Models 8500- 8500M Operators Manual

About the Manual There are many contraindications, warnings, and cautions throughout this manual. Read them carefully; they are important to the use of the product. 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. CAUTION! Federal law (USA) restricts this device to sale by or on the order of a physician. CAUTION! Read this manually carefully before using the Model 8500.

Nonin Medical, Inc. 2605 Fernbrook Lane North Plymouth, MN 55447-4755 USA (763) 553-9968 (800) 356-8874 (USA and Canada) Fax (763) 553-7807 E-mail: [email protected] www.nonin.com

Authorized EC Representative: MPS, Medical Product Service GmbH Borngasse 20 D-35619 Braunfels, Germany

References to “NONIN” in this manual shall imply Nonin Medical, Inc. NONIN, nVISION, Flexi-Form, and FlexiWrap are registered trademarks or trademarks of Nonin Medical, Inc. References to “8500” in this manual imply Models 8500 and 8500M. © 2002 Nonin Medical, Inc.

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Table of Contents Precautions for Use ... 1 Unpacking the Model 8500 ...3 Introduction...4

Indications for Use ... 4 General Description ... 4

Basic Operation...5

Installing Batteries... 5 Connecting Sensors ... 7

Features ... 10

Controls... 10 Displays ... 15 Printer/Serial Output... 17 Memory Option (8500M Only) ... 18

Specifications...20 Service... 21 Warranty ...22 Accessories ...23 Troubleshooting Guide ...24

Guide to Symbols Attention: See instructions for use. Type BF Applied Part (Patient isolation from electric shock)

Canadian Standards Association

UL

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

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Precautions for Use Contraindications • Do not use the 8500 in an MRI environment. • Do not use the 8500 in a situation where alarms are required. The 8500 has no alarms.

Warnings • Explosion Hazard. Do not use the 8500 in an explosive atmosphere. • The 8500 is intended only as an adjunct in patient assessment. It must be used in conjunction with other methods of assessing clinical signs and symptoms. • Use only NONIN-manufactured pulse oximeter sensors. These sensors are manufactured to meet the accuracy specifications for NONIN Pulse Oximeters. Using other manufacturers’ sensors may cause improper pulse oximeter performance. • As with all medical devices, carefully route patient cabling to reduce the possibility of patient entanglement or strangulation. • Check the application site frequently to determine the positioning of the sensor and the circulation and skin sensitivity of the patient. Each patient’s sensitivity to NONIN sensors might vary, depending upon medical status or skin condition. • Discontinue use of adhesive tape strips if the patient exhibits an allergic reaction to the adhesive material. • Do not stretch the adhesive tape while applying the sensor. This may cause inaccurate readings or skin blisters. • General operation of the 8500 might be affected by the presence of an electrosurgical unit (ESU). • Do not use a damaged sensor.

Cautions • Federal law (USA) restricts this device to sale by or on the order of a physician. • Read this manual carefully before using the 8500. • Before use, carefully read the package insert provided with the sensor(s). • The 8500 is intended for spot-checking or monitoring by a health care professional. Because the 8500 has no audible alarms, international labeling requirements dictate that it be labeled "Not for continuous monitoring." • The 8500 pulse oximeter is not an apnea monitor. 1

• Verify that all visible indicators illuminate during the startup (initialization) sequence. If any indicator is not lit, do not use the 8500. Contact NONIN Customer Support for repair or replacement. • The 8500 must be able to measure the pulse properly in order to obtain an accurate SpO2 measurement. Verify that nothing is hindering the pulse measurement before relying on the SpO2 measurement. • The 8500 might not work on all patients. If you are unable to achieve stable readings, discontinue use. • The 8500 might misinterpret motion as good pulse quality. Minimize patient motion as much as possible. • The 8500 is designed to determine the percentage of arterial oxygen saturation of functional hemoglobin. Significant levels of dysfunctional hemoglobin may affect the accuracy of the measurement. • Cardiogreen and other intravascular dyes, depending on the concentration, might affect the accuracy of the SpO2 measurement. • Ear Clip and Reflectance pulse oximeter sensors are not recommended for pediatric or neonatal use. The accuracy of these sensors has not been established for pediatric or neonatal use. • Do not immerse the 8500 or NONIN sensors in liquid. • Do not use caustic or abrasive cleaning agents on the 8500 or on the sensors. • The 8500 must be repaired only by trained NONIN personnel. • Do not use different types of batteries or mix fully- and partiallycharged batteries at the same time.; battery leakage might result. • Do not remove any covers (except the battery cover) when replacing batteries. • Follow local ordinances and recycling instructions regarding disposal or recycling of the device and device components, including batteries. Batteries might leak or explode if used or disposed of improperly. • Remove the batteries to avoid the risk of leakage if the 8500 will be stored for more than one month. • This equipment complies with International Standard EN 60601-12:1993 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 (for example, cellular phones, electrical appliances), it is possible that high levels of such interference due to close proximity or strength of a source might result in disruption of performance of this device. 2

