Gima LEO User Manual
PROFESSIONAL MEDICAL PRODUCTS
MISURATORE DI PRESSIONE LEO CON SOFTWARE
LEO BLOOD PRESSURE MONITOR
WITH SOFTWARE
TENSIOMÈTRE LEO AVEC LOGICIEL
DE LEO MEDIDOR DE PRESIÓN
CON SOFTWARE
MEDIDOR DA TENSÃO LEO COM SOFTWARE
32902 / CONTEC08A
CONTEC MEDICAL SYSTEMS CO., LTD
No.112 Qinhuang West Street, Economic & Technical Development Zone,
Qinhuangdao, Hebei Province, PEOPLE’S REPUBLIC OF CHINA
Made in China
Shanghai International Holding Corp. GmbH (Europe)
Eiffestrasse 80, 20537 Hamburg, Germany
Importato da / Imported by / Importé par / Importado por / Importado por:
Gima S.p.A.
Via Marconi, 1 - 20060 Gessate (MI) Italy
gima@gimaitaly.com - export@gimaitaly.com
www.gimaitaly.com
M32902-M-Rev.2.05.20
0123
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Foreword
Please read the User Manual carefully before using this product. The User Manual which describes the operating
procedures should be followed strictly. This manual detailed introduce the steps must be noted when using the product,
operation which may result in abnormal, the risk may cause personal injury and product damage and other contents, refer
to the chapters for details. Any anomalies or personal injury and device damage arising from use, maintain, store do not
follow requirements of the User Manual.
Note: Please read the User Manual carefully before using this product.
Described in this User Manual is in accordance with practical situation of the product. In case of modications and software
upgrades, the information contained in this document is subject to change without notice.
The warning items
Before using this product, you should consider the safety and efcacy of the following described:
• Described each measurement results combined with clinical symptoms by qualied doctors.
• The reliability and operation of using this product whether meets the operation of this manual relate to the maintenance
instructions.
• The intended operator of this product may be the patient.
• Do not perform maintenance and service while the device is in use.
Warning: Replace accessories which not provided by our company may lead to the occurrence of errors.
Replace adapters, cuffs or SpO2 probes at will may result in wrong measurement results. Without our company
or other approved maintenance organizations trained service personnel should not try to maintain the product.
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Contents
Chapter 1 Safety Precautions ....................................................................................................................................... 53
1.1 Operation for AC Adapter (Separate Sale) ............................................................................................... 56
1.2 Operation for Battery ................................................................................................................................ 56
Chapter 2 Main Unit ....................................................................................................................................................... 58
Chapter 3 External Interfaces ....................................................................................................................................... 61
Chapter 4 Battery/AC Adapter Installation ..................................................................................................................63
4.1 Battery Installation .................................................................................................................................... 63
4.2 Usage of power adapter ........................................................................................................................... 64
Chapter 5 Button Functions .......................................................................................................................................... 64
Chapter 6 Setting the Date and Time ........................................................................................................................... 65
Chapter 7 About Unit ..................................................................................................................................................... 66
Chapter 8 User Switch ................................................................................................................................................... 66
Chapter 9 Over-limit Prompt Function ......................................................................................................................... 67
9.1 Physiological parameter over-limit prompt ............................................................................................... 67
9.2 Technical parameter over-limit prompt ..................................................................................................... 68
Chapter 10 The Usage Method of Sphygmomanometer .............................................................................................. 68
10.1 Accurate Measurement Way ..................................................................................................................68
10.2 Applying the Cuff ....................................................................................................................................70
10.3 BP Measurement .................................................................................................................................... 72
Chapter 11 Memory Function.......................................................................................................................................... 73
11.1 Review Memory Values .......................................................................................................................... 73
11.2 Delete Memory Values ............................................................................................................................ 73
Chapter 12 SpO2 Measurement Function ...................................................................................................................... 74
Chapter 13 SpO2 Measurement Method ........................................................................................................................ 77
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Chapter 14 Installation of the Software.......................................................................................................................... 78
14.1 Demand of Editor.................................................................................................................................... 78
14.2 Installation of Software ........................................................................................................................... 78
Chapter 15 Error Message............................................................................................................................................... 79
Chapter 16 Troubleshooting ........................................................................................................................................... 80
Chapter 17 Keys and Symbols........................................................................................................................................ 82
Chapter 18 Maintenance, Cleaning and Keeping .......................................................................................................... 83
Chapter 19 NIBP Specication ........................................................................................................................................ 85
Chapter 20 SpO2 Specication ....................................................................................................................................... 88
Appendix ........................................................................................................................................................................ 89
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Chapter 1
SAFETY PRECAUTIONS
• In order to use it correctly, please read the “Safety Precautions” carefully before using it.
