O-Two E01EQ7000 Equinox II Administration System User Manual

O-Two E01EQ7000 Equinox II Administration System

Introduction

The Nitrous Oxide/Oxygen Administration System is designed to provide a mixture of 50% Nitrous Oxide and 50% Oxygen to the patient using a Demand Valve. The pressure regulator is intended to lower the high, variable cylinder pressure to a lower constant working pressure for the Demand Valve. This product is made in Canada by O-Two Medical Technologies Inc. and comes with a Part Number: 15PL1342 Rev.16 Aug 2022.

Performance Specification

An inspiratory effort by the patient will activate the demand valve and Nitrous Oxide/Oxygen will flow to the patient at a rate and volume in line with their inspiratory effort.

Operating Procedure

1. Place the mask on the patient’s face, covering both the nose and mouth.
2. Turn the cylinder hand wheel counter clockwise to the ON position. Ensure that the regulator contents gauge reads at least 500 psi. If not, replace with a full cylinder.
3. Instruct the patient in its operation. Most protocols require the gas mixture be self-administered by the patient to prevent inadvertent excessive administration by an attendant.
4. To trigger the demand valve and obtain an adequate flow of gas, it is necessary to make a good mask to face seal. Instruct the patient to hold the mask on his/her face with a light pressure and breathe normally. The sound of gas flowing should be heard with each inspiration. If not, adjust the patient’s hold on the mask for a better seal and ask the patient to breath more deeply.

Safety Precautions

Following precautions should always be observed:

• CAUTION: FEDERAL LAW IN THE U.S.A. RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A LICENSED PRACTITIONER.
• When the unit is in use, do not smoke or use near open flame either during use or when changing the cylinder.
• When not in use, always turn off the cylinder.
• Never allow oil or grease to come into contact with any part of the cylinder, regulator or demand valve.
• Do not disassemble any part of the demand valve except where described in this manual as any unauthorized disassembly will invalidate the warranty.
• After use, always ensure that all components are cleaned in accordance with the instructions provided in this manual.
• Always use the check list to ensure that all components are reassembled correctly and ready for use.
• After use, always ensure that a full gas cylinder is attached before returning the unit to its normal storage position.

Servicing

Routine maintenance should be performed as per instructions provided in the manual. Cleaning and disinfection of all components is necessary after every use.

Warranty Information

The manufacturer shall be liable under this warranty only if the device 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 which may vary according to local regulations.

 INTRODUCTION

Equinox® II ADMINISTRATION SYSTEM
The Equinox® II Administration System is intended for administration of 50%/50% N2O/O2 analgesic gas mixture and is specifically designed for use in emergency and obstetric analgesia. The Equinox® II Administration System consists of a demand valve, a single stage pressure regulator, a supply hose and a universal patient face mask. It can be operated anywhere 50% Nitrous Oxide/50% Oxygen mixture cylinders are available. The Equinox® II Demand Valve is lightweight, portable, and extremely durable and is intended to administer 50%/50% N2O/O2 analgesic gas on patient’s demand. The pressure regulator is intended to lower the high, variable cylinder pressure to a lower constant working pressure for the Demand Valve.

Note: Only those individuals trained in the administration of Nitrous Oxide/Oxygen mixtures should use this equipment. Thoroughly review the instruction manual before use.

 WARRANTY

Equinox® II Administration System 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 Equinox® II Administration System 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 device 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 device 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 which may vary according to local regulations.

SAFETY PRECAUTIONS

The Equinox® II Administration System is intended for use by suitably trained and qualified personnel.
The following precautions should always be observed:

1. CAUTION: FEDERAL LAW IN THE U.S.A. RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A LICENSED PRACTITIONER.
2. WHEN THE UNIT IS IN USE, DO NOT SMOKE OR USE NEAR OPEN FLAME EITHER DURING USE OR WHEN CHANGING THE CYLINDER.
3. WHEN NOT IN USE, ALWAYS TURN OFF THE CYLINDER.
4. NEVER ALLOW OIL OR GREASE TO COME INTO CONTACT WITH ANY PART OF THE CYLINDER, REGULATOR OR DEMAND VALVE.
5.  DO NOT DISASSEMBLE ANY PART OF THE DEMAND VALVE EXCEPT WHERE DESCRIBED IN THIS MANUAL AS ANY UNAUTHORIZED DISASSEMBLY WILL INVALIDATE THE WARRANTY.
6.  AFTER USE, ALWAYS ENSURE THAT ALL COMPONENTS ARE CLEANED IN ACCORDANCE WITH THE INSTRUCTIONS PROVIDED IN THIS MANUAL.
7. ALWAYS USE THE CHECK LIST TO ENSURE THAT ALL COMPONENTS ARE REASSEMBLED CORRECTLY AND READY FOR USE.
8.  AFTER USE, ALWAYS ENSURE THAT A FULL GAS CYLINDER IS ATTACHED BEFORE RETURNING THE UNIT TO ITS NORMAL STORAGE POSITION.

