baxter TruLight 5000 User manual

Instructions for use
TruLight 5000 / 3000
Surgical light
ENGLISH
en-US
Read the instructions for use carefully before using the
product and keep them safe for future reference.

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TruLight 5000 / 3000
7990005_030_05 – 2078240 – 2023-01-19 3
Manufacturer Baxter Medical Systems GmbH + Co. KG
Carl-Zeiss-Straße 7-9
07318 Saalfeld
Germany
[email protected]
hillrom.com
Baxter Medical Systems GmbH + Co. KG is a Baxter International
Inc. company. The manufacturer is hereinafter referred to as
Baxter.
Technical Customer Service The contact details for the current Technical Customer Service
hubs in the individual countries are listed on the Internet at
www.hillrom.com.
Information about the document Original instructions for use
These instructions for use are included in paper form in the scope
of the product supply.
This document applies to the following sales units:
Supporting documents The products listed are individually combined with various Baxter
products. Chapter 2.1 lists the compatible products along with
their associated instructions for use. The instructions for use of all
the products used then apply.
The following additional documents are available online under
ois.hillrom.com/ois:
Phone: [phone]
Fax: [phone]
Document number: 7990005
Language ID: 030
Version: 05
Part number: 2078240
Date of publication: 2023-01-19
Product designation Part number
TruLight 5000 / 3000 Ceiling Single 4038110
TruLight 5000 / 3000 Mobile [phone]
TruLight 5000 / 3000 Wall 4038130
TruLight 5000 / 3000 Pendant 4038140
TruLight 5000 / 3000 Ceiling Duo 4038210
TruLight 5000 / 3000 Ceiling Trio 4038310
TruLight 5000 / 3000 Ceiling Quad 4038410
Product designation Document
number
SVHC list (Substances of Very High Concern) –

TruLight 5000 / 3000
47990005_030_05 – 2078240 – 2023-01-19
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TruLight 5000 / 3000
7990005_030_05 – 2078240 – 2023-01-19 5
Basic information
After purchase, the product is handed over to the operator in an appropriate and professional manner.
Handover is performed by someone authorized by the manufacturer and is documented using a
handover protocol.
Check the packaging on delivery for damage sustained during transport. If damage is noticed before
unpacking, contact the Technical Customer Service.
Before using the product, familiarize yourself with the settings options and how to operate the product.
Observe the information notices on the product.
About the instructions for use
– This instructions for use contain important information about the safe and effective use of this
product.
– The instructions for use are part of the product and must be complied with.
– Read the instructions for use carefully and fully before using the product. The instructions for use
must be thoroughly understood. In the event of uncertainty or questions about the product, please
contact the manufacturer.
– The instructions for use must also be handed over in the event of a change of location or personnel.
– The instructions for use must be kept where the product is used.
– The instructions for use must be easily accessible in full to all users of the product at all times.
– The figures in the instructions for use are highly simplified and are intended to provide a basic
understanding.
– Residual dangers that may occur while using the product are identified in the document with a signal
word. The safety measures required and potential consequences of failing to take these are listed. A
corresponding signal word provides information about the severity of the danger:
© Baxter Medical Systems GmbH + Co. KG
Reprinting, copying, or translating this document, in whole or in part, is forbidden without the express
written permission of Baxter. All rights under copyright law are expressly reserved by Baxter.
Signal word Meaning
DANGER The signal word indicates a dangerous situation that will immediately lead to
death or serious injury if no precautionary measures are taken.
WARNING The signal word indicates a dangerous situation that may lead to death or serious
injury if no precautionary measures are taken.
CAUTION The signal word indicates a dangerous situation that may lead to moderate to
slight injury if no precautionary measures are taken.
NOTICE The signal word indicates a dangerous situation that may lead to material
damage or damage to the environment if no precautionary measures are taken.

