PalmSAT Model 2500 Operators Manual 2014

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 Display... 5 Low Battery Indicator... 5 Sensor Fault or Inadequate Signal Display ... 5

Using the PalmSAT Pulse Oximeter ... 6 Unpacking the Model 2500... 7 Installing and Using the Batteries ... 8 Important Notes about Battery Use ... 9 With AA Batteries ... 9 With Rechargeable NiMH Battery Pack ... 9 Recharging Batteries (NiMH Battery Pack only)... 10 Connecting the Sensor ... 10 Power On/Off... 10 Power On Self-Test ... 10 Monitoring... 11

Detailed Operation... 12 Setup Mode ... 12 Entering Setup Mode ... 12 Making Selections in Setup Mode... 12

Care and Maintenance... 14 Visual Indicators ... 15 Memory Functions... 16 Memory Download... 16 Downloading the Data Stored in Memory ... 16 Clearing the Memory ... 17 Clear Memory Mode ... 17 Choosing Calendar and Clock Settings... 17

Communications... 18 Serial Output... 18 Connecting the Device into a Medical System ... 19

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Contents (Continued) Service, Support and Warranty...20 Warranty...21

Parts and Accessories...22 Troubleshooting ...23 Technical Information ...25 Manufacturer’s Declaration ...25 Equipment Response Time...29 Testing Summary ...30 SpO2 Accuracy Testing ...30 Pulse Rate Motion Testing...30 Low Perfusion Testing ...30 Principles of Operation...30 Specifications ...31

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Figures Figure 1. Displays, Indicators and Buttons... 6 Figure 2. Rear View... 7 Figure 3. Installing Batteries... 9 Figure 4. Connecting a Sensor... 10

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Tables Table 1. Labeling Symbols... 4 Table 2. Adjustable Parameters and Settings... 12 Table 3. Pulse Oximeter Sensor Connector Pin Assignments... 18 Table 4. Electromagnetic Emissions... 25 Table 5. Electromagnetic Immunity... 26 Table 6. Guidance and Manufacturer’s Declaration-Electromagnetic Immunity... 27 Table 7. Recommended Separation Distances ... 28

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Indications for Use

Indications for Use The Nonin® Model 2500 Pulse Oximeter is indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for adult, pediatric, and neonatal patients. The device is intended for continuous monitoring and/or spot-checking of patients during both motion and no-motion conditions, and for patients who are well or poorly perfused.

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. Oximeter readings of this device may be affected by the use of an electrosurgical unit (ESU). Inspect the sensor application site at least every 6 to 8 hours to ensure correct sensor alignment and skin integrity. Patient sensitivity to sensors and/or double-backed adhesive strips may vary due to medical status or skin condition. 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 patient 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, cables, and power supplies 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.

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Indications for Use

Warnings (Continued) 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. 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. 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. Replace the batteries as soon as possible after a low-battery indication. Always replace the batteries with fully charged batteries. Use only Nonin-specified battery types with this device. Do not use fully charged and partially charged batteries at the same time. This may cause the batteries to leak. 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. This device’s display will go blank after 10 seconds of inadequate signals. The data update period is every 1.5 seconds. 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. Replace batteries within 30 seconds to avoid losing settings (date, time, and patient data stored in memory) or corrupting data. 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 Model 2500 and in this manual. Table 1: Labeling Symbols Symbol

Description 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 under 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 Display Low Battery LED No Alarms Front Panel Buttons On/Off Advance

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Displays and Indicators

Displays and Indicators SpO2 Display The SpO2 display is the upper numeric display (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 the lower numeric display (identified by the LED display shows the pulse rate in pulses per minute.

symbol). This 3-digit

Pulse Quality Display The Pulse Quality display (identified by the symbol) is a tricolor LED that blinks once for each detected pulse. The Pulse Quality display changes color to indicate changes in the pulse waveform signal that may affect the SpO2 data. It may blink green, amber or red. • 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 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.

