Bililux LED Phototherapy Light 1.n Instructions for Use May 2021

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Instructions for use BiliLux

Contents

Contents 1

Information about this document ... 7 1.1 Typographical conventions ... 7 1.2 Illustrations ... 7 1.3 Use of terms ... 7 1.4 Trademarks ... 7

2

Safety-related information ... 9 2.1 Target groups ... 9 2.2 Information on safety instructions and precautionary statements ... 11 2.3 Basic safety instructions ... 12 2.4 Device compatibility safety ... 14 2.5 Safety instructions for accessories ... 14 2.6 Electrical safety ... 15 2.7 Explosion and fire protection ... 16 2.8 Drug storage precautions ... 16 2.9 Mechanical safety ... 17 2.10 Device failure ... 17

3

Application ... 19 3.1 Intended use ... 19 3.2 Environment of use ... 19 3.3 Indications/contraindications ... 19

4

Overview ... 21 4.1 BiliLux phototherapy light ... 22 4.2 BiliLux with optional spring arm ... 23 4.3 BiliLux with optional trolley ... 24 4.4 Radiometer (optional) ... 25 4.5 Description ... 25 4.6 Abbreviations ... 26 4.7 Definitions ... 27 4.8 Symbols ... 27

5

Operating concept ... 29 5.1 Control panel ... 29 5.2 Displaying BiliLux screens ... 30 5.3 Adjusting the BiliLux with spring arm ... 31

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Assembly and preparation ... 33 6.1 Unpacking ... 33 6.2 Proper assembly ... 33 6.3 Placing the BiliLux phototherapy light on an incubator hood ... 34 6.4 Installing the BiliLux with optional spring arm ... 34 6.5 Installing the BiliLux with optional trolley ... 37 6.6 Installing the optional radiometer ... 38

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Getting started ... 39 7.1 System startup ... 39

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Contents

7.2

Functional check procedure ... 41

8

Operation ... 45 8.1 Positioning the BiliLux ... 48 8.2 Adjusting light distance and coverage for the patient ... 54 8.3 Starting therapy ... 55 8.4 Using the BiliLux radiometer (option) ... 56 8.5 Exporting a phototherapy report ... 57 8.6 Checking device status ... 58 8.7 Ending phototherapy ... 59 8.8 Using the MEDIBUS.X interface for data transfer ... 59 8.9 Shutting down the device ... 60

9

Configuration ... 61 9.1 Adjusting the date and time ... 61 9.2 Adjusting the language ... 62

10 Troubleshooting ... 63 11 Reprocessing ... 65 11.1 Safety information ... 66 11.2 Information on reprocessing ... 67 11.3 Classifications for reprocessing ... 67 11.4 Before reprocessing ... 67 11.5 Validated reprocessing procedures ... 68 11.6 Other agents and reprocessing procedures ... 69 11.7 After reprocessing ... 71 12 Service ... 73 12.1 Safety information ... 74 12.2 Overview ... 75 12.3 Definition of service terminology ... 75 12.4 Inspection ... 75 12.5 Maintenance ... 76 12.6 Maintenance instructions ... 76 12.7 Repair ... 76 13 Disposal ... 79 13.1 For countries subject to the EU Directive 2002/96/EC ... 79 14 Technical data ... 81 14.1 Device classification ... 82 14.2 Physical attributes ... 82 14.3 Environmental requirements ... 84 14.4 Electrical requirements ... 84 14.5 Noise requirements ... 84 14.6 RS-232 communication port ... 84 14.7 Irradiance ... 85 14.8 Radiometer option requirements ... 86 14.9 Device combinations ... 87 14.10 EMC Declaration ... 87

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Instructions for use BiliLux

Contents

15 List of accessories ... 95 15.1 Device ... 96 15.2 Accessories ... 96 15.3 Optional components ... 96 Index ... 97

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Instructions for use BiliLux

Information about this document

1

Information about this document

1.1

Typographical conventions 1

Consecutive numbers indicate steps of action, with the numbering restarting with "1" for each new sequence of actions.



Bullet points indicate individual actions or different options for action.

–

Dashes indicate the listing of data, options, or objects.

(A)

Letters in parentheses refer to elements in the related illustration.

A

Letters in illustrations denote elements referred to in the text.

►

Preventive measures in a safety message.



Result of a step.

✓

Final result of a sequence of steps. Indicates information that makes it easier to use the product. Bold, italicized text indicates labels on the device and texts that are displayed on the screen.

1.2

Illustrations Illustrations of products and screen content in this document may differ from the actual products depending on configuration and design.

1.3

Use of terms Dräger uses the term "accessories" not only for accessories in the sense of IEC 60601-1, but also for consumables, removable parts, and attached parts.

