Page 2 The information in this manual applies to the software version and product models on the first page of the manual. Due to continuing innovation, specifications in this manual are subject to change without notice. For technical documentation purposes, the abbreviation GE is used for the legal entity name, GE Medical Systems Information Technologies, Inc., and GE Healthcare Finland Oy.
Page 3: Table Of Contents
Contents Legal manufacturer information ...............13 Manufacturer information................13 Standards......................15 Standards compliance.................. 15 IEC 60601-1 ....................15 standards compliance................. 16 Impedance respiration standards compliance ........... 16 Introduction to this manual ...............17 Manual intended use ..................17 Intended audience of this manual ............... 17 Training requirements ..................
Page 4 Defibrillation warnings................27 Alarm warnings ................... 27 Accessories warnings ................. 28 Battery warnings..................28 Care warnings ..................... 28 Respiration warnings .................. 29 warnings..................... 29 Cautions......................30 Alarm cautions .................... 30 System cautions ..................30 Operation cautions ..................30 Disposal cautions ..................31 Respiration cautions ...................
Page 5 Hub passcode view ..................58 Hub patient list .................... 58 Hub patient details..................58 Hub LIVE view ....................59 Hub detailed view..................60 Hub menu ....................61 Managing patients and monitoring ............63 Admitting a patient ..................63 Editing patient demographics ..............64 Powering on the Hub ..................
Page 6 Hub and modes ....................81 About modes ....................81 Selecting the use mode ................81 10 Alarms ......................83 Safety precautions ..................83 Alarm conditions ................... 83 Alarm priority levels ..................83 Active alarms....................83 Alarm signals and user position..............84 Visual alarm indicators ................. 84 About alarm messages................
Page 7 Respiration measurement setup..............96 Preparing the patient's electrode sites ............96 Starting the respiration measurement ............96 Checking the respiration measurement ............ 98 Removing respiration electrodes ..............98 Troubleshooting the measurement ............. 98 13 Pulse oximetry and pulse rate..............99 Safety precautions ..................99 Portrait Wearable Pulse Oximetry Sensor P-SA01 (Portrait SpO2 P-SA01) intended use..................
Page 8 Safety precautions ..................113 Cleaning, disinfection, and care overview..........113 Visual inspection, cleaning, and disinfection frequency......113 Cleaning....................... 114 General cleaning instructions..............114 Cleaning points to note................114 Permitted detergents ................114 Cleaning procedure for the Hub............... 115 Cleaning procedure for the respiration sensor ........117 Cleaning procedure for the SpO sensors ..........
Page 9 FCC information ..................145 Radio Equipment Directive (RED) information ........... 146 ISED information ..................146 RF exposure information ................146 Technical specifications, Hub ..............147 Technical specifications, charger............... 147 Technical specifications, sensors ............... 148 Technical specifications, sensor batteries..........148 Technical specifications, alarming unit ............. 149 Minimum requirements, Central Viewer ............
Page 10 List of abbreviations..................165 Skills checklist ....................167 Safety......................167 System introduction..................168 Graphical user interface ................168 Configuration ....................169 Managing patients and monitoring ............169 Battery management ................. 170 Hub modes ....................170 Alarms......................171 Parameter filtering and signal quality ............171 Impedance respiration ................
Page 11 EMC warnings....................189 About EMC disturbance ................190 Essential performance in EMC ..............190 Electromagnetic emissions ................ 191 Electromagnetic immunity ................. 191 Electromagnetic immunity for RF .............. 193 Recommended separation distances............194 Proximity field immunity compliance............194 Applicable RF receiver and transmitter specifications ......196 5815148-01 Portrait ™...
Page 12 5815148-01 Portrait ™ Mobile Monitoring Solution...
Page 13: Legal Manufacturer Information
Legal manufacturer information Manufacturer information Portrait HUB01, SBT01, SpO2 P-SA01, SpO2 P-SP01, SpO2 P-W01, SpO2 P-SE01, RR P-RR01 GE Healthcare Finland Oy Kuortaneenkatu 2 FI-00510 Helsinki Finland Tel: +358 10 39411 www.gehealthcare.com Portrait CSS01, CVA01, CAU01 GE Medical Systems GE Medical Systems SCS Information Technologies, Inc.
Page 14 Legal manufacturer information 5815148-01 Portrait ™ Mobile Monitoring Solution...
Page 15: Standards
Standards Standards compliance The system complies with the following standards. IEC 60601–1:2005 + A1:2012 ● IEC 60601–1–2:2014 ● IEC 60601–1–8:2006 + A1:2012 ● IEC 62366–1:2015/COR1:2016 ● IEC 62304:2015 ● IEC 60601–1–6:2010 + A1:2013 ● ISO 80601–2–61:2017 ● ISO 80601–2–49:2018 ● Type BF defibrillator-proof APPLIED PART per IEC 60601–1 Clause 6 Type CF defibrillator-proof APPLIED PART per IEC 60601–1 Clause 6 Power supply mains plug is the means for isolation from supply mains.
Page 16: Spo 2 Standards Compliance
Standards Sensor battery: IP67 ￭ sensors P-SA01 and P-SP01, and respiration sensor: IP67 ￭ sensors P-SE01 and P-W01: IP44 ￭ All SpO sensors with battery, respiration sensor with battery: IP44 ￭ Charger: IPX2 ￭ Power supply unit of the charger: IPX0 ￭...
Page 17: Introduction To This Manual
Introduction to this manual Manual intended use This manual is an integral part of the Portrait Mobile Monitoring Solution system. It should always be kept in a place accessible to users, and information indicating that place should be available close to the equipment. Observance of the manual is a prerequisite for proper performance and correct operation and ensures patient and user safety.
Page 18: Training Requirements
Introduction to this manual Training requirements No product-specific training is required for the use of the Portrait Mobile Monitoring Solution. Manual conventions This manual uses the following styles to emphasize text or indicate an action. Item Description bold Indicates hardware keys and connectors. bold italic Indicates software terms.
Page 19: Illustrations And Names
Ordering manuals A paper copy of this manual will be provided upon request. Contact your local GE representative and request the paper manual part number on the first page of the manual.
Page 20: Product Availability
Super Sani-Cloth is a trademark of PDI, Inc. CaviWipes is a trademark of Metrex Research, LLC. Manufacturer responsibility GE is responsible for the effects on safety, reliability, and performance of the equipment only if: Assembly operations, extensions, readjustments, modifications, servicing, or ●...
Page 21: Safety And Intended Use
Safety and intended use Safety message signal words Safety message signal words designate the severity of a potential hazard. The signal words danger, warning, caution, and notice are used throughout this manual to point out hazards and to designate a degree or level of seriousness. A hazard is defined as a source of potential injury to a person.
Page 22: Reporting Of Serious Incidents
Any serious incident related to the use of this product should be reported to both the manufacturer and the health authority/competent authority where the product is installed. To report to GE, contact your local service representative or report to In-box.complaints@ge.com. Please provide the following information: The catalogue number or the model designation of the product as stated on its ●...
Page 23 Safety and intended use WARNING INTERFACING OTHER EQUIPMENT. Connect only items that are specified as part of the system and as compatible. For more information, see the list of compatible devices. WARNING LOSS OF MONITORING. Connect only items that are specified as part of the system and as compatible.
Page 24: Emc Warnings
Changes or modifications to this device/system not expressly approved by GE may cause EMC issues with this or other equipment. This device/system is designed and tested to comply with applicable standards and regulations regarding EMC and...
