GE CARESCAPE ONE User Manual

ECG
thedesignlimitsoftheanalysisprogram.Thus,asbeats
becomeextremelywideornarrow,orespeciallyasbeats
becomesmall,arrhythmiainterpretationperformancemay
degrade.
●Othermorphologyconsiderations.Automatedarrhythmia
detectionalgorithmsaredesignedfundamentallytodetect
signicantchangesinQRSmorphology.Ifanarrhythmia
eventispresentanddoesnotexhibitasignicantchange
fromthepatient’spredominantmorphology,itispossible
forthoseeventstoremainundetectedbythesystem.
WARNING
PAUSEDANALYSIS.Certainconditionspausearrhythmia
analysis.Whenpaused,arrhythmiaconditionsarenot
detectedandalarmsassociatedwitharrhythmiasdonot
occur.Conditionscausingpausedarrhythmiaanalysisinclude
arrhythmiaoff,arrhythmiapaused,leadsfail,alarmpause,all
alarmsoff,anddischargedpatient.
WARNING
FAILURETODETECTLETHALARRHYTHMIA.Alwaysmonitor
ECGforarrhythmiadetectionpurposes.HRcalculatedfrom
pulsatileSpO
2
waveformmaydiffersignicantlyfromECGHR
measuredvalues.UsersshouldbeawarethattheSpO2probe
offandCheckprobetechnicalalarmsescalatenohigherthan
aMediumpriority.
WARNING
FAILURETODETECTLETHALARRHYTHMIA.TheSpO
2
parameterpulsatileheartratemeasurementisbasedonthe
opticaldetectionofaperipheralowpulseandtherefore
cannotdetectarrhythmias.Thepulseoximetryparameter
shouldnotbeusedasareplacementorsubstituteforECG
basedarrhythmiaanalysis.
WARNING
ARRHYTHMIAPAUSEDalarm.TheArrhythmiapausedalarm
indicatesthatthesystemisnolongermonitoringarrhythmia
orheartratefromECG.Ifyouadjustthealarmprioritylevel
lowerthanthedefaultvalue,keepthepatientunderclose
surveillance.
Arrhythmiameasurementlimitations
●Sincethearrhythmiadetectionalgorithmsensitivityandspecicityislessthan
100%,sometimestheremaybesomefalsearrhythmiasdetectedandalsosome
truearrhythmiaeventsmaynotbedetected.Thisisespeciallytruewhenthesignal
isnoisy.
●TheECGsizeandQRSwidthsettingsaffectarrhythmiadetectionandheartrate
calculationsensitivity.
●IfQRSamplitudeislow,themonitormightnotbeabletocalculateHRandfalse
Asystole,ArrhythmiaPaused,orBradyalarmsmayoccur.
●Duringthelearningphaseofthealgorithm,arrhythmiadetectionisnotavailable.
Asaresult,thepatientconditionshouldbecloselymonitoredduringthelearning
phaseandforseveralminutesafterthelearningphasetoallowthealgorithmto
reachoptimaldetectionperformance.
116CARESCAPEONE2094480-001
CARESCAPE ONE User Manual DRAFT 26 October 2017

GE CARESCAPE ONE Specifications

General

Category	Medical Equipment
Manufacturer	GE Healthcare
Model	CARESCAPE ONE
Display Size	10.1 inches
ECG	Yes
SpO2	Yes
NIBP	Yes
Temperature	Yes
Respiration	Yes
Parameters	ECG, SpO2, NIBP, Temperature, Respiration
Device Type	Patient Monitor
Connectivity	Bluetooth
Operating Temperature	0° to 40°C (32° to 104°F)
Storage Temperature	-20°C to 60°C (-4°F to 140°F)
Humidity	15 to 95% RH, non-condensing
Display Type	Touchscreen LCD

Summary

About this manual

Intended use of this manual

Describes the manual's purpose and compatible products for the CARESCAPE ONE system.

Intended audience of this manual

Identifies clinical professionals as the target audience with working knowledge of medical procedures.

Manual conventions

Explains text styles and terminology conventions used throughout the manual.

Safety

Safety message signal words

Defines DANGER, WARNING, CAUTION, and NOTICE signal words to indicate hazard severity.

Electrical warnings

Details critical warnings related to power supply, leakage current, and interfacing equipment.

Indications for use

Specifies the monitor's intended applications and contraindications, including MR environment.

System introduction

System safety precautions

Covers system warnings and operation warnings for safe system setup and use.

Short description of the equipment

Offers a brief overview of the CARESCAPE ONE's functionality and components.

Monitoring basics

Main screen layout

Describes the layout of the main screen, including alarm, information, and menu areas.

Main keys

Explains the functions of the primary keys accessible from the main menu.

