Models 8500A-8500MA Operators Manual

About the Manual 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.

Trademarks is a registered trademark of NONIN Medical, Inc.

References References to "NONIN" in this manual shall imply NONIN Medical, Inc. References to "8500A" in this manual shall imply Models 8500A and 8500MA.

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

COPYRIGHT 2005

Nonin Medical, Inc. 13700 1st Avenue North Plymouth, MN 55441-5443 • (763) 553-9968 • (800) 356-8874 • FAX (763) 553-7807

Table of Contents Precautions for Use ... 1 Unpacking Your Pulse Oximeter ... 3 Introduction ... 4 A. Indications for Use ... 4 B. General ... 4 Operating Instructions ... 5 A. Batteries ... 5 B. General ... 6 Features ... 9 A. Controls ... 9 B. Displays ... 14 C. Printer/Serial Output ... 17 D. Memory Option (8500MA Only) ... 18 Specifications ... 20 Service ... 21 Warranty ... 22 Accessories ... 23 Troubleshooting Guide ... 24

Guide to Symbols Symbol

Definition Of Symbol ATTENTION: Consult Accompanying Documents Type BF Applied Part (patient isolation from electric shock)

UL Mark for Canada and the United States with respect to electric shock, fire, and mechanical hazards only in accordance with UL 60601-1 30EM and CAN/CSA C22.2 No. 601.1

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

Indicates separate collection for electrical and electronic equipment (WEEE).

Precautions for Use Contraindication • Do not operate in an explosive atmosphere. • Do not operate the NONIN 8500A in an MRI environment.

Warning • The 8500A is intended only as an adjunct in patient assessment. It must be used in conjunction with clinical signs and symptoms. • The audible alarm of the 8500A 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.

• 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 the application site frequently to determine the circulation and skin sensitivity of the patient and the positioning of the sensor. Each patient's sensitivity to NONIN sensors might vary depending upon medical status or skin condition.

• 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.

Caution • Federal law (USA) restricts this device to sale by or on the order of a physician. • Read this manual carefully before use of the 8500A. • Carefully read the instructional insert provided with the sensor before use. • The 8500A is intended for spot checking or continuous monitoring by an attending health care professional. • The 8500A 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.

• Fingernail polish may reduce light transmission and thereby affect SpO2 accuracy. • The 8500A may not work on all patients. If you are unable to achieve stable readings, discontinue use. • 8500A Pulse Oximeters are sensitive and must be repaired by knowledgeable and specially trained personnel only. • The 8500A may interpret motion artifact of sufficient amplitude and regularity as good perfusion (green). • The NONIN 8500A Hand Held Pulse Oximeter 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 SpO2 measurement. • Do not use different types of batteries at the same time. Do not mix fully charged and partially charged cells at the same time. These actions may cause the batteries to leak. • Do not immerse the 8500A or NONIN sensors in liquid to clean. • Do not use caustic or abrasive cleaning agents. • 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. • Do not remove any covers other than the battery cover when battery replacement is necessary. There are no user serviceable parts inside other than the replaceable batteries. • Alkaline batteries may leak or explode if used or disposed of improperly. • 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. • This device has not been tested for immunity to electromagnetic disturbances. • Portable and mobile RF communications equipment can affect medical electrical equipment. • In compliance with the European Directive on Waste Electrical and Electronic Equipment (WEEE) 2002/96/EC, do not dispose of this product as unsorted municipal waste. This device contains WEEE materials; please contact your distributor regarding take-back or recycling of the device. If you are unsure how to reach your distributor, please call Nonin for your distributor's contact information.

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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

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.

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.

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Unpacking Your Pulse Oximeter Contact the carrier immediately if the shipping carton for the 8500A is damaged. Carefully unpack the instrument and its accessories. Confirm that the items listed below are packed with the 8500A Hand Held Pulse Oximeter. The 8500A/8500MA shipment includes: • • • •

8500A or 8500MA Hand Held Pulse Oximeter Operator’s Manual for Models 8500A and 8500MA Six AA batteries 8000K2 Sensor (Adult Finger Clip) or 8000AA 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's Customer Support department at (800) 356-8874.

