Directions for Use
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Micropaq® Monitor
Directions for Use Model 402 and Model 404 Software version 1.5X
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Welch Allyn Micropaq Monitor
Copyright 2007, Welch Allyn. All rights are reserved. No one is permitted to reproduce or duplicate, in any form, this manual or any part thereof without permission from Welch Allyn. Welch Allyn assumes no responsibility for injury or for any illegal or improper use of the product that may result from failure to use this product in accordance with the instructions, cautions, warnings, or indications for use published in this manual. Welch Allyn®, Acuity®, Micropaq®, FlexNet® and Flexible Monitoring® are registered trademarks of Welch Allyn, Inc. Nellcor® is a registered trademark of Nellcor Puritan Bennett. Masimo® and SET® are registered trademarks of Masimo Corporation. Software in this product is Copyright Welch Allyn or its vendors. All rights are reserved. The software is protected by United States of America copyright laws and international treaty provisions applicable worldwide. Under such laws, the licensee is entitled to use the copy of the software incorporated within this instrument as intended in the operation of the product in which it is embedded. The software may not be copied, decompiled, reverse-engineered, disassembled or otherwise reduced to human-perceivable form. This is not a sale of the software or any copy of the software; all right, title and ownership of the software remain with Welch Allyn or its vendors. For information about any Welch Allyn product, please call Welch Allyn Technical Support: USA 800 535 6663 315 685 4560 Canada 800 561 8797
Australia 61 2 9638 3000 800 074 793 China 86 21 6327 9631
European Call Center 353 46 9067790
France 33 1 55 69 58 49
Germany 49 7477 9271 86
Japan 81 3 3219 0071
Latin America 305 669 9003
Netherlands 31 157 505 000
Singapore 65 6419 8100
South Africa 27 11 777 7555
United Kingdom 44 1332 363812
Reorder Part Number 810-1464-XX Manual Part Number 810-1177-06 Rev. A, 02/2007 Welch Allyn 8500 SW Creekside Place Beaverton, Oregon 97008-7101 USA www.welchallyn.com Printed in USA
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Contents 1 - General Information... 1 Summary of New Features... 1 Intended Use... 1 Symbols... 2 General Warnings and Cautions... 3 Introducing the Monitor... 6 Model 402... 6 Model 404... 6 Understanding the Monitor and the FlexNet Network... 7 Monitor Features... 8 Controls and Connectors... 8 Display... 11 Accessories... 15 Operating Settings... 15 Default Settings... 16 Demonstration Mode... 16
2 - Monitoring... 19 Connect a New Patient... 19 Connect to the Network... 19 Perform ECG Monitoring... 21 Perform SpO2 Monitoring... 26 Install the Carrying Pouch... 28 Monitor a Patient Out of Range of Acuity... 29 Stop Monitoring a Patient... 30 Reconnect a Recently Monitored Patient... 31 Reassign a Monitored Patient to a New Room in the Same Unit... 32 Transfer a Monitored Patient to a New Room in a Different Unit... 33 Reassign the Monitor to a New Patient... 34
3 - Alarms & Alerts... 35 About Alarms and Alerts... 35 Alarm Holdoffs... 35 Respond to a Patient Alarm at Monitor... 36 Customize Patient Alarm Limits at the Monitor... 37 Respond to an Equipment Alert at the Monitor... 38 Alert Messages and Display Information... 40
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Contents
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4 - Monitor Patient at Acuity... 41 5 - Maintenance... 43 Change the Battery... 43 Recharge a Battery... 43 Inspect and Clean the Monitor and Accessories... 45 Recycling Monitor Components... 46 Within the European Union... 46 Change the Network Name... 47
6 - Reference... 49 Operating Settings... 49 Specifications... 50 Monitor Radio Specifications... 50 ECG Specifications... 50 Heart Rate and Arrhythmia Analysis Option... 52 Pulse Oximetry (SpO2) Specifications - Masimo... 53 Pulse Oximetry (SpO2) Specifications - Nellcor... 54 Patient Alarm and Equipment Alert Specifications... 55 Display Specifications... 56 Environmental Specifications (with Battery Installed)... 56 Physical Specifications... 57 Battery Specifications... 57 Battery Charger Specifications... 59 EMC Compliance... 60
Index... 69
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1 General Information Summary of New Features The following table summarizes the new features that are implemented in this software version 1.5. The version previously released was 1.4. Feature
Reference
Patient alarm tones are now discontinuous, and life-threatening alarms beep at a faster pace than other patient alarms.
