Philips OxiMax M1904B Notice D'utilisation

Adult SpO Sensor
2
M1904B OxiMax
a
This product complies with the requirements of the Council
Directive 93/42/EEC of 14 June 1993 (Medical Device
Directive
*M1904-9001B*
For more information, please call your local Philips sales office listed in your
telephone directory or a Philips regional office listed below for the location of
your nearest sales office.
United States:
Philips Medical Systems
Cardiac and Monitoring Systems
Headquarters
3000 Minuteman Road
Andover, MA 01810, USA
(800) 934-7372
Canada:
Philips Medical Systems Canada
281 Hillmount Road
Markham, ON
L6C 2S3
(800) 291-6743
Latin America Headquarters:
Philips Medical Systems
1550 Sawgrass Corporate Parkway #300
Sunrise, FL 33323
Tel: (954) 835-2600
Fax: (954) 835-2626
This sensor is sold under the following U.S. Patents and foreign equivalents for single
patient use only: 4,621,643; 4,700,708; and 4,830,014.
Any other use of this sensor is not authorized. OXIMAX is a registered trademark of
Nellcor Puritan Bennett Inc.
Manufactured by Nellcor Puritan Bennett Inc., Pleasanton, CA 94588 USA
Authorized representative
Philips Medizin Systeme
Böblingen GmbH
Hewlett-Packard-Strasse 2
71034 Böblingen
Germany
All manuals and user guides at all-guides.com
TM
Rx ONLY
Contains no
Latex
Sterile in unopened, undamaged
package, sterilized in the U.S.A.
Europe, Middle East and Africa:
Philips Medizin Systeme Böblingen GmbH
Cardiac and Monitoring Systems
Hewlett-Packard Str. 2
71034 Böblingen
Germany
Fax: (+49) 7031 463 1552
Asia Pacific Headquarters:
Philips Medical Systems
30/F Hopewell Centre
17 Kennedy Road
Wanchai
Hong Kong
Tel: (852) 2821 5888
Fax: (852) 2527 6727
http://shop.medical.philips.com
© Copyright 2005 Koninklijke Philips
Electronics N.V. All Rights Reserved.
Subject to modification
Printed in Germany 07/2005
M1904-9001B
4512 610 10901
English
Instructions for Use
The M1904B Philips adult SpO
2
continuous noninvasive arterial oxygen saturation and pulse rate
monitoring are required for adults weighing over 30 kg.
For sensor compatibility, accuracy specifications, and further instructions,
warnings, and cautions, please consult the monitor Instructions for Use.
Do not use on patients who exhibit allergic reactions to the adhesive tape.
The sensor does not contain latex.
1. Select a site for sensor placement, preferably on an extremity without
an arterial catheter, blood pressure cuff, or intravascular infusion line.
An index finger is best, although a different finger or a big toe can be
used instead.
2. Remove the plastic backing from the M1904B and locate the optical
components on the adhesive side, marked (a) in the figure on the
front of this document.
3. With the sensor opened out and its cable pointing away from the
patient, place the patient's finger at the dashed line in the middle of
the sensor. Wrap the adhesive flaps around the patient's finger from
below.
4. Fold the cable end of the sensor over the top of the patient's finger so
that the optical components are directly opposite each other. Wrap
the adhesive flaps securely around the patient's finger from above.
5. Plug the M1904B into the oximeter and verify correct operation as
described in the oximeter instructions for use.
Warnings
1. Failure to apply the M1904B properly may cause incorrect measure-
ments.
2. While the M1904B is designed to reduce the effects of ambient light,
excessive light may cause inaccurate measurements. In such cases,
cover the sensor with opaque material.
3. Circulation distal to the sensor site should be checked routinely. The
site must be inspected every 8 hours to ensure adhesion, skin
integrity, and correct optical alignment. If skin integrity changes,
move the sensor to another site.
4. Intravascular dyes or externally applied coloring such as nail polish,
dye, or pigmented cream may lead to inaccurate measurements.
5. Excessive motion may compromise performance. In such cases, try to
keep the patient still, or change the sensor site to one with less
motion.
6. Do not immerse in water or cleaning solutions. Do not resterilize.
7. If the sensor is wrapped too tightly or supplemental tape is applied,
venous pulsations may lead to inaccurate saturation measurements.
8. Do not use the M1904B or other oximetry sensors during MRI
scanning. Conducted current may cause burns. Also, the M1904B
may affect the MRI image, and the MRI unit may affect the accuracy
of oximetry measurements.
9. Do not alter or modify the M1904B. Alterations or modifications
may affect performance or accuracy.
10. In the event of damage to the sterile packaging, do NOT resterilize.
Follow local governing ordinances and recycling instructions
regarding disposal or recycling of sensors.
sensor is for single-patient use when