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Table of Contents
Related Manuals for EDAN iM70
Summarization of Contents
About this Manual
Statement
Details regarding the manual's purpose, copyrights, and user responsibilities.
Responsibility of the Manufacturer
Defines manufacturer's responsibility for safety, reliability, and performance.
Chapter 1 Intended Use and Safety Guidance
1.1 Intended Use/Indications for Use
Specifies the intended use and patient populations for the monitor.
1.2 Safety Guidance
Provides essential safety precautions and warnings for monitor operation.
Chapter 2 Installation
2.1 Initial Inspection
Instructions for inspecting packaging and monitor contents before use.
2.2 Mounting the Monitor
Guidance on physically mounting the monitor in its intended location.
2.3 Connecting the Power Cable
Procedure for connecting the monitor to the AC power supply.
2.4 Checking the Monitor
Steps to verify the monitor's basic functionality after setup.
Chapter 3 Basic Operation
3.1 System Components
Overview of the monitor's physical parts and interfaces.
3.1.1 Front View
Identification of components on the front panel of the monitor.
3.2 Operating and Navigating
3.2.1 Using Keys
Explanation of permanent and shortcut keys for monitor operation.
3.3 Operating Mode
3.3.1 Demo Mode
Procedure to enter and exit the demonstration mode.
3.3.2 Standby Mode
How to enter and exit standby mode and its behavior.
3.3.3 Night Mode
Instructions for activating night mode to reduce screen brightness and sound.
3.3.4 Privacy Mode
Steps to activate privacy mode for reduced visual and audio alarms.
3.3.5 NFC Mode
Description of NFC mode for constant HR physiological alarm.
3.4 Changing Monitor Settings
3.4.1 Adjusting Screen Brightness
How to adjust the screen brightness settings.
3.4.2 Changing Date and Time
Procedure to set the monitor's date and time.
3.5 Adjusting Volume
3.5.1 Adjusting Key Volume
Instructions for adjusting the volume of key presses and knob rotation.
3.5.2 Adjusting Alarm Volume
How to adjust the volume for all audible alarm signals.
3.5.3 Adjusting Beat Volume
Procedure to adjust the volume of the beat sound.
Chapter 4 Networked Monitoring
4.1 Cybersecurity Measures
Guidelines for protecting patient data and network security.
4.1.1 Personal Information Safety
Strategies to protect personal health information and device performance.
Chapter 5 Alarms
5.1 Alarm Category
Classification of alarms into physiological, technical, and prompts.
5.1.1 Physiological Alarms
Details on alarms triggered by patient physiological parameters.
5.1.2 Technical Alarms
Details on alarms triggered by device technical status.
5.1.3 Prompts
Information on character indications for monitoring process or functions.
5.2 Selecting Alarm Tone Type
Options for selecting standard or customized alarm sound types.
5.3 Alarm Levels
Classification of alarms by severity: high, medium, and low.
5.4 Controlling Alarm
5.4.1 Setting Parameter Alarm
How to configure individual parameter alarm settings.
Chapter 6 Alarm Information
6.1 Physiological Alarm Information
Detailed information on physiological alarms, causes, and levels.
Chapter 7 Managing Patients
7.1 Confirming a Patient
Procedure to confirm or admit a new patient.
7.2 Admitting a Patient
Steps to enter patient data for safe and accurate monitoring.
7.2.1 Patient Category and Paced Status
How patient category affects algorithms and alarm limits.
7.5 Managing Patient Information
7.5.1 Editing Patient Information
How to edit patient details after admission.
7.5.2 Obtaining Patient Information from the Network Server
Procedure to retrieve patient data from a network server.
Chapter 8 User Interface
8.1 Setting Interface Style
Options for customizing waveform sweep and monitored parameters.
8.2 Selecting Display Parameters
How to choose and display desired monitoring parameters.
8.3 Changing Waveform Position
Method to exchange waveform positions between parameters.
8.4 Changing Interface Layout
Options for configuring screen layout and control bar display.
8.9 Viewing the Bed View Window
8.9.1 Opening the Bed View Window
Steps to open the Bed View window for remote monitoring.
8.9.2 Settings of the Bed View Window
Configuration options for the Bed View window.
Chapter 9 Monitoring ECG
9.1 Overview
Introduction to ECG monitoring principles and features.
9.2 ECG Safety Information
Critical safety precautions for ECG monitoring procedures.
