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Innovo® CMS 50F PLUS User Manual

Guidance and manufacture’s declaration – electromagnetic

immunity –

for EQUIPMENT and SYSTEMS that are not

LIFE-SUPPORTING

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

Содержание CMS 50F PLUS

Страница 1: ...ng 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 instruction...

Страница 2: ...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 lite...

Страница 3: ...out 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 t...

Страница 4: ...cifications 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 Stora...

Страница 5: ...Innovo CMS 50F PLUS User Manual V 9 Symbols Error Bookmark not defined 3 10 Function Specification Error Bookmark not defined Appendix 1 Error Bookmark not defined Appendix 2 27 ...

Страница 6: ...O 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...

Страница 7: ...d 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...

Страница 8: ...n 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 cou...

Страница 9: ... 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 ...

Страница 10: ...ration 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 ...

Страница 11: ...f 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 SpO2 and Pulse Rate PR with precision even at low blood perfusion 4 Blocking ambient light from reach...

Страница 12: ...alue 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 7...

Страница 13: ... 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 ...

Страница 14: ...igure 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 ...

Страница 15: ...ting 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 ...

Страница 16: ...ght 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...

Страница 17: ...ter 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 p...

Страница 18: ...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 ...

Страница 19: ...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 de...

Страница 20: ... 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 in...

Страница 21: ... 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 pleas...

Страница 22: ... 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 poi...

Страница 23: ... 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 th...

Страница 24: ...e 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 a...

Страница 25: ...g 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 ...

Страница 26: ...y 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 sto...

Страница 27: ...e 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...

Страница 28: ... 1 Please contact the local service center 9 Symbols 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 ...

Страница 29: ...nadequacy indicator IP22 International Protection WEEE 2002 96 EC 10 Function specification 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 ...

Страница 30: ...e 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 Volt...

Страница 31: ...nsions 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 ...

Страница 32: ...ectromagnetic 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 th...

Страница 33: ...Innovo CMS 50F PLUS User Manual 28 emissions IEC 61000 3 3 domestic purposes ...

Страница 34: ...ironment 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 ...

Страница 35: ...LUS User Manual 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 ...

Страница 36: ... 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 Vrms 150 kHz to 80 MHz 3 V m 80 MHz to 2 5 GHz 3 Vrms 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 rec...

Страница 37: ...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 ...

Страница 38: ... 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 b...

Страница 39: ... 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...

Страница 40: ...smitter 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 Distributed by Innovo Gro...

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