Invivo Essential 865353 Instructions For Use Manual

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Essential

MRI Patient Monitor

(Model 865353)

Instructions for Use

989803173791 Rev 0.6

English

*989803173791*

989803173791

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Page 1 Essential MRI Patient Monitor (Model 865353) Instructions for Use 989803173791 Rev 0.6 English *989803173791* 989803173791...
Page 2 989803173791 Rev 0.6 2 ...
Page 3 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. A, October 2010 Equipment Classification EQUIPMENT CLASSIFICATION (according to IEC 60601‐1) According to the type of protection Class I equipment against electrical shock According to the degree of protection Type CF (defibrillator‐proof) equipment against electrical shock: According to the degree of protection IPX2 (enclosed equipment tilted 15 degrees against harmful ingress of water: with protection against dripping liquid). According to the methods of sterilization Non‐sterilizable. Use of liquid surface or disinfection: disinfectants only. According to the mode of operation: Continuous operation Equipment not suitable for use in the presence of flammable anesthetic mixture with air or with oxygen or nitrous oxide. NOTE Laws in the United States restrict this device to sale by or on the order of a physician. 989803173791 Rev 0.6 3...
Page 4 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. Invivo provides this document without warranty of any kind, implied or expressed, including, but not limited to, the implied warranties of merchantability and fitness for a particular purpose. Invivo has taken care to ensure the accuracy 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, or design. Invivo may make improvements or changes in the products or programs described in this document at any time. New editions of this document will incorporate all material updated since the previous edition. Update packages may be issued between editions and contain replacement and additional pages. Note that pages which are rearranged due to changes on a previous page are not considered revised. The documentation part number and revision indicate the current edition. The printing date changes when a new revision is printed. (Minor corrections and updates which are incorporated at reprint do not cause the date to change.) The document revision letter changes when extensive technical changes are incorporated. 989803173791 Rev 0.6 4 ...
Page 5: Table Of Contents
Contents Chapter 1: Important Information Intended Audience ............1 Warnings .
Page 6 Navigating the Menu Groups and Controls........38 Controlling Menu Changes.
Page 7 Pulse Oximeter............78 Alarm Limits .
Page 8 989803173791 Rev 0.6 iv Contents...
Page 9: Chapter 1: Important Information
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. This product will perform in conformity with the description contained in this manual and accompanying labeling when assembled, operated, maintained, and repaired in accordance with the instructions provided. This device must be checked periodically. A malfunctioning device must not be used. Parts that are broken, missing, plainly worn, distorted, or contaminated must be replaced immediately. Refer the device to qualified service personnel for repair or replacement. This device or any of 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 responsibility for any malfunction which results from improper use, faulty maintenance, improper repair, damage or alteration by anyone other than Invivo or Invivo‐authorized service personnel. Intended Audience The Essential MRI Patient Monitor (Model 865353) is intended for use by healthcare professionals trained in the use of the equipment and vital signs monitoring. Warnings Before using the Essential MRI Patient Monitor (Model 865353), read the warnings here and those in the Safety section below. The warnings and notes below refer to the Essential MRI Patient Monitor (Model 865353) in its entirety. WARNINGS • Thoroughly read and understand these Instructions for Use prior to use. • Shock hazard exists if the system is operated without covers. • Use only supplied power cords and connect only to properly grounded AC outlets to avoid electrical shock. 989803173791 Rev 0.6 Chapter 1: Important Information 1...
Page 10: Conventions
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. These electrical conductors will react with the MR environment or with the Invivo accessory (if applied directly over the conductor), thus increasing the risk of heating. NOTE The Essential MRI Patient Monitor (Model 865353) is not intended for use on a patient being transported outside a healthcare facility. Conventions The Essential 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 to assist you in finding and understanding information. System Conventions These conventions are used in the system: • Operational control is accomplished through the display panel. • When control or menu items are provided on the display panel, touching that control or item will activate or open it. • To protect against accidental changes of irreplaceable data, a confirm/cancel prompt is associated with certain menu options. When a prompt is displayed, you must confirm or cancel this action; otherwise, a delay of approximately 30 seconds without selection will be equivalent to selecting cancel. Document Conventions • All procedures are numbered, while any sub‐procedures are lettered. Complete the steps in the sequence presented to ensure success. Procedures are indicated by the following table: 989803173791 Rev 0.6...
Page 11: Warnings
Step Action • 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. • 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 you stand in front of the system, facing it. The front of the system is nearest you as you operate it. • The front of the module is nearest you as you operate it. Warnings WARNING Warning Warnings provide information you should know to avoid injuring yourself, patients or personnel. Cautions CAUTION Cautions provide information you should know to avoid damaging the equipment and software. Notes NOTE Notes provide additional information regarding system usage. 989803173791 Rev 0.6 Chapter 1: Important Information 3...
Page 12: Accessories
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. Description Part Number Quick Connect SpO Clip, Adult 989803166531 2 Quick Connect SpO Clip, Pediatric 989803166541 2 Quick Connect SpO Grip, Adult, 20/box 989803166551 2 Quick Connect SpO Grip, Infant, 20/box 989803166571 2 Quick Connect SpO Grip, Neonatal, 20/box 989803166581 2 Quick Connect SpO Grip, Pediatric, 20/box 989803166561 2 Quick Connect SpO Grip, Starter Pack 989803167111 2 Quick Connect SpO Sensor, MRI 989803161991 2 Wireless SpO Module (Expression) 989803163111 Wireless SpO...
Page 13: Miscellaneous
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 989803173931 Information for Use Manual, French 989803173941 Information for Use Manual, German 989803173951 Information for Use Manual, Greek 989803173961 Information for Use Manual, Hungarian 989803173971 Information for Use Manual, Italian 989803173981 Information for Use Manual, Japanese 989803173991 Information for Use Manual, Norwegian 989803174001 Information for Use Manual, Polish 989803174011 Information for Use Manual, Portuguese 989803174021 Information for Use Manual, Russian 989803174031...
Page 14: 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). WSpO EIRP: 0 dBm (peak) EMC WARNINGS EMC WARNINGS • Operation of the system outside the specifications indicated in Appendix A may cause inaccurate results. • The use of portable and mobile radio‐frequency (RF) communications equipment can affect the operation of this device. • The 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 replacement parts for internal components) will result in increased emissions or decreased immunity of the equipment or system. • The system should not be used adjacent to or stacked with other equipment (except other Invivo equipment, as detailed in this document) and that if adjacent or stacked use is necessary, the equipment or system must be observed to verify normal operation in the configuration in which it will be used. • The system needs to be installed and put into service according to the EMC information provided below. Portable and mobile RF communications equipment can affect medical electrical equipment. The system may be interfered with by other equipment with CISPR emission requirements. 989803173791 Rev 0.6 6 Chapter 1: Important Information ...
Page 15: Emc Emissions
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. The customer or the user of the Essential MRI Patient Monitor (Model 865353) should assure that it is used in such an environment. The system uses RF energy only for its internal functions. RF Emissions Therefore, its RF emissions are very low and are not Group 1 likely to cause any interference in nearby electronic CISPR 11 equipment. RF Emissions Class A CISPR 11 The system is suitable for use in all establishments, other Harmonic Emissions than domestic establishments and those directly Class A IEC 61000‐3‐2 connected to the public low‐voltage power supply network that supplies buildings used for domestic purposes. Voltage Fluctuations/flicker emissions Complies IEC 61000‐3‐3 989803173791 Rev 0.6 Chapter 1: Important Information 7...
Page 16: Emc Immunity
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 IEC 60601 Compliance Immunity Test Electromagnetic Environment ‐ Guidance Test Level Level The Essential MRI Patient Monitor (Model 865353) is intended for use in the electromagnetic environment specified below. The customer or the user of the Essential MRI Patient Monitor (Model 865353) should assure that it is used in such an environment. Conducted RF 3 Vrms V1 = 3 Vrms Portable and mobile RF communications equipment should not be used closer to any part IEC 61000‐4‐6 150 KHz to 80 MHz of the system (including cabling) than the recommended separation distance, as calculated Radiated RF 3 V/m E1 = 3 V/m by the equation applicable to the frequency of IEC 61000‐4‐3 80 MHz to 2.5 GHz the transmitter. Recommended separation distance: d = (3.5/V1) d = (3.5/E1) (80 MHz to 800 MHz) d = (7/E1) (800 MHz to 2.5 GHz) Where P is the maximum transmitter 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 ...
Page 17: Recommended Separation Distances
