Expression MR200 MRI Patient Monitoring System INSTRUCTIONS FOR USE Revision B English *989803184961* 989803184961
Manufacturer Invivo, a division of Philips Medical Systems 12151 Research Parkway Orlando, FL 32826 USA 877‐468‐4861 +31 (0) 499 378299 www.invivocorp.com Copyright Copyright © 2013, Koninklijke Philips N.V. All rights reserved. REF 989803184961 Rev. B, October 2013 Printed in USA Proprietary Information This document and the information contained in it is proprietary and confidential information of Koninklijke Philips N.V.
Contents Manufacturer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-ii Copyright . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-ii Proprietary Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-ii Chapter 1: Important Information Intended Audience . . . . . . . . . . . . . . . . . . . . . . . . . .
Rear Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Wheel Locks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Battery Compartments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Guide Handles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Chapter 4: Monitoring ECG wECG Module and Lead Cable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1 Defibrillator Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2 Patient Preparation for ECG Monitoring. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3 ECG Site Considerations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
SPO2 Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-9 ALARM LIMITS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . SIZE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . AVERAGING TIME . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Chapter 8: Monitoring RESP Patient Preparation for RESP Monitoring. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1 Monitoring Respiration using CO2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-1 Monitoring Respiration using the Bellows. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-1 Bellows Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Graphical Trend Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Viewing Individual Trend Graphical Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Viewing Multi Trend Graphical Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . HISTORY Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . PREV PAGE . . .
Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Environment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Dimensions and Weights . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Liquid Crystal Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
8 Contents
CHAPTER 1 Important Information Important user information about the Expression MR200 MRI Patient Monitoring System and contact information for Royal Philips is discussed here. Information regarding the safety, accessories, assembly and operation of a fully equipped Expression MR200 MRI Patient Monitoring System can be found in this document. Some information may depict monitoring features not present on your MR200.
Indications for Use The Expression MR200 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 of the MRI scanner. The Expression MR200 provides monitoring for the following vital sign parameters: ECG, pulse oximetry (SpO2), non‐invasive blood pressure (NiBP), and (optional) carbon dioxide (CO2).
Document Conventions These document conventions are used: • The Expression MR200 MRI Patient Monitoring System will hereafter be referred to as the MR200. • 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 • Unless noted, all procedures start from the normal mode of operation. • Control names, menu items, vital sign references, etc.
Contraindications Refer to all warnings. Before using the MR200, read the warnings and the safety information below. The warnings below refer to the MR200 in its entirety. WARNINGS • Thoroughly read and understand these Instructions for Use prior to use of the MR200. • A shock hazard exists if the MR200 is operated without the covers installed. • Only use only supplied power cords and connect to properly grounded AC outlets to avoid electrical shock.
Safety Equipment Classification (According to IEC 60601-1) According to the type of protection against electrical shock: Class I equipment According to the degree of protection against electrical shock: Type CF (defibrillator-proof) equipment According to the degree of protection against harmful ingress of water: IPX0 (ordinary) protection against ingress of fluids According to the methods of sterilization or disinfection: Non-sterilizable; use of liquid surface disinfectants only According to the m
WARNINGS • Operation of the MR200 outside the specifications indicated in Appendix A will cause inaccurate results. • The use of portable and mobile radio-frequency (RF) communications equipment can affect the operation of this device.
Guidance and Manufacturer’s Declaration - Electromagnetic Immunity The MR200 is intended for use in the electromagnetic environment specified below. The customer or the user of the MR200 should assure that it is used in such an environment.
Guidance and Manufacturer’s Declaration - Electromagnetic Immunity The MR200 is intended for use in the electromagnetic environment specified below. The customer or the user of the MR200 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 MR200 The MR200 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the MR200 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the MR200 as recommended below, according to the maximum output power of the communications equipment.
Caution CAUTIONS • If the battery contacts become dirty, wipe them clean with a dry cloth before use. • Store batteries in a dry place, between 0°C to 40°C. • Keep metal objects away from the battery contacts. List of Symbols The symbols in the following table may appear on the MR200, the packing materials, or in this manual. Symbol Meaning Symbol Meaning CSA certified for both the U.S.
Symbol Meaning Warning! Specific warnings associated with the devices that are not otherwise found on the label; when located on the wECG module connector, indicates that only specified ECG cables shall be used to ensure safe use in the MR and defibrillation protection.
Symbol Meaning Symbol Meaning Toe site Thumb site Finger site Foot site Toe site Temperature range Prescription only NiBP cuff, wrong side out NiBP cuff, correct side out NiBP cuff circumference range Weight Keep dry Humidity range Atmospheric pressure limitation Fragile Up Patient ECG 1‐12 Important Information Expression MR200 Instructions for Use
Symbol Meaning Symbol Meaning Non-invasive blood pressure (NiBP) Universal Serial Bus (USB) Contains no latex Dispose of the battery or electronic waste in accordance with your country’s requirements Non-ionizing radiation Pneumatic respiration Cardiac gating output Input connection Manufacturer name and address information Date of manufacture, YYYYMM Conforms to the RoHS directive Battery Non-magnetic part Wheel lock, press to engage Apply wheel locks and do not move the MR200 inside the
Symbol Meaning Symbol Meaning Print key Patient key Silence key Setup key Alarm sound on Suspend key Alarm sound on hold Power switch Alarm sound silenced Alarm sound off Current setups have changed Heartbeat detected On AC power Breathing effort detected wECG battery time remaining Good battery power wSPO2 battery time remaining No AC, on battery power No MR200 communication with the wECG module Low battery power Network channel A No MR200 communication with the wSPO2 module Netwo
Symbol Meaning Symbol Meaning Network channel D Network channel E Cart connected to AC mains, batteries installed Cart connected to AC mains, batteries not installed Printer ready Printing in progress and time remaining, in seconds No printer available Printer not ready Examining the Contents To report shipping damage, or to resolve any issues or concerns with your order, contact Customer Service.
Assembly This section provides important information about assembly and system requirements. Observe the warnings and cautions that appear throughout this manual when assembling and using the MR200. For the location of cart components not detailed below, see the illustration on page 2‐3. WARNING Warning Only perform assembly of the MR200 at a location outside of the MR magnet room. Failure to observe this warning may result in serious injury.
AC Inlet Is the input connection for AC voltage to the cart. Strain relief Secures the AC power cord to the cart. Caution CAUTIONS • When making connections to the rear panel of the MR200, ensure that the final installation complies with IEC/EN 60601-1-1, General Requirements for the Safety of Medical Electrical Systems, to assure operator and patient safety. Always check the summation of leakage currents when the MR200 is connected to additional external equipment.
To install cart batteries Orient a battery for insertion (label side down, connector facing forward) then slide it into a battery compartment. When properly inserted, the battery will latch into place. A “click” will be heard and the battery will be flush with the face of the battery compartment. Repeat the process for the remaining battery. NOTE Before initial use, charge the batteries for at least 12 hours with the MR200 turned off and connected to AC mains power.
Step Action 5 Lower the strain relief over the AC power cord. 6 Connect the AC power cord to an approved AC mains outlet. To remove the MR200 from AC mains power Pull out the plug at the wall outlet and then remove the AC power cord from the MR200. Store the cord in a safe place. MR200 Battery Operation WARNING Warning Do not touch the internal battery compartments of the cart and the patient simultaneously. Cart batteries are charged and conditioned by an integrated intelligent charging system.
Attaching the SPO2 Sensor to the wSPO2 Module WARNINGS • Only perform this assembly at a location outside of the MR magnet room. Failure to observe this warning may result in serious injury. • Connecting other than specified SPO2 sensors to the wSPO2 module can cause inaccurate SPO2 readings and damage the module. To attach the SPO2 sensor to the wSPO2 module Insert the SPO2 sensor to the DB‐9 connector on the wSPO2 module. Then, using a standard screwdriver, securely tighten both screws.
To install a module battery Orient the battery as shown and then slide the battery between the slots on back of the module until both tabs latch into place. Store the modules in the module holders on the cart; see 2‐5 for details. Tabs Slots Battery Module To remove a module battery Using the thumb and index finger of one hand, press the tabs inward and hold. Then place the thumb or a finger of your other hand on the recess and push the battery out of the module.
To press the network button Place the module on a flat steady surface (or hold the module as shown in the figure, right) and then use your thumb to press the network button. Changing the Network Channel of a Module Before starting the procedure to change the network channel of the module, take note of these conventions that are used to explain the process: • In the procedure below, the following symbols are used to convey the state of the network icon on a wireless module. .
Step 2 Action Insert a battery into the module; see page 1‐21. The network icons will flash briefly and then the current network icon will illuminate (for example, “C” in the illustration below). 3 Enter the network change mode: After the current network icon has been illuminated (and within 15 seconds from module power‐ up) press and hold the network button until the current network icon begins to rapidly blink then release the button.
Step 5 Action When you reach the desired icon, press and hold the button for approximately 5 seconds to lock and save the new setting. The selected network's icon will turn off while the button is depressed. Then it will illuminate (not blink) when the new network setting is saved. Once illuminated, release the button. The module will begin using the selected network channel.
Additional Options Additional options, such as those listed below, may be suggested by your biomedical technician to increase user ease. The MR200 is configured with input/output ports to permit the connection of external equipment, including: • Facility information systems • Gating source for MRI functions • USB port for software installation Consult your biomedical technician or technical support with specific requests.
