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V1.0I2 PULSE OXIMETER OPERATOR

＇

S MANUAL

Recommended separation distances between portable and mobile RF

communications equipment and the EQUIPMENT or YSTEM - for

EQUIPMENT or SYSTEM that are not

LIFE-SUPPORTING

Summary of Contents for MD300I2

Page 1: ...Pulse Oximeter Instruction Manual Ver 1 0 ...

Page 2: ...ral Descriptions 6 2 1 Front Panel Displaying 7 2 2 Rear Panel 10 2 3 Product Features 10 CHAPTER 3 Install the Batteries and the Sensor 11 3 1 Install the Batteries 11 3 2 Install the Sensor 12 CHAPTER 4 Setting ID Date and Time 12 4 1 Date Time Setting 13 4 2 ID Number Setting 14 CHAPTER 5 Take a Measurement 15 CHAPTER 6 Other Settings 17 6 1 Alarm Setting 17 6 2 Sound Setting 21 6 3 Backlight S...

Page 3: ...her Information 22 CHAPTER 7 Maintenance and Repair 23 7 1 Maintenance 23 7 2 Calibration and Verification 24 7 3 Trouble Shooting 25 7 4 Warranty and Repair 25 7 5 Storage and Transportation 27 APPENDIX A Specifications 28 APPENDIX B Declaration 30 ...

Page 4: ...as a pivotal notice to avoid preventable incidents during application of this equipment Warnings The handheld pulse oximeter should be confined to sophisticated operator exclusively Prior to application we strongly suggest you should follow instructions listed in this document or any wrong doing operation which causes serious damage will take full responsibility for this Our company will assume no...

Page 5: ...tient so please pay attention to data cable and check it frequently The disposable peripheral should not be repeatedly used Precautions Rinsing the sensors with ethylene oxide solution may have adverse influence on the machine Apart from this the sensor should not be autoclaved or submerged This device is intended for use by persons trained in professional health care The operator must be thorough...

Page 6: ...he SpO2 value is averaged pulse average is the number of seconds over which the pulse value is averaged Hazards arising from software errors have been minimized Hazard analysis conforms to meet ISO14971 2000 and EN60601 1 4 1996 Significant levels of dysfunctional hemoglobins such as carboxy hemoglobin or methemoglobin will affect of the accuracy of the SpO2 measurement Optical cross talk can occu...

Page 7: ...C standard complying with the international standard for the EMC of the electronic medical device IEC 60601 1 2 However because of the proliferation of radio frequency transmitting equipment and other sources of electrical noise in the health care and home environments e g cellular phones mobile two way radios electrical appliances it is possible that high levels of such interference due to close ...

Page 8: ...recorded to PC 2 the UP button Select the different item and adjust parameters While in adjustment press the UP button repeatedly to increase a parameter by one increment 3 the ENTER OK button Press this button to enter the selected menu or submenu confirm your selection or return to the main menu 4 the POWER button Press this button for about 3s to turn the oximeter on and 4s to turn it off 5 the...

Page 9: ...dle of screen refer to Fig 2 Or else it won t be shown refer to Fig 15 4 Beep and alarm are on Beep and alarm are off Beep is on while alarm is off Alarm is on while beep is off 5 Battery power indicator See battery life and replacement 6 It is SpO2 area of display below the indication It shows the oxygen saturation level of functional hemoglobin during normal measurement The measured SpO2 in Fig ...

Page 10: ... PR lower alarm limit indicator 12 PR upper alarm limit indicator Note If you set Display in Alarm Set menu On SpO2 upper lower alarm limit values and PR upper lower alarm limit values will be shown on the screen refer to Fig 2 If you set it off all the alarm limit indicators will not be shown refer to Fig 35 13 PR bpm it is PR area of display below the indication It shows the pulse rate in beats ...

Page 11: ...d 72 hour record storage visual audio alarm low battery alarm Data transfer to PC for storage or printing Two AA size alkaline batteries Suitable for adult pediatric and neonatal patient Notice To transfer data to PC the oximeter need to be registered As for detailed setup and operation please refer to the MedView instruction manual Transmission software and data cable are not standard accessories...

