Gima 35134 User manual

MULTI-PARAMETER PATIENT MONITOR
M35134-GB-Rev.5-10.20
User Manual
PROFESSIONAL MEDICAL PRODUCTS
35134
Gima S.p.A.
Via Marconi, 1 - 20060 Gessate (MI) Italy
[e-mail] - [e-mail]
www.gimaitaly.com
Made in China
0476

I
Preface
Manual Purpose
The instructions for safe operation of product in keeping with its function and intended use are contained in this
manual. In order to operate product properly, and to protect both the patient and operator from injury,
compliance with this manual is first priority.
Based on the maximum configuration, some contents of this manual may not apply to your product. Please keep
in touch with the manufacturer or your local sales if you have any question.
As an indispensable portion of the product, this manual should always be placed near the equipment so that it
can be got easily when needed.
Only clinical professionals, anyone who are under their guidance of people who have been trained adequately
can use this monitor. The unauthorized or the untrained are forbidden to operate the product.
Intended Audience
This Manual applies to clinical professionals with knowledge medical procedures, practices and terminology
required for monitoring of critically ill patients.
Illustrations
Setup or data displayed on your monitor may not be necessarily shown in all illustrations within this Manual,
illustration are used only as examples.
All names mentioned in this Manual and illustrations are fictitious. Any similarity is purely coincidental.

II
Terms used in this User Manual:
"View": Main screen when there is no any pop-up window.
"Long press": The operation pressing shortcut key for over 3 seconds.
"SpO2": Oxygen saturation.
Notes:
This patient monitor can be customized with different functional modules, therefore, the monitor you
purchased may not cover all operations described.
Caution:
Federal law restricts this device to sale by or on the order of a physician.

III
Table of Contents
Chapter 1 Safety .....................................................................................................................................................1
1.1 Safety Information.......................................................................................................................................1
1.1.1 Warnings...........................................................................................................................................1
1.1.2 Cautions............................................................................................................................................2
1.1.3 Notes ................................................................................................................................................2
1.2 Equipment Symbols.....................................................................................................................................4
1.2.1 Symbol/Icon on the Device...............................................................................................................4
1.2.2 Icons List on the Screen....................................................................................................................5
Chapter 2 The Basics ..............................................................................................................................................7
2.1 Monitor Description ....................................................................................................................................7
2.1.1 Product Name and Model ................................................................................................................7
2.1.2 Intended Use ....................................................................................................................................7
2.1.3 Features............................................................................................................................................7
2.2 Main Unit.....................................................................................................................................................9
2.3 Display Screen .......................................................................................................................................... 13
2.3.1 Information Area ........................................................................................................................... 14
2.3.2 Parameter Area and Waveform Area ............................................................................................ 14
Chapter 3 Operations ............................................................................................................................................. 16
3.1 Installation................................................................................................................................................ 16
3.1.1 Unpacking and Checking ............................................................................................................... 16
3.1.2 Environmental Requirements........................................................................................................ 16
3.2 Getting Started ......................................................................................................................................... 17
3.2.1 Connecting to Power Source ......................................................................................................... 17
3.2.2 Turning the Monitor On................................................................................................................. 18
3.2.3 Starting Monitoring ....................................................................................................................... 18
3.3 Turning the Monitor Off ........................................................................................................................... 19
3.4 Using Keys................................................................................................................................................. 19
3.4.1 Shortcut Key .................................................................................................................................. 19
3.5 Using the Main Menu............................................................................................................................... 19
3.5.1 How to Select the Menu Item ....................................................................................................... 19

IV
3.6 Data Uploading......................................................................................................................................... 20
Chapter 4 Screen Display........................................................................................................................................ 21
4.1 SpO2 Trend Data List Screen..................................................................................................................... 21
4.1.1 Screen Description......................................................................................................................... 21
4.1.2 Operating Instructions................................................................................................................... 21
4.2 NIBP Data List Screen ............................................................................................................................... 21
4.2.1 Screen Description......................................................................................................................... 21
4.2.2 Operating Instructions................................................................................................................... 22
4.3 Screen Display for Graphic Trend ............................................................................................................. 22
4.3.1 How to View the Graphic Trend .................................................................................................... 22
4.3.2 Operation Instructions................................................................................................................... 24
4.4 Screen Display for Waveform Recall......................................................................................................... 24
4.4.1 Operation Instructions................................................................................................................... 25
4.5 Screen Display for Arrhythmia Event List ................................................................................................. 27
4.5.1 Operation Instructions................................................................................................................... 27
4.6 Screen Display for System Setting ............................................................................................................ 28
4.6.1 How to Select the System Setup Item ........................................................................................... 28
4.7 Display Color Settings ............................................................................................................................... 28
4.7.1 How to Change the Parameter Color............................................................................................. 29
4.8 File Management Screen.......................................................................................................................... 29
4.8.1 How to Add a New Patient ............................................................................................................ 29
4.9 OxyCRG Screen ......................................................................................................................................... 30
4.9.1 Operation Instructions................................................................................................................... 30
4.10 Event List Screen..................................................................................................................................... 31
4.10.1 Screen Description....................................................................................................................... 31
4.10.2 Operating Instructions................................................................................................................. 31
4.11 MC Calculator ......................................................................................................................................... 31
4.11.1 Medicine Dosage Calculator........................................................................................................ 31
4.12 Tourniquet Function ............................................................................................................................... 34
4.12.1 Operation Instructions ................................................................................................................ 34
Chapter 5 Parameter Settings ................................................................................................................................ 35