Page 25: Operation Warnings
Safety and intended use WARNING INTERFERENCE. Other equipment may interfere with the system, even if that other equipment complies with CISPR emission requirements. WARNING LOSS OF MONITORING. To avoid losing the Hub and sensor connectivity and thus patient monitoring, do not use an RFID reader operating at the frequency of 2.45 GHz close to any part of the Hub and sensors.
Page 26 Safety and intended use WARNING LOSS OF MONITORING. Make sure to always lock the Hub screen when not interacting with it. Locking the screen will prevent unintentional interactions, which could lead to interrupted monitoring. WARNING LEAKAGE CURRENT. To avoid excessive patient leakage current, do not simultaneously touch the patient and the pins on the charger.
Page 27: Defibrillation Warnings
Safety and intended use WARNING UNEXPECTED SYSTEM PERFORMANCE. To prevent erroneous readings, do not use physically damaged sensors or cables. Discard a damaged sensor or cable immediately. Never repair a damaged sensor or cable never use a sensor or cable repaired by others Defibrillation warnings WARNING...
Page 28: Accessories Warnings
Safety and intended use Accessories warnings WARNING PATIENT SAFETY. Single-use products are not designed to be reused. Reuse may cause a risk of cross-contamination, affect the measurement accuracy and/or system performance, and cause a malfunction as a result of the product being physically damaged due to cleaning, disinfection, re-sterilization and/or reuse.
Page 29: Respiration Warnings
Safety and intended use WARNING EQUIPMENT DAMAGE, UNEXPECTED PERFORMANCE. Do not use any automated cleaning or disinfection processes for the Portrait Mobile Monitoring Solution system components. Incorrect cleaning may result in damage to the equipment and unexpected performance, such as loss of monitoring. WARNING LEAKAGE CURRENT.
Page 30: Cautions
Safety and intended use WARNING PATIENT INJURY. To avoid patient injury, always check the compatibility of the SpO measurement components prior to use. Incompatible components can result in degraded performance, device malfunction, and patient injury. WARNING PATIENT SAFETY. A pulse oximeter should not be used as an apnea monitor.
Page 31: Disposal Cautions
. If you have any questions concerning disposal of a product, please contact GE or its representatives. Respiration cautions CAUTION PATIENT DISCOMFORT.
Page 32 Clinical Alarming Unit is intended for use under the direct supervision of a licensed practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility. Portrait Mobile Patient Monitor (Portrait HUB01) intended use The Portrait Mobile Patient Monitor (Portrait HUB01) is intended for use with adult...
Page 33 Safety and intended use continuous physiologic monitoring of oxygen saturation (SpO ) and pulse rate (PR) parameters. The Wearable Pulse Oximetry Sensor acquires parameter data from the patient and transmit it to the sensor battery for communication to a host device through the Medical Body Area Network (MBAN) connection.
Page 34: Equipment Markings
Safety and intended use Portrait RR Electrode Patch (Portrait RRP01) intended use The Portrait RR Electrode Patch (Portrait RRP01) is intended for use with adult and pediatric patients (3 years of age and older, and weighing more than 10 kg) for continuous physiologic monitoring of respiration rate (RR) parameter.
Page 35 Safety and intended use Marking Explanation Hub power button icon. Degree of ingress protection. This equipment is protected against ingress of dust, and against ingress of water in harmful quantity in immersion up to 1 meter of submersion. Degree of ingress protection. IP X2: This equipment is protected against water drops falling vertically over a 15°...
Page 36 Safety and intended use Marking Explanation Manufacturer address, may include date of manufacture as in this example. If date is marked: the first four digits identify the year, the following two digits identify the month, and the last two digits identify the day.
Page 37 Safety and intended use Marking Explanation Humidity limitations. Keep dry. Fragile. Handle with care. This symbol indicates that the waste of electrical and electronic equipment must not be disposed as unsorted municipal waste and must be collected separately. Please contact an authorized representative of the manufacturer for information concerning the decommissioning of your equipment.
Page 38 Safety and intended use Marking Explanation China only. The number in the symbol indicates the EFUP period in years, as explained below. This symbol indicates the product contains hazardous materials in excess of the limits established by the Chinese standard GB/T 26572.
Page 39: Unique Device Identifier (Udi)
Safety and intended use Marking Explanation Assembled in Mexico Country of origin Mexico. Assembled in USA Country of origin USA. Made in USA Unique Device Identifier (UDI) Unique Device Identifier. (UDI) Every medical device has a unique marking for identification. The UDI marking appears on the device labeling.
Page 40 Safety and intended use 5815148-01 Portrait ™ Mobile Monitoring Solution...
Page 41: System Description
System description Short description of the system The Portrait Mobile Monitoring Solution consists of the Core Services hosted on the EHL Platform, Hub, Wearable SpO Parameter, Wearable RR Parameter, Central Viewer software hosted on an off-the-shelf computer, alarming unit, and charger. The system can be used for monitoring adult and pediatric patients (3 years of age and older, and weighing more than 10 kg) within a hospital or healthcare facility.
Page 42: System Components
System description System components All components listed below can be used within the patient environment, except for the non-medical grade devices: the Central Viewer computer, alarming unit, and the EHL Platform. 1. Central Viewer CVA01 software with off-the-shelf computer, keyboard and mouse 2.
Page 43: Core Services Overview
System description Core Services overview The Core Services provide centralized software services that enable the communication and interaction of the Hub and Central Viewer in a secure manner within a healthcare facility. The Core Services provide clinical, operational, configuration, and serviceability functionality to support the system. These services include physiological data storage and licensing.
Page 44 System description Introduction to the alarming unit The alarming unit is connected to the Central Viewer computer with a USB cable. This cable is integrated in the alarming unit and cannot be removed. WARNING PERSONAL INJURY. Route the cable of the alarming unit in such a way that it will not present a stumbling hazard.
Page 45: Hub And Sensors Overview
System description Hub and sensors overview The Hub collects and displays real-time monitoring data from the wireless sensors that are specifically designed for ambulatory patients. The Hub can visually and audibly annunciate alarms, and the alarming behavior can be modified by selecting the appropriate monitoring mode (REMOTE or LOCAL).
Page 46 System description 1. MBAN 2. WLAN The sensors can send data simultaneously, allowing for multiparameter monitoring. Pairing or unpairing a sensor will automatically adjust the data flow from the sensor to the Hub and then to the Central Viewer when online. The Hub has two monitoring modes, REMOTE and LOCAL: The REMOTE monitoring mode displays alarms on the Central Viewer only.
Page 47 System description Introduction to the Hub NOTE Pay attention to the following when using the Hub: When you are with a patient, always make sure that the ● Hub is positioned so that you can operate it and view the screen to avoid missing any alarms.
Page 48 System description 9. Graphical user interface screen 10. Connector for the charger 11. Camera (not in use) 12. Flash (not in use) LED indicators on the Hub The three LED indicators show the following: Description and functionality LED indicator for audio silencing (audio off). Illuminated in cyan color when audible alarm volume is set to zero.
Page 49 System description Introduction to the sensors There are four SpO sensors with different types of probes. The respiration sensor is used with a disposable respiration patch. The sensors acquire physiological data from the patient. All sensors are wearable and wireless, communicating with the Hub via an MBAN connection.
Page 50: System Installation Points To Note
System description When using the charger with a table mount, always place it on a flat surface and in a place where the risk of accidentally causing it to fall or being exposed to fluid splashes is minimal. The charger powers on automatically when it is plugged into the mains. Ensure an easy access to disconnect the charger mains plug from the mains.
