background image

  BT-450 Operation manual 

P/N:450-ENG-OPM-EXP-R01 

Bistos Co., Ltd. 

2021.06 

 

Eye protection: Do not look directly into the LED. During treatment, always protect your baby’s 
eyes  with  an  eye  patch  or  protective  equipment.  Periodically,  check  the  hospital  or  treatment 
protocol and makes sure  that the baby’s eyes are protected from contamination. Patients near 
the light should use protective pads or equipment to protect their eyes.

 

 

Sensitive people may develop headaches, nausea, or mild dizziness if left in the irradiated area 
for too long. Wearing yellow lens glasses can reduce the potential impact.

 

 

Bilirubin Photo isomers may have toxic effects.

 

 

Water balance: Water balance may be disturbed for some patients.

 

 

Photosensitive  Drugs:  Irradiation  may  reduce  the  effectiveness  of  light-sensitive  drugs.  Do  not 
store the medication near light irradiation.

 

 

Flammable gas: Do not use the device near combustible gases. (eg oxygen, nitrogen dioxide, or 
other anesthetics)

 

 

Power  off:  When  cleaning  the  light  source,  always  turn  off  the  power  and  remove  the  power 
cable.

 

 

Even an adult may be affected by staying in the light for a long time.

 

 

Do not use flammable solution directly on the LED lamp. The LED lamp may be damaged or its 
function  may  deteriorate.  For  cleaning  or  maintenance,  follow  the  instructions  described  in 
section 7 of this manual.

 

 

Use  of  other  accessories  not  provided  by  Bistos  Co.,  Ltd.  may  degrade  the  safety  and 
performance of the device, so be sure to use the designated accessories.

 

 

Using a reflective film can cause an increase in body temperature when the film affects a type of 
phototherapy radiation.

 

 

Blue light might interfere with the clinical management of a patient with cyanosis.

 

 

Infants with increased direct reactions or cholestatic jaundice after receiving phototherapy may 
develop the bronze-baby syndrome.

 

 

Do not use any damaged parts including the power adapter.

 

 

Before  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 communication equipment (including peripheral devices such as antenna cables and 
external antennas) should not be used closer than 30cm (12 inches) to any part of the BT-450, 
including cables specified by the manufacturer. Otherwise, the performance of  this device may 
be  degraded.  Wireless  home  network  devices,  mobile  phones,  wireless  phones,  and  wireless 
communications equipment such as base stations and radios can affect the device and should be 
used at a distance of 1 m or more.

 

 

This  device  requires  special  precautions  regarding  EMC  and must  be  serviced  according  to  the 
EMC information provided in this manual. 

 

 

Excessive electromagnetic interference may cause the device to generate excessively high or low 
light levels temporarily. Use the device in an appropriate environment stated in this manual.

 

 

Components  other  than  those  approved  for  use  with  this  device  may  increase  or  decrease 
immunity.

 

 

Do not open the pad cable where there the power is connected. There is a risk of electric shock.

 

 

Do not disassemble the device. The  battery  can be replaced by disassembling the device by an 
authorized  service  person  and  must  be  replaced  with  a  battery  of  the  same  model  and 
specification.

 

 

Incorrect battery replacement may cause high temperature, fire, or explosion.

 

 

If  the  device  is not  used for  a long  time,  the  battery  must  be  removed and stored.  Charge  the 
battery and store it at room temperature with low humidity.

 

 

Use only the AC/DC power adapter supplied or designated by Bistos. Use of adapters other than 
those  provided  or  specified  by  the  manufacturer  may  increase  electromagnetic  emissions  or 
reduce the electromagnetic immunity of the device, resulting in improper operation. 

 

Содержание BT-450

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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 ...

Страница 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 ...

Страница 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 ...

Страница 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...

Страница 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...

Страница 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 ...

Страница 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...

Страница 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...

Страница 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 ...

Страница 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...

Страница 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...

Страница 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 ...

Страница 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...

Отзывы: