Essential MRI Patient Monitor (Model 865353) Instructions for Use 989803173791 Rev 0.
989803173791 Rev 0.
Manufacturer Invivo Corporation Orlando, Florida 32826 U.S.A. (407) 275‐3220 (800) 331‐3220 www.invivocorp.com Copyright Copyright © 2010, Invivo. All rights reserved. Printed in the United States. REF 989803173791 Rev.
Proprietary Information This document and the information contained in it is proprietary and confidential information of Invivo and may not be reproduced, copied in whole or in part, adapted, modified, disclosed to others, or disseminated without the prior written permission of Invivo. This document is intended to be used by customers and is licensed to them as part of their Invivo equipment purchase. Use of this document by unauthorized persons is strictly prohibited.
Contents Chapter 1: Important Information Intended Audience . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 Conventions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 System Conventions. . . . . . . . . . . . . . . . . . . . . . . .
Navigating the Menu Groups and Controls. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38 Controlling Menu Changes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38 Locking and Unlocking the Screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39 Patient Menu. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Pulse Oximeter. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78 Alarm Limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79 Power Adapter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79 Power Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
iv Contents 989803173791 Rev 0.
Chapter 1: Important Information Information regarding the safety, accessories, installation, and operation of a fully equipped Essential MRI Patient Monitor (Model 865353) is included in this manual. For additional information about your accessories, please consult the documentation that accompanies the accessory.
WARNINGS • Patient motion or position of the accessories may affect measurement accuracy. Always consult a physician for interpretation of measurements provided by the system. • Perform operational verification prior to use. If the system fails to function properly, remove it from use and contact Invivo Technical Support personnel. • Screen all patients for metallic wires, implants, stents, etc. prior to MR procedures.
Step Action 1 2 3 • Bulleted lists indicate general information about a particular function or procedure, and do not imply a sequential procedure. • Messages regarding a condition in the device are given within quotation marks (“”) spelled and punctuated as they appear in the system, unless included as information in a table. • Control names, buttons and menu items or titles are spelled and punctuated as they appear in the system. • Symbols appear as they appear on the system.
Accessories Available accessories are listed in the tables below. Only use recommended Invivo patient sensors, grips, etc, as other brands may compromise the safety and accuracy of the system.
Miscellaneous Description Part Number Carry Case 989803171711 Mount Adapter 989803171681 Roll Stand 989803173761 Universal Holder Pole Kit (for use with Roll Stand) 989803174281 Information for Use Manual, Chinese, Simplified 989803174041 Information for Use Manual, Chinese, Traditional 989803174081 Information for Use Manual, Czech 989803173911 Information for Use Manual, Dutch 989803173921 Information for Use Manual, English 989803173791 Information for Use Manual, Finnish 98980317393
Safety Electromagnetic Compatibility (EMC) The system is intended for use in the electromagnetic environment specified below. Given the system’s electromagnetic emissions and immunity characteristics, the customer or the user should assure that the system is used within such an environment. Radios Frequency Range: 2402 to 2482 MHz. Modulation Type: GMSK. Monitor EIRP: 4.2 dBm (peak).
EMC Emissions Electromagnetic emissions is the ability of a product, a device, or a system to introduce intolerable electromagnetic disturbances into the use environment. Guidance and Manufacturer’s Declaration – Electromagnetic Emissions Emissions Test Compliance Electromagnetic Environment ‐ Guidance The Essential MRI Patient Monitor (Model 865353) is intended for use in the electromagnetic environment specified below.
EMC Immunity Electromagnetic immunity is the ability of a product, a device, or a system to function satisfactorily in the presence of electromagnetic interference. Guidance and Manufacturer’s Declaration ‐ Electromagnetic Immunity Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment ‐ Guidance The Essential MRI Patient Monitor (Model 865353) is intended for use in the electromagnetic environment specified below.
Recommended Separation Distances The system is intended for use in an electromagnetic environment where radiated RF disturbances are controlled. The customer or user of the system can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the system as recommended below, according to the maximum output power of the communications equipment.
Battery Disposal The system uses lithium batteries that are subject to strict disposal regulations for user and environmental safety. Caution CAUTIONS • Store batteries in a dry place, between 0°C to 40°C. • Never heat or throw a battery into fire. Heating the battery will damage the safety circuitry, which can cause rupture or ignition of the battery. • Never disassemble the battery. The batteries contain hazardous material that must be recycled or disposed of properly.
