Operating Instructions 0070-01-0628-02_revD_Trio ops color.
Operating Instructions
Trio™ is a U.S. trademark of Mindray DS USA, Inc. Navigator™ is a U.S. trademark of Mindray DS USA, Inc. Masimo SET® is a U.S. registered trademark of Masimo Corp. Nellcor® and OxiMax® are U.S. registered trademarks of Nellcor Puritan Bennett Inc. SatSeconds™ is a U.S. trademark of Nellcor Puritan Bennett Inc. Copyright © Mindray DS USA, Inc., 2008. All rights reserved. Contents of this publication may not be reproduced in any form without permission of Mindray DS USA, Inc.
Table of Contents Foreword ....................................................................................................................................................... v Warnings, Precautions And Notes .................................................................................................................... v Warnings ...................................................................................................................................................... vi Precautions ....
Table of Contents User Maintenance ............................................................................................................. 4 - 1 Introduction .................................................................................................................................................... 4 Decontamination of the Monitor........................................................................................................................ 4 Care and Cleaning of the Monitor ..........
Table of Contents Environmental and Safety Characteristics.................................................................................................... 6 - 22 Warranty Statements ....................................................................................................................................... 6 - 28 Phone Numbers and How To Get Assistance...................................................................................................... 6 - 29 Manufacturer’s Responsibility ...
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Foreword Introduction Foreword The Trio Operating Instructions are intended to provide information for proper operation. General knowledge of monitoring and an understanding of the features and the functions of the Trio Monitor are prerequisites for proper use. Do not operate this monitor before reading these instructions. Information for servicing this instrument is contained in the Trio Monitor Service Manual, (Part Number 0070-00-0627-03).
Introduction Warnings Warnings WARNING: Equipment not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or with nitrous oxide. WARNING: The AC line cord and interface cables (i.e. non-patient cables) may utilize the same ground. Therefore, removal of the AC line cord does not necessarily isolate the Trio, if nonpatient interface cables are attached. WARNING: Observe extreme caution when a defibrillator is used on a patient.
Precautions Introduction Precautions CAUTION: The use of portable and mobile RF communications equipment, in the proximity of the Trio, can affect the performance of this monitor. CAUTION: The use of unapproved accessories may diminish monitor performance. CAUTION: The Trio should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the Trio should be observed to verify normal operation in the configuration in which it will be used.
Introduction Precautions CAUTION: viii Inaccurate SpO2 measurements may be caused by: • incorrect sensor application or use • significant levels of dysfunctional hemoglobins, (e.g., carboxyhemoglobin or methemoglobin) • intra-vascular dyes such as indocyanine green or methylene blue • exposure to excessive illumination such as surgical lamps (especially ones with a xenon light source), bilirubin lamps, fluorescent lights, infrared heating lamps, or excessive ambient light.
Precautions Introduction CAUTION: A patient's skin is sometimes fragile (i.e. on pediatric and geriatric patients or due to physiological conditions). In these cases, a longer time duration between measurements should be considered to decrease the number of cuff inflations over a period of time. In extreme cases, a thin layer of soft roll or cotton padding may be applied to the limb in order to cushion the skin when the cuff is inflated.
Introduction Precautions CAUTION: x Prolonged and continuous monitoring may increase the risk of skin erosion and pressure necrosis at the site of the sensor.
Notes Introduction Notes NOTE: Potential hazards due to errors in software or hardware have been minimized by actions taken in accordance with IEC 60601-1. NOTE: Messages are provided to assist in the identification and correction of problems that may occur with the monitor. NOTE: Should the device become accidently saturated with any liquid, immediately discontinue use and contact Customer Service.
Introduction Symbols Symbols SYMBOL DESCRIPTION SYMBOL DESCRIPTION Attention, Consult Accompanying Documents / Type BF Equipment Refer to Manual Dangerous Voltage Equipotentiality Alternating Current (AC) ON/OFF (only for a part of the equipment) Defibrillator Proof Type BF Equipment Defibrillator Proof Type CF Equipment Alarm Off Alarm Mute Battery Charging Full Battery Indicator Data Output Low Battery Indicator Data Input/Output No Battery in Unit NIBP Connection Non-ionizing elec
1.0 General Product Description The Trio is a vital signs monitor intended for intra-hospital use on human patients. It is adaptable for use with adult and pediatric patients. The Trio is a three (3) to four (4) trace monitor. The unit has many features and functions, yet is easy to use through an integrated keypad, Navigator™ Knob (see FIGURE 1-2) and an intuitive menu system. Refer to Front Panel Keypad for details.
General Product Description Key Features The Trio offers several new features that enhance the capabilities of the monitor. The main improvements of this release are as follows: • Support for the full line of adult and pediatric NIBP Cuffs, see Section 5. • Determination of heart rate from an NIBP measurement, see Section 2. • An enhancement to SpO2 monitoring that enables audible distinction of oxygen saturation changes, see Section 2.
General Product Description 1.1 Front Panel Front Panel 1 2 3 FIGURE 1-1 Front View of Monitor 1. Alarm Light Illuminates when an alarm is triggered. 2. Display 8.4” color TFT LCD (800 x 600 resolution). 3. Front Panel Keypad Navigator™ Knob and dedicated quick-action keys.
Front Panel 1.1.1 General Product Description Front Panel Keypad The front panel keypad is used to access many main functions quickly and easily (see FIGURE 1-2). 1 2 3 5 4 6 7 8 FIGURE 1-2 Keypad 1. POWER Press this key to power the Trio ON or OFF. NOTE: 2. The power supply and battery charger are active any time AC power is supplied, regardless of whether the monitor is ON or OFF.
General Product Description 6. Front Panel ALARM MUTE Press this key to suspend audio alarms on all currently alarming parameters. The alarms remain suspended for a user selected amount of time as set in the ALARM SETUP menu or until the alarm condition is no longer present. Any new alarms that occur while the alarm tone is silenced will disable the silence and sound the alarm tone. While the alarms are suspended, an ALARM MUTE icon is displayed in the message bar.
Front Panel 1.1.2 General Product Description Display The Trio display provides menus, waveforms, parameter information, patient information, and messages. The Trio includes various features that enable the user to customize the display. Additionally, the user default feature enables the user to save the customized settings. The display is divided into the following areas (see FIGURE 1-3): 1. Demographics 2. Technical Alarms 3. Waveform Data/Menus 4. Parameter Tiles 5.
General Product Description Front Panel Gender Gender of the patient: M (Male), F (Female) Current Date XX-XX-XXXX (month-day-year) Current Time XX:XX:XX (hours:minutes:seconds) (24-hour format) Indicates that all alarm tones have been manually disabled. It is displayed when the ALARM MUTE button is pressed. 2. Technical Alarms Technical Alarms are failures or errors that require resolution or attention to continue patient monitoring (also called System Error Messages). 3.
Front Panel General Product Description 4. Parameter Tiles The numeric data in each parameter tile refreshes continuously, except for the NIBP value, which refreshes each time a measurement is completed (see section 6). Using the MODULE SETUP menu, parameters can be turned ON or OFF, and the screen display will adjust accordingly. The numeric data is displayed at fixed positions within each parameter tile. (see FIGURE 1-4). A B C D E F FIGURE 1-4 Parameter Tiles A.
General Product Description Front Panel 5. Status Bar The status bar is located at the bottom of the screen. It displays the DEMO MODE status, the battery icons and the MENU icon. • The DEMO MODE status message indicates that the monitor is in demo mode and is displaying simulated patient data. • The battery icons indicate the relative charge status of the optional battery. • Battery (Full) The battery full icon appears in the lower right portion of the display when the unit is operated by battery power.
Left Side Panel 1.2 General Product Description Left Side Panel The optional, two-trace thermal strip chart recorder and the battery compartment are located on the left side panel (see FIGURE 1-5). 1 2 3 4 FIGURE 1-5 Left Side Panel 1. Handle/bedrail hook Handle with integrated bedrail hook 2. Recorder (Optional) Two-trace thermal strip chart recorder 3. Recorder Power LED A green LED that indicates that the recorder is receiving power 4.
General Product Description 1.3 Right Side Panel Right Side Panel The connectors for patient cables and sensors are located on the right side panel (see FIGURE 1-6). 1 SpO 2 ¨ 4 2 IBP 1 T1 ECG 3 5 FIGURE 1-6 Right Side Panel 1. SpO2 Receptacle This receptacle is used to attach the SpO2 sensor to the monitor. 2. Optional IBP A six-pin male receptacle used for an IBP connection. 3. ECG Receptacle A six position female receptacle used to attach a 3 or 5 Lead ECG cable. 4.