CO2 REF 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 REF GEL, ECG/EEG, SKIN PREP, TUBE, 3-PACK 989803152291 CAB, 4 LD, MRI ECG 989803152301 CAB, 4 LD, NEO.
Non-invasive Blood Pressure REF NIBP CUFF, SINGLE LUMEN, INFANT 989803182611 NIBP CUFF, SINGLE LUMEN, PEDIATRIC 989803182621 NIBP CUFF, SINGLE LUMEN, SMALL ADULT 989803182631 NIBP CUFF, SINGLE LUMEN, ADULT 989803182641 NIBP CUFF, SINGLE LUMEN, ADULT-L 989803182651 NIBP CUFF, SINGLE LUMEN, LRG ADULT 989803182661 NIBP CUFF, SINGLE LUMEN, LRG ADULT-L 989803182671 NIBP CUFF, SINGLE LUMEN, THIGH 989803182681 NIBP CUFF, SINGLE LUMEN, INFANT, DISP 989803182511 NIBP CUFF, SINGLE LUMEN, PEDIATRIC
Power REF EUROPEAN LINE CORD 453564177501 NORTH AMERICAN LINE CORD 989803168211 CORD, JUMPER, 25 FEET 989803168221 BRAZILIAN POWER CORD, 3 METER 989803173901 UK LINE CORD, 3 METER 989803174171 POWER CORD, AUS/NZL, 3 METER 989803181291 POWER CORD, S AFRICA, 3 METER 989803181321 POWER CORD, DANISH, 3 METER 989803181331 POWER CORD, ISRAELI, 3 METER 989803181341 POWER CORD, ARGENTINA, 3 METER 989803181351 POWER CORD, SWISS, 3 METER 989803181361 SPO2 REF QUICK CONNECT SPO2 PROBE, MRI 9
Miscellaneous REF PAPER, THERMAL ARRAY, BLK, 50MM, OMNI MP05 QUICK REFERENCE GUIDE, MR200 453564357851 MANUAL, SERVICE, MR200 989803181911 MANUAL, OPERATORS, MR200, ENGLISH 989803184961 MANUAL, OPERATOR, MR200, DANISH 989803181971 MANUAL, OPERATOR, MR200, DUTCH 989803181981 MANUAL, OPERATOR, MR200, FINNISH 989803181991 MANUAL, OPERATOR, MR200, FRENCH 989803182001 MANUAL, OPERATOR, MR200, GERMAN 989803182011 MANUAL, OPERATOR, MR200, ITALIAN 989803182041 MANUAL, OPERATOR, MR200, NORWEGIA
1‐30 Important Information Expression MR200 Instructions for Use
CHAPTER 2 System Overview Familiarize yourself with the MR200 and its components. The MR200 combines wireless communications, radio frequency shielding and digital signal processing technologies to provide accurate, continuous and reliable patient monitoring performance in the dynamic magnetic resonance environment. The monitoring capabilities of the MR200 can be configured to meet the needs of a wide spectrum of patients from neonate to adult.
MRI magnet room MR200 Modules to MR200 (wireless) Patient bed HIS system MR200 to IP5 (wireless) MRI control room IP5 Printer USB Ethernet Hospital network Acquisition and Control The use of the MR200 is restricted to one patient at a time. The MR200 displays patient measurements acquired during monitoring.
WARNING The use model specifies one IP5 per MR200 system. If more than one IP5 is present on the MR200 system, there is an increased risk of units within the system not synchronizing and displaying incorrect or corrupted settings. CAUTION If the monitor’s settings are adjusted since they were last recalled or stored (manually, or via synchronization - if using an IP5 ), the current setup name (see page 2-14) will be appended with a plus symbol (+).
Display and control assembly Speaker Patient connection panel Storage basket Module holders Guide handles Wireless processing unit Battery compartments Rear panel Wheel locks WARNING Never store ferrous items on the cart or in the storage basket. Failure to observe this warning may result in serious injury. CAUTION Do not place more than 4 pounds (1.8 kg) of combined weight in the storage basket, module holders and on the optional hose management handle hooks (not shown).
Module Holders The module holders provide safe storage for the wireless modules. Place a wireless module in a module holder so that a connected accessory hangs downward through the opening. Wireless Processing Unit The wireless processing unit (WPU) houses the communication, processing and power systems for the MR200. Rear Panel The rear panel contains the AC inlet, gating connector and USB port; see page 1‐16 for details. Wheel Locks Locks are provided on each wheel to prevent movement of the cart.
CAUTIONS • Never apply excessive force, lean against, stack or drape objects over the guide handles; instead, use specially designed hose management handle hooks; see page 1-28 for details. • If the MR200 rolls to the face of the MR system due to magnetically induced pull force, Do not attempt to dislodge the MR200 by pulling from the display panel or guide handles; instead, dislodge the MR200 by gently pulling from the lowest point of the base.
When positioning the MR200 for use, observe the warning and cautions below. WARNING Do not move the MR200 inside the 1,500 gauss field line of the MR magnet or within 1.5 m (4.9 feet), whichever is greater, as measured from the center line of the bore. Always secure the wheel locks when the MR200 is located in the MR magnet room. Failure to properly place the MR200 in the MR magnet room will result in monitoring system failure, and possible patient or user injury.
wECG Module The wireless ECG module (wECG) transmits measured ECG signals through a wireless link to the MR200. The module also receives information to perform commanded tasks (for example, lead configuration and filter mode changes). Two ECG channels can be displayed and are available for interfacing with the MR system cardiac gating input.
System Power-Up and Communications Verification WARNING Always perform operational verification prior to use and during monitoring by ensuring proper communications between the MR200, the wireless modules and the IP5 (if equipped). Failure to ensure proper communications can result in the loss of patient monitoring and the loss of data transfer in networked systems equipped with an IP5. If a device fails to function properly, remove it from use and contact technical support.
System Parameters The MR200 simultaneously processes and displays multiple parameters, waveforms, numeric values and alarms. All patient information is provided on the display panel.
Power Switch Power is controlled by the power switch : • Press the power switch to turn on the MR200. • Press and hold the power switch for approximately two seconds to turn off the MR200. Keypad The keypad has eight keys for quick access to frequently used functions. Key Function Controls the alarm sound; see page 9-7 for details. Silence Enters suspend mode; see page 2-19 for details.
Control Knob The control knob allows you to navigate and select options, items and settings in the menu system: • Rotating the control knob clockwise moves the “cursor” down and rotating the knob counterclockwise moves the “cursor” up. • In the normal mode, rotate the knob to highlight different vital sign boxes and press the knob to open the associated menu. • When a menu is displayed, rotate the knob to highlight options and items and press the knob to select that option or item.
LCD The display panel features a color liquid crystal display (LCD). Always adjust the cart so that your view of the LCD complements your line of sight. CAUTION Never apply unnecessary force to the LCD as it can result in screen damage or failure. NOTE To change the language displayed by the MR200, see page 11-16.
Informational Area The informational area, along the top of the screen, provides user and patient information: Time Symbol area Current setup name Patient Notification area • Time provides current time, given in a 12‐ or 24‐hour format (hh:mm:ss); see Set Time on page 3‐12 for details. • Symbol area provides indications of the alarm sound setting, configuration status, and heartbeat and respiration detection.
ECG VS box (see page 4-16) SPO2 VS box (see page 5-7) CO2 VS box (see page 7-6) NiBP VS box (see page 6-7) RESP VS box (see page 8-3) No Data Available Indication Under certain conditions one or more of the numerics in the VS boxes may display three dashes (‐ ‐ ‐) to indicate that no data is available.
Depending upon the nature of this indication, an alarm may be generated if no parameter data is available. In this case, the dashes will be displayed in red and an alarm will sound. An alarm is generated when: • Parameter data was present but is no longer available (for example, a sensor that was applied may no longer be connected to the patient). • The hardware associated with a parameter has experienced a problem or failure that prevents proper operation.
– When on battery power, the battery level with a time remaining counter is displayed; and, if less than 45 minutes of operating time remain, then is displayed and an alarm is sounded. NOTE After the start of battery power mode, the time remaining counter may take several minutes to stabilize. • wSPO2 module status icon indicates the communication and battery status of the wSPO2 module: – Where indicates the battery level (with a time remaining counter, formatted in hours:minutes).
Vital Sign Traces Area The vital sign traces area, in the middle of the screen, provides vital sign (VS) waveforms and system status messages. Trace waveforms (A–D) are uniquely colored to match their corresponding VS box, and are fixed across the LCD and updated with an erase bar: Trace A Trace B Trace C Trace D System message area • Trace A is assigned and displayed depending upon the ECG menu options; see page 4‐16. • Trace B displays ECG2 when two ECG sources are on.
Suspend Mode Suspend mode supports patient‐clinician interaction without nuisance alarms, which is useful where minimal user interaction is required (for example, while a patient is not being monitored, during transitions when removing the monitor from one patient and connecting it on another, or if certain adjustments are being made to the device or other equipment).
2‐20 System Overview Expression MR200 Instructions for Use
CHAPTER 3 Getting Started Initial setup is important to achieve expected results and seamless operation. Setup menus provide the ability to select monitoring options, control functions, store and recall operating configurations and access test routines. CAUTIONS • A minor but noticeable degradation in wireless module communications may occur in the presence of high-powered radios.
operate as follows: • The alarm tone will sound while an alarm condition exists, provided that any pre‐alarm sound delay has expired and the symbol is displayed. • Messages related to other alarm sound states will be removed from the display. • An alarm condition not previously placed in a silenced state will cause the alarm to sound (provided that any pre‐alarm sound delay has expired).
