Patient momitoring AXCENT, Summaries of Health sciences

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CETUS x12 / x

MULTI-PARAMETER PATIENT MONITOR

INSTRUCTIONS FOR USE

[Version 1. 1 ]

Notice Thanks for purchasing Multi-parameter Patient Monitor. Before operating, please read this Manual carefully to ensure proper use. Please keep this Manual properly for future reference. Product Type: Model: Structure and Components: Scope of Application: Patient Monitor CETUS x12, CETUS x The monitor consists of master unit, display, ECG cable, SpO probe, blood pressure cuff, and temperature probe. Monitors patient ECG, respiration (RESP), blood oxygen saturation (SpO2), pulse rate (PR), noninvasive blood pressure (NIBP), and temperature (TEMP) as well as displays, reviews and stores the monitoring information. Manufacturer: aXcent medical GmbH Josef-Görres-Platz 2 56068 Koblenz / Germany Version: 1. 1 Date of Issue: January 2019

If you do not pay or delay the payment of maintenance fees, manufacturer will suspend the repair services until you pay up. Preface

Notice

This Operator’s Manual is the necessary instructions for the safe use of this product. This Manual introduces the use, properties, method of operation, safety information and intended use of the Multi-parameter Patient Monitor in details. Before using the product, please carefully read and understand the contents of this Manual and abide by the method of operation stated in this Manual in order to ensure the safety of patients and operators. This Operator’s Manual is a major component of the product and should always be placed near the product for easy reference.

Object of Application

This Operator’s Manual is intended for professional clinical staff or personnel with experience in the use of monitoring equipment. The readers should have knowledge and work experience in medical procedures, practices and terminology of patient monitoring.

Illustration

All the illustrations in this Operator’s Manual are for reference only. The menus, settings and parameters of the illustrations may be different from the monitor.

Convention

◼ [Character]: Used to represent the string in the software or characters on the interface. ◼ →: This symbol is used to indicate operation step.

INDEX Chapter 1. Safety ................................................................................................................. - 13 - 14.1 Safety Information.............................................................................................. - 13 - 14.1.1 Danger ........................................................................................................ - 13 - 14.1.2 Warning ...................................................................................................... - 13 - 14.1.3 Caution ....................................................................................................... - 14 - 14.1.4 Note ............................................................................................................ - 14 - 14.2 Symbols .............................................................................................................. - 15 - Chapter 2. Monitor Overview.............................................................................................. - 16 - 2.1 Introduction ....................................................................................................... - 16 - 2.1.1 Scope of Application................................................................................... - 16 - 2.1.2 Contraindications ....................................................................................... - 16 - 2.1.3 Composition and Structure ........................................................................ - 16 - 2.2 Master Unit ........................................................................................................ - 16 - 2.2.1 Front View .................................................................................................. - 16 - 2.2.2 Side View .................................................................................................... - 18 - 2.2.3 Rear View ................................................................................................... - 19 - 2.3 Screen Display .................................................................................................... - 20 - 2.4 Smart Hotkeys .................................................................................................... - 21 - Chapter 3. Basic Operation.................................................................................................. - 23 -

3. 1 Installation .......................................................................................................... - 23 - 3.1.1 Unpacking................................................................................................... - 23 - 3.1.2 Environmental Requirements ..................................................................... - 23 - 3.2 Connecting to AC Power..................................................................................... - 24 - 3.3 Turning on .......................................................................................................... - 25 - 3.3.1 Checking the Monitor................................................................................. - 25 - 3.3.2 Starting the Monitor................................................................................... - 25 - 3.3.3 Connecting the Sensor ............................................................................... - 26 - 3.3.4 Starting Monitoring .................................................................................... - 26 - 3.4 Turning off .......................................................................................................... - 26 - 3.5 Basic Operation .................................................................................................. - 26 - 3.5. 1 Using the Shuttle ........................................................................................ - 26 - 3.5.2 Using Keys .................................................................................................. - 27 - 3.5.3 Using the Touch Screen .............................................................................. - 27 - 3.5.4 Using Soft Keyboard ................................................................................... - 27 - 3.5.5 Using Menu ................................................................................................ - 27 - 3.6 Operating Mode ................................................................................................. - 28 - 3.7 Measurement Setup........................................................................................... - 29 - 3.8 Freezing Waves................................................................................................... - 29 - 3.9 Other Common Setup ........................................................................................ - 30 - 3.9.1 Defining the Monitor.................................................................................. - 30 - 3.9.2 Language Setup .......................................................................................... - 30 - 3.9.3 Date and Time ............................................................................................ - 30 -

