TruLight 1000 Examination Light system Instructions for Use June 2020

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Examination Light Manufacturer

TRUMPF Medizin Systeme GmbH + Co. KG Carl-Zeiss-Straße 7-9 07318 Saalfeld Germany Telephone: Fax:

+49 3671 586-0 +49 3671 586-41165

[email protected] hillrom.com Trumpf Medizin Systeme GmbH + Co. KG is a subsidiary of HillRom Holdings, Inc. The manufacturer is hereinafter referred to as Trumpf Medizin Systeme. Authorised Australian Sponsor

Technical Customer Service

Information about the document

Trumpf Med (Aust) Pty Ltd Unit 4.01, 2-4 Lyonpark Road Macquarie Park NSW 2113 Telephone: +1 800 650 083 The contact details for the current sites of the Technical Customer Service in the individual countries are listed on the Internet at hillrom.com. Original instructions for use Document number: Language ID: Version: Material number: Date of publication:

7990083 002 00 2075982 2020-06-12

The instructions for use are in print format and form part of the product delivery scope. This document applies to the following sales units: Designation

Material number

Examination Light

Other applicable documents

TruLight 1000 / ceiling

4058110

TruLight 1000 / wall

4058120

TruLight 1000 / Mobile

4058130

TruLight 1000 / pendant

4058140

The products listed are individually combined with various Trumpf Medizin Systeme products. Chapter 2.1 lists the compatible products and their associated instructions for use. The instructions for use for all products used apply.

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Examination Light

Basic information After purchasing, the product is correctly and professionally handed over to the operator. The handover is carried out by a person authorised by the manufacturer and is documented with the aid of a handover report. On delivery, the packaging should be checked for any transport damage. In the event of damage, please contact the Technical Customer Service before unpacking. Ensure that you are familiar with the adjustment options and the operation of the product before using it. Pay attention to the signs on the product. About these instructions for use – The instructions for use contain important information on the safe and effective use of the product. – The instructions for use are part of the product and must be followed. – Read the instructions for use carefully and in full before using the product. The instructions for use must be properly understood. If anything is unclear, or if any questions arise about the product, please contact the manufacturer. – The instructions for use must be passed on in case of relocation or change of personnel. – The instructions for use must be available at the place where the product is used. – The instructions for use must be fully accessible to all users of the product at any time. – The diagrams in the instructions for use are a simplified version for basic comprehension. – Residual risks that may occur when handling the product are identified in the document using a signal word. The necessary safety measures and possible risks are listed if they are not observed. A corresponding signal word identifies the severity of the danger: Signal word

Meaning

DANGER

This signal word denotes a dangerous situation that will lead to immediate death or severe injury, unless precautionary measures are taken.

WARNING

This signal word denotes a dangerous situation that may lead to death or severe injury, unless precautionary measures are taken.

CAUTION

This signal word denotes a dangerous situation that may lead to moderate or slight injury, unless precautionary measures are taken.

NOTICE

This signal word denotes a situation that may lead to product or environmental damage, unless precautionary measures are taken.

© TRUMPF Medizin Systeme GmbH + Co. KG Reprinting, copying, or translating this document, in whole or in part, is prohibited without the express written permission of Trumpf Medizin Systeme. All rights under the copyright laws are expressly reserved by Trumpf Medizin Systeme.

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Contents

Contents 1 1.1 1.2 1.3 1.4 1.5 1.6 1.7

Usage specifications... 9 Intended purpose... 9 Contraindication... 9 Patient definition... 9 User definition... 9 Use environment... 9 Storage and transport conditions... 9 Service life...10

2 2.1 2.2 2.3 2.4 2.5 2.5.1 2.6 2.6.1 2.6.2

Safety... 10 Combination with other Trumpf Medizin Systeme products...10 Combination with products of other manufacturers... 11 Responsibility of the operator... 11 Malfunction due to other devices... 12 Behaviour in the event of a fault... 12 Failure of the electrical functions of the examination light... 12 Signs... 12 Safety instructions... 12 Location and meaning... 13

3

Overview... 15

4 4.1 4.1.1 4.1.2 4.1.3 4.1.4 4.1.5 4.2 4.3 4.4 4.4.1 4.4.2

Description... 16 Overview of the examination light... 16 Ceiling-mounted version (TruLight 1000 / ceiling)... 16 Light on a ceiling-mounted supply unit (TruLight 1000 / pendant)... 17 Wall-mounted version (TruLight 1000 / wall)... 18 Mobile version (TruLight 1000 / Mobile)... 19 Control panel... 20 Light bulbs... 20 Power supply... 20 Setting options... 21 Lighting intensity... 21 Working range... 21

