Operating Instructions
36 Pages
Preview
Page 1
Operating Lights marLED® V10 / V16
Operating Instructions
V. 1.2-EN (02.12)
Valid for marLED®, HW 14 and SW 10 or higher
Operating Instructions Operating Lights marLED® V10 / V16 P
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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... 6 Symbols Used on the Product ... 7 Terms & Abbreviations / Acronyms... 8
3
Safety Notices... 8
3.1 3.2 3.3 3.4
General Information ... 8 Personal Protection... 10 Operation... 10 Cleaning and Infection Protection ... 11
4
Light Models and Combination Options ... 12
4.1 4.2
Light Models ... 12 Light Combinations... 13
5
Description of the Lights... 13
5.1 5.2 5.3
LED Technology ... 13 Starting Performance... 13 Options... 13
5.3.1 5.3.2 5.3.3
Emergency Power (ASPS) Changeover Module ... 13 KLS Martin surgiCam® digital, surgiCam®HD ... 14 KLS Martin Pilot Laser ... 14
6
Operating the Lights ... 15
6.1 6.2 6.3 6.4
Mounting the Sterilizable Handle ... 15 Operation via the sensoTouch Control Panel ... 15 Using the Sterilizable Handle (sensoGrip) for Light Control ... 17 Using a Wall Control Panel for Light Control ... 18
7
Replacing Components ... 19
7.1 7.2
Replacing the Sterilizable Handle ... 19 Handle for Sterile Disposable Covers (Optional) ... 20
7.2.1
Replacing the Sterile Disposable Cover... 20
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Accessories... 21
9
Cleaning and Disinfecting the Light ... 21
9.1 9.2 9.3
Cleaning the Light’s Externally Accessible Parts... 22 Disinfecting the Light’s Externally Accessible Parts ... 22 Handle Disinfection and Sterilization ... 23
10
Maintenance ... 24
10.1 10.2
Regular Checks to Be Carried out by Owner / Operator ... 25 Maintenance to Be Performed by Manufacturer ... 25
11
Troubleshooting ... 26
12
Technical Data ... 27
12.1
Technical Data for marLED® V10 / V16 ... 27
13
Serial Number Structure ... 29
14
Periodic Safety Checks ... 30
15
Guidelines and Manufacturer’s Declaration on Electromagnetic Compatibility ... 31
16
Ecological Information ... 35
16.1 16.2 16.3
Disposal of Packing ... 35 Ecological Aspects of Operation... 35 Disposal of the Unit ... 35
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Operating Instructions Operating Lights marLED® V10 / V16 P
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Product Liability and Warranty
1.1
General Information
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We thank you for having decided to buy a KLS Martin product. This product carries the CEmark, 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 Strasse 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 a surgical or examination field by surgeons, physicians and adequately trained assistant personnel 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!
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. 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.
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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 question on its clinical application, please do not hesitate to contact the 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 13 “Serial Number Structure”, page 29.
1.6
Validity of these Operating Instructions
These Operating Instructions are valid for software version 10 and hardware status HW 14. If older hardware versions are used, it may be that functions described in this user manual are not available. Upon turning on your marLED® light, the currently active software version is indicated on the sensoTouch control panel (see section “Starting Performance”, page 13) to ensure that users are never in doubt about which version of the user manual is the currently valid edition.
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Operating Instructions Operating Lights marLED® V10 / V16 P
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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
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 Information to avoid financial risks (incl. material damage). For example, tips on how to perform a task or action efficiently to prevent losing time or money. •
This symbol marks enumerations. - Subordinate enumerations are marked with this symbol.
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Operating Instructions Operating Lights marLED® V10 / V16 P
2.2 Symbol
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Symbols Used on the Product Explanation CE-mark
Protection class (acc. To IEC 60601-1): I
Observe safety notices for this product!
Observe Operating Instructions!
Warning: Hot surface!
Warning: Dangerous electric voltage!
