O-Two Medical Technologies Inc 01EQ2000 Equinox Advantage User Manual

O-Two Medical Technologies Inc 01EQ2000 Equinox Advantage

Product Information: Nitrous Oxide/Oxygen Administration System

The Nitrous Oxide/Oxygen Administration System is a medical device manufactured by O-Two Medical Technologies Inc. in Canada. The product is designed to mix and deliver a gas mixture of nitrous oxide and oxygen to patients through a demand valve. The device has two input connectors for pressure-regulated gas sources of nitrous oxide and oxygen, and it has only one control for turning ON or OFF. The gas mixture output can be selected among various percentages from 25%/75% (O2/N2O) to 100%/0% (O2/N2O). The device has an Oxygen Enrichment function that allows healthcare professionals to provide a continuous flow of 100% oxygen to patients.

Indications for Use and Contraindications
The Nitrous Oxide/Oxygen Administration System is indicated for use in medical facilities to deliver a gas mixture of nitrous oxide and oxygen to patients during medical procedures. However, nitrous oxide/oxygen 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 abdomen may also expand. Therefore, the device is contraindicated for patients with these conditions.

Product Usage Instructions

Preparation for Use
Before using the Nitrous Oxide/Oxygen Administration System, perform the following:

1. Ensure that all components are present according to the Component List provided in the user manual.
2. Perform pre-use functional checks to ensure the device is functioning correctly.

Operating Instructions

Follow these instructions to operate the Nitrous Oxide/Oxygen

Administration System:

1. Connect the hoses to the input connectors of the device.
2. Turn ON the device using the control switch.
3. Select the desired gas mixture output by adjusting the control switch. The output can be selected among various percentages from 25%/75% (O2/N2O) to 100%/0% (O2/N2O).
4. The demand valve will activate the output of the gas mixture only when the patient takes an inspiratory effort.
5. If oxygen supply runs out or shuts off, the device will automatically shut off; however, it will continue to provide atmospheric room air on demand to the patient.
6. The Oxygen Enrichment function allows healthcare professionals to provide a constant flow of 100% oxygen to the patient.
7. If either the nitrous oxide or oxygen input falls below 40 PSI, both visual and audible alarms will be generated. If the oxygen input falls below 35 PSI, the device will automatically shut off.
8. If the alarm sounds continuously, immediately discontinue use and shut off the gas supply.

Preventive Maintenance and Servicing
To maintain the Nitrous Oxide/Oxygen Administration System, perform routine maintenance and cleaning according to the instructions provided in the user manual.

Introduction

Indications for Use
The Equinox® Advantage N2O/O2 Analgesic Gas Mixing and Delivery System is intended to administer an adjustable mixture of Nitrous Oxide analgesic gas and Oxygen, on demand, to a conscious, spontaneously breathing patient.
The device is suitable for use in:

• Pre-hospital (emergency medical) use, and
• In-hospital use (ER, Labor and Delivery etc.)

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 abdomen may also expand.

Product Description/Principles of Operation
Two input connectors are provided on the device for the connection of pressure regulated gas sources of nitrous oxide and oxygen. The device has only one control for turning ON or OFF. When it is turned ON, the output of N2O/O2 gas mixture will only be activated by an inspiratory eff ort by the patient. The output of gas mixture can be selected among various percentages from 25%/75% (O2/N2O) to 100%/0% (O2/N2O).
The gas specific built-in alarm systems will generate both visual and audible alarms should either the nitrous oxide or oxygen input fall below 40 PSI, and the device will be automatically shut ff should the oxygen input fall below 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.
If Oxygen Supply runs out or shuts off , the device will automatically shut off ; however the device will continue to provide atmospheric room air on demand to the patient.
An Oxygen Enrichment function allows the healthcare professional to provide a constant fl ow of 100% oxygen to the patient.

Note: The O-Two Equinox® Advantage System is considered a critical device, and its components considered critical components. Only those individuals trained in the operation of nitrous oxide/oxygen analgesic gas delivery systems should use this equipment. Thoroughly review the instruction manual before use.

