Capnomed HIMA Plus User manual

HIMA Plus Handheld Vital Sign Monito
User Manual
Company name: Qinhuangdao Kapunuomaite Medical Equipment S&T Co.,Ltd.
Address: 2 Area, 5th Floor, No.10 Standard Workshop, Yanghe Road,
Economic-Technological Development Area，Qinhuangdao City, Hebi Province,
China.
ZIP code: 066000 Tel: [phone]

HIMA Plus Handheld Vital Sign Monito User Manual（1.0）
Email: [email protected] Web site: www.capno-med.com

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Contents
1. Product Overview....................................................................................................................................... - 4 -
1.1.Application background.........................................................................................................................- 4 -
1.2.Intended use........................................................................................................................................... - 6 -
1.3.Product structure....................................................................................................................................- 6 -
1.4.Working, transportation and storage conditions............................................................................... - 6 -
1.5.Technical specifications........................................................................................................................ - 6 -
1.6.Product Safety Classification............................................................................................................... - 8 -
1.7.Contraindications................................................................................................................................... - 8 -
2. Precautions, warnings and tips..............................................................................................................- 8 -
2.1. Warning...................................................................................................................................................- 8 -
2.2. Matters needing attention.................................................................................................................. - 11 -
2.3. Icon description................................................................................................................................... - 11 -
3. Appearance of the instrument..............................................................................................................- 12 -
4. Instructions for use................................................................................................................................. - 13 -
4.1. Unpacking............................................................................................................................................ - 13 -
4.2. Install SpO2 Probe and EtCO2 Module.......................................................................................... - 13 -
4.3. Factors affecting performance..........................................................................................................- 15 -
4.4. Boot....................................................................................................................................................... - 16 -
4.5. Monitoring process............................................................................................................................. - 16 -
4.6. Shutdown............................................................................................................................................. - 17 -
5. Settings........................................................................................................................................................- 17 -
5.1. Volume setting.....................................................................................................................................- 18 -
5.2. Alarm settings......................................................................................................................................- 19 -
5.2.1 Physiological alarm.......................................................................................................................... - 19 -
5.3. Time setting......................................................................................................................................... - 21 -
5.4. Record settings................................................................................................................................... - 21 -
5.5. System Settings.................................................................................................................................. - 22 -
5.6. File System.......................................................................................................................................... - 23 -
6. Maintenance and maintenance of the instrument.............................................................................. - 24 -
6.1. Troubleshooting.................................................................................................................................. - 24 -
6.2. Battery use and maintenance...........................................................................................................- 26 -
6.3. Instrument cleaning............................................................................................................................ - 26 -
6.4. Waste treatment..................................................................................................................................- 27 -
6.5. Packing list...........................................................................................................................................- 27 -
7. Alarm and indication................................................................................................................................... - 28 -
7.1. Alarm signal......................................................................................................................................... - 28 -
7.2. Default alarm settings........................................................................................................................ - 28 -
7.3. Mute...................................................................................................................................................... - 29 -
7.4. Battery indicator.................................................................................................................................. - 29 -
7.5. Alarm threshold setting...................................................................................................................... - 29 -
7.6. Sound characteristics.........................................................................................................................- 30 -
7.7. Alarm function verification................................................................................................................. - 30 -
8. EMC statement..............................................................................................................................................- 30 -
8.1.Description............................................................................................................................................ - 31 -
8.2.precautions in use................................................................................................................................- 31 -
8.3. precautions regarding........................................................................................................................ - 31 -
9. quality promise.............................................................................................................................................- 34 -

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1. Product Overview
1.1 Application background
The handheld vital signs monitor integrates blood oxygen measurement, end-expiratory
carbon dioxide monitoring, body temperature monitoring and other functions. It uses a color
display to display blood oxygen saturation, pulse rate, EtCO2, respiration rate, body
temperature, and system information. , And error messages (prompts such as falling off of
each parameter measuring probe) and alarm messages.
a Principle of pulse oximetry
Firstly, the difference between the absorption of red light and infrared light by
oxyhemoglobin and reduced hemoglobin (as measured by spectroscopic measurement);
secondly, the flow of arterial blood in the tissue is determined by the pulse (as recorded by
hematogram). ) Change when pulsating. The pulse oximeter adds red light and infrared
light to the arteries and measures the changes in light absorbed during the pulse cycle to
determine SpO2. Low-pressure red and infrared light-emitting diodes (LEDs) in the blood
oxygen probe are used as light sources, and photodiodes are used as light detectors.
Oxyhemoglobin and reduced hemoglobin absorb different light. The amount of red light and
infrared light absorbed by blood is related to the oxygen saturation of hemoglobin. In order
to identify the oxygen saturation of arterial hemoglobin, the oximeter uses the pulsating
characteristics of arterial blood flow. During systole, new arterial blood enters the ventricle,
blood volume and light absorption increase; during diastole, blood volume and light
absorption reach their lowest point. The SpO2 measurement of the oximeter depends on
the difference between the maximum and minimum absorption (eg, measured during
systole and diastole). In this way, the light absorbed by the arterial blood pulsation is the
focus of the problem. It is necessary to eliminate non-pulsatile absorption such as the
absorption effect of tissues, bones and venous blood. The vital signs monitor uses a
photodetector to measure SpO2 and pulse rate through two wavelengths of red light and
infrared light through human tissue. During the measurement, the color and thickness of
the human tissue, the position of the probe, the brightness of the light source, and the
absorption of blood in the arteries and veins of the human tissue affect the result of the
signal strength.

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b End-breathing carbon dioxide concentration (EtCO2)
Human tissue cells produce CO2 through metabolism, which is then transported to the
lungs through capillaries and veins through the body, and is excreted from the body during
exhalation. In this process, the inhaled oxygen is transported by hemoglobin in the blood,
and the CO2 produced in the human body is dissolved in the blood and brought out by
ventilation. According to the law of gas diffusion, CO2 diffuses from high-concentration
areas to low-concentration areas. Therefore, CO2 diffuses from pulmonary blood vessels
(high-concentration areas) to alveoli (low-concentration areas), and then is discharged from
the lungs.
The carbon dioxide monitor adopts infrared monitoring technology. This method is based
on the principle that the absorption rate of infrared light is related to the concentration of
carbon dioxide when the infrared light passes through the gas sample to be tested: CO2
mainly absorbs infrared light with a wavelength of 426nm, which attenuates the infrared
beam, and its attenuation degree It is proportional to the concentration of CO2. When
infrared rays pass through the gas, the CO2 in the gas will absorb part of the infrared rays
and weaken the remaining infrared signal strength. By measuring the initial infrared
intensity and the infrared intensity after the exhalation passes, the CO2 component exhaled
by the patient is calculated, that is, the end-tidal carbon dioxide (EtCO2). details as follows:
The invisible infrared light emitted by the passed infrared light source passes through the
airway adapter, and the respiratory airflow flows in the airway adapter. When the light beam
passes through the airway adapter, some of the light is absorbed by the gas mixture. The
absorbed light beam reaches the infrared detector fixed at the other end. The infrared
detector converts the light beam into an electrical signal. The electrical signal is converted
into a digital value by the ADC and sent to the microprocessor. The microprocessor will