Warning: Laser radiation!
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Terms & Abbreviations / Acronyms
backLite
Brightness regulation 2 % for endoscopic background illumination
Cardanic system
Cardan joint integrated into suspension bracket of light head
- fully cardanic suspension
Double suspension bracket with cardan joint, rotatable in three axes
- LC cardanic suspension
Low-ceiling cardanic system: simplified suspension bracket, rotatable in two axes, for use in low rooms
Light engine
LED illumination unit with 16 individual LEDs
Power module
Switching power supply located on an external mounting plate
sensoGrip
Multifunctional handle
sensoTouch
Control panel with display as status indicator
surgiCam®
Camera system in surgiCam® digital “SD” or surgiCam® HD version
SC
Safety check
SPS
Safety power supply (mains)
variLUX
Switches form of light field
ASPS
Additional safety power supply (battery)
3
Safety Notices
3.1
General Information
KLS Martin operating 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!
•
Safeguard the light or its components against dangerous contact with persons! Place warning signs where appropriate.
•
Contact the manufacturer or service technician at once!
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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 operating lights any components or systems other than accessories that have been expressly approved by Gebrüder Martin.
Pilot Laser (Option) The built-in pilot laser is a Class 2 laser according to the German DIN/VDE 0837 standard (corresponds to EN 60825 and lEC 60825). These regulations, together with local accident prevention regulations (VBG 93 for Germany), must be duly observed when operating the laser.
NOTICE Due to the eyelid closure reflex, the pilot laser radiation is harmless for non-narcotized persons. As long as the impact of the laser radiation is accidental and limited to a maximum period of 0.25 s, Class-2 laser equipment does not pose a danger to the human eye. Therefore, Class-2 laser equipment may be used without any special protective measures, provided that the application requires neither deliberate eye contact for more than 0.25 s nor repeated eye contact with the direct or reflected laser radiation. As the eye-protecting lid closure reflex cannot usually be taken for granted, we recommend closing the eyes deliberately and turning away from the light source immediately if Class-2 laser radiation hits the eye.
WARNING Eye injury hazard for anesthetized persons! In the case of anesthetized persons, measures must be taken to prevent the laser radiation from hitting the open eye for more than 0.25 s. For example, cover the patient’s eyes with a towel!
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“Laser radiation” warning labels •
These warning signs are attached to the sterilizable handle and next to the control panel. The laser beam’s exit opening (aperture) is located inside the central handle.
•
Operating the sterile handle activates the pilot laser, which is automatically deactivated after approx. 5 seconds.
It is the user’s own responsibility to observe and implement the above provisions / regulations.
3.2
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)!
WARNING Danger of explosion! The operating 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.
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)!
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WARNING Danger from 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 (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 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!
3.4 •
Cleaning and Infection Protection
In addition to the following safety notices, observe the cleaning and disinfection instructions provided in section 9 “Product Liability and Warranty”, page 21.
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 light system from splash water; do not use wet cleaning / disinfection.
•
Never insert any objects into the openings of the units!
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Operating Instructions Operating Lights marLED® V10 / V16 P
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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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Light Models and Combination Options
4.1
Light Models
The lights are available in the following variants: •
Size of light head: - marLED® V10 (max. illuminance of 120,000 lx): 64 x 46 cm - marLED® V16 (max. illuminance of 160,000 lx): 87 x 64 cm
•
Options: - pilot laser - surgiCam® camera system (this product comes with its own user manual) - wall operation (wall-mounting control panel) - RS232 Com interface for integrated OR systems - backLite on tracking arm provides diffuse, indirect background light at the end of the respective tracking arm, emitted in an upward direction. The light is automatically switched on and off through a photoelectric sensor. For switching threshold details, see marLED® / marLux® Mounting Instructions. - emergency power (ASPS) changeover module - LC (Low Ceiling) cardanic suspension for low rooms
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Available mounting / installation options: - ceiling-mounting: single lights, light combinations - wall-mounting (marLED® V10) with separate power supply on external mounting plate - mobile version (stand version): marLED® V10
4.2
Light Combinations
The lights can be mounted either individually (as single lights) or in combinations of two, three or four lights (optionally in conjunction with TFT monitor or separate camera). Each light is controlled via a separate sensoTouch control panel.
