Models 8500- 8500M Operators Manual 2014

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CAUTION: Federal law (USA) restricts this device to sale by or on the order of a licensed practitioner. Consult Instructions for Use. 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. 13700 1st Avenue North Plymouth, Minnesota 55441-5443 USA +1 (763) 553-9968 (800) 356-8874 (USA and Canada) Fax: +1 (763) 553-7807 E-mail: [email protected] Nonin Medical B.V. Prins Hendriklaan 26 1075 BD Amsterdam, Netherlands +31 (0)13 - 79 99 040 (Europe) Fax: +31 (0)13 - 79 99 042 E-mail: [email protected] nonin.com 0123

EC

REP

MPS, Medical Product Service GmbH Borngasse 20 D-35619 Braunfels, Germany References to “Nonin” in this manual shall imply Nonin Medical, Inc. Nonin, PureLight and nVISION are registered trademarks or trademarks of Nonin Medical, Inc. Microsoft® and Windows® are registered trademarks of Microsoft Corporation. © 2014 Nonin Medical, Inc. 6130-001-03

Contents Indications for Use ... 1 Contraindications... 1 Warnings ... 1 Cautions ... 2

Guide to Symbols ... 4 Displays and Indicators ... 5 SpO2 Display ... 5 Pulse Rate Display ... 5 Pulse Quality Indicator... 5 Low Battery Indicator... 5 Sensor Fault or Inadequate Signal Display ... 5

Using the 8500 and 8500M Pulse Oximeters... 7 Unpacking the Model 8500 and 8500M... 7 Installing and Using the Batteries ... 7 Important Notes about Battery Use ... 8 Connecting the Sensor ... 9 Turn On/Off... 9 Startup Self-Test... 9

Detailed Operation... 11 Setup Mode ... 11 Entering Setup Mode ... 11

Care and Maintenance... 12 Visual Indicators ... 13 Memory Functions (8500M only) ... 14 Memory Download (8500M only)... 14 Downloading the Data Stored in Memory ... 14

Communications... 15 Serial Output... 15 Connecting the Device into a Medical System ... 16

Service, Support and Warranty ... 17 Warranty ... 18

Parts and Accessories ... 19 Troubleshooting ... 20 Technical Information ... 23 Manufacturer’s Declaration... 23 Equipment Response Time ... 27 Testing Summary ... 28

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Contents (Continued) SpO2 Accuracy Testing ...28 Pulse Rate Motion Testing...28 Low Perfusion Testing ...28 Principles of Operation...28 Specifications ...29

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Figures Figure 1. Front View ... 6 Figure 2. Installing Batteries in the 8500 ... 8 Figure 3. Connecting a Sensor... 9

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Tables Table 1. Labeling Symbols... 4 Table 2. Pulse Oximeter Sensor Connector Pin Assignments... 15 Table 3. Electromagnetic Emissions... 23 Table 4. Electromagnetic Immunity... 24 Table 5. Guidance and Manufacturer’s Declaration-Electromagnetic Immunity... 25 Table 6. Recommended Separation Distances ... 26

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Indications for Use

Indications for Use Nonin® Models 8500 and 8500M Handheld Pulse Oximeters are indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for adult, pediatric, and neonatal patients in hospitals, ambulatory, home and EMS environments. Models 8500 and 8500M are intended for continuous monitoring and/or spotchecking of patients when attended by a healthcare professional.

Contraindications Do not use this device in an MR environment. Explosion Hazard: Do not use in an explosive atmosphere or in the presence of flammable anesthetics or gasses. This device is not defibrillation proof per IEC 60601-1.

Warnings This device is intended only as an adjunct in patient assessment. It must be used in conjunction with other methods of assessing clinical signs and symptoms. Inspect the sensor application site at least every 6 to 8 hours to ensure correct sensor alignment and skin integrity. Patient sensitivity to the sensor may vary due to medical status or skin condition. Oximeter readings of this device may be affected by the use of an electrosurgical unit (ESU). To avoid patient injury, use only with Nonin-branded PureLight® pulse oximeter sensors. These sensors are manufactured to meet the accuracy specifications for Nonin Pulse Oximeters. Using other manufacturers’ sensors can result in improper pulse oximeter performance. To prevent improper performance and/or patient injury, verify compatibility of the monitor, sensor(s), and accessories before use. No modifications to this device are allowed as it may affect device performance. Do not use a damaged sensor. If the sensor is damaged in any way, discontinue use immediately and replace the sensor. As with all medical equipment, carefully route patient cabling to reduce the possibility of entanglement, strangulation, or injury to the patient. 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 specified in the Parts and Accessories List may result in increased electromagnetic emission and/or decreased immunity of this device. This device must be able to measure the pulse properly to obtain an accurate SpO2 measurement. Verify that nothing is hindering the pulse measurement before relying on the SpO2 measurement. Operation of this device below the minimum amplitude of 0.3% modulation may cause inaccurate results. Discontinue use of adhesive tape strips if the patient exhibits an allergic reaction to the adhesive material. Avoid excessive pressure to the sensor application site as this may cause damage to the skin beneath the sensor.