1.4

Trademarks Trademarks owned by Dräger Trademark

Babytherm® BiliLux®

Caleo® MEDIBUS®

The following web page provides a list of the countries in which the trademarks are registered: www.draeger.com/trademarks

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Information about this document

Trademarks owned by third-party manufacturers

Trademark

Trademark owner

Dismozon

BODE Chemie

Mikrobac Korsolex Neodisher Mediclean

Dr. Weigert

acryl-des

Schülke & Mayr

Mikrozid Perform Actichlor

Ecolab

Incidin

Ecolab USA

Oxycide BruTab 6S

Brulin

Dispatch

Clorox

Klorsept

Medentech

Descogen

Antiseptica

Oxygenon

8

Dismozon

Bode Chemie

SteriMax

Aseptix

Cleanisept

Dr. Schumacher

Rely+On

DuPont

Virkon

DuPont

Instructions for use BiliLux

Safety-related information

2

Safety-related information

2.1

Target groups

2.1.1

Duties of the operating organization The tasks described in this document specify the requirements that have to be met by each respective target group. The operating organization of this product must ensure the following: – The target group has the required qualifications (e.g., has undergone specialist training or acquired specialist knowledge through experience). – The target group has been trained to perform the task. – The target group has read and understood the chapters required to perform the task.

2.1.2

Description of target groups The target groups may only perform the following tasks if they meet the corresponding requirements.

2.1.2.1

2.1.2.2

2.1.2.3

User Task

Requirement

Use of the product in accordance with the intended use

Specialist medical knowledge in neonatology and in the use of the product

Reprocessing personnel Task

Requirement

Reprocessing

Specialist knowledge in the reprocessing of medical devices

Service personnel Task

Requirement

Installation

Experience in the servicing of medical devices

Basic service work (inspection, maintenance according to the "Maintenance" chapter)

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Safety-related information

2.1.2.4

Specialized Service Personnel Task

Requirement

Basic and complex service work (inspec- Specialist knowledge in electrical engition, maintenance, repair) neering and mechanics Experience in the servicing of medical devices Experience in complex service work on this product Dräger recommends arranging a service contract with DrägerService.

2.2

Information on safety instructions and precautionary statements Safety instructions and precautionary statements warn of risks and give instructions for the safe use of the product. Failure to observe them may lead to personal injury or property damage.

2.2.1

Safety instructions This document contains sections with safety instructions that warn of risks. The type of risk and the consequences of non-compliance are described in each safety instruction.

2.2.2

Precautionary statements Precautionary statements relate to process steps and warn of risks that may arise when executing the process steps. Precautionary statements precede the process steps. The following warning signs and signal words indicate precautionary statements and differentiate the possible consequences of noncompliance. Symbol

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Signal word

Consequences of non-compliance

WARNING

May result in death or serious injury.

CAUTION

May result in moderate or minor injury.

NOTICE

May result in property damage.

Instructions for use BiliLux

Safety-related information

2.3

Basic safety instructions The following statements apply to general operation of the medical device.

2.3.1

Strictly follow these instructions for use Failure to observe these safety information statements constitutes a use of the medical device that is inconsistent with its intended use. ► Any use of the medical device requires full understanding and strict observation of all sections of these instructions for use. The medical device must only be used for the purpose specified under Intended use on page 19 and with appropriate patient monitoring (see page 13). ► Strictly observe all precautionary statements throughout these instructions for use and all statements on medical product labels. ► Instructions for use must be kept accessible to the user.

2.3.2

Restrictions for use ► Device for use in healthcare facilities only and exclusively by persons with specific training and experience in its use.

2.3.3

Service If service is not performed regularly, malfunctions may occur, which can result in personal injury and property damage. ► Observe chapter Service. ► The medical device must be inspected and serviced regularly by service personnel. Repair and complex maintenance carried out on the medical device . must be performed by specialized service personnel. ► Dräger recommends that a service contract is obtained with DrägerService and that all repairs are performed by DrägerService. For maintenance, Dräger recommends the use of authentic Dräger repair parts. ► Do not service or maintain the device while it is in use with a patient.

2.3.4

Modifications to the product Modifications to the product may lead to malfunctions and unforeseen risks. This may result in injury to the patient or the user or in property damage. ► Do not modify this product.

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Safety-related information

2.3.5

Training Training for users is available from the Dräger organization. See www.draeger.com. Device misuse may result in harm to an infant. ► Only properly trained personnel should use the device as directed by a qualified attending physician familiar with the currently known risks and benefits of infant phototherapy equipment.

