B125 and B105 Users Manual Sw ver 1.0 April 2017

Due to continuing product innovation, specifications in this manual are subject to change without notice. For technical documentation purposes, the abbreviation GE is used for the legal entity names, GE Medical Systems Information Technologies, Inc.

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Patient Monitor B125/B105

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Contents 1

About this manual and device ...17 Intended use of this manual... 17 Intended audience of this manual ... 17 Manual conventions ... 17 Illustrations and names ... 18 Related documents... 18 Ordering manuals ... 18 Indications for use... 18 Training requirements ... 18 Trademarks ... 19 Third party trademarks ... 19 Manufacturer responsibility ... 19 Product availability ... 19 Warranty... 19

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Safety ...21 Safety message signal words... 21 System safety... 21 System warning safety messages ... 21 Indications for use warnings ... 21 Accessories warnings ... 22 Cables warnings... 22 Defibrillation warnings... 22 Electrical warnings ... 23 EMC warnings... 24 Equipment warnings ... 25 Site requirement warnings ... 25 System caution safety messages ... 25 Indications for use cautions ... 26 Loss of data ... 26 Electrical caution... 26 EMC cautions ... 26

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Site requirement cautions ... 26 Notice safety messages ... 26 ESD safety precautions... 27 3

System introduction ...29 System safety precautions ... 29 System warnings... 29 System caution... 30 System components ... 30 Front view ... 31 Main side view ... 31 Main back view... 32 Hemodynamics connectors ... 33 Hemodynamics parameters... 33 E-miniC module... 33 Recorder ... 34 Keypad... 34 Monitor battery ... 35 Inserting and removing battery ... 35 Checking the battery charge with monitor software... 36 Monitor battery charge symbols on screen... 36 Battery test button ... 36 Network central station ... 37 Other devices... 37 Equipment symbols ... 37

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Monitoring basics ...43 Operation safety precautions ... 43 Operation warnings ... 43 Monitor installation points to note... 43 Connecting and removing parts ... 44 Connecting E-module ... 44 Removing E-module... 44 Connecting the recorder... 44 User interface keys ... 45 User interface symbols ... 48

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Normal screen layout ... 49 Waveform layout... 49 Large number layout... 50 An example of a menu... 50 Menu options... 51 Selecting menu options with a touchscreen ... 51 Selecting menu options with the Trim Knob control... 51 Entering data ... 51 Setting the touchscreen off ... 52 Turning on/off the monitor ... 52 Performance check... 52 Pre-monitoring checklist... 52 Supply mains interruption ... 52 Downloading logs to USB disk... 53 5

Setting up the monitor before use...55 Waveform field safety precautions... 55 Normal screen... 55 Adjusting sound volumes ... 55 Adjusting the display brightness ... 56 Screen setup modifications... 56 Waveform layout... 56 Large number layout... 56 Setting waveform layout... 56 Setting large number layout... 57 Setting parameters ... 57 Setting up printing options ... 57 Other setup changes ... 57

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Starting and ending monitoring ...59 Starting and ending safety precautions ... 59 Starting and ending warnings... 59 Starting and ending caution... 59 About the user default settings... 59 About user modes... 59 Selecting a mode... 60

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Starting monitoring... 60 Entering patient data with the monitor ... 61 About standby... 61 Starting standby... 61 End of standby... 61 About night mode ... 62 Setting and entering night mode ... 62 Exiting night mode ... 62 About Demo Mode ... 62 About patient discharge ... 63 Discharging a patient... 63 7

Alarms ...65 Alarm safety precautions ... 65 Alarm warnings ... 65 Alarm overview ... 66 Alarm types... 66 Alarm conditions ... 67 Alarm priority levels... 67 Alarm priority escalation... 67 Broadcast only alarms... 67 Checking alarm function ... 68 Alarm indications ... 68 Alarm icons on the screen ... 68 Description of alarm and information messages... 68 Audible alarm signals... 68 Visual alarm signals ... 69 Auditory information signals ... 69 Audible alarms off behavior ... 70 Turning audible alarms on/off... 70 Pause audio and alarm reset behaviors... 70 Alarms’ deactivation with the pause audio key ... 71 Breakthrough alarms... 72 Latched alarms ... 72 Alarm limits setup ... 72

