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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 .................................................... 149

Technical specifications, EHL Platform ...................................................... 150

20 Alarm specifications..................................................................................151

Auditory alarm volume, IEC tones.............................................................. 151

Audio alarm sound tolerances ................................................................... 151

IEC alarm tone sound patterns .................................................................. 152

Auditory information signal characteristics .............................................. 152

Alarm delay specifications ......................................................................... 152

Alarm delay specifications for impedance respiration alarms............... 153

Alarm delay specifications for SpO

and PR alarms ............................... 154

Alarm delay specifications for technical issues ...................................... 154

21 Parameter specifications..........................................................................157

SpO

displayed saturation values .............................................................. 157

SpO₂ summary of clinical studies used to establish accuracy
claims........................................................................................................... 157

Accuracy of Portrait

sensor technology ............................................... 157

SpO

test methods used to establish accuracy claims during

motion........................................................................................................ 157

SpO

test methods used to establish accuracy claims during low

perfusion.................................................................................................... 158

SpO

test methods used to establish pulse rate accuracy..................... 158

SpO

performance specifications .............................................................. 158

SpO₂ supplemental analysis graphs.......................................................... 159

Additional accuracy information for Portrait

sensors ......................... 159

Impedance respiration performance specifications................................. 163

22 Abbreviations .............................................................................................165

5815148-01

Portrait

™

Mobile Monitoring Solution

Содержание Portrait Hub01

Страница 1: ...Portrait Mobile Monitoring Solution User Manual Software version 1 Portrait Mobile Monitoring Solution English 5815148 01 1st edition 2021 General Electric Company All rights reserved...

Страница 2: ...e 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 GE GE Monogram...

Страница 3: ...conventions 18 Naming conventions 18 Illustrations and names 19 Ordering manuals 19 Accessing manuals online 19 Accessing third party software notices 19 Product availability 20 Trademarks 20 Third p...

Страница 4: ...quipment markings 34 Unique Device Identifier UDI 39 CE marking application year 39 5 System description 41 Short description of the system 41 Clinical benefits 41 System components 42 Core Services o...

Страница 5: ...ng a patient to a new bed 69 Using the Hub pouch 69 Unassigning the patient from the Hub 70 Shutting down the Hub 70 Discharging a patient 71 8 Battery management 73 Safety precautions 73 Connecting a...

Страница 6: ...Alarm acknowledgement 87 Acknowledging alarms 87 Reactivating alarms 88 Checking alarm function 88 Alarms during power cycle 88 Alarm logs 89 11 Parameter filtering and signal quality 91 Parameter fil...

Страница 7: ...measurement description 100 SpO measurement quality 101 SpO2 and pulse rate measurement interference 101 SpO2 waveform quality 101 SpO2 and pulse rate measurement practicalities 102 SpO2 and pulse ra...

Страница 8: ...to note 126 Permitted disinfectants 127 Disinfection procedure 127 Care 128 Care schedules 128 16 Periodic maintenance 129 Daily checks 129 Preventive maintenance 129 About service and maintenance dur...

Страница 9: ...delay specifications for impedance respiration alarms 153 Alarm delay specifications for SpO2 and PR alarms 154 Alarm delay specifications for technical issues 154 21 Parameter specifications 157 SpO2...

Страница 10: ...and configuration 177 About configuration settings 177 Config UI Patient default profiles configuration 177 D Compatible devices 183 Hub HUB01 compatibility 183 SpO2 sensor SpO2 P SA01 P SP01 compatib...

Страница 11: ...ectromagnetic emissions 191 Electromagnetic immunity 191 Electromagnetic immunity for RF 193 Recommended separation distances 194 Proximity field immunity compliance 194 Applicable RF receiver and tra...

Страница 12: ...12 Portrait Mobile Monitoring Solution 5815148 01...

Страница 13: ...358 10 39411 www gehealthcare com PortraitTM CSS01 CVA01 CAU01 GE Medical Systems Information Technologies Inc 9900 Innovation Drive Wauwatosa WI 53226 USA www gehealthcare com GE Medical Systems SCS...

Страница 14: ...Legal manufacturer information 14 Portrait Mobile Monitoring Solution 5815148 01...

Страница 15: ...5 A1 2009 A2 2013 The EHL Platform hardware must comply with the following relevant standards IEC 62368 1 2020 A11 2020 A and or IEC 60950 1 2005 A1 2009 A2 2013 IEC 60601 1 Type of protection against...

Страница 16: ...ion Continuous Safe and proper operation should always be verified with the device manufacturer s instructions for use and system standards IEC 60601 1 clause 16 and the requirements of the local auth...

