O-Two CAREvent CA User manual

USER MANUAL
CAREvent® CA
Part Number: 15PL2151 - REV 11 Feb, 2021
CHEMICAL AGENT ENVIRONMENT AUTOMATIC
AND MANUALLY TRIGGERED RESUSCITATOR
01CV3000-CA

2CAREvent® CA - User Manual
TABLE OF CONTENTS
1. The CAREvent® CA Chemical Agent
Environment Automatic and Manually
Triggered Resuscitator
4
1.1. Introduction 4
1.2. Warranty Information 5
1.3. The CAREvent® CA Features 5
1.4. Performance Specifications 7
1.5. Safety Precautions 8
2. Pre Use Functional Checks 8
2.1. Set Up 8
2.2. Testing of the Individual Features
of the Ventilator 9
3. Operating Procedure 9
3.1. Connecting the Supply Hose, Pressure
Gauge and Patient Circuit 9
3.2. Manual Ventilation and
Cardiac Compressions 10
3.3. Automatic Ventilation 11
3.4. Action to be Taken if Patient
Vomits During Resuscitation 12
3.5. Demand Breathing and Automatic
Circuit Shut O 12
4. Servicing 13
4.1. Routine Maintenance 13
4.2. Cleaning and Sterilization 14
5. CAREvent® CA Accessories 15

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CAREvent® CA - User Manual
1. The CAREvent® CA Chemical Agent Environment
Automatic and Manually Triggered Resuscitator
1.1. Introduction
The CAREvent® CA Handheld Resuscitator provides trained
individuals with a safe and eective means of providing artificial
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 confined 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 confined space rescue in
IDLH (Immediately Dangerous to Life and Health) environment,
pre-hospital, Intra-hospital, inter- hospital of non-breathing
patients.
The material used in this device contains “DEHP”.
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.
PHT
DEHP

4CAREvent® CA - User Manual
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® 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 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 vary
according to local regulations.
1.3. 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 e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 specified) for immediate use.

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CAREvent® CA - User Manual
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 o
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.

6CAREvent® CA - User Manual
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 cmH
2
0 / -2.0 mBar
Inspiratory Resistance -6.0 cmH
2
0 / -5.9 mBar
Expiratory Resistance 6.0 cmH
2
0 / 5.9 mBar
Input Pressure 45 - 70 PSI / 3.1 - 4.8 Bar
Maximum Airway Pressure 60 cmH
2
0 / 58.8 mBar
Operating Temperature -18
o
C - + 50
o
C / 0
o
F - +122
o
F
Storage Temperature -40
o
C - +60
o
C / -40
o
F - +140
o
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”
Cylinder Duration: @ 10 Bpm / 0.5 Litres V
t
82 minutes*
1.4. Performance Specifications
* (Based on an Aluminum “D” size cylinder containing 415 Litres of oxygen.)

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CAREvent® CA - User Manual
1.5. Safety Precautions
The CAREvent® CA Handheld Resuscitator is designed to provide
emergency ventilatory support to patients suering from
respiratory and/or cardiac arrest.
The CAREvent® CA 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 o 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.
2. Pre Use Function Check
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:
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)

8CAREvent® CA - User Manual
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.
2.2. 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 O
5. Bleed Flow
6. Function of Pressure Gauge
3. Operating Procedure
3.1. 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 “finger tight” (fig 1).
The facemask is attached to the patient connection port by
simply pushing the mask onto the 22mm taper.
WARNING
The use of excessive force in tightening the supply hose may
damage the seal and /or thread.

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CAREvent® CA - User Manual
3.2. 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 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 flowrate provided is equivalent to the
preset automatic flowrate.
1. If no respiratory e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 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 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.
Manual Button
Pressure Gauge
Attach supply
hose here
Connecting the supply hose (fig 1)

10 CAREvent® CA - User Manual
4. If the patient’s chest does not rise or gas escapes around
the mask or the pressure relief system (c) operates (fig 3),
reposition the patients head and adjust your hand position to
obtain an e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.
3.3. 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 o
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.

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CAREvent® CA - User Manual
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.
WARNING
The 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 not being ventilated.
3.4. 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.
3.5. Demand Breathing and Automatic Circuit Shut O
Should the patient commence spotaneous breathing at a flowrate
of greater than 30 lpm for more than 1 second the CAREvent®
CA will sense the patient’s inspiratory e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.

12 CAREvent® CA - User Manual
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
sta 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 field 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.
4. Servicing
4.1. Routine Maintenance
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.

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CAREvent® CA - User Manual
4.2. 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.
G
Facemask
F
Pressure Gauge
D
Manual Button
A
Resuscitator Body
B
Gas Supply Inlet
C
Pressure Relief
System
E
Patient Valve
Swivel Housing
Disassembly of the resuscitator (fig 3.)
DESCRIPTION PROCEDURE CRITERIA SCHEDULE BY
PM Visual
Inspection
User Manual
Chapter 4.1
Monthly
Checking
Device in work
order, gas tanks are
full, no missing item Month User
PM Function
Check
Regulator
work
pressure
limiting
pressure
Within specification Every 6
months User
PM Level I Service
Manual Within specification Every year User
Servicing Level II
Service Service Manual Meet product specifications Every 2 years Manufacturer/ Service Center

14 CAREvent® CA - User Manual
Note: If the single use valve/mask combination and the single use
airway pressure gauge is being used, safely dispose of these items.
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 (fig 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.
5. CAREvent® CA Handheld Resuscitator Accessories
ORDER N0PART
17MP9039 Reusable Patient Valve Swivel Housing
17MP1528 Reusable Patient Valve Diaphragm
01FG6500 Mask Retaining Insert
01FG6501 Mask Insert Extraction Tool
01FG6502 Head Harness System
17MP7010 Single Use PEEP Valve
01CV8065 Disposable Pressure Gauge 0 - 60 cmH2O (mBar)
02FM4999 Universal Mask

15
CAREvent® CA - User Manual

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
EC REP
SERIAL N
0
:
www.otwo.com
45A Armthorpe Road, Brampton, ON, Canada, L6T 5M4
Telephone: [phone]-OTWO (6896) N.A. Toll Free: [phone]
Facsimile: [phone] Email: [e-mail]
PHT
DEHP