Operating Instructions
178 Pages
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Trio
™
Operating Instructions
innovation is the best medicine
Datascope® is a U.S. registered trademark of Datascope Corp. Trio™ is a U.S. trademark of Datascope Corp. Navigator™ is a U.S. trademark of Datascope Corp. Masimo SET® is a U.S. registered trademark of Masimo Corp.
Copyright © Datascope Corp., 2003. Printed in U.S.A. All rights reserved. Contents of this publication may not be reproduced in any form without permission of Datascope Corp.
Table of Contents
Foreword ... v Warnings, Precautions And Notes ... v Warnings ... vi Precautions ... vii Notes ... xi Indication For Use ... xi Unpacking ... xi Symbols... xii
General Product Description... 1 - 1 Front Panel... 1 - 3 Front Panel Keypad ... 1 - 4 Display... 1 - 6 Left Side Panel ... 1 - 10 Right Side Panel ... 1 - 11 Rear Panel ... 1 - 12
Operations ... 2 - 1 Getting Started ... 2 - 1 Setting-up Patients... 2 - 1 Setting the Clock (Date and Time) ... 2 - 2 Menus ... 2 - 2 System Menu... 2 - 3 Patient Setup ... 2 - 3 List Trend ... 2 - 5 Graphic Trend ... 2 - 5 Mark Event ... 2 - 6 Monitor Setup ... 2 - 6 Maintenance... 2 - 13 Normal Screen... 2 - 13 Parameter Menus ... 2 - 14 Electrocardiogram (ECG) Monitoring ... 2 - 14 Respiration Monitoring ... 2 - 30 SpO2 Monitoring ... 2 - 33 NIBP Monitoring... 2 - 50 Temperature Monitoring ... 2 - 59 IBP Monitoring (Optional) ... 2 - 64 Alarms... 2 - 71 Alarm Categories ... 2 - 71 Alarm Priorities... 2 - 72 Alarm Setup Menus ... 2 - 72 Alarm Troubleshooting ... 2 - 85 Trends ... 2 - 86 Graphic Trend ... 2 - 86 List Trend ... 2 - 89 Recorder (Optional) ... 2 - 92 Print Functions ... 2 - 92 Recorder Troubleshooting ... 2 - 96
Defaults ... 3 - 1 Default Configurations ... 3 - 1 Factory Default Configuration... 3 - 1 User Default Configuration... 3 - 6 Current Configuration ... 3 - 6 Non-Volatile Configuration ... 3 - 7
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Table of Contents
User Maintenance ... 4 - 1 Introduction ... 4 - 1 Care and Cleaning of the Monitor ... 4 - 2 Care and Cleaning of Accessories ... 4 - 2 SpO2 Sensors ... 4 - 2 Blood Pressure Cuffs ... 4 - 3 Temperature Sensor Cleaning and Disinfection (Reusable)... 4 - 4 Battery Replacement and Maintenance ... 4 - 4 Recorder Maintenance ... 4 - 5 Recorder Paper Replacement ... 4 - 6 Care and Storage of Thermal Paper ... 4 - 7 Care and Cleaning of ECG Cables and Leadwires ... 4 - 7
Accessories ... 5 - 1 Standard Kits... 5 - 1 SpO2 Kits ... 5 - 1 NIBP/ECG Kits... 5 - 2 Optional Accessories ... 5 - 3 NIBP Accessories... 5 - 3 SpO2 Accessories... 5 - 4 Basic Sensors and Accessories ... 5 - 5 Reusable Temperature Probes... 5 - 5 Disposable Temperature Probes... 5 - 5 ECG Accessories ... 5 - 6 IBP Accessories ... 5 - 8 Miscellaneous Accessories... 5 - 8 Mounting Kits and Accessories ... 5 - 8
Appendix ... 6 - 1 Specifications ... 6 - 1 Safety Standards ... 6 - 1 Safety Designations ... 6 - 2 Performance / Accuracy ... 6 - 2 Environmental / EMC ... 6 - 3 United States Food and Drug Administration Documents ... 6 - 4 Patient Parameter Specifications ... 6 - 5 ECG ... 6 - 5 ECG Performance Requirements ... 6 - 5 ANSI/AAMI EC13-2002 Compliance... 6 - 6 ECG Systole Detector and Heart Rate Meter ... 6 - 8 ECG Respiration Performance Requirements... 6 - 8 IBP Parameter Sub-System Performance Characteristics... 6 - 11 IBP Safety Requirements... 6 - 11 Temperature Parameter Performance Characteristics ... 6 - 12 SpO2 Performance Requirements ... 6 - 12 Physical Specifications... 6 - 16 Information Display and Control ... 6 - 16 LED Indicators ... 6 - 16 Real Time Clock ... 6 - 17 Input/Output Communications... 6 - 17 Power Supply... 6 - 18 AC Mains Power Source ... 6 - 18 Battery Power... 6 - 18 Data Storage ... 6 - 19
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Table of Contents
Printers ... 6 - 19 Physical Characteristics ... 6 - 19 Environmental and Safety Characteristics... 6 - 20 Warranty Statements ... 6 - 26 Phone Numbers and How To Get Assistance ... 6 - 28 Datascope’s Responsibility ... 6 - 30