Sensor Fault or Inadequate Signal Display If the device determines that a sensor fault 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 after 10 seconds. 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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Using the PalmSAT Pulse Oximeter

Using the PalmSAT Pulse Oximeter The Model 2500 PalmSAT is a digital handheld pulse oximeter that displays numerical values for blood oxygen saturation (%SpO2) and pulse rate. This device will typically operate for 80 hours continuously between alkaline battery replacements, or for 40 hours with the Model 2500B Rechargeable NiMH (Nickel Metal Hydride) Battery Pack (optional). The device requires no routine calibration or maintenance other than replacement of alkaline batteries or recharging the optional battery pack with the Model 2500C Charger Stand (refer to the Model 2500C Operator’s Manual). 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. Pulse Oximeter Sensor Connector

SpO2 Display Pulse Rate Display

Low Battery Indicator

Pulse Quality Display (Tricolor)

Advance Button On / Off Button

Figure 1: Displays, Indicators and Buttons Oxygen saturation and pulse rate values are displayed by light-emitting diode (LED) digital displays. On each detected pulse, the Pulse Quality display blinks. Patient pulse quality signals are graded as good, marginal, or inadequate and are indicated as such by the Pulse Quality display blinking green, amber or red, respectively. This simple method gives the user a pulse-bypulse visual indication of waveform signal quality without requiring the user to perform complex waveform analysis.

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Using the PalmSAT Pulse Oximeter

The Model 2500 Pulse Oximeter may be used with a variety of Nonin-branded PureLight pulse oximeter sensors. A sensor disconnect or malfunction is indicated by an inadequate Pulse Quality display 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 numerical values will be replaced by dashes. Low and critically low battery conditions will be indicated by the Low Battery indicator.

See Accompanying Documents

NONIN MEDICAL, INC.

C

C

ED

MN USA IP32 PLYMOUTH, 4 X 1.5V AA MODEL 2500 IEC LR6 S SI FI PULSE OXIMETER LA 60601-1 UL US UL30EM

0123

US PATENT # Re.33,643 5822-000-05

Battery Cover Latch

Battery Cover

Figure 2: Rear View

Unpacking the Model 2500 The Model 2500 complete system includes the following items: • 1 Model 2500 Pulse Oximeter • 1 Model 2500 Operator’s Manual on CD • 1 Nonin Pulse Oximeter Sensor • 4 AA-Size Alkaline Batteries Confirm that the items listed are packed 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.

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Using the PalmSAT Pulse Oximeter

Installing and Using the Batteries The Model 2500 can be powered by 4 AA-size alkaline batteries, or by the optional Rechargeable NiMH Battery Pack, Model 2500B.

!

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

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. WARNING: Before changing the batteries, make sure the device is off and the sensor is not applied to a digit.

!

CAUTION: Replace the batteries as soon as possible after a low battery indication. Always replace the batteries with fully charged batteries.

1. Press the battery cover latch, and remove the battery cover on the bottom of the unit. 2. Insert four new AA-size alkaline batteries or a Rechargeable NiMH Battery Pack. Be sure to insert the batteries in the correct position, as indicated by the polarity markings (+ and -) inside the battery compartment. Proper battery positioning is essential for correct operation. 3. Replace the battery cover and turn on the device. If the unit does not turn on, see “Troubleshooting.”

!

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CAUTION: Replace batteries within 30 seconds to avoid losing settings (date, time, and patient date stored in memory) or corrupting data.

Using the PalmSAT Pulse Oximeter

Battery Pack

AA-size Alkaline Batteries

Battery Orientation

Figure 3: Installing Batteries

Important Notes about Battery Use Four AA alkaline batteries provide the device with approximately 80 hours of continuous operation, while the Rechargeable NiMH Battery Pack provides approximately 40 hours of continuous operation. Clock/calendar settings can significantly 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.

With AA Batteries • 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. • Using the oximeter will shorten the required replacement time.

With Rechargeable NiMH Battery Pack • If the clock/calendar is not set when the unit is stored, and if the unit has not been used, the Rechargeable NiMH Battery Pack will need recharging at least every 2 months. • If the clock/calendar is set when the unit is stored, and if the unit has not been used, the Rechargeable NiMH Battery Pack will need recharging at least every 3 weeks. • Using the oximeter will shorten the required recharging time.

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Using the PalmSAT Pulse Oximeter

Recharging Batteries (NiMH Battery Pack only) • Completely recharging the NiMH battery pack requires approximately 180 minutes when the unit is completely discharged. • The expected useful life of the Rechargeable NiMH battery pack is 500 charge/discharge cycles, or approximately 10 years, whichever is first. The battery pack must be charged at least once each year to maintain optimal battery life. • AA alkaline batteries cannot be recharged in the charging stand.

