Gima 35134 User manual

MULTI-PARAMETER PATIENT MONITOR
M35134-GB-Rev.3-06.19
35134
Gima S.p.A.
Via Marconi, 1
20060 Gessate (MI) - Italy
Made in China
0476
Gima S.p.A.
Via Marconi, 1 - 20060 Gessate (MI) Italy
[e-mail] - [e-mail]
www.gimaitaly.com
User Manual
ATTENTION: The operators must carefully read and completely
understand the present manual before using the product.
PROFESSIONAL MEDICAL PRODUCTS

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This Manual is written and compiled in accordance with standards and requirements for electromedical de-
vices.
The Manual is written for the current Patient Monitor.
The Manual describes, in accordance with the Patient Monitor’s features and requirements, main structure,
functions, specications, correct methods for transportation, installation, usage, repair, maintenance and stor-
age, etc. as well as the safety procedures to protect both the user and equipment. Refer to the respective
chapters for details.
This manual it consists of two parts, part I covers almost the all necessary content, except the operations for
user interface, which is included separately in part II.
We reserve the right to improve and amend it at any time without prior notice. Amendments will however be
published in a new edition of this manual.
This manual is an integral part of the product, it should always be kept close to the equipment so that it can be
obtained conveniently when needed
Marks in the Manual
Warning: must be followed to avoid endangering the operator and the patient.
☞Note: contains some important information and tips about operations and application.
Attention: must be followed to avoid causing damage to the monitor.
Instructions to User
Dear Users,
Thank you very much for purchasing our product. Please read the following very carefully before using this
equipment.
Read these instructions carefully before using this monitor. These instructions describe the operating proce-
dures to be followed strictly. Failure to follow these instructions can cause monitoring abnormality, equipment
damage and personal injury. The manufacturer is NOT responsible for the safety, reliability and performance
issues and any monitoring abnormality, personal injury and equipment damage due to user’s negligence of the
operation instructions. The manufacturer’s warranty service does not cover such faults.
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.
If uncertain about the accuracy of any measurement, rst check the patient’s vital signs by any alternative
means, and then make sure the monitor is functioning properly.
The device should be considered an early warning device. As a trend towards patient deoxygenation is
indicated, blood samples should be analyzed by a laboratory CO-oximeter to completely understand the
patient's condition.
The monitor is not suitable for use in the presence of ammable anesthetic mixture with air, oxygen or ni-
trous oxide.
Monitoring a single person at a time.
The monitor is debrillator proof. Verify that the accessories can function safely and normally and the mon-
itor is grounded properly before conducting debrillation.
Disconnect the monitor and sensors before MRI scanning. Use during MRI could cause burns or adversely
affect the MRI image or the monitor’s accuracy.
If you have any doubt to the grounding layout and its performance, you must use the built-in battery to
power the monitor.
All combinations of equipment must be in compliance with the standard IEC 60601-1.
Check SpO2probe application site periodically (every 30 minutes) to determine circulation, positioning and
skin sensitivity.
The SpO2measurement of this monitor may not work for all testees. If stable readings cannot be obtained
at any time, discontinue use.

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Do not immerse the monitor or its accessories in liquid to clean.
Do not use accessories other than those provided/recommended by the.
Each time the monitor is used, check the alarm limits to ensure that they are appropriate for the patient
being monitored.
Do not silence the audible alarm if patient safety may be compromised.
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 equipment in single area.
The monitor is intended only as an adjunct in patient assessment. It must be used in conjunction with clin-
ical signs and symptoms.
When taking the measure of a pediatric or neonates(less than 10 years old) blood pressure, do NOT operate
in the adult mode. The high ination pressure may cause lesion or even body putrescence.
The monitor is prohibited from applying to those who have severe hemorrhagic tendency or who are with
sickle cell disease for they may develop partial bleeding when this monitor is used to take the blood pres-
sure measurement.
DO NOT take blood pressure measurement from a limb receiving ongoing transfusion or intubations or skin
lesion area, otherwise, damages may be caused to the limb.