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Trio™ Operating Instructions
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 Datascope 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 0070-00-0560-02). For additional information or assistance, please contact an authorized Datascope representative in your area. NOTE:
Some aspects of the Trio Operating Instructions may differ in certain countries. Please refer to the language specific Trio Operating Instructions to ensure the accuracy of the text.
CAUTION:
U.S. Federal Law restricts this device to sale by or on the order of a physician or other practitioner licensed by U.S. state law to use or order the use of this device.
Patents: This device is covered under one (1) of more of the following U.S. patents and any foreign equivalents 4,621,643, 4,700,708, 4,770,179, 4,869,254, 4,653,498, 4,911,167, 4,928,692, 4,934,372, 5,078,136, 5,368,224, 5,482,036, 5,490,505, 5,632,272, 5,685,299, 5,758,644, 5,769,785, 6,002,952, 6,036,642, 6,067,462, 6,157,850, 6,206,830. Possession or purchase of this device does not convey any express or implied license to use this device with replacement parts which would, alone, or in combination with this device, fall within the scope or one (1) or more of the patents related to this device.
Warnings, Precautions And Notes Please read and adhere to all warnings, precautions and notes listed here and in the appropriate areas throughout this manual. A WARNING is provided to alert the user to potential serious outcomes (death, injury, or serious adverse events) to the patient or the user. A CAUTION is provided to alert the user to use special care necessary for the safe and effective use of the device. They may include actions to be taken to avoid effects on patients or users that may not be potentially life threatening or result in serious injury, but about which the user should be aware. Cautions are also provided to alert the user to adverse effects on this device of use or misuse and the care necessary to avoid such effects. A NOTE is provided when additional general information is applicable.
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Introduction
Warnings
Warnings
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WARNING:
Equipment not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or with nitrous oxide.
WARNING:
This unit uses a common isolation path for the ECG leads and the Invasive Pressure Channel. Ensure that conductive parts of the ECG electrodes do not contact other conductive parts including earth ground. Do not connect any nonisolated accessories to the Trio or to the ECG or invasive pressure channel inputs when connected to a patient. Insure that the total chassis leakage currents of all connected units does not exceed 300µA. Use an EN 60601-1 approved isolation / separation transformer if required. Do not simultaneously touch the patient and any piece of electrical equipment if any cover has been removed from the equipment.
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. Do not touch any part of patient, table or monitor when a defibrillator is in use.
WARNING:
Route cables neatly. Ensure cables, hoses, and wires are away from patient’s neck to avoid strangulation. Keep floors and walkways free of cables to reduce risk to hospital personnel, patients and visitors.
WARNING:
This monitor is not intended for use in an MR environment.
WARNING:
When using electrosurgery equipment, leads should be placed equidistant from electrosurgery electrotome and the grounding plate to avoid cautery. Ensure that wires from electrosurgery equipment and ECG cables do not become tangled.
WARNING:
The Trio monitor is intended for hospital use under the direct supervision of a licensed health care practitioner.
WARNING:
Ensure that the conductive parts of ECG electrodes do not contact other conductive parts, including earth ground.