V
5.1 System Parameter Settings....................................................................................................................... 35
5.2 Network Related Settings ......................................................................................................................... 36
5.3 ECG Related Settings ................................................................................................................................ 37
5.4 Temperature Related Settings .................................................................................................................. 38
5.5 NIBP Related Settings ............................................................................................................................... 39
5.6 SpO2Related Settings ............................................................................................................................... 40
5.7 Respiration Related Settings..................................................................................................................... 40
Chapter 6 Alarms.................................................................................................................................................... 42
6.1 Alarm Categories ...................................................................................................................................... 42
6.2 Alarm Levels ............................................................................................................................................. 42
6.3 Alarm Indicators ....................................................................................................................................... 43
6.3.1 Alarm lamp .................................................................................................................................... 44
6.3.2 Alarm message .............................................................................................................................. 44
6.3.3 Highlighting Numeric..................................................................................................................... 44
6.3.4 Audible Alarm Tones...................................................................................................................... 44
6.3.5 Alarm Status Symbols:................................................................................................................... 44
6.3.6 Changing Alarm Volume ................................................................................................................ 45
6.4 Understanding the Alarm Setting............................................................................................................. 45
6.4.1 High and Low Alarm Setting Range ............................................................................................... 45
6.4.2 Factory Default Alarm Limit Setting Value..................................................................................... 47
6.5 Testing Alarms .......................................................................................................................................... 47
6.6 When an Alarm Occurs............................................................................................................................. 47
Chapter 7 ECG Monitoring ..................................................................................................................................... 49
7.1 Introduction.............................................................................................................................................. 49
7.2 Safety Information.................................................................................................................................... 49
7.3 Preparing to Monitor ECG ........................................................................................................................ 50
7.3.1 Preparing the Patient and Device.................................................................................................. 50
7.3.2 ECG Electrodes Placement............................................................................................................. 51
7.4 Understanding the ECG Display................................................................................................................ 52
7.5 Changing ECG Settings.............................................................................................................................. 53
7.6 About Arrhythmia Detection and Template Learning .............................................................................. 53

VI
7.6.1 Understand the ARR Type.............................................................................................................. 54
7.7 About S-T Segment Monitoring................................................................................................................ 55
7.8 Freezing Waveform................................................................................................................................... 56
7.9 Factors Affecting ECG signal ..................................................................................................................... 56
Chapter 8 Monitoring Respiration (RESP) .............................................................................................................. 57
8.1 Introduction.............................................................................................................................................. 57
8.2 Safety Information.................................................................................................................................... 57
8.3 Understanding the RESP Display .............................................................................................................. 57
8.4 Changing RESP Settings ............................................................................................................................ 58
Chapter 9 Monitoring NIBP .................................................................................................................................... 59
9.1 Introduction.............................................................................................................................................. 59
9.1.1 The Oscillometric Blood Pressure Measurement .......................................................................... 59
9.1.2 The Oscilometric method vs. the Korotkoff Sound Method.......................................................... 59
9.2 Safety Information.................................................................................................................................... 59
9.3 Measurement Limitations ........................................................................................................................ 60
9.4 Measurement Mode................................................................................................................................. 60
9.5 Setting Up the NIBP Measurement .......................................................................................................... 61
9.5.1 Preparing to Measure NIBP ........................................................................................................... 61
9.5.2 Starting and Stopping Measurements........................................................................................... 61
9.5.3 Factors Affecting NIBP Measurement............................................................................................ 62
9.6 Understanding the NIBP Numerics........................................................................................................... 62
9.7 Changing NIBP Settings ............................................................................................................................ 63
Chapter 10 Monitoring Oxygen Saturation (SpO2) ................................................................................................. 64
10.1 Introduction............................................................................................................................................ 64
10.2 Safety Information.................................................................................................................................. 64
10.3 Apply the Sensor .................................................................................................................................... 65
10.4 Using Probe and Sensor.......................................................................................................................... 66
10.5 Understanding the SpO2and PR Display ................................................................................................ 68
10.6 Changing SpO2and PR Settings .............................................................................................................. 68
Chapter 11 Monitoring Temperature..................................................................................................................... 69
11.1 Introduction............................................................................................................................................ 69