Continuous use of SpO2sensor may result in discomfort or pain, especially for those with microcirculatory
problem. It is recommended that the sensor should NOT be applied to the same place for over two hours,
change themeasuring site periodically if necessary.
SpO2measuring position must be examined more carefully for some special patient. Do NOT install the
SpO2sensor on the nger with edema or vulnerable tissue.
To prevent the risk of the short circuit and to ensure the ECG signal quality, the equipment must be properly
grounded.
Although biocompatibility tests have been performed on all the applied parts, some exceptional allergic
patients may still have anaphylaxis. Do NOT apply to those who have anaphylaxis.
All the connecting cables and rubber tubes of the applying parts should be kept away from the patient's
cervix to prevent any possible suffocation of the patient.
All the parts of the monitor should NOT be replaced at will. If necessary, please use the components pro-
vided by the manufacturer or those that are of the same model and standards as the accessories along
with the monitor which are provided by the same factory, otherwise, negative effects concerning safety and
biocompatibility etc. may be caused.
DO NOT stare at the light of SpO2sensor (infrared is invisible) when switch it on, for the infraredmay do
harm to the eye.
If the monitor falls off accidentally, please do NOT operate it before its safety and technical indexes have
been tested minutely and positive testing results obtained.
The system might not meet its performance specications if stored or used outside the manufacturer’s
specied temperature and humidity ranges.
Reuse, disassembly, cleaning, disinfecting the single patient use CO2cannula kits and on-airway adapters
may compromise functionality and system performance leading to a user or patient hazard. Performance is
not guaranteed if an item labeled as single patient use is reused.
Electrical Shock Hazard: Always disconnect the CO2Sensor before cleaning. Do NOT use if it appears to
have been damaged. Refer servicing to qualied service personnel.
Electrical Shock Hazard:No user serviceable parts inside the CO2Sensor.
After the life cycle of the Sidestream CO2Sensor and its accessories has been met, disposal should be
accomplished following national and/or local requirements.
Please peruse the relative content about the clinical restrictions and contraindication.
The accessories which can be used repeatedly should have a thorough cleanness before it is used to an-
other patient. Please refer to the related chapter for maintenance method.
When disposing of the monitor and its accessories, the local law should be followed.
Substitution of a component different from that supplied might result in measurement error.

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INDEX PART I
Chapter 1 Overview ...................................................................................................................................... 7
1.1 Product Name......................................................................................................................... 7
1.2 Applications and Scope.......................................................................................................... 7
1.3 Operating Environment........................................................................................................... 7
1.4 Impact on Environment and Resources.................................................................................. 7
1.5 Safety...................................................................................................................................... 7
Chapter 2 Working Theories........................................................................................................................ 8
2.1 Overall Structure..................................................................................................................... 8
2.2 Composition ........................................................................................................................... 8
2.3 Working Theories .................................................................................................................... 8
Chapter 3 Installation and Connection....................................................................................................... 9
3.1 Installation............................................................................................................................... 9
3.1.1 Opening the Box and Check.......................................................................................... 9
3.1.2 Connecting the AC Power Cable ................................................................................... 9
3.1.3 Starting the Monitor ..................................................................................................... 10
3.2 Connection ........................................................................................................................... 10
3.2.1 ECG Cable/Lead Wires Connection............................................................................. 10
3.2.2 Cuff Connection for Blood Pressure Measurement ..................................................... 12
3.2.3 SpO2Probe Connection.............................................................................................. 14
3.2.4 CO2 Sensor Connection .............................................................................................. 17
3.2.5 TEMP Probe Connection ............................................................................................. 20
3.2.6 Loading Printing Paper ................................................................................................ 21
Chapter 4 Alarm.......................................................................................................................................... 22
4.1 Alarm Description ................................................................................................................. 22
4.1.1 Alarm Condition ........................................................................................................... 22
4.1.2 Alarm Priority................................................................................................................ 22
4.1.3 Alarm Modes................................................................................................................ 23
4.1.4 Alarm Setting ............................................................................................................... 23
4.2 Alarm Technical Specications ............................................................................................. 23
Chapter 5 Technical Specications .......................................................................................................... 24
5.1 ECG Monitoring .................................................................................................................... 24
5.2 RESP Monitoring .................................................................................................................. 25
5.3 TEMP Monitoring .................................................................................................................. 25
5.4 NIBP Monitoring ................................................................................................................... 25