Rear Panel 1.4 General Product Description Rear Panel The following connectors are located on the rear panel (see FIGURE 1-7). 1 CS1 2 4 AO1 SP1 XXXX - XX - XXXX - XXXXX 3 XXXX - XX - XXXX - XXXXX 5 FIGURE 1-7 Rear Panel 1. Ethernet Port (CS1) The ethernet port is an RJ45 jack that is used for software upgrades. NOTE: This port should not be used while monitoring a patient. 2.
General Product Description Rear Panel 3. Serial Port (SP1) or VGA Output (RD1) Trio monitors bearing a model number of 0998-00-0600-4XXXX are equipped with a 9-position D-shell serial port connector. Trio monitors bearing a model number of 0998-000600-0XXXX or 0998-00-0600-2XXXX are equipped with a 15-position D-Shell VGA output connector. The proprietary serial port is a 9-position D-shell plug connector with interface based on TIA/ EIA-232-F signal compliance.
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2.0 Operations 2.1 Getting Started The Trio features default factory settings that enable monitoring to begin without setting waveforms, parameters, alarms, or functions. Each of these settings can be changed based on specific patient or departmental needs. Certain operating characteristics (e.g. NIBP start pressure) are based on the selected patient size. CAUTION: The patient size selection should be matched to the actual patient before monitoring begins.
Menus Operations 4. Enter the desired patient information into the Trio via the PATIENT SETUP menu. Select appropriate patient SIZE. 5. If desired, press the NIBP key to initiate a non-invasive blood pressure measurement. 6. When monitoring has concluded, clear the patient's data by selecting PATIENT DISCHARGE from the PATIENT SETUP menu. 2.1.2 Setting the Clock (Date and Time) From the MONITOR SETUP menu the date and time can be set. 1.
Operations 2.3 System Menu System Menu The SYSTEM MENU provides the following submenu choices: PATIENT SETUP, LIST TREND, GRAPHIC TREND, MARK EVENT, MONITOR SETUP, MAINTENANCE, and NORMAL SCREEN. For the default settings of all menu selections, refer to section 3.0, “Defaults”. Use the Navigator Knob to select the MENU icon in the lower right corner of the screen. The SYSTEM MENU (FIGURE 2-1) is displayed. From the SYSTEM MENU, select a submenu. FIGURE 2-1 System Menu 2.3.
System Menu Operations The PATIENT SETUP menu provides the following choices for entering patient demographic information and for patient discharge. NOTE: The ID #, BED#, FIRST NAME and LAST NAME use the onscreen keypad to enter demographic information. The remaining demographic information is chosen from DropDown or Spin Edit Boxes.
Operations System Menu Entering the ID #, BED#, FIRST NAME and LAST NAME Use the onscreen keypad to enter the ID #, BED#, FIRST NAME and LAST NAME information, proceed as follows: 1. Select the PATIENT SETUP menu and use the Navigator™ Knob to scroll to the item that will be entered or changed. 2. Press the Navigator Knob and the cursor will automatically move to the on-screen keypad. 3. Move the cursor to the appropriate character and press the knob so that the character appears in the box above.
System Menu 2.3.4 Operations Mark Event The Mark Event function places a time stamp event marker (A, B, C or D) in the trend memory. This function may be used to identify medication delivery, change in patient status, etc. There may be a time delay between the time at which the event is marked and the point in time at which it displays on the trend screen. Select MARK EVENT from the SYSTEM MENU (see FIGURE 2-4).
Operations 2.3.5.1 System Menu Alarm Setup Select ALARM SETUP from the MONITOR SETUP menu (see FIGURE 2-5). The ALARM SETUP menu allows the user to adjust various alarm functions. Refer to section 2.5, “Alarms” for details on Alarm functions. 2.3.5.2 Time Setup From the MONITOR SETUP menu, select the TIME SETUP menu to modify the time and date settings displayed on the monitor (see FIGURE 2-6). The TIME SETUP menu allows the user to set the YEAR, MONTH, DAY, HOUR, MINUTE and SECOND.
System Menu 2.3.5.3 Operations Printer Setup Select PRINTER SETUP from the MONITOR SETUP (see FIGURE 2-7). FIGURE 2-7 Printer Setup Menu Printer Setup Menu Selections WAVEFORM 1 or The PRINTER SETUP menu allows the user to designate which two WAVEFORM 2 (2) parameter waveforms are displayed on the printout as WAVEFORM 1 and WAVEFORM 2. Only waveforms that are displayed on screen are available for selection.
Operations System Menu TIME TIME represents the length of recording time. There are two (2) selections available: CONTINUAL and 8s. CONTINUAL means once the user presses the PRINT key on the front panel, the recorder will continuously print out the selected waveform(s) until the button is pressed again. 8s indicates a waveform recording time length of 8 seconds. INTERVAL INTERVAL represents the time interval between the start of recorder activations.
System Menu 2.3.5.4 Operations Analog Setup The monitor can output an analog waveform from the analog output connector (AO1) on the rear panel. Select ANALOG SETUP from the MONITOR SETUP menu (see FIGURE 2-8). Select ANALOG OUT, to set analog out to ON or OFF. Select ANALOG WAVE to select the parameter waveform output. Choices are ECG and IBP (optional). Select PREVIOUS MENU to return to the previous menu.
Operations 2.3.5.6 System Menu Trace Setup TRACE SETUP allows the user to choose the traces that will be displayed in the waveform area and to choose the viewing mode. The viewing modes improve the viewability of the display depending on how the Trio is positioned for use. There are two viewing modes that can be selected from the WAVE DISPLAY pull-down menu. • MODE 1 – provides an enhanced view angle and a less smooth wave. This mode should be used when the Trio is being viewed from an angle.
System Menu 2.3.5.7 Operations Parameter Colors 1. Select PARAMETER COLORS from the MONITOR SETUP menu. The PARAMETER COLORS menu (FIGURE 2-11) is displayed. From this menu, the colors for displayed parameters can be selected. The numeric and waveform data for each parameter displays in the same color, as selected by the user. The color choices are: GREEN, RED, YELLOW, BLUE, and WHITE. FIGURE 2-11 Parameter Colors Menu 2. Select PREVIOUS MENU to return to the previous menu.
Operations 2.3.5.9 System Menu Save Current SAVE CURRENT allows the user to save the current customized settings as the default settings (or the “User Default Configuration”), replacing the existing user-defined configuration for the current patient size. 1. Select SAVE CURRENT from the MONITOR SETUP menu. The confirmation dialog box in FIGURE 2-13 is displayed. 2. Select YES to replace the existing user-defined configuration with the current customized settings. Select NO to cancel the task.
Parameter Menus Operations 2.4 Parameter Menus 2.4.1 Electrocardiogram (ECG) Monitoring ECG is a continuous waveform of a patient's cardiac electrical activity. The ECG waveform will display in the first waveform area of the Trio. The quality of an ECG signal is directly affected by electrode site skin preparation, electrode patch quality and ECG lead placement.
Operations Parameter Menus NOTE: 2.4.1.2 Prepare the electrode site with alcohol only if the skin is extremely greasy. If alcohol is used as a drying agent, always allow the skin to dry before placing the electrode patch on the skin. Electrode Patch Location NOTE: Store electrode patches at room temperature and open just prior to use. NOTE: Avoid more than one type of electrode on a patient because of variations in electrical resistance.
Parameter Menus 2.4.1.3 Operations Lead Placement The computerized arrhythmia algorithm works best when the patient’s R wave is significantly larger than the P wave or the T wave. If the R wave is not significantly larger than other lower voltage waves on the ECG tracing, the computer may have some difficulty in identifying the appropriate waves. On some patients, electrode patch placement and/or the viewed ECG lead may need to be adjusted in order to obtain a significant R wave.
Operations Parameter Menus Standard 5-wire Lead Sets Standard 5-wire lead sets monitor 7 ECG leads: I, II, III, aVR, aVL, aVF and V. White Black RA LA Red Yellow R Brown V Lead (any V position) L White C Lead (any C position) C V Green Black Red RL LL Green N F FIGURE 2-16 5-wire Lead Placement (AHA) FIGURE 2-17 5-wire Lead Placement (IEC) • Place the RA (white) electrode under the patient’s right clavicle, at the midclavicular line within the rib cage frame.
