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Copyright 2019 Dilon Technologies, Inc. All rights reserved. Version 1.7

4

Содержание CoPilot VL+

Страница 1: ...Video Laryngoscope System Instructions for Use Dilon Technologies Inc 12050 Jefferson Ave Newport News VA 23606 1 855 CoPilot 1 855 267 4568 www CoPilotVL com ...

Страница 2: ...2 Copyright 2019 Dilon Technologies Inc All rights reserved Version 1 7 ...

Страница 3: ...3 Copyright 2019 Dilon Technologies Inc All rights reserved Version 1 7 ...

Страница 4: ...Copyright 2019 Dilon Technologies Inc All rights reserved Version 1 7 4 ...

Страница 5: ...isposable Sheaths 12 IV Pole Clamp Use 15 Using the Built In Stand 18 Powering the CoPilot VL 19 Using the CoPilot VL 21 Assemble the CoPilot VL 21 Check the Operational Status 24 Tips for Intubating with the CoPilot VL 25 Cleaning and Maintenance 28 Specifications 32 TemperatureGuidelines 32 General Cautions 33 Icons 35 Warranty Service and Replacement 37 Limited Warranty 37 Ordering Replacement ...

Страница 6: ...ll rights reserved Version 1 7 The CoPilot Video Laryngoscope CoPilot VL was developed from the ground up by practitioners who believe that video laryngoscopy should be the standard of care for all intubations Every patient Every time Our affordable video laryngoscope makes video laryngoscopy available for ALL your patients ...

Страница 7: ...hnologies Inc All rights reserved Version 1 7 The CoPilot VL system comes with everything you need to start using it right out of the box Inspect all components prior to use for any obvious physical damage that may have occurred during shipping ...

Страница 8: ...ht 2019 Dilon Technologies Inc All rights reserved Version 1 7 Display 2100 Video Handle 2500 IV Pole Clamp Power Supply AC Adapter CoPilot VL Rigid Stylet CoPilot VL Disposable Bougies CoPilot VL Disposable Sheaths Adult Size 3 Adult Size 4 1160 1400 1300 1511 3730 3740 Part Description Part No ...

Страница 9: ...sable sheaths The CoPilot VL is compact and can be used in a variety of environments it goes easily from the operating room to the ambulance and other health care settings The CoPilot VL was designed with simplicity in mind There are no buttons to push and no settings to change When the video blade is fully opened the display will turn on and the battery status indicator will illuminate Display Fr...

Страница 10: ...sed to charge the built in internal battery The video cable is used to attach the video handle to the display Do not twist or screw the video handle cable into or out of the connector To connect the Video Handle to the display line up the white hash mark on the handle connector with the white hash mark on the side of the display and then push the handle connector into the display Display Side View...

Страница 11: ... blade portion of the video handle so that it engages with the upper portion of the video handle Note Prior to use confirm full functionality of the device Open the video blade to engage the unit and verify that the LEDs on the end of the blade are illuminated and that the display is showing a clear image Video Handle and Blade 1 2 ...

Страница 12: ...d can be quickly replaced with a new one eliminating down time Sheaths are single use only and must be disposed of after every use in accordance with hospital procedures for general refuse Do not attempt to use the CoPilot VL without a disposable sheath Note Sheaths are provided in sealed pouches Examine each pouch for damage including breach of seal prior to use Do not use sheath if the seal is d...

Страница 13: ...es Inc All rights reserved Version 1 7 With the system powered on slide a new CoPilot VL disposable sheath over the end of the video blade until it snaps into place Install the Disposable Sheath Note Examine the sheath for any visible signs of damage prior to use ...

Страница 14: ...ly and must be disposed of immediately following use To remove the CoPilot VL disposable sheath from the video blade depress the eject button on the back of the handle until the sheath is released This mechanism allows the contaminated sheath to be disposed of without requiring the user to touch the sheath Eject the Disposable Sheath Depress eject button to discard sheath ...

Страница 15: ...lay can be quickly released from the IV pole clamp and may be placed on a table or other flat surface using the built in stand To use the IV pole clamp position the clamp at the desired level Tighten the threaded mounting screw in a clockwise fashion until the clamp is firmly secured to the IV pole Hand tighten only Do not use tools to tighten the knob Do not use the clamp to support any other dev...

Страница 16: ...16 Features of the CoPilot VL Copyright 2019 Dilon Technologies Inc All rights reserved Version 1 7 Next slide the display unit onto the IV pole mount until it locks into place CLAMP CLAMP ...

