Expression MR400 MRI Patient Monitoring System INSTRUCTIONS FOR USE Revision A English *989803193211* 989803193211
Manufacturer Invivo, a division of Philips Medical Systems 12151 Research Parkway Orlando, FL 32826, USA 877‐468‐4861 E‐mail: Info@invivocorp.com Websites: www.ExpressionMR.com www.invivocorp.com www.philips.com Identification and Publication Details Published by Invivo, a division of Philips Medical Systems. Invivo, a division of Philips Medical Systems, reserves the right to make changes to both this Instructions for Use and to the product it describes.
Regulatory Compliance The Expression MR400 MRI Patient Monitoring System complies with relevant international and national standards and laws. Information on compliance will be supplied on request by your local Royal Philips representative, or by the manufacturer. Explanation of Symbols The symbols in the following table may appear on the Expression MR400 MRI Patient Monitoring System, the accessories, or the packing material.
Symbol iv Symbol Sterilized using radiation Unique device identifier Sterilized using ethylene oxide In vitro diagnostics compliant MR Conditional: Use in the MR environment is restricted to certain conditions of use to ensure patient and operator safety. MR unsafe: Must not be used in an MRI environment MR safe: Completely safe for use with no potential for interaction with the MR field.
Symbol YYYY-MM-DD YYYY-MM Symbol Use by date; do not use after the year (YYYY), month (MM) and day (DD) indicated Cable tag marked with use by date; do not use after the year (YYYY) and month (MM) indicated Use by date; do not use after the year (YYYY), month (MM) AC receptacle, below Do not push Correct Alternating current Not sterile SPO2 probe quantity equals Direct current Adult SPO2 clip quantity equals Pediatric SPO2 clip quantity equals Infant SPO2 grip quantity equals Neonatal SPO2 g
Symbol vi Symbol Prescription only Foot site NIBP cuff, correct side out Temperature range Non-pyrogenic fluid path NIBP cuff, wrong side out Airway adapter quantity equals NIBP cuff circumference range Anesthetic oxygen (O2) sensor location and part number IBP transducer cable quantity equals Weight Cannula quantity equals Humidity range Humidity range, non condensing For indoor use only Equipotential (earth) ground Fragile Keep dry
Symbol Symbol Keep away from heat Atmospheric pressure limitation Packages per box Up Quantity equals Non-invasive blood pressure (NIBP) connection Not manufactured with natural latex rubber Quadtrode electrode Contains or presence of phthalate: bis (2ethylhexyl) phthalate Quadtrode electrode per package Non-ionizing radiation ECG AAMI ECG CV lead cable connections AAMI ECG lead cable connections AAMI ECG NEO lead cable connections IEC ECG CV lead cable connections IEC ECG lead cable conne
Symbol viii Symbol Cardiac gating output Universal Serial Bus (USB) Conforms to the RoHS directive Not for general waste Center positive connection: Positive (+) center pin, negative (-) outer ring Pneumatic respiration connection Gas input indicator Gas output indicator Electrical input indicator Electrical output indicator Temperature connection Electrostatic discharge (ESD) warning Manufacturer name and address Date of manufacture (year-month) YYYY-MM Non-magnetic part Battery Main ba
Symbol Symbol Do not move the Expression MR400 MRI Patient Monitoring System inside the 5000 gauss field line of the MR magnet or up to the face of a 3T magnet, whichever is greater, as measured from the center line of the bore. Apply wheel locks and do not move the Expression MR400 MRI Patient Monitoring System inside the 5000 gauss field line of the MR magnet or up to the face of a 3T magnet, whichever is greater, as measured from the center line of the bore.
Symbol x Symbol Alarm audio paused After opening, allow at least 1 hour to pass before use Alarm audio off Current setups have changed Power switch (Standby switch) Heartbeat detected Module battery adequate charge indication Breathing effort detected Module battery low charge indication Battery 1 indicator, wireless ECG patient module, Battery 2 indicator, wireless ECG patient module, Battery indicator, wireless SpO2 patient module No communication IP5 connected Network channel 1 Network c
Symbol Symbol Network channel 5 Network channel 10 Ten FlexTEMP System Jackets per box Conventions Certain conventions are used throughout the Expression MR400 MRI Patient Monitoring System to speed use and familiarity with the device. This accompanying user information also uses document conventions to assist you in finding and understanding information.
• All procedures are numbered and any sub‐steps are lettered. Complete the steps in the sequence presented to ensure success. Procedures are indicated by the following table: Step Action 1 2 3 xii • Unless noted, all procedures start from the normal mode of operation. • Select means to press on an active element on the touch screen LCD (menu or sub‐menu item, button, key, vital sign box, et cetera).
Contents Manufacturer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-ii Identification and Publication Details . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-ii Regulatory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-iii Explanation of Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
System Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2 Use Model. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Acquisition and Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Synchronization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Monitor Setup Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-14 Edit User Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-15 Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-18 Sound Adjust . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Alarm Limit Factory Defaults . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-24 Measurement Limits and Over / Under Values . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-25 Listing of Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-26 Patient and INOP Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Applying the SpO2 Attachment to the Patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-3 Perfusion Index Value . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-6 Positioning the wSpO2 Module for Scanning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-6 SPO2 Waveform and VS Box . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
The IBP transducer must not be mounted to the patient, or patient burn may result. . . 8-8 VI. Fast Flushing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-9 VII. Checking for Leaks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-9 VIII. In the MR Room . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
CO2 Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-27 Size . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-28 Grids . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-29 Zero Cal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Mean Format. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Changing the NIBP Format. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Changing the Unit of Measure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Changing the NIBP Alarm Limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Repair . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-16 Environmental Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-17 Passing the Product on to another User . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-18 Packaging the MR400 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
10 Contents
CHAPTER 1 Important Information About About the Expression MR400 MRI Patient Monitoring System and this Instructions for Use This Instructions for Use is intended to assist users in the safe and effective operation of the Expression MR400 MRI Patient Monitoring System. Before attempting to operate the product, you must read this Instructions for Use, noting and strictly observing all WARNINGS and CAUTION notices.
Intended Use This Philips product is intended to be used and operated only in accordance with the safety procedures and operating instructions given in this Instructions for Use for the purposes for which it was designed. The purposes for which the product is intended is given below. However, nothing stated in this Instructions for Use reduces users’ responsibilities for sound clinical judgment and best clinical procedure.
Indications for Use The Expression MR400 MRI Patient Monitoring System is intended for use by healthcare professionals to monitor vital signs of patients undergoing MRI procedures and to provide signals for synchronization for the MRI scanner (also referred to as “triggering” or “gating”).
Training Users of this product must have received adequate training on its safe and effective use before attempting to operate the product described in this Instructions for Use. Training requirements for this type of device will vary from country to country. Users must make sure they receive adequate training in accordance with local laws or regulations. If you require further information about training in the use of this product, please contact your local Philips Medical Systems representative.
SAFETY AWARENESS WARNING Warning Do not use the product for any application until you have read, understood and know all the safety information, safety procedures and emergency procedures contained in this SAFETY section. Operation of the product without a proper awareness of how to use it safely could lead to fatal or other serious personal injury. It could also lead to clinical misdiagnosis or to clinical mistreatment.
MECHANICAL SAFETY WARNING Warning Do not remove covers from this product unless expressly instructed to do so in this Instructions for Use. Moving parts are present within this product. Removing covers could lead to serious or fatal personal injury. Covers should normally only be removed by qualified and authorized service personnel.
ELECTROMAGNETIC COMPATIBILITY (EMC) This Philips product complies with relevant international and national law and standards on EMC (electromagnetic compatibility) for this type of product when used as intended. Such laws and standards define both the permissible electromagnetic emission levels from product and its required immunity to electromagnetic interference from external sources.
Electromagnetic Compatibility (EMC) The device is intended for use in the electromagnetic environment specified below. Given the device’s electromagnetic emissions and immunity characteristics, the customer or user should assure that the device is used within such an environment. The following information is mandated by IEC 60601‐1‐2, the international standard for the electromagnetic compatibility (EMC) of medical electrical equipment.
Guidance and Manufacturer’s Declaration - Electromagnetic Emissions The Expression MR400 MRI Patient Monitoring System is intended for use in the electromagnetic environment specified below, and the customer or the user should assure that it is used in such an environment. Emissions Test Compliance Electromagnetic Environment - Guidance RF Emissions, CISPR 11 Group 1 The Expression MR400 MRI Patient Monitoring System uses RF energy only for its internal functions.
Guidance and Manufacturer’s Declaration - Electromagnetic Immunity The Expression MR400 MRI Patient Monitoring System is intended for use in the electromagnetic environment specified below. The customer or the user of the Expression MR400 MRI Patient Monitoring System should assure that it is used in such an environment.
Guidance and Manufacturer’s Declaration - Electromagnetic Immunity The Expression MR400 MRI Patient Monitoring System is intended for use in the electromagnetic environment specified below. The customer or the user of the Expression MR400 MRI Patient Monitoring System should assure that it is used in such an environment. Immunity Test IEC 60601 Test Level Compliance Level Conducted RF IEC 61000-4-6 3 Vrms 150 KHz to 80 MHz V1 = 3 Vrms Radiated RF IEC 61000-4-3 3 V/m 80 MHz to 2.
Recommended Separation Distances between Portable and Mobile RF Communications Equipment and the Expression MR400 MRI Patient Monitoring System The Expression MR400 MRI Patient Monitoring System is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
WARNING Warning Do not use a damaged battery. Periodically check batteries, stop using and replace 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.
• Module battery charger • Module batteries Disposing of the Packaging The packaging can be retained for future use. Otherwise, the packaging for the system (which is made of recyclable materials that include corrugated paper, polyethylene [PE] foam and plastic) may be subject to disposal regulations for user and environmental safety. For disposal, it may be necessary to separate these materials by type.
To perform initial setup of the MR400 Step 1 Action Perform a visual inspection of the MR400, checking for loose or missing hardware or damage. If loose or missing hardware or damage is observed, contact technical support. 2 Install the main batteries into the cart and connect the reserve batteries; see page 1‐16. 3 Connect AC mains power to the MR400, but DO NOT turn on the power switch. Allow the batteries to charge for at least 12 hours before use; see page 1‐20.
Step 10 Action Verify that the status indicator on the wECG and wSpO2 modules is illuminated steady green: • For the wECG module, see page 2‐9. • For the wSpO2 module, see page 2‐11. 11 Verify that the wireless network channels on the wECG and wSpO2 modules are set to the channel used by the MR400; see page 1‐29. 12 Place the wECG and wSpO2 modules into the module holders on the MR400; see page 2‐12. This completes the initial setup process.
Step 2 Action Hold a main cart battery with the label side down and with its connector facing forward. (Silk screening above each battery compartment provides the correct battery orientation—the left side is shown in the example below.) Then, slide the battery completely into the battery compartment until a “click” is heard as the battery latches into place. Battery compartment WPU Main cart battery (If the battery does not latch into place when inserted, then it is not properly oriented.
Step 5 Action Locate the battery switch and toggle it into the On (I) position. Battery switch 6 Reinstall the service panel cover, and secure it to the WPU using the two screws. 7 Replace the shield cap. This completes the installation and connection of the main and reserve batteries. Connect AC mains power then allow these batteries to charge for at least 12 hours before initial use; see page 1‐21.
Rear Panel Connections Depending upon the options included with your MR400 or the use model, some connections may be required after moving the MR400 into the MR magnet room. In addition to the connection for AC mains power, connections for the waste gas port and the gating cable are available on the rear panel of the MR400. (For information about the placement of the MR400 in the MR magnet room, see page 3‐2.
4 Strain relief for retention of the power cord. 5 AC receptacle for connection of the power cord. Connecting AC Mains Power When connecting the MR400 to the mains electrical supply, do not route the detachable power cord where it will be an obstruction or stepped upon. Do not block access to the MR400 with other equipment and never position the MR400 in such a way that would make it difficult to unplug.
Understanding Battery Operations Cart Batteries WARNING Warning Do not touch the patient and the circuitry in the battery compartments of the MR400 simultaneously. Cart batteries, when installed (main) and switched on (reserve), are charged and conditioned by an integrated charging system. When turned on and connected to AC mains, the MR400 operates from AC power and simultaneously charges all cart batteries. When turned off and connected to AC mains, battery charging functions continue.
To charge the cart batteries Step 1 Action Ensure that all cart batteries are installed and switched on. See Installing and Connecting Cart Batteries on page 1‐16 for details. 2 Connect the MR400 to AC mains power. See Connecting AC Mains Power on page 1‐20. 3 Ensure that the MR400 is turned off and that it remains off for the next 12 hours. Charged capacity of all cart batteries can be displayed; see the Status Information Panel on page 2‐18).
2 Press the battery eject button to partially eject a main battery from the battery compartment, and then grasp the battery and pull to remove it completely from the MR400. Battery compartment Battery eject button Main battery (If the battery does not release, apply a slight forward pressure to the battery while pressing the battery eject button.) 3 Repeat steps 1 and 2 to remove the other main cart battery on the opposite side of the MR400.
Charging Module Batteries Module batteries must be charged for at least 4 hours before initial use. Module batteries are charged in the Philips‐specified battery charger. Refer to the instructions provided with this battery charger for information. Installing Batteries in the wECG Module The wECG module can accept up to two batteries.
Step 2 Action Orient a module battery so that the tip of the battery arrow aligns with the tip of the bay 1 arrow on the wECG module. Then slide the module battery into bay 1, pressing until it seats completely. Bay 1 arrow Module battery Battery arrow 3 Orient a module battery so that the tip of the battery arrow aligns with the tip of the bay 2 arrow on the wECG module. Then slide the module battery into bay 2, pressing until it seats completely.
To remove battery 2 from the wECG module 3 Press a battery eject button 2 (item 3, right). Then grasp the partially ejected module battery (item 4) and pull to remove it. 4 Installing a Battery in the wSpO2 Module The wSpO2 module uses one battery. When a module battery is inserted, the wSpO2 module will turn on. And, when the battery is removed, the wSpO2 module will turn off. To install a battery in the wSpO2 module Step 1 Action Hold the wSpO2 module so that its battery bay is oriented as shown.
Removing the Battery from the wSpO2 Module 1 To remove the battery from the wSpO2 module Press the battery eject button (item 1, right). Then grasp the partially ejected module battery (item 2) and pull to remove it. 2 Understanding Wireless Network Operations A wireless network channel is used for system communication between the MR400 cart and the wECG and wSpO2 modules (and, if equipped, the IP5). All wireless devices must use the same wireless network channel for proper system communications.
WARNINGS • Care should be taken to guard against inadvertent changes to the network channel setting. Before use, always ensure that all devices are communicating properly. Failure to do so may cause a lapse in patient monitoring. • An MR400 system is comprised of one MR400 cart, one wECG module, and one wSpO2 module, and optionally an IP5. In environments where multiple MR400 MRI patient monitoring systems are being used, you must be aware of each component’s network setting.
Step 3 Action Select the desired setting from the options: 1 2 3 4 5 6 7 8 9 10 The setting is entered and the network icon is changed to the current selection. 4 Ensure that the network channel used by the wECG and wSpO2 modules (see page 1‐29) and the IP5 (if equipped) are identical to the network setting of the cart. Setting the Wireless Network Channel of the wECG and wSpO2 Modules All indicators and controls for wireless network channel selection are located on the front of the wireless modules.
Before starting the procedure to change the network channel of the wireless module, take note of these conventions that are used to explain the process: • The following symbols are used to convey the state of the network channel indicator on a wireless module. Symbol illuminated • Symbol blinking The following illustrations are used to convey actions concerning the use of the network selection button.
Step 3 Action Enter the network channel change mode: After the current network channel indicator has been illuminated (and within 10 seconds of module power‐up), press and hold the network selection button until the current network channel indicator begins to rapidly blink then release the button. Note If the network channel change sequence was not started within 10 seconds after the module has been turned on, network channel changes will not be allowed.
Step 5 Action When you reach the desired symbol, press and hold the button for approximately 5 seconds to lock and save the new setting. The selected network channel's symbol will turn off while the button is depressed. Then it will illuminate (not blink) when the new network channel setting is saved. Once illuminated, release the button. The module will begin using the selected network channel.
Advanced User Options Expression Information Portal (Model IP5) Providing system control outside the MR magnet room, the Expression Information Portal (Model IP5), hereafter referred to as the IP5, is a wireless device that also features printing capabilities and HL7 data output options. The MR400 uses a wireless connection for communication with the IP5. The IP5’s connection to the hospital information system (HIS) is explained in detail in the IP5 IFU.
WARNING Warning The MR400 has been validated with all of the accessories listed below. Only use these specified accessories as other types or brands may compromise the safety and accuracy of the MR400. Patient injury or loss of monitoring may result if incorrect accessories are used. WARNING Warning Do not use sterile items if the packaging is damaged. Patient injury may result if non-sterile accessories are used.
CO2 REF LOFLO LINE, PED DVD CANNULA, BOX 20 989803183281 LOFLO LINE, ADU AIRWAY ADPT, BOX 20 989803183291 LOFLO SAMPLE LINE, ADULT CANNULA,BOX 100 989803185331 LOFLO SAMPLE LINE, PED CANNULA, BOX 100 989803185341 LOFLO SAMPLE LINE, NEO CANNULA, BOX 100 989803185351 LOFLO LINE, ADU DVD CANNULA, BOX 100 989803185361 LOFLO LINE, PED DVD CANNULA, BOX 100 989803185371 LOFLO LINE ADU AIRWAY ADPT, BOX 100 989803185381 ECG Original Part Number REF 9009 989803152291 EXPRESSION MR ECG LEADS, AA
Invasive Blood Pressure REF EXPRESSION MR IBP TRANSDUCER CABLE, 5FT 989803194601 EXPRESSION MR IBP DPT KIT, A/P, BOX 20 989803194631 EXPRESSION MR IBP DPT KIT, I/N, BOX 20 989803194641 (Note that Hospira [Transpac models], and Edwards Lifesciences [Transducer, Model PX260 and adapter cables], have also been qualified for use. Please contact Hospira or Edwards Lifesciences for information about Invivocompatible devices, and contact your sales representative with any questions.
