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CAREvent® ALS Handheld Resuscitator

Purpose

To provide ventilatory assistance in the pre-hospital setting to persons in respiratory distress or arrest due to cardiac arrest, drowning, trauma and other causes.

Features

The CAREvent® ALS handheld Resuscitator is 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 patients to “Demand Breathe” on 100% oxygen while their inspiratory efforts causes the automatic cycling to cease. Should they stop breathing, the ventilator will automatically restart cycling in the setting selected.

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 specified) for immediate use.

The CAREvent® ALS handheld Resuscitator:

· Delivers 100% oxygen during resuscitation (when attached to an oxygen source).
· Meets American heart Association/J.A.M.A. recommendations for C.P.R.
· Provides physiologically normal respiratory rates and volumes.
· Has an Audible Airway Pressure Limiting System set in accordance with the recommendations of the American Heart Association/J.A.M.A.
· Is lightweight and extremely durable.
· Is designed for emergency resuscitation and pre-hospital care/ patient transport and for resuscitation and inter-departmental transport in the hospital environment where the potential patient use is with children and adults.
· Has a Manually Actuated, Automatic Ventilation Override Button (Manual Button).

· Has a seven (7) position selector providing six, preset, automatic settings for a range of patient sizes from children to adults with tidal volumes and frequencies of ventilation inline with established guidelines for the range of patient sizes indicated and as OFF position to allow the ventilator to be left in a “standby mode” with the oxygen supply turned on.
· Provides “Demand Breathing” with automatic cycling shut off and re-start.

Performance Specifications

All specifications are subject to a tolerance of +/- 10% except the I:E Ratio which is subjected to a tolerance or +/- 20%

Tidal Volume: 0.2 – 1.1 liters
Breaths per Minute: 20-12
I:E Ration: 1:2
Automatic Flow Rate: 12 – 39.6 LPM
Manual flow Rate: As per automatic setting
Demand Breathing Flow Rate Min 100 LPM
Demand Breathing Triggering
Pressure: -5cm H2O
Minimum Input Pressure: 45 PSI / 3.1 Bar
Maximum Input Pressure: 70 PSI/4.8 Bar
Maximum Airway Pressure: 60cm H2O / 58.8 mBar
Operating Temperature: -18º C to + 50º C
0º F to + 122º F
Storage Temperature: -40º C to + 60º C
-40º F to + 140º F
Input Connection: 9/16” DISS
Patient Connection: 15/22 mm
Cylinder Duration:
(a) 20 BPM / 0.21 Vt 103 minutes
(b) 12 BPM / 1.1 Vt 31 minutes

(Based on an Aluminum “D” size cylinder containing 415 Liters of oxygen)

Safety Precautions

The CAREvent® ALS Handheld Resuscitator is designed to provide emergency ventilatory support to patients suffering from respiratory and/or cardiac arrest. The CAREvent® ALS Handheld Resuscitator is intended for use by suitably trained and qualified 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 n 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.

Operating Procedures

A. Connecting the supply hose

The supply hose provided is attached to the oxygen inlet on the rear of the resuscitator and is fastened “finger tight.”

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.

B. Manual Ventilation and Cardiac Compressions

The CAREvent® ALS Handheld Resuscitator has a Manually Actuated Automatic Ventilation Override Button (Manual Button) 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 inflation occurs. (It has been shown in some studies that, in patients that are intubated, this overlap of compression and inflation may increase cardiac output without the danger of gastric distension.) The flow rate provided is equivalent to the setting on the automatic setting selector providing flow rates equivalent to the size of patients being ventilated, thereby reducing airway pressures and the risk of aspiration of stomach contents still further.

1. If no respiratory effort is observed, position yourself above the patient’s head and apply the facemask over the patient’s mouth and nose. The thumb and index fingers are used to hold the mask to the face while the remaining three fingers of each hand are placed along the angle of the jaw. A tilt action is used to hyperextend the neck and moves the jaw forward. This helps displace the tongue away from the back of the throat and maintains an open airway.