PERFORMANCE SPECIFICATION

DEMAND VALVE

• (Minimum) Peak Flow rate ……………………..……..……..……………. 140 L/min
• Exhalation Resistance ……………………………….0 to 6 cmH2O @ 60 L/min
• Inhalation Resistance…..………………………0 to -6 cmH2O @ 60 L/min
• Input Pressure ………………….………………………………………..……..….………50 PSI
• Initiation Pressure …………………………..………….………..…… -2 to -2.5 cmH2O
• Operating Temp ……..……………………….-180C to 500C (00F to 1220F)
• Storage Temp ……….…………………-400C to 600C (-400F to 1400F)
• Input Connection ………………………………..…………..…….…….……… 5/8”-18 TPI
• Patient Connector ……………………………………………..……………………15/22 mm
• Weight ……………….………..……………………………………………..…. 0.21 Kg (7.4 oz)
• Dimensions ………….…………………………….…Dia. 51mm x 81mm (2.0” x 3.2”)

PRESSURE REGULATOR

• Inlet Connection……………………..CGA 965 N2O/O2 Pin Indexed Yoke
• Outlet Connector…………..……….……..……………..…………………..…5/8” Thread
• Operating Pressure…………………………………….….…………….500 -3000 PSI
• Output Pressure…………………………………………………………..…………50 -60 PSI
• Weight………………………..……….…………….…………………………….0.45 Kg (1.0 lb)

OPERATING PROCEDURE

DEMAND BREATHING

The O-Two Equinox® II Demand Valve is designed to operate on compressed Nitrous Oxide/ Oxygen gas. It is intended to provide 50/50% Nitrous Oxide/Oxygen mixture to the patient at a safe delivery pressure and adequate fl ow rate upon demand. An inspiratory eff ort by the patient will activate the demand valve and Nitrous Oxide/ Oxygen will fl ow to the patient at a rate and volume in line with their inspiratory effort.

OPERATING INSTRUCTIONS

1.  Ensure that the Equinox® II Demand Valve/Regulator connection is secured and no leaks present.
2. Turn the cylinder hand wheel counter clockwise to the ON position. Ensure that the regulator contents gauge reads at least 500 psi. If not, replace with a full cylinder.
3.  If used, connect the bacterial filter between the Equinox® II Demand Valve and the Universal Facemask.
4.  Instruct the patient in its operation. Most protocols require the gas mixture be self-administered by the patient to prevent inadvertent excessive administration by an attendant.
5.  To trigger the demand valve and obtain an adequate fl ow of gas, it is necessary to make a good mask to face seal. Simply place the mask on the patient’s face, covering both the nose and mouth. Instruct the patient to hold the mask on his/her face with a light pressure and breathe normally. The sound of gas fl owing should be heard with each inspiration. If not, adjust the patient’s hold on the mask for a better seal and ask the patient to breath more deeply.
6.  Continue administration as per local management protocol and scavenge waste gas as per 2.3 if required.
7. Turn OFF the cylinder after each use and release remaining gas from the system by placing the bleed pin attached to the regulator into the center hole on top of the Demand Valve and depress until gas fl ow ceases.

NOTE
 The use of a patient circuit or bacterial/viral filter with the Equinox® II demand valve may increase the patient’s inspiratory work of breathing.

SCAVENGING OF WASTE EXHALED GAS

To scavenge exhaled air from the patient during inhalation analgesia a scavenging system must be employed. There are two options for exhaled gas scavenging:

Scavenger Adapter
The optional Patient Valve with Scavenger Adapter (17MP1100-90DEG) is designed for exhaled gas scavenging.
To apply,

• Remove the Non-rebreathing Patient Valve from the demand valve;
• Attach the Patient Valve with Scavenger Adapter on to the demand valve;
•  Connect a scavenging tube to the 19mm/30mm outlet of the Scavenger Adapter to divert the exhaled gas to the exhaust system.

NOTE
 The 30 mm exhalation port meets the requirements of the International Standards for Conical Connectors for Low Pressure Medical Gas Systems and will allow the attachment of corrugated tubing so that the patient’s exhaled breath can be scavenged from the exhalation valve to the exhaust method chosen by the facility using the device.

