Instructions for Use
36 Pages
Preview
Page 1
Examination Light marLED® E3
Instructions for Use
EN V. 1.2 (2015-04) 90-736-52-12
Valid from hardware release HW 06 and software release SW 02
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.
Follow Instructions for Use
Follow Instructions for Use
Reference number for ordering Gebrüder Martin products (item number) Serial number 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 11.3 “Disposal of the Device”, page 35.
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Instructions for Use Examination Light marLED® E3
Contents Terms & Acronyms ... 5 1
Product Liability and Warranty ... 6
1.1 1.2 1.3 1.4 1.5
General Information ... 6 Intended Purpose ... 6 Warranty ... 8 User’s Inspection ... 8 Hotline... 9
2
Notices Concerning this Document... 9
2.1 2.2
Validity of this Document ... 10 Symbols Used in this Document ... 10
3
Safety Notices... 11
3.1 3.2 3.3 3.4
General Information ... 11 Personal Protection ... 12 Operation ... 13 Cleaning and Infection Protection ... 14
4
Operating the Examination Lights ... 15
4.1 4.2
Putting the Light into Service ... 15 Positioning the Light ... 15
4.2.1
Ceiling-Mounting Lights (Ceiling Tube Diameter 42 mm) ...15
4.2.2
Wall-Mounting Lights ...16
4.2.3
Mobile Lights ...17
4.3
Operating the Light ... 18
5
Cleaning and Disinfecting the Light ... 19
5.1 5.2 5.3 5.4
General Information ... 19 Cleaning of Externally Accessible Parts ... 21 Manual Disinfection of Externally Accessible Parts ... 21 Sterilizable Handle (Optional) ... 23
5.4.1
Replacing the Sterilizable Handle ...23
5.4.2
Machine Disinfection and Sterilization of the Sterilizable Handle ...23
5.5
Handle for Sterile Disposable Cover (Optional) ... 25
5.5.1
Replacing the Sterile Cover ...25
6
Maintenance ... 26
6.1 6.2
Regular Checks to be Carried out by Owner/Operator ... 26 Maintenance to be Performed by Manufacturer ... 26
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Technical Data ... 27
7.1
Technical Data for marLED® E3 ... 27
8
Serial Number Structure... 29
9
Safety Checks (SC) ... 30
10
Guidelines and Manufacturer’s Declaration Regarding Electromagnetic Compatibility (EMC) ... 31
11
Ecological Information ... 35
11.1 11.2 11.3
Disposal of Packing ... 35 Ecological Aspects of Operation... 35 Disposal of the Device ... 35
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Instructions for Use Examination Light marLED® E3
Terms & Acronyms Designation
Description
Cardanic system
Light head suspension up to spring arm, with one or more cardan joints
PEI
Polyetherimides
SC
Safety check
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Instructions for Use Examination Light marLED® E3
1
Product Liability and Warranty
1.1
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
1.2
Intended Purpose
These lights may only be used for the specific purpose for which they have been designed: Illumination of a surgical or examination field by surgeons, physicians and adequately trained assistant personnel These 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 from electric shock! To prevent any risk of electric shock, be sure to connect the lights only to power supply systems providing protective grounding.
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 Examination Light marLED® E3
NOTICE Risk of interference and malfunction •
As a medical electrical device, the examination lights marLED® E are subject to special precautions regarding electromagnetic compatibility (EMC). It is mandatory to install and operate them in accordance with the EMC Guidelines provided herein, see section 10 “Guidelines and Manufacturer’s Declaration Regarding Electromagnetic Compatibility (EMC)”, page 31.
•
Operating RF devices near the lights may degrade the performance of the lights. For separation distances to be observed, see section 10 “Guidelines and Manufacturer’s Declaration Regarding Electromagnetic Compatibility (EMC)”, page 31.
•
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. The operational safety of the device must be verified at regular intervals, see section 6 “Maintenance”, page 26 and section 9 “Safety Checks (SC)”, page 30. 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.
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Instructions for Use Examination Light marLED® E3
1.3
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. Important Notices 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.
1.4
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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1.5 •
•
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, please do not hesitate to turn to our Martin Service Center: Tel:
+49 7461 706-343
Fax:
+49 7461 706-408
E-mail: [email protected] •
Should you have any questions concerning maintenance contracts or training courses, please contact our Technical Service Manager: Tel:
+49 7461 706-332
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 8 “Serial Number Structure”, page 29.