7.3.4 Installing Electrodes ................................................................................... - 51 - 7.3.5 Checking the Pacemaking Status ................................................................ - 54 - 7.4 ECG Display......................................................................................................... - 54 - 7.5 ECG Setup ........................................................................................................... - 55 - 7.6 Alarm Setup ........................................................................................................ - 56 - Chapter 8. Resp ................................................................................................................... - 57 - 8.1 Overview ............................................................................................................ - 57 - 8.2 Safety Information.............................................................................................. - 57 -

8. 3 Placing Electrodes for Respiration Monitoring ................................................... - 57 - 8.3.1 Adjusting Position of Respiration Electrode ............................................... - 58 - 8.3.2 Cardiomotility Superimposing .................................................................... - 58 - 8.4 Resp Display ....................................................................................................... - 59 - 8.5 Resp Setup.......................................................................................................... - 59 - 8.5.1 Setting Apnea Time .................................................................................... - 60 - 8.5.2 Adjusting Wave Gain .................................................................................. - 60 - 8.5.3 Setting Scanning Speed .............................................................................. - 60 - 8.6 Alarm Setup ........................................................................................................ - 60 - Chapter 9. PR ....................................................................................................................... - 61 - 9.1 Overview ............................................................................................................ - 61 - 9.2 Display ................................................................................................................ - 61 - 9.3 Setting PR Sound ................................................................................................ - 61 - 9.4 Alarm Setup ........................................................................................................ - 61 - Chapter 10. SpO2................................................................................................................. - 62 - 10.1 Overview ............................................................................................................ - 62 - 10.2 Safety Information.............................................................................................. - 62 - 10.3 Monitoring Steps ................................................................................................ - 63 - 10.4 Display ................................................................................................................ - 64 - 10.5 Setting SpO2 ....................................................................................................... - 64 - 10.5.1 Setting Wave Speed.................................................................................... - 65 - 10.5.2 Setting Wave Mode .................................................................................... - 65 - 10.5.3 Setting Average Time.................................................................................. - 65 - 10.6 Measuring Influencing Factors ........................................................................... - 65 - 10.7 Alarm Setup ........................................................................................................ - 66 - Chapter 11. NIBP ................................................................................................................. - 67 - 11.1 Overview ............................................................................................................ - 67 - 11.2 Safety Information.............................................................................................. - 68 - 11.3 Measurement Limits .......................................................................................... - 68 - 11.4 Measurement Procedure ................................................................................... - 70 - 11.4.1 Preparing for Measurement ....................................................................... - 70 - 11.4.2 Patient posture requirements during measurement ................................. - 70 - 11.4.3 Starting / Stopping Measurement .............................................................. - 70 - 11.4.4 Correcting Measurement Results ............................................................... - 70 -

