Nonin 8600 Manual de usuario

Operator’s Manual

Models 8600 & 8600M

Pulse Oximeters

CAUTION! Federal law (USA) restricts this device to sale by or on the order of a physician.

CAUTION! Read this manual carefully before using the 8600.

The information in this manual has been carefully checked and is believed to be accurate. In the interest of

continued product development, NONIN reserves the right to make changes and improvements to this

manual and the products it describes at any time, without notice or obligation.

Nonin Medical, Inc.

2605 Fernbrook Lane North

Plymouth, MN 55447-4755

USA

(763) 553-9968

(800) 356-8874

FAX (763) 553-7807

References to “NONIN" in this manual shall imply Nonin Medical, Inc.

Nonin is a registered trademark of Nonin Medical, Inc.

References to “8600” in this manual shall imply Models 8600 and 8600M.

Authorized EC Representative:

MPS, Medical Product Service GmbH

Borngasse 20

D-35619 Braunfels, Germany

Guide to Symbols

ATTENTION: Consult Accompanying Documents

CE Marking indicating conformance to EC directive No. 93/42//EEC concerning medical

devices

UL Mark for Canada and the United States with respect to electric shock, fire, and mechanical

hazards only in accordance with UL 2601-1 and CAN/CSA C22.2 No. 601.1.

Precautions For Use

Contraindications

• Do not operate the 8600 in an explosive atmosphere.

• Do not operate the 8600 in an MRI environment.

• Do not use the 8600 for home healthcare. The 8600 alarms can easily be turned off, and the alarm settings

can easily be modified.

Warnings

• The 8600 is intended as an adjunct in patient assessment. It must be used in conjunction with clinical signs

and symptoms.

• Do not set the alarm volume too low to be heard. Doing so could compromise patient safety.

• The audible alarm of the 8600 is for the convenience of the attendant near the patient. It is not intended to

call an attendant from another room or from a distance. The user must determine the audible distance

based on the operating environment.

• The use of supplemental oxygen with premature infants has been associated with an increased incidence of

retinopathy of prematurity and bronchopulmonary dysplagia. The SpO2high alarm setting must be chosen

with regard to accepted clinical standards.

• Use only NONIN manufactured sensors. These sensors are manufactured to meet the calibration

requirements for NONIN pulse oximeters. Use of other manufacturer's sensors may cause improper pulse

oximeter performance.

• Check application site frequently to determine circulation, positioning, and skin sensitivity of the patient.

Each patient's sensitivity to NONIN sensors may vary depending on their medical status or the condition of

their skin.

• Use of NONIN double-backed adhesive strips or the Hydrogel tape strips should be discontinued if the

patient exhibits allergic reactions to the adhesive material.

• Do not stretch the adhesive tape while applying the sensors. This may cause inaccurate readings or skin

blisters.

• This device should not be used adjacent to or stacked with other equipment. If adjacent or stacked use

is necessary, the device should be observed carefully to verify normal operation.

• The use of accessories, sensors, and cables other than those listed in this manual may result in increased

emission and/or decreased immunity of this device.

Cautions

• This equipment complies with International Standard EN 60601-1-2:2001 for electromagnetic compatibility

for medical electrical equipment and/or systems. This standard is designed to provide reasonable protection

against harmful interference in a typical medical installation. However, because of the proliferation of radio-

frequency transmitting equipment and other sources of electrical noise in healthcare and other

environments, it is possible that high levels of such interference due to close proximity or strength of a

source might disrupt the performance of this device. Medical electrical equipment needs special precautions

regarding EMC, and all equipment must be installed and put into service according to the EMC information

specified in this manual.

• Portable and mobile RF communications equipment can affect medical electrical equipment.

• Federal law (USA) restricts this device to sale by or on the order of a physician.

• Carefully read this manual and the instructional insert provided with the sensor before use of the 8600.

• Ear Clip and Reflectance sensors are not recommended for pediatric or neonatal use. The accuracy of the

sensors has not been established for pediatric or neonatal use.

• Remove earrings from the patient’s ear before applying the Ear Clip Sensor.

• The 8600 must be able to measure the pulse properly to obtain accurate SpO2measurement. Verify that

nothing is hindering the pulse measurement before relying on the SpO2measurement.

• Inaccurate SpO2and/or pulse rate measurement may result if the 8600 is operated in a low battery condition

• Fingernail polish may reduce light transmission and thereby affect SpO2accuracy.

• The 8600 may not work on all patients. If you are unable to achieve stable readings, discontinue use.

• The 8600 may interpret motion artifact of sufficient amplitude and regularity as good perfusion (green).

