Nonin 7500FO Instructions For Use

Model 7500FO
Instructions For Use
Thank you for trusting Nonin with your patients' healthcare needs. We sincerely appreciate your
business. Please read your Operator's Manual carefully and direct any further questions to a Nonin
Technical Service representative. If you would like to order products or check the status of a current
order, please contact Customer Service.
Contact Customer Service or Technical Service
Toll Free: 800.356.8874 (U.S. and Canada only)
Phone: +1 763.553.9968
Email: customerservice@nonin.com
Nonin Medical Inc. Nonin B.V.
13700 1st Avenue North Doctor Paul Janssenweg 150
Plymouth, MN 55441-5443, USA
5026 RH Tilburg, Netherlands
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7500FO Specifications
*Additional specifications are available in the IFU/Operator's Manual that can be located using the QR Code.
• Oxygen saturation measured from 0%-100% SpO . With an accuracy typically ± 2 with a maximum of ± 3.
2
• Pulse rate measured from 18bpm-321bpm. With an accuracy data is typically ± 3 with a maximum of ± 5.
Measurement Wavelengths and Output Power:
• Red: 660 nanometers @ 0.8 mW maximum average
• Infrared: 910 nanometers @ 1.2 mW maximum average

Indications for Use/Intended Use/Intended Purpose

The Nonin Model 7500FO Pulse Oximeter is a portable tabletop device indicated for use in simultaneously measuring, displaying, and recording
functional oxygen saturation of arterial hemoglobin (SpO ) and pulse rate of adult, pediatric, and infant patients in a Magnetic Resonance (MR) environ-
2
ment. Testing was performed in MR conditional environments at 1.5T and 3T. It is intended for spot checking and/or continuous monitoring of patients
who are well or poorly perfused.

Warnings

• Do not operate this device with the oximeter or sensor connectors within the MR room. The oximeter and sensor connector should be positioned in
the control/observation room with the fiber optic cable and sensor entering the MR room through the wall.
• Do not use in an explosive atmosphere or in the presence of flammable anesthetics or gases.
• This device is not defibrillation proof per IEC 60601-1.
• The battery charger cannot be used in the MR environment.
• This device is intended only as an adjunct device 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 4 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.
• Avoid excessive pressure to the sensor application site as this may cause damage to the skin beneath the sensor.
• Oximeter readings of this device may be affected by the use of an electrosurgical unit (ESU).
• To avoid patient injury, use only 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.
• Verify all alarm settings and limits during system startup to ensure that they are set as intended.
• Do not use this device in or around water or any other liquid, with or without AC power.
• As with all medical equipment, carefully route patient cables and connections to reduce the possibility of entanglement, strangulation, or injury to
the patient.
P/N 115157-000-01 05/2023 13700 1st Avenue North, Plymouth, MN 55441-5443 USA
Warnings (continued)
• Use this device only with power adapters supplied by Nonin Medical.
• This device turns off after approximately 30 minutes when in low battery mode.
• 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 battery pack must be installed at all times while the device is operating—even when operating on AC power. Do NOT use the device without
batteries.
• The use of accessories, sensors, and cables other than those listed in this manual may result in increased electromagnetic emission and/or
decreased immunity of this device.
• 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 obstruct any speaker openings.
• The fiber cable for this device is extremely sensitive and must be handled with caution at all times. Do not use a damaged sensor.
• Ensure that the routing of the sensor cable from the 7500FO device in the control/observation room to the MR room does not compromise the
RF shielding of the MR room. A proper wave guide for the sensor cable passage through the RF cage must be taken into account by the RF cage
builder during site planning, or created afterwards.
• Portable RF communications equipment such as cell phones or radios (including peripherals such as antenna cablesand external antennas)
should be used no closer than 30 cm (12 inches) to any part of the medical electrical system, including cables specified by the manufacturer.
Otherwise, degradation of the performance of this equipment could result.
Cautions
• 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 this manual.
• 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.
• If the device does not beep during the initialization sequence, the speaker may not be functioning properly. Discontinue use until the situation is
corrected by Nonin Technical Service.
• Review all limits to ensure they are appropriate for the patient.
• Setting alarm limits to extremes can render the alarm system useless.
• Do not simultaneously touch the accessible connector pins and the patient.
• This device is a precision electronic instrument and must be repaired by Nonin Technical Service. 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.
• If this device fails to respond as described, discontinue use until the situation is corrected; contact Nonin Technical Service.
• The sensor might not work on cold extremities due to reduced circulation. Warm or rub the finger to increase circulation, or reposition the
sensor.
• Do not gas sterilize or autoclave this device.
• Batteries might leak or explode if used or disposed of improperly.
• 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.
• Do not place liquids on top of this device.
• Do not immerse this device or sensors in any liquids.
• Do not use caustic or abrasive cleaning agents on the unit or sensors.
• Follow local, state and national governing ordinances and recycling instructions regarding disposal or recycling of the device and device
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 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.
• To prevent potential loss of monitoring or inaccurate data, remove any objects that might hinder pulse detection and measurement (e.g., blood
pressure cuffs).
• If the entire memory is filled, portions of the oldest record will be overwritten when a new record begins.
• 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 • Improperly applied sensor
• Incorrect sensor type
• Excessive motion
• Electrosurgical interference • Poor pulse quality
• Blood flow restrictors (arterial catheters, • Venous pulsations
blood pressure cuffs, infusion lines, etc.)
• Anemia or low hemoglobin concentrations
• Moisture in the sensor • Cardiogreen and other intravascular dyes
• 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 Standard EN 60950, IEC 62368-1,
or UL 1950 for data-processing equipment.
• Operation of this device below the minimum amplitude of 0.3% modulation may cause inaccurate results.
• The two-minute alarm silence is automatically engaged at startup.
• Do not use the power supply if the integrity of the AC cord conductors or the outlet is in doubt.
• Failure of a network data coupling (serial cable/connectors) will result in loss of data transfer.
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©2023 Nonin Medical, Inc. All trademarks are the property of Nonin Medical, Inc. unless otherwise noted.
Model 7500FO
Instructions for Use
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.
• Carboxyhemoglobin
Warranty
• Methemoglobin
• Dysfunctional hemoglobin
• Artificial nails or fingernail polish
The device warranty
• A sensor not at heart level
is 3 years.
• Residue (e.g., dried blood, dirt, grease, oil)
in the light path
nonin.com/warranty
For summary of safety and clinical data see above QR code.
EC REP
P/N 115157-000-01 05/2023
Instructions for Use / Operator's Manual
https://www.nonin.com/support/7500fo
Symbol Compliance
Glossary
This product complies
with ISO 10993.
nonin.com/symbols
Not made from
natural rubber latex.
MPS, Medical Product Service GmbH MedEnvoy Switzerland
CH REP
Borngasse 20 Gotthardstrasse 28, 6302 Zug
D-35619 Braunfels, Germany Switzerland
13700 1st Avenue North, Plymouth, MN 55441-5443 USA nonin.com