Operator`s Manual
Contents
1. a when the blade clip is firmly latched to SNI the CameraStick i i N lt n nr waa V y he J N PS d N NN U ENSURE THAT LOCAL HANDLING PROCEDURES ARE FOLLOWED AT ALL TIMES WHILST HANDLING STERILE DEVICES CHECK THAT THE BLADE IS CORRECTLY FITTED TO THE CAMERASTICK BEFORE USING ON A PATIENT SERIES 5 VIDEO LARYNGOSCOPE DO NOT ATTEMPT TO USE ANY OTHER LARYNGOSCOPE BLADE WITH THIS EQUIPMENT IF THERE IS ANY EVIDENCE THAT THE STERILE BARRIER ON THE BLADE PACKAGING HAS BEEN BREACHED DO NOT USE THE BLADE DO NOT PUT LIQUID ON THE CAMERASTICK OR ON INTERNAL SURFACES OF THE BLADE McGRATH BLADES MUST ONLY TO BE USED WITH A McGRATH AIRCRAFT MEDICAL AIRCRAFT MEDICAL 2 6 McGRATH Video Laryngoscope Series 5 HLDi Operator s Manual Revision 1 1 21st August 2009 Document Number 505 100 008 Blade and Monitor Adjustment The length of the CameraStick may be adjusted for operation by sliding laterally through the clamp The ratchet tooth grips the blade at 3 different length settings The monitor may be rotated in a horizontal and vertical plane for best viewing angle 135 degrees 90 degrees THE MONITOR HAS POSITION STOPS AT THE ENDS OF ITS TRAVEL DO NOT FORCE THE MONITOR BEYOND THESE POINTS 2 7 STANDBY Switching on off The Laryngoscope is switched on by pushing the STANDBY button The LED on the monitor will light up2. Top Cap is replaced the unit disarticulated and adequate cleaning be performed prior to sterilization per the procedure detailed in this manual Ethylene Oxide Sterilization e The device is compatible with EtO sterilizing processes STERRAD 100 200 NX Sterilization e Sterilize as instructed in the STERRAD User Manual the standard cycle contains no user variables STERIS V Pro Sterilization e Sterilize as instructed in the STERIS V Pro User Manual the standard cycle contains no user variables Disposal of Intubation Blades The intubation blade must be disposed of after each procedure The blade must be disposed of in accordance with standard departmental practices Handling and Product Preservation Ensure that care is taken at all times while handling the device If the device is dropped it is recommended that you check for any visible signs of damage If the device is showing no signs of damage but is not functioning refer to the Troubleshooting Section It is also recommended that the battery is removed from the device and the device returned to its original packaging when not required for use Avoid leaving unattended in situations where it may be misused or damaged Environmental Operating Conditions Storage amp Transport Conditions e 10 C to 40 C ambient e 10 C to 40 C ambient e Relative Humidity 10 to 50 e Relative Humidity 10 to 90 e Atmospheric Pressure 700h Pa to 1060 hPa e Category 2 Poll
3. and rinsing is to remove all visible soil and to reduce the number of particulates microorganisms and pyrogens Thorough rinsing is important for removing any residual cleaning agents from the medical devices The decontamination methods have been validated by Aircraft Medical together with external independent experts and companies Other decontamination methods may be suitable but must be validated by the user of the device before use AIRCRAFT MEDICAL 11 AIRCRAFT MEDICAL 3 1 4 Before Cleaning e Remove battery and replace Top Cap e Separate the Handle and CameraStick Rotate safety catch so that it is in the out position to aid cleaning 3 1 5 Manual Cleaning Cleaning Equipment required McGRATH e A warm water detergent solution at correct dilution such as ENZOL Video Laryngoscope e A clean disposable absorbent non shedding cloth for application of Series 5 HLDi detergent solution e A clean disposable absorbent non shedding cloth for wiping product Operator s Manual Aircraft Medical recommends the use of a ultra absorbent microfiber cloth Revision 1 1 21st August 2009 WARNING ALWAYS ENSURE THE BATTERY IS REMOVED BEFORE CLEANING Document Number 505 100 008 12 AIRCRAFT MEDICAL If Visible Soiling is present e Immerse both parts of the device for a minimum of five 5 minutes in enzymatic detergent e Use cleaning brushes to remove additional soil as necessary taking care not to scratch
