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V-Spec™ Monitoring System Instruction Manual

1. SENSPEC SPECTRAL MONITORING SYSTEMS V SPEC Monitoring System Instruction Manual P A alA A sia A R Al A U A AN l 1 A A A 4 Woy 4 i US In k 1 1 4 i i l 1 1 1 4 An 1 i i L i 4 r i i i 1 WW u iT W Y Su gt J MW k k QM Document No 0101001 IM 002 Revision B 07 2013 The V Spec Monitoring System Is user friendly and applies ease of use fundamentals Please read this operating manual carefully before starting the system to familiarize yourself with the operation of the VSMS All warnings and safety instructions are listed here Property of Senspec Any reproduction or copying of this operating manual is not allowed without the written consent of Senspec GmbH V Spec is a registered trade mark and protected by trade mark rights of Senspec GmbH SENSPEC SPECTRAL MONITORING SYSTEMS Declaration of Guarantee The manufacturer warrants the original purchaser of this product that each new component of the V Spec Monitoring System see list of components is free from detects in workmanship and materials Under the warranty the manufacturer is only obliged to replace one component which is covered by the guarantee at the sole discretion of the manufacturer Warranty exclusion and performance of the system The Senspec GmbH can neither warrant nor verity the performance parameters of the device and expressly denies any warranty or liability claims in case of misuse
2. Switches or openings in on the housing Warning If the VSM accidentally becomes wet it must be dried before use and inspected by a qualified service employee Warning Keep the VSMS like all the other accessories out of the reach of children Risk of ingestion or risk of injury Page 9 4 Safety Information dy gt ENSP EC Warning Risks of explosion and flammability Do not use the VSMS in the presence of flammable anesthetic agents gases or other flammable substances or in environments with increased oxygen content f Warning The VSM is protected against electrostatic defibrillator discharge However it is possible that the parameter display fails temporarily during the discharge defibrillation and the values are unreliable of up to 20 seconds after defibrillation Follow the instructions in the user s manual of the defibrillator A Warning During electro surgery the VSM sensor and lines have to be physically separate from the electrosurgical devices The sensor must not be placed between the cutting electrode and the counter electrode The measured values can be influenced by the electro surgery and can be unreliable up to 20 seconds after the end of the electro surgery Warning For the protection of patients operators and the devices only original cables sensors connectors and connections distributed by Senspec may be used Warning The impact on patient safety and the performance of the V
3. semen 7 display area status indicators Ge Be change of language 9 8 sensor socket 9 display area settings 10 display area spectra Rear view 11 VESA mount mounting sockets 12 fuse box 13 power connector 14 power switch 15 ground connection 16 type plate 17 Right side view RS232 connector male Page 1 6 The V Spec Monitoring System VSMS dy SENSPEC 6 3 Setting up the V Spec Monitor VSM 6 3 1 Connection to the AC power Connect the monitor to the power source by inserting the appliance plug of the power cord into the socket on the rear of the unit and the mains plug of the power cord into a properly grounded power source Use only power outlets that meet the requirements for hospitals The V Spec system requires 100 240VAC 50 or 60Hz The charging of the internal battery is done with the power supply A fully charged battery allows an operating duration of approximately one hour When the device Is switched on the battery indicator informs you about the battery charge level Full charging of a discharged battery can take up to 4 hours Caution Charge the battery fully before initial start up The connection for a ground earth pin G5 offers if needed a redundant connection to the external ground conductor 6 3 2 Turning the VSM On and Off The power switch G turns the monitor on and off When you turn on the VSM first of all the fan can be heard After about 3
4. Extension Cable By connecting other i e third party cable extensions the connection and the system can be damaged Senspec guarantees a proper function of the system only if genuine equipment is connected The V Spec Monitoring System is only tested with V Spec Extension Cable as cable extension 6 4 2 Application of the V Spec Sensor to the measuring point of the patient Before you start with the monitoring on the patient it s important that you become familiar with the operation of the VSM Check the sensor status with the help of the sensor status indicator on the screen of the powered on VSM 2 The following instructions must be strictly consider when using all V Spec Sensors A correct measurement can only be carried out if all instructions are followed Page 20 dy SENSPEC 6 The V Spec Monitoring System VSMS Warning The operation of the V Spec Sensors is only approved for adults and children with more than 20kg of body weight A Warning Do not leave the sensor longer than 72 hours at the measuring point Is a longer monitoring necessary change the Attachment Tape and where appropriate the application site In the case of non compliance it can lead to redness of the skin or skin inflammation Should the skin show redness or inflammation remove the attachment tape and if necessary select a new application site Warning Make sure the sensor is not covered The sensor could heat
5. which sometimes may result into an increase in the perfusion and a related increase in the tissue oxygen saturation Wait with a therapy or a diagnostic evaluation of the parameters until this physiological stabilization phase is completed Note The VSMS is not a blood gas analyzer The above mentioned restrictions must be included in the interpretation of the values Note If you compare the readings displayed on the VSM with values of arterial or venous blood gas analysis BGA pay attention to the following points Vv F Carefully take and handle blood samples Blood collection should be done in the steady state e Measurement values which are determined trom the BGA must be compared with the values of the VSM at the time of the blood sample e Make sure that the blood gas analyzer operates correctly Note Techniques for the measurement of arterial oxygen saturation including pulse oximetry cannot determine hyperoxemia Here tissue values can allow conditional inferences Note Because of the S shape of the oxygen dissociation curve ODC pulse oximetry abnormalities of breathing in patients can not be reliably detected under oxygen administration Page 3 1 Range of Application and limitations dy SENSPEC SPECTRAL MONTI Page 4 2 Abbreviations 2 ABBREVIATIONS LED O2 PI PLI POST RO PR SaO VSM VSMS AT VS VS EC SpO2 S02 Hb HbO2 HHb H20 ctHb HCT light emitt
6. For this use water or a disinfectant soaked cloth The disinfectant must be aldehyde tree otherwise blood contamination could dry or manitest and must have an approved efficiency classification e g VAH DGHM or FDA EPA approval clearance registration or CE label Use only a soft brush or clean soft cloth for the manual cleaning Under no circumstances use metal brushes or steel wool Please note that the disinfectant used in pretreatment is only intended for your personal safety and cannot replace the disinfection steps of the further cleaning 11 3 1 3 Manual cleaning and disinfection Please note the following when selecting cleaning and disinfection agents General suitability for the cleaning and disinfection of plastic equipment Use disinfectants with proven efficiency e g DGHM DGHM or FDA EPA approval clearance registration or CE label Page 92 dy SENSPEC 11 Maintenance Compatibility with used cleaning agents Do not use combined cleaning and disinfection agents Cleaning disinfection methods of the VSM The monitor must only be wiped off with a disinfectant soaked cloth If the monitor has coarse contamination or residuals which can not be removed hand over the device for thorough cleaning to your authorized service technician D Caution The monitor must not be immersed in liquid or cleaned by means of autoclaving radiation or steam sterilization Cleaning disinfection methods o
7. Decontamination must be performed by a skilled person only The instructions on cleaning and disinfection vary trom hospital to hospital If you may have any doubts or questions regarding contamination or decontamination issues please contact your local infection authority regulatory authority or hygiene department If devices or accessories must be returned to the supplier or manufacturer for the purpose of servicing repairing the operator in the clinic must ensure proper decontamination A Page 90 dy SENSPEC 11 Maintenance Certificate of Disintection should be issued by the person responsible for the device and must be included in the return consignment for servicing and repair If devices are serviced on site the service technician also requires a Certificate of Disinfection which must be submitted to him Note A PDF template of the Certificate of Disinfection is available on the manual CD for the VSMS Caution Plugs and couplings must be carefully cleaned and kept dry at all times Do not expose the VSM to humidity and do not spill liduids over or into the VSM If the VSM got accidently wet it must be wiped dry carefully Make sure that the device is completely dry before you start using it Caution Do not use other cleaning or disinfection methods agents than recommended here A Caution Do not use solutions based on paraffin and mineral oil or acetone based solutions or any other a
8. This is also the case if the system is restarted after a Critical battery load alarm A list of the default settings and if the standard values or user inputs are added after a reboot can be found in table 1 in chapter Fehler Referenz nicht gefunden Fehler Referenz nicht gefunden on page 35 If an error occurs when you save the user settings it may happen that all settings will be set back to the default values 7 4 Alarms in the past The VSMS stores alarms that have occurred This gives the user information about alarm States that lie in the past and are otherwise not directly visible In the case of medical alarms a past alarm is indicated by a slow flashing alarm icon next to the corresponding parameters Past technical alarms will be signaled by a slow flashing alarm symbol in the alarm indicator field see section 6 6 6 Alarm Indicator field By tapping on this alarm symbol the corresponding alarm message will appear In addition to the text of the alarm message also the time of the first occurrence of the alarm is displayed By tapping on the message It will disappear 7 5 Alarm triggering From the occurrence of an event on the patient e g hypoxia to the triggering of the alarm system related delays occur The parameters are subject to different notification procedures that cause this delay The parameter update period is 1Hz in the VSMS The time that elapses until the update of the displayed parameters i e the time betwee
9. VS SS L Select an appropriate measuring point for the V Spec Soft Sensor Large VS SS L The index finger is ideal Alternatively the thumb and the other fingers are suitable as a measuring point Clean the application site the finger with a tested and approved disinfectant and dry it thoroughly Make sure that the patient s skin is completely intact dry and tree trom grease Apply the V Spec Soft Sensor as described in the owner s manual of the sensor Run the sensor wires to the fingers and along the arm and fix it if necessary with a plaster strip The following figures show a correctly applied V Spec Soft Sensor Page 22 SPECTRAL MONITORING dy SENSPEC 6 The V Spec Monitoring System VSMS 6 4 2 2 V Spec Sensor with Attachment Tape The V Spec Sensor VSS in conjunction with the Attachment Tape AT VS should only be used on fully developed and intact skin and be used on the forehead Clean the application site the forehead with a tested and approved disinfectant and dry this location thoroughly Make sure that the patient s skin is completely intact dry and free from grease Note Should the skin at the measuring point be not completely intact alternatively use the V Spec Soft Sensor for the measurements Apply the V Spec Sensor as described in the owner s manual of the sensor and the Attachment Tape Run the sensor wires along the forehead to the outside and fix it if necessary
10. cc cececcccccee eee ccceeeeeeeeeeeeceeeeeeeean ees 61 oo SS 102 10 a 1616 ae me EEE eee eee ne ee ere 63 SMe E CSS GINO a re a ee 64 9 1 Environment Transport and Storage Conditions u222uuseeeseeeeenseeeneneeneennen 64 9 1 1 Transport Storage CONITIONS cccccesseccssseeeeecccessseceneueessaeeenseveraeeecseeeens 64 9 1 2 Operating COMO NO en ae an naar nee 64 9 2 V Spec Monitor IVI EEE SEREEENEEENEUNNEUIEUNEREEEREEENR 64 9 2 1 Physical CNALSEIE ISIS ee area ea 64 J22 DD T oee EN EEE EEE EEE RHENRENE NENNEN 65 9223 CONO HON ae en an en a ee ee ei 6 9 2 4 EVO Ural ae een ee een 67 92 5 VOLLAE SUP yes seen ee Eee 68 OZ ond Mans Opera UOI eos ae nase en nn ee near ern 68 0 2 2 EI MORE eE a E ne E EEE 69 I VD OHM SONS Ol ge ae re 70 VI SENSPEC 93 1 V Spec SOME Sensor Lal gE anne nennen anna Eaei Edea 70 9 3 2 Physical CHidl d CLOMISUCS cin een ernennen 70 9 3 3 Sensor Lele AUG anscntancsonsaacien saute ee en eeenseeuacuieann 71 IB ORANGE TING een ee ee 71 es AU D E E S E E EE 71 9 3 6 Permissible measuring points cceeeeeeseensseeenenssnnennnnennennnnnennnennnn nennen 71 9 3 7 Measurement principle neseeeeesseennnseeennsnnnnnnnnnnnnnnnnnnnnnennnn nennen 72 9 3 8 Digital TMC OL NOS ea een ae ee errungen 72 9 3 3 SEHE OL IDEE EEE E ES 72 9 3 10 Sensor temperature MONIOTING ss sssisssisesriusriresrnesrirerirerrrrnrrrnrirerrrnrenrerre 72 9 311 Se MSOF CA
