat The battery is weak and should be ex teries changed The remaining capacity at start of red flashing
85. ve false alarms occur check that the sen sor is properly connected Allow a nurse or doctor to show you how to apply the sensor properly Alarms If the displayed SpO value falls below the lower alarm limit or rises above the upper alarm limit VitaGuard VG 300 will generate an alarm and display an appropriate message You should go immediately to the patient and check its condition If the SpO value moves back within the set limits the alarm will automatically cease The ex ceeded alarm limit on the LCD display and the alarm Operator manual VitaGuard VG 300 WARNINGS e The site must be checked and changed at least every eight 8 hours NOTE Exercise extreme caution with poorly per fused patients skin erosion and pressure necrosis can be caused when sensors are not frequently moved As sess the site at least every two 2 hours with poorly perfused patients e If the sensor is damaged in any way discontinue use immediately e To prevent damage do not soak or immerse the sensor in any liquid solution Do not attempt to sterilise e Intravascular dyes may lead to inaccurate SpO2 meas urements e Elevated levels of Carboxyhaemoglobin COHb may lead to inaccurate SpO2 measurement e Elevated levels of Methaemoglobin MetHb will lead to inaccurate SpO2 measurements e Failure to apply the LNOP Pdt properly may cause in correct measurements e Do not use the LNOP Pdt during MRI scanning e Avoid placing th
86. y tug on the connectors to en sure a positive contact If required tape may be used to secure the cable to the patient C Reattachment The sensor may be reapplied to the same patient if the emitter and detector windows are clear and the adhesive still adheres to the skin Technical alarm and common reasons 5 PER ILE P Fig 35 Connecting patient cable and sensor NOTE Prior to reattachment or rejuvenation disconnect the sensor from the sensor cable e The adhesive can be partially rejuvenated by wiping with a 70 isopropyl alcohol pad and allowing the sensor to thoroughly air dry prior to replacement on the patient e If the adhesive can not be adequately rejuvenated use a new sensor D Disconnecting Sensor and Patient Cable 3 Place thumb and index finger on grey buttons on ei ther side of the patient cable Fig 36 4 Press firmly on the grey buttons and pull to remove the sensor Important Fig 36 Disconnecting patient cable and sensor Operator manual VitaGuard VG 300 Pulse rate alarm limits Operator manual VitaGuard VG 300 LED will flash in intervals of 1 second to indicate that an alarm has occurred Should two alarms occur within the period of one minute the alarm will not automatically cease To stop the acous tic alarm press lt ALARM Stop gt The upper alarm limit can be deactivated by setting the upper limit value to 100 A technical alarm will be generated if

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