Page 51: Graphical User Interface
Graphical user interface User interface indicators The following indicators appear in the Central Viewer, Hub, or Config UI graphical user interface. Indicator Explanation General warning sign. Displays when the SpO2 low - alarm priority setting deviates from the recommendation of international alarm safety standards. Alarm acknowledgement.
Page 52 Graphical user interface Indicator Explanation Loading data. Processing. Refresh. Signal search indicator. Connection to the CSS01 Core Services is working. No connection to the CSS01 Core Services. WLAN. The number of segments corresponds to the signal strength: the more segments, the stronger the signal. Not connected to a wireless network.
Page 53: Central Viewer
Graphical user interface Indicator Explanation Battery is charging indicator. Pair a sensor. Unpair a sensor. Locked screen. Alarm volume. Central Viewer Multiple Patient View The Multiple Patient View provides simultaneous views of real-time patient information for multiple patients within a care area. The view is separated into distinct areas for each patient called slots.
Page 54 Graphical user interface Alarm limits ● Waveforms ● Signal quality indicators for each displayed real-time numeric value ● Trends with event markers ● A list of active events ● Only the parameters currently being monitored for a patient appear in the Single Patient View.
Page 55: Hub
Graphical user interface The patient location is indicated as room number-bed. ● The alarm message. ● Actions menu The actions menu can be accessed by hovering the mouse pointer over the menu, or by selecting the patient name in the Single Patient View. To close the menu, move the mouse pointer away from the menu or select elsewhere in the Single Patient View.
Page 56: Hub Locked View
Graphical user interface 3. Alarm area: alarm messages, indicator of the alarms list (...), acknowledgement control (timed or indefinite) with background color according to alarm priority level, and the selection Reactivate alarms at the end of the list. 4. Data area (LIVE view, TRENDS view, detailed view, menu). 5.
Page 57 Graphical user interface Local or remote monitoring, no assigned patient LOCAL mode REMOTE mode In these examples: No Patient (No patient) = there is no assigned patient ● SURGICAL WARD = Care area ● Arrow at the bottom of the screen = access to the passcode view for unlocking the screen; ●...
Page 58: Hub Passcode View
Graphical user interface Patient assigned (Patient assigned) = there is an assigned patient ● Arrow at the bottom of the screen = access to the passcode view for unlocking the screen; ● touch the arrow or swipe your finger upwards on screen = locked screen indicator ●...
Page 59: Hub Live View
Graphical user interface In this example: Patient details (Patient details) = Title of the view showing ● patient-related information WARD 001–107 = Unit, room, and bed as entered during ● patient admission Last name, first name = Patient’s last and first names as ●...
Page 60: Hub Detailed View
Graphical user interface 2. Activate the screen. Note that you may need to enter the passcode to unlock the Hub. The LIVE view opens showing the numeric value(s) for the measured parameter(s). The LIVE view can contain data for one or more parameters, depending on the paired sensors.
Page 61: Hub Menu
Graphical user interface 3. Touch the arrow on screen or swipe your finger from left to right to return to the LIVE view Hub menu You can check various device-related functionalities regarding the sensors, sensor batteries, or the Hub through the menu on the Hub. This menu is accessible from any view by pressing on the Hub.
Page 62 Graphical user interface 2. Select SpO2 or RR. 3. Select any of the following to see the related details: a. Battery b. Sensor Status c. Device Information 4. You can return to the main menu by selecting on top of the screen in each menu.
Page 63: Managing Patients And Monitoring
Managing patients and monitoring Admitting a patient To start monitoring, you must first admit the patient to the Central Viewer. Admitting assigns a patient to a patient slot. 1. Select an available patient slot in the Multiple Patient View. Available patient slots display Admit Patient.
Page 64: Editing Patient Demographics
Managing patients and monitoring WARNING PATIENT SAFETY. Implantable Minute Ventilation Rate Responsive Pacemakers may react with the respiration sensor and cause the pacemaker to execute pacing with the maximum programmed rate. Before pairing the sensor and Hub, always check that the patient does not have this type of pacemaker.
Page 65: Powering On The Hub
Managing patients and monitoring 3. Select Save to save the edited patient demographics, or select Cancel to cancel editing and return to the previous screen (the window closes and no changes are saved). If patient demographics are successfully saved, the Single Patient View for the patient is displayed with the edited demographic information.
Page 66: Selecting A Patient
Managing patients and monitoring 2. Once you have given all the digits of your passcode, select the confirm key. If the code is correct, the screen unlocks. If the code is not correct, the ellipses are replaced with the text Enter passcode. Enter the correct passcode to unlock the screen.
Page 67: Attaching Measurement Devices To The Patient
Managing patients and monitoring Patient is not available appears: another Hub has already been assigned to this ● patient, or the patient has been discharged remotely. Check the patient and Hub assignments and patient admission status on the Central Viewer. No wireless network appears: there is no wireless network connection.
Page 68: Pairing Another Sensor
Managing patients and monitoring 1. Connect the sensor battery to the sensor: 2. Create the wireless connection by tapping the sensor to the rear of the Hub: You will feel a short vibration of the Hub during the pairing to indicate that the pairing was successful.
Page 69: Unpairing A Sensor
Managing patients and monitoring 2. Select the plus (+) indicator at the bottom left of the screen: The text Pair another sensor and a related graphic appear on screen. 3. Pair the sensor by tapping it to the rear of the Hub. The sensor must have a battery connected.
Page 70: Unassigning The Patient From The Hub
Managing patients and monitoring 1. Insert the Hub into the pouch. Check that the Hub parts indicated with the exclamation mark are aligned with the pouch as in the graphic. It is especially important that the speaker is not covered by the pouch to avoid missing any audible alarms.
Page 71: Discharging A Patient
Managing patients and monitoring 1. Press the key for 1.5 seconds. If the screen was active with a measurement and passcode accepted, a text ● appears asking you if you want to end patient monitoring, remove patient data from the Hub, and shut down. Confirm shut down. If the screen was off, the locked screen appears.
Page 72 Managing patients and monitoring 5815148-01 Portrait ™ Mobile Monitoring Solution...
Page 73: Battery Management
Battery management Safety precautions Familiarize yourself with the safety chapter of this manual for all safety precautions related to the system. Some warnings or cautions may also be listed with detailed instructions in this chapter. Connecting and disconnecting sensor batteries 1.
Page 74 Battery management 1. MBAN connection 2. Sensor connection 3. Battery charge The following table describes their functionality. Description and functionality MBAN connection indicator. Blinking amber slowly: the sensor battery is connected to the sensor, ● but sensor has not been paired with the Hub. Blinking amber quickly: MBAN connection to the Hub is lost.
Page 75: Led Indicators On The Charger
Battery management To save power, these LED indicators are off when: The sensor battery is in the charger ● The sensor battery is disconnected (the indicators turn off after 40 seconds of ● no movement) Monitoring is ongoing (except in error situations, see the table above) ●...
Page 76: Charging Batteries
Battery management Hub battery low: this alarm is triggered when the Hub battery capacity decreases ● to the configured alarming limit (5%, 10%, 15% capacity left) Charge Hub: this alarm is triggered when the Hub has 3% battery capacity left or ●...
Page 77: Charging An Empty Sensor Battery
Battery management 3. Place the sensor battery into any of the four battery slots in the charger, or the Hub into the dedicated slot: Ensure that the sensor battery or the Hub is firmly in its slot. 4. When the battery is fully charged, the LED indicator of that slot is lit with solid green.
