GCE Healthcare MediSelect-II High Pressure Regulators Instruction Manual

GCE Healthcare MediSelect-II High Pressure Regulators Instruction Manual

FOREWORD

GCE Medical Regulators are medical devices classifi ed as class IIb according to the Medical Device Directive 93/42/EEC.
Their Compliance with essential requirements of 93/42/EEC Medical Device Directive is based upon EN 10524-1 standard.

INTENDED USE

GCE Medical Regulators are designed for use with high-pressure medical gas cylinders equipped with a medical cylinder valve. They regulate pressure and fl ow of medical gases to the patient. They are intended for the administration of the following medical gases in the treatment, management, diagnostic evaluation and care of the patient:

• Oxygen;
• Nitrous oxide;
• Air for breathing;
• Helium;
• Carbon dioxide;
• Xenon;
• Specifi ed mixtures of the gases listed.
• Air or nitrogen to power surgical tools.

OPERATIONAL, TRANSPORT AND STORAGE SAFETY REQUIREMENTS

Keep the product and its associated equipment away from:

• All sources of heat,
• Flammable materials,
• Oil or grease (including all hand creams),
• Water,
• Dust.

The product and its associated equipment must be prevented from falling over.
Always maintain oxygen cleanliness standards.
Use only the product and its associated equipment in a well ventilated area.

Before initial use the product should be kept in its original packaging. GCE recommends use of the original packaging (including internal sealing bag and caps) if the product is withdraw from operation (for transport, storage). Statutory laws, rules and regulations for medical gases, accident prevention and environmental protection must be observed.

In case of storage at a temperature below -20 °C, d o not operate the regulator until it has been allowed to increase its temperature to a minimum of -20 °C.
At regulators intended for use with mixture of medical gases O2+N2O is lower operation temperature limit +5°C. During normal use the fl ow outlet and pressure outlet will sometimes have a frosty appearance. This is a normal physical reaction in the valve, due to that the gas is going from high pressure to low pressure (Joule Thompson e ect). Ensure that all equipment that is connected to the valve by at least a 2 metre hose.

PERSONNEL INSTRUCTIONS

The Medical Devices Directive 93/42/EEC states that product provider must ensure that all personnel handling the product are provided with the operating instructions & performance data.

Do not use the product without properly familiarization of the product and its safe operation as defined in this Instruction for use. Ensure user is aware of particular information and knowledge required for the gas in use.

PRODUCT DESCRIPTION

FIG. 1: Typical confi guration of MediSelect® II regulator

FIG. 2: Confi guration of MediReg® II regulator with fl owmeter
The regulator acts as a pressure-reducer, gas from the cylinder valve passes through the pressure regulator to the user outlets.

A – INLET STEM
Regulator is fi tted to the medical cylinder valve by mean of an inlet stem.
The stem can be bull nose type (male thread), nut type (female thread) or pin index type. The inlet stem includes a fi lter.

B – INLET PRESSURE INDICATOR OR SENSOR
The regulator is fi tted with a pressure indicator or sensor which is intended for cylinder gas content indication only, not for measuring purposes. The pressure indicator or sensor can be equipped with output of electric signal.
The connection of pressure indicator with output of electric signal must be carried out by trained personnel in accordance with national regulations pertaining to the electric device and standard EN ISO 7396-1. Output of electric signal shall be connected only to device which is in accordance with standard EN ISO 60601-1 and 60601-1-2.

C, D, E – FLOW-METERING DEVICE AND FLOW OUTLET
GCE regulators can be supplied with a fl ow-metering device – fl ow control head “C” or fl owmeter “D”. This function is used to supply a gas fl ow (l/min) at atmospheric pressure directly to the patient through the fl ow outlet “E”, e.g. through a cannula or a facemask.
The fl ow outlet “E” can be hose nipple (for cannula or mask) or outlet with thread (for humidifi er).

F – PRESSURE OUTLET
The regulator may be fi tted with a pressure outlet. The pressure outlet is the outlet directly from the low-pressure chamber. Two types of the pressure outlet can be used:
Pressure outlet I – is fi tted with a gas specifi c medical quick connector also called “quick coupler” . The user can connect another piece of equipment to this outlet with a gas specifi c male probe. The quick connector self seals when the male probe is disconnected. This outlet is for supplying gas at a controlled pressure to power medical devices, e.g. medical ventilator. Pressure outlet II – is fi tted with a threaded connector. The regulator with this type of pressure outlet shall be only an integral part of a medical equipment (e.g. emergency ventilators, anaesthesia devices, etc.)