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Introduction A. Indications For Use The 8500A Hand Held Pulse Oximeter is intended to be used for monitoring oxygen saturation and pulse rate for adult, pediatric, and neonatal patients in hospital, ambulatory, home, and EMS environments. The 8500A may be used for spot checking and/or continuous monitoring when attended by a healthcare professional. The variety of individual sensors available must be checked frequently to ensure proper circulation and application.

B. General The 8500A Hand Held Pulse Oximeter is small and light weight. The 8500A has audible and visual alarms for tracking patient status. It typically will operate for 100 hours continuously between battery replacements. The 8500A requires no routine calibration or maintenance. The 8500A 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 LED flashes. Patient perfusion signals are graded as good, marginal or inadequate and are indicated as such by the LED flashing green, yellow, or red. 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 a dash to the upper left of the SpO2 value on the LED display. Ultimately, if adequate perfusion pulses are not received, the SpO2 and Pulse Rate (♥ ) numerical values will be replaced by dashes. When the batteries are low, the digital displays will blink. The 8500 Pulse Oximeter may be used with all NONIN pulse oximeter sensors (except fiber optic) enabling proper operation for nearly every patient. NOTE: Nonin sensors do not contain natural rubber latex. Natural rubber latex has been found to cause allergic reactions in some individuals.

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Operating Instructions A. Batteries Caution: • Do not remove any covers other than the battery cover when battery replacement is necessary. There are no user serviceable parts inside other than the replaceable batteries. • Alkaline batteries may leak or explode if used or disposed of improperly. • Do not use different types of batteries at the same time. In addition, do not mix fully charged and partially charged cells at the same time. These actions may cause the batteries to leak. The 8500A Hand Held Pulse Oximeter is powered by 6 AA Alkaline cells that will typically provide 100 hours of continuous operation. The 8500A 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 back of the 8500A. 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 8500A 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:

Replacing batteries erases the clock settings of the 8500A. The memory of the 8500MA will also be erased when the batteries are replaced. These settings should be reset after the batteries are replaced.

NOTE:

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

Figure I: Replacing Batteries in the 8500A

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B. General The 8500A Hand Held Pulse Oximeter is portable and is intended for attended patient monitoring by trained personnel. It displays numerical values for oxygen saturation and pulse rate.

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

Figure II: Connecting Sensors to the 8500A

2. Turn on the Pulse Oximeter Turn on the 8500A Hand Held Pulse Oximeter by pressing the "" switch on the front of the pulse oximeter. Refer to Figure III. When the 8500A is powered on, the SpO2 and ♥ displays will cycle through the following sequence before displaying valid data values: • " " • current time • software revision number • "- -"

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Figure III: Front View of the 8500A

Figure IV: Rear View of the 8500A

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3. Verify Operation Caution: • The 8500A 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. Ensure the system is 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. If the alarm is not disabled, the Alarm Active Indicator will flicker for the first 2 minutes of operation. This indicates that the alarm is enabled, but the audible alarm is temporarily disabled when powered on. During this time, the "" switch may be pressed to enable the audible alarm. After the 2 minute power on period is completed or the "" switch has been pressed, the Alarm Active Indicator will be continuously illuminated and the audible alarm will be enabled. If the alarm is disabled, the Alarm Active Indicator will not illuminate, and pressing the "" switch will not affect the operation of the 8500A.

4. Cleaning the Pulse Oximeter Caution: • Do not immerse the 8500A in liquid to clean. • Do not use caustic or abrasive cleaning agents. The 8500A Hand Held Pulse Oximeter may be cleaned with a mild detergent and a soft cloth or with an isopropyl alcohol wipe. Allow enough time for the 8500A to dry thoroughly before reusing.