11. negligence and damaging of Senspec products or their external damaging or if the products were not used in accordance with the enclosed user guide or accessories were used which were not recommended by Senspec GmbH or repairs were performed by service personnel not authorized by Senspec Caution For the United States only Federal law restricts this device to sale on prescription and based on FDA approval Patents Registered Trade Mark Copyright European Patent Application No EP2011 060337 V Spec is a registered trade mark of Senspec GmbH 2010 All rights reserved Any reproduction or copying in whole or in part of this document or its disclosure to third parties is not allowed without the express written consent of Senspec GmbH Senspec GmbH has made every effort to ensure the accuracy of the information contained in this document Senspec GmbH denies any liability for errors or missing contents We reserve the right to changes on the document without prior notice The V Spec Monitoring System is a medical device in accordance with EU guideline 93 42 EEG and complies with international standards IEC 60601 1 DIN EN 80601 2 61 and EN ISO 10993 1 further relevant standards which were taken into account in the product manufacture can be inquired at Senspec GmbH SENSPEC SPECTRAL MONITORING SYSTEMS SENSPEC Table of Contents 1 Range of Application and limitations usssnneeeeeeensenneesennennennnnn
12. In addition to the alarm messages also information are issued which signal no alarm Like the alarm messages the info messages contain important information and must not be ignored The information messages are shown in table 8 Page 52 SENSPEC Priority Medium priority Type 7 Alarms and Messages Table 7 Alarms in the VSMS and associated messages Alarm description low SpO2 saturation Melody opt SpO2 Message English amp German SpO2 low limit violation SpO unterschreitet den Alarm Grenzwert high SO saturation opt SpO2 SpO2 high limit violation Uberschreitet den Alarm Grenzwert Critical battery load fix battery critical Critical battery charge connect main supply or VSM will shut down Batterie kritisch Netzstecker anschlieBen oder Abschaltung erfolgt Sensor temperature too high High sensor temperature remove or change sensor berh hte Sensortemperatur Sensor entfernen oder ersetzen PR low limit violation Low pulse rate Ppt Ee PR unterschreitet den Alarm Grenzwert PR high limit violation a High pulse rate a PR berschreitet den Alarm Grenzwert ed ae SiOz low limit violation low SO saturation opt S102 SO unterschreitet den Alarm Grenzwert SiOz high limit violation acie ea SO berschreitet den Alarm Grenzwert Power on self test failed with error xx Power on self test failed Power On S
13. and described in chapter 9 2 3 Connections Follow all warnings and operating instructions enclosed with your system The V Spec Monitoring system only works with the V Spec Sensors or V Spec Soft Sensors delivered by Senspec Do not connect sensors of other manufacturers the device could be destroyed If the device is damaged due to connection of devices or sensors not intended for the use the warranty will be voided Risk of explosion The V Spec Monitoring System must not be operated in the presence of flammable anesthetics or other highly flammable substances Page EWETER ME t i 3 Warnings and Precautions dy SENSPE Risk of cross contamination Clean the sensor carefully before each use as described in the User Guide for the sensor Only manual cleaning disinfection procedures are permitted For this purpose use running water or an aldehyde tree disinfectant If the V Spec Sensor is used in conjunction with the attachment tape Ref AT VS it should be noted that the AT VS is for one time use only and must not be reused The V Spec Monitoring System not even parts of it should not be cleaned in an ultrasonic bath autoclaved gas sterilized or steam sterilized Risk to the patient The V Spec Sensor and V Spec Soft Sensor are intended for external use only Please note the enclosed instruction for each sensor and never use the sensors for internal applications e Make sure that all
14. and time are set to 2008 01 01 00 00 00 Page 9 Technical description dy SENSPEC If the clock was reset due to the empty and defective CMOS battery the POST is not passed and the VSM must not be operated 9 6 1 2 Loudspeaker test When booting the VSM the power on self test is performed which also tests the audio system by giving three short sounds with increasing sound level Warning The audible POST signals serve as acoustic confirmation that the VSM audio system is properly functioning Do not use the VSM if you have not heard the audible signals The audio system including the alarm system may be defective In such cases contact qualified technical staff or your local Senspec representative Warning Check whether the alarm volume is set in a way that the operator is able to hear the alarm signals in the designed environment Warning Make sure that the loudspeakers are not blocked Otherwise an alarm could be ignored which prevents an adequate response to the alarm 9 6 1 3 Display Test Check whether the VSM display is readable and legible when starting the POST screen Check the display for pixel flaws while starting the VSM WARNING Do not use the VSM if the display of the VSM is not activated or the POST identifies an internal problem message displayed not passed with respective error code on the POST screen In such cases contact qualified technical personnel or your local S
15. arrays Header PI PLI Status Date amp Time yyyy mm dd hh mm ss SPO2 lt low limit gt lt high limit gt PR bpm lt low limit gt lt high limit gt StiO2 lt low limit gt lt high limit gt lt date gt lt time gt lt SpO value gt lt Limit violation gt lt unstable gt lt PR value gt lt Limit violation gt lt unstable gt Data arrays lt SiO value gt lt Limit violation gt lt unstable gt lt P value gt lt PLI value gt lt code gt a A plus sign behind a reading indicates the set value is above the upper alarm limit A minus sign Indicates that the lower limit was exceeded b A u behind a reading indicates that the returned value is marked as not stable c The status codes contain further information of the VSMS You can find a detailed list of all status codes under 8 3 4 Status Code Depending on the sensor status the quality of the measured values will be given out as follows Table 14 Forms of output of the parameters Sensor position quality of the readings Parameters On Patient parameter is valid Value On Patient parameter not stable Value u On Patient parameter is invalid Not on patient Sensor not connected Page 62 O gt ENSPEC 8 Data Communication 8 3 4 Status Code The specified status codes in table 15 are put out through the serial interface Table 15 Status C
16. connections are tight and Tree from grease and moisture The ingress of moisture can lead to incorrect or inaccurate readings e Be careful when attaching and removing the V Spec Sensor with the Attachment Tape AT VS The AT VS may be used only on intact and fully developed skin Page 8 dy gt ENSP EC 4 Safety Information 4 SAFETY INFORMATION 4 1 Warnings This icon indicates a warning Warnings alert you to conditions that can lead to risks or injuries to the patient or a user Warning The V Spec Monitoring System VSMS may only be operated by qualitied personnel This manual accessories instructions for use all precautions information and specifications should be read before use Warning The V Spec Monitor VSM is not intended for the diagnosis It is intended only as a supplement to the assessment of the patient s status The VSMS is a non invasive pulsatile spectrometer and no blood gas analyzer Warning Lay and secure the cables carefully so that the patient can not get caught In it Warning In order to ensure the safety of the patient place the monitor so that it cannot fall on the patient and the patient cannot be hurt Warning Do not move the monitor by pulling or lifting by the sensor cable or power cable The cable connections can become loose and the device can fall on the patient and harm him Warning Do not spray or pour liquids on the VSM accessories connectors
17. distinction is made between medical and technical alarms with the visual alarms A list of all visual alarm indicators can be found in table 5 Table 5 Visual alarm indicators in the VSMS Medical Technical Red frame around the SpO gt value flashing Red symbol with three exclamation marks with f 2Hz flashing with f 2Hz High priority Yellow frame around the value flashing Yellow symbol with two exclamation marks with f 1Hz flashing with f 1Hz Symbol in Cyan cyan icon with an exclamation mark static No medical alarm low priority included in Low priority the VSMS Page 51 7 Alarms and Messages dy 5 ENSPEC 7 2 3 Alarm Limits The adjustable alarm limits are listed in table 6 Table 6 maximum and minimum alarm limits and default values Minimum Maximum Default Values 60 100 85 100 30 240 50 140 SiO2 0 100 60 95 Note The alarm limits of the SpO2 parameter are set back to the default values 85 100 each time the monitor is re booted 7 2 4 Alarm messages In addition to the audible and visual alarms the VSMS issues more information and descriptions of the alarm as a text message In the English language via the message system VSMS see section 6 6 7 Message system You can tind an overview of all alarms and the associated messages in table 7 Z In addition the table contains information whether an alarm melody is available optionally opt
18. personnel P0302 Display is not legible dark Brightness not properly set Set the brightness of the display as described in chapter 6 5 1 2 Brightness of the screen night mode VSM defective Turn off the VSM and then turn it on again If the problem persists contact authorized service personnel P0303 Batteriy is not charging power cord not connected defective Select another power cord to connect the VSM Battery defective Contact authorized service personnel VSM defective Contact authorized service personnel P0304 Fully charged battery is discharged after less than 30min Battery defective Contact authorized service personnel P0305 POST Screen not hidden Power on self test failed Note the error number message Turn off the VSM and then on If the problem persists contact authorized service personnel P0306 VSM does not respond if touch screen is touched VSM defective Contact authorized service personnel P0307 Fan defective or contaminated Contact authorized service personnel Fan is very noisy P0308 Fan defective or Contact authorized service personnel Fan is blocked contaminated P0309 Audio output paused or Activate audio output if necessary No sound turned off Audio system defective Contact authorized service personnel P0310 power cord defective Replace power cord Mains connection cable cannot be connected with VSM Powe
19. service partner immediately The VSM can operate on battery or on AC power Information on the status of the power supply gives you the power status indicator 3 which informs you about the following states of the power supply Page 43 6 The V Spec Monitoring System VSMS dy S ENSPEC Power mode active battery fully charged e The VSM is connected to the external power supply and the battery is fully charged Power mode active battery fully charged e The VSM is connected to the external power supply and the battery is charged Battery mode active Battery fully charged e The battery is fully charged and enables the operation for approx Ih Battery mode active battery charge low e The battery charge level decreases The operation is possible for max 15 min A medium priority alarm informs you about it battery operation active battery load critical e The battery load does not suffice for the operation of the VSMS The system shuts off four minutes after the appearance of the symbol and the alarm Critical Battery charge if no power cord is connected A re charging is carried out automatically when connected to the electrical network If the battery is Tully discharged approximately four hours are required to Tully charge the battery Page 44 dy SENSPEC 6 The V Spec Monitoring System VSMS 6 6 9 Sensor status The status indicator of the sensor nforms you about the current status
20. solvent for adhesive tape Note In dark skinned patients it is possible that the skin is not detected and the sensor is displayed as not applied In this case use the V Spec Soft Sensor for measurements Note It can happen that the sensor detects skin and the sensor appears as applied even though the sensor was not applied e g if sensor lies on clothes Always apply the sensor first on the patient before you connect it to the VSM Page 24 6 The V Spec Monitoring System VSMS 6 5 Operating the V Spec Monitors 2 Display area medical parameter 2 1 2 2 2 3 O SpO value PR value 4O2 value 4 Heart symbol 7 Display area status indicators 7 1 7 2 7 3 7 4 1 5 Alarm indicator field Message system Power status Sensor status Date and time Display area spectra 10 1 Pulsatile absorption spectrum 10 2 Extracted blood spectrum 10 3 Tissue spectrum 3 Display area trend graphs 3 1 trend graph field 1 3 2 trend graph field 2 3 3 trend graph field 3 6 Display area technical parameter 6 1 Pulsation Index 6 2 Pleth Index 9 Display area settings 9 1 Alarm pause button 9 2 Screen brightness button 9 3 Spectral view button 9 4 Main menu 9 5 Language setting Page 25 6 The V Spec Monitoring System VSMS dy S ENSPEC The main screen consists of several different areas These include in the upper area the real time values of the parameters Sp
21. strong decrease of the SpO2 value produces sometimes a life threatening condition of the patient Falling below the StO gt value produces an alarm of medium priority Be sure to check the Status of the patient look for any limitations in circulation Check if an extreme change in the physiology of the patient or in the circulation at the monitoring point has occurred e g by the inflated cuff of a sohygmomanometer a bruise arterial blood sampling at the hand at which the sensor is located heavy hypotension peripheral constriction of blood vessels in response to hypothermia drugs administered or Raynaud s syndrome It is possible that pulse oximeter at extremely low perfusion may only measure the peripheral saturation which may differ significantly trom the central arterial saturation This localized hypoxemia may be a consequence of the metabolic demands of other tissues extract the oxygen proximal to the monitoring location under conditions sustainable of peripheral hypo perfusion This can also occur in the case of a pulse rate which correlates with the ECG heart rate Page 4 7 a 6 The V Spec Monitoring System VSMS dy S ENSPEC Caution If frequently a weak blood circulation is displayed a better perfusion application site must be sought Until that is done the oxygenation status of the patient must be checked in a different way Corrective Action f the SpO2 display values show significant differences th
