Contec Medical Systems CMS50K Users manual

Content

1 Precautions ....................................................................................................................................... 1

1.1 General Precautions .............................................................................................................. 1

1.2 Measurement Precautions ..................................................................................................... 1

1.3 Safety Precautions ................................................................................................................. 2

1.4 EMC Statement .................................................................................................................... 2

2 Overview .......................................................................................................................................... 4

2.1 Features ................................................................................................................................. 4

2.2 Range of Application ............................................................................................................ 4

3 Main Technical Specification ........................................................................................................... 5

3.1 Environment Requirements ................................................................................................... 5

3.2 Main Parameters ................................................................................................................... 5

3.3 Main Performance ................................................................................................................. 5

3.4 Product applied part .............................................................................................................. 5

4 Device Introduction.......................................................................................................................... 6

4.1 Appearance Introduction ....................................................................................................... 6

4.2 Interface Introduction ............................................................................................................ 6

5 Operation Instruction ....................................................................................................................... 7

5.1 Power On and Power Off ...................................................................................................... 7

5.2 SpO

5.3 Pedometer ............................................................................................................................. 8

5.4 ECG Measurement ................................................................................................................ 8

5.5 Charge ................................................................................................................................... 8

5.6 Data Upload .......................................................................................................................... 8

5.7 The Installation and Replacement of SpO

5.8 Accessories ............................................................................................................................ 9

5.9 Clinical Restrictions .............................................................................................................. 9

6 Troubleshooting ............................................................................................................................. 10

7 Maintenance&Transportation&Storage ......................................................................................... 11

7.1 Cleaning and Disinfecting ................................................................................................... 11

7.2 Maintenance ........................................................................................................................ 11

7.3 Transportation and Storage ................................................................................................. 11

8. Meaning of Symbol ....................................................................................................................... 12

9. Specification ................................................................................................................................. 13

Measurement ............................................................................................................... 7

2

Probe ................................................................. 8

2

I

Instructions to User

Dear users, thank you very much for purchasing the CMS50K Wearable SpO2/ECG Monitor.

This Manual describes, in accordance with the product's features and requirements, main structure,

functions, specifications, correct methods for transportation, installation, usage, operation, repair,

maintenance and storage, etc. As well as the safety procedures to protect both the user and

equipment. Refer to the respective chapters for details.

Please read the User Manual carefully before using this product. The User Manual which describes

the operating procedures should be followed strictly. Failure to follow the User Manual may cause

measuring abnormality, equipment damage and human injury. The manufacturer is NOT

responsible for the safety, reliability and performance issues and any monitoring abnormality,

human injury and equipment damage due to users' negligence of the operation instructions. The

manufacturer’s warranty service does not cover such faults.

Owing to the forthcoming renovation, the specific products you received may not be totally in

accordance with the description of this User Manual. We would sincerely regret for that.

This product is medical device, which can be used repeatedly.

This User Manual is compiled by our company. All rights reserved. Reproduction, adaption or

translation, for any part of the manual without prior written permission, is prohibited.

 Our company have the responsibility to provide qualified product which conform to company

standard of this product.

 Our company have the responsibility to complete product installation, debugging and technical

training according to the contract.

 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.

Note: before using this product, please read the User Manual carefully.

II

1 Precautions

1.1 General Precautions

1) Do not use the product in high temperature or high humidity environment, the operating

temperature of the product is 10˚C~40˚C, the operating humidity of the product is

0%~75%RH.

2) Do not clean the product with water, if the device gets wet, please stop operating it.

3) When the device is carried from cold environment to warm or humid environment, please

do not use it immediately.

4) Do not use or store the product in the following conditions:

 areas near flame or fire;
 areas with strong shock;
 areas with strong electromagnetic field.

5) Do not disinfect the product in autoclaves or gas sterilizer.

6) The device has useful life for five years, when the device reach the end of life and can not

be used, please do not discard it at will, the disposal should follow the local laws and

regulations.

7) Keep the operation environment away from dust, vibration, corrosive substances,

explosive materials, high temperature and humidity.

8) Strenuous action of the subject or extreme electrosurgical interference may affect the

accuracy.

9) After using, refer to the relative chapter(7.1) in User Manual for instructions of cleaning

and disinfection.

10) The device is worn on the arm, fixed position, too tight or too loose will affect the

measurement accuracy.

11) Please don't measure this device with functional tester for the device's related

information.

12) Please don't use the device during MRI or CT scanning.

13) The disposal of scrap instrument and its accessories and packings(including battery,

plastic bags, foams and paper boxes) should follow the local laws and regulations.

14) The user must check that the equipment functions safely and see that it is in proper
working condition before being used.

15) The patient is an intended operator.

16) A warning against servicing and maintenance while the ME equipment is in use.

1.2 Measurement Precautions

1) If subjects' skin is too dry to measure ECG, wipe them with disinfectant alcohol or

electric salve so that the electric capability can be strengthened.

2) When measuring ECG, the subject should maintain a natural sitting posture with a

straight back, and begin to measure after the waveform is stable.

