MEDICORE SA-3000P User manual

SA-3000P
Operation Manual
Ver.2.0.0

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TABLE OF CONTENTS
General........................................................................................................................3
Service Request..........................................................................................................5
How to contact for customer service ........................................................................6
How to use this manual..............................................................................................7
1.1 Contents of Manual..........................................................................................................7
1.2 Manual Construction........................................................................................................ 8
1.3 Meaning of Symbols used in this Manual ........................................................................ 9
Operational Dos and Don’ts.....................................................................................10
2.1 Don’ts in Operational Environment ................................................................................ 10
2.2 Cautions for Electrical Safety......................................................................................... 12
2.3 Maintenance and Cleaning ............................................................................................13
2.4 Cautions for Measurement.............................................................................................15
Description of SA-3000P ..........................................................................................17
3.1 The features of SA-3000P..............................................................................................17
3.2 Theoretical background of SA-3000P............................................................................17
3.4 Description of Equipment symbols.................................................................................19
Installation of SA-3000P...........................................................................................20
4.1 Installation......................................................................................................................20
Operation...................................................................................................................22
5.1 Before use SA-3000P .................................................................................................... 22
5.2 Use the SA-3000P ......................................................................................................... 22
5.3 Main window of software................................................................................................23
5.4 Data Backup...................................................................................................................26
5.6 RSATRAINING.............................................................................................................. 36
Trouble shooting.......................................................................................................43
6.1 System malfunction........................................................................................................ 43
Use of Finger Sensor................................................................................................44
7.1 Attachment of the PPG Probe........................................................................................44
7.2 Treatment and Checks...................................................................................................44
Description of Terms................................................................................................45
Certificate of quality and warranty ..........................................................................46
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Introduction
General
Thank you for using SA-3000P. Please read this User’s Manual carefully before operating
this equipment for proper handling and maintenance, and get familiar with all the functions
and features of this equipment for safe handling and reliable performance.
Please, try to fully understand the features and operation and maintenance methods of
this equipment prior to actual operation by thoroughly and carefully reading this manual.
This is the only way to insure safe operation and reliable performance of the equipment for
a long time.
Medicore Co., Ltd. only provides the reliable products to our customers.
All of assembling, extending, adjusting or repairing of this equipment shall be
carried out only by the service personnel authorized by our Company or Medicore
Co., Ltd.
Electrical connection or installation location has to comply with relevant regulations.
Operate the equipment as directed by this manual.
This equipment has to be operated under the supervision of licensed medical
professionals.
This equipment is used to monitor the conditions of patients. You are strongly requested to
use accessories that are recommended in manual for safety of your patients.
In the event this equipment needs to be used by connecting with other equipment that is
not listed in this manual, be sure to notify us, or our authorized dealers for proper
measurement.
This is operation instruction, and the products are protected by the Copyright Act.
No part of this instruction and the products may be reproduced or transmitted in any form

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or by any means, electronic or mechanical recording, or any information storage and
retrieval system, without permission in writing from Medicore Co., Ltd. This operation
instruction and the products may contain printing or technical errors, and are subject to
change without notice.
This manual includes operation instructions for the best use of the product. Please read
the manual carefully and keep it in a safe place.
Do not alter or modify the products. Do not use the product other than normal purpose.
Medicore Co., Ltd. is not liable for damage caused by the use of the persons without
appropriate medical license or education.

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Service Request
Only people of Medicore Service Center or authorized distributor can carry out warranty
repair or after-sales-service. If an unauthorized person tries to warranty repair, warranty is
void.
Medicore Service Center or authorized distributor is obligated to perform warranty repair
or after-sales service for the service requested by user.
Hospital or user must ask early and adequate maintenance if there is the risk or possibility
of harming to human body in its equipment usage.
If there are any problems with the equipment, please take the following steps.
Contact to the authorized distributor or Medicore Co., Ltd. immediately.
Advise the model name, serial number, date of purchase, and description of the
problem.
Resolve the problem on the phone or online communication at first, and in case it’s
difficult to resolve on the phone or online communication, you can ask visit of
service person.

