Vita Course Technologies DISCOVERY User Manual

Non-invasive Hemodynamic Blood

Pressure Monitor

Discovery 1

User Manual

Vita-Course Technologies Co., Ltd.

User Notes:

Thank you for using the Non-invasive Hemodynamic Blood Pressure Monitor.

Please read the instruction manual carefully before using the product.

Vita-Course shall not take corresponding responsibility for any abnormality or any personal or

machine damage caused by the irregular use, maintenance and reposition without the

guidance of the instruction, and shall not provide free maintenance for such failures.

This manual is only applicable to Discovery 1 type Non-invasive Hemodynamic Blood Pressure

Monitor (hereinafter referred to as "equipment")

Contraindications: unclear

copy or disseminate any part or all of the instruction without prior written permission in any

form or by any means. Otherwise, the legal liability will be held accountable.

Vita-Course Technologies has the final interpretation of the instruction and reserves the right

to upgrade and alter specifications as well as contents of the products. If there are upgrade and change, we won’t track users’ upgrade.

Vita-Course Technologies tries its best to make contents of the instruction be complete and

accurate, but cannot guarantee that the instruction is free from any errors or omissions.

Vita-Course Technologies shall not bear any responsibility for any consequences arising from

the irregular execution of the contents of this instruction.

All the copyrights, trademarks, patent applications and patent rights that may arise from the

instruction or relate to the products of Vita-Course Technologies are owned by Vita-Course

Technologies. Without the written permission agreement, this instruction does not grant any

license of any of the above rights and the instruction itself cannot be used as a license

agreement to authorize any of the above rights.

If other units or individuals, without the written permission, use or disseminate the contents of

the instruction without authorization, which accordingly affects the interests of themselves or

the third parties, Vita-Course Technologies shall not shoulder any responsibility

File Updating

This instruction was finally revised by Vita-Course Technologies on February 22, 2017.

1. Before the use of the equipment, users need to check the equipment so as to ensure its safe use

and normal work.

2. Do not use the equipment in these places full of the flammable gas and explosion.

3. Allergic reactions may occur in very few other users. If it happens, please stop using the

equipment immediately.

4. When users connect other equipment to their bodies, please be cautious: the total leakage

current may exceed the permissible limitation, causing potential damage to the user.

5. Equipment accessories, such as pulse wave probes and cables whose materials have been tested

for biocompatibility, cannot be replaced at will. Please use the accessories provided by our

company in case it may lead to some adverse consequences related to safety and biocompatibility

etc.

6. All the connections of applications should be away from the user's neck so as not to choke the

user's neck.

7. Before carrying out maintenance, please turn off the equipment.

8. The scrap of this equipment and parts shall comply with local laws and regulations.

9. This equipment belongs to professional medical equipment, and only the professionals

appointed by the factory are responsible for the maintenance.

10. Apply to those who are 16~70 years old.

11. Please close the equipment and evacuate the sensor during magnetic resonance imaging MRI

scanning; if not, it may cause burns or affect the accuracy of MRI images as well as equipment.

12. Please make sure children can't touch it when you keep it.

13. Please do not use the high frequency operation equipment at the same time so as not to affect

the measurement accuracy of the equipment.

 Warning

Safety Announcements:

 Warning: The patient or the operator may die or be seriously injured when the equipment

is operated mistakenly.  Caution ：The damage may happen to people or equipment when the equipment is

employed incorrectly.

Note：Important tips on operation and use

1. Please keep and use the equipment within the regular range of temperature, humidity and

atmospheric pressure; if not, it would lead to damage of the equipment and inaccurate measurement

results.

2. Please do not directly open the equipment after it is affected with damp to avoid damaging the

equipment, and use it after it is dried.

3. The equipment is limited to one user at the same time.

4. Please be away from equipment with strong electromagnetic interference, such as microwave

ovens, large printers, induction cooker, etc. when using it.

5. When using high frequency surgical equipment, close the equipment and evacuate the sensor.

1. When common arrhythmias, such as atrial fibrillation, premature ventricular fibrillation, and

atrial fibrillation, occur, they may affect the accuracy of output results.

2. Professionals shall interpret the measuring results of the equipment.

3. The value of blood pressure measured by this equipment is equivalent to that measured by

auscultation, and the error is in line with the requirements specified in YY 0667-2008.

4. If those who are equipped with heart pacemaker, a stent and beyond the measurement range

use the equipment, the accuracy of the output results will be affected.

5. Please remove your callus of your hands and nail polish before using the equipment.

6. Check the battery power after each use. When the battery is less than 1 cell, you must charge the

battery, and ensure sufficient storage of electricity.

7. Please stop using the equipment if there is any indication of malfunction.

8. Signal input and output interfaces can only be connected to the required devices.

Caution

Note

Table of Content

Chapter 1 Summary ......................................................................................................................................... 1

1.1 Characteristics of products .................................................................................................................................................... 1

1.2 Intended Use/Instruction for use .......................................................................................................................................... 1

1.3 The scope of products ........................................................................................................................................................... 1

1.4 Structure ............................................................................................................................................................................... 1

1.5 Product classification ............................................................................................................................................................ 1

1.6 Operating environment ......................................................................................................................................................... 2

1.7 Safety .................................................................................................................................................................................... 2

Chapter 2 Wearing and Connecting ...................................................................................................................... 3

2.1 Out of box audit .................................................................................................................................................................... 3

2.2 Appearance presentation ...................................................................................................................................................... 3

2.3 Marks .................................................................................................................................................................................... 4

2.4 Wearing ................................................................................................................................................................................. 4

Chapter 3 Interface Introduction and Operation .................................................................................................. 7

3.1 Boot ....................................................................................................................................................................................... 7