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. Recommended Separation Distances between Portable and Mobile RF Communications Equipment and the System Separation Distance According to Frequency of Transmitter (m) Rated Maximum Output Power of 150 KHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz Transmitter d = (3.5/V1) d = (3.5/E1) 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 Essential MRI Patient Monitor (Model 865353) should assure that it is used in such an environment. 0.01 0.117 0.117 0.233 0.369 0.369 0.738 1.167 1.167 2.333 3.689 3.689 7.379 11.667 11.667 23.333 For transmitters rated at a minimum output power not listed above, the recommended separation distance (d) in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the ...
Page 18: Battery Disposal
Battery Disposal The system uses lithium batteries that are subject to strict disposal regulations for user and environmental safety. CAUTIONS Caution • 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. (Refer to the disposal guidelines below.) Disposing of Batteries in Europe The European Community (EC) has issued two directives regarding battery disposal: 91/157/EEC and 93/86/EEC. Each member country implements these independently. Thus, in each country the manufacturers, importers, and users are responsible for the proper disposal or recycling of batteries. Confirm proper disposal requirements with your healthcare facility or 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, as conveyed by the Resources Conservation and Recovery Act (RCRA). The only metal of possible concern in the battery is the lithium metal, which is not listed or characterized as a toxic hazardous waste. A significant amount of spent cells and batteries that are untreated and not fully discharged are considered as reactive hazardous waste. Thus, hazardous waste of spent cells and batteries can be disposed after they are first neutralized through an approved secondary treatment prior to disposal (as required by U.S. Land Ban Restriction of the Hazardous and Solid Waste Amendments of 1984). Disposal of spent batteries must be performed by an authorized, professional disposal company, which has the knowledge in the requirements of the Federal, the State and the Local authorities regarding hazardous materials, transportation, and waste disposal. Confirm proper disposal ...
Page 19: List Of Symbols
List of Symbols The following symbols are used on the system, packing materials, and in this document: MR Conditional: Use in the MR environment is restricted Attention, consult to certain conditions of use to accompanying documents ensure patient and operator safety. Non‐ionizing radiation Not MR safe Percent oxygen pulse Power on / off saturation Product part number Earth ground Alternating current Antenna Device conforms to the Direct current Medical Device Directive Product serial number Warning Shock Hazard Date of manufacture YYYY‐MM Warning / Caution 989803173791 Rev 0.6 Chapter 1: Important Information 11...
Page 20 Defibrillator‐Proof type CF Attention: Electrostatic safety equipment (IEC 60601‐1) device, observe precautions protection against shock Potential restrictions for equipment including radios may apply within one or more Dangerous voltage European (EU) member states. Type CF applied part Patient Main battery gauge Module battery gauge No Battery Communications No (Module) Communications Energy Star rated product Green Seal product Do not adjust without Radio network (wireless referring to service manual modules) Network A Network 1 Network B Network 2 989803173791 Rev 0.6 12 Chapter 1: Important Information ...
Page 21 Network C Network 3 Network D Network 4 Network E Network 5 Device conforms to the Canadian Standards R&TTE Directive (Radio & Association (CSA) Safety Mark Telecommunications Terminal for the United States and Equipment) Canada Dispose of the battery in Federal Communications accordance with your Commission country’s requirements Dispose of electrical Indoor, dry location use only equipment in accordance with your country’s requirements Device conforms to the External power supply Electrical Appliance and international efficiency mark, Materials Law of Japan level 4 Underwriters Laboratories Recognized Component Mark, compliance in Canada and U.S.A. 989803173791 Rev 0.6 Chapter 1: Important Information 13...
Page 22: Unpacking The System
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 The Essential MRI Patient Monitor (Model 865353) 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 items: • Monitor and battery • Power adapter (not MR safe) • Power cord • IFU manual • Wireless SpO module, battery and accessories (optional) Accessories Optional accessories are available to protect, carry and mount the system. CAUTION When using the accessories make sure that the view of the display panel is not obstructed. Carry Case The carry case (REF 989803171711) offers convenient protected storage for the monitor, even during operation. A large clear window allows visual and operational access to the display panel, while side and rear pockets offer storage for modules and accessories. 989803173791 Rev 0.6...
Page 23: Mount Adapter
CAUTIONS Caution • 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. Pins Thumbscrew Clamp Knob 989803173791 Rev 0.6 Chapter 1: Important Information 15...
Page 24: Roll Stand
To install the monitor onto the mount adapter, follow the steps below: Step Action Align the pins (Item 1) of the mount adapter to the locator holes in the base of the monitor. Insert the Thumbscrew (Item 2) into the base of the monitor then tighten to secure the monitor to the mount. With the monitor in the desired location, place the clamp (Item 3) around a pole or rail then securely tighten the knob (Item 4). If needed, pivot the mount horizontally or vertically to orient the monitor for viewing. If needed, loosen the knob (Item 4) slightly to readjust the monitor for the optimum viewing angle then retighten the knob. This completes the procedure. Roll Stand The roll stand (REF 989803173761) offers a wheeled mobility solution when transporting the monitor (mount adapter option also required). And, for convenient storage of the module and accessories, the Universal Holder Pole Kit (REF 989803174281) is available. 989803173791 Rev 0.6 16 Chapter 1: Important Information ...
Page 25: Chapter 2: Getting Started
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. The system combines wireless communications, radio frequency shielding, digital signal processing and adaptable mounting technologies to provide accurate, continuous and reliable 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 situations of a wide spectrum of patients from neonate to adult, specifically: • Critically ill patients • Intervention procedures • Intraoperative procedures • Patient transport within the MR environment NOTE The system is suitable for use in the presence of electrosurgery. System Components The components that comprise a working Essential MRI Patient Monitor (Model 865353) system include the monitor and a WSpO module with attachments. CAUTION To minimize the chance of image artifacts, none of the monitoring components should be placed within the MRI Field of View. 989803173791 Rev 0.6 Chapter 2: Getting Started 17...
Page 26: Battery Operation
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. 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. Batteries have life cycles. When the equipment operating time provided by battery power becomes much shorter than 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 discarding a battery. To ensure the safety of operators and patients, observe the following warnings and cautions. WARNING Stop using any battery that exhibits abnormal heat, odor, color, deformation, or other condition. If a battery is punctured or if battery liquid leaks onto your skin or clothing, immediately wash the area and clothing with fresh water. If battery liquid gets into your eyes, do not rub your eyes; immediately flush your eyes with clean water and consult a physician. CAUTIONS • If the battery contacts become dirty, wipe them clean with a dry cloth before use. • Keep metal objects away from the battery contacts. Main Battery The main battery fits the contour of the monitor and latches into the battery compartment. CAUTION Never force the battery into the battery compartment as damage to the battery and/or the monitor could occur. 18 Chapter 2: Getting Started 989803173791 Rev 0.6...
Page 27 I n s t a l l i n g t h e m a i n b a t t e r y To install the main battery follow these steps: Step Action Place the cover over the DC inlet on the main battery. Cover DC inlet Lower the main battery into the battery compartment then pivot it into place, as shown below. Battery compartment Slide the locking tab to the left until latched. Locking tab 989803173791 Rev 0.6 Chapter 2: Getting Started ...
Page 28: Module Battery
R e m o v i n g t h e m a i n b a t t e r y To remove the main battery follow these steps: Step Action Slide the locking tab on the main battery to the right. Main battery Locking tab Lift the main battery out of the battery compartment. Battery compartment Module Battery The module battery latches into the wireless module. I n s t a l l i n g t h e m o d u l e b a t t e r y To install the module battery, slide the battery in between the slots on the module until both ...
Page 29: Charging Batteries
R e m o v i n g t h e m o d u l e b a t t e r y 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. NOTE Before initial use, place the main battery on the charger for at least 5 seconds, as the battery is shipped in a hibernating, partially charged, condition. Module battery Power adapter (AC cord not shown) DC plug DC inlet (with cover) Main battery charge indicator...
Page 30 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 Press the power switch for at least 1 second to turn off the monitor. Remove the main battery; see Removing the main battery, above. Remove the module battery; see Removing the module battery, above. Insert the module battery into the charging bay on the main battery. (The charging bay is keyed for proper battery insertion; do not force the battery.) Remove the cover from the DC inlet on the main battery. Connect the AC cord to the AC inlet on the power adapter. Connect the AC cord to an AC outlet located outside of the MR system room. 22 Chapter 2: Getting Started 989803173791 Rev 0.6...
Page 31: Monitor Overview