9.3 ECG Display
9.3.1 Changing the Size of the ECG Wave
How to adjust the gain and size of ECG waveforms.
9.5 Monitoring Procedure
9.5.1 Preparation
Steps for preparing the patient's skin for electrode placement.
9.5.2 Connecting ECG Cables
Instructions for correctly connecting ECG cables and electrodes.
9.5.3 Selecting Electrode Type
How to select the appropriate ECG electrode type.
9.5.4 Installing Electrodes
3 Electrodes Placement
Guidance on placing 3 ECG electrodes on the patient's body.
5 Electrodes Placement
Instructions for placing 5 ECG electrodes on the patient's body.
6 Electrodes Placement
Guidance on placing 6 ECG electrodes on the patient's body.
10 Electrodes Placement
Instructions for placing 10 ECG electrodes for 12-lead monitoring.
9.6 ECG Menu Setup
9.6.1 Setting Alarm Source
How to configure the source for HR/PR or AUTO alarm settings.
9.7 12-Lead ECG Monitoring
9.7.1 Activating 6/10 Electrodes ECG Monitoring
Procedure to activate 6/10 electrodes monitoring function.
9.7.2 Analysis Function
How to perform automatic analysis for 12-lead ECG.
9.7.3 Waveform Durations and Isoelectric Segments
Definitions for waveform durations and isoelectric segments.
9.8 ST Segment Monitoring
9.8.1 Setting ST Analysis
How to turn ST analysis on or off.
9.8.2 ST Display
Information on how ST values and templates are displayed.
9.8.3 About ST Measurement Points
Explanation of ISO and ST measurement points.
9.9 Arrhythmia Monitoring
9.9.1 Arrhythmia Analysis
How the arrhythmia algorithm monitors and alarms for ECG changes.
9.10 QT Analysis
9.10.1 Measurement Limitations
Factors affecting QT analysis accuracy and potential limitations.
Chapter 10 Monitoring RESP
10.1 Overview
Introduction to respiration monitoring using impedance.
10.2 RESP Safety Information
Critical safety warnings for respiration monitoring.
Chapter 11 Monitoring SpO2
11.1 Overview
Introduction to SpO2 monitoring, including pulse rate and plethysmogram.
11.2 SpO2 Safety Information
Essential safety precautions and warnings for SpO2 sensor use.
11.3 Measuring SpO2
Measurement Procedure
Step-by-step guide for applying and measuring SpO2.
11.11 SatSeconds Alarm Management
11.11.1 Describing SatSeconds
Explanation of the SatSeconds technique for managing oxygen saturation alarms.
11.11.2 SatSeconds “Safety Net”
Description of the SatSeconds safety net feature.
11.11.3 Setting SatSeconds Duration
How to configure the duration for SatSeconds settings.
Chapter 12 Monitoring PR
12.1 Overview
Explanation of pulse rate measurement and its parameters.
12.2 Setting PR Source
How to select the source for pulse rate measurement.
12.3 Setting PR Volume
Instructions for adjusting the pulse rate volume.
12.4 Selecting the Active Alarm Source
How to choose HR or PR as the active alarm source.
Chapter 13 Monitoring NIBP
13.1 Overview
Introduction to NIBP measurement using the oscillometric method.
13.2 NIBP Safety Information
Critical safety precautions and warnings for NIBP measurements.
13.5 Measurement Procedures
13.5.1 Operation Prompts
Detailed operating procedures for manual, auto, continuous, and sequence NIBP.
13.5.2 Correcting the Measurement if Limb is not at Heart Level
How to correct NIBP measurements based on limb position.
Chapter 14 Monitoring TEMP
14.1 Overview
Introduction to body temperature measurement using thermistor probes.
14.2 TEMP Safety Information
Critical safety precautions for temperature probe usage.
Chapter 15 Monitoring Quick TEMP
15.1 Overview
Introduction to quick temperature measurement for thermal balance.
15.2 Quick TEMP Safety Information
Critical safety warnings for quick temperature measurements.
15.3 Measuring Procedure
15.3.1 Measurement for Oral Temperature
Procedure for taking oral temperature measurements.
15.3.2 Measurements for Rectal Temperatures
Procedure for taking rectal temperature measurements.
15.3.3 Measurements for Axillary Temperatures
Procedure for taking axillary temperature measurements.
