Innovo CMS 50F PLUS User manual

Innovo® CMS 50F PLUS User Manual
I
Instructions to User
Dear users, thank you for purchasing our Pulse Oximeter.
This Manual is written and compiled in accordance with the
council directive MDD93/42/EEC for medical devices and
harmonized standards. 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, its features, functions, specifications,
transportation methods, 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 lead to measurement abnormality, equipment malfunction
and body injury. The manufacturer is NOT responsible for any
safety, reliability, monitoring abnormality, malfunction and
performance issues with regards to the equipment and/or any
personal injuries that arise due to user’s negligence to follow the
manual’s instructions.
As the device is undergoing constant revision and improvisation,
the product(s) you received may not be in total accordance with
the description of this User Manual. We sincerely regret for the
inconvenience.
Caution: This device is not intended to diagnose or treat any
medical condition or disease. It is intended for non-medical
use in healthy people to monitor their pulse and blood oxygen
levels during sports and/or aviation only. People who need
SpO2and pulse rate measurements because of a medical
condition should not use the device and should consult with

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their physician.
WARNING:
Users might experience discomfort if the device is used
continuously for a long period of time, especially for
users suffering from poor microcirculation. It is
recommended that the sensor should not be applied to
the same finger for over 2 hours.
The device should not be clipped on edema affected
and/or tender tissue.
The infrared light emitted from the device is invisible
and can cause irreversible damage to the eyes, possibly
leading to blindness. You should not stare at the light.
Users should not use enamel or other makeup on the
finger.
User’s fingernail should be kept neat and short for best
result.
Please refer to correlative literature about clinical
restrictions of the device
This device is not intended for medical treatment.

Innovo® CMS 50F PLUS User Manual
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Copyright © Innovo Groups
2014-2015. All rights reserved.
Innovo Groups owns and reserves all of the rights comprised
in the copyright of this document. No part of this document
may be changed, excerpted, copied, reproduced, or imitated
in any form or by any means without prior written consent of
Innovo groups
All statements, information, and recommendations in this
document are provided "AS IS" without warranties, guarantees or
representations of any kind, either express or implied. The
information in this document is subject to change without notice.
Summit DME reserves the right of final interpretation of this
document.
Version 2.0
Issuing Date: May 2015
To download the latest manual or watch videos on how to use
the CMS 50F, please visit http://www.innovogroups.com

Innovo® CMS 50F PLUS User Manual
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CONTENTS
1 Safety ........................................................................................1
1.1 Saftey Information.............................................................1
1.2 Warning .............................................................................1
1.3 Attention............................................................................2
2 Overview...................................................................................3
2.1 Features .............................................................................4
2.2 Major Applications and Scope of Application....................4
2.3 Environment Requirements ...............................................4
3 Principle....................................................................................5
4 Technical Specifications...........................................................7
4.1 Features .............................................................................7
4.2 Parameters .........................................................................7
5 Product Description....................Error! Bookmark not defined.
5.1 View of the Front Panel .....................................................9
5.2 Probe Connection ..............................................................9
5.3 Accessories .......................Error! Bookmark not defined.
6 Operating Guide ....................................................................11
6.1 Using the Device .............................................................11
6.2 Warnings........................................................................199
6.3 Clinical Restrictions.........................................................20
7 Maintain, Transportation and Storage.................................21
7.1 Cleaning and Disinfecting ...............................................21
7.2 Maintain ..........................................................................21
7.3 Transportation and Storage..............................................21
8 Troubleshooting...........................Error! Bookmark not defined.

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9 Symbols......................................Error! Bookmark not defined.3
10 Function Specification..............Error! Bookmark not defined.
Appendix 1 .....................................Error! Bookmark not defined.
Appendix 2 ................................................................................27

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1 Safety
1.1 Safety Information
a) Check the main unit and all accessories periodically to make
sure that there is no visible damage that may affect patient’s
safety and/or monitoring performance of the device. The device
should be inspected at least once a week. Stop using the device if
physical damage is observed.
b) Maintenance must be performed by qualified service engineers
ONLY. Users should not to maintain the device by themselves.
A.The oximeter should only be used with devices and/or
accessories specified in this User’s Manual.
B. This product is calibrated before leaving factory.
1.2 Warning
Explosive hazard—DO NOT use the oximeter in environment
with inflammable gas such as ignitable anesthetic agents.
DO NOT use the oximeter while the user is undergoing MRI or
CT scan.
Do not remove the wristband while using the oximeter. Users
who are allergic to the wristband should not use the pulse
oximeter.
The person who is allergic to rubber cannot use this device.
The disposal of the device, accessories and packing material
(including but not limited to battery, plastic bags, foams and paper
boxes) should follow local laws and regulations.
Please check that all the device and accessories listed in the
packing list are accounted for before use.
Please make sure that the accessories you use with the
oximeter are approved by the manufacturer. Unapproved
accessories may cause irreversible damage to the device.
Please make sure that the battery chargers are in compliance

