Contec Medical Systems CMS50EW Users manual
Instructions to User
Dear users, thank you very much for purchasing the Pulse Oximeter.
This Manual is written and compiled in accordance with the
medical devices and harmonized standards. In case of modifications and software upgrades, the
information contained in this document is subject to change without notice.
The Manual describes, in accordance with the Pulse Oximeter’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.
WARNING:
council directive MDD93/42/EEC for
0 Uncomfortable or painful feeling may appear if using the device ceaselessly, especially for
the microcirculation barrier patients. It is recommended that the sensor should not be
applied to the same finger for over 2 hours.
0 For the special patients, there should be a more prudent inspecting in the placing process.
The device can not be clipped on the edema and tender tissue.
0 The light (the infrared is invisible) emitted from the device is harmful to the eyes, so the
user and the maintenance man should not stare at the light.
0 Testee can not use enamel or other makeup.
0 Testee’s fingernail can not be too long.
0 Please refer to the correlative literature about the clinical restrictions and caution.
0 This device is not intended for treatment.
The User Manual is published by our company. All rights reserved.
1
Contents
1. Safety ......................................................................................................................... 3
1.1. Instructions for safe operations ............................................................................ 3
1.2. Warning ................................................................................................................ 3
1.3. Hazards ................................................................................................................. 4
1.4. Indication for Use ................................................................................................. 5
2. Overview .................................................................................................................... 6
2.1. Classification ........................................................................................................ 6
2.2. Features ................................................................................................................ 6
2.3. Major applications and scope of application ........................................................ 6
2.4. Environment requirements ................................................................................... 6
3. Principle ..................................................................................................................... 7
4. Technical specifications ............................................................................................ 7
4.1. Main performance ................................................................................................ 7
4.2. Main Parameters .................................................................................................. 8
5. Installation ................................................................................................................. 9
5.1. View of the front panel ......................................................................................... 9
5.2. Installing the hanging rope ................................................................................... 9
5.3. Accessories ........................................................................................................... 9
6. Operating Guide ....................................................................................................... 9
6.1. Application method .............................................................................................. 9
6.2. Attention for operation ....................................................................................... 14
6.3. Clinical restrictions ............................................................................................ 14
7. Maintain,transportation and storage .................................................................... 14
7.1. Cleaning and disinfecting ................................................................................... 14
7.2. Maintain ............................................................................................................. 14
7.3. Transportation and storage ................................................................................. 15
8. Troubleshooting ...................................................................................................... 15
9. Key of Symbols ....................................................................................................... 15
10. Function Specification .......................................................................................... 17
Appendix 1 ..................................................................................................................... 18
Appendix 2 ..................................................................................................................... 18
2
1. Safety
1.1. Instructions for safe operations
Check the main unit and all accessories periodically to make sure that there is no visible
damage that may affect patient’s safety and monitoring performance about cables and transducers. 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.
Necessary maintenance must be performed by qualified service engineers ONLY. The users are
not permitted to service the device by themselves.
The oximeter cannot be used together with devices not specified in User’s Manual.Only the
accessory that is appointed or recommendatory by manufacture can be used with this device.
This product is calibrated before leaving factory.
Do not maintain the device while the equipment is in use.
1.2. Warning
0 Explosive hazard—DO NOT use the oximeter in environment with inflammable gas such as
some ignitable anesthetic.
0 DO NOT use the oximeter while the patient is being scanned by MRI or CT.
0 DO NOT strand the lanyard in order to avoid device drop and damage.The lanyard is made of
non-sensitive material.Please do not use lanyard if the user is allergic to lanyard.Do not enwind neck
with lanyard in order to avoid accident.
0 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.
0 The person who is allergic to rubber can not use this device.
0 Please check the packing before use to make sure the device and accessories are totally in
accordance with the packing list, or else the device may have the possibility of working abnormally.
0 The product is suitable for children above four years old and adults (Weight should be
between 15kg to 110kg).
0 Please choose the accessories which are appointed or recommended by the manufacturer for
avoiding device damage.
0 Please choose the battery chargers which should be ensured compliance with the requirements
of IEC 60601-1, or else it may damage the device.
0 Please don't use the device in the course of charging.
0 The device can only be matched with the compatible probe( optional ).
0 Please don't measure this device with functional tester for the device's related information.
3
0 Please don’t change the battery yourself.
0 The patient is an intended operator.
0 The probe of the device is the applied part.
0 Please don’t use multiple wireless devices connected to the product at the same time.
1.3. Hazards
Keep the oximeter away from dust, vibration, corrosive substances, explosive materials, high
temperature and moisture.
If the oximeter gets wet, please stop using it immediately.
When it is carried from cold environment to warm or humid environment, please do not use it
immediately
DO NOT operate keys on front panel with sharp materials.
High temperature or high pressure steam disinfection of the oximeter is not permitted. Refer to
User Manual in the relative chapter (7.1)for instructions of cleaning and disinfection.
Do not have the oximeter immerged in liquid. When it needs cleaning, please wipe its surface
with medical alcohol by soft material. Do not spray any liquid on the device directly.
When cleaning the device with water, the temperature should be lower than 60℃.