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calculate the carbon dioxide concentration in the breathing gas mixture based on the ratio
of the light of the two measurement channels.
1.2 Intended use
Hand-held vital signs monitors are suitable for medical institutions to perform spot
measurement or continuous dynamic monitoring of patient (or animal) blood oxygen
saturation, pulse rate, carbon dioxide (EtCO2) and respiration rate, and can send out
alarms.
1.3 Product structure
It consists of a host (composed of circuit board, housing, display screen and buttons),
mainstream or sidestream carbon dioxide module (optional), blood oxygen sensor, body
temperature sensor, data transfer cable (optional) and power adapter.
1.4 Working, transportation and storage conditions
Working conditions
Ambient temperature: 5℃～40℃;
Relative humidity: ≤95%;
Atmospheric pressure: 70kPa～106kPa;
Power supply mode: There are two modes to choose from,
which are AC 220V powered by network power and 3.7V
powered by internal lithium battery.
Transportation and
storage conditions
Ambient temperature: -20℃～55℃;
Relative humidity: ≤95%;
Atmospheric pressure: 70kPa～106kPa
1.5 Technical specifications
1.5.1 The technical specifications of the host
SPO2
Measuring range 0～100%
Precision 1%
Accuracy 70～100%：± 2%
sensor The pulsed oxygen sensor contains light-emitting diodes, which emit red
light with a wavelength of about 660 nanometers and infrared light with a
wavelength of about 905 nanometers.

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The total light output power of the sensor led is less than 15mw.
Anti-interference Automatic anti-interference
Anti-interference
ability
Strong anti-hypoperfusion ability, strong anti-hypoperfusion ability, PR
amplitude can reach 0.2% under the displayed value of blood oxygen.
alarm Select high and low alarm limits for blood oxygen
Alarm adjustment
value
stand by
Pulse rate
Measuring range 25 bpm ～250 bpm
Resolution 1 bpm
Precision ±1% or ± 1 bpm
alarm Select the high and low alarm limits of PR
Alarm adjustment
value
stand by
Temperature
Measuring range 25.0℃～45.0℃
Resolution 0.1℃
Precision ±0.3℃
alarm Select high and low alarm limits for body temperature
Alarm adjustment
value
stand by
1.5.2 Technical specifications of the end-tidal carbon dioxide module
If the end-tidal carbon dioxide module is selected, please refer to the module manual for
the technical specifications of the end-tidal carbon dioxide module.
1.5.3 Main functions
Storage: The instrument can store and query the patient's test results and test trend
graphs.
It can monitor whether the blood oxygen sensor falls off.
It can detect real-time waveforms, end-tidal carbon dioxide concentration, inhaled
carbon dioxide concentration and respiratory rate.
The measurement results of end-tidal carbon dioxide are available in mmHg, %, and
kPa.
You can select the display speed, waveform amplitude and other parameters of the
end-tidal carbon dioxide waveform;
The instrument has two operation interfaces in English and Chinese for users to
choose.

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1.6 Product Safety Classification
Classified by type of protection against electric shock: internal power supply equipment;
According to the degree of protection against electric shock: BF.
Classified according to the degree of protection against ingress of liquid: IPX3;
According to the safety level of flammable anesthetic gas mixed in the air or flammable
anesthetic mixed with oxygen or nitrous oxide: this instrument cannot be used in flammable
anesthetic gas or mixed gas with oxygen or nitrous oxide The equipment used in the case.
Classified by operating mode: continuous operation;
The rated voltage of the equipment: power supply AC 220V, 50Hz; internal lithium
battery power supply 3.7V;
Input power of the equipment: 30VA;
Does the equipment have an applied part to protect against the effects of defibrillation
discharge: none;
Whether the equipment has a signal input or output part: there is a signal input part;
Permanent installation equipment or non-permanent installation equipment:
non-permanent installation equipment;
1.7 Contraindications
Not found yet.
2. Precautions, warnings and tips
2.1. Warning
Explosion hazard: Do not use in an environment where flammable anesthetics or
flammable gases are present. There is a risk of explosion when using a carbon dioxide
monitor in this environment.
Risk of electric shock: Always disconnect before cleaning, and do not use damaged
instruments.
Danger of electric shock: There are no user-serviceable parts inside, so
non-professionals should not disassemble it.
This product needs to be used by professional medical staff after training.
Follow measures to prevent electrostatic discharge (ESD) and electromagnetic
interference (EMI) between equipment.
If the product does not achieve the expected function, please do not use it unless

