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Bistos BT-450, Operation Manual

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Bistos BT-450 Operation Manual Download Page 22

  BT-450 Operation manual 

P/N:450-ENG-OPM-EXP-R01 

Bistos Co., Ltd. 

2021.06 

22 

Environmental conditions 
Operation 

Operating temperature 

15 °C to 30 °C (59 °F to 86 °F) 

Operating humidity (R.H.) 

5 % to 85 % non-condensing 

Atmospheric pressure 

70 kPa to 106 kPa 

Storage and Transport 

Storage temperature 

-20 °C to 60 °C (-4 °F to 140 °F) 

Storage humidity (R.H.) 

0 % to 95 % non-condensing 

Atmospheric pressure 

70 kPa to 106 kPa 

 

Dimension and weight 
Size 

Control box 

    84 mm x 184 mm x 27 mm 

Pad 

    123 mm x 459 mm x 12 mm 

Weight 

Control box 

    360 g 

Pad 

    510 g 

 

IP rating 

Control box 

    IP 21 

Pad 

    IP 23 

Power adapter 

    IP 22 

 

Summary of Contents for BT-450

Page 1: ...Infant Phototherapy Equipment BT 450 Operation Manual Please keep this user s guide for future reference P N 450 ENG OPM EXP R01 ...

Page 2: ...2 3 3 Product operation 13 3 3 1 Operation mode 13 3 3 2 How to operate 13 4 Alarm 15 4 1 Alarm condition 15 4 2 Alarm characteristics 15 5 Precautions for Pad 16 6 Essential Performance 16 7 Cleaning and maintenance 16 7 1 Brightness check 16 7 2 Cleaning 17 8 Troubleshooting 17 9 Manufacturer s declaration on EMC 17 9 1 Electromagnetic emissions 18 9 2 Recommended separation distances between po...

Page 3: ...gate the bilirubin is poor and the function to excrete bilirubin out of the body is also weak Phototherapy refers to the use of light to convert unconjugated bilirubin molecules into water soluble isomers that can be excreted in bile or urine without the need for conjugation Bilirubin absorbs light most strongly in the blue region of the spectrum near 460 nm a region in which penetration of tissue...

Page 4: ...e supplied Part 1 General requirements 5 4 4 Used to display safety information for caution Before using the BT 450 please be fully understand the information provided with the device IP21 IP22 IP23 IEC 60529 Degrees of protection provided by enclosures These indicate the protection level against the ingress of solid objects and liquid IPX1 is protection against falling water drops vertically IPX2...

Page 5: ...lied Part 1 General requirements 5 3 1 This symbol indicates the medical device that can be broken or damaged if not handled carefully ISO 7000 Graphical symbols for use on equipment Registered symbols 0623 This symbol indicates to keep upright ISO 15223 1 Medical Devices Symbols to be used with medical device labels labeling and information to be supplied Part 1 General requirements 5 3 2 This sy...

Page 6: ...mattresses heating blankets etc During phototherapy the patient s skin and core body temperature should be monitored Do not use the device with ECG EKG device Do not use the device in the presence of flammable materials Class I equipment There is a risk of electric shock so this equipment should be connected to a power supply with protective earth If the power rating is inappropriate or the device...

Page 7: ...fore using the device visually check each part for cracks folds tears discoloration or deterioration If damage to the device is observed discontinue until the part is replaced Do not use the BT 450 for neonatal jaundice treatment near or in combination with other equipment If you want to use adjacent to or overlapping with devices you must confirm the normal operation or BT 450 Portable RF communi...

Page 8: ...ed for a long time check whether it operates safely before use BT 450 can only be repaired or replaced by qualified personnel Do not use the device outdoors where aerosol spray products are being used or where oxygen is administered When disposing of BT 450 please follow all laws regarding recycling When disposing of packaging materials comply with local waste disposal laws and regulations Keep th...

Page 9: ...Power Adapter Control Box Shape Quantity 1 1 1 Name Pad Cover Eyeshield Patch Shape Quantity 1 1 disposable 1 disposable CAUTION Use only Bistos accessories Check the consumables for wear or damage before use and replace them if necessary Do not use them if there are signs of damage or defects The eyeshield patch and cover are disposable multiple uses are prohibited To maintain optimum performance...

Page 10: ...nal to plug in the power adapter for charging Pad Has a built in LED module and temperature sensor Light emitting area Light emitting area from the built in LED Pad connection part Part to connect with control box Temperature Sensor Measures temperature in the pad to protect the patient from the heat of the LED 2 2 Button Description No Name Description Power Button For power ON OFF Light Intensit...