Chapter 16 Monitoring IBP
16.1 Overview
Introduction to Invasive Blood Pressure (IBP) measurement.
16.2 IBP Safety Information
Critical safety precautions for IBP monitoring.
16.3 Monitoring Procedures
16.3.1 Selecting a Pressure for Monitoring
How to select and label the pressure type for monitoring.
16.3.2 Zeroing the Pressure Transducer
Procedure for zeroing the pressure transducer to ensure accuracy.
16.3.3 Troubleshooting the Pressure Zeroing
Common issues and corrective actions for pressure zeroing.
16.3.4 IBP Calibration
Information on IBP calibration performed by qualified service professionals.
16.6 Measuring PAWP
16.6.1 Measurement Procedures
Steps for measuring Pulmonary Artery Wedge Pressure (PAWP).
16.7 Calculating CPP
16.7.1 Measurement Procedures
Steps to calculate Cerebral Perfusion Pressure (CPP).
Chapter 17 Monitoring CO2
17.1 Overview
Introduction to CO2 monitoring methods: sidestream and mainstream.
17.2 CO2 Safety Information
Critical safety precautions and warnings for CO2 monitoring.
17.3 Monitoring Procedures
17.3.1 Zeroing the sensor
Procedure for zeroing the CO2 sensor for EDAN, Respironics, and Masimo modules.
17.3.2 Sidestream CO2 Module
Measurement steps for sidestream CO2 modules.
17.3.3 Mainstream CO2 Module
Measurement steps for mainstream CO2 modules.
Chapter 18 Monitoring C.O.
18.1 Overview
Introduction to Cardiac Output (C.O.) measurement using Thermodilution.
18.2 C.O. Safety Information
Critical safety precautions for Cardiac Output monitoring.
18.3 C.O. Monitoring
Preparing Measurement
Steps to prepare for Cardiac Output measurement.
Chapter 19 Monitoring AG
19.1 Overview
Introduction to Anesthetic Gas (AG) monitoring modules.
19.2 Safety Information
Critical safety information for various AG modules.
19.2.1 Safety Information for G7 Module
Specific safety warnings for the G7 AG module.
19.2.2 Safety Information for Masimo ISA Analyzer
Specific safety warnings for the Masimo ISA Analyzer.
19.2.3 Safety Information for Dräger Minimodule
Specific safety warnings for the Dräger Minimodule.
19.2.4 Safety Information for Masimo IRMA Module
Specific safety warnings for the Masimo IRMA Module.
19.3 Monitoring Steps
19.3.1 Monitoring Steps for G7 Module
Procedure for monitoring anesthetic gases with the G7 module.
19.3.1.1 Zeroing the Sensor
Steps for zeroing the G7 module sensor.
19.3.1.2 Measurement Steps
Procedure for measuring anesthetic gases with the G7 module.
19.3.1.3 MAC Calculation
Formula and explanation for MAC value calculation.
19.3.2 Monitoring Steps for Masimo ISA Module
NomoLine Sampling Lines
Information on NomoLine sampling lines for Masimo Sidestream CO2.
Working Status of ISA analyzer
Indicators for the working status of the ISA analyzer.
19.3.3 Monitoring Steps for Dräger Minimodule
19.3.3.1 Zeroing
Information on the automatic zeroing process for the Dräger Minimodule.
19.3.3.2 MAC Calculation
Explanation of standard MAC values and calculation.
19.3.4 Monitoring Steps for Masimo IRMA Module
19.3.4.1 Placement of IRMA Probe
Correct placement of the IRMA probe for infant patients.
19.3.4.2 Performing a Pre-use Check
Steps to verify IRMA module functionality before use.
19.3.4.3 Zeroing
Recommendations for precise IRMA probe zeroing.
Chapter 20 Freeze
20.1 Entering/Exiting Freeze Status
Instructions for activating and deactivating waveform freeze status.
20.1.1 Entering Freeze Status
Steps to enter the freeze status from a non-freeze screen.
20.1.2 Exiting Freeze Status
Operations that will exit the freeze status and resume waveforms.
Chapter 21 Review
21.1 Trend Graph Review
How to review trend data using graphs and parameters.
21.2 Trend Table Review
Procedure for reviewing trend data in a tabular format.
Chapter 22 Calculation
22.1 Drug Calculation
Procedures for calculating drug dosages and titration.
