Innovo CMS 50F PLUS User Manual

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Innovo® CMS 50F PLUS User Manual
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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 SpO2 and 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.
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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
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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.
The oximeter should only be used with devices and/or
A.
accessories specified in this User’s Manual.
This product is calibrated before leaving factory.
B.
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
2 Overview
SpO2 stands 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. SpO2 is an important bio-parameter. A number of diseases relating to the respiratory system may cause a decrease of SpO2 in 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' SpO2 is 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 SpO2 and 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 Major Applications and Scope of Application
The Pulse Oximeter can be used to measure SpO2 and 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’
The use of pulse oximeters is limited by a number of factors: Abnormal movement, such as occurs with agitated patients, will cause interference with SpO2 measurement. 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
Figure 1.
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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 SpO
during sleep and/or exercise.
2
2) Increasing the sensitivity of the sensor/receipt tube (See Figure
3) so that it can measure user’s SpO
and Pulse Rate (PR) with
2
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. 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. Screen brightness can be changed F. A pulse sound indication G. With alarm function H. Store 24 hours of SpO2 value 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 SpO2 is 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 SpO2 and pulse rate at blood perfusion level as low as 0.4%. However, SpO2 error 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 SpO2 probe/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.
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 5.
E. Wait 10-30 seconds for the pulse oximeter to be optimized. The
Figure 6.
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 SpO2 and 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 SpO2 levels.
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 SpO2 is 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 SpO2 and 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: SpO2 high limit (SpO2 ALM HI), SpO2 low limit (SpO2 ALM 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 SpO2 and 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 SpO2 or 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.
A) When entering the clock setting menu, “Set time” will always
Figure 9. Clock Setting Menu
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”.
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B) PUSH the button to select the parameter that you want to change. HOLD the button to adjust the data. C) PUSH the button to select "Exit". HOLD the button to exit the clock setting menu. If you have reset the time or date, when exiting the clock setting menu, the renewed time and date would be displayed on the screen before returning to the main menu; if you didn’t reset the time and date, the device would return to the main menu directly when exiting the clock setting menu.
4) Wireless setting (This option will appear in Bluetooth enabled model only) PUSH the button to select "Wireless". HOLD the button to turn on/off the Wireless function.
It is recommended to use the included 2.4GHZ wireless adapter which uses CSR as the main chip to transmit your data. Please do not unplug the USB cable or wireless adapter when the data is being transmitted between device and computer. When the data is being transmitted between the device and the computer, the user will not be able to alter "Wireless" settings. If the user still could not alter "Wireless" settings after completion of data transmission, please wait 30 seconds before trying again.
5) Record - Data storage setting This device has the ability to store 24 hours of data. The data can then be transferred to the computer for analysis via the included “SpO2 Assistant” software. Please refer to <SpO2 Assistant user manual> for instructions. A. To record data, in the main menu interface, PUSH the button to select "Record", then HOLD the button to choose "Yes" to
begin data recording. Select “No” if you want to turn off data
recording. B. The device will register the time of the recording
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automatically. C. If the data storage function is being turned on, a red "REC" sign and a flashing red dot would appear on the screen when returning to the measuring interface. D. When the device is storing data, “Recording" would appear in the screen for 30 seconds irregardless of the interfaces the device might be in. The clock interface would then appear after several seconds and the screen automatically shut down. If you PUSH the button at this moment, "Recording" would appear on the screen again, and then the screen will be automatically shut down again; if a HOLD is applied to the button, the device would return to the former interface. E. Turning on the data storage function will erase previous stored data F. While recording, the pulse sound indication would be turned off after the screen is shut down to save power. G. When the storage space is full, "Memory is full" will be displayed on the screen whenever you activate the device. No data will be recorded at this point. Please upload the data to the PC so that the space can be freed up to record new data. A PUSH to the button will trigger the pulse oximeter to enter into the measuring interface.