TruLight 5000 / 3000
67990005_030_05 – 2078240 – 2023-01-19
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Contents
7990005_030_05 – 2078240 – 2023-01-19 7
Contents
1 Usage specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9
1.1 Normal use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
1.2 Intended purpose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
1.3 Contraindication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
1.4 Patient definition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
1.5 Improper use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
1.6 User definition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
1.7 Usage environment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10
1.8 Ambient conditions for storage and transport . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10
1.9 Service life . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10
2 Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
2.1 Combination with other products from Baxter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
2.2 Combination with products from other manufacturers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
2.3 Operator's responsibility. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
2.4 Malfunction caused by other devices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
2.5 What to do in the event of a malfunction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
2.5.1 Failure of the surgical light electrical functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13
2.6 Information notices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
2.6.1 Safety instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
2.6.2 Position and meaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14
3 Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
4 Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
4.1 Overview of surgical light . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
4.1.1 Ceiling and wall-mounted versions: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
4.1.2 Mobile version . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
4.2 Summary of control modules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .19
4.2.1 Controls at the TruLight 3000 lamp head . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
4.2.2 Controls at the TruLight 5000 lamp head . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
4.2.3 Controls at the TruLight 5000 comfort strap . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
4.2.4 Wall control panel. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
4.2.5 Sterilizable ALC Handle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
4.2.6 Operating Integration System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
4.3 Illuminant . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
4.4 Power supply. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
4.5 Setting options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
4.5.1 Light field size . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
4.5.2 Lighting intensity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
4.5.3 ALC (Adaptive Light Control) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
4.5.4 ALC Plus (Adaptive Light Control Plus) - automatic . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
4.5.5 Color temperature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
4.5.6 Synchronization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
4.5.7 Operating range . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
4.6 Illuminated side handles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
5 Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .26
5.1 Safety instructions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
5.2 Installation of the wall and ceiling versions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
5.3 Inspections during operation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
5.4 Selection of functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
5.5 Connecting the power supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
5.5.1 Ceiling and wall-mounted versions: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
5.5.2 Mobile version . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

Contents
87990005_030_05 – 2078240 – 2023-01-19
5.6 Disconnecting the power supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
5.6.1 Ceiling and wall-mounted versions: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .30
5.6.2 Mobile version . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
5.7 Switching on the surgical light . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
5.8 Switching off the surgical light. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
5.9 Positioning the surgical light. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
5.10 Moving the mobile pedestal version . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
5.11 Adjusting the lighting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
5.11.1 Adjusting the light intensity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
5.11.2 Set color temperature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .34
5.11.3 Set size of light field . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .34
5.11.4 Adjusting the ALC (Adaptive Light Control) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .34
5.11.5 Adjusting the ALC Plus (Adaptive Light Control Plus) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
5.11.6 Synchronizing the color temperature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
5.12 Adjusting the swivel range of the spring arm up and down . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
5.12.1 Spring arm type AC 2000 NRH (Version: Low room height) . . . . . . . . . . . . . . . . . . . . . . . . . . 36
5.12.2 Spring arm. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
5.13 Adjusting the spring force. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
5.13.1 Spring arm type AC 2000 NRH (Version: Low room height) . . . . . . . . . . . . . . . . . . . . . . . . . . 37
5.13.2 Spring arm. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
5.14 Setting the brake force . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
5.14.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
5.14.2 Braking force for extension arm and spring arm. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
5.14.3 Brake force for the transmission joint . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
5.14.4 Brake force on the lamp head. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .40
5.15 Decommissioning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
6 Cleaning and disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .42
6.1 Wipe-down disinfection. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .43
6.2 Recommended disinfecting agents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .44
7 Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
8 Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
9 Repair . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
10 High-wear parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .47
11 Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
12 Technical data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
12.1 Device data. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .49
12.1.1 TruLight 3000. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .49
12.1.2 TruLight 5000. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .50
12.1.3 Support arm system swivel ranges . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
12.2 Electromagnetic compatibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
12.3 SVHC (Substance of very high concern) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .59
13 Product certification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60
13.1 European Union. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .60
13.2 USA/Canada. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .60
13.3 Ukraine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .60
13.4 Serbia . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .60

Usage specifications
7990005_030_05 – 2078240 – 2023-01-19 9
1 Usage specifications
1.1 Normal use
The surgical light system can have up to four support arms with up
to three lamp heads. In addition to the lamp heads, other products
can also be attached using a spring arm (e.g. VidiaPort spring arm
with monitor holder and monitor).
It is possible to attach a camera, depending on the lamp head.
The surgical light can be moved in a sterile manner by using a
sterile handle and be controlled in line with the version of the
handle and the lamp head.
The specifications and guidelines of the manufacturer must
always be adhered to.
1.2 Intended purpose
The product is used for visual illumination of the operating field or
the patient.
1.3 Contraindication
There are no known contraindications
1.4 Patient definition
No limitations in terms of patient age, gender or other
physiognomic features are imposed.
1.5 Improper use
– The light suspension unit must not be exposed to additional
loads.
– The surgical light may not be exposed to strong vibrations.
– The surgical light system must not be used for investigatory
and diagnostic purposes.
1.6 User definition
The users must be authorized for the use and service of the
product. Users can be sterile and non-sterile employees in the
operating room, such as surgeons, nurses, cleaning personnel, as
well as service, maintenance and hospital technicians.