Страница 17: ...Sensor PortraitTM SpO2 P SP01 SpO2 Wearable Pulse Oximetry Sensor PortraitTM SpO2 P W01 SpO2 Wearable Pulse Oximetry Sensor PortraitTM SpO2 P SE01 SpO2 Wearable Pulse Oximetry Sensor PortraitTM RR P R...

Страница 18: ...alarming unit PortraitTM HUB01 Mobile Patient Monitor Hub EdisonTM HealthLink Platform EHL Platform PortraitTM CSS01 Core Services Core Services PortraitTM monitoring network monitoring network Portr...

Страница 19: ...tps www gehealthcare com documentationlibrary 2 Enter the Customer Documentation Portal 3 Select Modality Monitoring Solutions MS 4 Select Products the products you want to search You may also select...

Страница 20: ...GE is responsible for the effects on safety reliability and performance of the equipment only if Assembly operations extensions readjustments modifications servicing or repairs are carried out by aut...

Страница 21: ...s a hazardous situation that if not avoided could result in minor or moderate injury NOTICE Indicates a hazardous situation not related to personal injury that if not avoided could result in property...

Страница 22: ...ixed on the product The SystemID serial number lot number of the product Date of incident Description of incident including any patient or user impact injury Your contact information facility address...

Страница 23: ...ent will result in loss of monitoring WARNING LOSS OF MONITORING Radio frequency identification RFID readers that operate at 2 45 GHz frequencies may cause a loss of network connectivity Do not use su...

Страница 24: ...edance respiration measurement Impedance respiration measurement value may be out of the measurement accuracy range and respiration waveform noise may be randomly high when the respiration sensor is t...

Страница 25: ...personnel regarding device system configuration WARNING MR UNSAFE Do not use the system in an environment containing an MRI magnet to avoid risks to the patient user or devices WARNING UNEXPECTED SYST...

Страница 26: ...does not receive a configuration from the Core Services for some reason it will use the factory defaults Always check the settings to ensure patient safety WARNING PATIENT SAFETY Take special care wh...

Страница 27: ...ile the patient is being monitored Ask an authorized user to check such settings of the alarm system that are available only to them for example alarm delays Inappropriate or extreme reduction of the...

Страница 28: ...he battery if it appears to be damaged Signs of damage include but are not limited to discoloration warping and leaking battery fluid Do not expose the battery to fire high temperature or direct sunli...

Страница 29: ...rate Before pairing the sensor and Hub always check that the patient does not have this type of pacemaker Failing to do so may compromise patient safety WARNING UNEXPECTED SYSTEM PERFORMANCE Movement...

Страница 30: ...7 clause 208 6 1 2 101 and may lead to missed events System cautions CAUTION EQUIPMENT DAMAGE PATIENT INJURY Always store the Hub and sensor batteries in the charger while not in use Equipment that is...

Страница 31: ...an 10 kg Physiological parameters and waveforms supported are Pulse oximetry SpO2 pulse rate Respiration rate RR Continuous pulse oximetry and respiration rate monitoring may be used for patients at r...

Страница 32: ...twork MBAN connection as well as displaying trends and events The device can be configured to provide local audible and visual alarms and can also provide real time trend and event data to PortraitTM...

Страница 33: ...in proper use of the equipment in a professional healthcare facility The PortraitTM Wearable Pulse Oximetry Sensor is not intended for use in a controlled Magnetic Resonance MR environment PortraitTM...

Страница 34: ...actitioner or by personnel trained in proper use of the equipment in a professional healthcare facility The PortraitTM Sensor Battery is not intended for use in a controlled Magnetic Resonance MR envi...

Страница 35: ...ipment but it applies to the P SE01 and P W01 SpO2 sensors to the combination of SpO2 or respiration sensor and sensor battery Degree of ingress protection Protection assured against solid objects tha...

Страница 36: ...its identify the day Batch or lot number Catalogue or orderable part number Device serial number Every device has a unique marking for identification The UDI marking appears on the device label Indica...

Страница 37: ...if the package is broken Recycled materials or may be recycled European authorized representative European Union Conformity Mark Conformity mark Indicates that the product is certified for both the U...

Страница 38: ...an EFUP value less than the product Periodic replacement of those consumables or parts to maintain the declared EFUP shall be done in accordance with the Product Maintenance Procedures This product m...

Страница 39: ...ode example above Device identifier 01 GS1 global trade item number GTIN of the device 0000000000000 Global trade item number Production identifiers 21 GS1 application identifier for the serial number...

Страница 40: ...Safety and intended use 40 Portrait Mobile Monitoring Solution 5815148 01...

Страница 41: ...gical trends and events The Hub enables non invasive continuous monitoring of patients by acquiring signals from Wearable SpO2 and RR Parameters through a Medical Body Area Network connection MBAN The...