Non-invasive Blood Pressure (NIBP) REF ADULT PRESSURE INTERCONNECT HOSE 989803183221 NEONATAL PRESSURE INTERCONNECT HOSE 989803183231 Respiration (Pneumatic) PNEUMOGRAPH,CHEST,NM,3160 SPO2 Original Part Number REF 94023 989803152791 REF QUICK CONNECT SPO2 PROBE, MRI 989803161991 QUICK CONNECT SPO2 CLIP, ADULT 989803166531 QUICK CONNECT SPO2 CLIP, PEDIATRIC 989803166541 QUICK CONNECT SPO2 GRIP, ADULT, 20/BOX 989803166551 QUICK CONNECT SPO2 GRIP, PED, 20/BOX 989803166561 QUICK CONNECT S
System REF POWER CORD, DANISH, 3 METER 989803181331 POWER CORD, ISRAELI, 3 METER 989803181341 POWER CORD, ARGENTINA, 3 METER 989803181351 POWER CORD, SWISS, 3 METER 989803181361 Temperature REF FLEXTEMP II SENSOR (ESOPHAGEAL/RECTAL/AXILLARY, DIRECT MODE) 989803194511 SURGICAL LUBRICANT, 12 PACK 989803168891 FLEXTEMP SYSTEM, JACKET (BOX 10) 989803178181 Miscellaneous REF MR400 QUICK REFERENCE GUIDE 453564557591 MANUAL, SERVICE, MR400 989803195211 MANUAL, OPERATOR, MR400, DANISH 98980
Miscellaneous REF MANUAL, OPERATOR, MR400, TRAD.
1‐40 Important Information Expression MR400 Instructions for Use
CHAPTER 2 System Overview The MR400 is designed to provide multi‐vital sign patient monitoring and MRI gating capability in the MRI environment while in close proximity to an MRI scanner magnet. The monitoring capabilities of the MR400 can be configured to meet the needs of a wide spectrum of patients from neonate to adult. Every parameter can be accessed and adjusted for the unique condition of each patient.
• Non‐invasive blood pressure (NIBP) • Respiration rate (CO2 or bellows) Note Depending upon the equipped options, your MR400 may not have all indicated parameters. System Components Before use, familiarize yourself with the MR400 and its components.
MRI magnet room MR400 Gating cable Modules to MR400 (wireless) Patient table HIS system MR400 to IP5 (wireless) MRI control room IP5 Printer USB Ethernet Hospital network Acquisition and Control Use of the MR400 is restricted to one patient at a time. The MR400 displays patient measurements acquired during monitoring.
WARNINGS • The use model specifies one IP5 per MR400 system. If more than one IP5 is present on the MR400 system, there is an increased risk of units within the system not synchronizing and displaying incorrect or corrupted settings. • The MR400 should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the equipment or system must be observed to ensure normal operation in the configuration in which it will be used.
Hardware Features Cart Designed for use in the MR magnet room and throughout the MR suite, the MR400 is a self‐ contained mobile patient monitoring system. The MR400 features a wheeled‐cart design with four large lockable casters under its aluminum frame and includes integrated systems for processing, power, display and control, as outlined below. 1 2 7 8 4 2 3 4 9 5 5 6 10 6 1 Display panel (see page 2-6 for details).
7 Storage basket provides storage for Quadtrodes, cuffs, SPO2 attachments and other small accessories; see page 2-12 for details. 8 Module holders provide storage for the wECG and wSpO2 modules; see page 2-12 for details. 9 Wireless processing unit (WPU) houses the communication, processing and power systems for the MR400. 10 Rear panel houses connections for AC mains power, earth ground, gating, USB port (service use only), (optional) waste gas output, and (optional) O2 sensor.
Patient Connection Panel The patient connection panel contains the power switch and LED, and input connections for various patient accessories. Note The illustration shown below features a composite of all available options. Your MR400 will not have all of these options.
Power LED Condition / Meaning Power Switch Color State Power Source Red Steady Power fault detected; contact technical support. N/A Blue Blinking Batteries are charging Off Blue Steady Batteries at full charge Off wECG and wSpO2 Modules The wECG and wSpO2 modules are battery powered and communicate with the MR400 through a bidirectional 2.4 GHz RF link, which is automatically established approximately 30 seconds after power is applied to the module.
wECG Module The wECG module transmits measured ECG signals through the RF link to the MR400, where two ECG signals can be displayed and are available for interfacing with the MR system cardiac gating input. The module also receives information from the MR400 to perform commanded tasks (for example, lead view and filter mode selections).
Network channel indicator illuminates to provide the wireless network channel indication and the status of the wECG module to MR400 communications, as detailed in the table below. Notes • The communication status is also displayed by the MR400; see page 2-16 for details. • For network channel selection details, see page 1-29.
wSpO2 Module The wSpO2 module transmits measured blood oxygen saturation, plethysmography, peripheral pulse data and pneumatic respiration rate values through the RF link to the MR400, where the processed information can be displayed and output for interfacing to the MR system pulse peripheral and respiration gating input.
Notes • The communication status is also displayed by the MR400; see page 2-16 for details. • For network channel selection details, see page 1-29.
To store the wECG module and a connected ECG lead cable Loop the ECG cable trunk with foam insulator and secure it using the Velcro storage strap (see page 5‐2). Then, place the wECG module into a module holder and allow the ECG lead cable to drape. WARNING Do not use the Velcro storage strap to loop the ECG lead cable during MR scanning; otherwise, there is a risk of cable heating and possibly skin burns.
1 2 5 3 4 1 Information bar 2 Soft keypad 3 Status information pane 4 Vital sign boxes 5 Vital sign traces Information Bar The information bar provides general use, vital sign detection and patient information. 1 2‐14 System Overview 2 3 4 5 6 7 1 Set Time indication, and when pressed accesses the date; see page 3-13. 2 Alarm sound state indication; see page 4-4. 3 Heart beat detection indication (and provides a detection tone) according to the HR Tone Source setting; see page 3-21.
5 Alarm Light setting indication; see 4-20. 6 Patient information area, which displays the patient’s name and identifier (ID) when available from an IP5. 7 Patient Type key and the current patient type setting indication; and, when pressed, accesses the Patient Type menu (see page 311).
6 Suspend key places the MR400 in suspend mode 7 Audio Pause key temporarily deactivates alarms 8 Alarm key acknowledges an active alarm 9 1-Touch Alarms key sets all alarm limits according to preset calculation values 10 NIBP Interval key accesses the automatic measurement Interval options 11 Clear Trends key clears stored trend data 12 Zero All key zeros all active invasive blood pressure channels 13 Setup key accesses the Monitor Setup, Printer, and Alarms menus Status Information Pane The status inform
• 3 Indicates the battery time-remaining (given in an hours:minutes format) until power will be exhausted for the wECG module; also, indicates that the wECG module’s communication with the MR400 is good. For detailed battery information regarding the wECG module batteries, see Status Information Panel on page 2-18. 4 Indicates the current power type used by the MR400 (AC power in this example). 5 Indicates that an IP5 is communicating with the MR400.
• Indications are provided for a loss of communication, which is indicated within 2 seconds, and a no data condition (see page 2‐20) will be displayed within 10 seconds for all vital sign information missing due to a non‐communicating wireless module. 2 1 1 1 Indicates that no communication is occurring between the MR400 and a wireless module (wECG in this example), or between the MR400 and the IP5.
Vital Sign Boxes Vital sign (VS) boxes are uniquely colored and labeled graphic frames that contain the numeric measurements and current alarm limits settings for each monitored parameter. Trending indications (arrows) are available for each monitored vital sign, except NIBP. In addition, the VS boxes (except AGENT and GAS) access the associated parameter’s menu. 1 2 3 4 5 10 9 8 7 6 1 ECG VS box provides electrocardiogram and heart rate measurements.
9 TEMP VS box provides temperature measurements when equipped with the temperature option. 10 NIBP VS box provides non-invasive blood pressure measurements. No Data Indications Under certain conditions, no waveforms and one or more vital sign numerics may display three dashes (‐ ‐‐ ), which indicates that no data is available for the parameter(s). Depending upon the cause of this missing data, an alarm condition may be generated.
Other Data Indications The Over State Indication (OVR) If the value of the numeric data item in the vital sign box is greater than the highest value specified for the item, OVR will be displayed in an alarm condition in place of the numeric. See the table on page 4‐25 for measurement range and declaration information.
4 Trace D displays the CO2 respiration waveform (breath rate) 5 Trace E displays invasive blood pressure, channel 1 (P1) waveform 6 Trace F displays invasive blood pressure, channel 2 (P2) waveform 7 System message area displays system messages and alarm flags; see chapter 4.
• To close a menu or item, select . • To clear an entry field, select • To save entered data and close a menu or item, select • To enter data, save changes and close a menu or item, select . . . Default Setting Indications The default setting of a menu appears as the highlighted item, or as the item with an asterisk in a menu. System Messages System messages are displayed to inform you about a current operation or condition, as discussed throughout this manual.
To enter normal mode Press the Main Screen key. Any open menu will close and any highlighted VS box will be deselected (that is, the normal screen will be displayed). See page 2‐14 for an illustration. Suspend Mode WARNING Suspend mode should never be used to silence alarms or when a patient is being actively monitored as a delay in treatment and possible patient injury could result.
CHAPTER 3 Getting Started Initial setup is important to achieve expected results and seamless operation. WARNINGS • Perform operational verification prior to use. If the MR400 fails to function properly, remove it from use and contact technical support personnel. • Do not allow the patient to move while the MR400 is being used as over-activity may result in prolonged or inaccurate readings. • Position of the accessories may affect measurement accuracy.
WARNINGS • The patient connector inputs for all parameters are protected against the use of a defibrillator by internal circuitry when the recommended patient cables or accessories are used. • Defibrillation and electrosurgery: Do not touch the patient, or table, or instruments, during defibrillation. This equipment does not provide protection against burning of the patient.
When positioning the MR400 for use, observe the following warning and cautions: WARNING Warning .The MR400 shall meet its full function and performance specifications when positioned in the MR room of a 3T magnet, up to the 5000 gauss line, 4W/kg SAR, and 7.2 µT B1rms in all orientations. Always secure the MR400’s wheel locks when the unit is placed within the MR system room.
Follow the steps below when operating the MR400. Step Action 1 Press the power switch ; see page 2‐7 for the location. 2 Ensure that the wECG and wSpO2 modules (and IP5, if equipped) have established good communications, and that sufficient power exists for the MR400 and the wireless modules. Also verify proper operation of the patient parameters. See System Power‐up and Communications Verification, below.
Step Action 4 Ensure that batteries are installed in the wSpO2 module (see page 1‐26). 5 Check the battery indicator on the wSpO2 module to ensure that enough charge exists: • Green battery indicator = Charge sufficient; proceed to step 7. • Red battery indicator = Charge low; proceed to step 6. See page 2‐11 for details. (Also, you can reference the status information pane; see page 2‐16.
Step Action 14 (Optional) If equipped with an IP5, ensure good communication between the MR400 and the IP5 by checking the status information pane (see page 2‐16). 15 Ensure proper operation of each patient parameter and alarms. Refer to appropriate chapters in this manual. CAUTION If power to the wireless device with established communications is lost or removed, its network connection will be dropped.
WARNING Warning When using an IP5, make sure that the content of the User Settings option matches that of the MR400 option, and that the same option is selected as the default setup on both systems (see page 3-26). This is important because the device first booted will determine the poweron settings of the system (that is, the MR400 and optional IP5).
User Settings In the Edit User Settings menu, up to ten customized user settings can be saved and one can be selected for use as the default at power‐on.
NOTE When a setting is changed in an active user settings file, a plus sign (+) will appear on the User Settings key. And when edits have been made to an existing user settings file, a warning box and setting change list will appear, prompting you to accept or cancel the changes to proceed. Soft Keyboard—Add New Names can be assigned to your user settings files using the soft keyboard that is displayed when the Add New option is selected; see page 3‐15.
2 1 1 Remove as Default button removes the file as the default user settings file 2 Delete Settings button deletes the file. Initial Alarm Indications After power‐up and immediately following the recall of a stored setup, the MR400 provides an indication of the alarm volume by sounding the alarm tone at its currently adjusted setting for 5 seconds and displaying Check Alarm Volume.
• Alarm flags related to other alarm sound states will be removed from the display. • An alarm condition not previously placed in an audio off state will cause the alarm to sound. Selecting the Patient Type Determining the Patient Type IEC 80601‐2‐30 Edition 1.0, the international standard regarding particular requirements for safety, including essential performance of automatic cycling non‐invasive blood pressure monitoring equipment, defines patient types in two categories: neonatal and adult.
Regardless of the definition, each agency recognizes that the patient type 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 Accordingly, the MR400 uses several operational parameters, including cuff inflation pressure and pulse sensitivity, that vary depending on the selec
• Neo (when selected, Pediatric ECG will also be set to On) NOTE Changing the Patient Type causes the alarm to sound, Change NIBP Cuff to be displayed for 30 seconds, the initial cuff inflation to be reset to the initial pressure for the patient type selected, NIBP > Auto Mode to be set to off, and the alarm limit settings to revert to the default values24). To select the patient type Step 1 Action Press the Patient Type key. (The current setting is displayed.) The Patient Type menu appears.
• Setting sweep speeds • Controlling ECG modes • Controlling alarms • Controlling remote printing WARNING Warning When using an IP5, wait at least 4 seconds if performing a recall or setting a parameter value, as these require a few seconds to propagate through the system. Performing another recall within 4 seconds of a previous recall or after a value change, may result in improperly recalled data.
The following Monitor Setup menu items are available: • Edit User Settings • Parameters • Sound Adjust • Set Time & Date • Sweep Speed • Resp Speed • Service(Bio-Med) To change settings in the Monitor Setup menu Step 1 Action Press the Setup key and then the Monitor key. The Monitor Setup menu appears. Current settings are displayed.
Press the Setup key and then the Monitor key. On the Monitor Setup menu, select Edit User Settings. 1 Factory 2 Add New 3 Backup/Restore 1 2 3 The following options are available: • Factory recalls the factory settings from memory, which cannot be modified. (Default) • Add New allows you to assign a file name, select a default setting, and store a current setup in the memory (up to ten setups can be stored); see page 3‐7 for more information.
Step 7 Action If desired, press the Set to Default button to save the current file as the default setup for use at power‐up. WARNING Warning If you choose to boot the device from a user settings file, confirm that alarm presets are appropriate for the patient prior to monitoring. Failure to do so may cause false or missed alarm conditions. 8 Press the Save & Close button to save the current setup and exit the menu.
Step Action 3 Press the Delete Settings key. 4 Press the Save & Close button to save the current setup. A warning box will appear, prompting you to accept the changes— press Accept to save the current settings or press Cancel to reject the changes. Parameters Controls monitoring functions, as indicated by the absence or presence of the VS box for the parameter, except ECG (see below).
– On turns on the ECG parameter. (Default) • NIBP allows non‐invasive blood pressure monitoring (does not have an associated waveform): – Off turns off the NIBP parameter. – On turns on the NIBP parameter. (Default) • P1 allows invasive blood pressure monitoring: – Off turns off the P1 parameter. (Default) – On turns on the P1 parameter. • P2 allows invasive blood pressure monitoring: – Off turns off the P2 parameter. (Default) – On turns on the P2 parameter.
• AGENT allows anesthetic agent and gas monitoring (but does not have an associated waveform), and CO2 and CO2‐derived respiration rate monitoring: – Off turns off the AGENT parameter. (Default) – On turns on the AGENT parameter. NOTE When AGENT is turned on, CO2 will also be activated, including GAS; however, if AGENT is then turned Off, CO2 will remain active. To control parameters Step 1 Action Press the Setup key and then the Monitor key. The Monitor Setup menu appears.
Press the Setup key and then the Monitor key. On the Monitor Setup menu, select Sound Adjust. 1 Alarms 2 HR Tone Source 2 3 Alarm Volume 3 4 Pulse Volume 4 5 Click Tone 5 6 Click Volume 6 1 The following menu items are available: • Alarms controls the alarm sound (identical to and interactive with Alarm Sound in the Alarms menu): – Off turns off the alarm sound, as indicated by the alarm audio off symbol (see page 4‐ 4).
To control the sounds Step 1 Action Press the Setup key and then the Monitor key. The Monitor Setup menu appears. Current settings are displayed. 2 On the Monitor Setup menu, select Sound Adjust. The Sound Adjust menu appears. Current settings are displayed. 3 Select the menu item for the sound function that you want to control: Alarms HR Tone Source Alarm Volume Pulse Volume Click Tone Click Volume The menu item appears. The current setting is highlighted.
Press the Setup key and then the Monitor key. On the Monitor Setup menu, select Set Time & Date. 1 IPx Time Sync 2 Time Format 3 Date Format 4 Second 5 Minute 6 Hour 7 Day 8 Month 7 9 Year 8 1 2 3 4 5 6 9 The following menu items are available: • IPx Time Sync synchronizes the time and date settings of the MR400 to that of an IP5 (IP5 option required).
Step 2 Action On the Monitor Setup menu, select Time and Date. The Time and Date menu appears. Current settings are displayed. 3 Select the menu item for the time or date function that you want to change: Time Format Date Format The menu item appears. The current setting is highlighted. 4 Select the desired setting from the menu options. The setting is entered. 5 To change other settings, repeat steps 3 and 4. To set the time or date Step 1 Action Press the Setup key and then the Monitor key.
Sweep Speed Sets the sweep rate for all waveforms (displayed and printed), except CO2. To open the Sweep Speed menu Press the Setup key and then the Monitor key. On the Monitor Setup menu, select Sweep Speed. 1 50 mm/s 2 25 mm/s 1 2 The following speeds (in millimeters per second) are available: • 50 mm/s • 25 mm/s (Default) To adjust the sweep rate for all waveforms (except CO2) Step 1 Action Press the Setup key and then the Monitor key. The Monitor Setup menu appears.
Press the Setup key and then the Monitor key. On the Monitor Setup menu, select Resp Speed. 1 25 mm/s 2 12.5 mm/s 3 6.25 mm/s 3 4 3.125 mm/s 4 1 2 The following speeds (in millimeters per second) are available: • 25 mm/s • 12.5 mm/s (Default) • 6.25 mm/s • 3.125 mm/s To adjust the sweep rate for the CO2waveform Step 1 Action Press the Setup key and then the Monitor key. The Monitor Setup menu appears. Current settings are displayed. 2 On the Monitor Setup menu, select Resp Speed.
Press the Setup key and then the Monitor key. On the Monitor Setup menu, select Service(Bio‐Med). 1 Revision Information 2 Simulation Mode 3 Gas Cal 3 4 System Config 4 5 ECG Tests 5 6 NIBP Tests 6 7 Backlight Brightness 7 8 Service Utilities 8 1 2 NOTE Some menu items require entry of a password for access; see page 2-23. To access the SERVICE(BIO‐MED) menu items Step 1 Action Press the Setup key and then the Monitor key. The Monitor Setup menu appears.