Unpacking the Model 8500 Confirm that the items listed below are packed with the 8500 Handheld Pulse Oximeter. The 8500 shipment includes: • 8500 or 8500M Handheld Pulse Oximeter • Operator’s Manual for Models 8500 and 8500M Pulse Oximeter • Six AA batteries • One sensor If any item on this list is missing or damaged, contact your distributor. Contact the carrier immediately if the shipping carton is damaged.

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Introduction Indications for Use The NONIN® 8500 Handheld Pulse Oximeter is indicated for measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for adult, pediatric, and neonatal patients in hospital, ambulatory, home, and EMS (emergency medical service) environments. The 8500 is intended for spot-checking and/or continuous monitoring when attended by a trained healthcare professional.

General Description The Model 8500 is a digital handheld pulse oximeter that displays numeric values for blood oxygen saturation and pulse rate. It typically operates for 100 hours continuously between alkaline battery replacements and requires no routine calibration or maintenance other than battery replacement. The pulse oximeter determines functional oxygen saturation of arterial hemoglobin (SpO2) by measuring the absorption of red and infrared light passing through perfused tissue. Changes in absorption caused by the pulsation of blood in the vascular bed are used to determine oxygen saturation and pulse rate. Oxygen saturation and pulse rate values are displayed by light-emitting diode (LED) digital displays. On each detected pulse, the pulse quality LED blinks. Patient pulse quality signals are graded as good, marginal, or inadequate and are indicated as such by the pulse quality indicator blinking green, yellow, or red, respectively. This simple method gives the user a pulse-by-pulse visual indication of waveform signal quality without requiring complex waveform analyses. The Model 8500 pulse oximeter may be used with a variety of NONIN pulse oximeter sensors. Because the Model 8500 has no patient alarms, SpO2 and pulse rate displays must be observed frequently. A sensor disconnect or malfunction is indicated by a lack of good pulse quality blinking and/or a dash to the left of the SpO2 value on the LED display. When adequate pulse signals are not received, the SpO2 and/or pulse rate numeric values will be replaced by dashes. Low and critically low battery conditions will be indicated by the low battery LED.

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Basic Operation Installing Batteries CAUTION! Do not use different types of batteries at the same time, and do not mix fully- and partially-charged batteries at the same time time. Battery leakage might result. Do not remove any covers (except the battery cover) when replacing batteries. Follow local ordinances and instructions regarding disposal or recycling of the device and components, including batteries. Batteries may leak or explode if used or disposed of improperly. Remove the batteries to avoid the risk of leakage if the Model 8500 will be stored for more than one month.

The 8500 Pulse Oximeter is powered by 6 AA Alkaline cells that will typically provide 100 hours of continuous operation. The 8500 indicates when the batteries are low by flashing the digital displays once each second. When the displays begin flashing, the batteries should be replaced as soon as possible. Replace the batteries by removing the battery door on the bottom of the 8500. Be sure to follow the polarity markings on the rear label of the pulse oximeter when installing new batteries. Refer to Figure I for an illustration of battery replacement. Rechargeable Nickel Cadmium batteries may be used in the 8500 if desired. Since NiCad batteries have less than half the capacity of alkaline batteries, the batteries will have to be recharged more often than every 100 hours. NOTE:

Reducing the display brightness can extend battery life up to 100%.

NOTE:

Replacing batteries erases the memory and clock settings of the 8500.

NOTE:

Batteries should be removed if the 8500 is going to be stored for more than 30 days. Batteries may leak if left in the device for a long period of time.

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Figure I: Replacing Batteries in the 8500

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Connecting Sensors Connect the sensor to its 9-pin mating jack on the top of the 8500 as shown in Figure II. If additional cable length is necessary, connect the Model 8500I Patient Cable between the sensor and the 8500 Pulse Oximeter. Position the appropriate sensor on the patient.

