Device Classification - ZOLL AEV Operator's Manual

S
PECIFICATIONS

Device Classification

The following table describes the ZOLL Ventilator's device classification:
Type of Protection against Electric
Shock
Degree of Protection against
Electric Shock
Applied Parts
Degree of Protection against
Harmful Ingress of Water
Method of Sterilization or
Disinfection
Degree of Safety of Application in
the presence of a Flammable
Anesthetic Mixture with Air or with
Oxygen or Nitrous Oxide
Mode of Operation
A-4
Category
The medical power supply (which contains the
system's safety barrier) is labeled as Class I or Class
II. Electrical shock protection is not dependent upon
earthing since this power supply design includes
double insulation.
The ventilator circuit is Type BF applied part.
The pulse oximeter is Type BF Defibrillation Proof
Applied Part.
IPX4: Splash-proof equipment rating, include:
• Padded case with rain flap
• Bacterial/viral filter to protect the compressor
O2 Supply hoses and connections should be wiped
with a damp, soapy cloth and thoroughly dried with a
lint-free cloth. The unit's housing should also be
cleaned as necessary with a damp, soapy cloth and
throughly dried with a lint-free cloth. Do not clean
with abrasives or chlorinated hydrocarbon cleansers.
Ventilator circuits are only for single use. Follow all
IFU instructions.
Equipment not suitable for use in presence of
Flammable Anesthetic Mixture of Air or with Oxygen
or Nitrous Oxide
Continuous Operation
www.zoll.com
Classification
906-0731-01-05 Rev. C