DEAS M34035EN Breathing Circuits and Accessories Instructions

DEAS M34035EN Breathing Circuits and Accessories

Product Information

Specifications

• Recommended maximum operating pressure: < 8,826 kPa (90 cmH2O)

• Patient category :

  • Adult : volume 300 ml, internal diameter 19 mm, increase in
    pressure < 0.06 hPa/l/min (cmH2O/l/min)

  • Paediatric : volume 50 – 300 ml, internal diameter 15 mm,
    increase in pressure < 0.12 hPa/l/min (cmH2O/l/min)

  • Neonatal : volume 50 ml, internal diameter 11 mm, increase in
    pressure < 0.74 hPa/l/min (cmH2O/l/min)

• Compliance limit at flow l/min:

  • Adult : < 5.0 ml/hPa
  • Paediatric : < 4.0 ml/hPa
  • Neonatal : < 1.5 ml/hPa

Product Usage Instructions

Before Using the Device

1. Carefully read the product label and the provided leaflet.
2. Open the packaging and check that it is complete and free from foreign bodies.
3. Do not use the device if the package is damaged. Any damage or opening in the package may affect sterility and/or device performance.

Breathing Circuit

• If the device has an expiratory port, do not seal or obstruct it. Sealing or obstructing the expiratory port may cause serious harm or death to the patient.
• If there are unidirectional valves in the device, check that they are functioning properly.
• Ensure the compatibility of the circuit to be installed with the relevant ventilator model. If unsure, contact DEAS or its local representative for verification.

Accessories

• If supplied with a pre-inflated or inflatable pad, adjust the inflation by injecting or removing air through a syringe connected to the appropriate valve. Disconnect the syringe when the adjustment is complete and check that the system is sealed.
• Ensure that the apparatus (V) or the breathing circuit has an adequate system for CO2 elimination.
• If the patient suffers from claustrophobia, skin irritation, or retching, remove the mask.
• Using this device increases the dead space.

Warnings

• The device is single-use and should only be used on a single patient. Reusing may cause cross-infections.
• Do not soak, wash, sterilize, or reuse this product.
• Avoid contact with chemical substances, cleaning products, or sanitizers as they may damage the device and cause malfunctions.
• The duration of use of the device on the same patient must be less than 30 days.

Storage and Disposal

The device should be stored respecting the instructions given by the symbols on the packaging. After use, the device should be disposed of according to local regulations.

Responsibility

DEAS devices guarantee top quality and products that are in compliance with the current safety standards. DEAS will not be responsible for any consequences resulting from incorrect choice of model or size or use other than that indicated. If you notice any issues with the device’s features or performance, contact DEAS or its local representative.

FAQ

1. Can the device be reused?
   No, the device is intended for single-use only. Reuse may cause cross- infections.

2. What should I do if the packaging is damaged?
   If the packaging is damaged, do not use the device as it may affect sterility and/or device performance.

3. How long can the device be used on the same patient?
   The device should be used on the same patient for less than 30 days.

4. Can I sterilize the device?

5. No, the device should not be sterilized. It is intended for single-use only.

BREATHING CIRCUITS AND ACCESSORIES

Instructions for use

INTENDED USE

Breathing circuits and related accessories (Mount catheter, reservoir bag, gas monitoring line, face mask, CPAP mask, PEEP valve), single use, for anaesthetic apparatus and lung ventilators, to conduct gases and/or vapour from the apparatus (V) to the patient (P). DEAS breathing circuits are manufactured in compliance with EN ISO 5367 standard. This device is intended for short term use (less than 30 days) in accordance with Directive 93/42/EEC and subsequent amendments.

TECHNICAL INFORMATION

Recommended maximum operating pressure: < 8,826 kPa (90 cmH2O)

Patient category| Intended delivered volume ml| Internal diameter mm| Increase in pressure hPa/l/min (cmH2O/l/ min)| At flow

l/min

| Compliance limit ml/hPa| At pressure hPa
---|---|---|---|---|---|---
Adult| ≥ 300| 19| < 0.06| 30| < 5.0| 60 ± 3
Paediatric| 50 < 300| 15| < 0.12| 15| < 4.0| 60 ± 3
Neonatal| ≤ 50| 11| < 0.74| 2.5| < 1.5| 60 ± 3

DIRECTIONS FOR USE

Carefully read the product label and this leaflet before using the device. Open the packaging, checking that it is complete and free from foreign bodies. Do not use the device if the package is damaged. Any damage or opening in the package may affect sterility and/or device performance. In this case do not use the device concerned.

