Instructions for Use
36 Pages
Preview
Page 1
Examination Light marLED® E3
Instructions for Use
V. 1.1-EN (03.12)
Valid from hardware version HW 01 and software version SW 00
Instructions for Use Examination Light marLED® E3
Table of Contents 1
Product Liability and Warranty ...4
1.1 1.2 1.3 1.4 1.5 1.6
General Information ...4 Intended Use ...4 Warranty ...4 User’s Inspection ...5 Hotline ...5 Validity of these Operating Instructions...5
2
Notices Concerning these Operating Instructions ...6
2.1 2.2 2.3
Symbols Used in this Manual ...6 Symbols Used on the Product ...7 Terms & Acronyms...7
3
Safety Notices ...8
3.1 3.2 3.3 3.4
General Information ...8 Personal Protection ...9 Operation ... 10 Cleaning and Infection Protection ... 11
4
Operating the Examination Lights... 12
4.1 4.2
Putting the Light into Service... 12 Positioning the Light... 12
4.2.1
Ceiling-Mounting Version (Ceiling Tube Diameter 42 mm) ... 12
4.2.2
Wall-Mounting Version ... 12
4.2.3
Mobile Version ... 13
4.3
Operating the Light ... 14
5
Cleaning and Disinfecting the Light... 15
5.1 5.2 5.3 5.4
Disinfecting the Standard Handle ... 15 Cleaning the Light’s Externally Accessible Parts ... 16 Disinfecting the Light’s Externally Accessible Parts... 16 Sterilizable Handle (Optional) ... 17
5.4.1
Replacing the Sterilizable Handle ... 17
5.4.2
Handle Disinfection and Sterilization ... 18
5.5
Handle for Sterile Disposable Cover (Optional) ... 19
5.5.1
Replacing the Sterile Cover... 19
6
Maintenance... 20
6.1 6.2 6.3
Regular Checks to Be Carried out by Operator ... 20 Replacing the Miniature Fuses... 21 Servicing by Manufacturer... 22
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Instructions for Use Examination Light marLED® E3
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Technical Data... 23
7.1 7.2
marLED® E3 Technical Specifications ... 23 Dimension Drawings... 24
7.2.1
Ceiling-Mounting Version (Ceiling Tube Ø 42 mm)... 24
7.2.2
Intermediate Ceiling Assemblies (Lengths and Weights) – Optional ... 25
7.2.3
Ceiling Tubes (Lengths and Weights) ... 25
7.2.4
Ceiling-Mounting Version on Light-Duty Suspension Arm (TA-L) incl. AC2000... 26
7.2.5
Ceiling-Mounting Version... 27
7.2.6
Mobile Version ... 28
8
Serial Number Structure ... 29
9
Periodic Safety Checks... 30
10
Guidelines and Manufacturer’s Declaration on Electromagnetic Compatibility ... 31
11
Ecological Information ... 35
11.1 11.2 11.3
Packaging ... 35 Environmentally-Friendly Operation ... 35 Disposal of the Unit... 35
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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 a KLS Martin product. This product bears the CE-mark, 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 Ludwigstaler Str. 132 · 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 Use
These lights may only be used for the specific purpose for which they have been designed: Illumination of an examination field by surgeons, physicians and adequately trained assistant personnel These examination lights may only be operated in medical locations 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!
1.3
Warranty
Gebrüder Martin warrants the products described in this user manual to be free from any defects in material or workmanship for a period of two years from the date of delivery as specified on the delivery slip, provided they are used as intended. This warranty shall not cover consumables such as lamps and sterile handles or potential software updates. In any other respects, our General Conditions of Sale as updated from time to time shall apply. Under this warranty, we will remedy free of charge any defects due to faulty workmanship or the use of faulty materials, either through our Customer Service or directly at the factory. 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 be dated and signed and include the firm’s details.
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Instructions for Use Examination Light marLED® E3 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. Unauthorized actions performed on the product shall invalidate any liability claims vis-à-vis 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.
1.5 •
Hotline
Should you have any questions on how to handle the unit/product or questions on its clinical application, please do not hesitate to contact Product Management
•
Tel.:
+49 7461 706-243
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 706-203
E-mail: [email protected] Our service representatives are available Monday through Friday from 8 a.m. to 5 p.m. (CET). Should you have any questions concerning maintenance contracts or training courses, please contact our Technical Service Manager at +49 74 61 706-332, or send an e-mail to: [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.
1.6
Validity of these Operating Instructions
These Operating Instructions are valid for hardware versions HW 01 or higher and software versions SW 00 or higher. If older hardware versions are used, it may be that functions described in this user manual are not available.