4. optical surfaces e Scrub crevices and around hinged mating surfaces with a brush e Rinse thoroughly with warm water e Check instruments for visible soil Repeat cleaning if soil is visible he soiling persists the device may be immersed in an ultrasonic bath for en 10 minutes in a warm enzymatic detergent solution to help loosen any particulate L gt Cleaning Procedure e Immerse the cleaning cloth in the enzymatic detergent solution and wring horoughly e Wipe all surfaces thoroughly ensuring that detergent solution comes into contact with all surfaces e Periodically rinse the cloth in clean water and repeat the above steps e Surfaces should be carefully hand dried using a cloth or industrial hot air dryer or placed into a drying cabinet e Safely dispose of cleaning materials 13 AIRCRAFT MEDICAL 3 2 McGRATH Video Laryngoscope Series 5 HLDi Operator s Manual Revision 1 1 21st August 2009 Document Number 505 100 008 Disinfection Manual Disinfection Preparation for Disinfection e It is important that the battery is removed from the device the Top Cap is replaced the unit separated and adequate cleaning be performed prior to disinfection per the procedure detailed in this manual Disinfection e All irritant disinfectant residues should be removed before the item is reused and care should be taken when rinsing to ensure that items are not re contaminated during this procedur
5. to show that power is applied to the system Switch the equipment to standby by pushing the STANDBY button Ensure that the equipment is always switched to standby after use to preserve the charge in the battery When the unit is switched on the device automatically checks the charge state of the battery If the battery has sufficient charge to operate the LED on the monitor illuminates continuously When the device battery requires to be changed the LED will begin to flash to indicate that the battery charge is low When this occurs it is recommended that the battery is changed IMMEDIATELY as the device will only remain operational for a short period of time in this condition lt LED on battery OK LED flashing check battery AIRCRAFT MEDICAL AIRCRAFT MEDICAL 2 8 McGRATH Video Laryngoscope Series 5 HLDi Operator s Manual Revision 1 1 21st August 2009 Document Number 505 100 008 Using the Laryngoscope The laryngoscope should be turned on as detailed in section 2 7 A bright light should appear at the tip of the CameraStick and an image on the screen at the top of the handle Anesthesia should be induced according to the anesthesiologist s preference The tip of the laryngoscope blade should be inserted into the mouth in the midline superior to the tongue and rotated towards the larynx in a sagittal plane until the epiglottis is visible Either direct vision along the superior surface of the bla
6. CENSED PRACTITIONER AIRCRAFT MEDICAL AIRCRAFT MEDICAL 2 2 1 McGRATH Video Laryngoscope Series 5 HLDi Operator s Manual Revision 1 1 21st August 2009 Document Number 505 100 008 Functional Unpacking and Inspection Unpack the McGRATH and check for any visible signs of damage that may have occurred during shipment In the event of signs of damage do not use the laryngoscope and inform your local agent or distributor The packaging should contain the following items CameraStick Module The McGRATH is supplied in a non sterile state It will be necessary to decontaminate the laryngoscope according to local requirements before use on a patient See section 3 1 The laryngoscope blade purchased separately is supplied in a sterile state Ensure that handling precautions are taken in accordance with local national and harmonised standards 2 2 2 3 Batteries The device is powered by a single AA battery For safety reasons the batteries are not supplied with the unit The MCGRATH will accept any AA battery The MCGRATH will give longer use with lithium batteries We do not recommend the use of Zinc Chloride batteries due to limited life A TIME Up to 3 hours Up to 2 25 hours Up to 1 5 hours Up to 0 75 hours 0 hours Lithium Nickel Metal Hydride Alkaline Unbranded NiMH rechargeable Zinc Chloride 2700 mA h Fitting the battery Unsc
