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Specifications

A-6

Operator's Manual

A.3

Guidance and Manufacturer’s Declaration—Electromagnet-
ic Compatibility (EMC)



WARNING:
The INVOS™ system is intended for use by healthcare professionals only. The INVOS™ system may
cause radio interference or may disrupt the operation of nearby equipment, regardless of whether
it is CISPR compliant or not. It may be necessary to take mitigation measures, such as reorienting
or relocating the INVOS™ system or shielding the location.



WARNING:
The INVOS™ system should not be used adjacent to or stacked with other equipment, except as
may be specified elsewhere in this manual. If adjacent or stacked use is necessary, the INVOS™
system should be observed to verify normal operation in the configurations in which it will be
used.



WARNING:
The use of accessories, sensors, and cables other than those specified may result in poor
performance of the INVOS™ system and increased electromagnetic emissions or decreased
electromagnetic immunity of the INVOS™ system.



Caution:
The INVOS™ system is not intended for use in residential environments and may not provide
adequate protection to radio communication services in such environments.

The INVOS™ system is suitable for prescription use only in the specified electromagnetic environ-
ments, in accordance with the IEC 60601-1-2:2014 standard. The INVOS™ system requires special
precautions during installation and operation for electromagnetic compatibility. In particular, the
use of nearby mobile or portable communications equipment may influence system perfor-
mance.

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Содержание INVOS 5100C

Страница 1: ...Operator s Manual INVOS Regional Saturation Patient Monitoring System Model 5100C...

Страница 2: ...IDIEN COVIDIEN with logo and Covidien logo and Positive Results for Life are U S and internationally registered trademarks of Covidien AG brands are trade marks of their respective owners Other brands...

Страница 3: ...Warranty 1 11 1 8 1 Key Points 1 11 1 8 2 Limited Warranty and Disclaimer 1 11 1 8 3 Warranty Labor 1 12 1 8 4 Disclaimer of Consequential Damages 1 12 1 8 5 Failure of Product 1 13 1 8 6 Purpose of...

Страница 4: ...nsor Application 3 12 3 16 1 OxyAlert NIRSensor Preuse Check 3 12 3 16 2 OxyAlert NIRSensor Lot Number 3 13 3 16 3 OxyAlert NIRSensor Cerebral Site Selection 3 13 3 16 4 OxyAlert NIRSensor Somatic Sit...

Страница 5: ...olume 6 16 6 5 5 rSO2 Scale 6 18 6 5 6 Time Scale in User Configuration Menu 6 19 6 5 7 USB Storage Rate 6 20 6 5 8 Event Mark List 6 21 6 5 9 Data Channel Labels 6 22 6 5 10 Color Coded Data Channel...

Страница 6: ...n Saturation Right 8 3 8 3 Database Operational Mode Screens 8 3 8 3 1 Start Screen in Database Operational Mode 8 4 8 3 2 Main Screen in Database Operational Mode 8 6 8 3 3 Tabular Trends for Enterin...

Страница 7: ...ooting Chart 9 8 9 8 4 Troubleshooting the Digital Output 9 9 9 8 5 Troubleshooting Signal Strength Indicator SSI 9 9 A Specifications A 1 Overview A 1 A 2 Specifications A 1 A 2 1 Physical A 1 A 2 2...

Страница 8: ...vi Operator s Manual B Clinical Studies B 1 Overview B 1 B 2 Hypoxia Study B 1 B 3 Pediatric Clinical Study B 3 B 4 Interventional Studies B 4 B 5 Validation Studies B 5 C Glossary...

Страница 9: ...nt Mark List Screen Vascular Event Mark List 5 9 Figure 5 11 Event Mark List Screen NICU Event Mark List 5 10 Figure 5 12 Baseline Reset Screen 5 11 Figure 5 13 Channel Inactivity Screen 5 11 Figure 5...

Страница 10: ...7 Database Summary Screen Real Time Review Before Skin Closure 8 9 Figure 8 8 Database Summary Screen Real Time Review After Skin Closure 8 9 Figure 8 9 Database Summary Screen Case Archive Review 8 1...

Страница 11: ...rt Settings Using HyperTerminal 7 13 Table 9 1 Maintenance Schedule 9 4 Table 9 2 Electrical Inspection Points 9 5 Table 9 3 INVOS System Troubleshooting Chart 9 8 Table 9 4 Digital Output Troubleshoo...

Страница 12: ...Page Left Intentionally Blank x Operator s Manual...

