Hillrom Compella - Page 108

Specifications
94 Compella™ Bariatric Bed System Instructions for Use (178951 REV 6)
Bed Classification and Standards
Surface and Air Supply Unit Classification and Standards
Technical and quality assurance standards IEC, EN, CAN/CSA, ANSI/AAMI ES 60601-1, Edition
3.1
IEC /EN 60601-2-52, Edition 1.1
IEC/EN 60601-1-2, Edition 4
IEC/EN 60601-1-6, Edition 3.1
IEC/EN 62366-1
IEC/EN 62304, Edition 1.1
EN ISO 9001 and EN 13485
REACH Directive 1907/2006
RoHS Directive 2011/65/EU
WEEE Directive 2012/19/EU
Equipment classification per IEC 60601-1 Class I equipment, internally powered
equipment
Degree of protection against electric shock Type B
Classification according to Directive 93/42/EEC Class Im for bed frame and foam surface
Class IIa for air surface
Degree of protection against ingress of water IPX4 for the bed and patient pendant
Degree of protection against the
presence of flammable anesthetic
mixtures
Not for use with flammable anesthetics
Mode of operation Continuous operation with intermittent
loading, 2 minutes ON / 18 minutes OFF
Sound level ≤ 52 dBA (patient resting continuous
operation)—measured from patient’s
perspective with siderails up
≤ 65 dBA (patient alert continuous
operation)—measured 1 m (39.4") from the bed
centered in a longitudinal direction with siderails
up
≤ 85 dBA (patient alert short term
operation)—measured 1 m (39.4") from the bed
centered in a longitudinal direction with siderails
up
Application environments Intensive/critical care
Acute care
Long term care
Outpatient/ambulatory care
Technical and quality assurance
standards
IEC, EN, CAN/CSA, ANSI/AAMI ES 60601-1, Edition 3.1
IEC 60601-1-2:2014, Edition 4
IEC/EN 60601-1-6 Edition 3.1
IEC/EN 60601-1-8 Edition 2.1
REACH Directive 1907/2006
RoHS Directive 2011/65/EU
WEEE Directive 2012/19/EU
Degree of protection against electric shock
for equipment classification per IEC 60601-1
Class I