Connect the power adapter to the DC inlet. Observe the power (PWR) indicator and verify that 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.) 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. Disconnect the power adapter from the DC inlet. Remove the module battery from the charging bay. Insert the module battery into the module; see Installing the module battery, above. Insert the main battery into the monitor; see Installing the main battery, above. This completes the procedure. Monitor Overview The monitor is an integrated device that houses communication, display, processing and power technologies (including the transceivers and antennas). The monitor has the following user features: CAUTION When using the monitor, ensure that your view of the display panel remains unobstructed. 989803173791 Rev 0.6 Chapter 2: Getting Started 23...
Page 32: Wireless Spo2 Module Overview
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. Speaker ‐ Provides audible prompts and alarm indications, at a maximum volume 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 Managing Alarms in Chapter 4 for details. 5. Display panel ‐ Provides visual information and is the all‐touch interface for operation, control and setup of the monitor. Wireless SpO Module Overview The wireless pulse oximetry (WSpO ) module provides the patient’s readings, as detected signals are converted then transmitted for processing and display. The module has the following user features: 24 Chapter 2: Getting Started 989803173791 Rev 0.6...
Page 33: Assigning The Module Network
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 SpO Quick Connect sensor. 2 3. Status indicator ‐ Indicates the power and communication conditions of the module: Status indicator Meaning Color State Power Communication Not The battery is not installed or it lacks None Not applicable applicable sufficient charge to power the module. Green Flashing Battery power good Not communicating Green Solid Battery power good Good communications Low battery condition Flashing Not communicating (less that 45 minutes remain) Low battery condition Solid Good communications (less that 45 minutes remain) 4. Network icons ‐ Indicate the wireless network designated for module communications, where the illuminated icon denotes the current network. Assigning the Module Network The module communicates through a bidirectional 2.4 GHz spread‐spectrum link, which is ...
Page 34: Changing The Module Network Setting
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. Changing the Module Network Setting The wireless network for the module is changed via its network selection button, located beneath 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 surface, or hold it as shown in the illustration, and use your thumb to press the network selection button. Before starting the procedure, take note of these conventions that are used to explain the process: • In the procedure below, the following symbols are used to convey the state of the network icon on a wireless module. Icon illuminated Icon flashing In the procedure below, the following illustrations are used to convey actions concerning • the use of the network selection button: Press the Release the Press and hold Repeat as button button the button desired 26 Chapter 2: Getting Started 989803173791 Rev 0.6...
Page 35 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 Action Identify the network setting of the monitor, as indicated by the network button. Network button Remove the module battery from the module; see Module Battery, above. Install the module battery. The network icons will flash briefly and then the current network icon will illuminate (for example, Network C in the illustration below). NOTE Depending upon your module, the network icons may have letter or numeric designators; and, though these examples show letter designators, the process is the same for numeric designators. 989803173791 Rev 0.6 Chapter 2: Getting Started 27...
Page 36 Step 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. You must cycle module power and restart the sequence. Changing the network, press the button again until the icon stops flashing, then release the button. When you do this, the next network icon in the sequence will blink rapidly. (In other words, if the module was originally using network “C,” now the “D” icon will be flashing.) Repeat this sequence of pressing and releasing the button until the icon of the network you prefer is rapidly flashing. If you pass the desired network, simply continue pressing and releasing the button until the desired network is flashing again. 28 Chapter 2: Getting Started 989803173791 Rev 0.6...
Page 37: Initial System Power-Up
Step 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. WARNING If the message box, “WARNING! Multiple wireless modules detected on network” is displayed, a module network setting conflict has been detected by the monitor. Before proceeding, for proper function, ensure that only one SpO module per network has been assigned and is being used. Initial System Power-Up To apply power to the system follow these steps: Step Action Ensure that the main battery is installed in the monitor; see Main Battery, above. Ensure that the module battery is installed the module; see Module Battery, above. 989803173791 Rev 0.6 Chapter 2: Getting Started 29...
Page 38 Step Action Press the power switch for at least 0.5 seconds to turn on the monitor. 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. Language buttons (If not set initially, the Language menu will continue to appear at subsequent power‐ups until a display language is selected.) 30 Chapter 2: Getting Started 989803173791 Rev 0.6...
Page 39 Step 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 0.6 Chapter 2: Getting Started 31...
Page 40 Step 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. Module battery indicators Verify proper operation of the SpO parameter; see Chapter 4. 32 Chapter 2: Getting Started 989803173791 Rev 0.6...
Page 41: Display Panel Overview
Display Panel Overview The display panel provides the following functions and information: ***** waveform message area Speaker button Alarms button Informational message area Demo Mode indicator Patient category button parameter identifier (in percent) high alarm limit indicator vital sign numeric low alarm limit indicator Heart rate (HR) parameter identifier (in beats per minute) Heart rate high alarm limit indicator Heart rate vital sign numeric Heart rate low alarm limit indicator Main Screen button Setup button Network button (dependent upon the network selection) Main battery indicators Module battery indicators Alarms Pause button Alarms Silence button Perfusion index value 989803173791 Rev 0.6 Chapter 2: Getting Started 33...
Page 42 NOTE Display update period is typically 1 second, up to a maximum of 30 seconds. 1. SpO 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. SpO message area ‐ Displays SpO related messages. For a listing, see System Messages in 2 Chapter 4 for details. 3. Speaker button ‐ Sets the volume for alarm tone, touch and pulse tones; see Sound Menu in Chapter 3 for details. 4. Alarms button ‐ Sets the high and low alarm limits for SpO and heart rate alarms; see Setup 2 Menu in Chapter 3 for details. 5. Informational message area ‐ Displays alarm messages when the Alarms Pause button or the Alarms Silence button is selected. For a listing, see System Messages in Chapter 4 for details. 6. Demo Mode indicator ‐ Indicates that the monitor is operating in demonstration mode; 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 the SpO parameter and unit of measurement. 2 9. SpO high alarm limit indicator ‐ Indicates and allows changes to the high limit setting for the alarm; see Alarm Limits Menu in Chapter 3 for details. 2 10. SpO vital sign numeric ‐ Indicates the SpO vital sign of the patient (given as a percentage) 2 and allows changes to the SpO alarm limits; see Waveform and Vital Sign Information in Chapter 2 4 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.
Page 43 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. Heart rate low alarm limit indicator ‐ Indicates and allows changes to the low limit setting for the heart rate alarm; see Alarm Limits Menu in Chapter 3 for details. 16. Main Screen button ‐ Closes any open menus, returns the display to the normal operating view, and can lock the screen; see Locking and Unlocking the Screen in Chapter 3 for details. 17. Setup button ‐ Opens the Setup menu; see Setup Menu in Chapter 3 for details. 18. Network button ‐ Opens the network setup menu; see Network Menu in Chapter 3 for details. 19. Main battery indicators: • Displays the remaining main battery power as a gauge and a time remaining counter (formatted in hours:minutes). When less than forty‐five (45) minutes remain, the time will flash in yellow and an alarm will be declared; see Managing Alarms in Chapter 4 for details. • Flashes the 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 power as a gauge and a time remaining counter (formatted in hours:minutes). When less than forty‐five (45) minutes remain, the time will flash in yellow and an alarm will be declared; see Managing Alarms in Chapter 4 for details. • Flashes the No Comm symbol if communications are not established, or have been lost, between the monitor and the module; also see No Data Available Indication in Chapter 4 for details. 21. Alarms Pause button ‐ Allows you to temporarily deactivate alarm functions, where during deactivation a 2 minute timer, flashing in red, will countdown in the informational message area; see Managing Alarms in Chapter 4 for details. 22. Alarms Silence button ‐ Allows you to mute the alarm sound and turn off the alarm light during an alarm (though indications will continue to appear in the informational message area, ...
Page 44 36 Chapter 2: Getting Started 989803173791 Rev 0.6...
Page 45: Chapter 3: Preparation For Use
Chapter 3: Preparation for Use The Essential MRI Patient Monitor (Model 865353) provides the flexibility needed to perform standard SpO monitoring, while allowing you to customize operations to fit your needs. 2 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. • A minor but noticeable degradation in the wireless SpO radio communications 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 display out of the MR system bore and avoid contact with the patient’s bare skin while the MRI scan is running. The device is electronic and susceptible to excessive heating from the MRI scan RF only if placed inside the bore of the MR system during that scan. Failure to do so may result in patient injury. WARNING 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. 989803173791 Rev 0.6 Chapter 3: Preparation for Use 37...