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 package insert for pulse oximeter sensor positioning information.

Figure 4: Connecting a Sensor

Power On/Off • Turn on the device by pressing and releasing the On/Off button on the front of the unit. • Turn off the device by pressing and holding the On/Off button for approximately 2 seconds. 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.

Power On Self-Test When the Model 2500 is turned on for normal operation, the unit 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 amber Low Battery LED turns on steadily for a few seconds.

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Using the PalmSAT Pulse Oximeter

• the Pulse Quality display turns red for 1 second, then green for 1 second, then shuts off. • 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, each for approximately 1 second): Main revision “r” + 3 digit; Memory revision “n” “n” (for m) + 3 digits. •

(two dashes) appear in the displays until a valid pulse signal is detected.

NOTE: This startup sequence varies slightly when entering setup mode at power on.

Monitoring Verify that the pulse oximeter sensor is properly positioned on the patient. Ensure that the pulse oximeter is sensing adequate pulse quality by: • verifying that the Pulse Quality display is blinking green and • verifying that the Pulse Rate and SpO2 displays are displaying readings and • verifying that blinking of the Pulse Quality display is in time with the pulse rate for at least 10 seconds If the Pulse Quality display is blinking red or amber or is blinking erratically, reposition the sensor or replace the sensor. If the sensor is not properly positioned, or no sensor is attached to the pulse oximeter after startup (a few seconds after powering on), both the SpO2 and Pulse Rate displays will display a single dash until a valid pulse signal is detected.

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Detailed Operation

Detailed Operation All functions of the Model 2500 are controlled by the On/Off on the front of the unit.

and Advance

buttons located

Setup Mode Setup mode is used to set: 1. memory clear function, 2. calendar and clock, and 3. memory playback function. In Setup mode, the Advance and On/Off buttons are used to make all selections. NOTE: Setting the month to “00” disables the calendar and clock functions and helps conserve battery life.

Entering Setup Mode 1. With the unit off, press and hold the Advance button while pressing and then releasing the On/Off button. 2. Release the advance button when 888 888 is displayed on the SpO2 and Pulse Rate displays. The clock time currently set in the memory, 04 41 for example, appears briefly in the displays, and then CLr no appears.

Making Selections in Setup Mode 1. When entering Setup mode, CLr no is displayed. (This indicates the memory clear setting is being adjusted, and that the default value is “no.” See Table 2.) Press and release the Advance button to change the value for this setting (or press and hold the Advance button to scroll quickly through the range of adjustable values). 2. When the desired value appears, press and release the On/Off button to store the value and advance to the next adjustable parameter, as listed in the following table. 3. Continue this process until all settings are chosen. When the setting sequence is complete, the device exits Setup mode, and is then ready to begin normal operation. Table 2: Adjustable Parameters and Settings Setting

Appears in SpO2 Display

Range of Values Appears in Pulse Rate Display

Default Value

Memory Cleara

CLr

yes or no

no

Delete (confirm clear)

dEL

yes or no

no

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Detailed Operation

Table 2: Adjustable Parameters and Settings (Continued) Setting

Appears in SpO2 Display

Range of Values Appears in Pulse Rate Display

Default Value

Year

y

00 - 99

07

Month

nn

00 - 12

00

Day

d

01 - 31

00

Hour

h

00 - 23

00

Minute

nn

00 - 59

00

a. Choosing “yes” for both the CLr and dEL settings (the memory clear function) will clear the memory and exit setup mode.

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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. The OxitestPlus7 by Datrend Systems, Inc. can be used to verify operation of the pulse oximeter.

!

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

!

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. 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.

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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 visual indicators and conditions. Condition Pulse Waveform Signal is inadequate

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

Visible Indication • Pulse Quality LED blinks red • SpO2 and heart rate LEDs display dashes after 10 seconds • Pulse Quality LED blinks • Dash (-) appears in the leftmost position of the SpO2 display • SpO2 and Heart Rate numeric displays freeze for 10 seconds • Pulse Quality LED is blank

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

• Dash (-) appears in the leftmost position of the SpO2 display

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

• Low Battery indicator is solid amber LED. No other displays are affected.

• SpO2 and Heart Rate numeric displays freeze for 10 seconds

• Critically Low Battery indicator is flashing Critically Low Battery

• SpO2 and pulse rate LEDs are blank • Pulse Quality display is solid red or amber

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