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Description of the Lights
5.1
LED Technology
The marLED® V10 / V16 lights 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.
5.2
Starting Performance
The marLED® V10 / V16 operating lights are “intelligent” lights. They are automatically set to a medium light field diameter and an illuminance of 75% during startup. Other startup parameters can be set as well upon request (such as the initial operating state after turning on the light via the mains switch, illumination intensity, color temperature, type and / or size of light field). Immediately upon switching them on, the software status and the accumulated operating hours (ten-hour units) are briefly displayed at the color temperature position (see pos. (5), page 16). (Example: “0078” = 780 hours) If the “wall-mounted control panel” option has been implemented, 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.
5.3
Options
5.3.1
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. V. 1.2
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A dual LED – which can be optionally installed in the canopy or on the mounting plate – indicates the type of power supply currently used:
5.3.2
Green LED
Safety power supply (SPS / mains)
Red LED
Additional safety power supply (ASPS / battery)
KLS Martin surgiCam® digital, surgiCam®HD
The KLS Martin surgiCam® digital and surgiCam® HD systems are imaging systems for documentation and / or training purposes. Each of these high-performance camera systems can either be integrated into the light head’s central handle or installed on an arm of its own. All KLS Martin camera systems come with a separate user manual. For image display, the optional KLS Martin med TFTpro flat-screen monitor system is used.
5.3.3
KLS Martin Pilot Laser
WARNING Eye injury hazard for anesthetized persons! In the case of anesthetized persons, measures must be taken to prevent the laser radiation from hitting the open eye for more than 0.25 s. For example, cover the patient’s eyes with a towel! The pilot laser integrated into the operating light marks exactly the center of the light field. This makes it very easy to focus the light field on small surgical sites. Operating the sterile handle activates the pilot laser for approx. 5 seconds. It is automatically switched off thereafter.
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Operating the Lights
The KLS Martin marLED® lights can be operated in two different ways: non-sterile via the sensoTouch control panel, or sterile via the sensoGrip integrated into the handle.
6.1
Mounting the Sterilizable Handle
Prior to each operation, the light must be fitted with the sterilized handle (see section 7.1 “Replacing the Sterilizable Handle”, page 19).
6.2
Operation via the sensoTouch Control Panel
All functions of the KLS Martin marLED® operating lights are clearly displayed via the sensoTouch control panel (1) installed on the cardan joint of the suspension system and can be conveniently controlled in this way.
The control buttons for the various functions are marked with symbols for easy orientation. They are sensor keys which you just need to touch lightly with your fingertip (no action point). Touching them briefly triggers an acoustic confirmation signal and the button function is immediately executed.
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Operating Instructions Operating Lights marLED® V10 / V16 P
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ON / OFF switch with green LED: ON: LED lit / OFF: LED goes out Press ON / OFF switch for at least 1 second. A red LED signals a fault.
2 (5)
Color temperature The color temperature is preset to 4,300 K (standard value). This function allows you to select one of the following values: 4,300 K – 4,800 K – 3,800 K – 4,300 K. The currently set value is then indicated on the display (5). If several lights are used, the color temperature is automatically synchronized.
3/10 (7)
Light field size The size (diameter) of the circular light field can be adjusted. The left button (3) must be used to decrease the diameter, the right button (10) is for increasing it. The currently set value is displayed in the center (7) of the display.