Страница 17: ...17 Features of the CoPilot VL Copyright 2019 Dilon Technologies Inc All rights reserved Version 1 7 The IV pole clamp also provides a convenient place to store the video handle when not in use ...

Страница 18: ...You may place the display on a table or other flat surface using the stand built into the back of the unit To remove the CoPilot VL from the IV pole clamp press the quick release button and lift the CoPilot VL straight up Place the display on the flat surface and pull out the bottom of the built in stand to the desired viewing position Using the Built In Stand ...

Страница 19: ...round the CoPilot VL logo indicates sufficient charge for use When the unit needs to be recharged the LED around the CoPilot VL logo will change from green to orange and then to red The charge status indicators are only approximate the CoPilot VL power supply should be kept immediately available for charging Powering the CoPilot VL R R R Green Charged Orange Approximately 20 battery life remaining...

Страница 20: ... illuminate indicating that the device is charging A depleted battery can be completely recharged in four hours When the unit is fully charged the battery charge status light will change from orange to green You may use the CoPilot VL while it is recharging To remove the power adaptor from the side of the display loosen the locking washer by unscrewing and pulling it Note The device may only be re...

Страница 21: ...g status indicator will light up If the unit is fully charged this light will be green An orange light indicates that the unit is actively charging Next locate the handle and plug the attached cable into the video cable input on the side of the display unit by aligning the white hash mark on the handle cable with the white hash mark on the side of the display The plug and receptacle are shaped to ...

Страница 22: ...Copyright 2019 Dilon Technologies Inc All rights reserved Version 1 7 To turn the device on simply open the video blade The LEDs will illuminate and an image will appear on the display 4 3 Power Supply Input Video Cable Input ...

Страница 23: ...9 Dilon Technologies Inc All rights reserved Version 1 7 Finally attach a new CoPilot VL disposable sheath to the video blade With the video blade open slide the disposable sheath over the end of the video blade until it snaps into place 5 ...

Страница 24: ... manner as you would with a traditional laryngoscope Check the Operational Status Visually inspect the unit to ensure that it is free from damage Open the blade portion of the video handle In doing so the display camera LEDs and battery status indicator will turn on While the device is powered on you should check the battery status indicator on the front of the display and recharge if necessary 1 ...

Страница 25: ...e mouth Observe the sheath passing into the oropharynx Then locate the vocal cords on the display Only insert the video blade and sheath deep enough to bring the epiglottis into view Advance the tip of the sheath into the vallecula Then gently tilt the tip of the sheath upwards until the vocal cords can be seen Inserting the video blade too deeply will make it MORE difficult to pass the endotrache...

Страница 26: ...pre load the bougie into the bougie port prior to introducing the disposable sheath into the patient s mouth Then advance the bougie and observe the bougie passing through the glottis on the display b Pass an endotracheal tube over the bougie in the usual fashion c Ensure that the bougie is dislodged from the Bougie Port as the endotracheal tube is advanced d Watch as the endotracheal tube passes ...

Страница 27: ...the display keep your eyes on the PATIENT when inserting the styleted endotracheal tube into the mouth Observe the endotracheal tube passing into the oropharynx then look at the display Watch for the distal tip of the endotracheal tube to enter the lower right hand corner of the display Once you see it then steer the endotracheal tube toward the glottis c Withdraw the stylet slightly if necessary ...

Страница 28: ...cument The CoPilot VL was designed in such a way that the single use disposable sheath is the only component that should come into direct contact with the patient when used as intended Dilon Technologies recommends the development of a policy routine to decrease the incidence of cross contamination This may include exercising care when handling the video laryngoscope or other medical devices when ...

Страница 29: ... EPA reg number 9480 4 and Sani Cloth Bleach wipes EPA reg number 9480 8 STEP 1 Preparation for decontamination STEP 2 Cleaning and intermediate level disinfection Select an appropriate quaternary ammonium isopropanol based germicidal cleaner labeled suitable for use on healthcare equipment and capable of intermediate level disinfection Reference EPA registered disinfectants http www epa gov oppad...

Страница 30: ... Package and store handle per facility policy to allow device to remain clean dry and ready for service Check operational status 1 1 3 2 Warning Discard any component that shows evidence of damage or deterioration Contact Dilon for component replacement STEP 1 Clean the CoPilot VL Rigid Stylet Rinse the stylet in clean tap water and scrub with a soft bristled brush until all visible contamination ...

Страница 31: ...r s instructions 2 removed Pay close attention to hard to reach areas Method Level Conditions Maximum Cycles Steris Autoclave steam cycle High Steriliza tion Standard cycles in the following processors V PRO 1 Standard Cycle V PRO 1 Plus Lumen and Non Lumen Cycles V PRO maX Lumen Non Lumen and Flexible Cycles V PRO 60 Lumen and Non Lumen Cycles and V PRO maX 2 Lumen Non Lumen Flexible and Fast Non...

