4. 5. 6. 7. ! align. The LEGI receptacle glows various colors to indicate status. See Section 6.3.10 Firmly insert the sampling line into the corresponding receptacle shown Ensure that sampling line is secure into the monitor and not loose Connect the appropriate airway adapter for the application as needed Connect exhaust port to the scavenging system using part number 1846 as desired CAUTION • Use only accessories specifically designed and approved for use with the IRadimed 3880 system.
.2.10.5. NIBP Lines The NIBP feature utilizes the oscillometric method for measuring and displays systolic, diastolic, and mean arterial pressures, and pulse rate. 1 2 To connect the NIBP Line: 1. Locate the NIBP line (1) and 1 the NIBP receptacle on the 3880 monitor (2) 2. Position the NIBP line with the NIBP receptacle so they align 3. Firmly insert the NIBP line onto the corresponding receptacle ( 2) until the NIBP line is secure, notice a snap when locked into place. 4.
• Use only temperature accessories specifically designed and authorized for use with the IRadimed 3880 system. Refer to section 9.6 for a complete list of available accessories. 2.2.10.7. Additional Installation Options Additional installation options such as those listed below may be suggested by your service personnel or IRadimed representative to increase operator efficiency. • Connection of 3885-B Base Station to an external monitor or external projector utilizing the HDMI output. 2.2.11.
2.2.11.2. Displayed Information The 3880 monitor and 3885-T Remote Tablet display the following types of information. Reference section 2.1 for images. • Vital Sign Waveforms • Vital Sign Numerics • Case Management data • System Status • Messages Alerts area 2.2.11.3. Navigation The 3880 monitor and 3885-T Remote Tablet utilize a combination of hard keys and touch screen soft keys to operate. 2.2.11.4. Using Screen Touch Points 2 1 4 3 5 15 14 13 12 6 7 16 10 9 11 8 1.
16. Messages and Alerts area NOTE • If the touchscreen is not responsive or blank, remove from use and refer the monitor to qualified service personnel. 2.2.11.5 Using Control Switch Hard Keys 1 1. 2 3 4 5 6 SETTINGS: Access monitor setup menus 2. ALARM OFF - Standby button: Indefinitely pauses all alarms and terminates automatic NIBP measurements 3. TRENDS: Trend Screen access and adjustment 4. PRINT: Prints to optional recorder in the Base Station 5.
2.2.11.7 Virtual Keyboard / Keypad 1 2 1. Select the desired field to input text by touching that area 2. Input desired text by utilizing the on screen virtual keyboard 2.2.12. Setup Menu Overview 2.2.12.1. Parameters The Parameters menu contains selections that allow users to customize and control functions and settings used to measure and monitor vital signs. To enable or disable parameters: 1. Press the SETTINGS button 2. Select “Parameter Setup” 3.
2.2.12.2. Sound Adjustment This menu allows you to enable, disable and adjust the volume of the sounds generated by the system. Adjusting Alarm Volume: 1. Press “SETTINGS” button 2. Select “Alarms Function“ 3. Select the Alarms Volume soft button 4. Select the desired sound level from the menu 5. Touch Back button to close the menu ! WARNING • Adjust sound level appropriate for the local environment to ensure alarms are heard during clinical use. Adjusting Heart Rate Volume: 1.
2.2.12.4. Wireless Setup The 3880 system utilizes specialized wireless technology to establish communications between the 3880 Monitor, 3881 and 3882 PODs and 3885-T Remote Tablet. The system has eight unique ‘Channels’ to choose from. ! CAUTION • Prior to starting a patient case, ensure that all wireless components are communicating on the same wireless channel. • If multiple 3880 systems are being used in the same area ensure that each individual system is set to a unique wireless channel. 2.2.12.4.
2.2.12.4.2 Adjusting the 3881 ECG ePOD Wireless Channel 1. Identify the channel setting of the 3880 monitor that the ePOD should communicate to 2. Power on the wireless ePOD 3. Press the yellow “CH Select” button to advance to the next wireless communicating channel in sequence, choosing the channel which matches the 3880monitor a. A white channel LED will light for channels 1(5), 2(6), 3(7) or 4(8) b. A blue “Channel Select” LED will illuminate indicating a shift to channels 5, 6, 7 and 8 4.