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

1. 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 oximetry circuitry into a low power standby mode. In order to conserve battery life, the 8500A will automatically power 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 alarm, printer, clock, and calendar mode setting functions when used in conjunction with the "×" switch.

2. Setup Mode Setup mode is used to control the alarms, internal time-of-day clock and calendar, 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 easily checked, since the first value displayed for each parameter represents the current setting. When the setting sequence has been completed, the 8500A exits the setup mode and begins normal operation. Parameter

Appears in ♥ Display

Range of Values , , (OFF) 0 (OFF), 80 - 100 0 (OFF), 50 - 95 0 (OFF), 75 - 275 1 0 (OFF), 30 - 110 00 - 15 00 - 99 00 - 12 01 - 31 00 - 23 00 - 59

Alarm mode High SpO2 limit Low SpO2 limit High Pulse Rate limit Low Pulse Rate limit Printer Year Month Day Hours Minutes

Default Value ON OFF 80% 200 BPM 50 BPM 00 94 00 01 00 00

Table I: Alarm, Printer, Calendar, and Clock Mode Parameters 1 The high pulse rate limit value increments by 5, while all other parameters are incremented in steps of 1.

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a. Alarm Settings Once setup mode is initiated, " " will appear in the SpO2 display indicating the alarm settings. There are three "), recall (" "), or OFF (" "). These options appear in the ♥ options for the alarm settings: default (" display. Refer to Figure V for a flow chart of setting the alarms. When the alarm setting sequence has been completed, the 8500A continues to the printer settings. NOTE:

When the 8500A is powered on, it resets to the default alarm settings unless the user specifies to recall parameters in the Setup mode each time the unit is powered on.

SpO2 Display Setup Mode

Display Default Settings

Alarms Off

Recall Settings Press

Press

Press

Press

Alarms are ON

Alarms are ON or OFF depending on previous setting

Default alarm settings

Press

Press

Set alarms to OFF

Press

Press Press Press Press Press

Modify settings

Press

Recall last non-default user-defined settings

Press Press

Press

Proceed to printer setup

Figure V: Flow Chart for Setting Alarms

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b. Printer Settings * NOTE:

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

" will appear in the SpO2 display indicating print After the alarm settings have been determined in the setup mode, " setup mode. There are 16 options for the printer mode: 00 through 15. Each printer mode is explained in Table II. The modes determine how often data is written out to the printer and the format of data written to the printer. Refer to Figure VI for a flow chart of setting the printer mode. When the printer setting sequence has been completed, the 8500A continues to the calendar settings (refer to Calendar Settings section). WARNING:

The use of the 8500P may result in increased emission and/or decreased immunity of this device.

SpO2 Display Setup Mode

Display Default Setting

Press

Press

Increment printer mode Press

Press

Proceed to calendar setup

Figure VI: Flow Chart for Setting Printer Mode

Printer Mode 00 01 02 03 04 05 15

Seconds per data point 10 30 120 10 30 120 ---

Minimum SpO2 printed?* No No No Yes Yes Yes No

Touch print capability?** 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 * NOTE:

Printer modes 06 - 14 are not used at this time. They are reserved for future development.

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c. 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 display will show " indicating the setup mode for the month. The 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 VII for a flow chart of setting the calendar. When the calendar setting sequence has been completed, the 8500A continues to the clock settings (refer to Clock Settings section). * 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

Proceed to clock settings

Press

Proceed to calendar setup

Figure VII: Flow Chart for Setting Calendar

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d. 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 flash the settings for the alarms and will then return to normal operation. Refer to Figure VIII for a flow chart 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 cycle through alarm settings

Figure VIII: Flow Chart for Setting Clock

3. Alarms Indicated On Demand The set points of the adjustable alarms may be displayed upon demand at any time during operation of the 8500A oximeter, either when SpO2 and Pulse Rate values are being displayed, or when the unit is out-of-track. Press the "" switch while holding the "×" switch depressed. This will cause the current settings of the four alarms - SpO2 high limit, SpO2 low limit, pulse rate high limit, and pulse rate low limit - to be displayed in the same format and order as during clock set. Each alarm set point is displayed for approximately three seconds. If the alarms are OFF, then " " will be displayed for settings.

