CAREvent 01CV3000-CA Chemical Agent Handheld Automatic Rescue User Manual

CAREvent 01CV3000-CA Chemical Agent Handheld Automatic Rescue

Product Information

Specifications

• Tidal Volume: 0.5 litres
• Breaths per Minute: 10
• I:E Ratio: 1 : 2
• Automatic Flow Rate: 15.0 L/min
• Manual Flow Rate: 15.0 L/min
• Delay to automatic cycling re-start after Manual Button depression: 20 sec.
• Positive Pressure Bleed Flow: 2.0 L/min
• Demand Breathing Flowrate: 0 – 120 L/min
• Demand Breathing Triggering Pressure: -2.0 cmH20 / -2.0 mBar
• Inspiratory Resistance: -6.0 cmH20 / -5.9 mBar
• Expiratory Resistance: 6.0 cmH20 / 5.9 mBar
• Input Pressure: 45 – 70 PSI / 3.1 – 4.8 Bar
• Maximum Airway Pressure: 60 cmH20 / 58.8 mBar
• Operating Temperature: -18°C – +50°C / 0°F – +122°F
• Storage Temperature: -40°C – +60°C / -40°F – +140°F
• Input Connection: 9/16 DISS
• Patient Connection: 15 / 22 mm
• Weight: 16 OZ (0.45 kg)
• Size: 140 x 63 x 73 mm / 5.5 x 2.5 x 2.9 inches

Product Usage Instructions

Pre Use Functional Checks
Before using the resuscitator, ensure the following steps are completed:

• Set up the equipment according to the instruction manual.
• Test the individual features of the ventilator to ensure proper functioning.

Operating Procedure
Follow these steps for operating the resuscitator:

1. Connect the supply hose, pressure gauge, and patient circuit as per the manual.
2. Perform manual ventilation and cardiac compressions when necessary.
3. Switch to automatic ventilation mode as needed.
4. If the patient vomits during resuscitation, take appropriate action as outlined in the manual.
5. Understand demand breathing and how the automatic circuit shuts off.

Servicing
Maintain the resuscitator by following these guidelines:

• Perform routine maintenance as recommended in the manual.
• Clean and sterilize the equipment regularly to ensure proper hygiene.

Frequently Asked Questions (FAQ)

• Q: Can this resuscitator be used on neonates?
  A: No, this resuscitator is not recommended for use on neonatesor pregnant/nursing women.

• Q: What is the warranty coverage for this product?
  A: The manufacturer provides warranty coverage if the resuscitator is used and serviced according to the manual instructions.

• Q: What type of environment is this resuscitator suitable for?
  A: The CAREvent CA is designed for use in IDLH (Immediately Dangerous to Life and Health) environments, including confined space rescue scenarios.

CAREvent® CA
CHEMICAL AGENT ENVIRONMENT AUTOMATIC
AND MANUALLY TRIGGERED RESUSCITATOR
01CV3000-CA

The CAREvent® CA Chemical Agent Environment Automatic and Manually

Triggered Resuscitator

Introduction
The CAREvent® CA Handheld Resuscitator provides trained individuals with a safe and eff ective means of providing artifi cial ventilation during respiratory and/or cardiac arrest.
The CAREvent® CA Handheld Resuscitator is lightweight, portable, and extremely durable. Designed for the demands of the emergency medical and rescue environment where toxic gas may be present, they can be operated anywhere a medical oxygen or breathing air supply is present.

Note : An Automatic and Manually Triggered Resuscitator is considered a critical device, and its components considered critical components. Only those individuals trained in Cardio- Pulmonary Resuscitation and the operation of oxygen-powered ventilators should use this equipment. Thoroughly review this instruction manual before use.

INDICATIONS FOR USE
The CAREvent CA is pneumatically powered, time/volume cycled ventilators used to provide ventilatory support to normal adults in confi ned space rescue in IDLH (Immediately Dangerous to Life and Health) environment.

