TruLight 5000 and 3000 lighting system Instruction Manual Sept 2017

Thank you very much

for buying the new TruLight 5000/3000 lighting system. Please read through this instruction manual carefully and ensure adherence to all safety instructions and requirements regarding the operation and care of the device. This instruction manual applies to the TruLight 5000 and TruLight 3000 lighting systems: • Implementation as an individual, small surgical light with a light head in stand, wall-mounted or ceiling-mounted versions. • Implementation as surgical lighting system, including the combination of two to three surgical lights mounted on the ceiling. • Optional equipment, such as light head with camera or laser. Light head For both machine versions – TruLight 5000 and TruLight 3000 – both the large light head (Ø 730 mm) as well as the small light head (Ø 640 mm) are available with various adjustments for the size of the field of illumination, light intensity and colour temperature. Optional camera system The operation of the optional camera system is described in the following instruction manual: • TruVidia SD camera system and VidiaPort TFT support arm system, • TruVidia HD camera system and VidiaPort TFT support arm system, • TruVidia 3D camera system and VidiaPort TFT support arm system.

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How to contact us

Manufacturer and distributor TRUMPF Medizin Systeme GmbH + Co. KG Carl–Zeiss–Straße 7–9 07318 Saalfeld Germany www.trumpfmedical.com Telephone: +49 3671 586-0 Fax: +49 3671 586-41165 E-mail: [email protected] Technical Customer Service TRUMPF Medizin Systeme GmbH + Co. KG Carl–Zeiss–Straße 7–9 07318 Saalfeld Germany Telephone: +49 3671 586-41911 Fax: +49 3671 586-41175 Email: [email protected]

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Notes relating to this documentation

Copyright

Modifications to the device

Changes to the instruction manual

Translations

Copyright and property rights All rights reserved. This instruction manual is protected by copyright. • Any use not currently regulated by law must be approved in writing by TRUMPF Medizin Systeme GmbH + Co. KG, hereinafter referred to as Trumpf Medical. • Trumpf Medical will assume no liability whatsoever arising from or connected with the use of unapproved information by any person or company. Modifications and translations We constantly work on the further development of our products and reserve the right to make changes to the scope of delivery in terms of form, equipment and technology. • The content of the instruction manual can be changed at any time without prior notice. • Please keep up to date on the current version of the instructions, e.g. using the TRUMPF Medical Online Information System (OIS) at regular intervals. • The German-language version of this instruction manual shall be binding as regards translations into foreign languages.

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Table of Content

1

Important information regarding safe use ... 10

1.1 1.2 1.3

Details for the identification of the system ... 10 Details for identification of the instruction manual... 10 Designation of groups of individuals... 10

1.3.1 1.3.2 1.3.3

Operator ...10 User...10 Specialist personnel ...10

1.4

Information for operators... 10

1.4.1 1.4.2 1.4.3 1.4.4 1.4.5

Initial commissioning ...11 Availability of the instruction manual...11 Guarantee ...11 Maintenance and repair ...11 Service life of the device ...11

1.5 1.6

Date of manufacture... 11 Delivery ... 12

1.6.1 1.6.2

Transportation damage ...12 Return address...12

1.7

Information for users ... 12

1.7.1 1.7.2

Training for use of the device ...12 Obligation of the user to inform and to inspect ...12

1.8

Purpose of the device ... 12

1.8.1 1.8.2 1.8.3 1.8.4 1.8.5 1.8.6

Identification...12 Standards and Directives ...13 Internationally applied standards...13 Intended use ...13 Special features...14 Improper use...14

1.9

Ambient conditions for operation and storage ... 14

1.9.1 1.9.2

Ambient conditions for operation ...14 Ambient conditions for storage ...14

1.10 1.11

Combination with other medical devices ... 15 Disposal ... 15

2

Safety instructions ... 16

2.1

Structure of the safety instructions in this instruction manual ... 16

2.1.1 2.1.2 2.1.3

Indicating risk of injury ...16 Indicating damage to property ...16 Indicating additional information ...16

2.2 2.3 2.4

Additional symbols for the safety information ... 16 Symbols on the device ... 17 Overview of the most important safety instructions... 17

