3880 MRI Patient Monitoring System Operation Manual REF 1200
Non-Magnetic Patient Monitoring System, Model 3880 Operation Manual, Part Number 1200 Release 03/01/2017 © 2016/2017 IRadimed Corporation TM IRadimed Corporation 1025 Willa Springs Drive Winter Springs, Florida 32708 U.S.A. Tel 407-677-8022 Fax 407-677-5037 www.iradimed.com 0843 European Authorized Representative Medical Device Consultancy 7 Pinewood Drive Ashley Heath, Market Drayton, Shropshire, UK, TF9 4PA www.medicaldeviceconsultancy.co.
Table of Contents 1. PREFACE ................................................................................................................. 1-1 1.1. About 3880 Non-Magnetic Patient Monitoring Systems ......................................... 1-1 1.1.1. Intended Use ................................................................................................ 1-1 1.1.2. Intended Audience ....................................................................................... 1-1 1.1.3.
2.2.7. System Power ............................................................................................ 2-40 2.2.8. Antenna Strategies ..................................................................................... 2-44 2.2.9. Loading Recorder Paper ............................................................................ 2-45 2.2.10. Connecting Patient Accessories ................................................................. 2-47 2.2.11. User Interface.................................
6.2.1. Limitations .................................................................................................. 6-11 6.2.2. Understanding the Display ......................................................................... 6-12 6.2.3. SpO2 Patient Application ............................................................................ 6-12 6.2.4. Changing SpO2 settings ............................................................................. 6-13 6.2.5. SpO2 Alarm Limits .........................
8. PRE-USE OPERATOR VERIFICATION, TROUBLESHOOTING AND USER MAINTENANCE ............................................................................................................... 8-1 8.1. Overview ............................................................................................................... 8-1 8.1.1. Battery Life Expectancy................................................................................ 8-1 8.1.2. Checking a Battery ......................................................
1. Preface 1.1. About 3880 Non-Magnetic Patient Monitoring Systems 1.1.1. Intended Use The IRadimed Corporation’s 3880 MRI Patient Monitoring System is intended to monitor a single patient’s vital signs for patients undergoing Magnetic Resonance Imaging (MRI) procedures. The 3880 MRI Patient Monitoring System is intended for use by healthcare professionals.
Classification according to IEC 60601-1 Type of protection against electrical shock Degree of protection against electrical shock Degree of protection against harmful ingress of water and particulate matter Methods of Sterilization or disinfection Class I ME Equipment – 3880, 3886 Note: 3881 and 3882 are Internally powered Body Worn Type CF (defibrillator-proof) equipment for use in Patient Environment - 3880, 3886, 3881 ePOD, 3882 oPOD IPX1 enclosed equipment protected against harmful effects of dripping
FCC COMPLIANCE STATEMENT: • This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. Warning: Changes or modifications not expressly approved could void your authority to use this equipment. 1.1.5. Intellectual Property This device is covered under one or more of the following U.S.
Copyright © 2017, IRadimed. All rights reserved. Printed in USA. 1.2.2. Manual Purpose This manual contains the instructions necessary to operate the product safely and in accordance with its function and intended use. Observance of this manual is a prerequisite for proper product performance and correct operation which ensures patient and operator safety. This manual is based on the full configuration (including all optional features) and therefore some content may not apply to your product.
• AUDIO ALARM OFF – Alarm Silence button: multi-function audible alarm control, resets sounding of alarm, pauses for 120 seconds the alarm sound, or re-enables alarm sound capability.
IRadimed provides this document without warranty of any kind, implied or expressed, including, but not limited to, the implied warranties of merchantability and fitness for a particular purpose. IRadimed has taken care to ensure the accuracy of this document. However, IRadimed assumes no liability for errors or omissions and reserves the right to make changes without further notice to any products herein to improve reliability, function, or design.
• To protect against injury, follow the directions below: o Avoid placing the device on surfaces with visible liquid spills. o Do not soak or immerse the device in liquids. o Do not attempt to sterilize the device. o Use cleaning solutions only as instructed in this operator's manual. Do not attempt to clean the device while monitoring a patient.
