O-two 01EQ1000 Equinox Relieve Nitrous Oxide Oxygen Analgesic Gas Mixing and Delivery System User Manual

: June 16, 2024
: O-Two

O-two 01EQ1000 Equinox Relieve Nitrous Oxide Oxygen Analgesic Gas Mixing

and Delivery System User Manual

Introduction

Indications for Use

The O-Two Equinox® Relieve N2O/O2 Analgesic Gas Mixing and Delivery System is intended for delivering a 50/50% mixture of nitrous oxide and oxygen, on demand, to a conscious, spontaneously breathing patient.
The device is suitable for use in:

Pre-hospital (ambulance) use, and
In-hospital use (ER, Labor and Delivery )

Contraindications

The contraindications for this device include, but may not be limited to:

Hypersensitivity to the medication
Head injuries with impaired consciousness
Maxillofacial injuries
Artificial, traumatic or spontaneous pneumothorax
Air embolism
Middle ear occlusion, ear infection
Decompression sickness
Abdominal distension / intestinal obstruction

Note: Nitrous Oxide/Oxygen (N2O/O2) mixtures must never be used in any condition where air is trapped in the body and expansion (up to 3x original size) would be dangerous. For example, it will exacerbate pneumothorax and increase pressure from any intracranial air. Air in any other cavities such as the sinuses, middle ear and gut may also expand.

Product Description/Principles of Operation

The device provides connectors for connection with nitrous oxide and oxygen cylinders through pressure regulators. The device has only one control for turning ON or OFF the device. When it is turned ON, the output of N2O/O2 gas mixture will only be activated by an
inspiratory effort by the patient. The output of N2O/O2 gas mixture is pre-set at 50/50%. Neither the patient nor medical personnel are able to adjust, eliminating the risk of delivering a hypoxic mixture.
The gas specific built-in alarm systems will generate both visual and audible alarms should either the nitrous oxide or oxygen input drop to 40 PSI, and the device will be automatically shut off should either the Nitrous Oxide or Oxygen input drop to 35 PSI.
Both visual indicator and audible alarm circuits for both gasses are powered by oxygen only to prevent dumping nitrous oxide gas into atmosphere during alarm cycling.
The device is also equipped with a primary “failsafe” circuit (3.6) that will activate a continuous alarm and shut off the device should the output pressure differential from the mixer exceed 2 psi.
If either the Nitrous Oxide or Oxygen Supply runs out or is shut off, the device will automatically shut off; however the patient will be able to breathe atmospheric room air through the emergency air intake.
Note: The O-Two Equinox® Relieve System is considered a critical device, and its components considered critical components. It shall only be used by patients under the guidance of those individuals trained in the operation of nitrous oxide/oxygen analgesic gas delivery systems. Thoroughly review the instruction manual before use.
The 01EQ1000F is fitted with an oxygen enrichment button to allow for the flushing of the system after use. Warranty

WARRANTY

O-Two Medical Technologies Inc. products are manufactured fromthe 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 O-Two Equinox® Relieve N2O/O2 Analgesic Gas Mixing and Delivery 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 specific legal rights. You may also have other rights which may vary according to local regulations.

Safety Precautions

The O-Two Equinox® Relieve System is a self-administered device. It shall only be used by patients under the guidance of qualified personnel trained in its use. Carefully read this manual prior to operation and use.
The following precautions should always be observed:

WARNING

When the unit is in use, do not smoke or use near open flameeither during operation or when changing the cylinder.
Never allow oil or grease to come into contact with any part of the cylinder, regulator or Equinox® Relieve System. The device has been degreased for oxygen service prior to
Equinox® Relieve System is designed for patient self-
Never attach the facemask to the patient using a head
If the alarm sounds continuously, immediately discontinue use and shut off the gas
It is recommended that an oxygen monitor be used with this device to monitor the gas However, if there is a concern that the device has not undergone regular maintenance, at the prescribed intervals, in accordance with this manual, then an oxygen monitor shall be used.

