Contec CONTEC08A User manual

32902 / CONTEC08A
M32902-M-Rev.2.05.20
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
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
PROFESSIONAL MEDICAL PRODUCTS
0123
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
[e-mail] - [e-mail]
www.gimaitaly.com

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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 modications 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 efcacy of the following described:
• Described each measurement results combined with clinical symptoms by qualied 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 Specication........................................................................................................................................ 85
Chapter 20 SpO2 Specication ....................................................................................................................................... 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 difcult to detect, the meas-
urement 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 heart-
beat. 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 peripher-
ies 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-inated 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 chil-
dren’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 specied 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 perfor-
mance of automated non-invasive sphygmomanometers.
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 inate before the cuff wraps around the arm.
Do not inect the cuff and the air tube forcibly.
Description of functions:
The Sphygmomanometer apply to measure the non-invasive blood pressure and SpO2of 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 buzz-
ing 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 SpO2measure-
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 specic 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 conrm
whether the production is whole.
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Cuff plug
Cuff air plug jack
Display
Adult cuff
USER SWITCH button
ON/OFF button
START/STOP button
Dry battery
UP/DOWN button
MEMORY button
AC adapter jack
MENU button
USB plug jack

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Accessories:
Specication: 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. SpO2measurement
Range:0%~100%
Error: 70~100%: ±2%; Below 70%: unspecied
Resolution: 1%
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Note: because SpO2probe measurements are statistically distributed,
only about two-thirds of SpO2probe 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%. SpO2error
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 SpO2probe, the measuring part is integrated with the
probe;
• The service life of the integrated SpO2probe is three years.
Cuff:
Choose the right cuff based on the patient’s upper arm circumference, there are several suitable cuffs(range of limb circum-
ference, 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 specication. If you want to know more information, please contact our company or
representative organization.
.
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 identier)
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Left side

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The right side of the device is USB socket and power adapter socket
• USB socket ( is USB identier)
• Power adapter socket ( is power socket identier)
Note
All analog and digital equipment connected to this device must be certied to IEC standards(such as IEC60950:
Information technology equipment-Safety and IEC60601-1: Medical electrical equipment-Safety), and all equip-
ment 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.
Right side
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Chapter 4
BATTERY/AC ADAPTER INSTALLATION
The product can use battery or AC adapter as power source.
4.1 Battery Installation
1. Demount the battery cover in the direction of the arrow.
2. Install “AA” batteries according to + - polarities.
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.
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4.2 Usage of power adapter
1. Connect the sphygmomanometer and the power adapter. Insert the power adapter plug into the power adapter socket
on the right side of the device.
2. Please insert the power plug of the adapter into the AC 100 V~240 V socket.
Note
The device can be disconnected from the power supply network by unplugging the adapter plug.
When cut off the power supply, rst cut off the connection of power socket and the regulated power supply, then
cut off the connection of regulated power supply and the sphygmomanometer.
Please be sure to use dedicated medical grade power adapter.
Note
When regulated power supply and batteries are both used at the same time, the battery power will not be con-
sumed.
Switch regulated power supply and battery as power supply when the device is off, otherwise, the device may
shutdown due to power failure.
The device can be used normally after it is turned on ,without waiting for the device to be prepared.
Chapter 5
BUTTON FUNCTIONS
All the operations to the Electronic Sphygmomanometer are through the buttons. The names of the buttons are above
them. They are:
• [ON/OFF] ON/OFF button. Press this button to turn on/off the device
• [START/STOP] Press it to inate the cuff and start a blood pressure measurement. During measuring, press it
to cancel the measurement and deate the cuff.
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• At all levels interface, the three buttons correspond respectively with the text prompts
below the LCD screen, pressing any button will carry on the corresponding function,
eg: [MENU] [ENTER] [LIST] [USER] etc.
• Up and down buttons, respectively carry on the functions of moving the cursor up and down, changing the param-
eters and switching the status.
Chapter 6
SETTING THE DATE AND TIME
It is necessary to set date and time after power on.
The Electronic Sphygmomanometer can automatically stores measurement results with date and time.
If batteries power exhausts or removed, the time to stop.
At the moment, please reset date and time.
The Electronic Sphygmomanometer stores measure results of three users automatically, and up to 100 items for every user.
If the date and time are set correctly, the date and time when measuring will be correct in the memory, otherwise it may not
be correct. The results can be uploaded to PC via USB and processed with the PC software.
1. There are two modes of time setting:
(1) When using the Sphygmomanometer for the rst time or after the Sphygmomanometer has been placed without pow-
er supply for a certain time(more than 3 minutes), after power on, there is a prompt of time error on the main interface,
set date and time with [UP], [DOWN] and [ENTER] button.
(2) Press [MENU] button on the main interface to enter system menu, then enter [SYSTEM TIME], item, the current time
will be displayed on the screen. Set date and time with [UP], [DOWN] and [ENTER] button.
2. After setting, select [CONFIRM] option and press [ENTER] button to conrm the setting value. If you do not want to
change the time, select [EXIT] option and press [ENTER] button to return to the previous menu.
Note
The range of year is from 2010 to 2099. When the year reaches 2099, pressing the [UP] button will return to 2010.
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Chapter 7
ABOUT UNIT
There are two units: “mmHg” and “kPa”.
The default is: “mmHg”.
Enter the [SYSTEM SETUP] submenu in [SYSTEM
MENU], then select [UNIT] option to switch units be-
tween “mmHg” and “kPa”.
Chapter 8
USER SWITCH
The Electronic Sphygmomanometer stores the measure
results of three users automatically, and up to 100 items
for every user.
Press [USER] button in main interface to switch users.
Or press [USER PREVIEW] item in [SYSTEM SETUP]
menu to switch users.
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Note
When the [USER PREVIEW] is set to [ALL], , current user
can be switched under main interface; when set to a cer-
tain user, it will not be able to switch under main interface.
User type can be set to adult, pediatric and neonatal three
different kinds, setting method is as follows:
Chapter 9
OVER-LIMIT PROMPT FUNCTION
The Sphygmomanometer has two kinds of reminding methods: the technical parameter over-limit prompt and the physio-
logical parameter over-limit prompt.
9.1 Physiological parameter over-limit prompt
The sphygmomanometer has the function of over-limit prompt, the user can press [MENU] button to enter system menu,
select [PROMPT SETUP] option to enter its interface, then set the limit value of blood pressure. When the BP measurement
result is higher than the high limit or lower than the low limit and the prompt is ON, the physiological prompt will occur; in
[PROMPT SETUP] interface, select [SpO2 PROMPT] option to enter its interface, when the SpO2measurement result is
higher than the high limit or lower than the low limit and the prompt is ON, the physiological prompt will occur.
In the state of physiological prompt, press any button to cancel the prompt and it does not affect the next prompt; the prompt
can be closed permanently with prompt switch of the prompt setup menu until the prompt switch be opened again.
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9.2 Technical parameter over-limit prompt
When power is about to exhaust and prompt is ON, the prompt will occur. This prompt can not be cancelled unless being
closed or the power replaced.
Chapter 10
THE USAGE METHOD OF SPHYGMOMANOMETER
10.1 Accurate Measurement Way
Measurement in quiet and relaxing state.
1. Adopt a comfortable sitting position, use back and arms to support the body.
2. Place your elbow on a table, the palm faces up and the body is relaxed.
3. The cuff is level with your heart.
4. Feet at on the oor, and do not cross your legs.
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