5 5.1 5.2 5.3 5.4 5.4.1 5.4.2 5.4.3 5.5 5.5.1 5.5.2 5.5.3 5.6 5.7 5.8 5.9 5.10 5.11 5.12 5.13

Use... 22 Safety instructions... 22 Installation of the examination light... 24 Inspections during operation... 25 Establish the power supply... 26 Light with fixed connection (Wall, Ceiling, Pendant variants)... 26 Wall-mounted version with cable connection... 26 Mobile stand version... 27 Disconnecting the power supply... 27 Light with fixed connection (Wall, Ceiling, Pendant variants)... 27 Wall-mounted version with cable connection... 28 Mobile stand version... 28 Switching on the examination light... 28 Switching off the examination light... 28 Positioning the examination light... 29 Moving the mobile stand version... 30 Setting the lighting intensity... 31 Adjusting the spring force on the spring arm... 31 Adjusting the braking force of the 1/4 bracket... 32 Decommissioning... 32

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Contents 6 6.1 6.2

Cleaning and disinfection...33 Wipe-over disinfection... 34 Recommended disinfectants... 35

7

Troubleshooting...36

8

Maintenance...37

9

Repair...37

10

Consumables...37

11

Disposal...38

12 12.1 12.2 12.3 12.4

Technical data... 39 Device data... 39 Rotation and swivel ranges of the support arm system...40 SVHC (substance of very high concern)... 41 Electromagnetic compatibility... 41

13 13.1 13.2

Product certification... 46 European Union...46 USA/Canada...46

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Usage specifications

1

Usage specifications

1.1

Intended purpose The examination light is intended to be used to provide visible illumination of the area to be examined.

1.2

Contraindication No contraindications have been found.

1.3

Patient definition No restrictions are made in terms of patient age, weight or other physiognomic characteristics.

1.4

User definition 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 intended purpose.

1.5

Use environment Temperature: Humidity: Air pressure: Operating height:

1.6

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

Storage and transport conditions Temperature:

-15°C to +60°C

Humidity:

5 % to 95 %

Air pressure:

700 hPa to 1060 hPa

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Safety

Fragile packaged goods

Top

Protect against moisture

1.7

Service life The service lifetime is 10 years, if used normally.

2

Safety

2.1

Combination with other Trumpf Medizin Systeme products Trumpf Medizin Systeme offers a variety of products for further attachment to the examination light. Not all products are available in all countries. Detailed information is available from the individual Trumpf Medizin Systeme branches, which can be found worldwide. Contact details are available online at hillrom.com. The examination light may be used in combination with the following Trumpf Medizin Systeme products. The products are described in separate instructions for use, which users must read carefully and in full. The document number of the instructions for use is listed in the right column. Pre-assembly set

Ceiling-mounted supply unit

10

Designation

Material number

Document number

TruLight 1000 / ceiling

4058110

–

TruLight 1000 preinstallation set

4058051

7990086

Designation

Material number

Document number

TruLight 1000 / pendant

4058140

–

FCS 700 Ceiling Supply Unit Solo/ TanPrep

4037210

7990001

FCS 700 Ceiling Supply Unit TanAdd

4037220

7990001

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Safety Accessories

Accessories from Trumpf Medizin Systeme are intended to be used together with the examination light in order to facilitate or support its intended purpose. Designation

Material number

Document number

4025708

7990009

Sterilisable handle Sterilisable Central Handle

2.2

Combination with products of other manufacturers The examination light is not intended for use with products of other manufacturers (third-party products) and Trumpf Medizin Systeme has not performed any compatibility tests. Exceptions to this are mentioned explicitly in these instructions for use. However, Trumpf Medizin Systeme does not exclude the possibility of use with third-party products. If the operator intends to combine the examination light with third-party products, the operator will be responsible for such combination. Trumpf Medizin Systeme does not accept responsibility for the combination of the examination light with third-party products. The guarantee/warranty for the Trumpf Medizin Systeme products may become void if they are combined with third-party products.