11.5 NIBP Display ....................................................................................................... - 71 - 11.6 Setting Inflation Pressure ................................................................................... - 71 - 11.7 NIBP Resetting .................................................................................................... - 71 - 11.8 NIBP Leakage Test............................................................................................... - 72 - 11.9 NIBP Calibration ................................................................................................. - 73 - 11.10 Clean and disinfection method of NIBP cuff ...................................................... - 73 - 11.10.1 Cleaning Method ................................................................................ - 73 - 11.10.2 Disinfection Method ........................................................................... - 73 - 11.11 Alarm Setup ........................................................................................................ - 74 - Chapter 12. Temp ................................................................................................................ - 75 - 12.1 Overview ............................................................................................................ - 75 - 12.2 Safety Information.............................................................................................. - 75 - 12.3 Measurement Steps ........................................................................................... - 75 - 12.4 Measuring Requirements ................................................................................... - 75 - 12.5 Temp Display ...................................................................................................... - 76 - 12.6 Selecting Resistance Type of Temp Probe .......................................................... - 76 - 12.7 Setting Temperature Unit ................................................................................... - 77 - 12.8 Alarm Setup ........................................................................................................ - 77 - Chapter 13. Review ............................................................................................................. - 78 - 13.1 Reviewing Trend Chart ....................................................................................... - 78 - 13.2 Reviewing Trend Table........................................................................................ - 79 - 13.3 NIBP Measurement Review................................................................................ - 80 - 13.4 Event Review ...................................................................................................... - 81 - Chapter 14. Gas Monitoring ..................................................................................... - 83 - 14.1 CO2 Monitoring (optional) ................................................................................. - 83 - 14.1.1 Introduction................................................................................................ - 83 - 14.2 Anesthetic Gases Monitoring (optional) ............................................................ - 84 - 14.2.1 Introduction................................................................................................ - 84 - 14.3 Mainstream Gas Analyzer .................................................................................. - 86 - 14.3.1 Intended use............................................................................................... - 86 - 14.3.2 Symbols ...................................................................................................... - 86 - 14.3.3 Technical specification................................................................................ - 87 - 14.3.4 IRMA Airway Adapter ................................................................................. - 88 - 14.3.5 System set-up ............................................................................................. - 88 - 14.3.6 Placement of IRMA Probe .......................................................................... - 90 - 14.3.7 Pre-use check ............................................................................................. - 91 - 14.3.8 Zeroing........................................................................................................ - 91 - 14.3.9 Alarms ........................................................................................................ - 92 - 14.3.10 Cleaning .............................................................................................. - 92 - 14.3.11 Gas span check ................................................................................... - 92 - 14.3.12 Warnings ............................................................................................ - 93 - 14.3.13 Cautions.............................................................................................. - 94 - 14.3.14 Classifications ..................................................................................... - 94 -

16.1.9 Measurement Restrictions ....................................................................... - 145 - 16.1.10 Influencing Factors ........................................................................... - 145 - Chapter 17. BIS (optional) ................................................................................................. - 145 - 17.1 Introduction ..................................................................................................... - 145 - 17 .2 Safety Information............................................................................................ - 146 - 17.3 BIS Display ........................................................................................................ - 146 - 17.4 Set up the BIS Measurement ........................................................................... - 148 - 17.5 BIS Setup menu ................................................................................................ - 149 - 17.5.1 Continuous Impedance Check .................................................................. - 149 - 17.5.2 Cyclic Impedance Check ........................................................................... - 150 - 17.5.3 BIS Sensor Check ...................................................................................... - 150 - 17.5.4 Filter ......................................................................................................... - 151 - 17.5.5 BIS Smoothing Rate .................................................................................. - 151 - 17.5.6 Wave scale ................................................................................................ - 151 - 17.5.7 Revision info ............................................................................................. - 151 - Chapter 18. NMT (optional) .............................................................................................. - 152 - 18.1 Overview .................................................................................................................. - 152 - 18.2 Short Set-up.............................................................................................................. - 152 - 18.2.1 Checking Patients For Muscle Relaxation ...................................................... - 152 - 18.2.2Checking Patient For Residual Curarization.................................................... - 153 - 18.2.3 Nerve Location For Loco-regional Anesthesia ............................................ - 153 - 18.3 Pre-Operative Set-up ................................................................................................ - 153 - 18.3.1 Cable Connections (Objective Monitoring) ................................................... - 153 - 18.3.2 Cable Connections (Subjective Monitoring).................................................. - 154 - 18.3.3 Cable Connections (Loco-regional Anesthesia) ............................................. - 154 - 18.3.4 Electrodes...................................................................................................... - 154 - 18.3.5 Electrode Placement ..................................................................................... - 154 - 18.3.6 Position Of The Transducer ........................................................................... - 155 - 18.3.7 Arm Position .................................................................................................. - 155 - 18.3.8 Connection To Stimulator .............................................................................. - 155 - 18.3.9 Skin Resistance .............................................................................................. - 156 - 18.3.10 Control Twitch Height.................................................................................. - 156 - 18.3.11 Calibration ................................................................................................... - 156 - 18.3.12 Sensitivity .................................................................................................... - 157 - 18.3.13 Stimulation Units ......................................................................................... - 157 - 18.4 NMT Display ............................................................................................................. - 157 - Chapter 19. Calculate ........................................................................................................ - 158 - 19.1 Overview .................................................................................................................. - 158 - 19.2 Dose Calculation....................................................................................................... - 158 - 19.2.1 Calculating Step ............................................................................................. - 158 - 19.2.2 Unit Of Measurement ................................................................................ - 159 - 19.2.3 Titration Table ............................................................................................... - 159 - 19.3 Oxygenation Calculation .......................................................................................... - 160 -