When connection is established, the channel link signal indicator “bars” illuminate green in the top left channel icon display area 2.2.12.4.5 Adjusting the 3885-B Base Station Wireless Channel 1. Complete the steps in section 2.2.12.4.4 to assign the channel on the 3885-T Remote Tablet 2. Dock the 3885-T Remote Tablet to the 3885-B Base Station and observe the LED display on the base station to confirm connection – OR 3.
To adjust the recorder settings follow these steps: 1. Press “SETTINGS” button 2. Select “Recorder Setup” 3. Make adjustments 4. Touch Back button to close the menu NOTE • Refer to section 7 for available choices for setting up the Recorder. 2.2.12.6. Alarm Setup Physiological and technical alarms are reported visually and audibly by the 3880 system. Alarm limit settings have a lower limit setting and an upper limit setting.
2.2.12.7. Store/Recall of User Setup This feature allows you to store multiple user setups and to select one for a default power up setting. Storage of different procedures, patient types and users are available by customizing the following: FACTORY DEFAULT • Alarms 1. Minimum and Maximum Limit Values, not including ‘OFF’ 2. Latched or unlatched Unlatched 3. Alarm volume level, not including OFF or 0 sound 100 % • 1. 2. 3. Patient Type Adult Pediatric Neonatal 1. 2.
NOTE • Wireless Channel cannot be stored under a user setting. The 3880 system components will power on with the last channel that was used. See 2.2.12.9 Auto settings Memory. • Settings modified during use will be retained and used for short power on to off to on cycle of < 1 minute. 2.2.12.7.1 Saving a New Setting To save a custom user setting, prepare the desired setup on the 3880 monitor or 3885-T Remote Tablet before entering the Edit User Settings menu.
2.3. Initial Use 2.3.1. Wireless Communication The 3880 system utilizes specialized wireless technology to establish communications between the 3880 Monitor, PODs and optional 3885-B Base Station Unit and 3885-T Remote Tablet. Ensure that the 3880, ECG ePOD, SpO2 oPOD and optional 3885-B Base Station and Remote Tablet are set to the same wireless channel. Please review the wireless setup section 2.2.12.4 for further details. ! 2.3.2.
2.3.2.2. Standby Mode, ALARMS OFF Pressing the ALARM OFF /STANDBY button places all communicated system components into standby mode with all ALARMS OFF and silences all audible alarms, pauses Tri-Color Alarm Dome Light, suspends automatic blood pressure cycles and suspends any automatic printout. This feature is useful during patient setup and in between cases. To exit Standby Mode press the ALARM OFF /STANDBY button again.
2.3.3. Patient Type This menu allows you to select the appropriate type of patient when monitoring, as several parameters including NIBP cuff inflation pressure, pulse sensitivity and all alarm limits, defaults and ranges, can vary depending on this selection.
2.3.4. Filter Operation Although it may appear that electrocardiogram (ECG) monitoring in the Magnetic Resonance Imaging (MRI) area is similar to that performed in other areas of the clinical environment, the conditions found inside the MRI area are unique and require additional precautions to be followed in order to permit the safe monitoring of the patient during MRI procedures. Please reference the ECG Monitoring section 6.1 for further ECG application details. 2.3.4.1.
3. Advanced Case Management Strategies The 3880 system includes several features to help facilitate the efficient management of patients undergoing a MRI procedure. 3.1. Case Management Many of the case management strategies are intended for use with a fully equipped 3880 system including the 3885-B Base Station and 3885-T Remote Tablet. Various strategy suggestions provided in this document are examples showing the capabilities of the system.
3.3. Patient Transportation The small size and light weight nature of the 3880 patient monitor allows continuous patient monitoring throughout the entire care cycle.
4. Using Alarms and Messages The 3880 MRI Patient Monitor features a comprehensive alarm system combining visual and audible indicators. Alarms triggered by a vital sign or by a technical problem of the patient monitor are indicated to the user by visual and audible alarm indications. NOTE • If any alarm recurs without apparent cause, verify the alarm limits are set appropriately.
4.1.3.1. Message System Overview The 3880 is equipped with a message area which automatically prioritizes and sorts messages in order of priority. When a message is present, it will show up in the lower left hand corner of the screen. Messages related to vital signs are color coded to priority and typically use a prefix denoting the associated vital sign before the message so the operators can quickly understand the context.