6) Device ID
The user can modify device ID by the “SpO2 Assistant " software.
Figure 10 Software Icon
7) Power off In the main menu interface, PUSH the button to select "Power off". PUSH the button again to shut down the device.
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8) Exit the main menu In the main menu interface, PUSH the button to select "Exit”. PUSH the button again to exit the main menu.
E. Uploading Data
You may connect the device to the computer via USB or Bluetooth (in selected model only). To connect the pulse oximeter to the computer via Bluetooth, please make sure that you set the “wireless” option to “on” (See Wireless Setting above at page 16).
Please do NOT connect the pulse oximeter to the computer via
“Add a Bluetooth device”. Please refer to the SpO2 Assistant Manual on how to connect the pulse oximeter to the computer to upload data. If you prefer to watch a video on how to connect the pulse oximeter to the computer, please refer to
http://innovogroups.com/products/cms50f.
If the users choose to turn on the synchronizing display function on computer, it would probably take several seconds for the data to appear in the computer screen. (If no data is displayed, unplug the Wireless adapter or the USB cable and try again.)
F. Charging the device
There are two ways to charge the device:
a) Connect the device to the computer with the USB cable b) Connect the device to the power supply via the power adaptor.
When the device is charging, the indication light will be orange. When the battery is full, the light turns to green.
If the alarm function is on, the device will display a high-priority alarm signal when the battery is in low power status. Intermittent alarm will occur and the battery icon turns red in the state of flashing.
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High priority alarm indicates that immediate operator response is required.
6.2 Cautions A. Please check device before use to confirm that it is working
normally. The SpO2 and PR should be displayed correctly on the screen. B. The finger should be place in between the LED lights and the sensor (see Figure 1 and 5 for reference), or it may result in inaccurate measurement. C. The SpO2 sensor should not be used on an arm with a blood pressure cuff or undergoing intravenous injection. It should not be used on the arterial canal too. D. Do not fix the SpO2 sensor with adhesive as it might lead to inaccurate measurement of the SpO2 and pulse rate. E. Excessive ambient light may affect measuring result although the Acc U Rate® SnugFit probe is designed to minimize such interference. Ambience light includes, but is not limited to fluorescent lamp, dual ruby light, infrared heater, direct sunlight and LED lights. F. Strenuous activities or extreme electrosurgical interference may affect accuracy pf device. G. User should not use enamel or other makeup to ensure accuracy. H. Please clean and disinfect the device according to instructions outlined in Chapter 7.1 of the user manual.
6.3 Clinical Restrictions A. As the accuracy of the device is based on the arteriole blood,
an adequate amount of blood flow is required. The SpO2 waveform (Plethysmography) will decrease for users with a weak
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pulse due to shock, low body temperature, major bleeding, or use of vascular contracting drug. Under such circumstances, the measurement will be more sensitive to interference. B. For users with a substantial amount of staining dilution drug such as methylene blue, indigo green and acid indigo blue, carbon monoxide hemoglobin (COHb), methionine (Me+Hb), thiosalicylic hemoglobin or icterus, the SpO2 readings may be inaccurate. C. Drugs like dopamine, procaine, prilocaine, lidocaine and butacaine may also affect the accuracy of SpO2 measurement. D. Patients with serious anemia may also report good SpO2 measurement. If you think that the above conditions apply to you, please consult a physician.
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7 Maintenance, Transportation and Storage
7.1 Cleaning and Disinfecting
Use medical alcohol to disinfect the device. Let it air dry or clean it with clean soft cloth.
7.2 Maintenance A. Please clean and disinfect the device as outline above.
B. Recharge the battery when the screen shows the empty battery
icon . C. The battery should be FULLY recharged before use if it has not
been used for six months. This will extend the battery life significantly. D. All units come pre-calibrated. You do not need to calibrate the oximeter.
7.3 Transportation and Storage A. The device should not be transported with toxic, harmful,
corrosive material. B. The packed device should be stored in room with no corrosive gases and with good ventilation. Temperature:
-40°C~60°C; Humidity: ≤95%
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8 Troubleshooting
Trouble
Possible Reason
Solution
No SpO2 and Pulse Rate is registered
1. The finger is not properly positioned.
2. The patient’s
blood perfusion is too low to be detected.
1. Make sure that the finger is inserted properly into the device.
2. Make sure nothing is restricting your blood flow (See Chapter 6.3).