Страница 13: ...copy Used in reference to the INVOS system Cerebral application for INVOS Brain area of measurement Pediatric application for INVOS Disposable INVOS pediatric regional saturation sensor has been desig...

Страница 14: ...upply and battery charge ON Caution consult accompanying documents Digital output Do not dispose in trash Use special collection Fuse Green LED indicates power ON HOME Potential equalization Preamplif...

Страница 15: ...2 Monitor 1 3 3 Other Symbols USB port VGA output port Alarm Baseline Battery Signal strength indicator Silence alarm Catalog number Follow instructions for use Consult instructions for use Authorize...

Страница 16: ...acturer Type BF equipment Dangerous voltage INMETRO certification CE Conformit Europ ene authorization mark 0123 T V S D Product Service GmbH notified body Prescription only US federal law restricts t...

Страница 17: ...PC or specified printer is used for data downloading and collection the deviceshouldbeincompliancewithIEC60601 MedicalElectricalEquipment StandardorIEC Non medical equipment in compliance with relevan...

Страница 18: ...ernally for any reason WARNING Fire hazard Do not block airflow to the back of the INVOS monitor WARNING The clinical value of trend data has not been demonstrated in disease states The INVOS system s...

Страница 19: ...ance may result WARNING Choking hazard The reusable sensor cables RSCs include a strain relief clip that if detached may pose a choking hazard WARNING As with all medical equipment carefully route pat...

Страница 20: ...eadings Cardiogreen Indigo Carmine Methylene Blue or other intravascular dyes Carboxyhemoglobin or other dyshemoglobins Hemoglobinopathies Conjugated hyperbilirubinemia direct Myoglobin Mb in muscle t...

Страница 21: ...th the warranty seal unless you have been authorized in writing by Covidien Repairs made by anyone not authorized by Covidien during the warranty period will void the product warranty 1 4 4 General No...

Страница 22: ...e immediately see section 9 8 Troubleshooting Techniques Caution Do not attempt to perform any service or tamper with the warranty seal unless you have been authorized in writing by Covidien Repairs m...

Страница 23: ...s must be prepaid and have a return materials authorization RMA number Certain software or hardware upgrades may be provided free of charge during the warranty period when units are returned to Covidi...

Страница 24: ...ly excludes disposable sensors accessory items and fuses 1 8 3 Warranty Labor If Covidien determines that the product is defective and that the claim was made within the war ranty period Covidien shal...

Страница 25: ...se of providing patients and physicians with information concerning regional oxygen changes in the brain and somatic tissue Accordingly Covidien makes no claim or warranty express or implied related t...

Страница 26: ...Introduction Page Left Intentionally Blank 1 14 Operator s Manual...

Страница 27: ...monitor of regional hemoglobin oxygen saturation of blood in the brain or in other tissue beneath the sensor in any individual 2 3 Contraindications None 2 4 Brief Device Description The INVOS system...

Страница 28: ...em for processing The sensors are designed for single use only and may not be reused Reuse of the sensors may cause inaccurate readings erratic readings or no readings at all Reuse will also cause an...

Страница 29: ...flects relative amounts of deoxyhemoglobin and total hemoglobin from which a regional oxygen saturation rSO2 value unique to the specific area under the sensor is calculated Values are measured contin...

Страница 30: ...Product Overview Page Left Intentionally Blank 2 4 Operator s Manual...

Страница 31: ...signs of damage or abuse during transit Carefully unpack the INVOS system and all accessories Verify the following pieces are present INVOS system monitor Preamplifier A channel 1 and 2 Reusable senso...

Страница 32: ...nitor the serial number format is YY 1XXXX where the YY 2 digits stands for year The pream plifier serial number appears on the back of the preamplifier For preamplifier A the serial number format is...

Страница 33: ...Back Connections and Elements 3 5 Digital Output Port This port provides real time every 5 6 seconds and stored every 30 seconds digital data com munications with other devices such as a PC Consult C...

Страница 34: ...monitor Cooling air enters through the vents in the back of the monitor and exhausts through the fan The fan does not require maintenance WARNING Fire hazard Do not block airflow to the back of the I...

Страница 35: ...ice Department for compatible products that meet these requirements REF number Description RSC 1 Reusable sensor cable channel 1 blue INVOS 5100C RSC 2 Reusable sensor cable channel 2 taupe INVOS 5100...

Страница 36: ...5100C SA Swivel arm INVOS 5100C 5100C GCX Mounting plate INVOS 5100C 5100C TC Travel case INVOS 5100C 5100C USB USB 2 0 flash drive hi speed INVOS 5100C 312170 Null modem cable for digital output INVO...