Страница 42: ...ff the shelf computer keyboard and mouse 2 Monitoring network 3 Core Services CSS01 software hosted on the EHL Platform 4 Charger BCH01 with power supply unit 5 Hub HUB01 6 Sensor batteries SBT01 7 Re...

Страница 43: ...patients edit patient demographic information acknowledge alarms and edit the alarm limit settings for any patient being viewed The alarming unit provides standards compliant audible alarm annunciati...

Страница 44: ...been authenticated and is communicating with the Central Viewer Flashing yellow the device has not been authenticated and is not communicating with the Central Viewer This can happen for instance whe...

Страница 45: ...llowing wireless technologies Near Field Communication NFC complies with ISO IEC 18000 3 Wireless local area network WLAN complies with IEEE 802 11abgn Radio frequency identification RFID complies wit...

Страница 46: ...es REMOTE and LOCAL The REMOTE monitoring mode displays alarms on the Central Viewer only They are indicated on the Hub visually and audibly only if you manually activate the screen by pressing the as...

Страница 47: ...ts of the Hub hardware 1 Power key Short press 1 5 s powers on the Hub When the Hub is powered on and the screen is locked activates or deactivates the screen Long press 1 5 s shuts down the Hub A con...

Страница 48: ...color Blinking amber slowly the Hub is searching for a WLAN or EHL Platform server connection Alternating between darker and lighter green the Hub is connected to the WLAN and EHL Platform server NOTE...

Страница 49: ...r use in case the current battery discharges completely during monitoring Loss of power will result in loss of monitoring A sensor battery Powers up a sensor when connected to it Enables pairing of a...

Страница 50: ...mains Make sure that the batteries and the Hub are always securely inserted not loose in their slots to enable charging System installation points to note The environmental operating conditions specif...

Страница 51: ...ies according to the alarm priority cyan yellow red Information signal is indicated with a gray background Infinite alarm acknowledgement The background color varies according to the alarm priority cy...

Страница 52: ...nected to a wireless network Control in the menus Back Erase Access to other menus or views Access to other menus or views Access to other menus or views Access to other menus or views REMOTE monitori...

Страница 53: ...patient slot Displays the room bed number if applicable pacemaker information Yes with indicator No Unknown with indicator and patient name if configured to be shown Depending on the number of configu...

Страница 54: ...larm display unit area is shown at the top of the Single Patient View to provide visibility to active alarms on other patients configured to the same Central Viewer Selecting an alarm message opens th...

Страница 55: ...m monitoring and allowing a new patient to be admitted in this room and bed Historical data for this patient will no longer be available Hub Hub screen elements The following describes the elements of...

Страница 56: ...tification Smith Peter patient s last name first name 90 OFF 90 OFF Pulse oximetry alarm limits critical low 87 critical low xx where xx is 87 in this example Critical low limit set for SpO2 SpO2 SpO2...

Страница 57: ...o the passcode view for unlocking the screen touch the arrow or swipe your finger upwards on screen locked screen indicator Local or remote monitoring assigned patient and no monitoring LOCAL mode REM...

Страница 58: ...patient list The patient list contains patients that have been admitted to the monitoring system but have not been assigned to a Hub In this example Select patient Select patient Title of the view for...

Страница 59: ...b LIVE view can contain data for one or more parameters depending on which sensors have been paired It shows numeric values parameter labels and units active alarm limits signal quality indicators and...

Страница 60: ...cators are visible in the detailed view The sensor battery status is displayed under the parameter label and unit of measure indication In this example 1 11 room bed identification Smith Peter patient...

Страница 61: ...Volume Adjustment bar for Alarm Volume This setting applies to the Hub alarm volume only It is available when there is an assigned patient Hub Hub Access to the Hub device submenu touch the area or ta...

Страница 62: ...he 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 Once in the main menu you can close the menu by swipi...

Страница 63: ...f the Patient ID 2 field can be changed during the system configuration Date of birth The date of birth of the patient Enter the day and the year and select the month from the drop down list A default...

Страница 64: ...First name Maximum length 30 characters Last name Maximum length 30 characters Patient ID 1 A site specific patient identifier Consult your site policy regarding the use of this field The name of the...

Страница 65: ...on with the power key 1 located on the side of the Hub 1 Press the power key short press 1 5 s You can feel a short vibration of the Hub when it is powered on If the Hub is not powered on when you pr...

Страница 66: ...the No patients view opens instead In this case admit the patient to the Central Viewer first If you see this indicator instead of a list of patients the list is being refreshed and will soon appear...

Страница 67: ...ake 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 available monitoring licenses Unassign one Hub or w...

Страница 68: ...r battery to the sensor prior to trying to pair the sensor you will see a prompt and graphic on the screen instructing you to complete it The measurement appears on the Hub screen and you can now pair...