• The 8600 is calibrated to determine the percentage of arterial oxygen saturation of functional hemoglobin.

Significant levels of dysfunctional hemoglobin such as carboxyhemoglobin or methemoglobin may affect the

accuracy of the measurement.

• Cardiogreen and other intravascular dyes, depending on the concentration, may affect the accuracy of the

SpO2measurement.

• Do not immerse the 8600 or NONIN sensors in liquid to clean.

• Do not use caustic or abrasive cleaning agents on the 8600 or NONIN sensors.

• This device has not been tested for immunity to electromagnetic disturbances.

• The 8600 is sensitive and must be repaired by knowledgeable and specially trained personnel only.

Manufacturer’s Declaration

Refer to the following table for specific information regarding this device’s compliance to IEC Standard 60601-1-2.

Table 1: Electromagnetic Emissions

Emissions Test Compliance Electromagnetic Environment— Guidance

This device is intended for use in the electromagnetic environment specified below.

The customer and/or user of this device should ensure that it is used in such an environment.

RF Emissions

CISPR 11

Group 1

This device uses RF energy only for its internal function. Therefore, its RF emissions

are very low and are not likely to cause any interference in nearby electronic

equipment.

RF Emissions

CISPR 11

Class B

Harmonic

Emissions

IEC 61000-3-2

N/A

Voltage

Fluctuations/

Flicker Emissions

IEC 61000-3-3

N/A

This device is suitable for use in all establishments, including domestic and those

directly connected to the public low-voltage power supply network that supplies

buildings used for domestic purposes.

Unpacking Your Pulse Oximeter

Contact the carrier immediately if the shipping carton for the 8600 is damaged. Carefully unpack the pulse

oximeter and its accessories. Confirm that the items listed below are packed with the 8600 Pulse Oximeter.

The 8600/8600M shipment includes:

• 8600 or 8600M Pulse Oximeter

• A/C Battery Charger

• Operator’s Manual for Models 8600 and 8600M

• 8800I Patient Interface Cable

• 8000AA-1 Sensor (Adult Articulated Finger Clip)

If any item on this list is missing or damaged, do not use the pulse oximeter. Contact your local distributor or,

if you do not know your local distributor, contact NONIN at (800) 356-8874 or (763) 553-9968.

Introduction

Indications For Use

The 8600 Pulse Oximeter is intended to be used to monitor oxygen saturation and pulse rate for adult,

pediatric, and neonatal patients in hospital, ambulatory, and EMS environments.

General

The 8600 Pulse Oximeter is small, light weight, and is intended to be portable. It has audible and visual alarms

for monitoring patient status. The 8600 may be connected to A/C power or run from its internal battery. It

typically operates for 30 hours on a fully charged battery. The 8600 requires no routine calibration or

maintenance.

The 8600 determines arterial oxyhemoglobin saturation (SpO2) by measuring the absorption of red and

infrared light passed through tissue. Changes in absorption caused by pulsation of blood in the vascular bed

are used to determine arterial saturation and pulse rate.

Oxygen saturation and pulse rate are displayed on light emitting diode (LED) digital displays. On each

detected pulse, the perfusion ( ) indicator flashes. Patient perfusion signals are graded as good, marginal, or

inadequate and are indicated by the indicator flashing green, yellow, or red, respectively. This simple

method gives the user a pulse-by-pulse visual indication of waveform signal quality without requiring the user

to perform complex waveform analysis during critical patient care situations.

Sensor disconnect or malfunction is indicated by lack of good perfusion flashes and/or the red SENSOR

indicator on the front panel illuminating. Ultimately, if adequate perfusion pulses are not received, the SpO2

and pulse rate numerical values will be replaced by dashes.

The 8600 Pulse Oximeter has been approved by the U.S. Air Force for use in the U.S.A.F. aeromedical

evacuation environment when operating on its internal battery or with the NONIN Model 7708 A/C Battery

Charger.

Operating Instructions

Battery Charging

If portable operation is not necessary, continuously charging with the proper battery charger is recommended.

The battery charger plugs into the back of the 8600 where it is marked "BATTERY CHARGER". Refer to

Figure II for illustration. This will assure a fully charged battery should portable operation be required.

The battery charger requires 15 hours to recharge a completely depleted battery pack. While the battery

charger is connected to AC power, the green indicator will be illuminated, and the pulse oximeter may be

operated during this time if the red indicator is not illuminated when the unit is turned on. If the red

indicator is illuminated when the unit is turned on, the battery must charge until the red is no longer

illuminated before it may be used.

The battery pack in the 8600 will typically power the unit for 30 hours with a full charge without needing to be

charged.

The 8600 indicates when the battery is low by illuminating the indicator in red.