2.3.6

Patient safety The design of the medical device, the accompanying documentation, and the labeling on the medical device are based on the assumption that the purchase and the use of the medical device are restricted to persons familiar with the most important inherent characteristics of the medical device. Instructions and precautionary statements are therefore limited to the specifics of the Dräger medical device. The instructions for use do not contain any information on the following points: – Risks that are obvious to users – Consequences of obvious improper use of the medical device – Potentially negative effects on patients with different underlying diseases Medical device modification or misuse can be dangerous. Risk of patient injury. ► Do not make therapeutic decisions based solely on individual measured values and monitoring parameters. ► Assess the patient frequently to observe any change in condition. ► To make therapeutic decisions, also use medical expertise and visual assessment of patient. ► If the surface that the patient is lying on is equipped with protective devices designed to prevent the patient from falling off, ensure that they are inspected regularly for safety.

2.3.7

Patient monitoring Patient safety can be achieved by a wide variety of means ranging from electronic surveillance of medical device performance and patient condition to direct observation of clinical signs. The user of the medical device is responsible for choosing a suitable patient monitoring system that provides appropriate information on medical device performance and patient condition. The responsibility for selecting the best level of patient monitoring lies solely with the user of the medical device.

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Instructions for use BiliLux

Safety-related information

2.3.8

Safe connection with other electrical equipment Unapproved electrical connections can lead to patient injury or device failure. ► Electrical connections to equipment not listed in these instructions for use or these assembly instructions must only be made when approved by each respective manufacturer. ► Connecting electrical equipment to a power socket strip effectively leads to creating a medical electrical system. The result can be a reduced level of safety. Comply with the requirements of IEC 60601-1 when constructing a medical electrical system.

2.4

Device compatibility safety The use of incompatible devices may adversely affect the functional integrity of the product. Personal injury and property damage may occur as a consequence. ► Ensure that other medical devices that are used in conjunction with the patient or that form a system with this device are in compliance with the applicable medical device requirements. ► Do not use the device adjacent to or stacked with other equipment unless verification of normal operation in such a configuration can be achieved. ► If other devices are used with the BiliLux, refer to their manufacturer’s instructions for use.

2.5

Safety instructions for accessories

2.5.1

Accessories The use of incompatible accessories may adversely affect the functional integrity of the product. Personal injury and property damage may occur as a consequence. ► Dräger has tested the compatibility only of accessories listed in the current list of accessories. ► Use only compatible accessories. The accessories that are compatible with this product are listed in the list of accessories supplied with the product.

2.5.2

Reusing or reprocessing accessories Reusing, reprocessing, or sterilizing disposable products can lead to a failure of the medical device and cause injury to the patient. ► Do not reuse, reprocess, or sterilize disposable products. Disposable products were designed, tested, and manufactured for one-time use only. ► Do not use packaged disposable products if the package has been compromised. Reusable accessories have a limited service life. Using accessories beyond their service life can lead to a failure of the medical device and cause injury to the patient. ► If the accessory shows external signs of wear such as cracks, deformations, discoloration, or peeling, exchange the accessory.

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Safety-related information

2.6

Electrical safety The potential for electrical shock exists when electrical equipment is used. To avoid the risk of personal injury and property damage, the following preventive measures must be taken: ► Establish policies and procedures to educate your staff on the risks associated with electrical equipment. ► Due to the risk of electrical shock, only properly trained personnel with appropriate service documentation should service the device. ► This device must only be connected to a properly grounded hospital-grade power socket. ► Due to potential shock hazard within the phototherapy light, do not use the device if the phototherapy light or other components fail to function properly. ► Always provide power to the device by connecting the power cable directly to the mains power supply. ► Do not use extension power cables or power socket strips. ► Do not connect any devices or accessories that operate on mains voltage to the USB port.

2.6.1

Electromagnetic compatibility (EMC) Medical electrical equipment is subject to special precautionary measures concerning electromagnetic compatibility. Observe the EMC information during installation and initial operation. For further information, see the following section: EMC Declaration on page 87. Portable and mobile high-frequency communication equipment can affect medical electrical equipment. Malfunctions that endanger the patient may occur if no protective measures against electrostatic discharge are employed in the following situations: ► When touching the pins of connectors that carry the ESD warning symbol. ► When establishing connections with these connectors. To prevent malfunctions, observe the following measures and train the relevant personnel: ► Observe the ESD protective measures. Such measures may include wearing anti-static clothing and shoes, touching a potential equalization pin before and while making the connection, or using electrically insulating and anti-static gloves. ► Observe the requirements for the electromagnetic environment. Observe the following section: "Electromagnetic Immunity" on page 89. Electromagnetic fields may interfere with the device function and consequently endanger the patient. Electromagnetic fields are generated by, e.g.: – Cellular phones – High-frequency electrosurgical equipment – Defibrillators – Shortwave therapy equipment ► Maintain the separation distances. Observe the following section: "Recommended separation distances" on page 92.

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Instructions for use BiliLux

Safety-related information

The device is designed to comply with electromagnetic compatibility requirements. However, potential electromagnetic or other interference may exist. If interference is observed: ► Move the equipment or identify the source of interference, and take appropriate action.