5.5 SpO2 Monitoring................................................................................................................... 26
5.6 Pulse Rate Monitoring .......................................................................................................... 26
5.7 CO2 Monitoring .................................................................................................................... 26
5.8 Data Recording..................................................................................................................... 26
5.9 Other Technical Specications ............................................................................................. 26
5.10 Classication....................................................................................................................... 26
5.11 Guidance and manufacturer’s declaration - Electromagnetic compatibility....................... 27
Chapter 6 Packaging and Accessories .................................................................................................... 29
6.1 Packaging ............................................................................................................................. 29
6.2 Accessori .............................................................................................................................. 29
Chapter 7 Working Principles.................................................................................................................... 30
7.1 Introduction to ECG Measurement ....................................................................................... 30
7.1.1 How to Obtain High Quality ECG and Accurate Heart Rate Value .............................. 30
7.1.2 Factors affecting ECG signal ....................................................................................... 30
7.2 Introduction to Blood Pressure Measurement...................................................................... 31
7.2.1 Blood Pressure Measuring Principle............................................................................ 31
7.2.2 Factors affecting NIBP measuring ............................................................................... 32
7.2.3 Clinical Limitations ....................................................................................................... 32
7.3 Introduction to Oxygen Saturation Measurement................................................................. 33
7.3.1 SpO2Measuring Principle ........................................................................................... 33
7.3.2 SpO2Measurement Restrictions (interference reason) ............................................... 33
7.4 Introduction to Respiration Measurement ............................................................................ 34
7.4.1 Respiration Measuring Principle .................................................................................. 34
7.4.2 Factors affecting respiration monitoring ...................................................................... 34
7.5 Introduction to Temperature Measurement .......................................................................... 34

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7.6 Introduction to Capnograph Measurement .......................................................................... 34
7.6.1 CO2 Measuring Principle ............................................................................................. 34
7.6.2 Mainstream vs. Sidestream Sampling ......................................................................... 34
Chapter 8 Troubleshooting ........................................................................................................................ 35
8.1 No Display on the Screen ..................................................................................................... 35
8.2 Excessive ECG Signal Interference or too Thick Baseline.................................................... 35
8.3 No Blood Pressure and Pulse Oxygen Measures................................................................. 35
8.4 System Alarm........................................................................................................................ 35
Chapter 9 Maintenance.............................................................................................................................. 35
9.1 Service and Examination ...................................................................................................... 35
9.1.1 Daily Examination......................................................................................................... 35
9.1.2 Routine Maintenance ................................................................................................... 36
9.2 Battery Maintenance............................................................................................................. 36
9.3 Cleaning and Disinfection of the Device............................................................................... 36
9.4 Cleaning and Disinfection of Accessories ............................................................................ 37
9.5 Storage ................................................................................................................................. 37
9.6 Transportation....................................................................................................................... 37
Chapter 10 Appendix.................................................................................................................................... 38
10.1 Alarm Information ............................................................................................................... 38
10.2 Default Alarming Values and Setup Range......................................................................... 39
10.3 Status/Error during NIBP Monitoring.................................................................................. 41
10.4 Status/Error during CO2Monitoring................................................................................... 42
10.5 Typical Pressures and CO2Readings at Altitudes ............................................................. 43
10.6 Accessories List.................................................................................................................. 43
INDEX PART II
Chapter 1 Overview .................................................................................................................................... 44
1.1 Features ................................................................................................................................ 44
1.2 Introduction to Panels........................................................................................................... 45
1.2.1 Front Panel................................................................................................................... 45
1.2.2 Left and Right Panel..................................................................................................... 46
1.2.3 Rear Panel.................................................................................................................... 47