19 .3.1 Calculating Step ............................................................................................. - 160 - 19.3.2 Input Parameter ............................................................................................ - 160 - 19.3.3 Output Parameter ......................................................................................... - 160 - 19.4 Ventilation Calculation ............................................................................................. - 161 - 19.4.1 Calculating Step ............................................................................................. - 161 - 19.4.2 Input Parameter ............................................................................................ - 161 - 19.4.3 Output Parameter ......................................................................................... - 161 - 19.5 Hemodynamic Calculation ....................................................................................... - 162 - 19 .5.1 Calculating Step ............................................................................................. - 162 - 19.5.2 Input Parameter ............................................................................................ - 162 - 19.5.3 Output Parameter ......................................................................................... - 162 - 19.6 Renal Function Calculation ....................................................................................... - 163 - 19.6.1 Calculating Step ............................................................................................. - 163 - 19.6.2 Input Parameter ............................................................................................ - 163 - 19.6.3 Output Parameter ......................................................................................... - 164 - 19.7 MEWS System .......................................................................................................... - 164 - Chapter 20. Spot Check ..................................................................................................... - 167 - 20.1 Outline...................................................................................................................... - 167 - 20.2 Set Point Measurement ........................................................................................... - 167 - 20.3 Use The Spot Check .................................................................................................. - 167 - Chapter 21. Recording (optional) ...................................................................................... - 171 - 21.1 Recorder Profile........................................................................................................ - 171 - 21.2 Loading Paper ........................................................................................................... - 172 - 21.3 Setting up the Recorder ........................................................................................... - 172 - 21.4 Clearing Recorder ..................................................................................................... - 173 - Chapter 22. Battery ........................................................................................................... - 174 - 22.1 Checking Battery Performance................................................................................. - 174 - 22.2 Overview .................................................................................................................. - 174 - 22.3 Installing the battery ................................................................................................ - 175 - 22.4 Battery Usage Guide................................................................................................. - 175 - 22.5 Battery Recycling ...................................................................................................... - 176 - Chapter 23. Caring and Cleaning ....................................................................................... - 177 - 23.1 Overview .................................................................................................................. - 177 - 23.2 Cleaning.................................................................................................................... - 177 - 23.3 Disinfection .............................................................................................................. - 178 - 23.4 Sterilization .............................................................................................................. - 179 - Chapter 24. Maintenance .................................................................................................. - 180 - 24.1 Checking ................................................................................................................... - 180 - 24.2 Viewing Software Version Info ................................................................................. - 181 - 24.2 Maintenance Plan .................................................................................................... - 181 - 24.3 ECG Calibration......................................................................................................... - 182 - 24.4 Touch Screen Calibration .......................................................................................... - 182 -

Chapter 1. Safety

14.1 Safety Information

Danger

⚫ A warning that alerts you to a potential serious outcome, adverse event or safety hazard. Failure to observe a warning may result in serious injury or death to the user or patient.