Warranty

WARRANTY
O-Two Medical Technologies Inc. products are 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 O-Two Equinox® Advantage 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.1.5. Safety Precautions
The O-Two Equinox® Advantage is a self-administered device intended to administer an adjustable mixture of nitrous oxide analgesic gas and oxygen, self-administered on demand, to a conscious, spontaneously breathing patient.

The following precautions should always be observed:

WARNING

1. Do not smoke or use near open flame either during operation or when changing the cylinder.

2. Never allow oil or grease to come into contact with any part of the cylinder, regulator or Equinox® Advantage System. Gas mixer has been degreased for oxygen service prior to delivery.

3. Equinox® Advantage System is designed for patient self-administration.

4. Never attach the facemask to the patient using a head harness.

5. If the alarm sounds continuously, immediately discontinue use and shut off the gas supply.

6. It is recommended that an oxygen monitor be used with this device to monitor the gas output. 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.

7. It is recommended to use cylinders that are at least 1/4 full.

8. Medical gases must be dry and free from dust and oil.
   CAUTION:

9. The nitrous oxide cylinder should be operated in an upright position. 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.

10. Always turn on cylinder valve slowly and fully.

11. When not in use, always turn off the cylinder.

12. After use, always ensure that a gas cylinder with sufficient volume is attached before returning the unit to its normal storage position.

13. After use, always ensure that all components are cleaned in accordance with the instructions provided in this manual.

14. Do not disassemble any part of the unit except where described in this manual as any unauthorized disassembly will invalidate the warranty.

15. Before use on a patient, the oxygen concentration of the delivered gas should be checked at the setting intended for use.

16. Us federal law restricts this device to sale by or on the order of a physician.

Performance Specifications

Oxygen Concentrations

(±5%V/V at Minimum Demand Flow 20 L/min)

| 25, 40, 50, 60, 70, 75, 90, 100%
Input Pressure| 50 to 70 PSI (3.5 – 4.8 Bar)
Low Input Pressure Alarm| 40 ± 1 PSI (2.7 Bar)
Device Cut-of Pressure| 35 ± 2 PSI (2.4 Bar)
Demand Valve Triggering Pressure| -1.5 to -2.5 cmH2O
Oxygen Enrichment Flow| 30 ± 5 L/min
Operating Temperature| 410F to 1040F (50C to 400C)
Storage Temperature| -400F to 1400F (-400C to 600C)
Device Input Connections| Nitrous Oxide: CGA1040 DISS Oxygen: CGA1240 DISS
Supply Hose Connections| Refer to Section 6
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
Weight| 4.4 lb. (2.0 Kg)
Dimensions W x D x H| 9.27”x7.6”x4.4” (236x194x112mm)

Preparation for Use

Component List
Ensure that all the following components have been received:

1. Operating Manual
2. O-Two Equinox® Advantage System
3. Single Use Patient Circuit with Mouth Piece
4. Nitrous Oxide Supply Hose

If any components are missing from the shipping carton, call the supplier immediately.

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).
• Vacuum generator w/30 L/min flowrate

Leak test
Having connected the supply hoses (ISO 5359 compliant) to the regulators (refer section 3.1 for CONNECTION OF HOSES), ensure that the O-Two Equinox® Advantage System ON/OFF selector is in the OFF position and turn on the N2O and O2 Gas source. 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
Equinox® Advantage is designed to meet “reverse fl ow” requirement of ISO 11195. It is recommended to test the reverse fl ow as follows before use:
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 Equinox® Advantage System can be individually tested or measured using calibrated pressure gauge and flowmeter during the pre-use Functional Check:1.

1. Demand Valve Function
   Apply a vacuum to the patient connector equivalent to a fl ow rate of 30 L/min for a minimum of 1 second. The demand valve will provide a fl ow rate equivalent to that demanded. Remove the vacuum from the patient connector; the fl ow from patient connector should stop.