Patient monitoring system or the pulse oximeter oPOD or ECG ePOD where the controls can be changed by the patient. In the case of the oPOD and ePOD, instruct the patient not to operate the controls. Never connect a patients IV lines to any part of this monitor including gas and / or blood pressure connections. Dropping, or shock to the monitor, PODs, Tablet, battery packs, or other accessories could result in damage and affect accuracy or safe operation.
transmissions, other than the MRI machine, should not be in close proximity to the 3800 MR monitoring system or the pulse oximeter oPOD or ECG ePOD. Connect only those 3880 system compatible items identified are section 1.1.3 and 9. 1.3.4. MRI Use Precautions Certain components of this device will be affected by the magnetic and radio frequency fields present in your MRI System.
• • If scanned directly across the plane of the ECG electrode, a slight image distortion may be seen at the skin surface where the electrode is positioned. Keep the ECG ePod and SpO2 oPOD out of the image Field of View (FOV). If scanned directly across the plane of either POD, image distortion may be seen where the POD(s) are positioned. Perform the following to minimize risk of RF burn: 1. Keep ePOD and ECG lead wires from pressing against the bore of the MR magnet. 2.
1.3.7.2. NIBP Use only NIBP accessories approved for MRI use (See MRI Accessory list in Section 9). When using the NIBP portion of this instrument to measure blood pressure, remember that the patient’s blood pressure readings are not continuous, but are updated each time a blood pressure measurement is taken. Set a shorter interval for more frequent updating of the patient’s blood pressure. Do not attach the NIBP cuff to a limb being used for infusion, therapy or an arterio-venous (A-V) shunt.
1.3.7.3. SpO2 The pulse oximeter should not be used as the sole basis for medical decisions. It must be used in conjunction with clinical signs and symptoms. Do not start or operate the pulse oximeter unless the setup was verified to be correct. Do not use the pulse oximeter if it appears or is suspected to be damaged. Use only MRI compatible SpO2 accessories (See MRI Accessory list in Section 9). Use only the Fiber-optic SpO2 sensors recommended by IRadimed Corporation.
The pulse oximeter may be used during electrocautery, but this may affect the accuracy or availability of the parameters and measurements. The pulse oximeter should not be used for arrhythmia analysis. If using pulse oximetry during full body irradiation, other than in MRI, keep the sensor out of the radiation field. If the sensor is exposed to the radiation, the reading might be inaccurate or the device might read zero for the duration of the active irradiation period.
should not be required, but if the specified operation does not occur, have a qualified service person recheck the calibration. Proper re-calibration can only be performed during factory service. Gas sampling patient tubing and associated components are intended for single-patient use only. Avoid cleaning or disinfecting these items for reuse. Inaccurate gas measurements or cross contamination could result.
This monitor, ECG ePOD(s), SpO2 oPOD(s), and the 3885-T Remote Tablet use lithium polymer rechargeable batteries, which must be recycled, or disposed of properly. For proper disposal methods, contact your local IRadimed Corporation representative or distributor. 1.3.8.
1.3.10.2. ! Caution CAUTION • Indicates a potential hazard or unsafe practice that, if not avoided, could result in minor injury or product/property damage. 1.3.10.3. Note NOTE • Provides application tips or other useful or important information. 1.3.11. Disposal ! WARNING To avoid contaminating or infecting personnel, the environment or other equipment, make sure you disinfect and decontaminate appropriately before disposing of it in accordance with local laws. 1.3.11.1.
2. Getting Started 2.1. About 3880 2.1.1. Introduction The 3880 system is a Non-Magnetic multi-parameter patient monitor to continuously monitor patients throughout the entire MRI care cycle. The 3880 monitor is comprised of the 3880 MRI Monitor, 3881 ePOD, 3882 oPOD and an optional 3885-T Remote Tablet with 3885-B Base Station. Further options include, CO2, Temperature, and the 3886 Multi-Gas unit.
2.1.2. System Hardware Overview 2.1.2.1.
3885-B Base Station (Optional) Base Unit acts as wireless repeater link between 3880 monitor and 3885-T remote tablet. Base also hosts the strip chart recorder/printer. MR “unsafe” for use outside MR magnet room. The 3885-B is for use only in Zone III. See section 2.1.8.