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approved by authorized personnel
It can only be used in the occasions specified in the manual, and can only be used for
the purposes described in the manual.
During use, do not apply external force to the well-connected gas path.
Read the instruction manual carefully before use.
After the instrument and its accessories have reached the end of their service life, you
should dispose of electronic waste in accordance with local regulations.
The measurement results of this device will be interfered by mobile phones or other
radio frequency communication devices. The user must ensure that it is used for
measurement in the specified electromagnetic environment.
This product is only an auxiliary device for clinical evaluation of patients, and must be
used with clinical signs and clinical diagnosis equipment.
Nursing staff may not hear audible alarms in a noisy environment, such as a siren
calling or the nursing staff is far away from the equipment. Therefore, the nursing staff
should do their own monitoring before use to ensure that any alarm sounds can be heard
and confirmed by the nursing staff in time.
During use and maintenance, using parts or materials beyond those specified in this
manual will reduce the minimum safety and product measurement accuracy.
This instrument cannot be used in a magnetic resonance imaging scanning system
(MRI). The induced current generated can be a potential cause of combustion. The
instrument may affect MRI images, and MRI may also affect the accuracy of blood oxygen
and carbon dioxide measurements.
Only use blood oxygen probes and end-breathing carbon dioxide modules that match
this instrument.
This instrument is mainly used in some health care centers that have been specially
trained. The operator must carefully understand the detailed information in the manual
before using it.
Before use, please set an appropriate alarm limit according to the actual situation of the
patient.
For long-term use or according to the needs of the patient, the position of the blood
oxygen probe should be changed regularly. In order to allow the patient's skin to breathe,
the probe should be repositioned at least every 4 hours.
The chemical substance after the display is broken is poisonous and needs to be
handled with care.

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Before use, the operator should check whether the host is damaged to ensure the
normal operation of the instrument.
If there is a problem with the measurement accuracy, check the patient's physical signs
and whether the instrument is normal.
This instrument may be interfered by some strong electromagnetic equipment, such as
electrosurgical equipment.
High-intensity light can interfere with the blood oxygen measurement. If necessary, the
blood oxygen probe can be covered with a surgical towel.
Severe cardiopulmonary disease, clogged or twisted sampling tube, and fast breathing
rate all affect EtCO2 measurement. Prevent the patient's sputum and secretions from
contaminating the tracheal tube and affecting the measurement of EtCO2.
The use of blood pressure cuffs or the strong resistance of blood vessels throughout
the body causes obstruction of blood flow, which will result in the inability to accurately read
the value of blood oxygen saturation and pulse rate.
The dysfunction of carboxyhemoglobin or methemoglobin will affect the measurement
accuracy of blood oxygen saturation.
This instrument cannot be used for apnea monitoring.
When two or more blood oxygen probes are placed in close positions, the
measurement accuracy will be affected.
Change the position of the blood oxygen probe at least every 4 hours, and always
observe whether there are signs of tissue damage. The frequency of changing/checking the
position of the blood oxygen probe depends on the ambient light, patient's skin condition,
total exposure time or other factors. The probe position can be changed multiple times.
The blood oxygen cable and CO2 module cable entangle the patient, which may cause
suffocation. Please prevent the cable from getting entangled in the patient. If necessary,
bundle the cables.
In some clinical situations, the monitor may display invalid values ("---"), or even
fail to measure blood oxygen saturation and pulse rate values. In these situations such as
patient movement, hypoperfusion, arrhythmia, rapid pulse, or a combination of the above
conditions, the monitor may also display incorrect values.
In some clinical situations, the CO2 module may display the wrong value of EtCO2 due
to air leakage, twisted catheters, blocked trachea, or the patient's malignant hyperthermia,
elevated body temperature, and increased CO2 production due to injection of a large
amount of NaHCO3.