Philips M1191B Manuel utilisateur
Instructions for Use
M1191B and M1191BL
Adult Finger Glove
M1192A
Pediatric Finger Glove
M1193A
Neonate Hand/Foot Wrap
M1194A
Adult/Pediatric Ear Clip
M1195A
Infant Finger/Toe Glove
Reusable SpO2Sensors
About This Edition
Contents
United States law restricts this device to sale by or on the order of a physician.
Notice
Copyright © 2009
Koninklijke Philips Electronics N.V.
All rights are reserved.
Printing History
Current Updated Edition/Revision:
March 2009
Part Number 453564154671
Previous Editions/Revisions:
April 2008
Part Number 453564095901
December 2006
Part Number 453564052251
Instructions for Use.................. 1
Manuel d’utilisation............... 10
Gebrauchsanweisung ............. 19
Gebruiksaanwijzing ............... 28
Instrucciones de uso............... 37
Instruções de Uso................... 46
Istruzioni d’uso ...................... 55
Brukerhåndbok....................... 64
Bruksanvisning ...................... 73
Käyttöopas ............................. 82
Brugsanvisning ...................... 91
Használati útmutató ............. 100
Instrukcja obsługi................. 109
Návod k obsluze................... 118
Návod na použitie ................ 127
Navodila za uporabo ............ 136
Instrucţiuni de folosire ......... 145
Указания за употреба......... 154
Kasutusjuhend...................... 163
Naudojimo instrukcija.......... 172
Lietošanas instrukcijas ......... 181
Инструкция по эксплуатации...190
Οδηγίες Χρήσης................... 199
Kullanım Talimatları............ 208
ユーザーズ・ガイド.......... 217
使用說明.............................. 226
使用说明书.......................... 235
1
Product Overview
Philips A-Series and B-Series reusable SpO2 sensors are available in three
different styles and can be used to monitor a broad range of patient types
as indicated in the Sensor Applications table below. Refer to
Specifications later in this IFU for sensor accuracy.
Intended Use
These SpO2sensors are for multi-patient use, when continuous non-
invasive arterial oxygen saturation and pulse rate monitoring are required.
Instrument Compatibility
All A-Series sensors (model numbers ending with A) are for use with any
Philips/Agilent/HP instrument that lists those sensors as an accessory. The
B-Series sensors (model numbers ending with B or BL) are for use with
any Philips/Agilent/HP instrument that lists them, or the obsoleted
M1191A and M1191AL sensors, as compatible accessories; i.e. the
M1191B sensor replaces the obsoleted M1191A; the M1191BL sensor
replaces the obsoleted M1191AL.
1M1191BL sensors have a Longer 3m (versus standard 2m) attached cable.
2Preferred application sites for M1193A and M1195A sensors.
Sensor Applications
Sensor
Model Number Sensor
Style
Adult Pediatric Infant Neonate
Finger Ear Finger Ear 2Finger Toe 2Hand Foot
M1191B Glove Style 3
1M1191BL Glove Style 3
M1192A Glove Style 3
M1193A Wrap Style 33
M1194A Ear-Clip Style 33
M1195A Glove Style 33
2
Accessories Supplied with Sensors
•M1627A Adult Wristband: Supplied only with adult glove style
sensors. Used to secure the sensor cable to top of adult patient’s hand
and wrist.
Accessories Available for Separate Purchase
•M1940A Adapter Cable: 8-pin (round female) to 12-pin (round male)
adapter cable. Adapts 8-pin sensor connector to 12-pin instrument jack.
Extends sensor cable length by 2m. DO NOT USE with M1191BL
sensors.
•M1941A Extension Cable: 8-pin (round female) to 8-pin (round male)
extension cable. Extends sensor cable length by 2m. DO NOT USE with
M1191BL sensors.
Definition of Product Symbols
Adult Pediatric Adult Finger Infant/Neo Hand Adult/Pediatric Ear
Infant Neonate (Neo) Pediatric/Infant
Finger
Infant Toe Infant/Neo Foot
Caution Consult
Accompanying
Documents
Prescription
Use Only
Storage
Temp
Contains
No Latex
3
Warnings
• These sensors are for use only with Philips/Agilent/HP instruments.