Page 12: ...he clasp into fixing hole and push as converse direction as arrow marked until the cover is closed Battery life and replacement There are five shapes of the indicator the centre with 4 bars full 3 bars 2 bars 1 bar empty and the frame in red That the frame of indicator become red means few of battery capacity remains and you should replace the batteries with new ones timely Or else the indicator d...

Page 13: ...ly three month or more Do not use batteries of a different type together Do not use new and used batteries together Dispose of the used batteries according to the applicable local regulations 3 2 Install the Sensor Fig 5 Insert the SpO2 sensor to the socket refer to Fig 5 Then SpO2 sensor connected indicator will be shown on the display refer to Fig 2 The indicator will not be shown if the SpO2 se...

Page 14: ...button to select 2 Time set item and then press the ENTER button to enter into the time setting menu refer to Fig 7 Fig 6 Fig 7 3 Hour setting Press the ENTER button to make the number in the cursor highlight and then press the UP button or the DOWN button to increase or decrease the time refer to the fig 8 After setting the hour press the ENTER button again to make the number in the cursor turns ...

Page 15: ... Minute setting you can set the Second the Year the Month and the Day 4 2 ID Number Setting Press the UP button or the DOWN button in the main menu to select the 3 User ID Set Refer to Fig 12 Press the ENTER button you can enter into the ID setting submenu as Fig 13 Press the ENTER button to make the ID number highlighted and then press the UP button or the DOWN button to increase or decrease the ...

Page 16: ...ig 16 Placement of the sensor Select the suitable sensor in terms of type and dimension Clip the sensor to the rational position of the patient finger Plug sensor into SpO2 port on top panel of pulse oximeter Note If the finger is not in the sensor Finger Out will be shown on the bottom of the screen Warnings The measurement would not be performed if the following instances come across in operatio...

Page 17: ...lication or use Significant levels of dysfunctional hemoglobins such as c arboxyhemoglobin or methemoglobin Intravascular dyes such as indocyanine green or methylene blue Exposure to excessive illumination such as surgical lamps especially ones with a xenon light source bilirubin lamps fluorescent lights infrared heating lamps or direct sunlight High frequency electro surgical interference and def...

Page 18: ... button to highlight the value refer to Fig 18 Press the UP button or the DOWN button to adjust the value and then press the ENTER button to finish the setup of SpO2 upper alarm limit The range of upper limit is 70 99 Fig 17 Fig 18 In the Alarm Set submenu press the UP button or the DOWN button to select the lowlimit value below SpO2 item refer to Fig 19 and then press the ENTER button to highligh...

Page 19: ...value and then press the ENTER button to finish the setup of PR upper alarm limit The range of upper limit is 31 235 Fig 21 Fig 22 In the Alarm Set submenu you can press the UP button or the DOWN button to select the lowlimit value below PR item refer to Fig 23 and then press the ENTER button to highlight the value refer to Fig 24 Press the UP button or the DOWN button to adjust the value and then...

Page 20: ...P button or the DOWN button to select the Display item and then press the ENTER button to highlight the value refer to Fig 27 Press the UP button or the DOWN button to select On Off and then press the ENTER button to confirm the setup If you set Display on SpO2 upper lower alarm limit value and PR upper lower alarm limit value will be indicated in screen refer to Fig 2 If you set it off all the al...

Page 21: ...s no silence The audible alarm has different tone pitch and on off beep patterns for each alarm priority High priority Di Di Di Di Di Di Di Di Di Di beeps every 10 seconds Medium priority Di Di Di beeps every 15 seconds Low priority Di beeps every 20 seconds ALARM ACTION Alarms will be activated on following conditions Physiological alarm The alarm will work when the SpO2 value or pulse rate beyon...

Page 22: ...ton to return to the main menu Beep and alarm are on Beep and alarm are off Beep is on while alarm is off Alarm is on while beep is off 6 3 Backlight Setup In the main menu press the DOWN button to select the 5 Backlight Set and then press the ENTER button to enter into the backlight setup screen Press the UP button or the DOWN button to adjust the brightness There are 5 levels More bars shown mea...

