CAREvent CPAP Manual Rev 5 Booklet June 11 - O
Contents
1. CYLINDER DURATION Aluminum D size cylinder Containing 415 Liters of oxygen Up to 100 180C to 500C OOF to 1220F 400C to 600C 40 F to 1400F 15 TO 95 5 TO 95 lt 6 cm H20 60 L min 6 cmH90 60 L min with no CPAP applied 40 cm H20 39 2 mBar 0 25 cm HO 4 of full scale 5 5 x 2 5 x 2 9 approx 140 x 63 x 73 approx 16 oz 0 45 kg approx 176 oz 5 kg approx 8 ML 16 ML 55 Min at a 6 L minute volume and 7 5 cm H2O CPAP pressure Note There are several factors that affect the length of time the device will operate from a tank of oxygen The major factors are Volume of oxygen in the tank e Patient s minute volume e CPAP setting 6 1 9 Warranty The CAREvent Handheld CPAP System is manufactured from the finest quality materials Each individual part is subject to strict quality control tests to ensure exceptionally high standards The manufacturer warrants to the purchaser of the CPAP System that its component parts are free from defects in material and workmanship for a period of two years from the date of purchase The manufacturer will replace and or repair all parts of the CPAP System at its option for two years from the date of purchase at no cost to the purchaser upon the notification of the defects in writing by the purchaser and confirmation of said defect by the manufacturer All shipping costs shall be borne by the purchaser The2. manufacturer shall be liable under this warranty only if the CPAP System and its parts have been used and serviced in the normal manner described in the instruction manual There are no other expressed or implied warranties This warranty gives no specific legal rights 1 10 Symbols and Definitions 0 gt _ Gas Input REF Model Number SN Serial Number IPX4 Splash Proof ual Manufacturer wa Manufacture Date 2 PREPARATION FOR USE 2 1 Component List Having unpacked the device from its shipping carton use the following list to ensure that all components have been received 1 Operating Manual 2 CAREvent CPAP unit 3 Supply Hose 4 Single Use Small Medium and Large Patient Circuits c w Patient Valve Airway Pressure Gauge Facemask and Head Harness Note If any components are missing from the shipping carton immediately call the supplier quoting the packing slip number your original purchase order number and the description of the item which is missing 2 2 Connection of Hoses The supply hose provided is attached to the input connection on the rear of the ventilator finger tight fig 2 WARNING Using a wrench or excessive force in tightening the supply hose may damage the seal or the thread of the connection The patient circuit is attached to the gas outlet on the front of the device by simply pushing the 22mm taper over the outlet fig 2 Gas supply hose j Patient Circuit Attachment of h
3. 11 8 Reassemble unit attach a new patient circuit and connect to an oxygen supply to check operation in accordance with 2 3 prior to packaging for emergency use Note Safely dispose of the single use valve mask combination in accordance with local protocols 4 2 After Use and Monthly Checking WARNING The CAREvent Handheld CPAP System is designed to provide respiratory support for respiratory impaired patients Failure to follow the maintenance and inspection routines properly could result in incorrect operation of the device To ensure proper operation of the CAREvent Handheld CPAP System regular inspection and checking of the device and accessories for correct function should be undertaken by a responsible member of staff on a routine basis This check is to ensure that all of the accessories and resuscitator components are present the oxygen cylinder is full and that the resuscitator is in working order Regulator working pressure and device limiting pressures should be checked at least every six months and more frequently in high use applications Units with test pressures outside of the ranges listed in the product specifications should not be used The product is not designed for field disassembly or service outside that indicated in this manual Any malfunctioning units should be returned to the manufacturer or an Authorized Dealer Unauthorized repairs will nullify the product warranty Note Units with test parameters o