• MONITOR SETUP (see below) • PRINTER SETUP (see chapter 10 for details) MONITOR Menu The MONITOR SETUP option (in the SETUP menu) opens the MONITOR menu, which contains options for setup and control of patient monitoring. . MONITOR menu Setup key Control knob To change settings in the MONITOR menu Step 1 Action Press the SETUP key . The SETUP menu appears. 2 Turn the control knob to MONITOR SETUP and then press the knob. The MONITOR menu appears. Current settings are displayed.
Step 3 Action Turn the control knob to select any of the following system‐wide options and then press the knob: RECALL SETUPS STORE SETUPS PARAMETER SELECTION SOUND ADJUST PATIENT PEDIATRIC ECG SET TIME DEFAULT SETUPS SWEEP SPEED RESP SPEED NETWORK SERVICE(BIO‐MED) For options information, see the appropriate sections below. 4 Turn the knob to the desired setting and then press the knob. 5 To change other settings, repeat steps 3 and 4. 6 Press the Main key to close the menu.
• E • F • USER (Factory programming will be recalled if this option is selected but was not previously stored; see page 3‐5.) To recall a setup from memory Step 1 Action Press the SETUP key . The SETUP menu appears. 2 Turn the control knob to MONITOR SETUP and then press the knob. The MONITOR menu appears. Current settings are displayed. 3 Turn the control knob to RECALL SETUPS and then press the knob: The RECALL SETUPS menu appears.
– NiBP manual or auto setting and automatic time interval – Trend graph time base and scale – Print control, trace delay, speed and selected traces The following memory block choices are available: • A • B • C • D • E • F • USER To store a setup in memory Step Action 1 Configure the settings and options of the MR200 as desired. 2 Press the SETUP key . The SETUP menu appears. 3 Turn the control knob to MONITOR SETUP and then press the knob. The MONITOR menu appears.
PARAMETER SELECTION Controls monitoring functions, as indicated by the absence or presence of the VS box for the parameter, except ECG (see below). The following choices are available: • ECG allows electrocardiogram monitoring: – ON turns on the ECG parameter. (Default) – OFF turns off the ECG parameter. Heart rate will remain in the VS box allowing it to be displayed from another selected source or if HR SOURCE is set to AUTO and ECG is in a LEAD FAIL condition.
Step 4 Action Turn the control knob to select one of the following parameters and then press the knob: ECG NiBP SPO2 CO2 (if installed) RESP The parameter’s activation menu appears. 5 Turn the knob to the desired setting and then press the knob. SOUND ADJUST WARNING 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.
• HR TONE SOURCE sets the source used for the heart rate tone (identical to and interactive with the same option in the ECG and SPO2 menus): – OFF removes the heart symbol from the display and produces no tone. (Default) – QRS provides a tone modulated by the QRS detection from the ECG vital sign. – SPO2 provides a tone modulated by the SPO2 vital sign, where a lower value produces a lower pitch. • ALARM VOLUME sets the alarm sound level from 1–10.
PATIENT Selects the type of patient to be monitored. 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. Neonatal patients are defined by the approximate age range of birth to a few weeks. All other patients are identified as adults.
– Limb circumference – Physiological development – Neurological development – Neuromuscular coordination Accordingly, the MR200 uses several operational parameters, including cuff inflation pressure and pulse sensitivity, that vary depending on the selected patient type. (Always refer to information about the corresponding parameter for other possible considerations when determining the patient type.
NOTE When PATIENT is set to NEO, PEDIATRIC ECG is set to ON and locked. When the 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 the pediatric ECG filter Step 1 Action Press the SETUP key . The SETUP menu appears. 2 Turn the control knob to MONITOR SETUP and then press the knob. The MONITOR menu appears. Current settings are displayed.
• MONTH sets the month. • YEAR sets the year. • ENTER saves any changes. To set the time and date Step 1 Action Press the SETUP key . The SETUP menu appears. 2 Turn the control knob to MONITOR SETUP and then press the knob. The MONITOR menu appears. Current settings are displayed. 3 Turn the control knob to SET TIME and press the knob. The SET TIME menu appears.
To set the default setups Step 1 Action Press the SETUP key . The SETUP menu appears. 2 Turn the control knob to MONITOR SETUP and then press the knob. The MONITOR menu appears. Current settings are displayed. 3 Turn the control knob to DEFAULT SETUPS and press the knob. The DEFAULT SETUPS menu appears. 4 Turn the control knob to select one of the following options and then press the knob: FACTORY USER The power‐on default is set. SWEEP SPEED Changes the trace speed of all waveforms except CO2.
• 0.33333 mm/s To adjust the sweep rate for CO2 respiration See Changing the Waveform Speed on page 7‐6. NETWORK Sets the wireless communications channel for the cart. The network used by the cart and the wireless modules must be the same. The following network choices are available: • A (Default) • B • C • D • E To set the network Step 1 Action Press the SETUP key . The SETUP menu appears. 2 Turn the control knob to MONITOR SETUP and then press the knob. The MONITOR menu appears.
SERVICE(BIO-MED) Allows access to pressure and miscellaneous configuration settings, diagnostic routines and firmware information; see page 11‐12 for details.
CHAPTER 4 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.
NOTE Refer to your facility's biohazard procedure for disposal of ECG lead cables when they become unusable. Usually cables are disposed of as medical waste per facility procedures. Defibrillator Use The MR200 has a defibrillation‐proof degree of protection that allows a patient to be defibrillated while connected to the wECG module and leads. When using a defibrillator, follow all precautions related to both the MR200 and the defibrillator equipment.
Patient Preparation for ECG Monitoring When monitoring ECG, the site selected on the patient, the Quadtrode electrode and ECG lead cable, the filter and lead view setting of the monitor, and the ambient environment will impact the performance and operation of the parameter. ECG Site Considerations Monitoring ECG in the MR environment is particularly challenging because of the inherent distortion of the ECG waveform caused by the MR magnetic field.
Selecting the Quadtrode Electrode and ECG Lead Cable ECG lead cables are specially constructed to avoid patient heating by reducing the amount of radio frequency (RF) energy that can flow through the wires. Suggested applications and the recommended lead cable (for part numbers, see page 1‐26) and electrode pairings are provided below.
Selecting sites on adult female patients Average weight adult female Overweight adult female CV Quadtrode (preferred) CV Quadtrode (preferred) Standard Quadtrode Standard Quadtrode Selecting sites on adult male patients Average weight adult male Overweight adult male CV Quadtrode (preferred) CV Quadtrode (preferred) Standard Quadtrode Standard Quadtrode Expression MR200 Instructions for Use Monitoring ECG 4‐5
Selecting sites on pediatric patients Pediatric female Pediatric male CV Quadtrode (preferred) CV Quadtrode (preferred) Standard Quadtrode Standard Quadtrode Selecting sites on infants and neonatal patients Infants and Neonates Standard Quadtrode Neonatal Quadtrode* *For patients weighing less than 22 pounds (10 kg) 4‐6 Monitoring ECG Expression MR200 Instructions for Use
Preparing the ECG Site To prepare an electrode site on a patient Step Action 1 Check the expiration date of the Quadtrode electrode package. 2 If necessary, shave the application area to remove hair from the selected electrode site(s). 3 Apply ECG Skin Prep Gel (REF 989803152291) to a gauze pad. 4 Briskly rub the selected site(s) with the gauze pad (the skin may turn pink). 5 Remove any excess gel with a clean gauze pad. 6 Follow the placement instructions provided on each Quadtrode package.
Attaching the Lead Cable Designators on the lead cable reference places on the torso where the electrodes should reside in relation to the patient’s extremities. However, depending upon the cable type (IEC or AHA), the respective cables use different designators and colors to reference lead placement. WARNINGS • Never use any ECG lead cables other than the specified ECG lead cables. • High levels of RF energy may cause patient heating or burns.
To attach the lead cable to the wECG module and lead cable clips to the Quadtrode electrode Step 1 Action Align the color coding on the lead cable connector (A) with color coding on the wECG module (B) then insert the connector into the module. (An AHA lead cable is shown in the example.) A B CAUTION When inserting or removing the lead cable or clip leads, only use the connector or clip; never pull or apply excessive force to the wires.
Lead Failure Indication If a disconnected or faulty Quadtrode electrode or ECG lead is detected during monitoring, the system will immediately notify you so that quick action can be taken to identify the source of the failure and proceed with an informed response. As shown in the example below, LEAD FAIL will be displayed and a red Lead Fail indicator will appear in the ECG VS box identifying the specific location (LL, LA, or RA); see page 9‐18 for troubleshooting information.
Positioning the wECG Module and Lead Cable for Scanning WARNINGS • When applying electrodes or connecting the patient lead cable, ensure that the electrodes or connectors never contact other conductive materials including grounded conductors. In order to prevent contact with other conductors or earth ground, make sure all the electrodes or connectors are properly attached to the patient. • No other electrical conductors (e.g. wires, leads, probes, etc.
NOTE Follow these guidelines to ensure the best possible performance of the wECG module, especially during harsh scan sequences (with PNS-peripheral nerve stimulation-levels above 80 percent): 1. Place the modules on or near the patient as close to the bore iso-center as possible (considering the scan to be performed). 2. Keep the wireless module outside the field of view. 3. Place the modules as close to the bore opening as possible.