4/9 (6, 8)
Illuminance The left button (4) decreases the illuminance, the right button (9) enhances it. The selected illuminance level is indicated by the density of the radial rays (6) arranged around the center of the display. Values ranging from 30% to 100% are intended for normal surgical use of the light. To activate the “backLite” mode (2%), the left button (4) must be operated again after selecting the minimum illumination level. When using this operating mode, the notice backLite is displayed in the bottom right corner (8) of the screen.
11 (7)
16
Light field shape (variLUX) Button (11) switches the form of the light field from circular (with adjustable diameter) to one main axis of the light head in a first step and then to the other main axis (fixed dimensions in either case). Oval light fields are indicated by corresponding symbols displayed in the center (7) of the display.
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When using light models equipped with surgiCam® digital Economy, Basic and Advanced versions, the buttons 3, 4, 9 and 10 are also used for additional functions such as zoom and image rotation (see surgiCam® digital user manual). To activate these additional functions, the buttons 4 and 9 or 3 and 10 must be pressed simultaneously.
Upon starting the light, the operating hours of the LED light sources are briefly displayed in field (5). Once 15,000 operating hours (indication: 1500) are exceeded, we recommend you to check the maximum illuminance with a luxmeter and have the light engines replaced if necessary.
6.3
Using the Sterilizable Handle (sensoGrip) for Light Control The sensoGrip is a multifunctional handle whose microswitches respond to rotary movements as well as up / down movements. Therefore, various light functions can be conveniently controlled by operating the sensoGrip handle in one of these four directions. Operating the sensoGrip handle is always accompanied by an acoustic signal (double beep). •
Light field adjustment (from the user’s perspective) - Rotating the handle leftwards increases the light field diameter. - Rotating the handle rightwards reduces the light field diameter.
•
Turning the light on / off - Moving the handle upwards for 5 seconds switches the light on or off.
•
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Moving the handle downwards for 5 seconds: so far 0000=no function.
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Other switching functions can be implemented upon request as well, e.g. camera zoom, camera rotation, type of light field, color temperature, light field size or backLite activation / deactivation. It is also possible to set the mode of handle operation, selecting from among the following options: •
Enabling by double-click, then brief single-click to carry out the function.
•
Direct operation by brief push, e.g. for backLite activation / deactivation.
•
Operation by long push (approx. 5 s), e.g. for switching the light on / off.
6.4
Using a Wall Control Panel for Light Control
The optional wall control panel offers control of the same functions as when using the normal control panel on the cardan joint of the light head.
In addition, the “L” button (1) allows you to operate either each light separately or control all the light heads simultaneously. Depending on the light head(s) selected, either the information “Λ1”, “Λ2”, “Λ3” or “ΑΛΛ” will be displayed at position 2.
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Replacing Components
7.1
Replacing the Sterilizable Handle
WARNING Danger of serious injury from electric shock! Be aware that the lights remain connected to the power supply (mains) after they have been turned off with the control-panel power switch! •
Therefore, be sure to disconnect the light with the main switch (line disconnector as part of the electrical installation) before removing the complete sensoGrip unit!
The sterilizable handle can be easily detached from marLED® operating lights by simply pressing the lever (1) located at the upper end of the handle and pulling off the handle. If the central handle features an optional camera system, button (2) must be operated instead. The new handle must click in place audibly. This may require a little sideway rotation (left or right).
Sterilizable handle unit for V10 / V16 models: without pilot laser, with pilot laser, and with camera system integrated into handle (from left to right)
NOTICE Be sure to observe and follow the cleaning and sterilization instructions given in section 9.3 “Handle Disinfection and Sterilization”, page 23!
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Handle for Sterile Disposable Covers (Optional) This handle version is not available for central handles equipped with a camera. To install a handle support for sterile disposable covers in an existing handle unit, please refer to the marLED® / marLux® Mounting Instructions, section ”Exchanging Handle Types”.
7.2.1
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Replacing the Sterile Disposable Cover
•
Pull the sterile disposable cover (2) downwards off the profiled handle (1).
•
Push a new sterile disposable cover (2) in place.
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