Страница 37: ...the red dot on the silver connector with the red dot on the side panel connection Insert the cable con nector into the side panel connection while keeping the dots aligned Be sure to fully insert the...

Страница 38: ...ings or no readings at all Caution Make sure that preamplifier A channel 1 and 2 is connected to the upper input and preamplifier B channel 3 and 4 is connected to the lower input To disconnect the pr...

Страница 39: ...aution Sensors do not need to be removed for x ray or CT scan However sensors will appear on image Sensors must be removed for MRI 3 15 1 Sensor Preuse Check WARNING The disposable INVOS adult regiona...

Страница 40: ...flective of tissue or no readings at all When two somatic site sensors are placed they must be connected into the preamplifier Sensor location is at the clinician s discretion pro vided it adheres to...

Страница 41: ...strain on the sensor to skin interface using strain relief clips Figure 3 5 Sensor Placement Caution To avoid pressure sores do not apply external pressure for example headbands wraps tape to the sen...

Страница 42: ...www fern dalelabs com 3M Remover Lotion 3M Health Care telephone 31 071 5450450 in the Netherlands 01 30 31 82 82 in France 02 9498 9333 in Australia 08705 360036 in the United Kingdom or www 3M com h...

Страница 43: ...tissue area of interest site selection will determine which body region is monitored Avoid placing the sensor over fatty deposits hair or bony protuberances Do not place the sensor over nevi hematoma...

Страница 44: ...every 24 hours or if the adhesive is inadequate to seal the sensor to the skin 3 16 7 Monitoring with the OxyAlert NIRSensor Note The OxyAlert NIRSensor is a disposable sensor with sensor cable that...

Страница 45: ...s Within the patient environment the level of safety equivalent to a medical system in compliance with IEC 60601 1 1 Outside the patient environment the level of safety equivalent to equipment complyi...

Страница 46: ...Installation Page Left Intentionally Blank 3 16 Operator s Manual...

Страница 47: ...and the battery is charging If the blue light is not on turn the back panel master mains power switch on 2 Connect the preamplifier or preamplifiers to the monitor Align the red dot on the preamplifie...

Страница 48: ...s 3 and 4 4 Attach the sensors to the reusable sensor cables Hold the connectors The sensor cable can be con nected to sensors before or after placement Different INVOS system sensors adult pediatric...

Страница 49: ...see section 3 12 Accessories 6 Check the location of all cables connected to the INVOS system Make sure that the patient is not lying on any cables or connectors To prevent entanglement and prolonged...

Страница 50: ...Quick Setup Page Left Intentionally Blank 4 4 Operator s Manual...

Страница 51: ...ser configuration Event mark list Baseline reset warning Channel inactivity warning RS 232 digital output format selection Tabular trends Case archive file list Review For more information about addit...

Страница 52: ...t the bottom of the screen and above the corre sponding menu key The operator selects the desired menu option by pressing the white menu keys or the HOME key on the key panel The INVOS system software...

Страница 53: ...tient data is restored and monitoring of the same patient con tinues Note The informational message RESTORING PATIENT DATA appears when selecting PREVIOUS PATIENT and there is a large amount of data t...

Страница 54: ...d files when using the Case archive function or AUC and Database operational mode Figure 5 3 Patient Identifier Screen 5 1 4 Main Screen The Main screen is composed of several elements These include r...

Страница 55: ...ents Two Channel Monitoring 1 Date time and operating status messages area 4 Battery symbol 2 Alarm messages and symbol area 5 Navigation bar menu options 3 Data channel area data channel label rSO2 v...

Страница 56: ...nnel indicator 4 Alarm status message 14 Time scale in hours selectable up to 24 hours 5 Alarm symbol 15 rSO2 trend high and low scale 6 Signal strength indicator 16 Menu options navigation bar 7 rSO2...

Страница 57: ...ing settings for parameters that the operator can change such as alarms and scales see section 6 5 Run Function Patient Monitoring inNormalMode Alarm messages channel identification and rSO2 area elem...

Страница 58: ...6 5 2 Event Mark There are four event mark lists to choose from OR ICU vascular and NICU White events reflect relatively routine occurrences These are listed in the order they typically occur during...

Страница 59: ...Overview Operator s Manual 5 9 Figure 5 9 Event Mark List Screen ICU Event Mark List Figure 5 10 Event Mark List Screen Vascular Event Mark List...