Note:

1. Ensure performing this test using the single use patient circuit for this device otherwise the demand valve will free fl ow.

2. The vacuum source can be as simple as a 1 Liter gas calibration syringe.

3. 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 can be undertaken by simply slowly closing the cylinder valve.
   With the adjustable outlet pressure regulator set with an outlet pressure of 50 PSI, gradually reduce the outlet pressure of the regulator to around 40 PSI while slowly releasing the gas until you hear the Low Input Pressure Alarm activate. 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 Gas Supply Status Indicator should cycle at the same rate of the alarm.

4.  Low Input Pressure Shut Off
   Continue decrease oxygen regulator outlet pressure to around 35 PSI, the device should be automatically shut off .

5. Oxygen Enrichment Button
   When pressed with the ON/OFF switch set to ON, Oxygen should fl ow out of the patient circuit.

6. Oxygen Concentration
   The percentage of the oxygen concentration of the delivered gas can be determined by the following procedure:

   • Connect an oxygen monitor to the output connector of the Advantage using a T-Connector (as shown in Fig 2).
   • Utilizing a 1 Liter gas calibration syringe, connect the syringe to the patient connection on the patient circuit connected to T- connector (as shown in Fig 2). Turn on the Advantage unit, select the 100% O2 setting and activate the demand valve by cycling the syringe until the oxygen reading on the monitor has stabilized
   • Repeat step “b’ for the remaining settings and confirm that the oxygen concentration reading falls within the following ranges for each setting:

| Setting                  Acceptable Range|
---|---|---
| | |
| 25%| | | 21 – 35| |
| 40%| | | 30 – 50| |
| 50%| | | 40 – 60| |
| 60%| | | 50 – 70| |
| 70%| | | 60 – 80| |
| 75%| | | 65 – 85| |
| 90%| | | 80 – 100| |
| 100%| | | 90 – 100| |

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 aff ect 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.

Operating Instructions

Connection of hoses
The Equinox® Advantage System is designed to operate on medical nitrous oxide and oxygen from either pressure regulated medical gas cylinders or “piped-in” systems. The inlet fittings on the device are non-interchangeable fittings specifically for nitrous oxide and oxygen.

The device is designed to operate under 50 – 70 PSI (3.5 – 4.8 Bar) input pressures for both N2O and O2 gas supplies.
In case of failure in gas input systems, Equinox® Advantage is equipped with internal pressure regulators that can handle input pressure up to 1.5 times the design input pressure without having damage to internal components.

Fig.1 Connecting the Supply hoses and Patient Circuit

The nitrous oxide supply hose provided shall be attached to the N2O input connection on the left side of the device when facing it. 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 (fi g 1).
Note: Using a wrench or excessive force when tightening the supply hose may damage the seal of 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.

ON/OFF Selector
ON/OFF SELECTOR controls the device in either normal operating function or shut off .

Gas Mixture Selection
The gas mixture selection knob allows the user to choose among 8 combinations of Oxygen and Nitrous Oxide mixtures as follows:

To monitor the output of the N2O/O2 mixture, an oxygen monitor with alarm should be used on the inspiratory line of the patient circuit. The monitor “Tee” piece is to be placed on the outlet of the mixer prior to the circuit being attached (fi g 2). 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.

Demand Valve
The device is equipped with a Demand System enabling spontaneously breathing patients to demand preselected mixture percentage of nitrous oxide and oxygen.
An inspiratory eff ort by the patient will open the demand valve and preselected percentage mixture of nitrous oxide and oxygen will fl ow to the patient at a rate in line with their inspiratory eff ort.

100% Oxygen Enrichment Supply
If at any time 100% Oxygen Enrichment is desired, press the Oxygen Enrichment button to activate “100% Oxygen” supply.
The Oxygen Enrichment function is designed to provide 30 L/min of 100% oxygen in order to flush any residual gas from the patient circuit following the completion of the patient treatment.
When the device ON/OFF switch is set to the “OFF” position or the device not connected to an oxygen supply, the Oxygen Enrichment function is disabled.

