International Biomedical AIRBORNE Technical Manual

Observation & phototherapy light system
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Observation & Phototherapy Light System
Technical Manual

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  • Page 1 ® Observation & Phototherapy Light System Technical Manual...
  • Page 2 serva ation n & P Photo other rapy Ligh ht Sys ystem echn ical M Manu  hone: (51 12) 873-00  ax: (512) 873-9090  Mail: les@int-b bio.com  ebsite: h http://www w.int-bio. .com  ailing add dress: ternation al Biome edical 206 Cross...
  • Page 3: Table Of Contents

    TABLE OF CONTENTS SECTION 1: GENERAL INFORMATION .................... 2 INTENDED USE ......................... 2 PHYSICAL CHARACTERISTICS ....................2 Light Bar ......................... 2 Control Box ........................3 AC Power Supply (Optional) ..................3 CLASSIFICATION ........................3 SECTION 2: SAFETY INFORMATION ....................4 EXPLANATION OF TERMINOLOGY ..................
  • Page 4: Section 1: General Information

    SECTION 1: GENERAL INFORMATION INTENDED USE The Airborne Observation and Phototherapy Light System is intended to be used in one of two modes: observation light mode or phototherapy light mode. The observation light mode utilizes white light and is intended to be used as auxiliary lighting that supplements the ambient lighting. The phototherapy light mode utilizes blue light and is intended to be used in the treatment of neonatal hyperbilirubinemia.
  • Page 5: Control Box

    SECTION 1: GENERAL INFORMATION Control Box The control box plugs into the incubator’s lamp connector and mounts to the incubator via two screws. Alternatively the control box can receive power form the optional AC power supply. It has a three position switch: O - OFF (center position), I - Observation Light ON, and II - Phototherapy Light ON.
  • Page 6: Section 2: Safety Information

    International Biomedical is not to be held responsible if the Observation & Phototherapy Light System is used in a manner inconsistent with the instructions herein. This device has no performance which is considered essential.
  • Page 7 SECTION 2: SAFETY INFORMATION  PLACEMENT OF LIGHT BAR: Placement should be centered between the top of the inner and outer chambers where the patient cannot access unit. Do not place the light bar inside the inner chamber.  EYE PROTECTION: Do not look directly into the LEDs. During observation or phototherapy light usage, always protect the patient’s eyes with eye shields or equivalent.
  • Page 8  Use only AirBorne cables and accessories. Cables and accessories other than those supplied   by AirBorne may result in unacceptable operation of the AirBorne Observation &  Phototherapy Light System and will void AirBorne equipment warranty.  Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the Observation &...
  • Page 9 SECTION 2: SAFETY INFORMATION  Refer to the jaundice management guidelines or regulations in your country to determine the best treatment path for neonatal hyperbilirubinemia; such as the AAP Guidelines (American Academy of Pediatrics Clinical Practice Guideline - Management of Hyperbilirubinemia in the Newborn Infant 35 or More Weeks of Gestation);...
  • Page 10 There are safety considerations that should be read and understood before use.  The unit uses a specific type of LED. Consult International Biomedical for repair and replacement of LEDs. Use of incorrect LEDs can adversely affect performance and/or damage the light.
  • Page 11: Symbols

    ECTION N 2: SA AFETY INFOR RMATIO YMBOL he following g symbols a appear in th he Observat tion & Phot totherapy L Light System m documen ntation and bels. These e internatio onally recog gnized symb bols are de efined by the e Internatio onal Electro...
  • Page 12: Section 3: Set-Up Instructions

    ECTION N 3: SE ET-UP I INSTRU UCTION NPACK KING A ND ASS SEMBL he Observa tion & Phot totherapy L Light System m consists o of the light bar with ca able attache ed and the ontrol box. Upon arriva al, inspect a all parts for r any damag...
  • Page 13: Control Box Features

    ECTION N 4: O PERAT TING IN STRUC CTIONS his section c contains op perating pro ocedures fo or the Obse ervation & P Phototherap py Light Sys stem. peration in both modes s and indica ators are de etailed. Th he light sho uld be off w when not in...
  • Page 14: Light Bar Features

    ECTION N 4: OP PERAT TING IN STRUC CTIONS Eye Shield ds Require ed Warning hen the ligh ht is in use, eye shield s or equiva alent should d be used to o protect th he patient fr rom the spo hting effect t and the irr radiation be...
  • Page 15: Section 4: Operating Instructions

    SECTION 4: OPERATING INSTRUCTIONS 1: Phototherapy Light Lifetime Indicator When the red phototherapy lifetime indicator on the light bar is illuminated, the blue LEDs have exceeded their 39,000 hour limit and it is time to replace the light bar. 2: Phototherapy LEDs NOTE: Check irradiance intensity monthly with a calibrated light meter to ensure that the light is outputting correctly.
  • Page 16: Section 5: Preventative Maintenance