4.1.4. Alarm Levels By severity, the patient monitor’s alarms can be classified into three categories: high priority, medium priority and low priority. NOTE • All monitor alarms are categorized as medium priority, unless otherwise stated. 4.1.4.1. High Priority Alarms indicated by red Dome Light High Priority Alarm Physiological Alarms Indicates Patient is in a life threatening situation or a medium priority alarm that has been ignored and requires immediate response.
4.2.1. Alarm Identification 4.2.1.1. Audible Alarm Pattern ! • HIGH Red: For life threatening situations: o 10 repeated every 2.6 seconds --- -- --- -- 2.6 --- -- --- -- 2.6 --- -- --- -- (rising tone) • MED Yellow: For serious but not life threatening problems: o 3 tones repeated every 3.6 seconds --- 3.6 --- 3.6 – • LOW Blue: For Low Priority Alarms o Single tone, repeats after 14.
4.2.1.5. Monitor Visual Alarm Indicators 1 4 5 5 2 5 5 3 5 5 5 5 1. 2. 3. 4. 5.
4.2.1.6. 3885-T Remote Tablet Visual Alarm Indicators 1 4 5 2 5 3 5 5 5 5 1. 2. 3. 4. 5.
4.3. Alarm Functionality 4.3.1. Alarm Condition Delay Unless specified for a particular alarm condition visual and audible alarms at the 3880 monitor will be triggered within 1 second of the initial alarm condition measurement. The average additional delay time to indicate a 3880 Monitor alarm at the optional 3885-T Remote Tablet is 1 additional second or less. ! • 4.3.2.
4.4. Controlling Alarms 4.4.1. Accessing Alarm Menu Quick Alarm setup allows a targeted adjustment of 1 vital sign measurement. The “quick alarm” is accessed by a user by pressing the corresponding vital sign box. 3 2 1 1. 2. 3. 4. 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.
9. Enflurane (Enf) Inspired Limit Selector 10. Isoflurane (Iso) Inspired Limit Selector 11. Sevoflurane (Sev) Inspired Limit Selector 12. Desflurane (Des) Inspired Limit Selector NOTE • Green: range of numerical values that are inside the alarm limits and will not trigger an alarm. • Red: range of numerical values that are outside the alarm limits and will trigger an alarm. • O2 Low Limit settings below 18% require an unlock sequence second touch at the center of the Lower Limit Up/Down arrows.
4.4.4.2. Pausing Alarms Temporarily If the operator presses and holds the Alarm Silence button for 2 seconds the system will “Pause” all audible alarm sound operation for 2 minutes. NOTE • Pressing the Alarm Silence button stops the alarm sound and dome light indicators, the visual waveform and numerical alarms are not affected. 4.4.5 Alarm Event Log A tabular log of all vital signs alarm events is maintained during all operating times.
5. Using Trends 5.1. Overview The 3880 MRI patient monitoring system enables you to view trend data. The monitor collects numerical trend data automatically from trended variables. Patient trend data is stored for up to 24 hours and is color coded to match the monitored vital signs. Once the data is stored, new data will overwrite the oldest trend data.
5.3. Trend Interval The 3880 system can store trend information at the following intervals: • OFF • 3 minute ( This is the Factory Default Setting) • 5 minutes • 8 minutes • 10 minutes • 15 minutes • 30 minutes • NIBP Auto Time NOTE • NIBP Auto Time will automatically store vital sign information when a new NIBP pressure is recorded. To adjust the trend interval follow these steps: 1. Press the TRENDS button 2. Select “Trend Interval” 3. Make your selection 4. Touch the Back button to close the menu 5.4.
6. Using Vital Sign Parameters 6.1. Cardiac Monitoring 6.1.1. ECG Overview The electrocardiography, ECG, reflects the electrical activity generated by the heart muscle and displays it on the patient monitor as a waveform and numeric heart rate value. ECG monitoring in the MRI is used for a heart rate measurement and is not intended to diagnose arrhythmic cardiac conditions.
• • ! Periodically inspect the electrode application site to ensure skin quality. If the skin quality changes, replace the electrodes or change the application site. No pacemaker rejection is present, and to keep pacemaker patients, and patients with arrhythmias, under close surveillance. Recommend using the SpO2 function as the primary heart rate source under those conditions. CAUTION • Pacer pulses are not specifically rejected and may be treated as part of the MRI gradient noise.
