marLED E9 , E9i and E15 Operating Instructions Rev 2 May 2016

Symbol Explanation Safety alert symbol CAUTION

Indicates a situation which, if not avoided, could result in minor or moderate injury.

WARNING

Indicates a situation which, if not avoided, could result in death or serious injury.

DANGER

Indicates a situation which, if not avoided, will result in death or serious injury.

Instructions for Use

Follow Instructions for Use

Reference number for ordering Gebrüder Martin products (item number) Serial number Store in a dry place

Information on minimum and maximum temperature for storage and transportation. See section 10 “Technical Data”, page 45 for valid values.

Information on minimum and maximum atmospheric pressure for storage and transportation. See section 10 “Technical Data”, page 45 for valid values. Information on minimum and maximum atmospheric humidity for storage and transportation. See section 10 “Technical Data”, page 45 for valid values. Fragile, avoid pressure and shock

Arrows pointing up, transport and store upright

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Stacking height max. 2 layers, max. load 250 kg per item

Manufacturer CE marking of conformity NRTL certification mark from TÜV Rheinland

Warning: Dangerous high voltage!

This product may not be disposed of as normal household garbage, see section 8.2 “Disposal of the Device”, page 40.

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Instructions for Use Operating Lights marLED® E9/E9i/E15

Contents 1

Notices Concerning this Document ... 6

1.1 1.2 1.3 1.4

Safety ... 6 Terms & Acronyms ... 6 Validity of this Document ... 7 Symbols Used in this Document ... 7

2

Product Liability and Warranty ... 8

2.1 2.2 2.3 2.4

General Information ... 8 Hotline ... 8 User’s Inspection ... 8 Warranty ... 9

3

Intended Use ... 10

3.1 3.2 3.3

Intended Purpose ... 10 Patient Group/Patient Selection... 10 Users ... 10

4

Mounting ... 11

5

Use ... 12

5.1

Description of the Components ... 12

5.1.1

Lights ... 12

5.1.2

LED Technology ... 13

5.1.3

Starting Performance ... 13

5.1.4

Emergency Power (ASPS) Changeover Module ... 13

5.1.5

Camera surgiCam ... 14

5.2

Commissioning ... 15

5.2.1

Attaching and Replacing the Sterilizable Handle ... 16

5.2.2

Attaching and Replacing the Sterile Disposable Cover ... 17

5.3

Operation ... 18

5.3.1

Personal Protection ... 18

5.3.2

Non-Sterile and Sterile Operation ... 20

5.3.3

Operation via the Control Panel ... 21

5.3.4

Operation via the sensoGrip ... 25

5.3.5

Operation via the Wall Box (Option) ... 26

5.3.6

Operation via the marTouch® Control Unit (Option) ... 26

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Instructions for Use Operating Lights marLED® E9/E9i/E15

6

Processing ... 27

6.1 6.2 6.3

Basic Notes on Care and Reprocessing ... 27 Cleaning of Externally Accessible Parts ... 29 Manual Disinfection of Externally Accessible Parts ... 29

6.3.1

Wipe Disinfection ... 29

6.4

Machine Disinfection and Sterilization of the Handles ... 31

7

Maintenance... 33

7.1 7.2 7.3 7.4

General Information ... 33 Regular Checks to Be Carried out by Owner/Operator ... 34 Maintenance to Be Performed by Manufacturer... 34 Troubleshooting ... 35

7.4.1

marLED® E9/E9i/E15 ... 35

7.4.2

surgiCam ... 36

7.5

Safety Checks (SC) ... 37

7.5.1

marLED® E9/E9i/E15 ... 37

7.5.2

surgiCam ... 38

7.6 7.7

Serial Number Structure ... 39 Accessories ... 39

8

Disposal ... 40

8.1 8.2

Packaging ... 40 Disposal of the Device ... 40

9

Guidelines and Manufacturer’s Declaration Regarding Electromagnetic Compatibility (EMC) ... 41

10

Technical Data ... 45

10.1 10.2

Technical Data for marLED® E9/E9i/E15 ... 45 Technical Data for surgiCam ... 46

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Instructions for Use Operating Lights marLED® E9/E9i/E15

1

Notices Concerning this Document

1.1

Safety

Failure to observe this document can lead to serious or even lethal injury to the patient or the user! Improper handling and care as well as non-intended use can lead to premature wear and/or pose a risk to patients and users! It is the operator’s responsibility to ensure that all personnel handling the product have understood and do observe the notes and instructions in this document. •

Every user is required to read this document completely and follow it carefully.