2.6.2

EMC precautions The use of accessory equipment not complying with the equivalent safety requirements of this equipment may lead to a reduced level of safety of the resulting system. ► All medical accessory equipment in the patient vicinity must comply with the safety requirements of IEC 60601-1 and must have the relevant safety certifications. ► Use of accessories other than what is listed and approved for use in this product as original or replacement items may result in increased electromagnetic emissions or decreased electromagnetic immunity. ► Devices connecting to the serial port must be compliant with IEC60601-1-2, the EMC requirement for Medical Devices. ► Medical electrical equipment needs special precautions regarding EMC and must be installed and put into service according to the EMC information provided in this manual. ► In addition, portable and mobile RF communications equipment can affect medical electrical equipment.

2.7

Explosion and fire protection Use of the device in areas of explosion and fire hazard can lead to patient injury or device failure. ► Do not use the device in areas where combustible gases are present (e.g., oxygen, nitrous oxide, anesthetic agents). The medical device is not approved for use in areas where combustible or explosive gas mixtures are likely to occur. ► Textiles, oils, and other combustibles are easily ignited and burn with great intensity in air enriched with oxygen. Keep matches, and all other sources of ignition, out of the room in which the device is located. ► Ensure adequate ventilation to avoid accumulation of oxygen around the device. ► Do not place auxiliary equipment that produces sparks near the device. ► Ensure that no oxygen sources are in use during maintenance or cleaning.

2.8

Drug storage precautions Photo effects of radiation can degrade the efficacy of drugs. ► Do not store infusion liquids or other drugs in the radiation area.

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Safety-related information

2.9

Mechanical safety

2.9.1

Using the phototherapy light with an incubator ► Phototherapy lights placed on top of the incubator may inadvertently fall off if the incubator is moved. Before moving the incubator, disconnect the phototherapy light from mains power and remove it from the top of the incubator. ► Phototherapy lights placed on the top of the incubator hood may interfere with upward travel of the height adjustment of the incubator. To prevent this interference, always remove the phototherapy light before adjusting the incubator height.

2.9.2

Moving the trolley To prevent injuries and damage to the device when moving the trolley, prepare the trolley as follows: ► Remove or secure all loose system components. ► Fold the spring arm down to a compact position. ► Lower the trolley pole to its lowest position. ► Push or pull the trolley in a straight line along the length of the trolley. Lateral or angular movement (across the width) can result in inadvertent tip-over if the wheels encounter any obstacle. ► Do not use the phototherapy light to move the trolley.

2.9.3

Preventing tip over of trolley The device could tip over. ► For optimum stability, always lower the trolley to its lowest position before moving the device. ► For optimum stability, always lock all trolley wheels. ► Do not leave the device unattended when parking on an incline.

2.10

Device failure In case of device failure, contact DrägerService.

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Instructions for use BiliLux

Application

1

Application

1.1

Intended use The BiliLux phototherapy light is designed to reduce the serum bilirubin concentration in premature babies and neonates with hyperbilirubinemia by means of phototherapeutic radiation. It is intended for use with patients up to 3 months of age who weigh less than 10 kg (22 lb).

1.2

Environment of use The BiliLux phototherapy light can be used in hospital departments that provide neonatal and infant care, including nurseries and Neonatal Intensive Care Unit (NICU) levels I-IV.

1.3

Indications/contraindications The BiliLux phototherapy light is indicated for the reduction of hyperbilirubinemia in newborn infants up to 3 months of age who weigh less than 10 kg (22 lb). The BiliLux phototherapy light is not indicated for home use or for use inside an incubator. It is also not indicated for the following patients: – patients with conjugated hyperbilirubinemia – patients with photosensitizing disorders (e.g., congenital erythropoietic porphyria) – patients who are being given photosensitive medication

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Instructions for use BiliLux

Overview

1

Overview

1.1

BiliLux phototherapy light

1.1.1

Top view

B

BiliLux

001

A A Control panel B Quick-connect plug (for connection to optional spring arm)

1.1.2

Bottom view

C B

B

002

A A Blue phototherapy LED lights B White observation LED lights C Rating plate

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Overview

1.1.3

Rear view

A

D

C

E

F 003

B

A On/off switch B Power cable receptacle C Quick-connect plug (for connection to optional spring arm) D RS-232 communication port E Receptacle for radiometer cable F USB port

1.2

BiliLux with optional spring arm

A B D

C

D

F

004

E A Quick-connect for phototherapy light B Release knob for phototherapy light C Spring arm D Cable clips E Plug to connect to trolley pole or rail clamp F Rail clamp for phototherapy light (to connect to 38 mm pole and DIN, Fairfield, and GCX rails)

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Instructions for use BiliLux