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with the requirements of IEC 60601-1, or the device might be
damaged.
Please do not use the device while charging.
The device should only be used with the Acc U Rate®
SnugFit probe. Using the Contec CMS 50F probe might
damage the oximeter.
1.3 Attention
Keep the oximeter away from dust, vibration, corrosive
substances, explosive materials, high temperature and moisture.
If the oximeter gets wet, stop operating 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 immerse the oximeter in liquid. To clean it, please wipe
its surface with medical alcohol with soft material. Do not spray
any liquid on the device directly.
When cleaning the device with water, the temperature should
be lower than 60°C.
The performance of the device is affected if the fingers are too
small or cold. As such, please clip and insert the thumb or middle
finger as deeply as possible into the probe.
The pulse oximeter can be used for adult or infant. However, a
special probe is required for infant. Please contact the
manufacturer for more details.
During measurement, the data is updated on average, every 5
seconds. However, this might change depending on individual.
Please read the measure value only when the amplitude of the
waveform is equal and steady. At this point, the measured value

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will be most accurate.
If some abnormal conditions appear on the screen during test
process, pull out the finger and reinsert to restore normal use.
You should not use the device after three years.
This device has a built-in alarm which will go off when the
measured data is beyond the highest or lowest limit. Please check
chapter 6.1 for more details.
The device may not work for all patients. If you are unable to
achieve stable readings, discontinue use.
2 Overview
SpO2stands for Peripheral capillary oxygen saturation. It is an
estimation of the oxygen saturation level in your blood. Oxygen
saturation is defined as the ratio of oxyhemoglobin to the total
concentration of hemoglobin (i.e. Oxyhemoglobin + reduced
hemoglobin) present in the blood. SpO2is an important
bio-parameter. A number of diseases relating to the respiratory
system may cause a decrease of SpO2in blood. Homeostasis
failure and surgery complications may only lead to a reduction of
oxygen supply to the human body. This could lead to vertigo,
impotence, emesis and in severe hypoxia, coma and death.
Therefore, prompt information of patients' SpO2is helpful to a
doctor to anticipate potential danger and is of great importance in
the clinical medical field.
The Pulse Oximeter feature herein is small, portable, non-invasive,
easy to use and requires little power. The user only needs to insert a
finger into the probe for SpO2and Pulse Rate measurement.

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2.1 Features
1. The device is simple and easy to operate.
2. The product is small and portable.
3. Low power consumption.
2.2 MajorApplications and Scope of Application
The Pulse Oximeter can be used to measure SpO2and pulse rate
through a finger. The product is suitable for used at home, hospital,
oxygen bar and community center. It can also be used during sports
and/or aviation. However, the device is not recommended to be
used when the user is exercising or physically active
The pulse oximeter might register a higher reading if the
user is suffering from toxicosis caused by carbon monoxide.
The device is not recommended to be used under such
circumstance.
2.3 Environment Requirements
Storage Environment
a) Temperature : -40°C to +60°C
b) Relative humidity : ≤95%
c) Atmospheric pressure : 500hPa~1060hPa
Operating Environment
a) Temperature: 10°C ~40°C
b) Relative Humidity : ≤75%
c) Atmospheric pressure: 700hPa~1060hPa