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How to contact for customer service
In the event of a malfunction or failure, contact Service Dept. of Medicore Co., Ltd along
with the model name, serial number, date of purchase and the detail description of
technical failure.
Tel No. Overseas department of Medicore Co., Ltd.
[phone]
E-mail [e-mail]
Website http://www.medi-core.com
Authorized
distributor
Contact to our distributor in your local market

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Chapter 1
How to use this manual
1.1 Contents of Manual
This manual contains all the information needed to operate our SA-3000P and
it further provides exact information on the conditions of the patients including
the measured parameter analysis.
As this manual is constructed by independent chapter, some contents may appear
in more than one chapter.
This manual is a guideline for the efficient use of SA-3000P.
You can understand clinical significance and pathology of the feature for each
function better if you refer to the documentations of medical-related literature.
The user can expect to use effectively as seen as the clinical literature with
this manual.
In this manual, the method of operation is described for proper using the equip
ment. Read the instruction manual carefully before operating and keep it.
In case you have some questions on the operation of the equipment while
operating, please contact to our Overseas Sales Department or our local distribu
tor.

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1.2 Manual Construction
Users have to carefully read this Manual before operating the Equipment.
This Manual consists of various Chapters as follows.
Chapter 1 How to use this Manual.
Chapter 2 Operational Dos and Don’ts
Chapter 3 Description of SA-3000P
Chapter 4 Installation of SA-3000P
Chapter 5 Operation
Chapter 6 Handing and check point
Chapter 7 Trouble shooting
Chapter 8 Description of terms
Chapter 9 Certificate of Warranty

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1.3 Meaning of Symbols used in this Manual
Symbols are used to specially emphasize the agreed details as follows. Users need
to follow all the cautions and notes listed in this manual.
In the event that the product is damaged to misuse or negligence by a user, the
manufacturer or the authorized dealers shall not be responsible for any damage
or system failure thereof.
Warning
The title “Warning” is used to inform the users of possible causes that could inflict the
injury, death, or property damage to the patients.
Caution

The title “Caution” is used to inform the users of possible causes that could inflict the
injury on the patients although it might not be severe to cause deaths.
NOTE
The title “Note” is used to inform the users of items that are of importance in terms of
installation, operation, or maintenance of the equipment although the failure does not
do the physical harm to the patients.

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Chapter 2
Operational Dos and Don’ts
2.1 Don’ts in Operational Environment
Do not operate or store the equipment under the following environments.
Avoid the damp locations, and do not
operate the equipment with wet hands.
Location where exposed to direct
sunlight.
Locations where the temperature fluctuation
is rather big (Operational temperature
range: 20~35°C, Moisture level: 30~75%)
Locations close to electrical heating
apparatus.
Locations where moisture level could go up
considerably or where air is not ventilated.
Locations where sudden impact or
vibration could occur.

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Locations exposed to chemical or explosive
gas.
Make sure to prevent dust and
especially metal debris.
The disassembling of equipment should be
done by the authorized personnel.
Otherwise, we will not be liable for any
system failure or malfunction.
Do not plug in the power, until the
installation is completed. Otherwise, it
can cause damage to the equipment.
When pulling out the power cord, be sure to
grab the plug, not the cord.
Standard operational conditions are as follows.
Temperature : 10℃~ 40℃(50℉~ 104℉)
Humidity : 80% RH max @40℃(104℉)
Atmospheric pressure: 700hPa ~ 1060hPa
Standard storage conditions are as follows.
Temperature : -20℃~ 60℃(-4℉~ 140℉)
Humidity : 95% RH max @50℃(122℉)
Atmospheric pressure: 700hPa ~ 1060hPa

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2.2 Cautions for Electrical Safety
Prior to operation of the equipment, make sure to check following items:
Whether power supply is appropriate. (100 – 240VAC).
Whether connections (power line or selected equipment) are properly made to the
equipment.
Whether the equipment is properly grounded. (If not, some noises could be
generated.)
Whether a right kind of measuring accessory made for measuring of that desired
parameter is connected to the equipment prior to turning on the equipment.
Classifications
Protection Class
Class I
Degree of Protection Type BF: Heart Rate Monitor, BCA
It is not proper to operate this equipment around combustible anesthetic or dissolvent.
NOTE
The equipment should be placed far from generator, X-
ray equipment, broadcasting
equipment, or transmitting wires to prevent the electrical
noises from being generated
during the operation. When these devices are placed close to the equipment, it can
produce inaccurate measurements. For SA-3000P, both independent circuit and stable
grounding are essentially required. In the event that same power source is shared with
other electronic equipment, it can also produce inaccurate output.
NOTE