3

The technology of the lighting system ... 22

3.1 3.2 3.3

The light head ... 22 The LED light source... 23 Accessories... 23

4

Identification of the lighting system ... 24

4.1

Use of serial numbers ... 24

4.1.1 4.1.2 4.1.3

Position of the serial numbers on the ceiling-mounted version...24 Position of the serial numbers on the wall-mounted version ...24 Position of the serial numbers on the mobile stand version ...25

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Table of Content

4.1.4

Position of the laser marking ...25

5

Description of devices and functions... 26

5.1

Description of the ceiling-mounted version ... 26

5.1.1 5.1.2 5.1.3 5.1.4 5.1.5

Implementation of the ceiling-mounted version...26 Components of the ceiling-mounted version ...26 Camera on light head, optional ...26 Size of the light heads ...26 Rotation / swivel ranges of the ceiling-mounted version...27

5.2

Description of the wall-mounted version ... 28

5.2.1 5.2.2 5.2.3 5.2.4

Implementation of the wall-mounted version ...28 Components of the wall-mounted version ...28 Size of the light heads ...28 Rotary / swivel movement of the wall-mounted version ...29

5.3

Description of mobile stand version ... 30

5.3.1 5.3.2 5.3.3 5.3.4 5.3.5

Implementation of the mobile stand version ...30 Components of the mobile stand version...30 Power supply of the mobile stand version ...30 Size of the light heads ...30 Rotating / swivel movement of the mobile stand version...31

5.4

Functional specifications of the light head ... 32

5.4.1 5.4.2 5.4.3 5.4.4 5.4.5 5.4.6 5.4.7 5.4.8 5.4.9

Positioning the light head ...32 Operating the light heads ...32 Controlling the light intensity ...34 Sterile Light Control (SLC) function, optional...35 Adaptive Light Control (ALC) function, optional ...36 Adaptive Light Control plus (ALC plus) function, optional ...37 Controlling the light field ...38 Controlling the colour temperature (optional)...39 Synchronisation of the colour temperature ...40

6

Commissioning ... 41

6.1 6.2

Checking the lighting systems... 41 Positioning of the lighting systems ... 42

6.2.1 6.2.2

Risks of collision during positioning...42 Positioning the cover-mounted / wall-mounted version...43

6.3

Positioning the mobile stand version... 45

6.3.1

Connecting the mobile stand version to the mains ...46

7

Decommissioning... 47

7.1 7.2

Switching off the ceiling- and wall-mounted version... 47 Switch off the mobile stand version ... 47

8

Operation... 48

8.1 8.2 8.3 8.4 8.5 8.6 8.7 8.8 8.9

Working rules... 48 Preparatory measures... 48 Measures to take when using the lighting system... 49 Attaching the sterile handle... 50 Control panels of the lighting system ... 51 Switching the light head on/off ... 52 Disconnecting the power to the lighting system ... 52 Setting the size of the light field ... 53 Setting the light intensity... 54

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Table of Content

8.9.1 8.9.2 8.9.3 8.9.4 8.9.5 8.9.6

Non-sterile setting of the light intensity at the control panel ...54 Set the light intensity in the sterile area using the Sterile Light Control (SLC) ...55 Setting the light intensity to the working distance in the non-sterile area with Adaptive Light Control (ALC)...56 Adjusting the light intensity with Adaptive Light Control plus (ALC plus) ...57 Setting colour temperature ...59 Synchronisation of the colour temperature ...59

9

Cleaning and disinfection ... 60

9.1

Cleaning and disinfection... 61

9.1.1 9.1.2 9.1.3

General ...61 Wipe-over disinfection ...61 Recommended disinfectants ...62

10

Sterilising handles of surgical lights ... 63

10.1 10.2

Preparation ... 63 Cleaning and disinfection... 63

10.2.1 Cleaning ...63 10.2.2 Disinfection ...63

10.3

Sterilisation ... 64

10.3.1 General information ...64 10.3.2 Steam sterilisation ...64 10.3.3 Sterilisation packaging ...65

11

Inspections, maintenance and repairs ... 66

11.1 11.2 11.3 11.4

Inspections during operation ... 66 Annual visual inspection ... 66 Maintenance every two years... 67 Repairs ... 67