• Operators do not need professional training, but should use this product after fully understanding the requirements in this
manual.
• To prevent users from suffering damage or loss due to improper use, please refer to “Safety Precautions” and use this
product properly.
Note
If not use correctly, it exists the possibility of damage for personnel and goods.
Good damage means the damage of house, property, domestic animal and pet.
Contraindication
No.
Warning
• You must not perform NIBP measurements on patients with sickle-cell disease or under any condition which the skin is
damaged or expected to be damaged.
• For patients with severe disturbances of blood coagulation, whether automatically measure the blood pressure should be
based on the clinical evaluation, because limb friction with the cuff may cause the risk of hematoma.
• For severe blood circulation disorder or arrhythmia patients, please use the device under the guidance of a doctor. If the
arm is squeezed during measurement, it may cause acute internal hemorrhage or inaccurate measurement results.
Measurement Limitations
To different patient conditions, the oscillometric measurement has certain limitations. The measurement is in search of
regular arterial pressure pulse. In those circumstances when the patient’s condition makes it difcult to detect, the measurement becomes unreliable and measuring time increases. The user should be aware that the following conditions could
interfere with the measurement, making the measurement unreliable or longer to derive. In some cases, the patient’s
condition will make a measurement impossible.
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Patient Movement
Measurements will be unreliable or can not perform if the patient is moving, shivering or having convulsions. These motions
may interfere with the detection of the arterial pressure pulses. In addition, the measurement time will be prolonged.
Cardiac Arrhythmia’s
Measurements will be unreliable and may not be possible if the patient’s cardiac arrhythmia has caused an irregular heartbeat. The measuring time thus will be prolonged.
Heart-lung Machine
Measurements will not be possible if the patient is connected to a heart-lung machine.
Pressure Changes
Measurements will be unreliable and may not be possible if the patient’s blood pressure is changing rapidly over the period
of time during which the arterial pressure pulses are being analyzed to obtain the measurement.
Severe Shock
If the patient is in severe shock or hypothermia, measurements will be unreliable since reduced blood ow to the peripheries will cause reduced pulsation of the arteries.
Heart Rate Extremes
Measurements can not be made at a heart rate of less than 40 bpm and greater than 240 bpm.
Round Patient
The thick fat layer of body will reduce the measurement accuracy, because the fat that come from the shock of arteries can
not access the cuffs due to the damping.
Warning
Self-diagnosis and treatment using measured results may be dangerous. Follow the instructions of your physician.
Please hand measurement results to the doctor who knows your health and accept diagnosis.
For Infant and the person who can’t express oneself, please use the device under the guidance of a doctor.
Otherwise it may cause accident or dissension.
Please do not use for any other purpose except BP measurement.
Otherwise it may cause accident or holdback
Please use special cuff.
Otherwise it is possible that measurement result is incorrect.
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Please do not keep the cuff in the over-inated state for a long time.
Otherwise it may cause risk.
Do not use the device in the case of there are ammable anesthetic gasses mixing with the air or nitrous oxide.
Otherwise it may cause risk.
If liquid splashes on the device or accessories, especially when liquids may enter the pipe or device, stop using
and contact the service department.
Otherwise it may cause risk.
Dispose of the packaging material, observing the applicable waste control regulations and keeping it out of children’s reach.
Otherwise it may cause harm to the environment or children.
Please use approved accessories for the device and check that the device and accessories are working properly
and safely before use.
Otherwise the measurement result may be inaccurate or an accident may occur.
When the device is accidentally damp, it should be placed in a dry and ventilated place for a period of time to
dissipate moisture.
Otherwise the device may be damaged due to moisture.
Do not store and transport the device outside the specied environment.
Otherwise it may cause measurement error.