4. E USE OF GAS PRESSURE REGULATORS THAT DO NOT MAINTAIN A MINIMUM OUTPUT PRESSURE AND FLOWRATE IN LINE WITH THE REQUIREMENTS OF THE SPECIFICATION MAY CAUSE THE DEVICE TO FAIL RESULTING IN THE PATIENT RECEIVING INCORRECT TREATMENT 12 DO NOTUSE IN HAZARDOUS OR EXPLOSIVE ATMOSPHERE CAUTION Federal law restricts this device to sale by or on the order of a physician In the USA the CAREvent Handheld CPAP System is a restricted medical device intended for use by qualified medical personnel under the direction of a physician During the transport of patients it is recommended that an alternate source of ventilation be available in the event of driving gas supply failure device malfunction or a change in the patient s respiratory requirements 1 4 Terms and Definitions Airway Resistance Baseline Pressure CPAP Demand Valve Expiratory Phase Expiratory Time Te Frequency f Inspiratory Flow Inspiratory Phase Inspiratory Time Ti Lung Compliance Minute Volume Vm Oxygen Concentration Proximal Airway Patient Valve Pressure Relief Valve pressure drop across the airway per unit flow The pressure at the commencement of the inspiratory phase A positive pressure applied to the lungs during all ventilation phases Continuous Positive Airway Pressure The application of CPAP raises the baseline pressure above O A valve that delivers gas to the patient at a flowrate equiv
5. P System is pneumatically powered No electrical power mains or battery is required The CAREvent Handheld CPAP System has been specifically designed for use by trained Emergency Medical Professionals Respiratory Therapists Nurses and Physicians both in the prehospital and in hospital environments 1 6 Principles of Operation The CAREvent Handheld CPAP System is a pneumatic device that provides Continuous Positive Airway Pressure CPAP It provides up to 20 cm HO CPAP at 120 L min peak flow for the spontaneously breathing patient To Patient Circuit Diagram Fig 1 1 With the gas supply turned on medical oxygen enters the device via the internal regulator a and is filtered and reduced to a lower working pressure 35 psi 240 kPa 2 Gas from the internal regulator is supplied to the demand valve b The demand valve will supply gas at a flowrate equivalent to that demanded by the patient up to 120 L min 3 The adjustable CPAP control system adjusts the CPAP level to provide the required amount of CPAP pressure Adjustment of the CPAP control will raise the baseline pressure above zero As the CPAP pressure setting is balanced against the patients respiratory condition the control d is adjusted until the desired CPAP level is shown on the airway pressure gauge A safety pressure relief valve c is internally located and is preset for 40 cm H20 4 Gas from the demand valve is supplied to the patient via the
6. REvent Handheld CPAP System e Patients undergoing procedures with flammable anesthetic gases e Patients undergoing hyperbaric treatment 1 3 Warnings The CAREvent Handheld CPAP System is intended for use by Suitably trained and qualified personnel The following precautions should always be observed 1 READ THIS MANUAL PRIOR TO ATTEMPTING TO USE THE DEVICE INCORRECT OPERATION OF THE DEVICE CAN BE HAZARDOUS 2 WHEN THE UNIT IS IN USE DO NOT SMOKE OR USE NEAR OPEN FLAME EITHER DURING USE OR WHEN CHANGING THE CYLINDER 3 WHEN NOT IN USE ALWAYS TURN OFF THE GAS SUPPLY 4 NEVER ALLOW OIL OR GREASE TO COME INTO CONTACT WITH ANY PART OF THE CYLINDER REGULATOR OR DEVICE 5 DO NOT DISASSEMBLE ANY PART OF THE VDEVICE EXCEPT WHERE DESCRIBED IN THIS MANUAL AS ANY UNAUTHORIZED DISASSEMBLY WILL INVALIDATE THE WARRANTY 6 AFTER USE ALWAYS ENSURE THAT ALL COMPONENTS ARE CLEANED IN ACCORDANCE WITH THE INSTRUCTIONS PROVIDED IN THIS MANUAL SEE SECTION 4 7 ALWAYS USE THE CHECK LIST TO ENSURE THAT ALL COMPONENTS ARE REASSEMBLED CORRECTLY AND READY FOR USE 8 IT IS RECOMMENDED THAT A MEANS OF VENTILATING THE PATIENT BE AVAILABLE IN CASE OF RESPIRATORY FAILURE 9 DURING USE THE PATIENT SHOULD NOT BE LEFT UNATTENDED 10 ONLY PATIENT CIRCUITS SUPPLIED BY O TWO MEDICAL TECHNOLOGIES INC SHOULD BE USED WITH THIS DEVICE AS THE USE OF OTHER CIRCUITS MAY ADVERSELY AFFECT THE OUTPUT PERFORMANCE OF THE DEVICE 11 TH
7. alent to that demanded by the patient s inspiratory effort The time period from the end of the inspiratory flow to the end of the expiratory flow Duration of the expiratory phase The number of breaths in one minute also expressed as BPM The flow delivered to the patient by the device during the inspiratory phase The interval from the start of the inspiratory flow to the start of the expiratory phase Duration of the inspiratory phase Volume added per unit pressure increase when gas added to a human or artificial lung The total volume of gas delivered to the patient in one minute The oxygen content of the inspired gases expressed as a percentage The airway pressure measured at Pressure of the patient valve The valve which directs the flow of gas into the lungs and out of the expiratory port to atmosphere during expiration Valve which limits the maximum lung inflation pressure by venting excess gas to atmosphere 3 1 5 General Description CAREvent Handheld CPAP System is a small lightweight handheld Continuous Positive Airway Pressure CPAP system designed for use on spontaneously breathing patients who require respiratory support The patient is allowed to breathe spontaneously through the device with minimal work of breathing while the CAREvent Handheld CPAP System provides positive pressure throughout the respiratory cycle delivered non invasively via a face mask The CAREvent Handheld CPA