Step Action 5 The wECG module, ECG lead cables and Quadtrode electrode are acceptable for use within MR systems with static magnetic field strengths of 3.0 Tesla or less within the MR system bore using a MR system reported whole body average Specific Absorption Rates (SAR) up to 4.0 W/kg. 6 Monitoring of ECG at power levels of greater than a MR system reported, whole body averaged SAR of 4 W/kg is not recommended for the general patient population.
To change the SCALE setting Step 1 Action Press the Patient key and then select the appropriate PATIENT type; see page 3‐10 for details. 2 Turn the control knob to highlight the ECG VS box (see page 4‐18) and then press the knob. The ECG menu appears. Current settings are displayed. 3 Turn the control knob to SCALE and then press the knob. The SCALE menu appears; see page 4‐21. 4 Turn the knob to select the setting and then press the knob. Only a setting of 5 mm/mV or 10 mm/mV is recommended.
Step 3 Action Turn the control knob to highlight the ECG VS box (see page 4‐18) and then press the knob. The ECG menu appears. Current settings are displayed. 4 Depending upon the trace being examined, turn the control knob to TRACE A LEAD or TRACE B LEAD and then press the knob. The respective menu appears; see page 4‐20 or 4‐20. 5 Change the setting to a different lead view to account for patient variability and then press the knob. I II III AVL AVR AVF The lead view changes; see page 4‐16.
Step 3 Action Turn the knob to select the filter and then press the knob. MONITOR PRIMARY SECONDARY CARDIAC ADVANCED The setting is applied, as indicated above the ECG VS box.
Definition 13 Is the detected ECG Trace A waveform 14 Displays messages; see page 9-16 for details 15 Is the selected FILTER MODE; see page 4-23 Changing the Waveform Speed To change the ECG (and SPO2) waveform speed Step 1 Action Press the SETUP key . The SETUP menu appears. 2 Turn the control knob to MONITOR SETUP and then press the knob. The MONITOR menu appears. Current settings are displayed. 3 Turn the knob to SWEEP SPEED and then press the knob.
Step 4 Action Turn the knob to change the setting value and then press the knob to make the change effective and return to the scrolling function. The setting is changed. 5 To change the remaining setting, repeat steps 3 and 4. NOTE To make global changes to the parameter alarm limit settings based upon the patient’s current vital sign readings, see Setting Alarm Limits Globally on page 9-4. ECG Menu The ECG menu allows you to control ECG traces, functions and settings.
Step 2 Action Turn the control knob to select any of the following ECG options: ALARM LIMITS TRACE A LEAD TRACE B LEAD SCALE GATING SOURCE HR SOURCE HR TONE SOURCE FILTER MODE ECG TEST SIGNAL T‐WAVE SUPPRESSION MAGNET CONTROL For information about these options, see the appropriate sections below. 3 Turn the knob to the desired setting and then press the knob. 4 To change other settings, repeat steps 2 and 3. 5 Press the Main key to close the menu.
Definition 4 Saves the settings then returns to the normal mode 5 Identifies heart rate alarm limits To set an alarm limit for heart rate See Changing the Heart Rate Alarm Limits on page 4‐17. TRACE A LEAD Sets the ECG A lead configuration. For best ECG and heart rate monitoring, always select the optimal lead configuration, the one that provides the least artifact and largest waveform detection for monitoring use.
To set the ECG B lead See Changing the Lead View on page 4‐14. SCALE Sets the scale for the ECG waveforms. After making this setting, take note of the scale indicator; see page 4‐16. If the selected scale results in a waveform with distorted or clipped peaks, OVERSCALE will be displayed and another setting should be selected until the message stops. The following choices (in millimeters per millivolt) are available: • AUTO makes the waveform fill the ECG trace area (not recommended for use in the MR).
NOTE Trace A is the default output channel for interfacing the cardiac gating input. To use Trace B, set Trace A to off, and ensure that Trace B is active (that is, not off); see page 4-20. HR SOURCE Selects the source that produces the heart rate, as displayed in the ECG VS box (identical to and interactive with the same option in the SPO2 menu).
The following choices are available: • OFF removes the heart symbol from the display and no pulse tone will be sounded. (Default) • QRS provides a tone triggered by the QRS detection from the ECG vital sign. • SPO2 provides a tone modulated by the SPO2 vital sign, where the lower the SPO2 value, the lower the pitch. To set the heart rate tone source Enter the ECG menu. Turn the control knob to HR TONE SOURCE and press the knob. Scroll to the desired setting and press the knob.
is achieved using the Advanced Filter ECG lead cable, which allows placement of the wECG module outside of the bore. Advanced filtering operates on one lead at a time from a restricted set of leads and cannot be applied to AVR, AVL or AVF leads. To provide the most convenient transition to this filter and lead configuration, the system will automatically select the lead to use by applying the following rules in the order shown below: 1.
T-WAVE SUPPRESSION Reduces the T‐wave amplitude when extremely large due to the magnetohydrodynamic effect (MHD), which can prevent gating. Use for accurate gating when an unusually high T‐wave amplitude, relative to the R‐wave amplitude, is seen. The following choices are available: • OFF (Default) • ON To apply T‐wave suppression Enter the ECG menu. Turn the control knob to T‐WAVE SUPPRESSION and press the knob. Scroll to the desired setting and press the knob.
NOTE FILTER MODE and T-WAVE SUPPRESSION settings will not be recalled when in MAGNET CONTROL or MAGNET FILTER mode. And, if a system recall is performed and then the MR200 is moved from the MR environment, the filter and T-wave suppression options will revert to their previous settings. • DISABLED allows the MR200 to control filtering and T‐wave suppression. To allow magnet control Enter the ECG menu. Turn the control knob to MAGNET CONTROL and press the knob.
Using SPO2 Gating To receive SPO2 gating signals Step 1 Action Verify the wSPO2 module status by checking the status indicator: • Solid green = Battery power OK/Good communication • Flashing green = Battery power OK/No communication • Solid red = Low battery power/Good communication • Flashing red = Low battery power/No communication 2 Ensure that the SPO2 attachment is properly attached; see Apply‐ ing the SPO2 Attachment to the Patient on page 5‐3.
4‐28 Monitoring ECG Expression MR200 Instructions for Use
CHAPTER 5 Monitoring SPO2 The pulse oximetry feature uses a motion‐tolerant signal processing algorithm based on Fourier Artifact Suppression Technology (FAST) to provide 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).
Patient Preparation for SPO2 Monitoring When monitoring SPO2, the site selected on the patient, the SPO2 attachment, the attachment’s position on the patient, and the ambient environment will impact the performance and operation of the parameter. Selecting the Site and Attachment When applying the clips or grips to the patient, site preparation and the pressure and alignment of the attachment are important factors to consider. Select the most appropriate limb that best fits the attachment size.
Applying the SPO2 Attachment to the Patient Read the warnings before applying an SPO2 attachment to the patient. WARNINGS • General fit: If a clip or grip is too loose, it might compromise the optimal alignment or dislocate.
To apply a disposable clip to the patient Step Action 1 Select the application site. It should match the clip size so that the sensor does not fall off or apply excessive pressure at the site. 2 If present, remove any colored nail polish from the application site. 3 Lift off the release liners that protect the adhesive. 4 Put the finger (or toe) onto either side of the attachment ‐ they are symmetrical ‐ such that the tip covers the window completely and does not protrude over the hinge.
Step Action 6 Secure the longer foam piece by pressing it firmly to the foam/ adhesive of the opposing side. 7 Ensure that the two fiber heads are opposing and have good skin contact. The angle between the two fiber heads should be as small as possible, not exceeding 45°. If the attachment opens too much, reattach or try another site. WARNING Disposable attachments are designed for single patient use and must be disposed after use. They must not be cleaned and reused.
Step 3 Action Verify the wSPO2 module status by checking the status indicator: • Solid green = Battery power OK/Good communication • Flashing green = Battery power OK/No communication • Solid red = Low battery power/Good communication • Flashing red = Low battery power/No communication Press the Patient key and then select the appropriate 4 PATIENT type; see page 3‐10 for details.
SPO2 Waveform and VS Box The elements contained in the SPO2 waveform (Trace C) and VS box are described below: 6 5 1 2 3 4 Definition 1 Is the high limit setting of the SPO2 alarm; see page 5-10 2 Is the low limit setting of the SPO2 alarm; see page 5-10 3 Is the heart rate numeric and the unit of measure, where BPM is beats per minute. 4 Is the name of the vital sign 5 Is the detected SPO2 waveform, not proportional to pulse volume and can be amplitude-adjusted for viewing; see page 5-8.
Changing the SPO2 Waveform Amplitude To change the SPO2 waveform amplitude Step 1 Action Turn the control knob to highlight the SPO2 VS box (see page 5‐9) and then press the knob. The SPO2 menu appears. Current settings are displayed. Turn the control knob to SIZE and then press the knob. 2 The SIZE menu appears; see page 5‐11 for details. 3 Turn the control knob to select one of the following options and then press the knob: 10, 20, 40, 60, 80 or 100 percent The setting is changed.
