Nonin Medical Inc. BT4100 User Manual
Wrist-Worn Pulse Oximeter Device (POD)
Nonin’s Bluetooth
®
-enabled Wrist-Worn Pulse Oximeter Device (POD) allows
SpO
2
, pulse rate, and plethysmographic data to be transmitted through a
Bluetooth radio to a Bluetooth-enabled device. Nonin’s POD includes a class II
Bluetooth radio with a range of approximately 30 feet (spherical radius).
Indications for XXX System Use
The NONIN
®
XXX Pulse Oximetry System with Bluetooth
®
Wireless
Technology is indicated for measuring, displaying, and storing functional oxygen
saturation of arterial hemoglobin (SpO
2
) and pulse rate of adult, pediatric, infant,
and neonatal patients. It is indicated for use in hospitals, medical facilities,
ambulatory, subacute, and sleep study environments.
Precautions for Use
•
Do not use any part of this system in an MRI environment.
•
Explosion Hazard: Do not use this system in an explosive atmosphere or in the presence of flammable anesthetics or gases.
•
This system is intended only as an adjunct in patient assessment. It must be used in conjunction with other methods of assessing clinical signs
and symptoms.
and symptoms.
•
Oximeter readings may be affected by the use of an electrosurgical unit (ESU).
•
Use only NONIN-manufactured 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.
NONIN pulse oximeters. Using other manufacturers’ sensors can result in improper pulse oximeter performance.
•
Do not use a damaged sensor.
•
As with all medical equipment, carefully route cables and connections to reduce the possibility of entanglement or strangulation.
•
To avoid the risk of confusing or misinterpreting patient data, verify that the patient is paired with the correct display unit. (See “Device Pairing”
in the XXX Pulse Oximetry System Operator’s Manual.)
in the XXX Pulse Oximetry System Operator’s Manual.)
•
This pulse oximetry system is designed to determine the percentage of arterial oxygen saturation of functional hemoglobin. Significant levels of
dysfunctional hemoglobin, such as methemoglobin, might affect the accuracy of the measurement.
•
Loss of monitoring can result if any objects hinder the pulse measurement. Ensure that no blood flow restrictors (e.g., blood pressure cuff)
hinder pulse measurements.
•
This equipment complies with International Standard EN 60601-1-2:2001 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
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 interference due to close proximity or strength of a source might disrupt the device’s performance.
•
If any part of this system fails to respond as described, discontinue use until the situation is corrected by qualified personnel.
•
This system might misinterpret motion as good pulse quality. Minimize finger motion or change the type of sensor being used.
•
Inspect the sensor application site at least every 6 to 8 hours to ensure correct sensor alignment and skin integrity. Patient sensitivity to sensors
may vary due to medical status or skin condition.
may vary due to medical status or skin condition.
•
Follow local governing ordinances and recycling instructions regarding disposal or recycling of the device and device components, including
batteries. Use only NONIN-approved battery packs, and remove batteries if the system is not used within 30 days.
batteries. Use only NONIN-approved battery packs, and remove batteries if the system is not used within 30 days.
•
Do not fasten the POD too tightly around the patient’s wrist. Inaccurate readings and patient discomfort could result.
Declaration of Conformity with FCC Rules for Electromagnetic Compatibility
Nonin Medical, Inc., of 2605 Fernbrook Lane North, Plymouth, Minnesota, 55447, declares under its sole responsibility that the products 4000 and
4100, to which this declaration relates, comply with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) this device may
not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation.
not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation.
Federal Communications Commission (FCC) Notice
This equipment has been tested and found to comply with the limits for a class B digital device, pursuant to part 15 of the FCC Rules. These limits are
designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses, and can radiate
designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses, and can radiate
radio frequency energy. If not installed and used in accordance with the instructions, it may cause harmful interference to radio or television reception,
which can be determined by turning the equipment off and on. The user is encouraged to try to correct the interference by one or more of the
following measures:
following measures:
•
Reorient or relocate the receiving antenna.
•
Increase the distance between the equipment and the receiver.
•
Connect the equipment to an outlet on a circuit different from the outlet where the receiver is connected.
•
Consult the dealer or an experienced radio/TV technician for assistance.