Chapter 2 Screen Display .......................................................................................................................... 47
2.1 Default Screen Display.......................................................................................................... 47
2.1.1 Date and Time Setup ................................................................................................... 47
2.1.2 Screen Description....................................................................................................... 48
2.3 Screen Display for Remote Observation .............................................................................. 51
2.3.1 Screen Description....................................................................................................... 51
2.3.2 NIBP Screen Display.................................................................................................... 51
2.3.3 Screen Display with ECG Waveforms only .................................................................. 52
2.3.4 Five Channels Real-time Waveforms and Trends on the Same Screen....................... 53
2.3.5 Parameter Screen ........................................................................................................ 54
2.4 ECG Waveform Freezing and S-T Segment Measurement .................................................. 55
2.4.1 Screen Description....................................................................................................... 55
2.4.2 Operating Instructions ................................................................................................. 55
Chapter 3 Screen Display for System Menu ............................................................................................ 56
3.1 System Menu Screen............................................................................................................ 56
3.1.1 How to Select the Menu Item ...................................................................................... 56
3.2 SpO2 Trend Data List Screen ............................................................................................... 56
3.2.1 Screen Description....................................................................................................... 57
3.2.2 Operating Instructions ................................................................................................. 57
3.3 NIBP Data List Screen .......................................................................................................... 57
3.3.1 Screen Description....................................................................................................... 57
3.3.2 Operating Instructions ................................................................................................. 57
3.4 Screen Display for Graphic Trend ......................................................................................... 57
3.4.1 How to View the Graphic Trend ................................................................................... 58
3.4.2 Operation Instructions ................................................................................................. 59

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3.5 Screen Display for Waveform Recall .................................................................................... 60
3.5.1 Operation Instructions ................................................................................................. 60
3.6 Screen Display for Arrhythmia Event List ............................................................................. 61
3.6.1 Operation Instructions ................................................................................................. 61
3.7 Screen Display for System Setting ....................................................................................... 62
3.7.1 How to Select the System Setup Item......................................................................... 62
3.7.2 Parameter Settings ...................................................................................................... 62
3.8 Display Color Settings .......................................................................................................... 66
3.8.1 How to Change the Parameter Color........................................................................... 67
3.9 File Management Screen...................................................................................................... 67
3.9.1 How to Add a New Patient........................................................................................... 67
3.10 oxyCRG Screen .................................................................................................................. 67
3.10.1 Operation Instructions ............................................................................................... 68
3.11 Event List Screen................................................................................................................ 68
3.11.1 Screen Description..................................................................................................... 68
3.11.2 Operating Instructions ............................................................................................... 68
3.12 MC Calculator..................................................................................................................... 68
3.12.1 Medicine Dosage Calculator...................................................................................... 68
3.13 Tourniquet Function ............................................................................................................ 70
3.13.1 Operation Instructions ............................................................................................... 70
Chapter 4 CO2 Monitoring (optional) ....................................................................................................... 70
4.1 CO2 Related Settings ........................................................................................................... 70
4.2 CO2 Monitoring Screen ........................................................................................................ 73
4.3 CO2 Graphic Trend ............................................................................................................... 74

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PART I
Chapter 1
OVERVIEW
1.1 Product Name
Name: MULTI-PARAMETER PATIENT MONITOR
1.2 Applications and Scope
This Patient Monitor is a multi-functional instrument designed for monitoring the vital physiological signs of
adult and pediatric patients. With the functions of real-time recording and displaying parameters, such as ECG,
heart rate, non-invasive blood pressure, functional oxygen saturation, end-tidal CO2concentration, respiration
rate, body temperature, and so on, it allows comprehensive analysis of patient’s physiological conditions.
This instrument is applicable for use in hospitals and clinical institutions. The operation should be performed
by qualied professionals only.
1.3 Operating Environment
1. Ambient temperature range: 5°C~40°C
Relative humidity: 30%~80%
Atmospheric pressure: 70kPa ~106.0kPa
Power Voltage: (100-240)VAC
Power frequency: 50Hz/60Hz
2. This equipment should be situated in a place protected against direct sunlight, so as to prevent overheating
inside the equipment.
