Nonin 2500A Vet Instructions For Use And Operator's Manual

Nonin Model 2500A Vet Oximeter with Alarms
Indications for Use/Intended Use/Intended Purpose
The Nonin Model 2500A VET PalmSAT® Veterinary Pulse Oximeter with Alarms is indicated for use in measuring and displaying functional oxygen
saturation of arterial hemoglobin (SpO2) and pulse rate for animals. The device is intended for continuous monitoring and/or spot-checking of
animals during both motion and no-motion conditions, and for animals who are well or poorly perfused.
Warnings
• Do not use this device in an MR environment.
• This device is not defibrillation proof per IEC 60601-1.
• The Model 2500A VET is intended for VETERINARY USE ONLY.
• This device is intended only as an adjunct in animal assessment. It must be used in conjunction with other methods of assessing clinical signs
and symptoms.
• Inspect the sensor application site at least every 4 hours to ensure correct sensor alignment and tissue integrity. Animal sensitivity to sensors
and/or double-backed adhesive strips 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).
• Do not use a damaged sensor. If the sensor is damaged in any way, discontinue use immediately and replace the sensor.
• 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 VET monitors in one care area.
• 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.
• To prevent improper performance and/or injury to the animal, verify compatibility of the monitor, sensor(s), and accessories before use.
• No modifications to this device are allowed as it may affect device performance.
• 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.
• 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.
• When a system fault occurs, the animal 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 critically low battery capacity.
• In the event the sensor becomes dislodged from the animal, audible and visual alarms are activated, requiring that a veterinary professional
investigate the reason for the alarm status. The veterinary professional must investigate animal status and sensor attachment after every sen-
sor alarm indication. It is possible when the sensor is dislodged from the animal (under certain conditions of light and vibration of the sensor)
for the pulse oximeter to display normal physiological values.
• Verify all alarm settings and limits during system startup to ensure that they are set as intended.
• Before changing the batteries, make sure the device is off and the sensor is not applied to the animal.
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 animal.
• Setting alarm limits to extremes can render the alarm system useless.
• This device may not work on all animals. If you are unable to achieve stable readings, discontinue use.
• Inadequate perfusion, thick fur, foreign matter that blocks light, or an improperly applied sensor can result in erratic and inaccurate oxygen satu-
ration and/or pulse rate measurement. Follow the instructions outlined in "Monitoring." If proper operation cannot be verified, remove the sensor
from the animal and DO NOT use the oximeter on the animal.
• 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 animal motion as much as possible.
• Do not place the Model 2500A VET in liquid or clean it with agents containing ammonium chloride, isopropyl alcohol, or products that are not
listed in this operator's manual.
• 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 sensor site to increase circulation, or
reposition the sensor.
• Sensor sites must be checked periodically to determine circulation, sensor positioning, and tissue sensitivity
• 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 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 compo-
nents, including batteries.
• Batteries may leak or explode if used or disposed of improperly.
Cautions (continued)
• Remove the batteries if the device will be stored for more than 1 month.
• 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 equip-
ment 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 eletrical 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 • Moisture in the sensor
• Excessive motion • Improperly applied sensor
• Incorrect sensor type
• Electrosurgical interference
• Inadequate signal
• Blood flow restrictors (arterial catheters,
blood pressure - carboxyhemoglobin cuffs, • Venous pulsations
infusion lines, etc.)
• Anemia or low hemoglobin concentrations
• 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.
• Use only the Nonin-branded Model 2000SL, 2000T, or 2000SA veterinary sensors for monitoring. These sensors are manufactured to meet the
calibration requirements for the Nonin Model 2500A VET pulse oximeter. The oximeter is calibrated for adult human hemoglobin measured
at the finger tip. Although animal hemoglobin has similar optical characteristics, other types of hemoglobin or alternate sensor locations may
affect the calibration.
• Certain pharmacologic agents used to sedate or anesthetize animals may have cardiovascular effects that can adversely affect the perfor-
mance of the pulse oximeter by reducing the perfusion to the sensor site. Examples of commonly used agents that may have this type of effect
on certain animal species are Detomidine HCl and Xylazine HCl.
• There is a wide range of variability between animal species and their respective differences in anatomy, physiology, and responses to veterinary
pharmacological agents. Therefore, the veterinary professional will need to use discretion when selecting sensors and/or sensor sites that are
appropriate for the animal species and the monitoring conditions.
• When attaching the pulse oximeter sensor, make sure to secure the sensor in a manner that will not restrict perfusion. An improperly applied
sensor could inhibit proper function of the pulse oximeter and cause discomfort or localized ischemia to the animal.
• Failure of a network data coupling (serial cable/connectors) will result in loss of data transfer.
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.
©2024 Nonin Medical, Inc. All trademarks are the property of Nonin Medical, Inc. unless otherwise noted.
Model 2500A Vet
Instructions for Use
• Cardiogreen and other intravascular dyes
• Carboxyhemoglobin
• Methemoglobin
• Dysfunctional hemoglobin
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
The device warranty
is 3 years.
nonin.com/warranty
For summary of safety and clinical data see above QR code.
P/N 115579-001-01 08/2024
Instructions for Use / Operator's Manual
https://www.nonin.com/support/2500A-Vet
Compliance
Symbol
This product complies
Glossary
with ISO 10993.
nonin.com/symbols
Not made from
natural rubber latex.
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