Страница 69: ...ement 4 Disconnect the measurement from the patient 5 Clean the devices as instructed 6 Insert the sensor battery to the charger if it is not needed Moving a patient to a new bed When moving a patient...

Страница 70: ...m that you wish to end monitoring d Press to unassign the patient from the Hub or select the X on the upper right corner of the message to return to the previous view without clearing the Hub and pati...

Страница 71: ...is still ongoing Otherwise the Hub will turn on as you place it into the charger Discharging a patient Discharging a patient on the Central Viewer removes the patient from continuous monitoring and de...

Страница 72: ...Managing patients and monitoring 72 Portrait Mobile Monitoring Solution 5815148 01...

Страница 73: ...isconnecting sensor batteries 1 To connect a battery push it into the sensor Respiration sensor SpO2 sensor 1 sensor battery 2 sensor 3 respiration patch connector 1 sensor battery 2 sensor 2 To disco...

Страница 74: ...slowly the sensor battery is disconnected from the sensor Blinking amber quickly the connected sensor is faulty Three slow blinks in green the sensor battery is connected to the sensor Blinking slowly...

Страница 75: ...ror in the charger The LED indicator of a slot is blinking There is an error in the sensor battery or Hub currently in that slot Unplug the charger from the mains and then plug it in again or remove t...

Страница 76: ...low limit whichever occurs first If the battery discharges completely the sensor will shut down Charging time for empty to fully charged is five hours but may be slower at elevated temperatures The H...

Страница 77: ...nths proceed as usual by placing it into one of the battery slots in the charger The LED indicator of that slot should light with solid amber in about 10 seconds If the LED indicator starts blinking a...

Страница 78: ...d to check 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 scre...

Страница 79: ...ry ages the full charge capacity of the battery degrades and is permanently lost As a result the amount of charge that is stored and available for use is reduced Battery recycling This product1 contai...

Страница 80: ...Battery management 80 Portrait Mobile Monitoring Solution 5815148 01...

Страница 81: ...device The LOCAL mode displays alarms on both the Central Viewer and Hub In this mode the Hub screen activates automatically whenever there are alarms Measurement data is available also when the Hub i...

Страница 82: ...Hub and modes 82 Portrait Mobile Monitoring Solution 5815148 01...

Страница 83: ...l alarm conditions are triggered by an electrical mechanical or other failure of the equipment or by failure of a sensor or component Alarm priority levels Priority level Color Priority definition Hig...

Страница 84: ...inside a yellow box Black text inside a cyan box Black text inside a gray box The highest priority most recent unac knowledged alarm is dis played until the condition is re solved Central Viewer only...

Страница 85: ...elected during patient admission Alarm settings for an individual patient can be changed from the default The following setting adjustments are available SpO2 high SpO2 low PR high PR low RR high RR l...

Страница 86: ...m settings take effect immediately Select Cancel to return to the Single Patient View without modifying alarm settings Adjusting alarm volume on the Central Viewer You can adjust the alarm volume of t...

Страница 87: ...d technical alarms of any priority The acknowledge alarm key is enabled if there are unacknowledged alarms The key functionality is either infinite or timed acknowledgement according to the system con...

Страница 88: ...he measured SpO2 values 2 Confirm that the following alarm notification events occur The audible alarms sound the correct tone The alarm indicators illuminate The SpO2 numeric value flashes with the c...

Страница 89: ...arm log once reconnected During a planned or unplanned server shut down logs of the system shutting down are captured and maintained through loss of power The alarm log storing capacity is 1000 most r...

Страница 90: ...Alarms 90 Portrait Mobile Monitoring Solution 5815148 01...

Страница 91: ...decrease the delay to alarms Similarly if the value is reliable and returns within the alarm limits the value is updated faster to reduce unnecessary alarms The fixed alarm delays are still applied S...

Страница 92: ...Parameter filtering and signal quality Signal amplitude Motion artifacts Noise Ambient light interference 92 Portrait Mobile Monitoring Solution 5815148 01...

Страница 93: ...itioner or by personnel trained in proper use of the equipment in a professional healthcare facility The PortraitTM Wearable Respiration Rate Sensor is not intended for use in a controlled Magnetic Re...

Страница 94: ...ent may cause suboptimal performance of the respiration measurement You can only use one impedance respiration measurement on a patient at a time Respiration measurement description Respiration measur...

Страница 95: ...regarding the following issues Always consider your hospital guidelines as well The respiration sensor should be detached before having a shower The respiration patch can be left attached After the sh...

Страница 96: ...ith an extra inspiration If these ventilator inspirations are substantially larger than the spontaneous breaths the respiration calculation may count only the inspirations and expirations produced by...

Страница 97: ...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 4 Respiration patch connector 5 Sensor 6 Batter...