Step 5 Action To change other settings, repeat steps 2, 3 and 4. Revision Information Depending upon the installed options, displays revision information for the software and firmware used in the MR400 and wireless modules. To view the revision information Press the Setup key and then the Monitor key. On the Monitor Setup menu, select Service(Bio‐Med). On the Service(Bio‐Med) menu, select Revision Information.
Simulation Mode WARNING Warning The MR400 is equipped with a simulation mode that displays computer generated data for training or demonstration. As a safety feature, Simulation is displayed and appears on all printouts while in simulation mode. Do not attach a patient to the MR400 when in simulation mode and never activate simulation mode when a patient is connected. The MR400 will not monitor patients while in the simulation mode.
Gas Cal Calibrates the gas function(s) when equipped with the CO2 or the AGENT option. NOTE As indicated by displayed message, allow any warm-up to complete before calibrating. To open the Gas Cal menu Press the Setup key and then the Monitor key. On the Monitor Setup menu, select Service(Bio‐Med). On the Service(Bio‐Med) menu, select Gas Cal.
To open the System Config menu Press the Setup key and then the Monitor key. On the Monitor Setup menu, select Service(Bio‐Med). On the Service(Bio‐Med) menu, select System Config.
– Portuguese – Italiano – Dansk – Svenska – Norsk – NLD • ECG Notch Filter applies a notch filter to the ECG signal: – Off – 50Hz – 60Hz (Default) • Pressure Units sets the unit of measure for P1, P2, and NIBP pressure readings: – mmHg (Default) – kPa • Gas Units sets the unit of measure for CO2 pressure readings: – mmHg (Default) – kPa ECG Tests Accesses testing functions for ECG. To open the ECG Tests menu Press the Setup key and then the Monitor key.
NOTE ECG Test Signal is unavailable when Filter Mode > Advanced 2 is selected; see 5-31. To control the ECG Test Signal Step Action 1 Ensure that the wECG module is communicating with the MR400. 2 Press the Setup key and then the Monitor key. The Monitor Setup menu appears. Current settings are displayed. 3 On the Monitor Setup menu, select Service(Bio‐Med). The Service(Bio‐Med) menu appears. Current settings are displayed.
Press the Setup key and then the Monitor key. On the Monitor Setup menu, select Service(Bio‐Med). On the Service(Bio‐Med) menu, select NIBP Tests. 1 Calibrate 2 Static Test 3 Leak Test 4 Stress Test 5 High Range Check 1 2 3 4 5 The following menu items are available: • Calibrate performs calibration of the NIBP system. (Password required) • Static Test performs a static pressure test of the NIBP system.
Press the Setup key and then the Monitor key. On the Monitor Setup menu, select Service(Bio‐Med). On the Service(Bio‐Med) menu, select Backlight Brightness. The following brightness levels are available: • 1 (Minimum) • 2 • 3 • 4 • 5 • 6 (Default) • 7 • 8 (Maximum) To control the brightness of the display backlight Step 1 Action Press the Setup key and then the Monitor key. The Monitor Setup menu appears. Current settings are displayed.
Press the Setup key and then the Monitor key. On the Monitor Setup menu, select Service(Bio‐Med). On the Service(Bio‐Med) menu, select Service Utilities. Enter the password. 1 NIBP Diagnostics 2 CO2 Diagnostics 3 Radio Diagnostics 1 2 3 The following menu items are available: 3‐36 Getting Started • NIBP Diagnostics opens a window that displays NIBP diagnostic data. • CO2 Diagnostics opens a window that displays CO2 diagnostic data.
• Radio Diagnostics opens a window that displays radio diagnostic data.
3‐38 Getting Started Expression MR400 Instructions for Use
CHAPTER 4 Alarms The alarm information here applies to all measurements. Measurement‐specific alarm information is discussed in the sections on individual measurements. The monitor provides patient alarms and INOP alarms. Patient Alarms Patient alarms will illuminate a red or yellow alarm light, where a red alarm light indicates a high priority alarm to alert you to potentially life threatening situations for your patient (for example, a disconnected catheter).
The blue alarm light can be on at the same time as the red or yellow alarm light. When a numeric value becomes missing due to an INOP, the INOP alarm will be present as well as the patient alarm (due to the missing value), with both originating from the same cause. Alarm Delays There is an alarm sound and an alarm light illumination delay of no more than 4 seconds following the displayed alarm flag, provided that the alarm condition still exists after this delay.
Alarm flags associated with a vital sign are displayed alongside the VS box of that parameter (see illustration below), while alarm flags associated with the system are displayed in the system message area (middle and top center of the touch screen, see page 2‐21). When multiple alarm flags are present, they will be stacked in a column.
Audible Alarm Indications WARNING Do not rely exclusively on the audible alarm system for patient monitoring. Adjustment of alarm volume to a low level or off during patient monitoring may result in patient danger. Remember that the most reliable method of patient monitoring combines close personal surveillance with correct operation of monitoring equipment.
Initial Audible Alarm Setting Indications After power‐up and immediately following the recall of a stored setup, the MR400 provides an indication of the alarm volume by sounding the alarm tone at its currently adjusted setting for 5 seconds and by displaying Check Alarm Volume.
Audio Pause Mode Audio pause mode can is useful to temporarily silence alarms and to temporarily extinguish the alarm light (for example, when changing ECG leads or during other user activities that might cause a “false” alarm). Audio pause mode is indicated when the Audio Paused alarm flag, the audio paused symbol (see page 4‐4) and a countdown timer are displayed. (The 120‐second countdown timer period is not user adjustable.
Alarm Volume The loudness of the alarm sounds can be adjusted (45–86 dB, typical). WARNING Always ensure that the alarm sound setting is appropriate for each patient. The alarm sound volume is adjustable for suitability to various clinical environments. When you use the MR400, always ensure that the alarm sound can be heard above the ambient noise level. Failure to do so may cause a lapse in patient monitoring. To control the alarm volume Step 1 Action Press the Setup key and then the Monitor key.
Managing Alarm Functions WARNINGS • Always respond promptly to any alarm condition; otherwise, treatment of the patient could be delayed. • You should ensure that the current alarm preset is appropriate prior to use on each patient. Failure to do so may cause a lapse in patient monitoring. • Setting the alarm limits to extreme values can render alarm monitoring useless.
Step 2 Action Select Limits Display. The Limits Display menu appears. The current setting is highlighted. 3 Select the desired option for display of the alarm limit settings: Off On The setting is selected. Adjusting the Alarm Limits WARNING Alarm limits can be set to a wide range of values, including off (with the exception of O2, N2O and FiCO2). It is the responsibility of the operator of the MR400 to ensure that alarm limit values appropriate for each patient are established and set.
1 23 4 5 16 15 14 13 12 11 4‐10 Alarms 10 9 8 7 6 1 Parameter label for alarm limit settings (active adjustment shown) 2 Low button 3 Lower alarm limit setting 4 Upper alarm limit setting 5 High button 6 Off button 7 Clear entry button 8 Enter button 9 Decimal point button 10 Gas Alarms button 11 Alarms button 12 Plus / minus button 13 Keypad 14 Decrement button 15 Current adjustment 16 Increment button Expression MR400 Instructions for Use
The Alarm Window Alarm limits have minimum and maximum values that are not adjustable (see page 4‐22). Within the minimum and maximum alarm limits, adjustable lower and upper limit settings establish an alarm window. Vital sign measurements that fall within the alarm window will not result in an physiological alarm. It is only when a vital sign measurement exceeds the alarm window for a monitored parameter that a physiological alarm will be declared. (An illustration is shown below.
The Extreme Tachycardia delta value will retain its adjusted value as the HR high alarm limit setting is adjusted downward, but will begin to shrink in value as the high alarm limit setting is adjusted closer to the alarm limit maximum. Desat Alarm Setting The Desat alarm setting is restricted to a maximum value that is 2 less the SPO2 low alarm limit setting, while the minimum setting can be as low as the alarm minimum. See page 6‐11 for setting details.
To adjust the upper and lower alarm limit settings for all monitored parameters Step 1 Action Press the Setup key and then the Alarms key. The Alarms menu appears. Current settings are displayed. 2 Select 1‐Touch High %. The 1‐Touch High % menu appears. The current setting is highlighted. 3 Select the desired percentage: 5% 10% 15% 20% 30% The setting is selected. 4 Select Lower Window. The Lower Window menu appears. The current setting is highlighted.
15 1 14 2 13 3 12 4 11 5 10 6 9 7 8 1 TEMP – (Temperature) 2 P1 (Sys) – (P1 [Systolic]) 3 P1 (Dia) – (P1 [Diastolic]) 4 P1 (Mean) 5 P2 (Sys) – (P2 [Systolic]) 6 P2 (Dia) – (P2 [Diastolic]) 7 P2 (Mean) 8 CO2 (RESP) – (CO2 [Respiration]) 9 CO2 (Fi) – (CO2 [Fractional inspired]) 10 CO2 (Et) – (CO2 [End-tidal]) 11 NIBP (Mean) 12 NIBP (Dia) – (NIBP [Diastolic]) 13 NIBP (Sys) – (NIBP [Systolic]) 14 SPO2 15 HR – (Heart rate) To adjust the alarm limit settings for a sing
Step 2 Action Press the desired parameter label on the Alarms menu: HR SPO2 NIBP (Sys) NIBP (Dia) NIBP (Mean) CO2 (Et) CO2 (Fi) CO2 (RESP) TEMP P1 (Sys) P1 (Dia) P1 (Mean) P2 (Sys) P2 (Dia) P2 (Mean) The background of the selected parameter becomes highlighted (TEMP in this example). 3 Depending upon the alarm limit to be modified, press the Low button or the High button. Parameter label Low button High button In this example, the Low button was selected to adjust the lower alarm limit setting.
Step 4 Action Use the increment or the decrement button to adjust the setting. Or, directly input the value using the keypad, the plus / minus button and/or the decimal point button then press the Enter button. (For item locations, see Alarm Limit Controls on page 4‐9.) Adjusted lower limit The current adjustment will reflect the setting. (In this example, the lower limit setting was adjusted from 36 to 33.) Lower alarm limit setting 5 To change the remaining setting, repeat steps 3 and 4.
Enabling Print on Alarm If the MR400 is connected to an IP5 that is equipped with a printer, a printout can be automatically generated when a physiological alarm occurs. See the IP5 IFU for details. Alarms Menu The Alarms menu allows you to configure the MR400 for setup and control of the vital sign alarms. To open the Alarms menu Press the Setup key and then the Alarms key.
The following Alarms menu items are available: • 1-Touch High % • 1-Touch Low % • Alarm Sound • Alarm Light • Default Limits • Limits Display To change settings in the Alarms menu Step 1 Action Press the Setup key and then the Alarms key. The Alarms menu appears. Current settings are displayed. 2 Select any of the following menu items: 1‐Touch High % 1‐Touch Low % Alarm Sound Alarm Light Default Limits Limits Display For information about these options, see the appropriate sections below.
• 10% • 15% • 20% (Default) • 30% To set the upper window See Setting Alarm Limits Globally on page 4‐12. Note If, during calculation, a patient’s monitored value is so high that it exceeds the alarm limit range for the parameter, then the respective alarm limit will be set to the highest value but not off, as indicated in the table on page 4-22. 1-Touch Low % Sets a percent value used to calculate the low alarm limits when the 1‐Touch Alarms key is pressed.
Alarm Sound WARNING The alarm sound can be turned off, as indicated by the symbol. Always ensure that the alarm sound setting is appropriate for the monitoring environment and for each patient. The alarm sound volume is adjustable for suitability to various clinical environments. When you use the MR400, always ensure that the alarm sound can be heard above the ambient noise level; otherwise, treatment of the patient could be delayed.
Note As defined in the table below, the current Alarm Light setting is indicated by the displayed symbol on the information bar (see page 2-14). Alarm Light Setting Displayed Symbol Continuous Temporary Off To adjust the alarm light setting Step 1 Action Press the Setup key and then the Monitor key. The Monitor Setup menu appears. Current settings are displayed. 2 On the Monitor Setup menu, select Alarm Light. The Alarm Light menu appears. The current setting is highlighted.
• Off does not display the alarm limit settings. • On displays the alarm limit settings. (Default) To control the display function for the alarm limit settings Step 1 Action Press the Setup key and then the Alarms key. The Alarms menu appears. Current settings are displayed. 2 Select Limits Display. The Limits Display menu appears. The current setting is highlighted. 3 Select the desired option for display of the alarm limit settings: Off On The setting is selected.
Vital Sign or Parameter Low Alarm Limit* Unit Patient Type mmHg kPa All RPM All Off, 4 mmHg kPa All °C °F Maximum 0 20, Off 2.7, Off 2 40 20 100, Off 2 Off, -30 Off, -4.0 250 33.3 -30 -4.0 250, Off 33.3, Off 2 All Off, 20.0 Off, 68.0 44.0 111.2 20.0 68.0 44.0, Off 111.2, Off 1 mmHg kPa Adult Off, 30 Off, 4.0 270 36.0 30 4.0 270, Off 36.0, Off 2 — Mean mmHg kPa Adult Off, 20 Off, 2.7 255 34.0 20 2.7 255, Off 34.
Low Alarm Limit High Alarm Limit Minimum Maximum Minimum Maximum Low and High Limit Separation Vol. % Off, 0.1 8.0 0.1 8.0, Off 1 Vol. % Off, 0.1 8.0 0.1 8.0, Off 1 0 80 1 18 100 1 Breath Phase and Gas Unit SEV (Et) Expired Sevoflurane SEV (Fi) Inspired Sevoflurane N2O (Fi) Inspired Nitrous Oxide Percent O2 (Fi) Inspired Oxygen Percent No low alarm 18 100 Alarm Limit Factory Defaults In the event of power loss, any alarm limit settings that were changed will be lost.
Adult Vital Sign or Parameter Pediatric Neo Unit Low Limit High Limit Low Limit High Limit Low Limit High Limit NIBP Systolic mmHg kPa 65 8.7 190 25.3 70 9.3 120 16.0 70 9.3 100 13.3 NIBP Mean mmHg kPa 55 7.3 135 18.0 50 6.7 90 12.0 40 5.3 90 12.0 NIBP Diastolic mmHg kPa 40 5.3 125 16.7 40 5.3 70 9.3 35 4.7 50 6.7 Temperature °C °F 36.0 96.8 39.0 102.2 36.0 96.8 39.0 102.2 36.0 96.8 39.0 102.2 DES (Et), Expired Desflurane Vol. % Off 12.0 Off 12.0 Off 12.
Vital Sign or Parameter Numeric Item Units Patient Type SPO2 Saturation % All P1 and P2 Systolic mmHg P1 and P2 Mean P1 and P2 P1 and P2 Measurement Range Over / Under Values Low High Under Over 1 100 none none Adult -30 250 -30 250 mmHg Ped -30 250 -30 250 Diastolic mmHg Neo -30 250 -30 250 Pulse Rate BPM All 30 250 30 250 NIBP Systolic mmHg Adult 30 270 30 270 NIBP Systolic mmHg Ped 30 180 30 180 NIBP Systolic mmHg Neo 30 130 30 130
Vital Sign Value State A vital sign value is considered missing (as indicated by three dashes, ‐ ‐ ‐) when the vital sign has produced a value since the monitor was turned on, but can no longer produce a value. Examples of the values that could become missing during normal use, include: • ECG heart rate value if the leads are removed. • SPO2 value during No Probe, Probe Off, et cetera. • Temperature value if the probe was removed. • Invasive pressure values if the transducer is removed.
Patient Alarm From Condition Indication Missing heart rate data ECG, SPO2, P1 The heart rate data, once present, Flashing yellow dashes (- - -) in the heart rate (or P2) can no longer be produced. numeric in the ECG VS box and in the SPO2 VS box, yellow alarm light, medium priority alarm tone Over maximum heart rate value ECG, SPO2, P1 The heart rate measurement has (or P2) violated the upper parameter range.
Patient Alarm From Condition Indication Violated CO2 respiration rate value CO2, AGENT The CO2 respiration rate measurement has violated an alarm limit setting. Depending upon RESP VS box configuration: Missing CO2 respiration rate data CO2, AGENT The CO2 respiration rate data, once present, can no longer be produced.
Patient Alarm From Condition Violated secondary agent Et value AGENT The end-tidal measurement for the Flashing yellow secondary agent Et numeric in secondary agent gas has violated the AGENT VS box, yellow alarm light, an alarm limit setting. medium priority alarm tone, where OVR displayed if the value is greater than the highest specified Violated secondary agent Fi value AGENT The fractional inspired measurement for the secondary agent gas has violated an alarm limit setting.
Patient Alarm From Condition Indication Violated non-invasive blood pressure mean value NIBP The non-invasive blood pressure Flashing yellow mean numeric in the NIBP VS mean measurement has violated an box, yellow alarm light, medium priority alarm alarm limit setting.
Message, Location, Indication What to Do Lead Saturation Baseline offset of the ECG input signal is too large for process and display of the waveform. Replace the Quadtrode electrode. ECG alarm flag area, blue alarm light, INOP alarm tone Note The error message can be displayed for trace A and/or for trace B. SPO2 Message, Location, Indication What to Do Bad Probe The SpO2 probe is defective. Replace the SpO2 probe.
Message, Location, Indication What to Do Noise Excessive patient motion, the MRI scan sequence or electrical interference is causing noise in the SpO2 system: SPO2 alarm flag area, blue alarm light, INOP alarm tone • Stop any patient motion, especially at the monitored site. • Ensure that the module is placed outside of the MR bore. • Ensure the clip (or grip) is positioned in a way that does not expose it to bright ambient light.
Message, Location, Indication What to Do CO2 Low Flow Message may appear when the sampling line is initially connected; allow the a few seconds for the flow to be established. Otherwise, the detected flow rate is 10 percent less than nominal; in this case, check the sampling line for pinches or obstructions then clear any pinch or replace if necessary. CO2 alarm flag area, blue alarm light, INOP alarm tone If the message persists, contact technical support or authorized service personnel.