Parameter Menus Operations V-Lead and C-Lead Electrode Positions 2 - 18 FIGURE 2-18 V-Lead Electrode Placement (AHA) FIGURE 2-19 C-Lead Electrode Placement (IEC) • V1 - Place the electrode at the fourth intercostal space, on the right sternal border • C1 - Place the electrode at the fourth intercostal space, on the right sternal border • V2 - Place the electrode at the fourth intercostal space, on the left sternal border • C2 - Place the electrode at the fourth intercostal space, on the left sterna
Operations Parameter Menus Lead II Monitoring Red White Yellow Black R L Red Green F FIGURE 2-20 Lead II Monitoring (AHA) FIGURE 2-21 Lead II Monitoring (IEC) • Place the RA (white) electrode under the patient’s right clavicle, at the midclavicular line within the rib cage frame. • Place the R (red) electrode under the patient’s right clavicle, at the midclavicular line within the rib cage frame.
Parameter Menus Operations Modified Chest Lead (MCL) Monitoring W hite Red RA R Red Black LA Yellow F LL FIGURE 2-22 MCL Monitoring with a 3-wire Lead Set (AHA) • Place the RA (white) electrode under the patient’s left clavicle, at the midclavicular line within the rib cage frame. • Place the LA (black) electrode on the right sternal border, at the fourth intercostal space within the rib cage frame. • Place the LL (red) electrode on the patient’s lower left abdomen within the rib cage frame.
Operations Parameter Menus Monitoring a Pacemaker Patient Pacer White White Pacer Black V Brown Black Red Green FIGURE 2-24 3-wire Lead Placement for a Pacemaker Patient (AHA) Red FIGURE 2-25 5-wire Lead Placement for a Pacemaker Patient (AHA) A Pacemaker patient usually requires a different electrode patch placement configuration than a non-pacemaker patient. Do not place an ECG electrode directly over the pacemaker generator.
Parameter Menus 2.4.1.4 Operations ECG Monitoring NOTE: If an electro-surgical device is to be used on the patient, use the ESIS cable. Respiration from ECG is not available if the ESIS cable is used. • Plug the patient cable firmly into the ECG connector on the Trio. An ECG waveform will begin to display in the ECG waveform tile and the heart rate will be displayed in the ECG parameter tile to the right (see FIGURE 2-26).
Operations 2.4.1.5 Parameter Menus ECG Lead, Size and Filter Settings 1 2 3 FIGURE 2-26 ECG settings on the Main Display Use the Navigator™ Knob to select the following ECG settings (located in the upper left corner of the ECG waveform tile): ECG Lead, ECG Size, and ECG Filter. 1.
Parameter Menus Operations • EXTENDED Mode EXTENDED mode should be used for diagnostic purposes. It has the widest frequency range and least noise suppression of the 3 modes. Its extended frequency range of 0.05 Hz to 100 Hz can provide a more accurate view of the waveform, but as a result can also be more susceptible to low frequency noise generated by patient motion, muscle artifact, etc.
Operations Parameter Menus ECG Setup Menu Selections ALM NOTE: In the French configuration, the HR (Heart Rate) alarm is always ON. It cannot be disabled by turning it OFF. Allows the user to turn the HR (Heart Rate) alarm ON or OFF. Choose ON to enable the alarm; choose OFF to disable the alarm. If the alarm is set to OFF, the alarm OFF symbol will display to the right of ECG on the screen. The HR alarm is activated when the heart rate is equal to or exceeds set high or low HR values.
Parameter Menus Operations AUTO: When AUTO is selected as the heart rate source, the label and associated numeric value in the ECG parameter tile will be displayed based on the following hierarchy: 1. ECG will be the heart rate source as previously described if ECG is currently being monitored. 2. SpO2 will be the heart rate source as previously described if SpO2 is currently being monitored and ECG is not currently being monitored. 3.
Operations Parameter Menus Heart Rate Alarm Limits* PATIENT SIZE HIGH ALARM (bpm) LOW ALARM (bpm) Adult (ADU) 60 – 250 [150] 30 – 120 [45] Pediatric (PED) 100 – 300 [175] 30 – 150 [70] * Factory default values shown in brackets. Alarms occurring during the process of ECG measurement include two (2) types: physiological alarms and technical alarms. Physiological alarms occur when the patient’s heart rate value is equal to or exceeds set alarm limits.
Parameter Menus Operations MESSAGE/ PROBLEM Excessive alarms: Heart rate, lead fault Low Amplitude ECG Signal No ECG waveform Base Line Wander 2 - 28 REASON SOLUTION Electrodes dry Repeat skin preparation and apply fresh, moist electrodes. Alarm limits set too close to patient's normal heart rate Readjust alarm limits. R-wave wrong size Readjust the waveform size or move ECG electrodes to optimize R-wave.
Operations 2.4.2 Parameter Menus Respiration Monitoring The Trio utilizes thoracic impedance to measure respiration. This is accomplished by passing a small electrical signal across the RA and LL (R and F) ECG limb leads. This signal changes as the patient's chest wall rises and falls during the breath cycle. The change of impedance between the two (2) electrodes, (due to the thoracic movement), produces a respiratory waveform on the screen. 2.4.2.
Parameter Menus Operations ALM PRIORITY Allows the user to select the priority of the RESP alarm. Choices are 1, 2 and 3. Priority 1 alarms are considered the most serious. ALM PRINT Enables or disables automatic printing during a RESP alarm condition. Choose ON to enable printing upon RESP alarm. Choose OFF to disable printing upon RESP alarm. ALM HI Allows the user to set the upper limit of the RESP alarm. (See “Respiration Rate Alarm Limits” on page 2-30.
Operations 2.4.2.
Parameter Menus 2.4.3 Operations SpO2 Monitoring Each of the following terms are associated with blood oxygenation: oxygen saturation, pulse oximetry, SpO2 and plethysmography. Oxygen saturation in capillary blood is measured by a method called pulse oximetry. Pulse oximetry is a continuous and non-invasive measurement of oxyhemoglobin saturation (the amount of oxygen attached to the hemoglobin in red blood cells). SpO2 is the estimation of arterial oxygen saturation.
Operations Parameter Menus Performance Considerations To ensure optimal SpO2 measurement, use an appropriate sensor, apply it as directed, and observe all warnings and cautions. Sensors are designed for specific sites on patients with designated weight ranges. To select the appropriate sensor, consider the patient’s weight, level of activity, adequacy of perfusion, available sensor sites and the sterility requirement. If excessive ambient light is present, cover the sensor site with opaque material.
Parameter Menus 2 - 34 Operations CAUTION: Do not place the SpO2 sensor on an extremity with an invasive catheter or blood pressure cuff in place. CAUTION: Tissue damage or inaccurate measurement may be caused by incorrect sensor application or use, such as wrapping too tightly, applying supplemental tape, failing to inspect the sensor site periodically or failing to position appropriately. Carefully read the sensor directions and all precautionary information before use.
Operations 2.4.3.1 Parameter Menus Masimo SET® SpO2 The Masimo pulse oximeter determines SpO2 in the traditional manner of passing red and infrared light into a capillary bed and measuring changes in light absorption during the pulsatile cycle. It assumes that arterio-venous shunting is highly variable and that fluctuating absorbance by venous blood is the major component of noise during the pulse. The Masimo pulse oximeter calculates the ratio of the arterial signals without the noise.
Parameter Menus 2.4.3.1.1 Operations Masimo SET® SpO2 Setup Menu FIGURE 2-32 Masimo SET SpO2 Setup Menu Accessing the Masimo SET SpO2 Setup Menu To access the MASIMO SPO2 SETUP menu, select SpO2 from the SpO2 parameter tile using the Navigator™ Knob. Once in the MASIMO SPO2 SETUP menu, use the Navigator Knob to adjust settings. To close the menu, select NORMAL SCREEN (from the menu or the Front Panel Keypad).
Operations Parameter Menus BEEP VOL Beep volume is the volume of the audible pulse rate tone when SpO2 is selected as the HR Source. The selections are OFF, LOW, MED and HIGH. AVG TIME Averaging time is the length of time during which the SpO2 value is calculated. The selections are 2-4, 4-6, 8, 10, 12, 14, and 16 seconds. When 2-4 or 4-6 are selected, the FastSAT mode is enabled. In this mode, shorter averaging times are achieved under low noise conditions.