Before using, verify that the combination of instrument/sensor is
specified in the instrument’s user documentation (e.g. Instructions for
Use); otherwise patient injury may result.
• Pulse oximetry measurements are statistically distributed. Two-thirds of
all pulse oximetry measurements can be expected to fall within the
stated accuracy (refer to Specifications later in this IFU for stated sensor
accuracy).
• Connect the sensor only to the SpO2connection or the SpO2adapter
cable of the oximeter.
• Do not reuse the sensor on a different patient until it has been
disinfected. The sensor can be reused on the same patient for the
patient’s entire stay.
• At elevated ambient temperatures, patient skin could be severely burned
after prolonged sensor application at sites that are not well perfused. To
prevent this condition, be sure to check patient application sites
frequently. All listed sensors operate without risk of exceeding 41o C on
the skin if the initial skin temperature does not exceed 35o C.
• Be sure to apply the sensor to the patient at the preferred or alternative
application site, while following application instructions provided later
in this document. Failure to do so can cause inaccurate measurements.
• To avoid venous pulsation, obstructed circulation, pressure marks,
pressure necrosis, artifacts and inaccurate measurements, make sure you
are using a sensor of the correct size and that the sensor is not too tight.
If the sensor is too tight, because the application site is too large or
becomes too large due to edema, the excessive pressure applied may
result in venous congestion distal from the application site, leading to
interstitial edema and tissue ischemia.
• If the sensor is applied too loosely it may fall off or compromise proper
alignment of sensor optics and result in inaccurate readings.
4
Warnings (cont.)
• Where possible, the application site for the sensor should be an
extremity free of arterial catheters, blood pressure cuffs, or intravascular
infusion lines.
• Avoid sites subject to excessive motion. Try to keep the patient still, or
move the sensor to a site with less motion.
• Dysfunctional hemoglobin or intravascular dyes can cause inaccurate
measurements.
• Make sure the application site for the sensor is not deeply pigmented, or
deeply colored. For example, nail polish, artificial nails, dye or
pigmented cream may cause inaccurate measurements. In any of these
cases reposition the sensor or choose an alternative sensor for use at a
different site.
• Cover the sensor with opaque material under conditions of strong or
excessive light (infrared lamps, OR lamps, photo therapy). Failure to do
so can result in inaccurate measurements.
• Protect the connector from contact with any liquid.
• Inspect the sensor application site every 2 to 3 hours to ensure skin
integrity, correct optical alignment, and circulation distal to the sensor
site. Skin irritation or ulceration may occur if the sensor is attached to
one location for too long. Change the sensor application site every
4 hours, or more often if circulation or skin integrity is compromised. If
the light source is not directly opposite the light detector, reapply the
sensor, or choose an alternative sensor for use at a different site.
• Do not use a sensor during MRI scanning. This may cause burns or
inaccurate measurements.
•M1191BL only: Do not use the M1191BL sensor with an extension or
adapter cable.
•M1195A only: Infant patients are prone to movement; therefore, when
applying the M1195A sensor to an infant, secure the sensor cable with
tape to prevent the sensor from coming off the infant’s finger. If
necessary, position the sensor on a different finger or an alternate site
(toe).
5
Before Applying the Sensor
Be sure to read and understand all Warnings listed in your SpO2
monitoring instrument IFU, as well as all Warnings described in this
sensor IFU. Use sensors only with validated instruments and at a
recommended patient application area.
Inspect Sensor for Damage
• Before reusing, inspect the sensor outside and inside. To check the inside
of a glove style sensor, gently open the finger cavity and check for splits
on or next to the transparent silicone that covers the optical elements. Be
sure there are no blisters on the silicone and no liquid leaking from
sensor optics.
• Any sensor showing signs of damage or alteration must not be used for
further patient monitoring; instead, dispose of it using proper disposal
procedures (see below).