If the regulator is fi tted with two pressure outlets, do not use both of them at the same time. If you use both of them in the same time the performance of the regulator will not be according to specifi cation (see appendix 1) !!!

Note also that the product colour (especially fl ow control knob) might not be gas specifi c colour coded.

OPERATIONS

BEFORE USE

VISUAL INSPECTION BEFORE USE

• Check if there is visible external damage to the product (including product labels and marking) and on the gas cylinder. If it shows signs of external damages, remove it from service and identify its status.
• Visually check if the product or the medical gas cylinder is contaminated; if needed, for the regulator, use the cleaning procedure detailed in this section (if required for the cylinder, refer to the gas cylinder manufacturer cleaning recommendation).
• Check that the total life time of the product and the gas cylinder has not been exceeded, (refer to GCE or owner’s date coding system). If life time has been exceeded, remove the product (or the gas cylinder) from service & suitably identify its status.
• Ensure that the product inlet stem is compatible with the medical cylinder valve (gas/ thread type).
• Check the presence & the integrity of inlet stem seals / correct size of seal.
  Always make sure the inlet stem o-ring is in good status, without damage.

Remove caps from inlet and/or fl ow outlet. Keep caps in a safe place for reuse during transport or storage.
The product is dedicated only for use with the gas specifi ed on its labelling. Never try to use for another gas.

FITTING TO MEDICAL CYLINDER VALVE

• Secure the gas cylinder stand.

SCREW CONNECTION (BULL NOSE OR NUT TYPE)

• Connection equipped with rubber sealing – tighten by hand!
• Connection equipped with metal to metal sealing or plastic sealing – tighten by means of a torque wrench (max. tightening torque is 50 Nm).
• Turn the regulator into the correct position for use and tighten the nut by hand – do not use tools.

PIN INDEX CONNECTION

• Position the pin-index over the cylinder valve with the pin(s) on the pressure regulator pointing towards the cylinder valve connector holes on the cylinder valve.
• Press the regulator inlet connection pins into the cylinder valve connector holes – do not use force, otherwise the pins or holes may be damaged.
• Tighten the screw on the regulator onto the cylinder valve connector via the T-bar handle. Do not use tools.
• Position the equipment so that the regulator user outlets point away from personnel or patient.

Fitting the regulator with too high a torque to the cylinder valve may result in damage.
During fitting to the cylinder valve, do not apply torque/load to any other parts of the product.

LEAKAGE CHECK BEFORE USE

• For regulators fi tted with a fl ow-metering device, set the fl ow control knob on the “ZERO” position – Ensure the fl ow control knob engages correctly.
• Open the cylinder valve slowly by turning the hand wheel in anticlockwise direction approx 1 to 1½ turns.

Sudden opening of the cylinder valve could result in a danger of fi re or explosion arising from oxygen pressure shocks. Insu cient opening of the cylinder valve could reduce actual fl ow delivered.

• Perform visual and audible check for possible leakages:
  • regulator inlet connection to cylinder valve
  • pressure indicator/sensor to regulator body
  • pressure relief valve vent hole(s)
  • fl owmeter (if any)
• Turn off the cylinder valve by turning the hand wheel in an clockwise direction to stop position. Do not use excessive force.

If any leakage is detected, use the procedure in chapter 6.3 and return the product to GCE for service.

FUNCTIONAL CHECKS BEFORE USE

• Ensure the fl ow control knob is on the “ZERO” position.
• Ensure the cylinder valve is open – in the “ON” position.
• Check that the gauge indicates pressure/contents. If the pointer reaches the red area send the cylinder for the fi lling
• For regulators fi tted with a fl ow-metering device check that there is gas fl ow at each setting (for instance, by listening for the sound of gas fl ow or checking presence of bubbles in a humidifi er).
• Turn off the shut off cylinder valve by turning the hand wheel in a clockwise direction to the stop position. Do not use excessive force.
• Reset the fl ow control knob to on the “ZERO” position once the gas fl ow stops and the regulator is vented..
• For regulators fi tted with a pressure outlet, ensure it is functional by connecting and disconnecting a male QC probe.

USER OUTLET(S) CONNECTION & USE

LIST OF RECOGNISED ACCESSORIES

TO BE CONNECTED TO THE FLOW OUTLET:
Humidifi ers, breathing masks or cannulas, gas savers, nebulizers.
TO BE CONNECTED TO THE PRESSURE OUTLET:
Flexible hoses, fl ow meters, Venturi suction ejectors.