22. up and cause burns A Warning Make sure that the sensor cable is not wrapped around the patient s neck or comes to a rest there to avoid the potential risk of asphyxiation and choking Warning Avoid pressure sores Do not apply external pressure on the sensor due to too tight band aids too tight bandage or a too tight headband The measurement results could be distorted Secure the sensor cable with the help of a strain relief in order to avoid that the optimal sensor seating is affected D Caution At the same time as the V Spec Sensor EEG and devices to monitor consciousness can be used Attention should be paid that the optical unit of the sensor Is not affected Maintenance of the sensors Please note the relevant care instructions in the owner s manual of the respective sensor Only manual cleaning disinfection procedures are permitted For this purpose use running water or an aldehyde tree disinfectant If you are using the V Spec Sensor with the Attachment Tape AT VS it should be noted that the attachment tape is intended for single use and a new tape must be used for each new placement of the sensor The V Spec Sensor and the V Spec Soft Sensor are not suitable for repeated use For more information please see the user manuals for the sensor and for the Attachment Tape Page 21 SPECTRAL MONITORING SYSTEMS 6 The V Spec Monitoring System VSMS dy SENSPEC 6 4 2 1 V Spec Soft Sensor
23. with a plaster strip Make sure that the cable does not pull on the sensor Note Check the fit of the sensor and the quality of the measurement with the technical parameters displayed on the VSM Pulsation Index PI A low Pl value can point to a sensor not correctly applied The following figure shows a correctly fitted V Spec M Sensor with Attachment Tape Page 23 6 The V Spec Monitoring System VSMS dy S ENSPEC Warning The Attachment Tape is for one time use and must be replaced after each use Use a new tape Tor each measurement and each patient Re use can lead to cross contamination poor application and thus result in inaccurate readings Use the Attachment Tape only on intact and fully developed skin Warning Use only original accessories for the V Spec system Secure the sensor A only with the corresponding AT VS of Senspec The use of other than the recommended fasteners can result in inaccurate readings Warning Make sure that the attachment Tape is well secured to the sensor and is completely applied on the application site of the patient Change the AT VS if it is not fitting tight The failure to do so could result in inaccurate readings Warning Remove the sensor and the Attachment Tape carefully and gently If it is difficult to remove please follow the hospital s policy on the conservation of the integrity of the skin Where required use commercially available non irritating
24. 0 seconds the VSM is ready for operation Turning off the VSM is carried out in any case by flipping the power switch Q4 to the O position If the system was shut down after a Critical battery alarm the power cord must be connected to power up the system A repeated flipping of the power button Is not necessary The settings made by the user remain partially intact as explained in chapter 7 3 Alarm System Reset in more detail Page 18 dy S ENSPEC 6 The V Spec Monitoring System VSMS SPECTRAL MONITORING 6 4 Connection of a V Spec Sensor Connect the sensor plug to the socket 3 on the VSM Make sure that the flat side of the plug securing points upwards and the connector clicks into place Check the sensor status with the help of the sensor status indicator on the screen of the powered on VSM GA To remove the sensor push the plug securing and gently pull the connector from the device Caution Use only genuine V Spec Sensors By connecting other i e third party sensors the connection and the system can be damaged Senspec guarantees a proper function of the system only if genuine equipment is connected The V Spec Monitoring System is only tested with V Spec Sensors Caution Make sure not to twist the connector plug while connecting The plug must be plugged in or removed straight and not with excessive force Caution Damaged defective or modified sensors must not be used Make sure that th
25. 25 6 1 Setup and Settings een en n EA EEEE araar i dininde 26 6 5 1 1 Pausing the alarm system cceeeeseeeensseneennnssnnnnnnnnennnnnenennenn nenn 26 6 5 1 2 Brightness of the screen night Mode neeneneeeeeenn 27 6 5 1 3 Switching the screen display eeeeeeenssennennnseennnnnsenennnnneneneennnn 28 BE TAI SING nn are mern ae taken 29 Settings in the volume menu cesnnnssssssseennenssenenennnenennnnnnennennnnenne een 30 Setting aata OUTPUT een se arava ana are ea ana ea Eu 31 POST AN TE es ee 32 Information in the information menu ueaeeeeneeesnsseeeeennssneenennnennenennene nennen 33 6 5 1 5 LAN OU SSC HUN ise ee en eiserne 34 6 5 1 6 Setting Date and TIMI vencscsascmucnerunasatwassaetngnssuncieminn ide remain 34 6 5 1 7 Storage of the user SETLINGS cece cece ccce see ecceceeeceeeeeeeeeeesaeeeeeeeeeesaaaeeees 34 6 6 The Monitoring with the V Spec Monitoring System 36 6 6 1 TING on the VSM nee 36 6 6 2 Medical measurement parameters uceeeeeesseneeenseeeennnenennnsnnennnenennenee nn 37 6 6 2 1 Setting the alarm MMM een ea 38 Adjusting with the help of the slider eeeneeeneeeen 39 Adjusting by means of the numeric keys cceeeennnnnneeennsenennnneennnenen een 39 6 6 3 Display area trend Qi aS Pie EEE NER TEENEEURCNESEIEEEEEEEENEERERTE 40 GA ENa Ta ee E E E E EE nenne 40 SENSPEC 0032 Peny Mogi GIN anne Bana
26. 50 104 F Humidity 15 93 non condensing 9 2 V Spec Monitor VSM 9 2 1 Physical Characteristics Weight 2 9 kg 6 4 Ibs Page 64 dy S EN S PEC 9 Technical description Size 23 4 cm x 28 0 cm x 12 0 cm HxWxD Placement fixation standing on rubber feet VESA Mount MIS E 200mmx100mm M4 for fixation at systems with VESA Standard Lock Kennsington Lock Casing ingress protection IPX1 splashproof 9 2 2 Display Display type 9 23cm colour display 800x480 pixel WVGA TFT LED backlight brightness 400cd m2 contrast ratio 600 1 large angel of vision 88 every direction at contrast gt 10 1 Data update period numerical values of SpO PR SyO2 and all other physiological measuring values 1s Pleth diagram 40Hz Online trend graphs 1s Validity of parameter Table 16 Validity of parameter Quality Attributes Description The respective data are valid The activated trend graphs are being updated The alarm system for the parameter Is active The respective data are not stable and probably do not reflect the patient s data When one Parameters displayed in parameter is marked as instable the activated gray or darker colour trend graphs are being updated The alarm monitoring for the respective parameter is active The respective data are instable and do not reflect the patient s data When one parameter is marked as invalid an empty value NaN is entered into the trend graph The a
27. D Caution Neither immerse the VSM nor the connections or accessories in liquid solutions a Caution The parts of the VSM must not be sterilized by irradiation steam ethylene oxide and H202 plasma Follow the instructions for cleaning in the corresponding manuals a Caution If the VSM with not fully charged battery is connected to an AC power source which is interrupted or not delivering power the monitor will not function or shut down after a short period of time Always pay attention to the state of charge of the battery A Caution Make sure that the VSM is properly grounded if the device Is operating on AC power If you are unsure whether the outlet is properly grounded disconnect the VSM from the electrical outlet and use the VSMS in battery mode Contact a qualitied electrician to have the outlet examined Page 11 4 Safety Information dy gt E NSPE C 4 3 Note K This symbol indicates notes which you should consider in the use of the VSMS in order to ensure a smooth operation The failure to comply with the instructions does however not lead to adverse effects on the patient the operator or the VSMS Page 12 SENSPEC 5 VSM SYMBOLS The following symbols are printed on the back of the VSM Symbol Name 5 VSM Symbols Description Consult instructions for use Please pay attention to the accompanying documents J E a me Catalog number Indicates the catalog de
28. IEIEUIRENEIEREENAE IRRE 80 O Toue Noon ege eat ee a EEE 83 10 1 Troubleshooting for the monitor usssseeeeseenenssseneennnneennenennnnnenenenene en 84 10 2 Sensor specific troubleshooting 222uueeeeennseeneennnnnssnneennnnnnennneennnnneneennnn 85 10 3 VSM specific troubleshooting nn iin nee 85 I MAN TINGS ee een ee 87 EEROR IOS ee E S 87 E E a a EEE AEE EE AEA A A E 88 DT TU Sana een en re 88 11 3 Cleaning and disinfection uececeeeeeeeeeensseeeeeeenennseneennnnnnnnnnnnnnnnnnnnnnenennnnenen 90 11 3 1 Recommended cleaning and disinfection Methods 91 Veg Vek BED ae a en ee ee 92 To 1 2 Pre ee ee A 92 11 3 1 3 Manual cleaning and disinfection nennen 92 Cleaning disinfection methods of the VSM ccccccceseeeceeeeeceeeeceeeeeeeneseanees 93 Cleaning disinfection methods of SENSOMS ccccceecccceseeeeeeeeseeeseeneseeneseaeees 93 iD gt TAEC EEE AE NEUHEITEN RER 93 11 4 Shipment instructions for the VSND nn een 93 VIII dy 5 ENSPEC 1 Range of Application and limitations 1 RANGE OF APPLICATION AND LIMITATIONS 1 1 Range of application of the V Spec Monitoring System VSMS TO The V Spec Monitoring System VSMS consisting of the V Spec Monitor VSM the V Spec Sensors and accessories is intended for the continuous and non invasive patient monitoring The basis for the V Spec Monitorin
29. If the alarm system is muted instead of the alarm limit the text OFF is displayed This is an additional reference that the acoustic alarm system Is deactivated 6 6 2 1 Setting the alarm limit By touching the medical parameters an input box opens in which you can set the alarm limits You can do this either by a slider or by entering a numerical value The slider bar has areas with different colors Thus physiological meaningful limits are marked If a limit value is set within the orange or red zone the color of the limit value varies according to the range The adjustable alarm limits and the default values are listed in Table 2 Table 3 contains the colored areas on the slider bar Table 2 maximum and minimum alarm limits and default values Parameter Minimum Maximum Default Values SPO 60 100 85 100 PR bpm 30 240 50 140 SiOz 0 100 60 95 Table 3 Physiological mark on the slider bar Parameter Red Yellow pO 60 79 80 84 PR bpm 30 40 200 240 40 50 140 200 SO 0 35 35 45 Page 38 dy SENSPEC 6 The V Spec Monitoring System VSMS Adjusting with the help of the slider Press the Slider of the upper or lower limit and shift it on the desired value The field of the selected limit will be grayed and the value will be updated immediately ur T 4 285 100 J ECET Adjusting by means of the numeric keys Press the limit
30. N i Nrg C D a iN 4 P sf e V Spec Sensor Attachment Tape AT VS e VSMS manual country specific e VSMS Manuals on CD with full information VSM technical manual in English only instructions for the use of V Spec Sensors and Accessories etc Page 15 6 The V Spec Monitoring System VSMS dy SENSPEC Verity the products tor completeness and any external damage If you should detect damage or defects despite careful processing and packaging by Senspec do not plug in the appliance and contact the customer care of Senspec We provide an easy and quick replacement or repair Further instructions on operating the V Spec Sensors are available in the respective operating instructions In order to ensure an error free operation of the VSM please follow the instructions In this manual Note The components listed above are not necessarily also included in the delivery A complete list of all available articles including accessories and supplies can be found on the Senspec website www senspec com Note In the following only the V Spec Sensor will be addressed Thereby it is expressly referred to all models of the V Spec Sensor Page 16 dy S ENSPEC 6 The V Spec Monitoring System VSMS 6 2 Description of the monitor Front view 1 handle 2 display area medical para meters 3 display area trend graph 4 heart symbol 5 speaker 6 display area technical para 1 meters Pe e
31. Note An acoustic signal with high priority is never interrupted by a signal with low priority Note Alarm signals are always completely transmitted before the system is automatically shut down e g in case of low battery charge Page 81 9 Technical description dy SENSPEC SPECTRAL MONITOR Page 82 dy gt ENSP EC 10 Troubleshooting 10 TROUBLESHOOTING This chapter describes problems potential causes and recommended troubleshooting the operator can initiate to fix problems If the recommended troubleshooting did not eliminate the failure please contact skilled Senspec service personnel Each problem is allocated a number PXXXxX If the troubelshooting and or repair requires to send the system or individual system parts to qualified Senspec service personnel please always state the error number PXXX on the attached repair note repair form RMA The error number facilitates the further troubleshooting process for the service personnel and reduces repair time Note The PDF version of the repair note repair form RMA is included in the manual CD for the VSM The troubleshooting is classified as follows Troubleshooting for the monitoring Sensor specific troubleshooting Monitor specitic VSM troubleshooting Page 83 10 Troubleshooting SENSPEC 10 1 Troubleshooting for the monitor Note This chapter is applicable for the V Spec Sensor and V Spec Soft Sensor Problem Potential causes Recommen
32. O2 PR and S O gt 2 the trend curves G in the central area the heart symbol in the lower left corner 4 the values of the technical parameters PI and PLI 6 on the bottom of the screen the display area with the status indicators 7 at the bottom right on the top of the left site the language setting the menu bar 9 on the right side and the display area of the spectra 10 on the upper right corner of the screen The display is equipped with a touch sensitive touch function By touching the screen in the appropriate place or on the corresponding icon you can open sub menus and switch between menus Note The touch panel works with acoustic technology and can also be operated with gloves 6 5 1 Setup and Settings 6 5 1 1 Pausing the alarm system By pressing on the symbol it is possible to temporarily pause the sound of the alarm system including the alarm system If the button is held for longer than 3 seconds a small menu opens by which the pause time and the alarm volume can be adjusted The volume of the alarms can be adjusted between 100 and 50 whereby the button serves simultaneously as an indicator of the current alarm volume 30sec 30 Sec 30sec 1 min 1 min 1 min F 2 min F 2 min J 2 min The pause time can be set to 30 seconds one minute or two minutes The selected time Is highlighted in gray By simply pressing the alarm pause button the sound out