Page 78: Checking The Status Of A Sensor Battery
Battery management 1. Press 2. Select Hub. 3. Select Battery. Detailed information about the battery appears. 4. You can return to the main menu by selecting repeatedly on top of the screen. You can close the menu by swiping down on screen or by pressing Checking the status of a sensor battery The sensor battery status indicators are always displayed in detailed views under the measurement labels.
Page 79: About The Lithium-Ion Battery
USA: You may follow the battery manufacturers instructions on the battery to ● recycle it. Alternatively, you may return GE product batteries to GE for recycling. For information about returning batteries to GE, contact your authorized GE Service representative or contact GE Equipment Services at 1-800-437-1171.
Page 80 Battery management 5815148-01 Portrait ™ Mobile Monitoring Solution...
Page 81: Hub And Modes
Hub and modes About modes You can select one of the two use modes on the Hub, REMOTE or LOCAL: The REMOTE mode displays alarms on the Central Viewer only. They are indicated ● on the Hub (visually and audibly) only after you manually activate the screen by pressing the asterisk key and entering the passcode.
Page 82 Hub and modes 5815148-01 Portrait ™ Mobile Monitoring Solution...
Page 83: Alarms
Alarms Safety precautions Familiarize yourself with the safety chapter of this manual for all safety precautions related to the system. Some warnings or cautions may also be listed with detailed instructions in this chapter. Alarm conditions There are two types of alarm conditions: physiological and technical. Physiological alarm conditions are triggered by a patient measurement being outside the parameter limits or by apnea.
Page 84: Alarm Signals And User Position
Alarms Alarm signals and user position Alarm signals are designed to alert the user visually and audibly. The signals should be detectable up to a distance of 1 meter/3.3 feet from the alarming device. Visual alarm indicators Visual alarm indicators have the following characteristics: Alarm location Priority level High...
Page 85: About Alarm Messages
Alarms About alarm messages For all alarm messages, refer to the tables listed at the end of this manual. The tables list the actual alarm message texts, their location on screen, their possible causes, and suggestions for actions. Auditory alarm indicators Alarm signals indicate that an alarm condition is present.
Page 86: Adjusting Alarm Volume On The Central Viewer
Alarms 3. Adjust the alarm settings by moving the sliders to the desired values, by pressing the up or down arrows with a field selected, or by entering values in the available fields. The profile used to set default values is displayed at the top of the Edit Alarm ●...
Page 87: Alarm Acknowledgement
Alarms NOTE Make sure that you adjust the volume so that it is suitable for the care environment and does not cause discomfort to the patient. NOTE When the Hub is out of network range, the alarm volume is increased to 50% if it was set below that level. 1.
Page 88: Reactivating Alarms
Alarms 2. Select (infinite acknowledgement) or (timed acknowledgement). The background color of the key is determined by the alarm priority. 3. Hub only: Confirm by pressing , or select X on the upper right corner of the message if you do not wish acknowledge the alarm. All active alarms are now silenced and display with the acknowledgement indicator.
Page 89: Alarm Logs
Alarms Alarm logs Alarm conditions, their priorities, and start and end times are recorded in the alarm log. Also alarm configurations and their changes are logged. The alarm log is stored in the persistence server. In the event that the Hub is disconnected from the server for any reason (even if the server is offline or powered down), it will store up to four hours of offline data for inclusion in the alarm log once reconnected.
Page 90 Alarms 5815148-01 Portrait ™ Mobile Monitoring Solution...
Page 91: Parameter Filtering And Signal Quality
Parameter filtering and signal quality Parameter filtering When configured, the parameter filter calculates a moving average of the calculated parameter values. The averaging time can be configured with the Config UI. Using the parameter filter makes the values more accurate but may delay the visibility of changes.
Page 92 Parameter filtering and signal quality Signal amplitude ● Motion artifacts ● Noise ● Ambient light interference ● 5815148-01 Portrait ™ Mobile Monitoring Solution...
Page 93: Impedance Respiration
Impedance respiration Safety precautions Familiarize yourself with the safety chapter of this manual for all safety precautions related to the system. Some warnings or cautions may also be listed with detailed instructions in this chapter. Portrait Wearable Respiration Rate Sensor (Portrait RR P-RR01) intended use The Portrait Wearable Respiration Rate Sensor (Portrait P-RR01) is intended for use...
Page 94: Respiration Measurement Limitations
Impedance respiration Respiration measurement limitations Impedance respiration is intended for patients over three years old and weighing ● ≥10 kg (22 lb). Motion artifact (such as mobile (walking) patient, shivering, and interference ● from the beating heart) may interfere with the respiration measurement, reduce the respiration rate accuracy, and/or disable apnea detection.
Page 95: Respiration Measurement Practicalities
Impedance respiration In addition to true breaths, patient motion can also change the impedance of the chest, and is thus visible in the impedance waveform. Motion artifact can be several times larger in amplitude than normal breathing. The following graphic illustrates how motion artifact is reflected in the respiration waveform: In this example: 1–11 = room-bed identification...
Page 96: Respiration Measurement Setup
Impedance respiration Do not use damaged sensors or respiration patches. ● Always check the patient and the measurement site if the accuracy of the ● respiration data is questionable. Respiration rate may be shown as 0 without an apnea alarm if the patient's ●...
Page 97 Impedance respiration 3. Attach the respiration patch to the patient as indicated in the graphic: where: 1 to 3 = Electrodes 1 to 3 ● 4 = Xiphoid process ● 5 = Navel ● 6 = Sternum ● 4. Connect the sensor connector to the respiration patch connector, and connect the battery to the sensor: where: 1 to 3 = Electrodes 1 to 3...
Page 98: Checking The Respiration Measurement
Impedance respiration 6. Pair the sensor and Hub. If the patient has a pacemaker and its status is either known or unknown , a notification similar to the following safety statement appears on the Hub: WARNING PATIENT SAFETY. Implantable Minute Ventilation Rate Responsive Pacemakers may react with the respiration sensor and cause the pacemaker to execute pacing with the maximum programmed rate.
Page 99: Pulse Oximetry And Pulse Rate
Pulse oximetry and pulse rate Safety precautions Familiarize yourself with the safety chapter of this manual for all safety precautions related to the system. Some warnings or cautions may also be listed with detailed instructions in this chapter. Portrait Wearable Pulse Oximetry Sensor P-SA01 (Portrait SpO2 P-SA01) intended use The Portrait Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SA01) is intended for...
Page 100: Wearable Pulse Oximetry Sensor
(HbO + Hb) is called functional oxygen saturation of arterial blood (SaO ). GE pulse oximetry is calibrated to display functional oxygen saturation. The actual measurement of arterial oxygen saturation is done by spectrophotometry, a technique that quantifies the amount of transmitted light.
Page 101: Spo₂ Measurement Quality
Pulse oximetry and pulse rate of these wavelengths, the oximeter can compare the ratio of each absorbance and convert it into an SpO value. Plethysmographic pulse waveform is derived from the infrared signal. It reflects the blood pulsation at the measuring site, and the amplitude of the waveform represents perfusion.
Page 102: Spo 2 And Pulse Rate Measurement Practicalities
Pulse oximetry and pulse rate Examples of pulse oximetry waveforms Normal waveform Low perfusion waveform Motion artifact If noise (artifact) is seen on the waveform because of poor SpO sensor placement, the photodetector may not be flush with the tissue. Check that the sensor is secured and the tissue sample is not too thick.
Page 103: Spo 2 And Pulse Rate Measurement Setup
Pulse oximetry and pulse rate Always check the patient and the measurement site if the accuracy of the SpO ● data is questionable. and pulse rate measurement setup The following graphic describes the options available for the SpO and pulse rate measurement setup.