The ventilator is suitable for use in

• Pulmonary resuscitation during respiratory and/or cardiac arrest.
• Short term ventilatory support in the confi ned space rescue in IDLH (Immediately Dangerous to Life and Health) environment, pre-hospital, Intra-hospital, inter- hospital of non-breathing patients.

WARNING
This resuscitator is not recommended for use on neonates and pregnant or nursing women.

CAUTION
Federal law restricts this device to sale by or on the order of a physician.

DEHP
The material used in this device contains “DEHP”.

Warranty

• This equipment is manufactured from the fi nest 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® CA Handheld Resuscitator 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 notifi cation 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 specifi c legal rights. You may also have other rights that may vary according to local regulations.

Features

The CAREvent® CA Handheld Resuscitator is a pneumatically powered, time/volume cycled ventilatory resuscitator with the added feature of a Manually Actuated, Automatic Ventilation Override Button (Manual Button) to allow the operator to control the ventilations manually at a rate and volume they desire. The ventilator allows the breathing patient to “Demand Breathe” on 100% oxygen while their inspiratory eff orts causes the automatic cycling to cease. Should they stop breathing, the ventilator will automatically restart cycling in the setting selected. A 2 Litre per minute constant “BLEED FLOW” is provided to ensure a positive pressure remains in the mask throughout the ventilation cycle to decrease the risk of entraining potential toxic atmospheric air into the mask.
The “pneumatic logic circuit” can be run on either approved, compressed, breathing air or medical oxygen. The unit is self contained and only requires its attachment to a regulated oxygen or air supply (as specifi ed) for immediate use.

The CAREvent® CA Handheld Resuscitator:

• Can be operated on either breathing air (for Canada only) or medical grade oxygen.
• Delivers 100% oxygen during resuscitation (when attached to an oxygen source).
• Meets the ERC and American Heart Association Guidelines 2005 (G05) recommendations for C.P.R.
• Provides physiologically normal adult respiratory rate and volume.
• Has an Audible Airway Pressure Limiting System.
• Is lightweight and extremely durable.
• Is designed for emergency resuscitation in potentially toxic atmospheres.
• Has a Manually Actuated, Automatic Ventilation Override Button (Manual Button) with a 20 second delay to re-start of automatic cycling to allow the provision of 30 chest compressions.
• Complies with the requirements of the ERC and AHA Guidelines 2005 (G05) for the provision of a 30:2 compression: ventilation ratio.
• Has a preset, automatic setting compatible with a range of adult patients with a tidal volume and frequency of ventilation in line with established guidelines.
• Provides “Demand Breathing” with automatic cycling shut off and re-start.
• Has a 2 L/min Bleed Flow to reduce the risk of air entrainment due to mask leakage.
• Has a pressure gauge to monitor airway pressure during ventilation.

Performance Specifications

• (Based on an Aluminum “D” size cylinder containing 415 Litres of oxygen.)

Safety Precautions
The CAREvent® CA Handheld Resuscitator is designed to provide emergency ventilatory support to patients suff ering from respiratory and/or cardiac arrest.
The CAREvent® CA Handheld Resuscitator is intended for use by suitably trained and qualifi ed personnel. The following precautions should always be observed:

1. When not in use, always turn off the cylinder.
2. Never allow oil or grease to come into contact with any part of the cylinder, regulator or resuscitator.
3. Do not disassemble any part of the resuscitator except where described in this manual, as any unauthorized disassembly will invalidate the warranty.
4. After use, always ensure that all components are cleaned in accordance with the instructions provided in this manual.
5. Ensure that all components are reassembled correctly and that all items are replaced in the carrying case.
6. After use, always ensure that a full air or oxygen cylinder is attached before returning the unit to its normal storage position.
7. Ensure that a new sealing washer is used every time you attach the regulator to the cylinder.
8. It is recommended that an alternative means of ventilating the patient be available in case of gas supply failure.