8. ircuits are not recommended This circuit may also be connected to an endotracheal tube or other artificial airway WARNINGS Patient circuits other than the O Two Medical Technologies circuit may alter the CPAP characteristics and or expiratory flow resistance They should NOT be used The patient circuit must be attached to CAREvent CPAP Handheld CPAP System properly Incorrect attachment could result in failure to provide adequate oxygen delivery 9 Notes The breathing circuit and all of its components are clean and 4 4 1 non sterile If required a high efficiency respiratory filter HME may be connected between the patient circuit and the facemask to protect the patient rescuers and the device from expired air contamination OPERATING INSTRUCTIONS With the device connected to the oxygen supply connect the appropriately sized CAREvent Handheld CPAP System circuit with facemask airway pressure gauge and head harness Inform the patient of what you will be doing With the CPAP control fully rotated counter clockwise to turn off the CPAP flow turn on the oxygen supply apply the mask to the patient and attach with the head harness ensuring that the mask seals and is comfortable for the patient Adjust the CPAP control to the desired level as per local protocols Monitor the pressure gauge to ensure proper delivery of CPAP Monitor the patient and the device as per local protocols If using a portable ox
9. o two CAREvent Handheld CPAP System 01CV0200 USER MANUAL Made in Canada by O Two Medical Technologies Inc Part Number 15PL2172 Rev 5 June 2011 Table of Contents Chapter Title 1 INTRODUCTION Indications for Use Contraindications Warnings Terms and Definitions General Description Principles of Operation Control Adjustment Technical Data Warranty 0 Symbols and Definitions PE ot et Se a ek G OONOOBRWDND PREPARATION FOR USE 2 1 Component List 2 2 Connection of Hoses 2 3 Pre use Functional Check 2 4 Patient Circuit Selection OPERATING INSTRUCTIONS AFTER USE CLEANING AND TESTING 4 1 Dismantling and Cleaning 4 2 After Use and Monthly Checking MAINTENANCE SCHEDULE 5 1 Annual Preventative Maintenance Inspection TROUBLE SHOOTING CHART CAREvent HANDHELD CPAP ACCESSORIES Page NNOORAA O oO O CO N 10 12 12 13 13 1 INTRODUCTION 1 1 Indications for Use The CAREvent Handheld CPAP System is intended to provide CPAP to spontaneously breathing patients in the hospital and pre hospital EMS environments The device is suitable for use In e Pre hospital transport applications including accident scene emergency rescue vehicles e Hospital ICU transport applications including emergency surgery post Anesthesia recovery e Air transport via helicopter or fixed wing 1 2 Contraindications The following conditions contraindicate the use of the CA
10. oses Fig 2 2 3 Pre use Functional Check Along with the contents of the shipping cartons you will require the following items to enable you to undertake the pre use functional check 1 Full oxygen cylinder 2 Oxygen regulator with a 50 psi 9 16 DISS outlet The regulator must be able to output a minimum of 140 L min at no less than 40 6 PSIG 2 8 Bar 3 Calibrated test lung set up to simulate a spontaneously breathing patient such as a Michigan Instruments Dual Adult TTL With the device connected to the oxygen supply connect a patient circuit to the outlet of the device and attach the test lung to the 15 22 mm connector on the circuit Turn on the oxygen supply and adjust the CPAP control to raise the baseline pressure to 10 cm H20 Operate the test lung at a rate of approximately 10 times per minute to simulate the patient s inspirations Ensure that the pressure gauge returns to 10 2 cm H2O after each squeeze Note After testing set the CPAP level to zero turn off the oxygen supply hose and re package the device ready for immediate use Always ensure that the cylinder is full 2 4 Patient Circuit Selection The patient circuit designed for use with CAREvent CPAP Handheld CPAP System comes in three sizes Small Medium and Large O Two Medical Technologies part s 01CV8006 CS 01CV8007 CS 01CV8008 CS These patient circuits are intended for single patient use Cleaning reprocessing and or reuse of these c
11. patient circuit f to the patient valve with pressure gauge g and then via the mask to the patient The mask is held in place with the supplied head harness WARNING The CPAP control is calibrated to the dynamics of the O Two Medical Technologies Inc disposable patient circuits P N 01CV8006 CS 01CV8007 CS 01CV8008 CS Using this circuit will ensure proper operation and the full O to 20 cm H2O CPAP range Using other patient circuits may adversely effect operation of the device 1 7 Control Adjustment To adjust the CPAP setting simply rotate the CPAP control d located on the top of the device in a clockwise direction to increase the CPAP level and in a counter clockwise direction to decrease the CPAP level 1 8 Technical Data All specifications are subject to a tolerance of 10 INPUT PRESSURE RANGE 45 87 PSI 3 0 6 0 Bar MINIMUM INPUT FLOWRATE REQUIRED 140 L min DEMAND BREATHING FLOWRATE 0 120 L min DEMAND BREATHING TRIGGERING PRESSURE 100 L min 6 cm H20 CPAP RANGE 0 20 cm H20 OXYGEN CONCENTRATION OPERATING TEMPERATURE STORAGE TEMPERATURE STORAGE RELATIVE HUMIDITY OPERATING RELATIVE HUMIDITY INSPIRATORY RESISTANCE EXPIRATORY RESISTANCE EMERGENCY PRESSURE RELIEF PRESSURE GAUGE DIMENSIONS INCHES MILLINETERS WEIGHT CPAP System only Including cylinder regulator carrying case PATIENT VALVE DEAD SPACE PATIENT VALVE DEAD SPACE With manometer