22.1.1 Calculation Procedures
Steps to access and perform drug calculations.
22.2 Hemodynamic Calculation
22.2.1 Calculation Procedure
Steps to perform hemodynamic calculations.
22.2.2 Input Parameters
List of input parameters required for hemodynamic calculations.
22.2.3 Output Parameters
List of output parameters and their calculation formulas.
22.3 Oxygenation Calculation
22.3.1 Calculation Procedure
Steps to perform oxygenation calculations.
22.3.2 Input Parameters
List of input parameters for oxygenation calculations.
22.3.3 Output Parameters
List of output parameters and formulas for oxygenation calculations.
22.4 Ventilation Calculation
22.4.1 Calculation Procedure
Steps to perform ventilation calculations.
22.4.2 Input Parameters
List of input parameters for ventilation calculations.
22.4.3 Output Parameters
List of output parameters and formulas for ventilation calculations.
22.5 Renal Function Calculation
22.5.1 Calculation Procedure
Steps to perform renal function calculations.
22.5.2 Input Parameters
List of input parameters for renal function calculations.
22.5.3 Output Parameters
List of output parameters and formulas for renal function calculations.
Chapter 23 Warning-Score System
23.1 Warning-Score Interface
How to access the NEWS and MEWS warning-score interfaces.
23.2 Warning-Score Method
Options for warning-score calculation: calculator or auto score.
23.3 Warning-Score Criteria
Criteria for NEWS and MEWS scoring based on vital signs.
Chapter 24 Recording
24.1 Performance of the Recorder
Specifications of the monitor's waveform recorder.
24.3 Recorder Operations and Status Messages
24.3.1 Record Paper Requirement
Information on the required type of record paper.
24.3.2 Proper Operation
Guidelines for correct operation of the recorder.
24.3.3 Paper Out
Action to take when the recorder runs out of paper.
24.3.4 Replacing Paper
Step-by-step instructions for replacing the record paper.
24.3.5 Removing Paper Jam
Procedure for clearing paper jams from the recorder.
Chapter 25 Printing Patient Reports
25.1 Printer Settings
How to configure printer settings for patient reports.
25.2 Starting and Stopping Report Printing
Procedure for printing various types of patient reports.
Chapter 26 Other Functions
26.1 Nurse Call
How to activate and use the nurse call function.
26.2 Analog Output and Defibrillator Synchronization
How to activate analog output and defibrillator sync pulse.
26.3 Storing Data in the Storage Device
Managing data storage on internal and removable devices.
26.3.1 Data Stored in the Storage Device
Information about the types and volume of patient data stored.
26.3.4 Reviewing Data Stored in the Storage Device
26.3.4.1 Reviewing Full Disclosure Waveform
How to review stored patient data, including full disclosure waveforms.
Chapter 27 Using Battery
27.1 Battery Safety Information
Critical safety precautions for handling and using rechargeable batteries.
Chapter 28 Care and Cleaning
28.1 General Points
General guidelines for keeping the monitor and accessories clean.
28.2 Cleaning
Validated cleaning agents and procedures for the monitor and accessories.
28.2.1 Cleaning the Monitor
Step-by-step guide for cleaning the monitor's exterior surfaces.
28.2.2 Cleaning the Reusable Accessories
Cleaning procedures for reusable accessories like ECG cables and cuffs.
28.3 Disinfection
Validated disinfectants and procedures for monitor and accessories.
28.3.1 Disinfecting the Monitor
Steps for disinfecting the monitor's display and exterior.
28.3.2 Disinfecting the Reusable Accessories
Disinfection procedures for reusable accessories.
Chapter 29 Maintenance
29.1 Inspecting
Checklist for overall monitor inspection by qualified personnel.
29.2 Maintenance Task and Test Schedule
Schedule for maintenance and testing performed by service professionals.
Chapter 30 Warranty and Service
30.1 Warranty
Details on product warranty terms and conditions.
30.2 Contact Information
Contact details for service, maintenance, and technical support.
Chapter 31 Accessories
31.1 ECG Accessories
List of available ECG accessories with part numbers.
31.2 SpO2 Accessories
List of available SpO2 sensors and accessories.
31.3 NIBP Accessories
List of available NIBP cuffs, tubes, and modules.
31.4 TEMP Accessories
List of available temperature probes and accessories.
31.5 Quick Temp Accessories
List of accessories specifically for Quick TEMP function.