33. SM during a diagnostic procedure of a magnetic resonance imaging for example CT MRI are not known Remove therefore during such procedures the sensors and cables that are connected with the VSM from the patient Warning During normal operation except transport it is recommended that the monitor is always connected to the electrical outlet The VSM must be connected to a grounded 3 wire electrical outlet Make sure that the lines of the power and ground wires are properly connected Warning For the United States or Japan A reliable grounding can only be achieved if the VSM is connected to an equivalent receptacle marked with HG hospital grade or HGJ Hospital Grade Japan Page 10 dy gt ENSP EC 4 Safety Information Warning This equipment has been tested and found to comply with the requirements for medical devices in accordance with the requirements of IEC 60601 1 ISO 80601 2 61 and the Council Directive 93 42 EEC These requirements are designed to provide reasonable protection against harmful interference in a typical medical installation Warning Certain types of mobile telecommunications equipment could interfere with the operation of the VSM Therefore mobile devices should not be used within five meters 16 4 feet of the VSM 4 2 Caution C This symbol indicates a caution statement Warning statements relate to conditions that lead to damage or malfunction of the device
34. T ION en nenne ne T EEE e EEEE nee 72 9 3 12 Characteristics of the SeNSOrLED cece cece cece see eeeeeeeeseneeeeeeeeesenneeeeees 73 De SAN OU eean E A E nap ana A E EA umdeniva A EAA A 73 PaA BIOKOTIDALD Venen ae EE EE E E EEEE 73 9 4 Attachment Tape for V Spec SONSOMS cccccccccesececeeseeeceeeeseeeeeecueeseneeseneseuneseaaees 74 Os OY lem Perran E ssena eaa EAEE iR OE in 74 9 5 1 Arterial oxygen saturation SPO2 arterial eeeeeneeneeenen 74 9 5 2 Pulse rate PR cccccceccecceccecceccuccuccucceeuceeeuceecaceseueeteeseeseseeteuseuteuteatenteeeess 75 9 5 3 Tissue oxygen Saturation StIO2 tiSSUC ceccccccceeccceeseeeeeeeeseeeeeeeeetaneeeeneeeanees 75 9 5 4 Pulsation Index Pl c ccc ccccccecceececccececccecceceecsecceccecsecseseeesesecsecteceeeeeecteeseeess 75 OB PICU PED E EEE EINE NEE EEE AET 76 Son SR AIC AON aay giao oscanieynenaincnae aaeseoweia E seit EE E E E S 76 B S EC an a IIN Gwe cascarargeunceimomn coset NENNEN EEE eaaaeamenas dnemres sacar 76 9 6 1 Power on self test POST cccccceccecceccecceceeccuceeececeeceuceessuceesseeteesestessntrerseeneee 76 9 6 1 1 Internal battery for the wall clock time enen 71 IOT Loua DCCL FC SL eat er ee 78 KOTS D CGY VES SEE EEE EE E 78 9 7 Alarms GUNN SSAC sein mine nee genen ee 79 Il PATE VOUI nennen as aa a a ee 79 9 7 2 Alarm an 0 6 OS sageretngauimepnanuesasiretanle ctuieer nicmwyada RNENNEN
35. afety reliably the sensor temperature is controlled by an integrated temperature sensor If the temperature increases beyond 42 C the sensor reduces the power of the internal power consuming units and switches to a power save mode which does not allow normal measurement operations The sensor returns to normal operation as soon as the sensor temperature is again within limits 9 3 11 Sensor calibration The V Spec Sensor is checked and calibrated for its valid optical setup at the manufacturer If the VSM does not recognize calibration data the message The connected Sensor is uncalibrated is displayed If the sensor is properly calibrated a re Page 2 dy gt ENSPEC 9 Technical description calibration is not required as long as the optical setup has not been changed through external impacts In order to ensure this the manufacturer regularly checks and if necessary re calibrates the sensors in regular intervals If the optical setup Is impaired the sensor is unable to recognized the blood circulated skin HbO2 and water spectra are recognized and does not start the measurement operations 9 3 12 Characteristics of the Sensor LED The illumination unit is based on a broadband fluorescent LED with a continuous spectrum in the wave length range 460nm to 880nm The medium emitted optical output is lower than 15mW This energy is only output if the sensor recognizes blood circulated skin on the sensor surface If the ski
36. al use Both the VSM and the external device must be connected to an earthed wall socket The respective communication protocol must be set up as described in this section Each PC or non medical instrument which is connected to the serial VSM data interface must be certified according to the IEC 60950 Standard All combinations of equipment must correspond to the requirements of the IEC standard 60601 1 Anyone who connects an external device with the VSM configures a medical system and is therefore responsible to ensure that the system corresponds with the requests of the standard to IEC 60601 1 1 and the electromagnetic compatibility standard IEC 60601 1 2 i Warning If you connect devices with the V Spec Monitor via the serial interface be sure to use the RS232 isolator ref RS232 IS Page 59 8 Data Communication dy SENSPEC 8 2 Data protocol 8 2 1 Serial data interface The serial interface 7 of the V Spec Monitor is used to enable a serial data communication between the V Spec Monitor and other devices The interface is located on the right hand side of the VSM Table 11 specifies the Pin arrangement Table 11 RS232 pin assignment Explanation Reserve Transmit Data Tx Receive Data Rx Reserve Signal ground Reserve Page 60 O gt ENSPEC 8 Data Communication 8 3 V Spec Link communication protocol The V Spec Link communication protocol is a pro
37. and intact skin Note Detailed information on the Attachment Tape can be referenced in the related user guide 9 5 System Performance 9 5 1 Arterial oxygen saturation S O arterial Measurement range 60 100 Resolution 1 SpO2 accuracy in the range between 60 bis 100 Sensor Type Measuring points Accuracy Arms V Spec Soft Sensor V SS L Finger 2 V Spec Sensor VSS with Attachment Tape AT VS Forehead 2 Warning The VSMS measures the functional oxygen saturation Note The SO accuracy specification is based on controlled hypoxy studies in healthy aft Subjects above the indicated saturation range by applying a sensor of the specified sensor type at each of the defined measuring points The SpO measurements were compared with SaO values which were determined by analysing arterial blood The SpO2 accuracy is indicated as RMS root mean square Page 4 dy gt ENSPEC 9 Technical description 9 5 2 Pulse rate PR Measurement range 30 250 bpm beats per minute Resolution 1 bom Accuracy 3 bom 9 5 3 Tissue oxygen saturation S O tissue Measurement range 10 100 Resolution 1 Accuracy 30 to 90 Sensor Type Measuring points _ Accuracy Arms V Spec Soft Sensor V SS L Finger 3 V Spec Sensor VSS with Attachment Tape AT VS Forehead 3 Warning The VSMS measures the functional oxygen saturation in the tissue The tissue parameters are continuous measurem
38. d time will open up The date and time can be set by pressing the correspondent or buttons Confirm the entry with the confirm box which closes the menu 6 5 1 7 Storage of the user settings Table 1 gives the default settings and what settings made by the user are stored at a restart and which will be reset to the default values Page 34 SENSPEC Setting 6 The V Spec Monitoring System VSMS Table 1 Settings Management Default values Setting SpO2 Limits 85 100 SpO2 Limits PR Limits 40 bpm 150bpm PR Limits StiO2 limits 60 95 StiO2 limits Alarm system status ON Alarm system status Alarm volume 75 Alarm volume Pulse tone volume 0 Pulse tone volume System click volume 25 System click volume Melodies OFF Melodies Dimmer 100 Dimmer Night mode OFF DAY Night mode Time GMT 1h Time Audio OFF Time 30 seconds Audio OFF Time Trend views 1 SpO2 time frame 10min 2 StiO2 time frame 10min 3 Pleth time frame 12sec Trend views Page 35 6 The V Spec Monitoring System VSMS dy S EN S PEC 6 6 The Monitoring with the V Spec Monitoring System Connect the sensor to the V Spec Monitor as described in section Connecting a V Spec Sensor Check the sensor status by means of the sensor status indicator on the screen of t
39. ded action P0100 SpO2 PR and or S402 too low or to high Page 84 Blocked veins e g in Trendelenburg position Procedure limited Cardiac arrhythmia Prcedure limited Insufficient local blood circulation at measuring point Check patient status Shock low cardiac index insufficient local vasodilation restrict the procedure Check sensor application and suitability of measuring point Avoid potential mechanical pressure at the sensor or at the measuring point and do not pull it Secure the sensor cable with adhesive tape and clothing clip Remove any blood pressure cuffs belts or similar items which may impair the blodd circulation Electroacoustics electrosurgery defibrallation Values get back to normal following an electroacoustics treatment electrosurgery or defibrillation Sensor is attached at a measuring point which is either not suitable or not recommended for the monitoring The VSMS monitoring is only permitted in adults and children with over 20 kg body weight The monitoring is only permitted for the measuring points e V Spec Soft Sensor VS SS L finger e V Spec Sensor VSS forehead Artifacts measuring errors caused by movements of the patient Check sensor application and suitability of measuring point Secure the sensor cable with adhesive tape or clothing clip Measurements are impaired by bright ambient light Screen the V Spec Sensor against brigh
40. e following should be done Ensure that the sensor is applied correctly and sately on the patient Select a application site with the best possible circulation Rub the measuring site with 70 isopropyl alcohol pad or rubefacient cream 10 30 methyl salicylate and 2 10 menthol for 20 30 seconds in order to improve the blood circulation Strong vasodilatory creams such as like nitroglycerin ointment are not recommended If possible remove electro surgical or other devices that may cause electrical interference If possible place the sensor at a location with low ambient light The VSM with integrated V Spec Technology is sufficiently protected against ambient light but excessive ambient light can cause measurement errors Caution If there are doubts as to the accuracy of measurements the vital signs of the patient should be checked in any other way before the functionality of the VSM will be further investigated Page 48 dy gt ENSPEC 7 Alarms and Messages 7 ALARMS AND MESSAGES 7 1 Introduction In the following section the VSMS alarm system as well as the messages displayed on the display will be explained in more detail The alarm system is an important element in the VSMS The operator should be familiar with the following information before the system Is put into service The V Spec Monitoring System allows the acoustic and visual output of alarm conditions The acoustic alarm messages will be issued ov
41. e sensor cables are undamaged If the cables show damage they must not be used In this case contact your Senspec dealer or service personnel authorized by Senspec Caution Do not immerse sensor and the sensor cable into water detergents or solvents Sensors must not be cleaned by irradiation autoclave or sterilization Please note the cleaning instructions in the manual for sensors and follow them Page 19 6 The V Spec Monitoring System VSMS dy S ENSPEC Prior to first use and with each patient the V Spec Sensor should be cleaned as described in the User manual for the sensor Only manual cleaning disintection procedures are permitted If you are using the V Spec Sensor with the Attachment Tape AT VS it should be noted that the attachment tape is intended for single use and a new tape must be used for each new placement of the sensor The V Spec Sensor and the V Spec Soft Sensor are suitable for repeated use Note Die operating life of the V Spec sensors is limited Please refer to the instruction manual of the sensor for more information 6 4 1 Operating the V Spec Sensor with the V Spec extension cable If an extension of the sensor cable is necessary the original V Spec Extension Cable can be coupled between the sensor and the monitor The connection of the connector of the V Spec Extension Cables VS EC is done in the same way as of the V Spec Sensor O Caution Use only genuine V Spec
42. ed will be displayed Note If the remaining operating time is under 60 minutes the yellow flashing text message connected sensor s lifetime expires in xx minutes Please change the sensor is displayed on the spectra display area xx s the number of minutes remaining If the sensor is applied while the operating time expires it will remain in operation and is only disabled if it is disconnected more than 15 minutes from the skin or from the VSM In this case the red flashing text message connected sensor s lifetime has expired Please change the sensor will be displayed on the display area of spectra 10 A measurement operation can thus be maintained even with expired sensor Page 46 dy SENSPEC 6 The V Spec Monitoring System VSMS 6 6 10 Operation with the V Spec Sensor 6 6 10 1 The measurements If the sensor is properly connected to the patient and to the VSM after a short stabilization period the current readings of the patient will appear A Caution Make sure that the sensor does not move at the application site Motion artifacts can distort the measurement Note the course of the plethysmogram to identify motion artifacts Note If the readings do not stabilize themselves test the correct fit of the V Spec Sensors Make sure that the sensor cable is fixed to ensure a good strain relief Falling below the SpO2 value triggers a high priority alarm Be sure to verify the patient s status A
43. elf Test fehlgeschlagen Fehlercode xx ar aaan meha The sensor operation period is exceeded i p g Sensor hat seine Lebens Betriebsdauer expired i berschritten anssrmetzalbrated E The connected sensor is uncalibrated Der angeschlossene Sensor ist nicht kalibriert Lost connection to the sensor Sensor not connected i Tech Verbindung zum Sensor verloren Sansor notinstalled nu Sensor lost skin contact Sensor hat den Hautontakt verloren Fest Low battery charge Lew Dattcly load battery_low Der Betterieladezustand ist niedrig Defective battery Battery defective Die Batterie ist defekt Multi functional board not attainable No connection to multifunction board Keine Verbindung zum Multifunktionsboard Page 53 7 Alarms and Messages dy SENSPEC Low signal quality Die Signalqualitat ist gering Weak signal quality Data update period exceeded 30 seconds Der letzte gemessene SpO2 Wert ist lter als 30 Sekunden Parameter update time exceeded for more than 30s Monitor fault xx Monitor error Kritischer Monitor Fehler i Table 8 Information messages Messages Power on self test passed VSM is ready for usel Power on self test failed with error xx Sensor Is now connected but without contact to patient s skin Low pulsation index Please check sensor application Main supply disconnected Main supply is not connected Ma
