USER`S MANUAL
Contents
1. allowed to use Truview PCD R blades Any piece of medical equipment may transmit infection from patient to patient Appropriate measures must be taken to clean disinfect and sterilize the Truview PCD R equipment between patients and to maintain them in a clean state Ensure that the Truview PCD R blades are clean and free from damage prior to use HOW TO PREVENT FOGGING To prevent fogging and to improve patient safety connect the Truview PCD R blade via the oxygen port to an oxygen or medical air supply line Connect oxygen to the blade s oxy port from a suitably available oxygen source wall supply cylinder or anesthesia machine using a standard hospital oxygen single use plastic supply tube and feel that there is a jet flow of oxygen over the lens surface Oxygen flow guidance Blade sizes 0 and 1 up to 5 liters minute Blade sizes 2 3 4 up to 10 liters minute These oxygen rates are for guidance purposes only Actual flow rates depend upon numerous clinical and professional considerations and are to be decided by the treating clinician SECTION 2 Alternatively the blade can be preheated in water 50 C 60 C 122 F 140 F temperature or antifogging solution can be applied to the lens For improved control of the endotracheal tube direction it is recommended to insert a Truflex flexible tip stylet or Optishape re usable stylet into the endotracheal tube prior to intubation2. Multi choice video laryngoscope system Provides all the components to build your own Failed DL Rescue Device at prices you can easily afford USER S MANUAL Please read this manual thoroughly before use and keep it safe for future reference For technical support or help contact helpdsk truphatek com or your local dealer How to use this User s Manual Sections Introduction to the System Optical Blades TruLED Rechargeable Handles Camera Data Using the Monitor Trouble Shooting Hints Technical Specifications Warranty Conditions Accessories Contact Se Se oe SE me m e a Page 2 4 5 10 11 12 13 16 17 18 19 20 21 22 23 24 SECTION 1 HOW TO CREATE YOUR TRUVIEW PCD R MODULAR VIDEO LARYNGOSCOPE SYSTEM SECTION 1 STEP 1 CHOOSE YOUR OPTICAL BLADES The Truview PCD R system comprises of a range of 5 stainless steel low profile laryngoscope blade sizes with special narrow tips that enable difficult oral and nasal intubations to be performed using a minimal amount of force and causing a reduced rate of patient side effects such as sore throat or soft tissue damage The Truview PCD R blades contain sophisticated optics that refract the line of vision with the result that an improved Cormack amp Lehane grade of difficulty score is obtained An oxygen jet spray delivered via a unique injector across the blade lenses during the intubation procedure serves to slow
3. 5 410001 ETT sizes 5 to 6 5 410004 ETT sizes 7 to 9 Rechargeable battery for handle 42143100 Adult 42103000 Infant Power supply chargers 4145 For screen 421460 For handle 410402 Truview PCD R FibreClip in sets containing 2 FiberClips 410005 Truflex articulating stylet General Information amp Contact Details TRUPHATEK INTERNATIONAL LTD 8051 NETANYA ISRAEL 42504 PHONE 972 9 8851155 FAX 972 9 8851212 helpdsk truphatek com www truphatek com Camera amp Monitor Regulatory Certifications IEC 60950 1 2005 2nd Edition Al 2009 Emtek Aug16 2012 EMC Directive 2004 108 EC Emtek Certification ES1207022001E Aug16 2012 AUTHORIZED REPRESENTATIVE EUROPE MEDES LIMITED 5 BEAUMONT GATE SHENLEY HILL RADLETT HERTS WD7 7AR U K EC REP CE CE Registration number with MHRA CA 7730 Patent US 8 251 898 B2 granted Aug 28 2012 TRUPHATEK www truphatek com USER S MANUAL
4. After exposure to the solution rinse with de mineralized water and THOROUGHLY DRY Thermal Disinfectors may also be used for disinfection Do not use chemical detergents containing caustic or alkaline ingredients such as bleach peroxide solutions sodium hypochlorite etc that can cause irreparable damage to the instrument It is recommended to sterilize the Truview PCD R blades using low temperature reprocessing methods such as Sterrad 50S 100 5 200 100 NX plasma systems or Ethylene Oxide ETO gas sterilization according to manufacturers recommendations DO NOT USE STEAM AUTOCLAVING FOR THESE OPTICAL BLADES OR EXPOSE THE OPTICAL VIEW TUBES TO TEMPERATURES IN EXCESS OF 95 C 203 F Satisfactory sterilization is dependent upon various factors including the use of various cleaners sterilizers and treatment with numerous cleaning chemicals These factors and variations are beyond the control of Truphatek and accordingly we cannot be held responsible for the cleanliness or degree of sterility of the instruments If in doubt handle in the same manner as endoscopic optical equipment SECTION 2 Disengage entire blade from handle Disassemble FibreClip by pushing with thumb in an outward direction away from the base of the blade until the FibreClip separates from the blade To re assemble FibreClip first place tip of light guide into the opening on the blade Then press base of FibreClip into the recess
