USER MANUAL - O-Two Systems International, Inc.
Contents
1. 5 sec Press mask harder tilt head more Beeps Compression Timer 30 Compression beeps Last beep is increased in length to signify changeover to ventilations is imminent 1 7 Safety Precautions The CAREvent PAR is designed to assist in the provision of cardio pulmonary resuscitation to patients suffering from sudden cardiac arrest CAREvent PAR is intended for use by suitably trained personnel The following precautions should always be observed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as recommended below according to the maximum output power of the communications equipment Rated maximum output Separation distance power of transmitter 80 MHz to 800 MHz 800 MHz to 2 5 GHz w 12 d 23 P 0 01 0 12 0 23 0 1 0 38 0 73 1 1 2 2 3 10 3 8 7 3 100 12 23 2 PRE USE FUNCTIONAL 2 1 Set Up Along with the contents of the shipping cartons you will require the following items to enable you to undertake the pre use functional check unless supplied with the CAREvent PAR 1 Full oxygen cylinder 2 Oxygen regulator with a 60 PSI 9 16 DISS outlet The regulator must be able to output a minimum of 120 L min at no less than 45 PSI 3 1 Bar Having connected the supply hose to the regulator turn on the oxygen supply Using a mild soap solution spray the input connection to the resuscitator to check for leaks If any leak is present tighten the connection and re test Once no leaks are found connect the Test Lung to the 15 22mm patient connector on the resuscitator 2 2 Testing of the Individual Features of Resuscitator The following features can be individually tested during the pre use Functional Check 1 Compression timing 2 Ventilation delivery and timing 3 Audible prompts and alarms Test steps Parameter 1 Connect PAR to oxygen source with 50 PSI output N A pressure and turn on the gas source 2 The de
3. 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 outside of their 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 4 2 Battery 4 2 1 Charging Press the yellow button on the front panel of the unit and observe the LED to check the battery status Battery Status LED Green Full Yellow Half Off Discharged When the charging LED becomes yellow or fails to illuminate recharge the battery by using the supplied charger Charging time from full discharge 16 20 Hours N WARNING Do not use CAREvent PAR when charging the battery N WARNING Battery is only replaceable by the manufacturer 4 2 2 Storage 13 1 Always store the battery in a fully charged condition 2 If the battery is to be stored for a long period apply a recovery top up charge every 6 months 3 Store Carevent PAR in a dry and cool location 4 Keep within ambient temperatures of 15 C to 50 C for both charging and discharging 4 3 Cleaning the CAREvent PAR and Accessories THE RESUSCITATOR MUST BE THOROUGHLY CLEANED
4. 96 voice warning Press mask harder tilt head more is activated and the ventilation pictogram turns red Classification PAR is classified as Internally Powered Type BF Equipment It is not suitable for use in the presence of a flammable anaesthetic mixture or nitrous oxide Electromagnetic Compatibility PAR is classified as 15 Equipment Class B Group 1 It complies with 60601 1 2 Electromagnetic Emissions and Immunity requirements 1 6 2 CAREvent PAR CYCLE Repeat cycles until professional help arrives Start u Allows 20 seconds to apply mask to face and position the head strap Prepare for compression 5 seconds 30 chest compressions 18 seconds Prepare for ventilation 4 seconds 1 second inspiration 2 seconds Deliver 2 breaths expiration 3 seconds inserted if alarm activated Change over to compression 5 seconds Change over to ventilations 4 seconds 1 6 3 CAREvent PAR VOICE PROMPTS Voice 0 On first start up of PAR Voice 1 Prepare for compression 5 sec Place mask on face Pull strap over head to secure mask Press green button to begin CPR Repeated at 4 seconds intervals until depressed Place hands in centre of chest Compress firmly in time with the tone Voice 2 Prepare for ventilation 4 sec Press mask to face tilt head back Voice 3 At end of 1st breath if alarm activated
5. AFTER EACH PATIENT USE Routine cleaning should be undertaken to maintain the equipment in a clean condition The single use patient circuits and masks should be safely discarded after each patient use and replaced with a new unit The cylinder should be replaced with a fresh cylinder of oxygen after each use The ventilator should be re charged after each use The control module should be wiped clean with a mild soap solution or commonly available hard surface disinfectant Under no circumstances should the unit be allowed to be soaked or immersed in cleaning solutions 1 off the oxygen source of the CAREvent PAR 2 Remove and discard the single use patient circuit and facemask 3 Remove and replace the oxygen cylinder with a fresh cylinder of oxygen 4 Wipe over the CAREvent PAR with a soft cloth and mild soap solution or commonly available hard surface disinfectant 5 Dry all components thoroughly 6 Reassemble unit including attaching a new patient circuit with facemask and head strap Connect to an oxygen supply to check operation prior to packaging for emergency use 4 4 Safe Decommissioning or Disposal of CAREvent PAR 14 and Accessories The single use patient circuits and masks should be safely discarded after each use in accordance with local state and institutional laws and procedures The CAREvent PAR uses a sealed lead acid battery which may contain hazardous materials Plea