Assessing Suspicious SPO2 Readings Pulse oximetry measurements are statistically distributed. With newer algorithms, such as FAST‐ SPO2, the calculation of SPO2 is not directly linked to the correct detection of each pulse. When the pulse rate is very low or a strong arrhythmia is present, the SPO2/plethysmography pulse rate may differ from the heart rate calculated from ECG. This does not indicate an inaccurate SPO2 value.
To change settings in the SPO2 menu Step 1 Action Turn the control knob to highlight the SPO2 VS box and then press the knob. The SPO2 menu appears. Current settings are displayed. 2 Turn the control knob to select any of the following SPO2 options and then press the knob: ALARM LIMITS SIZE AVERAGING TIME GATING SOURCE HR SOURCE HR TONE SOURCE For information about these options, see the appropriate sections below. 3 Turn the knob to the desired setting and then press the knob.
Definition 1 Is the setting of the high alarm limit 2 Is the current measurement 3 Is the setting of the low alarm limit 4 Saves the settings and returns to the normal mode 5 Identifies SPO2 alarm limits To set the alarm limits for SPO2 See Changing the SPO2 Alarm Limits on page 5‐8. SIZE Changes the vertical scale of the SPO2 (pleth) waveform so that high amplitudes can be scaled down to avoid clipping of the peaks and low amplitudes can be scaled up to view the peaks.
To set the averaging time of the SPO2 reading Enter the SPO2 menu. Turn the control knob to AVERAGING TIME and press the knob. Scroll to the desired time and press the knob. GATING SOURCE Sets the cardiac gating source based on a measured signal. (This is the same option as in the ECG menu.) The following choices are available: • ECG is an output that represents the detection of the R‐peak of a QRS complex, a signal the MR system can use directly for triggering.
Step 3 Action Turn the control knob to select one of the following options and then press the knob: AUTO ECG SPO2 The setting is changed. HR TONE SOURCE Sets the source used for the heart rate tone (identical to and interactive with same option in the MONITOR > SOUND ADJUST menu and in the ECG menu). The following choices are available: • OFF removes the heart symbol from the display and no pulse tone will be sounded.
5‐14 Monitoring SPO2 Expression MR200 Instructions for Use
CHAPTER 6 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.
Patient Preparation for NiBP Monitoring WARNING The NiBP cuff inflation rate may increase and the initial pressure may increase up to 180 mmHg when changing the patient type. The PATIENT type setting determines the inflation pressures of the NiBP cuff and the reading times. In some cases, a patient may exhibit a low pulse amplitude due to any of the following conditions.
Selecting the NiBP Cuff WARNING To ensure accurate reliable measurements, use only the recommended NiBP accessories. Use the appropriate NiBP cuff size for each patient, as recommended by the current American Heart Association guidelines for blood pressure monitoring, to ensure safety and accuracy. The NiBP cuff should be selected and positioned as it would be for an auscultatory blood pressure determination. The current guidelines of the American Heart Association must be followed.
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 3 Position the cuff on the patient; see page 6‐4. 4 Ensure that the cuff and interconnect hoses are not kinked. Choosing the Measurement Mode NiBP measurements can be taken using a mode (auto or manual) that best suits the needs of your patient. Selecting Auto Mode You can automatically measure a patient’s blood pressure at pre‐defined intervals, which are measured from the start of one NiBP measurement to the start of the next.
NOTE If gauss shutdown occurs during an AUTO MODE measurement, NiBP readings will stop. When at a safe distance, operation will resume—a reading will be taken and then the intervals will begin again. Making Manual Measurements You can manually define the measurement interval of a patient’s blood pressure. To control manual operation Step 1 Action Press the Patient key and then select the appropriate PATIENT type; see page 3‐10 for details.
Stopping an NiBP Measurement Press the NiBP key to stop a reading cycle. NiBP VS Box Depending upon the selected FORMAT (see page 6‐14), the NiBP VS box is displayed accordingly. Systolic/Diastolic Format The elements contained in the SYS/DIA format are described below.
Definition 8 Is the name of the vital sign 9 Is the mode: where MANUAL is displayed when in Manual mode, and NEXT when in Auto mode.
Definition 7 Is the mode: where MANUAL is displayed when in Manual mode, and NEXT when in Auto mode.
Changing the Unit of Measure NOTE When using the 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 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 . The SETUP menu appears. 2 Turn the control knob to MONITOR SETUP and then press the knob.
NiBP Menu The NiBP menu allows you to control non‐invasive blood pressure functions and settings. To change settings in the NiBP menu Step 1 Action Turn the control knob to highlight the NiBP VS box and then press the knob. The NiBP menu appears. Current settings are displayed. 2 Turn the control knob to select any of the following NiBP options and then press the knob: ALARM LIMITS INTERVAL AUTO MODE HR SOURCE HISTORY FORMAT For information about these options, see the appropriate sections below.
ALARM LIMITS Controls the alarm limit settings for NiBP. (See the table on page 9‐15 for a listing.
• 15 Minutes • 20 Minutes • 30 Minutes • 45 Minutes • 1 Hour • 2 Hours • 4 Hours To set the interval for NiBP readings Enter the NiBP menu. Turn the control knob to INTERVAL and press the knob. Scroll to the desired time and press the knob. AUTO MODE Sets the mode used to take NiBP readings. NOTE A manual reading will not restart this cycle time. The following choices are available: • ON takes readings automatically.
FORMAT Changes the format of the displayed pressure numerics. The following choices are available: • SYS/DIA displays the NiBP readings in the systolic/diastolic format; see page 6‐7. (Default) • MEAN displays the NiBP readings in the mean format; see page 6‐8. To change the format Step 1 Action Turn the control knob to highlight the NiBP VS box (see page 6‐11) and then press the knob. The NiBP menu appears. Current settings are displayed. 2 Turn the control knob to FORMAT and then press the knob.
CHAPTER 7 Monitoring CO2 When equipped with the CO2 option, the MR200 samples and analyzes the patient’s airway respiratory gas using sidestream measurement to produce: • An inspired (FiCO2) value derived during inspiration and an end tidal (EtCO2) value measured during expiration. • A respiration rate (RESP): The number of breaths per minute; see chapter 8 for details. • A waveform of the concentration of carbon dioxide in the respiratory gases.
• All accessories are single use. Connecting the Sampling Line To connect the sampling line Step 1 Action Insert the sampling line connector into the CO2 port and then push the connector forward until you feel or hear it click into place. CO2 port Sampling line connector 2 If CO2 WARMING UP is displayed, wait as the system thermally stabilizes. When the message is cleared, CO2 is fully operational. 3 Always remove the patient sampling line from the CO2 port when not in use.
• If CO2 values for patients who are not on a breathing circuit appear extremely low, check whether the patient is breathing through the mouth or whether one nostril is blocked. NOTES • For optimum fit and compatibility, use only specified parts. • Always inspect patient sampling line after attachment to the MR200. Applying the Sampling Line to the Patient Select the patient sampling line that is appropriate for the patient size and application.
Step Action 3 Place the sampling line onto the patient, as shown below. 4 If using the sampling line with the airway adapter, proceed to step 5; otherwise go to step 7. 5 Place the airway adapter at the proximal end of the airway circuit between the elbow and the breathing circuit wye, as shown below. CAUTION Always insert the patient sampling line into the CO2 port before inserting the airway adapter into the breathing circuit.
Step 7 Action Check that the connections have been made correctly by verifying the patient’s breathing efforts with the displayed waveform. WARNING Before completion of patient setup, ensure that the patient’s breathing efforts coincide with the displayed CO2 waveform. 8 If the following warning is displayed: Persistent CO2 occlusion detected. Please clear occlusion and press OK to resume using CO2 Clear any pinches or obstructions in the sampling line before proceeding.
CO2 Waveform and VS Box The elements contained in the CO2 waveform (Trace D) and VS box are described below.
Step 3 Action Turn the knob to RESP SPEED and then press the knob. The RESP SPEED menu appears. The current setting is highlighted. 4 Turn the control knob to select any of the following settings (see page 3‐14 for details) and then press the knob: 25 mm/s 12.5 mm/s 6.25 mm/s 3.125 mm/s 1.5625 mm/s 0.33333 mm/s The selection is entered.
Changing the Unit of Measure To change the unit of measure Step 1 Action Turn the control knob to highlight the CO2 VS box (see below) and then press the knob. The CO2 menu appears. Current settings are displayed. 2 Turn the control knob to UNIT and then press the knob. The UNIT menu appears. The current setting is highlighted. 3 Turn the knob to select one of the following CO2 settings: mmHg kPa The setting is selected.
Step 2 Action Turn the control knob to select any of the following CO2 options and then press the knob: ALARM LIMITS SIZE GRIDS ZERO CAL UNIT For information about these options, see the appropriate sections below. 3 Turn the knob to the desired setting and then press the knob. 4 To change other settings, repeat steps 2 and 3. 5 Press the Main key to close the menu. Alternative: Turn the knob to RETURN and then press the knob, or wait approximately 60 seconds.
To set the alarm limits for CO2 See Changing the CO2 Alarm Limits on page 7‐7. SIZE Sets the CO2 waveform size. The following choices are available: • 40 mmHg (Default) • 60 mmHg • 80 mmHg To adjust the grid size for the CO2 waveform Enter the CO2 menu. Turn the control knob to SIZE and press the knob. Scroll to the desired size and press the knob. GRIDS Controls the CO2 grid display.