•

In particular, be sure to heed all cautions, warnings and danger notices.

•

Keep this document accessible to users at all times.

1.2

Terms & Acronyms

Abbreviation

Description

ASPS

Additional safety power supply (battery)

backLite

5% brightness adjustment for endoscopic background illumination in endo mode

boost

Large light field with maximum illuminance

Cardanic system

Cardan joint integrated into suspension bracket of light head

fully cardanic

Double suspension bracket with cardan joint, rotatable in 3 axes

LC cardanic

Low-ceiling cardanic system: simplified suspension bracket, rotatable in 2 axes, for use in low rooms

Light engine

LED illumination unit with 16 individual LEDs

PEI

Polyetherimides

Power module

Switching power supply for supplying the lamp

SC

Safety check

sensoGrip

Multifunction handle unit for sterilizable handles or sterile disposable covers

SPS

Safety power supply (mains)

surgiCam

Camera system in surgiCam SD or surgiCam HD version

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Instructions for Use Operating Lights marLED® E9/E9i/E15

1.3

Validity of this Document

This document is valid from software release SW 16 and hardware release HW 32. If older hardware and software versions are used, it may be that newer functions described in this document are not available.

1.4

Symbols Used in this Document

Throughout this document, important information (such as general or safety-related notices) is marked with the following symbols and signal words:

WARNING Life hazard or serious injury! Indicates a situation which, if not avoided, could result in death or serious injury!

CAUTION Risk of injury! Indicates a situation which, if not avoided, could result in minor or moderate injury!

NOTICE Risk of material damage! Indicates a situation which, if not avoided, could lead to material damage (loss of time, data loss, device/machine failure, etc.)!

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Instructions for Use Operating Lights marLED® E9/E9i/E15

2

Product Liability and Warranty

2.1

General Information

We thank you for having decided to buy one of our products. This product bears the CE-marking, which means that it satisfies the essential requirements laid down in the EC Directive concerning medical devices. We are the manufacturer of this product: Gebrüder Martin GmbH & Co. KG A company of the KLS Martin Group KLS Martin Platz 1 · D-78532 Tuttlingen · Germany Postfach 60 · D-78501 Tuttlingen · Germany Tel. +49 7461 706-0 · Fax +49 7461 706-193 [email protected] · www.klsmartin.com

2.2 •

•

Hotline

Should you have any questions on how to handle the product or use it for clinical applications, please do not hesitate to contact the Product Management: Tel:

+49 7461 706-109

Fax:

+49 7461 706-190

Should you have any technical questions or questions concerning maintenance contracts or training courses, please contact our Martin Service Center: Tel:

+49 7461 706-343

Fax:

+49 7461 706-408

E-mail: [email protected]

NOTICE To answer your technical questions as efficiently as possible, our service technicians require the serial number of the product. Therefore, please have this number at hand when contacting our hotline. It is part of the information provided on the rating plate; see section 7.6 “Serial Number Structure”, page 39.

2.3

User’s Inspection

•

Immediately upon receipt, the goods must be checked for completeness and potential damage in transit.

•

Notice of any such damage must be given immediately.