2.1.3. 3880 Monitoring System Components 2.1.3.1. 3880 Multi-Parameter Monitor The 3880 system is a small and portable Non-Magnetic multi-parameter patient monitor designed for use when a large magnetic field such as a MRI system will be present during the patient’s care cycle. The 3880 system is used to acquire, process, and display all vital sign measurements during patient transport and during the MRI procedure. 2.1.3.1.1 Front View 12 1 2 11 3 10 9 8 7 6 5 4 1.
2.1.3.1.2 Side View Left Right 1 1 2 2 3 3 4 6 5 7 8 1. 2. 3. 4. 5. 6. 7. 8.
2.1.3.1.3 Rear View 1 2 12 3 4 5 11 6 10 9 8 7 1. 2. 3. 4. 5. 6. Handle Cable Management Clip Flex Mount IV Pole / Bed Rail Mount Speaker Gating Output POD Charging Status Indicator, Blinking = No connection, Amber = Charging, Green = Charged 7. Future Option Expansion Connector 8. USB Port 9. Power Input, 19 VDC 10. Input / Output Connector, serial RS232 11. SD memory card slot 12.
• Remove any protective port covers prior to use. 2.1.3.2. 3885-T Remote Tablet The 3885-T optional Remote Tablet is a convenient user interface mirroring the 3880 Monitor unit, to display, monitor, control and document the patient case. The 3885-T Remote Tablet is non-magnetic up to 15,000 Gauss, but is not RF shielded for use inside of zone IV during imaging. The 3885-T Remote Tablet has the following hardware features. 2.1.3.2.1 Front View 11 1 10 2 3 9 8 7 6 5 4 1. Non-Magnetic Case 2.
2.1.3.2.2 Remote Tablet Rear View 3 2 1 1. Replaceable Battery 2. USB Port 3. Base Station Dock 2.1.3.3. 3885-B Base Station The 3885-B Base Station is the communication hub of the 3880 MRI Patient Monitoring System. The Base Station is facilitates transfer of data through the MRI shielding, enabling wireless communication between the 3880 Patient Monitoring System components during MRI procedures. The Base Station also serves as a MRI Control room charging and strip chart recording/printing station.
1. 2. 3. 4. 5. 6. Power Status Indicator of the Base Station, Tablet Charge Indicator (Amber) Charging Indicators for 1133 Battery Packs Thermal Strip Chart Recorder/Printer Tablet / Base Station Dock Channel LED Indicator Channel Select Button 2.1.3.3.2 Rear View 2b 2a 1 1 8 7 6 5 4 3 10 9 1. 3880 Monitor unit Battery charging bay 2. Antenna Connectors: 2a MRI Room Zone IV antenna connection, Base/3880 monitor 2b Zone II and III 3885-T Tablet / 3885-B Base Station antenna 3. AC Power Receptacle 4.
2.1.3.3.3 Top View 1 1 6 5 1. 2. 3. 4. 5. 6. 33 4 2 3880 Monitor unit Battery Charging Bay Power LED status of the Base Station Charging Indicators for 1133 Battery Packs Thermal Strip Chart Recorder Tablet / Base Station Dock Tablet Lock 2.1.3.4. 3882 Wireless SpO2 oPOD The Wireless SpO2 oPOD communicates the pulse waveform, heart rate and perfusion index to the 3880 monitor. The pulse waveform can be displayed and is output from the 3880 monitor as a MRI system gating input.
2.1.3.5. 3881 Wireless ECG ePOD The Wireless ECG ePOD communicates two channels of ECG simultaneously to the 3880 monitor. These two channels of ECG can be displayed with lead of Trace A output from the 3880 monitor as a MRI system cardiac gating input. The ECG ePOD is powered by one battery that is charged when docked to the 3880 monitor. The wireless ePOD features internal temperature cutoff protection in the event that the operating temperature exceeds the designed limits.
2.1.3.6. 3886 Wireless Multi-Gas Unit The 3886 Multi-Gas unit removes the airway tether to the monitor by residing on the anesthesia machine and wirelessly communicating patient gas information to the 3880 MRI Monitor. 1 2 3 5 4 1. 2. 3. 4. 5. 2.1.4. Antenna Zero Port Nomoline Sample line Receptacle Wireless Communication LED Power LED User Interface Overview 2.1.4.1.