7. McGRATH Video Laryngoscope Series 5 HLDi Operator s Manual AIRCRAFT MEDICAL Doc No 505 100 008 Revision 1 1 2 st August 2009 AIRCRAFT MEDICAL McGRATH Video Laryngoscope Series 5 HLDi Operator s Manual Revision 1 1 21st August 2009 Document Number 505 100 008 1 2 1 3 1 4 2 1 2 2 2 3 2 4 2 5 2 6 2 7 2 8 3 1 3 2 3 3 3 4 3 5 3 6 3 7 Contents Introduction Description Accessories and Part Numbers Specifications Regulatory Functional Unpacking and Inspection Batteries Fitting the Battery Fitting the CameraStick Blade Fitting Blade and Monitor Adjustment Standby Switching On Off Using the Laryngoscope Cleaning and Decontamination Decontamination of MCGRATH Series 5 HLDi Devices Disinfection Drying and Storage Sterilization Disposal of Intubation Blades Handling and Product Preservation Environmental Maintenance Troubleshooting Replacement Parts amp Repair Warranty Oo wo N N PY n o Oo ON OA SI A A AIRCRAFT MEDICAL 1 1 1 1 2 McGRATH Video Laryngoscope Series 5 HLDi Operator s Manual Revision 1 1 21st August 2009 Document Number 505 100 008 Introduction Description The McGRATH Series 5 HLDi Video Laryngoscope the MCGRATH is a device designed to aid the intubation of the trachea A rigid laryngoscope blade restrains the tongue allowing a clear view of the larynx and entrance to the trach
8. TO ENSURE THAT THE CLEANING PROCESS AS IT IS ACTUALLY PERFORMED ACHIEVES THE DESIRED RESULT WARNING AFTER ANY CLEANING DISINFECTION STERILIZATION PROCESS ENSURE THAT THE DEVICE HAS NO DAMAGE OR LOOSE PARTS AND OPERATES CORRECTLY WARNING ANY TRAYS OR CONTAINERS THAT ARE USED IN ANY OF THE PROCESSES BELOW SHOULD BE INSPECTED FOR VISIBLE SOIL AND MUST BE CLEANED BEFORE USE WARNING CHEMICALS AND EQUIPMENT RECOMMENDED IN THIS DOCUMENT MUST BE USED IN ACCORDANCE WITH THE MANUFACTURER S INSTRUCTIONS FOR USE AND LOCAL HANDLING PROCEDURES These instruction have been prepared to provide decontamination and sterilization instructions for the McGRATH Series 5 HLDi Video Laryngoscope These methods were developed using standard equipment and practices common to global healthcare facilities using the guidance given in AAMI TIR 12 Designing Testing Labelling Reusable Medical Devices for Reprocessing in Health Care Facilities A Guide for Device Manufacturers and ISO 17664 2004 Sterilization of medical devices Information to be provided by the manufacturer for the processing of resterilisable medical devices PEP HEY SETA The device should be decontaminated after each patient use Dispose of all chemicals used in accordance with manufacturer s guidelines General Information for Disinfection and Sterilization of Medical Devices Thorough cleaning and rinsing are vital for the decontamination of the product The purpose of cleaning
9. d in the handle e The bottom top and contact point side of the CameraStick For re ordering Kit use Part Number 500 070 005 AIRCRAFT MEDICAL 17 AIRCRAFT MEDICAL McGRATH Video Laryngoscope Series 5 HLDi Operator s Manual Revision 1 1 21st August 2009 Document Number 505 100 008 Troubleshooting Replacement Parts amp Repair Any other faults will require to be diagnosed by an authorised repair centre The device must only be diagnosed repaired and serviced by an official Aircraft Medical Limited distributor or agent Distributor Contact Details When switched on there is no display on the screen ee Is the battery charge LED illuminated The LED is not illuminated e Check that the battery is inserted in the correct orientation refer to section 2 3 e Replace battery e Check for oxidization on the battery contacts and if required clean the contacts using Maintenance Kit LED Flashing The LED flashing indicates that the battery requires changing e Change the battery The LED is illuminated e Check the LEDs situated at the end of the CameraStick module If these are not lit there may be oxidization of the CameraStick or CameraStick clamp contact strips pins Clean using Maintenance Kit e The unit may be receiving no signal from the camera This also may be caused by oxidization of the CameraStick or CameraStick clamp Clean using Maintenance Kit
