DEAS M34035IT Breathing Circuits and Accessories Instructions

DEAS M34035IT Breathing Circuits and Accessories

INTENDED USE

Breathing circuits and related accessories (Mount catheter, reservoir bag, gas monitoring line, face mask, CPAP mask, PEEP valve), disposable, for anesthesia devices and lung ventilators designed to direct gas and/or vapors from the device (V) to the patient (P). DEAS breathing circuits are made in compliance with the EN standard

ISO 5367. The device is intended for short-term use deadline (less than 30 days) pursuant to Directive 93/42/ EEC and subsequent updates.

TECHNICAL INFORMATION

Recommended maximum operating pressure: < 8.826 kPa (90 cmH2

Patient category| Volume dispensed expected ml| Internal diameter mm| Increase of pressure hPa/l/min (cmH2O/l/ min)| At the Flow of i/min| Limit of compliance ml/hpa| At the Pressure
of hpa
---|---|---|---|---|---|---
Adult| ≥ 300| 19| < 0.06| 30| < 5.0| 60 ± 3
Pediatric| 50 < 300| 15| < 0.12| 15| < 4.0| 60 ± 3
Neonatal| ≤ 50| 11| < 0.74| 2.5| < 1.5| 60 ± 3

INSTRUCTIONS FOR USE

Read the product label and this document carefully leaflet before using the device. Open the package checking its integrity and the absence of foreign bodies. Do not use the device if the packaging is damaged.

Any damage or opening in the packaging may affect the sterility and/or performance of the device. Then do not use the affected device.

RESPIRATORY CIRCUIT

Connect the device components as shown in the graphic representation. Make sure the connections are tight firm. Therefore, pay particular attention to the following:

• if the breathing circuit contains a condensate collection bottle (Fig. C point 7), this must be kept vertical and in a position that allows drainage of the fluid which forms inside the tubes; check frequently fill level and empty it when necessary. Make sure that the ampoule is then correctly closed;

• the monitoring sockets (Fig. B, C, D, E, F point 4) are needed for the control of respiratory gases and/or blood pressure airways and must remain closed when not in use;

• if there is a gas monitoring line in the breathing circuit (Fig. D, E, F point 5), this must be connected to the control socket on the fan (V). To make sure periodically that a considerable amount of condensation does not form inside it as it could jeopardize the correct operation of the fan (V);

• if the device has an expiratory port (Fig. D, E, F point 6), this must not be sealed or obstructed.
  Its obstruction can cause serious harm to the patient to death;

• if there are one-way valves in the device, check the correct functionality and directionality of the flows before use;

• if the circuit contains a pressure relief valve (Fig. E point 8), make sure it works properly first of use on the patient. If you need to deactivate it, use the appropriate stop;

• the breathing circuits represented in Fig. D, E must be installed exclusively on the fan models (V) shown on the label.
  Installing the breathing circuit on a different model of the fan can compromise correct operation of the system. If the user wishes to install the circuit on fan models not indicated on the label, the user you must first contact DEAS or its local representative to check the compatibility of the circuit to be installed with the fan model required.

ACCESSORIES

Catheter Mount: The Catheter Mount (Fig. A, B, C, D point 2) is a flexible adapter connecting the respiratory system to the tracheal or tracheostomy tube connector or of the face mask. The connection to the patient interface it can be straight or angled, with or without a cap. Connect Mount the catheter to the respiratory circuit as per the graphic representation. Remove the cap (Fig. A, B, C, D point 3) only for the time strictly necessary to carry out a tracheal aspiration or bronchoscopy. The opening of cap causes a loss of pressure in the respiratory system and the inability to ventilate the patient. Routinely check the patency of the device. The use of this device leads to an increase in dead space.

Reservoir balloon: The reservoir balloon (Fig. A point 10) is a device for induction of inhalation anesthesia or for ventilatory support. It is connected to the anesthesia machine or manual breathing unit. Check if it is correct operation before use on the patient. Do not use the device in case of malfunction.

Gas monitoring line: The gas monitoring line (Fig. D, E, F point 5) is a device for controlling gases respiratory and/or airway pressure. This one comes connected to the control port of the ventilator or monitoring equipment and the monitoring socket on the respiratory circuit. Periodically make sure that you do not forms a considerable amount of condensation inside it as it can jeopardize the correct functioning of the fan (V).

