Anesthesia Mask Standards & IFU
INFORMATION FOR USE
Need information about best practices, shelf-life, donning and doffing?
Below you will find information and instructions for how to properly use our anesthesia masks.
PRIMAFORM™ and PRIMAFORM™ Grip Anesthesia masks are intended for the transmission of medical gases to patients. The masks are to be worn over the mouth and nose of the patient to allow delivery of the required gases. PRIMAFORM™ and PRIMAFORM™ Grip masks come in various sizes to fit different user populations.
- Single patient use only, do not reuse.
- Do not clean or sterilize as it may compromise the integrity of the product.
- Do not over inflate or use excessive pressure when applying the mask.
- Do not attach mask to any connection size that is not compatible. Please refer to connection sizing indicated on the product.
- The effect of “dead space” in an anesthesia mask on patient ventilation should be evaluated on an individual basis.
Shelf Life and Storage
- It is recommended the product be stored in a cool, dry environment; however, room temperature storage of this product is also acceptable.
- Although individually packed, product is supplied non-sterile. Do not use if the packaging has been compromised.
- All PRIMAFORM™ and PRIMAFORM™ Grip Anesthesia Masks have an expiry date on the packaging. Do not use the product if it is past expiry.
Instructions for Use
Note: To be administered by a trained/licensed practitioner
- Select size of mask based on the patient, then remove mask from bag.
- Check the mask for leaks in the air cushion.
- Examine the seal and fit of the mask on patients’ face. Use a syringe to inflate or deflate the cuff if required.
- Secure mask to patient. If the hook ring is not required, you should remove it and dispose of it appropriately.
- Attach corresponding attachments (i.e., anesthesia system) as per sizing and hospital practices.
- This mask is a single-use product. Please dispose of after use, according to your hospital’s waste control policies.
FREQUENTLY ASKED QUESTIONS
Do you have questions about PRIMAFORM™ and PRIMAFORM™ Grip Anesthesia Mask standards?
Below you will find the answers you need to the frequently asked questions we receive about anesthesia masks.
Why should I choose a "single-use" anesthesia mask over a traditional reusable mask?
The primary reason one would choose a "single-use" (also known as a "disposable") anesthesia mask over a traditional reusable anesthesia mask is to reduce the risk of cross-contamination across patients. Switching to single-use masks is considered best practice from an infection control perspective.* When a single-use mask is selected, there is no risk of cross-contamination between patients, and there is no "wear and tear" on the mask. Each mask will perform to optimal performance.
Another reason one would choose single-use anesthesia masks over traditional reusable masks is to reduce one's carbon footprint and overall harm to the environment. Since single-use masks can be autoclaved and recycled (depending on jurisdictional recycling programs), single-use masks do not require excessive amounts of water, detergents and harsh chemicals like traditional masks require during the re-sterilization process.
How do I know if I have the right size of anesthesia mask for my patient?
The correct size of mask is based on whether or not it can form an appropriate seal on the patient’s face. Selecting the correct size is at the discretion of the clinician. While multiple sizes may appear to fit on a given patient, one size will fit better than the others.
What health standards should my single-use anesthesia mask meet?
We recommend anesthesia manufacturing facilities meet ISO13485 standards. All PRIMAFORM™ and PRIMAFORM™ Grip Anesthesia mask meet this standard.
Why are PRIMAFORM anesthesia masks, hook rings and packaging different colours?
PRIMAFORM™ Anesthesia Masks come in two colours:
- PRIMAFORM™ = Blue
- PRIMAFORM™ Grip = Purple
Colour-coding the actual mask helps clinicians quickly determine which style of mask to use.
The hook rings of all PRIMAFORM™ and PRIMAFORM™ Grip Anesthesia Masks (as well as the packaging on most popular sizes), are also colour-coded. Colour coding the hook rings helps clinicians quickly determine the size of the mask required for the patient. Refer to the charts below for further details.
|Anesthesia Mask||Size||Hook Ring Colour||Packaging Colour|
|PRIMAFORM™ PM4-6007||Extra Large||Blue||Clear|
|Anesthesia Mask||Size||Hook Ring Colour||Packaging Colour|
|PRIMAFORM™ FIT - PM4-6202||Infant||Orange||Purple|
|PRIMAFORM™ FIT - PM4-6203||Toddler||White||Purple|
|PRIMAFORM™ FIT - PM4-6204||Small||Yellow||Blue|
|PRIMAFORM™ FIT - PM4-6205||Medium||Red||Red|
|PRIMAFORM™ FIT - PM4-6206||Large||Green||Green|
The air cushion doesn’t seem to be inflated quite enough for my patient. What can be done about this?
Our anesthesia mask lines are designed to give the clinician ultimate control of the mask’s fit. If the air cushion does not appear to have the optimal amount of inflation, use a needle-less syringe with a Luer lock tip to inflate and deflate the cushion through the mask valve.
What are the coloured hook rings used for around the connection port?
Hook rings are used primarily to secure the mask to the patient’s face using an adjustable mask strap. Coloured hook rings also provide a visual cue to the clinician to help identify the size of the mask.
Why are there ridges along the dome of the anesthesia mask?
The ridges on the dome of the mask are called “lateral finger grips” and they are designed for increased control of the dome. These lateral grips on the dome provide non-slip surface area to ensure easy manipulation and flex of the dome. This makes it easier to find the ideal fit on each individual patient.
Is there a reason anesthesia masks are transparent?
The dome area of the anesthesia mask is transparent to aid the clinician in patient observation and checking vitals.
When should I dispose of the anesthesia mask?
PRIMAFORM and PRIMAFORM Grip Anesthesia Masks are single-use. As such, they should be disposed of after each patient use. The anesthesia mask must not be used with multiple patients. If a mask comes in contact with unsanitary or uncleanly surfaces, dispose of the mask and use a new mask for your patient.