User interface indicators

Explains various indicators displayed in the software user interface for status and feedback.

Setting up the monitor before use

Adjusting sound volumes

Details how to adjust various sound volumes, including alarm and beat volumes.

Screen setup modifications

Explains how to configure parameter windows, including size and area.

Checking the battery status

Explains how to check the battery status and replace the battery when necessary.

Starting and ending monitoring

Pre-monitoring checklist

Lists essential checks before starting patient monitoring for safety and functionality.

Entering patient data

Guides on how to enter patient demographics such as MRN, name, and date of birth.

About standby

Describes the standby mode and its use for temporary patient removal.

Alarms

Alarm safety precautions

Covers critical warnings and precautions related to alarm management and ensuring patient safety.

Visual alarm indications

Explains visual cues like alarm icons and messages displayed on the screen.

Audible alarm indications

Describes audible alarm signals, tones, and priority levels.

Alarm priorities and escalation

Explains how alarms are categorized by priority and how they escalate over time.

Transport use

Preparing to transport a patient

Outlines the steps required to prepare the monitor and patient for safe transport.

Transport settings

Explains how settings are transferred between the CARESCAPE ONE and host monitor during transport.

Transport troubleshooting

Provides solutions for common issues encountered during transport monitoring.

ECG

ECG safety precautions

Includes warnings and cautions related to ECG measurement and leadwire usage.

ECG warnings

Details critical warnings for ECG monitoring, including electrosurgery and leadwire safety.

Applying the electrodes to the patient

Explains the proper procedure for applying ECG electrodes to the patient.

Selecting the leads for ECG analysis

Explains how to choose ECG leads for analysis, including single vs. multi-lead modes.

Pacemaker detection

Explains pacemaker detection functionality, warnings, and points to note.

Arrhythmia monitoring

Covers warnings and limitations associated with arrhythmia detection algorithms.

ST detection

Details ST analysis, measurement limitations, and starting the ST detection.

Impedance respiration

Respiration safety precautions

Includes warnings and cautions related to respiration measurement, leadwires, and electrosurgery.

Respiration warnings

Covers critical warnings for respiration monitoring, including leadwire safety and interference.

Using the respiration measurement

Covers turning on the measurement, selecting leads, and adjusting waveform settings.

Respiration troubleshooting

Provides solutions for common issues with respiration measurement, such as failure or incorrect detection.

SpO₂

SpO2 safety precautions

Includes warnings and cautions for SpO2 monitoring, covering defibrillation, sensor compatibility, and patient safety.

SpO2 warnings

Details critical warnings for SpO2 monitoring, including sensor compatibility, accuracy, and environmental factors.

SpO₂ measurement guidelines

Covers guidelines for GE TruSignal, Masimo SET, and Nellcor OxiMax technologies.

Nellcor™ sensors with OxiMax™ technology data averaging and updating

Details data averaging and updating for Nellcor sensors with OxiMax technology.

Nellcor™ OxiMax™ SatSeconds™ alarm management

Explains SatSeconds alarm management for reducing false SpO2 alarms.

Setting the SpO2 alarms and alarm limits

Guides on setting SpO2 alarms and their corresponding limits.

Deactivating the SpO2 probe off alarm

Explains how to deactivate the SpO2 probe off alarm when ending monitoring.

SpO2 troubleshooting

Offers solutions for common SpO2 monitoring issues like poor signal or motion artifact.

Non-invasive blood pressure

NIBP safety precautions

Includes warnings and cautions for NIBP measurement, covering patient safety and device operation.

NIBP warnings

Details critical warnings for NIBP monitoring, including patient safety, cuff application, and arrhythmias.

NIBP points to note

Offers important notes on electrosurgery suitability, accessory compatibility, and patient populations.

Preparing the NIBP patient connection

Details the steps for correctly positioning the NIBP cuff on the patient.

Automatic NIBP measurements

Covers NIBP Auto mode, including cycle time and clock synchronization.

NIBP cuff selection and placement

Details how to choose the appropriate cuff size and position it correctly on the patient.

NIBP alarms

Covers setting NIBP alarms for systolic, mean, and diastolic pressures.

NIBP troubleshooting

Provides solutions for common NIBP measurement problems like failure, instability, or unexpected readings.

Invasive pressures

Invasive pressure safety precautions

Includes warnings and cautions related to invasive pressure procedures, transducers, and electrosurgery.

Invasive pressure warnings

Details critical warnings for invasive pressure monitoring, including defibrillator precautions and aseptic technique.

About zeroing the invasive pressure transducers

Emphasizes the importance of zeroing transducers for accurate measurements and lists when to zero.