See “Respond to a Patient Alarm at Monitor” on page 36.
If you press to silence a patient alarm tone and a new patient vital sign alarm or equipment alert occurs, a tone for the new alarm or alert will break the silence period at the monitor.
Intended Use The Micropaq™ monitor is intended to be used by clinicians for single or multiparameter vital signs monitoring of ambulatory and nonambulatory pediatric and adult patients in health care facilities. It is also intended for patient transport. The monitor is able to withstand light rain exposure over short periods of time (uniform distribution of approximately 1 mm of water/ minute for 10 minutes or less). The Micropaq monitor is intended to operate with an Acuity® Central Station through wireless communication over Welch Allyn’s FlexNet™ network. FlexNet connects multiple devices to the Acuity Central Station through hardwired Ethernet networks and Wireless Local Area Networks (WLANs). If the Micropaq monitor is moved out of range or loses communication with the FlexNet network, it continues to monitor the patient, display patient data, and generate local patient alarms or alert messages. •
The ECG channel is intended primarily for five-lead ECG monitoring, although three-lead ECG monitoring is supported.
•
The Pulse Oximetry channel is intended for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor).
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The most likely locations for patients monitored by this device are step-down units, telemetry departments, general medical/surgical floors, emergency departments, and inhospital transport. This guide was written for clinicians. Although this guide may describe some monitoring techniques, Welch Allyn expects that the operator is a trained clinician who knows how to take and interpret a patient’s vital signs. Federal USA law restricts sale of the device identified in this manual to, or on the order of, a licensed medical practitioner.
Symbols Warning Warning statements in this manual identify conditions or practices that could result in personal injury. Caution Caution statements in this manual identify conditions or practices that could result in damage to the equipment or other property.
The following symbols appear on the monitor or accessories. Direct current
IPX1
Alternating current (battery charger) The CE Mark and Notified Body Registration Number signify the device has met all essential requirements of European Medical Device Directive 93/42/EEC Signifies the device has met all essential requirements of European Medical Device Directive 93/42/EEC for a Class 1 product (battery charger) Protective earth ground (battery charger) Li++
US
C kj
Enclosure Protection Drip proof: Classification IPX1 per EN60529: 1991 Fuse This device has been tested and certified by the Canadian Standards Association International to comply with applicable U.S. and Canadian medical safety standards. Patient connections are Type CF, isolated for direct cardiac application, and protected against defibrillation Protected during defibrillation
Lithium Ion battery
Separate batteries from other disposables for recycling Li++
Caution: Refer to Directions For Use and accompanying documentation
For indoor use only (battery charger)
This way up
Keep away from rain
Humidity limit
Stacking limit (by number)
Fragile
Altitude limit
Temperature limits
IATA/ICAO Hazard Class 9 Package (International Air Transport Association/ International Civil Aviation Organization) Single use only
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Non-ionizing electromagnetic radiation
Directions for Use
Chapter 1 General Information
Monitor Front Panel Keys Scroll Up Key and Reset Alarm Tone KeySelect Key and Silence Patient Alarm/ Scrolls up menus on the display. During patient Equipment Alert Key- Selects the choice alarms, resets the tone at the monitor and at highlighted on the menu. During patient alarms, Acuity (if connected). silences the tone at the monitor and at Acuity (if connected) for 90 seconds. During equipment alerts, silences or acknowledges (dismisses) the alert. Nurse Call Key - When connected to Acuity, Scroll Down Key and Main Menu Key- Pressing pressing this key sends Acuity a Nurse Call this key scrolls down menus on the display, or message. causes the Main Menu to appear if no menu is displayed. Recycle the monitor and battery separately from other disposables. www.welchallyn.com/weee
Battery Charger Label and LEDs Green LED on continuously Battery is fully charged.
Green LED flashing
kj
Battery is charging.
Green LED flashing very slowly
Battery detected and waiting to be charged.
Yellow LED on continuously
Something is wrong with the battery or the charger. (See “Battery Status and Possible Response” on page 44.)