Page 46: System Parameters
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. Touching an active button or indicator with your finger or a passive object (such as a stylus) 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 unpredictable results.) To guard against accidental changes, a locking feature allows you to protect the monitor settings. CAUTION Never use sharp objects on the display panel or apply unnecessary pressure to the display panel, as action can result in screen damage or failure. Controlling Menu Changes Depending upon the menu, these buttons control changes made to the options and settings: NOTE If a menu is open, delaying selection of an option for longer than 30 seconds closes the menu. • Confirm and Close button : Touch to save changes and close the menu. • Close button : Touch to discard changes that require confirmation and close the menu. (Or touch another button.) 38 Chapter 3: Preparation for Use 989803173791 Rev 0.6...
Page 47: Locking And Unlocking The 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 2.5 seconds after a button or indicator is touched. To restore operation to a locked screen, press and hold the Unlock Screen button for about 3 seconds. Locking and unlocking methods are described below. NOTE The Main Screen button is dynamic, changing to reflect the current state of the display where “Main Screen” indicates an unlocked condition and “Unlock Screen” indicates a locked condition. To lock the screen: Touch the Main Screen button for about 3 seconds. Main Screen button To unlock the screen: Touch the Unlock Screen button for about 3 seconds. 989803173791 Rev 0.6 Chapter 3: Preparation for Use 39...
Page 48: Patient Menu
Unlock Screen button Patient Menu The Patient menu allows you to select the patient category. Determining the appropriate patient category Each safety agency recognizes that the patient category descriptions can be arbitrary and that the following patient factors are more accurate in determining the appropriate method of patient monitoring and treatment: • Weight • Body size • Limb circumference • Physiological development • Neurological development • Neuromuscular coordination CAUTION There may be occasions 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 measurement technique. The clinical decision shall be based on all of the factors listed in Determining the appropriate patient category (above) to ensure the best possible and most timely measurement acquisitions. NOTES • The patient category button is dynamic, changing to reflect the current patient category. • Alarm limit default settings are applied whenever the patient category is changed, and previously changed alarm settings for a certain patient category will be lost; see Alarm Limits Menu (below) for details. 40 Chapter 3: Preparation for Use 989803173791 Rev 0.6...
Page 49: Setup Menu
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. To enter the Setup menu: Touch the Setup button. Setup menu Setup button The following options are available: 989803173791 Rev 0.6 Chapter 3: Preparation for Use 41...
Page 50: Service Menu
• 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. Other options remain reserved for use by qualified service providers, as noted below. To enter the Service menu: Touch the Setup button and then Service. Service menu Setup menu Setup button The following options are available: • Status: Allows you to check the Real Time Clock, and to display the communication status of the module and the main battery. 42 Chapter 3: Preparation for Use 989803173791 Rev 0.6...
Page 51 • 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. As a safety feature, a “Demo Mode” message is displayed while in simulation 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 simulation mode. Failure to properly monitor the patient will result. To exit simulation mode, turn off Demo Mode using the menu, or power off the monitor, or remove the battery. • Radio: Allows a service provider to change the radio and to test radio power; see the service manual for details. NOTE The correct password is required for access. • Language: Allows you to set the language used to display menus, messages and interface items, where the following options are available: – English – Espanol – Deutsch – Francais – Nederlands – Dansk – Svenska – Italiano –...
Page 52: Network Menu
Network Menu The Network menu allows you to set the network used by the monitor to communicate with the WSpO 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.) WARNING Warning If the message box, “WARNING! MULTIPLE WIRELESS MODULES DETECTED ON NETWORK” is displayed, recheck the desired configuration of the module and monitor. In environments where multiple systems are being used, you must be aware of each system’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 obtained and displayed as a result. Before proceeding, you must resolve the conflicting assignments. NOTE The network button is dynamic, changing to reflect the current network setting. To enter the Network menu: Touch the Network button. Network menu Network button Network selection buttons The following options are available by pressing the associated Network selection button: • (Network 1): Allows you to set system communications for wireless network 1 (compatibility with a Precess MRI Patient Monitor and module, Model 3160 ‐ Blue version). • (Network 2): Allows you to set system communications for wireless network 2 (compatibility with a Precess MRI Patient Monitor and module, Model 3160 ‐ Blue version). 44 Chapter 3: Preparation for Use 989803173791 Rev 0.6...
Page 53: Alarm Limits Menu
• (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). • (Network A): Allows you to set system communications for wireless network A (compatibility with an Expression MRI Patient Monitor and module, Model 865214). • (Network B): Allows you to set system communications for wireless network B (compatibility with an Expression MRI Patient Monitor and module, Model 865214). • (Network C): Allows you to set system communications for wireless network C (compatibility with an Expression MRI Patient Monitor and module, Model 865214). • (Network D): Allows you to set 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 (compatibility with an Expression MRI Patient Monitor and module, Model 865214). Alarm Limits Menu The Alarm Limits menu allows you to set limits for the SpO and HR (heart rate) alarms, and to control the presence of these settings on the display. During patient monitoring when a vital sign has violated an alarm limit, a high priority alarm is declared; see Managing Alarms in Chapter 4 for details. WARNINGS • Always respond promptly to any alarm condition. • Setting the alarm limits to extreme values can render the alarm monitoring useless. A potential hazard can exist if different alarm monitoring settings are used for the same or similar equipment in any single patient care unit. • Alarms generated by the Essential MRI Patient Monitor (Model 865353) will not ...
Page 54 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. Alarm Limits can also be accessed by: – Touching the SpO or HR vital sign numeric, – Touching a specific alarm limit indicator (for direct access to that setting), or – Touching the Setup button and then Alarm Limits. Alarms button Default Limits button vital sign numeric Alarm Limits menu high alarm limit indicator Display Limits button low alarm limit indicator HR high alarm limit indicator HR low alarm limit indicator HR vital sign numeric...
Page 55 • 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. • Increment button: Allows you to increase an Alarm Limits setting, where touching it once increases the count by one and holding it increases the count continuously. • Default Limits button: Allows you to automatically change the low and high alarm limits for both parameters to the default settings (see the tables below). • Display Limits button: Allows you to control the presence of the high and low alarm limit indicators for SpO and HR, where a checked box displays the indicators. • SpO2 vital sign numeric: Indicates the SpO vital sign of the patient (given as a percentage) 2 and allows you to change to the SpO alarm limits, where touching it opens the Alarm 2 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 alarm limits, where touching it opens the Alarm Limits menu. • SpO2 high alarm limit indicator: Indicates and allows direct changes to the high limit setting for the SpO2 alarm, where touching it opens the Alarm Limits menu. • SpO2 low alarm limit indicator: Indicates and allows direct changes to the low limit setting for the SpO2 alarm, where touching it opens the Alarm Limits menu. • HR high alarm limit indicator: Indicates and allows direct changes to the high limit setting for the heart rate alarm, where touching it opens the Alarm Limits menu. • HR low alarm limit indicator: Indicates and allows direct changes to the low limit setting for the heart rate alarm, where touching it opens the Alarm Limits menu.
Page 56 Adult Alarm Limits Low Limit High Limit Vital Sign Unit Parameter Default Default Percent 30 To change an alarm setting, follow the steps below: Step Action If a change in the patient category is needed, touch the Patient category button then make that change; otherwise, proceed to Step 2. Touch the Alarms button Touch the high or the low Alarm Limits button for the parameter. (The touch tone will sound and the button will be highlighted.) The example below follows a SpO high alarm limit change. 2 Touch the decrement or the increment button until the desired setting is reached, as displayed in the highlighted Alarm Limits button. For example, the decrement button was touched twice, resulting in a high alarm limit of 98. Repeat Steps 2 and 3 to adjust additional alarm limits. 48 Chapter 3: Preparation for Use 989803173791 Rev 0.6...
Page 57: Sound Menu
Touch the confirm and close button to save your changes. 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. Speaker button Sound menu Alarm volume buttons Touch volume buttons Pulse volume buttons The following options are available: • Alarm volume buttons: Sets 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. 989803173791 Rev 0.6 Chapter 3: Preparation for Use 49...