6. O Two MEDICAL TECHNOLOGIES INC CARE wen PAR PUBLIC ACCESS RESUSCITATOR 01CV0100 USER MANUAL Made in Canada by O Two Medical Technologies Inc Rev 6 Nov 2009 TABLE CONTENTS CHAPTER TITLE 1 THE CAREvent PAR PUBLIC ACCESS RESUSCITATOR 1 1 Introduction 1 2 Warranty 1 3 Indications for Use 1 4 Contraindications 1 5 Features 1 6 Performance Specifications 1 7 Safety Precautions 1 8 Electromagnetic Compatibility PRE USE FUNCTIONAL CHECK 2 1 Set Up 2 2 Testing of the Individual Features of Resuscitator OPERATING PROCEDURE 3 1 Connecting the Supply Hose and Patient Circuit 3 2 Use of the CAREvent PAR during CPR 3 3 Action to be taken if patient vomits during resuscitation 3 4 Operation in Extreme Conditions SERVICING 4 1 Routine Maintenance 4 2 Battery 4 3 Cleaning the CAREvent PAR and Accessories 4 4 Safe Decommissioning or Disposal of CAREvent PAR and Accessories SYMBOLS AND DEFINITIONS CAREvent PAR ACCESSORIES PAGE YX OUONNN 10 10 11 11 11 12 13 14 14 15 1 1 1 Introduction CAREvent PAR Public Access Resuscitator provides trained individuals with a safe and effective means of providing artificial ventilation during cardiac arrest with the addition of voice prompts and audible signals for chest compression timing NOTE The CAREvent PAR is considered a critical device and its components considered critical component
7. Relief 54 60 cmH 0 Inspiratory Expiratory Resistance lt 6 cmH20 60 L min Operating Temperature 18 C to 50 0 to 122 F Storage Temperature Operating Humidity 40 C to 60 40 1 140 15 to 95 Storage Humidity 15 to 95 Input Connection 9 16 DISS Patient Valve Dead Space 8 10 Control Module Dimensions lt 93 4 x 7 5 8 x 3 5 16 Weight Without Cylinder 2 7 lb 1 23 kg Operating Duration 30 minutes when used with an 4 size cylinder containing 113 liters of oxygen Battery Type Sealed Lead Acid 6VDC 1 2Ah Operating Time On Full Charge gt 2 hours at 25 C ambient temperature Battery Monitoring LED Off Battery charge too low and device is inoperable Yellow Device can work properly but the battery should be charged Green Battery full Monitoring circuit is activated either by pressing a button or connecting the device to an external power supply Charging Type Continuous Trickle Charge Charging Time 16 20 Hours from full discharge Battery Life 3 to 5 years in normal applications or more than 1000 discharge recharge cycles can be realized depending on the average depth of discharge and operating storage temperature Alarms If there is mask leakage Airway Pressure 8 cmH O 1096 or an airway obstruction Airway Pressure gt 40 cmH O 10
8. USE IN THE PRESENCE OF A FLAMMABLE ANAESTHETIC MIXTURE WITH AIR OR WITH OXYGEN OR NITROUS OXIDE AVOID USING THE EQUIPMENT WHEN POTENTIAL ELECTROMAGNETIC OTHER INTERFERENCE EXIST 1 8 Electromagnetic Compatibility The CAREvent PAR has been tested and found to comply with IEC 60601 1 2 requirements The CAREvent PAR is intended for use in the electromagnetic environment specified below The user of the CAREvent PAR should assure that it is used in such an environment 1 Electromagnetic Emissions Emission test Compliance Electromagnetic environment guidance RF emissions Group 1 The CAREvent PAR uses RF energy CISPR 11 Class B only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment 2 Electromagnetic Immunity Immunity test IEC60601 test level Compliance level Electrostatic discharge 6 kV contact 6 kV contact IEC61000 4 2 8 kV air 8 KV air Power frequency 50 60 3 A m 3 Hz magnetic field IEC61000 4 8 Radiated RF 10 Vim 0 10 V m IEC61000 4 3 80 MHz to 2 5 GHz The CAREvent PAR is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled The user can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the CAREvent
9. ary according to local regulations 1 3 Indications for Use The CAREvenf PAR Public Access Resuscitator is indicated for Cardio Pulmonary Resuscitation CPR short term ventilatory support It is an electronically controlled pneumatically powered resuscitator with incorporated voice instructions compression beeps and automatic ventilations to assist CPR trained personnel for both inter and intra hospital and pre hospital EMS settings for non breathing adult patients 1 4 Contraindications The CAREvent PAR is designed for use on adult patients over 40 Kg body weights who are in cardiac arrest Use on smaller patients may result in activation of the pressure relief system during the ventilation phase and a warning to Press mask harder tilt head more 1 5 Features The CAREvent PAR is an electronically controlled pneumatically driven automatic resuscitator designed for use with adult patients in cardiac arrest The device incorporates a resuscitation guidelines compliant algorithm that provides compression prompts for closed chest compressions followed by two automatically delivered breaths Audible and visual indicators assist the rescuer in performing CPR as well as warning the rescuer of airway obstruction or mask leakage Additional audible and visual instructions for mask placement and head tilt as well as hand placement for chest compressions are also included Specifically designed for the first responder the CAREve