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. The maximum time required for is approximately 40 seconds. Under certain conditions, ZERO CAL will not be allowed: • If less than 20 seconds have passed since detection of the last breath; • If the CO2 temperature is unstable; or • When the sampling line is disconnected from the CO2 port.
7‐12 Monitoring CO2 Expression MR200 Instructions for Use
CHAPTER 8 Monitoring RESP If equipped with the CO2 option, the patient’s respiration rate will be calculated by measuring the time interval between detected breaths. When monitoring respiration derived from CO2, alarm functions are provided for monitoring. Respiration rate can also be measured using the bellows device; however, alarm functions for this method are not provided.
Respiration is monitored by detecting abdominal or chest wall motion using a pneumatic bellows device. Note that there are no user adjustable options or alarms for bellows‐derived respiration as it is not intended for vital sign monitoring. NOTE If bellows respiration is turned on while the CO2 is on, bellows respiration data will appear in the RESP VS box and CO2 respiration data will appear in the CO2 VS box.
Step 5 Action Press the Patient key and then select the appropriate PATIENT type (see page 3‐10 for details). 6 Check the respiratory signal before the patient is placed in the MR system. 7 Position the patient in the MR system. Ensure that the flexible hose does not get caught (for example, between the tabletop and the patient support). CAUTIONS • Avoid excessive bending of the flexible hose, as this will impair detection of the patient’s respiration.
Definition 3 Is the unit type for the respiration numeric data, where RPM is respirations per minute 4 Is the source used for the respiration monitoring, where CO2 is CO2-derived, and BEL is bellows-derived; see page 8-6 5 Is the name of the vital sign/parameter 6 Is the respiration rate measurement (numeric) Changing RESP Alarm Limits To change the RESP alarm limit settings Step 1 Action Turn the control knob to highlight the RESP VS box (see page 8‐5) and then press the knob.
RESP Menu The RESP menu allows you to control respiration functions and settings. To change settings in the RESP menu Step 1 Action Turn the control knob to highlight the RESP VS box and then press the knob. The RESP menu appears. Current settings are displayed. 2 Turn the control knob to select any of the following RESP options and then press the knob: ALARM LIMITS SOURCE For information about these options, see the appropriate sections below.
5 4 3 2 1 Definition 1 Is the setting of the high alarm limit 2 Is the current measurement 3 Is the setting of the low alarm limit 4 Saves the settings and returns to the normal mode 5 Identifies CO2-derived respiration rate alarm limits To set the alarm limits for respiration See Changing the RESP Alarm Limits on page 8‐4. SOURCE Selects the source used to acquire respiration measurements.
CHAPTER 9 Alarms The MR200 alerts the user to physiological, technical and status alarms which may require attention or intervention. Alarm Indications Active alarms consist of both visual and audible components, where visual indications are provided by the LCD and audible indications are provided by the speaker.
NOTE If a systemic failure of the processing hardware, software or communications renders an intended task incomplete and unperformed, a watchdog circuit will automatically shutdown power to the WPU. This will result in the removal of all patient data and displayed information, and a continuous alarm will sound until power to the MR200 is turned off. If this problem persists, contact technical support.
Controlling Alarm Indications 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.
To change the alarm limit display Step 1 Action Press the SETUP key . The SETUP menu appears. 2 With ALARM SETUP highlighted, press the control knob. The ALARMS menu appears. Current settings are displayed. 3 Turn the knob to LIMITS DISPLAY and then press the knob. 4 Scroll to the desired setting and press the knob. The setting is selected. Setting Alarm Limits WARNING Alarm limits can be set to a wide range of values, including off.
To adjust the alarm limit settings for all monitored parameters Step 1 Action With the patient connected to the MR200 and with the desired parameters turned on, press the SETUP key . The SETUP menu appears. 2 With ALARM SETUP highlighted, press the control knob. The ALARMS menu appears. Current settings are displayed. 3 Turn the knob to UPPER WINDOW and then press the knob. The current setting is highlighted. 4 Scroll to the desired percentage and press the knob.
To adjust the alarm limit settings for a single parameter (using the ALARMS menu) Step 1 Action Press the SETUP key . The SETUP menu appears. With ALARM SETUP highlighted, press the control knob. 2 The ALARMS menu appears. Current settings are displayed. 3 With SET INDIVIDUAL highlighted, press the knob. The cursor highlights a low alarm limit setting in the menu. 4 Turn the control knob to select the alarm limit to be changed and then press the knob.
Controlling the Alarm Sound The alarm volume can be adjusted. In addition, the alarm sound can be temporarily disabled by pressing the Silence key, or it can be permanently disabled in the ALARMS menu (although the numeric and waveform will continue to flash while the parameter violates its alarm limit). Once silenced, an alarm will not sound again for any reason as long as that condition continues. Only a different parameter violation will cause the alarm sound to reactivate.
within its alarm limit, the numeric and waveform will stop flashing and return to their designated color. • If LATCHED, while the parameter continues to violate its limit, the Silence key will mute the alarm sound. The numeric and waveform will continue to flash in red after the parameter returns to within its alarm limits, then upon pressing the Silence key a second time the numeric flashing stops and the audible alarm is placed into Alarm Hold mode. To silence audible alarms Press the Silence key.
ALARMS menu Setup key Control knob To change settings in the ALARMS menu Step 1 Action Press the SETUP key . The SETUP menu appears. With ALARM SETUP highlighted, press the control knob. 2 The ALARMS menu appears. Current settings are displayed.
Step Action 5 To change other options, repeat steps 3 and 4. 6 Press the Main key to close the menu. Alternative: Turn the knob to RETURN and then press the knob, or wait approximately 60 seconds. SET INDIVIDUAL Controls the alarm limit settings for individual parameters.
To globally adjust the low and high alarm limit settings See Setting Alarm Limits Globally on page 9‐4. NOTE If a patient’s monitored value is so high or low that it exceeds the alarm limit range for the parameter, the respective alarm limit will be set to the highest or lowest possible value, but not to off, as indicated in the table on page 9-14. UPPER WINDOW Sets a percent value used to calculate the high alarm limits when CALCULATE ALL is selected.
Enter the ALARMS menu. Turn the control knob to LOWER WINDOW and press the knob. Scroll to the desired percentage and press the knob. ALARM SOUND WARNING The alarm sound can be turned off. 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 MR200, always ensure that the alarm sound can be heard above the ambient noise level.
TYPE Determines the response of an alarm when the Silence key is pressed. The following choices are available: • UNLATCHED alarms cease audio and visual alerts if the violated parameter returns within its limits or if the Silence key is pressed. (Default) • LATCHED alarms cease audio and visual alerts only when the Silence key is pressed. To set the type of the alarm Enter the ALARMS menu. Turn the control knob to TYPE and press the knob. Scroll to the desired setting and press the knob.
Step 3 Action Verify the wSPO2 module status by checking the status indicator: • Solid green = Battery power OK/Good communication • Flashing green = Battery power OK/No communication • Solid red = Low battery power/Good communication • Flashing red = Low battery power/No communication 4 Place the SPO2 attachment on your finger and wait for a value to appear in the SPO2 VS box. 5 Remove the clip from your finger.
Adjustable Alarm Limit Ranges Vital Sign or Parameter Low Alarm Limit * Unit High Alarm Limit * Minimum Maximum Minimum Maximum NiBP Mean, Adult mmHg kPa Off, 26 Off, 3.5 239 31.9 26 3.5 239, Off 31.9, Off NiBP Mean, Pediatric mmHg kPa Off, 26 Off, 3.5 239 31.9 26 3.5 239, Off 31.9, Off NiBP Mean, Neonate mmHg kPa Off, 26 Off, 3.5 94 12.5 26 3.5 94, Off 12.5, Off NiBP Diastolic, Adult mmHg kPa Off, 16 Off, 2.1 224 29.9 16 2.1 224, Off 29.
Factory Default Alarm Limits* Neonate Vital Sign or Parameter Pediatric Adult Unit Low Limit High Limit Low Limit High Limit Low Limit High Limit NiBP Diastolic mmHg kPa 35 4.7 50 6.7 40 5.3 70 9.3 40 5.3 125 16.7 SPO2 Percent 90 Off 90 Off 85 Off * Allow ± one least significant digit to accommodate the round‐off error for calculated values. Listing of Alarms All alarms are categorized as high priority.
Displayed Message/ Indication Message Location CHANGE NiBP CUFF Notification area CHECK ALARM VOL Probable Cause Recommended Action L The PATIENT type was changed and this message is displayed as a reminder. Ensure the correct cuff size is used for the patient. System message area U Power was just turned on, settings were recalled, or an adjustment was made to a sound setting No action necessary. Allow the process to complete.
Displayed Message/ Indication Message Location HW FAIL NiBP VS box HW FAIL INFL TO Probable Cause Recommended Action L A hardware or other error has occurred in the NiBP system. Discontinue use of NiBP and contact technical support. SPO2 VS box L A hardware or other error has occurred in the wSPO2 module. Replace the wSPO2 module.
Displayed Message/ Indication Message Location LEAD SATURATION ECG trace area Type Reported within 10 seconds, Replace the Quadtrode electrode. the baseline offset of the ECG input signal is too large for the system to process and display the waveform. U Accuracy may be compromised due to low perfusion. The tissue at the site may be too opaque, thick or cold. If the heart rate source is set to ECG, no HR value will be displayed in the ECG VS box.