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2.3 Maintenance and Cleaning
SA-3000P and its accessories can be cleaned using various methods. Please follow the
methods mentioned below to avoid unnecessary damage or contamination to the
equipment.
In the event that harmful (NOT allowed) materials are used for cleaning the damaged,
contaminated equipment shall not be serviced without charges regardless of warranty
period.
Caution
Although SA-3000P has been manufactured in compliance with existing EMI/EMC
requirements, use of this system in the presence of an electromagnetic field can
cause momentary degradation of the SA-3000P. If this occurs often, Medicore
suggests a review of the environment in which the system is being used, to identify
possible sources of radiated emissions. These emissions could be from other
electrical devices used within the same room or an adjacent room. Communication
devices such as cellular phones and pagers can cause these emissions. The
existence of radio, TV, or microwave transmission equipment located nearby can
cause emissions. If EMI causes disturbances, it may be necessary to relocate your
system.
Electrostatic discharge (ESD), commonly referred to as a static shock, is a naturally
occurring phenomenon. ESD is most prevalent during conditions of low humidity,
which can be caused by heating or air conditioning. During low humidity conditions,
electrical charges naturally build up on individuals and can create static shocks. An
ESD condition occurs when an individual with an electrical energy build-up comes in
contact with objects such as metal doorknobs, file cabinets, computer equipment,
and even other individuals. The static shock or ESD is a discharge of the electrical
energy build-up from a charged individual to a lesser or non-charged individual or
object. The level of electrical energy discharged from a system user or patient to the
SA-3000P can be significant enough to cause damage to the system or probes. The
following precautions can help to reduce ESD: anti-static spray on carpets; anti-static
spray on linoleum; anti-static mats; or a ground wire connection between the system
and the patient table or bed.

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At least once a month, clean and wipe off the frame by using the soft cloth after wetting
it in lukewarm water or alcohol. Do not use lacquer, thinner, ethylene, or oxides, which
could be harmful to the equipment.
Make sure both cables and accessories are free of dust or contaminants, and wipe
them off with soft cloth wetted with lukewarm water (40℃/104℉), and at least once a
week, clean them. Do not submerge the accessories under any liquid or detergent.
Also, make sure ant liquid not to penetrate into the equipment or accessories.
Caution
When you finish cleaning up the device, please check the main body and the
sensor.
If the device is outworn or damaged, please do not use it.
Caution
If you have using substances that could damage the produ
ct (unauthorized
substance), the warranty period of the product is not even valid.
Please check carefully both frame and sensor, after cleaning the equipment.
Do not use the equipment that is worn out or damaged.

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2.4 Cautions for Measurement
2.4.1 Things to remember in measurement
Please do not behave to cause the fluctuation of heartbeat just before measuring. For
example, taking a significant workload, taking drugs or smoking shall be refrained.
2.4.2 Preparation of the patient before measuring
Patient shall maintain the fully stable condition to allow it to reflect the condition of the
patient as much as possible.
Please consult with the doctor in case of taking drug.
2.4.3 Preparation of patient on the testing day
Please refrain from smoking or drinking, or taking drug or beverage that may stimulate
the nervous system.
Please refrain from wearing accessory (ring, watch, and necklace) that may interfere
with measuring.
Please relax for about 15 minutes in measuring room before taking the measurement in
physically and mentally calm condition.
The measurement shall be taken in supine or sitting position of relaxed with eyes open.
Please do not move or speak but breathe regularly during the measurement.
2.4.4 Things to remember during testing
The people with difficulty in walking including the elderly and the psychosomatic patient,
especially the stroke patient, shall require the presence of a guardian in the testing
room.
2.4.5 Why to get different result when testing multiple times
In general, a healthy person has a large change in heart rate, and conversely, a person
with a disease (diabetes, myocardial infarction, arteriosclerosis, obesity, etc.) or older
people has less change in heart rate.
In other words, a large change in heart rate means that the autonomic nervous system
functions and the resistant to stress are good, thus lowering the incidence risk of
stress-related diseases.
The cycle of heartbeat changes by affecting the autonomic nervous system (Sinus