Страница 60: ...Screen NICU Event Mark List 5 1 7 Baseline Reset Screen The Baseline reset screen is displayed when the operator attempts to reset a baseline after the baseline has been previously set either manually...

Страница 61: ...erator s Manual 5 11 Figure 5 12 Baseline Reset Screen 5 1 8 Channel Inactivity Screen The Channel inactivity screen is displayed if all channels are inactive for 25 minutes Figure 5 13 Channel Inacti...

Страница 62: ...se history data output formats The operator should select Output Formats 1 3 based on the person al computer multi parameter monitor or data collection system interface software see section 7 5 Data O...

Страница 63: ...ections 6 5 Run Function Patient Monitoring in Normal Mode and 6 6 Case Archive Function Alarm messages channel identification and rSO2 area elements will continue to be displayed when operating in Ru...

Страница 64: ...le List Screen The Case archive file list screen allows the operator to select stored case history data files to review The Case archive file list screen is displayed in Case archive function see sect...

Страница 65: ...24 hours or mid night is reached a new case file will be started Stored case data files can be viewed on screen or downloaded see sections 6 5 16 Real Time Review 6 6 Case Archive Function 7 3 Using t...

Страница 66: ...data will be temporarily stored until the unit is turned off When the case memory is full the oldest line of data will be deleted to make room for newer line of data Figure 5 20 Trend Graph Screen Cas...

Страница 67: ...s of damage The preamplifier should be clean and show no signs of damage The pins of the reusable sensor cable connector should not be bent The sensor should show no signs of damage Check the location...

Страница 68: ...DATE Day Use the INCREASE or DECREASE options to adjust and change the day as necessary Press PRE VIOUS MENU again to return to the Start screen Clinical study mode The Clinical study mode also known...

Страница 69: ...ng menu options to change the TIME Hours Use the INCREASE or DECREASE options to adjust and change the hour as necessary Press PRE VIOUS MENU again to return to the Start screen NEW PATIENT PREVIOUS P...

Страница 70: ...ws the operator to locate stored data files with a unique alphanumeric identification when using the Case archive function or AUC and Database operational mode Entering Patient Identifier after Start...

Страница 71: ...SO2 trend monitoring Once INVOS system components are connected and the system is on select NEW PATIENT or PREVIOUS PATIENT The monitor displays the Patient identifier screen followed by the Main scre...

Страница 72: ...annel monitoring will resume when this configuration is selected and vice versa Note A type matic repeat function is active for navigation key menus that are repetitive for example Next It allows the...

Страница 73: ...esaturation threshold be set using the manual baseline feature Set Individual Channels to Current rSO2 Baseline Set Individual Channels to Current rSO2 Baseline Two Channel Monitoring To set an indivi...

Страница 74: ...ime corresponding to the previous day the manual set baseline is not displayed in the case history of the previous day The manually set baseline feature is used when previous rSO2 values are to be set...

Страница 75: ...trend graph at the marked time An event code will appear at that time in the line of tabular trends screen or stored and outputted data There are four event mark lists to choose from OR ICU vascular a...

Страница 76: ...listed in the order they typically occur during a case Yellow events mark events clinicians may consider cautionary because they could cause ischemia These are listed alphabetically Green events mark...

Страница 77: ...rences These are listed in the order they typically occur Yellow events mark events clinicians may consider cautionary because they could cause ischemia These are listed alphabetically Green events ma...

Страница 78: ...sted in the order they typically occur during a case Yellow events mark events clinicians may consider cautionary because they could cause ischemia These are listed alphabetically Green events mark in...

Страница 79: ...alarm limits to extreme values that can render the INVOS system ineffective Ensure alarm limits are appropriate for each patient Alarm limits can be set and adjusted in the User configuration menu Not...

Страница 80: ...arm limit is displayed numerical and graphical The upper alarm limits may be turned on or off according to operator preference The default setting is OFF To disable the visual and audible UPPER ALARM...

Страница 81: ...electing a new patient are set to default 40 prior to baseline capture Note If the variance value or values are changed for a channel subsequent to setting the baseline the lower alarm limit for the c...

Страница 82: ...finished press the HOME key to exit the User configuration menu and return to the Main screen Alarm Audio Off Reminder When this feature is enabled the monitor emits a beep longer than the low priorit...

Страница 83: ...Run Function Patient Monitoring in Normal Mode Operator s Manual 6 17 3 Press key 3 five times The indication changes to ALARM OFF REMINDER ON...

Страница 84: ...ication changes to ALARM OFF REMINDER OFF 4 Press the HOME key to save changes Absent further changes the setting is retained until the monitor is turned off 6 5 5 rSO2 Scale To change the rSO2 value...