Displayed Message/ Indication Message Location Type Probable Cause Recommended Action NiBP: MEASUREMENT Notification FAILED area L Same as MSMT FAIL See MSMT FAIL for details. NiBP: MEASUREMENT Notification TIMEOUT area L Same as MSMT TO See MSMT TO for details. NiBP: OVER PRESSURE Notification area L Same as OVR PRESS See OVR PRESS for details. NiBP: PRESSURE Notification CORRECTION ERROR area L Same as PRESS CORR See PRESS CORR for details.
Displayed Message/ Indication Message Location PERFORMING CO2 ZERO Notification area PRESS CORR PROBE OFF Type Probable Cause Recommended Action U Displayed while performing CO2 zeroing. No action necessary. Allow the process to complete. NiBP VS box L An NiBP pressure correction error has been detected. SPO2 VS box U The SPO2 attachment is not properly applied to the patient.
Displayed Message/ Indication Message Location SIMULATION System message area Type Probable Cause Recommended Action L Simulation mode is running. Cycle power off and on. U Power was turned on, or the Silence key was pressed. Wait until the 120-second countdown completes or press the Silence key. U The Suspend key was pressed and alarms are now suspended. Press the Suspend key to exit the mode.
Displayed Message/ Indication Message Location Communication and power status display area Type U Probable Cause Recommended Action No communication between the cart and wECG module Ensure that the wECG module is set to the same network channel as the cart. If both are the same, use an alternate setting. If the indication persists, contact technical support.
Displayed Message/ Indication Message Location OVR ECG or SPO2 VS box Type Probable Cause U (Replaces the numeric, except for ECG, which will alternate with a numeric value that is more than the highest specified heart rate.) UND ECG or SPO2 VS box (Replaces the numeric, except for ECG, which will alternate with a numeric value that is less than the lowest specified heart rate.
CHAPTER 10 Trend Data and Printing Trend Data The trend feature, accessed using the TRENDS key , provides options that include tabular and graphical trends reporting and trend arrow indications. Trend data is useful for assessing a patient over a period of time.
Definition 1 Is the name of the dialog 2 Are the CO2-derived respiration readings 3 Are the CO2 readings 4 Are the SPO2 readings 5 Are the heart rate readings 6 Is the page number, displayed oldest (first) to newest (last) 7 Are the NiBP mean readings 8 Are the NiBP systolic/diastolic readings 9 Is the time of the reading 10 Is the date of the reading Viewing Multi-Parameter Tabular Trend Data To view tabular trend data for multiple parameters Step 1 Action Press the TRENDS key (while
1 2 2 3 3 4 4 6 5 Definition 1 Is the name of the graph 2 Are the numeric values of the selected parameters (y-axes) and plotted in the same color 3 Are the selected parameters (y-axis labels) 4 Is the y-axis plot 5 Is the plot grid 6 Is the x-axis plot Viewing Individual Trend Graphical Data To view graphical trend data for a single parameter Rotate the control knob to highlight the VS box of the desired parameter and then press the TRENDS key .
Viewing Multi Trend Graphical Data To view graphical trend data for multiple parameters Step 1 Action Press the TRENDS key (while in the normal mode). The HISTORY menu appears and the first page of trend data are displayed. 2 Turn the control knob to MULTI TRENDS and then press the knob. The MULTI TRENDS submenu appears. 3 Turn the control knob to SELECT and then press the knob to choose the parameters used in the plot.
HISTORY Menu The HISTORY menu provides options to select pages. Up to 48 trend records can be stored. A history file can be viewed for all parameters. The elements contained in the history file page are described below. To change settings in the HISTORY menu Step Action Press the TRENDS key (while in the normal mode). 1 The HISTORY menu appears. Current settings are displayed.
Step 7 Action Press the Main key to close the menu. Alternative: Turn the knob to RETURN and then press the knob, or wait approximately 60 seconds. PREV PAGE Displays the previous page of the history file. To display the previous page of the history file See Viewing Multi‐Parameter Tabular Trend Data on page 10‐2 for details. NEXT PAGE Displays the next page of the history file. To display the next page of the history file See Viewing Multi‐Parameter Tabular Trend Data on page 10‐2 for details.
MULTI TRENDS Displays a graphical representation of selected monitored parameters. The following choices are available: • SELECT configures up to four simultaneous trends used to plot the y‐axis of the graph. The following choices are available: – HR plots heart rate – NiBP plots NiBP – SPO2 plots SPO2 – ETCO2 plots EtCO2 – RESP[CO2] plots CO2‐derived respiration • CURSOR/ZOOM zooms into the trend chart, opening a window where individual points in time can be viewed.
TREND ARROWS Controls a vital sign trend indication, where a trend arrow is displayed alongside the VS box (not available for bellows‐derived respiration) with a meaning as defined in the table below. (See page 2‐14 for an example.) Indication Meaning Rising Declining Stable None declared The following choices are available: • ON turns on the trend arrows. • OFF turns off the trend arrows. (Default) To display trend arrows Press the TRENDS key. Turn the control knob to TREND ARROWS and press the knob.
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. Alternately, if the newly selected period is longer than the previous period, recalculation will occur using all available data. Print Functions When equipped with an IP5 printer, the MR200 can provide single or dual waveform strip charts.
. Setup key PRINTER menu Control knob To change settings in the PRINTER menu Step 1 Action Press the SETUP key . The SETUP menu appears. Turn the control knob to PRINTER SETUP and then press the knob. 2 The PRINTER menu appears. Current settings are displayed. 3 Turn the control knob to select any of the following printer options and then press the knob: TRACE 1 TRACE 2 TRACE DELAY For information, see the appropriate sections below. 4 Turn the knob to the desired setting and then press the knob.
TRACE 1 Enables the first trace to be output by the printer. The strip chart may be configured to contain one or two waveforms (see TRACE 2, below). A description of each item printed on the strip chart is provided below.
TRACE 2 Enables the second trace to be output by the printer. The following choices are available: • OFF (Default) • ECG 1 outputs the Trace A waveform. (Default) • ECG 2 outputs the Trace B waveform. • SPO2 outputs the Trace C waveform. • RESP (CO2) outputs the Trace D waveform. To print a Trace 2 waveform Enter the PRINTER menu. Turn the control knob to TRACE 2 and press the knob. Scroll to the desired output and press the knob.
CHAPTER 11 Cleaning and Maintenance Environmental Requirements Royal Philips Healthcare is concerned about protecting the natural environment and to help ensure continued safe and effective use of this product through proper support, maintenance and training. Royal Philips equipment is therefore designed and manufactured to comply with relevant guidelines for environmental protection. As long as the equipment is properly operated and maintained, it presents no risk to the environment.
Clean using a lint‐free cloth, moistened with warm water (40°C/104°F maximum) and mild soap, a diluted non‐caustic detergent or alcohol‐based cleaning agent. Never use strong solvents such as acetone or trichloroethylene. Stains can be removed by scrubbing briskly with a moistened cloth. If disinfection is required, clean the equipment before disinfecting it. Use only the Royal Philips‐approved substances and methods listed in this chapter to clean or disinfect the equipment.
CAUTIONS • Other than those specified in the preceding table, avoid ammonia-, phenol- and acetonebased cleaners as they will damage the surfaces of the MR200. • Disinfect the cart and modules as determined by your hospital’s policy to avoid long term damage to the product. • Do not permit liquid to contact the front or rear of the display panel. Do not permit liquid to drip into or around the LCD. Contact technical support if liquid enters any component.
Step Action 6 Allow the cart and the modules to dry. (No rinsing is required.) 7 Check the cart and the modules for any residual debris. If any debris is present, repeat steps 3 through 6 then re‐examine the cart and modules before proceeding. 8 Check the cart and modules for damage and contact technical support if damage is found.
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 sensor.
Inspecting the Accessories for Damage The accessories are exposed to potentially damaging situations during use and cleaning. Before each use, carefully inspect the accessories for the following signs of damage: • Cracks, holes, tears, gouges, cuts, etc. • Cracks or other signs of damage to the connector, including bent or damaged pins. WARNING Cracks, tears, cuts and gouges interfere with standard cleaning procedures and therefore pose a potential risk to patients and personnel.
WARNING Do not dispose of this product (or any parts of it) in industrial or domestic waste. The system may contain materials and hazardous substances that can cause serious environmental pollution. The system also contains privacy sensitive information. It is advisable to contact your Royal Philips Service Organization before disposing of this product. Royal Philips Healthcare gives support for: • Recovery of reusable parts. • The recycling of useful materials by competent disposal companies.
CAUTIONS • Never heat or throw a battery into fire. Heating the battery will damage the safety circuitry, which can cause rupture or ignition of the battery. • Never disassemble a battery. The batteries contain hazardous material that must be recycled or disposed of properly. (Refer to the disposal guidelines below.) Maintenance Periodic maintenance for the MR200, as outlined below, must be followed. CAUTION Annual preventative maintenance is recommended unless stated otherwise in the service manual.
To test the NiBP system for leakage Step 1 Action Attach a normal adult cuff and interconnect hose, or a test volume to the MR200. Press the PATIENT key . 2 The PATIENT menu appears. 3 Turn the control knob to ADULT (or PEDIATRIC) and then press the knob. 4 Press the SETUP key . The SETUP menu appears. 5 Turn the control knob to MONITOR SETUP and then press the knob. The MONITOR menu appears. Current settings are displayed. 6 Turn the control knob to SERVICE(BIO‐MED) and press the knob.