Usage specifications
10 7990005_030_05 – 2078240 – 2023-01-19
1.7 Usage environment
DANGER
Risk of explosion posed by anesthetics
If high concentrations of flammable mixtures of anesthetic vapors
with oxygen or nitrous oxide occur in the environment for use of
the surgical light, there is a risk of ignition under certain
conditions. According to EN ISO 11197, the danger zone is formed
in a range between 5 cm/1.97 inch and 25 cm/ 9.84 inch from the
point where the gas leaks or escapes.
• The surgical light is not suitable for operation in explosive areas.
The surgical light is not suitable for use in rooms with
inflammable mixtures of anesthetics with air or oxygen or N2O
(nitrous oxide).
The surgical light may not be used near strong magnetic fields.
1.8 Ambient conditions for storage and transport
1.9 Service life
With normal use, the service life is 10 years.
Temperature: +10 °C to +40 °C / 50 °F to 104 °F
Air humidity: 30% to 75%
Atmospheric pressure: 70kPa to 106 kPa / 10 psi to 15 psi
Temperature: -15 °C to +60 °C / 5 °F to 140 °F
Air humidity: 5% to 95%
Atmospheric pressure: 50 kPa to 106 kPa / 7 psi to 15 psi
Fragile contents
Top
Keep dry

Safety
7990005_030_05 – 2078240 – 2023-01-19 11
2Safety
2.1 Combination with other products from Baxter
Baxter offers a wide variety of products for further equipping of
the surgical light. Not all products are available in all countries.
Detailed information can be obtained from the relevant
representative offices of Baxter, which are represented
worldwide. Contact details are available online at hillrom.com.
Use of the surgical light is permitted in combination with the
following Baxter products. The products are described in separate
instructions for use, which must be read carefully and in full. The
document number of the instructions for use is listed in the
column on the right.
Pre-assembly set
Ceiling-mounted
supply unit
Camera
Support arm
Product designation Part number Document
number
Pre-Install Set TruLight 5000 /
3000
4038051 7990000
Product designation Part number Document
number
TruPort Solo / Tandem
preparation
4037210 7990001
TruPort Tandem addition 4037220 7990001
FCS 500 Ceiling Carrier ML Solo/
TanPrep
4037251 7990002
FCS 500 Ceiling Carrier ML
TanAdd
4037252 7990002
FCS 500 Ceiling Carrier HL Solo/
TanPrep
4037261 7990002
FCS 500 Ceiling Carrier HL
TanAdd
4037262 7990002
Product designation Part number Document
number
TruVidia HD 2000 2072249 7990006
TruVidia HD 5000 2072520 7990006
TruVidia HD 7500 2072521 7990006
Product designation Part number Document
number
VidiaPort Springarm Bottom 4028150 7990008
VidiaPort Springarm Top 4028155 7990008
VidiaPort Springarm Middle 4028152 7990008

Safety
12 7990005_030_05 – 2078240 – 2023-01-19
Sterilizable handle
2.2 Combination with products from other manufacturers
The surgical light is not designed for combination with products
from other manufacturers (third-party products) and where no
compatibility tests have been carried out by Baxter. Baxter does
not, however, exclude combination with third-party products. If
the operator intends to combine the surgical light with third-party
products, the operator is responsible for this combination. Baxter
accepts no responsibility for the combination of the surgical light
with third-party products. The guarantee/warranty for products
from Baxter may become void in the event of combination with
third-party products.
2.3 Operator's responsibility
The operator is the natural or legal person who operates the
product himself for commercial or economic purposes or who
leaves its operation to a third party. The operator bears the legal
product responsibility for protecting personnel or third parties.
The medical device may only be operated and applied according
to its 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.
Instruction regarding the proper handling of the medical device is
required. However, training is not required when the medical
device is self-explanatory or instructions for a product with the
same design have already been provided.
Medical devices connected to each other as well as medical
devices connected to accessories including software, or other
objects, may only be operated and used when the specific
combination is suitable with regard to its intended purpose and
the safety of the 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.
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.
Product designation Part number Document
number
Sterilizable ALC Handle 1660214 7990009
Sterilizable Central Handle 4025708 7990009