Page 58 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. Do not rely exclusively on the 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 combines close personal surveillance with correct operation of monitoring equipment. • Touch volume buttons: Sets the volume (range is 0 – 5) of the tone generated when an active area of the display panel is touched, where touching the decrement button (left) lowers the volume or touching the increment (right) button increases the volume. • Pulse volume buttons: Sets the volume (range is 0 – 5) of the tone generated when a pulse is detected, where touching the decrement button (left) lowers the volume or touching the increment (right) button increases the volume. 50 Chapter 3: Preparation for Use 989803173791 Rev 0.6...
Page 59: Chapter 4: Monitoring Spo2
• Oxygen saturation of arterial blood (SpO ): The percentage of oxygenated hemoglobin in relation to the sum of oxyhemoglobin and deoxyhemoglobin (functional arterial oxygen saturation). • Plethysmographic waveform: A visual indication of the patient’s pulsatile blood flow. • Heart rate: The number of detected pulsations per minute. • Perfusion index value: A numeric value for the pulsatile portion of the measured signal caused by arterial pulsation. Sensor and Wireless SpO Module The SpO sensor and wireless SpO (WSpO ) module may be used in the MR system bore, although the module must not be placed within the MRI field of view (FOV). Invivo‐specified fiber optic SpO sensors and the WSpO module are designed for use in the MR environment. Use only the specified fiber optic SpO sensors; see Accessories in Chapter 1 for a listing. 2 WARNING Connecting SpO sensors other than those specified by Invivo into the WSpO module can cause inaccurate SpO readings or damage the module. CAUTIONS • If dropped, the WSpO module must be verified for correct operation before use. 2 •...
Page 60: Connecting The Sensor And Attachments To The Wspo2 Module
Connecting the Sensor and Attachments to the WSpO Module Verify the SpO sensor and WSpO module status as follows: Step 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. Connect a SpO sensor to the module. Connect the attachment (clip or grip) to the SpO sensor. Check the status indicator on the module to verify sufficient power and good communications for monitoring: • Solid green = Good battery power and good communications • Flashing green = Good battery power but no communications • Solid red = Low battery power and good communications • Flashing red = Low battery power but no communications Proceed to Applying and Positioning the SpO2 Sensor, below. WSpO module sensor attachment (clips or grips) 52 Chapter 4: Monitoring SpO2 989803173791 Rev 0.6...
Page 61: Patient Preparation
Patient Preparation To prepare a patient for MRI SpO monitoring, follow the instructions below. Applying and Positioning the SpO Sensor Apply the WSpO attachment to the patient as follows: Step Action Follow the Instructions for Use provided with the SpO sensor, adhering to all warnings and cautions, and choose an application site. If present, remove any colored nail polish from the application site. Apply the attachment to the patient. The application site should match the size of the attachment used, so that the sensor does not fall off the site or apply excessive pressure to the site (see the Warnings, below). Ensure the sensor is not placed within the MRI Field of View (FOV). Check that the light emitter and the photodetector are directly opposite each other, as the light must pass through the patient’s tissue to the photodetector for proper operation. Proceed to Measuring SpO2, below. WARNINGS • GENERAL SENSOR FIT: If a sensor is too loose, it might compromise the optimal alignment or dislocate. If the sensor is too tight (for example, if the application site is too large or becomes large due to edema), excessive pressure may be applied resulting in venous congestion distal from the application site, which could lead to interstitial edema, hypoxemia, tissue malnutrition, and inaccurate measurements. Skin irritations may occur as a result of the sensor being attached to one location for too long. Periodically inspect the sensor application site and change the application site at least every four hours. Exercise care when using tape to secure the sensor, as the stretch memory properties of most tapes can apply unintended pressure to the sensor site easily. •...
Page 62: Positioning The Wspo2 Module
Positioning the WSpO Module The selected site, sensor position, attachment connection, and ambient environment all impact performance and operation during SpO monitoring. To ensure best possible results from the WSpO module during harsh scan sequences (with peripheral nerve stimulation [PNS] levels above 80 percent), observe the following general placement rules: – Place the WSpO module on or near the patient, as close as possible to the bore iso‐ center (considering the scan to be performed), but keep the wireless module outside the FOV. – Place the WSpO 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.) – Place the WSpO module on a cushioned surface to minimize the MR vibrations. WARNING If the WSpO module is incorrectly positioned when used within the MR system room, the following factors can cause SpO waveform distortion and numeric inaccuracies: • Fast magnetic field changes, usually found but not limited to scan sequences using PNS levels above 80 percent; • Severe vibrations induced by scan sequences using PNS levels above 80 percent; • The distance from the MR bore opening; and, • The distance from the bore iso‐center in the x, y, or z directions. 54 Chapter 4: Monitoring SpO2 989803173791 Rev 0.6...
Page 63: Measuring Spo2
Measuring SpO To display functional SpO values, follow the instructions below: Step Action Select the patient category (Adult, Pediatric, or Neonatal). 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. As a trend towards patient deoxygenation is indicated, blood samples must be analyzed by a laboratory co‐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 table below. 989803173791 Rev 0.6 Chapter 4: Monitoring SpO2 55...
Page 64: No Data Available Indication
Item Number Explanation The SpO (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 SpO numeric is the patient's arterial oxygen saturation reading, given as a percentage. Also, if Displayed Limits are set to on, the SpO alarm settings are shown in the high and low alarm limit indicators. NOTE Averaging time is fixed and may be overridden by Expression or Precess workflow. The HR numeric is the patient’s heart rate, as derived from the SpO measurement, given in beats per minute. Also, if Displayed Limits are set to on, the HR alarm settings are shown in the high and low alarm limit indicators. No Data Available Indication Under certain conditions, the vital sign numerics and/or the perfusion index value may be displayed as 3 dashes (‐ ‐ ‐), which means no data is currently available for the parameter(s). This can happen for any of the following reasons: • The parameter is in a start‐up state; • The SpO sensor is not applied to the patient; • There is no communication with the module; or • The measurement is distorted, the pulse too weak ...
Page 65: Assessing Suspicious Spo2 Readings
Assessing Suspicious SpO Readings With newer algorithms, such as FAST‐SpO , the calculation of SpO 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 SpO / plethysmography pulse rate may differ from the heart rate calculated via an ECG. This does not indicate an inaccurate SpO value. If you doubt the measured SpO , use the plethysmography wave and perfusion index value to assess the signal quality. WARNINGS • Always shield the SpO sensor from extraneous incidental light sources (for example, cover the sensor with opaque material), as such light can cause erroneous SpO readings or pulse detection errors. • monitoring requires the detection of valid pulses to correctly determine SpO and heart rate values. Any of the following items can lead to inaccuracies of the SpO readings and/or prolonged measurement time: Ambient light (including photodynamic therapy), physical movement (patient and imposed motion), arrhythmias and/or erratic heart beats, diagnostic testing, low perfusion, electromagnetic interference, electrosurgical units, dysfunctional 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 vital signs by alternate means before administering medication. • Sensor movement, ambient light (especially strobe lights or flashing lights), or electromagnetic interference can give unexpected intermittent readings when the sensor is not attached to a patient. Bandage and grip sensor designs are particularly sensitive to minimal sensor movement that might occur when the sensor is dangling, not attached to the patient. Unapplied sensors may cause readings to be displayed on the monitor. To avoid misdiagnosis, verify sensor is applied to patient correctly. Perfusion Index Value The perfusion index value is an indication of the pulsatile portion of the SpO signal caused by ...
Page 66: Managing Alarms
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. Alarm Types, Priorities and Indications The Essential MRI Patient Monitor (Model 865353) assigns different priorities and indications when reporting alarms. Alarms are assigned a high or 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 (maximum volume setting) in 1m distance. • Medium priority alarms sound levels range from at least 49dB (a minimum volume setting) to 71dB (maximum volume setting) in 1m distance. • The delay time of making visual and audible alarms available from the alarming equipment to the remote equipment at the signal output port is less than 1 second. In the case of artifact or poor signal conditions, update time of SpO and HR numerics can take as long as 30 seconds. Alarm limit violations are reported as a high priority alarm within 1 second. 58 Chapter 4: Monitoring SpO2 989803173791 Rev 0.6...
Page 67: Physiological Alarm Violations