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Instructions for Use Operating Lights marLED® E9/E9i/E15

2.4

Warranty

Our Standard Terms and Conditions of Sale effective at the time shall apply. Agreements diverging from these Standard Terms and Conditions do not restrict the legal rights of the buyer. Any warranty exceeding the above provisions shall require a contractual form and shall exclude component-related vandalism, software updates and consumables. Maintenance information The product may only be repaired by Gebrüder Martin or a qualified person or firm expressly authorized by Gebrüder Martin to perform such work. If the repair is carried out by a person or firm specially authorized by Gebrüder Martin, the operator of the product is required to obtain from the repairer a certificate with details about the nature and scope of the repair work done. This certificate must show the date of the repair and the details of the person or firm carrying out the work and must be signed. In all cases where a party other than the product manufacturer performed the work, repaired products must be additionally marked with the repairer’s ID label. Improper interventions or alterations performed by third parties during the period of limitation shall void any and all warranty claims. Performing unauthorized actions on the product is strictly prohibited at any time. Non-compliance will void any liability claim against Gebrüder Martin.

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Instructions for Use Operating Lights marLED® E9/E9i/E15

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Intended Use

3.1

Intended Purpose

The operating lights may be used only for illumination of a surgical or examination field.

3.2

Patient Group/Patient Selection

There are no known restrictions.

3.3

Users

Surgeons, physicians and adequately trained assistant personnel.

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Instructions for Use Operating Lights marLED® E9/E9i/E15

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Mounting

NOTICE The installation may be performed only by Gebrüder Martin or by service technicians authorized by Gebrüder Martin. These operating lights may only be operated in medical-use rooms whose electrical installation complies with DIN VDE 0100 Part 710 requirements (the German standard in force since Nov. 1, 2002) or with the corresponding local regulations of the country in which they are used!

WARNING Danger of injury by electric shock! To prevent any risk of electric shock, be sure to connect the lights only to power supply systems providing protective grounding.

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Instructions for Use Operating Lights marLED® E9/E9i/E15

5

Use

5.1

Description of the Components

5.1.1

Lights

The lights are available in the following variants: •

marLED® E9 (max. illuminance of 130,000 lx)

•

marLED® E9i (max. illuminance 160,000 lx)

•

marLED® E15 (max. illuminance of 160,000 lx)

Options •

camera system surgiCam

•

wall operation (wall-mounting control panel)

•

COM interface (RS232) for integrated OR systems

•

emergency power (ASPS) changeover module

•

LC (Low Ceiling) cardanic suspension for low rooms

•

Handle unit without control function, for sterile disposable covers

•

Handle unit without control function, for sterilizable handles

•

Multifunction handle unit sensoGrip, for sterile disposable covers

•

Multifunction handle unit sensoGrip, for sterilizable handles

Available mounting/installation options •

ceiling-mounting: single lights, light combinations

•

wall-mounting (marLED® E9/E9i) with separate power supply on external mounting plate

•

mobile lights: marLED® E9/E9i

The lights can be mounted either individually (as single lights) or in combinations of 2, 3 or 4 lights (optionally in conjunction with TFT monitor). Each light is controlled via an individual control panel.

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Instructions for Use Operating Lights marLED® E9/E9i/E15 5.1.2

LED Technology

The operating lights marLED® E9/E9i/E15 operate on the basis of LED illumination units (so-called “light engines”) of the latest technology. Compared with conventional halogen lamps, these “engines” offer significantly more flexibility regarding several basic lighting parameters. Besides, the generated light has no infrared content at all. As the lights do not contain any moving parts either, they are completely maintenance-free. The E9 and E9i series are identical with the exception of the Light Engines. This results in a higher light intensity and an improved residual light intensity for shading in case of the E9i, see section 10.1 “Technical Data for marLED® E9/E9i”, page 45. 5.1.3

Starting Performance

The operating lights marLED® E9/E9i/E15 are “intelligent” lights. When switching off the lights, the last-used operating mode (light field size, illuminance and color temperature) is automatically saved for reuse when the light is turned on the next time. If the “wall-mounted control panel” option is utilized, indication of the software version is followed by indication of the communication status of the external interface (e.g. OR1): ΣΧβ0 = no connection, ΣΧβ1 = connection OK. 5.1.4

Emergency Power (ASPS) Changeover Module

All lights can be optionally equipped with an emergency power (ASPS) changeover module, which can either be integrated into the ceiling tube or installed separately. Where the light has an external power supply located in a switchbox, the ASPS changeover assembly is installed on the same mounting plate as the power module. A dual LED – which can be optionally installed in the canopy or on the mounting plate – indicates the type of power supply currently used:

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Green LED

Safety power supply SPS (mains)

Red LED

Additional safety power supply ASPS (battery)

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Instructions for Use Operating Lights marLED® E9/E9i/E15 5.1.5

Camera surgiCam The camera surgiCam system is an imaging system for documentation and training purposes. Also observe section 10.2 “Technical Data for surgiCam”, page 46.