Page 104 Pulse oximetry and pulse rate 3. Connect the sensor battery to the sensor and attach the probe to the patient’s finger: When using a wrap sensor, make sure to position the light source (1) directly opposite the detector (2). This graphic shows the attachment of the probe to the attachment accessory band.
Page 105: Checking The Spo 2 And Pulse Rate Measurement
1. Press both sides of the probe gently to make the probe more rounded. This will help when inserting the finger. 2. Align the probe with the GE logo upwards and insert the finger all the way to the end of the probe.
Page 106: Troubleshooting The Measurement
Pulse oximetry and pulse rate Troubleshooting the measurement Refer to the troubleshooting chapter in this manual for guidance regarding the most common measurement-related problems. You can find a list of error messages and alarms in the messages chapter. functional testers You can verify the functionality of pulse oximeter sensors with a functional SpO tester, but you cannot evaluate their accuracy with such a device.
Page 107: Trends
Trends About trends on the Central Viewer Similar to trends on the Hub, the trends on the Central Viewer also show the most representative values of a patient’s physiological parameter data for each minute. In the case of the Central Viewer, the trend data undergoes an additional smoothing process.
Page 108: Using The Trend Cursor On The Central Viewer
Trends In this example: Trends = Trends area title ● 2 hours, 4 hours, 8 hours, 12 hours, 24 hours = trend time interval selections ● SpO2% = pulse oximetry label and unit of measure ● PR/min = pulse rate label and unit of measure ●...
Page 109: About Trends On The Hub
Trends Where: Trends (Trends) = Trends area title ● 2 hours, 4 hours, 8 hours, 12 hours, 24 hours (X hours) = trend time interval ● selections SpO2% (SpO2%) = pulse oximetry label and unit of measure ● PR/min (PR/min) = pulse rate label and unit of measure ●...
Page 110: Using The Trend Cursor On The Hub
Trends In this example: 1–11 = room-bed identification ● Smith, Peter = patient’s last name, first name ● SpO2% (SpO2%) = pulse oximetry label and unit of ● measure PR/min (PR/min) = pulse rate label and unit of measure ● RR/min (RR/min) = respiration rate label and unit of ●...
Page 111 Trends You can move the cursor by touching another location in the trend area, or by dragging the cursor to left or right. If you touch the trend scale area, the cursor moves to the oldest time available. 5815148-01 Portrait ™...
Page 112 Trends 5815148-01 Portrait ™ Mobile Monitoring Solution...
Page 113: Cleaning, Disinfection, And Care
GE. For cleaning, disinfection, and care information for devices, device components, supplies, and accessories made by manufacturers other than GE, see the applicable instructions for use provided by the manufacturer. Visual inspection, cleaning, and disinfection frequency Carefully inspect devices visually to verify proper function.
Page 114: Cleaning
Cleaning points to note Warranty does not cover any damages caused by using substances or methods ● not approved by GE. Always dilute cleaning and disinfectant agents according to their manufacturer’s ● instructions. Always consider your hospital guidelines as well.
Page 115: Cleaning Procedure For The Hub
Cleaning, disinfection, and care Cleaning procedure for the Hub 1. Power key 2. * (asterisk) key 3. Audio silence LED area 4. Active alarms LED area 5. Audio silence indicator 6. Alarm indicator 7. Wireless network connection LED indicator 8. Speaker 9.
Page 116 Cleaning, disinfection, and care 2. If the Hub is not in clinical use, make sure that it is powered off. If the Hub is powered on: a. Activate the screen by pressing the key and entering the passcode with the on-screen keyboard. Confirm with the key.
Page 117: Cleaning Procedure For The Respiration Sensor
Cleaning, disinfection, and care 7. Rinse the device thoroughly using a soft, clean non-linting cloth saturated with lukewarm tap water (temperature range 27 to 44°C, 81 to 111°F). 8. Allow the device to air dry until it is visually dry, or dry thoroughly with a soft, clean, non-linting cloth before placing the device into the charger.
Page 118 Cleaning, disinfection, and care Preparing the respiration sensor for cleaning 1. Remove the sensor battery from the sensor. where: 1 = sensor battery ● 2 = sensor ● 3 = respiration patch connector ● 2. Disconnect the respiration patch from the respiration sensor. Dispose of the used respiration patch according to your hospital guidelines.
Page 119: Cleaning Procedure For The Spo Sensors
Cleaning, disinfection, and care 8. Allow the device to air dry until it is visually dry, or dry thoroughly with a soft, clean, non-linting cloth before taking the device into use or placing it into the charger. Pay special attention to metal parts (marked here with red) when drying device ●...
Page 120 Cleaning, disinfection, and care Initiate cleaning and disinfection as soon as possible after use (recommended within 1 hour). Remove any soil as soon as possible by wiping the device to prevent the drying of soil on the device as described in following procedures. Soiled devices must be separated from non-contaminated devices to avoid contamination of personnel or surroundings.
Page 121 Cleaning, disinfection, and care 3. Wipe the cable and all sensor surfaces, including the lenses. Ensure that the entire surface is wet and make sure all surfaces are uniformly cleaned. Pay special attention to hard-to-clean areas (marked here with red), like ●...
Page 122: Cleaning Procedure For Sensor Batteries
Cleaning, disinfection, and care Post-cleaning inspection Inspect devices visually after cleaning and prior to disinfection for the following: Cleanliness ● If there is any visible soil present, repeat the cleaning procedure until no visible ￭ soil remains. Damage, including, but not limited to, corrosion (rust, pitting), discoloration, ●...
Page 123 Cleaning, disinfection, and care 2. Wring excess liquid from the cloth (wet but not dripping). 3. Wipe the exterior surface. Ensure that the entire surface is wet and make sure all surfaces are uniformly cleaned. Pay special attention to hard-to-clean areas (marked here with red), like ●...
Page 124: Cleaning Procedure For The Charger
Cleaning, disinfection, and care Cleaning procedure for the charger Initiate cleaning and disinfection as soon as possible after use (recommended within 1 hour). Remove any soil as soon as possible by wiping the device to prevent the drying of soil on the device as described in following procedures. Soiled devices must be separated from non-contaminated devices to avoid contamination of personnel or surroundings.
Page 125: Cleaning Procedure For The Alarming Unit
Cleaning, disinfection, and care 7. Rinse the device thoroughly using a soft, clean non-linting cloth saturated with lukewarm tap water (temperature range 27 to 44°C, 81 to 111°F). 8. Allow the device to air dry until it is visually dry, or dry with thoroughly with a soft, clean, non-linting cloth.
Page 126: Disinfection
Cleaning, disinfection, and care Cleaning the alarming unit In case there is some dried or gross soil, perform pre-cleaning by wiping with a soft, clean non-linting cloth saturated with lukewarm tap water (temperature range 27 to 44°C, 81 to 111°F) until visible dried or gross soil is removed. 1.
Page 127: Permitted Disinfectants
Cleaning, disinfection, and care Visually ensure that no substance residue remains on the device. ● Permitted disinfectants All third party trademarks are property of their respective owners. Trademark names and product availability may vary by country. CaviWipes wipes ● Super Sani-Cloth (purple top) ●...
Page 128: Care
Cleaning, disinfection, and care Care Care schedules Check daily that the Hub, sensors, sensor batteries, charger, alarming unit, and the ● hardware running the Central Viewer application are clean and intact. Check the battery capacity of the Hub and sensors daily. ●...
Page 129: Periodic Maintenance
Periodic maintenance Daily checks Check that the accessories, cables, cable connectors, Hub, sensors, sensor ● batteries, and hardware running the Central Viewer are clean and intact. Check the charge of the Hub and sensor batteries. ● Preventive maintenance There is no other preventive maintenance than cleaning and daily checks. ●...
Page 130 Periodic maintenance 5815148-01 Portrait ™ Mobile Monitoring Solution...
Page 131: Troubleshooting
Troubleshooting Troubleshooting the Central Viewer Problem Solution Retry admitting the patient. ● Restart the Central Viewer. ● Cannot admit a new patient If the problem persists, contact qualified service ● personnel. Cannot select the bed and room Contact qualified service personnel. ●...
Page 132: Troubleshooting The Hub
Troubleshooting Problem Solution Check that the alarm limits and priorities are set ● correctly for your care area. Check the alarm volume. ● Check that the alarming unit is connected to the ● Loss of audible and/or visual alarms Central Viewer computer. Check the alarm function as instructed in the ●...
Page 133 Troubleshooting Problem Solution No connection to patient monitoring services ● appears: the Hub is not connected to the Core Services. Make sure that the Hub is within the network coverage range. If that does not help, contact service personnel. No license available appears: there are no ●...
Page 134: Troubleshooting The Respiration Measurement
Troubleshooting Troubleshooting the respiration measurement Problem Solution What can I do if the respiration measurement fails? Check electrode quality (e.g. that the gel is not dry) ● and positioning. Check that the SQI for respiration shows a good ● signal. Other electrical devices may interfere with the ●...
Page 135: Troubleshooting The Spo 2 And Pulse Rate Measurements
Troubleshooting Problem Solution If the problem persists, contact qualified service personnel. Troubleshooting the SpO and pulse rate measurements Problem Solution signal is poor Check the sensor and sensor position. ● Check the probe and probe position. ● Check that the patient is not shivering, moving, or ●...
Page 136 Troubleshooting Problem Solution Keeping the sensor cable away from the power ● cord of the electrosurgical unit. What does motion artifact look like, what problems Motion artifact occurs with excessive motion of can it cause, and how can it be corrected? the sensor.
Page 137: Alarm Messages
Alarm messages Alarms related to the respiration rate measurement Alarm priorities are given in the section discussing alarm specifications. Make sure that you are familiar with the generic layout of the Hub and Central Viewer screens. This will help you identify where the following alarm messages appear. The alarm location is indicated with the following abbreviations: al.
Page 138 Alarm messages Location Alarm message Possible explanations Suggested actions Hub: data The patient’s breathing pattern Replace the respiration patch. ● ● is being learned because the Learning ● Wait until the message ● measurement has just been disappears. started or because of very large artifacts in the signal.
Page 139: Alarms Related To The Spo 2 And Pulse Rate Measurement
Alarm messages Location Alarm message Possible explanations Suggested actions Hub: al. area Connection between the Hub Place the Hub closer to the ● ● and sensor is poor and there patient. Weak Resp ● was a data loss between the connection If the problem persists, ●...
Page 140 Alarm messages Physiological messages Alarm message Location Possible explanations Suggested actions Hub: al. area Measurement values are equal Check the patient. ● ● to or outside the alarm limits. PR high ● data Adjust alarm limits on the ● ● Central Viewer if necessary.
Page 141 Alarm messages Technical messages Alarm message Location Possible explanations Suggested actions Hub: al. area and PR values are not yet Reposition the probe. ● ● available due to ongoing signal Pulse search ● Clean the application site ● control and data acquisition. (remove nail polish, for instance).
Page 142: Alarms Related To Device Issues
Alarm messages Location Alarm message Possible explanations Suggested actions Hub: Hub: Battery has been removed from Connect a sensor battery. ● the sensor. No SpO2 battery al. area ● ● No battery data ● ● Central Viewer: Central Viewer: No SpO2 battery ●...
Page 143 Alarm messages Location Alarm message Possible explanations Suggested actions Hub: al. area The Hub battery has no charge Charge the Hub. ● ● left. Charge Hub ● Central Viewer: Charge Hub ● Hub: al. area The Hub battery charge is Charge the Hub.
Page 144 Alarm messages 5815148-01 Portrait ™ Mobile Monitoring Solution...
Page 145: Technical Specifications
Technical specifications Design, environmental, and physical specifications For additional specifications, refer to the documentation provided with your equipment. For more information on products that can be used with the system, refer to the list of Compatible devices. Operating altitude: The system shall meet specifications when subjected to altitudes corresponding to pressure readings from 620 mbar to 1060 mbar.
Page 146: Radio Equipment Directive (Red) Information
Technical specifications Radio Equipment Directive (RED) information This device complies with Radio Equipment Directive (2014/53/EU). Only indoors usage is permitted with 5150 to 5350 MHz WLAN. ISED information Hub ISED IC: 25821-HUB01, contains ISED IC: 25821-WL18DBMOD ● Sensor battery ISED IC: 25821-SBT01 ●...
Page 147: Technical Specifications, Hub
Technical specifications Technical specifications, Hub Size (H x W x D) 14.1 x 6.3 x 2.1 cm (5.6 x 2.5 x 0.8 in) Weight 223 g (0.5 lb) Operating temperature 0 to 35°C (32 to 95°F) Operating humidity 5 to 95% RH non-condensing Operating pressure 620 to 1060 hPa Storage temperature...
Page 148: Technical Specifications, Sensors
Technical specifications IPX2 Fluid ingress Power supply Type: Switching power adaptor ● Model: ACM36US12–XZ1110A ● Manufacturer: XP Power ● Fluid ingress: IPX0 ● Rated input voltage: 100 to 240 Vac 50/60 Hz ● Rated output voltage: 12 Vdc ● Rated output power: 3.0 A ●...
Page 149: Technical Specifications, Alarming Unit
Technical specifications Operating temperature 0 to 40°C (32 to 104°F) Operating humidity 5 to 95% RH non-condensing Operating pressure 620 to 1060 hPa Storage and transport Storage: -20 to 40°C (–4 to 104°F) temperature Transport: –20 to 50°C (–4 to 122°F) Storage and transport 5 to 95% non-condensing humidity...
Page 150: Technical Specifications, Ehl Platform
Technical specifications 8 GB (minimum) 16 GB preferred Storage type SSD preferred Storage size 120 GB (minimum) Free disk space 1 GB (minimum) Monitor requirements Size 20 inches (50 cm) (minimum) Resolution 1920 x 1080 (minimum) Refresh rate 60 Hz (minimum) Ports Digital Video Interface (HDMI or DisplayPort) (required if display is not built into the computer)
Page 151: Alarm Specifications
Alarm specifications Auditory alarm volume, IEC tones Tested in accordance with IEC 60601-1-8 subclause 6.3.3.2 with alarm volume control set to maximum level (100%) and minimum level (10%).. Alarming unit Alarm volume setting Maximum sound pressure level 100% High priority alarm: 68 dB(A) Medium priority alarm: 67 dB(A) Low priority alarm: 56 dB(A) High priority alarm: 61 dB(A)
Page 152: Iec Alarm Tone Sound Patterns
Alarm specifications Time ≥ 5 s: ±1 s ● Frequencies: ±5 Hz ● IEC alarm tone sound patterns Priority Corresponding sound pattern High Beep “C” (523 Hz/100 ms) Silence (100 ms) ● Beep “F” (698 Hz/100 ms) Silence (100 ms) ●...