Safety
7990005_030_05 – 2078240 – 2023-01-19 13
2.4 Malfunction caused by other devices
There are no known functional failures of the surgical light due to
other devices.
2.5 What to do in the event of a malfunction
In the event of a failure of the electrical functions of the surgical
light, the surgical light is to be disconnected from the power
supply and the Technical Customer Service notified.
2.5.1 Failure of the surgical light electrical functions
According to current state-of-the-art technology, failure of the
surgical light cannot be completely ruled out, with the result that
the electrical functions on the operating table are no longer
available. In this rare case, stop using the surgical light and notify
the Technical Customer Service.
2.6 Information notices
2.6.1 Safety instructions
– The information notices on the product provide information
about residual dangers during use, or provide additional useful
information.
– The device label and all information notices must be present
and be undamaged in the prescribed locations on the product.
A damaged, illegible or missing device label / information
notice must be replaced immediately.
– Observe the information notices on the product.
– The information notices must not be altered or removed.

Safety
14 7990005_030_05 – 2078240 – 2023-01-19
2.6.2 Position and meaning
3
A
B
A
B
C
C
2
8
8
1
9
9
18
9
5
10
9
4
679
9
9
9
9
7a
7a
7a
No. Information
notice
Meaning
[1] Note to the service technician for mounting the circlip on the
spring arm (connection to the extension arm)
[2] Pull the mains power plug out of the socket before opening the
housing.
[3] Manufacturer’s logo
[4] Follow the instructions for use
[5] Laser identification
Class of the installed laser product for distance measurement
according to EN/IEC 60825-1:2007
[6] UL mark: device tested by Underwriter Laboratories Inc. for use
in the USA and Canada

Safety
7990005_030_05 – 2078240 – 2023-01-19 15
[7] – PATENTS / PATENT www.hillrom.com/patents
May be covered by one or more patents. See above Internet
address. The Hillrom companies are the proprietors of
European, US, and other patents and pending patent
applications.
[7a] Not available –
[8] Device label of the surgical light system
[9] Device label for the individual component
[10] Additional device label (TruLight 5xxx)
Manufacturer
Unique device identification (UDI), comprising:
– Data Matrix Code
– (01) Global Trade Item Number (GTIN)
– (11) Date of manufacture (Year Month Day)
– (21) Serial number
– (240) Part number
Baxter part number
Serial number
Medical product
The device conforms to Regulation 2017/745/EU concerning
medical devices.
Caution! Follow the warnings in the instructions for use!
The product must be disposed of at a suitable disposal facility
for the recycling of electrical and electronic devices in
accordance with the requirements of Directive
WEEE II 2012/19/EU and country-specific regulations.
Date of manufacture
No. Information
notice
Meaning

Summary
16 7990005_030_05 – 2078240 – 2023-01-19
3Summary
The surgical light can be custom combined using various Baxter
products. The approved products are listed in Chapter 2.1.
12
11
15
12
14
A
B
11
15
16
13
17
17
17
[A] Ceiling version of the surgical light (for example, Solo)
[B] Ceiling version of the surgical light on a ceiling-mounted
supply unit (pedestal)
[11] Surgical lights
[12] VidiaPort support arm
[13] TruVidia HD camera
[14] VidiaPort monitor holder
[15] Flat screen
[16] Ceiling-mounted supply unit (FCS 700 Ceiling Supply Unit)
[17] Sterilizable handle

Description
7990005_030_05 – 2078240 – 2023-01-19 17
4Description
4.1 Overview of surgical light
4.1.1 Ceiling and wall-mounted versions:
The lamp head is mounted using a support arm system to the
ceiling or a wall. The support arm system can be used to turn the
lamp head in any direction and to align it accurately with the
wound field. The surgical light is operated via the controls on the
lamp head or via the separate wall control panel (optional). The
light system can be individually adjusted with the following
functions:
Function TruLight
3000 5000
Light field size – x
Lighting intensity x x
ALC (Adaptive Light Control) x x
ALC Plus
(Adaptive Light Control Plus)
–x
Color temperature – x
Synchronization – x
Ceiling-mounted version
(for example, Ceiling Duo)
Wall-mounted version
20
20
20
21
28
22
22
22
23
27
24
23
23
24
26
26
30
29
24 27
19
18
25 17
[17] Sterilizable handle
[18] Ceiling conduit
TruLight 5000 / 3000 Pendant: Light adjustment on the
ceiling-mounted supply unit
[19] Control panel at the wall control panel
(Example TruLight 5x20)