The numeric of the violated parameter flashes red. d. The high priority alarm tone sounds‐‐at a high pitch‐‐5 pulse tones followed by a 1 second delay then 5 pulse tones, repeating every 5 seconds. e. The numeric continues to flash while the parameter violates its alarm limit, even after the alarm tone has been muted by touching the Alarms Silence button. f. If the 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 displayed numeric of the violated parameter flashes and the audible alarm, once silenced, will not sound again until the alarm condition has been corrected and re‐ violated. Only a second different parameter alarm will cause the alarm sound and alarm light to reactivate. Example, visual physiological alarm indicators: Red alarm light Red vital sign numeric Physiological alarm testing can be performed using a patient SpO simulator to exceed an 2 individual alarm limit. Alarm testing can also be performed using the monitor’s Demo mode where an individual parameter alarm limit can be adjusted‐‐a high limit set below the simulated numeric or a low limit set above the simulated numeric (except SpO )‐‐to trigger a physiological alarm. If a problem with the alarm tone or message system is suspected, this system must be referred to an Invivo‐authorized service personnel for evaluation. 989803173791 Rev 0.6 Chapter 4: Monitoring SpO2 59...
Page 68: Technical Alarm Violations
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. • At module power‐up, if communication with the module battery is lost, a medium priority alarm will be declared. • If the system loses communication with the main battery, a medium priority alarm will be declared. The reaction of the system to a technical alarm depends upon specific system operations and generally as follows: a. The alarm light flashes 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 battery or communications failure conditions) to identify the cause of the alarm; see System Messages, below, for the listing. d. If a low battery condition exists, the corresponding battery indicator and time remaining counter will flash in yellow. e. If a communications failure exists, the corresponding symbol will flash in yellow (the No Comm symbol for monitor to module communications, or the No Battery Communication symbol for monitor to main battery communications). f. The alarm condition stops after the problem is corrected or the system status returns to a normal condition. g. The message flashes and the audible alarm, once silenced, will not sound again until the alarm condition has been corrected and re‐violated. Only a second different ...
Page 69: Alarm Controls
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. • Once the numeric has exceeded the alarm limit, the delay to announcing the alarm condition is less than 1 second, and the total alarm delay is less than 1 second. Alarms Pause button Alarms Silence button • Alarms Silence button: Allows you to mute the alarm tone and turn off the alarm light during an alarm condition (although alarm indications will continue to be displayed). When 989803173791 Rev 0.6 Chapter 4: Monitoring SpO2 61...
Page 70: System Messages
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. • Alarms Pause button: Allows you to temporarily deactivate the alarm functions (helpful, for example, when prepping a patient for monitoring). When selected, the “Alarms Paused” message and a 2 minute countdown timer, flashing in red, will be displayed in the informational message area. NOTE Alarm functions are restored when the countdown timer reaches zero (0) or when the Alarms Pause button is touched during the countdown. System Messages The following table lists messages that can 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 action(s), contact Invivo Technical Support or Invivo‐authorized service personnel for assistance. Message Meaning Probable Cause Recommended Action Alarms are paused Alarms Paused The Alarms Pause No action required. Normal alarm monitoring until the countdown button was touched. function will resume upon expiration of the timer reaches zero. countdown (or immediately if Alarms Pause is touched again.) Alarms have been Alarms Silenced The Alarms Silence Touch the Alarms Pause button twice to ...
Page 71 Message Meaning Probable Cause Recommended Action hardware HW FAIL A hardware or other Try another WSpO module. If the failure failure. fatal error has persists, immediately remove the system from occurred inside the service and contact Invivo for repair, as the wireless module or system must not be used on any patient the monitor. requiring SpO measurement. The signal quality of INTRFERNCE The probe light • Check the alignment of the probe. the light channels is source may not be • Try a different limb or site. inadequate for aligned with the light • Try using a different probe. accurate saturation receiver, or the calculation. probe may be poorly positioned. The perfusion LOW PERFUSION The tissue at the site ...
Page 72 Message Meaning Probable Cause Recommended Action The system is SEARCHING The probe was just If the probe was just applied, give the system searching for a good applied to the time (usually less than 20 seconds) to lock pulse. patient, or the probe onto a good pulse; otherwise, check the probe has shifted position position and re‐position. since being applied. The system has WRONG PROBE The probe connected Attach the correct SpO sensor to the module. detected that an to the module is incorrect probe is wrong. connected to the module. 64 Chapter 4: Monitoring SpO2 989803173791 Rev 0.6...
Page 73: Chapter 5: Workflow
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 Precess MRI Patient Monitor (Model 865214) (Model 3160 ‐ Blue version) When using the Essential with these other Invivo MRI monitors, observe the following warnings and notes. WARNINGS • Alarm 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 SpO modules must be on different networks; otherwise, interference, or wrong 2 patient or alternating pickup between patients can occur. NOTES • The Essential MRI Patient Monitor (Model 865353) is not compatible with the original Precess WSpO module. 2 • The numerics and waveform are generated by the WSpO module, and therefore are identical regardless of the monitoring system used. 989803173791 Rev 0.6 Chapter 5: Workflow 65...
Page 74: Workflow Management
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. Workflow Management The following diagrams illustrate typical and alternate workflow objectives when using the Essential as a standalone device or when using it together with compatible Invivo 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 settings (network A versus B, 1 versus 2, etc) should be observed. Workflow when using the Essential as a standalone monitor with one WSpO module: • A patient, an MR induction room, an MR system room and an MR recovery room. – The Essential and the WSpO2 module are set to network A or network 1, depending upon the module type (Expression or Precess ‐ Blue version). Step Action Prep the patient in the MR induction room. Turn on the Essential and the WSpO module. Both are set to network A (or 1). Verify sufficient power and good communications. Apply the SpO sensor to the patient. 66 Chapter 5: Workflow 989803173791 Rev 0.6...
Page 75 Set the patient category and verify pulsatile flow. Transport the patient with the Essential into the MR system room. Scan the patient, monitoring SpO with the Essential through the control room window. Transport the patient with the Essential and the WSpO module into the MR recovery room. Transition the patient into the MR recovery room to bedside monitoring, if needed, then take the Essential and the WSpO module into the MR induction room for the next patient. Workflow when using the Essential with an Expression (or a Precess ‐ Blue version) system and one WSpO module: • A patient, an MR induction room, an MR system room with an Expression (or a Precess) and an MR recovery room. – The Essential, the Expression and the WSpO2 module are set to network A (or if using a Precess ‐ Blue version, network 1). Step Action Prep the patient in the MR induction room. Turn on the Essential and the WSpO module. Both are set to network A (or 1 if using a Precess). Verify sufficient power and good communications. Apply the SpO sensor to the patient. Set the patient category and verify pulsatile flow. Transport the patient with the Essential into the MR system room for scanning, where the Expression is set to network A (or if using a Precess, network 1). 989803173791 Rev 0.6 Chapter 5: Workflow 67...
Page 76 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 WSpO module is within range, the Expression [or Precess] will begin monitoring SpO automatically and you can turn off the Essential. Scan the patient, using the Expression (or Precess) in the control room. Turn on the Essential to monitor SpO (The Essential will now begin 2. to monitor SpO automatically.) 2 In order to transport the patient to the MR recovery room, disconnect the patient from all vital sign measurements except provided by Expression (or Precess). Transport the patient with the Essential and the WSpO module into the MR recovery room. If needed, transition the patient in the MR recovery room to bedside monitoring. Take the Essential and the WSpO module into the MR induction room for the next patient. Workflow when using the Essential with an Expression (or a Precess ‐ Blue version) system and two WSpO modules: • Two patients simultaneously, an MR induction room, an MR room with an Expression (or a Precess) and an MR recovery room. – The Expression and a WSpO module are set to network A (or for Precess, network 1). – The Essential and a WSpO module are set to network B (or for Precess, network 2). Step Action One (current) patient is in the MR system room, where an ...
Page 77 Turn on the Essential and the WSpO module. Both are set to network B (or if using a Precess, network 2). Verify sufficient power and good communications. Apply the SpO sensor to the new patient. Set the patient category and verify pulsatile flow. When the scan of the current patient has finished, transport the new patient with the Essential and the WSpO module into the MR system room. From the current patient in the MR system room, disconnect the sensor from the SpO Quick Connect attachment (grip). NOTE Press the Alarms Silence key to temporarily disable the alarm functions. From the new patient in the MR system room, disconnect the sensor from the SpO Quick Connect attachment (grip). NOTE Touch the Alarms Pause button to temporarily disable the alarm functions. In the MR system room, connect the new patient to the additional vital measurements on the Expression, still on network A (or the Precess, still on network 1). Transport the current patient with the Essential and the WSpO module, still on network B (or for the Precess still on network 2) into the MR recovery room. If needed, transition the current patient in the MR recovery room to bedside monitoring. Take the Essential and the WSpO module into the MR induction room for the next patient. Scan new the patient, using the Expression DCU (or the Precess CRD) in the control room. 989803173791 Rev 0.6 Chapter 5: Workflow ...
