Gradian CCV, User Manual

Page 1: ...Gradian CCV User Guide Gradian CCV User Guide ...

Page 2: ......

Page 3: ... TABLE OF CONTENTS ...

Page 4: ...s for bedside or transport use The Gradian CCV is CE certified and has been cleared by the U S FDA WARNING The CCV should not be used on children weighing 5 kg 11 lbs or less WARNING This device should only be operated by qualified personnel under approved medical supervision WARNING Use only as directed Improper usage or unauthorized modification of this product may result in user or patient inju...

Page 5: ...r Volume SIMV CPAP Bi PAP can be programmed in custom modes Control Settings Flow 5 60 LPM 80 LPM with Pressure Support CPAP demand flows Tidal volume 40 2 000 mL Respiratory rate 0 or 5 60 breaths per minute Inspiratory time 0 5 2 0 sec PEEP CPAP 0 25 cmH2O Pressure Support 0 25 cmH2O Breath trigger sensitivity 5 to 1 cmH2O FiO2 can be set from 21 100 NOTE The FiO2 is not measured but calculated ...

Page 6: ...y Hot swappable ruggedized battery providing an additional 14 hours of operating time for a total of up to 21 hours Stand and Base Sturdy aluminum frame with a convenient handle and basket mounted on a no tip base with 5 durable casters 2 locking COMPONENTS OF THE CCV Portability Features Bed hooks handle and shoulder strap for convenient use and transportation in any setting Reservoir Allows for ...

Page 7: ...5 User interface Quick Start modes Power switch Carrying handle Bed hooks Mounting plate Internal battery ...

Page 8: ... flow O2 inlet External battery connection Air entrainment inlet and filter Casing pressure relief Fuses Mains charging port 110 240 VAC Exhalation valve port Patient circuit port Airway pressure port Alarm system port Warranty sticker Serial number ...

Page 9: ...l battery is sufficiently charged 12 Press and hold the charge indicator on the external battery and confirm that it is sufficiently charged and that it is not connected to the CCV 13 Plug the CCV extension cable back into mains 14 Turn the O2 source back on 15 Confirm that the programmed settings are appropriate for the patient and ensure that no alarms are active FOLLOWING EVERY PATIENT 1 Turn o...

Page 10: ...y pressure alarms will activate Ventilation Modes where the physician will choose between delivery methods Additional Settings for delivery of manual breaths oxygen conservation when using a concentrator or emergency cylinder and keys to change any of the settings on the CCV Battery Parameters including level and status confirmation of mains power supply and connection to external battery Ventilat...

Page 11: ...nd 60 BPM When a patient is fully spontaneously breathing the CCV may be used to monitor the patient with the BPM set to 0 This allows the physician to read measured values and will trigger the Apnea Ventilation Mode if the patient stops breathing see Automatic Apnea Mode O2 is a setting not a measured value and may be programmed to deliver between 21 room air and 100 oxygen The purpose of the O2 ...

Page 12: ...volume and ranges from 40 mL to 2000 mL In volume modes this is the single breath tidal volume target NOTE The allowable ranges for I Time BPM and Vt settings are linked together so as not to exceed the CCV s maximum flow rate of 60 LPM in volume modes For example if Vt is set at 1000 mL I Time will be limited to 1 00 second or more as 1 L divided by 1 60 minutes is 60 LPM If the maximum flow has ...

Page 13: ...lowable airway pressure and is adjustable from 15 to 55 cmH2O When exceeded flow halts and the CCV provides both audible and visual alarms Low Pressure Alarm sets the minimum allowable airway pressure and is adjustable from 5 to 20 cmH2O It will also trigger audible and visual alarms when pressure falls below the set limit Ventilation Modes Volume Control with Assist Volume AC In volume control th...

Page 14: ...timing of the mechanically delivered breaths thus synchronizing the pre set breathing schedule to the variable patient initiated breaths Otherwise the volume and pressure ventilation modes with SIMV are similar to those with assist In addition to the regular settings the clinician can also use Pressure Support for either volume or pressure SIMV When activated pressure support recognizes the interm...

Page 15: ...he first breath in the pressure mode Automatic Apnea Mode If apnea is detected the ventilator will operate in Apnea Ventilation Mode The Apnea ventilation settings automatically default to Ventilation Mode Pressure AC Peak Inspiratory Pressure 20 cmH2O BPM 10 Inspiratory Time 2 00 seconds PEEP 3 cmH2O The ventilator display will show the apnea settings The ventilator will revert to the previous se...

Page 16: ...nel When activated a blue light will illuminate beneath the button The Alarm Silence Reset button is still active Control Lock will automatically come on if Apnea Ventilation Mode is engaged To change ventilation modes or settings you must first disable the lock Parameter mode Adjustment arrows are used to adjust settings or choose between programmed Custom Modes For more information on changing s...

