Sunset Healthcare Solutions Ven56051000a Standard 72hr Closed Suction System Instruction Manual

VEN56051000A Standard 72hr
Closed Suction System
Instruction Manual

General Instructions for Use

Intended Use
Sunset Standard 72hr Closed Suction System is intended for endotracheal or tracheostomy suction of ventilator dependent adult patients. It is operated by health   professionals in medical institutions for single patient use within 72 hours.

• Maximum period of use is 72 hours and it is indicated 72 hrs on the pack.
• For the series used with tracheostomy tubes, the length of catheter is 305mm and is indicated on the pack.

Product Description

Sunset Standard 72hr Closed Suction System consists of 3 essential parts: a suction catheter with a protective sleeve, a vacuum control device and a patient end adaptor with a flushing system. The device connects between the breathing circuit and the artificial airway for simultaneous suction and ventilation. It features for a non-return valve design for longer 72-hour use. There are different catheter lengths of the device, one for endotracheal tube and one for tracheostomy tube, and it can be with or without a MDI port.

Contraindications

The device intends to suck the secretions from the patients with artificial airways. The pulmonary secretions from a patient’ s artificial airways should be removed to prevent its obstruction, otherwise, they cause the patient’ s death or to be lethal. Therefore, there is no absolute contraindication to the closed suction system.

Size

Product Code A	Catheter Length	Remark	Outer Diameter	Packaging	ISO Colour
VEN56051000A / VEN56051000AM	540mm	Endotracheal	10FR /3.33 mm	20ea/box
VEN56061000A / VEN56061000AM	305mm	Tracheostomy
VEN56051200 / VEN56051200M	540mm	Endotracheal	12FR /4.0 mm	20ea/box
VEN56061200 / VEN56061200M	305mm	Tracheostomy
VEN56051400 / VEN56051400M	540mm	Endotracheal	14FR /4.67 mm	20ea/box
VEN56061400 / VEN56061400M	305mm	Tracheostomy
VEN56051600 / VEN56051600M	540mm	Endotracheal	16FR / 5.3 mm	20ea/box
VEN56061600 / VEN56061600M	305mm	Tracheostomy

Symbol

	Caution
	Contains or presence of phthalate-DINP
	Sterilized using ethylene oxide
	Sale by or on the order of a physician
	Does not contain natural rubber latex
	Do not use if package is damaged
	Do not reuse
	Do not desterilize
	Do not use in MRI
	Consult instructions for use
	Temperature limitation Upper limit: 49°C Lower limit: 5°C
	Manufacturer
	Date of manufacture
	Catalog number
	Batch code
	Use by date
	Keep dry
	Keep away from sunlight

Warning

1. Do not use endotracheal length catheter in patient with tracheostomy tube. The extra length may cause mucosal tissue injured. Do not use tracheostomy length catheters for endotracheal tubes. The short length will result in insufficient suctioning.
2. This is single use product. Do not reuse or desterilize this device. Reuse and desterilization may lead to the device not performing as intended, malfunction or create a risk of cross infection.
3. Do not CUT endotracheal tube while Closed Suction System is attached. Otherwise, the suction catheter may be cut and the cut portion of catheter may be aspirated into lower respiratory tract.

Caution

1. Check the product package before use. Do not use if product packaging has been damaged.
2. Withdraw suction catheter from the patients until the black marking can be seen on the distal side of patient-end adaptor.
3. Do not pull suction catheter out of patient-end adaptor.
4. Ensure the non-return valve is locked prior to rinsing the catheter.
5. The product should be handled by trained and qualified clinicians.
6. Rx Only – Federal law restricts this device to sale by or on the order of a physician.
7. For the series used with tracheostomy tubes, the length of catheter is 305mm and is indicated on the pack.
8. Do not leave catheter within the airway, it will cause increased airway resistance.
9. Recommended vacuum settings: 80 to 120mm/Hg.
10. The entire suction procedure should last no longer than 10 to 15 seconds.
11. When used in conjunction with other manufacture’s products always refer to their instruction for use.
12. Excess fluid in heat and moisture exchangers (HMEs) or heat and moisture exchanging filters (HMEFs) may increase resistance to flow. Follow manufacturer’s instructions and replace HME(F).

Pre-Use Check

• There are no standard connections for suction catheter, hospitals should qualify the tubing fits the Series of Sunset Standard Closed Suction Systems.
• Inspect the package before opening. Ensure the product has not been compromised.
• Select the appropriate catheter length and size following clinical guideline. It is recommended that the catheter size is no more than half the size of patient’s artificial airway.

Suggested Suction Procedure

1. (Fig. 1) Attach the 15 mm male connector ( B ) of the patient end adaptor to the breathing system (machine-end); the 15 mm female connector ( C ) to the patient’s  artificial airway (patient-end).
   Note: A corrugated connector (optional accessory) can be attached between the 15 mm male connector ( B )and the breathing system if needed.
2. (Fig. 1) Attach the suction tube with the hospital vacuum system to the catheter-end connector of the vacuum control device ( G ).
3. (Fig. 1) Attach a day label to the vacuum control device indicating the date of use.
4. (Fig. 2) Unlock the switch of the vacuum control device( H ).
   (Fig. 2) Hold the patient end adaptor with one hand. Carefully advance the catheter down the airway with the other hand.
5. Advance catheter to desired depth. For endotracheal tube type, line up the marking numbers.
6. There are no markings on tracheostomy tubes. Follow hospital procedures when advancing the catheter.
7. (Fig. 3) Hold the vacuum control device ( G ) and depress switch of vacuum control device ( H ).
8. (Fig. 4) Then gently withdraw catheter until the black ring( F ) is visible on the distal side of the patient-end adaptor.
9. Repeat steps 5-7 above if necessary.

Catheter Irrigation

1. (Fig. 5) Open cap on irrigation port( J ). A prefilled saline vial or a 15ml syringe filled with saline is prepared to be used.
2. (Fig. 5) Attach saline vial/syringe to the irrigation port.
3. Depress the the switch of the vacuum control device ( H ) for saline to enter the irrigation chamber ( A ). Ensure the non-return valve ( L ) is closed and continue to  irrigate until the catheter is clear of secretion.
4. (Fig. 6) Lock the switch of the vacuum control device ( H ) when not in use to prevent accidental depression.
5. Close the cap of the irrigation port ( J ) .
6. Turn off the vacuum after use. If the suction catheter is disconnected in-line use, put the protective cap ( I ) on the end of vacuum control device ( G ) .

Metered Dose Inhaler (MDI)

1. Remove the cap of the MDI port ( K ) , and attach canister. Avoid discharge of canister when connecting.
2. Hold canister in vertical position. Depress canister during inspiration cycle. Repeat as put the prescribed by physician or protocol.
3. Remove canister and put the cap on MDI port ( K ).

Disconnection (optional accessory)

1. A disconnect wedge (optional accessory) can be used for easier disconnection with Sunset Standard Closed Suction System from the patient’s airway by steps below (Fig. 7).
2. Press upwards against the thumb to disconnet the system.
3. After use, the product must be disposed in conformance with the local hygiene and waste disposal protocols and regulation.

Manufactured for
Sunset Healthcare Solutions
180 N Michigan Ave Ste 2000
Chicago, IL 60601
United States
www.SunsetHCS.com
Made in Taiwan
IFU-00052 REV 1.00
2021-12-21

References

• Sunset Healthcare Solutions