Smiths Medical Z110N-12 - Portex SuctionPro 72 Closed Ventilation Suction System, 12FR, Single Lumen, 20/CS

Smiths Medical Z110N-12 - Portex SuctionPro 72 Closed Ventilation Suction System, 12FR, Single Lumen, 20/CS

Smiths Medical Z110N-12 Portex SuctionPro 72 Closed Ventilation Suction System

The Portex SuctionPro 72 Closed Ventilation Suction System is a single patient use suctioning device for the removal of secretions from the tracheobronchial tree of ventilator dependent adult patients. Intended for 72-hour use. Please see the Instructions for Use for a complete listing of the indications, contraindications, warnings and precautions.

Catalog No.	Size	Lumen	Qty.
Z110N-12	12FR	Additional Single Lumen (USA ONLY)	20/CS

Smiths Medical Z110N-12 Portex SuctionPro 72 Closed Ventilation Suction System Features and Benefits

• 3-day recommended duration of use.
• Clear pathway evacuation port.
• Lockable thumb valve end cap.
• Sterile, single patient use.
• Patient label with day of the week stickers.
• Clear T piece for visualisation of the pathway.
• Soft but strong catheter sleeve.
• Trac-Wedge device to aid in disconnection of the catheter from the patients tracheal or tracheostomy tube.
• Swivel connector to reduce torque to patient in some packs.
• Sterile, single patient use
• Available in single or dual lumen configurations

Smiths Medical Z110N-12 Portex SuctionPro 72 Closed Ventilation Suction System Instructions for Use

Set-up and Set Suction Flow

• Before attaching system to patient, attach control valve to the suction catheter inlet tube, turn on suction, make sure lock is turned to Open position and check operation of control valve by sliding back the thumb actuator completely.
• Set suction flow at prescribed level
• Once in the fully retracted position, release and ensure the device correctly ceases to suction.

Attach to Ventilator Circuit

• Attach ventilator circuit to T-piece. If desired, place swivel or expandable flex tube between circuit and T-piece.

Attach to Endotracheal or Tracheostomy Tube

• Attach T-piece to the endotracheal or tracheostomy tube. If desired, the swivel connector may be used between the endo/trach tube and the suction catheter to reduce torque on the patient.
  
  WARNING: Suction pressures should not exceed -200 mmHg (-27k Pa). The recommended range of negative pressure is from -60 mm Hg (-8k Pa) to -200 mmHg (-27k Pa). Pressures outside this range may have adverse effects upon the inspiratory flow rate and delivered tidal volume or may result in barotraumas.

Begin Suction Procedure

NOTE: Patients may benefit from pre-oxygenation with 100% oxygen.

• Advance catheter until desired depth is achieved. If resistance is met, withdraw catheter 2-3 cm before applying suction.
• Grasp control valve and apply backwards-sliding pressure on blue thumb actuator to suction.
  
  WARNING: Prolonged or aggressive suctioning may cause fluctuations in airway pressures (inspiratory/ expiratory). Prolonged or aggressive suctioning may cause arterial hypoxemia, atelectasis and arrhythmia. Coughing associated with prolonged or aggressive suctioning may potenially cause abnormally high airway pressure, pneumothorax or barotraumas.

Withdraw Catheter

• Withdraw the catheter slowly with suction activated in a straight motion to avoid kinking, until catheter tip resides in cone of T-piece and blue mark is just fully visible in catheter sleeve.
  
  WARNING: Following suction, withdraw the catheter until the blue indicator is just fully visible in the sleeve. Failure to do so may result in an increased Peak Inspiratory Pressure (PIP). Over withdrawing of catheter may result in the loss of tidal volume.

Prepare to Flush 6 Catheter Tip

• Ensure the catheter tip is out of the breathing path and blue mark is just fully visible in catheter sleeve.

NOTE: The suction source may be turned off when not in use.

WARNING: Failure to irrigate and clean the catheter following use could result in encrustation of secretions, which may lead to:

• Occlusion of the catheter.
• Only partial closure of the suction control valve, preventing total isolation of the suction source.

WARNING: Failure to remove white cap prior to continuous flow therapy may result in serious injury or death.

Flush Catheter Tip: Single Lumen

• Instill saline through the irrigation inlet while suction is applied and begin to clean catheter tip. Ensure the catheter tip and area surrounding it is fully flushed with saline. Release control valve actuator and turn the valve lock to the Closed position when finished.

Flush Catheter Tip: Dual Lumen

• Instill saline through the irrigation inlet while suction is applied and begin to clean catheter tip. Ensure the catheter tip and area surrounding it is fully flushed with saline. Release control valve actuator and turn the valve lock to the Closed position when finished.

Device Characteristics of Smiths Medical Z110N-12 Portex SuctionPro 72 Closed Ventilation Suction System

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No