Product Manual

Specifications
104
Physical Characteristics
Weight 3.07 lbs. (1.39 kg) without pole mount
Dimensions 2.95 " (H) × 9
.06 " (W) × 5.04" (D)
75 mm (H) × 230 mm (W) × 128
mm (D)
Compliance
Item Standard Description
Quality System EN ISO 13485: 2000,
ISO 13485: 1996
Quality system — Medical
Devices, Particular
Requirements for application
of ISO 9001: 2000
EC Directive 93/42/EEC Medical Device Directive
(Europe + Int.)
FDA Guidance FDA RG (Nov. 1993) Reviewers Guide for
Premarket Notification
Subm
ission
Safety — EC EN 60601-1: 1995 General Rqmts for Safety,
Medical Equipm
ent
Safety — USA UL 60601-1: 2003 Safety — Medical Electrical
System
Safety — Canada CSA C22.2 No 601,
1-M90: 1998
Safety — Medical Electrical
Sys, Requ
ires NRTL Listing
Electric Shock
Classificatio
n
EN 60601-1 Class I or Internally powered
(Battery mode), Type BF
Applied part
Protection against
Wa
ter Classification
EN 60601-1 IPX1
Mode of Operation
Classificatio
n
EN 60601-1 Continuous Operation
Flammable
Anaesthet
ic
Classification
EN 60601-1 Equipment not suitable