List of Symbols The following symbols are used on the system, packing materials, and in this document: Attention, consult accompanying documents MR Conditional: Use in the MR environment is restricted to certain conditions of use to ensure patient and operator safety.
Defibrillator‐Proof type CF equipment (IEC 60601‐1) protection against shock Attention: Electrostatic safety device, observe precautions Potential restrictions for equipment including radios may apply within one or more European (EU) member states.
Network C Network 3 Network D Network 4 Network E Network 5 Device conforms to the R&TTE Directive (Radio & Telecommunications Terminal Equipment) Canadian Standards Association (CSA) Safety Mark for the 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 requirements Indoor, dry location use only Device conforms to the Electrical Appliance and Materials
Unpacking the System Remove the contents from the shipping container(s). Carefully examine all items for signs of damage that may have occurred during shipment. Also, check all items against the packing list and the purchase request. To report shipping damage or to resolve any issues or concerns with your order, contact Invivo Customer Service. (Save all packing materials and related shipping documents, as these will be required to process a damage claim with the carrier.
Caution CAUTIONS • Do not place magnetic items inside the carry case, as they could be inadvertently brought into 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 visible. Mount Adapter The mount adapter (REF 989803171681) is a secure solution when attaching the monitor to a pole or rail.
To install the monitor onto the mount adapter, follow the steps below: 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 monitor to the mount. 3 With the monitor in the desired location, place the clamp (Item 3) around a pole or rail then securely tighten the knob (Item 4).
Chapter 2: Getting Started The Essential MRI Patient Monitor (Model 865353) is intended for use by health care professionals monitoring pulse oximetry and pulse rate in an MRI system room and in close proximity to the scanner magnet. Additionally, this monitoring is provided before, during and after active scanning in the MRI environment.
Battery Operation The Essential MRI Patient Monitor (Model 865353) operates from rechargeable batteries that provide approximately 8 hours of continuous power. Visual indications of the charged capacity of the batteries is constantly reported, while alarms provide alerts when low power conditions are detected. Using Batteries Safely The batteries in this system are non‐magnetic and can be handled safely in the MR system room. WARNING Do not use or take the power adapter inside the MR system room.
Installing the main battery To install the main battery follow these steps: Step 1 Action Place the cover over the DC inlet on the main battery. Cover DC inlet 2 Lower the main battery into the battery compartment then pivot it into place, as shown below. Battery compartment 3 Slide the locking tab to the left until latched. Locking tab 989803173791 Rev 0.
Removing the main battery To remove the main battery follow these steps: Step 1 Action Slide the locking tab on the main battery to the right. Main battery Locking tab 2 Lift the main battery out of the battery compartment. Battery compartment Module Battery The module battery latches into 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.
Removing the module battery To remove the module battery, press both locking tabs and then slide the battery out of the module. Locking tab Slot Module battery Charging Batteries The intelligent charger, an integral part of the main battery assembly, simultaneously charges the main and module batteries, while the external power adapter supplies the appropriate DC input.
WARNING Do not use or take the power adapter inside the MR system room. The device is magnetic and will be pulled into the MR system. The device is intended for use with the main battery and the module battery only when outside the MR system room. To charge batteries follow these steps: Step Action 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.
8 Connect the power adapter to the DC inlet. Observe the power (PWR) indicator and verify that power is applied: 9 • 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.) Allow both batteries to fully charge, as indicated by the charge indicators: • Green = Charging complete • Yellow = Battery charging • None = No battery is installed or an error was detected.
2 3 4 1 5 1 2 3 4 5 Power switch Handle Speaker Alarm light Display panel 1. Power switch ( ) ‐ Controls power to the monitor, where pressing the switch for more than 0.5 seconds turns power on, and pressing the switch for more than 1 second turns power off. NOTE If communications have not been detected for 15 minutes, the monitor will automatically turn off. 2. Handle ‐ Provides portability and houses the antennas. 3.