The SpO2 and Pulse Rate values displayed on the screen are erractic or lower than a spot check monitor
1. The finger is not placed deep enough into the probe.
2. The finger is moving.
1. Place the finger properly and try again.
2. Try to keep the patient stationary
The device cannot be turned on or the display turns off suddenly
1. The battery is drained.
2. The device has malfunctioned.
1. Please recharge the battery.
2. Please contact the local service center.
After a full charge, the battery is discharged after only a few hours of usage
1. The battery is not fully charged.
2. The battery has malfunctioned
1. Please recharged the battery.
2. Please contact the local service center.
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The battery is not fully charged after 10 hrs.
1. The battery has malfunctioned
1. Please contact
the local service center.
Symbol
Description
Refer to instruction manual/booklet
%SpO2
Oxygen saturation (%)
PRbpm
Pulse rate (bpm)
Full-voltage
Low-voltage
Alarm is deactivated
Alarm paused
Alarm is activated
Bluetooth is enabled (option available in selected model only)
Pulse sound deactivated
9 Symbols
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Pulse sound activated
menu button/power button
Type BF
SN
Serial number
1. the finger clip falls off ( no finger
inserted)
2. Probe error
3. Signal inadequacy indicator
IP22
International Protection
WEEE (2002/96/EC)
Information
Display Mode
The Pulse Oxygen Saturation(SpO2)
2-digit digital OLED display Pulse Rate(PR)
3-digit digital OLED display
Pulse Intensity (bar-graph)
bar-graph OLED display
SpO2 Parameter Specification
Measuring range
0%~100%, (the resolution is 1%).
Accuracy
70%~100%:±2% , Below 70% unspecified.
10 Function specification
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Average value
Average value is derived from 4 previous values. The deviation between average and true value does not exceed 1%.
Pulse Parameter Specification
Measuring range
30bpm~250bpm, (resolution = 1bpm)
Accuracy
±2bpm or±2% (select larger)
Average pulse rate
Average value is derived from 4 previous values. The deviation between average and true value does not exceed 1%.
Safety Type
Interior Battery, BF Type
Pulse Intensity
Range
Continuous bar-graph display, higher amplitude indicates stronger pulse.
Battery Requirement
Voltage 3.7 rechargeable lithium battery × 1
Battery working life
Charge and discharge no less than 500 times.
Power Adapter
Input Voltage
100 to 240V AC, 50/60 Hz
Output voltage
5V DC
Output current
1A
Wireless Module
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Transmit frequency
2.4GHz
Dimensions and Weight
Dimensions
61(L) × 56(W) × 24 (H) mm
Weight
About 50g (with the lithium battery*1)
Appendix 1
State
Alarm condition delay
Alarm signal generation delay
Low voltage alarm
0.6s
20ms
SpO2 alarm
400ms
20ms
Pulse rate alarm
400ms
20ms
Probe error alarm
400ms
20ms
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Guidance and manufacture’s declaration –
electromagnetic emission
The CMS50F PLUS Pulse Oximeter is intended for use in the electromagnetic environment specified below. The user should assure that it is used in such environment.
Emission
test
Compliance
Electromagnetic
environment – guidance
RF emissions CISPR 11
Group 1
The CMS50F PLUS Pulse Oximeter uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
RF emission CISPR 11
Class B
The CMS50F PLUS Pulse Oximeter is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for
Harmonic emissions IEC 61000-3-2
Not
applicable
Voltage fluctuations flicker
Not
applicable
Appendix 2
Guidance and manufacture's declaration
– electromagnetic emissions for all EQUIPMENT and
SYSTEMS
Page 33
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28
emissions IEC 61000-3-3
domestic purposes.
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29
Guidance and manufacture’s declaration – electromagnetic
immunity
The CMS50F PLUS Pulse Oximeter is intended for use in the electromagnetic environment specified below. The user should assure that it is used in such an environment.
Immunity
test
IEC 60601
test level
Complianc
e level
Electromagneti
c environment
- guidance
Electrostatic discharge (ESD) IEC 61000-4-2
6 kV contact
8 kV air
6 kV
contact 6 kV air
Floors should be wood, concrete or ceramic tile. If floor are covered with synthetic material, the relative humidity should be at least 30%. The manufacturer may recommend the ESD precautionary procedures to user.
Guidance and manufacture’s declaration – electromagnetic
immunity –
for all EQUIPMENT and SYSTEMS
Page 35
30
Power frequency (50/60Hz) magnetic field IEC 61000-4-8
3A/m
3A/m
Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.
Innovo® CMS 50F PLUS User Manual
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Innovo® CMS 50F PLUS User Manual
31
Guidance and manufacture’s declaration – electromagnetic
immunity
The CMS50F PLUS Pulse Oximeter is intended for use in the electromagnetic environment specified below. The user should assure that it is used in such an environment.
Immunity
test
IEC 60601
test level
Comp liance
level
Electromagnetic
environment -
guidance
Conducted RF IEC 61000-4-6
Radiated RF IEC 61000-4-3
3 V
rms
150 kHz to 80 MHz
3 V/m 80 MHz to
2.5 GHz
3 V
rms
3 V/m
Portable and mobile RF communications equipment should be used no closer to any part of the CMS50F PLUS Pulse Oximeter, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
Recommended separation distance
Guidance and manufacture’s declaration – electromagnetic
immunity –
for EQUIPMENT and SYSTEMS that are not
LIFE-SUPPORTING
Page 37
32
P
V
d
 