It is recommended that you check if there is any damage on the device or the accessories regularly, if you nd any
damage, stop using it, and contact the biomedical engineer of the hospital or our Customer Service immediately.
Do not disassemble, repair and modify the device without permission.
Otherwise it cannot be accurately measured.
This device can not be used on mobile transport platforms.
Otherwise it may cause measurement error.
This device can not be used on a tilted tabletop.
Otherwise there is a risk of falling.
Dispose of packaging materials, waste batteries and end-of-life products in accordance with local laws and regulations.
The end-of-life products and materials are properly disposed of by the user in accordance with the authority’s decree.
Replace accessories which not provided by our company may lead to the occurrence of errors.
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Without our company or other approved maintenance organizations trained service personnel should not try to
maintain the product.
This device can only be used for one test object at a time.
If the small parts on the device are inhaled or swallowed, please consult a doctor promptly.
The device and accessories are processed with allergenic materials. If you are allergic to it , stop using this product.
After pressing the power button, if the device has display fault such as white screen, blurred screen or no display
content, please contact our company.
The device shall comply with the standard IEC 80601-2-30:Particular requirements for basic safety and essential performance of automated non-invasive sphygmomanometers.
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1.1 Operation for AC Adapter (Separate Sale)
Note
The device can be powered by a power adapter that is a part of the medical electrical system.
Be sure to use the dedicated medical grade power adapter of this device.
Otherwise it may cause trouble
Dedicated power adapter must use AC 100 V~240 V
Otherwise it may cause re or electric shock.
When there is breakage of dedicated power adapter plug or wire, please do not use it.
Otherwise it may cause re or electric shock.
Please do not plug or unplug the adapter on the socket with wet hands.
Otherwise it may cause electric shock or injury.
1.2 Operation for Battery
Note
Please use 4 “AA” size manganese or alkaline batteries, do not use batteries of other types.
Otherwise it may cause re.
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New and old batteries, different kinds batteries can not be put off.
Otherwise it may cause battery leakage, heat, rupture, and damage to Electronic Sphygmomanometer.
Please don’t put wrong the positive and negative of battery. When the batteries power exhausts, replace with four
new batteries at the same time.
Please take out the batteries when you do not use the device for a long time (3 months or more).
Otherwise it may cause battery leakage, heat, rupture, and damage to Electronic Sphygmomanometer.
If electrolyte of the batteries immodestly get in your eyes, immediately rinse with plenty of clean water.
It will cause blindness or other hazards, should immediately go to the nearest hospital for treatment.
If electrolyte of the batteries immodestly glues on the skin or the clothes, immediately rinse with plenty of clean
water.
Otherwise it may hurt the skin.
Advice
Do not strike or drop the device.
Do not inate before the cuff wraps around the arm.
Do not inect the cuff and the air tube forcibly.
Description of functions:
The Sphygmomanometer apply to measure the non-invasive blood pressure and SpO2 of human (adult, children, neonate),
uses three-user mode, each user can store 100 items records of measurement results at most. Each record includes
detailed measuring time, systolic pressure, diastolic pressure, average pressure, pulse rate and record number, etc. With
2.8 inch color LCD screen, clear interface, the function of data review is complete. User can implement ON/OFF, manual
measuring, system setup, parameters change and other operations with seven buttons which are located on the front panel
of the device.
The Sphygmomanometer uses audible and visual prompt, when the battery power is low, the buzzer will intermittent buzzing and LCD screen displays “Low Power” to prompt user replace batteries. When the measurement data exceeds the set
prompt limit, the font color of measurement results will change to red and the audible prompt will occur, user can open and
close the prompt sound according to needs. With timing shutdown function, if there is no operation and SpO2 measure-
ment, the device will automatically turn off after 2 minutes. With USB interface, Users can send measurement results to PC.
Refer to the help or explication of the related software for specic operation.
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Purpose:
The device apply to measure the non-invasive blood pressure and SpO2 (optional) of human. Record parameter value of
blood pressure to provide the reference for the health care professional.
Chapter 2
MAIN UNIT
The production is in the package.
Open the package and conrm
whether the production is whole.