2 1 4 3 1 2 3 4 Network selection button Sensor connector Status indicator Network icons 1. Network selection button ‐ Selects the network setting of the module. 2. Sensor connector ‐ Connects the module to the SpO2 Quick Connect sensor. 3. Status indicator ‐ Indicates the power and communication conditions of the module: Status indicator Color State None Not applicable Green Meaning Power Communication The battery is not installed or it lacks sufficient charge to power the module.
match the setting assigned to the monitor; see Network Menu in Chapter 3 for monitor setup details. The wireless network for the module is indicated by its illuminated icon, while the currently assigned network for the monitor is indicated by the network button on the display panel. CAUTION For system communications, the monitor and module must have the same network setting.
NOTE Any part of the above sequence not completed will cause the module to revert to the network previously set 30 seconds after the network selection button was last released. To assign the wireless module to the monitor’s network follow these steps: Step 1 Action Identify the network setting of the monitor, as indicated by the network button. Network button 2 Remove the module battery from the module; see Module Battery, above. 3 Install the module battery.
Step 4 Action Set the network of the module to the same network as the monitor (see Step 1). Enter the network change mode. After the current network icon has been illuminated (and within 15 seconds from module power‐up) press and hold the network selection button until the current network icon begins flashing rapidly. Then release the network selection button. NOTE If the network change sequence is not started within 15 seconds after the module has been turned on, a network change will not be allowed.
Step 6 Action When you reach the desired network, press and hold the button for approximately 5 seconds to lock and save the new network. The selected network's icon will turn off while the button is depressed. Then it will illuminate (not blink) when the new network setting is saved. Once illuminated, release the button. The module will begin using the selected network.
Step Action 3 Press the power switch for at least 0.5 seconds to turn on the monitor. 4 The first time the monitor is turned on, set the display language for the system: NOTE 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 Navigating the Menu Groups and Controls in Chapter 3 for details.
Step 5 Action Ensure sufficient monitor power by checking the main battery indicators, where: • 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 remaining). • No Battery Communications symbol = No communications between the monitor and the main battery. Main battery indicators 989803173791 Rev 0.
Step 6 Action Ensure sufficient module power and communications with the monitor by checking the module battery indicators, where: • Blue gauge and time = 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 power remaining). • No Comm symbol = No communications between the monitor and the module.
Display Panel Overview The display panel provides the following functions and information: 3 6 5 4 7 8 2 ***** 9 10 11 12 13 14 15 1 23 22 21 20 19 1 SpO2 waveform 2 SpO2 message area 3 4 5 6 7 8 Speaker button Alarms button Informational message area Demo Mode indicator Patient category button SpO2 parameter identifier (in percent) 18 17 16 9 SpO2 high alarm limit indicator 10 SpO2 vital sign numeric 11 SpO2 low alarm limit indicator 12 13 14 15 16 17 18 19 20 21 22 23 Heart ra
NOTE Display update period is typically 1 second, up to a maximum of 30 seconds. 1. SpO2 waveform ‐ Provides the plethysmographic waveform, fixed across the screen and updated with an erase bar, where a red waveform indicates an alarm condition; see Waveform and Vital Sign Information in Chapter 4 for details. 2. SpO2 message area ‐ Displays SpO2 related messages. For a listing, see System Messages in Chapter 4 for details. 3.
14. Heart rate vital sign numeric ‐ Indicates the heart rate vital sign of the patient (given in beats per minute) and allows changes to the heart rate alarm limits; see Waveform and Vital Sign Information in Chapter 4 for details for details. NOTE Normal response time of the numerics is approximately 10 seconds; however, in case of artifact or poor signal conditions, the update period can be longer. 15.
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Chapter 3: Preparation for Use The Essential MRI Patient Monitor (Model 865353) provides the flexibility needed to perform standard SpO2 monitoring, while allowing you to customize operations to fit your needs. WARNING Warning Always verify proper communications between the module and monitor prior to patient use. CAUTIONS • Avoid the use of cellular phones or other radio‐frequency transmitters in the proximity of an operating system.
System Parameters The Essential MRI Patient Monitor (Model 865353) facilitates processing and display of the plethysmographic waveform, and the associated numeric values and alarms for the oxygen saturation of arterial blood and the derived heart rate. All patient information is provided on the display panel. Navigating the Menu Groups and Controls The menu groups and controls for the Essential MRI Patient Monitor (Model 865353) are accessed and navigated by touching the active areas on the touch screen.