12

Adjustments ... 68

12.1

Setting spring arm swivel range type AC 2000 LCH ... 68

12.1.1 Disconnecting the power to the lighting system ...68 12.1.2 Setting the swivel range...68

12.2

Setting spring arm swivel range type AC 2000 and type AC 3000 ... 69

12.2.1 Disconnecting the power to the lighting system ...69 12.2.2 Setting the swivel range...69

12.3

Setting spring arm swivel range type AC 5000 ... 70

12.3.1 12.3.2 12.3.3 12.3.4

Disconnecting the power to the lighting system ...70 Removing the covers ...70 Setting the swivel range...70 Installing the covers ...70

12.4

Setting spring arm spring force type AC 2000 LCH ... 71

12.4.1 Disconnecting the power to the lighting system ...71 12.4.2 Adjusting the spring force...71

12.5

Setting spring arm spring force type AC 2000 and type AC 3000 ... 72

12.5.1 Disconnecting the power to the lighting system ...72 12.5.2 Adjusting the spring force...72

12.6

Setting the spring arm spring force type AC 5000 ... 73

12.6.1 Disconnecting the power to the lighting system ...73 12.6.2 Adjusting the spring force...73

12.7

Adjusting the brake force of the friction brakes ... 74

12.7.1 Disconnecting the power to the lighting system ...74 12.7.2 Adjusting the braking force for the boom ...74

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Table of Content

12.7.3 12.7.4 12.7.5 12.7.6 12.7.7 12.7.8

Adjusting the braking force for the spring arm...75 Adjusting the brake of the convenience bracket on AC 3000...75 Adjusting the brake force of the cardan joint rod ...76 Setting the braking force of the cardan joint axle on the standard light head...77 Setting the braking force on the light head SLC / ALC plus...78 Setting the cardan joint axis braking force on the standard light head with camera...79

13

Consumables ... 80

14

Troubleshooting ... 81

15

Technical data ... 82

15.1 15.2 15.3

Equipment versions for the light models ... 82 Device data ... 82 EMC information... 86

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1

1.1

Important information regarding safe use

Details for the identification of the system

This instruction manual is solely intended for systems with rating plates that show the following information: – TruLight single – TruLight mobile – TruLight wall – TruLight duo – TruLight trio / quad

System identification

1.2 Updated status of this instruction manual

4038110 4038120 4038130 4038210 4038310

Details for identification of the instruction manual

To indicate the updated status of the instruction manual, all pages are marked with a 7-figure identification number and the status: – Material no.: – Date of publication: – Document number:

Identification of the instruction manual

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This identification coding is binding for the validity of the instruction manual and must not be removed irrespective of the type of publication (in printed or electronic form, in full or excerpted).

1.3

Designation of groups of individuals

The following groups of individuals are named in this instruction manual.

1.3.1

Operator

An operator (e.g. a medical practice, hospital, etc.) is any natural or legal person who owns a device and is authorised to use it or by whose authority the device is used. • The operator is obliged to provide a safe device and appropriately instruct the user regarding operation and proper use of the device.

1.3.2

User

Users are individuals who by their qualifications or an appropriate briefing by specialist personnel are authorised to operate and work with the device. • Users are fully responsible for the safe application of the device for the purpose intended.

1.3.3

Specialist personnel

Specialist personnel means authorised individuals, generally employed by the operator, who: • have acquired their knowledge by a technical education in the field of medical technology, • can assess the work they carry out on the basis of professional experience and briefing about safety regulations, and can recognize possible hazards in their work. • In countries where there is certification regarding performance of work in the field of medical technology, classification as specialist personnel requires the corresponding authorization.

1.4 Procedural guidelines

Information for operators

The device has been manufactured to the current state of technology and is operationally safe. • The device can nevertheless be a source of danger, especially when it is operated by inadequately trained personnel or is used incorrectly or not for the purpose intended.

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1

Important information regarding safe use

• The device may only be operated, cleaned, disinfected and maintained by qualified personnel.

1.4.1 Scope

This instruction manual is only valid after successful initial operation by the operator or an installer authorised by the manufacturer. • The device must be thoroughly cleaned and disinfected before its first use. • Once the device has been released for use, the information in this instruction manual will be binding for the user.