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Indications for Use

Warnings (Continued) The device turns off after approximately 10 minutes when at critically low battery capacity. Before changing the batteries, make sure the device is off and the sensor is not applied to a digit.

Cautions Before use, carefully read the Instructions for Use provided with the sensors. When mounting the monitor to a mobile pole, mounting the monitor higher than 1.5 meters (5 feet) or mounting more than 2 kilograms (4.5 pounds) of equipment onto the pole may result in tipping, damage to the equipment, or injury. This device is not an apnea monitor. Verify that all visible indicators illuminate during the startup (initialization) sequence. If any indicator is not lit, do not use the device. Contact Nonin Technical Service for assistance. The presence of a defibrillator may interfere with the performance of this device. This device may not work on all patients. If you are unable to achieve stable readings, discontinue use. This device has motion tolerant software that minimizes the likelihood of motion artifact being misinterpreted as good pulse quality. In some circumstances, however, the device may still interpret motion as good pulse quality. Minimize patient motion as much as possible. Ear Clip and Reflectance 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 autoclave or immerse the device or sensors in liquid. Do not expose the device or components to excessive moisture or liquids. Do not use caustic or abrasive cleaning agents on the device or the sensors. The oximeter sensor might not work on cold extremities due to reduced circulation. Warm or rub the finger to increase circulation, or reposition the sensor. The device is not designed to retain data in memory once the batteries are removed. Memory will clear 3 minutes after removing the batteries. Replacing the batteries before 3 minutes have elapsed most likely will result in corrupt data. Always replace the batteries with fully charged batteries. Do not use fully charged and partially charged batteries at the same time as this may cause the batteries to leak. Use only Nonin-specified battery types with this device. Do not remove any covers other than the battery cover when replacing batteries. There are no user-serviceable parts inside other than the replaceable batteries. Follow local, state and national governing ordinances and recycling instructions regarding disposal or recycling of the device and device components, including batteries. Batteries may leak or explode if used or disposed of improperly. Remove the batteries if the device will be stored for more than 1 month.

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Indications for Use

Cautions (Continued) This equipment complies with IEC 60601-1-2 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 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. Portable and mobile RF communications equipment can affect medical electrical equipment. This device is designed to determine the percentage of arterial oxygen saturation of functional hemoglobin. Factors that may degrade pulse oximeter performance or affect the accuracy of the measurement include the following: - excessive ambient light - excessive motion - electrosurgical interference - blood flow restrictors (arterial catheters, blood pressure cuffs, infusion lines, etc.) - moisture in the sensor - improperly applied sensor - incorrect sensor type

- inadequate signal - venous pulsations - anemia or low hemoglobin concentrations - cardiogreen and other intravascular dyes - carboxyhemoglobin - methemoglobin - dysfunctional hemoglobin - artificial nails or fingernail polish.

A functional tester cannot be used to assess the accuracy of a pulse oximeter monitor or sensor. All parts and accessories connected to the serial port of this device must be certified according to at least IEC 60950 or UL1950 for data-processing equipment. This device is a precision electronic instrument and must be repaired by trained Nonin personnel only. Field repair of the device is not possible. Do not attempt to open the case or repair the electronics. Opening the case may damage the device and void the warranty. Any sign or evidence of opening the system, field service by non-Nonin personnel, tampering, or any kind of misuse or abuse of the system, shall void the warranty in its entirety. Radios and cell phones or similar devices can affect the equipment and must be kept at least 2 meters (6.5 feet) away from equipment. Failure of a network data coupling (serial cable/connectors/wireless connections) will result in loss of data transfer.

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Guide to Symbols

Guide to Symbols This table describes the symbols that are found on the Models 8500 and 8500M and in this manual. Table 1: Labeling Symbols Symbol

Description CAUTION!

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Consult Instructions for Use. Follow Instructions for Use.

C

SSI FI E LA

D

C

Type BF Applied Part (Patient isolation from electrical shock).

UL US 0123

UL Mark for Canada and the United States with respect to electric shock, fire, and mechanical hazards only in accordance with UL 60601-1 and CAN/CSA C22.2 No. 601.1. CE Marking indicating conformance to EC directive No. 93/42/EEC concerning medical devices.

