Datex-Ohmeda S/5 FM, User Manual

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About this guide
This User’s Guide describes the most common features and functions
offered by the Datex-Ohmeda S/5 FM. Descriptions refer to S/5
software licenses L-FICU03 and L-FICU03A.
If you are a new user of the monitor, we suggest you begin with
sections "Safety precautions", “System introduction” and
"Monitoring basics.” The following conventions are used:
-
Names of the hard keys on the Command Board, Remote
Controller and modules are written in the following way:
ECG
.
- Menu items are written in bold italic typeface: ECG Setup.
- Menu access is described from top to bottom. For example, the
selection of the
Screen 1 Setup menu item and the Waveform
Fields menu item would be shown as Screen 1 Setup -
Waveform Fields .
- Messages (alarm messages, informative messages) displayed on
the screen are written inside single quotes: ‘Learning.’
- When referring to different sections in this manual, section names
are enclosed in double quotes: “Cleaning and care.”
- In this manual, the word “select” means choosing and confirming.
Related documentation
Clinical aspects, basic methods of measurement and technical background:
S/5 FM User’s Reference Manual
Installation, technical solutions and servicing: S/5 FM Technical Reference
Manual
Options and selections of the software: S/5 FM Default Configuration
Worksheet
Compatible supplies and accessories: S/5 FM Supplies and Accessories
Other devices closely related to the S/5 FM:
S/5 iCentral User’s Reference Manual
S/5 Network Wireless LAN Installation Guide
Intended purpose (Indications for use)
The Datex-Ohmeda S/5 FM is intended for multiparameter patient
monitoring. The S/5 FM with L-FICU03 or L-FICU03A software is
indicated for monitoring of hemodynamics (including arrhythmia and
ST-segment analysis) and respiratory status of all hospital patients.
Impedance respiration measurement is indicated for patients three
years old and up. NIBP and CO
2
(using option N-FCREC or N-FC)
measurements are indicated for patients weighing over 5 kg (11 lb).
The S/5 FM is 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 is 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.
In accordance with IEC 60529:
- IPX1 - degree of protection against harmful ingress of water.
In accordance with EU Medical Device Directive:
IIb
In accordance with CISPR 11: Group 1 Class B; see page 4 of this
User’s Guide
Responsibility of the manufacturer
Datex-Ohmeda Division, Instrumentarium Corp. is responsible for the
safety, reliability and performance of the equipment only if:
-
assembly, extensions, readjustments, modifications, service and
repairs are carried out by personnel authorized by Datex-Ohmeda.
- electrical installation complies with appropriate requirements.
- the equipment is used in accordance with this User’s Guide.