Zimmer TotalShield II Manual De Instrucciones

TotalShield
GENERAL INFORMATION
INDICATIONS FOR USE
TotalShield II
The Surgical Helmet or
TotalShield II
Surgical Hood as the
between the operating environment and the surgical personnel in order to protect against contamination and/or exposure of infectious body
fluids and harmful microorganisms.
DESCRIPTION
TotalShield II
The Surgical Helmets are components of
Surgical Toga and Surgical Hood. The
circulates it throughout the helmet to aid in user comfort. The
SPECIFICATIONS
REFERENCE
NUMBER
Product
Surgical Helmet
Description
Height 10.2 in. (25.9 cm)
Width 9.1 in. (23.1 cm)
Length 12.9 in. (32.8 cm)
Beam Intensity Not Applicable
Fan Speed Four Speeds 10.4 cfm, 12.8 cfm, 16.0 cfm, 19.5 cfm (nominal)
Supply/Input
Useful Life
Approximately 3 years or 900 uses
Note
Transport or store in an environment that limits exposure to dust, moisture and temperature extremes.
Warning: Inspect the device prior to each use. If you see the following, it is recommended to replace your device:
• Damaged control buttons or LED adjustment slide.
• Damaged LED lens or shroud
• Helmet exhibits evidence of blood or bodily fluid soiling. (Follow cleaning instructions before using the helmet for future procedures.)
Approval
ANSI/AAMI Std ES 60601-1 CLASSIFICATION
IPX0
Affixed CE mark indicates compliance with the following European
Directives:
Directive 93/42/EEC – Medical Device
•
Regulation 2016/425/EEC – Personal Protective Equipment (PPE);
•
Helmets were developed in accordance with EN 166:2001
PPE has been EC-type examined by the following Notified Body
BSI Group The Netherlands B.V.
Say Building, John M. Keynesplein 9,
1066 EP Amsterdam, The Netherlands
II Surgical Helmet
®
TotalShield II
Surgical Helmet with LED Light is for use with the
TotalShield II
Surgical Helmet System that is intended to be worn by surgical personnel to provide a barrier
TotalShield II
TotalShield II
Helmet draws external ambient air in via an integrated Battery-operated fan and
00992000100
Surgical Helmet with LED
Light
10.2 in. (25.9 cm)
9.1 in. (23.1 cm)
12.9 in. (32.8 cm)
≥ 40,000 lux (Working
Distance 40 cm )
14.4 V, 3100 mAh and 6200 mAh
Medical – General Medical Equipment as to Electric Shock, Fire and Mechanical Hazards Only, in
Accordance with:
Conforms To:
AAMI STD ES60601-1:2005+A1 (2012)
IEC STD 60601-1-6: 2010 Ed.3+A1
Certified To:
CSA STD C22.2 No. 60601-1:2014 Ed.3
Type of protection against electric shock
Degree of protection against electric shock
Mode of operation
Classification according to the degree of
protection against ingress of water
Surgical Helmet System which includes the
TotalShield II
Surgical Helmet includes optional Battery powered LED lighting.
00992000200
Surgical Helmet w/
Lock
10.2 in. (25.9 cm)
9.1 in. (23.1 cm)
12.9 in. (32.8 cm)
Not Applicable
Internally Powered Equipment
No applied parts
Continuous operation
IPX0 (Ordinary Equipment)
MARKING DEFINITIONS – Z166F
Code Definition
Z Manufacture Code, Zimmer
European Standard – Eye Protection
166
Specification
F Mechanical Strength, Low Energy Impact
TotalShield II
Zippered Surgical Toga or
TotalShield II
00992000500
Surgical Helmet LED w/
Lock
10.2 in. (25.9 cm)
9.1 in. (23.1 cm)
12.9 in. (32.8 cm)
≥ 40,000 lux (Working
Distance 40 cm )
English
Zippered
00992000600