    SECTION 5: PREVENTATIVE MAINTENANCE To ensure proper operation, standby readiness, malfunction reporting, and performance of required maintenance, International Biomedical recommends following a preventative maintenance program. The daily preventative maintenance can be performed and recorded by knowledgeable incubator transport personnel. Monthly maintenance should be performed and recorded by a qualified biomedical technician.
  • Page 17: Monthly Maintenance

    PRODUCT RECYCLING The lighting system should be returned to International Biomedical for recycling when it reaches the end of its life (8 years). Part No. 715-0002, Rev. D...
  • Page 18: Section 6: Troubleshooting And Replacements

    SECTION 6: TROUBLESHOOTING AND REPLACEMENTS Problem Possible Solutions  Turn the incubator ON.  Plug in the control box.  Ensure the power switch is in the “I” or the “II” position. Neither set of LEDs comes on, and in ...
  • Page 19: Removal/Replacement Of Control Box

    SECTION 6: TROUBLESHOOTING AND REPLACEMENTS Problem Possible Solutions In observation light mode, the white LEDs turn  The switch in the control box has ON, but in Phototherapy Light mode, all of the gone bad and the control box blue LEDs and the yellow warning LED are not needs replacing, service needed.
  • Page 20: Section 7: Circuit Description

    SECTION 7: CIRCUIT DESCRIPTION The theory of operation of the lighting system is described. The individual schematics for the LED board and display board should be referred to when reading the theory of operation. CONTROL BOX This section describes the theory of operation of the Lighting Systems Control Box. The power comes into the control box through connector J1, but only when the incubator is ON (or when plugged into the option AC power supply which is receiving AC power).
  • Page 21: Section 8: Specifications

    SECTION 8: SPECIFICATIONS GENERAL MECHANICAL SPECIFICATIONS Height Width Depth Weight inches (cm) inches (cm) inches (cm) oz. (g) Light Bar .64 (1.63) 18.27 (46.40) 1.13 (2.86) 6.5 (184) Control Box 1.12 (2.84) 3.00 (7.63) 1.38 (3.50) 1.2 (33) AC Power Supply 1.24 (3.15) 4.92 (12.5) 1.97 (5.00)
  • Page 22 ECTION N 8: SP PECIFIC CATION OTE: Only mount the light bar in between th he chamber rs. The dis stance betw ween the lig bar a nd the effe ctive surfac ce area sho ould be 8.8 inches. If the distanc ce between light b...
  • Page 23: Operating, Storage, And Transport Environment

    SECTION 8: SPECIFICATIONS OPERATING, STORAGE, AND TRANSPORT ENVIRONMENT The Observation and Phototherapy Light System requires the following environmental conditions for transport and storage: Temperature ----------------------------------------------------- -15 C to 40 C Humidity ----------------------------------------------------------- 10% to 95% non-condensing Pressure ---------------------------------------------------------- 50 kPa to 106 kPa The requirements of the International Standard, EN60601-2-20:2001 are met.
  • Page 24 SECTION 8: SPECIFICATIONS GUIDANCE AND MANUFACTURER’S DECLARATION - IMMUNITY The Observation and Phototherapy Light is intended for use in the electromagnetic environment specified below. The customer or user of the Observation and Phototherapy Light should ensure that it is used in such an environment. COMPLIANCE ELECTROMAGNETIC IMMUNITY...
  • Page 25 SECTION 8: SPECIFICATIONS GUIDANCE AND MANUFACTURER’S DECLARATION - IMMUNITY The Observation and Phototherapy Light is intended for use in the electromagnetic environment specified below. The customer or user of the Observation and Phototherapy Light should ensure that it is used in such an environment. COMPLIANCE ELECTROMAGNETIC IEC 60601...
  • Page 26: Section 9: Warranty

    Sale or Service is performed by a non-certified service / dealer agency or any other unauthorized agency. All shipping claims must be made within 30 days from date of shipment from International Biomedical; otherwise factory will not be liable for claims of missing items. Any item ordered in error and returned to the factory for credit, will be subject to a minimum restocking charge of 15%.
  • Page 27: Section 10: System Documentation

    Phototherapy Light System is: Emergo Europe Prinsessegracht 20 2514 AP The Hague, The Netherlands PARTS AND ACCESSORIES For general Airborne Observation and Phototherapy Light System assistance or for parts and accessories, contact: International Biomedical 8206 Cross Park Drive Austin, TX 78754 512-873-0033 www.int-bio.com...

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