Page 153: Alarm Delay Specifications For Impedance Respiration Alarms
Alarm specifications lost, Network connection lost alarms are generated on the Hub and on the Viewer (delays reported below). The determination of an alarm condition has nominal factors (such as signal quality and movement artifact) that may affect the ability to derive the parameter value. The following disclosures list the alarm system delays as an average and include the delay of the first activated priority alarm.
Page 154: Alarm Delay Specifications For Spo 2 And Pr Alarms
Alarm specifications Alarm delay specifications for SpO and PR alarms The following table lists the alarm delays for physiological alarms related to the pulse oximetry and pulse rate measurements. Any alarm delays that are less than 5 s are given as <5 s.
Page 155 Alarm specifications Alarm Alarm delay <5 s Charge Hub <5 s Hub battery low <5 s Hub charging failure <5 s Hub overheating Network connection lost (Hub) WLAN connection lost: 33 s (average) (32 to 33 s range) Connection to Central Viewer lost: 193 s (average) (187 to 204 s range) Network connection lost (Central Viewer) 37 s (average) (37 to 38 s range) 5815148-01...
Page 156 Alarm specifications 5815148-01 Portrait ™ Mobile Monitoring Solution...
Page 157: Parameter Specifications
Parameter specifications displayed saturation values Portrait pulse oximetry technology is calibrated to display functional saturation. NOTE You can verify the functionality of pulse oximeter sensor and monitor with a functional SpO tester but you cannot evaluate their accuracy with such a device. For more information, refer to the standard ISO 80601-2-61:2017 Annex FF (Simulators, calibrators and functional testers for pulse oximeter equipment).
Page 158: Spo 2 Test Methods Used To Establish Accuracy Claims During Low Perfusion
Parameter specifications test methods used to establish accuracy claims during low perfusion Portrait technology with Portrait sensors P-SA01, P-SP01, P-W01, and P-SE01 has been validated for SpO low perfusion accuracy in bench top testing using a Fluke Biomedical ProSim 8 Vital Signs Simulator with signal strength setting of 0.2% modulation and oxygen saturation levels of 70 to 100% at a pulse rate of 90 bpm.
Page 159: Spo₂ Supplemental Analysis Graphs
Parameter specifications SpO₂ supplemental analysis graphs Additional accuracy information for Portrait sensors The table information provides supplemental data analysis for Portrait sensors’ measurement accuracy. The following modified Bland-Altman plots show SpO data by sensor type. Bland-Altman plot for SpO - P-SA01 sensor, non-motion - P-SA01 sensor measured accuracy, non-motion Accuracy 70-80% (Arms) Accuracy 80-90% (Arms)
Page 160 Parameter specifications Bland-Altman plot for SpO - P-SP01 sensor, non-motion P-SP01 sensor accuracy, non-motion Accuracy 70-80% (Arms) Accuracy 80-90% (Arms) Accuracy 90-100% (Arms) 1.48 1.383 1.185 Bland-Altman plot for SpO - P-SP01 sensor, motion P-SP01 sensor accuracy, motion Accuracy 70-80% (Arms) Accuracy 80-90% (Arms) Accuracy 90-100% (Arms) 1.312...
Page 161 Parameter specifications Bland-Altman plot for SpO - P-W01 sensor, non-motion P-W01 sensor accuracy, non-motion Accuracy 70-80% (Arms) Accuracy 80-90% (Arms) Accuracy 90-100% (Arms) 2.169 1.638 1.525 Bland-Altman plot for SpO - P-W01 sensor, motion P-W01 sensor accuracy, motion Accuracy 70-80% (Arms) Accuracy 80-90% (Arms) Accuracy 90-100% (Arms) 2.625...
Page 162 Parameter specifications Bland-Altman plot for SpO - P-SE01 sensor, non-motion P-SE01 sensor accuracy, non-motion Accuracy 70-80% (Arms) Accuracy 80-90% (Arms) Accuracy 90-100% (Arms) 1.669 1.348 1.121 Bland-Altman plot for SpO - P-SE01 sensor, motion P-SE01 sensor accuracy, motion Accuracy 70-80% (Arms) Accuracy 80-90% (Arms) Accuracy 90-100% (Arms) 2.261...
Page 163: Impedance Respiration Performance Specifications
Parameter specifications Impedance respiration performance specifications Impedance respiration measurement 0 to 99 breaths per minute value and display range Impedance respiration measurement 4 to 60 breaths per minute: ±3 breaths per minute accuracy Impedance respiration measurement 1 breath per minute precision Impedance respiration measurement 100 Ω...
Page 164 Parameter specifications 5815148-01 Portrait ™ Mobile Monitoring Solution...
Page 165: Abbreviations
Abbreviations List of abbreviations The following abbreviations appear in the software or in the device manuals. Abbreviation Explanation April August Type BF: Applied parts electrically connected to the patient, but not directly to the heart Beats per minute Type CF: Applied parts electrically connected to the heart of the patient December Electronic article surveillance Electrocardiogram...
Page 166 Abbreviations Abbreviation Explanation MR, MRI Magnetic resonance imaging Near field communication November Oxygen October PaCO Partial pressure of carbon dioxide in the arteries Hydrogen ion concentration Pulse rate PURW Purified water Radio frequency RFID Radio-frequency identification Respiration rate Arterial oxygen saturation September SpO2 Arterial blood oxygen measured with pulse oximetry...
Page 167: Skills Checklist
Skills checklist Safety To familiarize yourself with these functions and features, study the topics listed as recommended reading. The numbers in brackets refer to the page numbers in the manual. As you proceed, mark your completed tasks in the table. Recommended reading Completed Not applicable...
Page 168: System Introduction
Skills checklist Recommended reading Completed Not applicable DISPOSAL SAFETY PRECAUTIONS Disposal cautions (31) ● SYMBOLS AND MARKINGS Safety symbols (21) ● Equipment markings (34) ● System introduction To familiarize yourself with these functions and features, study the topics listed as recommended reading.
Page 169: Configuration
Skills checklist Recommended reading Completed Not applicable USER INTERFACE INDICATORS User interface indicators (51) ● CENTRAL VIEWER Multiple Patient View (53) ● Single Patient View (53) ● Hub screen elements (55) ● Hub locked view (56) ● Hub passcode view (58) ●...
Page 170: Battery Management
Skills checklist Recommended reading Completed Not applicable SENSOR PAIRING AND UNPAIRING Pairing the first sensor (67) ● Pairing another sensor (68) ● Unpairing a sensor (69) ● PATIENT AND BED CHANGE Moving a patient to a new bed (69) ● ENDING MONITORING AND DISCHARGE Unassigning the patient from the Hub (70) ●...
Page 171: Alarms
Skills checklist Alarms To familiarize yourself with these functions and features, study the topics listed as recommended reading. The numbers in brackets refer to the page numbers in the manual. As you proceed, mark your completed tasks in the table. Recommended reading Completed Not applicable...
Page 172: Pulse Oximetry And Pulse Rate
Skills checklist Recommended reading Completed Not applicable ABOUT THE MEASUREMENT Respiration measurement limitations (94) ● Respiration measurement description (94) ● Respiration points to note (95) ● MEASUREMENT SETUP Preparing the patient's electrode sites (96) ● Starting the respiration measurement (96) ●...
Page 173: Cleaning, Disinfection, And Care
Skills checklist Recommended reading Completed Not applicable TRENDS ON THE CENTRAL VIEWER About trends on the Central Viewer (107) ● Viewing trends on the Central Viewer (107) ● Using the trend cursor on the Central Viewer (108) ● TRENDS ON THE HUB About trends on the Hub (109) ●...