• Main Screen button : Touch to close an open menu (and save any changes ‐ except those that require confirmation) and return to the normal operating view. Locking and Unlocking the Screen The touch screen can be locked to protect against accidental changes to the setup or alarm controls, while allowing monitoring functions to continue. When locked, the touch screen functions will be inaccessible, as denoted by the “Screen Locked” message which will appear for about 2.
Unlock Screen button Patient Menu The Patient menu allows you to select the patient category.
To enter the Patient menu: Touch the Patient category button. Patient category button Patient menu The following options are available: • Adult: Allows you to set the monitoring functions for adult patients. • Pediatric: 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 limits, adjust the brightness of the display panel and access the service functions.
• Alarm Limits: Allows you to access the Alarm Limits menu (see below). • Brightness: Allows you to set the desired intensity of the display, where: – 3 (Brightest) – 2 (Bright) – 1 (Normal) NOTE Brightness options higher than the Normal setting will reduce battery run time. • Service: Allows you to access 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.
• Revision Info: Allows you to examine the firmware and software level of the boot loader, application and power programs. • Demo Mode: Allows system operations to be simulated; see the service manual for details. NOTE The correct password is required for access: 12151. WARNING Warning The Essential MRI Patient Monitor (Model 865353) is equipped with a simulation mode that displays computer generated data for training purposes.
Network Menu The Network menu allows you to set the network used by the monitor to communicate with the WSpO2 module. For proper communications, the monitor and module must be linked on the same network. For ease of identification, network selection buttons have unique shapes, designators and colors. (To change the module’s network setting, see Assigning the Module Network in Chapter 2.
• (Network 3): Allows you to set system communications for wireless network 3 (compatibility with a Precess MRI Patient Monitor and module, Model 3160 ‐ Blue version). • (Network 4): Allows you to set system communications for wireless network 4 (compatibility with a Precess MRI Patient Monitor and module, Model 3160 ‐ Blue version). • (Network 5): Allows you to set system communications for wireless network 5 (compatibility with a Precess MRI Patient Monitor and module, Model 3160 ‐ Blue version).
NOTES • The system automatically prevents crossover of the low and high alarm limit settings. • Alarm limit setting changes are saved when power is turned off or when changing the battery. • When the patient category is changed, factory default alarm limit settings are used. To enter the Alarm Limits menu: • Touch the Alarms button.
• HR Alarm Limits buttons: Indicates the current setting and allows you to set the limits for the HR (heart rate) alarm, adjusted by touching the button (High or Low) followed by the increment or decrement button. • Decrement button: Allows you to decrease an Alarm Limits setting, where touching it once decreases the count by one and holding it decreases the count continuously.
Adult Alarm Limits Vital Sign Parameter Unit SpO2 HR Low Limit High Limit MIN MAX Default MIN MAX Default Percent 50 99 85 70 99 Off BPM 30 249 45 60 249 160 To change an alarm setting, follow the steps below: Step Action 1 If a change in the patient category is needed, touch the Patient category 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.
6 Touch the confirm and close button to save your changes. 7 If Display Limits are enabled, the alarm setting(s) will be indicated by the high and low alarm limit indicators. (This completes the procedure.) Sound Menu The Sound Menu allows you to adjust the volume level of the alarm, touch and pulse tones produced by the monitor. To enter the Sound menu: Touch the Speaker button.
WARNING Warning Adjustable for suitability to various clinical environments, the alarm volume can be turned low but never completely off. Always ensure that the alarm volume setting is appropriate for each patient. When you use the system, always verify that the alarm tone can be heard above the ambient noise level. Be sure the minimum alarm volume setting is still audible during MRI scanning because in some environments a particular setting is barely audible.
Chapter 4: Monitoring SpO 2 The pulse oximetry feature uses a motion‐tolerant signal processing algorithm based on Fourier Artifact Suppression Technology (FAST) to provide oxygenated hemoglobin measurements and a pulse rate, specifically: • Oxygen saturation of arterial blood (SpO2): The percentage of oxygenated hemoglobin in relation to the sum of oxyhemoglobin and deoxyhemoglobin (functional arterial oxygen saturation).
Connecting the Sensor and Attachments to the WSpO 2 Module Verify the SpO2 sensor and WSpO2 module status as follows: Step 1 Action Press the power switch for about 0.5 seconds. After the monitor is on, check the main battery indicators to ensure sufficient power. NOTE Use Alarms Pause to temporarily disable the alarm functions. 2 Connect a SpO2 sensor to the module. 3 Connect the attachment (clip or grip) to the SpO2 sensor.