Page 23: ...page down by one page Press the ENTER button to return to main menu Fig 33 Fig 34 6 5 Other Information In the main menu press the DOWN button to select the 7 About and press the ENTER button to enter into the screen as the Fig 36 shown You can know the product version and remain storage spare room The oximeter can store 72 hours SpO2 and Pulse rate data at most The time interval is 4 seconds Fig ...

Page 24: ...upplies This plan includes inspection and clearance and it must comply with the policy of epidemical control unit or health department b Please take out battery before cleaning the oximter c Should make regular clearance Must comply with the policy of epidemical control unit or health department The appearance of oximeter can be cleared by not denuded wet cloth Please use the following permitted s...

Page 25: ...ld be checked every year It should also be checked after every maintenance and repair Required Test Equipment SpO2 signal Simulator Note The simulator cannot be used to assess the accuracy of a pulse oximeter probe or a pulse oximeter 7 2 1 Control Key Verification Press Menu key display the history data 7 2 2 Sound Verification a Set the oximeter sound ON b The simulated heart beep sound Can be h...

Page 26: ... was connected with the oximeter correctly If the sensor is connected with extension cable please check whether the extension cable is connected with the sensor correctly 7 4 Warranty and Repair 7 4 1 Maintenance Method a Maintenance responding time 9 00am 17 30pm Monday to Friday b Service support Our company will offer user telephone and e mail technology support and parts change Parts change ou...

Page 27: ...es the parts manufactured by other manufacturers without our company permission our company is entitled to stop contract 7 4 3 User Guarantee a Please read user manual carefully before operation b Please operate and make daily maintenance as request of manual and guarantee c Power supply and environment 7 4 4 No guarantee Principle There is no dispelled smut and not original mark in the crust Ther...

Page 28: ...ing for such user asking more than three years guarantee time our company will not buy oximeter parts during maintenance Our company will upgrade oximeter or change new maintenance methods for this we charge the lowest price for new oximeter with user permission 7 4 6 Repackage Take all the accessories and put them into plastic cover Try to use original package and packing material User will be re...

Page 29: ...arm Alarm SpO2 and pulse rate value probe off finger out battery exhausted Alarm mode audio alarm visual alarm and information Range SpO2 69 99 PR 30 235bpm Default values SpO2 Upper 99 lower 90 PR Upper 100 lower 60 SpO2 Display range 0 99 Resolution 1 Accuracy 3 70 99 Unspecified 0 69 Probe LED Specifications Pulse Rate Display range 0 254bpm Measurement range 30 235bpm Resolution 1bpm Accuracy ...

Page 30: ...ulse rate value the time interval is 4 seconds Accessories Standard accessories 1 Two AA batteries 2 One instruction manual 3 One adult finger sensor M 50E03CSO Optional accessories 1 Finger sensor for pediatric and infant M 50C04CSO Pediatric 15 45 Kg Infant 3 15 Kg 2 Finger sensor for neonate compatible with BCI Neonate 3kg 3 USB data cable 4 Software CD for data transmission ...

Page 31: ...V1 0I2 PULSE OXIMETER OPERATOR SMANUAL 30 APPENDIX B Declaration Guidance and manufacture s declaration electromagnetic immunity for all EQUIPMENT and SYSTEMS ...

Page 32: ...V1 0I2 PULSE OXIMETER OPERATOR SMANUAL 31 Guidance and manufacture s declaration electromagnetic immunity for EQUIPMENT and SYSTEMS those are not LIFE SUPPORTING ...

Page 33: ...I2 PULSE OXIMETER OPERATOR SMANUAL 32 Recommended separation distances between portable and mobile RF communications equipment and the EQUIPMENT or YSTEM for EQUIPMENT or SYSTEM that are not LIFE SUPPORTING ...

Page 34: ...V1 0I2 PULSE OXIMETER OPERATOR SMANUAL 33 Fig 9 ...

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