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3 Principle
Oxygenated blood absorbs light at 660nm (red light), whereas
deoxygenated blood absorbs light preferentially at 940nm
(infra-red). Pulse oximeters consist of two light emitting diodes,
at 600nm and 940nm, and two light collecting sensors, which
measure the amount of red and infra-red light emerging from
tissues traversed by the light rays. The relative absorption of light
by oxyhemoglobin (HbO) and deoxyhemoglobin is then
processed according to the Beer-Lambert's law and an oxygen
saturation level is reported. The device directs its attention at
pulsatile arterial blood and ignores local noise from the tissues.
The result is a continuous qualitative measurement of the patients’
oxyhemoglobin status. Oximeters deliver data about pulse rate,
oxygen saturation (SpO2) and cardiac output.
Figure 1.
The use of pulse oximeters is limited by a number of factors:
Abnormal movement, such as occurs with agitated patients, will
cause interference with SpO2measurement. Low blood flow,
hypotension, vasoconstriction and hypothermia will reduce the
pulsatility of capillary blood, and the pulse-oximeter will
under-read or not read at all. Conversely, increased venous
pulsation, such as tricuspid regurgitation, may be misread by the

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pulse-oximeter as arterial blood, with a low resultant reading.
Finally, it is generally accepted that the saturation percentage is
unreliable on the steep part (around 60 mm Hg) of the
oxyhemoglobin dissociation curve.
The Acc U Rate® SnugFit probe attempts to ameliorate some of
the problems by
1) Fitting snugly without causing discomfort to the user’s finger
even under prolonged use. This allows reliable measurement of
user’s Pulse Rate and SpO2 during sleep and/or exercise.
2) Increasing the sensitivity of the sensor/receipt tube (See Figure
3) so that it can measure user’s SpO2and Pulse Rate (PR) with
precision even at low blood perfusion.
4) Blocking ambient light from reaching the sensor/receipt tube in
(See Figure 1) that might affect the precision and reliability of the
readings.

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4 Technical Specifications
4.1 Main Performance
A. SpO2value 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. Screen brightness can be changed
F. A pulse sound indication
G. With alarm function
H. Store 24 hours of SpO2value and pulse rate data which can
be uploaded to computers for analysis
I. Uses an external oximeter probe to take measurement
J. Data can be transmitted to computers
K. With clock and alarm function
L. Wireless Transmission function (Bluetooth enabled model
only)
4.2 Main Parameters
A. Measurement of SpO2
Measuring range: 0%~100％
Accuracy:
When the range of SpO2is 70%~100％, the permissible error is
±2％;
Below 70% - unspecified.
B. Measurement of pulse rate
Measuring range: 30 bpm~250 bpm
Accuracy: ±2 bpm or ±2% (select larger)
C. Resolution
SpO2: ±1%, Pulse rate: ±1bpm.
D. Measurement Performance under low blood perfusion

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The device can measure SpO2and pulse rate at blood perfusion
level as low as 0.4%. However, SpO2error is increased to ±4%,
and pulse rate error to ±2 bpm or ±2% (select larger).
E. Resistance to ambient light
The deviation between the values measured indoors or under
man-made light and that of a darkroom is less than ±1%.
F. Power supply requirement: 3.6 V DC ~ 4.2V DC.
G. Optical Sensor
Red light (wavelength is 660nm,6.65mW)
Infrared (wavelength is 880nm, 6.75mW)
H. Adjustable alarm range
SpO2: 0%~100%
Pulse Rate: 0bpm~254bpm

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5 Product Description
5.1 Front Panel View
Figure 2. Front view
Figure 3. Left view
1. This USB port has multiple uses. It can be used to connect
the SpO2probe/sensor, upload the data to a personal computer or
to charge the lithium battery.
2. Charging indication light. When the device is charging, the
indication light will be orange. When the battery status is full, the

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light turns to green.
5.2 Probe Connection
When connecting the Acc U Rate®SnugFit probe, make sure it is
inserted properly and all the way into the pulse oximeter as shown
in Figure 4.
Figure 4.
5.3 Accessories
A. User Manual
B. Power adapter
C. USB Cable
D. Minidisc (PC software)
E. An adult-oximeter probe
An infant-oximeter probe (Purchase separately)

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6 Operating Guide
6.1 Using the Device
A.Install the probe as outlined in Chapter 5.2. (Please do not use
probes made by other manufacturers as the algorithm used by
the watch will not work with them. Unapproved probes might
also damage the oximeter)
B. Put the finger into the probe as shown in Figure 5 below.
Figure 5.
C.Turn on the device by pushing the button on the panel for >1
second.
D.User should try to stay still as much as possible during
measurement. Do not move the finger as this is the most
common reason for inaccurate measurements.
Figure 6.
E. Wait 10-30 seconds for the pulse oximeter to be optimized. The
pulse oximeter is optimized when the plethysmograph gives a