General Warnings and Cautions Familiarize yourself with all warnings and cautions before using the monitor.
WARNING When considering a treatment protocol that involves wireless communication of patient data, be sure to recognize some limitations inherent in wireless communications. When the monitor is not connected to the network: • • • •
There are no patient alarms or alerts at the Acuity Central Station. Acuity does not perform arrhythmia and ST analysis on the patient data and does not generate related alarms. Patient data is not saved. Pressing (Nurse Call) on the monitor does not cause any response at Acuity.
WARNING Do not try to monitor neonatal patients with the monitor. The monitor is intended for adult or pediatric patients. It is not intended for use with pediatric patients (or infants) weighing less than 22 lbs (10 kg).
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WARNING Always check the patient mode at Acuity when monitoring a new patient. The patient mode determines default alarm limits and internal algorithm settings. WARNING The monitor may not meet its performance specifications if stored or used outside the specified temperature and humidity ranges. WARNING Do not connect more than one patient to a monitor. Do not connect more than one monitor to a patient. WARNING During defibrillation, keep the discharge paddles away from ECG and other electrodes, as well as other conductive parts in contact with the patient. WARNING Do not operate this product in the presence of flammable anesthetics or other flammable substances in combination with air, oxygenenriched environments, or nitrous oxide; explosion can result. WARNING Do not use the monitor in a Magnetic Resonance Imaging (MRI) suite or a hyperbaric chamber. Such use can cause fire or explosion resulting in patient injury and monitor damage. WARNING Electronic equipment that emits strong electromagnetic or radio frequency signals can cause electrical interference with monitor operation. This interference may distort the ECG signal, thereby preventing accurate rhythm analysis. Avoid operating this device near equipment of this type. WARNING Exposure to Radio Frequency (RF) radiation. To comply with Federal Communications Commission (FCC) RF exposure requirements, this device shall be used in accordance with the operating conditions and instructions provided in this manual, including the section “Install the Carrying Pouch” on page 28. WARNING Pacemaker signals can differ from one pacemaker to the next. The Association for Advancement of Medical Instrumentation (AAMI) cautions that “in some devices, 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. All pacemaker patients should be kept under close or constant observation.” See “ECG Specifications” on page 50 for disclosure of the pacemaker pulse rejection capability of this instrument. WARNING For patients with a pacemaker, position the monitor to maintain a minimum 6-inch distance between the monitor and pacemaker. Immediately turn the monitor off and provide appropriate patient care if you have any reason to suspect that the monitor is interfering with the pacemaker. The Health Industry Manufacturers Association recommends this minimum 6-inch distance between a hand-held wireless radio and a pacemaker, which is consistent with the independent research by, and recommendations of, Wireless Technology Research.
Directions for Use
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WARNING Make frequent electrical and visual checks on cables, sensors, and electrode wires. All cables, sensors, and electrode wires must be inspected and properly maintained and in proper working order to allow the equipment to function properly and protect patient safety. WARNING Avoid electrosurgery burns at monitoring sites by ensuring proper connection of the electrosurgery return circuit so that the return paths cannot be made through monitoring electrodes and probes. WARNING Use of ECG cables not specified by Welch Allyn may negate defibrillator protection and risk patient injury due to shock. WARNING To ensure patient safety, the conductive parts of the ECG electrodes (including associated connectors) and other patient-applied parts should not contact other conductive parts, including earth ground, at any time. WARNING Motion artifact can affect the accuracy of patient vital sign measurements. Minimize patient motion whenever possible. WARNING For best product performance and measurement accuracy, use only accessories supplied by Welch Allyn or recommended in the Welch Allyn Products and Accessories booklet (810-0409-XX). Use accessories according to your facility’s standards and the manufacturer’s recommendations. Always refer to the manufacturer’s Directions for Use. WARNING As with all medical equipment, carefully route the patient cabling to reduce the possibility of patient entanglement or strangulation. Use the supplied garment clips to secure the cable properly. WARNING When positioning the monitor pouch on the patient, make sure the straps do not entangle the patient’s neck or cause choking. Make sure the straps do not restrict the movement of the patient’s limbs or create a hazard when walking or moving. WARNING If a product has been dropped or severely abused, send it to a qualified service person to confirm proper operation. Caution Do not autoclave the monitor. Autoclave accessories only if the manufacturer’s instructions clearly approve it. Many accessories can be severely damaged by autoclaving. It is possible for the monitor to detect a problem that prevents the monitor from operating properly. If this occurs, the monitor displays an error message and error number. Report such errors to Welch Allyn. The monitor should be serviced only by a Welch Allyn service technician while under warranty. Contact Welch Allyn for information about post-warranty period service.