6.1.2. Understanding the Display 1. 2. 3. 4. 5. 6. 7. 8.
6.1.3. ECG Patient Application 6.1.3.1. ECG Electrode Site Selection A general guideline for non-neonatal applications, when placing the electrodes the RA and LA electrodes should be placed just above the imaginary nipple line avoiding fatty breast tissue. The RA and RL electrodes should be placed just to the left side of the sternum. The bottom electrodes LA, LL should be placed along the bottom of the rib cage with the optional V lead placed for the vector desired.
6.1.3.1.1. Female Average Female Example Obese Female Example 6.1.3.1.2. Male Average Male Example Obese Male Example 6.1.3.1.3.
6.1.3.2. Applying the ECG Electrode ECG safety and quality during MRI procedures can be greatly affected by the quality of patient preparation. To prepare the electrode site, follow these steps: A. Preparing the Electrode Site 1. Select the electrode sites 2. Check the electrode expiration date 3. Shave any hair from the application site B. Placing the Electrode on the Patient 4. Apply a sufficient amount of 1813 Skin Prep Gel to a gauze pad or cloth 5.
• • • • • • 6.1.4. ECG QRS signal is greater than1/3 of the Scale Indicator ECG Lead wire is positioned straight ECG ePOD is positioned outside of the field of view Ensure the ECG filter is appropriate for the MRI Scan Ensure SAR does not exceed 4 W/Kg ECG is selected to be displayed through Monitor Setup patient parameters menu Changing ECG Settings 6.1.4.1. Trace A lead View The ECG trace A is considered the primary ECG waveform and is the top position waveform when both A and B waveform are enabled.
• See the WARNING at 6.1.3 regarding the non-standard lead placement and the foreseeable changes the ECG waveform due to placement. 6.1.4.3. HR Source HR Source permits the user to select the vital sign source that will to be used to produce the heart rate displayed in the ECG vital sign box. The following options are available: Option ECG SpO2 NIBP Corresponding Vital Sign Electrocardiogram Pulse Oximetry Most recent NIBP Measurement 6.1.4.4.
6.1.4.6. Sweep Rate The sweep rate setting determines the speed at with the ECG waveform trace moves across the display. You can change the waveform sweep rate between 25 mm/s and 50 mm/s by selecting the appropriate setting under the ECG menu. To adjust the sweep rate follow these steps: 1. Touch the ECG vital sign box 2. Touch Sweep button 3. Select 25 mm/s or 50 mm/s 4. Touch Back button to close the menu 6.1.5.
• • • • • • • • • • • guidelines for appropriate disposal. Reuse of single-use devices can result in spread of patient infection, degradation of monitoring performance, or inaccurate measurements. Do not use damaged SpO2 sensors. Do not immerse the SpO2 sensor in water, solvents, or cleaning solutions. Make sure oPOD is charged prior to use. Do not sterilize SpO2 sensors by irradiation, steam or ethylene oxide. Refer to the cleaning instructions for the SpO2 sensor.
! CAUTION • If SpO2 values indicate hypoxemia, a laboratory blood sample should be taken to confirm the patient’s condition • Never attach a SpO2 sensor to a limb being monitored with a blood pressure cuff or a limb with restricted blood flow. • Because SpO2 measurements depend upon light from a sensor, excessive ambient light can interfere with the pulse oximeter’s measurements.
• Decrease of arterial blood flow to unmeasurable levels which can be caused by shock, anemia, low temperature or vasoconstrictive drugs The patient has hypotension, severe vasoconstriction, severe anemia, or hypothermia The patient is in cardiac arrest or is in shock • • 6.2.2. Understanding the Display 1. 2. 3. 4. 5.
NOTE • Each sensor requires site-specific application procedures. The quality of the patient’s pulse oximetry measurements and pulse signals may be adversely affected by certain environmental factors, by oximetry sensor application errors, and by patient conditions. Any of these factors can interfere with the ability to detect and display measurements and may result in a loss-of-pulse condition.
Adult SpO2 Pediatric SpO2 Neonatal SpO2 Adult Pulse Rate Pediatric Pulse Rate Neonatal Pulse Rate 6.2.6.