Pre Use Function Check

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:

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 120 L/min at no less than 45 PSI (3.1 Bar).
3. Calibrated Test Lung (supplied with ventilator)

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 15/22 mm patient connector on the resuscitator.

Testing of the Individual Features of the Ventilator.
The following features can be individually tested during the pre-use Functional Check:

1. Maximum Airway Pressure and Audible Alarm
2. Frequency/Tidal Volume Adjustment
3. Manual Ventilation
4. Demand Valve Function and Automatic Circuit Shut Off
5. Bleed Flow
6. Function of Pressure Gauge

Operating Procedure

Connecting the Supply Hose, Pressure Gauge and Patient Circuit
The supply hose provided is attached to the oxygen inlet on the rear of the resuscitator and is tightened “fi nger tight” (fi g 1).

WARNING
The use 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.

Connecting the supply hose (fi g 1)

Manual Ventilation and Cardiac Compressions.
The CAREvent® CA Handheld Resuscitator has a Manually Actuated, Automatic Ventilation Override Button (Manual Button) with a 20 second delay to automatic cycling re-start to assist in the timing of ventilations in conjunction with external cardiac compressions.
By using the Manual Button, the operation of the ventilator can be easily timed with the chest compressions so as to avoid the potential problem of the aspiration of stomach contents due to gastric distension which may occur if overlap of chest compression and infl ation occurs. (It has been shown in some studies that, in patients that are intubated, this overlap of compression and infl ation may increase cardiac output without the danger of gastric distension.) The fl owrate provided is equivalent to the preset automatic fl owrate.

1. If no respiratory eff ort is observed, position yourself above the patient’s head. Turn on the gas supply.
2. Allow the device to cycle once and then apply the face mask over the patients mouth and nose.The thumb and index fi ngers are used to hold the mask to the face while the remaining three fi ngers of each hand are placed along the angle of the jaw. A tilt action is used to hyperextend the neck and move the jaw forward. This helps displace the tongue away from the back of the throat and maintains an open airway.
3. If manual Ventilation is to be used depress the manual button and observe the rise of the patient’s chest. Release the button when chest rise is adequate.
4. If the patient’s chest does not rise or gas escapes around the mask or the pressure relief system (c) operates (fi g 3), reposition the patients head and adjust your hand position to obtain an eff ective mask seal and an open airway.
5. Monitor the patient’s skin, nailbed and lip colour.
6. If mask indicates signs of vomitus, remove immediately and clear the airway. Ensure the mask and valve are free from obstruction. Restart ventilation immediately after clearing airway. (See also 2.4)
7. Continue ventilation at an appropriate rate until relieved or until spontaneous breathing returns.

Automatic Ventilation

1. If you are commencing automatic ventilation immediately, follow steps 1, 2 and 4 – 7 above.
2. Closely observe the patient’s chest movement. If there is any leak from around the mask (indication on pressure gauge will decrease) or any obstruction in the patients airway (blow off valve will operate) reposition patients head and adjust mask and hand position to ensure a good airway and mask to face seal.

Note: If the patient is intubated (or if the patient is to be intubated following mask ventilation), remove the face mask from the 22mm connector and attach the device onto the 15 mm Endotracheal tube connector.

Note: For one person CPR (and when using a head harness to secure the resuscitator to the patient) the use of the manual override provides a 20 second delay to automatic cycling re-start allowing for the provision of 30 chest compressions at the recommended rate of 100 compressions/minute.

WARNING
Automatic ventilation of the patient who is intubated or whose mask is held in place with the optional head harness system, does not mean that the patient is safe to be left unattended and constant observation of the patient’s pulse and chest movement must be continued.

WARNING
The use of gas pressure regulators that do not maintain a minimum output pressure and fl owrate in line with the requirements of the specifi cation may cause the device to fail resulting in the patient not being ventilated.