Patient Preparation To prepare a patient for MRI SpO2 monitoring, follow the instructions below. Applying and Positioning the SpO 2 Sensor Apply the WSpO2 attachment to the patient as follows: Step Action 1 Follow the Instructions for Use provided with the SpO2 sensor, adhering to all warnings and cautions, and choose an application site. 2 If present, remove any colored nail polish from the application site. 3 Apply the attachment to the patient.
Positioning the WSpO 2 Module The selected site, sensor position, attachment connection, and ambient environment all impact performance and operation during SpO2 monitoring.
Measuring SpO 2 To display functional SpO2 values, follow the instructions below: Step Action 1 Select the patient category (Adult, Pediatric, or Neonatal). 2 During measurement, ensure that the application site: • has a pulsatile flow, ideally with a perfusion index value above 1.0; and, • has not changed in thickness (for example, due to edema) causing an improper sensor fit. NOTE A pulse oximeter should be considered an early warning device.
Item Number Explanation 1 The SpO2 (pleth) pulsatile waveform, updated from left to right across the display panel. If the pulse is above a minimum level, the amplitude of the waveform will automatically be adjusted for proper viewing. If you need an indication of change in pulse volume, use the perfusion index value described in item 4. The SpO2 numeric is the patient's arterial oxygen saturation reading, given as a percentage.
Assessing Suspicious SpO 2 Readings With newer algorithms, such as FAST‐SpO2, the calculation of SpO2 is not directly linked to the correct detection of each pulse. When the pulse rate is very low or a strong arrhythmia is present, the SpO2 / plethysmography pulse rate may differ from the heart rate calculated via an ECG. This does not indicate an inaccurate SpO2 value. If you doubt the measured SpO2, use the plethysmography wave and perfusion index value to assess the signal quality.
Yellow alarm light Message Perfusion index value Managing Alarms Access to every parameter alarm is provided by the Alarms button (see Alarm Limits Menu in Chapter 3 for details). Alarm limits may be turned on, adjusted (manually or automatically) or turned off using the Alarm Limits menu. The system gives visual alarm signals (on the display panel and by the alarm light) and audible signals.
Physiological Alarm Violations Physiological alarms receive the highest priority reporting status. A physiological alarm is violated when a patient parameter (SpO2 or heart rate) exceeds the high or low setting of the corresponding alarm limit. The reaction of the system to a physiological alarm depends upon the settings described below and generally as follows: a. The alarm light flashes red (see illustration below). b. If SpO2 related, a red waveform is displayed. c.
Technical Alarm Violations Technical alarms receive a medium priority reporting status. A technical alarm is violated when a change in system status or a problem with the hardware or the measurement is detected (for example ‐ a low battery, a communications failure, or a SpO2 inoperative condition). NOTES • At system power‐up, if the monitor does not have communication with the module, a medium priority alarm will be declared.
Example, visual technical alarm indicators: Yellow alarm light Low battery, module Low battery, monitor Alarm Controls Alarms can be controlled using the Alarms Silence button or the Alarms Pause button. WARNINGS • When alarm indicators (light, message, or sound) are generated, always confirm alarm conditions with clinical observation of the patient before administering interventions. Failure to do so may result in inappropriate intervention.
selected, the “Alarms Silenced” message, flashing in red, will be displayed in the informational message area. A new alarm condition will cause reactivation of the sound and light functions. WARNING Warning An active silenced alarm may not be accompanied by an “ALARMS SILENCED” message if Alarms Pause has been activated, or if a subsequent additional alarm has occurred and was self‐corrected.
Message Meaning HW FAIL INTRFERNCE LOW PERFUSION NO PROBE NON‐PULSAT NOISE PROBE OFF PULSE? Probable Cause Recommended Action SpO2 hardware failure. A hardware or other fatal error has occurred inside the wireless module or the monitor. Try another WSpO2 module. If the failure persists, immediately remove the system from service and contact Invivo for repair, as the system must not be used on any patient requiring SpO2 measurement.
Message Meaning Probable Cause Recommended Action SEARCHING The system is searching for a good pulse. The probe was just applied to the patient, or the probe has shifted position since being 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. The system has detected that an incorrect probe is connected to the module. The probe connected to the module is wrong.