Description
18 7990005_030_05 – 2078240 – 2023-01-19
4.1.2 Mobile version
The mobile surgical light is a mobile individual lamp head with
spring arm. The surgical light can be moved freely in any direction,
since the 4 wheels are all able to rotate on their own axes. Two
wheels arranged diagonally on the stand foot can be braked. The
parking brake allows the surgical light to be safely parked.
The lamp head is attached to a spring arm. The spring arm can be
used to turn the lamp head in any direction and to align it
accurately with the wound field. The surgical light is operated with
the controls on the lamp head or the power supply unit. The light
system can be individually adjusted with the following functions:
[20] Extension arm
[21] Spring arm
[22] Comfort strap
[23] Lamp head
[24] Control element
Depending on the version at the comfort strap or the lamp
head.
The functions available on the controls depend on the
functional scope of the surgical light.
[25] Transmission joint
[26] Non-sterile side handle (illuminated for TruLight 5000)
[27] Handle adapter (holder for the sterilizable handle)
for TruLight 5x20 with ALC Plus (laser measuring unit)
[28] Spring arm type AC 2000 NRH (Version: Low room height)
[29] Wall bearing
[30] Camera holder
Function TruLight
3000 5000
Light field size – x
Lighting intensity x x
ALC (Adaptive Light Control) x x
ALC Plus
(Adaptive Light Control Plus)
–x
Color temperature – x
Synchronization – x

Description
7990005_030_05 – 2078240 – 2023-01-19 19
4.2 Summary of control modules
The functions of the surgical light are set with the following control
units:
– Control element
– Sterilizable ALC Handle (#1660214)
– Wall control panel
The wall control panel is used for external control of the
surgical light.
– User interface of an external control unit (operating integration
systems)
The control units available depend on the configuration of the
surgical light.
[17] Sterilizable handle
[23] Lamp head
[24] Control element
The functions available on the controls depend on the
functional scope of the surgical light.
The functional scope of the controls on the lamp head can
be more limited than the functional scope of the controls on
the power supply unit.
[25] Transmission joint
[26] Non-sterile side handle (illuminated for TruLight 5000)
[27] Handle adapter (holder for the sterilizable handle)
[28] Spring arm type AC 2000 NRH (Version: Low room height)
[31] Pedestal rod
[32] Power supply unit
[33] Mains power cable
[34] Connector socket for power cable
[35] On/ Off switch (underside of the power supply unit)
[36] Wheel
[37] Stand foot
36
34
35
27
37
33
31
28
26
25
23
24
24
17
32

Description
20 7990005_030_05 – 2078240 – 2023-01-19
4.2.1 Controls at the TruLight 3000 lamp head
4.2.2 Controls at the TruLight 5000 lamp head
[i2] Switching the surgical light function on and off
[i3] Reducing the lighting intensity function
[i4] Increasing the lighting intensity function
[i8] ALC (Adaptive Light Control) function - setting the working
distance
(80 cm/31.50 inch; 100 cm/39.37 inch; 120 cm/47.24 inch)
Status indicator on the button: The indicator lights up when
the distance is switched on.
[a1] Lighting intensity indicator (Endo < 10%, 6 steps: 50% - 100%)
[a6] Endo indicator
The indicator lights up when the Endo lighting intensity is
switched on.
[a3] Working distance indicator
(3 steps from left to right: 80 cm/31.50 inch; 100 cm/
39.37 inch; 120 cm/47.24 inch)
i3 i4
a6
a1
i2 i8 i8 i8
a3 a3 a3
[i2] Switching the surgical light function on and off
[i3] Reducing the lighting intensity function
[i4] Increasing the lighting intensity function
[i7] Synchronize color temperature (optional)
[a1] Lighting intensity indicator (Endo < 10%, 6 steps: 50% - 100%)
[a4] Narrow light field indicator
The indicator lights up when the narrow light field is
switched on.
[a5] Wide light field indicator
The indicator lights up when the wide light field is switched
on.
[a6] Endo indicator
The indicator lights up when the Endo lighting intensity is
switched on.
i3 i4
a6
a1
i2
i7
a5a4