Invivo Essential 865353 Instructions For Use Manual Download

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*989803173791*

989803173791

Essential

MRI Patient Monitor

(

Model 865353

)

Instructions for Use

989803173791 Rev 0.6

English

Summary of Contents for Essential 865353

Page 1: ...989803173791 989803173791 Essential MRI Patient Monitor Model 865353 Instructions for Use 989803173791 Rev 0 6 English...

Page 2: ...2 989803173791 Rev 0 6...

Page 3: ...ding to the type of protection against electrical shock Class I equipment According to the degree of protection against electrical shock Type CF defibrillator proof equipment According to the degree o...

Page 4: ...curacy of this document However Invivo assumes no liability for errors or omissions and reserves the right to make changes without further notice to any products herein to improve reliability function...

Page 5: ...eries in Europe 10 Disposing of Batteries in the United States 10 List of Symbols 11 Unpacking the System 14 Examining the Contents 14 Accessories 14 Carry Case 14 Mount Adapter 15 Roll Stand 16 Chapt...

Page 6: ...odule 54 Measuring SpO2 55 Waveform and Vital Sign Information 55 No Data Available Indication 56 Assessing Suspicious SpO2 Readings 57 Perfusion Index Value 57 Managing Alarms 58 Alarm Types Prioriti...

Page 7: ...Appendix B Warranty Warranty Statement 81 Appendix C Regulatory Information European Union 83 Declaration of Conformity 83 Authorized Representative 83 Appendix D Guidelines and References Guidelines...

Page 8: ...iv Contents 989803173791 Rev 0 6...

Page 9: ...its parts must not be repaired other than in accordance with written instructions provided by the manufacturer The device shall not be altered without written approval of Invivo The user has the sole...

Page 10: ...ssential MRI Patient Monitor Model 865353 uses certain conventions throughout the interface to make it easy for you to learn and use This accompanying user information also uses document conventions t...

Page 11: ...as they appear on the system Select means to touch or tap lightly with a finger or stylus within the boundaries of a control item on the display panel The left side of the system is on your left as yo...

Page 12: ...ect SpO2 Grip Infant 20 box 989803166571 Quick Connect SpO2 Grip Neonatal 20 box 989803166581 Quick Connect SpO2 Grip Pediatric 20 box 989803166561 Quick Connect SpO2 Grip Starter Pack 989803167111 Qu...

Page 13: ...nish 989803173931 Information for Use Manual French 989803173941 Information for Use Manual German 989803173951 Information for Use Manual Greek 989803173961 Information for Use Manual Hungarian 98980...

Page 14: ...e use of accessories and components other than those specified in the Accessories list accompanying these instructions for use with the exception of items sold by Invivo for the equipment or system as...

Page 15: ...customer or the user of the Essential MRI Patient Monitor Model 865353 should assure that it is used in such an environment RF Emissions CISPR 11 Group 1 The system uses RF energy only for its interna...

Page 16: ...smitter output power rating in watts W according to its manu facturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromag...

Page 17: ...to 800 MHz d 3 5 E1 800 MHz to 2 5 GHz d 7 E1 The Essential MRI Patient Monitor Model 865353 is intended for use in the electromagnetic environment specified below The customer or the user of the Ess...

Page 18: ...distributor Disposing of Batteries in the United States Lithium batteries are neither specifically listed nor exempted from the Federal Environmental Protection Agency EPA hazardous waste regulations...

Page 19: ...tional Use in the MR environment is restricted to certain conditions of use to ensure patient and operator safety Non ionizing radiation Not MR safe Power on off Percent oxygen pulse saturation Produc...

Page 20: ...strictions for equipment including radios may apply within one or more European EU member states Dangerous voltage Type CF applied part Patient Main battery gauge Module battery gauge No Battery Commu...

Page 21: ...United States and Canada Federal Communications Commission Dispose of the battery in accordance with your country s requirements Dispose of electrical equipment in accordance with your country s requ...

Page 22: ...must be used and stored according to the environmental specifications in Appendix A Failure to follow these specifications may affect system accuracy Examining the Contents The system includes these...

Page 23: ...o the MRI system room Ensure that the alarm tone is audible when operating the monitor using the carry case Use caution when operating the monitor using the carry case as the alarm light will not be v...

Page 24: ...le Step Action 1 Align the pins Item 1 of the mount adapter to the locator holes in the base of the monitor 2 Insert the Thumbscrew Item 2 into the base of the monitor then tighten to secure the monit...