Sensor Disposal
Disposal of Deteriorated Sensors
Any sensor showing signs of physical or electrical deterioration or failure
should be disinfected, decontaminated, and disposed of according to local
laws regarding the disposal of hospital waste.
Change Application Site Periodically
Move the sensor application site every 4 hours, or more often if
circulation or skin integrity is compromised.
6
Applying Glove Style Sensors
Adult Patients (>50kg)
Apply M1191B or M1191BL Sensor to any finger
except thumb.
Pediatric Patients (15-50kg)
Apply M1192A Sensor to any finger except thumb.
Infant Patients (4-15kg)
Apply M1195A Sensor to any finger (except thumb), or to any toe. Finger
or toe diameter should measure between 7-8mm (0.27-0.31”).
Step Applying the Glove Style Sensor
1 Select appropriate sensor for patient size (defined above).
2 Position sensor over patient’s finger. If applying an adult finger
sensor, be sure the sensor cable is positioned ON TOP of the fin-
ger/hand as shown above.
3 Patient fingertip should touch but not protrude from end of sensor.
If necessary, trim the fingernail to correctly position the sensor.
4 If applying an adult finger sensor, secure the cable to BACK OF
HAND with M1627A wristband (supplied only with adult finger
sensors.)
5 Plug sensor into instrument (or into adapter cable if needed).
6 Inspect and change the sensor application site periodically.
adult application
shown
7
Applying Wrap Style Sensors
Neonate Patients (1-4kg)
Apply M1193A Sensor to hand or foot as shown.
Applying Ear-Clip Style Sensors
Adult or Pediatric Patients (>40kg)
Clip M1194A Sensor to ear as shown.
Step Applying the Wrap Style Sensor
1 Position the sensor so that it surrounds the hand or foot with opti-
cal components opposite each other.
2 Holding sensor, stretch strap slightly (not more than 2.5cm (1.0”).
3 Insert stretched strap into slot, hold it there while threading end
through latch. If strap is too long, thread it through second latch.
4 Plug sensor into instrument (or into adapter cable if needed).
5 Inspect and change the sensor application site periodically.
Step Applying the Ear-Clip Style Sensor
1 To improve perfusion, massage or warm the ear lobe.
2 Clip probe onto fleshy part of the lobe. Do not position probe on
cartilage or pressed against the head. Clip plastic fixing mecha-
nism on top of the ear. The fixing mechanism minimizes artifact
generated by patient motion.
3 Plug sensor into instrument (or into adapter cable if needed).
4 Inspect and change the sensor application site periodically.
8
Cleaning and Low-Level Disinfection
These reusable sensors should be cleaned and disinfected, but never
sterilized. Follow the procedure outlined below.
Warnings
• Use only validated cleaning agents and disinfectants listed below; use
of others that are not validated may damage the sensor or its connect-
ing wires and shorten product lifetime or cause safety hazards.
• Select disinfectants carefully as some have very similar names but
completely different compositions.
• Do not immerse the sensor connector in any of the cleaning solutions,
disinfectant, or other liquid (the sensor and cable housing may be
immersed, but not the connector).
• Do not soak sensors in disinfectants longer than specified by the dis-
infectant manufacturer.
• Do not sterilize or autoclave the sensors.
Validated Cleaning Agents
Validated Disinfectants
- Mild Detergent - Salt Solution (1%)
Metricide®28 Cidex®Formula 7 Kohrsolin®(2%)
Metricide®Plus 30 Cidex®OPA Mucapur®-CD (1%)
Terralin®Liquid Cidex®Plus Isopropanol (70%) or
Isopropanol Wipe (70%)
Incidin®Liquid Omnicide®28
Step Cleaning and Low-Level Disinfection
1 Clean sensor following instructions supplied with cleaning agent.
2 Disinfect sensor following instructions supplied with disinfectant.
3 Rinse sensor and cable (but not the connector) in water, wiping it dry with a
clean cloth, leaving to dry completely. If you notice any deterioration or
damage to sensor or cable, dispose the sensor immediately.
Ce manuel convient aux modèles suivants
5
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