Chapter 5: Workflow The Essential MRI Patient Monitor (Model 865353) can be used in conjunction with the Expression MRI Patient Monitor (Model 865214) and the Precess MRI Patient Monitor (Model 3160 ‐ Blue version) to provide seamless patient monitoring from induction to scanning to recovery. Expression MRI Patient Monitor (Model 865214) Precess MRI Patient Monitor (Model 3160 ‐ Blue version) When using the Essential with these other Invivo MRI monitors, observe the following warnings and notes.
NOTES • To establish patient monitoring, the Essential must be communicating on the same network as the module and attached to the patient. • Monitor settings (for example, patient category, alarm limits, etc.) do not transfer between monitoring systems, and alarm behavior remains linked to the alarm limit settings and the detected numerics.
5 Set the patient category and verify pulsatile flow. 6 Transport the patient with the Essential into the MR system room. 7 Scan the patient, monitoring SpO2 with the Essential 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 needed, then take the Essential and the WSpO2 module into the MR induction room for the next patient.
7 In the MR system room, connect the patient to the additional vital signs measurements then adjust the alarm limits, patient category, and other settings as needed on the Expression (or Precess). As soon as the WSpO2 module is within range, the Expression [or Precess] 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.
3 Turn on the Essential and the WSpO2 module. Both are set to network B (or if using a Precess, network 2). 4 Verify sufficient power and good communications. 5 Apply the SpO2 sensor to the new patient. 6 Set the patient category and verify pulsatile flow. 7 When the scan of the current patient has finished, transport the new patient with the Essential and the WSpO2 module into the MR system room.
Workflow when using the Essential with a Precess (Blue version) system, two WSpO2 modules and two ECG modules: • Two patients simultaneously, an MR induction room, an MR room with a Precess and an MR recovery room. – The Precess, a WSpO2 module and an ECG module are set to network 1. – The Essential, a WSpO2 module and an ECG module are set to network 2. Step Action 1 One (current) patient is in the MR system room, where a Precess, a WSpO2 module and a ECG module are set to network 1.
10 In the control room, on the Precess CRD display panel, press the MONITOR SETUP key. Turn the control knob to NETWORK, press the knob and select Network 2. 11 On the Essential display panel, press the Network button then select Network 1. NOTE Touch the Alarms Pause button to temporarily disable the 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.
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Chapter 6: Maintenance and Repair Methods to keep the Essential MRI Patient Monitor (Model 865353) clean and in proper working condition are discussed here. Maintenance Cleaning Use only the Invivo approved substances and methods listed in this section to clean or disinfect the Essential MRI Patient Monitor (Model 865353). Warranty does not cover damage caused by using unapproved substances or methods.
CAUTIONS • Avoid ammonia‐based, phenol‐based, and acetone‐based cleaners. They will damage the system surfaces. • If the system becomes accidentally wet during use, discontinue operation until all affected components have been cleaned and permitted to dry completely. Contact Invivo Technical Support if additional information is required. Cleaning the Accessories Any reusable patient accessories must be cleaned after each use. Disposable patient accessories must be discarded and replaced with new items.
Repair All repairs on products under warranty must be performed by Invivo personnel or an authorized Invivo Service and Repair Center. Unauthorized repairs will void the warranty. WARNING A shock hazard exists if the system is operated without covers. If the Essential MRI Patient Monitor (Model 865353) fails to function properly or requires maintenance, contact Technical Support: In the United States: 1‐877‐INVIVO1 ‐or‐ 1‐877‐468‐4861 Internationally, please contact your Key Market.
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Appendix A: Specifications General Patient Safety Conforms to UL STD 60601‐1. Certified to CAN/CSA STD C22.2 No. 601.
Dimensions and Weights (Note: all measurements made including handle) Height Monitor: 6.1 inches (155 mm) Wireless SpO2 Module: 5.5 inches (13.9 cm) Width Monitor: 6.9 inches (175 mm) Wireless SpO2 Module: 2.5 inches (6.4 cm) Depth Monitor: 3.7 inches (94 mm) Wireless SpO2 Module: 0.91 inches (2.3 cm) Weight Monitor: 3.3 lbs (1.5 Kg) Wireless SpO2 Module: 5.2 oz (147 gm) Display (LCD) Type 640 x 480 pixels, color VGA Liquid Crystal Display with 5‐Wire touch screen Screen Size 5.7 inches (14.