1. 2. 3. 4. 5. 6. 7. 8. 9. Vital Sign Unit of Measure Alarm Upper and Lower Limits Current Vital Sign Numerical Measurement Vital Sign Description Vital Sign Waveform SpO2 Perfusion Index ECG Indicator Message and Alerts Area Information Bar 2.1.4.1.1 Information Bar The information bar (located along the top of the screen) provides system, patient and monitoring information including access to case management, patient type and user setting functions. 1 2 3 1. 2. 3. 4. 5. 6. 7. 8. 9.
1 2 3 4 5 9 1. 2. 3. 4. 5. 6. 7. 8. 9.
2.1.4.3. Vital Sign Waveforms Vital sign waveforms (located in the center of the screen) are uniquely colored waveforms for the ECG, SpO2 and CO2 parameters. These waveforms are fixed across the screen, adjustable and updated from left to right with an erase bar. The color of the waveform corresponds to the associated vital sign box numeric for that parameter. 9 1 2 8 7 3 6 P. I. 3.1 4 5 1. 2. 3. 4. 5. 6. 7. 8. 9.
2.1.4.4. Alarm Example Alarm adjustments can be made by touching the corresponding vital sign numerical box of the alarm that needs adjusting. 2 1 1. 2. 3. 4. 3 4 Lower Alarm Limit Fine Adjustment Lower Alarm Limit Quick Slide Adjustment Upper Alarm Limit Quick Slide Adjustment Upper Alarm Limit Fine Adjustment NOTE • Green: range of numerical values that are inside the alarm limits and will not trigger an alarm.
2.1.5. System Use Model The diagram below illustrates an example of the 3880 system when used for MRI patient monitoring. The 3880 non-magnetic patient monitor (2) is a multi-parameter vital sign monitor positioned near the patient during the procedure as well as transport. The 3880 acquires the patient vital sign measurements wirelessly from the ECG and SpO2 PODs (1) as well as traditional connections for NIBP cuff, CO2, and fiber optic temperature probe.
2.1.6. General Wireless Principles There are 8 user selectable wireless channels utilized by the 3880 system. Once a user matches the desired wireless channels of the PODs, 3880 monitor, 3885-B Base Station, and 3885-T Remote Tablet the system will automatically communicate the information utilizing wireless technologies. The 3880 system utilizes a frequency hopping 2.4 GHz spread spectrum wireless technology (FHSS) with proprietary hopping durations and patterns.
• 2.1.7. Locate the 3885-B Base Station antennas, the 3880 Monitor and 3885-T Remote Tablet and the PODs more than 1 meter (3 feet) from other sources of RF energy in the 2.4 GHz band. (ie: WiFi Hot Spot) Wireless Commands Menu commands that control the patient parameter and strip recorder/printing functions are communicated between the 3880 non-magnetic monitor and the 3885-T Remote Tablet. Other operational control settings remain localized to each device and are not communicated.
3880 Patient Worn ECG Accessories • Use with Ultra-High Field MRI Systems greater than 0.5 Tesla static field. • Use with whole body average Specific Absorption Rates (SAR) up to 4.0 W/kg or less. NOTE • When moving the 3880 monitor within high magnetic fields (>2,000 gauss) Eddy Current effects may be noticeable. These are forces generated in the device which resists motion through the intense magnetic field. Such effects are normal and present no risk of free magnetic movement of the unit.
Typical MRI Facility Zones 2.1.9. Cleaning For cleaning guidelines review the Care and Cleaning section 8.4 of this manual. 2.1.10. Repair The 3880 System or any of its parts should be repaired in accordance with written instructions provided by the IRadimed. The user has the sole responsibility for any malfunction which results from improper use, faulty maintenance, improper repair, damage or alteration by anyone other than IRadimed-authorized service personnel.
2.2. Initial Setup 2.2.1. Safety Precautions ! WARNING • The monitor and its components should not be used adjacent to or stacked with non IRadimed equipment. If adjacent or stacked use is necessary, the monitor and its components should be observed to verify normal operation in the configuration prior to use. Never install the monitor directly above the patient.