10. de or indirect vision via the camera can be used to guide the laryngoscope tip toward the larynx Care should be taken as with conventional laryngoscopy that the blade does not make contact with the teeth The tip of the blade should be guided into the vallecula Further rotation and or minimal force applied along the long axis of the handle should lift the epiglottis and allow a view of the glottis Again either direct or indirect vision can be used to view the glottis Once the glottic opening has been correctly identified a correctly sized tracheal tube can be passed between the vocal cords A bougie or a malleable introducer may be used to assist the passage of the tracheal tube If a malleable introducer is used we recommend that a hockey stick curve be made at a point about 5cm from the tip of the tracheal tube The laryngoscope can then be carefully withdrawn by reversing the process described above Confirmation of the correct placement of the tracheal tube should be both visual and by the use of capnography 3 1 3 1 1 3 1 2 3 1 3 Cleaning and Decontamination Decontamination of McGRATH Series 5 HLDi Devices WARNING DO NOT AUTOCLAVE THIS DEVICE WARNING ENSURE THE DEVICE IS COMPLETELY DRY BEFORE USE WARNING ALWAYS ENSURE THE BATTERY IS REMOVED BEFORE DECONTAMINATION WARNING THIS DEVICE SHOULD NOT UNDERGO DECONTAMINATION OR DRYING PROCESSES ABOVE 60 C WARNING IT IS THE RESPONSIBILITY OF THE USER
11. e Receptacles and containers used to contain devices should be cleaned before use Disinfection Equipment required e A receptacle with a lid which can be disinfected and with sufficient capacity to immerse the item fully e A means to contain or extract any irritant vapours e A solution of freshly prepared chemical disinfectant at the manufacturer s recommended concentration such as Cidex OPA e A receptacle which can be sterilized or disinfected to contain rinse water e Sterile clean water to rinse items after chemical disinfection e A clean disposable absorbent non shedding cloth or mechanical drying facility Aircraft Medical recommends the use of an ultra absorbent microfiber cloth 3 3 AIRCRAFT MEDICAL Disinfection Procedure e Liquid chemical disinfectants can be supplied ready to use or may require mixing with an activator Alternatively it may need accurate dilution to an in use strength as per the manufacturer s instructions e Ensure that the disinfectant receptacle is clean and dry e Wearing appropriate personal protective equipment to include impervious gown Nitrile or Butyl gloves face mask shield or face shield fill the receptacle with sufficient prepared disinfectant solution so as to ensure complete immersion of the item to be processed e Carefully immerse the item in the solution in such a way as to displace any trapped air within the item it is important to ensure that the solution reach
12. ea The need to provide a guaranteed airway is fundamental to an anaesthesiologist s task prior to an operation Paramedics Emergency Department Consultants and General Practitioners may also be required to insert a tracheal tube to keep the airway open in an unconscious patient The McGRATH incorporates a light source and miniature camera within the CameraStick assembly to view the larynx during the procedure of intubation The image is displayed on an LCD screen mounted to the handle of the device A single AA 1 5V battery mounted within the handle powers the camera display and light The disposable sterile blade covers the CameraStick light assembly Accessories and Part Numbers LARYNGOSCOPE BLADE BE USED WITH THIS MEDICAL DEVICE DO NOT OPEN ANY SEALED PART OF THE DEVICE UNDER ANY CIRCUMSTANCES TO DO SO WILL IMPAIR THE PERFORMANCE OF i UNDER NO CIRCUMSTANCES SHOULD ANY OTHER TYPE 0F THE DEVICE AND PATIENT SAFETY AND INVALIDATE THE WARRANTY The McGRATH is not supplied with batteries or with disposable intubation blades blades should be purchased separately from your distributor or agent McGRATH Intubation Blades Carton of 30 550 006 000 McGRATH Series 5 HLDi Video Laryngoscope 505 000 000 McGRATH Maintenance Kit 500 070 005 1 3 1 4 Specifications Laryngoscope Assembly Size 200mm x 50mm x 150mm Weight 0 28kg Power AA 1 5V Battery For information regarding battery life refer to section 2 2 of t