2. Select the tidal volume/frequency of ventilation for the size of patient being resuscitated. Depress the manual button and observe the rise of the patient’s chest. Release the button when chest rise is adequate.

3. If the patient’s chest does not rise or gas escapes around the mask or the blow off valve operates, reposition the patient’s head and adjust your hand position to obtain an effective mask seal and an open airway.

4. Monitor the patient’s skin, nail bed and lip color.

5. If mask indicates signs of vomitus, remove immediately and clear the airway. Restart ventilation immediately after clearing airway.

6. Continue ventilation at an appropriate rate until relieved or until spontaneous breathing returns.

C. Automatic Ventilation

1. If you have been ventilating manually simply release the manual button and after a short pause, the ventilator will commence automatic cycling at the rate and volume selected. If you are commencing automatic ventilation immediately, rotate the setting selector to the setting appropriate for the size of patient being ventilated and the ventilator will commence automatic cycling.

2. Closely observe the patient’s chest movements. If there is any leak from around the mask or any obstruction in the patient’s 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.

3. Should repositioning the mask and adjusting hand/neck position not resolve the situation, adjust the automatic selector control to establish the correct tidal volume. This is accomplished by moving the control toward the child setting if the blow off valve operates or towards the adult setting if the chest rise is insufficient. This can be done by simply using your thumb to slide the control without removing your hand from the mask.

Note: For one person CPR the Automatic mode may be used with chest compression performed in between automatic ventilation.

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 flow rate in line with the requirements of the specifications may cause the device to fail resulting in the patient not being ventilated.

D. 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 patient 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, either disconnect the resuscitator from the gas supply or turn the selector to the OFF position, remove the facemask and unscrew patient valve swivel housing (a) from the resuscitator body being careful to ensure that the diaphragm (b) is retained.

3. Shake out any foreign material from the resuscitator, diaphragm, facemask and patient valve swivel housing.

4. Rotate the selector to the appropriate position and either operates the manual button to blow out any contaminant or cycle automatically for a few breathes.

5. Re-assemble diaphragm, patient valve and facemask and operate the manual button or automatically cycle the resuscitator for a few breaths to ensure correct function.

6. Re-start resuscitation as previously indicated.

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

E. Demand Breathing and Automatic Circuit Shut Off

Should the patient commence spontaneous breathing at a flow rate of greater than 30 lpm for more than 1 second the CAREvent® ALS will sense the patient’s inspiratory effort 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 recommence automatic cycling after a delay of 4 – 7 seconds (depending on the depth of the patients previous respiration) without intervention by the rescuer.

Routine Maintenance

A. General Inspection

Warning: The CAREvent® ALS Handheld Resuscitator is designed to provide respiratory support in all 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 on a routine basis to ensure that all of the accessories and 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. 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 outside of their ranges listed in the product specifications should not be used. Any unit’s not meeting performance criteria should be returned to the Manufacturer or an authorized repair center.

B. Cleaning CAREvent® ALS Handheld Resuscitator and Accessories

Reusable patient valve swivel housing and diaphragm can be cleaned using a mild soap solution and disinfectant 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. All other components should be wiped clean with a mild soap solution. Under no circumstance should the complete unit be soaked or immersed in cleaning solutions.

The resuscitator must be thoroughly cleaned after use with each patient using the following guidelines:

1. Operate CAREvent® ALS Handheld Resuscitator to blow out any contaminant from the patient valve.

2. Ensure CAREvent® ALS Handheld Resuscitator is disconnected from the gas supply source.

3. Remove the patient valve swivel housing (1) from the body of the resuscitator (2) being careful to ensure that the diaphragm (3) is retained.

4. Remove the facemask from the resuscitator (after removing the mask retaining insert (if supplied) using the extrication tool).

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.

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

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