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constant, stable reading. In other words, the wavelength and
amplitude of each wave will be identical to the next (Figure 6).
F. You may now read the SpO2and PR displayed on the OLED
screen.
ATTENTION
The Fingernails should be facing the LED lights and not
the sensor
Make sure that your finger is put deep into the probe
such that the fingertip is directly in between the LED
sensor and the LED light source.
Make sure your finger is stationary in the probe while
you are measuring your SpO2levels.
Excessive ambient infra-red light, especially for people
who use the pulse oximeter in an overly bright lit room
can interfere with the sensor.
Poor circulation can affect oximeter readings. Warm
your hands and fingers before taking your
measurements. Remember your pulse oximeter is
measuring your SpO2 and PR based on your blood flow.
If the blood flow in your finger drops below a certain
level, the pulse oximeter will not be able to function.
If the alarm function is on, a medium-priority alarm will
go off when the probe does not register a reading (like
when the finger is out). User will hear an intermittent
beeping sound and a "FINGER OUT" message will be
displayed across the user interface. Medium priority
alarms indicate that prompt operator response is
required.
The pulse oximeter is sensitive to the duration of the button (See
Figure 2) being pressed. A short PUSH (<1 sec) or a long HOLD

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(>1 sec) of the button activates different functions of the pulse
oximeter.
A. Enter the clock interface
You can press the button to enter the clock interface from the
measuring interface.
B. Exit the clock interface
1) The clock interface will automatically return to the measuring
interface if no operations are registered within 30 seconds.
2) You may also press the button to exit the clock interface.
C. Pause alarm
1. The built in auditory and visual alarm will be activated if the
oximeter is not place correctly on the finger, the battery is low or
when your SpO2is beyond set limits. You may pause the alarm
function by a PUSH to the button, but the alarm will be
reactivated again in 60 seconds
2. If you do not want the alarm to go off, you must enter the
operation menu to turn it off permanently (see below).
D. Menu operations
Figure 7. Main Menu Interface
When the device is in the measuring interface, HOLD the button
in order to enter the operation menu shown in Figure 7. Users can
adjust the backlight, alarm, clock, wireless transmission (option
available only in Bluetooth enabled model), data storage, and
power settings through the main menu. The specific operation
methods are as follow:

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1) Backlight adjustment
In the main menu interface, PUSH button to select "Brightness".
HOLD the button to adjust backlight brightness.
2) Alarm setting
In the main menu interface, PUSH button to select "Alarm".
HOLD the power button to enter the alarm setting interface as
shown in Figure 8:
Figure 8. Alarm Setting Menu
Adjusting the alarm parameters
PUSH the button to select "Direction", then HOLD the button to
choose Up or Down. (This will be the direction the value of the
SpO2and pulse rate limits will be adjusted)
To raise the SpO2 and pulse rate limit, choose "Direction" as "up",
then PUSH the button to highlight the parameter to be adjusted:
SpO2high limit (SpO2ALM HI), SpO2 low limit (SpO2ALM LO),
Pulse rate high limit (PR ALM HI), Pulse rate low limit (PR ALM
LO). HOLD the button to adjust the high limit to the desired
value and release the button once the desired limit has been
reached.
To lower the SpO2and pulse rate limit, choose "Direction" as
"down", then PUSH the button to choose the parameter to be
adjusted. HOLD the button to adjust the selected limit to the
desired value and release the button once the desired limit has
been reached.

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If the alarm function is on, the device will provide
medium-priority alarm signal when the data of SpO2or pulse
rate falls beyond set limit. Intermittent alarm will occur and
the measurement will be displayed in yellow font.
Medium priority indicating that prompt operator response is
required.
The alarm state setting
PUSH the button to select "Alarm". HOLD the button to set
alarm on or off. Select "on" to turn on the alarms and "off" to turn
off the alarms.
Pulse sound indication setting
PUSH the button to select "Pulse Sound". HOLD the button to
set Pulse Sound (heart beat) alarm to "on" or "off".
Exit the Alarm settings
PUSH the button to select "EXIT". HOLD the button to exit the
Alarm Settings Menu.
3) Clock setting
On the main menu interface, PUSH the button to select "Clock".
HOLD the button to enter the clock setting interface.
Figure 9. Clock Setting Menu
A)When entering the clock setting menu, “Set time” will always
be set to “NO” to prevent unexpected changes to the time as
shown in Figure 9. If you want to change the time, HOLD the
button to change “Set time” to “YES”.