Alarm Limits SpO2 Alarm Limits Low: 50 to 99 or Off High: 70 to 99 or Off Heart Rate Alarm Limits Low: 30 to 249 or Off High: 60 to 249 or Off Note: Measurement validation: SpO2 accuracy has been validated in human studies against arterial blood sample reference measured with a CO‐oximeter. In a controlled desaturation study, healthy adult volunteers with saturation levels between 70% and 100% SaO2 were studied.
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Appendix B: Warranty Warranty Statement Invivo warrants this product, other than its expendable parts, to be free from defects in materials and workmanship for a period of twelve (12) months from the date of original delivery to the buyer or to buyer's order, provided that same is properly operated under conditions of normal use, and that periodic maintenance and service is performed. This same warranty is made for a period of thirty (30) days on expendable parts.
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Appendix C: Regulatory Information European Union Declaration of Conformity To obtain a copy of the Declaration of Conformity to the European Union Medical Device Directive (93/42/EEC) and Radio & 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 representative.
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Appendix D: Guidelines and References Guidelines for the Prevention of Excessive Heating And Burns Associated with Magnetic Resonance Procedures In general, magnetic resonance (MR) imaging is considered to be a relatively safe diagnostic modality. However, the use of radiofrequency coils, physiologic monitors, electronically‐activated devices, and external accessories or objects made from conductive materials has caused excessive heating, resulting in burn injuries to patients undergoing MR procedures.
1. Prepare the patient for the MR procedure by ensuring that there are no unnecessary metallic objects contacting the patient's skin (e.g., metallic drug delivery patches, jewelry, necklaces, bracelets, key chains, etc.). 2. Prepare the patient for the MR procedure by using insulation material (i.e., appropriate padding) to prevent skin‐to‐skin contact points and the formation of “closed‐loops” from touching body parts. 3.
12. Do not position electrically conductive materials across an external metallic prosthesis (e.g., external fixation device, cervical fixation device, etc.) or similar device that is in direct contact with the patient. 13. Allow only properly trained individuals to operate devices (e.g., monitoring equipment) in the MR environment. 14.
Finelli DA, Rezai AR, Ruggieri PM, Tkach JA, Nyenhuis JA, Hrdlicka G, Sharan A, Gonzalez‐Martinez J, Stypulkowski PH, Shellock FG. MR imaging‐related heating of deep brain stimulation electrodes: In vitro study. Am J Neuroradiol 2002;23:1795‐1802. Hall SC, Stevenson GW, Suresh S. Burn associated with temperature monitoring during magnetic resonance imaging. Anesthesiology 1992;76:152. Heinz W, Frohlich E, Stork T. Burns following magnetic resonance tomography study. (German) Z Gastroenterol 1999;37:31‐2.
Shellock FG. Radiofrequency‐induced heating during MR procedures: A review. Journal of Magnetic Resonance Imaging 2000;12: 30‐36. Shellock FG. Reference Manual for Magnetic Resonance Safety: 2003 Edition, Amirsys, Inc., 2003. Shellock FG, Slimp G. Severe burn of the finger caused by using a pulse oximeter during MRI. American Journal of Roentgenology 1989;153:1105. Shellock FG, Hatfield M, Simon BJ, Block S, Wamboldt J, Starewicz PM, Punchard WFB.
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Notes 91
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Index A accessories carry case, 14 miscellaneous, 5 mount adapter, 15 power, 4 roll stand, 16 SpO2, 4 alarm testing, 59 controls, 61 alarm indicators physiological, 59 technical, 61 Alarm Limits decrement button, 47 Default Limits button, 47 increment button, 47 alarm limits adult, 48 default, 48 neonatal, 47 default, 47 pediatric, 47 default, 47 Alarm Limits Menu, 45 alarm priorities, 59 alarm violations physiological, 59 technical, 60 Alarms Types, Priorities and Indications, 58 Alarms button, 33, 34 Alar
sensor applying and positioning, 53 sensor and wireless module, 51 suspicious readings, 57 vital sign numeric, 33, 34, 47 waveform, 33, 34, 51, 56 symbols list, 11 system battery operation, 18 components, 17 main battery, 18 94 Index 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 989803173791 Rev 0.
