NONIN Model 7500 Pulse Oximeter Instruction Manual

June 16, 2024
NONiN

NONIN Model 7500 Pulse Oximeter

Translations of the IFU can be found using this QR code.

Warranty
The device warranty is 3 years. nonin.com/warranty

Glossary
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Compliance
This product complies with ISO 10993. Not made from natural rubber latex. For a summary of safety and clinical data see above QR code. To set up and use the Nonin Model 7500 pulse oximeter, please follow the simple instructions below.

Operating the Model 7500

  1. Fully charge the battery pack, which takes approximately four hours.
  2. Press the ON/STANDBY button. Make sure all LEDs (except the AC Power Supply LED) light up and the unit beeps three times during the startup sequence.
  3. If any LED is not lit, do not use the device and contact Nonin Technical Service for assistance.
  4. Insert the sensor into the Model 7500, then apply it to the patient and take the measurement. For more information on how to use a specific sensor, please refer to that sensor’s Operator’s Manual.
  5. When done using the Model 7500, press and hold the ON/STANDBY button for one to three seconds to turn the device off.

Displays, Indicators, and Controls

NONIN-Model-7500-Pulse-Oximeter-fig-2
For more information on the displays, indicators, and controls, please refer to the Operator’s Manual.

NONIN-Model-7500-Pulse-Oximeter-fig-3

Operator Functions

Refer to the Operator’s Manual for more information about advanced options, which are only recommended for trained operators.

NONIN-Model-7500-Pulse-Oximeter-fig-4

Operating Modes and Defaults
The Model 7500 is shipped with factory defaults active. Refer to the Operator’s Manual for more information about its other modes, including Setup mode, User-Defined Defaults, and Patient Security mode.

Parameter Factory Default
SpO2 High Alarm Limit Off
SpO2 Low Alarm Limit 85%
Pulse Rate High Alarm Limit 200 BPM
Pulse Rate Low Alarm Limit 50 BPM
Alarm Volume High
Oximetry Averaging Standard/Fast Averaged SpO2 (no)

Clinical Benefits
Nonin pulse oximeters allow for the management of patients’ medical conditions by providing fast, accurate, real-time, noninvasive oxygen measurements to meet patients’ medical needs.

Alarms and Limits
Audio and visual alarms alert you about product malfunctions or changing patient conditions. To silence an alarm for two minutes, press the Alarm Silence button.

Alarm Indicated By What It Means

High priority alarm

| Rapidly-blinking red Alarm Bar LED and a red Pulse Strength Bargraph LED|

Immediate patient attention is required.

Medium priority alarm| Slowly-blinking amber Alarm Bar LED| There may be problems with the equipment, or a non-life-threatening change in patient condition.
Watchdog alarm| Loud, two-tone,

steadily-beeping signals

| Hardware of software malfunction.
Informational tone| Single beeps or series of three beeps| Communicating important information, such as startup/initialization.

Memory Features inter-model?
Patient dales retail store e when both external and battery we are lost. For information on clearing patient memory or playing back memory data, please refer to the Operator’s Manual.

Care and Maintenance

Clean the Model 7500 separately from the sensors. Please refer to the sensor’s Operator’s Manual for information on how to clean the sensors.

To clean the Model 7500

  1. Dampen a soft cloth with isopropyl alcohol, mild detergent, or a 10% bleach (5.25% sodium hypochlorite with water solution.
  2. Do not pour or spray any liquids onto the Model 7500, and do not allow any liquid to enter any openings in the device.
  3. Allow the unit to dry thoroughly before reusing it.
  4. Field repair of the Model 7500 circuitry is not possible. If the Model 7500 is not functioning properly, please reference the “Troubleshooting” section of the Operator’s Manual.