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Notices Concerning this Document
Non-observance of this document can lead to serious or even lethal patient injury! 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.
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Instructions for Use Examination Light marLED® E3
2.1
Validity of this Document
This document is valid from software release SW 02 and hardware release HW 06. If older hardware and software releases are used, it may be that newer functions described in this document are not available.
2.2
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 Examination Light marLED® E3
3
Safety Notices
3.1
General Information
The lights are quality products designed and manufactured in accordance with the recognized technical rules. The lights leave the factory in a perfectly safe working condition. To maintain this status, you – as the end user – are required to abstain from or prevent any action that might have an adverse effect on the lights’ safety characteristics. •
Observe the following safety notices!
•
Be sure to follow the instructions provided in this document!
Should the light or any of its components become damaged or defective •
Disconnect the light from the power supply!
•
Safeguard the light or its components against dangerous contact with persons! Place warning signs where appropriate.
•
Contact the manufacturer or service technician at once!
Upon completion of any repair or service work, it is mandatory for the service technician to check all functions of the light, the tracking and spring arms and the power supply units, thus ensuring their proper working order and operational safety!
NOTICE It is not permitted to attach to or install on the lights any components or systems other than accessories that have been expressly approved by Gebrüder Martin.
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Instructions for Use Examination Light marLED® E3
3.2
Personal Protection
WARNING Danger of serious injury from defective lights! Defective examination lights can damage the health or even threaten the lives of users and/or patients! •
Therefore, never operate defective lights!
WARNING Danger of explosion! The examination light may be used only at a safe distance from openings or surfaces emitting or releasing anesthetic gases, oxygen or other flammable or oxidizing gases.
WARNING Danger of serious injury from excessive heat development! When using several lights in combination, the light fields must 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)!
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Instructions for Use Examination Light marLED® E3
3.3
Operation
•
Prior to each use, be sure to check the lights for safe functioning and proper operating condition!
•
Be sure to handle the lights in accordance with the instructions provided in this user manual (including putting them into and out of operation)!
WARNING Danger of serious injury from light failure! When working with a single light, there will be a residual risk of functional failure in spite of the additional safety power supply (ASPS). Therefore, it is the user’s responsibility to decide whether the intended intervention can be carried out under such circumstances or not.
NOTICE Risk of light damage! •
Protect the light from mechanical impact during operation, such as may be caused by 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 examination light!
•
Avoid collision with other OR equipment (such as ceiling-mounted pendant systems or articulated arm systems)!
•
Approach stops slowly using moderate force only!
•
Always guide the light when moving it on its castors. Do not just give it a push to reposition it!
•
Be sure to use only the handle provided on the stand tube when wheeling the light through the room! Do not use the light head handle for this purpose as this could lead to spring arm fracture.
•
It is not permitted to put any additional weight on the lights.
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 Examination Light marLED® E3
3.4 •
Cleaning and Infection Protection
In addition to the following safety notices, observe the cleaning and disinfection instructions provided in section 5 “Cleaning and Disinfecting the Light”, page 19.
WARNING Danger of serious injury from electric shock! Prior to performing any cleaning or disinfecting work, be sure to de-energize the light system: •
Disconnect the light system all-pole from the power supply
•
Secure it against reconnection
•
Protect light system from splash water; do not use wet cleaning/disinfection
•
Never insert any objects into the openings of the units!
WARNING Danger of infection from non-sterile handling! •
To protect yourself against infection, maintenance or service work should only be performed after the lights and associated equipment have been adequately cleaned and disinfected where appropriate!
•
Clean only cold lights! This avoids potential hazards due to disinfectant or cleaning agent evaporation and a consequential ineffectiveness of the disinfection because the disinfectant would not have enough time to take effect.
NOTICE Risk of light damage! When using the “wiping” technique as permitted by Gebrüder Martin for surface disinfection, apply just enough disinfecting liquid to prevent the formation of “pools” and the consequential capillary action through which the liquid could be drawn into the light head.
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Instructions for Use Examination Light marLED® E3
4
Operating the Examination Lights
4.1
Putting the Light into Service
It is assumed here that the light has already been correctly mounted and installed by a qualified service technician in compliance with the marLED® E3 Mounting Instructions.