VII
11.2 Safety Information.................................................................................................................................. 69
11.3 Making a TEMP Measurement ............................................................................................................... 69
11.4 Understanding the TEMP Display........................................................................................................... 70
11.5 Changing TEMP Settings......................................................................................................................... 70
Chapter 12 Screen Display for Remote Observation .............................................................................................. 71
12.1 Default Remote Screen........................................................................................................................... 71
12.2 NIBP Screen Display................................................................................................................................ 72
12.3 Screen Display with ECG Waveforms only .............................................................................................. 73
12.4 Five Channels Real-time Waveforms and Trends on the Same Screen .................................................. 75
12.5 Parameter Screen ................................................................................................................................... 76
Chapter 13 Battery ................................................................................................................................................. 78
13.1 Overview ................................................................................................................................................ 78
13.2 Battery Maintenance.............................................................................................................................. 78
13.3 Battery Recycling .................................................................................................................................... 79
Chapter 14 Cleaning and Disinfection.................................................................................................................... 80
14.1 Cleaning the Device and Accessories ..................................................................................................... 80
14.2 Disinfecting the Device and Accessories ................................................................................................ 81
Chapter 15 Maintenance........................................................................................................................................ 82
15.1 Daily Examination................................................................................................................................... 82
15.2 Routine Maintenance ............................................................................................................................. 82
15.3 ECG Verification...................................................................................................................................... 83
15.4 Pressure Accuracy Verification ............................................................................................................... 83
16 Accessories ........................................................................................................................................................ 86
17 Technical Specifications .................................................................................................................................... 87
17.1 ECG ......................................................................................................................................................... 87
17.2 RESP........................................................................................................................................................ 88
17.3 TEMP ...................................................................................................................................................... 88
17.4 NIBP........................................................................................................................................................ 88
17.5 SpO2........................................................................................................................................................ 89
17.6 Pulse Rate............................................................................................................................................... 89
17.7 S-T Segment............................................................................................................................................ 90

VIII
17.8 Data Recording ....................................................................................................................................... 90
17.9 Other Technical Specifications................................................................................................................ 90
17.10 Classification......................................................................................................................................... 90
17.11 Operating Environment ........................................................................................................................ 91
17.12 Storage ................................................................................................................................................. 91
17.13 Transportation ...................................................................................................................................... 91
17.14 Packaging.............................................................................................................................................. 92
Chapter 18 Troubleshooting .................................................................................................................................. 93
18.1 No Display on the Screen ....................................................................................................................... 93
18.2 Excessive ECG Signal Interference or too Thick Baseline........................................................................ 93
18.3 No Blood Pressure and Pulse Oxygen Measures.................................................................................... 93
18.4 System Alarm.......................................................................................................................................... 93
18.5 Alarm Problems...................................................................................................................................... 93
18.6 Power Supply Failure .............................................................................................................................. 94
A Alarm Information ........................................................................................................................................... 95
B Status/Error during NIBP Monitoring............................................................................................................... 96
C EMC Compliance .............................................................................................................................................. 97

Operator ’s Manual for Patient Monitor
1
Chapter 1 Safety
1.1 Safety Information
The safety statements presented in this chapter refer to the basic safety information that the operator of the monitor
shall pay attention to and abide by. There are additional safety statements in other chapters or sections, which may be
the same as or similar to the followings, or specific to the operations.
Warning: indicates a potential hazard or unsafe practice that, if not avoided, could result in
death or serious injury.
Caution: indicates a potential hazard or unsafe practice that, if not avoided, could result in
minor personal injury or product/property damage.
☞Note: provides application tips or other useful information to ensure that you get the most
from your product.
1.1.1 Warnings
WARNING for PACEMAKER PATIENTS: Although the pacemaker pulse inhibition function is available in this
device, the heart rate meter may continue to count the pacemaker rate during occurrences of cardiac arrest or
some arrhythmias. Do not rely entirely upon rate meter ALARMS. Keep pacemaker patients under close
surveillance. See this manual for disclosure of the pacemaker pulse rejection capability of this instrument.
Disconnect the monitor and sensors from the patient before MRI scanning. Use them during MRI could cause
burns or adversely affect on the MRI image or the monitor’s accuracy.
If uncertain about the accuracy of any measurement, firstly check the patient’s vital signs by any alternative
means, and then make sure the monitor is functioning properly.
The monitor is intended only as an adjunct in patient assessment. It must be used in conjunction with clinical
signs and symptoms.
Monitoring a single person at a time.
The monitor is defibrillation-proof. Verify that the accessories can function safely and normally and the
monitor is grounded properly before conducting defibrillation.
The monitor is not suitable for use in the presence of flammable anesthetic mixture with air, oxygen or nitrous
oxide.
Each time the monitor is used, check the alarm limits to ensure that they are appropriate for the patient being
monitored.
The alarm limit value shall be within the measuring range, or it may disable the alarm system. Please refer to
the related chapter for alarm limit range.
A HAZARD can exist if different alarm presets are used for the same or similar device in a single area.