NOTE: The Nonin Model 7708 Battery Charger must be used in place of other NONIN battery

chargers to meet U.S. Air Force requirements for the U.S.A.F. aeromedical evacuation

environment

Connecting the Cable and Sensors

Connect the patient interface cable (Model 8800I) to the 8-pin female latching connector on the front of the

8600 shown in Figure I. Connect the sensor to the patient interface cable. Position the appropriate sensor on

the patient. If additional cable length is necessary, connect the Model 8604X-10, -20, or -30 Extension Cable or

the Model 8500I Patient Extension Cable between the sensor and the 8800I.

Turning On The Pulse Oximeter

Turn on the 8600 by pressing the " I" power switch on the front of the pulse oximeter. Refer to Figure I.

When the 8600 is turned on, the displays will cycle through the following sequence before displaying valid data:

• "" (8600) or " " (8600M)

• current time in hours and minutes saved in memory

• software revision number

• ""

• SELF

TEST indicator illuminates

• SENSO

indicator illuminates

• indicator illuminates

NOTE: If this sequence does not complete properly, do not use the pulse oximeter. Contact

Nonin Customer Support.

Figure 1: Front View of the 8600

Figure 2: Rear View of the 8600

Figure 3: Labels on the 8600

Verifying Operation

CAUTION! The 8600 must be able to measure the pulse properly to obtain accurate SpO2

measurement. Verify that nothing is hindering the pulse measurement before relying

on the SpO2measurement.

Verify that the sensor is properly positioned. Ensure the system is sensing adequate perfusion by observing

that the indicator is blinking green and correlates to the pulse rate for 10 seconds. Should the perfusion

light be red or yellow or flashing erratically, reposition the sensor or try a different sensor.

For the first 2 minutes of operation, the indicator will flash to indicate the audible alarm is temporarily

disabled during power on. During the first two minutes, the audible alarm may be enabled by pressing the

AUDIO button. If the audible alarm is not permanently disabled, the indicator will not be illuminated after

the first 2 minutes of operation and the audible alarm will be enabled.

If the alarm is permanently disabled, the indicator will illuminate continuously, and pressing the AUDIO

button will not have no effect on the audible alarm.

Cleaning the Pulse Oximeter

CAUTION! Do not immerse the 8600 in liquid, and do not use caustic or abrasive cleaning

agents.

The 8600 Pulse Oximeter may be cleaned with a mild detergent and a soft cloth or with an isopropyl alcohol

wipe. Allow enough time for the 8600 to dry thoroughly before reusing.

Features

Controls

All functions of the 8600 are controlled by switches found on the front and rear of the unit. Refer to Figures I

and II for illustrations of these switches.

Power Switch

Pressing the power switch ON (" I") causes power to be applied to all internal circuitry. Pressing the power

switch to STBY (" O") causes power to be removed from the displays and puts the pulse oximetry circuitry

into a low power standby mode.

AUDIO Button

The AUDIO button has 4 different functions, which are described below.

Function Activation Instructions

Audible Alarm Enable/Disable Momentary press during normal operation

Calibrate Recorders Hold for more than 5 seconds during normal operation

Memory Playback (8600M only) Hold for less than 2 seconds during power up

Real-time Setup Mode Hold for more than 2 seconds during power up

Audible Alarm Enable/Disable

Momentarily pressing the AUDIO button disables the audible alarm for 2 minutes. Pressing this button again

will override the 2 minute period, re-enabling the audible alarm.

NOTE: Pressing this button has no effect if the audible alarm has been permanently disabled.

Calibrate Recorders

When using a strip-chart recorder for outputting data, calibration between the recorder and the 8600 may be

necessary. To do this during normal operation, hold the

UDIO button for more than 5 seconds to activate the

recording output calibrate sequence. You can select the calibration sequence with Option Switch 3.

NOTE: Calibration signals are sent via the SpO2 and pulse rate lines; not the serial output line.

Standard Calibration:

The value sent for the SpO2will alternate from 0% (for 5 seconds) to 100% (for 6 seconds) to 50% (for 5

seconds) and then repeat. The value sent out for the pulse rate will alternate from 0 BPM to 125 BPM to

250 BPM and then repeat. To end calibration sequence, release the

UDIO button, and the 8600 will return

to normal operation.

Alternate Calibration:

The value sent for the SpO2will step through at 5% intervals when actuated by the user by pressing the

AUDIO button beginning at 0% through 100% and then repeat. The value sent out for the pulse rate will

remain at 60 BPM. To end calibration sequence, hold the

UDIO button for 5 seconds, and the 8600 will

return to normal operation.

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