Page 78 Workflow when using the Essential with a Precess (Blue version) system, two WSpO 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 WSpO module and an ECG module are set to network 1. – The Essential, a WSpO module and an ECG module are set to network 2. Step Action One (current) patient is in the MR system room, where a Precess, a WSpO module and a ECG module are set to network 1. Prep the second (new) patient in the MR induction room. Turn on the Essential, the WSpO module and the ECG module. All are set to network 2. Verify sufficient power and good communications. (The ECG module cannot not be checked at this point.) Apply the SpO sensor and the ECG leads to the new patient. Set the patient category and verify pulsatile flow. When the scan of the current patient has finished, transport the new patient with the Essential, the WSpO module and the ECG module into the MR system room. In the MR system room, on the Precess display panel, press the MONITOR SETUP key. Turn the control knob to NETWORK, press the knob and select Network 2. NOTE Press the Alarms Silence key to temporarily disable the alarm functions. In the MR system room, connect the new patient to the additional vital measurements on the Precess. Verify sufficient power and good communications for the modules. 70 Chapter 5: Workflow 989803173791 Rev 0.6...
Page 79 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. 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. Verify sufficient power and good communications for the WSpO module. (The ECG module will not be used and cannot not be checked at this point.) Transport the current patient with the Essential, the WSpO module and the ECG module into the MR recovery room. If needed, transition the current patient in the MR recovery room to bedside monitoring. Take the Essential the WSpO module and the ECG module into the MR induction room for the next patient. Scan new the patient, using the Precess CRD in the control room. 989803173791 Rev 0.6 Chapter 5: Workflow 71...
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Page 81: Chapter 6: Maintenance And Repair
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. Invivo makes no claims regarding the efficacy of the listed chemicals or methods as a means for controlling infection. Consult your facility's Infection Control Officer or Epidemiologist. For comprehensive details on cleaning agents and their efficacy refer to “Guidelines for Prevention of Transmission of Human Immunodeficiency Virus and Hepatitis B Virus to Health Care and Public‐ Safety Workers” issued by the U.S. Department of Health and Human Services, Public Health 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 be sterilized. Always turn off the system to perform cleaning. Do not immerse any part of the system in any fluid or attempt to clean it with liquid cleaning agents. Remove dirt and dust from the monitor and the wireless module by wiping them with a lint‐free cloth, moistened with warm water (40°C/104°F maximum). Gently wipe all surfaces to be cleaned briefly (30 seconds to 1 minute) as needed to ensure proper cleaning. Stains can be removed by scrubbing briskly with the moistened cloth. If disinfection is required, use only the dilute solutions of any of the following recommended liquid surface disinfectants: • CaviWipes • Alcohol (70%) • Antibacterial Soap (0.1% Triclosan) WARNING To avoid damage to the connector, do not remove the battery before performing any cleaning or maintenance. And, to avoid an electrical hazard, never immerse any part of the system in any cleaning agent or attempt to clean it with liquid cleaning agents. ...
Page 82: Cleaning The Accessories
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. The accessories cannot be sterilized. WARNING Single‐use devices, as indicated on the device packaging, should be disposed of after use and must never be reused. CAUTION Never immerse an accessory in any cleaning fluid. To clean reusable accessories (such as SpO sensors and grips), complete the following steps: Step Action Remove the accessory from use. Remove dirt and dust from the accessory using a lint‐free cloth, moistened with warm water (40CF maximum) gently wiping all surfaces to be cleaned briefly (30 seconds to 1 minute) as needed to ensure proper cleansing. Stains can be removed from the accessory by scrubbing briskly with the moistened cloth. Inspect the accessory for any cracks, holes, tears, cuts, etc. that could affect operation and replace as necessary. If disinfection is required, use only the recommended liquid surface disinfectants, unless otherwise specified in the accessory’s instructions for use. Recommended surface disinfectants include dilute solutions of any of the following: • CaviWipes • Alcohol (70%) •...
Page 83: Repair
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. For a current listing, go to www.invivocorp.com CAUTIONS • No repair should ever be undertaken or attempted by anyone not having a thorough knowledge of the repair 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 service. • This product, or any of its parts, must not be repaired other than in accordance with written instructions provided by Invivo (Philips), or altered without prior written approval. Changes and modifications to the radio and its components not expressly approved by Invivo (Philips) can void your authority to operate this equipment under Federal Communications Commission’s rules. • The user of this product shall have the sole responsibility for any malfunction which results from improper use, faulty maintenance, improper repair, damage, or alteration by anyone other than Invivo (Philips) or its authorized service personnel. NOTE Dispose of the system and parts thereof according to local regulations. 989803173791 Rev 0.6 Chapter 6: Maintenance and Repair 75...
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Page 85: Appendix A: Specifications
Appendix A: Specifications General Patient Safety Conforms to UL STD 60601‐1. Certified to CAN/CSA STD C22.2 No. 601.1 According to degree of protection against harmful ingress of water: IPX 2 (equipment is protected from vertically dripping liquid) This equipment complies to the following international industry standards for safety and performance: • IEC 60601‐1, General Requirements for Safety of Medical Electrical Equipment • IEC 60601‐1‐2, General Requirements for Safety ‐ Electromagnetic Compatibility • IEC 60601‐1‐4, General Requirements for Safety of Programmable Electrical Medical Systems • IEC 60601‐1‐8, General Requirements, Tests and Guidance for Alarm Systems in Medical Electrical Equipment and Medical Electrical Systems • ISO 9919, Particular Requirements 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 system feature, when considering the indications for use within the MR environment. Power Requirements Operating Voltage Battery only Battery Type Lithium polymer Operation Time Monitor: Approximate operation time is 8 hours. Module: Approximate operation time is 8 hours. Charge Time Monitor: Time required to recharge a fully discharged battery is approximately 8 hours. Module: Time required to recharge a fully discharged battery is approximately 6 hours. Environment Operating Temperature 10°C to 40°C (50°F to 104°F) ...
Page 86: Dimensions And Weights
Dimensions and Weights (Note: all measurements made including handle) Height Monitor: 6.1 inches (155 mm) Wireless SpO Module: 5.5 inches (13.9 cm) Width Monitor: 6.9 inches (175 mm) Wireless SpO Module: 2.5 inches (6.4 cm) Depth Monitor: 3.7 inches (94 mm) Wireless SpO Module: 0.91 inches (2.3 cm) Weight Monitor: 3.3 lbs (1.5 Kg) Wireless SpO 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 (14.5 cm) Sweep Speed 25 mm/second gives 2.7 seconds of display Waveform Display Mode Fixed Trace, Moving Erase Bar Displayed Parameters Alarms High and low limit selectable Heart Rate Derived from SpO Pulse Oximeter Heart rate, pulse waveform, percent saturation, and perfusion index Pulse Oximeter Pitch of pulse tone is modulated by saturation value. Saturation Range 0 to 100% Saturation Accuracy ±3% at 70 to 100% (The specified accuracy is the root‐mean ...
Page 87: Alarm Limits
Alarm Limits 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: 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% SaO were studied. The population characteristics for those studies were: • about 50% female and 50% male subjects • age range: 19‐27 • skin tone: from light to black A functional tester cannot be used to 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 to fulfill a particular accuracy specification. measurements are statistically distributed; therefore, in accordance to ISO 9919:2005, it is possible that only two‐thirds of the measurements will fall within ±3 percent of the value measured by the CO‐Oximeter Power Adapter Power Requirements Input Voltage (to AC inlet) Universal AC; 100 to 240VAC @ 50 to 60Hz. Input Power 0.4 amps, without power factor correction. DC Connector 15 VDC Environment Location Console room (Outside the MR system room) Operating Temperature 10°C to 40°C (50°F to 104°F) Storage Temperature ‐25° to 70°C (‐13°F to 158°F) Relative Humidity 15% to 90%, non‐condensing ...
Page 88 80 Appendix A: Specifications 989803173791 Rev 0.6...
Page 89: Appendix B: Warranty
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. This warranty shall become null and void if the system has been repaired by someone other than Invivo 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 Service Center during normal business hours and shipped transportation prepaid. Invivo shall not be liable for any damages including but not limited to incidental damages, consequential damages or special damages. This warranty is in lieu of any other warranties, guarantees or conditions, including merchantability or fitness for a particular purpose. The remedies under this warranty are exclusive and Invivo assumes nor authorizes anyone to assume for it any other obligation in connection with the sale or repair of its products. INVIVO PRODUCTS CONTAIN PROPRIETARY COPYRIGHTED MATERIAL. ALL RIGHTS RESERVED 989803173791 Rev 0.6 Appendix B: Warranty 81...
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Page 91: Appendix C: Regulatory Information