Message, Location, Indication What to Do Multiple Agents More than one anesthetic agent gas was detected in a given breath phase, with a total MAC of the detected mix is less than 3 MAC. AGENT alarm flag area, blue alarm light, INOP alarm tone Note If multiple agents have been detected with a total MAC of the detected mix greater than 3 MAC then this message will be accompanied by a yellow alarm light and medium priority alarm tone.
Message, Location, Indication What to Do Transducer Faulty A electrical transducer malfunction has been detected. P1 (or P2) alarm flag area, yellow alarm light, medium priority alarm tone Transducer Not Present P1 (or P2) alarm flag area, yellow alarm light, medium priority alarm tone • Check the transducer cable connection. • Replace the transducer. • Contact technical support or authorized service personnel if the message persists. An IBP transducer was not found.
NIBP Message, Location, Indication What to Do Communication Error An internal NIBP error has occurred. Discontinue use of NIBP and contact technical support or authorized service personnel.
Other Status Indications Message, Location, Indication Condition All Alarms Are Off All alarm limits have been turned off. System message area, no alarm light, no alarm tone Audio Off Alarm sound is silenced. System message area, no alarm light, no alarm tone Audio Paused Alarm sound is paused. System message area, no alarm light, no alarm tone Change NIBP Cuff The Patient Type was changed so the NIBP cuff should be changed.
Message, Location, Indication Condition Charge level of the cart batteries is low. Connect the MR400 cart to external power and allow the batteries to charge. WARNING A red battery symbol indicates that the main batteries in the MR400 have fallen below the required operational output and system shutdown with loss of monitoring will occur. Immediately locate an AC outlet and connect the MR400 to avoid a loss in monitoring.
4‐40 Alarms Expression MR400 Instructions for Use
CHAPTER 5 Monitoring ECG Electrocardiogram (ECG) monitoring inside the MRI environment is unique and requires additional precautions to permit safe patient procedures. It is always important to remember that the risk of radio frequency (RF) heating is ever present when any electrical conductors (for example, ECG lead cables) are placed in the MR system bore. By following the operating precautions, warnings and the guidelines below, these risks can be minimized.
The proper placement of the ECG electrodes in the MRI is critical to reducing the blood flow induced distortion of the ECG waveform. With proper strategic placement of the ECG electrodes and minimization of ECG lead cable length, this blood flow induced distortion can be kept to a minimum, as discussed in this section.
Quadtrode Electrodes The Quadtrode electrodes serve as patient connection points for the ECG lead cable clips. Different Quadtrode electrodes are available to meet each monitoring requirement. The components of a Quadtrode electrode are detailed below.
Step 4 Action Prep the placement site(s) on the patient and then apply the Quadtrode electrode to the patient. See Preparing the Quadtrode Electrode Site on page 5‐11. 5 Attach the lead cable clips to the contacts on the Quadtrode electrode. See Attaching the ECG Lead Cable on page 5‐12. 6 Evaluate the ECG signal strength and make adjustments as needed before the patient enters the scanner. See Checking the ECG Signal Strength on page 5‐16.
Step 11 Action Begin scan sequence and observe the ECG waveform. If the ECG waveform becomes compromised during scanning, then change the lead view and/or the Filter Mode on the MR400. Note ECG performance during MRI scanning can be further improved by modifying scan sequence parameters at the MRI console.
The table below highlights the recommended uses of ECG lead cables and Quadtrode electrodes.
Identifying the Placement Site for the Quadtrode Electrode WARNING Warning Ensure that the location of the electrodes is compliant to the requirements of your electrosurgical equipment to reduce the possibility of burns; however, note that monitoring in the MR environment requires specific electrode placement. (See page 5-3 to ensure the highest quality ECG signal. For questions and guidance regarding placement, contact technical support; see page 14-16 for contact information.
The diagrams below illustrate Quadtrode electrode placement site(s) according to patient type, including the preferred Quadtrode electrode type and location for different patient body sizes. Selecting sites on adult female patients Average weight adult female* Overweight adult female* CV Quadtrode CV Quadtrode Preferred Preferred Standard Quadtrode Standard Quadtrode *Where grayed images indicate placement sites against the ribcage under the breast.
Selecting sites on adult male patients Average weight adult male Overweight adult male* CV Quadtrode CV Quadtrode Preferred Standard Quadtrode Standard Quadtrode Preferred *Where the grayed image indicates a placement site against the ribcage under the breast.
Selecting sites on pediatric patients 5‐10 Monitoring ECG Pediatric female Pediatric male CV Quadtrode CV Quadtrode Standard Quadtrode Standard Quadtrode Preferred Preferred Expression MR400 Instructions for Use
Selecting sites on infants and neonatal patients Infants and Neonates Standard Quadtrode Neonatal Quadtrode Preparing the Quadtrode Electrode Site Proper preparation for the application of the Quadtrode electrode is critical to ECG performance. The result of poor application preparation will be poor ECG monitoring performance. If electrode contact with the skin is poor, then remove and discard the Quadtrode electrode, and repeat the site preparation process again according to the instructions below.
Step Action 3 If necessary, shave the application area to remove hair from the selected Quadtrode electrode site(s). 4 Apply ECG Skin Prep Gel (REF 989803152291) to a gauze pad. 5 Briskly rub the selected site(s) with the gauze pad (the skin may turn pink). 6 Remove any excess gel with a clean gauze pad. 7 Place the Quadtrode electrode at the prepared site(s) on the patient.
AAMI ECG Lead Cable Connections IEC ECG Lead Cable Connections AAMI ECG Lead Cable Clip Designator / Color IEC ECG Lead Cable Clip Designator and Color RA / White R / Red Right arm RL / Green N / Black Right leg LA / Black L / Yellow Left arm LL / Red F / Green Left leg Associated Limb CAUTION ECG lead cable clips should not be placed on the patient’s extremities.
Step 2 Action Depending upon the ECG lead cable type, attach the clips to the Quatrode electrode contacts, as shown in the appropriate connection diagram on page 5‐12. Squeeze each clip open then place the clip onto the electrode contact and release. CAUTION When inserting or removing the clip leads, use the clip as the fingerhold; never pull or apply excessive force to the wires. 3 If using a standard Quadtrode electrode, secure the lead cable wires using the lead retainer.
Step 8 Action Ensure that the ECG signal has the necessary amplitude by checking the displayed waveform; see Checking the ECG Signal Strength on page 5‐16. If Lead Fail is displayed, see page 5‐15 for troubleshooting details; or, if Lead Saturation is displayed, replace the Quadtrode electrode, see page 5‐11. Note During a Lead Fail condition, if the HR Source is set to ECG, then no HR measurement numeric will be displayed in the ECG and SPO2 VS boxes; see page 5-15 for an example.
Checking the ECG Signal Strength Evaluate the ECG signal produced by the patient before entry into the MRI scanner, the optimum time to correct any problem. A minimum signal strength should be present, as weaker signals may be prone to gradient interference: • Select Scale to adjust the displayed size of the waveform(s), where the scale indicator provides, a 1 millivolt (mV) reference at any given setting; see Selecting the Scale, below).
Step 4 Action Select the setting. Only a setting of 5x or 10x is recommended. Auto 1x 5x 10x 15x 20x 25x 30x 40x The setting is applied. 5 Take note of the scale indicator; see page 5‐22. If the selected scale results in an ECG trace so large that the waveform peaks are distorted or clipped, Overscale will be displayed. In this case, select another setting to resize the waveform until the message stops.
Step 6 Action Select the desired lead view setting. I II III AVL AVR AVF The setting is changed. Note When presented with poor gating or heart rate performance, it may be necessary to use the Pediatric ECG setting; see page 5-32. 7 If the amplitude did not improve, repeat step 5 and cycle through the remaining lead view settings until a 1 mV signal amplitude is attained. 8 If the amplitude did not improve, remove the ECG lead cable and the Quadtrode electrode.
• Selecting Monitor as the Filter Mode for the scan sequence; see page 5‐31. • Scan sequence parameters. • Improper connection of ECG lead cable to Quadtrode electrode contact locations. • Routing the ECG lead cable adjacent to the body coil or underneath an extremity coil. • Excessive distance between electrodes when using CV Quadtrode electrodes.
Positioning the ECG lead cable Position and keep the ECG lead cables in a straight line. Never allow the ECG lead cables to touch the MR system bore. Any loop (circular, U‐shaped, S‐shaped) in the cables or cable contact with the MR system bore will cause heating in the cables or in the patient electrodes. Follow the steps below to minimize the cable heating risk.
Positioning the wECG module WARNING Warning The wECG module must be kept outside the system bore or image distortion may result. This is a result of proton emissions from the ECG module.
WARNING Warning If the wECG module is positioned incorrectly when used within the MR magnet room, the following factors may cause ECG waveform distortion and numeric inaccuracies: • Fast magnetic field changes usually found with, but not limited to, scan sequences using Peripheral Nerve Stimulation (PNS) levels above 80 percent. • Severe vibrations induced by scan sequences using PNS levels above 80 percent. • The distance from the bore iso-center in the x, y, or z directions.
1 16 2 3 4 5 6 15 7 8 14 9 13 12 Item Name Definition 1 Is the ECG waveform (Trace A, when enabled) ECG VS waveform 11 10 Note To change the waveform speed, see Sweep Speed on page 3-25. 2 Alarm flag area Displays ECG alarm flags when detected; see page 4-31.
Item Name Definition 12 Is the ECG waveform (Trace B, when enabled) ECG VS waveform Note To change the waveform speed, see Sweep Speed on page 3-25.
7 Enter button 8 Current adjustment 9 Extreme Bradycardia delta value 10 Extreme Bradycardia alarm setting 11 Alarm limit, minimum 12 Lower alarm limit setting 13 Upper alarm limit setting 14 Alarm limit, maximum 15 Extreme Tachycardia alarm setting 16 Extreme Tachycardia delta setting To change the heart rate alarm limit settings Step 1 Action Select the alarm limit settings in the ECG VS box. The HR Alarm Limits menu appears. Current settings are displayed.
ECG Menu ECG menu items allow you to control ECG traces, functions and settings. To open the ECG menu Select the ECG VS box. ECG menu ECG VS box The following ECG menu items are available:.
To change settings in the ECG menu Step 1 Action Select the ECG VS box. The ECG menu appears. Current settings are displayed. 2 Select from the following ECG menu items: Trace A Lead Trace B Lead Scale Gating Source HR Source HR Tone Source Filter Mode Extreme HR Pediatric ECG T‐Wave Suppression The menu item appears. The current setting is highlighted. 3 Select the desired setting from the menu options (except Extreme HR, Pediatric ECG and T‐Wave Suppression, which are selectable on the ECG menu).
See Changing the Lead View on page 5‐17. Trace B Lead Sets the ECG B lead configuration (lead view), allowing you to view two ECG waveforms simultaneously. The following options are available: • Off (Default) • I • II • III • AVL • AVR • AVF To set the ECG B lead See Changing the Lead View on page 5‐17. Scale Sets the scale for the ECG waveforms. After making this setting, take note of the scale indicator (see page 5‐22).
Note Scale does not affect the signal analyzed by the MR400 for QRS detection and ECG gating. Gating Source Sets the cardiac gating source based on a measured signal that is used for MR system triggering. (This is the same option as in the SPO2 menu.) The following options are available: • ECG outputs a signal that represents the detection of the R‐peak of a QRS complex. (Default) • Pulse outputs a signal that represents the detection of the peak of the peripheral pulse complex.
• SPO2 sets SPO2 as the source. To set the heart rate source Step 1 Action Select the ECG VS box. The ECG menu appears. Current settings are displayed. 2 Select HR Source. The HR Source menu appears. The current setting is highlighted. 3 Select the desired setting for the heart rate source: Auto ECG ABP SPO2 The source is changed.
Step 2 Action Select HR Tone Source. The HR Tone Source menu appears. The current setting is highlighted. 3 Select the desired setting for the tone source: Off QRS SPO2 The setting is changed. Filter Mode Sets the filtering mode for the ECG signal. All filtering mode except Monitor utilize an adaptive filter scheme for removal of gradient artifacts generated by MR systems.
• Advanced 2 provides the best possible performance on 1.5 and 3.0T MR systems for removal of gradient artifacts generated by MR systems during MRI sequences such as neurological and cardiovascular scans. To set the filter mode See Selecting the Filter Mode on page 5‐22.
Note If Patient Type is set to Neo then Pediatric ECG is set to On and locked. When Patient Type is changed to Adult, Pediatric ECG will be set to off and unlocked. Pediatric ECG Patient Type Condition Off Adult Unlocked On Pediatric Unlocked On Neonatal Locked To control pediatric ECG filtering Step 1 Action Press the Setup key and then the Monitor key. The Monitor Setup menu appears. Current settings are displayed.
To control T‐wave suppression Step 1 Action Select the ECG VS box. The ECG menu appears. Current settings are displayed. 2 Locate T‐Wave Suppression and select the desired setting: Off On The setting is entered.
CHAPTER 6 Monitoring SPO2 The pulse oximetry feature of the MR400 uses a motion‐tolerant signal processing algorithm based on Fourier Artifact Suppression Technology (FAST) and is calibrated to display oxygenated hemoglobin measurements, a visual pulse indication and a pulse rate, specifically: • Oxygen saturation of arterial blood (SPO2): The percentage of oxygenated hemoglobin in relation to the sum of oxyhemoglobin and deoxyhemoglobin (functional arterial oxygen saturation).
WARNING Philips has verified the compatibility of the monitor, probe, and cable specified in the Accessory List. The user should verify that only Philips accessories specified in the Accessory List are used. Otherwise, patient injury can result. CAUTION If dropped, the wSpO2 module must be verified for correct operation before use; see page 14-12. Note Refer to your facility's biohazard procedure for disposal of SPO2 attachments and probes when they become unusable.
Attaching the Clip or Grip to the SpO2 Probe To attach a clip (or grip) to the SpO2 probe Carefully snap the fiber heads on the SpO2 probe into the receptacles (windows) on the SpO2 attachment (clip or grip). Either fiber head can be inserted into either window on a clip or grip. 2 3 1 SpO2 probe 2 SpO2 attachment (clip shown) 3 Fiber heads 1 Applying the SpO2 Attachment to the Patient Read the warnings before applying an SPO2 attachment to the patient.
To apply a reusable SpO2 clip to the patient Step Action 1 Select the application site. It should match the SpO2 clip size so that the attachment does not fall off or apply excessive pressure at the site. 2 If present, remove any colored nail polish from the application site. 3 Press the clip to open. 4 Push the clip over a finger so either fiber head is on the top over the root of the nail and the other fiber head opposite to it.
To apply a disposable neonate SpO2 grip to the patient Step Action 1 Select the application site. It should match the SpO2 grip size so that the attachment does not fall off or apply excessive pressure at the site. 2 Lift off the release liners that protect the adhesive. 3 Proceed according to the application site: • Foot application: Align the hinge on the outside facing ridge of the foot. Make sure the attachment is as far as possible to‐ ward the small toe but not over it.
Perfusion Index Value When enabled, the displayed perfusion index value (see page 6‐8) is an indication of the pulsatile portion of the SpO2 signal caused by the patient's arterial blood flow. If you need an indication of change in pulse volume, use perfusion index value. This value can also be used as a quality indicator of the SpO2 measurement from the module. The table below provides general guidelines regarding this index value. Perfusion Index Value Meaning Above 1.
WARNING If the wSpO2 module is incorrectly positioned when used within the MR magnet room, the following factors can cause SPO2 waveform distortion and numeric inaccuracies, and respiration 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. • Distance from the bore opening. • Distance from the bore iso-center in the x, y, or z direction.
Step 8 Action Select the Patient Type. See Selecting the Patient Type on page 3‐11. 9 Check for any displayed SPO2 messages If a message is present, follow the recommended action to achieve better results (see page 4‐26). 10 Place the 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.) 11 Keep the SpO2 probe and module outside the MR system bore. 12 Place the module on a cushioned surface.
Item Name Definition 1 Is the detected SpO2 (pleth) pulsatile waveform (Trace C), automatically adjusted for proper viewing if above a minimum level SpO2 VS waveform Note To change the waveform speed, see Sweep Speed on page 3-25. 2 Alarm flag area Displays SPO2 alarm flags when detected; see page 4-31.
WARNINGS • SPO2 monitoring requires the detection of valid pulses to correctly determine SPO2 and heart rate values.
Changing the SPO2 Alarm Limits The SPO2 Alarm Limits menu can be accessed by touching the alarm limit settings in the SPO2 VS box.
Step 3 Action Using the keypad, or the increment, decrement, or Off buttons, enter the desired setting. The current adjustment will reflect the setting. 4 Press the Enter button to save the setting. The alarm limit setting is updated. 5 To change other limit settings, repeat steps 2, 3, and 4. The current adjustment will reflect the change. Note See chapter 4 for detailed alarm limit setting instructions and options. SPO2 Menu SPO2 menu items allow you to control SPO2 functions and settings.
The following SPO2 menu items are available: 1 Size 2 Averaging Time 2 3 Perfusion Index 3 4 Gating Source 4 5 Desat 5 6 Desat Time 6 7 HR Source 7 8 HR Tone Source 8 1 To change settings in the SPO2 menu Step 1 Action Select the SPO2 VS box. The SPO2 menu appears. Current settings are displayed. 2 Touch the menu item to select one of the following SPO2 options: Size Averaging Time Perfusion Index Gating Source Desat Desat Time HR Source HR Tone Source The menu item appears.
• 10% • 20% • 40% • 60% • 80% • 100% (Default) To adjust the size of the SPO2 waveform See Changing the SPO2 Waveform Amplitude on page 6‐10. Averaging Time Selects how quickly the reading responds to changes in the patient’s saturation, where selecting a longer duration will prevent the saturation value from changing quickly which can be useful for avoiding alarm triggering in patients with very dynamic conditions such as neonatal and pediatrics.
Perfusion Index Controls the perfusion index value indication and alarm function (see page 5‐6). The following options are available: • Off disables the perfusion index functions. • On enables the perfusion index functions. (Default) To control the perfusion index functions Step 1 Action Select the SPO2 VS box. The SPO2 menu appears. Current settings are displayed. 2 Locate Perfusion Index and select the desired setting: Off On The setting is entered.
• On enables the desat alarm function. (Default) To control the desat alarm function Step 1 Action Select the SPO2 VS box. The SPO2 menu appears. Current settings are displayed. 2 Locate Desat and select the desired setting: Off On The setting is entered. Desat Time When Desat is on, this sets the time that must pass before declaring that a desaturation condition exists.