Страница 98: ...n LED on the Hub is lit and keeps alternating between dimming and brightening green b Check that the learning animation three dots in a horizontal line and the message Learning are displayed When they...

Страница 99: ...y personnel trained in proper use of the equipment in a professional healthcare facility The PortraitTM Wearable Pulse Oximetry Sensor is not intended for use in a controlled Magnetic Resonance MR env...

Страница 100: ...t sources fluorescent lights direct sunlight dimmable LED lights patient s mobile device in the same hand may interfere with the measurement accuracy To avoid erroneous measurement data do not use a b...

Страница 101: ...terials such as nail polish High ambient light conditions like conditions created from one or more of the following sources Surgical lights especially xenon light sources Fluorescent lights Direct sun...

Страница 102: ...or more frequently if perfusion is poor and change site if necessary Instruct the patient regarding the following issues Always consider your hospital guidelines as well Avoid using mobile devices wit...

Страница 103: ...be suitable for adult and pediatric patients weighing 10 kg 22 lb 4 PortraitTM SpO2 P W01 sensor with wrap finger tip probe suitable for adult and pediatric patients weighing 10 kg 22 lb Preparing the...

Страница 104: ...attach the Velcro support straps around the sensor 5 Adjust the cable length according to the size of the patient s hand by positioning the sensor in one of the ways shown below or Make sure that the...

Страница 105: ...site Do not restrict circulation To replace the wrap 1 Gently remove the worn wrap 2 Clean the light source and detector 3 Place the sensor in a new wrap Checking the SpO2 and pulse rate measurement...

Страница 106: ...r messages and alarms in the messages chapter SpO2 functional testers You can verify the functionality of pulse oximeter sensors with a functional SpO2 tester but you cannot evaluate their accuracy wi...

Страница 107: ...indicate that the trend data from either device is incorrect or inaccurate those differences occur because the trends on the Central Viewer have been further smoothed to provide a specific and focused...

Страница 108: ...ew you can use the trend cursor to view the trended value s at the selected moment of time When hovering the cursor over an event marker in the Single Patient View you can see the high and low limits...

Страница 109: ...for each minute For this reason trends may not always show all changes in the patient s data even when that data is related to physiological alarms The physiological parameter trends from the past fou...

Страница 110: ...cursor on the Hub Once in the TRENDS view you can use the trend cursor to view the 1 minute average value s at the selected moment of time 1 Touch the trend area The trend cursor vertical line appears...

Страница 111: ...rsor 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 Mobil...

Страница 112: ...Trends 112 Portrait Mobile Monitoring Solution 5815148 01...

Страница 113: ...ers 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 functio...

Страница 114: ...ethods not approved by GE Always dilute cleaning and disinfectant agents according to their manufacturer s instructions Always consider your hospital guidelines as well Your hospital guidelines permit...

Страница 115: ...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 f...

Страница 116: ...essive scratches wear and cracks Cleaning the Hub 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 tempera...

Страница 117: ...o 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...

Страница 118: ...th with detergent or use ready to use detergent wipes Prepare the detergent according to the manufacturer s instructions 2 Wring excess liquid from the cloth wet but not dripping 3 Wipe the exterior s...

Страница 119: ...ior 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 pi...

Страница 120: ...sensor 4 Visually ensure that the device is intact Evidence of damage may include but is not limited to discoloration excessive scratches wear and cracks Cleaning the SpO2 sensors In case there is so...

Страница 121: ...t the cleaning until the device is visibly clean 6 Discard disposable wipes or non linting cloths according to your hospital guidelines Do not reuse wipes 7 Rinse the device thoroughly using a soft cl...

Страница 122: ...rying 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 Preparing a sensor b...

Страница 123: ...r dry until it is visually dry or dry with thoroughly with a soft clean non linting cloth before placing the device into the charger Drying times may vary based on the environmental conditions Do not...

Страница 124: ...re 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 Dampen a soft non li...

Страница 125: ...ncluding but not limited to corrosion rust pitting discoloration excessive scratches flaking cracks and wear Missing or worn device labeling or marking Do not use devices that are not functioning prop...

Страница 126: ...oft clean non linting cloth saturated with lukewarm tap water temperature range 27 to 44 C 81 to 111 F 8 Dry thoroughly with a soft clean non linting cloth before taking it into use Post cleaning insp...

Страница 127: ...evice remains wet continuously per the disinfectant manufacturer s instructions for contact time Pay special attention to hard to reach areas like recessed areas and ridges To identify these refer to...

Страница 128: ...rger alarming unit and the hardware running the Central Viewer application are clean and intact Check the battery capacity of the Hub and sensors daily Always consider your hospital guidelines as well...

Страница 129: ...ry maintenance refer to the chapter discussing battery management For all service and maintenance instructions refer to the service manual About service and maintenance during monitoring Service or ma...