CAUTION:

Medical gases must be dry and free from dust and
The Nitrous Oxide cylinder should be operated in an upright If the Nitrous Oxide cylinder is in a valve-down position while the post valve is open, liquid may be expelled through the vent passages. This liquid Nitrous Oxide can cause burns by freezing on exposed skin.
It is recommended to use cylinders that are at least 1/4 Always turn on cylinder valve slowly and fully. When not in use, always turn off the cylinder.
After use, always ensure that a gas cylinder with sufficient volume is attached before returning the unit to its normal storage position.
After use, always ensure that all components are cleaned in accordance with the instructions provided in this
Do not disassemble any part of the unit except where described in this manual as any unauthorized disassembly will invalidate the
Before use on a patient, the oxygen concentration of the delivered gas should be
US Federal Law restricts this device to sale by or on the order of a physician.

Performance Specifications

Minimum Flow rate	120 L/min
Exhalation Resistance	0 to 6 cmH2O @ 60 L/min
Inhalation Resistance	0 to -6 cmH2O @ 60 L/min
Oxygen Concentration	42.5 to 57.5%
Oxygen Enrichment Flow (01EQ1000F only)	30 L/min
Input Pressure	50 to 70 PSI (3.5 – 4.8 Bar)
Low Input Pressure Alarm	40 ± 1 PSI (2.7 Bar)
Device Shut-off Pressure	35 ± 4 PSI (2.7 Bar)

Failsafe protection

| ~ 2 PSI differential pressure between O2 and N2O output gas. Prevents the output of high nitrous oxide concentrations
Demand Valve Triggering Pressure| -1.5 to -2.5 cmH2O
Supply Hose Connections| Refer to Section 6
Device Input Connections| Nitrous Oxide: CGA1040 DISS Oxygen: CGA1240 DISS
Patient Connector| 15/22 mm

Patient Circuit (Single use)

| Dual limb circuit with one-way valves and 19 mm Scavenging Port Connection on the exhalation limb.
Patient Valve Dead Space| 32 ml
Operating Temperature| 410F to 1040F (50C to 400C)
Storage Temperature| -400F to 1400F (-400C to 600C)
Weight| 3.3 lb. (1.5 Kg)
Dimensions W x D x H| 8.9”x6.6”x3.9” 226x168x99mm)

Preparation for use

Component List

Operating Manual
O-Two Equinox® Relieve System
Single Use Patient Circuit with Mouth Piece
Oxygen Supply Hose
Nitrous Oxide Supply Hose
Test hose

Note: If any components are missing from the shipping carton, immediately call the supplier quoting the packing slip number, your original purchase order number and the description of the item which is missing.

Pre-use Functional Checks

Along with the contents of the shipping cartons you will require the following items to enable you to undertake the pre-use functional check:

Nitrous oxide and oxygen pressure sources with 60 PSI output capable to provide a minimum of 100 L/min at no less than 42 PSI (2.9 Bar).
A breathing simulator with 30 L/min demand flow over a minimum of 1 As a simple option a 1 Liter calibrated gas syringe may be used.

Note: Factory calibration of this device uses a +/- 5% V/V tolerance. These Pre-Use tests are designed for the user to confirm function and accuracy of the device while taking into account differences in test equipment and test procedures that may affect the results obtained. Any devices with results outside of the tolerance stated in the chart should be returned to an authorized service center for checking.

Leak Test

Having connected the supply hoses to the regulated gas supplies (refer to section 3.1 for CONNECTION OF HOSES), ensure that the O-Two Equinox® Relieve ON/OFF selector is in the OFF position and turn on the N2O and O2 supplies. Using a mild soap solution, spray the input connections to the device to check for leaks. If any leak is present, tighten the connection and re-test. Once no leakage is confirmed, turn the ON/OFF control to the ON position.

Reverse gas flow test

To test the reverse flow, connect one gas at a time to the corresponding input connector, spray the other input connector, no bubbles allowed from this connector.

Function test

The following features of the Equinox® Relieve System can be individually tested or measured using a calibrated pressure gauge and flowmeter during the Pre-use Functional Check:

Demand Valve Function and Oxygen Concentration Demand Valve function and oxygen concentration of the delivered gas can be determined by the following procedure:
Connect an oxygen monitor to the output connector of the Relieve using the “3-Way T” Connector test assembly
Utilizing a 1 Liter calibrated syringe, connect the syringe to the patient connection on the patient circuit connected to T- Turn on the Relieve unit and activate the demand valve by cycling the syringe until the oxygen reading on the monitor has stabilized. Demand valve function is confirmed by a change in the reading on the monitor.