WARNING
The Oxygen Enrichment function should never be used to provide positive pressure ventilation to non-breathing patients.

Low Input Pressure Alarms
Gas Supply Status Indicators
Located on the front panel, the O2 visual indicator shows green when oxygen is supplied to the unit and N2O visual indicator shows green when nitrous oxide is 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
The alarm system will generate a 45 to 75 BPM visual (flashing Green/Black) and an audible alarm should nitrous oxide input drop to 40 PSI. Should the oxygen input pressure drop to 40 PSI, a 90 to 150 BPM visual (flashing Green/Black) and audible alarm will be generated.

Low Input Pressure Shut Off
The device will automatically shut off should oxygen input pressure drop to 35 PSI. This indicates that the drive gas is now exhausted to the point where the device will no longer function correctly.
When only oxygen is applied, the device will not shut off , and an audible alarm will be activated with cycled N2O visual Indicator.
When only nitrous oxide is applied, the device will automatically shut ff with O2 gas supply indicator showing black and no audible alarms activated. However the Equinox® Advantage will continue to allow the patient to breathe through the device on atmospheric room air.

Preventive Maintenance and Servicing

Routine Maintenance
To ensure proper operation of the O-Two Equinox® Advantage, 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 a preventive maintenance record be maintained for each unit.
It is recommended that the routine preventive maintenance be carried out and the Equinox® Advantage mixer be returned to O-Two Medical Technologies or its authorized service center for maintenance and service every 2 years as follows:

Monthly checking
This check is to ensure that all of the accessories and device components are present, the nitrous oxide and oxygen cylinders are full and that the device is in working order.
The device should be checked for proper function and mixing percentage (oxygen concentration) 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.
Any malfunction unit should be returned to the manufacturer or an authorized service center since this product is not designed for fi eld disassembly or service. Unauthorized repairs will nullify the product warranty.

Level II service
The device shall be returned to the manufacturer or a service center authorized by the manufacturer for bi-annual 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.

| 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| Monthly| User
PM| Leak test| User Manual Chapter 2.2| No leak observed| Every 6 months| User
PM| Function check| User Manual Chapter 2.2
[1] – [5]| Within specification| Every 6 months| User
Servicing| Level II service| Service manual| Meet product specifications| Every 2 years| Manufacturer/ service center
Servicing| Full service| Service manual| Meet product specifications| Every 6 years| Manufacturer

Cleaning
Routine cleaning of the device shall be undertaken to maintain the device in a clean condition.
Patient circuit with mouth piece of the device is 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 procedures are as follows:

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

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

Schematic Flow Diagram

Replacement Parts & Accessories

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***

Supply Fitting and N2O DISS Nut Device Connection
01FV4303-AGA-N2O| O-Two 6 Foot (1.85 Meter) N2O Supply Hose with AGA Gas Supply Fitting and DISS Nut Device Connection
01FV4303-CZCH-N2O| O-Two 6 Foot (1.85 Meter) N2O Supply Hose with Czech Gas Supply Fitting and DISS Nut Ventilator Connection
01FV4303-DIN-N2O| O-Two 6 Foot (1.85 Meter) N2O Supply Hose with DIN Nut and DISS Nut Device Connection
01FV4310| O-Two 6 Foot (1.85 Meter) N2O Supply Hose with DISS Gas Supply Fitting and DISS Nut Device Connection
01FV4303-UNF-N2O| O-Two 6 Foot (1.85 Meter) N2O Supply Hose with UNIFOR Gas Supply Fitting and DISS Nut Device Connection
01FV4303-BM-N2O| O-Two 6 Foot (1.85 Meter) N2O Supply Hose with BRITISH Gas Supply Fitting and DISS Nut Device Connection

*Select the hose connection type for the country of use.

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

SERIAL N0:_____

Address: 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: [email protected]

References

• O-Two Controlled Ventilation – Controlled Ventilation

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