5
8995B-eIFU-1115
CAUTION: FEDERAL LAW (U.S.A.) RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN.
For professional use. See instructions for use for full prescribing information, including indications, contraindications, warnings, precautions and
adverse events.The following symbols may appear on the product or product labeling:
SYMBOL DEFINITION SYMBOL DEFINITION
i
Consult Instructions for Use
LOT
Lot code
(blue background)
Follow Instructions for Use
REF
Catalogue number (model number)
Title: Graphic, Manufacturer Symbol, Masimo
PCX-1986
Revision A
DRO-23934
05/09
Manufacturer Masimo reference number
Use By YYYY-MM
NON
STERILE
LATEX
Title: Graphics, Sensor/Cable symbols, 03/06
GR-14231
DRO-13914
-40 C
+70 C
+1060 hPa - +500 hPa
795 mmHg - 375 mmHg
5%-95% RH
5%
95%
%
Pediatric patient
Single Patient Use only
NON
STERILE
LATEX
Title: Graphics, Sensor/Cable symbols, 03/06
GR-14231
DRO-13914
-40 C
+70 C
+1060 hPa - +500 hPa
795 mmHg - 375 mmHg
5%-95% RH
5%
95%
%
Body weight
NON
STERILE
LATEX
Title: Graphics, Sensor/Cable symbols, 03/06
GR-14231
DRO-13914
-40 C
+70 C
+1060 hPa - +500 hPa
795 mmHg - 375 mmHg
5%-95% RH
5%
95%
%
Non-Sterile Greater than
Not made with natural rubber latex Less than
R
x
Only
Federal law (USA) restricts this device to sale by
or on the order of a physician
Storage Humidity Limitation
Mark of Conformity to European Medical Device
Directive 93/42/EEC
Storage Temperature Limitation
EC REP
Authorized representative in the European
community
Keep Dry
Separate collection for electrical and electronic
equipment (WEEE).
Do not use if package is damaged
X
Light Emitting Diode (LED)
LED emits light when current ows through
Instructions/Directions for Use/Manuals are
available in electronic format @
http://www.Masimo.com/TechDocs
Note: eIFU is not available for CE mark
countries.
Patents: http://www.masimo.com/patents.htm
Adhesive Sensors are licensed to purchasers under the foregoing patents for Single-Patient Use Only.
Masimo, SET,
, rainbow and RRa are federally registered trademarks of Masimo Corporation.
rainbow Acoustic Monitoring, rainbow acoustic, and RAM are trademarks of Masimo Corporation.
Printed in USA.