Step 2 Action Select Desat Time. The Desat Time menu appears. The current setting is highlighted. 3 Select the desired time (in seconds) for the alarm indication: 20 Sec 25 Sec 30 Sec 35 Sec 40 Sec The setting is changed. HR Source Selects the source that produces the heart rate, as displayed in the ECG and SPO2 VS boxes (identical to and interactive with same option in the ECG, P1 and P2 menus).
Step 3 Action Select the desired setting for the heart rate source: Auto ECG ABP SPO2 The source is changed. HR Tone Source Sets the source used for the heart rate tone (identical to and interactive with same option in the in the Monitor Setup > Sound Adjust menu and in the ECG menu). The following options are available: • Off removes the heartbeat detected symbol from the display and no pulse tone will be sounded.
CHAPTER 7 Monitoring CO2 (LoFlo Option) When equipped with the LoFlo CO2 option, the patient’s airway respiratory gas can be monitored. The system uses sidestream measurements to produce: • A fractional inspired CO2 (FiCO2) value (the lowest reading of the CO2 waveform in the previous 20 seconds) and an end‐tidal CO2 (EtCO2) value measured during expiration. • A respiration rate: The number of breaths per minute. • A waveform of the concentration of carbon dioxide in the respiratory gases.
Operation and Use When monitoring anesthetic agent gases, the typical operations and possible conditions that can arise may result in potential messages requiring your attention. See page 4‐26 for a message listing and suggested actions. Warm-Up Period In order to achieve accurate identifications and measurements, the LoFlo system requires a warm‐up period to thermally stabilize. This warm‐up period begins when the CO2 parameter is activated.
Step 2 Action Select the CO2 VS box. The CO2 menu appears. Current settings are displayed. 3 Select Zero Cal. Calibration will begin and Performing CO2 Zero will be displayed. When complete, the message will be removed. Breath Rate Distortion The effect of rise time distortion to the gas curve becomes apparent when the breathing rate increases so that the time for a full inspiratory or expiratory event gets shorter.
Patient Preparation for CO2 Monitoring When preparing a patient, the accessory position on the patient will impact the performance and operation of the CO2 parameter. Selecting the CO2 Accessory In patients on a breathing circuit, a sample of the respiratory gas is drawn from the patient’s breathing circuit through an airway adapter and a gas sampling line. In patients who are not on a breathing circuit, the gas sample is drawn through a nasal cannula.
2 If CO2 Warming Up is displayed, wait as the system thermally stabilizes (about 2 minutes). When the message is cleared, proceed. 3 Always remove the patient sampling line from the CO2 port when not in use. (To remove the sampling line, press down on the locking tab and pull the connector from the port.) Note To increase the life of the filter and pump, when CO2 will not be used to monitor a patient, we recommend turning the CO2 parameter off; see Parameters on page 3-18.
Applying the Sampling Line to the Patient Select the patient sampling line that is appropriate for the patient size and application. Patient sampling lines with the airway adapter are intended for use with breathing circuits and anesthesia circuits that have an integrated airway adapter. WARNING Patient sampling lines are intended for single-patient use only. Do not clean or disinfect these items. Follow your hospital’s guidelines for appropriate disposal.
Step 7 Action Place the airway adapter at the proximal end of the airway circuit. CAUTION Always insert the patient sampling line into the CO2 port before inserting the airway adapter into the breathing circuit. Failure to follow this may introduce a leak in the circuit, thereby reducing set minute volume. Note Do not place the airway adapter between the ET tube and the elbow as this may allow patient secretions to accumulate in the adapter. If pooling does occur, replace the airway adapter.
also provided in this area of the screen. (CO2 [RESP] information can be displayed in the CO2 VS box or in the RESP VS box, as detailed below.) 1 2 3 4 5 6 7 8 9 10 12 Item Name Definition 1 Is the detected CO2 waveform (Trace D) CO2 VS waveform 11 Note To change the waveform speed, see Resp Speed on page 3-25. 2 Alarm flag area Displays CO2 alarm flags when detected; see page 4-31.
Changing the CO2 and CO2 (RESP) Alarm Limits The CO2 (Et) and CO2 (Fi) Alarm Limits menu can be accessed by touching the alarm limit settings in the CO2 VS box.
Step 3 Action Select the Low button or the High button. The selected button will be highlighted and the current adjustment will be displayed. 4 Using the keypad, or the increment, decrement, or Off buttons, enter the desired setting. The current adjustment will reflect the setting. 5 Press the Enter button to save the setting. The alarm limit setting is updated. To change the remaining settings, repeat steps 2–5. 6 The current adjustment will reflect the change.
To change the CO2 (RESP) alarm limit settings Step 1 Action Select the CO2 (RESP) alarm limit settings in the RESP VS box (or, in the CO2 VS box, see page 7‐7.) The CO2 (RESP) Alarm Limits menu appears. Current settings are displayed. 2 Select the Low button or the High button. The selected button will be highlighted and the current adjustment will be displayed. 3 Using the keypad, or the increment, decrement, or Off buttons, enter the desired setting. The current adjustment will reflect the setting.
Step 4 Action On the System Config menu, select Gas Units. The Gas Units menu appears. The current setting is highlighted. 5 Select the desired unit of measure: mmHg kPa The setting is changed. CO2 Menu The CO2 menu allows you to control the CO2 and CO2 (RESP) monitoring functions and settings. To open the CO2 menu Select the CO2 VS box.
The following CO2 menu items are available: 1 Size 2 Grids 3 Zero Cal 1 2 3 Note Apnea and Apnea Time will be in the CO2 menu when bellows (BEL) is the selected RESP > Source; see page 10-7 for setting details. To change settings in the CO2 menu Step 1 Action Select the CO2 VS box. The CO2 menu appears. Current settings are displayed. 2 Touch the menu item to select one of the following CO2 options: Size Grids Zero Cal The menu item appears. The current setting is highlighted.
To adjust the size of the CO2 waveform Step 1 Action Select the CO2 VS box. The CO2 menu appears. Current settings are displayed. 2 Select Size. The Size menu appears. The current setting is highlighted. 3 Select the desired size: 40 mmHg 60 mmHg 80 mmHg The setting is changed. Grids Displays a scaled grid, which is graduated according to the Size selection for the CO2 waveform. Size Grid The following options are available: • Off does not display a grid. (Default) • On displays a grid.
To control the display function for the CO2 grid Step 1 Action Select the CO2 VS box. The CO2 menu appears. Current settings are displayed. 2 Locate Grids and select the desired setting: Off On The setting is entered. Zero Cal Initiates a zero calibration (an automatic function during normal use) of the CO2 system to allow for the different characteristics of each accessory type. Zero Cal is not required when switching sampling lines.
7‐16 Monitoring CO2 (LoFlo Option) Expression MR400 Instructions for Use
CHAPTER 8 Monitoring Invasive Blood Pressure When equipped with the invasive blood pressure option, the MR400 provides compatibility with standard invasive blood pressure transducers having a 5 µV/V/mmHg sensitivity, and offers two invasive blood pressure channels, P1 and P2.
Contraindications • Left atrial monitoring without an air‐eliminating filter between the solution source and continuous flush device • Intracranial pressure monitoring • Compartmental pressure monitoring • Intrauterine pressure monitoring Patient Preparation for IBP Monitoring When positioning the patient, routine IBP measurements (including for the condition hypertension) require the patient to remain silent, still and relaxed, with legs uncrossed and arms supported.
7 Press here to disconnect transducer from reusable cable 8 Reusable cable connector 9 Transducer cable connector 10 To fluid source 11 Squeeze continuous flush device MR 400 Preparation for IBP Monitoring Follow the procedure below to prepare the MR400 for IBP monitoring when using the Expression MR IBP DPT Kits (Adult / Pediatric, REF 989803194631; and, Infant/Neonatal, REF 989803194641). As there are preparation differences, always follow the appropriate procedure.
WARNING Disposable attachments are designed for single patient use and must be disposed after use. They must not be cleaned and reused. Follow your hospital’s guidelines for appropriate disposal. Reuse of single-use devices can result in spread of patient infection, degradation of monitoring performance, or inaccurate measurements.
II. Kit Set Up Set up the disposable transducer monitoring kit using aseptic technique. Step Action 1 Open package containing the sterile disposable transducer monitoring kit. 2 Remove transducer monitoring kit assembly from the package. Check all fittings to ensure tight connection. 3 Connect the reusable cable, REF 989803194601 (or equivalent), to the transducer cable. Reusable cable (REF 989803194601, or equivalent) Transducer cable Transducer 4 Prepare a collapsible I.V.
Step Action 6 Insert the I.V. solution bag into the pressure administration cuff. 7 Hang the pressure administration cuff from an MR I.V. pole. 8 With the administration set clamp closed, gently squeeze the drip chamber and fill drip chamber approximately 1/2 full. 9 Open clamp on administration set. III. Purging Air from the Monitoring Line A. Attach the transducer to an MR IV pole mount. B. Turn zero reference stopcock “off” to patient.
IV. Zeroing, Leveling and Calibration A. After the system has been primed and mounted, zero the transducer using one of the following methods: Step 1 Action Turn the zero reference stopcock “off” to the patient and remove yellow non‐vented cap from the side port which opens the zero reference stopcock to air. Note The air-fluid interface of the zero reference stopcock should be at or near the right atrial (mid-axillary) level. 2 Zero the transducer. Press the Zero All key.
Step Action 3 Place transducer in the position (horizontal plane) it will maintain during pressure measurement. 4 Place the catheter tip at the right atrial (mid‐axillary) level. 5 Zero the transducer. Zero the transducer. Press the Zero All key. (Alternatively, use Zero Set in the respective P1 or P2 menu to zero a specific channel connected to the transducer; see page 8‐24).
catheter filled with I.V. solution prior to insertion. Follow catheter manufacturer’s insertion instructions. VI. Fast Flushing A. Activate the fast flush mechanism of the continuous flush device and check drip chamber to confirm fast flush. B. FOLLOWING EACH FAST FLUSH, DRIP CHAMBER DROP RATE MUST BE OBSERVED TO VERIFY COMPLETE CLOSURE. VII.
Note When monitoring invasive blood pressure, routinely inspect the catheter and/or pressure line for leaks after zeroing, and always follow the pressure transducer/catheter manufacturer’s use recommendations. Neonatal Patients: Expression MR IBP DPT Kit, I/N (REF 989803194641) I. Connecting the Reusable Cable to the MR400 Connect the reusable cable, REF 989803194601 (or equivalent), to the P1 or the P2 port on the patient connection panel.
Step 5 Action Connect the reusable cable, REF 989803194601 (or equivalent), to the transducer cable. Reusable cable (REF 989803194601, or equivalent) Transducer cable Transducer B. Preparing Solution Step Action 1 Assemble pump administration set appropriate for the infusion pump that is to be used. 2 If using heparin, add prior to air removal. CAUTION If an air-free solution source is not used (i.e.
C. Connecting Kit to the Infusion Pump Step 1 Action Remove vented cap from the female port of flush device and con‐ nect flush device fluid line to distal connector of infusion pump administration set. CAUTION In this application, the flush device is not intended to control flow rate. Flow rate must be controlled by an infusion pump. Do not use with pressure administration cuff. III. Purging Air from the Monitoring Line A.
Step 1 Action Turn the zero reference stopcock “off” to the patient and remove non‐vented cap from the side port which opens the zero reference stopcock to air. Note The air-fluid interface of the zero reference stopcock should be at or near the right atrial (mid-axillary) level. 2 Zero the transducer. Press the Zero All key. (Otherwise, to zero a single channel, use Zero Set in the respective P1 or P2 menu; see page 8‐24).
Step 5 Action Zero the transducer. Press the Zero All key. (Alternatively, use Zero Set in the respective P1 or P2 menu to zero a specific channel connected to the transducer; see page 8‐24). Zeroing All Pressure Channels (or Zeroing Pressure Channel for a single channel if Zero Set was used) will be displayed and zeroing will begin; where, upon completion, Done will be displayed to indicate success.
CAUTIONS • Be certain not to introduce air into the system during connection procedure. • If this product is used with fat emulsions, they must be introduced through the lipid compatible stopcock that is distal to the flush transducer assembly to avoid cracking of the transducer line. VI. Checking for Leaks After approximately 1 minute has elapsed, the flow rate should be observed at the drip chamber to ensure that the continuous flush device is operating properly.
Note When monitoring invasive blood pressure, routinely inspect the catheter and/or pressure line for leaks after zeroing, and always follow the pressure transducer/catheter manufacturer’s use recommendations. Zeroing the Pressure Transducer WARNING The transducer must be zeroed prior to the MRI examination after the transducer is in its final setup position. Moving the transducer after zeroing may cause a measurement offset to occur. Otherwise, inaccurate patient pressure readings may result.
Note Except for the VS box annotations and waveform locations, the definitions described below are applicable to both P1 and P2 channels. Systolic/Diastolic Format 2 1 3 4 5 6 7 8 9 12 Item Name Definition 1 Is the detected P1 (or P2) waveform, Trace E (or Trace F) P1 VS waveform, or P2 VS waveform 11 10 Note To change the waveform speed, see Sweep Speed on page 3-25. 2 Alarm flag area Displays P1 (or P2) alarm flags when detected; see page 4-31.
Item Name Definition 9 Diastolic lower alarm limit Is the lower limit setting for the P1 (or P2) diastolic alarm, and accesses the P1 Alarm Limits menu (or the P2 Alarm Limits menu) 10 Systolic lower alarm limit Is the lower limit setting for the P1 (or P2) systolic alarm, and accesses the P1 Alarm Limits menu (or the P2 Alarm Limits menu) 11 Mean numeric Indicates the patient’s detected mean invasive blood pressure measurement 12 or Indicates the Set Label name, if assign
Item Name Definition 7 Mean lower alarm limit Is the lower limit setting for the P1 (or P2) mean alarm, and accesses the P1 Alarm Limits menu (or the P2 Alarm Limits menu) 8 Diastolic numeric Is the patient’s detected invasive diastolic blood pressure measurement 9 Systolic numeric Indicates the patient’s detected systolic invasive blood pressure measurement 10 or Indicates the Set Label name, if assigned, for P1 (or P2) Changing the P1 (or P2) Format To control the forma
To change the P1 (or P2) waveform amplitude Step 1 Action Select the P1 (or P2) VS box. The P1 (or P2) menu appears. Current settings are displayed. 2 Select Size. The Size menu appears. The current setting is highlighted. 3 Select the desired size: 40 mmHg 75 mmHg 100 mmHg 150 mmHg (Default) 200 mmHg 250 mmHg The setting is changed.
7 Current adjustment 8 P1 Systolic Alarm Limits menu label (active adjustment shown) 9 Alarm limit, minimum 10 Lower P1 (Sys) alarm limit setting 11 Upper P1 (Sys) alarm limit setting 12 Alarm limit, maximum To change the invasive blood pressure alarm limit settings Step 1 Action Select the alarm limit settings in the P1 (or P2) VS box. The P1 Alarm Limits (or the P2 Alarm Limits) menu appears. Current settings are displayed.
Changing the Unit of Measure Note When using an IP5 and Pressure Units is changed, the displayed formatting of the value and placement of the decimal point is changed immediately. However, it can take up to 2 seconds for the measurement numeric values to reflect the new unit of measure. Do not print or perform data captures during this period. To change the unit of measure Step 1 Action Press the Setup key and then the Monitor key. The Monitor Setup menu appears. Current settings are displayed.
To open the P1 menu (or P2 menu) Select the P1 VS box (or the P2 VS box). P1 menu P1 VS box The following P1 (and P2) menu items are available:. 1 Zero Set 2 Set Label 3 Size 4 HR Source 5 Grids 6 Grids Size 7 Format 1 2 3 4 5 6 7 To change settings in the P1 (or P2) menu Step 1 Action Select the P1 (or P2) VS box. The P1 (or P2) menu appears. Current settings are displayed.
Step 2 Action Touch the menu item to select one of the following P1 (or P2) options: Zero Set Set Label Size HR Source Grids Grids Size Format The menu item appears. The current setting is highlighted. 3 Select the desired setting from the menu options (except Grids, which is selectable on the P1 [or P2] menu): The setting is entered. 4 To change other settings, repeat steps 2 and 3. Zero Set Zeros the pressure transducer for P1 (or P2).
• CVP (central venous pressure) displayed in blue. • LAP (left atrial pressure) displayed in purple. • ICP (intracranial pressure) displayed in light blue. To assign a label to an P1 (or P2) channel Step 1 Action Select the P1 (or P2) VS box. The P1 menu (or the P2 menu) appears. Current settings are displayed. 2 Select Set Label. The Set Label menu appears. The current setting is highlighted. 3 Select the desired label: None ABP PAP CVP LAP ICP The label is changed.
HR Source Selects the source that produces the heart rate, as displayed in the ECG and SPO2 VS boxes (identical to and interactive with same option in the ECG and SPO2 menus). The following options are available: • Auto sets the source automatically according to the highest priority active input that is first to report valid patient data. The priority ranking (highest to lowest) is ECG, P1, P2, SPO2 (provided that the P1 and P2 channels have been labeled ABP; see Set Label on page 8‐24 for details).
Grids Size Grid The following options are available: • Off no grid is displayed. (Default) • On displays a scaled grid (also see Grids Size, below). To control the display function for the pressure grid Step 1 Action Select the P1 (or P2) VS box. The P1 menu (or the P2 menu) appears. Current settings are displayed. 2 Locate Grids and select the desired setting: Off On The setting is entered. Grids Size Sets the scale size when Grids is on (see Grids, above).
To adjust the grid size for the P1 (or P2) waveform Step 1 Action Select the P1 (or P2) VS box. The P1 menu (or the P2 menu) appears. Current settings are displayed. 2 Select Grids Size. The Grids Size menu appears. The current setting is highlighted. 3 Select the desired size: 40 mmHg 75 mmHg 100 mmHg 150 mmHg 200 mmHg 250 mmHg The setting is changed. Format Sets the displayed format of the P1 (or P2) numeric data, except when using certain pressure channel labels.
CHAPTER 9 Monitoring Agents and Gases (AGENT Option) When equipped with the AGENT option, the patient’s level of anesthetic agent gases, oxygen (O2), carbon dioxide (CO2), and nitrous oxide (N2O) concentrations can be monitored. An anesthetic gas sensor (AGS) system uses infrared spectroscopy combined with digital signal processing to quickly and accurately identify gas concentrations.