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Arterial Node).
In other words, repeatedly testing effected of internal and external environmental
factors (mental stress, emotional changes, breathing, blood pressure, body
temperature or hormone, etc.) make a change of result value.
People with diseases or older people are not able to respond immediately to changes
in internal and external environments. Therefore, the difference of the result value is
small in the continuous measurement, but the difference in the result value for the
health person is large because of quick response to the changes of internal and
external environment.
In addition, since vital signs are very sensitive, the following points should be carefully
taken for the measurement.
If there is a lot of change, it is recommended to read the average after 2 to 3
measurements.
1) After exercise, you should measure after 10 minutes stabilization.
2) Do not move or talk during testing.
3) Maintain most comfortable and normal breathing. (Coughing, sneezing, sighing,
yawning and abdominal breathing are not allowed during the measurement)
4) Avoid 8 hours before drinking and at least 2 hours before smoking or coffee.
5) When measuring, do not apply pressure with sensor finger.
6) The proper temperature should be maintained. (Room temperature 22 to 25 ° C)
Higher room temperature causes expansion of the peripheral blood vessels, resulting
in higher wave height. Lower temperature causes contraction of blood vessel,
resulting lower wave height.
In particular, measurement with cold finger may be fail.
7) Measure with the left index finger (measurement standard).
8) Nail polish must be removed for the measurement (a cause of measurement error)
9) There is a difference between the results in the morning and afternoon, but the
measurement in the morning is recommended for periodic test.
10) In case of hypertension, high fever or tachycardia, the result value tend to get
better because of rapid blood flow in artery.
Even after drinking, the result value tend to get better due to increased blood flow.
11) In the case of arrhythmia, heart disease or asthma, the result value is unreliable.

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Chapter 3
Description of SA-3000P
3.1 The features of SA-3000P
HRV is aims to quantitatively assess the overall health forecasting and autonomic nervous
system activity by measuring heart rate variability for a certain period time, and used to
determine the physical/mental stress level and autonomic balance through it.
The simple and fundamental theory is that heart rate variation is larger for a healthy
adult. To show quantitative data, both of the time-domain analysis and the frequency
domain analysis are used.
3.2 Theoretical background of SA-3000P
SA-3000P HRV quantify the full extent of the patient's heart rate variability during the
measurement time. The healthy individual with excellent ability to regulate autonomic
function has bigger variability of heart rate but a person under any disease or stressed
state has reduced variability. There are two method for analyzing heart rate variability, the
one is a statistical analyzing including the RR intervals, the mean heart rate and its
standard deviation in a time domain and the other is the frequency domain analysis which
is a way to quantify the relative strength of each frequency band. Especially through
frequency domain analysis, it can evaluate the activities of two branches, sympathetic and
parasympathetic nerve of the autonomic nervous system.
SA-3000P TRAINING is a respiratory training program through the RSA.
RSA (Respiratory Sinus Arrhythmia) is a normal arrhythmia rhythm influenced by breathing
on the signal of the sympathetic and vagus nerve that affect the sinus node. In other words,
the variation of heart rate caused by breathing. Through this respiratory training, we can
develop the ability to lead a balanced biological rhythms, and get the stress relaxation
effect. You can increase the training effect by selecting respiratory rate and expiratory-
inspiratory ratio for the patient.

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3.3 Composition of Equipment
Be sure to check the following product and accessories are available:
The list of components
①SE-3000P Main Unit :1EA
②Operation Manual :1EA
③PPG Sensor :1EA
④Power Cable : 1 EA
⑤Fuse(250V/2A) : 4 EA

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3.4 Description of Equipment symbols
Type BF
Type CF
Power “ON”
Power “OFF”
Attention
PPG Photo-PlethysmoGraphy
HRV Heart Rate Variability
Ground
LAN/USB

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Chapter 4
Installation of SA-3000P
4.1 Installation
Check point for installation
While installing SA-3000P, observe the following points.
SA-3000P has to be used under the ambient temperature of 10℃~40℃and
humidity of 80%.
Check the connection with power cord.
Do not plug in the cords into the same port of other equipment.
Place the frame on the horizontal surface.
Be sure to ground the equipment.
Do not use the electrical cord that generates the connection noise
Handle the equipment with care, because the equipment can be easily
damaged by sudden impacts.
Place it in a clean place without dust or combustible materials