5. SECTION 2 The following table is for guidance purposes only The correct blade size to use depends upon numerous clinical parameters and conditions The final decision remains the sole responsibility of the clinician Blade Blade Size Patient s Weight Weight range Name Age years range Kg Pounds 0 8 4 0 2 0 9 0 3 4 0 8 0 9 0 18 0 Child 8 0 60 0 18 0 132 0 Infant 1 50 0 120 0 110 0 265 0 16 Extra gt gt 120 0 gt 265 0 large Check that all parts are clean positioned properly that the glass prism in the optical eye piece is undamaged that the view through the optical system is unhindered and that there is blade tip illumination when the blade is mounted onto the laryngoscope handle Always check that the view tube is inserted properly into the groove on the blade SECTION 2 Incorrect Ensure that batteries in the handle are fully charged When plugged in the green LED at the bottom of the TruLED PCD R handle lights up to indicate that batteries are fully charged Mount the Truview PCD R laryngoscope blade onto the TruLED PCD rechargeable handle and ensure that the laryngoscope blade lights up in the horizontal position Before every use check the optical view tube lenses for signs of scratches or damage and replace the optical view tube if necessary Tracheal intubation requires specialized training Only personnel who have received such training should be
6. and exceptions Truview PCD R LCD screens with dedicated Picture Capture Device are guaranteed to perform for a period of 12 months from date of manufacture as it appears on the rear panel of the outer casing of the screen FibreClip replaceable fibre optic light guides are guaranteed to perform for a period of 12 months from date of manufacture as it appears embossed on the base of each FibreClip OptiShape metal reusable preformed stylets are guaranteed to perform for a period of 12 months from date of manufacture as it appears on the embossed disk on each OptiShape stylet Tru LED green system laryngoscope handles with LED light source are guaranteed to perform for a period of 5 years from date of manufacture as it appears embossed on each handle This guarantee period does not cover the performance of the rechargeable battery Tru LED rechargeable batteries are guaranteed to perform for a period of 12 months from date of manufacture as it appears on the battery cartridge All of the above guarantees are conditional to the product being used cared for handled cleaned disinfected and or sterilized according to the manufacturer s instructions as they appear in the Instructions for Use that accompany every Truphatek product The above Truphatek warranty does not cover products that have been deemed defective due to misuse improper cleaning and handling neglect accident unauthorized repair unr
7. on the base of the blade ensuring it is firmly secured Always check that the blade lights up after cleaning or replacing FibreClip to ensure proper performance of the blade Certain hospital detergents and disinfectants can cause accumulation of residue on the tips of the FibreClip which can be detrimental to the performance and life expectancy of the FibreClip It is recommended to use at frequent intervals a non abrasive material with ethanol or other non acidic cleaning solutions to wipe off tip and distal end of the FibreClip to prevent residue buildup Protect from scratches Ultrasonic cleaning and flash autoclaving are not recommended and will void warranty Repeated autoclaving may reduce light transmission and the life expectancy of the FibreClip SECTION 2 Sterilization Manually clean internal and external surfaces using a soft brush Do not use abrasive materials such as steel wool Immerse in rinse water Soak the device in enzymatic solution per the manufacturers recommendations If the Truview PCD R blades are to be treated in a washing machine ensure that the temperature within the program does not exceed 95 C 203 F Feel free to use detergents per the washing machine manufacturer s recommendation It is recommended to use detergent with neutral PH level Use Sterrad plasma systems or Ethylene Oxide Gas ETO sterilization per the manufacturer s recommendations If Truview