2.3

Responsibility of the operator The operator is the natural or legal person who directly operates the product for commercial or economic purposes or allows a third party to use it. The operator has legal product responsibility regarding the protection of personnel or third parties. The medical devices may only be operated and used according to their intended purpose and the general rules of technology. Medical devices may only be used by persons who have the training or knowledge required to do this. Training on the proper handling of the medical device is required. However, training is not required when the medical device is selfexplanatory or instructions for a product with the same design have already been provided. Interconnected medical products, as well as those combined with accessories, including software or other objects, may be operated and used only if they are suitable for use in this combination, taking into account their intended purpose and the safety of patients, users, employees or third parties. Before the medical device is applied, the user must ensure that the product is operational and in an appropriate state and the user must further have read the instructions for use as well as other, attached, safety-relevant information and maintenance instructions. The instructions for use and the instructions provided with the medical device must be stored in a way that ensures that the user can access the information required for using the medical device at any time.

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Safety The user and/or patient must report any serious incidents related to the use of the medical device to the manufacturer and the relevant authorities of the member state of which the user and/or the patient is a resident.

2.4

Malfunction due to other devices There is no known functional interference by other devices with the examination light.

2.5

Behaviour in the event of a fault If the electrical functions of the examination light fail, isolate the examination light from the power supply and contact the Technical Customer Service.

2.5.1

Failure of the electrical functions of the examination light According to the current state of technology, failure of the examination light cannot be completely excluded, in which case the electrical functions of the examination light would no longer be available. In this rare case, do not continue to use the examination light and inform the Technical Customer Service.

2.6

Signs

2.6.1

Safety instructions – Signs on the product inform about residual risks during use or provide useful additional information. – The device label and all signs must be undamaged and attached at the specified locations on the product. A damaged, illegible or missing device label/sign must always be replaced. – Pay attention to the signs on the product. – Signs may not be changed or removed.

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Safety 2.6.2

Location and meaning

TruLight 1000 / pendant

TruLight 1000 / ceiling

H A

I

B

C

B

C

B

C

A B

A

A

TruLight 1000 / Mobile TruLight 1000 / wall

D

G E F

No.

C

I

Sign

Meaning

[A]

UL marking: device has been tested by Underwriter Laboratories Inc. for the USA and Canada

[B]

Note for the service technician when mounting the safety ring on the spring arm (connection to the boom)

[C]

Not available

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–

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Safety

No.

Sign

Meaning

[D]

Safety information

[E]

Before installation/removal of mains plug

[F]

Observe the instructions for use

[G]

Notes on patents for TruLight 1000

[H]

Device label for the examination light

[I]

Device label for the individual component Manufacturer Trumpf Medizin Systeme material number Serial number Follow the instructions for use Caution! Note the warning information in the Instruction Manual! The product must be disposed of in accordance with the requirements of Directive 2012/19/EU on WEEE II and relevant national regulations at a suitable waste disposal point for the recycling of electrical and electronic devices. Product is declared compliant with Regulation 2017/745/EU concerning medical devices. Manufacturing date

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Overview

3

Overview The examination light is available as a permanently installed version or mobile version.

A

B

C D

[A] [B] [C] [D]

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Examination light in combination with a ceiling-mounted supply unit (TruLight 1000 / pendant) Ceiling-mounted version of the examination light (TruLight 1000 / ceiling) Wall-mounted version of the examination light (with fixed or cable connection) (TruLight 1000 / wall) Mobile version of the examination light (TruLight 1000 / Mobile)

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Description

4

Description

4.1

Overview of the examination light The TruLight 1000 examination light may be used in a variety of settings including, but not limited to, Physicians’ offices, hospitals including anesthesiology, procedure rooms, laboratories, recovery rooms, critical and intensive care, emergency department (ED) and general functional rooms. TruLight 1000 ceiling, wall and pendant mounted examination lights are permanent installations with a movement radius of up to 1.7 meters.

4.1.1

Ceiling-mounted version (TruLight 1000 / ceiling) The light head is attached to the ceiling with a single arm support arm system. The support arm system can be used to position the light head, accurately pointing at the examination field. The light head has a sterilisable handle to allow sterile positioning. The examination light is operated ergonomically with the nonsterile control panel on the light head. Light intensity can be set as preferred.