44. ennensnnnennennnneenenennenen 1 1 1 Range of application of the V Spec Monitoring System VSMS 1 1 2 Limits of the pulse resolved spectroscopic measurement of vital parameters 2 7 ADDITION See een ee ee 5 3 Warnings and PLrEC AION ensure nern seine rennen nee er A Sal EV IONA ON re ne rn ae een 9 A NVA e ne ee ee ee E 9 AP O NN et cee ected NE EI ententeacnsa seh E E A 11 A INO ee ane ures nee pated a re ee 12 SV ME SVMMIOOIS een ae ae ee ee ne er en 13 6 The V Spec Monitoring System VSMS ccseessssseennnenensseneennnnnnsenee nennen nennen 15 6 1 Components and Aelveny nn einen 15 6 2 Description of KISS aa ar a t e rnrn e rrr E rreren renni 17 6 3 Setting up the V Spec Monitor VSM uni een 18 6 3 1 Connection to the AC DOWEL ccccccccccccccee ee ceceeeeeeeeeeeeeeeeeeeneeee essen eesneeeaeeeens 18 6 3 2 Turning the VSM On and OM ernennen 18 6 4 Connection of a V Spec SenSoOr sss seessniuussriiiee stirt rerit rriren ee eee aes 19 6 4 1 Operating the V Spec Sensor with the V Spec extension cable 20 6 4 2 Application of the V Spec Sensor to the measuring point of the patient 20 6 4 2 1 V Spec Soft Sensor CV 5 534 iicoseaniuscnnsdetinnaeenenonustwotnusaunlaseucdabiientansastwides 22 6 4 2 2 V Spec Sensor with Attachment Tape eeeeneeeseeneeeeeneen 23 6 5 Operating the V Spec MOnllors nn
45. enspec representative Note The software version numbers used in the VSM are displayed on the POST screen The software version numbers are required to get support from qualified technical personnel or your local Senspec representative Note down the software version numbers and keep them ready when you request technical support Page 8 SENSPEC 9 7 Alarms and messages 9 Technical description The VSM has an alarm system which is described in chapter 7 Alarms and Messages Below further technical details on the alarms are listed 9 7 1 Alarm volume Depending on the priority the alarms sound at different levels Table 18 gives an overview of the alarm volumes measured in front of the device with Im distance Table 18 Alarm volumes Alarm Minimum volume Maximum volume High priority 62 7dBA 78 0dBA Medium priority 58 3dBA 72 1dBA Low priority Table 19 shows the alarm timing 49 4dBA 61 9dBA Table 19 Alarm Timing Alarm Item Result Pulse length 0 115s Time between 1 and 2 sound 0 06s Time between 2 and 3 Sound 0 06s Time between 3 and 4 Sound 0 25s Time between 4 and 5 Sound 0 06s Time between 5 and 6 Sound 0 5s High priority Time between 6 and 7 Sound 0 06s Time between 7 and 8 Sound 0 06s Time between 8 and 9 Sound 0 25 Time between 9 and 10 Sound 0 06s Interburst Interval 10s Rising fall
46. ents via the optical path Note The SO accuracy is based on the comparison with in vitro measurements by means of a blood gas analyser 9 5 4 Pulsation Index PI Measurement range 0 1 20 lower signal level 0 5 Resolution 0 1 Page 5 9 Technical description dy gt ENSPEC 9 5 5 Pleth Index PLI Measurement range 0 80 Resolution 1 9 5 6 Validation The described medical and technical parameters have been validated in comprehensive studies In all cases the validation was performed with all possible components of the VSMS cf chapter 6 1 Components and delivery A list of validation studies can be inquired at Senspec 9 6 System reliability The VSM performs several tests indepenently in order to ensure the system reliability Power On Self Test After turning on the VSM performs a Power On Self Test POST which checks the circuits and functions internal test Watch Dog Timer The firmware of the VSM and the V Spec Sensor have a Watchdog Timer which resets the VSM and the V Spec Sensor in the case of software errors Various tests which ensure the In order to ensure the continuing reliability of the calibration of the V reliability of calibration Spec Sensor the VSM tests automatically the camera module and the spectrometer setup Test of the functionality of the Various tests to identify potential problems or errors of the connected connected sensor system are independently perf
47. er the built in soeaker of the V Spec Monitor The visual output is carried out through various displays on the screen of the monitor A distinction is essentially be made between the visual alarm indicators and the reporting system The audible alarms can be muted for a period of a half minute one minute or two minutes the visual alarm output can not be disabled N Warning Always adjust the volume of the alarm system to the ambient noise Alarm conditions may not be observed or noticed too late if you do not follow this Instruction Page 49 7 Alarms and Messages 7 2 Alarms SENSPEC The alarms of the VSM are distinguished in high medium and low The alarms will be further divided into medical and technical alarms The table 4 contains a general overview of the possible alarms Table 4 VSMS overview of the alarms Description Audible and visual alarms for exceeding the SpO2 limits medical with optional melody Audible and visual alarms for a critical battery level technical only as melody alarm and a too high sensor temperature technical no melody Immediate response required Audible and visual alarms for exceeding the alarm limits of the parameter pulse rate and SiO2 medical with optional melody Audible and visual alarms for problems with the monitor POST failed the sensor operating time has expired not calibrated not connected without skin contact the battery defect
48. f sensors Follow the respective operating instructions to clean and disinfect sensors 11 3 1 4 Check Check all system parts monitor sensors after cleaning and or cleaning disinfection for corrosion damaged surfaces and contamination Damaged parts of the system must not be further used If the parts are still contaminated repeat the cleaning disinfection DrOcess If the parts should still have coarse contamination or residuals which can not be removed hand over the device for thorough cleaning to your authorized service technician N Warning Under no circumstances use contaminated parts for any monitoring process 11 4 Shipment instructions for the VSMS Please contact your local Senspec dealer before you return the system for safety tests and or servicing repair to the supplier or manufacturer If not covered by the warranty the shipping costs and repair and maintenance costs are Page 93 11 Maintenance dy SENSPEC charged to the sender The following instructions apply to all shipments of VSMS or parts thereof to qualified Senspec authorized technical personnel or your local Senspec dealer 1 If not otherwise instructed please send the VSM with power cord and or V Spec Sensor but without accessories 2 Appliances must be properly disinfected Disinfection information can be referenced in this manual or in the user guide of the sensor 3 The Certificate of Disintection and the Repai
49. g System VSMS is the powerful clinically proven V Spec Technology which is intended for use in adults and children over 20 kg body weight in accordance with the information contained in the sensor package Insert The V Spec Soft Sensor REF VS SS L and the V Spec Sensor REF VSS are intended for use with the V spec Monitor if a continuous and non invasive monitoring of vital parameters is necessary The monitoring parameters are oxygen saturation arterial SpO gt pulse PR tissue oxygen saturation S02 pulsation index Pl and Pleth index PLI The VSMS is intended for use in hospitals hospital type facilities transport within the hospital The VSMS may be operated by doctors nurses and trained nursing staff The VSMS is only to be used on a medical prescription Caution The VSMS measures the functional oxygen saturation Note The use in the hospital includes operating theaters specialist departments emergency and intensive care units and wards Hospital type facilities include surgery centers special care facilities and special sleep facilities outside a hospital Internal transportation means patient transport within Page 1 1 Range of Application and limitations dy SENSPEC the hospital or the hospital type institution Note In the course of x ray examinations or CT the sensor can remain on the patient but is then visible on the images The sensor should be removed with the MRI 1 2 Li
50. ggressive solvents to clean the screen These substances can attack the device and cause a device failure A Caution The device and its accessories must not be sterilized by means of u irradiation steam or ethylene oxid Autoclaving and pressure sterilization is not permitted Caution Do not touch or rub the VSM surface do not expose to cleaning powders tools brushes and materials with rough surfaces They can scratch the surfaces of the VSM and the touch sensitive screen may be damaged 11 3 1 Recommended cleaning and disinfection methods Use only manual cleaning methods The devices must not be cleaned by means of autoclaving irradiation or steam sterilization Page 91 11 Maintenance dy gt ENSPEC 11 3 1 1 Basic principle Make sure that the accessories were separated from the monitor before you start cleaning or disinfecting and that the monitor is disconnected from the mains Make sure that only sufficiently specified and validated procedures of the Equipment and Product Safety Act are used for the cleaning and disinfection Regular reviews must be made to ensure that validated parameters have been used in every cycle Observe the statutory provisions applicable in your country and the hygiene regulations in your institution This applies in particular to the various guidelines in terms of the inactivation of prions 11 3 1 2 Pretreatment Remove coarse contamination directly after every treatment within 2h maximum
51. he V Spec Soft Sensor is a combination of the V Spec Sensor technology and the Soft Fingerclip technology frequently used in many standard pulsoximeters The sensor consists of the sensor head which contains the optical components a shaped silicon finger clip and a cable with plug The ergonomic shape of the silicon part which is suitable for manual cleaning ensures ease of handling and cleaning In order to attach the sensor to the patient slide the V Spec Soft Sensor simply over the finger of the patient The digital V Spec Sensor electronic system contains information such as calibration data and Senspec identification code which identity the sensor clearly as V Spec Sensor Any sensor without valid Senspec Identification code which is connected to the VSM is not supported 9 3 2 Physical characteristics Sensor head Description splashprooft reusable Size 43 mm x 16 5 mm x 24 mm LxHxW Weight lt 8g Colour black Page 0 dy gt ENSPEC 9 Technical description Sensor cable Description highly flexible screened PU cable Length 100 cm Colour white gp Additional information on the V Spec Sensors can be found in the special user guides for the sensors 9 3 3 Sensor temperature not displayed Measuring range O 80 C Resolution 1 C Accuracy 1 C 9 3 4 Operating time The operating time of the V Spec Sensors is limited Please refer to the user guides for sensors for further infor
52. he turned on VSM GA Note The operating life of the V Spec Sensors is limited Please refer to the instruction manual of the sensor for more information 6 6 1 Turning on the VSM Turn on the VSM by pressing the power switch Q4 n the back of the VSM After turning on the VSM the Senspec Logo appears When you turn on the VSM it performs a self test Power on self test POST The result is displayed to you on the so called POST screen shown below ir V Spec Monitoring System Power on self test i ey ig O SENSPEC MFB functional Touchpanel found fP CMOS Battery OK wP Main supply available a Battery functional P Battery load status 100 System fans working Installed System RAM 1 5 Free System RAM 79 6 Monitor OS Release 1 0 0 MIFE Firmware Release 20 VS Monitor Release 205 Touchpanel Driver release 020 Serial Data Interface m V Spec proprietary A Philips IntelliBridge il available protocol active 3 protocol active 7 Sensor connected a Serial Number D01 301 12 4 00078 Sensor has skin faa Firmware Driver ar s f contact Version mink J i Lut Sound audible gt Display readable Display lighted F 7 Power on self test passed 2012 06 18 12 40 42 Page 36 dy SENSPEC 6 The V Spec Monitoring System VSMS On the POST screen serial number software releases existing interfaces tested f
53. if necessary Sensor defective Replace the V Spec Sensor P0202 Sensor gets too warm and causes pain Insufficient local blood circulation at measuring point Remove the sensor Re apply only if the cause was eliminated Avoid potential mechanical pressure at the sensor or at the measuring point and do not pull it Secure the sensor cable with adhesive tape and clothing clip Remove any blood pressure cuffs belts or similar items which may impair the blood circulation Sensor defective 10 3 VSM specific troubleshooting Problem Potential causes Remove the sensor and replace it against another V Spec Sensor Recommended action P0300 VSM does not work VSM turned off Turn on the VSM VSM not connected to the mains and battery is discharged Connect the VSM with the mains connection which starts the battery charging power cord defective Select another power cord to connect the VSM Fuse defective Change fuse as described in chapter 11 2 1 Fuse change Page 85 10 Troubleshooting SENSPEC Problem Potential causes Recommended action VSM defective Turn off the VSM and then turn it on again If the problem persists contact authorized service personnel P0301 VSM turned off Turn on the VSM f the problem persists Display is black off contact authorized service personnel Display VSM defective Contact authorized service