WARNINGS • Organic vapors (for example, from cleaning agents) in the sampling line or room air may alter anesthetic agent readings. • Alcohol in the patient’s breath can modify the anesthetic agent readings. Warm-Up Period In order to achieve accurate identifications and measurements, the AGS system requires a warm‐ up period to thermally stabilize. This warm‐up period begins when the AGENT or the CO2 parameter is activated.
Note Whenever the Agent sensor changes from a steady state condition, the system will perform an zero reference adjustment to restabilize the sensor readings. During this time it is possible for a false identification and concentration value to occur. Change from a steady state condition may occur when: – Applying a sampling line for the first time. – Switching from one agent to another. – Going from high agent concentrations to low or off.
- - at gas sampling site — as presented by gas analyzer Et error Percent Fi error Time The breath rate limit for accurately resolved end‐tidal gas values (at an I:E ratio of 1:1) may be found in Appendix A.
the low flow or the occlusion condition is due to a pinched sampling line, or a blocked sampling line due to excessive moisture from patient expiration. Selecting AGENT Accessories Various accessories are available for use with the AGENT option.
• Monitoring using the nasal cannula 1 2 3 4 5 • 1 Water trap 2 Sample port (with Luer lock connector) 3 Sampling line 4 Luer lock connector 5 Nasal cannula connected to a patient airway Monitoring using a divided nasal cannula (when delivering O2 to the patient) 1 2 3 4 5 6 1 Water trap 2 Sample port (with Luer lock connector) 3 Sampling line 4 Luer lock connector 5 Large tubing connector to patient O2 source 6 Divided nasal cannula connected to a patient airway 9‐6 Monitorin
To prepare the AGENT tubing Step Action 1 Ensure that the water trap has been installed in the water trap receptacle (see page 9‐13 for installation instructions). 2 Insert the Luer lock connector on the sampling line (REF 94018) into the sample port on the water trap and then tighten the connector (no more than one half‐turn should be required).
WARNINGS • Remove the sampling line from the patient airway whenever nebulized medications are being delivered. • Continuous exposure to waste anesthetic gases (including halogenated agents and nitrous oxide) is not recommended. Always connect a line between the system’s waste gas port and your facility’s gas scavenging/evacuation system. Avoid venting any waste anesthetic gas directly into the room air as exposure to these gases above the recommended OHSA limits could result.
Step 2 Action Allow the AGS system to run and sample room air for at least 1 minute. The FiO2 reading displayed in the GAS VS box should be approximately 21 percent. If the reading remains outside this range for more than 1 minute after first checking the reading, replace the oxygen sensor as described in chapter 14. 3 After allowing the AGS system to run for at least 1 minute, pinch or seal the input line (to the water trap) for 5 seconds and verify that Occlusion is displayed.
CAUTION Routinely inspect the hose assemblies for proper attachment and orientation. Replace hose assemblies with cracks, holes, tears, or cuts that could cause leaks in the system. If hose assemblies with damage that could result in leaks are used, prolonged and/or inaccurate patient readings could result. Note Always inspect the patient sampling line after attachment to the MR400.
Step Action 3 Pass the tubing over the ears and behind the head, ensuring the patient’s head will not rest on any part of the cannula while the patient is lying down. 4 Slide the sleeve toward the patient’s head to assure a good fit of the cannula. 5 Select the Patient Type. See Selecting the Patient Type on page 3‐11. 6 Check that the connections have been made correctly by verifying the patient’s breathing efforts with the displayed CO2 waveform.
Step 2 Action Place the airway adapter at the proximal end of the airway circuit. CAUTION Always insert the patient sampling line into the water trap port before inserting the airway adapter into the breathing circuit. Failure to follow this may introduce a leak in the circuit, thereby reducing set minute volume. Note Do not place the airway adapter between the ET tube and the elbow as this may allow patient secretions to accumulate in the adapter. If pooling does occur, replace the airway adapter.
Water Trap Replacement The water trap is intended to protect the AGENT system from humidity, secretions, bacterial contamination and dust. Replacement of the water trap is necessary when the contents in the water trap reach its full line. Water trap Full line CAUTION Always discard the water trap when it becomes filled. Do not attempt to clean or reuse the water trap. Accidental water ingress into the system can affect the gas measurements.
Step 3 Action With the new water trap positioned so that the sample port is facing toward you, align the trap’s release tabs to the release tab slots in the water trap receptacle. Press the water trap into the water trap receptacle until audible “clicks” are heard as both of the release tabs lock into the release tab slots. Release tab slots Release tabs Sample port Water trap receptacle 4 Attach the sampling line to the sample port.
CO2 VS box GAS VS box AGENT VS box RESP VS box Multiple (Mixed) Agents Whenever two or more anesthetic agent gases of detectable concentrations are sensed by the AGS system or when the agent gases in the inspired and end‐tidal breath phases are pure but differ from one another, a multiple agents condition exists and Multiple Agents will be displayed.
AGENT VS Box 1 2 3 6 5 4 Item Name Definition 1 Alarm flag area Displays AGENT alarm flags when detected; see page 4-31.
GAS VS Box 1 2 5 Item Name 3 4 Definition 1 GAS VS box label Indicates the gas parameter 2 MAC numeric Is the total MAC value (see MAC Window on page 9-20) 3 EtN2O numeric Is the patient’s detected end-tidal nitrous oxide concentration in percent 4 FiN2O numeric Is the patient’s detected fractional inspired nitrous oxide concentration in percent 5 FiO2 numeric Is the patient’s detected fractional inspired oxygen concentration in percent Note No data indication is denoted by three dashes
Setup key Gas Alarms menu Alarms key Gas Alarms button Lower and upper alarm limit settings for agents and gases are illustrated below.
5 O2 (Fi) – (Oxygen [Fractional inspired]) 6 N2O (Fi) – (Nitrous oxide [Fractional inspired]) 7 Enf (Fi) – (Enflurane [Fractional inspired]) 8 Enf (Et) – (Enflurane [End-tidal]) 9 Iso (Fi) – (Isoflurane [Fractional inspired]) 10 Iso (Et) – (Isoflurane [End-tidal]) 11 Hal (Fi) – (Halothane [Fractional inspired]) 12 Hal (Et) – (Halothane [End-tidal]) Individual alarm limit settings can be adjusted by selecting the parameter that you want to change on the Gas Alarms menu.
8 Enter button 9 Current adjustment To change an individual alarm limit setting in the Gas Alarms menu Step 1 Action Touch the agent or gas parameter that you want to change on the Gas Alarms menu. The selection appears on a highlighted background. (HAL [Et] was selected for this example.) Current settings are displayed. 2 Select the Low button or the High button. The selected button will be highlighted and the current adjustment will be displayed.
WARNING MAC values are empirical, not absolute values. The MAC values correspond to those of healthy adults and cannot be applied to children. Age and other individual factors influencing the behavior of volatile agents are not taken into account. To open the MAC window Select the AGENT or the GAS VS box (see page 9‐14 for the location). Note If AGENT is set to Single in the System Config menu, the MAC window will display Mixed Agents Not Included In MAC Calculation.
Item Name Definition 4 Is the MAC value that each individual gas contributes to the total MAC value, calculated by C/M, where: # MAC C = the current concentration of the given gas M = the 1 MAC value for the given gas 5 TOTAL MACs Is the total MAC value, which is equal to the sum of the values in the # MAC column, calculated using the following formula: TOTAL MAC = EtN2O / (1 MAC N2O) + (Et 1st Agt) / (1 MAC 1st Agt) + (Et 2nd Agt) / (2 MAC 2nd Agt) Where: • EtN2O = The current value of end-tidal
Item Name Definition 1 Is the detected CO2 waveform (Trace D) CO2 VS waveform Note To change the waveform speed, see Resp Speed on page 3-25. 2 Alarm flag area Displays CO2 alarm flags when detected; see page 4-31. 3 CO2 VS box label Indicates the CO2 vital sign parameter, and accesses the CO2 menu 4 Unit of measure Indicates that the gas measurement numeric values are given in mmHg (millimeters of mercury) or kPa (kilopascals); see page 9-26.
7 8 9 10 11 1 6 5 4 3 2 1 Alarm limit settings, CO2 (Et), CO2 VS box 2 High button 3 Low button 4 CO2 (Et) Alarm Limits menu label (active adjustment shown) 5 CO2 (Fi) Alarm Limits menu label 6 Enter button 7 Current adjustment 8 Alarm limit, minimum 9 Lower alarm limit setting 10 Upper alarm limit setting 11 Alarm limit, maximum To change the CO2 (Et) and CO2 (Fi) alarm limit settings Step 1 Action Select the (Et) CO2 alarm limit settings in the CO2 VS box.
Step 4 Action Using the keypad, or the increment, decrement, or Off buttons, enter the desired setting. The current adjustment will reflect the setting. 5 Press the Enter button to save the setting. The alarm limit setting is updated. To change the remaining settings, repeat steps 2–5. 6 The current adjustment will reflect the change. At the default setting, the CO2 (RESP) Alarm Limits menu can be accessed by touching the alarm limit settings in the RESP VS box.
To change the CO2 (RESP) alarm limit settings Step 1 Action Select the CO2 (RESP) alarm limit settings in the RESP VS box (or, in the CO2 VS box, see page 9‐22.) The CO2 (RESP) Alarm Limits menu appears. Current settings are displayed. 2 Select the Low button or the High button. The selected button will be highlighted and the current adjustment will be displayed. 3 Using the keypad, or the increment, decrement, or Off buttons, enter the desired setting. The current adjustment will reflect the setting.
Step 4 Action On the System Config menu, select Gas Units. The Gas Units menu appears. The current setting is highlighted. 5 Select the desired unit of measure: mmHg kPa The setting is changed. CO2 Menu The CO2 menu allows you to control the CO2 (Et) and CO2 (RESP) monitoring functions and settings. To open the CO2 menu Select the CO2 VS box.
The following CO2 menu items are available: 1 Size 2 Grids 3 Zero Cal 1 2 3 Note Apnea and Apnea Time will be in the CO2 menu when bellows (BEL) is the selected RESP > Source; see page 10-7 for setting details. To change settings in the CO2 menu Step 1 Action Select the CO2 VS box. The CO2 menu appears. Current settings are displayed. 2 Touch the menu item to select one of the following CO2 options: Size Grids Zero Cal The menu item appears. The current setting is highlighted.
To adjust the grid size for the CO2 waveform Step 1 Action Select the CO2 VS box. The CO2 menu appears. Current settings are displayed. 2 Select Size. The Size menu appears. The current setting is highlighted. 3 Select the desired size: 40 mmHg 60 mmHg 80 mmHg The setting is changed. Grids Displays a scaled grid, which is graduated according to the Size selection for the CO2 waveform. Size Grid The following options are available: • Off does not display a grid. (Default) • On displays a grid.
To control the display function of the CO2 grid Step 1 Action Select the CO2 VS box. The CO2 menu appears. Current settings are displayed. 2 Locate Grids and select the desired setting: Off On The setting is entered. Zero Cal Initiates a zero calibration (an automatic function during normal use) of the CO2 system to allow for the different characteristics of each accessory type. Zero Cal is not required when switching sampling lines.
CHAPTER 10 Monitoring RESP When equipped with the CO2 or AGENT option, the patient’s respiration rate can be measured as the time interval between detected breaths. Alternatively, the patient’s respiration rate can be measured using the pneumatic bellows and the wSpO2 module. Patient Preparation for RESP Monitoring When preparing a patient, the monitoring method used will impact the performance and operation of the RESP parameter.
Bellows Preparation Respiration measurements that are determined using the bellows method make chest wall expansion very important for accurate monitoring of a patient’s breathing. If the respiratory signal appears to weaken between scans, instruct the patient to breathe more deeply during the scan to create more movement at the sensor site. CAUTIONS • Avoid excessive bending of the flexible hose, as this can impair respiration detection.
Step 6 Action Check the network channel indicator on the wSpO2 module to ensure communication is established with the MR400: • Steady = Good communication; proceed to step 7. • Flashing = No communication; proceed to step 6. See page 2‐11 for details. (Also, you can reference the status information pane; see page 2‐16.) 7 Ensure that the wSpO2 module is within 9.
• When RESP > Source > CO2 is selected, the CO2‐derived respiration measurement and alarm limit settings (displayed in the same color as the CO2 VS box data) will populate the RESP VS box. 1 2 3 4 7 5 6 Item Name Definition 1 Alarm flag area Displays CO2 (RESP) alarm flags when detected; see page 4-31.
Item Name Definition 2 Unit of measure Indicates that the respiration rate numeric is given in RPM (respirations per minute) 3 Respiration rate numeric Is the patient’s detected respiration rate measurement 4 Source label Is the source used for the respiration monitoring, where BEL is bellows-derived; see page 10-7 Changing the CO2 (RESP) Alarm Limits To change the CO2 (RESP) alarm limit settings: • If equipped with the CO2 LoFlo option, see page 7‐9.
RESP menu RESP VS box The following RESP menu items are available:. 1 Source 2 Apnea 3 Apnea Time 1 2 3 Note If RESP > Source > BEL, then Apnea and Apnea Time will be in the CO2 menu. To change settings in the RESP menu Step 1 Action Select the RESP VS box. The RESP menu appears. Current settings are displayed.
Step 2 Action Touch the menu item to select one of the following RESP options: Source Apnea Apnea Time The menu item appears. The current setting is highlighted. 3 Select the desired setting from the menu options (except Apnea, which is selectable on the RESP menu). The setting is entered. 4 To change other settings, repeat steps 2 and 3. Source Selects the source used to acquire the respiration rate measurements displayed the RESP VS box.
Apnea WARNING The respiration measurement does not recognize obstructive and mixed apneas—it only indicates an alarm when a pre-adjusted time has elapsed since the last detected breath. The safety and effectiveness of the respiration measurement method in the detection of apnea, particularly the apnea of prematurity and apnea of infancy, has not been established.
To set the apnea time delay Step 1 Action Select the RESP VS box. The RESP menu appears. Current settings are displayed. 2 Ensure that Apnea is On. If Apnea is not On, enable the setting as described on page 10‐8. 3 Select Apnea Time. The Apnea Time menu appears. The current setting is highlighted. 4 Select the desired time delay (in seconds) for the alarm indication: 20 Sec 25 Sec 30 Sec 35 Sec 40 Sec The setting is changed.
10‐10 Monitoring RESP Expression MR400 Instructions for Use
CHAPTER 11 Monitoring Temperature When equipped with the temperature option, the patient’s surface or body temperature can be monitored using the reusable sensor, FlexTEMP II Sensor (Esophageal/Rectal/Axillary, Direct Mode), REF 989803194511. The FlexTEMP II Sensor (Esophageal/Rectal/Axillary, Direct Mode), hereafter referred to as the temperature sensor, is designed specifically for use with MR400. The components of the temperature sensor are shown below.
CAUTION The sensor contains no latex, and is constructed of fiber-optic glass. Always handle the sensor with care to prevent damage, as improper handling can result in inaccurate readings. Never bend any portion of the sensor into a radius of less than 15 mm (0.6 inches).
Connecting and Disconnecting the Sensor CAUTION When inserting or removing the temperature sensor from the MR400, only use the connector and never pull or apply excessive force or tension to any other portion of the device. To connect the temperature sensor Grasp the sensor connector then align the connector to the temperature port on the MR400 and push the connector forward until you feel or hear it “click” into place.
Temperature Measurements Depending upon the monitoring method (surface or body), follow the corresponding procedure below to make a temperature measurement. Allow at least 2 minutes for measurement stabilization, with or without the sensor cover (jacket). Note A temperature difference exists between a patient’s surface temperature and body temperature.
Making Body Temperature Measurements FlexTEMP System Jackets are mandatory for use with the temperature sensor when making esophageal or rectal (body) temperature measurements. Before making temperature measurements at esophageal or rectal sites, cover the sensor according to the steps below. WARNINGS • Use of FlexTEMP System Jackets are mandatory when using the sensor for body (i.e., esophageal or rectal) site temperature measurements. Failure to comply may result in patient infection.
Step 5 Action Ensure that the patient segment of the sensor is completely inserted. There should be no excess space at jacket tip and the jacket tabs should extend over the sensor’s jacket retainer. Jacket tabs Patient segment Jacket retainer Jacket tip 6 If needed, secure the jacket tabs to the jacket retainer using medical tape. Follow the steps below to make a body temperature measurement.
To make body temperature measurements Step Action 1 Ensure that a jacket has been placed on the sensor (see Placing the Sensor in a Jacket, on page 11‐5). 2 If needed, apply lubricant to the jacket for insertion into the patient. CAUTION Never use petroleum-based lubricants. A water-based lubricant (for example, Surgical Lubricant, REF 989803168891) can be used to facilitate insertion. 3 Insert the sensing tip of the sensor into the patient at an appropriate depth.
To process the temperature sensor after use Step Action 1 If a jacket was placed on the sensor, remove the jacket and any medical tape (if used). Refer to your facility’s biohazard procedure for disposal of used jackets and medical tape. Typically, jackets and tape are disposed of as medical waste per facility procedures due to contamination concerns. 2 Thoroughly clean and disinfect the sensor; see Cleaning, Disinfecting, and Inspecting the Accessories, on page 14‐7, for details.
Item Name Definition 2 Temperature upper alarm limit Is the upper limit setting for the TEMP alarm, and accesses the TEMP Alarm Limits menu 3 Temperature lower alarm limit Is the lower limit setting for the TEMP alarm, and accesses the TEMP Alarm Limits menu 4 Temperature numeric Is the patient’s detected temperature measurement 5 Unit of measure Indicates that the temperature numeric is given in degrees Celsius (°C) or degrees Fahrenheit (°F) 6 TEMP VS box label Indicates the temperature vita
Changing the Unit of Measure To change the unit of measure Step 1 Action Select the TEMP VS box. The TEMP menu appears. Current settings are displayed. 2 Select Units. The Units menu appears. The current setting is highlighted. 3 Select the desired unit of measure: °C °F The setting is changed. TEMP Menu The TEMP menu item allows you to control the unit of measure for temperature. To open the TEMP menu Select the TEMP VS box.
The following TEMP menu items are available: 1 Units 1 Units Selects the unit of measure used for presentation of the temperature numeric data. The following options are available: • °C (Default) • °F To select the unit of measure for temperature See Changing the Unit of Measure on page 11‐10.
