Reusable Pediatric SpO2 Finger Clip Sensor
Directions for use
Intended Use
When used with a compatible patient monitor or a pulse oximeter device, the sensor is intended to be used for continuous, non-invasive functional arterial oxygen saturation (SpO2) and pulse rate monitoring forì
pediatric patients weighing between 15~40kg (or finger thickness
between 8mm~16mm).
Contraindications
This sensor is contraindicated for use on active patients or for prolonged use.
Instructions for Use
1) With the upper and lower jaws open, place an index finger evenly on
the base of the clip. Push the finger tip against the stop so that it is over
the sensor window (A). If an index finger cannot be positioned correctly,
or is not available, other fingers can be used.
Note: When selecting a sensor site, priority should be given to an extremity free of an arterial catheter, blood pressure cuff, or intravascular
infusion line.
2) Spread open the rear tabs of the sensor to provide even force over
the length of the pads (B).
3) The sensor should be oriented in such a way that the cable is positioned along the top of the hand (C).
4) Plug the sensor into the oximeter and verify proper operation as
described in the oximeter operator’s manual.
5) Inspect the monitoring site every 4 hours for skin integrity.
6) Before each use, surface-clean sensor and cable with a soft gauze
pad by saturating it with a solution such as 70% isopropyl alcohol. If low
-level disinfection is required, use a 1:10 bleach solution.
Caution: Do not sterilize by irradiation steam, or ethylene oxide.
Warnings
1) Some factors may affect the accuracy of saturation measurements.
Such factors include: excessive patient motion, fingernail polish, use of
intravascular dyes, excessive light, poor blood perfusion in the finger,
extreme finger sizes or improper placement of the sensor.
2) Using the sensor in the presence of bright lights may result in inaccurate measurements. In such cases, cover the sensor site with an opaque material.
3) The sensor must be moved to a new site at least every 4 hours. Because individual skin condition affects the ability of the skin to tolerate
sensor placement, it may be necessary to change the sensor site more
frequently with some patients. If skin integrity changes, move the sensor to another site.
4) Do not apply tape to secure the sensor in place or to tape it shut;
venous pulsation may lead to inaccurate saturation measurements.
5) Do not immerse sensor as it causes short.
6) Do not use NIBP or other constructing instruments on same appendage as sensor for blood flow interrupted by NIBP cuff or circulatory
patient condition will result in no pulse found or loss of pulse.
7) Do not use the sensor or other oximetry sensors during MRI scanning.
8) Carefully route cables to reduce the possibility of patient entanglement or strangulation.
9) Do not alter or modify the sensor. Alterations or modifications may
affect performance or accuracy.
10) Do not use the sensor if the sensor or the sensor cable appears
damaged.
Reusable Pediatric SpO2 Finger Clip Sensor
Directions for use
Disposal: The product must not be disposed of along with
other domestic waste. The users must dispose of this
equipment by bringing it to a specific recycling point for
electric and electronic equipment.
GIMA WARRANTY TERMS
The Gima 12-month standard B2B warranty applies.
Symbols
Follow instructions for use
Product code
Lot number
Date of manufacture
15040015 (GIMA 34347)
Shenzhen Creative Industry Co., Ltd.
Floor 5, BLD 9, BaiWangxin High-Tech Industrial Park,
Songbai Road, Xili Street, Nanshan District,
518110 Shenzhen, P.R. China
MADE IN CHINA
Shanghai International Holding Corp. GmbH
(Europe) Eiffestrasse 80, 20537 Hamburg, Germany
Imported by:
GIMA S.p.A. - Via Marconi, 1 - 20060 Gessate (MI) - Italy
gima@gimaitaly.com - export@gimaitaly.com
www.gimaitaly.com
3502-2290027 V1.3 Date: May 26, 2023
Manufacturer
Authorized representative in the European com-
munity
WEEE disposal
Medical Device complies with Directive 93/42/
EEC
Caution: read instructions (warnings) carefully
Keep in a cool, dry place
Keep away from sunlight
Type BF applied part
Non-sterile
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