Optional equipment with additional cable harness and wall box: Wall box surgiCam HD

Wall box surgiCam SD

1 Video signal Y, BNC socket, 75 Ω 2 Video signal Pb, BNC socket, 75 Ω 3 Video signal Pr, BNC socket, 75 Ω

1 without function 2 Video signal Y, BNC socket, 75 Ω 3 Video signal C, BNC socket, 75 Ω

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Instructions for Use Operating Lights marLED® E9/E9i/E15

5.2

Commissioning

NOTICE Risk of interference and malfunction! As a medical electrical device, the operating lights marLED® E9/E9i/E15 are subject to special precautions regarding electromagnetic compatibility (EMC). It is mandatory to install and operate the lights in accordance with the EMC Guidelines provided herein, see section 9 “Guidelines and Manufacturer’s Declaration Regarding Electromagnetic Compatibility (EMC)”, page 41. •

Operating RF devices near the lights may degrade the performance of the lights. For separation distances to be observed, see section 9 “Guidelines and Manufacturer’s Declaration Regarding Electromagnetic Compatibility (EMC)”, page 41.

•

Using the lights in conjunction with accessories other than those approved by the manufacturer may lead to increased interference emission and reduce the immunity of the lights.

•

The lights should not be placed next to or onto other devices. If close proximity to other devices cannot be avoided, be sure to verify the functional reliability of the lights before using the lights in such setup.

The operator may operate the device only if an on-site functional test has previously been performed by Gebrüder Martin or a person authorized by Gebrüder Martin. In addition, a responsible person designated by the operator must have been instructed in the proper handling, application and operation of the device, as well as in its permissible combination with other medical devices, objects and accessories. This duly instructed officer shall subsequently be responsible for familiarizing the operator’s staff with the device as the need arises. We recommend documenting all user instructions in a medical device logbook. A copy of the logbook is available from Gebrüder Martin.

WARNING Risk of injury due to unauthorized modification of the product! Altering the product in any way can pose a life hazard due to electric shock caused by a defect in the light. Moreover, it can result in the light crashing down or the spring arm snapping up violently in response to high spring forces! Therefore, unauthorized modifications are strictly forbidden under any circumstances.

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Instructions for Use Operating Lights marLED® E9/E9i/E15 5.2.1

Attaching and Replacing the Sterilizable Handle

Prior to each operation, the light must be fitted with the sterilized handle.

WARNING Danger of infection due to non-sterile handling! Gebrüder Martin’s exchangeable handles are delivered non-sterile. Therefore, they must be sterilized prior to their first sterile use, see section 6.4 “Machine Disinfection and Sterilization of the Handles”, page 31. Improper sterilization and non-sterile handling of the handles can pose serious health hazards to patients. The responsibility for handle cleaning, disinfection and sterilization lies with the operator/product user. Approved sterilization packaging (e.g. conforming to EN 868, ISO 11607) must be used for sterilization, subsequent transportation and storage of the handles. Be sure to observe all relevant national/local regulations as well.

Fig. 5-1:

Handle unit for sterilizable handles – without (left) and with (right) a camera system installed in the central handle

Assembly •

Slide sterilizable handle onto the handle unit until it latches audibly. Slightly rotating it to the left or right may be required.

Disassembly •

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Remove sterilizable handle by pressing on the latch (1) on the upper end of the handle, and pull downwards.

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Instructions for Use Operating Lights marLED® E9/E9i/E15

WARNING Danger of infection due to non-sterile handling! Latch (1) and button (2) of the handle units are non-sterile by design. •

Remember this when replacing the sterilizable handles.