At regulators fi tted with pressure outlet together with ejector outlet don´t use quick coupler and ejector outlet in the same time. Especially when inlet pressure is bellow 50 bar it may negatively a ect performance of the regulator.
Before connecting any accessory or medical device to the regulator, always check that it is fully compatible with the product connection features & the product performances.

PRESSURE OUTLET CONNECTION PRESSURE OUTLET I

• Ensure the male quick coupler is compatible with the pressure outlet feature.
• Connect the male quick coupler.
• Check if the male quick coupler is fully engaged.

Regulator with threaded connector as pressure outlet shall be only an integral part of medical equipment. Do not use it for other purposes!

PRESSURE OUTLET II

• Ensure the counterpart is compatible with the pressure outlet features.
• Screw the counterpart.
• Check the counterpart is fully screwed.

When is pressure outlet used by medical product with high fl ow consumption (for example lung ventilator with request of source fl ow 100 l/min at minimal pressure 2,8 bar) check the required capacity of source device with regulator pressure outlet performance listed in appendix 1. To obtain enough performance of the regulator is recomended replace cylinder when gauge reach the red area.

FLOW OUTLET CONNECTION

When connecting any accessory to the fl ow outlet make sure that it is not connected to the patient before operating the product.

• Ensure the hose/humidifi er is compatible with the fl ow outlet feature.
• Push the hose onto the regulator fl ow outlet/outlet for humidifi er.
• Ensure the hose/humidifi er is well engaged.

USE OF PRODUCT THROUGH THE FLOW OUTLET (FLOW SETTING)

• Ensure that the fl ow control knob is on the ZERO position.
• Ensure that the accessory is connected to the fl ow outlet.
• Slowly open the cylinder valve by turning the hand wheel in anticlockwise direction approx. 1 to 1½ turns.

Sudden opening of the cylinder valve could result in a danger of fi re or explosion arising from oxygen pressure shocks. Insu cient opening of the cylinder valve could reduce actual fl ow delivered.

• Set the fl ow control knob on the required one of the available fl ow rates.

Always ensure that the fl ow control knob has engaged and not placed between two settings otherwise the fl ow selector will not deliver the correct fl ow of medical gas.
Do not try to apply an excessive torque on the fl ow control knob when it stops on the maximum fl ow position or in zero position.
The oxygen fl ow rate must be prescribed and administered by a clinically trained user.

AFTER COMPLETION OF THE THERAPY

• Turn off the cylinder valve by turning the hand wheel in a clockwise direction to stop position. Do not use excessive force.
• Vent gas pressure from downstream equipment.
• Reset fl ow control knob on the ZERO position when gas venting has ceased.
• Disconnect the tube/humidifi er from the fl ow outlet.

USE OF PRODUCT THROUGH THE PRESSURE OUTLET.

• Ensure that the fl ow control knob is on the ZERO position (if any).
• Ensure the accessory IS NOT connected to the pressure outlet.
• Slowly open the cylinder valve by turning the hand wheel in anticlockwise direction approx 1 to 1½ turns.

Sudden opening of the cylinder valve could result in a danger of fi re or explosion arising from oxygen pressure shocks. Insu cient opening of the cylinder valve could reduce actual fl ow delivered.

• Connect the accessory to the pressure outlet.

AFTER COMPLETION OF THE THERAPY

• Turn off the cylinder valve by turning the hand wheel in a clockwise direction to the stop position. Do not use excessive force.
• Vent gas pressure from downstream equipment.
• Disconnect the male QC probe from the pressure outlet.

AFTER USE

• Turn off the cylinder valve by turning the hand wheel in a clockwise direction to the stop position. Do not use excessive force.
• Reset the fl ow control knob on the “ZERO” position – when the gas venting has ceased (valid for version with fl ow-metering device only).
• Ensure the pressure indicator does not show any residual pressure.
• Remove connections from user outlets.
• Refi t pressure outlet and fl ow outlet protection caps. Before refi tting the caps, ensure they are clean.

CLEANING

Remove dirt with a soft cloth damped in oil free soap water & rinsed with clean water. Disinfection can be carried out with an alcohol-based solution (with damped wipes). If other cleaning solutions are used, check that they are not abrasive and they are compatible with the product materials (including labels) and gas (convenient cleaning solution – i.e. Meliseptol).