6.3. Respiration, Carbon Dioxide and Multi-Gas (Anesthetic Agents) Monitoring Capnography (CO2) and Respiration or Capnography, Respiration and Multi-Gas Anesthetic Agent sidestream options, can be equipped with the 3880. Both options feature automatic barometric pressure compensation. The CO2/Respiration only unit is a built in, integrated option to the 3880 MRI monitor unit and operable to the full 30,000 gauss rating of the 3880.
• • • • ! only. Do not clean or disinfect these items. Reuse of these items may lead to inaccurate gas measurements or patient injury. Verify that the patient’s breathing efforts and timing coincide with the CO2 waveform on the displays before completion of the patient setup. Always place the 3880 monitor in a well ventilated area. The calibration system assumes that the ambient air will contain normal amounts of waveform CO2.
6.3.1.1. Sampling Lines The IRadimed 3880 uses low maintenance and easy to apply sampling lines. There are two basic types of sample lines. One type is via P/N 1842 A, P, or I type nasal cannula. These cannula are to be used on non-ventilated/intubated patients not receiving anesthetic agents, see 6.3.3.2. These nasal cannula will only mate with the built in CO2 only option.
6.3.3. CO2 and Multi-Gas Patient Application To apply the CO2 / Agent accessories follow these steps: 1. Ensure hardware is fully warmed up 2. Connect exhaust port of the monitor to the scavenge system using part number 1846 3. Connect an unused IRadimed sampling line to the 3880 CO2 gas inlet port 4. Connect the sampling line to either the airway adapter or in the case of nasal cannula, to the in 6.3.3.1 5.
! WARNING Nasal cannula (P/N 1842 A, P, or I)are not for use with anesthetic agents. 6.3.3.3. Setup Checklist • • • • • 6.3.4. Ensure 3880 is warmed up prior to connecting All connections are secure with no leaks or kinks A new cannula or sampling line is used with each patient. For neonatal patient select suitable gas sampling line No residual of alcohol based disinfectants Inspect lines regularly during use Changing Respiration Settings 6.3.4.1.
6.3.4.4. Zero Calibration (CO2/Agent Multi-Gas Unit Only) The zero calibration eliminates the effect of baseline drift during CO2 measurement and therefore maintains the accuracy of the CO2 measurements. The Zero calibration also recalibrates the optional O2 measurements to 21% ambient room air. Zero calibration is carried out automatically when necessary. You can also start a manual zero calibration by following these steps: 1. Touch the CO2 vital sign box 2.
6.3.8. Multi-Gas (Anesthetic Agents) Option Overview, P/N 3886 (Not intended for neonatal use) The Anesthetic Agent option determines the concentration of certain gases using the infrared (IR) light absorption measurement. The gases that can be measured by the module absorb IR light and the system can detect up to two agent concentrations greater than 0.1%. Each gas has its own absorption characteristic.
6.3.8.1. Understanding the Agent Display 1. 2. 3. 4. Measurement unit Current gas label of detected gases Current exhaled measurement of detected gases Current inspired measurement of detected gases 6.3.8.2. MAC Values Minimum alveolar concentration (MAC) is a standard for comparing the minimum concentration of the inhalation agents in the alveoli. It is a basic index to indicate the depth of anesthesia.
6.3.8.5. Limitations The following factors may affect the accuracy of measurement: • Leaks or kinks in the line • Mechanical shock • Airway pressure • Improper accessories for patients breathing style 6.3.9. Alarm Limits, Multi-Gas O2 N2O Insp Hal Et Hal Insp Iso Et Iso Insp Enf Et Enf Insp Sev Et Sev Insp Des Et Des 6.3.10. Low Limit Range Off, 15-99 Off, 3-60 Off, 0.1-8.0 Off, 0.1-8.0 Off, 0.1-8.0 Off, 0.1-8.0 Off, 0.1-8.0 Off, 0.1-8.0 Off, 0.1-10.0 Off, 0.1-10.0 Off, 0.1-22.0 Off, 0.1-22.
6.4. Non Invasive Blood Pressure Monitoring This monitor uses the oscillometric method for measuring non-invasive blood pressure (NIBP). This measurement can be used for adults, pediatrics and neonates, however to clarify, for purposes of NIBP operation, the term “Pediatrics” does not include neonates. The oscillometric technique applies specific algorithmic adaptations for neonatal cuffs and pulse levels.