11‐12 Monitoring Temperature Expression MR400 Instructions for Use
CHAPTER 12 Monitoring NIBP The NIBP (non‐invasive blood pressure) parameter measures and displays systolic, diastolic and mean arterial pressures. Alarm limit settings are available for all three pressures. When using NIBP to measure blood pressure, readings are not continuous but are updated each time a blood pressure measurement is taken. Set a shorter interval when frequent updating of the patient’s blood pressure is needed.
CAUTIONS • Substitution of components or accessories different from those supplied or recommended can result in measurement errors. • NIBP accuracy has not been verified in the presence of some common arrhythmias such as atrial or ventricular premature beats or atrial fibrillation. Patient Preparation for NIBP Monitoring WARNINGS • The NIBP cuff inflation rate may increase and the initial pressure may increase up to 180 mmHg when changing the patient type.
CAUTION There may be occasions when a particular mode is not suitable for its apparent category of patients based on age alone. In these cases, a clinical decision shall be made to use another patient type, NIBP cuff size or measurement technique. The clinical decision shall be based on all of the factors listed in Determining the Patient Type (see page 3-11) to ensure the best possible and most timely NIBP measurement acquisition.
The bladder width of the cuff must be 40 percent of the circumference of the limb. It is also advisable to keep the air volume to a minimum by using the smallest cuff size possible for each patient. The point of maximum oscillations is coincident with mean arterial pressure regardless of arterial elasticity so long as the ratio of air volume in the cuff to the volume of the artery under compression does not greatly exceed ten (10) to one (1).
Positioning the NIBP Cuff WARNINGS • Avoid compression, kinking or restriction of the NIBP cuff hose, as the effect of blood flow interference can result in patient injury caused by continuous cuff pressure. • Do not use the NIBP cuff on a limb with an intravenous infusion or where an arterial catheter or arterio-venous (A-V) shunt is in place because of temporary interference to blood flow. This could result in injury to the patient.
Step Action 2 Attach a NIBP cuff appropriate for the patient type and size to the interconnect hose. 3 Position the cuff on the patient; see page 12‐5. 4 Ensure that the cuff and interconnect hoses are not kinked. Choosing the Measurement Mode NIBP measurements can be taken automatically or manually, using the mode that best suits the needs of your patient. The following are frequently used functions related to NIBP; also refer to page 12‐14 for other NIBP functions.
Step Action 4 Select the NIBP VS box. On the NIBP menu, toggle Auto Mode to On. 5 To begin automatic operation, press the NIBP Start/Stop key. Making Manual Measurements You can manually define the measurement interval of a patient’s blood pressure. To control manual operation Step 1 Action Select the Patient Type. See Selecting the Patient Type on page 3‐11. 2 To start or stop the measurement, press the NIBP Start/Stop key.
Stopping an NIBP Measurement Press the NIBP Start/Stop key to stop a reading cycle. Suspend Mode during NIBP Measurements When the Suspend key is pressed, NIBP functions will be affected as follows: • Any reading in progress will be stopped. • The system will pump to the initial inflation pressure for the selected patient type. • Manual readings can be taken. • Auto readings cannot be taken. • The “NEXT” timer will not run. • When exiting Suspend Mode, any manual reading will not be stopped.
Item Name Definition 1 Alarm flag area Displays NIBP alarm flags when detected; see page 4-31.
Mean Format 1 2 3 10 9 8 7 6 5 4 Item Name Definition 1 Alarm flag area Displays NIBP alarm flags when detected; see page 4-31.
Item Name Definition 9 Indicates Manual when in manual mode; or, Next when in automatic mode along with the time until the next NIBP measurement, displayed in the following format: Auto Mode setting ::, where = Two-digit hours field = Two-digit minutes field = Two-digit seconds field 10 NIBP VS box label Indicates the NIBP vital sign parameter, and accesses the NIBP menu Changing the NIBP Format To control the format of the NIBP data Step 1 Action Select the NIBP VS box.
To change the unit of measure Step 1 Action Press the Setup key and then the Monitor key. The Monitor Setup menu appears. Current settings are displayed. 2 On the Monitor Setup menu, select Service(Bio‐Med). The Service(Bio‐Med) menu appears. 3 On the Service(Bio‐Med) menu, select System Config. The System Config menu appears. Current settings are displayed. 4 On the System Config menu, select Pressure Units. The Pressure Units menu appears. The current setting is highlighted.
5 Alarm limit, minimum 6 Lower alarm limit setting 7 Upper alarm limit setting 8 Alarm limit, maximum 9 High button 10 Low button 11 NIBP Diastolic Alarm Limits menu label 12 NIBP Mean Alarm Limits menu label To change the NIBP alarm limit settings Step 1 Action Select the alarm limit settings in the NIBP VS box. The NIBP Alarm Limits menu appears. Current settings are displayed. 2 Select the desired pressure: NIBP (Sys) NIBP (Dia) NIBP (Mean) The pressure is selected.
NIBP Menu The NIBP menu allows you to control non‐invasive blood pressure functions and settings. To open the NIBP menu Select the NIBP VS box. NIBP menu NIBP VS box The following NIBP menu items are available:. 1 Interval 1 2 Auto Mode 2 4 Format 3 To change settings in the NIBP menu Step 1 Action Select the NIBP VS box. The NIBP menu appears. Current settings are displayed.
Step 2 Action Touch the menu item to select one of the following NIBP options: Interval Auto Mode Format The menu item appears. The current setting is highlighted. 3 Select the desired setting from the menu options (except Auto Mode, which is selectable on the NIBP menu). The setting is entered. 4 To change other settings, repeat steps 2 and 3. Interval Sets the interval for automatic NIBP measurements.
Step 2 Action Select Interval. The Interval menu appears. The current setting is highlighted. 3 Select the desired minute(s) for the interval: 1 Min 2 Min 3 Min 5 Min 10 Min 15 Min 20 Min 30 Min The setting is changed. Auto Mode Sets the mode used to take NIBP readings. Note A manual reading will not restart this cycle time.
Format Sets the displayed format of the NIBP numeric data. The following options are available: • SysDia displays the systolic and diastolic numerics in a large font separated by a slash and the mean numeric will be in a smaller font bracketed with parenthesis. (Default) • Mean displays the mean measurement numeric in a large font, and the systolic and diastolic measurement numeric values in a smaller font and separated by a slash.
12‐18 Monitoring NIBP Expression MR400 Instructions for Use
CHAPTER 13 Trend Data and Printing Trending Functions The MR400 provides versatile trending features, including trend arrow indications for monitored parameters and tabular trends reporting. The MR400 stores up to 12 hours of historical trend data, retaining information when new patients are connected to the host and through short power cycles; however, if power is removed for 10 minutes or longer, all stored trend data will be lost.
Notes • Refreshing Trend Data may be displayed while the information on the page is being populated. • In the illustration below, the trend buttons for all parameters are shown in their selected state.
Item Name Definition 3 Parameter headings Identifies the parameter reading for the associated column of data (in the same color as that of the vital sign) 4 Trends key Opens the Tabular Trends menu 5 Agents trend button Displays the AGENT parameter readings, where percentages for primary and secondary end-tidal (Et) and fractional inspired (Fi) gases (ID) are provided in the form: Et ID% Fi ID% 6 N2O trend button Displays the N2O parameter readings 7 O2 trend button Displays the O2 parameter
The following Tabular Trends menu items are available:. 1 Trend Arrows 1 2 Arrow Period 2 3 Data Interval 3 4 Clear Trends 4 5 Print Page 5 6 Print All 6 7 Stop Print 7 To change settings and control functions in the Tabular Trends menu Step 1 Action Press the Trends key. The Tabular Trends menu appears. Current settings are displayed.
WARNING Depending upon the Arrow Period menu option and measurement cycles of the vital signs, NIBP trend arrow indications may not be representative of the current condition of the patient. 1 1 Trend arrow indications, where is rising is declining is stable is none declared The following options are available: • Off turns off the trend arrows. (Default) • On turns on the trend arrows.
To control trend arrow indications Step 1 Action Press the Trends key. The Tabular Trends menu appears. Current settings are displayed. 2 On the Tabular Trends menu, select Trend Arrows. The Trend Arrows menu appears. The current setting is highlighted. 3 Select the desired setting: Off On The setting is changed, and the display is changed accordingly. Arrow Period Controls the time that must elapse before a trend arrow change can occur.
Step 3 Action Select the desired setting: 30 Seconds 1 Minute 3 Minutes 5 Minutes 10 Minutes The setting is changed. Note If a newly selected period is shorter than the previous period (and the arrows have been on for the longer of the two periods) then immediate recalculation using the new period will occur. However, if the newly selected period is longer than the previous period, recalculation will occur using all available data.
To control the data interval Step 1 Action Press the Trends key. The Tabular Trends menu appears. Current settings are displayed. 2 On the Tabular Trends menu, select Data Interval. The Data Interval menu appears. The current setting is highlighted. 3 Select the desired setting: 1 Minute 5 Minutes 10 Minutes 15 Minutes 20 Minutes 25 Minutes 30 Minutes 45 Minutes 60 Minutes Auto NIBP The setting is changed.
Print Page Prints the currently displayed Trends page when connected to a printer‐equipped IP5. To print the page Step 1 Action Press the Trends key. The Tabular Trends menu appears. Current settings are displayed. 2 On the Tabular Trends menu, select Print Page. Print All Prints all Trends pages when connected to a printer‐equipped IP5. To print the all pages Step 1 Action Press the Trends key. The Tabular Trends menu appears. Current settings are displayed.
Printing Functions When equipped with an IP5 and printer, the MR400 can produce hard copies of up to two waveforms, trend information and patient data reports. Notes • If a printer-equipped IP5 is not installed or connected, an indication is displayed on the Print key; see page 13-11. • Any print command from the MR400 automatically initiates a 30-second print cycle at the IP5. • Any print command initiated from the MR400 takes precedence over the IP5 print functions.
Printer Indications The symbol displayed on the Print key indicates the state of the remote printer, as shown in the table below. Symbol Indication The printer is ready. Printing is in process and seconds remain (25, in the example) until completion. No printer is available. There is a printer error condition. Printer Menu The Printer menu allows you to configure the MR400 for printing when an optional IP5 and printer are connected.
. Setup key Printer menu Printer key The following Printer menu items are available: 1 Trace 1 1 2 Trace 2 2 3 Trace Delay 3 To change settings in the Printer menu Step 1 Action Press the Setup key and then the Printer key. The Printer menu appears. Current settings are displayed. 2 Select from the following menu items: Trace 1 Trace 2 Trace Delay The selected menu appears. Current settings are displayed. (For menu item information, see the appropriate section below.
Step 4 Action Select the desired setting from the menu options. The setting is entered. 5 To change other settings, repeat steps 2, 3 and 4. Trace 1 Prints a selected parameter’s waveform in the Trace 1 waveform location on a strip chart, as shown in the illustration below. (A strip can contain two waveforms.) Note If Trace 2 is off, then Trace 1 is printed using the full 40 mm width of the strip.
• ECG 2 outputs the Trace B waveform • SPO2 outputs the Trace C waveform • RESP (CO2) outputs the Trace D waveform • P1 outputs the Trace E waveform • P2 outputs the Trace F waveform To print a waveform in the Trace 1 location Step 1 Action Press the Setup key and then the Printer key. The Printer menu appears. Current settings are displayed. 2 Select Trace 1. The Trace 1 menu appears. The current setting is displayed.
• P2 outputs the Trace F waveform. • RESP(CO2) outputs the Trace D waveform. To print a waveform in the Trace 2 location Step 1 Action Press the Setup key and then the Printer key. The Printer menu appears. Current settings are displayed. 2 Select Trace 2. The Trace 2 menu appears. The current setting is displayed. 3 Select the desired setting from the menu options: Off ECG 1 ECG 2 SPO2 P1 P2 RESP(CO2) The setting is entered.
Step 3 Action Select the desired setting from the menu options: 0S 4S 8S 16 S The setting is entered.
CHAPTER 14 Maintenance and Troubleshooting WARNINGS • Schedule: Failure on the part of the responsible individual hospital or institution employing the use of this equipment to implement a satisfactory maintenance schedule may cause undue equipment failure and possible health hazards. • To reduce the possibility of damage to the equipment or injury to patients/personnel, perform all cleaning, disinfection, maintenance, software update, testing, disassembly and repair outside of the MR system room.
Use only the Royal Philips‐approved substances and methods listed in this chapter to clean or disinfect the equipment. Royal Philips makes no claims regarding the efficacy of the listed chemicals or methods as a means for controlling infection. Warranty does not cover damage caused by using unapproved substances or methods. The recommended types of disinfecting agents are listed in the table below.
Step 3 Action Press the battery eject button to partially eject a main cart battery from a battery compartment, and then grasp the battery and pull to remove it completely from the MR400. Battery compartment Battery eject button Main cart battery (If the battery does not release, apply a slight forward pressure to the battery while pressing the battery eject button.) 4 5 Repeat steps 1 and 2 to remove the other main cart battery on the opposite side of the MR400.
Step 6 Action Locate the battery switch and toggle it into the Off (O) position. Battery switch Restoring all Power to the MR400 To restore all power to the MR400, see page 1‐16. Removing Power from the Wireless Modules In order to clean, disinfect or inspect a wireless module it may be necessary to remove power from the device. To turn power off to the wireless modules, proceed according to the module type: • wECG module: Remove all installed batteries (see page 1‐25).
The user of the product must institute a routine‐checks program as detailed in the table below. The user of the product shall make sure that all checks and actions have been satisfactorily completed before using the product for its intended purpose. Area / Item Frequency Required Action Accessories Daily Clean and inspect for damage; see page 14-7. Alarms Daily Confirm proper function; see Testing Alarms on page 14-11.
Area / Item Frequency Required Action Cart batteries: two main and two reserve Every 12 months • Replace the main batteries; see page 1-16. Module batteries Every 12 months Replace the module batteries; see page 1-23. • Replace the reserve batteries; contact technical support. Cleaning, Disinfection, and Damage Inspection Cleaning and disinfection of this product is required periodically. General guidelines for each are given below.
WARNING Do not use flammable or potentially explosive disinfecting sprays. Such sprays create vapors, which can ignite, causing fatal or other serious personal injury. CAUTION Disinfecting a medical product room by means of sprays is not recommended, since the vapor could penetrate the product, causing electrical short-circuits, metal corrosion or other damage to the product.
To clean a reusable accessory Step Action 1 Remove the accessory from use. 2 Remove all visible debris from the accessory using soap and water. CAUTION Never pour liquid onto the accessory. 3 Clean the accessory by thoroughly wiping it using CaviWipes disinfectant towelettes. Discard the used towelettes (refer to your facility's biohazard procedure for disposal). Note Follow the Instructions for Use from the disinfectant manufacturer to clean the probe.
Cleaning, Disinfecting, and Inspecting MR400 and Wireless Modules Follow the general guidelines to clean the MR400 cart and the wECG and wSpO2 modules. Always turn off the cart and the wireless modules to perform cleaning. Never immerse any portion of the cart or wireless modules in fluid or attempt to clean the devices by directly applying liquid cleaning agents.
Step 5 Action Clean the cart and modules by thoroughly wiping the devices using CaviWipes disinfectant towelettes. Discard the used towelettes (refer to your facility's biohazard procedure for disposal). Note Follow the Instructions for Use from the disinfectant manufacturer to clean the cart and wireless modules. 6 Disinfect the cart and modules by thoroughly wetting the devices using CaviWipes disinfectant towelettes.
Testing Alarms Note If a problem with the alarm sound or messaging system is suspected, discontinue use of the MR400 and immediately refer it to authorized service personnel for evaluation. To verify the alarm functions Step Action 1 With the MR400 turned on and not in suspend mode, ensure that Alarm Sound is turned on in the Alarms menu. 2 Make sure that the lower alarm limit for SPO2 is not off.
Step Action 8 Remove your finger from the attachment. 9 Verify the following: • Non‐Pulsat or Probe Off appears in the SPO2 alarm flag area, • The SPO2 waveform flat lines. • The numeric flashes in yellow; and, • The alarm tone sounds. This completes the test of the alarm system. Testing a Dropped Wireless Module In the event that the wECG or wSpO2 module has been dropped, it is important to determine the functionality of the device before attempting to monitor a patient.
Step Action 5 This completes basic functional testing of the dropped module. However, if during further usage, problems are encountered, such as status messages (Lead Fail, No Probe, et cetera) then discontinue use of the module and replace it before using the MR400 system. 6 Discontinue use of the module and replace it before using the MR400 system.
To replace the O2 sensor. Step Action 1 Turn off the MR400. 2 Ensure that any gas sampling line has been disconnected from the water trap on the patient connection panel. 3 Remove the two screws that secure the service panel cover to the back of the WPU and then remove the service panel cover. Screws 4 Service panel cover Locate the sensor tool and the O2 sensor port.
Step 6 Action Insert a new O2 sensor into the sensor port and then, using the sensor tool, turn the sensor clockwise until secure. Sensor port O2 sensor 7 Replace the service panel cover and secure it using the two screws. 8 Connect a gas sampling line to the water trap. 9 Turn on the MR400. 10 Turn on the Agents parameter and allow the system to run until CO2 Warming Up is no longer displayed. 11 Calibrate the O2 sensor by performing the following steps: a. Press the Monitor key. b.
WARNING When performing software updates (or upgrades) to the operating software of the MR400, ensure that all remaining devices in the monitor’s network are at the same or a compatible software revision level. Failure to observe this requirement could result in compatibility conflicts, communication problems, et cetera. Calibrating the Touch Screen Note Touch screen calibration is not routinely required, but will occur after installation of new operating software.
WARNINGS • A shock hazard exists if the MR400 is operated without covers. • Do not modify the MR400 Patient Monitoring System without authorization of the Invivo (Royal Philips). If the MR400 fails to function properly or requires maintenance, contact technical support: 1‐877‐INVIVO1 or 1‐877‐468‐4861 Internationally, please contact your Key Market representative. For a current listing, go to www.invivocorp.
Passing the Product on to another User If this product passes to another user, it must be in its complete state, including all product support documentation. Make the new user aware of the support services that Philips Medical Systems provides for installing, commissioning and maintaining the product. Before passing on the product or taking it out of service, all patient data must be (backed up elsewhere if necessary, and) unrecoverable be deleted on the product.
Step Action 3 Cover the display panel and the WPU with protective film then install foam A over the display panel. 4 With the packaging oriented so that the slotted foam will be nearest the top, raise the crate into an upright position. Roll the MR400 into the crate and then carefully lower the crate.