Page 25: ...iable patient monitoring performance in the dynamic MRI environment The Essential MRI Patient Monitor Model 865353 can be configured accessed and adjusted for the unique vital needs conditions and sit...

Page 26: ...n usual the battery life is at an end Immediately remove a battery that has an expired life cycle and replace it with a new Invivo specified battery refer to Battery Disposal in Chapter 1 when discard...

Page 27: ...main battery follow these steps Step Action 1 Place the cover over the DC inlet on the main battery 2 Lower the main battery into the battery compartment then pivot it into place as shown below 3 Sli...

Page 28: ...to the wireless module Installing the module battery To install the module battery slide the battery in between the slots on the module until both locking tabs latch Step Action 1 Slide the locking ta...

Page 29: ...in and module batteries while the external power adapter supplies the appropriate DC input NOTE Before initial use place the main battery on the charger for at least 5 seconds as the battery is shippe...

Page 30: ...on 1 Press the power switch for at least 1 second to turn off the monitor 2 Remove the main battery see Removing the main battery above 3 Remove the module battery see Removing the module battery abov...

Page 31: ...power is applied Green DC power is connected None No power is connected or an error was detected Ensure that the power adapter is properly connected to the AC outlet 9 Allow both batteries to fully ch...

Page 32: ...ume of up to 85 dB see Sound Menu in Chapter 3 for details 4 Alarm light Provides a 360 degree visual alert for alarm conditions glowing yellow or red depending upon the condition detected see Managin...

Page 33: ...link which is automatically established upon monitor power up The wireless network can be changed as needed to comply with the requirements of your operating environment but should always 1 Network se...

Page 34: ...the overlay in the front upper left corner of the device A slight bump can be felt when you pass a finger over the button When selecting a network for the module place the module on a flat steady surf...

Page 35: ...Identify the network setting of the monitor as indicated by the network button 2 Remove the module battery from the module see Module Battery above 3 Install the module battery The network icons will...

Page 36: ...econds after the module has been turned on a network change will not be allowed You must cycle module power and restart the sequence 5 Changing the network press the button again until the icon stops...

Page 37: ...e new network setting is saved Once illuminated release the button The module will begin using the selected network WARNING If the message box WARNING Multiple wireless modules detected on network is...

Page 38: ...It can take up to 30 seconds until the boot up process has finished and the monitor becomes ready In the Language menu select a display language by touching a corresponding Language button see Navigat...

Page 39: ...Gray gauge and time Battery power OK time remaining field indicates approximate remaining charge in hours and minutes Flashing yellow gauge and time Low battery power 45 minutes or less power remainin...

Page 40: ...me Battery power OK time remaining field indicates approximate remaining charge in hours and minutes and good communications Flashing yellow battery gauge and time Low battery power 45 minutes or less...

Page 41: ...alarm limit indicator 10 SpO2 vital sign numeric 11 SpO2 low alarm limit indicator 12 Heart rate HR parameter identifier in beats per minute 13 Heart rate high alarm limit indicator 14 Heart rate vita...

Page 42: ...e see Service Menu in Chapter 3 for details 7 Patient category button Indicates and allows changes to the patient category see Patient Menu in Chapter 3 for details 8 Parameter identifier Indicates th...

Page 43: ...No Battery Communications symbol if communications are not established or have been lost between the monitor and the main battery 20 Module battery indicators Displays the remaining module battery po...

Page 44: ...36 Chapter 2 Getting Started 989803173791 Rev 0 6...

Page 45: ...ons will occur in the presence of high powered radios Using the Monitor Observe all warnings and cautions when using the Essential MRI Patient Monitor Model 865353 Warning WARNING Keep the Essential d...

Page 46: ...tylus will cause the system to produce a touch tone and open that menu or select that option setting or value Note that simultaneously touching two or more areas of the screen may produce unpredictabl...

Page 47: ...inaccessible as denoted by the Screen Locked message which will appear for about 2 5 seconds after a button or indicator is touched To restore operation to a locked screen press and hold the Unlock Sc...

Page 48: ...ccasions when a particular patient category is not suitable for its apparent categorization based only on age In these cases a clinical decision shall be made to use another patient category or measur...

Page 49: ...ric Allows you to set the monitoring functions for pediatric patients Neonatal Allows you to set the monitoring functions for neonatal patients Setup Menu The Setup menu options configure the alarm li...

