Philips M1191B Manual de usuario

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

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

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

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

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.

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).

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.

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

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.

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.

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