1.4.2 Obligation to inform

Availability of the instruction manual

The instruction manual is part of the device and must therefore be kept in a place in the immediate vicinity of the device to allow consultation regarding safety instructions and important operating information at any time. • Never hand the device to third parties without the valid instruction manual. Ensure that the instruction manual provided with the device is valid by checking the identity and version number.

1.4.3 Guarantee

Initial commissioning

Guarantee

Trumpf Medical guarantees the safety and functionality of the device as long as the following conditions are met: • the device is exclusively used for the purpose intended and is operated and maintained in accordance with the provisions of this instruction manual • only original spare parts or accessories approved by Trumpf Medical are used • no modifications are made to the device • inspections and maintenance work are carried out at the time intervals specified • an initial commissioning is carried out and the device is released for operation with a handover declaration

1.4.4

Maintenance and repair

The device or parts thereof may only be maintained or repaired by: • Trumpf Medical Customer Service • authorised service companies trained by Trumpf Medical • the operator's service personnel when trained and authorised by Trumpf Medical

1.4.5

Service life of the device

Trumpf Medical products are designed in compliance with all safety and maintenance requirements for a service life of 10 years. • This life span includes the functionality of the product when used according to the specifications in the instruction manual, a guaranteed service and the supply with spare parts. • Trumpf Medical makes use of a quality management system certified in accordance with DIN EN ISO 13485 for all company processes. • This guarantees: – Top quality – Easy operation – Functional design – Optimisation for the intended purpose

1.5

Date of manufacture

The rating plate indicates the date of manufacture of the device. The position of the rating plate on the device is shown in Chapter 4.1, page 24.

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1.6

Important information regarding safe use

Delivery

Before installation, check the delivered components for completeness and for any possible transportation damage. • To check the delivery, unpack all components and carry out visual inspection. • The components can be identified on the basis of the order number on the delivery note and / or the order-specific dimension sheet.

1.6.1 Damage claims

Accompanying documents

Claims for damage cannot be accepted unless Trumpf Medical is notified without delay. In the event of damage during transport or missing components, please send Trumpf Medical a report containing the following information: • Damage record giving details of damage or defects. • Primary serial number of the device or system or the serial numbers of the damaged components, • Order number (shown on the delivery note and/or the order-specific dimension sheet) • Name and address of the customer, • Consignee.

1.6.2 Returns

Transportation damage

Return address

In the event of a return, use the original packaging if possible. Address returns to: TRUMPF Medizin Systeme GmbH + Co. KG Carl-Zeiss-Straße 7–9 07318 Saalfeld Germany

1.7

Information for users

Note that the device may only be operated by persons who have had the corresponding instruction.

1.7.1 Instruction

Training must be carried out directly at the device by qualified staff of the operator or by an installer of the device who has been authorised by the manufacturer. • At the end of the briefing, it must be documented that the user in question has understood the special operating measures necessary regarding use for the intended purpose.

1.7.2 Dealing with problems

Conformity

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Training for use of the device

Obligation of the user to inform and to inspect

The instruction manual must be carefully read before commissioning to prevent possible injuries and damage to goods. • Check the functional capability and correct condition of the device before every application or handover for use. • While the device is in use, do not fail to comply with the provisions of the instruction manual. • Get the information you require from the operator’s technical service or from Trumpf Medical in the event of specific problems that are not treated in sufficient detail in this instruction manual.

1.8

Purpose of the device

1.8.1

Identification

The manufacturer declares that this product complies with the fundamental requirements according to MDD Appendix I and documents this by means of the CE and UL marking. 12

1

Important information regarding safe use

CE mark: This device is a Class I medical device as defined by the European Medical Device Directive (MDD). UL mark (only NRTL region)

UL marking: device has been tested by Underwriter Laboratories Inc. for the USA and Canada with regard to electric shock and fire hazard as well as mechanical hazards.