3.2 Connecting APP ..................................................................................................................................................................... 7

3.3 Calibration ............................................................................................................................................................................. 8

3.4 Measurement ........................................................................................................................................................................ 9

3.5 Measuring result ................................................................................................................................................................... 9

3.6 Prompt in measurement ..................................................................................................................................................... 10

3.7 Battery level ........................................................................................................................................................................ 11

Chapter 4 Structural Features and Working Principle .......................................................................................... 13

4.1. Overall structure framework chart ..................................................................................................................................... 13

4.2 Principle of blood pressure measurement .......................................................................................................................... 13

Chapter 5 Technical Characteristics ..................................................................................................................... 14

5.1 Blood pressure .................................................................................................................................................................... 14

5.2 Pulse wave ........................................................................................................................................................................... 14

5.3 Size and weight ................................................................................................................................................................... 14

Chapter 6 Maintenance, Preservation, Storage and Transportation .................................................................... 15

6.1. Cleaning of equipment ....................................................................................................................................................... 15

6.2 Cleaning of accessories ....................................................................................................................................................... 15

6.3. Maintenance test ............................................................................................................................................................... 16

Chapter 7 Storage and Transportation of Equipment .......................................................................................... 17

7.1 Storage ................................................................................................................................................................................ 17

7.2 Transportation..................................................................................................................................................................... 17

Chapter 8 Troubleshooting .................................................................................................................................. 18

8.1 Check the equipment and accessories ................................................................................................................................ 18

8.2 Check cable and charging line ............................................................................................................................................. 18

8.3 Troubleshooting .................................................................................................................................................................. 18

8.4 Disposal of equipment ........................................................................................................................................................ 19

Chapter 9 Appendix ............................................................................................................................................. 20

The warranty ordinance of the product ............................................................................................................... 25

Chapter 1 Summary

1.1 Characteristics of products

Noninvasive and cuff-less equipment



The self-contained screen to monitor blood pressure measurement data; real-time clock to



display the time.

Rapid measurement of blood pressure and pulse rate.



Automatic measurement.



Dynamic continuous measurement can keep 24 hours.



Real-time power display, low battery alert and auto sleep for power save.



Wireless connection via display terminal, such as Bluetooth and intelligent mobile phone,



1.2 Intended Use/Instruction for use

etc.

The Discovery 1 - Non-invasive blood pressure trending device is a small, lightweight, handheld,

device intended for measuring and display of Blood Pressure trending (systolic and diastolic) and

spot-check of Peripheral pulse rate (PPR) and Peripheral pulse wave (PPW). Measurement is

performing on capillary fingertip tissue (other than the thumb). The ring finger is the recommended

site. The results of each measurement are stored in the system memory.

It is intended to be used by any person aged above 18 years old.

1.3 The scope of products

Apply to medical institutions or families to monitor the blood pressure and pulse rate of the human

body.

1.4 Structure

The cuff-less equipment consists of a host, mobile APP software and accessories. Accessories include ：Pulse wave probe and cable, arm band (optional), power adapter, data

transmission line / charging line.

1.5 Product classification

According to the classification of medical device management categories: Class II

According to the type of protection against electric shock: class II internal power supply equipment

According to the degree of protection against electric shock: BF-type equipment

According to the degree of protection against harmful liquid into: ordinary equipment (the closed

equipment that cannot stop the liquid into)

According to the safety degree related to a mixture of flammable anesthetizing gas and air or

oxygen or Nitrous Oxide: not applicable in the place existing flammable anesthetizing gas.

According to the work system: continuous operation of equipment

1.6 Operating environment

1．Operating temperature：5 ℃～45 ℃； Relative humidity：10%～95%( non-condensing)； Atmospheric pressure：70.0 kPa～106.0 kPa； 2．Working mode: internal power supply: DC 3.7, V/2200, mAh;

Charging mode: power adapter input voltage: 220 V, 50Hz.

1.7 Safety

1. Comply with IEC 60601-1:2012 “Medical electrical equipment; Part 1: General requirements for safety”

2. Comply with IEC 60601-1-2:2014 “Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests”

3. Comply with ISO 80601-2-61 “Particular requirements for basic safety and essential performance of pulse oximeter equipment”

Content

Description

Non-invasive Hemodynamic Blood Pressure Monitor

Pulse wave probe

Pulse wave probe interface

Screen On/off key

Charging interface USB connection port

Chapter 2 Wearing and Connecting

2.1 Out of box audit

1、Open the packing box and take out the equipment and accessories. 2、Open the random file and check accessories according to the packing list:

1) Check whether the equipment has any mechanical damage.

2) Check whether all accessories including plug, wires and sensor have scoring or shortness.

3) Before using the equipment, check whether the equipment and accessories are in danger or have abnormality; if it has abnormality (such as patients’ cable rupture, shell cracking, etc.), do not carry

out measurement.)

If you have any questions, please contact the seller or contact us. We will provide you with

satisfactory service in time.

2.2 Appearance presentation

Figure 2.1 product drawing

On/off key

Press the power on / off button for 1 second to turn on the equipment

Press the power on / off button for 4 seconds to turn off the battery

Screen

Display interface content

USB connection port

Connect line USB to charge upgrade the program and export

data

Pulse wave probe

interface

Connect pulse wave probe

Content

Description

Be careful！Consult the random file

USB connection port

PPG

Pulse wave probe

BF applied part

On /off button

Non-Ionizing Radiation

2.3 Marks

2.4 Wearing

Please wear arm belt as shown in Figure 2.2

Figure 2.2 wearing arm belt

+ 23 hidden pages

Vita Course Technologies DISCOVERY User Manual

Specifications and Main Features

Frequently Asked Questions

User Manual