3) When measuring ECG, the finger and arm electrodes should touch subjects' skin exactly,

roundly and well.

4) When measuring SpO

, the subject should entirely put a finger into the black pane on the

2

side of the device, the finger entirely touch the contact.

5) During exercise, it is not suitable for measuring ECG and SpO

.

2

6) The device can only be matched with the compatible probe.

7) The product is not suitable for use in continuous supervision for patients. The problem of

overrating would emerge when the patient is suffering from toxicosis which caused by

carbon monoxide, the device is not recommended to be used under this circumstance.

1.3 Safety Precautions

1) Do not use the device under the state of charging.

2) No servicing and maintenance while the ME equipment is in use

3) When the device is not used for a long time, it should be placed in a cool, dry room, and

power it every three month.

4) Do not use the device in environment with inflammable gas such as some ignitable

anesthetic agents.

5) The infrared is harmful to eyes, so the user and the maintenance man should not stare at

the light part of the SpO

6) Inspect periodically, make sure that there is no visible damage that may affect patient’s

safety and monitoring performance. It is recommended that the device should be

inspected at least once a week. Please stop using the oximeter if there is obvious damage

to the device.

7) When measuring SpO

8) Please refer to the correlative medicinal literature about the clinical restrictions and

contraindications.

9) The disposal of scrap instrument and its accessories and packings(including battery,

plastic bags, foams and paper boxes) should follow the local laws and regulations.

10) Necessary maintenance must be performed by qualified service engineers ONLY. Users

are not permitted to maintain it by themselves.

11) The device cannot be used together with equipments not specified in User’s Manual.

Only the accessory that is appointed or recommendatory by manufacture can be used

with this device.

12) The device is not intended for treatment.

13) The device has been calibrated before leaving factory.

probe (the infrared is invisible).

2

with probe, subjects can not use enamel or other makeup.

2

1.4 EMC Statement

1) When using the device, EMC should be paid more attention, the device shall be used in

the environment complied with the appended table.

FCC Cautions:

1) 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.

2

2) 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.

3) Any Changes or modifications not expressly approved by the party responsible for

compliance could void the user's authority to operate the equipment.

4) The device has been evaluated to meet general RF exposure requirement. The device can

be used in portable exposure condition without restriction.

3

2 Overview

CMS50K Wearable SpO

/ECG Monitor integrated functions of SpO2, ECG and pedometer in one

2

product.
The pulse oxygen saturation is the percentage of HbO

in the total Hb in the blood, so-called the O2

2

concentration in the blood. It is an important bio-parameter for the respiration. A number of

diseases relating to respiratory system may cause the decrease of SpO

in the blood, furthermore,

2

some other causes such as the malfunction of human body's self-adjustment, damages during

surgery, and the injuries caused by some medical checkup would also lead to the difficulty of

oxygen supply in human body, and the corresponding symptoms would appear as a consequence,

such as vertigo, impotence, vomit etc. Serious symptoms might bring danger to human's life.

Therefore, prompt information of patients' SpO

is of great help for the doctor to discover the

2

potential danger, and is of great importance in the clinical medical field.

The ECG function of CMS50K Wearable SpO

/ECG Monitor is a good helper in the prevention of

2

cardiovascular disease, as it can monitor ECG with easy operation at any time and any place. The

device can record, analyze and display users' ECG waveform, capture the pathological ECG

waveform when users happen to transient heart attack or other unpleasant symptoms. The heart can

be monitored not limited in the hospital, which saves money from the physical check-up for users.

After connecting with a computer or APP in mobile phone, the device can provides data reference

for doctors.

The pedometer function of CMS50K Wearable SpO

/ECG Monitor is basing on counting steps by

2

acceleration sensor, adopts the recognition principle of pace waveform and its acceleration and

deceleration process for recognizing the waveform produced by person walking, finally gets the

number of steps. Detailed method: use the acceleration sensor to collect user’s steps(more than five

steps), via analyzing and calculating, obtain the peak value of step vibration waveform and the

average value of acceleration difference value, and set it to the threshold value. Collect the user’s

actual step waveform data, if it is in the threshold range, then it is considered that user walks one

step forward.

2.1 Features

1) Compact shape, handsome appearance, easy to operate and carry.

2) Monitor and record real-time SpO

value, pulse rate value, ECG waveform, heart rate,

2

step number and calories anytime and anywhere.

3) With real-time clock function, the device can display year, month, day, hour, minute and

second, it can be used as an electronic clock when there is no measurement activities.

2.2 Range of Application

1) Applicable situations: the device applies to family, medical clinics and hospitals, and

can't be used for clinic medical examination instead of conventional electrocardiograph.

2) Applicable object: people under high pressure and workload for long time, heart disease

patients, the elderly and sub-health people.(The patient is an intended operator)

3) Purpose: the device does not belong to the therapy equipment, it is just for the

measurement and storage of SpO

Operation is simple and less requirement for the operating personnel.

, ECG and step number at anytime and anywhere.

2

4