12. se CPAP Circuit Large c w facemask airway pressure gauge and head harness Case 10 01CV8007 CS Single patient use CPAP Circuit Medium c w facemask airway pressure gauge and head harness Case 10 01CV8008 CS Single patient use CPAP Circuit Small c w facemask airway pressure gauge and head harness Case 10 01FV4302 6 Foot Nylon Braided Replacement Supply Hose with 9 16 DISS Fittings 01CC8013 CAREvent CPAP softpack carrying case 13 MANUFACTURERS AND DISTRIBUTORS OF CPR Bio Barriere Face Shields Universal Pocket Ventilators Rescue Breathere CPR Protective Barriers Demand Valve Resuscitators Oxygen Demand amp BVM Oxygen Supply Refill Valves CAREvente Range of Automatic Transport Ventilators SQ Unibody Regulators SQs Aluminum Free Unibody Regulators Easy Gripe Bag Valve Mask Resuscitators SMART BAGe Bag Valve Mask Resuscitators SMART BAG MOeBag Valve Mask Resuscitators Burn Reliefe Burn Kits and Dressings Genesise Il IDLH Rescue Resuscitators Equinoxe 50 Nitrous Oxide 50 Oxygen Administration Systems Your Representative Is C 9429 O TWO MEDICAL TECHNOLOGIES INC EU Innovation in Resuscitation Pr Marin 7575 Kimbel Street E Mississauga Ontario 4030 LIEGE Canada L5S 1C8 Belgique el 905 677 9410 Fax 905 677 2035 Website www otwo com E mail resuscitation otwo com For your nearest Authorized O Two Distributor In North America call Toll Free 1 800 387 3405
13. utside of the ranges listed in the product specifications should not be used Any units not meeting performance criteria should be returned to the Manufacturer or an authorized repair centre D MAINTENANCE SCHEDULE 5 1 Annual Preventative Maintenance Inspection It is recommended that the CAREvent Handheld CPAP System is returned to a service centre authorized by the manufacturer to undertake service and repair of this device for an Annual Preventative Maintenance inspection more frequently in high use areas The inspection will incorporate a full diagnostic test of all parameters When complete a certificate of compliance will be issued to cover the device for the next service period 12 This maintenance inspection providing it is carried out by an authorized service centre will not affect the product warranty 6 TROUBLE SHOOTING CHART Note If any of the remedies do not resolve the problem you are experiencing please contact your nearest Approved Service Centre Symptom Probable Cause Remedy Device does not insufficient gas supply Replace cylinder operate Insufficient CPAP Incorrect setting Adjust CPAP level Pressure CPAP pressure Circuit leak Adjust mask fit or does not adjust replace circuit Insufficient Demand Supply pressure low Check gas supply flow and replace as required 7 _CAREvent HANDHELD CPAP SYSTEM ACCESSORIES 17MP9039 CPAP CS NON REBREATH V C ASSY FOR CPAP Case 10 01CV8006 CS Single patient u
14. ygen cylinder monitor the supply level to ensure there is sufficient gas to power the device Never leave the patient unattended AFTER USE CLEANING AND TESTING Dismantling and cleaning the CAREvent Handheld CPAP System and Accessories Routine cleaning of the equipment should be undertaken to maintain the equipment in a clean condition Reusable patient valve swivel housing can be cleaned using a mild soap solution and disinfected using a legally marketed commercially available disinfectant suitable for the application Single use patient valves and masks should be discarded after each patient use and replaced with a new unit 10 All other components should be wiped clean with a mild soap solution Under no circumstances should the complete unit be allowed to be soaked or immersed in cleaning solutions Disassembly of the CAREvent Handheld CPAP System fig 3 Cleaning procedure 1 Ensure that the CAREvent Handheld CPAP System is disconnected from the gas supply source Remove the single patient use circuit from the device Remove the patient valve swivel housing a from the body of the resuscitator b fig 3 Wash all components thoroughly in a mild soap solution and disinfect as required The body of the CAREvent Handheld CPAP System can be wiped over with a soft cloth and mild soap solution If there is ingrained contamination a soft bristled brush may be used Dry all components thoroughly
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