Default Initialization The settings for the MR200 can be restored to factory default values. Step 1 Action Press the SETUP key . The SETUP menu appears. 2 Turn the control knob to MONITOR SETUP and then press the knob. The MONITOR menu appears. Current settings are displayed. 3 Turn the control knob to DEFAULT SETUPS and press the knob. 4 Scroll to FACTORY and press the knob. All current settings will be lost. 5 Turn off the MR200. 6 Turn on the MR200.
Step 3 Action Insert the USB program update device that contains the desired software into the USB port. USB port USB program update device 4 The WPU Program Update window appears. Current software revisions are displayed, where any needed update will be denoted by an asterisk. 5 Turn the control knob to YES and then press the knob to proceed. The software update begins.
Step 11 Action Press the Setup key . The SETUP menu appears. 12 Turn the control knob to MONITOR SETUP and then press the knob. The MONITOR menu appears. Current settings are displayed. 13 Turn the control knob to SERVICE(BIO‐MED) and then press the knob. The SERVICE(BIO‐MED) menu appears. Current settings are displayed. 14 With S/W REV highlighted, press the control knob. Verify that the displayed REVISION INFORMATION includes the version number for the software that was updated.
To enter the SERVICE(BIO‐MED) menu Step 1 Action Press the SETUP key . The SETUP menu appears. 2 Turn the control knob to MONITOR SETUP and then press the knob. The MONITOR menu appears. Current settings are displayed. 3 Turn the control knob to SERVICE(BIO‐MED) and then press the knob. The SERVICE(BIO‐MED) menu appears. Current settings are displayed.
Places the MR200 into simulation mode. To enter simulation mode Press the control knob. A dialog box will prompt you for confirmation. Use the control knob to highlight the desired action and then press the knob to proceed. While in simulation mode, to initiate simulated NiBP functions, press the NiBP key. To exit simulation mode Turn off the power switch. WARNING The MR200 is equipped with a simulation mode that displays computer generated data for training or demonstration.
• ZERO CAL performs a zero calibration of the CO2 system. (Also see page 7‐11.) To start zero calibration Enter the SERVICE(BIO‐MED) menu. Turn the control knob to GAS CAL and press the knob. Scroll to ZERO CAL and press the knob. • CO2 ACCURACY CHECK tests the CO2 function (a 5% source must be connected). Provides a CO2 waveform value (as a percentage), an atmospheric pressure reading and a numeric CO2 value (in mmHg). To perform an accuracy check Connect the 5% CO2 source to the CO2 port.
• LANGUAGE sets the language displayed by the MR200 (to make the selection effective, cycle power after saving your changes): – ENGLISH (Default) – DEUTSCH – ESPANOL – FRANCAIS – PORTUGUES (Br) – ITALIANO – DANSK – SVENSKA – NORSK – NLD • PRESSURE UNITS sets the unit of measure for NiBP readings: – mmHg provides readings in millimeters of mercury. (Default) – kPa provides readings in kilopascals Repair The MR200 contains no user‐serviceable parts.
If the MR200 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.com CAUTIONS • This product, or any of its parts, must not be repaired other than in accordance with written instructions provided by Invivo (Royal Philips), or altered without prior written approval.
Previous users who are not able or prepared to do this should inform Royal Philips Healthcare about the new user, so that Royal Philips Healthcare can provide the new user with safety‐related information. Packaging the MR200 To package the MR200 for shipment, use the MR200 packing materials to safely transport the monitor. CAUTION If shipment of the MR200 is required, batteries must be removed prior to transport.
Step Expression MR200 Instructions for Use Action 3 With the crate oriented as shown, place it into an upright position. Roll the cart into the crate. 4 Carefully lower the crate. Slide foam B into foam C then insert it between the base of the cart and the crate. 5 Insert foam D into foam A, and insert foam E between foam C and the crate.
Step 11‐20 Cleaning and Maintenance Action 6 Place the lid on the crate. 7 Install all the clips into the lid on the crate, ensuring that each is locked.
APPENDIX A Specifications General Patient Safety Conforms to ANSI/AAMI ES60601‐1. Certified to CAN/CSA C22.2 No. 60601‐1.
Additionally, this equipment complies to the following national or regional industry standards for safety and performance: • 1999/5/EC, Radio & Telecommunications Terminal Equipment Directive • SAA AS/NZS 3200.1.
Environment Operating Temperature Range 10°C to 35°C (50°F to 95°F) Storage/Transport Temperature Range Batteries: 0°C to 40°C (32°F to 104°F) Cart: ‐20°C to 50°C (‐4°F to 122°F) Wireless modules: ‐25°C to 75°C (‐13°F to 167°F) Accessories: ‐20°C to 60°C (‐4°F to 140°F) (When storing or transporting in temperatures beyond the ranges specified above, remove the designated component and store or move it appropriately.
Displayed Parameters Time Battery‐backed quartz crystal clock Alarms High and low limits selectable for patient parameters ECG ECG waveform scale, displayed leads (2) Heart Rate Normally derived from ECG. May be manually selected to be derived from pulse oximetry, or automatically in order of priority.
Alarm Limits (HR) Lower Upper Off or 30 to 249 60 to 249 or off Test/Calibrations Square Wave Test Signal 60 BPM ± 1 BPM, 1 mV ± 10% ECG Supplemental Information, as required by IEC 60601-2-27 Heart Rate Averaging Method Mean filtering is applied to the output of the median filter of a continuously updating group of QRS complexes. The ECG heart rate numeric is updated twice a second. Time to Alarm for Tachycardia B1 ‐ Vent Tachycardia 1 mVpp, 206 BPM Gain 0.5 (12.03, 11.04, 14.1, 11.8, 11.
Pulse Oximeter Pulse tone pitch is modulated by the saturation value Saturation Range 0 to 100% Saturation Accuracy ± 3% at 70% to 100% Pulse Measurement Range 30 BPM to 250 BPM Pulse Accuracy ± 2% or 1 BPM, whichever is greater Wavelength Range 500 nm to 1000 nm Emitted Light Energy < 15 mW Pulse Oximeter Calibration Range 70% to 100% Alarm Limits Lower Upper Off or 50 to 99 70 to 99 or off When “HR” is derived from SPO2 Lower Upper Off or 30 to 249 60 to 249 or off NOTE Measurement valid
Non-Invasive Blood Pressure General Oscillometric technology (with an inflatable cuff) determines systolic, diastolic and mean arterial pressures Patient Types Adult, Pediatric and Neonate Pneumatic Systems Cuff Inflation Pressure Initial: 165 mmHg for Adult, 130 mmHg for Pediatric, and 100 mmHg for Neonate (all pressures are ± 15 mmHg) Subsequent inflation pressures determined by last NiBP measurement Overpressure Protection Automatic release of cuff pressure if inflation pressure exceeds 300 mmHg f
Alarm Limits Systolic Adult & Pediatric Lower Upper Neonate Lower Upper Mean Adult & Pediatric Lower Upper Neonate Lower Upper Diastolic Adult & Pediatric Lower Upper Neonate Lower Upper Off or 46 to 254 46 to 254 or off Off or 46 to 124 46 to 124 or off Off or 26 to 239 26 to 239 or off Off or 26 to 94 26 to 94 or off Off or 16 to 224 16 to 224 or off Off or 16 to 84 16 to 84 or off Modes Manual Immediate upon operator command Automatic Determinations automatically made with selectable intervals of
CO2 (Optional) Side stream, non‐dispersive infrared absorption technique. Including multiple filtration system and microprocessor logic control of sample handling and calibration.
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. Anesthetic Agent Sensitivity (compensated): Testing at agent levels defined by accepted regulatory standards (i.e., ISO 21647, ASTM F1456, IEC/CDV 60601‐2‐55) currently in process.
Bellows Respiration Respiration Rate Measurement Range 0 to 60 breaths per minute Respiration Rate Resolution 1 breath per minute Respiration Rate Accuracy ± 1 breath per minute Gating Connector Wiring view Pin Designator A Signal Name Description and Characteristics DIGITAL GATING PULSE ECG/SPO2 digital gating pulse • Peak to peak voltage: 3.3 V to 5.
A‐12 Specifications Expression MR200 Instructions for Use
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 MR200 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 MR200 Instructions for Use
APPENDIX D Guidelines and References Guidelines for the Prevention of Excessive Heating and Burns Associated with Magnetic Resonance Procedures In general, magnetic resonance (MR) imaging is considered to be a relatively safe diagnostic modality. However, the use of 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, etc.). 2. Prepare the patient for the MR procedure by using insulation material (i.e., appropriate padding) to prevent skin‐to‐skin contact points and the formation of “closed‐loops” from touching body parts. 3.
12. Do not position electrically conductive materials across an external metallic prosthesis (e.g., external fixation device, cervical fixation device, etc.) or similar device that is in direct contact with the patient. 13. Allow only properly trained individuals to operate devices (e.g., monitoring equipment) in the MR environment. 14.
Finelli DA, Rezai AR, Ruggieri PM, Tkach JA, Nyenhuis JA, Hrdlicka G, Sharan A, Gonzalez‐Martinez J, Stypulkowski PH, Shellock FG. MR imaging‐related heating of deep brain stimulation electrodes: In vitro study. Am J Neuroradiol 2002;23:1795‐1802. 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.
D‐6 Guidelines and References Expression MR200 Instructions for Use
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