8. the rate of de saturation prevent misting and remove secretions on the lenses thereby ensuring that a clear visual picture is maintained throughout the entire intubation procedure These blades can be used by direct view or by linking them either to a Truview PCD R dedicated camera LCD screen combination or to most endoscopic HD cameras LCD screens that are already used in operating rooms STEP 2 CHOOSE YOUR RECHARGEABLE HANDLE The Truview PCD R system requires very powerful LED illumination with a bluish white colour spectrum in order to give the optimal clarity of view It is highly recommended to use TruLED re chargeable handles that were specially designed to provide the strongest illumination at constant power output levels that can be easily maintained by simple re charging TruLED soft feel rechargeable handles available in standard and mini sizes provide over 10 hours of continuous use They can be easily cleaned by removing the inner core and can be successfully sterilized using all STERRAD gas plasma systems Various local territory plug options are available SECTION 1 STEP 3 CHOOSE YOUR CAMERA ATTACHMENT Main Choice SONY CAMERA The Truview PCD R dedicated camera is based on use of a Sony CCD II Exview HAD CCD II with an added focus lens and presented as a magnetic attachment that easily attaches onto all the blades Alternate Choice STORZ or OTHER ENDOSCOPIC CAMERAS The Truview PCD
9. your TruLed handles and your Truview PCD R screen especially before first use and after storage or non use for more than 7 days HOW TO CARE FOR TruLed HANDLES Remove inner battery cartridge Battery cartridge can be wiped with a dry cloth Take care not to scratch protective glass covering the LED Outer sleeve may be cleaned disinfected and sterilized using cold disinfection solutions Thermal Disinfectors Steris Sterrad ETO and steam autoclave procedures Protect battery cartridge from direct contact with water and fire Do not open or tamper with the battery cartridge or the power supply unit HOW TO CARE FOR LITHIUM ION RECHARGEABLE BATTERIES Store in cool dry conditions at temperatures between 0 C 45 C 32 F 113 F Cartridge stored unused for 6 months or more will require re charging Always discard in suitable container Keep away from fire amp water The Sony Exview HAD CCD camera has been used to provide a clear true colour image of the epiglottis Carefully disengage the PCD R dedicated camera head 12 from the magnetic cradle on the side of the Truview PCD R screen Make sure to securely connect the PCD R camera head 12 to the eyepiece of the Truview PCD R laryngoscope blade Ensure alignment of the guiding pins on the Truview PCD R camera head with the matching gaps in the outer ring of the eyepiece Point the blade at a suitable surface and check that you obtain a view
10. Ensure that the tip of the stylet is correctly positioned in the ETT and does not protrude past the Murphy eye Remember to remove the stylet before entering the ETT into the alveoli Do not steam autoclave the optical view tube of the Truview PCD R blade Follow cleaning and maintenance instructions herein HOW TO CLEAN TRUVIEW PCD R OPTICAL BLADES Immediately after use the Truview PCD R laryngoscope blades should be immersed in water to prevent residue adhering to the instrument External surfaces should be gently scrubbed in soapy water with a soft brush to remove encrusted deposits Do not use abrasive materials such as steel wool Rinse blades in de mineralized water and THOROUGHLY DRY before disinfection and or storage Oxygen port can be cleared and or cleaned by passing an air or gas jet through the oxygen connector on the blade Whereas it is possible to clean the Truview PCD R blade in its assembled form Truview PCD R Blade Sizes 2 3 4 have removable FibreClip fibre optic light guides and removable optical view tubes that allow even easier cleaning However make sure to reassemble these parts very carefully prior to sterilization procedure When reassembling ensure optical view tube is correctly inserted into groove on blade SECTION 2 Hospital disinfectants such as Cidex Plus and Cidex OPA may be used Follow the manufacturers guidelines for recommended exposure times and solution concentration
11. O Before first use and after storage of the monitor for a period of two weeks or more fully charge the monitor with power button 2 in Off position This procedure can take up to 2 5 hours Fully charged battery will provide 3 hours of continuous use before requiring recharging All three LEDs will light up when turning on the screen in a full charge status Before every use Press power button 2 to ON position and check battery status to confirm that at least two battery status LEDs are lit up e f only the red battery status LED is on then there is 50 minutes of battery charge left e When both Yellow 15 and Red LEDs 16 are lit up there will be nearly 120 minutes of battery charge left e During charging of the screen no LEDs 14 15 16 will light up e When the screen is fully charged all three LEDs will light up Do not use the Truview PCD R screen while the battery is being charged Unplug screen from A C electrical connection before use Between uses switch off power button 2 on the monitor to preserve power IMPORTANT At the end of each day ensure power button 2 is in OFF position and charge the monitor and handle SECTION 5 TRUVIEW PCD R Monitor HOW TO RECORD amp STORE Instructions for recording watching deleting Video Clips Press Press To proceed to intubation AOUN ELERS Turn on ae or I a press screen to display to select the it