When using the optional equipment with a camera system, the handle is removed by pressing the button (2) on the upper end of the handle.

NOTICE Be sure to observe and follow the cleaning and sterilization instructions given in section 6.4 “Machine Disinfection and Sterilization of the Handles”, page 31.

5.2.2

Attaching and Replacing the Sterile Disposable Cover The installation of the optional profiled handle adapter (1) for sterile disposable covers into an existing handle unit is described in the installation manual for the marLED®. This handle version is not available for the equipment version “camera in handle”. Assembly •

Attach the new sterile disposable cover (2) from below.

Disassembly •

Pull off sterile disposable cover (2) downwards from the handle adapter (1).

WARNING Danger of infection due to non-sterile handling! The disposable cover is non-sterile after use. It is not suitable for sterilization and must be disposed of.

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Instructions for Use Operating Lights marLED® E9/E9i/E15

5.3

Operation

5.3.1

Personal Protection

WARNING Danger of serious injury from defective lights! Defective lights can damage the health or even threaten the lives of users and/or patients! •

Therefore, never operate defective lights!

WARNING Danger of serious injury from excessive heat development! When using several lights in combination, the light fields should not overlap when using maximum illuminance and very small light field diameters. Non-compliance could pose a hazard of excessive heat generation in the light field (>1,000 W/m²)! •

Be sure to handle the lights in accordance with the instructions provided in this user manual (including putting them into and out of operation)!

•

Prior to each use, be sure to check the lights for safe functioning and proper operating condition!

•

The operational safety of the device must be verified at regular intervals, see section 7.2 “Regular Checks to Be Carried out by Owner/Operator”, page 34 and section 7.5 “Safety Checks (SC)”, page 37.

If the device is not functionally reliable and/or safe to operate, it must be marked as such and withdrawn from service. A technical check is mandatory in any such case.

NOTICE Turn off device in case of longer treatment breaks to increase operational safety permanently and to save energy.

WARNING Danger of serious injury in the event of light failure! When working with a single operating light, there will be a residual risk of functional failure in spite of the additional safety power supply. Therefore, it is the surgeon’s responsibility to decide whether the intended intervention can be carried out under such circumstances or not.

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Instructions for Use Operating Lights marLED® E9/E9i/E15

NOTICE Risk of damage to light! •

Protect the light from mechanical impact during operation, such as may be caused by arm movements when inserting a hip prosthesis or pulling off components. As such movements are typically performed with edged or sharp instruments, there is a potential danger of damaging the bottom glass pane of the operating light!

•

Avoid collision with other OR equipment (such as ceiling-mounted pendant systems or articulated arm systems)!

•

Adjust the light head’s position with care, approaching the arm stops slowly and applying only moderate force!

WARNING Danger of patient eye damage! For anesthetized patients, there is a danger of eyesight overstrain or permanent eyesight damage due to suspended eyelid closure reflex. •

Do not direct the light towards the eyes of the patient where avoidable.

•

If necessary, cover the patient’s eyes.

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Instructions for Use Operating Lights marLED® E9/E9i/E15 5.3.2

Non-Sterile and Sterile Operation

1 Control panel, non-sterile 2 Handle unit (sensoGrip) 3 Handle on the outside of the lamp body

Non-sterile The non-sterile positioning of the lamp body is done using the handles on the outside of the lamp body (3). The non-sterile control of the light is done using the control panel on the lamp body (1), see section 5.3.3 “Operation via the Control Panel”, page 21. Sterile The sterile control and positioning of the lamp body is done using the centrally located handle (2), see section 5.3.4 “Operation via the sensoGrip”, page 25.

WARNING Danger of infection from non-sterile handling! Sterilizable handles by Gebrüder Martin are delivered in non-sterile condition and must be sterilized before first sterile use, see section 6.4 “Machine Disinfection and Sterilization of the Handles”, page 31. Improper sterilization and non-sterile handling of the handles can pose serious health hazards to patients.

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