Error Codes
This device includes error codes that indicate problems with the unit. Error codes are indicated by “Err” in the %SpO, display, and a capital “E” followed by a 2-digit code in the pulse rate display. To correct error conditions, perform the following steps:

  1. Turn the unit off and then back on again to remove the error code.
  2. If the error persists, disconnect all power, and then reconnect the power and turn the unit back on.
  3. If the error persists, note the error code and contact Nonin Technical Service.
  4. Please refer to the Operator’s Manual on nonin.com/support/7500 for trouble chanting guidance and more detailed generating instructions

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.
13700 1st Avenue North
Plymouth, MN 55441-5443, USA
Nonin B.V.
Doctor Paul Janssenweg 150
5026 RH Tilburg, Netherlands

Have other questions or want to learn more?
Visit nonin.com to read more about our history, product offerings, and more. Nonin is committed to sustainable practices. This paper is made with FSC-certified materials, printed with soy ink, and is 100% recyclable.

Specifications

  • Additional specifications are available in the IFU/Operator’s Manual which can be located using the QR Code.
  • Oxygen saturation measured from 0%-100% SpO2
  • With an accuracy typically ± 2 with a maximum of ± 3.
  • 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 7500 Pulse Oximeter is a portable tabletop device indicated for use in simultaneously measuring, displaying and recording functional oxygen saturation of arterial hemoglobin (SpO2 and pulse rate of adult, pediatric, infant, and neonatal patients. It is intended for spot-checking and/or continuous monitoring of patients during both motion and no-motion conditions and for patients who are well or poorly perfused.

Warnings

  • Do not use it in an explosive atmosphere or the presence of flammable anesthetics or gases.
  • Do not use this device in an MRI environment.
  • This device is not defibrillation proof per IEC 60601-1.
  • 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.
  • Oximeter readings of this device may be affected by the use of an electrosurgical unit (ESU).
  • 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 on the sensor application site as this may cause damage to the skin beneath the sensor.
  • To avoid patient injury, use only Non-in-branded PureLight® pulse oximeter sensors. These sensors are manufactured to meet the accuracy specifications for non-in 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 device settings, alarm settings and limits in setup mode to ensure that they are set as intended.

Warnings (continued)

  • A hazard can exist if different presets are used on multiple 7500 monitors in one care area.
  • 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.
  • Use this device only with Non-in-specified power supplies.
  • 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 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 the Parts and Accessories List 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 hinder any speaker openings.
  • 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

  • When mounting the monitor to a mobile pole, mounting the monitor more than 1.5 meters (5 feet) or mounting more than 2 kilograms (4.4 pounds) of equipment onto the pole may result in tipping, damage to the equipment, or injury.
  • 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, high levels of such interference due to 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.
  • If this device fails to respond as described, 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.
  • 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 artifacts being misinterpreted as good pulse quality.
  • In some circumstances, however, the device may still interpret motion as good pulse quality.
  • This device is a precision 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.
  • 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.
  • To prevent potential loss of monitoring, do not use ear clips or reflective sensors on pediatric or neonatal patients.
  • 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
  • Carboxyhemoglobin
  • Excessive motion
  • Incorrect sensor type Methemoglobin
  • Electrosurgical interference
  • Poor pulse quality
  • Dysfunctional hemoglobin
  • Blood flow restrictors (arterial catheters, blood pressure cuffs, infusion lines, etc.)
  • Venous pulsations
  • Artificial nails or fingernail polish
  • Anemia or low hemoglobin concentrations
  • A sensor not at heart level
  • Moisture in the sensor
  • Cardiogreen and other intravascular dyes
  • Residue (e.g., dried blood, dirt, grease, oil) in the light path

When using the monitor in the home, avoid exposing the monitor to lint and dust.

  • When using the monitor around small children and pets, avoid leaving the monitor unattended. Cables pose a risk of injury, including strangulation.
  • 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.
  • 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.
  • The two-minute alarm silence is automatically engaged at startup

Adverse Event Statement
Users and/or patients should report adverse events involving 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.

References

Read User Manual Online (PDF format)

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