Figure II: Connecting Sensors to the 8500

Turning on the Pulse Oximeter Turn on the Model 8500 by pressing the "" button on the front of the pulse oximeter. Refer to Figure III. When the 8500 is powered on, the SpO2 and ♥ displays will cycle through the following sequence before displaying valid data values: • " " • time saved in memory in hours and minutes • software revision number • "- -"

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Figure III: Front View of the 8500

Figure IV: Rear View of the 8500

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Verifying Operation CAUTION! The 8500 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 SpO2 measurement.

Verify that the sensor is properly positioned, and ensure that the system is (perfusion) sensing adequate perfusion by observing that the indicator is blinking green, and the blinking is correlated 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.

Cleaning the Pulse Oximeter CAUTION! Do not immerse the 8500 in liquid, and do not use caustic or abrasive cleaning agents.

The 8500 Pulse Oximeter may be cleaned with a mild detergent and a soft cloth or with an isopropyl alcohol wipe. Allow enough time for the 8500 to dry thoroughly before reusing.

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Features Controls All functions of the 8500 are controlled by switches found on the front of the unit. Refer to Figure III for an illustration of these switches.

Power Pressing the ON switch ("") causes power to be applied to all internal circuitry. Pressing the OFF switch ("∅") causes power to be removed from the displays and puts the pulse oximetry circuitry into a low power standby mode. In order to conserve battery life, the 8500 automatically powers off after 10 minutes of inactivity. Inactivity is indicated by dashes on the displays and is caused by: • no sensor connected to the pulse oximeter • patient pulse too low • sensor not attached to a patient Each time a reading is displayed, the 10 minute timer is restarted. The "" switch has additional clock and printer mode setting functions when used in conjunction with the "×" switch.

Display Brightness The arrow switch ("×") causes the brightness of the digital displays to change. When powered up, the digital display defaults to the maximum brightness. Pressing the "×" will advance the brightness to the lowest setting, and each subsequent press will advance the brightness through 8 different settings. The function is circular, which means it will cycle through the entire brightness range and then start at the beginning again. Lower brightness may be used to preserve battery life; higher brightness may be used to view the displays from a distance. NOTE:

Reducing the LED display brightness can extend battery life up to 100%.

The "×" switch has additional clock mode setting functions when used with the "" switch.

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Setup Mode

Setup mode is used to control the internal time-of-day clock and the external real-time printer (purchased separately). The setup mode is initiated by holding the "×" switch when the unit is turned on by pressing the "" switch. In setup mode, the "" switch and the "×" switch are used to make the selections.

Advance to the next sequential mode by pressing the "" switch. Each time the "×" switch is pressed, the number on the ♥ display will increment. It starts with the current value stored in memory for the parameter designated in the SpO2 display. When the correct value appears in the ♥ display, pressing the "" switch will advance the SpO2 display to the next sequential parameter as listed in Table I. This process is continued until all parameters are set. The settings can be checked easily, since the first value displayed for each parameter represents the current setting. When the setting sequence has been completed, the 8500 exits setup mode and begins normal operation. Sequence

Appears in SpO2 Display

Range of Values From To 00 00 00 01 00 00

Printer Year Month Day Hours Minutes

15 99 12 31 23 59

Table I: Printer, Clock, and Calendar Mode Parameters

Printer Settings NOTE:

The 8500P prints real-time data only. Data stored in the 8500M can not be downloaded to the 8500P.

" " will appear in the SpO2 display, indicating print setup mode. There are 16 options for the printer mode: 00 through 15. The modes determine how often and in which format data is written to the printer. Refer to Figure V for a flowchart of setting the printer mode. When the printer setting sequence is completed, the 8500 continues to the calendar settings.

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SpO2 Display Setup Mode

Display Default Setting

Press

Press

Increment printer mode Press

Press

Proceed to calendar setup

Figure V: Flow Chart for Setting Printer Mode

Printer Mode

Seconds per data point

Minimum SpO2 printed?*

Touch print capability?**

00 01 02 03 04 05 15

10 30 120 10 30 120 ---

No No No Yes Yes Yes No

Yes Yes Yes Yes Yes Yes Yes

* For modes where the minimum SpO2 data is written, there are two lines of data written for each data output. The first line contains the minimum value for SpO2 since the last printout, and the second line contains the current data values. ** The touch print mode enables the user to print out data at any time. This is activated by pressing the "" switch.

Table II: 8500P Printer Modes

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Calendar Settings After the printer setting has been determined in the setup mode, " " will appear in the SpO2 display, indicating calendar setup mode for the year. The year may be set to "00" through "99". After selecting the year, the ," indicating the setup mode for the month. The display will show " month may be set to "00" through "12". After selecting the month, the display will show " ," indicating the setup mode for the day of the month. The day may be set to "01" through "31". Refer to Figure VI for a flowchart of setting the calendar. When the calendar setting sequence is completed, the 8500 continues to the clock settings. NOTE:

Setting the month to "00" disables the clock function and helps conserve battery life.