BREATHING CIRCUIT

Connect the breathing circuit’s components as shown on the graphical representation. Make sure that the connections are properly secured. Pay special attention to the instructions provided below:

• if the breathing circuit contains a water trap to collect condensation (Fig. C point 7), this must be kept vertical and in a position which allows the fl uid collecting inside the tubes to drain; check the level of filling frequently and empty it when necessary. Then make sure that the water trap is properly closed;

• the monitoring ports (Fig. . B, C, D, E, F point 4) allow the respiratory gases and/ or airway pressure to be checked and should remain closed when not in use;

• if there is a gas monitoring line (Fig. D, E, F point 5) in the breathing circuit, this must be connected to the control outlet positioned on the ventilator (V). Regularly make sure that large amounts of condensation are not forminginside as this can stop the ventilator (V) from functioning properly;

• if the device has an expiratory port (Fig. D, E, F point 6) this must not be sealed or obstructed. If it is obstructed this may cause serious damage to the patient or even his death;

• if there are unidirectional valves in the device, check that they are working properly and the direction of fl ow prior to use;

• if the circuit contains a pressure-limiting valve (Fig. E point
  8), make sure that it is working properly before using it with a patient. If it needs to be deactivated, use the appropriate stop switch;

• the breathing circuits represented in Fig. D, E must only be installed on models of ventilator (V) as indicated on the label. Installing the breathing circuit on a different model of ventilator can prevent the system from working correctly. Should the user want to install the circuit on ventilator models not indicated on the label, the user should first contact DEAS or its local representative to verify the compatibility of the circuit to be installed with the relevant ventilator model.

ACCESSORIES

Catheter Mount: The Catheter Mount (Fig. A, B, C, D point 2) is a flexible adaptor for joining or connecting the breathing system to a tracheal or tracheostomy tube connector or to a face mask. The patient side connector can be straight or at an angle, with or without a cap. Connect the catheter Mount to the breathing circuit as shown in the illustration. Remove the cap (Fig. A, B, C, D point 3) only for the time strictly necessary for carrying out tracheal aspiration or a bronchoscopy. Opening the cap causes a loss of pressure in the breathing system and the impossibility of ventilating the patient Routinely check the patency of the device. Using this device causes the increase of the dead space.

Reservoir bag : The reservoir bag (Fig. A point 10) is a device  for inhaled anaesthesia induction or for ventilatory support. It isconnected to the anaesthesia machine or the manual breathing unit. Check that it is functioning properly before using 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 checking respiratory gases and/or airway pressure. It is connected to the control port of the ventilator or monitoring apparatus and to the monitoring port on the breathing circuit. Regularly make sure that large amounts of condensation are not forming inside it as this can stop the monitoring apparatus from functioning properly. Regularly make sure that large amounts of condensation are not forminginside as this can stop the ventilator (V) from functioning properly.

Face mask : The face mask (Fig. A point 1) is a device for  inhaled anaesthesia induction or for ventilatory support. It issupplied with a pre- inflated or inflatable pad. The inflation of the pad can be adjusted by injecting or removing air through a syringe which must be connected to the appropriate valve; disconnect the syringe when the adjustment is compleand check that the system is sealed. Make sure that the apparatus (V) or the breathing circuit has an adequate system for CO2 elimination. The mask must be removed if the patient suffers claustrophobia, skin irritation or retching. Usingthis device causes the increase of the dead space.

CPAP mask : The CPAP face mask (Fig. F point 11) is a devicefor positive airway pressure mechanical ventilation. It is connected to the patient’s face through a mask. It is supplied with two connections: inspiratory, for connecting the circuit or the ventilation tube, and expiratory for connecting the PEEP valve. Both connections have unidirectional valves. It is also equipped with a port for monitoring pressure or EtCO2. At theedge of the mask is an inflatable pad. The inflation of the pad can be adjusted by injecting or removing air through a syringe which must be connected to the appropriate valve; disconnectthe syringe when the adjustment is complete and check that the system is sealed. Check that it is functioning properly before using on the patient. Do not use the device in case of malfunction. The mask must be removed if the patient suffers claustrophobia, skin irritation or retching. Using this device causes the increase of the dead space.