Parameter Menus Operations Masimo SET SpO2 Alarm Limits* PATIENT SIZE SpO2 HIGH ALARM (%) SpO2 LOW ALARM (%) PR HIGH ALARM (bpm) PR LOW ALARM (bpm) Adult (ADU) 80 – 100 [OFF] 50 – 99 [85] 60 – 240 [150] 25 – 120 [45] Pediatric (PED) 80 – 100 [OFF] 50 – 99 [85] 100 – 240 [175] 25 – 150 [70] * Factory default values shown in brackets. NOTE: If the SpO2 alarm high is set to OFF, the alarm OFF symbol will display in the SpO2 parameter tile.
Operations 2.4.3.2 Parameter Menus Nellcor® SpO2 Nellcor provides a family of sensors suitable for a wide variety of clinical settings and patients. Specific sensors have been developed for a variety of patient sizes. Nellcor’s SatSeconds™ Alarm Management feature in their OxiMax® SpO2 sensor offers an effective means of managing nuisance alarms without sacrificing patient safety.
Parameter Menus Operations CAUTION: 2.4.3.2.1 Prolonged and continuous monitoring may increase the risk of skin erosion and pressure necrosis at the site of the sensor.
Operations Parameter Menus PR ALM HI Allows the user to set the upper limit of the Pulse Rate alarm. (See “Nellcor SpO2 Alarm Limits” on page 2-42.) PR ALM LO Allows the user to set the lower limit of the Pulse Rate alarm. (See “Nellcor SpO2 Alarm Limits” on page 2-42.) SWEEP Adjusts the speed of the SpO2 waveform on the display. The selections are 12.5 and 25.0 mm/sec. BEEP VOL Beep volume is the volume of the audible pulse rate tone when SpO2 is selected as the HR Source.
Parameter Menus Operations Nellcor SpO2 Alarm Limits* PATIENT SIZE SpO2 HIGH ALARM (%) SpO2 LOW ALARM (%) PR HIGH ALARM (bpm) PR LOW ALARM (bpm) Adult (ADU) 80 – 100 [OFF] 50 – 99 [85] 60 – 250 [150] 20 – 120 [45] Pediatric (PED) 80 – 100 [OFF] 50 – 99 [85] 100 – 250 [175] 20 – 150 [70] * Factory default values shown in brackets. NOTE: If the SpO2 alarm high is set to OFF, the alarm OFF symbol will display in the SpO2 parameter tile.
Operations Parameter Menus MESSAGE REASON ACTION SPO2 EXCEED SpO2 value exceeds the measurement range. Check patient, notify physician PR EXCEED PR value exceeds the measurement range.
Parameter Menus 2.4.4 Operations NIBP Monitoring The Trio utilizes the oscillometric method of measuring Non-Invasive Blood Pressure (NIBP). The measurement includes Systolic (SYS), Diastolic (DIA) and Mean Arterial Pressures (MAP). Two (2) frequency modes of obtaining measurements are available: MANUAL and INTERVAL. Each mode will display the Systolic (SYS), Diastolic (DIA) and Mean Arterial Pressure (MAP) values in the NIBP tile.
Operations Parameter Menus The initial default cuff inflation pressure is dependent on the patient size setting as follows: PATIENT SIZE SETTING DEFAULT CUFF INFLATION PRESSURE Adult 178 ± 5 mmHg Pediatric 133 ± 5 mmHg After the first successful measurement, the subsequent inflation pressure for the same patient will be 50 ±10 mmHg above the previous systolic pressure measurement. Upon power ON of the Trio, the NIBP unit of measure defaults to the most recent setting made in the NIBP SETUP menu. 2.
Parameter Menus 2.4.4.2 Operations Measurement 1. Ensure that the appropriate PATIENT SIZE (Adult or Pediatric) has been selected from the PATIENT SETUP menu accessible from the SYSTEM MENU. 2. Depending on the desired measurement frequency mode, proceed as follows: Manual Mode Press the NIBP key, located on the front panel keypad, to begin the NIBP measurement. Interval Mode a. Open the NIBP SETUP menu by selecting NIBP from the main display using the Navigator™ Knob.
Operations 2.4.4.3 Parameter Menus NIBP Display Tile If ECG and NIBP are selected in the MODULE SETUP menu, NIBP will be displayed in the second parameter tile, beneath the ECG parameter tile. If ECG is not selected in the MODULE SETUP menu, NIBP will be displayed in the first parameter tile. The following data is displayed: Systolic Value Unit of Measure NIBP Diastolic Value Alarm OFF Symbol mmHg 108 (84) 70 Interval:OFF Cont measuring...
Parameter Menus 2.4.4.4 Operations NIBP Setup Menu FIGURE 2-38 NIBP Setup Menu Accessing the NIBP Setup Menu To access the NIBP SETUP menu, select NIBP from the NIBP parameter tile using the Navigator™ Knob. Once in the NIBP SETUP menu, use the Navigator Knob to adjust settings. To close the menu, select NORMAL SCREEN (from the menu or the Front Panel Keypad). NIBP Setup Menu Selections ALM Allows the user to turn the NIBP alarm ON or OFF.
Operations Parameter Menus MEAN ALM HI Allows the user to set the upper limit of the Mean NIBP alarm. (See “NIBP Alarm Limits” on page 2-50.) MEAN ALM LO Allows the user to set the lower limit of the Mean NIBP alarm. (See “NIBP Alarm Limits” on page 2-50.) DIA ALM HI Allows the user to set the upper limit of the Diastolic NIBP alarm. (See “NIBP Alarm Limits” on page 2-50.) DIA ALM LO Allows the user to set the lower limit of the Diastolic NIBP alarm. (See “NIBP Alarm Limits” on page 2-50.
Parameter Menus Operations NIBP Alarm Limits* SYS HIGH (mmHg) SYS LOW (mmHg) MEAN HIGH (mmHg) MEAN LOW (mmHg) DIA HIGH (mmHg) DIA LOW (mmHg) Adult (ADU) 70 – 240 [180] 50 – 150 [80] 60 – 200 [100] 40 – 140 [40] 40 – 130 [100] 30 – 120 [50] Pediatric (PED) 40 – 180 [150] 15 – 130 [70] 50 – 180 [80] 10 – 100 [30] 50 – 100 [80] 10 – 50 [40] PATIENT SIZE * Factory default values shown in brackets.
Operations Parameter Menus Other Factors An accurate determination of blood pressure can be difficult to obtain if a patient's cardiac rhythm is irregular. Irregular cardiac rhythm changes the stroke volume from beat to beat. This changing stroke volume may increase the time it takes to complete a measurement cycle. Newborn NIBP Technique Newborn patients present unique obstacles to NIBP measurement. Their vital signs can change frequently and their physiological signals are prone to noise interference.
Parameter Menus 2.4.4.
Operations 2.4.5 Parameter Menus Temperature Monitoring The temperature (TEMP) measurement function of the Trio is designed to take continuous temperature readings from the YSI 400 series probes. One (1) temperature channel is standard on the Trio. 1. If using a disposable temperature probe: Connect the preferred disposable temperature probe into the reusable temperature cable. Plug the cable into the monitor. 2. If using a reusable temperature probe: Plug the reusable probe directly into the monitor 3.
Parameter Menus Operations Temperature Setup Menu Selections ALM Allows the user to turn the TEMP alarm ON or OFF. Choose ON to enable the alarm; choose OFF to disable the alarm. If the alarm is set to OFF, the alarm OFF symbol will display to the right of TEMP on the screen. The TEMP alarm is activated when the temperature value exceeds set high or low TEMP values. ALM PRIORITY Enables priority selection for the TEMP alarm. Choices are 1, 2 and 3. Priority 1 alarms are considered the most serious.
Operations 2.4.5.
Parameter Menus 2.4.6 Operations IBP Monitoring (Optional) Invasive Blood Pressure (IBP) is a direct measurement of the patient's arterial or venous blood pressure. IBP utilizes a catheter that is inserted directly into a vein or artery and is connected to a transducer for interpretation of Systolic (Sys), Diastolic (Dia) and/or Mean Arterial Pressures (MAP). The user may label the IBP channel according to the insertion site of the catheter or according to the vessel being monitored.
Operations 2.4.6.1 Parameter Menus IBP Select Menu The IBP Select menu allows the user to access two sub-menus: IBP ZERO or IBP SETUP (see FIGURE 2-42). FIGURE 2-42 IBP Select Menu Accessing the IBP Select Menu To access the IBP SELECT menu, select IBP from the IBP parameter tile using the Navigator™ Knob. Once in the IBP SELECT menu, use the Navigator Knob to open the IBP ZERO menu (to zero the invasive pressure) or IBP SETUP menu.