Страница 85: ...n bar options In the User configuration menu select NEXT to scroll to LOWER rSO2 SCALE Select the INCREASE and DECREASE options to adjust the scale When finished press the HOME key to exit the User co...

Страница 86: ...USB Storage Rate Note The USB flash drive should be inserted when the case begins to capture real time data to the USB Keep the USB flash drive inserted for the full duration of the case If removed t...

Страница 87: ...ark list vascular event mark list or NICU event mark list may be set for the user to mark events during the case To determine which event mark list appears in Run function press the HOME key to displa...

Страница 88: ...s appear to the left of the real time rSO2 value 6 5 10 Color Coded Data Channel Labels Note For quicker access to parameters on page 2 of the User configuration menu select PREVIOUS to wrap around fr...

Страница 89: ...oring Previous settings for two channel monitoring will resume when this configuration is selected and vice versa Note For quicker access to parameters on page 2 of the User configuration menu select...

Страница 90: ...select PREVIOUS to wrap around from the top to bottom of page 1 then select NEXT to access page 2 Restore defaults affects the following settings rSO2 alarm limit and alarm volume settings Upper alarm...

Страница 91: ...visual and audible Alarm messages and tones alert the INVOS system operator of a condition in the patient or the INVOS system requiring attention Upon alarm the operator should check the patient s co...

Страница 92: ...nd condition of the battery there is no additional delay once the condition is detected Physiological Alarms Physiological alarm conditions arise from a change in the patient s condition Upon an alarm...

Страница 93: ...see section A 2 6 Alarm Tone Definitions The alarm is nonlatching that is if the condition passes the alarm will automat ically reset see section 6 5 4 Alarm Volume During a physiological alarm condi...

Страница 94: ...e the interference or move the sensor Replace sensor both adult and infant neonatal sensors are connected or sensor is damaged or defec tive make sure that only sensors appropriate for the patient are...

Страница 95: ...um priority alarm condition is present the monitor issues a medium priority alarm tone The alarm tone is a burst of three short beeps on the same pitch repeated at 9 second intervals until the alarm c...

Страница 96: ...d Table 6 5 Status Messages rSO2 Value Displayed Status message Status code Color location Cause Action ALARM HIGH accompa nied by alarm tone 5 Red top right corre sponding rSO2 value is red Upper ala...

Страница 97: ...too much outside light No rSO2 will appear Check the connection to patient andreplacesensor ifnecessary If the sensor is properly adhered to the patient try loosely draping the sensor POOR SIGNAL QUA...

Страница 98: ...e disturbances from secondary sources influences in the monitor s envi ronment The SSI scale ranges from one to five bars with five bars being the highest Generally the SSI symbol will read five bars...

Страница 99: ...ator to review the most recent 24 hours of stored data trends and event marks on the monitor The data may be displayed in graphical trend data graph or tabular trend screen format The stored trending...

Страница 100: ...e Real time review in tabular trends screen format press the HOME key to display the Main screen then perform the following navigation bar options Select NEXT PAGE PREVIOUS PAGE and LAST PAGE to scrol...

Страница 101: ...ate rSO2 desaturations of 20 or values 40 see section Data File Name Format 6 6 1 Case Archive Function Graphical Format Note More than 1 hour of data must be stored to scroll in Case archive function...

Страница 102: ...on in Tabular trends screen format press the ON OFF key to display the Start screen then perform the following navigation bar options Select NEXT PAGE PREVIOUS PAGE and LAST PAGE to scroll through the...

Страница 103: ...data outputting download functions WARNING AccessoriesnotsuppliedbyCovidienmaynotmeetIEC60601 1standards ContacttheCovidien customer service department for compatible products that meet these requirem...

Страница 104: ...pin out left Monitor cable male connector pin out right Table 7 1 VGA Video Connector Pin Out Descriptions Pin Signal name Pin Signal name 1 Red 9 No connect 2 Green 10 Ground 3 Blue 11 No connect 4 N...

Страница 105: ...e should be inserted when the case begins to capture real time data to the USB Keep the USB flash drive inserted for the full duration of the case If removed there will be gaps in the case data collec...

Страница 106: ...ve file list press the ON OFF key to display the Start screen then perform the following navigation bar options All files except EXAMPLE 1 and EXAMPLE 2 will be transferred to the USB flash drive in a...

Страница 107: ...to the Start screen Delete All Case Archive Files from USB Flash Drive To access Case archive function and delete all files on the USB flash drive press the ON OFF key to display the Start screen then...