Page 17: ...t is being used to run the CCV while charging The external battery takes 10 to 20 hours to recharge depending upon whether or not it is being used while it is charging When the CCV is connected to active mains power the top indicator light to the right of the battery level will illuminate When the external battery pack is attached the bottom indicator light will illuminate NOTE The CCV has an inte...

Page 18: ...or fails the alarm sounds and a light will turn on This alarm may not be silenced WARNING Any ventilator with a System Failure Alarm may pose a danger to the patient and must be removed from service immediately Critical Battery Alarm Activates when about 20 minutes of battery life remain clears 10 seconds after adequate power is restored This alarm may not be silenced See CCV BATTERIES for more in...

Page 19: ...cmH2O or lower When the airway pressure reaches this limit the valve will open and gas will be vented to prevent the pressure from increasing This is a redundant safety measure as the High Airway Pressure Alarm limits the maximum pressure WARNING Preset tidal volumes may not be delivered when the pressure relief setting is reached Inspiratory times will remain constant however no additional tidal ...

Page 20: ...uring inspiration in Volume AC and Volume SIMV It is not the same as minute volume PIP shows the airway pressure measured in the patient circuit near the connection to the endotracheal tube or mask This value will change during the course of a breath and the maximum value achieved during the breath the Peak Inspiratory Pressure will be displayed for half a second at the end of the breath Delivered...

Page 21: ...ys to change the setting To make changes in larger steps hold the Alarm Silence Reset button down while pressing the Increase or Decrease arrow buttons For example this will change O2 in increments of 10 rather than 1 4 Press the button for the setting you are changing again The displayed value will stop blinking and the new setting will be active NOTE If using a Custom Mode or Quick Start Mode an...

Page 22: ...time and these settings will be activated If the button is not pushed a second time within 10 seconds the displayed settings will revert back to the current ventilator settings and the process must be started over Selecting a Custom Mode 1 Make sure the Control Lock is not activated When it is on a blue light illuminates above it Control Lock may be used to provide additional protection against ac...

Page 23: ... The changes made will not be saved Revising a Quick Start Mode 1 Make sure the Control Lock is not activated When it is on a blue light illuminates above it Control Lock may be used to provide additional protection against accidentally changing any setting 2 Enter the mode to be amended by pressing the button for either the Adult or Child Quick Start mode twice 3 Once that mode has been selected ...

Page 24: ...t is on a blue light illuminates above it Control Lock may be used to provide additional protection against accidentally changing any setting 2 Push the Custom Mode Selection button and use the Parameter mode Adjustment arrows to move the blinking light to the custom mode to be revised 3 Push the Custom Mode Selection button again to begin using that mode The blinking light will become solid 4 Pus...

Page 25: ...reason WARNING The CCV operates with medical gases under pressure including oxygen Do not use this device while smoking or near open flames Do not use this device or operate near flammable materials including anesthetics Oxygen Hose The CCV comes with a green high pressure oxygen hose which connects to the Diameter Index Safety System DISS port on the CCV DISS is a secure threaded fitting which gu...

Page 26: ...rectly to a cylinder regulator or using the provided adapter to a pipeline system WARNING Verify that there are no noticeable leaks after connection to the 3 4 Bar 344 kPa 50 psi Medical O2 or Medical Air source Low Flow Sources The reservoir should be employed whenever the oxygen source to be used delivers less than 10 LPM such as a flowmeter or concentrator While the barb allows for connection t...

Page 27: ...ical grade air is readily available via cylinder or a pipeline system the internal compressor should be used as a reliable source of compressed air The inlet port includes a filter which prevents dust and other matter from being sucked into the CCV This filter should be checked every three months and replaced if dirty see PREVENTATIVE MAINTENANCE BREATHING CIRCUIT Components and Function The CCV c...

Page 28: ... that gas is directed the correct way during each part of ventilation During inspiration fresh gas flows into the main body of the valve At the same time gas from the control line presses down on top of the silicone disc which seals off exhaust holes in the side of the main valve body The fresh gas for ventilation flows directly through the main body and to the patient The pressure line at the bot...

Page 29: ...p If it is not the valve will leak 2 The control line port is facing straight back towards the ventilator and the locating features on the top cover and main body shown circled below are correctly aligned If they are not the valve may be broken when the securing ring is tightened and will leak 3 The securing ring is threaded on straight and is not overtightened 4 The sampling port on the bottom of...

Page 30: ... ventilator associated pneumonia VAP Keeping the gas delivered to the patient warm and humid can help reduce this risk Some ventilators use active humidifiers but these often fail due to lack of diligent maintenance or the availability of distilled water The CCV is designed to work with disposable Heat Moisture Exchanger HME filters which trap the heat and moisture in a patient s exhaled breath an...

Page 31: ...tilating pediatric patients as increases in dead space will increase the work of breathing For pediatric patients small increases in apparatus dead space lead to large increases in the ratio between dead space and tidal volume This can lead to hypercapnia requiring a larger minute ventilation to clear excess CO2 When possible accessories with lower amounts of dead space should be used for pediatri...