1

2 8 4

5

3 6 7

A

[1]

[2] [3] [4] [5] [6]

16

Canopy Under the canopy, there is the ceiling fastening and the components for the power supply to the examination light. Ceiling conduit Boom (horizontally rotatable) Spring arm (adjustable horizontally and vertically) Light head 1/4 bracket

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Description

[7] [8] [A] 4.1.2

Handle adapter with sterilisable handle [A] for sterile positioning of the light head Control panel for switching the light head on/ off and for adjusting light intensity Sterilisable handle (accessory)

Light on a ceiling-mounted supply unit (TruLight 1000 / pendant) The light head is equipped with a single-armed support arm system and is fastened to a ceiling-mounted supply unit. The support arm system can be used to position the light head, accurately pointing at the examination field. The light head has a sterilisable handle to allow sterile positioning. The examination light is operated ergonomically with the nonsterile control panel on the light head. Light intensity can be set as preferred.

8 4

5

6 3 B

7

A

[3] [4] [5] [6] [7] [8] [A] [B]

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Boom (horizontally rotatable) Spring arm (adjustable horizontally and vertically) Light head 1/4 bracket Handle adapter with sterilisable handle [A] for sterile positioning of the light head Control panel for switching the light head on/ off and for adjusting light intensity Sterilisable handle (accessory) Light adaptation at the ceiling-mounted supply unit

17

Description 4.1.3

Wall-mounted version (TruLight 1000 / wall) The light head is attached to the wall with a single-armed support arm system. The support arm system can be used to position the light head, accurately pointing at the examination field. The light head has a sterilisable handle to allow sterile positioning. The examination light is operated ergonomically with the nonsterile control panel on the light head. Light intensity can be set as preferred.

8 5 4 7 6 A 3

9

10 11

12

13

[3] [4] [5] [6] [7] [8] [9] [10] [11] [12] [13] [A]

18

Boom (horizontally rotatable) Spring arm (adjustable horizontally and vertically) Light head 1/4 bracket Handle adapter with sterilisable handle [A] for sterile positioning of the light head Control panel for switching the light head on/ off and for adjusting light intensity Wall support Power supply box with fixed connection 100 V to 240 V Power supply box fed by a mains power cable with colddevice plug, 100 V to 240 V Connector socket for the power cable Mains power cable Sterilisable handle (accessory)

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Description 4.1.4

Mobile version (TruLight 1000 / Mobile) The mobile examination light is a mobile individual light with a spring arm (single-armed support arm system). The examination light can be moved freely in any direction, as all 4 wheels are able to turn on their own axles. The front wheels can be braked. The parking brake can be used for safe parking of the examination light. The light head is attached to a spring arm. The spring arm can be used to position the light head as desired, accurately pointing at the examination field. The light head has a sterilisable handle to allow sterile positioning. The examination light is operated ergonomically with the nonsterile control panel on the light head. Light intensity can be set as preferred. [4]

8 5

7

6 4

[5] [6] [7] [8]

A

[12] [13] [14] [15] [16] [17] [18] [19] [A] [B]

17

18 12

Spring arm (adjustable horizontally and vertically) Light head 1/4 bracket Handle adapter with sterilisable handle [A] for sterile positioning of the light head Control panel for switching the light head on/ off and for adjusting light intensity Connector socket for the power cable Mains power cable Stand base Wheel Front wheel with parking brake (locking [B]) Stand rod Support handle for moving the examination light Power supply unit Sterilisable handle (accessory) Locking

13 19 14

15

16

16

B

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Description 4.1.5

Control panel

a1 i2

4.2

i3

i4

TruLight 1000

[i2] [i3] [i4]

Function to switch the examination light on and off Function to reduce the lighting intensity Function to increase the lighting intensity

[a1]

Light intensity indication (30%, 60%, 100%)

Light bulbs The examination light is equipped with LED light bulbs. The use of many LEDs means that the examination light is unlikely to fail. The failure of up to 3 LEDs does not adversely affect the basic functions of the examination light, meaning it will remain fully functional. The examination light may no longer be used only if more than 3 LEDs have failed.

4.3

Power supply Light with fixed connection (Wall, Ceiling, Pendant variants): The examination light is firmly connected to the external power supply in the room and can only be disconnected from the power supply in an emergency, for cleaning or for servicing. The examination light does not have its own breaker devices to isolate it from the mains power. The power supply can therefore only be switched off at the consumer unit. Wall-mounted version with cable connection: The examination light is connected to the power network of the room using a mains power cable. The wall-mounted version (protection class I) may only be connected to an earthed safety socket. Mobile stand version: The mobile stand version of the examination light is connected to the mains of the room via the mains power cable. The mobile stand version (Protection Class I) must only be connected to an earthed socket.

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