1.8.2

Standards and Directives

The device complies with the safety requirements of the following standards and directives: MDD • COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 concerning medical devices RoHS • DIRECTIVE 2011/65/EU OF THE EUROPEAN PARLIAMENT AND COUNCIL dated 8 June 2011 to restrict the use of specific harmful substances in electrical and electronic devices – EN 50581 Technical documentation for the assessment of electrical and electronic products with respect to the restriction of hazardous substances Electrical safety • EN 60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance • EN 60601-1-2 (IEC 60601-1-2) - Medical electrical equipment - Electromagnetic compatibility

1.8.3

Internationally applied standards

• UL 60601-1 • ANSI / AMI ES 60601-1 • CAN/ CSA-C22.2 No. 60601-1 • IEC 60601-1 • IEC 60601-1-2

1.8.4 Intended use

Intended use

The device is intended for use in a patient environment in hospitals or medical practices to illuminate a part of the patient with high light intensity for examination or surgical purposes. The working range lies at a distance between 70 cm to 150 cm to the wound area. The device is suitable for continuous operation. Application does not involve the patient; unintentional contact is possible. Each use exceeding the aforementioned conditions is not considered to be intended use. Only the user or operator will be liable for any loss or damage arising as a result.

Cleaning

Definition: small surgical light

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As part of daily clinical routine, the equipment is cleaned several times. This is most often done by turning around housing parts for wiping and drying that are usually facing down. Single light A small surgical light is a single lamp for use in operating theatres to support diagnoses or treatments that do not pose a risk to the patient due to interruptions by lighting failure (IEC 60601-2-41).

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1

Definition: Surgical lighting system

Surgical lighting system A surgical lighting system consists of two or multiple small surgical lamps and is usable without restrictions.

1.8.5 High light intensity Overlap of the light fields

Surgical interventions in the field of vision

Restriction

Special features

The light heads provide high light intensity to ensure good visual conditions for the surgeon. • Visible light generates heat in the operating area, due to physical effects. High irradiation densities are generated when the light fields of several light heads overlap. This can cause drying of tissue and, particularly after prolonged exposure, reduced perfusion and tissue damage. The light intensity must be reduced when perfusion is reduced or the tissue starts to dry out. • For operations in the field of vision with unprotected and open eyes, high levels of local light intensities of surgical lamps or direct visual contact with the laser beam may lead to damage to eyesight. The patient's eyes must be closed or protected as necessary (e.g. with safety goggles with an optical density of at least 2 or designed according to protection level 6 EN169). • The laser used in the ALC plus function to measure distance is classified as a class 2 laser, and has the following specifications: – max. output power 0.95 mW – wave length -620-690 nm, – beam divergence 0.16 x 0.6 mRad – pulse duration 0.4 x 10 ^ -9 s – pulse refresh rate 320 MHz.

1.8.6 Improper use

Important information regarding safe use

Improper use

• Additional load on the light support is not permitted. • The device may not be exposed to severe vibration. • The device is not suitable for operation in areas at risk of explosions • The device should not be used in the vicinity of strong magnetic fields • The device is not suitable for use in rooms or areas in which inflammable mixtures of anaesthetics with air or oxygen or laughing gas (N20) are used. • Mixtures of combustible anaesthetic vapours with oxygen or laughing gas may arise in the vicinity of the device in such a high concentration that ignition could occur under certain circumstances. The danger area according to EN 11197 lies in an area between 5 cm and 25 cm from the point of outflow or escape of the gas.

1.9

Ambient conditions for operation and storage

Various ambient conditions apply to the operation and temporary storage of the device.

1.9.1

Ambient conditions for operation

• Ambient temperature: • Relative humidity: • Air pressure: • Operating height

1.9.2

Ambient conditions for storage

• Ambient temperature: • Relative humidity: • Air pressure:

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10°C to 40°C; 30 % to 75 %; 700 hPa to 1060 hPa up to 3000 m above sea level

-15°C to 60°C; 5 % to 95 %; 500 hPa to 1060 hPa

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1.10 Observe the instruction manuals of combined medical devices

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Combination with other medical devices

• The system can be combined with medical devices from other manufacturers (e.g. monitoring systems). The operation of the devices is described in the relevant instruction manual. • Only medical devices approved in accordance with IEC 60601-1 or UL 60601-1 may be attached to the system. If a medical device is installed afterwards, the installation must be performed as specified in IEC 60601-1 and IEC 60601-1-1 or in accordance with the specifications provided by the manufacturer. Compliance with this standard must be ensured by the service technician responsible. • No BF or CF Class application components according to IEC 60601-1 may be directly connected. • Devices of third-party manufacturers in the patient environment must have safety levels equivalent to that of the TruLight 5000/3000 lighting systems. • Devices of third-party manufacturers outside the patient environment must have safety levels appropriate for the devices and compliant with the relevant IEC or ISO safety standards.