Parameter Menus Operations FIGURE 2-43 IBP Zero Menu 4. Label the Invasive Pressure line • Use the Navigator™ Knob to select the IBP label located in the upper left corner of the IBP waveform tile • Turn the Navigator Knob to scroll through the various labels. Choices are: ART, PA, CVP, RAP, LAP, and ICP • Press the Navigator Knob to select the desired label 2.4.6.
Operations Parameter Menus IBP Setup Menu Selections ALM Allows the user to turn the IBP alarm ON or OFF. Choose ON to enable the alarm; choose OFF to disable the alarm. If the alarm is set to OFF, the alarm OFF symbol will display to the right of IBP on the screen. The IBP alarm is activated when the blood pressure value exceeds set high or low IBP values. ALM PRIORITY Enables priority selection for the IBP alarm. Choices are 1, 2 and 3. Priority 1 alarms are considered the most serious.
Parameter Menus Operations SCALE ADJUST Opens the IBP SCALE ADJUST menu and is used to change the scale at which the invasive pressure is displayed. Scale should be adjusted to make the waveform as large as possible on the display without clipping or cutting off any part. To adjust the scale, use the Navigator™ Knob to scroll to the desired area of the scale and select the desired limit. Three (3) scale choices are available: HI, LO and MID.
Operations Parameter Menus IBP Alarm Limits* SYS HIGH (mmHg) SYS LOW (mmHg) MEAN HIGH (mmHg) MEAN LOW (mmHg) DIA HIGH (mmHg) DIA LOW (mmHg) Adult 5 – 300 [180] 0 – 150 [80] 5 – 150 [100] - 5 – 100 [40] 5 – 140 [100] 0 – 120 [50] Ped 5 – 240 [150] 0 – 130 [70] 5 – 100 [80] - 5 – 50 [30] 5 – 100 [80] 0 – 95 [40] Adult 5 – 300 [180] 0 – 150 [80] 5 – 150 [100] - 5 – 100 [40] 5 – 140 [100] 0 – 120 [50] Ped 5 – 240 [150] 0 – 130 [70] 5 – 100 [80] - 5 – 50 [30] 5 – 100 [80] 0 – 9
Parameter Menus 2.4.6.3 Operations IBP Troubleshooting MESSAGE/ PROBLEM REASON SOLUTION SENSOR OFF, FAIL Transducer may be disconnected during attempt to zero Check transducer and cables for connection. If problem persists, notify hospital technician or Customer Support IN DEMO FAIL Monitor is in DEMO mode during attempt to zero Turn monitor OFF.
Operations 2.5 Alarms Alarms The Trio provides audio and visual alarms to indicate: • The functional status of the monitor • That the measured parameter values are equal to or exceed the alarm limits These alarms are divided into three categories: Physiological, Technical and General. Alarms in each category are classified in one of three levels based on their degree of severity. These levels are Priority 1, 2 or 3.
Alarms Operations General Alarms General alarms are alerts that cannot be classified as physiological or technical, but that require attention. General alarms are not related to patient medical condition. 2.5.2 Alarm Priorities Alarms in each category (Physiological, Technical or General) are classified based on their degree of severity. The priority determines the frequency of audio and visual alerts. There are two (2) visual alerts: the alarm light and the alarm-related message on the display.
Operations Alarms COMMON ALARM SETUP Menu Selections FIGURE 2-47 Common Alarm Setup Menu ALM SEL Choose COMMON ALARM SETUP. (Alarm Selection) ALARM VOL Volume of the audio alert. Selections are: LOW, MED, and HIGH. ALM PRINT TIME Length of the printed waveform. Selections are: 8s, 16s, or 32s. ALM MUTE TIME Length of time for the alarm to be silenced. Selections are:1min, 2min, 5min, 10min, and PERMANENT.
Alarms Operations HR ALARM SETUP Menu Selections FIGURE 2-48 HR Alarm Setup Menu ALM SEL Choose HR ALARM SETUP. (Alarm Selection) ALM NOTE: In the French configuration, the HR (Heart Rate) alarm is always ON. It cannot be disabled by turning it OFF. Allows the user to turn the HR (Heart Rate) alarm ON or OFF. Choose ON to enable the alarm; choose OFF to disable the alarm. If the alarm is set to OFF, the alarm OFF symbol will display to the right of ECG on the screen.
Operations Alarms SPO2 ALARM SETUP Menu Selections FIGURE 2-49 SPO2 Alarm Setup Menu (Masimo® only) FIGURE 2-50 SPO2 Alarm Setup Menu (Nellcor® only) NOTE: See the appropriate subsection of the “SpO2 Monitoring” section for the alarm limits ALM SEL Choose SPO2 ALARM SETUP. (Alarm Selection) ALM PRIORITY Allows the user to select the priority of the alarm. Choices are 1, 2 and 3. Priority 1 alarms are considered the most serious.
Alarms Operations ALM PRINT Allows the user to enable or disable automatic printing during a physiological alarm condition. Choose ON to enable printing upon alarm. Choose OFF to disable printing upon alarm. See “Recorder (Optional)” on page 2-82 for details. SPO2 ALM HI Allows the user to set the upper limit of the SPO2 alarm. Choices are 80 – 100% and OFF. Choose OFF to disable the alarm. If the alarm is set to OFF, the alarm OFF symbol will display within the parameter tile.
Operations Alarms NIBP ALARM SETUP Menu Selections FIGURE 2-51 NIBP Alarm Setup Menu ALM SEL Choose NIBP ALARM SETUP. (Alarm Selection) ALM Allows the user to turn the alarm ON or OFF. Choose ON to enable the alarm; choose OFF to disable the alarm. If the alarm is set to OFF, the alarm OFF symbol will display within the parameter tile. The alarm is activated when the measurement exceeds the high or low limits. ALM PRIORITY Allows the user to select the priority of the alarm.
Alarms Operations MEAN ALM LO Allows the user to set the lower limit of the Mean NIBP alarm. (See “NIBP Alarm Limits” on page 2-50.) DIA ALM HI Allows the user to set the upper limit of the Diastolic NIBP alarm. (See “NIBP Alarm Limits” on page 2-50.) DIA ALM LO Allows the user to set the lower limit of the Diastolic NIBP alarm. (See “NIBP Alarm Limits” on page 2-50.
Operations Alarms IBP ALARM SETUP Menu Selections FIGURE 2-52 IBP Alarm Setup Menu ALM SEL Choose IBP ALARM SETUP. (Alarm Selection) ALM Allows the user to turn the alarm ON or OFF. Choose ON to enable the alarm; choose OFF to disable the alarm. If the alarm is set to OFF, the alarm OFF symbol will display within the parameter tile. The alarm is activated when the measurement exceeds the high or low limits. ALM PRIORITY Allows the user to select the priority of the alarm. Choices are 1, 2 and 3.
Alarms Operations MEAN ALM LO Allows the user to set the lower limit of the Mean IBP alarm. (See “IBP Alarm Limits” on page 2-61.) DIA ALM HI Allows the user to set the upper limit of the Diastolic IBP alarm. (See “IBP Alarm Limits” on page 2-61.) DIA ALM LO Allows the user to set the lower limit of the Diastolic IBP alarm. (See “IBP Alarm Limits” on page 2-61.
Operations Alarms RESP ALARM SETUP Menu Selections FIGURE 2-53 RESP Alarm Setup Menu ALM SEL Choose RESP ALARM SETUP. (Alarm Selection) ALM Allows the user to turn the alarm ON or OFF. Choose ON to enable the alarm; choose OFF to disable the alarm. If the alarm is set to OFF, the alarm OFF symbol will display within the parameter tile. The alarm is activated when the measurement exceeds the high or low limits. ALM PRIORITY Allows the user to select the priority of the alarm.
Alarms Operations TEMP ALARM SETUP Menu Selections FIGURE 2-54 TEMP Alarm Setup Menu ALM SEL Choose TEMP ALARM SETUP. (Alarm Selection) ALM Allows the user to turn the alarm ON or OFF. Choose ON to enable the alarm; choose OFF to disable the alarm. If the alarm is set to OFF, the alarm OFF symbol will display within the parameter tile. The alarm is activated when the measurement exceeds the high or low limits. ALM PRIORITY Allows the user to select the priority of the alarm.