3. The device should be stored and used within specied temperature, humidity and atmospheric pressure
range, or it may cause damage to the device or inaccurate measurement result.
4. If the device gets wet by accident, the operator should NOT power it on directly until it has been air-dry
enough to avoid any damage to it.
5. Do not use this equipment in an environment with toxic or inammable gas.
6. This equipment should be placed on a stand or at platforms, so as to prevent possible shock.
7. Do not use this equipment in combination with any equipment other than those expressly permitted in the
manual.
8. The monitor is debrillator discharge proof and can be used with electrosurgical unit. But when the device
is used together with debrillator or electrosurgical equipment, the user (doctor or nurse) should keep the
patient under close surveillance for his/her safety. Refer to the following function description for specic
protective measures or notes.
9. Make sure that the equipotential grounding terminal is grounded correctly.
10.Do not use mobile phone nearby, so as to avoid strong radiant eld interference.
1.4 Impact on Environment and Resources
Low
1.5 Safety
a) This device conforms to IEC60601-1, electric safety classication: Class I, with Type BF and CF applied
parts.
b) This device can resist against the discharge of debrillator and the interference of electrosurgical unit. c) .
This device can monitor the patients with pace-maker.
d) DO NOT use this device while the patient is under MRI scanning.

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Chapter 2
WORKING THEORIES
2.1 Overall Structure
The overall structure of the monitor is shown as Figure 2.1
Figure 2.1
2.2 Composition
1. The monitor consists of the main units and the corresponding functional components (ECG cables/lead
wires, non-invasive blood pressure cuff, SpO2probe, temperature transducer, accessories for invasive
blood pressure and CO2monitoring).
2. The patient monitor has multiple measurement channels including ECG/Heart Rate, NIBP, SpO2/Pulse Rate,
Respiration Rate, Temperature, and CO2Concentration.
3. The patient monitor has output ports including networking communication and the built-in printer.
4. Basic conguration includes the functions of ECG/Heart Rate, NIBP (systolic, diastolic, mean aterial pres-
sure & pulse rate), SpO2/Pulse Rate, Respiration Rate, and Temperature.
2.3 Working Theories
This Patient Monitor, which performs physiological parameter measurement through different modules, is a
product with modular design. It consists of several modules: ECG/RESP/TEMP module, NIBP module, SpO2
module, CO2module (optional), the mother board and other auxiliary boards
1. The ECG/RESP/TEMP module detects the ECG signal through ECG cable/lead wires via electrodes, it also
measures the respiration by use of the same ECG electrodes. The temperature is measured through the
temperature probe. The heart rate and respiration rate are calculated from its signal waveform respectively.
2. The SpO2module detects the plethysmograph data via the SpO2probe and calculates the pulse rate and
oxygen saturation (SpO2) accordingly.
3. The NIBP module measures the blood pressures including systolic, diastolic, mean arterial pressure and
pulse rate through the pneumatic system and cuff. The cuffs are designed for adult and pediatric patients
respectively, and it can work in different modes to adapt different patient categories.
4. The CO2module detects CO2concentration through the sampling line (side stream) or within the airway
(main stream), and calculate the respiration rate, end tidal CO2concentration (EtCO2), and inspired CO2
concentration (InsCO2).

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5. The mother board is the main controlling unit, which also connects to the interface board and key board.
The interface board inter-connects the functional modules with the mother board.
Chapter 3
INSTALLATION AND CONNECTION
3.1 Installation
3.1.1 Opening the Box and Check
1. Open the package, take out the monitor accessories from the box carefully and place it in a safe stable and
easy to watch position.
2. Open the user manual to sort the accessories according to the packing list
• Inspect the accessories for any mechanical damages
• Check all the exposed leads and inserted accessories
• Check whether any risk or abnormity exists in the device and its accessories before using the monitor. If
any abnormity (such as broken cable or crack of the enclosure etc.) is found, stop using this device.
☞The user can customize the module conguration by choosing necessary modules to meet your own needs.
Therefore, your monitor may not have all the monitoring functions and accessories.
Please contact the local dealer or our company in case of any problems. We will offer the best solution for
your satisfaction.