Action to be taken if patient vomits during resuscitation
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 patients airway. Depress the manual button or allow the resuscitator to cycle automatically for a few breaths to clear the mask and valve of foreign material.
2. If depressing the manual button repeatedly or automatically cycling the resuscitator does not clear the foreign material from the patient valve,turn the selector to the OFF position, remove the facemask and unscrew patient valve swivel housing (e) from the resuscitator body being careful to ensure that the diaphragm is retained (Fig.3).
3. Shake out any foreign material from the resuscitator, diaphragm, face mask and patient valve swivel housing.
4. Reassemble the facemask, patient valve and diaphragm and attach to the resuscitator.

Note: When using the single use patient valve, vomitus may be forced past the diaphragm and contaminate the bio-fi lter. This may necessitate the use of a new single use valve.

Demand Breathing and Automatic Circuit Shut Off
Should the patient commence spotaneous breathing at a fl owrate of greater than 30 lpm for more than 1 second the CAREvent® CA will sense the patient’s inspiratory eff ort and will stop cycling automatically allowing the patient to “Demand Breathe” at their own rate and volume on 100% oxygen (if connected to an oxygen supply). If they cease spontaneous breathing the ventilator will recommense automatic cycling after 5 – 8 seconds delay (depending on the depth of the patients previous respiration) without intervention by the rescuer.

Servicing

Routine Maintenance

WARNING
The CAREvent® CA Automatic Rescue Resuscitator is designed to provide respiratory support in emergency situations. 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 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 air or oxygen cylinder is full and that the resuscitator is in working order.
• Regulator working pressure, suction (if equipped), and ventilator limiting pressures should be checked at least every six months, and more frequently in high use applications.
• Level I Preventative Maintenance should be performed annually and a Level II Factory Preventative Maintenance Service should be performed every 2 years.
• The product is not designed for fi eld disassembly or service outside that indicated in this manual. Any malfunctioning units should be returned to the manufacturer or an Authorised Dealer. Unauthorised repairs will nullify the product’s warranty.

Note: Units with test parameters outside of their ranges listed in the product specifi cations, should not be used. Any units not meeting performance criteria should be returned to the Manufacturer or an authorized repair centre.

Cleaning the CAREvent® CA Handheld Resuscitator and Accessories
Routine cleaning of the equipment should be undertaken to maintain the equipment in a clean condition.
Reusable patient valve swivel housing and diaphram 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, airway pressure gauges and masks should be discarded after each patient use and replaced with a new unit.
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.

THE RESUSCITATOR MUST BE THOROUGHLY CLEANED AFTER EACH PATIENT USE.

1. Operate CAREvent® CA Handheld Resuscitator to blow out any contaminant from the patient valve.
2. Ensure CAREvent® CA Handheld Resuscitator is disconnected from the gas supply source.
3. Remove the facemask and airway pressure gauge from the resuscitator (after removing the mask retaining insert (if supplied) using the extraction tool).
4. Remove the patient valve swivel housing from the body of the resuscitator, being careful to ensure that the diaphram is retained (fi g 3).
5. Shake out any foreign material.
6. Wash all components thoroughly in a mild soap solution and disinfect as required.
7. The resuscitator can be wiped over with a soft cloth and mild soap solution.
8. Dry all components thoroughly.
9. Reassemble unit, connect to an air or oxygen supply to check operation prior to packaging for emergency use.

Note: If the single use valve/mask combination and the single use airway pressure gauge is being used, safely dispose of these items.

CAREvent® CA Handheld Resuscitator Accessories

Your Representative is

O-TWO MEDICAL TECHNOLOGIES INC.

For your nearest Authorized O-Two Distributor In North America call Toll Free 1-800-387-3405

MedNet EC-REP GmbH Borkstrasse, 10
48163 Münster, Germany

www.otwo.com
45A Armthorpe Road, Brampton, ON, Canada, L6T 5M4
Telephone: +1 905 792-OTWO (6896) N.A. Toll Free: +1 800 387 3405 Facsimile: +1 905 799 1339 Email: resuscitation@otwo.com

References

• O-Two Controlled Ventilation – Controlled Ventilation

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