Puritan Bennett 840 Service Manual

General information 1
Puritan Bennett 800 Series Ventilator System Service Manual 1-9
1.6 Compliance and approvals
The Puritan Bennett 840 Ventilator System was developed in accordance with pertinent
North American and International standards (Table 1-2). The manufacturing facility for this
product is certified to EN ISO 13485:2000 (ISO 13485:1996) Quality Systems - Medical
Devices - Particular Requirements for the Application of ISO 9001:1994.
The ventilator’s IEC 60601-1/EN 60601-1 classification is Protection class I, Type B, internally
powered, IPX1 drip-proof equipment, continuous operation.
Table 1-2: Compliance with standards
Standards/certifications Configurations Certification agency
North America
Authorized to bear the CSA certification mark
with NRTL/C indicator, signifying the product
has been evaluated to the applicable ANSI/
Underwriters Laboratories Inc. (UL) and CSA
standards for use in the US and Canada.
CSA Std. No. 601-1-M90
CSA 601-1 Supplement 1:1994
CSA Std. No. 60601-2.12-1994
UL No. 60601-1 (1st Edition)
IEC 60601-1:1988
IEC 60601-1 Amendment 1:1991
IEC60601-1 Amendment 2:1995
IEC 60601-2-12:2001
120 V, 60 Hz
220 – 240 V, 50 Hz
220 – 240 V, 60 Hz
Canadian Standards
Association (CSA)
IEC 60601-1-2:2007 Manufacturer self-
certification
International
CB scheme certification:
IEC 60601-1:1988
IEC 60601-1 Amendment 1:1991
IEC 60601-1 Amendment 2:1995
IEC 60601-2-12:2001
100 V, 50/60 Hz
120 V, 60 Hz
220 – 240 V, 50 Hz
220 – 240 V, 60 Hz
Canadian Standards
Association (CSA)
IEC 60601-1-2:2001+A1:2004 100 V, 50/60 Hz
120 V, 60 Hz
220 – 240 V, 50 Hz
220 – 240 V, 60 Hz
Manufacturer self-
certification

Puritan Bennett 840 Specifications

General

Type	Ventilator
Flow Rate	Up to 180 L/min
Power Requirements	100-240 VAC, 50/60 Hz
Display	Color LCD Touchscreen
Category	Critical Care
Manufacturer	Medtronic
Model	840
Operating Modes	Assist/Control, SIMV, Spontaneous, BiLevel
FiO2 Range	21 to 100%
PEEP/CPAP Range	0-45 cmH2O
Alarms	High/Low Pressure, High/Low Volume, Apnea, High Respiratory Rate
Power Source	AC Power
Data Connectivity	RS-232
Compliance	ISO 80601-2-12