54. in supply connected Monitor problem xx 7 2 5 Required Responses The required responses to the alarms are provided in table 9 Table 9 Alarms and required response Alarm description Required Response Consequences if response is lacking Immediately check patient status SpO2 saturation low terminate any hypoxia Death or irreversible damages Immediately check patient status SpO2 saturation high marc Irreversible damages reversible damages Critical battery load Immediately connect the power VSM shuts down monitoring can not be cord continued Sensor temperature too Immediately remove sensor and Pain and reversible damages to the high if required replace by other V measuring point by burning sensor SENSPEC Spec Sensor 7 Alarms and Messages terminates measuring operation monitoring can not be continued Low pulse rate Promptly check patient status terminate any bradycardia Irreversible damages reversible damages High pulse rate Promptly check patient status terminate any bradycardia Irreversible damages reversible damages SpO 2 saturation low Promptly check patient status terminate any hypoxia ischemia Irreversible damages reversible damages SpO2 saturation high Promptly check patient status terminate hypoxia Irreversible damages reversible damages Sensor not calibrated Promptly replace V Spec Senso
55. ing diode oxygen pulsation index Pleth Index Power On Self Test responsible organization pulse rate arterial oxygen saturation V Spec Monitor V Spec Monitoring System Attachment Tape V Spec extension cable functional oxygen saturation of arterial hemoglobin measured with a pulse oximeter tissue oxygen saturation oxygen saturation of the measured hemoglobin of the tissue hemoglobin oxygen hemoglobin hydrogen hemoglobin water hemoglobin concentration hematocrit Page 5 2 Abbreviations dy gt E N SP EC SPECTRAL MONITOR Page 6 dy S ENSPEC 3 Warnings and Precautions 3 WARNINGS AND PRECAUTIONS Special warnings Please read this owner s manual carefully and follow all instructions warnings and precautions The VSM must be carried out by health care professionals and be operated without prior training by Senspec Conditions for the proper use of the VSMS are general knowledge of pulse oximetry spectroscopic blood gas analysis and an understanding of the characteristics and functions of the device Risk of electric shock e Do not attempt to open the unit and possibly perform the maintenance yourself If repairs or modifications to the device are performed by persons not authorized by Senspec the warranty will be voided e The battery cannot be exchanged by the user e Do not immerse the V Spec MMonitoring System in liquids Electric shock hazard e Only connect equipment intended for the system
56. ing sound time Sms Frequency 858Hz Page 9 9 Technical description SENSPEC Pulse length 0 17s Time between 1 and 2 Sound 0 14s Time between 2 and 3 Sound 0 14s Medium priority Interburst Interval 10s Rising falling sound time 12 4ms Frequency 487HZz Pulse length 0 235 Time between 1 and 2 Sound 0 22s Time between 2 and 3 Sound 0 225 Low priority Interburst Interval 30s Rising falling sound time 15ms Frequency 391Hz 9 7 2 Alarm melodies As an option you may choose between several alarm melodies for the medical parameters The frequencies of the alarm melodies are listed in table 20 Table 20 Frequencies of alarm melodies Ite Frequency SpO melody Sound 1 88Hz Sound 2 702Hz Sound 3 661Hz Sound 4 585Hz Sound 5 5 13HZz PR melody Sound 1 88Hz Sound 2 702Hz Sound 3 661Hz StiO2 melody Page 80 Sound 1 398Hz Sound 2 494Hz Sound 3 585Hz dy S ENSPEC 9 Technical description Note The VSM does not interfere the audible signals i e there is only one acoustic signal at a time The VSM counts the output priority for acoustic signals as follows sorted in descending order High priority alarm Medium priority alarm Low priority alarm Information signals AUDIO OFF reminder Power On Self Test signal Pulse tone Key sound
57. ive low battery condition only melody alarm at connection problems with the multi functional board or a defective V Spec extension cable technical without a melody Immediate response required Acoustic and visual alarms at low signal quality exceeded parameter update period or an identified problem with the monitor technically without a melody 7 2 1 Acoustic Alarm Indicators The acoustic alarm tones without melody are marked as follows High priority Medium priority Low priority Attention and response required Sequence of ten high sounds sounding in four bursts 3 2 3 2 repeating every 10 seconds Sequence of three medium pitch tones sounding as a single burst repeating every 10 seconds Sequence of two low pitch tones sounding as a single burst repeating every 30 seconds Audible alarm signals can be muted with the help of the alarm pause button DoT for 30 seconds one minute or two minutes push gt 3 seconds Page 50 dy S ENSPEC 7 Alarms and Messages Note The permanent muting of the alarm system is permitted only to authorized users and only available with a PIN code As a reminder that the alarm system Is inactive you will hear a reminder signal every ten minutes Note For more information on the alarms and the alarm melodies that can be optionally set parameters specific can be found in section 9 7 2 Alarm melodies 7 2 2 Visual Alarm Indicators A
58. ized by Senspec There are no replacement parts for users inside the device 11 2 1 Fuse change The VSM has two interchangeable microfuses which are located in the fuse box 2 aat the rear of the VSM The specification of the required fuses can be referenced in chapter 9 2 4 Electrical characteristics Page 88 dy SENSPEC 11 Maintenance SPECTRAL MONITORING Please follow the steps below to change fuses 1 Release the fuse socket with a small screw driver or another suitable item by slightly pressing the socket right and left 2 Remove the fuse socket 3 Now you can either check or replace the fuse if necessary 4 Once you have checked or replaced the fuses re insert the fuse box in the same manner Make sure that the slot in the casing matches the shape of the counterpiece at the fuse socket Press the fuse box in the casing until it engages noticeably on both sides Page 89 11 Maintenance 11 3 Cleaning and disinfection Warning Turn off the VSM and disconnect it from the mains before you start cleaning the monitor Due to the nature and severity of infectious diseases such as AIDS and hepatitis B it is essential that devices and accessories which may come in contact with human and animal tissues or fluids particularly blood should always be considered as contaminated or potentially hazardous Contaminated devices and accessories must be decontaminated as described in the process below
59. larm monitoring for the respective parameter Is not active Parameters displayed in valle pre defined colours Instable replaces the Invalid parameter value Page 65 9 Technical description dy 5 ENSPEC Trend graphs displayed parameters freely selectable time domain x axis for online trends can be set between 10 min and 72 h values margin y axis is scaled automatically depending on the value within the displayed time domain Plethysmogram time domain x axis selectable between 15 30 45 60 and 75 seconds values margin y axis is scaled automatically depending on the value within the displayed time domain Display options brightness can be adjusted during the monitoring switchable between day mode continuous brightness and night mode brightness is automatically reduced if no interaction is made input alarm The user is offered two selectable measurement displays Standard screen updated medical and technical measuring values alarm limits online trends and or plethysmogram and heart symbol minimized display of spectral data status messages status Indicators for battery sensor alarm and wall clock time settings of volume display brightness serial output protocol Page 66 dy SENSPEC 9 Technical description Spectral screen updated medical measuring values alarm limits spectral data instead of trend graphs technical parameters and heart symbol Status messages s
60. ll restore following settings to the factory default values alarm melodies volume settings display lightness night mode parameter alarm limits and parameter selection of the trend graph fields Information in the information menu Via the Information menu additional information to VSMS will be made available to you aia me V Spec Monitoring System Q N E VSM Msw 2 0 5 0001 301 12 04 00028 a S0 WO m PI Pu Senspec GmbH Alter Hafen Sid 4 D 18069 Rostock 7 SPECTRAL MONITORING SYSTEMS SENSPEC The top row displays the serial number of the VSM and the firmware version of the multifunctional board The second field shows the version number of the VSM monitoring software The third and largest field shows the serial number of the connected V Spec sensor the enabled measurement parameters the remaining operating time and the version numbers of the sensor firmware and of the sensor driver Below you will find the Senspec contact address Page 33 6 The V Spec Monitoring System VSMS dy S ENSPEC 6 5 1 5 Language setting By touching the button in the upper left corner of the screen you can choose between the languages German and English The currently selected language is shown in the upper left corner of the screen English German 6 5 1 6 Setting Date and Time 6 18 Open the sub menu date time by touching the symbol 5 40 42 The menu for setting the date an
61. mation 9 3 5 Patients The system can be used for adults and children with a body weight of more than 20 kg 44 Ibs 9 3 6 Permissible measuring points Table 17 Permissible measuring points a a Bier rn i V Spec Sensor VSS with Fully developed Attachment Tape AT VS Forehead V Spec Soft Sensor V SS L V Spec Soft Sensor V SS L Sensor V SS L Se r Page 1 9 Technical description dy gt ENSPEC Note We recommend a flat area with good blood circulation centrally located spots preferred Avoid placing the sensor on top of large superficial venues or areas with skin damages or oedema 9 3 7 Measurement principle Miniaturized 2D spectroscopy system with integrated illumination unit and pulsatile time resolution for the spectral range 500nm to 850nm for the measurement of physiological arterial blood and tissue parameters The measurement is performed with transflexion remission spectroscopy 9 3 8 Digital microtechnology Opto electronic units 2D CMOS Megapixel camera sensor stabilized broad band LED illumination unit temperature sensor micro controller with high speed data transfer and storage clip located on the sensor PCB 9 3 9 Sensor memory Sensor data eg spectroscopy calibration serial number are stored after the manufacture of the sensor Additional data needed for the operation are stored in the sensor 9 3 10 Sensor temperature monitoring In order to ensure patient s
62. mits of the pulse resolved spectroscopic measurement of vital parameters The VSMS measures the vital parameters of arterial blood and the tissue The following clinical situations or factors may affect the readings e Poor blood circulation e g as a result of low cardiac index shock hypothermia or proactively blood pressure titration Drugs e Quality of the skin and subcutaneous tissue e g direct placement over veins damaged skin edema moles or a very strong subcutaneous fat layer e Poor contact between the sensor and the skin where the light passes through the point of input of light and the point of output of light and thereof light can pass light directly from the light source to the spectrometer unit e Intra vascular dyes Not all dyes are included in the analysis and can thus affect the chemo metric blood and tissue analysis e Low perfusion at the measuring point e g by mechanical pressure or local hypothermia of the measuring point or part of the vascular system which supplies the measuring point cold fingers e Skin pigmentation or tattoos The usual skin pigmentation by Melanin is taken into account in the evaluation since the spectral analysis is carried out on the 2nd derivation e severe anemia Page 2 dy S ENSPEC 1 Range of Application and limitations e Strong ambient light e Arterial venous shunts Warning For the measurements the tissue is heated in the measurement volume
63. n is not recognized the sensor switches to standby mode and the medium emitted optical radiation energy falls below 1mW m This information is particularly important for hospitals hospital physicians 9 3 13 Safety The sensor LED light has neither angular nor spectral coherence Therefore the laser regulations EN 60825 1 2007 do not apply The European legislation is based on the EU Directive 2006 25 EC Safety requirements regarding artificial optical radiation Special precautionary measures are not required There are no X ray UV or infrared radiations 9 3 14 Biokompatibility The biocompatibility has been verified for the V Spec M Sensor and den V Spec Soft Sensor in compliance with EN ISO 10993 1 2010 and the biological evaluation of medical devices part 1 Both sensors have passed the biocompatibility test and therefore comply with EN ISO 10993 1 2010 The sensor Is free of latex The materials used to produce the sensor do not contain raw rubber latex protein Page 3 9 Technical description dy 5 ENSPEC 9 4 Attachment Tape for V Spec Sensors The material for the Attachment Tape is a product by the company 3M Health Care and the biocompatibility has been veritied in compliance with EN ISO 10993 1 2010 and the biological evaluation of medical devices part 1 Upon request the respective clinical data sheet can be obtained at Senspec GmbH The AT VS is recommended for adults and children with fully developed
64. n two valid values is therefore one second Figure 1 illustrated the delay that occurs from the entry of an event until triggering the alarm with an exemplary SpO2 course The alarm condition occurs at time t and is detected at time tz by the algorithm At time tz the alarm is issued The time period t gt t Is Page 56 O gt ENSPEC 7 Alarms and Messages determined by the averaging and processing times of the algorithms and is called alarm condition delay The time period t3 t2 is the delay occurring by the signal run time within the VSMS or by the alarm forwarding to the connected systems and is called alarm signal generation delay Algorithm response SpO2 S Timet Figure 1 Illustration of the alarrm delay at the instance of parameter SO If the VSMS is used as standalone system the time f3 t2 is significantly less than one second which is below the parameter update period Since the time t3 tz to the time t2 t is negligible the overall delay is mainly characterized by the time t2 t7 The delay times of the medical alarms are given in table 10 Table 10 Delay times of the alarm system Delay t2 t 15 seconds 5 seconds 15 seconds Technical alarm lt 1 seconds Page 5 7 Alarms and Messages dy SENSPEC The delay time from determining the alarm condition t2 until the output over the serial port is a maximum of two seconds Note If the VSMS is used in connec