Setting Acceptable Range

50%| 40% – 60%

Low Input Pressure Alarms

Note: To fully test this function it is necessary to have a supply regulator with an adjustable output pressure and a release valve (Not supplied). Checking of the alarm may be undertaken by simply slowly closing the cylinder valve.
With the adjustable inlet pressure regulator set to a supply pressure of 50 PSI, gradually reduce the supply pressure of the regulator to around 40 PSI while slowly releasing the gas until you hear the Low Input Pressure Alarm activated. For the nitrous oxide alarm the pulsed tone frequency is set at a low frequency of approximately 60 BPM. For the low oxygen alarm, the pulsed tone frequency is set at high frequency of approximately 120 BPM.
When low pressure alarm is activated, the corresponding Gas Supply Status Indicator will also cycle at the same rate of the alarm.

Low Input Pressure Shut Off

Continue to decrease the outlet pressure of the regulator to around 35 PSI, the device should automatically shut off, and at the same time, in the event the N2O pressure drops below 35 PSI, an additional continuous alarm will be activated.

Oxygen Enrichment Button (01EQ1000F only)

The oxygen flow and concentration can be measured at the patient connection port using an O2 monitor and flow meter.

Operating instructions

Connection of Hoses

The O-Two Equinox® Relieve System is designed to operate on medical nitrous oxide and medical oxygen from either individual gas cylinders or piped-in medical gas systems.
The inlet fittings on the device are non-interchangeable, DISS fittings, specifically for nitrous oxide and oxygen.
The device is designed to operate under 50 – 70 PSI input pressures for both gas supplies.
The nitrous oxide supply hose provided shall be attached to the N2O input connection on the left side of the device. The oxygen supply hose provided shall be attached to the O2 input connection on the right side of the device. Tighten the supply hoses “Finger tight” only – DO NOT USE A WRENCH (fig 1).

WARNING

Using a wrench or excessive force in tightening the supply hosemay damage the seal or the thread of the connection.
The patient circuit is attached to the gas outlet on the front panel of the control module by simply pushing the 22 mm taper over the outlet

– Connecting the Supply hoses and Patient Circuit

ON/OFF selector

The ON/OFF SELECTOR controls the device in either its normal operating mode or shut off.

Demand Valve

The device is equipped with a Demand System enabling spontaneously breathing patients to demand 50/50% nitrous oxide and oxygen.
An inspiratory effort by the patient will open the demand valve and 50/50% nitrous oxide and oxygen will flow to the patient at a rate in line with their inspiratory effort.

Low Input Pressure Alarms

Gas Supply Status IndicatorsLocated on the front panel, the O2 and N2O visual indicators turn green when oxygen and Nitrous Oxide are supplied to the unit. Used in conjunction with the Low Input Pressure alarms, these indicators provide additional reference for the operator as to the gas supply status.Low Input Pressure Alarms
At any time, if the input pressure of either gas drops to 40 PSI, a visual and audible Low Input Pressure alarm will be activated. The alarm will cycle 45 to 75 times per minute for Nitrous Oxide, or 90 to 150 times for Oxygen and the gas supply indicators will flash Green to black.

Low Input Pressure Shut Off

The device will automatically shut off should the input pressure of either gas drop to 35 PSI. This indicates that the drive gas is now exhausted to the point where the device will no longer function correctly (see also the Note in 3.6).
Note: The shut off alarms will cease to function completely should the O2 input pressure drop below 20 PSI.
If either the Nitrous Oxide or Oxygen Supply runs out or is shut off, the device will allow the patient to breathe on atmospheric room air through the emergency air intake.
Oxygen Enrichment Button (01EQ1000F only)
With the ON/OFF switch set to ON, a constant flow of oxygen will be supplied to the patient when the enrichment button is depressed.
Note: If the oxygen enrichment control is held depressed for an extended period the device may alarm. Releasing the button will cancel the alarm.

Failsafe Protection

The O-Two Equinox® Relieve System is equipped with a primary “Failsafe” protection circuit.
Should the output pressure differential of the internal mixer valve exceed 2 psi the “Fail Safe” protection circuit will activate, a continuous alarm will sound and the device will shut off.
Note: In Use, the drop in low input pressure may cause a difference in output pressure and trigger the Failsafe protection. In this case the shut off alarm will activate instead of the low pressure alarm.
When the device is turned off the Failsafe protection circuit is deactivated. Once initiated the alarm will continue its constant tone until the device is turned off or the pressure differential is resolved.