Страница 108: ...utting to the USB flash drive automatically at the user selected USB storage rate see section 6 5 7 USB Storage Rate Up to 24 hours of data may be stored per case file When data storage exceeds 24 hou...

Страница 109: ...through this port is either real time case history or Database summary menu data Digital output port interfacing is described in this section using a VueLink Open Interface module and the HyperTermin...

Страница 110: ...ator should not rely upon the distributed alarm system for generating alarms In Run function the digital output port may be set to output real time data to communicate with a Philips VueLink Open Inte...

Страница 111: ...s on the remote monitor making sure the VOI B locks into place 2 Connect the VOI RS 232 interface cable to the VOI B module 3 Connect the DB 25 plug of the VueLink adapter cable to the VOI RS 232 inte...

Страница 112: ...steps to configure the remote monitor include the following 1 Press the MONITOR SETUP key on the front panel 2 Press the OPERATING MODES soft key 3 After entering the correct password press the CHANGE...

Страница 113: ...uter PC with a terminal emulator program via a 9 pin to 9 pin null modem cable One such terminal emulator program is HyperTerminal available in some Window operating systems This section describes usi...

Страница 114: ...n in Figure 7 3 are acceptable HyperTerminal Settings 1 Open HyperTerminal To locate the HyperTerminal program on the PC select Start All Pro grams Accessories Communications HyperTerminal 2 Create an...

Страница 115: ...w enter the file name and directory to save the file 3 Select START 4 On the INVOS system select operating mode and data output format see below 5 On the PC when monitoring is complete select CALL DIS...

Страница 116: ...Monitoring will resume when the outputting function is complete Up to 24 hours of data may be stored per case history file In Case Archive Function Case History Data Output To access Case archive fun...

Страница 117: ...tes a desatura tion of 20 from baseline or 40 rSO2 values occurred during the case Up to 24 hours of data may be stored per case file When data storage exceeds 24 hours or mid night is reached a new c...

Страница 118: ...3 Insert an empty row at the top of the data by selecting Row from the Insert menu Enter the column headings in row 1 4 Select CTRL PC or Command Mac on the keyboard and select or highlight the time c...

Страница 119: ...cept the auto baseline value when prompted by the device approximately 5 minutes after monitoring begins Baselines should not be reentered at any othertimeortheintegrityofAUCwillbecompromised Similarl...

Страница 120: ...ration rSO2 values at the beginning of the operation when the patient is awake and functional Patient can be sedated or on supplemental oxygen at the time measurement is taken In the absence of a user...

Страница 121: ...could potentially lead to an adverse patient outcome 8 2 6 Field Name Skin Closure Regional Oxygen Saturation Left Format Integer Valid Data 1 99 Definition Indicates the left cerebral regional oxyge...

Страница 122: ...rational Mode The Start screen displays the software version date time and operator selectable navigation bar The INVOS system software version appears where XX XX XX is shown in Figure 8 1 and Figure...

Страница 123: ...Database Operational Mode Screens Operator s Manual 8 5 Figure 8 2 Four Channel Start Screen in Database Operational Mode...

Страница 124: ...de 1 Date and time 10 Datachannellabel forexample L leftcerebral R right cerebral S somatic 2 Adult pediatric or neonatal indication for sensor model 11 Event mark line and numerical code 3 Trend data...

Страница 125: ...1 Alarm messages channel identification and rSO2 area elements will continue to be displayed Figure 8 4 Tabular Trends for Entering Induction Time Screen 8 3 4 Tabular Trends for Entering Skin Closure...

Страница 126: ...e Database summary screen displays the database metrics in a summary menu format see Fig ure 8 6 Figure 8 7 Figure 8 8 Figure 8 9 and section 8 6 Collecting Metrics in Database Opera tional Mode Alarm...

Страница 127: ...Database Operational Mode Screens Operator s Manual 8 9 Figure 8 7 Database Summary Screen Real Time Review Before Skin Closure Figure 8 8 Database Summary Screen Real Time Review After Skin Closure...

Страница 128: ...e the area of the curve below 75 of baseline and continuously update the AUC as a cumulative variable in the memory For AUC to also display on the screen an induction time must be set after the baseli...

Страница 129: ...es prior to induction in real time or accept the auto baseline value when prompted by the device approximately 5 minutes after monitoring begins Baselines should not be reentered at any other time or...

Страница 130: ...e set for all channels in use at once individually for the selected channel or chan nels or automatically to an rSO2 value 5 6 minutes after an rSO2 value is obtained Set Current rSO2 as Baseline for...

