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About this guide
Classifications
This guide describes the most common features and functions offered by
the GE Datex-Ohmeda Cardiocap/5 monitor. Descriptions refer to the
Anesthesia software (S-XANE 01).
IEC/EN 60601-1:
•
Type of protection against electric shock: Class I
•
Degree of protection against electric shock (indicated by a symbol
beside each connector): Type BF or Type CF applied part
Related documentation
•
Mode of operation: Continuous
More information about clinical aspects, basic methods of measurement
and technical background:
”Cardiocap/5 User's Reference Manual - Anesthesia”
•
Equipment is not suitable for use in the presence of a flammable
anesthetic mixture with air, or with oxygen or nitrous oxide.
IEC/EN 60529:
Degree of protection against the harmful ingress of water: IPX1
More information about technical solutions and servicing:
”Cardiocap/5 Technical Reference Manual”
EU Medical Device Directive:
Iib
More information about other devices closely related to the Cardiocap/5:
“S/5 iCentral Technical Reference Manual”
CISPR 11
: Group 1, class A
Intended use
Responsibility of the manufacturer
The GE Datex-Ohmeda Cardiocap/5 and accessories are indicated for
indoor monitoring of hemodynamic (ECG, impedance respiration, NIBP,
temperature, SpO
2
, and invasive pressure), respiratory (CO
2
, O
2
, N
2
O,
respiration rate, anesthetic agent, and agent identification), ventilatory
(airway pressure, volume, and flow), and relaxation status (NMT) of all
hospital patients.
Datex-Ohmeda Division, Instrumentarium Corp. is responsible for the
safety, reliability and performance of the equipment only if:
•
Assembly, operations, extensions, readjustments, modifications,
service and repairs are carried out by personnel authorized by the
manufacturer.
•
Electrical installation complies with appropriate requirements.
With the N-XOSAT option, monitoring of arterial oxygen saturation
includes monitoring during conditions of clinical patient motion.
•
The equipment is used in accordance with this guide
Cardiocap/5 is indicated for patients weighing 5 kg (11 lb.) or more.
Trademarks
Impedance respiration measurement is indicated for patients ages
3 years and older.
Datex®, Ohmeda®, and other trademarks S/5, D-lite, D-lite+, Pedi-lite,
Pedi-lite+, Mini D-fend, D-fend, D-fend+, , MemCard, ComWheel,
EarSat, FingerSat, FlexSat, PatientO
2
, Entropy, Patient Spirometry and
Tonometrics are property of Instrumentarium Corp. or its subsidiaries.
All
other product and company names are property of their respective
owners.
The monitor is indicated for use by qualified medical personnel only.
CAUTION
: US Federal law restricts this device to sale by or on the order
of a licensed medical practitioner.
© 2004 General Electric Company. All rights reserved.