Output Concentration Monitoring

An oxygen monitor with alarm should be used to monitor the output of the N2O/O2 mixture. The monitor “Tee” piece is to be placed on the outlet of the mixer prior to the circuit being attached (fig 2).

– Connecting the Oxygen Monitor

Note: Placing an oxygen monitor in the above location will remove the additional monitoring line from becoming an issue for the patient if the “Tee” piece is placed proximal to the facemask. Additionally, the one-way valve system in the O-Two Equinox® circuit will prevent expired air from reaching the monitor

Servicing

Routine Maintenance

To ensure proper operation of the O-Two Equinox® Relieve, regular inspection and checking of the device and accessories for correct function should be undertaken by a responsible member of staff.
It is recommended that the routine preventive maintenance be carried out and the Equinox® Relieve mixer be returned to O-Two Medical Technologies or its authorized service center for maintenance and service every 2 years as follows:

Monthly inspection

The device should be visual inspected and leak tested monthly to ensure that the components and accessories are present, the gas cylinders are full and the device is in working order.
Function check
The device should be checked for proper function and mixture output concentration at least every six months, and more frequently in high use applications. Malfunction unit should be returned to the manufacturer or an authorized service center since this product is not designed for field disassembly or service. Unauthorized repairs will nullify the product warranty.
Level II service
The device shall be returned to the manufacturer or an authorized service center for Level II service every 2 years.
Manufacturer full service
The device shall be returned to O-Two Medical Technologies for Manufacturer Full Service every 6 years.

Cleaning

Routine cleaning of the device shall be undertaken to maintain the device in a clean condition.
The patient circuit and mouth piece of the device are intended for single use and shall be discarded after each patient use in accordance with local protocols and replaced with a new circuit.
All other components should be wiped clean with a mild soap solution or hard surface disinfectant suitable for the materials of manufacture of the device. Under no circumstances should the complete unit be allowed to be soaked or immersed in cleaning solutions.
Detailed cleaning procedure is as follows:

Ensure that the device is disconnected from the gas supply
Remove N2O and O2 input hoses and wipe clean with a mild soap or hard surface Ensure no cleaning solution enters the hoses.
Remove the single patient use circuit from the device and dispose of safely in accordance with local protocols
The enclosure of the device can be wiped over with a soft cloth and mild soap solution or hard surface disinfectant. Ensure no cleaning solution enters the input If there is ingrained contamination a soft bristled brush may be used.
Dry all components
Attach a new patient circuit and connect the unit to gas supply to check function prior to packaging for emergency

WARNING

Do not attempt to clean and sterilize any components that are designated as disposable.

Replacement Parts & Accessories

ORDER N0	PART
01CV8028-Cs	O-Two Single-Use Analgesic Gas Patient Circuit with Scavenger

Hose and Adapter with Mouthpiece (Case/10)
17MP1997| 90o (Male to Female) adjustable Oxygen DISS elbow
17MP1998| 90o (Male to Female) adjustable Nitrous Oxide DISS elbow
01FM4999| Universal Facemask (Case/12)

Oxygen Hoses*

ORDER N0	PART
01FV4303-AFNR	O-Two 6 Foot (1.85 Meter) O2 Supply Hose with AFNOR probe and

9/16” DISS Nut Device Connection
01FV4303-AGA| O-Two 6 Foot (1.85 Meter) O2 Supply Hose with AGA probe and 9/16” DISS Nut Device Connection
01FV4303-CZCH| O-Two 6 Foot (1.85 Meter) O2 Supply Hose with CZECH probe and 9/16” DISS Nut Device Connection
01FV4303-DIN| O-Two 6 Foot (1.85 Meter) O2 Supply Hose with DIN probe and 9/16” DISS Nut Device Connection
01FV4303-DISS| O-Two 6 Foot (1.85 Meter) O2 Supply Hose with 9/16 DISS Nut and 9/16” DISS Nut Device Connection
01FV4303-UNFR| O-Two 6 Foot (1.85 Meter) O2 Supply Hose with UNIFOR probe and 9/16” DISS Nut Device Connection
01FV4303-BM| O-Two 6 Foot (1.85 Meter) O2 Supply Hose with BRITISH probe and 9/16” DISS Nut Ventilator Connection

Nitrous Oxide hoses*