Philips M1902B OxiMax Gebrauchsanweisung

Infant SpO
2
M1902B OxiMax
a
Sterile in unopened, undamaged package,
sterilized in the U.S.A.
This product complies with the requirements of the Council
Directive 93/42/EEC of 14 June 1993 (Medical Device
Directive)
*M1902-9001B*
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 Puri-
tan Bennett Inc.
Manufactured by Nellcor Puritan Bennett Inc., Pleasanton, CA 94588 USA
Address of the Manufacturer
Philips Medizin Systeme
Böblingen GmbH
Hewlett-Packard-Strasse 2
71034 Böblingen
Germany
Sensor
TM
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
M1902-9001B
4512 610 10881
English
Instructions for Use
The M1902B Philips infant SpO
noninvasive arterial oxygen saturation and pulse rate monitoring are required for
infants weighing between 3 and 20 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 arte-
rial catheter, blood pressure cuff, or intravascular infusion line. The big toe is
best, although a finger or toe of similar size can be used instead.
2. Remove the plastic backing from the M1902B and locate the optical
components on the adhesive side, marked (a) in the figure on the front of this
document.
3. Place the sensor under the patient's toe so that the sensor cable is underneath
the big toe and extends towards the heel. Wrap the adhesive flaps snugly
Rx ONLY
around the patient's toe from below. Wrap any excess tape loosely around the
toe.
4. Use the additional tape provided to secure the cable across the bottom of the
foot. Do not restrict circulation.
5. Plug the M1902B into the oximeter and verify correct operation as described
Contains no
in the oximeter instructions for use.
Latex
Reuse
The M1902B can be reused on the same patient
as long as the adhesive tape attaches without
slippage.
To prepare the sensor for reuse, place one of the
adhesive dots provided over each optical
component, then remove the protective paper
that covers the dot.
Warnings
1. Failure to apply the M1902B properly may cause incorrect measurements.
2. High oxygen levels may predispose a premature infant to develop retinopathy.
Therefore, the upper alarm limit for oxygen saturation must be carefully
selected in accordance with accepted clinical standards and considering the
accuracy range of the oximeter being used.
3. While the M1902B is designed to reduce the effects of ambient light, excessive
light may cause inaccurate measurements. In such cases, cover the sensor with
opaque material.
4. 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.
5. Intravascular dyes or externally applied coloring such as nail polish, dye, or
pigmented cream may lead to inaccurate measurements.
6. Excessive motion may compromise performance. In such cases, try to keep the
patient still, or change the sensor site to one with less motion.
7. Do not immerse in water or cleaning solutions. Do not resterilize.
8. If the sensor is wrapped too tightly or supplemental tape is applied, venous
pulsations may lead to inaccurate saturation measurements.
9. Do not use the M1902B or other oximetry sensors during MRI scanning.
Conducted current may cause burns. Also, the M1902B may affect the MRI
image, and the MRI unit may affect the accuracy of oximetry measurements.
10. Do not alter or modify the M1902B. Alterations or modifications may affect
performance or accuracy.
11. 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 continuous
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