Страница 131: ...E LINE SET PLEASE ACCEPT OR SET NEW BASELINES message in yellow see Figure 8 6 Perform the following navigation bar options Select ACCEPT AUTO BASELINES if the automatic baseline time is appropriate f...

Страница 132: ...d SELECT to input the high lighted character When entry is complete select DONE in the Patient identifier entry screen to save the unique alphanumeric identification and return to the Main screen Up t...

Страница 133: ...Time in the OREventList To select an earlier time use the Database summary screen see section Markingthe Induction Time Using Tabular Data Marking the Induction Time Using Tabular Data To mark the ind...

Страница 134: ...uction Select SELECT EVENT to choose the highlighted event code and return to the trend data graph A vertical dashed line and event code will appear on the Main screen at the induction time and the AU...

Страница 135: ...the Current Time as Skin Closure Time in the OR Event List To mark the skin closure event press the HOME key to display the Main screen then perform the following navigation bar options From the even...

Страница 136: ...s have been entered 1 Baseline see section Mark a Baseline at the End of a Case 2 Induction time see section Marking the Induction Time Using Tabular Data 3 Skin closure see section Marking the Skin C...

Страница 137: ...will be started Stored case data files can be viewed on screen real time review or downloaded case archive in the Database operational mode 8 7 1 Real Time Review of Database Information At any time...

Страница 138: ...at Note Alarm messages channel identification and rSO2 area elements will continue to be displayed while in real time review To use real time review in Tabular trends screen format press the HOME key...

Страница 139: ...les with an asterisk next to them indicate rSO2 desaturations of 20 or values 40 see section Data File Name Format Case Archive Function Database Summary Note More than 1 hour of data must be stored t...

Страница 140: ...B Flash Drive During a Case or Prior to Next Patient Note USB flash drives not supplied by Covidien may not meet system requirements Additional drives may be ordered from Covidien see section 3 12 Acc...

Страница 141: ...reen then perform the following navigation bar options Select TO USB to download the Database summary screen When outputting during a case a message in yellow may be displayed in the upper area to ale...

Страница 142: ...Database Operational Mode and Area Under the Curve Page Left Intentionally Blank 8 24 Operator s Manual...

Страница 143: ...calibration is not required 9 2 Software Upgrades Software upgrades are performed using a USB flash drive supplied by Covidien To inquire about software upgrades contact Covidien s customer service d...

Страница 144: ...kup battery is not user replaceable The battery charges itself while the INVOS system is connected to AC power It acts as a backup for data storage power outages and patient transport The battery has...

Страница 145: ...er switch off A battery symbol gauge should appear in the lower right side of the display screen indicating the battery status If the symbol shows a full battery there is no need for battery charging...

Страница 146: ...ck the INVOS system see section 9 7 Annual Inspection Procedure After 5 years Replace the backup battery The battery is not user replaceable See section 1 8 8 WhotoContact for Authorized Repair After...

Страница 147: ...observe that the monitor continues to run and that the battery capacity indicator on the screen shows a full charge The monitor should operate for about 20 minutes on a fully charged battery Unit self...

Страница 148: ...ee Figure 3 2 3 Connect the optional field test device to the preamplifier 4 Turn the mains power switch ON Observe the illuminated blue LED on the key panel 5 Turn the INVOS system on by pressing the...

Страница 149: ...www covidien com or via an authorized repair representative see section 1 8 8 Who to Contact for Authorized Repair 9 8 2 Check Fuses Above the mains power switch is the external access fuse compartme...

Страница 150: ...into a hospital grade electrical outlet Turn on the back panel AC power switch Monitor turns off Defective battery Service the INVOS system 1 Blown fuse on internal module Service the INVOS system 1 D...

Страница 151: ...values on screen may soon cease if the signal continues to degrade Similarly bars fluctuating rapidly between five through one bar rather than appearing stable may also reflect a signal that could soo...

Страница 152: ...fer ence such as electrocautery or similar elec trical equipment interferences intense light or radiation sources moving artifacts or perturbations on the mains Sensor application over nevi sinus cavi...

Страница 153: ...eight 4 95 kg 10 9 lbs 0 52 kg 1 2 lbs Preamplifier cable length 4 5 m 15 ft Reusable sensor cable length INVOS adult regional saturation sensor or pediatric regional saturation sensor 1 5 m 5 ft INVO...