WARNING:
Pacemaker patients’ rate meters may continue to count the pacemaker rate during occurrences of cardiac arrest or some arrhythmias. Do not rely entirely upon rate meter alarms. Keep pacemaker patients under close surveillance. See Appendix section of this manual for disclosure of the pacemaker pulse rejection capability of this instrument.
WARNING:
Do not clean the monitor or sensors while it is on and/or connected to AC power.
WARNING:
Ensure that the ECG lead wires are neatly secured in a manner that will prevent them from encircling the patient’s neck, creating a strangulation hazard.
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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.
CAUTION:
Operation of the Trio below the minimum amplitude or value of PATIENT physiological signal may cause inaccurate results (see section 6.0, Appendix).
CAUTION:
When using electrosurgery equipment, never place an electrode near the grounding plate of the electrosurgery device. This may create interference with the ECG signal.
CAUTION:
The patient size selection should be matched to the actual patient before monitoring begins.
CAUTION:
To avoid possible damage to the Trio, use only ECG cables and accessories available from Datascope.
CAUTION:
Line isolation transients may resemble actual cardiac waveforms, thus inhibiting heart rate alarms. Check lead wires for damage and ensure good skin contact prior to and during use. Always use fresh electrodes and follow proper skin preparation techniques.
CAUTION:
Defibrillation protection is provided by the Datascope approved cables listed in the accessories section of this manual (see section 5.0).
CAUTION:
Thoracic respiration measurement may interfere with some pacemakers. Refer to the pacemaker’s manufacturer supplied manual.
CAUTION:
If a 3 Lead cable is used when a unit is set to 5 lead mode, no ECG signal will be obtained. If a 5 lead cable is used when the unit is set to 3 lead mode only Lead I, II and III are operable.
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.
CAUTION:
Excessive ambient light may cause inaccurate measurements. In such cases, cover the sensor site with opaque material.
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Introduction
Precautions
CAUTION:
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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. In such cases, cover the sensor site with opaque material.
•
excessive patient movement
•
venous pulsations
•
electro-surgical interference
•
placement of a sensor on an extremity that has a blood pressure cuff, arterial catheter or intra-vascular line.
•
nail polish or fungus
CAUTION:
In certain situations in which perfusion and signal strength are low, such as in patients with thick or pigmented skin, inaccurately low SpO2 readings will result. Verification of oxygenation should be made, especially in preterm infants and patients with chronic lung disease, before instituting any therapy or intervention.
CAUTION:
Many patients suffer from poor peripheral perfusion due to hypothermia, hypovolemia, severe vasoconstriction, reduced cardiac output, etc. These symptoms may cause a loss in vital sign readings.
CAUTION:
If the sensor or patient cable are damaged in any way, discontinue use immediately. To prevent damage, do not soak or immerse the sensor in any liquid solution. Do not attempt to sterilize.
CAUTION:
The SpO2 sensor site should be checked frequently, at least every eight (8) hours (every four (4) hours with the Adult and Pediatric re-usable finger sensor). Ensure proper positioning, alignment and skin integrity. Exercise extreme caution with poorly perfused patients. Skin erosion and pressure necrosis can be caused when sensors are not frequently monitored.
CAUTION:
When equipped with Masimo SpO2, use only Masimo oxygen sensors and cables. Use of other oxygen sensors may cause improper oximeter performance.
CAUTION:
When equipped with Nellcor SpO2, use only Nellcor oxygen sensors and cables. Use of other oxygen sensors may cause improper oximeter performance.
CAUTION:
When equipped with Basic SpO2, use only Basic oxygen sensors and cables. Use of other oxygen sensors may cause improper oximeter performance.
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Precautions
Introduction
CAUTION:
When using the Trio equipped with SpO2, use only Datascope supplied oxygen transducers and Patient Cables. Use of other oxygen transducers may cause improper oximeter performance.
CAUTION:
Use only Datascope blood pressure cuffs and hoses with the Trio.
CAUTION:
Please consult a physician for interpretation of blood pressure measurements.
CAUTION:
A blood pressure measurement can be affected by the position of the patient, and his/her physiological condition as well as other factors, such as patient movement.
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. This measure may affect NIBP performance and should be used with caution.