SN

Serial Number (located on the back cover).

IP32

Protected against vertically falling water drops when enclosure is tilted up to 15 degrees and ingress of solid foreign objects greater than or equal to 2.5 mm (0.1 in.) in diameter per IEC 60529. Indicates separate collection for electrical and electronic equipment (WEEE).

EC

REP

Authorized Representative in the European Community. Manufacturer

SpO2

%SpO2 Display Pulse Rate Display Pulse Quality Indicator No Alarms Front Panel Buttons

|

ON

Ø

OFF Advance/Dimmer Button

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Displays and Indicators

Displays and Indicators SpO2 Display The SpO2 display is identified by the SpO2 symbol. This 3-digit light-emitting diode (LED) display shows the current oxygen saturation percentage.

Pulse Rate Display The Pulse Rate display is identified by the  symbol. This 3-digit LED display shows the pulse rate in pulses per minute.

Pulse Quality Indicator The Pulse Quality Indicator display (identified by the symbol) is a tricolor LED that blinks once for each detected pulse. The color of the Pulse Quality indicator changes with the pulse strength signal, as described below. • Green indicates a good pulse strength signal. • Amber indicates a marginal pulse strength signal. To improve signal quality, reposition the sensor, try a different sensor type, reduce patient movement, or improve the site’s circulation. • Red indicates an inadequate pulse strength signal. While the Pulse Quality display is red, SpO2 and pulse rate values are not updated. After about 10 seconds, the values are replaced with dashes, indicating that readings are not possible.

Low Battery Indicator When battery capacity is low, the display will blink once each second. If the batteries are not replaced, they will reach critically low capacity and the display will blink dashes. The Pulse Quality LED will blink red or amber, not green. After 10 minutes of critically low battery capacity, the display will go blank.

Sensor Fault or Inadequate Signal Display If the device determines that a sensor fault or inadequate signal condition exists (a sensor disconnect, failure, misalignment or incompatibility with the monitor) or if a pulse oximeter sensor signal is no longer detected, a dash (-) appears in the leftmost position of the SpO2 display. The readings that are displayed will freeze for 10 seconds if the pulse oximeter sensor fault or the inadequate signal continues. If the sensor fault or the inadequate signal is not corrected, the frozen readings and the dash in the leftmost position will be replaced by dashes in the middle of both the SpO2 and the Pulse Rate displays. When the sensor fault or the inadequate signal is corrected, the SpO2 and pulse rate displays will return to normal operation.

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Displays and Indicators

% Oxygen % Oxygen Saturation Saturation

Pulse Rate Heart Rate

Pulse Quality

Pulse Quality Indicator Indicator

On Button On Button

Advance/ Advance/Dimmer Dimmer Button Button

Off Button Off Button

Figure 1: Front View

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Using the 8500 and 8500M Pulse Oximeters

Using the 8500 and 8500M Pulse Oximeters Unpacking the Model 8500 and 8500M The Models 8500 and 8500M systems includes the following items: • 1 Model 8500 or 8500M Pulse Oximeter • 1 Model 8500 or 8500M Operator’s Manual on CD • 1 Nonin 8000AA Pulse Oximeter Sensor • 6 AA-Size Alkaline Batteries Confirm that the items listed are included with the system. If any item on this list is missing or damaged, contact your distributor. Contact the carrier immediately if the shipping carton is damaged.

Installing and Using the Batteries Models 8500 and 8500M are powered by 6 AA-size alkaline batteries. WARNING: Before changing the batteries, make sure the device is off and the sensor is not applied to a digit.

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CAUTION: Use only Nonin-specified battery types with this device.

1. Press the battery cover latch, and remove the battery cover on the back of the device. 2. Insert six new AA-size alkaline batteries. Insert the batteries as indicated inside the battery compartment. Proper battery positioning is essential for correct operation. 3. Replace the battery cover and turn the device on. If the device does not turn on, see “Troubleshooting.”

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CAUTION: The device is not designed to retain data in memory once the batteries are removed. Memory will clear 3 minutes after removing the batteries. Replacing the batteries before 3 minutes have elapsed most likely will result in corrupt data. Always replace the batteries with fully charged batteries. Do not use fully charged and partially charged batteries at the same time as this may cause batteries to leak.

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Using the 8500 and 8500M Pulse Oximeters

Figure 2: Installing Batteries in the 8500 When batteries are critically low, the digital displays will go blank, and the Pulse Quality display will blink amber or red, but not green. After 10 minutes at critically low battery capacity, the pulse oximeter will shut off automatically. .