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Setting parameter alarm limits ... 72 Setting arrhythmia alarms... 73 Setting alarm limits automatically ... 73 Returning the default alarm limits ... 74 Remote management of alarms... 74 Nurse call... 74 Alarm settings after a power loss ... 74 Stored alarm data during a power cycle or power loss ... 75 8

ECG ...77 ECG safety precautions ... 77 ECG warnings ... 77 ECG cautions ... 78 ECG measurement limitations... 78 ECG points to note ... 78 ECG measurement setup... 79 ECG equipment to patient connection... 79 Preparing the patient’s electrode sites ... 79 Applying the electrodes to the patient... 79 3– lead or 5–lead ECG electrode placement ... 80 Checking the ECG measurement ... 80 Using the ECG measurement ... 80 ECG leads settings... 80 Selecting the ECG waveform size ... 81 Selecting the hemodynamic waveform sweep speed... 82 Setting the beat volume... 82 Selecting the ECG waveform filter... 82 Setting the QRS width ... 82 Selecting the number of electrodes for 5–lead ECG ... 83 Setting the primary HR source ... 83 Showing a second HR value ... 83 Displaying the ECG grid... 83 Relearning the patient’s QRS pattern... 83 ECG alarm limits ... 84 ECG measurement practicalities... 84

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Alternate pulse rate source ... 84 Auto algorithm... 85 ECG troubleshooting ... 85 Pacemaker detection... 85 Pacemaker detection warnings ... 85 Pacemaker detection points to note... 86 Selecting the pacemaker detection ... 86 Pacemaker detection troubleshooting ... 86 Arrhythmia monitoring ... 87 Arrhythmia monitoring warnings... 87 Arrhythmia measurement limitations... 89 Setting arrhythmia alarms... 89 Setting the alarm pause interval... 89 Arrhythmia alarm messages ... 89 Arrhythmia detection description ... 90 Arrhythmia troubleshooting ... 91 ST detection... 92 About the ST analysis... 92 ST detection measurement limitations ... 92 ST detection points to note... 92 Adjusting the ST point manually... 92 Adjusting the isoelectric measurement (ISO) point ... 93 Adjusting the J point ... 93 Setting alarm limits for lead groups... 93 9

Impedance respiration...95 Respiration safety precautions ... 95 Respiration warnings ... 95 Respiration cautions ... 96 Respiration measurement limitations... 96 Respiration points to note ... 96 Respiration measurement setup... 96 Respiration equipment to patient connection... 96 Preparing the patient’s respiration electrode sites ... 97 Respiration measurement checks... 97

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Using the respiration measurement ... 97 Turning on the respiration measurement... 97 Selecting the respiration waveform size... 97 Selecting the detection limit ... 98 Selecting the waveform speed... 98 Selecting the respiration rate source... 98 Setting the No Breath alarm delay for neonatal ... 98 Setting the respiration alarm limits... 99 Turning off the respiration measurement ... 99 Respiration measurement description ... 99 Respiration troubleshooting ... 99 10 Pulse oximetry ...101 SpO₂ safety precautions ... 101 SpO2 warnings... 101 SpO2 cautions ... 104 SpO2 measurement limitations ... 104 SpO2 points to note ... 104 SpO₂ measurement guidelines... 105 GE TruSignal technology and sensor measurement guidelines... 105 Masimo SET technology and sensor measurement guidelines... 105 Nellcor OxiMax technology and sensor measurement guidelines... 109 SpO₂ measurement setup ... 110 SpO2 equipment to patient connection ... 110 Preparing the SpO2 connection... 110 Checking the SpO2 measurement ... 111 Using the SpO2 measurement... 111 Changing the SpO2 waveform scale ... 111 Selecting the GE TruSignal SpO2 response averaging time... 111 Selecting the Masimo SpO2 averaging time ... 111 Selecting the Masimo SpO2 sensor sensitivity level ... 112 Selecting the SpO2 as the primary heart rate source ... 112 Adjusting the SpO2 pulse beep tone volume ... 112 Setting the SpO2 alarm limits... 112