65. na E E Eine ii 42 Oo AR AI ADO Eo ee a ae eisen 42 6 6 5 Technical parameter display area cueueesseeeeeesseeneseneneennsnnnenneneenenneen 42 6 6 6 Alarm Indicator 1G wis an euere 42 09 0 7 Ne SACOG Eee a EAA EE SEAE ENEA 43 0 0 TFN SA ee ee ee 43 sO SS ee ee ee ee 45 6 6 10 Operation with the V Spec Sensor ueeeeeessseeeenesenenenseneennnenenennene nennen 47 6 6 10 1 The measurements arena 47 7 Alarms and IWC SS ACC Sor cis soe ss cnorictncactnaeis aqesemaahin ends eeeleusdainetimaucinasvensetnabemsiadoreindemncgedamaed 49 Ze OU e a ee ne EEE 49 PZ PVN Sessa ss aceseseeasee E E E E E E E E E A S 50 7 2 1 Acoustic Alarm MA CIGANON ee ee 50 7 2 2 Visual Alarm AUTO ee ee rer 51 72 3 A See E A EA EA A ee 52 72 4A Alarm messages ree a E E EEE ESE S ENEE EEE ES 52 Fao REGUEO RESPONS O ensen a ee ae 54 7 3 PGI OVS UCM ING 5 er een ann ai ee een nee 56 BAR a ne Eee 56 FAAN E N ERINNERN oust tinmatnan E E EE EE E E RE 56 FeO MGI OO er e a E E E E E AAEE E EE EE EEE 58 8 Daa SINN CUO ea iea E E ee Ener 59 ICY E EA E EE AS 59 8 2 Dal ALOLE o MA EEE E E E EE EET EE A E E TE 60 8 2 1 Serial data el CC ce aiascecmcousesncanesuiseteasonecupa chcanseausinemusasiinen ssancuneeeceutnscteeesss 60 8 3 V Spec Link communication protocol 20eeeeeeenneeeennnsenennneneennnennenen een 61 ik MOG ACO SOUL NO onen EE RER 61 8 3 2 V Spec Link data i ee ee ae 61 8 3 3 Layout of the header and the data ArrayS
66. nical parameter Pulsation Index PI 6 1 and Pleth Index PLI D 6 6 6 Alarm Indicator field The alarm indicator field 0 shows the alarm status in the event of an alarm Note The alarms are explained in more detail in the section Alarms and Messages Page 42 dy SENSPEC 6 The V Spec Monitoring System VSMS 6 6 7 Message system The symbol G P lt includes the message system of the V Spec Monitor Here the latest news and information is displayed in English to assist the user in operating the VSMS New messages will appear as a banner and disappear again after a few seconds If several messages are present at the same time the information about it takes place at the end of the message e g Sensor is now connected but without contact to patient s skin 1more By touching the message in the foreground it will disappear or the next message will appear If the symbol 2 is touched already disappeared messages of the systems can be accessed again Note A detailed overview of all messages can be found in section Alarms and Messages 6 6 8 Power status The V Spec Monitoring System is equipped with a rechargeable internal lithium ion battery to bridge a power interruption of one hour maximum without the need for measurements to be interrupted Cd Caution The battery must only be replaced by authorized qualified personnel If you find a defect in the battery inform your
67. nification of the spectra is shown The spectral view consists of the e pulsatile absorption spectrum shown as white curve the e extracted blood spectrum A shown as a red curve and the e tissue spectrum shown as a green area Page 28 dy SENSPEC 6 The V Spec Monitoring System VSMS are each shown in a wavelength range of 500nm to 800nm The button 6 3 wil change in the spectra view and serves now to switch to the main screen The display areas Settings and Status Indicators on the right side remain otherwise unchanged 6 5 1 4 Main menu By touching the menu button the main menu opens SPECTRAL MONITORING SYSTEMS SENSPEC Volume menu Data output menu Nel POST and reset menu Information menu 3 By touching the button JS you can exit the menu Page 29 6 The V Spec Monitoring System VSMS dy S ENSPEC Settings in the volume menu By touching the button the window for setting the alarm sounds opens e e e 6 PECTRAL MONITORS i SENSPEC A a a ir BILLS PAF P SPECTRAL MONITORING SS TEN With the help of the sliders you can adjust the volume for the e alarm sounds a e the heart sound a e and the key sound a With the alarm off button Al authorized users can disable the audio output including the alarm system This option is secured with a PIN code The user will be made aware by an audible tone at reg
68. odes Meaning Critical battery load Sensor temperature too high Incompatible sensor Sensor defective Sensor operating time has expired Sensor not calibrated Sensor not connected Sensor not installed Low battery load Defective battery Multifunctional board not attainable Sensor extension defective Weak signal quality Parameter update time exceeded Alarm system OFF Alarm system paused Power on self test failed Monitor problem xx Page 63 9 Technical description dy 5 ENSPEC 9 TECHNICAL DESCRIPTION The VSMS is a medical device according to EC Directive 93 42 EEC certified according to the International Standards IEC 60601 1 DIN EN 80601 2 61 and EN ISO 10993 1 further relevant standards which were taken into account in the device production can be inquired at Senspec GmbH 9 1 Environment Transport and Storage Conditions 9 1 1 Transport Storage Conditions The following conditions apply to all units of the V Spec Monitoring System transport storage in original packaging Temperature O 50 C 32 122 F Humidity 10 93 non condensing For the listed devices we recommend the following long term storage conditions Temperature 15 26 C 59 78 F V Spec Soft Sensor V Spec Sensor Attachment Tape Humidity 40 60 Attachment Tape AT VS 9 1 2 Operating Conditions Temperature 10 40 C
69. of the sensor This is supported by the message system The indicator shows you the following states of the sensor Sensor not connected e There is no sensor connected to the VSM Sensor not applied e The sensor is connected to the VSM but has no skin contact to the patient Sensor active e The sensor is connected to the VSM applied on the patient and is working properly Following the stabilization of the readings you can see it on the screen Sensor temperature is too high e The sensor is connected to the VSM applied on the patient and the sensor temperature is too high The sensor turns off a high priority alarm is generated and the text message High sensor temperature remove or change sensor appears Warning Remove a sensor with a too high temperature immediately from the patient and trom the VSM The alarm is only ended by removing the sensor from the VSM Caution If a too high temperature Is displayed at a sensor frequently the sensor must not be used again In this case use a different V Spec Sensor and contact your Senspec partner Page 45 SPECTRAL MONITORING 6 The V Spec Monitoring System VSMS dy S ENSPEC Sensor operating time has expired SEK y The sensor is connected to the VSM and the operating time of the sensor has expired The sensor turns off please note below a medium priority alarm will be generated and the text message Sensor operation period exceed
70. of the trend graph can be seen whereby the current time is shown on the right You can change the time span by pressing on the field and wipe to the right or left The time span is set for all trend graphs and can be adjusted between a minimum of 10 minutes and a maximum of 72 hours The value range of trend graphs is automatically scaled for the medical parameters according to the values displayed in the selected time range Maximum and minimum of the display are visible as numeric values right next to the field The current alarm limits are shown as red horizontal lines The area outside of the alarm limits is highlighted in red Page 41 6 The V Spec Monitoring System VSMS dy S ENSPEC 6 6 3 2 Plethysmogram The plethysmogram can be displayed by dragging the heart symbol on one of fields G G or 63 The time span of the plethysmogram can be set equivalent to the trend graphs and can be set to a value between 15 and 75 seconds in 15 second increments The set time span is visible below the plethysmogram The scaling of the height of the plethysmogram is carried out automatically for the selected range 6 6 4 Heart symbol The active pulse pulse cycle is apparent in the vibrant heart symbol Op T no sensor is connected or applied or the pulse rate is too low the heart symbol is displayed with a question mark Y 6 6 5 Technical parameter display area In the lower screen area you see the display area 6 for the tech
71. ormed by the VSM 9 6 1 Power on self test POST While the VSM is booting a Power on self test POST is performed It includes the following inquiries e Multifunctional board MFB operable e Touch panel recognized e CMOS battery functioning e Mains connection established e Battery functional Page 6 dy gt ENSPEC 9 Technical description Battery charging condition Fan functional Installed RAM storage in GByte Free RAM storage in Monitor OS Release Number MFB Firmware Version VSM Monitoring Software Version Touchpanel driver version Serial interface available Active serial output protocol Sensor connected Sensor serial number Sensor has skin contact Sensor Firmware Version Sensor driver version Apart from automatic inquiries the operator must test the audible and visual output interfaces If the POST does not identity errors the message power on self test successfully passed is displayed for 5 seconds and the VSM changes to one of the available measurement screens Check the date wall clock time settings of the VSM after the POST and set them properly if necessary 9 6 1 1 Internal battery for the wall clock time The VSM contains one additional internal battery which stores the set clock time If the voltage of the internal clock battery of the VSM falls below a critical value the real time clock deletes the date and time settings After restarting the VSM date
72. ous oxide not suitable for this environment 9 2 5 Voltage supply 9 2 5 1 Mains operation If the VSM is connected to the mains supply the power status indicator shows the following conditions Mains operation active battery fully charged E 55 The VSM is connected to the external power supply and the battery is fully charged Mains operation active battery is charging m The VSM is connected to the external power supply and the battery is charging Page 68 dy gt ENSPEC 9 Technical description Note If the mains operation is not displayed while the VSM is connected to the mains check the power cord the socket and the fuses Note The VSM adjusts automatically to the respective local voltage 100 240V 50 60Hz Note Whenever the VSM is connected to the mains the internal battery is charging Therefore we recommend keeping the VSM connected to the mains even if it is not used This ensures that the battery is fully charged when needed 9 2 5 2 Battery mode The V Spec Monitoring System is equipped with a rechargeable internal lithium ion battery to bridge a power supply interruption of one hour maximum to ensure uninterrupted measurements If you use the VSM battery mode the power status indicator displays the following conditions Battery mode active battery fully charged w o e The battery is fully charged and allows approximately 1h operation Battery mode active battery low e The bat
73. prietary uni directional protocol to enable the exchange of real time patient data between the V Spec Monitor and other devices 8 3 1 Interface settings For establishing a communication the parameters at the receiver must be set according to table 12 Table 12 RS232 Interface settings Parameter Setting Standard RS 232 Baud rate 9600 Data bits 8 Stop bits 1 Parity Flow Control 8 3 2 V Spec Link data transfer The V Spec Link communication protocol issues one data row per second The header will be issued every 50 seconds or in case of a change of information contained in the header e g alarm limits The output of the parameters is carried out delayed via the serial interface to the output on the screen The delay is a maximum of two seconds Not included here is the time for the processing and output to the connected device 8 3 3 Layout of the header and the data arrays The data output takes place in ASCII format whereby the fields are separated by tabs The structure of the header and the data arrays Is specified in table 13 Page 61 8 Data Communication SENSPEC Table 13 Assembly V Spec Link protocol Monitor Header Info Monitoring Software Monitor SN lt Value gt Seria number of VSM Software lt Value gt version number of the VSM Sensor SN lt Value gt Seria Number Header Info SW lt Value gt version number of the sensor software Data
74. put will be paused The icon Page 26 dy S ENSPEC 6 The V Spec Monitoring System VSMS changes with paused sound output amp After the expiry of the pause time the sound output is activated again and the normal symbol will be displayed 6 5 1 2 Brightness of the screen night mode By touching the screen brightness button a small window opens in which you can adjust the brightness and switch between e day mode and e night mode In the night mode the screen brightness is slowly reduced ten seconds after the last user interaction if no alarm condition exists If an alarm occurs or the screen is touched the brightness immediately returns to 100 The screen brightness button also serves as an indicator of the current brightness level Caution Adjust the brightness of the screen depending on the brightness of the surroundings Important information could be missed Page 27 6 The V Spec Monitoring System VSMS dy S ENSPEC 6 5 1 3 Switching the screen display The V Spec Monitoring System offers you two different screens e the main screen described above with trend display and e ascreen with the enlarged display of the spectra Go With the touch of the button a screen opens with the spectral data TC rh ere OC i 50 nm B50 On this screen you can see in the upper part the medical parameters and the respective alarm limits In the lower part a mag
75. r Form if applicable must be attached to the device when shipped for a safety check and or servicing repair If the devices are maintained on site the service technician also requires a Certificate of Disinfection Note PDF templates of the Certificate of Disinfection and the Repair Form are available on the manual CD for the VSMS 4 If you wish to return electronic parts make sure to comply with the ESD precautionary measures 5 For any return use the VSM original packaging if possible or alternatively a packaging that provides similar protection Use only clean and hygienically perfect packaging material for your return shipment Page 94
