Saros 4000 Operator's Manual page 3

Operator Manual
COUNCIL DIRECTIVE 93/42/EEC; CONCERNING
MEDICAL DEVICES
If the product unique device identifier (UDI)
label has the CE#### symbol on it, the device
complies with the requirements of Directive
93/42/EEC concerning medical devices. The
CE#### symbol indicates notified body number.
INTERNAL SYMBOLS
Keep away from flammable materials, oil and
grease.
Oxygen Output; The port from which the Oxygen
O
flows and where the tubing or interface(standard
2
nasal cannula) is connected.
Amperes (Current)
Alert (Yellow) Indicator*: When illuminated, this
indicates an awareness condition or Caution.
ON/OFF (Standby); Powers the device ON or
OFF, but does not directly disconnect the main
power.
Increase Flow Setting; Increases the flow setting
by 1.0 LPM increments or by 1 pulse setting
each time the button is pressed.
Decrease Flow Setting; Decreases the flow
setting by 1.0 LPM increments or by 1 pulse
setting each time the button is pressed.
Activates either Continuous Flow Mode or Pulse
Flow Mode Operation.
Utility; The Button that activates a utility menu
to access information or to change settings.
External Power is Present Indicator; Indicates the
presence of external power.
Battery Status Indicator; Shows the amount of
charge remaining in the battery. When charging,
battery displays as a "Waterfall" Effect.
"Alarm Off" indicator displayed during Tactical
Mode.
21 CFR 801.15: CODE OF FEDERAL REGULATIONS TITLE
Federal law restricts this device to sale by or on
the order of a physician.
COUNCIL DIRECTIVE 2012/19/EU: WASTE ELECTRICAL
AND ELECTRONIC EQUIPMENT (WEEE)
WEEE
IEC 60601-1: MEDICAL ELECTRICAL EQUIPMENT -
PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND
ESSENTIAL PERFORMANCE
Classification; Class II Equipment, double
insulated.
Certified for both the U.S. and Canadian markets,
to the applicable U.S. and Canadian standards.
Protected from tools and wires greater than 2.5
millimeters, Protected from water spray less than
60 degrees from vertical.
*Alarms for the SAROS are considered information-only signals.
This product may be covered by one or more patents, US and inter-
national. Please visit our website below for the listing of applicable
patents. Pat.: www.caireinc.com/corporate/patents/.
21
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