WARNING: The device turns off after approximately 10 minutes when at critically low battery capacity.

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CAUTION: Replace the batteries as soon as possible after a low battery indication. Always replace the batteries with fully charged batteries. Do not use fully charged and partially charged batteries at the same time. This may cause the batteries to leak.

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CAUTION: Remove the batteries if the device will be stored for more than 1 month.

Important Notes about Battery Use • Six AA alkaline batteries provide the device with approximately 100 hours of continuous operation. • Display brightness can affect battery life; the lower settings will conserve battery life. • Clock/calendar settings can affect battery storage life. Batteries drain during storage, but they drain much more quickly when the unit’s clock/calendar functions are set. Refer to “Clock and Calendar Settings” for more information. • If the clock/calendar is not set when the unit is stored, alkaline batteries will need replacement in 10-12 months if the unit has not been used. • If the clock/calendar is set when the unit is stored and if the unit has not been used, alkaline batteries will require replacement in about 6 weeks.

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Using the 8500 and 8500M Pulse Oximeters

Connecting the Sensor Connect the pulse oximeter sensor (with the Nonin logo facing up) to the top of the device as shown. Ensure that the sensor is firmly plugged in. Refer to “Specifications” or to the specific sensor Instructions for Use.

Figure 3: Connecting a Sensor

Turn On/Off • Turn on the device by pressing the ON ( | ) button. • Turn off the device by pressing the OFF (Ø) button. To conserve battery life, the device automatically powers off after 10 minutes of inactivity. Inactivity is indicated by dashes on the displays and may result from an improperly connected or positioned sensor, or from an inadequate patient pulse signal. The Advance/Dimmer button controls the brightness of the digital displays. When turned on, the digital display defaults to the maximum brightness. Pressing the Advance/Dimmer button will decrease the brightness to the lowest setting, and each subsequent press will increase the brightness through 8 different settings. Lower brightness settings will conserve battery life. NOTE: Reducing the LED display brightness can extend battery life up to 60%.

Startup Self-Test When the device is turned on, the device will cycle through a startup/initialization sequence before displaying valid data. During startup, always check for any missing indicators or LED display segments. If any indicator is not functioning, do not use the device. Contact Nonin Technical Service for repair or replacement. During its normal startup sequence, the device will cycle as follows: • “888 888” appears briefly in the SpO2 and Pulse Rate displays. • the Pulse Quality display turns red for 1 second, then green for 1 second, then shuts off.

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Using the 8500 and 8500M Pulse Oximeters

• the clock time currently set in the memory (in hours and minutes, 04 41 for example) appears briefly in the displays. • the software revision numbers (display in the following order): Main revision “r” + 3 numbers (8500 & 8500M); Memory revision “n” “n” (for m) + 3 numbers for Model 8500M; the 8500 will display “n” “n” and “no” for Model 8500. • ( - ) a dash appears for Model 8500 in the displays until a valid pulse signal is detected. Apply the pulse oximeter sensor to the patient’s finger; ensure the system is obtaining an adequate pulse signal by verifying: • the pulse oximeter sensor is properly positioned • the Pulse Quality indicator is blinking green • the Pulse Rate and SpO2 readings are displayed • the Pulse Quality indicator is blinking in time with the pulse rate for at least 10 seconds If the Pulse Quality indicator is blinking red or amber or is blinking inconsistently, reposition the sensor or replace the sensor. The SpO2 and Pulse Rate will display a single dash until a pulse signal is detected.

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Detailed Operation

Detailed Operation Setup Mode Setup mode is used to: 1. Set the calendar and clock. 2. Memory download function (8500M only). In Setup mode, the Advance/Dimmer button and the ON ( | ) button are used to make all selections. NOTE: Setting the month to “00” disables the calendar function and conserves battery life.

Entering Setup Mode 1. With the device off, press and hold the Advance/Dimmer button while pressing and then releasing the ON ( | ) button; the month and year will appear. 2. Release the Advance/Dimmer button when 888 888 appears in the SpO2 and Pulse Rate displays. The current time and year appear briefly in the displays. To view the other settings, press and release the ON ( | ) button until all settings are reviewed. To change current settings, press the Advance/Dimmer button until the calendar or clock entry to be changed appears in the display. Dashes appear in the SpO2 and Pulse Rate displays when Set-Up is complete. The device is ready for use. To review settings: • Press and release the ON ( | ) button until all settings are reviewed. To change settings when set-up mode is entered: • The year y 07 (or user-set year) automatically appears in the display; • Press the ON ( | ) button to advance the calendar/clock options; • Set each calendar or clock option by pressing the Advance/Dimmer button until the correct value is displayed; • Press the ON ( | ) button to go to the next calendar/clock option; • Repeat until all values are set. Dashes appear in the SpO2 and Pulse Rate displays when Set-up is complete. The device is ready for use. See the table below for display sequence, appearance, and range. Sequence

SpO2 Display

Range

Year

y

00 - 99

Month

nn

00 - 12

Day

d

01 - 31

Hours

h

00 - 23

Minutes

nn

00 - 59

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Care and Maintenance

Care and Maintenance Clean the device separately from the sensors. For instructions on cleaning pulse oximeter sensors, refer to the respective sensor instructions for use.

