Saniclave 200 FDA approved Q&A

Question 1

What is the FDA standard for sterilization? View answer

Question 2

Is an autoclave a medical device? View answer

Question 3

Is there a dry mode for wrapped instruments?

Answer:

Yes, it has a dry mode that allows you to sterilize and dry wrapped instruments. Dry mode ensures instruments are ready for immediate use or storage, saving time and maintaining sterility.

Question 4

Does this autoclave have automatic operation?

Answer:

Yes, it offers simple one-button automatic operation. One-button operation simplifies the sterilization process, making it user-friendly and reducing the chance of user error.

Question 5

Is this autoclave lightweight and portable?

Answer:

Yes, it is designed to be lightweight and portable. Portability allows for easy relocation and use in different rooms or facilities, which is especially valuable for mobile or multi-use environments.

Question 6

What is the safety approval status of this autoclave?

Answer:

This autoclave is FDA approved (K112811), IEC compliant, CE marked, and ANSI/AAMI-ST55 Standard Approved. FDA stands for the Food and Drug Administration, IEC is the International Electrotechnical Commission, CE marking indicates conformity with European standards, and ANSI/AAMI-ST55 is a sterilization equipment standard. These approvals ensure the unit meets rigorous safety and performance standards, providing peace of mind to buyers.

Question 7

Does the autoclave have alarms for temperature and water levels?

Answer:

Yes, it has under and over temperature alarms as well as an insufficient water alarm. These alarms help prevent damage to instruments and ensure safe operation, making the unit more reliable and user-friendly.

Question 8

Does this autoclave have a digital display?

Answer:

Yes, it features a digital display for temperature, time, and pressure. A digital display provides precise control and monitoring, which enhances user confidence and ensures accurate sterilization.

Question 9

Does this autoclave have a specific sterilization cycle approval?

Answer:

Yes, it features an ST79 approved sterilization cycle. ST79 is a standard set by the Association for the Advancement of Medical Instrumentation (AAMI) for steam sterilization, ensuring effective and reliable sterilization performance.

Question 10

What material is used for the chamber and door?

Answer:

The chamber and door are made from corrosion-resistant stainless steel. Stainless steel construction prevents rust and extends the lifespan of the unit, offering reliability and low maintenance.

Question 11

What other material is used in the construction of the autoclave?

Answer:

Rugged ABS (Acrylonitrile Butadiene Styrene) is also used in its construction. ABS is a durable plastic that adds to the unit’s strength and impact resistance, making it suitable for frequent use.

Question 12

What is the power requirement for this autoclave?

Answer:

The power requirement is 120 volts AC, 700 watts, and it uses a grounded cord. This standard power setup makes it easy to use in most North American facilities, providing convenience and safety.

Question 13

How many trays can this autoclave hold?

Answer:

It can hold up to 3 trays. The ability to process multiple trays at once increases productivity and reduces turnaround time for sterilized instruments.

Question 14

What type of gasket is used in the door?

Answer:

The door uses a silicone rubber gasket. Silicone rubber is durable and heat-resistant, which means a longer service life and better sealing for effective sterilization.

Question 15

What is the chamber capacity of this autoclave?

Answer:

The chamber capacity is 10.5 liters. This generous capacity lets users sterilize multiple trays or larger instruments in a single cycle, improving workflow efficiency.

Question 16

What is the overall length or depth of this autoclave?

Answer:

The overall length (or depth) is 21 inches. This length provides enough internal space for sterilizing multiple instruments while maintaining a small footprint.

Question 17

What is the depth of the autoclave chamber?

Answer:

The chamber depth is 10.5 inches. This depth allows for effective placement of trays and instruments, ensuring thorough sterilization.

Question 18

What are the full external dimensions of the autoclave?

Answer:

The full external dimensions are 16 inches wide by 13.5 inches high by 21 inches deep. These dimensions ensure the unit is compact yet spacious enough for most sterilization needs, maximizing usability without taking up excessive space.

Question 19

What is the width of the autoclave chamber?

Answer:

The chamber width is 9 inches. This width accommodates a variety of instrument sizes, making it versatile for different medical and dental tools.

Saniclave 200 FDA approved Q&A

Activity timeframe

Is there a dry mode for wrapped instruments?

Does this autoclave have automatic operation?

Is this autoclave lightweight and portable?

What is the safety approval status of this autoclave?

Does the autoclave have alarms for temperature and water levels?

Does this autoclave have a digital display?

Does this autoclave have a specific sterilization cycle approval?

What material is used for the chamber and door?

What other material is used in the construction of the autoclave?

What is the power requirement for this autoclave?

How many trays can this autoclave hold?

What type of gasket is used in the door?

What is the chamber capacity of this autoclave?

What is the overall length or depth of this autoclave?

What is the depth of the autoclave chamber?

What are the full external dimensions of the autoclave?

What is the width of the autoclave chamber?

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