4.2
Positioning the Light
WARNING Danger of infection in the event of non-sterile handling! Gebrüder Martin’s exchangeable handles are delivered non-sterile. Therefore, they must be sterilized prior to their first sterile use. Improper sterilization and non-sterile handling of the handles can pose serious health hazards to patients. Sterilization must be carried out according to a validated steam sterilization process, for example in a sterilizer complying with EN 285:2009 and ANSI/AAMI ST79, validated in accordance with ISO 17665-1:2006. ANSI/AAMI ST79 recommends a minimum cycle time of 4 min at 132°C (270°F) for dynamic air removal steam sterilization cycles. Please follow the instructions of the user manual of your steam sterilizer.
4.2.1
•
Ceiling-Mounting Lights (Ceiling Tube Diameter 42 mm)
Use the handle (1) to position the light as required. Thanks to the four joints (2) provided, perfect positioning is an easy process.
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Instructions for Use Examination Light marLED® E3 4.2.2
•
16
Wall-Mounting Lights
Use the handle (1) to position the light as required. Thanks to the four joints (2) provided, perfect positioning is an easy process.
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Instructions for Use Examination Light marLED® E3 4.2.3
Mobile Lights
CAUTION Danger of injury from toppling light! •
Protect the examination 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 plate of the examination light.
•
Avoid collision with other OR equipment (such as ceiling-mounted pendant systems or articulated arm systems)!
•
Always guide the light when wheeling it to another position. Do not just give it a push to reposition it!
•
Approach stops slowly using moderate force only!
•
Be sure to use only the handle (3) provided on the stand tube when moving the mobile light through the room!
Be aware that using the light head handle (1) for moving the entire light poses a danger of spring arm fracture! Do not put any additional weight on the lights! Moving the entire light •
Unlock the castors (4) of the stand base.
•
Grasp the handle (3) and guide the light to its new position.
•
Arrest it in its new place by locking the castors (4) on the stand base.
Positioning the light head •
Use the light head handle (1) to position the light head as appropriate.
The flexibility provided by the three joints (2) make it easy to position the light head exactly as you need it.
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Instructions for Use Examination Light marLED® E3
4.3
18
Operating the Light •
To turn on the light, operate the ON/OFF switch (1).
•
The LED (4) indicates the current status of the light: -
Green: light turned on and ready for operation
-
Red: malfunction
•
To adjust the brightness (light intensity), operate button (2, darker) or button (3, brighter).
•
The currently set brightness is indicated by the level indicator (5), with intensity increasing from left to right.
•
To turn off the light after use, operate the ON/OFF switch (1) again.
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Instructions for Use Examination Light marLED® E3
5
Cleaning and Disinfecting the Light
5.1
General Information
Proper care of the light system requires regular cleaning and disinfection using suitable cleaners and disinfectants. The responsibility for cleaning and disinfection lies with the operator/user of the product. Be sure to observe your local cleaning and hygiene regulations!
WARNING Danger of serious injury from electric shock! •
Prior to cleaning or disinfection, be sure to de-energize the system completely: -
Disconnect the total system from the power supply in all poles.
-
Secure it against reconnection.
•
Protect the entire system from splash water. Do not use wet cleaning/disinfection.
•
Never insert objects into light openings!
WARNING Explosion hazard! It is not permitted to use cleaning agents and disinfectants that can generate flammable, deflagrating or explosive gases or gas mixtures!
WARNING Danger of serious injury when using defective accessories! A light that is not in good working order, as well as defective accessories, can pose a health hazard to patients or users and can also deteriorate the intended performance of the light. •
The light and its accessories must always be kept in a perfect working condition. Visually check for cleanliness, integrity and intact insulation.
•
If the light is not functionally reliable and/or safe to operate, it must be marked as “out of order” and withdrawn from service. A technical check is required in any such case.
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Instructions for Use Examination Light marLED® E3 Before putting the light into service, make sure that all disinfectant residues have been reliably removed.
WARNING Danger of infection from non-sterile handling! •
Be sure to disinfect only cold lights!
This is important because warm/hot lights would pose a danger of partial evaporation of the disinfectant or cleaning agent – with the result that the disinfectant cannot take effect due to insufficient exposure time.
NOTICE Risk of light damage! When using the “wiping disinfection” method permitted by Gebrüder Martin, the amounts of liquid used must be limited to a point that the formation of “pools” is prevented. If not, liquid could penetrate into the light as a result of capillary action. •
When using spray disinfectants, spray the agent on a soft towel, then wipe the light with the moistened cloth.
•
Never spray the light directly with the disinfectant!
NOTICE Use qualified staff only! Cleaning and disinfection must be done by duly instructed cleaning personnel.
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