Page 32: ...owing a concentrator or flowmeter to be used Gas from the reservoir is used during inspiration at any flow rate required by the ventilation settings and the reservoir is refilled by the oxygen source during exhalation NOTE The CCV reservoir is not an emergency supply of gas and will not hold sufficient volume to ventilate a patient for any significant period of time beyond a single breath The CCV ...

Page 33: ...e Additional Settings panel of the CCV interface The green light will come on when O2 Conserve mode is engaged If the ventilation settings are changed such that more than 10 LPM of oxygen is used while in O2 Conserve mode the red alarm light will turn on in the Ventilation Settings panel next to the message O2 Setting cannot be achieved in O2 Conserve Mode If this light comes on the CCV is outputt...

Page 34: ... the reservoir inlet barb hose fitting 4 Turn the source on and check for leaks 5 Lower the O2 setting to 21 and set the other ventilation parameters as desired 6 Ensure that Control Lock is not engaged and press O2 Conserve noting that the green light above the O2 Conserve button turns on 7 Increase the O2 setting until the red alarm light next to the message O2 Setting cannot be achieved in O2 C...

Page 35: ... down with water to remove any film left by the cold disinfecting solution 4 Make sure the unit is dry before putting the unit away BREATHING CIRCUIT The following methods are approved for disinfection of the CCV reusable silicone breathing circuit While other compatible breathing circuits may be used with the CCV manufacturers instructions must be understood and followed Single use accessories sh...

Page 36: ...eries fully charged and make sure that a backup is always available it is recommended that the CCV be plugged into mains power at all times to charge the internal battery and that the external battery be plugged into mains separately and not connected to the CCV When plugged into the CCV the external battery cannot be charged by connecting it to mains If the external battery is connected to the CC...

Page 37: ...id cells of the internal and external batteries should be replaced every 3 years as part of normal planned maintenance to ensure continued performance PREVENTATIVE MAINTENANCE In order to ensure patient and user safety and to achieve the longest possible usable lifetime of the CCV regular maintenance is required by users and Gradian certified technicians USER MAINTENANCE General Care While designe...

Page 38: ...he protective screen by prying it off with fingernails or a dull flat tool Discard the filter insert a fresh one and replace the protective screen Battery Care To prolong battery life keep the internal and external batteries plugged into mains at all times Do not allow a battery to run the ventilator until fully depleted the ventilator stops working as this will reduce the battery life Batteries s...

Page 39: ...unction and safety This includes replacement of the batteries compressor flow sensors plastic tubing and fittings and all seals in the ventilator as well as calibration and performance testing This major service means that the internal components of the machine will operate just as when the CCV was fresh from the factory and will allow for years of use to come Contact your Gradian representative f...

Page 40: ...rating WARNING Use only a 12 VDC HC1221W battery or equivalent for the internal battery Improper function or damage may occur with the wrong battery WARNING Use only the specified fuse Improper fuse rating may result in damage to the ventilator or electrical shock to the user WARNING Grounding reliability can only be achieved when the equipment is connected to a hospital grade receptacle WARNING T...

Page 41: ...d if using high voltages Airway Pressure 0 99 cmH2O accuracy 5 or 1 cmH2O whichever is greater Internal Battery Life Run time at 21 C 70 5 F BPM 10 and Vt 600 mL 100 O2 7 5 hours Approx 5 hours at 0 F 18 C 100 Air 7 5 hours Approx 5 hours at 0 F 18 C 21 Air Compressor 7 hours Approx 4 hours at 0 F 18 C Oxygen Inlet Filter 65 micron sintered bronze Burst Pressure 145 psi 1000kPa minimum through oxy...

Page 42: ...nce in a typical medical installation There is no guarantee that interference will not occur in a particular installation If this equipment does cause harmful interference with other devices which can be determined by turning the equipment off and on the user is encouraged to try to correct the interference by one or more of the following measures Reorient or relocate the receiving device Increase...

Page 43: ...0068 2 27 Shock IEC 60068 2 6 Sinusoidal Vibration IEC 60068 2 31 Rough Handling Shocks IEC 60068 2 64 Random Broadband Shocks The above listing of standards is not intended to be a complete listing of standards reviewed and tested during the development of this product It may also not reflect latest versions as standards change Gradian Health Systems regularly reviews the standards and updates th...

Page 44: ...40 WHATSAPP 1 929 400 3796 ADDRESS Gradian Health Systems 915 Broadway Ste 1001 New York NY 10010 USA 42 For service issues please contact Gradian EMAIL service gradianhealth org WEB www gradianhealth org PHONE 1 212 537 0340 WHATSAPP 1 929 400 3796 ADDRESS Gradian Health Systems 915 Broadway Ste 1001 New York NY 10010 USA ...