CAUTION:
Observe caution on all patients (Neonates, Pediatrics and Adults) when NIBP is set to the Continuous mode and the 1 minute Interval. When the NIBP “Continuous” interval is chosen, the Trio will continually take back to back blood pressure readings. As a safety precaution, a limit is placed on the Continuous mode to revert to an interval of every 5 minutes after 5 minutes of continuous readings.
CAUTION:
Any condition which may affect the regularity and strength of arterial pressures (such as patient movement, cardiac arrhythmias, restriction of hose, etc.), will affect the accuracy and ability to measure the NIBP.
CAUTION:
When cleaning sensors, do not use an excessive amount of liquid. Wipe the sensor surface with a soft cloth, dampened with a cleaning solution.
CAUTION:
Do not subject the sensor to autoclaving.
CAUTION:
Do not use sensors or cables that are damaged or have deteriorated.
CAUTION:
Some disinfectants may cause skin irritation. Please rinse cuff thoroughly with water to remove any residual disinfectants.
CAUTION:
Using dark colored soaps may stain the cuffs. Test a single cuff to ensure that no damage will occur.
CAUTION:
This product contains natural rubber latex which may cause allergic reactions.
CAUTION:
Disposable cuffs can be cleaned using a mild soap solution and dried with a clean cloth.
CAUTION:
Replace the sealed lead-acid battery with Datascope part number 0146-00-0043.
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Introduction
x
Precautions
CAUTION:
Remove the battery if the Trio is not likely to be used for an extended period of time.
CAUTION:
Remove the battery prior to shipping the Trio.
CAUTION:
To avoid permanent damage, do not expose metal components (pins, sockets, snaps) to disinfectants, soaps or chemicals.
CAUTION:
The cuff must be properly applied to the patient’s limb before inflating. If it is inflated without being securely wrapped, damage to the cuff can result.
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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 Datascope service personnel.
NOTE:
The comparison testing conducted via the auscultatory method used both Phase 4 and Phase 5 Korotkoff sounds. Reports of study findings for both the auscultatory method as well as the intra-arterial methods are available by contacting Datascope Technical Support (201) 995-8116.
NOTE:
Only operate this device within the specified operating signal range.
Indication For Use The Trio monitor is intended for hospital use under the direct supervision of a licensed health care practitioner. The intended use of the monitor is to monitor physiologic parameter data on adult and pediatric patients. Physiologic data includes: electrocardiogram, invasive blood pressure, noninvasive blood pressure, pulse oximetry, heart rate (derived from ECG or SpO2), respiration and temperature as summarized in the operating instructions manual. The information can be displayed, stored, trended and printed. The monitor is not intended for home use. The monitor is not intended to be an apnea monitor. It was not designed or validated for use as an apnea monitor.
Unpacking Remove the instrument and accessories from the shipping cartons and examine them for signs of shipping damage. Save all packing materials, invoice and bill of lading. These may be required to process a claim with the carrier. Check all materials against the packing list. Contact your Datascope Sales Representative or Distributor for assistance in resolving shipping problems.
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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 electromagnetic radiation
A symbol designating compliance of the Trio monitor with the Medical Device Directive (MDD) 93/42/EEC, Class II b device.
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1.0
General Product Description
The Datascope Trio is a vital signs monitor intended for intra-hospital use on human patients. It is adaptable for use with adult, pediatric and neonatal 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. The patient parameters that can be monitored with the Trio are: ECG (3-lead or 5-lead selectable), SpO2, Non-Invasive Blood Pressure, Respiration, Temperature and Invasive Blood Pressure. The Trio is equipped with an 8.4" Color High Resolution (800 x 600) TFT LCD. Digital displays are provided for Heart Rate, Pulse Rate, Pulse Oximetry (SpO2), Non-Invasive Blood Pressure (NIBP), Respiration Rate and Temperature (T1). Optional digital displays provided are Invasive Blood Pressure (IBP) or second Temperature (T2). Waveform displays are provided for ECG, PLETH and Respiration (RESP). An optional waveform display for Invasive Blood Pressure (IBP) is available. The optional built-in thermal recorder provides hard copies of all digital data and waveforms, as well as Tabular and Graphic Trend information. The Trio monitor can be mounted on a rolling stand, a wall mount bracket, a bedrail or operated as a tabletop device. The Trio is powered by an AC connection or an optional internal battery. NOTE:
The Trio is suitable for use in the presence of the discharge of a defibrillator.