 
1
5.3
P
E
d
 
 
1
5.3
80 MHz to 800 MHz
P
E
d
 
 
1
7
800 MHz to 2.5 GHz Where P is the
maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,a should be less than the compliance level in each frequency range.b Interference may occur
Innovo® CMS 50F PLUS User Manual
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33
in the vicinity of equipment marked with the following symbol:
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
a
Field strengths from fixed transmitters, such as base stations
for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the CMS50F(W) PLUS Pulse Oximeter is used exceeds the applicable RF compliance level above, the CMS50F PLUS Pulse Oximeter should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the CMS50F PLUS Pulse Oximeter.
b
Over the frequency range 150 kHz to 80 MHz, field strengths
should be less than 3 V/m.
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34
Recommended separation distances between
portable and mobile RF communications equipment and the
CMS50F PLUS Pulse Oximeter.
The CMS50F PLUS Pulse Oximeter is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The user can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the CMS50F PLUS Pulse Oximeter as recommended below, according to the maximum output power of the communications equipment.
Rated
maximum
output
power of
transmitter
(W)
Separation distance according to frequency of
transmitter
(m)
150 kHz to 80
MHz
P
V
d
 
 
1
5.3
80 MHz to
800 MHz
P
E
d
 
 
1
5.3
800 MHz to
2.5 GHz
P
E
d
 
 
1
7
0.01
0.117
0.117
0.233
0.1
0.369
0.369
0.738
1
1.167
1.167
2.333
Recommended separation distances between portable and
mobile
RF communications equipment and the EQUIPMENT or
SYSTEM –
for EQUIPMENT or SYSTEM that are not
LIFE-SUPPORTING
Page 40
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35
10
3.689
3.689
7.379
100
11.67
11.67
23.33
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
Phone: +1-858-888-9781
http://www.innovogroups.com
Distributed by:
Innovo Groups
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