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Setting the Masimo SpO2 alarm delay ... 112 Stopping the SpO2 measurement ... 113 SpO₂ measurement description... 113 Masimo SET data averaging and updating ... 113 Nellcor OxiMax data averaging and updating ... 113 How to interpret the SpO₂ values... 113 SpO2 signal strength ... 113 SpO2 waveform quality ... 114 SpO2 waveform stability ... 114 SpO2 wavelengths and optical output power ... 114 SpO2 measurement and interference... 115 SpO2 troubleshooting... 115 11 Non-invasive blood pressure...117 NIBP safety precautions ... 117 NIBP warnings ... 117 NIBP cautions ... 118 NIBP measurement limitations ... 118 NIBP points to note ... 119 NIBP measurement setup... 119 NIBP equipment to patient connection... 119 Preparing the NIBP patient connection ... 120 NIBP measurement on screen ... 120 NIBP cuffs ... 120 NIBP cuff selection and placement ... 120 Selecting NIBP cuff size... 121 Initial NIBP cuff inflation pressure ... 121 Using the NIBP measurements ... 122 Manual NIBP measurements... 122 Starting or stopping a single NIBP measurement from the NIBP menu ... 122 Starting for stopping a single NIBP measurement from the keypad key ... 122 Automatic NIBP measurements... 122 NIBP Auto mode ... 122

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NIBP STAT mode ... 123 NIBP volume and display settings... 123 Adjusting the NIBP measurement completion tone volume ... 123 Selecting the blood pressure unit of measurement... 123 Selecting the NIBP color... 123 NIBP alarms... 124 Setting the NIBP alarm limits... 124 NIBP alarms’ deactivation with pause audio key ... 124 NIBP recheck after alarm violation ... 124 NIBP measurement description ... 124 DINAMAP SuperSTAT NIBP technology... 125 NIBP calibration... 126 NIBP troubleshooting... 126 12 Invasive blood pressure ...127 Invasive blood pressure safety precautions... 127 Invasive pressure warnings ... 127 Invasive pressure points to note ... 127 Invasive blood pressure measurement setup ... 128 Invasive pressure equipment to patient connection ... 128 Connecting the invasive pressure transducer and cable ... 128 Checking the invasive pressure measurement ... 128 Invasive pressure measurement on the monitor screen... 128 Using the invasive blood pressure measurement... 129 About zeroing the invasive pressure transducers... 129 Zeroing the invasive pressure transducers ... 129 Selecting an invasive pressure channel label... 130 Selecting the size of the invasive pressure waveform ... 130 Selecting the hemodynamic waveform sweep speed... 130 Selecting the displayed invasive pressure format... 130 Selecting invasive pressure as the primary heart rate source ... 131 Selecting the ventilation mode... 131 Selecting the invasive pressure response time ... 131 Selecting the blood pressure unit of measurement... 131 Selecting the invasive pressure noise reduction filter... 132

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Setting invasive pressure alarm limits ... 132 Invasive pressure calibration ... 132 Invasive blood pressure practicalities... 132 Invasive pressure parameters... 132 Invasive pressure troubleshooting... 133 13 Temperature...135 Temperature safety precautions... 135 Temperature warnings ... 135 Temperature points to note... 135 Temperature measurement setup... 136 Temperature equipment to patient connection... 136 Preparing the patient for temperature measurement... 136 Checking the temperature measurement ... 136 Temperature measurement on the monitor screen ... 136 Using the temperature measurement... 137 Changing the temperature site label ... 137 Selecting the temperature unit ... 137 Setting temperature alarms ... 137 Temperature practicalities ... 137 Temperature troubleshooting ... 138 14 Airway gases ...139 Airway gases safety precautions ... 139 Airway gases warnings... 139 Airway gases cautions ... 140 Airway gases measurement limitations ... 140 Airway gases points to note ... 140 Airway gases measurement setup ... 141 Airway gases equipment to patient connections with E-miniC, critical care setup ... 141 Setting up the airway gases measurement ... 141 E-miniC module connectors ... 142 E-miniC indications for use ... 142 Airway gases alternative patient connections ... 142 Checking the airway gases measurement ... 143

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Airway gases parameters ... 143 Airway gases parameters, E-miniC ... 143 Using the E-module for CO2 measurement ... 144 Turning on the CO2 measurement ... 144 Selecting the CO2 scale ... 144 Selecting the FiO2 level... 144 Selecting the N2O level... 145 Selecting the CO2 sweep speed... 145 Selecting the CO2 unit ... 145 Setting CO2 limit alarms ... 145 Preventing operating room pollution... 145 Scavenging through the ventilator reservoir... 145 Scavenging through the anesthesia gas scavenging system... 145 Connecting directly to the scavenging system ... 146 Stopping the airway gases measurement ... 146 Calibrating airway gases ... 146 Basics of airway gases measurement... 147 Airway gases measurement description, E-miniC ... 147 Sidestream gas sampling ... 147 Basics of CO₂ measurement... 148 Normal CO2 waveform... 148 The origin of the CO2 waveform ... 148 Dips in capnogram... 149 Airway gases practicalities... 149 Ventilation management ... 149 Prevention of the breathing system contamination ... 150 How to prevent effects of humidity... 150 Airway gases troubleshooting... 151 15 Trends, snapshots, and alarm history ...153 Patient data safety precautions... 153 Patient data cautions... 153 Patient data views... 153 Graphic trends... 153 Viewing graphic trends ... 153

