GE B30 Technical 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 (including monitoring during conditions of clinical patient motion), and invasive blood pressure.
2
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
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 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. (GE) 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."
Trademarks
Dash, Datex, Ohmeda, S/5, D-fend, D-fend+, Mini D-fend, OxyTip+, ComWheel, ComBar, EarSat, FingerSat,
FlexSat are trademarks of GE Healthcare. All other product and company names are property of their
respective owners.
Product availability
Some of the product parts and accessories mentioned in this manual may not be available in all
countries.
Please, consult your local representative for the availability.
measurements are indicated for patients who weight over 5
2
and
2