31.6 IBP Accessories
List of available IBP accessories and cables.
31.7 CO2 Accessories
List of available CO2 modules, cannulas, and adapters.
31.8 C.O. Accessories
List of accessories for Cardiac Output monitoring.
31.9 AG Accessories
List of accessories for Anesthetic Gas monitoring.
31.10 Other Accessories
List of miscellaneous accessories like batteries, trolleys, and scanners.
A Product Specification
A.1 Classification
Classification of the equipment based on safety and standards.
A.2 Physical Specifications
Details on monitor size, weight, and environmental requirements.
A.2.1 Size and Weight
Physical dimensions and weight of the monitor models.
A.2.2 Environment Specification
Operating and storage environmental conditions for the monitor.
A.2.6 Data Management
Data Review
Information on accessing and reviewing stored data.
A.3 Wi-Fi
A.3.1 Wi-Fi Technical Specifications
Technical details of the monitor's Wi-Fi capabilities.
A.3.2 Wi-Fi Performance Specifications
Performance specifications related to wireless network connectivity.
A.4 ECG
Lead Mode
Available lead configurations for ECG monitoring.
Electrode Standard
Supported electrode standards (AHA, IEC).
Display Sensitivity
Gain selection options for ECG waveform display.
Sweep
Available sweep speeds for ECG waveforms.
Bandwidth (-3dB)
ECG filter bandwidth settings for different modes.
CMRR (Common Mode Rejection Ratio)
Common Mode Rejection Ratio specifications for ECG modes.
Hum Filter
Hum Filter settings for various ECG modes.
Differential Input Impedance
Input impedance specification for ECG signals.
Input Signal Range
Input signal range specification for ECG.
Pace Pulse
Pulse Indicator
Requirements for marking pace pulses.
Pulse Rejection
Requirements for rejecting pace pulses.
Pace Pulse Detecting Lead
Lead selection for detecting pace pulses.
Heart Rate
HR Calculation
Range, accuracy, resolution, and sensitivity for HR calculation.
QRS Detection Range
Detection range requirements for QRS complexes.
PVC
Range and resolution for PVC detection.
Pause/min
Range for Pause/min measurement.
Range of Ventricular Rhythm
V-Tach (Ventricular Tachycardia)
Conditions for ventricular tachycardia detection.
Vent Rhythm (Ventricular Rhythm)
Conditions for ventricular rhythm detection.
Vent Brady (VBRADY)
Conditions for ventricular bradycardia detection.
Acc. Vent Rhythm
Conditions for accelerated ventricular rhythm.
Maximum Start-up Alarm Time for Tachycardia
V-Tach (Ventricular Tachycardia)
Maximum start-up alarm time for tachycardia with different gains.
Arrhythmia analyses (Advanced)
Asystole
Conditions for Asystole arrhythmia analysis.
V-Fib/V-Tach
Conditions for Ventricular Fibrillation/Tachycardia analysis.
Couplet
Conditions for Couplet arrhythmia analysis.
Vent Rhythm
Conditions for Ventricular Rhythm analysis.
PVC Bigeminy
Conditions for PVC Bigeminy analysis.
PVC Trigeminy
Conditions for PVC Trigeminy analysis.
Tachy
Conditions for Tachycardia analysis.
R on T
Conditions for R on T arrhythmia analysis.
PVC
Conditions for PVC analysis.
Irr Rhythm
Conditions for Irregular Rhythm analysis.
Brady
Conditions for Bradycardia analysis.
Pacer not Pacing
Conditions for Pacer not Pacing analysis.
Missed Beat
Conditions for Missed Beat analysis.
PAC Bigeminy
Conditions for PAC Bigeminy analysis.
Pacer not Capture
Conditions for Pacer not Capture analysis.
VEB
Conditions for Ventricular Escape Beat analysis.
Vent Brady
Conditions for Ventricular Bradycardia analysis.
ExtremeBrady
Conditions for Extreme Bradycardia analysis.
PVCs High
Conditions for high PVCs rate analysis.
Pauses/min High
Conditions for high pauses per minute analysis.
Multiform PVCs
Conditions for Multiform PVCs analysis.
Sustain VT
Conditions for Sustained Ventricular Tachycardia analysis.
ExtremeTachy
Conditions for Extreme Tachycardia analysis.