Страница 130: ...Periodic maintenance 130 Portrait Mobile Monitoring Solution 5815148 01...

Страница 131: ...ed on and within the WLAN coverage range Check the patient If the problem persists contact qualified service personnel Numeric data is not updating Check that the correct patient is assigned to the Hu...

Страница 132: ...nsor and Hub pairing fails There may be a stronger NFC reader like a cell phone in close proximity Increase the distance between the Hub and other NFC devices and retry Check the sensor placement on t...

Страница 133: ...nnel Loss of audible and or visual alarms Check that the alarm limits are set correctly for your care area Check the alarm volume adjustment Check the use mode REMOTE or LOCAL and change as needed Che...

Страница 134: ...y low Apnea alarm appears if there are no detected breaths during user configurable apnea alarm time Patient apnea is not detected Respiration measurement can only detect central type apnea Apnea cann...

Страница 135: ...iologic and metabolic status this curve and all values may be shifted away from normal Thus the oximeter which measures O2 saturation may not agree with the blood gas What effect can ambient light hav...

Страница 136: ...otion artifact can be reduced if not eliminated by selecting the non dominant hand of the patient Why is the measurement not displayed after connecting the sensor The sensor is out of range Reposition...

Страница 137: ...area Physiological messages Alarm message Location Possible explanations Suggested actions Hub Apnea APN Central Viewer Apnea APN al area data No breathing detected during the time that has been set a...

Страница 138: ...ion patch is not properly connected to the patient or the sensor is not properly connected to the respiration patch Check the respiration patch placement and skin to electrode contact Check the sensor...

Страница 139: ...erheating Hub al area data Central Viewer al area Sensor battery surface temperature is too high The maximum surface temperature of the devices being worn by the patient Hub sensor battery and wearabl...

Страница 140: ...k the sensor and sensor positioning Hub SpO2 high SpO2 low Central Viewer SpO2 high SpO2 low al area Measurement values are equal to or outside the alarm limits Check the patient Adjust alarm limits o...

Страница 141: ...robe off Probe off Central Viewer SpO2 probe off Hub al area data Central Viewer al area SpO2 probe is off the patient Check the connections and adjust as needed Hub Faulty SpO2 probe Faulty probe Cen...

Страница 142: ...rsonnel Hub SpO2 device overheating Device overheating Central Viewer SpO2 device overheating Hub al area data Central Viewer al area Sensor battery surface temperature is too high The maximum surface...

Страница 143: ...the clinician to take appropriate action to ensure the time of exposure is limited based on the condition of the patient Check the Hub and ensure that it is not covered by anything that might lead to...

Страница 144: ...Alarm messages 144 Portrait Mobile Monitoring Solution 5815148 01...

Страница 145: ...CCURATE READINGS After transport or storage of the device outside the specified operating temperature range always allow the device to stabilize back to operating temperature range before applying pow...

Страница 146: ...5350 MHz est restreinte une utlisation a l int rieur seulement High power radars are allocated as primary users i e priority users fo the bands 5250 5350 MHz and 5650 5860 MHz and that these radars co...

Страница 147: ...0 to 1060 hPa Fluid ingress IP67 Operating time 16 hours with full battery Charging time at 25 C 8 hours from empty to full capacity Technical specifications charger Size H x W x D 11 5 x 23 8 x 4 3 c...

Страница 148: ...t SpO2 P SA01 52 g 1 8 oz SpO2 P SP01 43 g 1 5 oz SpO2 P W01 38 g 1 3 oz SpO2 P SE01 38 g 1 3 oz RR P RR01 34 g 1 2 oz Operating temperature 0 to 40 C 32 to 104 F Operating humidity 5 to 95 RH non con...

Страница 149: ...Weight 268 g 9 5 oz 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 temperature 40 to 70 C 40 to 158 F...

Страница 150: ...mum Ports Digital Video Interface HDMI or DisplayPort required if display is not built into the computer Operating system requirements Operating system type Windows 10 Professional minimum Operating s...

Страница 151: ...A Low priority alarm 52 dB A 10 High priority alarm 46 dB A Medium priority alarm 42 dB A Low priority alarm 37 dB A Hub Alarm volume setting Maximum sound pressure level 100 High priority alarm 63 dB...

Страница 152: ...wer failure alarming unit 2700 300 500 Communication failure alarming unit 2700 300 200 Alarm delay specifications The disclosed alarm system delays are measured by simulator or respective methods whi...

Страница 153: ...ration alarms The following table lists the alarm delays for physiological alarms related to the impedance respiration measurement Any alarm delays that are less than 5 s are given as 5 s Physiologica...

Страница 154: ...rage 45 to 46 s range PR low 30 to 240 beats per minute 1 beat per minute 40 s average 40 to 40 s range SpO2 high 70 to 100 1 19 s average 19 to 20 s range SpO2 low 70 to 100 1 33 s average 32 to 33 s...