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Graphic trend symbols... 154 Changing the graphic trend scales ... 154 Setting the graphic trend pages... 155 Numeric trends... 155 Viewing numeric trends ... 155 Changing the time interval of numeric trends ... 155 Snapshots... 156 Description of snapshots ... 156 Snapshot configuration ... 156 Manually created snapshots ... 156 Automatically created snapshots ... 156 Viewing snapshots ... 156 Alarm history ... 157 Viewing alarm history ... 157 OxyCRG... 157 OxyCRG description ... 157 Viewing the realtime OxyCRG... 157 Viewing OxyCRG snapshot ... 157 Setup OxyCRG snapshot... 158 Time change during a patient admit ... 158 Erasing patient data ... 158 16 Printing...159 Printing description ... 159 Printing waveforms... 159 Printing waveforms on alarms ... 159 Starting a waveform printout ... 160 Stopping a waveform printout ... 160 Setting the print delay... 160 Setting the print speed... 160 Setting the print duration ... 160 Selecting waveforms to print... 160 Printing trends... 161 Printing numerical trends ... 161 Printing graphical trends ... 161

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Printing format ... 161 Waveform printout format ... 161 Numerical trends printout format ... 162 Inserting recorder paper... 162 17 Cleaning and care...163 Cleaning and care safety precautions... 163 Cleaning and care warnings... 163 Cleaning and care cautions... 164 Disposal safety precautions ... 164 Disposal warnings ... 164 Disposal cautions ... 164 Cleaning and care schedules ... 164 Daily checks... 165 Check every two months ... 165 Check every six months ... 165 Once a year checks... 165 Regular calibration checks ... 165 Cleaning and care points to note... 165 Permitted detergents... 166 Cleaning and care instructions ... 166 Setting the touchscreen off ... 166 Cleaning non-applied parts, general instructions... 166 Other parts cleaning instructions... 167 Water trap care instructions ... 167 Monitor battery care ... 167 18 Messages ...169 Messages related to ECG measurement ... 169 Messages related to impedance respiration measurement ... 171 Messages related to SpO2 measurement... 172 Messages related to NIBP measurement ... 173 Messages related to invasive pressures measurement ... 175 Messages related to temperature measurement ... 179 Messages related to gases measurement ... 180 Messages related to trends, and snapshots ... 181

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Messages related to various situations ... 182 A

Abbreviations ...185 List of abbreviations... 185

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About this manual and device

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Intended use of this manual This manual is an integral part of the device and describes its intended use. It should always be kept close to the equipment. Observance of the manual is a prerequisite for proper performance and correct operation and ensures patient and user safety. Information which refers only to certain versions of the product(s) is accompanied by the model number(s) of the product(s) concerned. The model number is given on the device plate of the product. See the supplemental information manual for the technical specifications, default settings and compatibility information, including electromagnetic compatibility.

Intended audience of this manual This manual is intended for clinical professionals. Clinical professionals are expected to have a working knowledge of medical procedures, practices and terminology required to provide patient care. Using the device should never replace nor impede the human intervention and required patient care provided by clinical professionals.

Manual conventions This manual uses the following styles to emphasize text or indicate action.

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Item

Description

bold

Indicates hardware terms.

bold italic

Indicates software terms.

italic

Indicates terms for emphasis.

>

Indicates menu options to select consecutively.

GE

For technical documentation purposes, the abbreviation GE is used for the legal entity names, GE Medical Systems Information Technologies, Inc., and GE Healthcare Finland Oy. It is also used to refer to GE Healthcare.

CARESCAPE Network

CARESCAPE Network is used to refer to the MC Network.

select

The word select means choosing and confirming.

NOTE

Note statements provide application tips or other useful information.