12. PCD R blade sizes 2 3 or 4 are to be sterilized in a steam autoclave remove the optical view tube and set aside to be sterilized separately as described above The remaining parts may be placed ina steam autoclave Truview PCD R blade sizes 0 amp 1 should not be autoclaved Each TruLed Soft Feel Handle is provided with a Santoprene sleeve that provides its soft feel Santoprene is a thermoplastic vulconizate TPV that combines the best attributes of vulcanized rubber such as flexibility and very hard wearing even at very wide temperature range 60 C 135 C 76 F 275 F showing no cracking or stickiness The outer sleeve can be subjected to most cleaning regimes and to both autoclave or any of the Sterrad gas plasma system protocols The TruLed handles are designed exclusively for use with TruLed Lithium lon Rechargeable batteries Connect the power supply directly into the bottom end of the inner battery cartridge Various local territory plug configurations are available Plug the power supply into the main electrical supply source e Red LED at bottom indicates that the battery is charging Flickering of red light might occur at this stage Green LED indicates that charging is completed and the TruLed handle is ready for use Continuous more than 15 minutes flashing red LED indicates a fault Contact your local dealer for replacement battery or regarding repair of the unit Always charge both
13. R Optical blades allows attachment to all camera systems used by standard operating room endoscopes that are fitted with 32 mm standard connection mounts STEP 4 CHOOSE YOUR MONITOR Main Choice TRUVIEW PICTURE CAPTURE DEVICE PCD MONITOR The Truview PCD R 5 inch digital LCD Monitor Screen allows recording storage and viewing of both single images and video clips taken during intubations The lightweight screen easily fits into a clinical jacket pocket and can thereby be taken from one operating room to another or to a main computer to download images and transfer them to patient files or for use during case demonstrations for teaching and research purposes The computer will recognize the monitor as if it was a memory storage key The installation of complicated software is not required A USB cable is used to download from the Truview PCD R monitor to another computer while an AV cable can be used to show images both on the Truview PCD R monitor and on a larger monitor screen The images will be seen on both monitors at the same time Alternate Choice OPERATING ROOM MONITORS THAT CONNECT TO STORZ or OTHER ENDOSCOPIC CAMERAS Truview PCD R Optical blades will easily fit into any 32mm standard C Mount camera attachments used by most operating room endoscopic systems The entire intubation process can be screened throughout the operating room for training and observation The data can also be stored for later use
14. easonable damage improper storage or application or that have worn out after a reasonable lifetime of use Truphatek will have no obligation under this warranty for e Products labeled Single Use or Single Patient Use where any attempt has been made to reprocess them e Reusable products that have been processed without following the appropriate use care repair and reprocessing guidelines and instructions provided by the manufacturer in the Instructions for Use manual e Consumables such as bulbs or LEDs Truphatek reserves the right to inspect prior to repair or replacement any product that is deemed by the customer to be subject to manufacturing or materials defect Truphatek s obligation shall be that warranty specifically defined in this statement and shall not be liable for any consequential incidental direct or indirect damages or loss arising out of the design manufacture sale use or repair of the products This warranty is given in lieu of and to the exclusion of any other warranty or condition either expressed or implied by statute or otherwise SECTION 9 Reorder Description Code Numbers 4144 Blade organizer stand 4132 Hard case empty 4131 Soft bag empty 410303E Replacement View Tubes SECTION 9 List of Parts amp Accessories Reorder Description Code Numbers OptiShape stylets for 41000 Set of 4 optishape stylets 410000 ETT sizes 2 5 to 3 5 410009 ETT sizes 4 to 5
