Related Manuals for mediprema B'BLOO 1980
Summary of Contents for mediprema B'BLOO 1980
- Page 1 Infant phototherapy unit B’BLOO Ref. 1980 MU-1980-EN-3.0-03/2021 MÉDIPRÉMA – ZA NODE PARK TOURAINE - 470 RUE GILLES DE GENNES – BP8 37310 TAUXIGNY - FRANCE +33 (0)2.47.28.36.86 ; sav@mediprema.com www.mediprema.com...
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Page 3: Table Of Contents
CONTENTS INTRODUCTION ........................ 2 1 General warnings ..........................2 2 Description of symbols ........................3 3 Intended use ............................ 4 4 General precautions for use ......................5 GENERAL DESCRIPTION ..................... 7 1 Description of components ......................7 2 Description of the user interface ..................... 9 3 Irradiance ............................ -
Page 4: Introduction
Our Customer Service Department is at your disposal to help ensure the efficient and safe operation of your equipment. Do not hesitate to contact it: +33 (0)2.47.28.36.86; sav@mediprema.com website: www.mediprema.com Médipréma – Customer Service Department – ZA Node Park Touraine – 470 rue Gilles de Gennes – BP8 37310 Tauxigny –... -
Page 5: Description Of Symbols
INTRODUCTION 2 Description of symbols Warning symbol. Not following the recommendations may incur a risk to the patient or operator. Obligation to read accompanying documentation. Device meeting the requirements of the European WEEE directive Date of manufacture (YEAR) of the device Device manufacturer Device trade name Device manufacturer’s catalogue reference... -
Page 6: Intended Use
INTRODUCTION 3 Intended use The B’Bloo reference 1980 is an infant phototherapy unit with LEDs designed to treat hyperbilirubinemia (jaundice). It is intended for use in maternity departments, intensive care units and neonatal resuscitation units. This device is not intended for home use. The B’Bloo phototherapy unit can be used to treat infants during skin-to-skin sessions, in a cot or in closed or open incubators. -
Page 7: General Precautions For Use
INTRODUCTION 4 General precautions for use Compliance with the general precautions indicated below is essential to ensure the safety of the newborn infant. DEVICE INSTALLATION As a result of the energy supplied, the phototherapy unit can disrupt equipment with its own heating system (e.g. - Page 8 INTRODUCTION range, it is important to take into consideration the infant’s condition (weight, weight/body surface ratio, type of jaundice, etc.) and modify the ambient temperature of the air around the infant accordingly. If an increase in the infant’s temperature is observed, it may be necessary to temporarily switch to 50% irradiance with the B’Bloo.
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Page 9: General Description
GENERAL DESCRIPTION GENERAL DESCRIPTION 1 Description of components The B’Bloo is an infant phototherapy unit with LEDs. The light is diffused through a pad containing optical fibres. It is composed of a control unit (1), and a fibreoptic pad (2). The control unit contains the LED light source and the control electronics. - Page 10 GENERAL DESCRIPTION To improve the newborn infant’s comfort, a single-use cover may be placed over the pad (reference 1983): To facilitate positioning of the newborn infant and help ensure he/she remains in the correct position on the pad, a cotton sleeping bag is supplied as an option (reference 1984). MU-1980-EN-3.0-03/2021 Page | 8...
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Page 11: Description Of The User Interface
GENERAL DESCRIPTION 2 Description of the user interface The B’Bloo is equipped with a timer used to set the exposure time. The phototherapy treatment is controlled by the timer. Therefore, the pad only lights up once a time has been set and treatment has been launched (see below). When the device is switched on by pressing the switch on the rear, the software version is displayed on the screen (1) and then the number of hours of use is displayed for 5 seconds. -
Page 12: Irradiance
GENERAL DESCRIPTION 3 Irradiance The irradiance of the B’Bloo reference 1980, measured using the Babyblue radiometer (device calibrated according to the DIN 5031 bilirubin absorption curve), is displayed in the graph below. The value in the centre of the illuminated zone and in contact with the phototherapy pad is greater than 3.5 mW/cm²... -
Page 13: Start-Up
START-UP START-UP 1 First start-up When the device is received at the user hospital, it is necessary to check that the delivery matches the order form and that it is in good overall condition. If the packaging is damaged, the transporter must be informed immediately. Incoming inspection It should be verified that the device is equipped with all its accessories and options and that the accompanying documentation is present. -
Page 14: Set Up
START-UP 2 Set up Installation of the pad ref. 1985, of the cover ref. 1983 and installation in the sleeping bag ref. 1984 (option) The fibre optic pad is placed under the infant’s back. It is important to regularly check that the infant is properly centred on the irradiated zone. -
Page 15: Installation On The Stand Ref. 1982 Or The Arm Ref. 1981
START-UP Installation on the stand ref. 1982 or the arm ref. 1981 Check that fastening plate present B’Bloo control unit. View of the underneath of the control unit with its support plate. Installation of the control unit on the stand. Installation of the arm on the vertical rail. - Page 16 START-UP Slide the B’Bloo control unit into the grooves of the stand fastening plate or arm, while pulling on the fixing pin. When the B’Bloo is correctly positioned on the stand or the arm, the fixing pin must be fully inserted and the control unit must be centred relative to the fastening plate.