76. r and send it to your Senspec partner Monitoring cannot be continued Sensor operating time has expired Promptly replace V Spec Sensor Monitoring cannot be continued Sensor not connected Promptly connect V Spec Sensor with VSM Monitoring cannot be continued Sensor not installed Promptly install V Soec Sensor again at measuring point Monitoring cannot be continued low battery load Promptly connect power cord Battery is discharged monitoring can be continued limited Defective battery Promptly contact your Senspec partner Monitoring cannot be continued Multi function board not attainable Promptly contact your Senspec partner Monitoring cannot be continued Sensor extension defective Promptly contact your Senspec partner Monitoring cannot be continued Weak signal quality Timely check Sensor application change measuring point or stimulate blood circulation Measured values may not match the actual parameter values Parameter update time exceeded Timely check Sensor application change measuring point Measurement of the parameter is not possible Monitor error Timely turn off VSM contact Senspec partner Damage to the VSM Page 55 7 Alarms and Messages dy 5 ENSPEC 7 3 Alarm System Reset If the V Spec Monitor is switched off certain settings are reset to default value if they have been changed by the operator
77. r connector faulty Contact authorized service personnel P0311 No communication via RS 232 interface Page 86 Wrong interface settings selected at the connected device Read interface settings in chapter 8 3 1 Interface settings and adjust settings at the connected device respectively VSM defective Contact authorized service personnel dy SENSPEC 11 Maintenance 11 MAINTENANCE Under normal use the VSMS is a maintenance free system and a recalibration or internal resetting is not required However in order to ensure the warranted performance reliability and satety you should perform regular routine checks regular care incl cleaning and disinfection and safety tests Cleaning and or disinfection instructions for the VSM and the V Spec Sensors including cable can be found in the respective instructions for use We recommend manual cleaning The system must not be autoclaved irradiated or steam sterilized 11 1 Routine tests This chapter describes routine checks and maintenance work which can be performed by the VSMS operator Routine checks and maintenance work should be performed regularly AM Caution Technical safety checks must only be performed by authorized service personnel in regular intervals at least every 24 months or in compliance with the local and statutory regulations The following checks should be performed regularly e Power on self test This test is automatically perfo
78. rmed at every restart and can be performed manually with the POST and reset menu s sec 6 5 1 4 Main menu If you leave the VSM continuously turned on Turn off the VSM and on at least once per month to check the Power on self test function e Check the VSM monthly for mechanical and functional damages e PCheck the V Spec Sensors including cable for mechanical and functional damages once per month e Check the power cord for mechanical and functional damages once per month Detective cables must be replaced by original spare parts Page 8 7 11 Maintenance dy gt ENSPEC e Check the alarm functions monthly For this change the alarm limits of the medical parameters in order to trigger the different alarms e Check occasionally the labels and markings at the monitor sensor and all accessories for integrity and readibility If they are damaged or not readable address this to your authorized service technician 11 2 Service We recommend to perform safety tests in regular intervals at least every 24 months or in compliance with local and statutory regulations for more details refer to the Service Manual Please contact sufficiently trained staff or your local Senspec partner to perform safety tests or repairs Please make sure that any service or repair that requires to open the casing must only be performed by authorized Senspec service personnel Warning The casing must only be opened by service personnel author
79. scription Serial Number Indicates the serial number of the device Date of manufacture Specities the year of manufacture BRE Potential balance Connection for potential balance ground Type BF defibrillator protected Degree of protection against electric shock Type BF DEFIBRILLATION applied part Fuse Indicates the fuse type IPX1 Degree of protection against Degree of protection against ingress of water ingress of water type IPX1 type IPX1 Splash proof C CE marking CE declaration for the device 0482 Caution Security related information is included in the enclosed documents WEEE old device disposal The consumer must dispose waste equipment Waste Electrical and Electronic Equipment WEEE according to the European waste legislation following the WEEE Statement Do not dispose with household waste Use the appropriate collection points Page 13 5 VSM Symbols dy SENSPEC SPECTRAL MONITOR Page 14 dy S ENSPEC 6 The V Spec Monitoring System VSMS 6 THE V SPEC MONITORING SYSTEM VSMS 6 1 Components and delivery The V Spec Monitoring System VSMS contains the following main components md Lu e V Spec Monitor VSM including power cord with a Bee country specific connection e V Spec Sensor V Spec Soft Sensor VS SS L and or V Spec Sensor VSS e V Spec extension cable VS EC N _
80. t ambient light e g lamps sun light etc Dyshaemoglobins Physiological limitation of the procedure Patients with high carboxyhaemoglobin values e g smokers the functional saturation measured with a pulse oximeter will be higher than the functional saturation values measured with an CO oximeter Intravascular dyes Procedure limited Dyes used as tracers contrast agents etc can absorb light of the same wave lenghts as the measurements use SENSPEC 10 2 Sensor specific troubleshooting Problem m gliche Ursachen 10 Troubleshooting Empfohlene Handlungen P0200 Although the V Spec Sensor is connected to the VSM the VSM indicates sensor not connected Poor contact cable possibly not connected contaminated contacts Check connections by disconnecting and reconnecting the sensor cable and or sensor extension Turn the device off and turn it on after briefly waiting V Spec Sensor In order to identify the defective part replace sensor and or sensor cable extension and try again If necessary change the VSM position and try another VSM If V Spec Sensor is damaged replace it by a new original V Spec Sensor VSM defective If the problem persists contact authorized service personnel P0201 Although the V Spec Sensor is applied to the patient the VSM indicates sensor not connected Sensor lost skin contact Check sensor application and renew
81. tatus indicators for battery sensor alarm and wall clock time settings of volume display brightness serial output protocol 9 2 3 Connections serial conetion RS EIA 232 avallable protocols Philips IntelliBridge Open Interface V Spec Link re The VSM does not provide the nurse call option 9 2 4 Electrical characteristics Internal battery rechargeable sealed lithium ion battery Duration 1 0 h at 100 charging condition new battery 20 C Charging time 4h from 0 to100 charging condition Power receptacle IEC 60320 C14 device connection Mains voltage 100 240V 50 60HZz Fuses 2x 2A device fuses time lag fuse 5 x 20mm Power input max 2 Ampere Operating mode designed for continuous operation Page 6 9 Technical description G S ENSPEC D Caution The internal battery must be replaced by authorized staff only Caution Chapter 11 2 1 Fuse change describes how to replace the fuses Use only fuses with the specifications given in this manual If you use other not permitted fuses any guarantee claim expires Electrical safety Type of protection against electric shock Class if mains operated Class Il with internal voltage supply Degree of protection against electric shock Type BF APPLIED PART DEFIBRILLATION checked Degree of protection against hazardous ingress of water IPX1 splashproot Level of safety in the presence of a combustible mixture of anaesthetics and air oxygen or nitr
82. tery charge reduces Operation is only possible for a max of 15 min A medium priority alarm indicates this Battery mode active battery charge critical Ca The battery charge is not sufficient to operate the VSMS The system switches off four minutes after the symbol and the alarm Critical battery charge were displayed The VSM can not be operated with a discharged battery Therefore connect the VSM to the mains and charge the battery for some minutes before you switch in the VSM The entire recharging takes about 4 hours if the VSM is switched off Page 69 9 Technical description dy gt ENSPEC Note We recommend to check the internal battery every 24 months by authorized Senspec service personnel and replace it if necessary This must only be performed by authorized Senspec personnel Replaced batteries must be recycled according to locale regulations and not disposed of in domestic waste m Note If the VSM is frequently operated in battery mode the maximum operation time of the VSM in battery mode may decline This may reduce the time interval between signalling the Battery Critical alarm and the switching off of the VSM 9 3 V Spec Sensors The V Spec Sensors are distinguished between the V Spec Soft Sensor and the V Spec Sensor for use of the Attachment Tape The following characteristics relate to the V Spec Sensor if not otherwise indicated 9 3 1 V Spec Soft Sensor Large T
83. tion with other systems the delay times of the designated manufacturer are valid for the connected system u Note While a parameter is invalid or is stabilized the alarm monitoring of this parameter is inactive Detailed information can be found in the section 9 2 2 7 6 Alarm Log The VSM records internally the alarms in log files At each start of the VSM a new Tile is created This is permanently stored even in the case of the loss of the operating voltage In a log file for each alarm event start end limit changes an entry Is created which Is named with the respective alarm ID As entries of the events are included Time Alarm event type Start START end END limit change LIM Alarm system status ASS LIM and ASS only if there is an alarm Alarm priority Alarm description set alarm limits The current parameter value Alarm volume and Alarm system status Note The alarm log Tile is saved internally and can be read only by authorized personnel Page 58 dy gt ENSPEC 8 Data Communication 8 DATA COMMUNICATION 8 1 Overview During the V Spec monitoring current patient data can be issued via the serial interface RS 232 which is located on the side panel of the VSM This port can be connected with external instruments such as multiparameter monitors personal computer PC and Poly SOMNO graphs When connecting the VSM to an external device verify correct operation prior to clinic
84. ular intervals that the acoustic alarm output Is disabled When operating the VSMS with connected systems the alarm forwarding will continue With the melody button and the sound button O you can select if the optional alarm melodies see section alarms and messages or sounds shall be used The selected field is shown in gray Page 30 dy SENSPEC 6 The V Spec Monitoring System VSMS Setting data output Tat E SENSPEC PHILIPS V Spec IntelliBridge mth Open LLI x ziy Link Ay interlace In the data output menu you can select how the output of measurement data via the serial RS232 interface C shall be done You have the option to choose between the SENSPEC V Spec V Spec Link protocol Glink and the PHILIPS a IntelliBridge PHILIPS IntelliBridge open interface protocol Open Interface The selected field is shown in gray Page 31 6 The V Spec Monitoring System VSMS dy SENSPEC POST and reset menu ING SYSTEMS SENSPEG SPECTRAL MONITOR In this submenu you have the option to display the POST screen s sec 6 6 1 Turning on the VSM again or reset the settings to factory settings Before you can actually reset the settings to factory settings a security query is shown Are you sure you want to reset to factory defaults Page 32 dy 5 FN S PEC 6 The V Spec Monitoring System VSMS Performing the settings reset wi
85. unctions and the respective status will be displayed e Green check mark w Test was successful e Redcheckmark 3 could not be verified or there is a problem In addition to the tests that the system can automatically perform further states are to be checked These tests relate to the audio system and the display and are to be performed by the user They are marked with a question mark Upon starting the VSM gives an audible signal If no signal tone is audible and or the display is not lit or not readable the VSMS is not functional and must not be put into operation If the Power on self test failed the message Power on self test not passed Error xxx appears where xxx represents an error code In this case the VSMS cannot be put into operation If the test was successful the message Power on self test passed appears the post screen is automatically closed and the V Spec Monitor is ready for operation D Caution If problems occur immediately contact the responsible service personnel 6 6 2 Medical measurement parameters The display area medical parameter 2 shows you the medical variables These are the e Oxygen saturation of the arterial blood SO in e Pulse rate PR in bpm Page 37 6 The V Spec Monitoring System VSMS dy S ENSPEC e Oxygen saturation of the tissue S02 in In addition to the values the current alarm limits and unit of measure will be displayed Note
86. value you want to change 1 Delete the current positions with the delete key 2 Enter the desired value e g 90 3 4 and confirm the input with the small confirmation field 5 The new limit is displayed updated If an invalid value is entered e g upper limit less than lower limit or limit outside of the adjustable range the value will be adjusted automatically Confirm the set limit values by pressing the confirm button 6 Page 39 6 The V Spec Monitoring System VSMS dy S EN S PEC Note Please note that not all set alarm limits are stored in a system reboot Detailed information can be found in the section 6 5 1 7 Storage of the user settings 6 6 3 Display area trend graphs Note Align the screen display so that you as a user in respecting the responsibility for the patient have the best overview of the required values for your application 6 6 3 1 Trend graphs The V Spec Monitor has a display area for the trend graphs 3 which you can customize It consists of the field G 1 6 2 and 6 3 The trend graphs are displayed with the same color as the corresponding parameters You can assign each field one of the medical and technical parameters by dragging the symbols G G G3 or 62 to the desired Page 40 dy SENSPEC 6 The V Spec Monitoring System VSMS field G G or 3 i A parameter can also be used in several fields parallel Below the edges of the trend graphs the time span

V-Spec™ Monitoring System Instruction Manual

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V-Spec™ Monitoring System Instruction Manual