Cuff plug
Cuff air plug jack
USER SWITCH button
ON/OFF button
START/STOP button
Display
UP/DOWN button
MEMORY button
AC adapter jack
MENU button
USB plug jack
Adult cuff
Dry battery
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Accessories:
Specication: limb circumference 22-32 cm (middle part of upper arm), please select suited cuff when measuring children
or other limb circumference.
USB Data Line Software CD User Manual
Optional Accessories:
AC adapter
Input: voltage: AC 100 V~240 V
Frequency: 50 Hz/60 HZ
Rated current: AC 150 mA
Output: DC 6.0 V±0.2 V 1.0 A
or DC5.0 V±0.2 V 1.0 A
SpO2 probe: Integrated SpO2 probe
(This part is only suitable for European Union market)
A. SpO2 measurement
Range:0%~100%
Error: 70~100%: ±2%; Below 70%: unspecied
Resolution: 1%
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Note: because SpO2 probe measurements are statistically distributed,
only about two-thirds of SpO2 probe measurements can be expected to
fall within ±Arms of the value measured by a CO-OXIMETER.
B. Pulse rate measurement
Range:30 bpm~250 bpm
Error: ±2 bpm or ±2% (select the larger)
Resolution: 1bpm
C. Optical sensor: red light(wavelength: 660 nm, output power less than
6.65 mW) infrared light(wavelength: 880 nm, output power less than
6.75 mW). Optical sensors are light-emitting components that affect oth-
er medical devices that use this wavelength range. This information may
be useful to clinicians who perform optical therapy.
D. Error in weak lling condition: SpO2 and pulse rate can be shown correctly when pulse-lling ratio is 0.4%. SpO2 error
is ±4%; when measuring range is 30 bpm~100 bpm, pulse rate error is ±2 bpm; when measuring range is 100 bpm~250
bpm, pulse rate error is ±2%.
Note:
• The optional probe of the Sphygmomanometer is an integrated SpO2 probe, the measuring part is integrated with the
probe;
• The service life of the integrated SpO2 probe is three years.
Cuff:
Choose the right cuff based on the patient’s upper arm circumference, there are several suitable cuffs(range of limb circumference, middle part of upper arm)
the range of limb circumference is 6-11 cm
the range of limb circumference is 10-19 cm
the range of limb circumference is 18-26 cm
the range of limb circumference is 32-43 cm
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Note
• The cuff is a consumable. Calculate by measuring 6 times a day(3 times each morning and evening), the service life of
the cuff is about 1 year.(using our experimental conditions).
• In order to correctly measure blood pressure, please replace the cuff in time.
• If the cuff leaks, please contact our company to buy a new one. The cuff purchased separately does not include the airway
tube plug. When replacing, please do not throw the airway tube plug away, install it on the new cuff.
Note
When the product and accessories described in this manual are about to exceed the period of use, they must be disposed
according to relevant product handling specication. If you want to know more information, please contact our company or
representative organization.
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Chapter 3
EXTERNAL INTERFACES
Note
When removing NIBP cuff, please take plug at the front of the windpipe to pull out.
• Cuff socket ( is cuff identier)
Left side
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The right side of the device is USB socket and power adapter socket
• USB socket ( is USB identier)
Right side
• Power adapter socket ( is power socket identier)
Note
All analog and digital equipment connected to this device must be certied to IEC standards(such as IEC60950:
Information technology equipment-Safety and IEC60601-1: Medical electrical equipment-Safety), and all equipment should be connected to in accordance with the requirement of the valid version of the IEC60601-1-1 system
standard. The person connecting the additional equipment to the signal input and output port is responsible for
whether the system complies with the IEC60601-1 standard.
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Chapter 4
BATTERY/AC ADAPTER INSTALLATION
The product can use battery or AC adapter as power source.
1 2 3
4.1 Battery Installation
1. Demount the battery cover in the direction of the arrow.
2. Install “AA” batteries according to
3. Slide to close the battery cover.
Icon “ ”: the batteries power will exhaust. Replace with four new batteries (the same sort) at the same time. Test while
low power may cause data deviation and other problems.
Turn the unit off before replacing the batteries.
Note
When the battery reaches the end of its life, or if the battery is found to have odor, deformation, discoloration or
distortion, stop using the battery and dispose of the used battery in accordance with local regulations, otherwise
it will cause environmental pollution.
+ -
polarities.
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