Patient Monitor B125/B105

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About this manual and device

Illustrations and names This manual uses illustrations as examples only. Illustrations in this manual may not necessarily reflect all system settings, features, configurations, or displayed data. Names of persons, institutions, and places and related information are fictitious; any similarity to actual persons, entities, or places is purely coincidental.

Related documents ●

B125/B105 Patient Monitor Supplemental Information Manual

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B125/B105 Patient Monitor Suppliers and accessories

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B125/B105 Patient Monitor Technical Manual

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CARESCAPE Network Configuration Guide

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CIC Pro Clinical Information Center Operator's Manual

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CARESCAPE Central Station User’s Manual

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HL7 Reference Manual

The documents in this list are subject to change without notice. Please, contact your local sales or service representative for possible updates.

Ordering manuals A paper copy of this manual will be provided upon request. Contact your local GE representative and request the part number on the first page of the manual.

Indications for use B125/B105 is a portable multi-parameter unit to be used for monitoring and recording of, and to generate alarms for multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and during intra-hospital transport. The device is intended for use under the direct supervision of a licensed health care practitioner. The device is not intended for use during MRI. The device can be a stand-alone monitor or interfaced to other devices via network. B125/B105 monitors and displays: ECG (including ST segment, arrhythmia detection), invasive blood pressure, heart/pulse rate, oscillometric non-invasive blood pressure (systolic, diastolic and mean arterial pressure), functional oxygen saturation (SpO2) and pulse rate via continuous monitoring( including monitoring during conditions of clinical patient motion or low perfusion), temperature with a reusable or disposable electronic thermometer for continual monitoring Esophageal/Nasopharyngeal/Tympanic/Rectal/Bladder/Axillary/Skin/Airway/Room /Myocardial/ Core/Surface temperature, impedance respiration, respiration rate, CO2.

Training requirements No product-specific training is required for the use of this device.

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About this manual and device

Trademarks GE, the GE Monogram, Imagination at work, CARESCAPE, DINAMAP, Trim Knob and TruSignal are trademarks of General Electric Company.

Third party trademarks Masimo and SET are trademarks of Masimo Corporation. Nellcor and OxiMax are trademarks of a Medtronic company. HL7 is a registered trademark of Health Level Seven (HL7), Inc. All other third-party trademarks are the property of their respective owners.

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 repairs are carried out by authorized service personnel.

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The electrical installation of the relevant room complies with the requirements of the appropriate regulations.

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The equipment is used in accordance with the instructions for use.

Product availability NOTE

Due to continual product innovation, design and specifications for these products are subject to change without notice.

Some of the products mentioned in this manual may not be available in all countries. Please consult your local representative for the availability.

Warranty This Product is sold by GE Medical Systems (China) Co., Ltd. under the warranty set forth in the following paragraphs. Such warranty is extended only with respect to the purchase of this Product directly from GE or GE's Authorized Dealers as new merchandise and is extended to the Buyer thereof, other than for the purpose of resale. For a period of twelve (12) months from the date of original delivery to Buyer, this Product, other than expandable parts, is warranted against functional defects in materials and workmanship and to conform to the description of the Product contained in this manual and accompanying labels and/or inserts, provided that the same is properly operated under the conditions of normal use, that regular periodic maintenance and service is performed and that the replacements and repairs are made in accordance with the instructions provided, using genuine parts and performed by a trained person. The foregoing warranty shall not apply if the Product has been repaired by anyone other than GE or otherwise than in accordance with written instructions provided by GE, or altered by anyone other than GE, or if the Product has been subject to abuse, misuse, negligence, or accident. GE's sole and exclusive obligation and Buyer's sole and exclusive remedy under the above warranty is limited to repairing or replacing, free of charge, at GE's option, a Product, which is telephonically reported to the nearest GE office or GE's Authorized

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About this manual and device

Dealers office and which, if so advised by GE, is thereafter returned with a statement of observed deficiency, not later than seven (7) days after the expiration date of the applicable warranty, to the GE office or GE's Authorized Dealers office during normal business hours, transportation charges prepaid, and which, upon GE's examination, is found not to conform to the above warranty. GE shall not be otherwise liable for any damages including but not limited to incidental damages, consequential damages, or special damages. There are no express or implied warranties, which extend beyond the warranty hereinabove set forth. GE makes no warranty of merchantability or fitness for particular purpose with respect to the product or parts thereof.

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