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Instructions for Use Examination Light marLED® E3
2
Notices Concerning these Operating Instructions
Non-observance of these Operating Instructions can lead to serious or even lethal patient injury! Be sure to read, understand and follow the instructions given below! •
Every user is required to read these Instructions completely and follow them carefully.
•
In particular, be sure to heed all cautions, warnings and danger notices.
•
Keep this manual accessible to users at all times.
•
It is the user’s responsibility to inform the patient on all the application and warning notices contained herein and to ensure that he/she has understood them.
2.1
Symbols Used in this Manual
Throughout this manual, important information (such as general or safety-related notices) is marked with the following symbols and signal words:
WARNING Danger of death or serious injury! Indicates a situation which, if not avoided, could result in death or serious injury!
CAUTION Danger of minor 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.)! •
This symbol marks enumerations. - Subordinate enumerations are marked with this symbol.
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Instructions for Use Examination Light marLED® E3
2.2
Symbols Used on the Product
Symbol
Explanation
CE mark Protection class (acc. to IEC 60601-1): I Observe safety notices/instructions!
Observe Operating Instructions!
Warning: Dangerous electric voltage!
2.3
Terms & Acronyms
Cardanic system
Cardan joint integrated into suspension bracket of light head
Power module
Power supply unit integrated into light head
SC
Safety check
SPS
Safety power supply (mains)
ASPS
Additional safety power supply (battery)
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Instructions for Use Examination Light marLED® E3
3
Safety Notices
3.1
General Information
KLS Martin examination lights are quality products designed and manufactured in accordance with the recognized technical rules. The products 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!
Should the light or any of its components become damaged or defective: •
Disconnect the light from the power supply and safeguard it against reconnection!
•
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 examination lights any components or systems other than accessories that have been expressly approved by Gebrüder Martin. It is the user’s responsibility to ensure compliance with the instructions provided above.
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Instructions for Use Examination Light marLED® E3
3.2
Personal Protection
WARNING Danger of serious injury from defective lights! Damaged lights can pose a life or health hazard to users and patients! •
Never put damaged lights into operation!
WARNING Danger of serious injury from excessive heat! When using maximum brightness, the light fields should not be allowed to overlap each other. Non-compliance poses a risk of excessive heat development in the light field (> 1000 W/m²).
WARNING Danger of explosion! Be sure to maintain a safe distance between the examination light and any openings or surfaces emitting anesthetic gases, oxygen or other flammable or oxidizing (fire-accelerating) gases.
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Instructions for Use Examination Light marLED® E3
3.3
Operation
•
Prior to each use, be sure to check the examination 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 examination light, be aware that there will be a residual risk of functional failure in spite of the additional safety power supply (ASPS). Therefore, it is the surgeon’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 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 moving it on its castors. Do not just give it a push to reposition it!
•
Approach stops slowly using moderate force only!
•
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.
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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 15.
WARNING Danger of serious injury from electric shock! Prior to performing any cleaning or disinfecting work, be sure to deenergize the light system: •
Disconnect the light system all-pole from the power supply
•
Secure it against reconnection
•
Protect the light system from splash water
•
Do not use wet cleaning/disinfection
•
Use only “wiping disinfection”
•
Never insert any objects into the openings of the unit!
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
4.2.1
Ceiling-Mounting Version (Ceiling Tube Diameter 42 mm)
4.2.2
Wall-Mounting Version
•
12
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 Version
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 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
14
Operating the Light •
To turn on the light, operate the ON / OFF switch (1).
•
To adjust the brightness (light intensity), operate button (2) (darker) or button (3) (brighter).
•
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
Disinfecting the Standard Handle
Proper care of the light system including the standard handle (1) requires regular cleaning and disinfection using suitable cleaning agents and disinfectants.
NOTICE Personnel qualification! Cleaning and disinfection must be carried out by instructed personnel.
WARNING Danger of serious injury from electric shock! Prior to cleaning or disinfecting the light, be sure to deenergize the entire system: •
Disconnect the light system all-pole from the power supply
•
Secure it against reconnection
•
Protect the light system from splash water. Do not use wet cleaning/disinfection!
•
Never insert any objects into the openings of the unit!
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 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.
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Instructions for Use Examination Light marLED® E3
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!
5.2
Cleaning the Light’s Externally Accessible Parts
NOTICE Risk of surface damage! •
To prevent damage, do not use scouring, alkaline, acidic or alcoholic cleaning agents (e.g. ethanol, propanol) or cleaners containing aldehydes.
•
As a rule, be sure to use cleaners in a way that no liquid can penetrate into the light head or the suspension arm system.
•
The piece of cloth used for cleaning the light system should be moist but not wet.