15. em to modify the CH menu to be modified selected item Press Press e Video clips are saved automatically Pde E Turn on e Recording time per clip is 5 minutes CER screen gt Total recording time is 60 minutes to begin again to stop e Recording can be stopped at any time recording recording Press ma OF stop selected saved video clip To proceed to intubation press VIEW Eia To proceed MELET O Turn on OEO screen to review to scroll between saved clips saved video clips Press twice to intubation DAGESE Turn on m press 4 screen VIEW TRUVIEW PCD R to delete selected clip to review to locate amp select saved clips saved video clips SECTION 5 Adjust data amp display settings Take snapshots Watch saved snapshots Delete saved snapshots TRUVIEW PCD R TRUVIEW PCD R Monitor HOW TO RECORD amp STORE Instructions for capturing watching deleting Snapshots Press Press H E to display to select the item menu to be modified Press To proceed WE to intubation or J press VIEW to modify the selected item FE e Snapshots are saved automatically Total memory capacity over 1000 snapshots if no video clips are saved Turn on screen Press ae Turn on screen m to take a snapshot Pres
16. lip is correctly inserted into the blade To insert it into the blade First place the tip of light guide pipe into blade groove Then press the base of FibreClip into the recess in the base of the blade ensuring it is firmly secured SECTION 7 Truphatek reserves the rights to change specifications of any component CAMERA Image Sensor 1 3 SONY Exview HAD CCD II Image format PAL Horizontal resolution 540 TV lines Focus Manually Adjusted POWER SOURCE Built in Li lon 16 8V rechargeable battery OUTPUT Analog Composite AV PAL Digital USB 2 CONNECTION PORTS Total line length of USB port and AV port are less than 3 meters MONITOR Please note that the Truview PCD R screen is categorized as a Class A product according to FCC standards XRU 4190 Type TFT digital LCD Digital Screen size 5 Resolution 640 480 Dot Pitch 0 2025 h 0 0675 w Brightness 200cd m 2 Color Depth 24Bit Support storage cards Built in 2GB TF Card which can hold over 1 000photos or 60 minutes video recording maximum 5 minutes lengths for each clip Video format AVI 25 5 Picture format JPEG STORAGE OF MONITOR Store between 0 C 35 C 32 F 95 F Following two weeks or more of storage recharge MONITOR while POWER button is in OFF position Warnings I 2 A Do not charge the monitor while it is in use Use only FCC CE approved charger supplied by manufacturer Avoid drop
17. on the monitor Ensure that Truview PCD R LCD screen is fully charged and at least two LEDs are lit up Switch on the monitor by pressing button 2 The monitor will light up after a few seconds Use the focus ring 13 to obtain clear sharp vision at a distance of 10 to 20mm from the tip of the blade Always ensure that optical view tube is correctly inserted into the groove on the blade Truview PCD R optical laryngoscope blades can also be connected to most endoscopic HD monitor camera heads available in operating rooms that have a 32mm Standard C Mount connection SECTION 5 A 5 inch pocket size TFT Digital LCD picture recording monitor provides the ideal option for most clinical situations It provides a large enough picture to use for training while the monitor is still small enough to be easily transferred from one operating room to another The monitor has a built in memory storage that can hold 1 000 photos or 60 minutes of video recording in 5 minute clips TRUVIEW PCD R Monitor HT AV port 5 R tating handle 6 Ventilation outlet 8 Control button 2 o Control button 3 3 Focus ring Green LED Full Battery Yellow LED Half Battery Red LED Low Battery SECTION 5 Monitor Camera Day amp Night COLOR e Brightness 30 e Backlight compensation method OFF e ATRset ON e Contrast 33 e AGC ON e Move Detection ON e Saturation 40 e Exposure mode AUTO SHUTTER IRIS AWB AUT
18. ping or striking the monitor screen Do not cover the ventilation outlets 6 The battery of the Truview PCD R MODEL PCD 4190 monitor and most other components are not user replaceable and should be returned to the local dealer All service and repairs must be performed only by Truphatek Authorized Service Technicians Any attempt to disassembly the Truview PCD R monitor will void the warranty TruLed ADULT TruLed INFANT HANDLES Maintenance Free Green System Rechargeable Laryngoscope Handles with LED light source TruLed handle and its power supply are compatible with the ISO 7376 2009 International Standard SECTION 7 Safety standards TruLed is certified as a medical system according to EN 60601 1 EN 60601 1 1 amp ITE 60950 1 European Power supply is not intended for use within the patient environment and UL 60601 1 IEC 60601 1 1 UL 60950 1 USA Handle is intended for use within the patient environment Safety information Do not disassemble Do not short circuit the battery terminals Do not expose the battery to water or fire Do not incinerate Recycle expended batteries Safety Instructions for Medical Equipment Environmental Conditions for Transport and Storage Ambient temperature range 0 C 45 C 32 F 113 F Relative humidity range 30 95 Atmospheric pressure range 700 1060 hPa Classification of the Equipment e According to the type of p