Do not use cleaning solutions containing ammonia!
Do not expose to water or any other liquid.
Do not expose to high temperature (such as autoclave).
To apply the cleaning solution do not spray it as the spray may enter into the inner parts of product and cause contamination or damage.
Do not use pressure wash as it could damage or contaminate the product.
If the inner parts of the product have been contaminated do not continue to use the product under any circumstances. It must be withdrawn from service.

MAINTENANCE

SERVICE AND PRODUCT LIFE TIME

SERIAL NUMBER AND DATE OF PRODUCTION

Form of nine digit serial number stamped on the product is following:
YY MM XXXXX
YY: year of production;
MM: month of production;
XXXXX : sequence number
Example: serial number 090300521 shows the regulator produced in March 2009, with sequence number 521.

MAINTENANCE

No special maintenance or service, apart from the tests before use, is needed. However, to make sure the product is in good working order, it would be good if the owner/cylinder distributor performs the checks (see 6.1) himself on a regular basis (ex. once every second year) and/or at every cylinder exchange. This is just for the owner to ensure that the product works well, especially in cases where the user has some health problems and is not able to check the product himself properly.

MAXIMUM LIFE TIME AND WASTE MANAGEMENT

Maximum life time of the product is 10 years from the manufacturing date.
At the end of the product’s life time (10 years maximum), the product must be withdrawn from service. The provider of the device shall prevent the reuse of the product and handle the product in compliance with “Directive of European Parliament and Council 2008/98/EC on waste“.
In accordance to Article 33 of REACH GCE, s.r.o. as responsible manufacturer shall inform all customers if materials containing 0.1% or more of substances included in the list of Substance of Very High Concern (SVHC).
The most commonly used brass alloys used for bodies and other brass components contain 2-3% of lead (Pb), EC no. 231-468-6, CAS no. 7439- 92-1. The lead will not be released to the gas or surrounding environment during normal use. After end of life the product shall be scrapped by an authorized metal recycler to ensure effi cient material handling with minimal impact to environment and health.
To date we have no information that indicates that other materials containing SVHC of concentrations exceeding 0.1% are included in any GCE product.

REPAIRS

REPAIRS
Repairs activities cover the replacement of the following damaged or missing components:

• Inlet stem,
• Flow-metering device,
• Indicator,
• Piston,
• Pressure relief valve,
• Quick coupler.

The repairs shall be carried out by a GCE authorised person only.

Any product sent back to a GCE authorised person for maintenance shall be properly packaged. The purpose of the maintenance has to be clearly specifi ed (repair, overall maintenance). For product to be repaired a short description of fault and any reference to a claim number might be helpful. Some repair activities concerning to the replacement of the damaged or missing components can be carried out by the owner of the product. The following parts can be replaced only:

• Caps,
• Flow knob and stickers,
• Hose nipple (including o-ring),
• Inlet stem o-ring.

Contact our customer service for appropriate component number.
All labels on the equipment must be kept in good, legible condition by the owner and the user during the entire product life time.
All seals and o-rings must be kept in dry, dark and clean environment by the owner and the user during the entire product life time.
Use only original GCE components!

GLOSSARY

care use
| Keep away from oil and grease| | Serial number
| Humidity limit| | Catalogue number
| Temperature limit| | Batch code
| Keep dry| | Fragile, handle with care
| Date of manufacture| | Manufacturer
| Use by date| | Weight of product
| Inlet parameter| | Outlet parameter
P1| Inlet pressure range| P2| Outlet pressure
P4| Max outlet pressure (closing pressure)| Q| Outlet flow
| Take back equipment for recycling. Do not dispose into unsorted municipal waste.| | Ambient pressure limit

WARRANTY

The Standard Warranty period is two years from date of receipt by the GCE Customer (or if this is not known 2 years from time of the product manufacture shown on the product).
The standard warranty is only valid for products handled according to Instruction for use (IFU) and general industry good practice and standards.

APPENDIX:
Nr 1 – Technical and performance data.
Nr 2 – Quick coupling feature and connecting/disconnecting procedure.

MANUFACTURER:
GCE, s.r.o. Tel: +420 569 661 111
Zizkova 381 Fax: +420 569 661 602
583 01 Chotebor http://www.gcegroup.com
Czech Republic © GCE, s.r.o.

Manufacturer:
GCE, s.r.o.
Žižkova 381, 583 01 Chotěboř, Česká republika
http://www.gcegroup.com
Doc. Nr. : IFU0120; DOI: 2022-04-06; Rev.:04; TI: A6, CB, V2

References

• GCE Group - Global Gas Control Equipment Solutions - GCE Group

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