Page 174 Skills checklist Recommended reading Completed Not applicable CLEANING THE CHARGER Cleaning procedure for the charger (124) ● Preparing the charger for cleaning (124) ● Cleaning the charger (124) ● CLEANING THE ALARMING UNIT Cleaning procedure for the alarming unit (125) ●...
Page 175: Quick Workflow Overview
Quick workflow overview Quick workflow instructions These instructions are NOT meant to be sufficient guidance for using the system. Before starting monitoring, ensure that you have read and understood the manual. 1. Admit a new patient on the Central Viewer. 2.
Page 176 Quick workflow overview 5815148-01 Portrait ™ Mobile Monitoring Solution...
Page 177: Default Settings And Configuration
Default settings and configuration About configuration settings There are certain system default configuration settings that are available for an authorized clinical user. These settings can be found in Config UI > Configuration > Default Profiles > Patient, and they are password-protected. Certain settings have different defaults per Care profile (Age 3-4, Age 5-6, Age 7-12, Age 13-17, Adult).
Page 178 Default settings and configuration Setting Description Options Unit of Default value measure Percent 0, 10, 20, 30, 40, Alarm volume - Hub 50, 60, 70, 80, 90, 100 Mode settings Hub monitoring mode Local Local| Remote Resp limit alarms RR high - alarm on Not adjustable.
Page 179 Default settings and configuration Setting Description Options Unit of Default value measure 10 to 120 Apnea - limit Select the time Seconds after which the Apnea alarm is triggered. Apnea - alarm priority Select the High/Medium High priority level for the Apnea alarm.
Page 180 Default settings and configuration Setting Description Options Unit of Default value measure SpO2 low - alarm priority Select the High| Medium| Medium priority for the Low| Info SpO2 low alarm. If you set the priority value so low that it deviates from the recommen- dation of inter-...
Page 181 Default settings and configuration Setting Description Options Unit of Default value measure 30 to 240 Age 3-4: 140 PR high - alarm limit Select the Beats/Min threshold alarm Age 5-6: 140 limit for the PR Age 7-12: 140 high alarm. Age 13-17: 150 Adult: 150 Facility: 140...
Page 182 Default settings and configuration 5815148-01 Portrait ™ Mobile Monitoring Solution...
Page 183: Compatible Devices
Compatible devices Hub (HUB01) compatibility The Portrait Mobile Patient Monitor HUB01 is compatible with the following Portrait Mobile Monitoring Solution components: Portrait CSS01, Core Services ● Portrait CVA01, Central Viewer Application ● Portrait SpO2 P-SA01, SpO2 Wearable Pulse Oximetry Sensor ●...
Page 184: Spo 2 Sensor (P-Se01) Compatibility
Compatible devices sensor (P-SE01) compatibility The Portrait SpO2 P-SE01 Wearable Pulse Oximetry Sensor with small wrap is compatible with the following products: Small replacement foam wrap, TS-RWS ● Medium replacement foam wrap, TS-RWM ● Replacement tape, TS-RTW ● Portrait SBT01, Sensor Battery ●...
Page 185: Sensor Battery (Sbt01) Compatibility
Compatible devices Sensor battery (SBT01) compatibility The Portrait SBT01 Sensor Battery is compatible with the following products: Portrait HUB01, Mobile Patient Monitor ● Portrait SpO2 P-SA01, SpO2 Wearable Pulse Oximetry Sensor ● Portrait SpO2 P-SP01, SpO2 Wearable Pulse Oximetry Sensor ●...
Page 186 Compatible devices 5815148-01 Portrait ™ Mobile Monitoring Solution...
Page 187: Supplies And Accessories
Supplies and accessories List of supplies and accessories Materials used in accessories are not toxic. Accessories do not contain natural rubber latex. Product code Description TS-RWL SpO2 Sensor Foam (large) TS-RWM SpO2 Sensor Foam (medium) TS-RWS SpO2 Sensor Foam (small) TS-RTW SpO2 Sensor Tape, disposable 5514246...
Page 188 Supplies and accessories 5815148-01 Portrait ™ Mobile Monitoring Solution...
Page 189: Electromagnetic Compatibility
Changes or modifications to this device/system not expressly approved by GE may cause EMC issues with this or other equipment. This device/system is designed and tested to comply with applicable standards and regulations regarding EMC and...
Page 190: About Emc Disturbance
Electromagnetic compatibility WARNING INTERFERENCE. Other equipment may interfere with the system, even if that other equipment complies with CISPR emission requirements. WARNING LOSS OF MONITORING. To avoid losing the Hub and sensor connectivity and thus patient monitoring, do not use an RFID reader operating at the frequency of 2.45 GHz close to any part of the Hub and sensors.
Page 191: Electromagnetic Emissions
Electromagnetic compatibility essential performance when signal strength is indicated as normal ( ) and no messages about questionable signal quality are displayed Pulse oximetry saturation measurement value (70 to 100%): ±2 accuracy (a root-mean-square difference for adult and pediatric patients per ISO 80601-2-61, Clause 201.12.1.101.1) Pulse oximetry peripheral pulse rate accuracy PR (30 to 250 bpm): ±2 bpm...
Page 192 Electromagnetic compatibility Guidance and manufacturer’s declaration — electromagnetic immunity This device is intended for use in the electromagnetic environment specified below. It is the responsibility of the hospital to assure that the device is used in such an environment. IEC 60601–1–2 test Electromagnetic environment —...
Page 193: Electromagnetic Immunity For Rf
Electromagnetic compatibility Electromagnetic immunity for RF Guidance and manufacturer’s declaration — electromagnetic immunity This device is intended for use in the electromagnetic environment specified below. It is the responsibility of the hospital to assure that the device is used in such an environment. Immunity IEC 60601 test Compliance...
Page 194: Recommended Separation Distances
Electromagnetic compatibility NOTE SpO2 sensor exempted from test per IEC 60601–1–2 Table 6 note c). NOTE Amplitude modulation at frequency 2 Hz used for testing the respiration sensor, sensor battery, and Hub. Recommended separation distances Recommended separation distances between portable and mobile RF communications equipment and the device.
Page 195 Electromagnetic compatibility Guidance and manufacturer’s declaration — electromagnetic immunity (IEC/EN 60601-1-2, 4th Edition) Service Maximum Dis- Immunity Immunity Test fre- Band Modulation power (W) tance compliance test level quency (MHz) level (V/m) (V/m) (MHz) 704 to LTE Band 13, Pulse Modulation 217 800 to Pulse...
Page 196: Applicable Rf Receiver And Transmitter Specifications
Electromagnetic compatibility Guidance and manufacturer’s declaration — electromagnetic immunity (AIM STANDARD 7351731 Rev 2.00, MEDICAL ELECTRICAL EQUIPMENT AND SYSTEM ELECTROMAGNETIC IMMUNITY TEST FOR EXPOSURE TO RADIO FREQUENCY IDENTIFICATION READERS) Test System component Distance Immunity Immunity test RFID standard frequency compliance level the test is level...
Page 197 content...
Page 198 Portrait HUB01/SBT01/P-SA01/P-SP01/P-W01/P-SE01/P-RR01 GE Healthcare Finland Oy Kuortaneenkatu 2 FI-00510 Helsinki Finland Tel: +358 10 39411 www.gehealthcare.com Portrait CSS01/CVA01/CAU01 GE Medical Systems GE Medical Systems SCS Information Technologies, Inc. Information Technologies 9900 Innovation Drive 283 Rue de la Miniere Wauwatosa WI 53226 USA...

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