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Introducing the Monitor The monitor is a patient-worn vital signs monitor for use by adult or pediatric ambulatory patients. •
One or two ECG channels displayed
•
Up to 2 ECG leads displayed at the monitor: I, II, III, V, aVR, aVL, or aVF with 5-lead cable
•
Up to 7 ECG leads displayed at Acuity: I, II, III, V, aVR, aVL, or aVF with 5-lead cable
•
One ECG lead displayed at the monitor and at Acuity: Fixed lead II with 3-lead cable, or 5-lead cable with only RA, LA and LL electrodes attached.
•
Pulse oximetry (SpO2) monitoring (Model 404 only)
•
Two-way wireless communication within Welch Allyn’s FlexNet network
•
LCD for display of ECG waveforms, SpO2 and heart rate/pulse rate data, and messages from Acuity
•
Standalone operation with patient alarms when out of range of the network
•
Patient alarm limits that can be set at the monitor or at Acuity
•
Configurable formats for single- or dual-waveform ECG display
•
Internal antenna
•
Nurse call key
•
Lightweight (slightly more than 1 pound with battery)
•
Rugged and tolerant of brief water exposure
•
Rechargeable battery
•
Sleep mode to extend battery life
Model 402 ECG monitoring
Model 404 ECG monitoring and either one of two pulse oximetry (SpO2) monitoring options: •
SpO2 with Masimo® SET® technology
•
SpO2 with NELLCOR® OxiMax™ technology
Directions for Use
Chapter 1 General Information
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Understanding the Monitor and the FlexNet Network The monitor is intended to operate with an Acuity® Central Station as part of Welch Allyn’s FlexNet network. FlexNet allows multiple devices to communicate through hardwired Ethernet networks and Wireless Local Area Networks (WLANs). The Acuity Central Station provides the primary display and entry of patient data for a patient connected to the monitor. To Other Acuity Central Stations
Access Points
HR
80 SpO2 97
Acuity Central Station
To Other Access Points
HR
80 SpO2 97
HR
80 SpO2 97
HR
80 SpO2 97
Micropaq monitors
FlexNet Network
Each patient-worn monitor supports two-way communication with an Acuity Central Station through an access point in the FlexNet network. The access point is a digital radio transceiver that connects to the FlexNet network. During monitoring, the monitor sends the patient data to Acuity. Acuity and the monitor continuously analyze the data. Acuity provides appropriate alarm or alert messages at the Central Station and other network devices such as a hallway message panel and the monitor itself. Acuity also stores the patient data for viewing or report printing. If the monitor is moved out of range or loses communication with the FlexNet network and Acuity, it continues to monitor the patient and display patient data. While not communicating with Acuity, the monitor continues to generate local patient alarms or alert messages. Patient data is not stored and Acuity does not perform waveform analysis or generate arrhythmia messages while the monitor is not communicating with Acuity. When the monitor is returned to within range of the FlexNet network, it automatically reconnects to Acuity.
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Monitor Features Controls and Connectors SpO2 Connector ECG Connector Visual Alarm Indicator
Liquid Crystal Display Select Key and Silence Patient Alarm/ Equipment Alert Key Scroll Up Key and Reset Patient Alarm Tone Key Scroll Down Key and Main Menu Key Nurse Call Key
Battery pack latch Battery
Back
Directions for Use
Chapter 1 General Information
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Visual Alarm Indicator Green
Flashes slowly during normal operation.
Red
Flashes during patient alarm, remains on continuously when alarms are silenced or suspended.
Yellow
Flashes during an equipment alert or while not connected to the network. Remains on continuously if the operator suspends an alert at Acuity for 90 seconds or acknowledges (dismisses) a low battery alert from the monitor or Acuity.