Wide QRS Tachy
Conditions for Wide QRS Tachycardia analysis.
Non-Sustain VT
Conditions for Non-Sustained Ventricular Tachycardia analysis.
Afib
Conditions for Atrial Fibrillation analysis.
Acc. Vent Rhythm
Conditions for Accelerated Ventricular Rhythm analysis.
Pause
Conditions for Pause analysis.
Low Voltage(Limb)
Conditions for Low Voltage in Limb analysis.
Arrhythmia analyses (Basic)
ASYSTOLE
Conditions for Asystole analysis in basic mode.
VFIB/VTAC
Conditions for VFIB/VTAC analysis in basic mode.
COUPLET
Conditions for Couplet analysis in basic mode.
VT > 2
Conditions for VT > 2 analysis in basic mode.
BIGEMINY
Conditions for Bigeminy analysis in basic mode.
TRIGEMINY
Conditions for Trigeminy analysis in basic mode.
R ON T
Conditions for R on T analysis in basic mode.
PVC
Conditions for PVC analysis in basic mode.
IRR
Conditions for Irregular Rhythm analysis in basic mode.
PNC
Conditions for Pacer Not Capture analysis in basic mode.
PNP
Conditions for Pacer Not Paced analysis in basic mode.
VBRADY
Conditions for Ventricular Bradycardia analysis in basic mode.
VENT
Conditions for Ventricular Rhythm analysis in basic mode.
A.5 RESP
Method
Respiration measurement method: Impedance.
Measurement lead
Available options for respiration measurement leads.
Calculation Type
Manual or Automatic calculation type for respiration.
Baseline Impedance Range
Baseline impedance range with ECG cables.
Measuring Sensitivity
Sensitivity setting within the baseline impedance range.
Waveform Bandwidth
Waveform bandwidth specification for respiration.
Respiration Waveform Excitation
Respiration waveform excitation parameters.
RR Measuring Range
Measuring range for RR (Respiration Rate) for adult and neo/ped.
Resolution
Resolution for RR measurement.
Accuracy
Accuracy specifications for RR measurement.
Gain Selection
Available gain selection options for respiration.
Sweep
Available sweep speed options for respiration waveforms.
Apnea Alarm Time Setup
Setup options for apnea alarm delay time.
Measuring Range
Adult Mode
NIBP measuring range for adult patients.
Pediatric Mode
NIBP measuring range for pediatric patients.
Neonatal Mode
NIBP measuring range for neonatal patients.
Pre-inflation Pressure
Adult/ Pediatric Mode
Pre-inflation pressure settings for adult and pediatric modes.
Neonatal Mode
Pre-inflation pressure settings for neonatal mode.
A.7 SpO2
EDAN Module
Specifications for EDAN SpO2 sensors.
Sensor
Specifications for SpO2 sensor light emitter and energy.
PI
Perfusion Index measuring range and resolution.
Nellcor Module
Specifications for Nellcor SpO2 sensors.
A.10 Quick TEMP
Measuring Range
Measuring range for quick temperature in monitoring and prediction modes.
Operating Temp
Operating temperature range for the module.
Sensor Type
Supported sensor types for quick temperature measurement.
Resolution
Resolution for quick temperature measurements.
Accuracy
Accuracy specification for quick temperature measurements.
Response time
Response time for quick temperature measurements.
Update time
Update time for quick temperature readings.
Warm-up time
Warm-up time required for quick temperature measurement.
Prediction time
Prediction time for quick temperature measurements.
Measuring Mode
Available measuring modes for quick temperature.
Transient Response Time
Transient response time for quick temperature measurements.
Clinical Bias
Clinical bias values for quick temperature measurements.
Limits of Agreement
Limits of agreement for quick temperature measurements.
A.11 IBP
Technique
IBP measurement technique: Direct invasive measurement.
Channel
Number of channels for IBP measurement on different models.
IBP Measure
Measuring range for IBP parameters like Art, PA/PAWP, CVP, etc.
Resolution
Resolution for IBP measurements.
Accuracy (not including sensor)
Accuracy specifications for IBP measurements.
Pressure Unit
Units for IBP pressure measurements.
Pressure sensor
Specifications for the pressure sensor.
Sensitivity
Sensitivity specification for the pressure sensor.
Impedance Range
Impedance range for the pressure sensor.
Filter
Filter settings for IBP measurements.
Zero Range
Zero range for pressure transducer.
