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The Vest® Airway Clearance System, Model 105
Instructions for Use
(145330 REV 18)
Specifications
Classification and Standards
The Vest® Airway Clearance System, Model 105 is a continuous operation
device classified with Underwriters Laboratories Inc.® (UL) in the United
States and licensed with Health Canada.
Classification
Standards
Technical and Quality
Assurance—Devices with
serial numbers
63-XXXXX, 64-XXXXX, and
65-XXXXX
ANSI/AAMI ES60601-1
ANSI/AAMI HA60601-1-11
CAN/CSA-C22.2 No. 60601-1
CAN/CSA-C22.2 No. 60601-1-11
IEC/EN 60601-1
IEC/EN 60601-1-6
IEC/EN 60601-1-11
IEC/EN 62366-1
EN ISO 13485
Technical and Quality
Assurance—Devices with
serial numbers
61-XXXXX and 62-XXXXX
UL/EN/IEC 60601-1
CAN/CSA C22.2 No. 601.1
ISO 13485
Equipment Classification
Percussor, powered electric Class II
Degree of Protection
Against Electric Shock
BF with type F applied part
Classification According to
Directive 93/42/EEC
IIa
Degree of Protection
Against Ingress of Water
IP21
Not
for use with flammable anesthetics.
Содержание Vest 105
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