10. ce Shields Revive Aid CPR Face Shields Rescue Breather CPR Pocket Ventilator Respiratory Disposable Products SQ Regulators O TWO MEDICAL TECHNOLOGIES INC Innovation in Resuscitation C 0120 EU Representative 7575 Kimbel Street Marcel Houben Mississauga Ontario Rue Vin ve 32 Canada L5S 1C8 4030 LIEGE Belgique Tel 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
11. d interval between the two ventilations Use a test lung to measure the Tidal Volume and ON time t5 for each and the interval t6 Vt 700ml 10 t5z1 0 s 16 2 0 s 11 The cycle shall go back to the Prepare for Compression phase Yes No 12 Remove the patient circuit from the CAREvent PAR At the end of the first ventilation in each cycle the left visual shall change from white to red and a warning message Press mask harder Tilt head more shall be played Yes No 13 Connect the output of the PAR to the Pressure P3 60 0 10 Relief test fixture The same warning message cmH O should appear as shown in step 12 Measure the maximum airway pressure during ventilation by 10 setting the test lung volume to its minimum 3 1 CHAPTER 3 OPERATING PROCEDURE Connecting the Supply Hose and Patient Circuit The supply hose provided is attached to the oxygen inlet on the side of the resuscitator and is tightened finger tight A WARNING of excessive force in tightening the supply hose may damage the seal and or thread The facemask is attached to the patient connection port by simply pushing the mask onto the 22mm taper having first ensured that the head strap is located on the mask 3 2 Use of the CAREvent PAR during CPR 1 2 3 4 If the patient is unresponsive immediately call 911 Locate the CAREvent PAR and defibrillat
12. nt PAR is a unique device providing excellent ventilations along with compression timing This device is designed for use anywhere there is a risk of cardiac arrest The CAREvent PAR e Delivers 100 oxygen during resuscitation e Meets current American Heart Association European Resuscitation Council Guidelines for CPR e Provides voice instructions for CPR automatic ventilations on 10096 oxygen and compression timing beeps The timings for compressions and ventilations are set in accordance with the current resuscitation guidelines 2 e Hasan Airway Pressure Limiting System with Audible and Visual alarms for airway obstruction set in accordance with current standards combined with audible and visual alarms for mask leakage e Is designed for use by CPR trained persons for the emergency resuscitation of the patient in cardiac arrest e an average mask leakage of 40 is common during resuscitation the CAREvent PAR has a tidal volume calibration Set to accommodate a 40 mask leakage factor 1 6 Performance Specifications 1 6 1 CAREvent PAR TECHNICAL SPECIFICATIONS Tidal Volume 700ml 10 Single Setting Automatic Flow Rate 42 L min 10 Inspiration Time Per Breath 1 second 0 5 second Expiration Time Per Breath 2 seconds 0 5 second Ratio 1 2 20 Compression Ventilation Ratio 30 2 Body Weight 88 220 Ib 40 100 kg Input Pressure 45 70 PSI Pressure
13. ons but may cause excessive wear in the resuscitator components over time Operation of the CAREvent PAR under supply pressures outside those detailed in this manual may result in a reduction in the resuscitator s performance Input pressures below the minimum stated will cause the delivered tidal volume out of spec as the pressure falls below 30 PSI will cause the resuscitator shut down Input pressures higher than that recommended in this manual may result in a risk of internal component failure if the pressure exceeds three times the maximum working pressure stated CHAPTER 4 SERVICING 4 1 Routine Maintenance ZAWARNING The CAREvent PAR is designed to provide respiratory support and CPR instruction during Cardiac Arrest Failure to follow the maintenance and inspection routines properly could result in incorrect operation of the resuscitator To ensure proper operation of the resuscitator regular inspection and checking of the resuscitator and accessories for correct function should 12 be undertaken by a responsible member of staff routine basis This check is to ensure that all of the accessories and resuscitator components are present the oxygen cylinder is full the battery is charged and that the resuscitator is in working order Regulator working pressure and ventilator limiting pressures should be checked at least every six months and more frequently in high use applications Units with test parameters outside