SpO2 Display Setup Mode

Display Default Setting

Press

Press

Increment year Press

Press

Press

Press

Increment month Press

Press

Press

Press

Increment day Press

Press

Proceed to clock setup

Figure VI: Flow Chart for Setting Calendar

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Clock Settings After the calendar settings have been determined in the setup mode, " " will appear in the SpO2 display, indicating clock setup mode for the hour. The hour may be set to "00" through "23". After selecting the hour, the display will show " ," indicating the setup mode for the minutes. The minutes may be set to "00" through "59". After selecting the minutes, the display will return to normal operation. Refer to Figure VII for a flowchart of setting the clock. SpO2 Display Setup Mode

Display Default Setting

Press

Press

Increment hour Press

Press

Press

Press

Increment minute Press

Press

Proceed to normal operation

Figure VII: Flow Chart for Setting Clock

Printer modes determine how often and in which format data is written to the printer. For modes where the minimum SpO2 data is written, two lines of data are written for each data output. The first line contains the minimum value for SpO2 since the last printout, and the second line contains the current data values. Touch print mode enables users to print data at any time by pressing the "" switch.

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Displays SpO2 Display

The left digital display is a 3-digit light emitting diode (LED) digital display that indicates oxygen saturation percentage. Refer to Figure III.

♥ (Pulse Rate) Display The right digital display is a 3-digit LED digital display that indicates pulse rate in pulses per minute. Refer to Figure III.

(Perfusion) Indicator The perfusion indicator (identified by the waveform symbol ) will flash once for each pulse while measuring oxygen saturation. The perfusion indicator changes color to indicate changes in the pulse waveform signal that may affect SpO2 data. The perfusion indicator may blink one of three colors: green, yellow, or red. These colors are similar to the colors of a stoplight such that: Red indicates the pulse amplitude is too small. During red perfusion, SpO2 and pulse rate values are not updated. After ten seconds, values are replaced with dashes, indicating SpO2 measurement is not possible. Yellow indicates the pulse waveform amplitude is marginal or the pulse oximeter has detected artifact. Although SpO2 data is acceptable, corrective measures should be considered to improve sensor placement, change sensor type, or reduce patient movement. Green indicates a good pulse waveform signal and accurate SpO2 data. CAUTION! The 8500 might interpret motion as good perfusion.

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Flashing Display

The numerical displays will flash once each second if the 8500 determines that a battery low condition exists. Replace all six batteries immediately. NOTE:

Inaccurate SpO2 and/or pulse rate measurement might result if the 8500 is operated in a low battery condition.

Dash in SpO2 Display

If the 8500 determines that a sensor fault exists (sensor disconnect, sensor failure, or sensor dislodgment), a dash (-) appears in the left-most digit of the SpO2 display. The readings displayed will remain unchanged while the sensor fault exists. If the sensor fault is not corrected, dashes will be displayed 10 seconds after the minus sign appears.

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Printer/Serial Output Both the 8500 and 8500M Hand Held Pulse Oximeters provide output capability to a custom printer via the 9-pin Sub-D connector. This connector serves as a sensor input connector as well as a printer interconnect device. The 9-pin Sub-D connector pin assignments are listed in Table III. Pin Number 1 2 3 4 5 6 7 8 9

Assignment Battery Voltage Infrared Anode, Red Cathode Infrared Cathode, Red Anode Serial Data, TTL Levels Detector Anode Logic Level Cable Shield Coaxial Shield Detector Cathode, +5 V

Table III: Printer/Sensor Interface Assignments

The information from the 8500 in the real-time mode is sent in an ASCII serial format at 9600 baud with 9 data bits, 1 start bit, and 1 stop bit. The data is output at a rate of once per second. NOTE:

The 9th data bit is used for parity in memory playback mode. In real-time mode, it is always set to the mark condition. Therefore the real-time data may be read as 8 data bits, no parity.

The data printed by the 8500P printer is in the following format: HH:MM:SS SPO2=XXX HR=YYY

where "HH" represents the hour, "MM" represents the minutes, "SS" represents the seconds, "XXX" represents the SpO2 value, and "YYY" represents the heart rate. SpO2 and heart rate will be displayed as "---" if there is no data available for the data reading.

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