Note
The flashing green LED indicates that the monitor is connected to the network but not necessarily connected to a patient. If the monitor is actively monitoring a patient, the green LED indicates no alarms or alerts are detected.
Audible Alarm Indicator Beeps to indicate a patient alarm, and beeps faster for life-threatening arrhythmia alarms (see “Patient Alarm and Equipment Alert Specifications” on page 55). Beeps to indicate when the equipment needs attention. This beep tone is slower than patient alarm tones (see “Patient Alarm and Equipment Alert Specifications” on page 55). Volume can be configured as high, low, or off (configured at Acuity). Volume can be configured differently for network connection or stand-alone operation (configured at Acuity).
Nurse Call Key When connected to Acuity, pressing this key sends a Nurse Call message to Acuity. Depending on how Acuity is configured, this will cause Acuity to: Generate a Nurse Call Alert at the Acuity Central Station. Print a “snapshot” of the patient waveform at the Acuity Central Station.
Scroll Up Key and Reset Patient Alarm Tone Key Scrolls up menus on the display. Resets a silenced patient alarm tone.
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Scroll Down Key and Main Menu Key Scrolls down menus on the display. Displays the Main Menu.
Select Key and Silence Patient Alarm/Equipment Alert Key Selects the choice highlighted on the menu. During patient alarms, silences the tone at the monitor and Acuity (if connected) for 90 seconds. During equipment alerts, silences or acknowledges (dismisses) the alert at the monitor and Acuity.
Battery Insert the battery to turn on power. Remove the battery to turn off power. (While the battery is removed, the monitor does not perform patient monitoring.) Recharge the battery while it is removed from the monitor. (See “Recharge a Battery” on page 43.) To order a new battery, see “Battery Status and Possible Response” on page 44.
Directions for Use
Chapter 1 General Information
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Display Although the Acuity Central Station is the primary location for viewing patient data, the monitor provides information to support patient care.
Waveform scale is selectable
Dashed lines indicate the monitor detects a pacemaker signal (display of pacer detection can be enabled or disabled at Acuity)
ECG lead is selectable HR indicates the heart rate is from ECG. PR (pulse rate) is displayed if SpO2 is active and ECG is not (pulse rate is derived from SpO2). If the monitor detects a vital sign outside the measurable range, it displays: - - - (below the range) + + + (above the range). Indicates the monitor is connected to Acuity. This symbol indicates the monitor is not communicating with Acuity: Flashing indicates the monitor is associated with an access point, but not communicating with Acuity. Continuous on indicates the monitor is not communicating with an access point or Acuity.
Patient name as entered at Acuity. If the patient name has not been entered, the monitor displays the last four digits of the monitor serial number, such as: ID:6472 Symbol is displayed at the monitor whenever the Nurse Call key is pressed. ECG waveform is displayed when active. SpO2 numeric data is a percentage value. SpO2 pulse amplitude indicator (not proportional to pulse volume)
Indicates one or more patient alarms are disabled (off).
Low battery icon flashes to indicate monitor will shut off in 30 minutes or less.
Display Sleep Mode In order to extend battery life, the display becomes blank after two minutes if no keys are pressed. The display becomes active again if an alarm or alert occurs, a key is pressed, the initial Acuity connection occurs, a cable is inserted, or an electrode is attached. The display will not become blank if a patient alarm is occurring, an Acuity message is displayed, or the monitor is in Demo mode or Service mode.
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Main Menu When you first press
Press Press
, the Main Menu appears:
to move through the menu.
to select or change the highlighted choice.
EXIT
Exit the Main Menu (the menu disappears).
ACUITY...
Access the Acuity Menu with network options. The Acuity Menu is only accessible while connected to Acuity. EXIT
Exit all menus and return to the monitoring screen.
END TELE
Discontinue monitoring a patient.
NEW ROOM
Reassign a patient to a new room in the same unit.
TRANSFER
Transfer a patient to a new room in a new unit.
NEW PATIENT
Assign the monitor to a new patient.
PATIENT INFO
Display patient information such as ID, name, unit and room.
