User's Manual

Electronic Sphygmomanometer / CONTEC08E
Contec Medical Systems Co., Ltd.
Address:NO.112 Qinhuang West Street, Economic & Technical Development Zone,
Qinhuangdao,Hebei Province, PEOPLE’S REPUBLIC OF CHINA
Tel: [phone] Fax: [phone]
Technical support:[phone]
E-mail: [e-mail]
Website: http://www.contecmed.com
EC REPRESENTATIVE
Shanghai International Holding Corp. GmbH (Europe)
Address: Eiffestrasse 80, 20537, Hamburg, Germany
Tel: [phone] Fax: [phone]
E-mail: [e-mail]
CMS2.782.253(LED)(CE)ESS/1.3 1.4.01.06.349 2022.07
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, Our company is not responsible for the safety,
reliability and performance guarantees! The manufacturer’s warranty service does not cover such faults!
Our company has a factory record and user profile for each device, users enjoy free maintenance services for one year
from the date of purchase. In order to facilitate us to provide you with a comprehensive and efficient maintenance
service, please be sure to return the warranty card when you need repair service.
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 modifications 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 efficacy of the following described:
 Described each measurement results combined with clinical symptoms by qualified 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 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.
Responsibility of operator
 The operator must carefully read the User Manual before use this product, and strictly follow the operating
procedure of the User Manual.
 Fully consider the security requirements during product design, but the operator should not ignore the observation
for the patient and the state of machine.
 The operator has the responsibility to provide the use condition of the product to our company.
Responsibility for our company
 Our company have the responsibility to provide qualified product which conform to company standard of this
product
 Our company will provide the circuit diagram, calibration method and other information at the request of the user
to help the appropriate and qualified technicians to repair those parts designated by our company.
 Our company have the responsibility to complete product maintenance according to the contract.
 Our company have the responsibility to respond the requirements of user in time.
 In the following case, our company is responsible for the impact on the safety, reliability and performance of the
device:
Assembly, addition, debugging, modification or repair are carried out by personnel approved by our company.
The electrical facilities in the room are in compliance with the relevant requirements and the device is used in
accordance with the User Manual.
The User Manual is written by our company. All rights reserved.
Chapter1 Functions and Purpose
1.1 Main Functions
 Measure blood pressure and store the measurement results.
 Data storage function, up to 199 records can be stored.
 With data review interface which is convenient for reviewing blood pressure parameter.
 The screen will prompt message when the power is low.
 When the measurement result can not be obtained due to some factors during the measurement, the device will
display the corresponding error information.
 Measurement units: mmHg and kPa, which can be switched by the button.
 With automatic shutdown function, if there is no operation, the device will automatically turn off.
 Vo ice broadcast(optional for devices with vioce function)
 The data stored can be uploaded to master device by Bluetooth(optional for devices with Bluetooth function)
1.2 Purpose
The device apply to measure the non-invasive blood pressure of human. Record parameter value of blood pressure to
provide the reference for the health care professional.The device applies measurement Blood Pressure (BP) and Pulse
of adult and adolescent .
Chapter2 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.
For safety reasons, be sure to comply with safety precautions.
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 difficult 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.
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 flow 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.
Please do not keep the cuff in the over-inflated state for a long time.
Otherwise it may cause risk.
Do not use the device in the case of there are flammable 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 specified 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 find 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.
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.
This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This
device may not cause harmful interference, and (2) this device must accept any interference received, including
interference that may cause undesired operation.
Any Changes or modifications not expressly approved by the party responsible for compliance could void the user's
authority to operate the equipment.
Note
This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part
15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a
residential installation. This equipment generates uses and can radiate radio frequency energy and, if not installed
and used in accordance with the instructions, may cause harmful interference to radio communications. However,
there is no guarantee that interference will not occur in a particular installation. If this equipment does cause
harmful interference to radio or television reception, which can be determined by turning the equipment off and
on, the user is encouraged to try to correct the interference by one or more of the following measures:
-Reorient or relocate the receiving antenna.
-Increase the separation between the equipment and receiver.
-Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.
-Consult the dealer or an experienced radio/TV technician for help.
The device has been evaluated to meet general RF exposure requirement.The device can be used in portable/mobile
exposure condition without restriction
2.1 Operation for power 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 fire or electric shock.
When there is breakage of dedicated power adapter plug or wire, please do not use it.
Otherwise it may cause fire 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.
When using the power adapter to connect with the power socket, make sure the power socket is conveniently
accessible, in order to timely disconnect from the power when emergency.
2.2 Operation for Battery
Note
Please use 4 "AA" size manganese or alkaline batteries, do not use batteries of other types.
Otherwise it may cause fire.
Do not mix old and new batteries and batteries of different types
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 inflate before the cuff wraps around the arm;
Do not inflect the cuff and the air tube forcibly.
Chapter3 Main Unit
All products are in the box. Open the box and confirm whether the product is whole.