13. es all surfaces e Place the lid on the receptacle and leave for the recommended time Follow manufacturer s recommended soak times Cidex OPA 12 minutes 25 C Metricide OPA 12 minutes 25 C Cidex Plus 20 minutes 25 C Metricide 45 minutes 25 C Cidex 45 minutes 25 C Metricide 28 90 minutes 25 C e Remove the item from the solution drain into receptacle before transferring to clean rinse receptacle e Rinse thoroughly with sterile water of suitable microbiological quality e Remove item from rinse solution and drain e Carefully hand dry using clean absorbent non shedding cloth or industrial hot air dryer or place into drying cabinet Drying and Storage The device must be completely dry before use Aid drying by placing the handle with the top removed on a drying spike so that the opening is facing downwards to aid drainage Place the Top Cap and CameraStick on a drying tray so that they are suspended to aid drainage A drying cabinet is suitable to aid drying time amp SS Storage of the device once decontaminated Store the device in a clean container covered to prevent airborne contamination 15 AIRCRAFT MEDICAL 3 4 3 4 1 3 4 2 3 4 3 3 5 3 6 McGRATH Video Laryngoscope Series 5 HLDi Operator s Manual Revision 1 1 21st August 2009 Document Number 505 100 008 Sterilization Preparation for Sterilization e It is important that the battery is removed from the device the
14. his manual Light source High intensity LED fibre Display Colour LCD 1 7 diagonal Camera VGA Protection IPx7 Materials Durable medical grade rubber thermoplastics and stainless steel This device and packaging are latex free Disposable Intubation Blade Size 110mm x 12mm x 15mm Material Medical grade optical polymer Packaging Packaged sterile for single use only This device and packaging are latex free Regulatory This product complies with EN 60601 1 and EN 60601 1 2 safety standards The CE mark indicates that it meets the requirements of European Council Directive 93 42 EEC concerning medical devices A EEE Aircraft Medical Limited operates an approved Quality Management System in accordance with BS EN ISO 13485 McGrath is a registered trademark of Aircraft Medical Limited Aircraft is a registered trademark of Aircraft Medical Limited CamerasStick is a trademark of Aircraft Medical Limited Only personnel trained in and licensed to perform intubation with a laryngoscope may use this device The user must contact the distributor to arrange responsible disposal and compliance with Waste Electrical and Electronic Equipment regulations as locally applicable and any similar future environmental regulation applicable including but not limited to Directives 2002 95 EC and 2002 96 EC as implemented in the Territory CAUTION FEDERAL USA LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A LI
15. lf none of the above achieves positive results return the unit to your local distributor or agent for repair Poor picture quality The image displayed on the screen is blurred or fuzzy e Check for fogging on the intubation blade Remove the blade and check that the image is clear and bright If necessary wipe the camera lens at the end of the CameraStick as per maintenance kit instructions e Check that the CameraStick is fully inserted in the blade and that the blade has latched to the CameraStick e Clean the contact strips on the CameraStick and the contact pins on the handle clamp using Maintenance Kit The image on the screen flickers or has lines across it e Check that the battery is fully charged e Remove battery and check battery for oxidization e Clean the contact strips on the CameraStick and the contact disc of the Top Cap using Maintenance Kit e Use of Pin Pusher e Push the contact pins in and out using the Pin Pusher as shown for 2 3 seconds e Push the ground contact pin using the teeth of the Pin Pusher Slide in and out SS for 2 3 seconds UW e Push the ratchet mechanism using the Pin Pusher as lever on the clamp area for 2 3 seconds lf none of the above achieves positive results return the unit to your local dealer for repair Loose or poorly fitting components lf any components become loose physically damaged or fit poorly under no circumstances use the equipment and