Operations Alarms Alarm Mute The ALARM MUTE function is used to silence parameter alarms that have been triggered. Press the ALARM MUTE key on the Front Panel Keypad to activate the ALARM MUTE function. When ALARM MUTE is active, press the key a second time to deactivate the function. The amount of time the alarm is silenced is programmable through the ALARM SETUP menu. Any new alarms that occur during the silenced period will disable the ALARM MUTE function in order for the new alarm to sound.
Trends Operations 2.6 Trends 2.6.1 Graphic Trend The Graphic Trend display allows the user to view a graphic summary of stored vital sign data. The most recent 1-hour of graphic trend data can be displayed in intervals of 1 or 5 seconds. The most recent 24-hours of graphic trend data can be displayed in intervals of 1, 2, 3 or 4 minutes. Select GRAPHIC TREND from the SYSTEM MENU to access this menu/display (see FIGURE 2-55).
Operations Trends Graphic Trend Menu Selections 1. PARAMETER • To change the parameter of data being displayed, select PARAMETER from the GRAPHIC TREND menu. Using the Navigator™ Knob, scroll to the desired parameter and press the knob. • The selections are: HR, NIBP, SpO2, PR, IBP, RR, and TEMP. 2. INTERVAL • To change the displayed INTERVAL, select INTERVAL from the GRAPHIC TREND menu.
Trends Operations Mark Event If, during the trended period of time, an event was marked, the corresponding event type (A, B, C or D) will display along the x-axis of the graphic trend. The event (A, B, C or D) will appear in a box, at the corresponding point in time that the event was marked. Remove Graphic Trend Display The GRAPHIC TREND menu/display does not automatically time-out. The user must manually exit this menu.
Operations 2.6.2 Trends List Trend The List Trend display allows the user to view a tabular list of stored vital sign data. Select LIST TREND from the SYSTEM MENU to access this menu/display (see FIGURE 2-56). A maximum of 24 hours of data may be stored. When List Trend reaches the maximum number of data entries, the oldest entry will be deleted from the trend record in order to allow storage of a new entry.
Trends Operations List Trend Menu Selections 1. INTERVAL • To change the INTERVAL, select INTERVAL from the LIST TREND menu. (The chosen interval can be saved as part of the “User Default Configuration” by using the SAVE CURRENT function as described in section 2.3.5.9.) • Select from intervals of in 1min, 2min, 3min, 4min, 5min, 10min, 15min, 30min, or 1HR. 2.
Operations Trends Delete List Trend Data To permanently delete all list trend data, the user must discharge the currently monitored patient from the monitor. To discharge a patient, open the SYSTEM MENU. Once in the SYSTEM MENU, select PATIENT DISCHARGE from the PATIENT SETUP menu. When given the prompt, Discharge patient from monitor?, select YES to confirm. Example: View NIBP List Trend Data 1. Select the MENU icon in the lower right corner of the display to access the SYSTEM MENU. 2.
Recorder (Optional) 2.7 Operations Recorder (Optional) The optional Trio Recorder provides a printed record of all patient monitored parameters, including numeric and waveform data. It is a two-trace thermal strip chart recorder. The Trio recorder uses plain white thermal paper, 50mm wide (part number 0683-00-0505-02.) See section 4.7 for Paper Replacement Instructions. 2.7.
Operations Recorder (Optional) Printer Setup Menu Selections WAVEFORM 1: Allows the user to designate the first of two (2) waveforms to print. If the user selects OFF, no waveform will print as WAVEFORM 1. Selections are: Any waveforms currently displayed and OFF. WAVEFORM 2: Allows the user to designate the second of two (2) waveforms to print. If the user selects OFF, no waveform will print as WAVEFORM 2. Selections are: Any waveforms currently displayed and OFF.
Recorder (Optional) Operations Interval Real-Time Printout The Trio can be set to print automatically at regular intervals, as designated by the user. To activate the interval print feature: 1. Select INTERVAL from the PRINTER SETUP menu. 2. Use the Navigator™ Knob to choose the interval at which an automatic printout will occur. The following time intervals are available: 10min, 20min, 30min, 40min, 50min, 1HR, 2HRS, 3HRS, and 4HRS. 3. Select OFF to disable the automatic print function.
Operations Recorder (Optional) When parameter alarms occur, a maximum of two (2) waveforms can print simultaneously. If more than two (2) parameter alarms are activated simultaneously, the recorder will print out those of the highest priority level. If the alarm events are of the same priority level, the most recent alarm event will be printed.
Recorder (Optional) Operations Clear Print Tasks To cancel all printouts in the print queue, select CLEAR PRINT TASK from the PRINTER SETUP menu. 2.7.2 Recorder Troubleshooting MESSAGE/ PROBLEM 2 - 86 REASON SOLUTION PRINTER HEAD HOT The thermal terminal is too hot Discontinue print operation. Notify hospital technician or Customer Support. PRINT HEAD IN WRONG POS.
3.0 Defaults 3.1 Default Configurations Trio has four default configurations. • Factory Default Configuration • User Default Configuration • Current Configuration • Non-Volatile Configuration 3.1.1 Factory Default Configuration The Factory Default Configuration is initially set by the manufacturer. These settings cannot be changed by the user. If the user changes settings to be different from the Factory Default settings, the Factory Default Configuration can be restored as follows: 1.
Default Configurations Defaults 2. Choose RESTORE FACTORY DEFAULTS. The confirmation dialog box in FIGURE 3-2 is displayed. 3. Select YES to restore the Factory Default Configuration. Select NO to cancel the task. FIGURE 3-2 Confirmation Dialog Box CAUTION: To ensure continued use of the Factory Defaults when the unit is powered off and on, save the Factory Defaults as the User Default Configuration (see section 3.1.2).
Defaults Default Configurations CONFIGURATION ITEM FACTORY DEFAULTS ADULT (Patient size) FACTORY DEFAULTS PEDIATRIC FACTORY DEFAULTS COMMON (Patient size) Print Grid ON ANALOG SETUP Analog Output Enable OFF Analog Wave ECG PARAMETER COLORS ECG - green PLETH - blue RESP - yellow NIBP/TEMP - white MODULE SETUP in MONITOR SETUP Will be the same as MODULE SETUP submenu of the FACTORY menu.
Default Configurations CONFIGURATION ITEM Defaults FACTORY DEFAULTS ADULT (Patient size) FACTORY DEFAULTS PEDIATRIC FACTORY DEFAULTS COMMON (Patient size) SpO2 Sweep Speed 25 mm/s SpO2 Beep Volume Medium SPO2 SENSOR OFF AUDIO ON SpO2 Average Time (Masimo only) 8 second SpO2 Sensitivity Mode Normal Sat Seconds (Nellcor only) OFF SpO2 Alarm Limit Hi OFF (for all languages) SpO2 Alarm Limit Lo 85 Pulse Alarm Limit Hi 150 175 Pulse Alarm Limit Lo 45 70 NIBP SETUP NIBP Alarm OFF NI
Defaults Default Configurations CONFIGURATION ITEM FACTORY DEFAULTS ADULT (Patient size) FACTORY DEFAULTS PEDIATRIC FACTORY DEFAULTS COMMON (Patient size) IBP Scale RAP High 40 IBP Scale LAP High 40 IBP Scale ICP High 40 IBP Scale ART Low 0 IBP Scale PA Low 0 IBP Scale CVP Low 0 IBP Scale RAP Low 0 IBP Scale LAP Low 0 IBP Scale ICP Low 0 IBP Scale ART Value 75 IBP Scale PA Value 50 IBP Scale CVP Value 20 IBP Scale RAP Value 20 IBP Scale LAP Value 20 IBP Scale ICP Value 2
Default Configurations 3.1.2 Defaults User Default Configuration All items listed in the preceding table can be customized by the user and saved as a unique User Default Configuration as follows: 1. Select SAVE CURRENT from the MONITOR SETUP menu. The confirmation dialog box in FIGURE 3-3 is displayed. 2. Select YES to save the new user-defined configuration, replacing the existing userdefined configuration for the current patient size. Select NO to cancel the task.
Defaults 3.1.4 Default Configurations Non-Volatile Configuration The Non-Volatile Configuration consists of a group of user-customizable settings that are not controlled by the Factory or User Defaults. (See the following table.) These settings are maintained when the monitor is powered OFF for any duration of time. When a patient is discharged, the items marked with an asterisk (*) in the following table are automatically cleared and will remain blank until the user re-enters information for each.
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4.0 User Maintenance 4.1 Introduction This section of the manual outlines routine maintenance to be performed by the user and/or biomedical technician. The Trio Monitor is designed for stable operation over long periods of time and under normal circumstances should not require technical maintenance beyond circumstances described in this section.