NOTE:
The Trio is suitable for use in the presence of electrosurgery.
NOTE:
The Trio may not meet performance specifications if stored or used outside of the specified environmental conditions (see section 6.0).
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1-1
General Product Description
Key Features FEATURES
STANDARD
Display
8.4 inch color TFT LCD
OPTIONAL
4-trace erase bar refresh ECG
3 or 5 Lead (I, II, III, aVR, aVL, aVF, V) ECG Cascade ESIS Capability (3 or 5 Lead)
Blood Pressure
Non-Invasive Blood Pressure
1 channel of Invasive Blood Pressure
SpO2
Masimo SET® SpO2
Nellcor® OxiMax™ SpO2 Basic SpO2
Respiration
Impedance
Temperature
One YSI 400 channel
Trend
Tabular and Graphic Trends up to 24 hours
Power
Internal isolated power module
Printing
Second YSI 400 channel Sealed lead-acid battery Two-trace recorder
Communication
Ethernet, Remote Display (VGA), Analog Output
Other
Handle with bedrail hook Navigator™ Knob
Wall mount and rolling stand kits
Dedicated keys
1-2
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General Product Description
1.1
Front Panel
Front Panel 1
7ULR
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.
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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 4
5
6
7
8
FIGURE 1-2 Keypad
1.
POWER
Press this key to power the Trio ON or OFF. NOTE:
2.
3.
The power supply and battery charger are active any time AC power is supplied, regardless of whether the monitor is ON or OFF.
BATTERY
A green LED that is illuminated constantly when the battery is
CHARGING
charging and will flash when the unit is being powered by the
INDICATOR
battery.
AC POWER
A green LED that is illuminated when AC power is present.
INDICATOR 4.
NIBP
Press this key to begin a NIBP measurement. During a measurement, press this key to cancel the measurement and deflate the cuff.
5.
FREEZE
When in normal mode, press this key to freeze the waveform display. When waves are frozen, the message Frozen is displayed on the bottom of the screen. When in freeze mode, press this key again to exit FREEZE mode and restore the realtime waveform.
6.
Press this key to initiate a real-time printout of numeric data and selected waveforms. Results are output via the optional internal printer. During a printing, press this key to cancel the print job. Various print settings (such as speed and duration of printout) are adjustable and may be set by accessing the PRINTER SETUP menu in the MONITOR SETUP menu. (Refer to section 2.3.5.3 for details).
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General Product Description
7.
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. When in ALARM MUTE mode, press this key again to re-enable the audio alarm. 8.
NAVIGATOR™
Rotate this knob to highlight the various menus on the display.
KNOB
When highlighted, the menu target will display as black text on a white background. Available menu targets on the main display include the MENU icon, ECG lead, ECG size, ECG filter, IBP label, ECG, NIBP, SpO2, IBP, RESP and TEMP. Press the knob to display the highlighted menu. Once a menu is displayed, rotate the knob to highlight one of the items listed. Press the knob to select the highlighted item. • When it is not highlighted, the MENU icon will display as white text on the footer background with a white outline. When all other menu targets are not highlighted, they will be displayed in the colors that are defined in the PARAMETER COLORS menu. • When navigating within a menu, the menu target will display as black text on a white background. When the menu target is selected by pressing the knob, it will display as follows: • If the menu target is a Drop-Down Box, it will open with the current selection displayed in black text on a white background. Rotate and press the knob as necessary to make a selection. • If the menu target is a Text Edit Box, a cursor will be inserted in the menu target and the letter “A” in the onscreen keypad will display in black text on a white background. Rotate and press the knob as necessary to input the desired text. Select “OK” in the onscreen keypad to accept the text and return the cursor to the Text Edit Box. • If the menu target is a Spin Edit Box, it will display as white text on a black background. Rotate and press the knob as necessary to make a selection.
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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. Status Bar 1
2
4
3
5
FIGURE 1-3 Main Display 1. Demographics The demographics area displays the following information:
1-6
Bed #
Bed number (6 characters maximum)
First Name
First name of the patient (10 characters maximum)
Last Name
Last name of the patient (10 characters maximum)
Patient Size
Size of the patient: ADU (Adult), PED (Pediatric), NEO (Neonatal)
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