Pressure Calibration Range
Range for IBP and ICP pressure calibration.
Volume Displacement
Volume displacement specification for IBP.
A.12 CO2
EDAN G2 Sidestram Module
Specifications for the EDAN G2 Sidestream CO2 module.
Intended Patient
Intended patient types for CO2 monitoring.
Measure Parameters
Parameters measured by the CO2 module.
Unit
Units for CO2 measurements.
Measuring Range
Measuring range for EtCO2, FiCO2, and AwRR.
Resolution
Resolution for EtCO2, FiCO2, and AwRR.
Accuracy
Accuracy specifications for EtCO2, FiCO2, and AwRR.
Exhaust Emission
Support
Support for zero calibration and O2/N2O compensation.
Masimo Mainstream Module
Dimensions (W × D × H)
Physical dimensions of the Masimo IRMA module.
Weight
Weight of the Masimo IRMA module.
According to the degree of protection against harmful ingress of water
IP rating for protection against water ingress.
Mechanical robustness
Mechanical robustness and transportation requirements.
A.13 C.O.
Not applicable to iM50 or M50.
Indicates C.O. monitoring is not available on iM50/M50 models.
Technique
Technique used for C.O. measurement: Thermodilution.
Measure Parameters
Parameters measured during C.O. monitoring.
Measuring Range
Measuring range for C.O., TB, and TI.
Resolution
Resolution for C.O., TB, and TI measurements.
Accuracy
Accuracy specifications for C.O., TB, and TI.
A.14 AG
Complies with ISO 80601-2-55: 2011.
Compliance with international standard for gas analysis.
EDAN G7 module and Masimo module are applicable to iM70, iM80 and M80. Dräger Minimodule is only applicable to iM80 and M80.
Module applicability for different monitor models.
A.14.1 Sidestream
Specifications for sidestream AG monitoring modules.
EDAN G7 Module
Specifications for the EDAN G7 Anesthetic Gas module.
Intended Patient
Intended patient types for AG monitoring.
Measure Parameters
Parameters measured during AG monitoring.
Unit
Units used for AG measurements.
Measuring CO2
Measuring range for CO2 in AG monitoring.
A.15 Interfaces
A.15.1 Analog Output
Specifications for the analog output interface.
Bandwidth (-3 dB; reference frequency: 10 Hz)
Bandwidth specifications for analog output in different modes.
Maximum Transmission Delay (Diagnosis Mode)
Maximum transmission delay for analog output in diagnosis mode.
Sensitivity
Sensitivity specification for analog output.
PACE Rejection/ Enhancement
PACE rejection and enhancement settings for analog output.
Waveform Display
Waveform display consistency with calculation leads.
Compliant with Standard and Directive
Compliance with short circuit protection and leakage current standards.
Output Impedance
Output impedance specification for analog output.
Interface Type
Interface type for analog output: PS2 connector.
A.15.2 Defibrillator Synchronization
Output Impedance
Output impedance for defibrillator synchronization.
Maximum Time Delay
Maximum time delay for defibrillator synchronization pulse.
Waveform
Waveform shape for defibrillator synchronization signal.
Amplitude
Amplitude levels for defibrillator synchronization signal.
Minimum Required R-wave Amplitude
Minimum R-wave amplitude required for synchronization.
Pulse Width
Pulse width specification for synchronization signal.
Limited Current
Limited current rating for synchronization signal.
Rising and Falling Time
Rising and falling time for synchronization signal.
Interface Type
Interface type for defibrillator synchronization: PS2 connector.
A.15.3 Nurse Call
Drive Mode
Drive mode for nurse call function: Voltage output.
Power Supply
Power supply specifications for nurse call.
Interface Signal
Interface signal specifications for nurse call.
Interface Type
Interface type for nurse call: PS2 connector.
B EMC Information
Guidance and Manufacture’s Declaration
Declarations regarding electromagnetic emissions and immunity.
B.1 Electromagnetic Emissions
Guidance and declaration for electromagnetic emissions.
B.2 Electromagnetic Immunity
Guidance and declaration for electromagnetic immunity.
C Default Settings
C.1 Patient Information Default Settings
Default settings for patient information entry.
C.2 Alarm Default Settings
Default settings for alarm parameters like pause time and latch.
C.3 ECG Default Settings
Default ECG settings including alarm limits and ARR analysis.
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