Analgesic Gas Patient Circuit

The optional Analgesic Gas Patient Circuit (01CV8028) can be connected to the Equinox® II demand valve with its expiratory tube attached to the exhaust system.
To apply,

• Remove the Non-rebreathing Patient Valve and the Diaphragm (17MP1528) from the demand valve;
•  Screw the 15/22mm housing adapter (provided with 01CV8028) on to the demand valve. Attach the white inspiratory tube of 01CV8028 to the housing adapter;
• Attach the pink expiratory tube of 01CV8028 to the exhaust system.

 SERVICING

ROUTINE MAINTENANCE

WARNING
The Equinox® II Administration System is designed to provide years of reliable service in all emergency situations. Failure to follow the maintenance and inspection routines properly could result in incorrect operation of the demand valve.

To ensure proper operation of the Equinox® II Administration System, regular inspection and checking of the demand valve and accessories for correct function should be undertaken by a responsible member of staff on a regular basis.
This check is to ensure that all of the accessories and demand valve components are present, the gas mixture cylinder is full and that the demand valve is in working order.

MAINTENANCE

Function parameters 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. O-Two Medical products are 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 Authorized O-Two Medical Technologies Dealer. Unauthorized repairs will nullify the product warranty.

 CLEANING AND DISINFECTION

Routine cleaning and/or disinfection of the Equinox® II Administration System should be undertaken after each patient use as follows to maintain the equipment in a clean condition.

NOTE
The use of a patient circuit or a bacterial/viral filter with the Equinox® II demand valve isolates the patient’s exhaled breath from the demand valve internal pathways. Therefore, the need for the cleaning and disinfection, after each patient use, of the Non-rebreathing Patient Valve (A & C) and Diaphragm (B), attached to the demand valve, is negated. It is however recommended that the demand valve is cleaned and disinfected externally using a hard surface disinfectant suitable for use with the materials of manufacture.

Ensure that the cylinder is turned off (completely clockwise) and bleed any remaining gas out of the gas supply hose.

1.  Remove the facemask, the patient circuit and the bacterial fi lter (if applicable) from the Equinox® II Demand Valve. Discard the bacterial fi lter and the patient circuit.
2.  Disconnect the demand valve from the regulator. The regulator can be cleaned with a clean soft cloth.
3. Unscrew patient valve (A) from the unit body (D) being careful to ensure that the diaphragm (B) is retained.
4. Remove the diaphragm and anti-entrainment ring (C) from the patient valve housing and wash these components thoroughly in a mild soap solution;
5. Disinfect the face mask, patient valve and diaphragm using commonly available cold chemical disinfecting solutions. Rinse thoroughly with water after disinfection.
6.  Sterilization, if required, may be achieved by other methods compatible with the materials of manufacture of these components including Ethylene Oxide Gas and Cidex.
7. The demand valve body (D) and gas supply hose can be wiped over with a soft cloth and mild soap solution and may be disinfected using a hard surface disinfectant that is compatible with aluminium.
8. Dry all components thoroughly.
9. Re-assemble and check performance.

WARNING
Do not immerse the demand valve unit or the pressure regulator into cleaning solution or disinfectant. Discontinue use and discard the face mask, the patient valve and the diaphragm should discoloration or deterioration be observed.

REPLACEMENT PARTS/ ACCESSORIES

and Adapter (case/10)

Other sizes and seal types are available. Contact your nearest O-Two  Medical authorized distributor for a complete catalogue on all O-Two
Medical manufactured products.
Optional hose configuration.

MANUFACTURERS AND DISTRIBUTORS OF

• O-Two eSeries Electronic Transport Ventilators
• O-Two Single Use Open CPAP Systems
• O-Two CAREvent® Range of Automatic Transport Ventilators
• O-Two CAREvent® Range of Automatic Resuscitators
• O-Two SMART BAG® MO “Controlled Flow” Manual Resuscitators
• O-Two Oxygen Demand Valve and Demand Valve Resuscitators
• O-Two Pressure Regulators
• O-Two Equinox® II 50% N2O/50% O2 Analgesic Gas Delivery System
• O-Two Equinox® Relieve 50% N2O/50% O2 Analgesic Gas Delivery System
• O-Two Equinox® Advantage Adjustable Analgesic Gas Delivery system
• O-Two First Response CPR Devices

O-TWO MEDICAL TECHNOLOGIES INC.

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

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

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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