3.1.2 Connecting the AC Power Cable
1. When powered by AC mains power supply:
• Make sure that the AC power supply is (100-240)VAC, 50Hz/60Hz.
• Use the power cable provided by the manufacturer. Insert one end of it to the AC power input of the monitor
and the other end to the three-pin outlet of the power source with protected-earth.
• It's required that the user should use the 3pin mains power outlet with the protected earth. If there is any
doubt with the mains power outlet for the protected earth, the user should use the built-in battery and dis-
connect the power cord to ensure electrical safety.
NOTE: The optionally provided grounding wire is for functional grounding purpose, which is used to reduce
the power line frequency noise or eliminate the potential difference while connecting the monitor to other
device, so making the system with equipotential grounding.
After the mains power supply has been interrupted while the power switch of the device remains in the “on”
position and the mains power supply is restored after a period of time that is longer than 30 seconds, the
monitor will run by the last settings when restarting the monitor.
The monitor is applicable to connect to the public mains power network.
Caution: ensure that the monitor is rmly connected to the mains power supply with protected earth.
2. Built-in battery
The following steps should be followed to install the battery:
Step 1: open the battery cover;
Step 2: pull out the battery cable and connect it to the battery pack;
Step 3: push the battery pack into the battery compartment and lock it;
Step 4: close the battery cover.
• Caution: it’s better to recharge the battery after it is used up, and the charging time should be 13~15 hours
long.
• Battery life: Provided that a battery is new and fully charged, the minimal working time of the monitor with
accessories connected is declared in the table below:
• NOTE: It will take 12-15 hours to charge battery from exhaust state to 90% charged.
The provided battery of the monitor must be recharged after transportation or storage. So if the monitor is
switched on without being connected to the AC power supply, it may not work properly due to insufcient
battery power.
Name Battery life
MULTI-PARAMETER PATIENT MONITOR 120 min

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3.1.3 Starting the Monitor
The system performs self-test and enters initial display after switch on the monitor, and the alarm rings to in-
form that the user can begin operating it.
• Check all the applicable functions to make sure that the monitor works normally.
• If the built-in battery is applied, please recharge it after using the monitor to ensure sufcient power storage.
It will take at least 8 hours to charge battery from depletion to 90% charge.
Do not use the monitor to monitor the patient if there are indications of damage or reminders of error.
Please contact the local dealer or our company.
Start the monitor again 1 minute later after it is switched off.
3.2 Connection
3.2.1 ECG Cable/Lead Wires Connection
ECG measurement is to collect the ECG signal via the ECG electrodes. Electrode connects the patient and
the lead wires and/or ECG cable. The lead wires and/or cable connect to the monitor. The locations of the
electrodes are very important for obtaining accurate ECG signals.
1. Connect the cable to the connector marked with the “ECG" icon on the signal input panel.
2. Select electrodes to be used. Use only one type of electrode on the same patient to avoid variations in elec-
trical resistance. For ECG monitoring, it is strongly recommended to use silver/silver chloride electrodes.
When dissimilar metals are used for different electrodes, the electrodes may be subject to large offset po-
tentials due to polarization. Using dissimilar metals may also increase recovery time after debrillation.
3. Prepare the electrode sites according to the electrode manufacturer’s instructions.
4. Skin clean
Clean and scrap skin to ensure low sensor impedance if necessary. Mild soap and Water is recommended
as a skin cleanser.
NOTE: If alcohol is used as cleanser, it is recommended to have 30-second dry time for a better con-
nection.
Scraping the skin gently with a dry wash cloth, gauze, for skin preparation is helpful to remove the non-con-
ductive skin layer.
The symbol indicates that the cable and accessories are designed to have special protection against
electric shocks and is debrillator-proof.
The locations of the electrode are in the following Figure:
Figure 3.5 Electrode Location
NOTE: If any side-effect such as allergic or itchy reaction is found, remove the electrodes from the patients
immediately.
5. After starting the monitor, if the electrodes become loose or disconnected during monitoring, the system
will display “LEAD OFF” on the screen to alarm the operator.