16. return the unit to your local distributor or agent for repair or replacement AIRCRAFT MEDICAL 19 AIRCRAFT MEDICAL McGRATH Video Laryngoscope Series 5 HLDi Operator s Manual Revision 1 1 21st August 2009 Document Number 505 100 008 20 Warranty Aircraft Medical Limited warrants that the device supplied is on leaving the factory free from defects in materials or workmanship This warranty is valid only if the product is supplied to the end user by an Aircraft approved distributor or agent and has been maintained in accordance with procedures documented in the Operator s Manual If failure occurs from manufacturing defects within 12 months of purchase Aircraft Medical will repair or replace the defective item AIRCRAFT MEDICAL 21 ned amp manufactured by Aircraft Medical Ltd 10 Saint Andrew Square Edinburgh EH2 2AF United Kingdom Tel 44 131 7186042 Fax 44 131 7186100 www aircraftmedical com
17. rew the Top Cap as per the diagram below and insert battery with positive terminal upwards Replace Top Cap he AIRCRAFT MEDICAL AIRCRAFT MEDICAL 2 4 McGRATH Video Laryngoscope Series 5 HLDi Operator s Manual Revision 1 1 21st August 2009 Document Number 505 100 008 Fitting the CameraStick Remove the protective labels from the contact strips on the rear of the CameraStick and from the end of the CameraStick Release the safety catch by pulling out and rotating then slide the CameraStick into the clamp at the bottom of the handle module Return the safety catch to the upright position It should be possible to hear the ratchet tooth clicking as the CameraStick passes through the clamp Ensure that the CameraStick slides smoothly through the clamp whilst still requiring a reasonable amount of force to deflect the ratchet tooth FAILURE TO RELEASE THE SAFETY CATCH WHEN FITTING THE CAMERASTICK WILL LEAD TO DAMAGE TO THE HANDLE Safety catch rotated l N N A A N N LA N ESS N sd 2 5 Blade Fitting The McGRATH is designed to be used only with MCGRATH Disposable Intubation Blades These blades are packaged and supplied sterile and MUST be disposed of after each patient use To fit the blade remove the blade from sterile packaging and slide over the CameraStickTM The blade is fully located
18. ution Degree 2 Decontamination and Drying Condition e 60 C Maximum 4 1 4 1 2 Maintenance Inspection The device should be inspected at regular intervals for e visible signs of external damage e scratches or defects on the lens of the CameraStick e signs of deterioration of the LCD display e build up of material on contact strips on CameraStick and contact pin area of Handle Product checks Additionally at six month intervals the following should be checked by a qualified technician e check for signs of oxidization on electrical contacts e perform the functional checks In the event of problems the device must be returned to the distributor for repair or exchange Maintenance Kit Lens Cleaning Procedure Every few months or if the image on the screen becomes blurred cloudy or obstructed clean the camera lens with a conical foam swab Dipping the swab in IPA will help shift stubborn dirt Contact Cleaning Procedure Every few months or if the image is flickering or the battery life is short clean the electrical contact points with the cleaning solution sachets found in this kit using a simple 2 step process Firstly open the sachet marked Cut amp Polish 1 and wipe down the contact points firmly Then open the sachet marked IPA 2 and wipe down the contact points firmly This will remove dirt and carbon build up on the product The contact points are located e In the battery cap an
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