19. rotection against electric shock INTERNALLY POWERED EQUIPMENT e According to the degree of protection against electric shock TYPE B APPLIED PART e According to the degree of protection against ingress of water IPXO ordinary equipment e According to the degree of safety of application in the presence of flammable anesthetic mixture with air or with oxygen or nitrous oxide Category APG equipment e According to the mode of operation SHORT TIME OPERATION Operation time 5 minutes Technical Specifications Power Supply Switching AC DC power adapter GFP051T 0505 for Europe GFPO51U 0505 for North America limited power source I P AC 100 240V 50 60Hz 0 2A O P DC 5V 0 5 Li ion rechargeable Battery 3 7V with PCM Protection Circuit Module and Recharge module White LED Voltage 3 7V Current 20mA Diameter 5mm Battery Cartridge Contains Li ion rechargeable battery of 3 7V Charger and Protection Circuit Module PCM White LED Voltage 3 7V Current 20mA Diameter 5mm SECTION 8 Truphatek products and parts manufactured from medical grade stainless steel are unconditionally guaranteed to be of good quality and free from manufacturing defects in material and workmanship for a period of 5 years from date of manufacture as it appears marked on the product Replacement product will be provided without charge for any Truphatek products not meeting this warranty subject to the following terms
20. s Press To proceed to intubation screen P to review to scroll between snapshots saved snapshots To proceed to intubation press twice Press Press Press twice EAR to review to scroll between snapshots saved snapshots Turn on screen to delete a selected snapshot Em Lu m Z lt O a SECTION 6 Description Blurred or unfocused picture Unclear foggy image during intubation The monitor goes dark during a procedure Image is not fully visible on the PCD screen The monitor is flickering or does not switch on Recommended solution Adjust the white focus ring 13 Oxygen port Check the oxygen port is connected to oxygen supply line as follows About 5 liters of oxygen minute for blades sizes 1 amp 2 If 5 l m rate does not help gradually and carefully raise the rate up to 10 liters of oxygen minute For blades sizes 3 amp 4 10 liters of oxygen minute Anti fog solution may be applied to prevent misting The tongue and or tissue in posterior lateral pharynx flopping over end of light bundle Ensure the blade was not inserted too deep Use two fingers as guideline for approximate insertion depth Ensure the front surface of the view tube is completely clean If necessary clean the surface with lint free cloth and alcohol Ensure that the front surface of the camera head is clean If necessary clean it with blow of clean air or use a lint free clo
21. th and alcohol Wait 10 seconds to see if the screen stabilizes Turn off the screen Wait several seconds and then turn it on again If the screen is still flickering follow procedure for obtaining replacement from local dealer PCD HANDLE OptiShape FibreClip SECTION 6 Description Handle does not light up Light intensity of the handle decreases How do bend the OptiShape Fiber Optic Bundle light failure Figures Recommended solution Check the handle s battery is fully charged Ensure the green LED at the bottom of the handle lights up to indicate charging is complete Make sure that the blade is mounted correctly on the TruLed handle Do not use other brand of handles Ensure you hear a click when the handle is connected to the blade If the handle still does not light up replace cartridge Still not working Contact local dealer Ensure battery cartridge is completely charged and is correctly connected inside the handle Still not sufficient light intensity Replace battery cartridge The OptiShape is a pre formed stylet The design is based on professional literature and extensive research to achieve its current ideal shape The OptiShape can be bent into another shape if the clinician prefers to do so however it will return to its original pre formed shape after a while Clean the ends of the fiber optic pipe with lint free cloth and alcohol Ensure the FibreC
Download Pdf Manuals
Related Search