Decontamination of the Monitor 4.2 User Maintenance Decontamination of the Monitor WARNING: Perform the decontamination process with the unit powered down and power cord removed. Decontamination of a unit that has come in contact with a biological material can be performed using LpH SE Germicidal detergent. Apply a small amount of detergent to a disposable wipe (paper based) and wipe down the outside of the unit. Discard the wipe appropriately.
User Maintenance Care and Cleaning of Accessories 4.4 Care and Cleaning of Accessories 4.4.1 SpO2 Sensors NOTE: Refer to the individual instruction sheets that are packaged with each sensor. • Check the sensors and cables for signs of damage on a daily basis. Replace as required. • The reusable sensors should be cleaned before and after each patient's use • Wipe the patient contact area using a soft cloth with a mild soap and water solution or isopropyl alcohol.
Care and Cleaning of Accessories User Maintenance 4.4.2 Blood Pressure Cuffs 4.4.2.1 Reusable Cuffs with Bladders Take out the bladder before cleaning and disinfecting the cuff. Cleaning The cuff can be hand washed or machine washed in warm water or with mild detergent. The bladder can be cleaned with a damp cloth. Air dry the cuff thoroughly after washing. NOTE: Machine washing may shorten the service life of the cuff.
User Maintenance Care and Cleaning of Accessories NIBP cuffs can be sterilized with gamma sterilization without effecting the repeated performance of the cuff. Steam sterilization is not recommended. Use of a washing liquid containing bleach is not recommended because chlorine will chemically break down the urethane on the inside of the cuff. Antimicrobial Coating Bladderless cuffs are treated with an antimicrobial coating.
Temperature Sensor Cleaning and Disinfection (Reusable) 4.5 User Maintenance Temperature Sensor Cleaning and Disinfection (Reusable) • The temperature probe should not be heated above 100 ºC (212 ºF).
User Maintenance 4.7 Recorder Maintenance Recorder Maintenance 2 1 FIGURE 4-2 Two-trace, integral recorder 1. Recorder door Open this door to access the recorder. 2. Recorder door latch Gently pull down on this latch to open the recorder door.
Recorder Maintenance 4.7.1 User Maintenance Recorder Paper Replacement The instructions below describe the replacement of recorder paper. Use only recommended recorder paper (Part Number 0683-00-0505-02.) This ensures that the print quality is acceptable and reduces printer head wear. 1. Open the recorder door, located on the left side panel, by pulling down on the recorder door latch, located on the upper right side of the recorder door.
User Maintenance 4.8 Care and Storage of Thermal Paper Care and Storage of Thermal Paper Thermal chart paper is chemically treated and the permanency of the printout can be affected by storage and handling conditions. Conditions which may affect the integrity of the paper and printouts are: • Ultraviolet Light We recommend storing the printouts in a filing cabinet within a few days of printing.
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5.0 Accessories 5.1 Optional Accessories 5.1.1 NIBP Accessories Hoses DESCRIPTION PART NUMBERS NIBP Hose, 5’ (1.5 m), Female Rectus/Female Rectus 0683-04-0003 NIBP Hose, 10’ (3.
Optional Accessories Accessories Color Coded Disposable Bladderless Cuffs - Quick-Connect DESCRIPTION PART NUMBERS Adult Thigh, Brown (Print) (box of 5) (45 – 56.5 cm circumference), latex-free 0683-07-0036-01 Large Adult, Burgundy (Print) (box of 10) (35.5 – 46 cm arm circumference), latex-free 0683-07-0035-01 Large Adult Long, Burgundy (Print) (box of 10) (35.5 – 46 cm arm circumference), latex-free 0683-07-0038-01 Adult, Navy Blue (Print) (box of 10) (27.5 – 36.
Accessories Optional Accessories 5.1.2 Oximetry Sensors and Accessories 5.1.2.1 Pulse Oximetry-Masimo SET® LNOP® SpO2 DESCRIPTION PART NUMBER LNOP® DCI Adult/Pediatric starter kit (one reusable adult sensor, 2 adult and 1 pediatric single patient adhesive sensors and one 12’ cable) 0020-00-0130 LNOP® DCI-Adult reusable finger sensor (with added “flaps” for ambient light shielding and 3’ cable) 0600-00-0047 LNOP® DCIP-Pediatric/slender digit reusable finger sensor 0600-00-0063 ® 5.1.2.
Optional Accessories Accessories DESCRIPTION PART NUMBER LNC-10 SpO2 Patient cable, 10' 0012-00-1599 LNC-14 SpO2 Patient cable, 14' 0012-00-1653 LNCS® to LNOP® PC series adapter 0012-00-1651 ® Masimo SET MAC-1 LNCS adapter cable 5.1.2.3 0012-00-1656 Nellcor® OxiMax® Cables and Accessories* DESCRIPTION PART NUMBER Durasensor DS100A Adult Reusable Sensor 0600-00-0051 DOC-10 OxiMax® SpO2 cable 0012-00-1464 * Sensors must be reordered through Nellcor. 5.1.
Accessories 5.1.5.2 Optional Accessories ECG Leadwires ECG Lead Wires - 3 Lead DESCRIPTION PART NUMBERS 3 Lead, Snap 18", AAMI (45.7 cm) 0012-00-1261-07 3 Lead, Snap 24", AAMI (61.0 cm) 0012-00-1261-08 3 Lead, Snap 40", AAMI (101.6 cm) 0012-00-1261-09 3 Lead, Pinch Clip 18", AAMI (45.7 cm) 0012-00-1262-07 3 Lead, Pinch Clip 24", AAMI (61.0 cm) 0012-00-1262-08 3 Lead, Pinch Clip 40", AAMI (101.6 cm) 0012-00-1262-09 ECG Lead Wires - 5 Lead 5.1.5.3 5.1.
Optional Accessories 5.1.8 5.1.
6.0 Appendix 6.1 Specifications 6.1.1 Safety Standards IEC 60601-1:1988 Medical Electrical Equipment - Part 2, (+ A1:1991, A2:1995)/ General Requirements for Safety EN 60601-1:1990 (+ A1:1993, A2:1995, A13:1995) UL 2601-1:1997 Medical Electrical Equipment General Requirements for Safety CSA Standard C22.2 No. 601.
Specifications Appendix EN 12470-4:2000 Clinical thermometers - Part 4: Performance of Electrical Thermometers for Continuous Measurement EN 1441:1997 Medical Devices - Risk Analysis EN ISO14971:2000 Medical Devices-Application of Risk Management Analysis to Medical Devices 6.1.2 Safety Designations Type of protection against electric shock -Class 1 with internal electric power source.
Appendix 6.1.
Specifications 6.1.
Appendix Patient Parameter Specifications 6.2 Patient Parameter Specifications 6.2.1 ECG 6.2.1.1 ECG Safety Requirements The 3/5 Lead ECG function is in accordance with the applicable requirements of EN 606012-27. 6.2.
Patient Parameter Specifications Appendix Electrical Surgical Unit (ESU) Use: Protection: 3 and 5 Lead ECG meets ANSI/AAMI EC13 requirements for functionality following ESU energy exposure. The system is capable of withstanding ESU stress with no permanent damage and regain normal function within 10 seconds after removal of the disturbance. Withstand: 3 and 5-Lead ECG will withstand ESU stress from a High Frequency Surgical Unit operating at 300 Watts in cut mode and 100 Watts on coagulate mode.
Appendix 6.2.3 Patient Parameter Specifications ANSI/AAMI EC13-2002 Compliance The ECG meets the section 4.2 Performance Requirements of ANSI/AAMI EC13-2002 except for paragraph 4.2.9.13, Synchronizing Pulse for Cardioversion, which is not applicable. 6.2.3.1 Disclosed Performance Specifications Tall T-Wave Rejection: When tested in accordance with ANSI/ AAMI EC13-2002 section 4.1.2.
Patient Parameter Specifications Appendix Step Change Response Time: When tested in accordance with ANSI/ AAMI EC13-2002 section 4.1.2.1f), the response time of the heart rate meter to changes in heart rate is: Less then 7 sec for step increase from 80 to 120 bpm Less then 8 sec for step decrease from 80 to 40 bpm Time to Alarm for Tachycardia: When tested in accordance with ANSI/ AAMI EC13-2002 section 4.1.2.