Page 11: ...the pad is high the pad is automatically turned off before the temperature exceeds 40 C The high temperature icon appears on the display Pad connection icon If the communication between the control box and the pad is not normal the pad connection icon appears on the display Light intensity Display the current set light intensity High Low OFF Battery icon Display the current battery level Charging ...

Page 12: ...k shield for blue light protection from phototherapy WARNING Eye protection Do not look directly at the LED During treatment the baby s eyes should always be protected with an eye shield or other eye protection device Make sure that the baby s eyes are protected from contamination regularly Patients near the light should use protective pads or equipment to protect their eyes 3 2 Patient placement ...

Page 13: ...timer indicates 0 then the device operates in the normal mode Timer Mode The pad is on when the timer indicates higher than 0minutes the device operates in Timer Mode In timer mode the pad operates as long as the set time When the set time reaches 0 minutes the pad turns off And the maximum setting time is 24hours The pad automatically turns off after 24hours 3 3 2 How to operate 1 Power ON OFF 1 ...

Page 14: ...ned on again and presses the intensity control button the pad output indicates the previous set status 5 However when the device power is turned off with the pad output is set to off the pad output status will indicate High when the light intensity control button is pressed after the device is turned on again Off High Low 4 LCD Auto Off When there is no button input for 10minutes during use the LC...

Page 15: ...the control box and the pad are properly reconnected 4 2 Alarm characteristics 1 High temperature Alarm priority Low priority Audible alarm Beep beep Alarm icon The high temperature icon is displayed and blinked until the user turns off the control box 2 Low battery Alarm priority Information signal Audible alarm Beep Alarm icon The battery icon is displayed and blinked 3 Pad connection Alarm prio...

Page 16: ...ed pads should always be on a patient s bare skin 6 Essential Performance EP The infant phototherapy equipment BT 450 irradiates the blue lights of the following conditions to treat jaundice low Intensity 30 10 μW cm2 nm high intensity 60 10 μW cm2 nm 7 Cleaning and maintenance 7 1 Brightness check Before use it is recommended to measure the light intensity of the pad using a calibrated measuring ...

Page 17: ...ice Center The power does not turn on Check the battery charging status Inspect the power button and the outside of the control box for foreign substances The control box gets wet Remove the plug of the power adapter from the socket Turn off the power of the control box Wipe the body with a dry cloth and store it in a warm dry place for at least 12 hours LED does not light up Check if the pad is p...

Page 18: ...equipment could result Use of adapter other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation 9 2 Recommended separation distances between portable and mobile RF communications equipment and the Infant Phototherapy Equipment The Infant Ph...

Page 19: ...ode 2 kV common mode The mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC61000 4 11 0 UT 100 dip in UT for 0 5 1 cyclesa 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 23 30 cyclesa for 0 5sec 0 UT 100 dip in UT for 250 300 cycles for 5 sec 0 UT 100 dip in UT for 0 5 1 ...

Page 20: ...o 2 7 GHz 80 1 kHz AM 10 V m 80 MHz to 2 7 GHz 80 1 kHz AM 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 mobil...

Page 21: ...de Timer Mode Pad temperature measurement Auditory information condition Volume Alarm High temperature 43 1 dBA Information signal Low battery 43 1 dBA Pad connection 43 1 dBA Power Power adapter For electrical safety a power adapter complying with IEC 60601 1 must be used Manufacturer Dongguan Shilong Fuhua Electronic Co Ltd Model UES18LCP4 150120SPA Input 100 to 240 V 50 60 Hz 500 mA Output 15 V...

Page 22: ... non condensing Atmospheric pressure 70 kPa to 106 kPa Storage and Transport Storage temperature 20 C to 60 C 4 F to 140 F Storage humidity R H 0 to 95 non condensing Atmospheric pressure 70 kPa to 106 kPa Dimension and weight Size Control box 84 mm x 184 mm x 27 mm Pad 123 mm x 459 mm x 12 mm Weight Control box 360 g Pad 510 g IP rating Control box IP 21 Pad IP 23 Power adapter IP 22 ...

Page 23: ...facturing date is based on the date indicated on the BT 450 control box label Purchase date Customer Information Name Address Contact Seller Manufacturer Bistos co Ltd Thank you for purchasing the Infant Phototherapy Equipment This product has passed strict quality control and inspection The compensation standard for repair exchange and refund of this product is subject to the Fair Trade Commissio...

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