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Summary of Contents for Bistos 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...
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Page 2: Table Of Contents
BT-450 Operation manual Table of Contents Intended use/Indications for use ------------------------------------------------------------------------------3 Product Description --------------------------------------------------------------------------------------3 Contraindications --------------------------------------------------------------------------------------- 3 Safety Information ------------------------------------------------------------------------------------4 Product Configuration --------------------------------------------------------------------------9 2.1 Description of each part --------------------------------------------------------------------9 2.2 Button descriptions ----------------------------------------------------------------------10 2.3 LCD Description -------------------------------------------------------------------------10 How to use --------------------------------------------------------------------------------------------------11 3.1 Preparation before use --------------------------------------------------------------------- 11... -
Page 3: Intended Use/Indications For Use
When the rectified PWM is output through the LED driver, the LED can be stably turned on. The intensity of light can be adjusted by changing the duty cycle of PWM, and BT-450 has two types of intensity, high and low. -
Page 4: Safety Information
Used to display safety information for colours and safety signs — Registered warnings. safety signs / W001 Before using the BT-450, please be fully understand the information provided with the device. ISO 15223-1, Medical Devices—Symbols Used to display safety information for to be used with medical device labels, caution. - Page 5 BT-450 Operation manual Part 1: General requirements / 5.1.1 ISO 15223-1, Medical Devices—Symbols to be used with medical device labels, This symbol indicates date labeling and information to be supplied – manufacture. Part 1: General requirements / 5.1.3 ISO 15223-1, Medical Devices—Symbols...
- Page 6 If the normal operation of this device with other devices nearby is not confirmed, the BT-450 cannot be used adjacent to or with other devices.
- Page 7 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.
- Page 8 Do not place drugs or liquids around the light source that may be deteriorated by the light source. While BT-450 is in operation, wear protective equipment to protect the patient’s eyes, and frequently check whether it is properly worn.
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Page 9: Product Configuration
BT-450 Operation manual 2. Product configuration When unpacking, make sure you have all the following items. The eyeshield patch and cover are disposable and the pad is consumable. The standard components are as follows. Name User Manual Power Adapter Control Box ... -
Page 10: Button Descriptions
BT-450 Operation manual Name Description Has a button to control the device and an LCD display shows the current ① Control Box operation status. Shows the current operation status. (Adapter and Battery status, ② LCD display running and remaining time, light intensity, etc.) ③... -
Page 11: How To Use
BT-450 Operation manual Name Description If the contact part temperature of the pad is high, the pad is ① High temperature icon automatically turned off before the temperature exceeds 40 °C. The high temperature icon appears on the display. ②... -
Page 12: Patient Placement
BT-450 Operation manual ② Put the pad in the disposable cover. Put the without Velcro side of the cover and the LED side of the pad facing the same side. NOTE If the cover gets dirty during use, discard the cover and use a new one. If there is any foreign substance on the pad, it must be cleaned according to “Section 7 Cleaning and maintenance.”... -
Page 13: Product Operation
BT-450 Operation manual • To minimize the heat between the pad and the patient, the patient WARNING should not be wrapped in a thick blanket or wrapped too tightly. • The patient’s body temperature may rise if the patient and pads are wrapped in a material that does not allow heat to escape, such as a thick blanket or clothes. - Page 14 BT-450 Operation manual 2) Timer mode ① Use the 30 minutes increase or decrease button( ) to set the desired Timer time. ② The timer can be set at a maximum of 24 hours. ③ Set the light intensity to High or Low by...
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Page 15: Alarm
BT-450 Operation manual 4. Alarm 4.1 Alarm condition (1) High temperature If the contact part temperature of the pad is high, the pad is automatically turned off before the temperature exceeds 40 °C. The high temperature icon ( ) appears on the LCD display, and the beep alarm sounds until the user turns off the control box. -
Page 16: Precautions For Pad
CAUTION pad and the patient. Covered 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/cm high intensity: 60 ±... -
Page 17: Cleaning
If the pad connection icon still appears, the pad needs to be still appears. replaced. Contact Bistos Service Center. ※ If the problem is not solved or have additional questions, contact Bistos Service Center. 9. Manufacturer’s declaration on EMC The Infant Phototherapy Equipment needs special precautions regarding EMC (Electromagnetic compatibility) and needs to be used according to the EMC information provided in this user manual. -
Page 18: Electromagnetic Emissions
BT-450 Operation manual 9.1 Electromagnetic emissions BT-450 is intended for use in the electromagnetic environment specified below. The user should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment-guidance The Infant Phototherapy Equipment uses RF energy only for its internal function. -
Page 19: Electromagnetic Immunity
BT-450 Operation manual 9.3 Electromagnetic immunity The Infant Phototherapy Equipment is intended for use in the electromagnetic environment specified below. The customer or the user of the Infant Phototherapy Equipment should assure that it is used in such an environment. - Page 20 BT-450 Operation manual Immunity test Test level Compliance level Electromagnetic environment-guidance 3 Vrms 3 Vrms Portable and mobile RF communications 150 kHz to 150 kHz to equipment should be used no closer to 80 MHz 80 MHz any part of the Infant Phototherapy...
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Page 21: Product Specifications
BT-450 Operation manual 10. Product Specifications Function Infant Phototherapy Equipment for Neonatal Jaundice Category Treatment With the disposable cover on the pad, Light intensity High : 60±10 μW/cm²/nm Light Low : 30±10 μW/cm²/nm source Effective light 412 mm x 102.7 mm... - Page 22 BT-450 Operation manual 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.)
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Page 23: Product Warranty
Battery: 6 months from the manufacturing date (excluding batteries consumed over time) Warranty period Pad: 8 months from the manufacturing date. The manufacturing date is based on the date indicated on the BT-450 control box label. Purchase date Name : ...
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