Page 50: ...ss the Service menu see below Service Menu The Service menu allows you to examine the status of the hardware and software revision levels and to set the language displayed by the monitor Other options...

Page 51: ...mode Do not attach a patient to the system when in simulation mode and do not activate simulation mode when a patient is connected to the system The system will not monitor patients while in the simul...

Page 52: ...em s network setting Operating multiple systems on the same network or with an incorrect network setting will interfere with communications and incorrect patient vital signs information may be obtaine...

Page 53: ...system communications for wireless network D compatibility with an Expression MRI Patient Monitor and module Model 865214 Network E Allows you to set system communications for wireless network E comp...

Page 54: ...ic alarm limit indicator for direct access to that setting or Touching the Setup button and then Alarm Limits The following options are available SpO2 Alarm Limits buttons Indicates the current settin...

Page 55: ...alarm limits where touching it opens the Alarm Limits menu HR vital sign numeric Indicates the heart rate vital sign of the patient given in beats per minute and allows you to change to the heart rate...

Page 56: ...button then make that change otherwise proceed to Step 2 2 Touch the Alarms button 3 Touch the high or the low Alarm Limits button for the parameter The touch tone will sound and the button will be h...

Page 57: ...ets the volume range is 1 5 of the tone generated during an alarm condition where touching the decrement button left lowers the volume or touching the increment right button increases the volume 6 Tou...

Page 58: ...audible alarm system for patent monitoring Adjustment of the alarm volume to a low level during patient monitoring may result in patient danger Remember the most reliable method of patient monitoring...

Page 59: ...ic value for the pulsatile portion of the measured signal caused by arterial pulsation SpO2 Sensor and Wireless SpO2 Module The SpO2 sensor and wireless SpO2 WSpO2 module may be used in the MR system...

Page 60: ...arm functions 2 Connect a SpO2 sensor to the module 3 Connect the attachment clip or grip to the SpO2 sensor 4 Check the status indicator on the module to verify sufficient power and good communicatio...

Page 61: ...n apply unintended pressure to the sensor site easily EXTREMITIES TO AVOID Avoid placing the sensor on extremities with an arterial catheter intravascular venous infusion line or inflated blood pressu...

Page 62: ...keep the wireless module outside the FOV Place the WSpO2 module as close as possible to the bore opening If the module can be placed outside the bore positioning at the iso center is not necessary Pla...

Page 63: ...oximeter to understand the patient s condition completely Waveform and Vital Sign Information The waveform and vital sign numeric data provides important physiological information as detailed in the...

Page 64: ...module and the monitor and that the communication between the devices is good Item Number Explanation 1 The SpO2 pleth pulsatile waveform updated from left to right across the display panel If the pu...

Page 65: ...hemoglobin intravascular dyes presence of dyes or pigments at the application site and inappropriate positioning of the pulse oximeter probe If questionable readings are obtained check the patient s...

Page 66: ...medium priority status by the system according to the type of violation physiological or technical NOTES High priority alarms sound levels range from at least 53dB a minimum volume setting to 84dB max...

Page 67: ...numeric exceeds the highest value that can be displayed OVR will be indicated in the parameter numeric g The numeric stops flashing after the parameter returns to within its alarm limits h The displa...

Page 68: ...lashes yellow see illustration below b The medium priority alarm tone sounds at a low pitch 3 pulse tones followed by a 10 second delay repeating c Messages are displayed in yellow except for low batt...

Page 69: ...nt before administering interventions Failure to do so may result in inappropriate intervention Once the numeric has exceeded the alarm limit the delay to announcing the alarm condition is less than 1...

Page 70: ...an be displayed by the system during operation and provides meanings probable causes and recommended actions if needed for problem resolutions If the message persists after performing the recommended...

Page 71: ...obe is connected The SpO2 probe is not connected or is not properly connected to the module Check the connection of the probe to the WSpO2 module If connection appears sound try another probe NON PULS...

Page 72: ...applied If the probe was just applied give the system time usually less than 20 seconds to lock onto a good pulse otherwise check the probe position and re position WRONG PROBE The system has detected...

Page 73: ...larm limit settings do not transfer between monitoring systems and may be different so always ensure correct alarm limit settings when using multiple monitoring systems All SpO2 modules must be on dif...

Page 74: ...o MRI monitors NOTE The network settings and groupings used below are given as examples only your selections may differ However the network conventions A E or 1 5 as well as the grouping of the settin...

Page 75: ...through the control room window 8 Transport the patient with the Essential and the WSpO2 module into the MR recovery room 9 Transition the patient into the MR recovery room to bedside monitoring if n...

Page 76: ...recess will begin monitoring SpO2 automatically and you can turn off the Essential 8 Scan the patient using the Expression or Precess in the control room 9 Turn on the Essential to monitor SpO2 The Es...

Page 77: ...disable the alarm functions 9 From the new patient in the MR system room disconnect the sensor from the SpO2 Quick Connect attachment grip NOTE Touch the Alarms Pause button to temporarily disable th...

Page 78: ...and the ECG module All are set to network 2 4 Verify sufficient power and good communications The ECG module cannot not be checked at this point 5 Apply the SpO2 sensor and the ECG leads to the new pa...

Page 79: ...he alarm functions 12 Verify sufficient power and good communications for the WSpO2 module The ECG module will not be used and cannot not be checked at this point 13 Transport the current patient with...

Page 80: ...72 Chapter 5 Workflow 989803173791 Rev 0 6...

Page 81: ...ealth Service Centers for Disease Control February 1989 Also refer to any policies that apply within your facility and country Cleaning the System The Essential MRI Patient Monitor Model 865353 cannot...

Page 82: ...essory in any cleaning fluid To clean reusable accessories such as SpO2 sensors and grips complete the following steps CAUTION Disinfect the accessory as determined by your facility s policy Step Acti...

Page 83: ...r of Invivo patient monitoring systems Only replace damaged parts with components manufactured or sold by Invivo Philips Contact the Technical Service and Repair Center for technical assistance and se...

Page 84: ...76 Chapter 6 Maintenance and Repair 989803173791 Rev 0 6...

Page 85: ...ements for the Basic Safety and Essential Performance of Pulse Oximeter Equipment for Medical use Where appropriate the equipment complies to worldwide standards for safety and performance of each sys...

Page 86: ...d Parameters Alarms High and low limit selectable Heart Rate Derived from SpO2 Pulse Oximeter Heart rate pulse waveform percent saturation and perfusion index Pulse Oximeter Pitch of pulse tone is mod...

Page 87: ...o assess the accuracy of a pulse oximeter monitor however it can be used to demonstrate that a particular pulse oximeter monitor reproduces a calibration curve that has been independently demonstrated...

Page 88: ...80 Appendix A Specifications 989803173791 Rev 0 6...

Page 89: ...or if the product has been subject to misuse accident negligence or abuse Invivo s sole obligation under this warranty is limited to repairing a system which has been reported to Invivo s Technical S...

Page 90: ...82 Appendix B Warranty 989803173791 Rev 0 6...

Page 91: ...io Telecommunications Terminal Equipment Directive 1995 5 EC contact the Regulatory Affairs Department of Invivo 407 275 3220 1 800 331 3220 Toll free Internationally please contact your Invivo sales...

Page 92: ...84 Appendix C Regulatory Information 989803173791 Rev 0 6...

Page 93: ...first second and third degree burns that were experienced by patients In many of these cases the reports indicated that the limbs or other body parts of the patients were in direct contact with body r...

Page 94: ...lly conductive materials e g bone fusion stimulators neurostimulation systems etc 6 Before using electrical equipment check the integrity of the insulation and or housing of all components including s...

Page 95: ...ze such a failure as a set of concentric semicircles in the tissue on the associated MR image or as an unusual amount of image non uniformity related to the position of the RF coil The adoption of the...

Page 96: ...loop in a patient at MR imaging Radiology 1996 200 572 5 Knopp MV Metzner R Brix G van Kaick G Safety considerations to avoid current induced skin burns in MRI procedures German Radiologe 199838 759 6...

Page 97: ...th effects and safety Boca Raton FL CRC Press 2001 393 414 U S Food and Drug Administration Center for Devices and Radiological Health CDRH Medical Device Report MDR http www fda gov CDRH mdrfile html...

Page 98: ...90 Appendix D Guidelines and References 989803173791 Rev 0 6...

Page 99: ...91 Notes...

Page 100: ...92...

Page 101: ...Managing Alarms 58 Measuring SpO2 55 menu change controls 38 message area informational 34 module network icons 25 network selection button 25 sensor connector 25 status indicator 25 Module battery in...

Page 102: ...tery 18 parameters 38 power up 29 unpacking 14 System Messages 62 U Using the Monitor 37 W Warranty 81 Waveform and Vital Sign Information 55 workflow 65 workflow management Essential standalone 66 Es...

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