Страница 155: ...re 5 s Hub overheating 5 s 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 Cen...

Страница 156: ...Alarm specifications 156 Portrait Mobile Monitoring Solution 5815148 01...

Страница 157: ...and spanned a range of ages and skin pigmentations For more detailed information refer to the supplemental analysis graphs Bland and Altman Agreement between methods of measurement with multiple obse...

Страница 158: ...square RMS difference between the measured values and the reference values Arms Because pulse oximetry equipment measurements are statistically distributed only about two thirds of the pulse oximetry...

Страница 159: ...ltman plots show SpO2 data by sensor type Bland Altman plot for SpO2 P SA01 sensor non motion SpO2 P SA01 sensor measured accuracy non motion Accuracy 70 80 Arms Accuracy 80 90 Arms Accuracy 90 100 Ar...

Страница 160: ...y non motion Accuracy 70 80 Arms Accuracy 80 90 Arms Accuracy 90 100 Arms 1 48 1 383 1 185 Bland Altman plot for SpO2 P SP01 sensor motion P SP01 sensor accuracy motion Accuracy 70 80 Arms Accuracy 80...

Страница 161: ...non motion Accuracy 70 80 Arms Accuracy 80 90 Arms Accuracy 90 100 Arms 2 169 1 638 1 525 Bland Altman plot for SpO2 P W01 sensor motion P W01 sensor accuracy motion Accuracy 70 80 Arms Accuracy 80 9...

Страница 162: ...non motion Accuracy 70 80 Arms Accuracy 80 90 Arms Accuracy 90 100 Arms 1 669 1 348 1 121 Bland Altman plot for SpO2 P SE01 sensor motion P SE01 sensor accuracy motion Accuracy 70 80 Arms Accuracy 80...

Страница 163: ...nute Impedance respiration measurement accuracy 4 to 60 breaths per minute 3 breaths per minute Impedance respiration measurement precision 1 breath per minute Impedance respiration measurement input...

Страница 164: ...Parameter specifications 164 Portrait Mobile Monitoring Solution 5815148 01...

Страница 165: ...arts electrically connected to the heart of the patient Dec December EAS Electronic article surveillance ECG Electrocardiogram EMC Electromagnetic compatibility EMI Electromagnetic interference ESD El...

Страница 166: ...ide in the arteries pH Hydrogen ion concentration PR Pulse rate PURW Purified water RF Radio frequency RFID Radio frequency identification RR Respiration rate SaO2 Arterial oxygen saturation Sep Septe...

Страница 167: ...IONS System warnings 22 System cautions 30 OPERATION SAFETY PRECAUTIONS Operation warnings 25 Operation cautions 30 ALARM SAFETY PRECAUTIONS Alarm warnings 27 Alarm cautions 30 ACCESSORIES SAFETY PREC...

Страница 168: ...42 CORE SERVICES CENTRAL VIEWER AND ALARMING UNIT Core Services overview 43 Central Viewer and alarming unit overview 43 Introduction to the Central Viewer 43 Introduction to the alarming unit 44 HUB...

Страница 169: ...pleted tasks in the table Recommended reading Completed Not applicable About configuration settings 177 Config UI Patient default profiles configuration 177 Managing patients and monitoring To familia...

Страница 170: ...licable SENSOR AND HUB BATTERIES Connecting and disconnecting sensor batteries 73 LED indicators on sensor batteries 73 About Hub and sensor batteries 75 CHARGING BATTERIES LED indicators on the charg...

Страница 171: ...ub 86 ALARM ACKNOWLEDGEMENT Alarm acknowledgement 87 Acknowledging alarms 87 Reactivating alarms 88 CHECKING ALARM FUNCTION Checking alarm function 88 Parameter filtering and signal quality To familia...

Страница 172: ...n the table Recommended reading Completed Not applicable ABOUT THE MEASUREMENT SpO2 and pulse rate measurement limitations 100 SpO2 measurement description 100 SpO2 and pulse rate measurement interfer...

Страница 173: ...applicable GENERIC INSTRUCTIONS Cleaning disinfection and care overview 113 Visual inspection cleaning and disinfection frequency 113 CLEANING INSTRUCTIONS Cleaning points to note 114 Permitted deter...

Страница 174: ...124 CLEANING THE ALARMING UNIT Cleaning procedure for the alarming unit 125 Preparing the alarming unit for cleaning 125 Cleaning the alarming unit 126 DISINFECTION INSTRUCTIONS Disinfection points to...

Страница 175: ...mit a new patient on the Central Viewer 2 Attach the Wearable SpO2 and RR Parameters to the patient 2 a sensor battery respiration sensor respiration patch 2 b sensor battery SpO2 sensor attachment ba...