Step 14‐20 Maintenance and Troubleshooting Action 5 Ensure that the guide handle is located in the slotted foam (see step 4)—if necessary, push the MR400 from the bottom. Pack the MR400 accessories in the accessory box (B) and then place the accessory box into the crate, alongside the display panel as shown below. Insert foam C over the WPU and between the base of the MR400 and the crate. 6 Place the lid on the crate.
Step 7 Action Install all the clips into the lid on the crate, ensuring that each is locked and that the crate is secure. Final Disposal of the Product Final disposal is when the user disposes of the product in such a way that it can no longer be used for its intended purposes. WARNING Do not dispose of this product (or any parts of it) in industrial or domestic waste. The product may contain materials and hazardous substances that can cause serious environmental pollution.
unsorted municipal waste. Collect it separately so that it can be safely and properly reused, treated, recycled or recovered. WARNING To avoid contaminating or infecting personnel, the environment or other equipment, make sure you disinfect and decontaminate the MR400 appropriately before disposing of it in accordance with your country's laws for equipment containing electrical and electronic parts. Do not dispose of this product (or any parts of it) in industrial or domestic waste.
APPENDIX A Specifications General Patient Safety Conforms to ANSI/AAMI ES 60601‐1. Certified to CAN/CSA C22.2 No. 60601‐1‐08; IEC 60601‐1‐2 Conforms to 93/42/EEC as amended by 2007/47/EEC, Medical Device Directive Defibrillator protection up to 5 KVDC According to the degree of ingress protection: Rated IP21 (Protected against access to hazardous parts and the ingress of solid foreign objects greater than 12.5mm (0.5 inch), and against vertically dripping liquid.
General • IEC 60068‐2‐64, Environmental Testing – Part 2: Test Methods Test FH: Vibration Broad‐band Random (Digital Control) and Guidance • IEC 60601‐1‐2, Medical Electrical Equipment Part 1‐2: General Requirements for Safety ‐ Collateral Standard: Electromagnetic Compatibility ‐ Requirements and Tests • IEC 60601‐1‐6, Medical Electrical Equipment ‐ Part 1‐6: General Requirements for Safety ‐ Collateral Standard: Usability • IEC 60601‐1‐8, Medical Electrical Equipment – Part 1‐8: General Requirement
General • 2002/96/EC, Directive on Waste of Electrical and Electronic Equipment • 2006/66/EC, Battery Directive • ANSI/AAMI BP22, Blood Pressure Transducers • ANSI/AAMI EC13, Cardiac Monitors, Heart Rate Meters, and Alarms • ANSI / AAMI EC53, ECG trunk cables and patient leadwires • ASTM E‐1112—2000, Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature • ASTM F2052‐14, Standard Test Method for Measurement of Magnetically Induced Displacement Fo
General Battery Type Cart: Lithium‐Ion Module: Lithium polymer Operation Time (Fully charged) Cart: Dependent upon enabled parameters and settings: • All displays, alarms, and monitoring functions continuously for 8 hours • ECG & SPO2 continuously for 8 hours • CO2 continuously for 6 hours (with or without AGENT) • P1 and P2 continuously for 6 hours • AGENT analysis continuously for 6 hours • Temperature continuously for 6 hours • NIBP readings every 5 minutes for 6 hours Module: Approximately 8 hours C
General Relative Humidity Range 5 to 80 percent, non‐condensing Philips IBP Transducer and cable (optional): 15 to 80 percent, non‐ condensing Operating Pressure Range Up to 3,000 m (9,842 ft) above sea level (708 mbar or 531 mmHg) Storage and Transport Pressure Range 708 mbar (708 hPA or 531 mmHg) to 1020 mbar (1020 hPA or 765 mmHg) MRI System Range 0.7 to 3.0 Tesla, at RF power levels not exceeding 4W/kg SAR, and 7.
General Sweep Speed For ECG, SPO2, and IBP, a speed of 25 mm/second gives 9.1 seconds of display time, while 50 mm/second gives 4.6 seconds. For respiration, a speed of 3.125, 6.25, 12.5 or 25 mm/second is provided.
Displayed Information Heart Rate Automatic mode selects the vital sign to provide the heart rate according to vital sign source availability and priority. If no source available (if no vital sign meets the criteria, then the heart rate source will be displayed as None and no heart rate will be produced. Manual mode selection to provide the heart rate is also available.
ECG Cardiotach Sensitivity (Monitor filter mode) Adult patient type: > 200 μV Neonate/Pediatric patient type: > 100 μV QRS Duration Adult patient type: 70 to 120 ms Neonate/Pediatric patient type: 40 to 120 ms Bandwidth (Monitor filter mode) 0.
ECG Heart Rate Meter Accuracy and Response to Irregular Rhythm A1: Ventricular bigeminy: 40 BPM A2: Slow alternating ventricular bigeminy: 30 BPM A3: Rapid alternating ventricular bigeminy: 115 – 125 BPM A4: Bidirectional systoles 58 – 85 BPM Note Measurements made in FILTER MODE - MONITOR, outside of the MR environment. The accuracy of the indicated heart rate may be affected by MRI gradient artifacts. Pulse Oximeter Pulse tone pitch is modulated by the saturation value.
Pulse Oximeter When “HR” is derived from SPO2 Lower Upper Off, or 30 to 250 BPM 60 to 250 BPM, or off Note Measurement validation: SPO2 accuracy 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 70–100 percent SPO2 were studied.
CO2 (Optional LoFlo) Fractional inspired CO2 (FiCO2) Measurement Range CO2 Accuracy (All measurements at gas temp of 25°C) 3 to 50 mmHg (0.4 to 6.7 kPa) Method: Lowest reading of the CO2 waveform in the previous 20 seconds ± 4 mmHg (± 0.5 kPa) or ± 12 percent, whichever is greater, after the specified warm‐up period CO2 Stability Short Term Drift Not to exceed 0.8 mmHg (0.
CO2 (Optional LoFlo) Compensations (Automatic CO2 ambient pressure compensation 400– 800 mmHg [53.3 – 106.6 kPa]) For end‐tidal O2 balance gas (N2, N2O, O, He) and anesthetic agentsB Uses gas compensation information to correct the raw carbon dioxide value Anesthetic Agent Effects (MAC Levels) Anesthetic Agent SensitivityA (uncompensated): Accuracy specification will be maintained for halogenated anesthetic agents present at accepted MAC (Minimum Alveolar Concentration ) clinical levels.
CO2 (Optional LoFlo) Alarm Limits End‐tidal CO2 Lower Upper Off, or 5 to 60 mmHg (Off, or 0.7 to 8.0 kPa) 5 to 90 mmHg, or off (0.7 to 12.0 kPa, or off) Fractional inspired CO2 Lower Upper No low alarm; 0 to 20 mmHg, or off (0 to 2.7 kPa, or off) Respiration Lower Upper Off, or 4 to 40 RPM 20 to 100 RPM, or off *For kilopascals (kPa), allow ± 1 least significant digit to accommodate round‐off error for calculated values. A.
Invasive Blood Pressure (Optional) Transducer Offset Range ± 300 mmHg Transducer (REF 989803179721) Operating Pressure Overpressure Limits Sensitivity Zero Offset Zero Drift Input Impedance ‐50 to 300 mmHg ‐400 to 5000 mmHg 5 µV/V/mmHg ±1 @ 6 VDC and 22°C (71.6°F) < 25 mmHg < 2 mmHg in 8 hours 300 to 350 ohms Auto Zero Range Zero Accuracy Response Time +300 mmHg ±1.
Invasive Blood Pressure (Optional) Transducer Adapter Cable Compatibility Invasive pressure input mates with an Amphenol connector (MS‐3106A 14S‐6P). With this connector and the following connection information, transducer adapter cables may be fabricated or ordered from various manufacturers.
AGENT (Optional) Accuracy* (includes stability and drift) ±0.15 Vol.% at 0 to 1.00 Vol% ±0.20 Vol% at 1.00 to 5.00 Vol% Unspecified > 5.00 Isoflurane: ±0.15 Vol.% at 0 to 1.00 Vol% ±0.20 Vol% at 1.00 to 5.00 Vol% Unspecified > 5.00 Sevoflurane: ±0.15 Vol.% at 0 to 1.00 Vol% ±0.20 Vol% at 1.00 to 5.00 Vol% ±0.40 Vol% at 5.00 to 8.00 Vol% Unspecified > 8.00 Desflurane: ±0.15 Vol% at 0 to 1.00 Vol% ±0.20 Vol% at 1.00 to 5.00 Vol% ±0.40 Vol% at 5.00 to 10.00 Vol% ±0.60 Vol% at 10.00 to 15.00 Vol% ±1.
AGENT (Optional) System Response and Rise Times (As measured from patient gas input of the complete pneumatic circuit, including tubing, from 10 – 90 percent of measured levels) Cannula, Adult Halothane— System response: 11.56 seconds Rise time: 5.77 seconds Enflurane— System response: 7.55 seconds Rise time: 1.75 seconds Isoflurane— System response: 6.71 seconds Rise time: 0.88 seconds Sevoflurane— System response: 6.45 seconds Rise time: 0.62 seconds Desflurane— System response: 6.
AGENT (Optional) Cannula, Infant Halothane— System response: 15.95 seconds Rise time: 8.63 seconds Enflurane— System response: 11.98 seconds Rise time: 4.75 seconds Isoflurane— System response: 9.26 seconds Rise time: 1.70 seconds Sevoflurane— System response: 6.48 seconds Rise time: 0.62 seconds Desflurane— System response: 6.47 seconds Rise time: 0.61 seconds Oxygen— System response: 8.61 seconds Rise time: 1.13 seconds Nitrous oxide— System response: 7.95 seconds Rise time: 0.
AGENT (Optional) Divided Cannula, Adult Halothane— System response: 20.81 seconds Rise time: 14.18 seconds Enflurane— System response: 13.83 seconds Rise time: 7.11 seconds Isoflurane— System response: 10.99 seconds Rise time: 3.91 seconds Sevoflurane— System response: 7.48 seconds Rise time: 0.78 seconds Desflurane— System response: 7.38 seconds Rise time: 0.64 seconds Oxygen— System response: 8.02 seconds Rise time: 1.07 seconds Nitrous oxide— System response: 7.16 seconds Rise time: 0.
AGENT (Optional) Divided Cannula, Infant Halothane— System response: 9.98 seconds Rise time: 3.95 seconds Enflurane— System response: 7.32 seconds Rise time: 1.37 seconds Isoflurane— System response: 6.75 seconds Rise time: 0.89 seconds Sevoflurane— System response: 5.45 seconds Rise time: 0.67 seconds Desflurane— System response: 6.25 seconds Rise time: 0.60 seconds Oxygen— System response: 7.25 seconds Rise time: 0.84 seconds Nitrous oxide— System response: 6.51 seconds Rise time: 0.
AGENT (Optional) Relevant Interference 0.5 mmHg equivalent with 37.5°C saturated with H2O (0.1% relative max) Display Resolution 0.1 percent volume Maximum Warm‐up Time 10 minutes; ISO accuracy achieved in < 45 seconds of activation Auto ID Threshold (full accuracy mode) Primary Agent ID: 0.15% Secondary Agent ID: 0.3% Multiple Agents Alarm Threshold 0.3% (0.5% during ISO accuracy mode) or 5%REL (10% for Isoflurane) of primary agent if primary agent > 10% (For Hal add 0.
AGENT (Optional) Fi Isoflurane Lower Upper Off, 0.1 to 5.0 Vol. % 0.1 to 5.0 Vol. %, Off Et Enflurane Lower Upper Off, 0.1 to 5.0 Vol. % 0.1 to 5.0 Vol. %, Off Fi Enflurane Lower Upper Off, 0.1 to 5.0 Vol. % 0.1 to 5.0 Vol. %, Off Et Sevoflurane Lower Upper Off, 0.1 to 8.0 Vol. % 0.1 to 8.0 Vol. %, Off Fi Sevoflurane Lower Upper Off, 0.1 to 8.0 Vol. % 0.1 to 8.0 Vol. %, Off Et Desflurane Lower Upper Off, 0.1 to 18.0 Vol. % 0.1 to 18.0 Vol. %, Off Fi Desflurane Lower Upper Off, 0.1 to 18.0 Vol.
AGENT (Optional) Offset ±1 percent O2 Interfering Gas Effects: N2O CO2 Halothane Enflurane Isoflurane Desflurane Sevoflurane Acetone Ethanol Helium Methane Nitric Oxide < 0.3 vol% @ 80 vol% N2O < 0.3 vol% @ 5 vol% CO2 < 0.3 vol% @ 5 vol% HAL < 0.3 vol% @ 5 vol% ENF < 0.3 vol% @ 5 vol% ISO < 0.3 vol% @ 18 vol% DES < 0.3 vol% @ 8 vol% SEV < 0.3 vol% @ 1 vol% Acetone < 0.3 vol% @ 0.1 vol% Ethanol < 0.3 vol% @ 80 vol% HE < 0.3 vol% @ 0.1 vol% Methane < 0.
Temperature (Optional) (All measurements made with or without a sterile jacket) Accuracy ±0.5°C (±0.9°F) Confirming changes in a measurement against other vital sign mea‐ surements should be standard routine during use.
Non-Invasive Blood Pressure Mean Adult Pediatric Neonate 20 to 255 mmHg (2.7 to 34 kPa) 20 to 160 mmHg (2.7 to 21.3 kPa) 20 to 120 mmHg (2.7 to 16 kPa) Diastolic Adult Pediatric Neonate 10 to 245 mmHg (1.3 to 32.7 kPa) 10 to 150 mmHg (1.3 to 20 kPa) 10 to 100 mmHg (1.3 to 13.3 kPa) Accuracy Pressure Measurement Accuracy Maximum mean error ± 5 mmHg (± 0.6 kPa) with a standard deviation of less than 8 mmHg (1 kPa) Pressure Measurement Resolution 1 mmHg (0.
Non-Invasive Blood Pressure Notes • The effectiveness of NIBP has not been established in the presence of any dysrhythmias included in the exclusion criteria. • The NIBP clinical study was performed on adult and pediatric patients with the following attributes: – The effectiveness of NIBP has not been established in the presence of any dysrhythmias included in the exclusion criteria.Gender: 61% male, 39% female. – No patients less than 29 days of age. – Patients with limb circumferences ranged from 10.
Non-Invasive Blood Pressure Alarm Limits Systolic Adult Lower Upper Pediatric Lower Upper Neonate Lower Upper Mean Adult Lower Upper Pediatric Lower Upper Neonate Lower Upper Diastolic Adult Lower Upper Pediatric Lower Upper Neonate Lower Upper Off, or 30 to 270 mmHg (Off, or 4.0 to 36.0 kPa) 30 to 270 mmHg, or off (or 4.0 to 36.0 kPa, or off) Off, or 30 to 180 mmHg (Off, or 4.0 to 24.0 kPa) 30 to 180 mmHg, or off (or 4.0 to 24.0 kPa, or off) Off, or 30 to 130 mmHg (Off, or 4.0 to 17.
Gating Outputs Gating connector pin-outs Pin Designator Signal Name Description and Characteristics A Digital gating pulse ECG/SPO2 digital gating pulse: • Peak to peak voltage: 3.3 V to 5.
APPENDIX B Warranty Warranty Statement Koninklijke Philips N.V. warrants this product, other than its consumable 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 ninety (90) days on consumable parts.
B‐2 Warranty Expression MR400 Instructions for Use
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 (1999/5/ EC), and/or Restriction on Hazardous Substance (RoHS) Directive, contact the Regulatory Affairs Department at Invivo: 407‐275‐3220 ‐or‐ 1‐800‐331‐3220 (toll‐free) Internationally, please contact your Key Market representative. Go to www.invivocorp.
C‐2 Regulatory Information Expression MR400 Instructions for Use
APPENDIX D Gating Feature The gating feature in the MR400 outputs data and discrete signals to the MRI scanner system resulting from the collection and processing of data from a monitored parameter. The scanner system uses these signals and data to precisely control the times that it collects MR image data from the patient.
Symphony, Siemens Alvanto, Philips Intera, et cetera; see page 1‐35). For detailed signal characteristics of the gating outputs, see A‐28. Using the Gating Feature The gating feature provides facilities for low latency MRI triggering and synchronization based on the measured ECG or SPO2 signal.
Step 7 Action Proceed according to the type of gating being used: Analog Gating — To receive the analog ECG gating waveform through the MR400, ensure that all of the following conditions have been met: • The correct gating cable is installed between the MR400 and the MR system; • The system is communicating with the wECG module; • The wECG module is properly attached to the patient; and, • Lead Fail does not exist for the measured ECG signal.
Using SPO2 Gating To receive SPO2 gating signals Step 1 Action Check the battery indicator on the wSpO2 module to ensure that enough charge exists: • Green battery indicator = Charge sufficient; proceed to step 5. • Red battery indicator = Charge low; proceed to step 4. See page 2‐11 for details. (Also, you can reference the status information pane; see page 2‐16.
APPENDIX E 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 radio frequency coils, physiologic monitors, electronically‐ activated devices, and external accessories or objects made from conductive materials has caused excessive heating, resulting in burn injuries to patients undergoing MR procedures.
1. Prepare the patient for the MR procedure by ensuring that there are no unnecessary metallic objects contacting the patient's skin (e.g., metallic drug delivery patches, jewelry, necklaces, bracelets, key chains, et cetera). 2. Prepare the patient for the MR procedure by using insulation material (i.e., appropriate padding) to prevent skin‐to‐skin contact points and the formation of “closed‐loops” from touching body parts. 3.
12. Do not position electrically conductive materials across an external metallic prosthesis (e.g., external fixation device, cervical fixation device, et cetera) or similar device that is in direct contact with the patient. 13. Allow only properly trained individuals to operate devices (e.g., monitoring equipment) in the MR environment. 14.
Finelli DA, Rezai AR, Ruggieri PM, Tkach JA, Nyenhuis JA, Hrdlicka G, Sharan A, Gonzalez‐Martinez J, Stypulkowski PH, Shellock FG. MR imaging‐related heating of deep brain stimulation electrodes: In vitro study. Am J Neuroradiol 2002;23:1795‐1802. Heinz W, Frohlich E, Stork T. Burns following magnetic resonance tomography study. (German) Z Gastroenterol 1999;37:31‐2. http://www.MRIsafety.
Shellock FG. MR safety update 2002: Implants and devices. Journal of Magnetic Resonance Imaging 2002;16:485‐496. 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.
E‐6 Guidelines and References Expression MR400 Instructions for Use
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