14. or if available and return to the patient If a defibrillator is available and the patient collapse was witnessed by the rescuer apply the defibrillator pads and follow the defibrillator instructions If the cardiac arrest was unwitnessed no defibrillator is available there is a long delay before starting resuscitation efforts shock is advised by the defibrillator or after shocking the patient the defibrillator advises the rescuer to recommence CPR turn on the oxygen supply of the CAREvent PAR and follow the voice prompts Continue CPR until professional help arrives 3 3 Action to be taken if patient vomits during resuscitation 11 Should the patient vomit into the mask during resuscitation the following steps should be followed to clear the foreign material 1 Remove the mask from the patient s face and clear any foreign material from the patient s airway Shake out any foreign material from the face mask 2 A ply the mask and head strap to the patient and recommence CPR following the voice prompts 3 4 Operation in Extreme Conditions Operation of the CAREvent PAR in environmental conditions outside of those detailed in this manual may result in a reduction in the resuscitator s performance In extreme cold weather a low delivered tidal volume of ventilation or a less working time of the battery may be seen In high temperature environments the effect is not noticeable in terms of delivered ventilati
15. s Only those individuals trained in Cardio Pulmonary Resuscitation should use this equipment Thoroughly review this instruction manual before use NOTE This resuscitator is intended for first response to aid a victim of sudden cardiac arrest The ventilation rates and volumes and the compression timing signals are provided in accordance with current resuscitation guidelines WARNING Under FDA Regulations Oxygen is a drug and can only be administered by or on the order of a physician 1 2 Warranty This equipment 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 CAREvent PAR 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 resuscitator 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 All shipping costs shall be borne by the purchaser The manufacturer shall be liable under this warranty only if the resuscitator 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 You may also have other rights that may v
16. se follow local regulations to disposal of the battery The printed Circuit Boards and electronic components inside the CAREvent PAR may also contain hazardous materials Contact the proper agency for information on permissible methods of disposal CHAPTER 5 SYMBOLS AND DEFINITIONS Start the Unit Check Battery Gas Output Gas Input Caution Refer to Instruction Manual Model Number N Serial Number E E Manufacturer Manufacture Date Meet Class equipment safety requirement A Type BF Equipment complying with IEC 60601 1 15 Pressure Relief Gas Pressure Solenoid Patient Input Regulator Valve Circuit Patient Emergency Air Intake Pressure Switch Pneumatic System Diagram CHAPTER 6 CAREvent PAR ACCESSORIES 01CV0101 POWER SUPPLY Input 100 240VAC 50 60Hz 1A Output 9VDC 4 0A 01CV0102 POWER SUPPLY CORD 01CV0103 CAR CHARGER 01CV8011 CAREvent PAR PATIENT CIRCUIT DISPOSIBLE 01FV4302 PVC NYLON BRAIDED 6 FT HOSE FOR SOFTPACK MOUNTED CAREvent PAR 010R8700 REGULATOR CGA 540 BRASS 16 MANUFACTURERS AND DISTRIBUTORS CAREvent Range of Handheld Automatic Resuscitators CAREvent Range of Automatic Transport Ventilators SMART BAG MO Bag Valve Mask Resuscitators Demand Valve Resuscitators Equinox 5096 Nitrous Oxide 5096 Oxygen Oxygen Demand Valves Burn Relief9 Burn Kits and Dressings Easy Grip Bag Valve Mask Resuscitators CPR Bio Barrier Fa
17. vice enters Startup phase The push button on the front panel shall be illuminated to green and Yes No flash once every second 1 sec On and 1 sec Off 3 Within 2 seconds upon turning on oxygen source Yes No 9 voice instructions Place Mask Face Pull Strap over Head to Secure Mask and Press Green Button to Begin shall be played alternatively and repeatedly After the two messages have been played for 3 times press the green button N A The cycle shall enter the Prepare for Compression phase The green button shall turn off and the visual on the right hand side of the front panel shall be illuminated continuously Meanwhile a voice message shall be played Place hands in centre of chest Compress firmly in time with the tone Yes No Yes No The cycle shall enter the Chest Compression phase The right side visual shall flash and audible beeps shall sound in phase with the visual flashing The last beep shall be prolonged Yes No The entire Compression phase shall last 18 seconds Measure the time t3 with a stopwatch from the beginning of the first beep and the end of the last beep 13 18 0 s 0 5 The next is Prepare for Ventilation A voice Press mask to face Tilt head back shall be played Yes No 10 The cycle shall enter the Ventilation phase Two ventilations shall be delivered with 1 second each and a 2 secon
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