Selecting invasive pressure as the primary heart rate source

Explains how to select invasive pressure as the primary source for HR calculation.

Setting invasive pressure alarm limits

Guides on setting alarm limits for invasive pressure channels, HR, and PR.

Invasive pressure troubleshooting

Offers solutions for common invasive pressure measurement issues, such as artifact or zeroing failure.

Temperature

Temperature safety precautions

Includes warnings and cautions related to temperature measurement, electrosurgery, and probe reuse.

Temperature warnings

Details critical warnings for temperature monitoring, including defibrillator precautions and probe hazards.

Temperature points to note

Offers important notes on electrosurgery suitability, accessory compatibility, and direct measurement mode.

Temperature measurement setup

Guides on connecting temperature equipment and preparing the patient.

Setting temperature alarms

Details how to set temperature alarm limits and enable alarms.

Temperature troubleshooting

Provides solutions for common temperature measurement issues like failure or incorrect readings.

CO₂

CO2 safety precautions

Includes warnings and cautions related to CO2 monitoring, airway adapters, and gas sampling.

CO2 warnings

Details critical warnings for CO2 monitoring, including airway adapter connection, leaks, and anesthetic agents.

CO₂ measurement setup

Guides on connecting CO2 equipment and preparing the setup.

Using the CO₂ measurement

Covers pump operation, selecting CO2 scale, and sweep speed for capnogram display.

Setting CO2 limit alarms

Guides on setting high/low limit values for EtCO2, FiCO2, and Resp Rate.

Deactivating the apnea alarm

Explains how to deactivate the apnea alarm when ending CO2 monitoring.

Zeroing the LoFlo Sidestream Module

Details the procedure for zeroing the LoFlo Sidestream Module when required.

Preventing care area pollution

Advises connecting the sample gas outlet to a scavenging system to prevent pollution.

CO2 troubleshooting

Provides solutions for common CO2 measurement issues like abnormal waveforms or elevated baselines.

Trends

Viewing numeric trends

Guides on how to view numeric trend data across three pages with 72 hours of information.

Changing the time interval of numeric trends

Explains how to adjust the time interval for displaying numeric trend data.

Cleaning and care

Cleaning safety precautions

Covers warnings and cautions related to cleaning agents, liquid immersion, and autoclaving.

General cleaning instructions

Provides step-by-step instructions for cleaning the device and its non-applied parts.

Disinfection

Covers disinfection precautions, notices, and permitted disinfectants.

Permitted disinfectants

Lists various permitted disinfectants and their manufacturers.

Messages

Messages related to ECG measurement

Provides a table of ECG-related messages, their locations, causes, and suggested actions.

Messages related to SpO2 measurement with CARESCAPE ONE

Details SpO2 measurement messages, their causes, and recommended actions.

Messages related to NIBP measurement

Lists NIBP messages, their possible causes, and suggested actions for troubleshooting.

Messages related to invasive pressures measurement

Covers messages related to invasive pressures, including causes and suggested actions.

Messages related to temperature measurement

Details temperature-related messages, their causes, and suggested actions.

Messages related to CO2 measurement

Lists CO2 measurement messages, their possible causes, and suggested actions.

Messages related to various technical issues

Covers technical messages not tied to specific parameters, related to hardware and configuration.

Abbreviations

List of abbreviations

Provides an alphabetical list of abbreviations used in the monitor software and manuals.

Skills checklist

System introduction

Recommends reviewing topics on system introduction for familiarization.

Starting and ending

Recommends reviewing topics on starting and ending monitoring procedures.

Monitoring basics

MAIN KEYS

Lists and describes the primary keys for accessing monitor functions.

OPERATION SAFETY PRECAUTIONS

Highlights essential safety precautions for operating the monitor.

Alarms

SAFETY PRECAUTIONS

Covers critical safety precautions related to alarm management.

OVERVIEW

Provides a general overview of alarm types, conditions, and priority levels.

Transport

TRANSPORT MONITORING

Covers monitoring during patient transport and related procedures.

ECG

Provides an overview of ECG measurement, including compatibility and safety.

Impedance respiration

GENERAL MEASUREMENT OVERVIEW

Covers compatibility, safety precautions, and warnings for respiration measurement.

RESPIRATION LEADS

Explains respiration leads and their electrode placement.

Pulse oximetry (SpO2)

GENERAL MEASUREMENT OVERVIEW

Covers compatibility, safety, and warnings for SpO2 monitoring.

SpO2 measurement limitations

Explains limitations related to distinguishing oxyhemoglobin, perfusion, and erroneous measurements.

B Compatibility

Measurement device compatibility

Lists compatible measurement devices and warnings against using identical devices simultaneously.

Dock compatibility

Lists compatible docks for the CARESCAPE ONE.