PEEP valve : The PEEP valve (Fig. F point 9) is a device for maintaining positive end-expiratory pressure. It is connected to the expiratory connection of the CPAP face mask (Fig. F point 6) or to that of the expiratory valve (Fig. D point 6). It can be fixed or adjustable. Check that it is functioning properly before using on the patient. Do not use the device in case of malfunction. Select or adjust the PEEP appropriately. Regularly check the level of positive expiratory pressure set using an adequate monitoring system. Once the breathing system is connected to the apparatus, check the seal in pressure using a test lung following the manufacturer’s instructions. Make sure that there are no leaks or blockages. Then connect the patient and monitor him throughout the  ventilation process. During use, regularly check that all theconnections are properly secured and that there are no leaks or blockages. For all the alarms issued by the connected apparatus make sure that the connection is adequate and check the patient’s condition and the adequacy of the connection each time there is a signal.

WARNINGS

This device should be used only by qualified and/or trained personnel. Before using the device, ensure that an appropriate pressure-limiting device is correctly installed in the breathing  system and is functioning. Excessive pressures can cause barotrauma! Ensure that the breathing circuit is adequately supported and positioned by a supporting arm. If the circuit is insufficiently supported or wrongly positioned, this maycause tensile stress to the circuit, unexpected disconnections or inhalation of any condensation produced by the humidifier and collected in the bend in the circuit. Using an inadequate supporting arm can damage the breathing circuit. Regularly check that condensation is not forming inside the device as this could cause an increase in resistance to fl ow, trigger  the ventilator’s alarm or cause incorrect measurements of respiratory signs. Do not stretch the device, allow it to form kinks or other types of mechanical stress. When connecting and disconnecting the breathing circuit, avoid compressing orpulling on the tube to prevent dam- age that could cause leaks in the breathing system, compromising ventilation. Operating temperatures above 43 °C can damage the breathing circuit. Non-conductive and inflammable product not suitable for use with inflammable (non-AP/APG) anaesthetic gases, electrosurgery or lasers. Use of the device in these situations can lead to the risk of fire. Do not use after lapse of the use- by date.

DURATION OF USE

Single-use device to be used on a single patient. Reuse may cause cross- infections. DO NOT soak, wash, sterilize or reuse this product. Avoid contact with chemical substances, cleaning products or sanitisers. These substances maydamage the device and cause the product to malfunction. Duration of use of the device on the same patient must bedetermined by the personnel responsible and in accordance with proven procedures for controlling infection. Prolonged use of the device may alter its mechanical safety characteristics Replace the device immediately in case of leakage, occlusion, and if connections become unsafe.

STORAGE AND DISPOSAL

The device should be stored respecting the instructions given by the symbols on the packaging. After use, the device must be treated and / or disposed of as hazardous medical waste according to local regulations in force.

RESPONSIBILITY

DEAS devices guarantee top quality and products which are in compliance with the standard in force for safe use. DEAS will not be responsible for any consequences resulting from incorrect choice of model or size or use other than that indicated. If you notice that the device’s features or performance have deteriorated or are malfunctioning and/or there are serious problems, inform DEAS straight away. If this happens, we will need you to send the device concerned along with appropriate photos, placed in the original packaging so the batch can be traced.

DIRECT TECHNICAL ASSISTANCE

If you are unsure about interpreting this instruction leaflet or if you would like any additional technical information, contact the DEAS customer services directly at the address indicated overleaf.

KEY TO SYMBOLS ON PACKAGING

TYPICAL CONFIGURATIONS

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

DEAS S.r.l.

• via dell’Industria, 49 48014 · Castel Bolognese (RA) · Italy
• Tel. +39 0546 656845 · Fax +39 0546 54706
• deas@deasnet.it ·
• www.deasnet.it

Made in Italy

References

• DEAS - Medical Products for Respiratory Care and Airway Management

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