3.1 Display
:Irregular pulse icon.Irregular pulse icon is displayed in the measurement results if the pulse internal is irregular
during measuring,
：Movement icon.The “Movement” icon appears if patient moves and continue measuring may lead to inaccurate
measurement.
：Cuff tied icon.The icon appears if Cuff tied properly.The icon disappears if not
：Memory Function icon.
：Bluetooth icon.The Bluetooth is enabled(optional for devices with Bluetooth function)
：The icon lights up if the device time is not synced, and the measured data cannot be uploaded to the terminal
equipment via the Bluetooth. After syncing the time by Bluetooth connection of the device, the icon goes off, and the
measured data can be uploaded.(optional for devices with Bluetooth function)
/ ：Voice icon.The voice function is enabled or not(optional for devices with Voice function)
3.2Accessories
Cuff User Manual AC Adapter
Cuff
Specification: limb circumference 22-32 cm (middle part of upper arm ), please choice suited cuff when measuring other.
Separate Sale:
AC Adapter
Input: voltage: AC 100 V~240 V frequency: 50 Hz/60 Hz Rated current: AC 150 mA
Output:DC5.0 V±0.2 V 1.0 A
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 specification. If you want to know more information, please contact our company or
representative organization.
Chapter4 External Interfaces
Note
When removing NIBP cuff, please take plug at the front of the windpipe to pull out.
①Cuff socket( is cuff identifier)
Left side
②Power adapter socket( is power socket identifier)
Back side
Note
All analog and digital equipment connected to this device must be certified 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.
Chapter5 Battery/AC Adapter Installation
The production can use battery and AC adapter.
5.1 Battery Installation
① ② ③
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.
5.2 Usage of power adapter
1.Connect the sphygmomanometer and the power adapter. Plug the power adapter plug into the power adapter socket
on the back 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, first 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
consumed.
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.
Chapter6 Button Functions
6.1 Description for button operation
All the operations to the Electronic Sphygmomanometer are through buttons. The names of the buttons are above them.
They are:
 Left button is “M” button, under “OFF” state, press this button to enter the review interface (refer to Chapter
8 for details.).
 Right button is “START/STOP” button, under “OFF” state, press this button to enter measurement mode,
inflate the cuff to measure blood pressure, press this button again to turn off the device.
6.2 Units setting
Under “OFF” state, press “M” button and “START/STOP” button simultaneously for 5 s to enter the setting interface,
the default unit in this interface is “mmHg”; short press “M” button to switch the unit between “mmHg” and “kPa”.
6.3 Volume setting (optional for devices with voice function)
 Press “START/STOP” button again in the unit setting interface to enter the volume setting interface. Press “M”
button to change the volume, the maximum volume is 4, and the minimum is 0 (silence).
 After completing the setting, repeatedly press the “START/STOP” button to turn the device off.
Note
 The default unit of the device when leaving factory is mmHg.
 In the volume setting interface, press “START/STOP” button to enter the factory setting interface, in which the
“CAL” is the static pressure interface, and the “FAC” is the aging interface, which does not require user to operate. If
you want to end the interface, press the “START/STOP” button twice to turn the device off.
Chapter7 The Usage Method of Sphygmomanometer
7.1 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 flat on the floor, and do not cross your legs.
Advice
Try to measure your blood pressure at the same time each day with the same arm and the same pose for
consistency.
The high and low location of cuff will cause changes in measure results.
Do not touch the sphygmomanometer, cuff and windpipe during measure.
Measurements should be taken in a quiet place and the body relax.
Remain still 4~5 minutes before measurement.
Do not talk and movement during the measurement. Relax the body, do not let the muscle activity.
Wait 4~5 minutes between measurements.
Do not use precision instrument near the Sphygmomanometer.
Warning
When repeatedly measuring, the accurate blood pressure value may not be measured due to congestion in the arm.
Please measure after the blood flow is smooth.
Repeated measurement for a long period of time, limbs rubbing with the cuff may be accompanied by purpura,
ischemia and nerve damage. When measurement a patient, it is necessary to frequently check the color, warmth and
sensitivity of the distal of the limb. Once any abnormalities are observed, place the cuff in another position or stop the
blood pressure measurement immediately.
Please use the device at an environment of suitable temperature and humidity otherwise it will cause measurement
error.
Do not twist or wrap the airway tube. It can cause constant pressure in the cuff which can block blood flow and cause
serious damage to the patient.
Do not use the cuff on the injured area, which will cause more serious damage to the area.
Do not use the cuff in the area where the treatment is being performed inside blood vessel or the arteriovenous
connection. This may cause temporary blockage of blood flow and cause injury to the patient.
Do not use the cuff on the side of the mastectomy.
When using the cuff to pressurize, some of the body’s functions may temporarily weaken. Do not use the measurement
medical electrical equipment at the appropriate arm position.