Страница 32: ...nspected for signs of damage corrosion or material degradation prior to reprocessing and prior to use Wipe the CoPilot VL display IV pole clamp and power supply in between uses and as needed with an EPA registered hospital disinfectant according to the disinfectant manufacturer s written instructions CoPilot VL Display IV Pole Clamp Power Supply STEP 3 Package the CoPilot VL Rigid Stylet Package a...

Страница 33: ...lot VL outside the recommended operating temperature environment may negatively impact device performance may cause damage to the device and will void the warranty Temperature Guidelines 10o C 40o C 20o C 45o C 10 95 10 95 Operating Conditions Storage and Transport Conditions 10 C 40 C 10 C 40 C 10 95 10 95 ...

Страница 34: ...ufficient battery life to perform intubation Ensure that the display provides a clear image before use Sheaths and bougies are single use disposables and may not be reused 1 2 3 4 5 Sheaths and bougies are provided in individually sealed packaging Inspect packaging for damage or breach of seal prior to opening Do not use if the packaging has been damaged or breached If the battery status indicator...

Страница 35: ...erviceable components with the CoPilot VL Do not attempt to open or service any components As with all medical electronic equipment care must be exercised to avoid exposing this device to powerful sources of electromagnetic interference Do not expose the CoPilot VL to X rays gamma rays or other ionizing radiation or to strong electric or magnetic fields A traditional laryngoscopy should be availab...

Страница 36: ... are non sterile No components of the CoPilot VL contain latex Indication not to use if packaging is open or damaged Consult the Instructions For Use this manual for further information Symbol for Use by This symbol is accompanied by a date to indicate that the device should not be used after the date indicated Fluid ingress protection Video Handle IXP2 is protected against falling water when tilt...

Страница 37: ...idity range Symbol is accompanied by lower and upper limits Contents are fragile Component sterilized using ethylene oxide Conforms To UL STD 60601 1 AAMI STD ES60601 1 IEC STDS 60601 2 18 60601 1 Certified To CSA STD C22 2 60601 1 Keep dry Shipping and storage temperature range Symbol is accompanied by lower and upper limits 10 C 40 C 5010123 ...

Страница 38: ...able components of the device are covered under the warranty Single use disposable components are not covered under the warranty This warranty extends only to you the original purchaser Any representation or warranty made by any other person including distributors resellers dealers employees and representatives of Dilon which are inconsistent or in conflict with or in addition to the terms of this...

Страница 39: ...is Limited Warranty also does not extend to any hardware that has been damaged or rendered defective a as a result of use of the hardware other than for its normal intended use failure to use the hardware in accordance with the instructions for use which is available for download from Dilon failure to clean the device in a manner described in the instructions for use misuse abuse or negligent care...

Страница 40: ... A PARTICULAR PURPOSE DILON MAKES NO REPRESENTATIONS THAT THE HARDWARE IS FREE OF THE RIGHTFUL CLAIM OF ANY THIRD PERSON BY WAY OF INFRINGEMENT OR OF INFRINGEMENT OF PATENT OR TRADEMARK OR THE LIKE AND DISCLAIMS ANY WARRANTY AGAINST INFRINGEMENT WITH RESPECT TO THE HARDWARE IN NO EVENT SHALL DILON BE LIABLE FOR ANY INCIDENTAL SPECIAL OR CONSEQUENTIAL DAMAGES INCLUDING BUT NOT LIMITED TO LOSS OF BU...

Страница 41: ...o consult applicable state or provincial laws for a full determination of your rights If you purchased Dilon hardware in the continental United States Alaska and Hawaii you are entitled to mail in return to service depot repair service during the applicable warranty period subject to the following terms and conditions 1 Mail in repair service is available for Dilon hardware purchased and located i...

Страница 42: ...return shipment charges for Product returned where Dilon determines there is no defect No Defect Found or for Product returned that Dilon determines is not eligible for warranty repair 5 The RMA number must be placed on the exterior shipping container Use the original shipping and packing materials and include a description of the hardware problem along with the RMA number on the inside of the pac...

Страница 43: ...cement Copyright 2019 Dilon Technologies Inc All rights reserved Version 1 7 Contact Dilon Technologies Inc to order replacement or extra parts 1 855 CoPilot 1 855 267 4568 www CoPilotVL com Ordering Replacement Sheaths and Bougies ...

Страница 44: ...The first time Every time CoPilot VL ...

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