Warning

⚫ Alerts you to potential hazard or unsafe operation. Failure to avoid such hazard or operation may result in minor or moderate personal injury or damage to the product or other properties, and possibly in a remote risk of more serious injury.

Caution

⚫ In order to safely use the device continuously, it is required to comply with the instructions listed. The instructions listed in this Manual are not substitute for the medical procedure being performed.

Note

⚫ Emphasize important considerations and provide a description or explanation in order to make better use of the product. ⚫ In order to safely use the device continuously, it is required to comply with the instructions listed. The instructions listed in this Manual are not substitute for the medical procedure being performed.

14.1.1 Danger

This product does not involve information of danger levels.

14.1.2 Warning

⚫ This monitor is used for clinical patient monitoring, and only trained and qualified doctors and nurses are allowed to use this monitor. ⚫ Before operating, the user must check if the device, cables and accessories are functioning properly and safely. ⚫ The alarm volume, upper and lower alarm limit should be set according to the actual situation of the patient. Do not just rely on audio alarm system while monitoring the patient, because too low alarm volume or complete shutdown may result in alarm failure and endanger the patient safety. Please pay close attention to the actual clinical situation of the patient.

14.2 Symbols

The symbols appearing on the instrument are as follows: Defibrillation-proof type CF applied part Auxiliary output interface Defibrillation-proof type BF applied part USB interface Caution: Refer to accompanying documents (Operator’s Manual). Network Interface Power on / off Signal input and output interface AC power supply (AC) Display Interface Battery operating indicator Equipotential terminal Alarm silence Serial Number NIBP Production date Wave freezing Manufacturer info Print Waste Electrical and Electronic Equipment Directive Refer to the Operator’s Manual

Chapter 2. Monitor Overview

2.1 Introduction

2.1.1 Scope of Application

This monitor is suitable for bedside monitoring for adults, pediatric and neonatal application. This monitor enables ECG, respiration (RESP), pulse rate (PR), blood oxygen saturation (SPO2), noninvasive blood pressure (NIBP), and temperature (TEMP) monitoring. It is equipped with a replaceable built-in battery to provide convenience for the patient movement in hospital.

2.1.2 Contraindications

None.

2.1.3 Composition and Structure

The monitor consists of master unit, display, ECG cable, SpO2 probe, blood oxygen cuff, temperature probe, and built-in lithium battery.

2.2 Master Unit

2.2.1 Front View

Fig. 2- 1 Front View

2.2.2 Side View

Fig. 2-2 Side View

1. ECG —— ECG cable interface
2. SpO2 ——SpO2 cable interface
3. T 1 —— Temperature probe interface
4. T 2 —— Temperature probe interface
5. NIBP —— NIBP cuff interface
6. Movable handle
7. SD card slot
8. Fan outlet
9. Battery cover

2.2.3 Rear View

Fig. 2 - 3 Rear View (example)

1. Speaker holes
2. Auxiliary output interface (nurse call, unrealized)
3. USB interfaces (2): Connect an external storage device to upgrade the monitor software.
4. Network interface
5. Signal input and output interface: standard DB9 interface, which can be connected to the PC to output data or connected with a compatible device.
6. Display interface: Connected to a standard color VGA monitor for auxiliary display and monitoring. External monitor displays the same content as the monitor display.
7. Equipotential terminal: When other devices are used in conjunction with the monitor, you should connect the equipotential terminals of other devices and the monitor with wires to eliminate the ground potential difference between different devices and ensure safety.
8. Power cord retaining hook
9. Hook
10. Fuse
11. AC power socket