Face mask: The face mask (Fig. A point 1) is a device for induction of inhalational anesthesia or for ventilatory support. It is equipped with a pre- inflated cushion or inflatable. Pad inflation can be adjusted injecting or removing air using a syringe to be connected to the appropriate valve; disconnect the regulating syringe completed and check the tightness of the system. Make sure that the ventilator (V) or the breathing circuit is equipped with a adequate system for the elimination of CO2 . The mask must be removed in case of claustrophobia, irritation of the skin or retching. The use of this device increases the dead space.
CPAP Face Mask: The face mask for CPAP (Fig. F point 11) is a ventilation device positive airway pressure mechanics. It is connected to the patient’s face using a mask holder.
It is equipped with two connections: inspiratory, for connecting the ventilation circuit or tube, and expiratory for connecting the PEEP valve. Both fittings they are equipped with a one-way valve. It is also accompanied by a socket for monitoring pressure or EtCO2. There is an inflatable cushion on the mask. The Pad inflation can be adjusted by injecting or by removing air using a syringe to be connected to the appropriate valve; disconnect the syringe once adjustment is complete and check the tightness of the system. Check its correct functioning before using it on the patient. Do not use the device in case of malfunction. The mask must be removed in case of claustrophobia or skin irritation or retching. Using this device involves the increase in dead space.

PEEP valve: The PEEP valve (Fig. F point 9) is a device for maintaining positive pressure at the end of expiration. It is connected to the expiratory connection of the CPAP face mask (Fig. F point 6) or a that of the expiratory valve (Fig. D point 6). Can be fixed or adjustable. Check its correct functioning before using it on the patient. Do not use the device in case of malfunction. Choose or adjust PEEP appropriately. Check the level regularly positive expiratory pressure set using an appropriate monitoring system. Once the respiratory system has been connected to the equipment, check its tightness under pressure using a test-lung following the instructions of the manufacturer. Check that there are no leaks or blockages. Then connect the patient and monitor him for the entire duration of the ventilation procedure. During use, periodically check that all connections are secure and that there are no leaks or blockages. Obey all alarms highlighted by the connected equipment and check, for example each report, both the patient’s status and the adequacy of the connection.

WARNINGS

The device must only be used by qualified and/or trained personnel. Before using the device, make sure that an adequate safety device is properly installed and functioning in the respiratory system pressure limitation. Excessive pressures can cause barotrauma! Make sure the breathing circuit is adequately supported and oriented by an arm support. The lack of support and the incorrect orientation of breathing circuit could cause traction on the circuit itself, unexpected disconnection or inhalation of any condensation produced by the humidifier collected in the loop of circuit. The use of an inadequate support arm, can damage the respiratory circuit. Periodically check that no condensation forms inside the device as it could cause an increase in resistance to the flow, trigger the fan alarm or cause incorrect measurements of respiratory parameters. Do not subject the device to pulling, kneeling or any other action mechanical stress. Connect and disconnect the breathing circuit avoiding compressing or pulling the tube to avoid possible breakages that cause leaks in the respiratory system compromising ventilation. Working temperatures above 43°C can damage the breathing circuit. Non-conductive and flammable product, not suitable for use with flammable anesthetic gases (not AP/APG), electrosurgical or laser. Using the device in such situations may cause a fire risk. Do not use the device after Expiration date.

DURATION OF USE

Disposable device to be used for a single patient. Reuse may cause cross- infection. Do not immerse in water, wash, sterilize or reuse the device. Avoid contact with chemicals, cleaning substances or disinfectants. These substances can damage the device and cause it to malfunction. The duration of use of the device on the same patient must be determined by the relevant personnel and based on proven procedures of infection control. Prolonged use of the device can alter its mechanical safety characteristics.
Replace the device immediately in case of leaks gas, occlusions and if the connections are not secure.

STORAGE AND DISPOSAL

The device should be stored according to the instructions indicated by the symbols on the sales packaging. After use, the device must be treated and/or disposed of, according to local regulations in forcenti, like medical waste dangerous at risk of infection.

RESPONSIBILITY

DEAS devices are a guarantee of the highest quality and produced in compliance with current standards for safe use. DEAS will not be held responsible for the consequences arising from an improper choice of model or size and from use other than the intended one. If any dysfunction or deterioration of the characteristics and/or device performance and/or serious incidents, please inform DEAS immediately. In these cases, sending the device is required involved accompanied by an appropriate photo and placed in its original packaging for traceability of the lot.

DIRECT TECHNICAL ASSISTANCE

For any doubts regarding the interpretation of this warning leaflet or for additional technical information, contact DEAS customer service directly at the contact details indicated on the back.

KEY TO SYMBOLS ON PACKAGING

| Re-order number
---|---
| Single use
| Lot number
| Use by
| Size
| Sterilised by ETO
| Non-sterile
| Phthalates free
| Latex free
| Open here
| See instructions for use
| Quantity
| Keep dry
| Keep cool
| Do not use hooks
| Do not use blades
| Temperature limitations
| Do not use if package is damaged
| Manufacturer

TYPICAL CONFIGURATIONS

For other configurations, please contact DEAS or its local representatives.

CUSTOMERS SUPPORT

DEAS S.r.l.
via dell’Industria, 49
48014 · Castel Bolognese (RA) · Italy
Tel. +39 0546 656845 · Fax +39 0546 54706
[email protected] · www.deasnet.it
Made in Italy

References

• DEAS - Medical Products for Respiratory Care and Airway Management

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