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B. Displays 1. Visual Indicators a. SpO2 Display The left digital display is a 3-digit light emitting diode (LED) digital display that displays oxygen saturation percentage.

b. ♥ (Pulse Rate) Display The right digital display is a 3-digit LED digital display that displays pulse rate in pulses per minute.

c.

(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 the SpO2 data. The perfusion indicator may blink one of three colors: green, yellow, or red: •

Red indicates the pulse amplitude is too small. During red perfusion, SpO2 and pulse rate values are not updated. After approximately twenty seconds, the 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 the pulse waveform signal is of good quality and SpO2 data is accurate.

Caution: • The 8500A may interpret motion artifact of sufficient amplitude and regularity as good perfusion (green).

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d. Flashing or Flickering Displays ♥ Display If the patient's pulse rate is equal to or goes beyond the set limits for pulse rate, the ♥ display flickers until the alarm condition concludes. SpO2 Display If the patient's SpO2 is equal to or goes beyond the set limits for SpO2, the SpO2 display flickers until the alarm condition concludes. ♥ and SpO2 Display If both the SpO2 and ♥ displays flicker, the pulse rate and SpO2 values are both equal to or go beyond their set limits. If both the SpO2 and ♥ displays flash at once per second, the batteries are low and need to be replaced. Replace all six batteries. Refer to Figure I: Replacing batteries in the 8500A. NOTE:

e.

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

(Alarm Active) Indicator • The Alarm Active Indicator continuously illuminated indicates audible alarms are enabled. (See Figure IX) • The Alarm Active Indicator not illuminated indicates audible alarms are disabled. (See Figure IX) • The Alarm Active Indicator flickers when the audible alarms are temporarily disabled.

Figure IX: Sensor Disconnect and Alarm Active Indicators

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f.

Dash in SpO2 Display

If the 8500A determines that a sensor fault exists (sensor disconnect, sensor failure, or sensor dislodgment), a dash (-) appears in the upper left-most digit of the SpO2 display (refer to Figure IX). The readings that are displayed remain unchanged while the sensor fault exists. If the sensor fault is not corrected, a dash will be displayed in both the SpO2 and ♥ displays 10 seconds after the sensor disconnect indicator appears.

2. Audible Indicators Caution: • The audible alarm of the 8500A 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.

a. Audible Alarm • During operation, pressing the "" switch disables audible alarms for 2 minutes (includes during power up). • Pressing the "" switch during the 2-minute disabled period immediately enables the audible alarm. • When enabled, the audible alarm sounds once per second for all patient alarms: high SpO2, low SpO2, high heart rate, low heart rate, and low perfusion. • When enabled, the audible alarm sounds steadily for equipment alarms: sensor alarm and low battery.

b. Audible Heart Beat • During operation, pressing the "×" switch toggles the audible heart beat status ON or OFF. • When enabled, the 8500A will sound once for each heart beat detected. • The audible heart beat is disabled when batteries are installed. • Each time the 8500A is turned on, the audible heart beat will default to the previously selected mode (audible heart beat ON or OFF).

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C. Printer/Serial Output Both the 8500A and 8500MA 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 SubD 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 8500A 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 the real-time clock is set to, "MM" represents the minutes, "SS" represents the seconds, "XXX" represents the SpO2 value, and "YYY" represents the pulse rate. The SpO2 and pulse rate will be displayed as "---" if there is no data available for the data reading.

WARNING:

The use of the 8500P may result in increased emission and/or decreased immunity of this device.

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