The fingers which are too thin or too cold may affect the measure accuracy , please clip the
thicker finger such as thumb or middle finger deeply enough into the probe.
The pulse oximeter can be used to adult or infant. Whether the device is used to adult or
infant,it depends on the probe selected ( optional ).
The update period of data is less than 5 seconds, which is changeable according to different
individual pulse rate.
Please read the measured value when the waveform on screen is equably and steady-going,
This measured value is optimal value. And the waveform at the moment is the standard one.
If some abnormal conditions appear on the screen during test process, pull out the finger and
reinsert to restore normal use.
The device has normal life for three years since the first electrified use.
This device has the function of alarming, users can check on this function according to chapter
6.1 as a reference.
The device has the function of limits alarming, when the measured data is beyond the highest
or lowest limit, the device would start alarming automatically on the premise of the alarming
function is on.
The device has the function of alarming, this function can either be paused, or closed (default
setting) for good.This function could be turned on through menu operation if you need.please check
4
the chapter 6.1 as a reference.
The device may not work for all patients. If you are unable to achieve stable reading,
discontinue use.
Do not contort or drag the connection of the device.
1.4. Indication for Use
This device complies with part 15 of the FCC Rules. Operation is subject to the following two
conditions:
A. This device may not cause harmful interference;
B. 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.
Some electronic devices are susceptible to electromagnetic interference sent by this equipment if
inadequately shielded. Please use this equipment at least 20cm or as far as you can from TV set,
radio and other automated office equipment so as to avoid interference.
This device is a radio transmitter and receiver. It is designed and manufactured not to exceed limits
for exposure to radio frequency (RF) energy set by the Federal Communications Commission (FCC)
of the U.S. Government. These limits are part of comprehensive guidelines and establish permitted
levels of RF energy for the general population. The guidelines are based on standards that were
developed by independent scientific organizations through periodic and thorough evaluation of
scientific studies. The standards include a substantial safety margin designed to assure the safety of
all persons, regardless of age or health.
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:
A. Reorient or relocate the receiving antenna.
B. Increase the separation between the equipment and receiver.
C. Connect the equipment into an outlet on a circuit different from that to which the receiver is
connected.
D. Consult the dealer or an experienced radio/ TV technician for help.
A minimum separation distance of at least 0.2m between this equipment and all persons shall be
guaranteed to satisfy the RF exposure compliance.
5
2. Overview
The pulse oxygen saturation is the percentage of HbO
in the total Hb in the blood, so-called the O
2
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, some other
2
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 potential danger, and is of
2
great importance in the clinical medical field. The Pulse Oximeter features in small volume, low
power consumption, convenient operation and being portable.It is only necessary for patients to put
one of his fingers into a probe for diagnosis, and a display screen will directly show the measured
value of pulse oxygen saturation with the high veracity and repetition.
2.1. Classification
Class II b(MDD93/42/EEC IX Rule 10)
2.2. Features
A. Operation of the product is simple and convenient.
B. The product is small in volume, light in weight and convenient in carrying.
C. Low power consumption.
2.3. Major applications and scope of application
The Pulse Oximeter can be used in measuring the pulse oxygen saturation and pulse rate through
finger. The product is suitable for being used in family, hospital, oxygen bar, community healthcare,
physical care in sports (It can be used before or after doing sports, and it is not recommended to use
the device during the process of having sport) and etc.
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.
2.4. Environment requirements
Storage Environment
a) Temperature :-40℃~+60℃
b) Relative humidity :≤95%
c) Atmospheric pressure :500hPa~1060hPa
Operating Environment
a) Temperature:10℃~40℃
b) Relative Humidity :≤75%
c) Atmospheric pressure:700hPa~1060hPa
6
3. Principle
Principle of the Oximeter is as follows: An experience formula of data process is established taking
use of Lambert Beer Law according to Spectrum Absorption Characteristics of Reductive
Hemoglobin (Hb) and Oxyhemoglobin (HbO
the device is: Photoelectric Oxyhemoglobin Inspection Technology is adopted in accordance with
Capacity Pulse Scanning & Recording Technology, so that two beams of different wavelength of
lights can be focused onto human nail tip through perspective clamp finger-type sensor. Then
measured signal can be obtained by a photosensitive element, information acquired through which
will be shown on screen through treatment in electronic circuits and microprocessor.
) in glow & near-infrared zones. Operation principle of
2
Figure 1
4. Technical specifications
4.1. Main performance
A. SpO2 value display
B. Pulse rate value display, bar graph display
C. Pulse waveform display
D. Low-voltage indication: low-voltage indicator appears before working abnormally which is due
to low-voltage
E. Automatically power off function: when the device is under the state of measuring interface
(without external probe), it will automatically power off within 5 seconds if the finger falls out of
probe.
F. The display mode can be changed
G. Screen brightness can be changed
H. With pulse rate sound indication
I. With alarm function
J. With SpO
K. It can be connected with an external oximeter probe( optional )
L. Data can be observed on computers synchronously by PC software
M. With two kinds of data transmission mode:data line and bluetooth.
and pulse rate value record function, the record data can be uploaded to computer.
2
7
Loading...