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. Authorized Representative The Authorized Representative for the European Union (as required by the Medical Device Directive, 93/42/EEC) is as follows: Philips Medical Systems Boblingen GmbH, Hewlett‐Packard‐Str. 2 71034, Boblingen Germany 989803173791 Rev 0.6 Appendix C: Regulatory Information 83...
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Page 93: Appendix D: Guidelines And References
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. Heating of implants and similar devices may also occur in association with MR procedures, but this tends be problematic primarily for objects made from conductive materials that have elongated shapes such as leads, guidewires, and certain types of catheters (e.g., catheters with thermistors or other conducting components). Notably, more than 30 incidents of excessive heating have been reported in patients undergoing MR procedures in the United States that were unrelated to equipment problems or the presence of conductive external or internal implants or materials [review of data files from U.S. Food and Drug Administration, Center for Devices and Radiological Health, Manufacturer and User Facility Device Experience Database, MAUDE, http://www.fda.gov/cdrh/maude.html and U.S. Food and Drug Administration, Center for Devices and Radiological Health, Medical Device Report, (http:// www.fda.gov/CDRH/mdrfile.html)]. These incidents included 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 radiofrequency (RF) coils or other RF transmit coils of the MR systems or there were skin‐to‐skin contact points suspected to be responsible for these injuries. MR systems require the use of RF pulses to create the MR signal. This RF energy is transmitted readily through free space from the transmit RF coil to the patient. When conducting materials are placed within the RF field, the result may be a concentration of electrical currents sufficient ...
Page 94 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. Insulating material (minimum recommended thickness, 1‐cm) should be placed between the patient's skin and transmit RF coil that is used for the MR procedure (alternatively, the RF coil itself should be padded). For example, position the patient so that there is no direct contact between the patient's skin and the body RF coil of the MR system. This may be accomplished by having the patient place his/her arms over his/her head or by using elbow pads or foam padding between the patient's tissue and the body RF coil of the MR system. This is especially important for those MR examinations that use the body coil or other large RF coils for transmission of RF energy. 4. Use only electrically conductive devices, equipment, accessories (e.g., leads, electrodes, etc.), and materials that have been thoroughly tested and determined to be safe and compatible for MR procedures. 5. Carefully follow specific MR safety criteria and recommendations for implants made from electrically‐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 surface RF coils, monitoring leads, cables, and wires. Preventive maintenance should be practiced routinely for such equipment. 7. Remove all non‐essential electrically conductive materials from the MR system (i.e., unused surface RF coils, leads, cables, wires, etc.). 8. Keep electrically conductive materials that must remain in the MR system from directly contacting the patient by placing thermal and/or electrical insulation between the conductive material and the patient. 9. Keep electrically conductive materials that must remain within the body RF coil or other transmit RF coil of the MR system from forming conductive loops. Note: The patient's tissue is conductive and, therefore, may be involved in the formation of a conductive loop, which can be circular, U‐shaped, or S‐shaped.
Page 95: References
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. Follow all manufacturer instructions for the proper operation and maintenance of physiologic monitoring or other similar electronic equipment intended for use during MR procedures. 15. Electrical devices that do not appear to be operating properly during the MR procedure should be removed from the patient immediately. 16. Closely monitor the patient during the MR procedure. If the patient reports sensations of heating or other unusual sensation, discontinue the MR procedure immediately and perform a thorough assessment of the situation. 17. RF surface coil decoupling failures can cause localized RF power deposition levels to reach excessive levels. The MR system operator will recognize 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 these guidelines will help to ensure that patient safety is maintained, especially as more conductive materials and electronically‐activated devices are used in association with MR procedures. References Bashein G, Syrory G. Burns associated with pulse oximetry during magnetic resonance imaging. Anesthesiology 1991;75:382‐3. Brown TR, Goldstein B, Little J. Severe burns resulting from magnetic resonance imaging with cardiopulmonary monitoring. Risks and relevant safety precautions. Am J Phys Med Rehabil 1993;72:166‐7. Chou C‐K, McDougall JA, Chan KW. Absence of radiofrequency heating from auditory implants during magnetic resonance imaging. Bioelectromagnetics 1997;44:367‐372. Dempsey MF, Condon B. Thermal injuries associated with MRI. Clin Radiol 2001;56:457‐65. Dempsey MF, Condon B, Hadley DM. Investigation of the factors responsible for burns during MRI. J Magn Reson Imaging 2001;13:627‐631. ECRI, Health Devices Alert. A new MRI complication? Health Devices Alert. May 27, pp. 1, 1988. ECRI. Thermal injuries and patient monitoring during MRI studies. Health Devices Alert. 1991;20: 362‐363. ...
Page 96 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. http://www.MRIsafety.com International Electrotechnical Commission (IEC), Medical Electrical Equipment, Particular requirements for the safety of magnetic resonance equipment for medical diagnosis, International Standard IEC 60601‐2‐33, 2002. Jones S, Jaffe W, Alvi R. Burns associated with electrocardiographic monitoring during magnetic resonance imaging. Burns 1996;22:420‐1. Kanal E, Shellock FG. Burns associated with clinical MR examinations. Radiology 1990;175: 585. Kanal E, Shellock FG. Policies, guidelines, and recommendations for MR imaging safety and patient management. J Magn Reson Imaging 1992;2:247‐248. Knopp MV, Essig M, Debus J, Zabel HJ, van Kaick G. Unusual burns of the lower extremities caused by a closed conducting 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 199838:759‐63. Nakamura T, Fukuda K, Hayakawa K, Aoki I, Matsumoto K, Sekine T, Ueda H, Shimizu Y. Mechanism of burn injury during magnetic resonance imaging (MRI)‐simple loops can induce heat injury. Front Med Biol Eng 2001;11:117‐29 Nyenhuis JA, Kildishev AV, Foster KS, Graber G, Athey W. Heating near implanted medical devices by the MRI RF‐magnetic field. IEEE Trans Magn 1999;35:4133‐4135. Rezai AR, Finelli D, Nyenhuis JA, Hrdlick G, Tkach J, Ruggieri P, Stypulkowski PH, Sharan A, Shellock FG. Neurostimulator for deep brain stimulation: Ex vivo evaluation of MRI‐related heating at 1.5‐Tesla. Journal of Magnetic Resonance Imaging 2002;15:241‐250. Schaefer DJ. Safety Aspects of radio‐frequency power deposition in magnetic resonance. MRI Clinics of North America 1998;6:775‐789. Schaefer DJ, Felmlee JP. Radio‐frequency safety in MR examinations, Special Cross‐Specialty Categorical Course in Diagnostic Radiology: Practical MR Safety Considerations for Physicians, Physicists, and Technologists, Syllabus, 87th Scientific of the Radiological Society of North America, Chicago, pp 111‐123, 2001. Shellock FG. Magnetic Resonance Procedures: Health Effects and Safety. CRC Press, LLC, Boca Raton, FL, 2001. Shellock FG. MR safety update 2002: Implants and devices. Journal of Magnetic Resonance Imaging 2002;16:485‐496. 88 Appendix D: Guidelines and References 989803173791 Rev 0.6...
Page 97 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. Implantable spinal fusion stimulator: assessment of MRI safety. Journal of Magnetic Resonance Imaging 2000;12:214‐223. Smith CD, Nyenhuis JA, Kildishev AV. Health effects of induced electrical fields: implications for metallic implants. In: Shellock FG, ed. Magnetic resonance procedure: health 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). The files contain information from CDRH's device experience reports on devices which may have malfunctioned or caused a death or serious injury. The files contain reports received under both the mandatory Medical Device Reporting Program (MDR) from 1984 ‐ 1996, and the voluntary reports up to June 1993. The database currently contains over 600,000 reports. U.S. Food and Drug Administration, Center for Devices and Radiological Health (CDRH), Manufacturer and User Facility Device Experience Database, MAUDE, (http://www.fda.gov/cdrh/ maude.html). MAUDE data represents reports of adverse events involving medical devices. The data consists of all voluntary reports since June, 1993, user facility reports since 1991, distributor reports since 1993, and manufacturer reports since August, 1996. 989803173791 Rev 0.6 Appendix D: Guidelines and References 89...
Page 98 90 Appendix D: Guidelines and References 989803173791 Rev 0.6...
Page 99 Notes...
Page 101 Index Demo Mode indicator, 33, 34 display panel accessories patient category overview, 33 carry case, 14 determination, 40 miscellaneous, 5 patient category button, 33, 34 mount adapter, 15 Patient Menu, 40 Erratic, 62 power, 4 Patient menu roll stand, 16 adult, 41 authorized representative, 83 SpO2, 4 neonatal, 41 external power adapter, 21 alarm pediatric, 41 testing, 59 patient preparation controls, 61...
Page 102 sensor parameters, 38 workflow management applying and positioning, 53 power‐up, 29 Essential standalone, 66 sensor and wireless module, 51 unpacking, 14 Essential with Expression or Precess and suspicious readings, 57 System Messages, 62 one module, 67 vital sign numeric, 33, 34, 47 Essential with Expression or Precess and waveform, 33, 34, 51, 56 two modules, 68 symbols Using the Monitor, 37 Essential ...

Invivo Essential 865353 Instructions For Use Manual

Chapter 1: Important Information

Chapter 2: Getting Started

Chapter 3: Preparation for Use

Chapter 4: Monitoring Spo2

Chapter 5: Workflow

Chapter 6: Maintenance and Repair

Appendix A: Specifications

Appendix B: Warranty

Appendix C: Regulatory Information

Appendix D: Guidelines and References

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