5.3
Disinfecting the Light’s Externally Accessible Parts
WARNING Danger of serious injury from noxious substances! Disinfectants may contain noxious substances: •
Use disinfectants only in compliance with the hygiene regulations of your hospital.
•
The operator must ensure that the requirements of the competent national Hygiene and Disinfection Panel are observed as well.
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Instructions for Use Examination Light marLED® E3
NOTICE Risk of surface damage! •
To prevent embrittlement of plastic parts, use only disinfectants with a low alcohol content.
•
Do not use highly alkaline solutions or strong acids.
•
As a rule, be sure to use disinfectants in a way that no liquid can penetrate into the light head or the suspension arm system.
The wiping disinfection procedure permitted by Gebrüder Martin can be performed with neutral disinfectants (such as surface disinfectants) based on aldehydes, quaternary ammonium compounds, etc. The instructions of the disinfectant manufacturer regarding material compatibility, dosage and exposure time must be duly observed. We recommend you not to use substances that cause stress cracking in acrylic glass or polycarbonate (e.g. Surfanios or Terralin® Liquid).
5.4
Sterilizable Handle (Optional)
5.4.1
Replacing the Sterilizable Handle
NOTICE To replace the standard handle with a sterilizable handle, be sure to observe the instructions provided in the marLED® E3 Mounting Instructions, section “Mounting the Handle”.
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•
Push latch (1) located on upper edge of handle upwards.
•
Pull off handle (2).
•
To install the new handle, align the groove with the latch (1) and click the handle (2) in place. If necessary, turn handle a little leftward or rightward to engage the latch.
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Instructions for Use Examination Light marLED® E3 5.4.2
Handle Disinfection and Sterilization
NOTICE Danger of handle damage! Never use hot air for handle sterilization as this would destroy the material! To remove/install the sterilizable handle, refer to section 5.4.1 “Replacing the Sterilizable Handle”, page 17. The exchangeable handle can be machine-processed with the same programs as approved for surgical instruments. The exchangeable handle is thermostable and can be thermally disinfected at 93 °C (199.4 °F). The instructions provided by the manufacturer of your cleaning machine (washer-disinfector) and the manufacturers of the processing agents used must be observed as well. Cleaning can be done with neutral or mildly alkaline cleaners. Cleaners containing active chlorine should be avoided due to the reaction that is to be expected between chlorine and plastic. As regards disinfection, we recommend using products based on alcohol or aldehydes. The disinfectants used must be approved for use on polyetherimide (PEI). The final rinse should be carried out with demineralized water to prevent spotting and the formation of deposits. The handle is steam-sterilizable. Sterilize in a fractionated vacuum process at 134 °C (273.2 °F) for 5 minutes, or 121 °C (249.8 °F) for 20 minutes (e.g. using a sterilizer complying with EN 285:2009, validated in accordance with ISO 17665-1:2006 requirements). To prevent permanent (plastic) deformation, the handle must not be exposed to mechanical loads during sterilization.
NOTICE Useful life of the handles! The exchangeable handles are subject to normal wear as a result of frequent sterilization. If fatigue is detected in the material (check for symptoms like cracks or tears or discoloration), the handle must be replaced.
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Instructions for Use Examination Light marLED® E3
5.5
Handle for Sterile Disposable Cover (Optional)
5.5.1
Replacing the Sterile Cover
NOTICE To replace the standard handle with a sterilizable handle, be sure to observe the instructions provided in the marLED® E3 Mounting Instructions, section “Mounting the Handle”.
WARNING Danger of infection from non-sterile handling! The disposable cover is no longer sterile after use. As it is not suitable for sterilization, it must be discarded and disposed of properly.
V. 1.1
•
Pull sterile cover (2) off the profiled handle (1).
•
Push new sterile cover (2) in place.
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Instructions for Use Examination Light marLED® E3
6
Maintenance
NOTICE Personnel qualification! All maintenance work must be carried out by a hospital technician (or comparably trained personnel).
WARNING Danger of infection from non-sterile handling! •
To prevent infections during maintenance work, make sure that such work is carried out only on lights (and equipment) that have previously been cleaned and disinfected!
6.1
Regular Checks to Be Carried out by Operator
All lights must be checked for proper functioning and operational safety at regular intervals, including a visual inspection for function-impairing mechanical damage. Routinely check the lights as follows: •
Perform functional check acc. to these Operating Instructions, with due regard to the instructions provided in the user manual of the spring arm manufacturer!
•
Check membrane keypad for damage
•
Check for defective paint work (poses a danger for open wounds)
•
Check for fissures/cracks in plastic parts (sharp edges)
•
Check for loose parts
•
Check rotary joints for proper functioning and ease of movement
•
To prevent injury or damage, contact the Martin Service Center (MSC) immediately if damage or malfunction is detected.
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