Страница 176: ...Quick workflow overview 176 Portrait Mobile Monitoring Solution 5815148 01...

Страница 177: ...he Hub does not receive a configuration from the Core Services for some reason it will use the factory defaults Always check the settings to ensure patient safety Config UI Patient default profiles co...

Страница 178: ...o Low RR high alarm delay Select the delay after which the RR high alarm is triggered Seconds 15 30 90 or 120 Age 3 4 15 Age 5 6 15 Age 7 12 15 Age 13 17 15 Adult 30 Facility 15 RR low alarm on Not ad...

Страница 179: ...enabled on or off n a Yes or No No SpO2 high alarm limit Select the threshold alarm limit for the SpO2 high alarm Percent 70 to 100 100 SpO2 high alarm priority Select the priority for the SpO2 high...

Страница 180: ...critically low alarm is triggered before the SpO2 low alarm delay has expired these two alarms are triggered simultaenously Seconds 5 10 15 20 30 60 or 90 Age 3 4 20 Age 5 6 20 Age 7 12 30 Age 13 17...

Страница 181: ...20 Adult 20 Facility 15 PR low alarm on Not adjustable n a n a Yes PR low alarm limit Select the threshold alarm limit for the PR low alarm Beats Min 30 to 240 Age 3 4 60 Age 5 6 60 Age 7 12 50 Age 1...

Страница 182: ...Default settings and configuration 182 Portrait Mobile Monitoring Solution 5815148 01...

Страница 183: ...e Oximetry Sensor PortraitTM RR P RR01 Wearable Respiration Rate Sensor PortraitTM RRP01 RR Electrode Patch PortraitTM SBT01 Sensor Battery PortraitTM BCH01 Bedside Charger PortraitTM MMP01 Mobile Pat...

Страница 184: ...1 Wearable Pulse Oximetry Sensor with large wrap is compatible with the following products Large replacement foam wrap TS RWL Replacement tape TS RTW PortraitTM SBT01 Sensor Battery PortraitTM HUB01 M...

Страница 185: ...raitTM Software Service Tool Bedside charger BCH01 compatibility The PortraitTM BCH01 Bedside Charger is compatible with the following products PortraitTM SBT01Sensor Battery PortraitTM HUB01 Mobile P...

Страница 186: ...Compatible devices 186 Portrait Mobile Monitoring Solution 5815148 01...

Страница 187: ...oduct 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 PortraitTM MMP01 Mobile Patient Monitor Pou...

Страница 188: ...Supplies and accessories 188 Portrait Mobile Monitoring Solution 5815148 01...

Страница 189: ...FID emissions are removed the measurement returns to expected measurement accuracy within 60 seconds without any changes to settings WARNING ELECTROMAGNETIC INTERFERENCE Magnetic and electrical fields...

Страница 190: ...el regarding device system configuration WARNING MR UNSAFE Do not use the system in an environment containing an MRI magnet to avoid risks to the patient user or devices WARNING UNEXPECTED SYSTEM BEHA...

Страница 191: ...missions IEC 61000 3 2 Class A Voltage fluctuations flicker emissions IEC 61000 3 3 Complies The equipment is suitable for use in all establishments other than domestic and those directly connected to...

Страница 192: ...t 70 25 30 cycles 0 degrees Mains power quality should be that of a typical commercial or hospital environment If the user of the equipment requires continued operation during power mains interruption...

Страница 193: ...s than the compliance level in each frequency rangef Interference may occur in the vicinity of equipment marked with the following symbol NOTE NOTE At 80 MHz and 800 MHz the higher frequency range app...

Страница 194: ...3 P d 7 0 P 0 01 0 12 0 35 0 44 0 12 0 35 0 23 0 70 0 1 0 38 1 1 1 4 0 38 1 1 0 73 2 2 1 1 2 3 5 4 4 1 2 3 5 2 3 7 0 10 3 8 11 14 3 8 11 7 3 22 100 12 35 44 12 35 23 70 For transmitters rated at a max...

Страница 195: ...9 NOTE The distance values represent the recommended separation distance between interfering equipment and the system components Guidance and manufacturer s declaration electromagnetic immunity AIM ST...

Страница 196: ...54 V m 2 45 GHz ISO IEC 18000 4 Mode 1 All system components2 20 0 cm 54 V m 54 V m To avoid performance degradation ensure that there is enough distance between RFID readers emitting RF per the above...

Страница 197: ...content...

Страница 198: ...are com Portrait CSS01 CVA01 CAU01 GE Medical Systems Information Technologies Inc 9900 Innovation Drive Wauwatosa WI 53226 USA GE Medical Systems SCS Information Technologies 283 Rue de la Miniere 78...

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