Nonin 2500 Instructions For Use

Nonin Model 2500 PalmSAT ® Pulse Oximeter and Model 2500A PalmSAT
Indications for Use/Intended Use/Intended Purpose
The Nonin ® Model 2500 PalmSAT ® Pulse Oximeter and Model 2500A PalmSAT ® Pulse Oximeter with Alarms are indicated for use in measuring
and displaying functional oxygen saturation of arterial hemoglobin (SpO ) and pulse rate for adult, pediatric, and neonatal patients. These devices
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are 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.
Warnings
• 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.
• 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 SpO measurement. Verify that nothing is hindering the pulse
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measurement before relying on the SpO measurement.
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• 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.
• When a system fault occurs, the patient will no longer be monitored.
• To comply with relevant product safety standards, ensure that all alarm volumes are set appropriately and are audible in all situations.
Do not cover or otherwise hinder any speaker openings.
• The device turns off after approximately 10 minutes when at low battery capacity.
• Before changing the batteries, make sure the device is off and the sensor is not attached to a digit.
• Portable RF communications equipment such as cell phones or radios (including peripherals such as antenna cables and external antennas)
should be used no closer than 30 cm (12 inches) to any part of the ME system, including cables specified by the manufacturer. Otherwise,
degradation of the performance of this equipment could result.
Warnings – only for the Model 2500A PalmSAT Pulse Oximeter with Alarms
• Verify all alarm settings and limits during system startup to ensure that they are set as intended.
• A hazard can exist if different presets are used on multiple 2500A monitors in one care area.
• Because operating environments vary, use caution to ensure that all audible alarms and indicators can be heard. Users must determine the
acceptable audible distance of all alarms.
• Do not place this device in an environment where its speaker opening may become blocked; alarms may become muffled or inaudible.
• Turning off the alarm volume creates a situation that is not compliant with relevant safety standards. The alarm silence indicator is lit solid
when the alarm volume is turned off or set below 45 dBA.
Cautions
• Before use, carefully read the package insert provided with the sensors.
• This device is not an apnea monitor.
• Verify that all visible indicators illuminate and that an audible indicator sounds during the startup (initialization) sequence. If any indicator is
not lit or the audible indicator does not sound, do not use the device. Contact Nonin Technical Service for assistance.
• Review all limits to ensure they are appropriate for the patient.
• 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.
Cautions (continued)
® Pulse Oximeter with Alarms
• 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 electri-
cal 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.
• 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 - carboxyhemoglobin cuffs,
infusion lines, etc.)
• 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.
Cautions – only for the Model 2500A PalmSAT Pulse Oximeter with Alarms
• Setting alarm limits to extremes can render the alarm system useless.
Nonin Model 2500C Charger Stand
Indications for Use/Intended Use/Intended Purpose
The Nonin Model 2500C Charger Stand is intended for use with the PalmSAT Models 2500 and 2500A Pulse Oximeters and the Model 2500B
Rechargeable NiMH (Nickel Metal Hydride) Battery Pack.
Warnings
• Do not use this product in an MR environment.
• Do not use this product in an explosive atmosphere.
• This product is not defibrillation proof per IEC 60601-1.
• As with all medical equipment, carefully route patient cabling to reduce the possibility of patient entanglement, strangulation, or injury to
the patient.
• This product should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the product should be
observed carefully to verify normal operation.
• The use of accessories, sensors, cables, and power supplies other than those listed in the Parts and Accessories List may result in increased
electromagnetic emission and/or decreased immunity of this product.
• 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.
• Portable RF communications equipment such as cell phones or radios (including peripherals such as antenna cables and external antennas)
should be used no closer than 30 cm (12 inches) to any part of the ME system, including cables specified by the manufacturer. Otherwise,
degradation of the performance of this equipment could result.
Cautions
• This equipment complies with International Standard 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 product. 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.
• Do not connect this product to an AC outlet controlled by a wall switch. If the switch is accidentally turned off before the battery pack is
recharged, the pulse oximeter may not function.
• Grounding reliability can only be achieved when the equipment is connected to an equivalent receptacle marked "Hospital Only" or "Hospital Grade".
• This product contains sensitive electronic components and must be repaired by trained Nonin personnel only.
• Do not immerse this product in liquid.
• Do not place liquids on top of this product.
• Do not use caustic or abrasive cleaning agents on this product.
• Do not remove any covers from the product. There are no user-serviceable parts inside the unit.
• Do not attempt to charge disposable batteries. Disposable batteries may leak or explode if used improperly.
• Follow local, state and national governing ordinances and recycling instructions regarding disposal or recycling of the product and product
components, including batteries. Use only Nonin-approved battery packs.
• 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 product contains WEEE materials; please contact your distributor regarding take-back or recycling of the
product. If you are unsure how to reach your distributor, please call Nonin for your distributor's contact information.
Adverse Event Statement
Users and/or patients should report adverse events involve their Nonin device to Nonin Medical, Inc. and the competent authority of the EU Member
State in which the user and/or patient is established, if applicable.
©2022 Nonin Medical, Inc. All trademarks are the property of Nonin Medical, Inc. unless otherwise noted.
• Moisture in the sensor • Cardiogreen and other intravascular dyes
• Improperly applied sensor • Carboxyhemoglobin
• Incorrect sensor type • Methemoglobin
• Inadequate signal • Dysfunctional hemoglobin
• Artificial nails or fingernail polish
• Venous pulsations
• Anemia or low hemoglobin concentrations • A sensor not at heart level
Model 2500
Instructions for Use
Instructions for Use / Operator's Manual
https://www.nonin.com/support/2500
ENG – Translations of the IFU can be found using this QR code.
FRE – Les traductions de cette notice d'utilisation peuvent être retrouvées à l'aide de ce code QR.
GER – Übersetzungen dieses Handbuchs können über diesen QR-Code abgerufen werden.
ITL – Utilizzando questo codice QR, è possibile trovare le traduzioni delle Istruzioni per l'uso.
SPA – Las traducciones de este manual se pueden encontrar utilizando este código QR.
POR – Pode aceder às traduções das instruções de utilização através deste código QR.
DUT – Vertalingen van de handleiding zijn te vinden met behulp van deze QR-code.
GRK – Με τη χρήση αυτού του κωδικού QR μπορείτε να βρείτε μεταφράσεις
των οδηγιών χρήσης (IFU).
DAN – Scan denne QR-kode for at finde oversættelser af denne brugsvejledning.
SWE – Översättningar av den här guiden kan hittas med denna QR-kod.
F IN – Käyttöohjeen käännökset löytyvät tällä QR-koodilla.
POL – Tłumaczenia tego przewodnika można znaleźć za pomocą tego kodu QR.
NOR – Oversettelser av denne bruksanvisningen kan finnes ved å bruke denne QR-koden.
Warranty Symbol
Glossary
The device warranty
is 3 years.
nonin.com/symbols
nonin.com/warranty
For summary of safety and clinical data see above QR code.
MPS, Medical Product Service GmbH
EC REP CH REP
Borngasse 20
D-35619 Braunfels, Germany
P/N 114856-001-01 11/2022 13700 1st Avenue North, Plymouth, MN 55441-5443 USA
Compliance
This product complies
with ISO 10993.
Not made from
natural rubber latex.
MedEnvoy Switzerland
Gotthardstrasse 28, 6302 Zug
Switzerland
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