C Compliance

Standards compliance

Lists the various standards the system complies with, including IEC and ISO.

IEC 60601-1

Details compliance with IEC 60601-1, including protection types and operational modes.

D Design, environmental, and physical specifications

CARESCAPE ONE specifications

Provides detailed physical and environmental specifications for the CARESCAPE ONE unit.

CARESCAPE ECG specifications

Provides performance and environmental specifications for the CARESCAPE ECG accessory.

CARESCAPE SpO2 specifications

Lists performance and environmental specifications for CARESCAPE SpO2 accessories (TruSignal, Masimo, Nellcor).

E Alarm specifications

Alarm standards compliance

States compliance with IEC 60601-1-8 for alarm standards.

Auditory alarm volume, IEC tones

Provides sound pressure level data for IEC alarm tones at maximum volume.

Alarm delay specifications

Explains how alarm delays are measured and lists factors affecting them.

Time to alarm for tachycardia

Provides specific time-to-alarm data for various tachycardia conditions.

Alarm priorities and escalation times for ECG

Shows ECG alarm messages with their priorities and escalation times.

Alarm priorities and escalation times for SpO2

Details SpO2 alarm messages with their priorities and escalation times.

Alarm priorities and escalation times for NIBP

Lists NIBP messages with their priorities and escalation times.

Alarm priorities and escalation times for invasive pressures

Covers invasive pressure messages with their priorities and escalation times.

F Parameter specifications

Parameter specifications

Provides general warnings about operating outside specified ranges.

ECG performance specifications

Details ECG performance metrics like heart rate range, accuracy, and resolution.

SpO2 displayed saturation values

Notes that SpO2 values are calibrated to display functional saturation.

SpO2 test methods used to establish accuracy claims during motion

Explains test methods used to establish SpO2 accuracy claims during patient motion.

G Default settings

Understanding your monitor configuration

Explains how monitor configuration depends on equipment, software, and settings.

Software packages

Lists the five available software packages that pre-configure monitor behavior.

Care unit settings

Explains care unit settings are password protected and apply to software packages and profiles.

Configuring care unit settings

Guides on accessing and customizing care unit settings, including alarm and parameter configurations.

Alarm settings

Lists factory default settings for alarm configurations across different care units.

Parameter alarms settings

Details default settings for parameter alarms, focusing on ECG priorities.

SpO2 default settings

Covers default settings for SpO2 measurement, including scale, size, and alarms.

NIBP default settings

Lists default settings for NIBP measurement, including Auto mode, cuff size, and alarms.

Invasive pressures default settings

Details default settings for invasive pressure channels and alarms.

CO2 default settings

Lists default settings for CO2 measurement, including scale, sweep speed, and alarms.

Temperature default settings

Covers default settings for T1 and T2 temperature measurements and alarms.

H Supplies and accessories

About this list

Introduces the list of approved supplies and accessories for the CARESCAPE ONE.

Ordering information

Provides contact information for ordering supplies and accessories through GE representatives.

Parameter accessories

Lists accessories specific to different parameters like ECG, SpO2, NIBP, etc.

ECG accessories

Lists ECG electrodes and leadwires, including part numbers and descriptions.

SpO₂ accessories

Lists SpO2 accessories, including Nellcor OxiMax, Masimo LNCS, and TruSignal sensors.

Non-invasive blood pressure accessories

Lists NIBP cuffs and assortment packs with part numbers and sizes.

Temperature accessories

Lists temperature probes and interconnect cables.

CO2 accessories

Lists CO2 accessories like nasal cannulas, airway adapters, and sample lines.

Mounting accessories

Lists mounting accessories such as roll stands and VESA adapters.

I Maintenance

Planned maintenance

Outlines checkout procedures to be performed by service personnel every 24 months.

Recommended regular checks

Lists daily and yearly checks for accessories, cables, and calibration.

Maintaining the battery

Discusses the lithium-ion battery, its capacity, and terms related to battery charge.

Improving battery performance

Provides guidelines to enhance battery performance, including positioning and charger use.

Replacing the CARESCAPE ONE battery

Provides a warning about loss of monitoring when changing the battery without a powered dock.

Battery recycling

Details proper disposal and recycling procedures for Lithium-Ion batteries.

J Electromagnetic compatibility

Essential performance in EMC

Defines the essential performance criteria that must be maintained under EMC conditions.

Electromagnetic compatibility safety precautions

Covers warnings and cautions regarding the use of specified accessories and avoiding other equipment interference.

Recommended separation distances

Gives recommended separation distances between the device and RF communications equipment.

Minimizing electromagnetic interference

Offers actions to take if EMI occurs, such as reorienting equipment or increasing separation.