Appendix Patient Parameter Specifications Resolution: 1 bpm Accuracy: ± 1 bpm or ± 1% whichever is greater. Trigger Threshold Level: 200 μV (Lead II) Trigger Indication: There is an audible beep on every beat captured 6.2.5 ECG Respiration Performance Requirements Sensing Leads: Lead II Source: 3-lead or 5-lead ECG Cable.
Patient Parameter Specifications 6.2.6.1 Appendix Systolic Pressure Measurement Accuracy*: Mean error is less than ± 5 mmHg, Standard Deviation is less than ± 8 mmHg Range: 6.2.6.
Appendix 6.2.6.
Patient Parameter Specifications Appendix NIBP Measurement Cycle There are two different modes of measurement operation: manual and interval modes.The manual mode requires the operator to initiate the measurement cycle.The interval mode follows a configured plan of automatically initiated measurement cycles. The Maximum Measurement Cycle Duration is 180 seconds for Adult and Pediatric patients.
Appendix 6.2.9 Patient Parameter Specifications Temperature Parameter Performance Characteristics The Trio monitor is capable of providing temperature measurements from a single temperature channel as measured from a YSI 400 probe and meets the requirements of EN12470-4:2000. 6.2.9.1 Temperature Performance Requirements Scale: selectable Celsius or Fahrenheit Range: 0 °C to 50 °C 32 °F to 122 °F Resolution: 0.1 °C 0.1 °F Accuracy: ± 0.1 °C (0 °C to 50 °C), exclusive of probe errors ± 0.
Patient Parameter Specifications Appendix SpO2 Accuracy No motion conditions1,4: PATIENT SIZE SATURATION RANGE 70% to 100% 0 – 69% Adult Mode ± 2 digits unspecified Pediatric Mode ± 2 digits unspecified During motion conditions2,5: PATIENT SIZE SATURATION RANGE 70% to 100% 0 – 69% Adult Mode ± 3 digits unspecified Pediatric Mode ± 3 digits unspecified SpO2 Response Time 20 seconds maximum to 95% of final step change of % SpO2 value from 60 to 95% at 75 bpm.
Appendix Patient Parameter Specifications Masimo SET® Reference Footnotes 1 The Masimo SET MS-7 pulse oximeter with LNOP or LNCS sensors has been validated for no motion accuracy in human blood studies on healthy adult volunteers in induced hypoxia studies in the range of 70% to 100% SpO2 against a laboratory co-oximeter and ECG monitor. This variation equals plus or minus one standard deviation. Plus or minus one standard deviation encompasses 68% of the population.
Patient Parameter Specifications 6.2.10.3 Appendix Nellcor® SpO2 Performance Requirements Sensor Compatibility: OxiMax series MAX-A, MAX-AL, MAX-N, MAX-P, MAX-I, MAX-FAST, MAX-R, OxiCliq A, OxiCliq N, OxiCliq P, OxiCliq I, D-YS, DYSE, D-YSPD, DS-100A, OXI-A/N and OXIP/I.
Appendix Physical Specifications 6.3 Physical Specifications 6.3.1 Information Display and Control 6.3.1.1 Front Panel Display 6.3.1.2 DISPLAY TYPE SIZE MINIMUM RESOLUTION Color active matrix TFT liquid crystal 8.4-inch diagonal 800 x 600 pixels Rotary Knob (Navigator™) The rotary knob is a 16-position per revolution encoder with an integral push button switch 6.3.2 LED Indicators 6.3.2.
Physical Specifications 6.3.3 Appendix Real Time Clock The Display Resolution for the Real Time 1 second Clock is: The Accuracy of the Real Time Clock is: ±1 minute/month (30 days) @ 21 °C ±3 °C Clock display format: 12 hr or 24 hr (user selectable) The Real Time Clock has a dedicated independent power source that allows it to keep time whether or not the Trio monitor has power provided. 6.3.4 6.3.4.
Appendix 6.3.4.4 Physical Specifications VGA Output (model numbers 0998-00-0600-0XXXX and 0998-00-0600-2XXXX) Trio Monitors bearing model numbers 0998-00-0600-0XXXX or 0998-00-0600-2XXXX are equipped with a a 15-position D-Shell VGA output connector. The VGA output connector provides connectivity to a medical grade remote repeater display. Connection to this port shall be made with the monitor power OFF. The monitor shall be powered ON after powering ON the remote display.
Physical Specifications 6.3.7.1 Appendix Sealed Lead Acid Battery: P/N 0146-00-0043 The minimum Battery Run Time is: 75 minutes from one fully charged new battery at 25 °C for the following conditions, which represent the most likely transportable configuration: ECG, SpO2, and NIBP running at the 15 minute interval. The Battery Recharge Time is: 6.3.7.2 8 hours maximum Lithium Ion Battery: P/N 0146-00-0069 The minimum Battery Run Time is: 3.
Appendix Physical Specifications 6.3.9 Printers 6.3.9.1 Integrated Thermal Printer The integrated printer is a maximum 2- trace thermal array strip chart printer. The printer uses plain white thermal paper 50.0 ± 0.1 mm wide. The printer supports 2 paper speeds: 25 and 50 mm/sec. The printer scaling is ± 5% of the scale set on the display for a single trace, and 50% of scale set on the display for dual trace, ± 5%.
Physical Specifications 6.3.
Appendix Physical Specifications Drop: Meets the requirements specified by ECRI PB296 892 section AIII 3.3 for Class 3 devices. Impact Meets the requirements specified by ECRI PB296 892, section AIII 3.2 for Class 3 devices. Electromagnetic Compatibility The Trio meets the requirements of IEC 60601-1-2:2001/EN 60601-1-2:2001. NOTE: The Trio needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided below.
Physical Specifications Appendix TABLE 6-2 GUIDANCE AND DECLARATION - ELECTROMAGNETIC IMMUNITY The Trio is intended for use in the electromagnetic environment specified below. The customer or the user of the Trio should assure that it is used in such an environment. IMMUNITY TEST IEC 60601 TEST LEVEL COMPLIANCE LEVEL ELECTROMAGNETIC ENVIRONMENT - GUIDANCE Electrostatic discharge (ESD) IEC 61000-4-2 ±6 kV contact ±8 kV air ±6 kV contact ±8 kV air Floors should be wood, concrete or ceramic tile.
Appendix Physical Specifications TABLE 6-3 GUIDANCE AND DECLARATION - ELECTROMAGNETIC IMMUNITY The Trio is intended for use in the electromagnetic environment specified below. The customer or the user of the Trio should assure that it is used in such an environment.
Physical Specifications Appendix TABLE 6-4 RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND MOBILE RF COMMUNICATIONS EQUIPMENT AND THE TRIO The Trio is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
Appendix Physical Specifications Isolation: Risk (Leakage) Currents: Meets the requirements of IEC 60601-1/ EN 60601-1 Enclosure Risk Current: Normal operating conditions <= 100 μA Single fault condition <= 300 μA for 120 VAC Single fault condition <= 500 μA for 230 VAC Patient Source Current: Normal operating conditions <= 10 μA Single fault condition <= 50 μA Patient Sink Current: Normal operating conditions not applicable Single fault condition <= 50 μA Dielectric Withstand Per IEC 606
Warranty Statements 6.4 Appendix Warranty Statements Mindray DS USA, Inc. warrants that components within the monitor unit will be free from defects in workmanship and materials for the number of years shown on the invoice. Under this extended warranty, Mindray DS USA, Inc. will repair or replace any defective component at no charge for labor and/or materials. This extended warranty does not cover consumable items such as, but not limited to batteries, displays, external cables and sensors.
Appendix Phone Numbers and How To Get Assistance Damage to any product or parts through misuse, neglect, accident, or by affixing any nonstandard accessory attachments or by any customer modification voids this warranty. Mindray DS USA, Inc. makes no warranty whatever in regard to trade accessories, such being subject to the warranty of their respective manufacturers.
. 0070-10-0666-01 Revision E June 12, 2010
Mindray DS USA, Inc. • 800 MacArthur Boulevard • Mahwah, NJ 07430 • USA • Dom. Customer Service: 1.800.288.2121 • Intl. Customer Service: +1.201.995.8000 • Dom. Fax: 1.800.926.4275 • Intl. Fax: +1.201.995.8680 • www.mindray.com Mindray Medical Netherlands B.V.• P.O. Box 26 • 3870 CA Hoevelaken • The Netherlands • Tel: +31 33 25 44 911 • Fax: +31 33 25 37 621 Mindray (UK) Limited • 3 Percy Road • St.