1.11

RoHS conformity

Important information regarding safe use

Disposal

The device should be disposed of in accordance with the pertinent national regulations and at a suitable waste disposal point for the recycling of electrical and electronic devices. • The device meets the requirements of Directive 2011/65/EU RoHS (restriction of the use of certain hazardous substances in electrical and electronic devices).

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2

2.1

Safety instructions

Structure of the safety instructions in this instruction manual

Important information is shown in this instruction manual by means of symbols and signal words.

2.1.1

Indicating risk of injury

Signal words such as DANGER, WARNING or CAUTION indicate the severity of the hazard. Various triangle symbols are used to add visual emphasis.

 DANGER

DANGER indicates an immediately dangerous situation in which non-compliance can cause death or serious injury.

 WARNING

WARNING indicates a potentially dangerous situation in which non-compliance may cause death or serious injury.

 CAUTION

CAUTION indicates a potentially dangerous situation in which non-compliance may cause minor injury.

2.1.2

ATTENTION

ATTENTION indicates a potentially dangerous situation in which non-compliance may cause damage to property.

2.1.3

NOTE

Indicating damage to property

Indicating additional information

NOTE provides you with additional information and helpful tips for safe and efficient use of the device.

2.2

Additional symbols for the safety information

Gas explosion: warns against the explosive ignition of gas mixtures.

Electric shock: warns against an electric shock, which can cause serious injury or even death.

The spring arm may bounce up: warns of the spring arm jumping up while dismantling the light head / flat screen.

Lighting system falling down: warns of a sudden downwards movement of the light system when it is exposed to additional load.

Patient eye protection: warns of damage to the patient's vision in examinations or surgery in the field of vision

Optical radiation: warns of possible damage to the retina by photobiologically active radiation (blue light of LEDs)

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2

Safety instructions

Risk of pinching: warns of pinching the fingers in the device.

Damage to surfaces: warns against damages to surfaces caused by unsuitable cleaning agents and disinfectants.

2.3

Symbols on the device

CE conformity mark: certifies that the device complies with the European Medical Device Directive (MDD).

Comply with instruction manual: makes reference to this instruction manual. UL marking: The device has been tested by Underwriter Laboratories Inc. for the USA and Canada. UL/cUL classification regarding electric shock, fire hazard and mechanical hazard only in accordance with UL 60601-1, 1st Edition, 2006-04-26, ANSI /AMI ES60601-1: 2005/(R) 2012 and CAN/CSA-C22.2 No. 60601-1: 2008. Makes reference to the need for users to read through the instruction manual for important safety information, such as warnings and precautionary measures which it may not be possible to apply to the medical device for a range of reasons.

1.

1x

2x!

2. KLICK!

!

3.

ca. 8 mm

Installation / dismantling of the securing ring: Only to be performed by authorised service personnel. The detailed instructions relating to the installation / dismantling of a securing ring must be complied with. Sensor marking: identifies the class of the laser product installed for distance measurement according to IEC 60825-1, Edition 2.0 (2007-03) and IEC 60825-1, Edition 3 (2014).

2.4

Overview of the most important safety instructions

Location requirements

 DANGER Gas explosion The lighting system is not suitable for use in an environment in which flammable mixtures of anaesthetics with oxygen or laughing gas in a high concentration are used. Mixtures of combustible anaesthetic vapours with oxygen or laughing gas may arise in the vicinity of the device in a sufficiently high concentration that ignition may occur under certain circumstances. The danger area according to EN 11197 lies in an area between 5 cm and 25 cm from the point of outflow or escape of the gas.

Strong magnetic fields The support arm systems of the lighting systems must not be used in the vicinity of strong magnetic fields.

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2

Safety instructions

BF/CF Class application components No BF or CF Class application components in accordance with IEC 60601-1 may be directly connected to the support arm systems of the lighting system.

 WARNING Electric shock The lighting system may only be connected to an appropriately earthed power supply with protective conductors in order to avoid the risk of an electric shock.

Electrostatic charge balance

 WARNING Complications due to electrostatic discharge To avoid complications due to electrostatic discharge between parts of the device and patients, the user must not touch parts of the surgical light and the patient at the same time.

