GE Healthcare B30 User's Reference Manual page 4

Intended purpose (Indications for use)
The B30 patient monitor is intended for multiparameter patient monitoring. The B30 monitor is
indicated for continuous monitoring of hemodynamic parameters (including arrhythmia and
ST segment analysis) and respiratory status and creation of limit alarms. The B30 monitor is
intended for all hospital patients and all hospital departments including intra-hospital
transport but excluding harsh physical environment like MRI.
The Patient side module E-PSM(P)W and accessories are indicated for monitoring of
hemodynamic parameters of all hospital patients. The hemodynamic parameters of the
module comprise ECG (including ST-Segment and arrhythmia), impedance respiration,
oscillometric NIBP (sys/dia/mean), temperature, SpO
of clinical patient motion), and invasive blood pressure. Impedance respiration measurement is
indicated for patients ages three years and up. The NIBP measurement is indicated for patients
who weight 5kg (11 lb) or up.The E-PSM(P)W is intended for all hospital departments including
intra-hospital transport but excluding harsh physical environment like MRI.
The extension module N-FCREC (option N-FCREC or N-FC) is indicated for monitoring of CO
respiration rate of all hospital patients. CO
weight over 5 kg (11 lb).
The B30 monitor and N-F(C)(REC) Extension Module and E-PSM(P)W Patient Side Module are
indicated for use by qualified medical personnel only.
Classifications
In accordance with IEC 60601-1
Class I and internally powered equipment – the type of protection against electric shock.
Type BF or CF equipment. The degree of protection against electric shock is indicated by a
symbol on each parameter module.
Equipment not suitable for use in the presence of a flammable anesthetic mixture with air or
with oxygen or nitrous oxide.
Continuous operation according to the mode of operation.
Portable Monitor.
In accordance with IEC 60529
IPX1 - degree of protection against harmful ingress of water.
In accordance with EU Medical Device Directive
The B30 patient monitor is classified as IIb.
In accordance with CISPR 11:
Group 1, Class B:
•
Group 1 contains all ISM (Industrial, scientific and medical) equipment in which there is
intentionally generated and/or used conductively coupled radio-frequency energy which is
necessary for the internal functioning of the equipment itself.
•
Class B equipment is suitable for use in domestic establishments and in establishments
directly connected to a low voltage power supply network which supplies buildings used for
domestic purposes.
Responsibility of the manufacturer
GE Medical Systems Information Technologies, Inc. is responsible for the effects on safety,
reliability and performance of the equipment only if:
•
assembly, extensions, readjustments, modifications, servicing and repairs are carried out
by personnel authorized by GE.
•
the electrical installation of the monitor room complies with appropriate requirements.
•
the equipment is used in accordance with the "User's Guide."
(including monitoring during conditions
2
measurements are indicated for patients who
2
and
2