INTERSURGICAL Anaesthetic Masks Instructions

: June 12, 2024
: INTERSURGICAL

Table of Contents

INTERSURGICAL Anaesthetic Masks
Product Information
Product Usage Instructions
Instructions For Use
Indications
Product Use
Disposal
References
Read User Manual Online (PDF format)
Download This Manual (PDF format)

INTERSURGICAL Anaesthetic Masks

intersurgical-anaesthetic-masks-product

Product Information

The product is a medical device used for delivering anaesthetic gas and oxygen to a patient. It is intended for single use and is compatible with a range of anesthetic breathing systems, and respiratory and anaesthetic equipment.
The product includes anesthetic face masks that come in various styles and sizes to meet different clinical needs.
It can be used for inducing anesthesia in patients of any age, as well as during manual resuscitation and ventilation.
The product is suitable for use on all patient populations, including adults, pediatrics, and neonates.
It should only be used under the supervision of appropriately qualified medical personnel.

Product Usage Instructions

Ensure that all packaging is undamaged before use.
Distribute the instructions to all product locations and users.
Read the instructions for use in their entirety, including warnings and cautions, before using the product.
Ensure that the product is stored in an accessible location for all users.
Position the anaesthetic face mask around the patient’s mouth and nose, attaching it to a breathing system.
Verify that an airtight connection with the respiratory system is established by applying pressure and rotating the mask.
Check that the bronchoscope is adequately lubricated before use.
Avoid direct exposure to sunlight and protect the product from light.
Replace the mask if visual contamination occurs.

Note: Failure to follow warnings, cautions, and instructions properly may result in serious injury or death to the patient.

Instructions For Use

The medical device is not supplied individually. Only one copy of theinstructions for use is provided per box and should therefore be kept in an accessible location for all users.

NOTE: Distribute instructions to all product locations and users. These instructions contain important information for the safe use of the product. Read these instructions for use in their entirety, including warnings and cautions before using this product. Failure to properly follow warnings, cautions and instructions could result in serious injury or death to the patient.

WARNING: A WARNING statement provides important information about a potentially hazardous situation, which, if not avoided could result in death or serious injury.

CAUTION: A CAUTION statement provides important information about a potentially hazardous situation, which if not avoided could result in minor or moderate injury.

Anesthetic Facemask:
To deliver anesthetic gas and oxygen to a patient.

Indications

Anesthetic masks should be positioned to create an airtight seal around the patient’s mouth and nose and attaches to a breathing system. They can be used to induce anaesthesia for patients of any age, and may also be used during manual resuscitation and ventilation. Contraindications Patients with abnormal facial anatomy or facial injury.

Product Use

The product is intended for single use with a range of anaesthetic breathing systems, respiratory and anesthetic equipment which may be in use in the acute and non-acute environment under the supervision of appropriately qualified medical personnel. Anaesthetic face masks are supplied in a variety of styles and sizes to meet a variety of clinical needs and provide user choice. Always familiarise yourself with the product prior to use. Use in the acute and non- acute environment under the supervision of suitably or appropriately qualified medical personnel. Anaesthetic face mask is safe for use with atmospheric gases: N2O, O2 and CO2; anaesthetic agents: isoflurane, sevoflurane, desflurane and other comparable volatile agents.

Patient Category
The product range is suitable for use on all patient populations including adults, pediatric and neonates.

Pre-Use Check

Prior to use, check that all system components are free of obstructions and foreign bodies.
Connect/disconnect the tapered connection of the mask to the tapered connection of the breathing system and respiratory equipment using a push and twist action to guarantee a safe and secure connection to breathing system.
Ensure that an appropriately sized mask is selected based upon the patient size and weight.
If the mask has an inflation port it may be used to adjust the pressure of the air cushion.
Once positioned ensure that an air tight seal has been achieved allowing delivery of prescribed gas and manual ventilation.
Give consideration to any impact that the internal volume of the device may have upon the effectiveness of the prescribed ventilation. The clinician should assess this on an individual patient basis.
Check that the valves are secure and in-situ on the mask.
Ensure that the scope is always adequately lubricated.
Do not use a scope that exceeds the maximum diameter of 13.3mm.

In-Use Check

Monitor the mask throughout use and replace if visual contamination occurs.
Ensure the valves are secure and in-situ on the mask after use.

Caution

The mask is only to be used under the supervision of appropriately qualified medical personnel.
The mask should be used with equipment with 22mm M/15mm F connector which complies with ISO 5356.
To avoid contamination, the product should remain packaged until ready for use. Do not use the product if the packaging is damaged.
The products have been designed, validated and manufactured for single use.
The product must not be re-used, cleaned or sterilized.
Following use, the product must be disposed of in accordance with a local hospital, infection control and waste disposal regulations.

FOR USA: Rx ONLY: Federal law restricts this device to sale by or on the order of a physician.

Warning

Single-use product. Do not reuse. Reuse poses a threat to patient safety in terms of cross-infection and device malfunction and breakage. Cleaning can lead to device malfunction.
Consult individual product labeling for the presence or absence of phthalates.
This anesthetic face mask is not suitable for use with flammable anesthetic agents.
Failure to adequately lubricate the scope prior to use can result in distortion and damage to the valves that will affect product function.
The use of a scope that exceeds the recommended maximum diameter (13.3mm) can result in distortion and damage to the valves that will affect product function.

Storage Conditions
Store out of direct sunlight. Recommended storage at room temperature over the indicated product shelf-life.