Surgical interventions in the field of vision

 WARNING Damage to vision In case of surgery in the field of vision of the patient, the high light intensity by the light heads may cause eye fatigue or damage to vision: • The eyes of the patients must be closed, covered or protected, e.g. with protective goggles. • Do not look directly into the light-emitting surface area of the light.

Overlapping fields of illumination from several light heads

 WARNING Damage to patient's tissue Overlapping fields of illumination from several light heads with high intensity illumination may cause damage to tissue. In the event of incipient tissue dehydration: • Separate the fields of illumination from several light heads. • Reduce the light intensity of the light heads.

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2

Safety instructions

Contact with laser beams

 WARNING Damage to vision Direct contact with the laser beam may cause damage to vision: • Do not look directly into the laser beam • Protect the patient's eyes: The patient's eyes must be closed or protected as necessary (e.g. with safety goggles with an optical density of at least 2 or designed according to protection level 6 EN169). • Use of operating methods or procedures other than those stated in these instructions for use may result in dangerous radiation effects due to the laser.

Light intensity of the light head

 CAUTION LED failure After failure of the tenth LED, the light head does not achieve the specified light intensity. • Take the lighting system out of service. • Inform Trumpf Medical Customer Service. Exchanging a light head or repairs to the lighting system may only be performed by Trumpf Medial Customer Service or by service staff trained and authorised by Trumpf Medical.

Additional loads

 WARNING Crashing of the light system Do not place any additional weight on the light system

Swivel movement of the light head

 WARNING Risk of injury due to uncontrolled swivel movement Uncontrolled movement of the spring arm may result when the spring force of the spring arm is not correctly adjusted.

Risk of jamming When rotating the light head, the distance between the cardan joint and the light head changes: • Do not insert your fingers between the cardan joint and the light head when swivelling the light head. 55000-00011_002_01 – 1756789 – 2017-09-06

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2

Safety instructions

• Only position the light head by using the sterile handle or the nonsterile handles (outer handles).

Cleaning and disinfection

 WARNING Improperly used cleaning agents or disinfectants can pose a risk for patients or damage products If the following information and instructions are not observed or complied with, this may result in a risk of contamination or infection for the patient or damage to the product. Furthermore, it would render any claim for damages void! • Use the wipe-over method only for disinfection. • For cleaning and disinfection, only wipe with a damp but not wet cloth. • Dispense cleaning agents and disinfectants so that no liquid can enter through joints or openings of the surgical light or parts of the support arm system. • Use the surface disinfectant only at the concentration specified by the manufacturer. • Only use disinfectants approved by the manufacturer for use with the following materials: Polycarbonate (PC), polyamide (PA), acrylonitrile butadiene styrene copolymer (ABS), polystyrene (PS), polyurethane (PUR), polyphenylene sulphone (PPSU), polybutylene terephthalate (PBT) and silicones. • In the event of an increased layer formation of surface disinfectant, thorough cleaning must be performed. • Due to the risk of surface damage: – Do not use sharp, pointed or abrasive objects, – Do not use abrasive substances or agents which can remove material, – Do not use solvents, benzene, paint thinners, alkaline cleaning agents or cleaning agents containing acids or aldehydes, – Do not use agents with glycol derivatives, phenols, phenol derivatives or quaternary compounds, – To prevent paint or corrosion damage, only use agents that do not contain chlorides or halogenides.

• It is essential that the hygiene instructions of the operator are observed. For more detailed information about cleaning and disinfection, see Chapter 9, page 60

Adjustments

 CAUTION Adjusting the device The manufacturer guarantees the safety and proper working of the device only under the condition that the work of adjustment has been

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Safety instructions

done by an authorised hospital technician or a person with equivalent qualification.

Deinstallation for service purposes

 WARNING The spring arm may bounce up When the light head/flat screen is removed before moving the spring arm to the top-most limit stop position, the spring arm will shoot up and can cause severe injuries: • The light head/flat screen may therefore only be de-installed by Trumpf Medical Customer Service.

Commissioning

 CAUTION Initial commissioning prior to use The light system must be handed to the user in a tested state after initial operation before it can be used in routine medical procedures. • The initial operation includes functional and safety checks on the entire lighting system. • Handover must be documented by a handover declaration.

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