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CAUTION: Do not autoclave or immerse the device or sensors in liquid. Do not expose the device or components to excessive moisture or liquids.

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CAUTION: Do not use caustic or abrasive cleaning agents on the device or the sensors.

Clean the device with a soft cloth dampened with isopropyl alcohol or a mild detergent. Do not pour or spray any liquids onto the device, and do not allow any liquid to enter any openings in the device. Allow the device to dry thoroughly before reusing. The OxitestPlus7 by Datrend Systems, Inc. can be used to verify operation of the pulse oximeter.

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Visual Indicators

Visual Indicators The intended operator’s position for correctly perceiving a visual signal and its priority is 1 meter (3.3 feet). The following table describes conditions and visual indicators. Condition

Visual Indication

Pulse Waveform Signal is inadequate

• Pulse Quality LED blinks red

Sensor Fault (i.e., sensor disconnect, failure, or incompatibility with the monitor)

• Pulse Quality LED blank • Dash (-) appears in the leftmost position of the SpO2 display • SpO2 and Pulse Rate numeric displays freeze for 10 seconds • After 10 seconds a dash (-) replaces the SpO2 and Pulse Rate numeric displays.

Inadequate Signal (sensor misalignment, ambient light, nail polish/artificial nails, etc.)

• Pulse Quality LED blinks • Dash (-) appears in the leftmost position of the SpO2 display • SpO2 and Pulse Rate numeric displays freeze for 10 seconds • After 10 seconds a dash (-) replaces the SpO2 and Pulse Rate numeric displays.

Inadequate SpO2 or pulse rate data (excessive motion or erratic heart rate, etc.) more than 20 seconds

• Dash (-) appears in SpO2 and pulse rate displays

Pulse rate data not updated for more than 30 seconds

• Pulse rate numeric display becomes dashes

Low Battery

• SpO2 and Pulse Rate displays blink.

Critically Low Battery

• SpO2 and pulse rate displays are blinking dashes • Pulse Quality LED is solid red or amber

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Memory Functions (8500M only)

Memory Functions (8500M only) Each time Model 8500M is turned on (except during Setup mode), data are automatically collected in memory. The device can collect and store up to 72 hours of SpO2 and pulse rate information. NOTE: The device is not designed to retain data in memory once the batteries are removed. Only recording sessions longer than 1 minute are stored in memory. Memory will clear 3 minutes after removing the batteries. Replacing the batteries before 3 minutes have elapsed most likely will result in corrupt data. Nonin’s nVISION data management software is available for use with Microsoft Windows operating systems. Refer to “Parts and Accessories.” The memory in the device functions as an “endless loop.” When the memory fills up, the unit begins overwriting the oldest data with the newest. Each time the device is turned on, the current time/date information (if the clock is set correctly) is stored in memory to allow quick differentiation of recording sessions. Patient SpO2 and pulse rate are sampled and stored every 4 seconds. Oxygen saturation values are stored in 1% increments in the range of 0 to 100%. The stored pulse rate ranges from 18 to 300 pulses per minute. The stored values are in increments of 1 pulse per minute in the interval from 18 to 200 pulses per minute, and increments of 2 pulses per minute in the interval from 201 to 300 pulses per minute.

Memory Download (8500M only) NOTE: Downloading the data in memory does not clear the memory.

Downloading the Data Stored in Memory 1. With the device off, press and hold the Advance/Dimmer button while pressing the ON ( | ) button. 2. Release the Advance/Dimmer button when 888 888 is displayed on the SpO2 and pulse rate LEDs. The clock time currently set in the memory (04 41 for example) appears briefly in the displays and y 07 appears (for example). 3. Data will be automatically downloaded from memory. Data is downloaded at a rate of 20 minutes of collected data per second. A 72-hour recording session (the maximum memory saved) is downloaded in approximately 3.5 minutes. 4. After downloading is complete, the device should be shut off before collecting new patient data. 5. The patient data is held in memory until the data is rewritten or the batteries are removed for at least 3 minutes.

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