2.2.3. Visual Inspection Perform the following visual inspection to the installed monitoring system: • Carefully inspect the patient monitor components for any damage. • Verify that the patient monitor is properly mounted with specified mounting solutions. • Verify that the cables between the patient monitor and the connected peripheral devices are intact and properly connected to the right connectors. • Verify that the battery is intact and locked into the monitor.
2.2.7. System Power 2.2.7.1. Battery Operation The 3880 system utilizes Lithium Polymer ‘smart’ battery technology with self-monitoring. When all components of the system are turned on and communicating, the battery charge status is displayed on the 3880 Monitor and 3885-T Remote Tablet displays. The actual battery capacity will decrease over time and a full battery symbol may not indicate the same capacity and operating time as compared to a new battery.
3880 multi-parameter monitor The 3880 system has a user replaceable battery located on the rear of the device. 1. Insert the user replaceable battery pack into the battery bay on the rear of the 3880 monitor as shown. The battery pack will lock into place if inserted properly. 2. Connect the system to AC power. Reference the Charging Instructions section 2.2.7.2 in this manual for additional details. 3.
3885-T Remote Tablet and 3885-B Base Station The 3885-T Remote Tablet has an integrated battery that is user serviceable. The Remote Tablet is charged by docking it to a 3885-B Base Station that is connected to AC power. 1. Connect the 3885-B Base Station to AC power. Reference the Charging Instructions section 2.2.7.2 in this manual for additional details. 2. Lower the 3885-T Remote Tablet onto the 3885-B Base Station Charging Dock. 3.
2.2.7.2. Charging Instructions 2.2.7.2.1. Connecting and Disconnecting AC Power Always connect the 1120 AC power supply to a properly grounded 3-wire power receptacle. If the quality of the earth grounding is in question, use battery power for the monitoring system. Avoid the use of extension cords. The 3880 Monitor and 3885-T Remote Tablet will automatically switch to battery power when disconnected from AC Power.
3885-B Base Station, Optional 1. Locate the power cord (P/N 1128 in US) and ensure the Base Station power switch is in the OFF position. (1) 2. Locate a suitable location in the control room that enables access and wireless communication. See 2.2.8 for antenna connection. 3. Attach the power cord to the 3885-B Base Station (2) 4. Place the power cord into the designated AC power outlet. 5. Turn the 3885-B Base Station power switch to the ON position (1) 6.
meter (3 feet) from other sources of RF energy in the 2.4 GHZ band. (ie: WiFi Hot Spot). 2.2.8.3.1 LED Power Indicator The power indicators located on the 3880 Monitor and optional 3885-B Base Station are two color LEDs and the PODs are a single color LED that provides a visual indication of the power status as indicated below. Reference the System Hardware Components (accessories not shown) section 2.1.2 of the operation manual for specific LED locations.
• Do not leave the recorder door open.
2.2.10. Connecting Patient Accessories 2.2.10.1. 1811 ECG Wires and 3881 ePOD The wireless ECG POD “3881 ePOD” and lead wires are constructed of special material to reduce the amount of radio frequency (RF) energy that can flow through the components. The ECG ePOD and lead wires are designed for use in the MRI system bore but should remain outside of the MRI procedure Field of View (FOV) where possible. 3 3 1 2 To connect the ECG Lead wires to the ECG ePOD: 1.
2.2.10.2. SpO2 1821 Cable and 3882 oPOD The wireless SpO2 POD “3882 oPOD” and accessories are constructed of special material to reduce the amount of radio frequency (RF) energy that can flow through the components. The SpO2 oPODs and accessories are designed for use in the MRI system bore but should remain outside of the MRI procedure field of view (FOV), where possible. 1 The SpO2 Sensor cable, P/N 1821 is fiber optic (glass), and mated to the SpO2 oPOD 1.
2.2.10.3. 3886 Multi-Gas / Agent Sampling Lines The optional CO2/ Multi-gas Anesthetic Agent unit (P/N3886) provides sidestream measurement of End-Tidal CO2, anesthetic agents, fast O2, respiration with a continuous realtime CO2 waveform display. This Multi-gas option will also identify and display any two of five anesthetic agent concentrations. This feature will perform automatic zeroing at periodic intervals or upon user demand. 2 1 To connect the sampling circuit: 1.