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Page 17: Recommendations Before Each Use
START-UP 3 Recommendations before each use It is essential to check the device before each use to ensure effective and safe operation. It is the responsibility of users to carry out the necessary checks prior to each use. In the event of any doubts concerning the operation of the device, it is essential to contact the Médipréma Customer Service Department before use. -
Page 18: Operation
OPERATION OPERATION 1 Use After installing the device, set the exposure time then launch treatment as described in the “Description of the user interface” chapter, page 9. Once the scheduled treatment time is completed, the phototherapy light source automatically switches off. Removing the optical connector automatically suspends the timer and irradiance. -
Page 19: Thermostat
OPERATION Monitor the infant’s temperature frequently, preferably continuously. Regularly check that the infant is centred on the pad and properly positioned in the sleeping bag if one is used. It is essential that newborn infants be fitted with special eye protectors for infant phototherapy before the phototherapy unit is used (unless the device is used with the sleeping bag, in which case the medical team must decide whether to fit the infant with eye protectors or not). -
Page 20: Cleaning / Disinfection
CLEANING / DISINFECTION CLEANING / DISINFECTION The following instructions are given for information purposes and represent the minimum cleaning and maintenance principles to be followed. A specific protocol must be defined by the hospital on the basis of its resources and the recommendations of the manufacturer of the products used. It must also indicate cleaning/disinfection frequencies. -
Page 21: Maintenance
MAINTENANCE MAINTENANCE The device's longevity and optimal performance depend on regular maintenance by technicians from the Médipréma Customer Service Department or by technicians trained and approved by Médipréma. This maintenance requires the exclusive use of Médipréma original parts. The detailed operating procedure for maintenance operations is described in the maintenance manual given to approved technicians at the end of their training. -
Page 22: Technical Characteristics
TECHNICAL CHARACTERISTICS TECHNICAL CHARACTERISTICS 1 CE marking The B’Bloo complies with European directive 93/42/EEC concerning medical devices. The year of first CE marking of this device is 2013. It is a class IIa device according to this directive. The main standards applied are: EN 60601-1: Medical electrical equipment: General requirements for basic safety and essential performance EN 60601-2-50: Medical electrical equipment: Particular requirements for the basic safety and... -
Page 23: Adjustment Ranges, Display Ranges And Precision
TECHNICAL CHARACTERISTICS Adjustment ranges, display ranges and precision ADJUSTMENT RANGE DISPLAY RANGE PRECISION 00.01 (1 minute) to 90.00 (90 TIMER 00.00 to 90.00 ±1% hours) 3 Accessories, consumables and spare parts The components listed below are those that may be replaced by the user, with no requirement for additional training. -
Page 24: Specific Information Relating To Electromagnetic Compatibility (Emc)
TECHNICAL CHARACTERISTICS 5 Specific information relating to electromagnetic compatibility (EMC) Special precautions concerning electromagnetic compatibility (EMC) must be taken for all medical electrical equipment, which must be installed and put into service in accordance with the EMC information provided hereafter. The generic term “EQUIPMENT” used hereafter refers to the B’Bloo (reference 1980). - Page 25 TECHNICAL CHARACTERISTICS Guidance and manufacturer's declaration – Electromagnetic immunity I The EQUIPMENT is intended for use in the electromagnetic environment specified below. The customer or user of the EQUIPMENT should ensure that it is used in such an environment. All the functions have been tested according to the tests below.
- Page 26 TECHNICAL CHARACTERISTICS Guidance and manufacturer's declaration – Electromagnetic immunity II The EQUIPMENT is intended for use in the electromagnetic environment specified below. The customer or user of the EQUIPMENT should ensure that it is used in such an environment. All the functions have been tested according to the tests below.
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Page 27: Protection Of The Environment
TECHNICAL CHARACTERISTICS Recommended separation distances between portable and mobile RF communications equipment and the EQUIPMENT The EQUIPMENT is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the EQUIPMENT can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communication equipment (transmitters) and the EQUIPMENT as recommended below, according to the maximum output power of the communications equipment.
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