Whenever the monitor is connected to Acuity and you select ACUITY... from the Main Menu, the monitor displays the message ACUITY CONTACTED to confirm that Acuity has been contacted. The monitor continues to display this message until Acuity responds, or you press to acknowledge the message and clear the screen. If the monitor detects an alarm or alert, it clears the screen to display the appropriate alarm or alert message. The length of time required for Acuity to respond to your selection at the monitor can vary widely depending on the amount of network traffic and other conditions. ECG LEAD...
Access a menu to change the ECG 1 or ECG 2 lead selection (I, II, III, aVR, aVL, aVF, or V). Available vectors depend on the connected electrodes.
Directions for Use
Chapter 1 General Information
ECG SCALE...
Change the scale of the ECG waveform. If two waveforms are displayed, both have the same scale.
1 WAVEFORM
There are four possible ECG waveform display selections: 1 WAVEFORM
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the default selection
2 WAVEFORMS 5 SECONDS FULL SCREEN Pressing changes to the next selection. This change does not take effect until after you exit the Main Menu. See “Display” on page 11 for descriptions. LIMITS...
Enter the Alarm Limits Menu (“Customize Patient Alarm Limits at the Monitor” on page 37) and change alarm limits.
SYSTEM INFORMATION
Display information about the network connection and SpO2 module.
SERVICE MENU Enter Service Mode for a demonstration mode (Demo, see “Demonstration Mode” on page 16) or service functions for technicians. Service Mode is not available if any cables are plugged in.
Note
To restrict access to the Main Menu, a Menu Lock option can be configured for the monitor at the Acuity Central Station. When the Menu Lock is enabled, the operator must press and hold down and for two seconds to gain access to the Main Menu. The Menu Lock is disabled if the monitor loses communication with Acuity.
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Waveform Options There are four ECG waveform options as shown:
1 Waveform The single ECG 1 (lead II) waveform is displayed.
2 Waveforms ECG 1 (lead II) and ECG 2 (lead V) are both displayed.
5 Seconds ECG 1 (lead II) cascades from one line to the other.
Full Screen The single ECG 1 (lead II) waveform is allowed to occupy most of the screen.
To change the waveform selection during operation: 1.
Press
to display the Main Menu.
2. Press as needed to highlight the current waveform selection. Then press needed to select the desired display.
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Directions for Use
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Messages from Acuity The monitor displays messages sent from Acuity as needed, including patient alarms and equipment alerts. When Acuity messages are displayed, they temporarily override information displayed on the lower half of the monitor screen.
Accessories 5-lead ECG cable
Battery
ECG electrodes
Battery charger (8-battery)
3-lead ECG cable (optional)
ECG extension cable (optional)
SpO2 cable (Masimo or Nellcor)
Carrying pouch
SpO2 sensors (Masimo or Nellcor)
Micropaq Directions For Use
WARNING For best product performance and measurement accuracy, use only accessories supplied by Welch Allyn or recommended in the Welch Allyn Products and Accessories booklet (810-0409-XX). Use accessories according to your facility’s standards and the manufacturer’s recommendations. Always refer to the manufacturer’s Directions for Use.
Operating Settings The following monitor operating settings can be set at the monitor or at the Acuity Central Station: •
Patient alarm limit settings (ECG and SpO2).
•
ECG lead and scale selection
•
ECG display format
Many other monitor operating settings (such as patient mode and alarms volume) can only be set at the Acuity Central Station. See “Operating Settings” on page 49 for a list of all settings and where they are set.
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Default Settings When the monitor connects to Acuity for a new patient, the Acuity Central Station downloads the appropriate default settings stored at Acuity. While the monitor is connected to Acuity, settings can be changed either at the monitor or at the Acuity Central Station. If the monitor is temporarily disconnected from Acuity and the operator changes settings at the monitor, those settings are transmitted to and stored at Acuity when the monitor reconnects.
Demonstration Mode You can practice using the monitor with the Demo mode of operation, including connection to Acuity. The Demo mode cannot be activated while you are monitoring a patient or if any cables have been plugged into the monitor. During the Demo mode, the monitor and Acuity display the message SIMULATION. To practice with the monitor in Demo mode: 1.
Disconnect all patient cables connected to the monitor.
2. Remove the battery (if installed). 3. Insert the battery and watch for the Power-Up screen.
Power-Up Screen
4. After the Power-Up screen disappears, press
Main Menu
to display the Main Menu.