Страница 154: ...AC Frequency 50 60 Hz Current 1 0 A 0 5 A maximum at 100 and 240 volts respectively Fuse F2 5 A 250V Backup battery 12 VDC approximately 20 minutes Digital output RS 232 communications USP port USB 2...

Страница 155: ...priority physiological alarm overrides a low priority alarm Table A 5 Alarm Conditions Priority Rate Color Type Messages Medium Sounds every 8 seconds while the alarm condi tion persists Yellow Steady...

Страница 156: ...olume 34 dB low volume Pitch 5 Hz 720 Hz Pulse width 20 msec 187 msec Number of pulses in burst 1 Repetitions Continually every 16 seconds while visual alarm is presented Interburst interval Approxima...

Страница 157: ...fetime is indefinite when used under specified operating conditions and preven tive maintenance is performed subject to component availability This product is designed to comply with the Waste Electri...

Страница 158: ...ould be observed to verify normal operation in the configurations in which it will be used WARNING The use of accessories sensors and cables other than those specified may result in poor performance o...

Страница 159: ...nt RF emissions CISPR 11 Class A The INVOS system is suitable for use in all establishments other than domestic and those directly connected to the publiclow voltagepowernetworkthatsuppliesbuildings u...

Страница 160: ...At 80 MHz and 800 MHz the higher frequency range applies Voltage dips short interrup tions and voltage variations on power supply input lines IEC EN 61000 4 11 Note UT is the AC mains voltage prior t...

Страница 161: ...etic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the mea sured field strength in the location in which the INVOS system is used exceeds the applicab...

Страница 162: ...a diagram of the INVOS system This diagram can also be used when trouble shooting see section 9 8 Troubleshooting Techniques Figure A 1 Diagram of INVOS System Model 5100C 1 Monitor 18 Main power supp...

Страница 163: ...PU 24 Sensor 2 8 Data memory 25 RSC3 orange 3 9 Program memory 26 Sensor 3 10 Data processing module 27 RSC4 green 4 11 Data acquisition module and digital interface 28 Sensor 4 12 USB interface 29 Fa...

Страница 164: ...Specifications Page Left Intentionally Blank A 12 Operator s Manual...

Страница 165: ...eported by the INVOS system to the field satura tion fSO2 calculated from arterial and jugular venous blood oxygen saturation measurements at five levels of oxygen saturation and two levels of inspire...

Страница 166: ...as data was excluded from the analysis due to the low signal quality but the trend data was left in as trending is not dependent on SQI Transitions 96 and 97 data last 20 subjects 179 data points y 0...

Страница 167: ...as successfully collected and used in the study Of these sub jects 14 were male and all had light skin Mean age was 103 months range 15 months to 34 years Methods A minimum of five blood samples was o...

Страница 168: ...89 3A A934 3 Samra S Dy E Welch K Dorje P Zelenock G Stanley J Evaluation of a cerebral oximeter as a monitor of cerebral ischemia during carotid endarterectomy Anesthesiology 2000 93 964 70 4 Murkin...

Страница 169: ...t Surgery Forum 2004 7 6 515 10 Yao FSF Tseng CCA Ho CYA Levin SK Illner P Cerebral oxygen desaturation is associated with early postoperative neuropsychological dysfunction in patients undergoing car...

Страница 170: ...Clinical Studies Page Left Intentionally Blank B 6 Operator s Manual...

Страница 171: ...ration that rSO2 is below the threshold Values are accumu lated throughout the operation Units are minute percent Authorized repair representative Those trained individuals authorized by Covidien to s...

Страница 172: ...tor The parameters are adjustable within established limits DIB board The digital interface board DIB controls communication between the preamplifier connection and the CPU board Distributes power to...

Страница 173: ...rt NIRSensor A disposable nonsterile sensor with cable applied to patients and used for transmitting and receiving light INVOS pediatric regional saturation sensor The INVOS pediatric regional saturat...

Страница 174: ...saturation levels and status Representative Any of various persons companies authorized to represent the INVOS system in conjunction with agreements between the manufacturer and the representative Reu...

Страница 175: ...ENSOR T Tabular trends Data generated by the INVOS system and displayed chronologically this data may be printed out for further review Time plotting scale Refers to hours viewed x axis plotted on the...

Страница 176: ...Glossary Page Left Intentionally Blank C 6 Operator s Manual...

Страница 177: ......

Страница 178: ...tionally registeredtrademarksofCovidienAG brandsaretrademarksoftheirrespectiveowners Otherbrandsare trademarks of a Covidien company 2013 Covidien All rights reserved Covidien llc 15 Hampshire Street...

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