NONIN 1000USB-C USB Interface Adapter Instruction Manual

: June 4, 2024
: NONiN

Table of Contents

NONIN 1000USB-C USB Interface Adapter
Indications for Use
Symbols
Specifications
References
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NONIN 1000USB-C USB Interface Adapter

Indications for Use

Nonin’s 1000USB-C interface adapter is designed for connecting Nonin handheld pulse oximeters to a Continua-compliant
Application Hosting Device (AHD) or personal computer (PC). Data is transferred between the pulse oximeter and the Continua AHD or
PC when you use this product with a Continua Certified™ AHD or
PC that supports the ISO/IEEE 11073-10404:2010 (Device Specialization-Pulse Oximeter).

Warnings

Setup of the device should be done in the order listed below to prevent the risk of shock to patient/operator.
The operator shall not touch the patient and the accessible pins on the accessory simultaneously to prevent the risk of shock to patient/operator.
Accessory equipment connected to the analog and digital interfaces must be in compliance with the respective nationally harmonized IEC standards (i.e., IEC 60950 for data processing equipment, IEC 61010-1 for laboratory equipment, and IEC 60601-1 for medical equipment).
To prevent improper performance and/or patient injury, verify compatibility of the monitor, sensor(s), and accessories before use.
To avoid patient injury, use only Nonin-branded accessories. Note: Refer to Nonin’s handheld pulse oximeter operator’s manuals for additional contraindications, warnings, and cautions.

Notes :

The 1000USB-C interface adapter is designed for use with all Nonin handheld pulse oximeters.
The 1000USB-C interface adapter may be used for real-time data collection only. The Nonin memory playback feature is not supported at this time.
The Application Hosting Device (AHD) or PC, AHD application, and corresponding USB Personal Health Device Class (PHDC) host driver are the responsibility of the AHD vendor. Contact the AHD vendor for product support on these items.
This device does not indicate connection problems associated with the Continua AHD or PC.
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.
The device’s expected service life is 1 year

Symbols

NONIN 1000USB-C USB Interface Adapter 1

Setup:

Follow the instructions provided by your Continua AHD vendor to set up your Continua AHD or PC.
Connect the sensor connector of the pulse oximeter to the “Oximeter” adapter port (1).
Connect the sensor to the “Sensor” adapter port (2).
Connect the “ ” adapter port (3) to the USB port on your Continua AHD or PC.
Follow the instructions provided by your Continua AHD vendor for collecting data from a Continua Certified™ pulse oximeter.
The LED on the unit will blink green until the appropriate PHDC driver is installed and loaded on your Continua AHD or PC. When the drivers have been successfully loaded and the unit is ready to transfer data, the LED will light steady and remain green.

Connecting the Device into a Medical System

Incorporating the device into a medical system requires the integrator to identify, analyze, and evaluate the risks to patient, operators, and third parties. Subsequent changes to the medical system after device integration could introduce new risks and will require additional analysis. Changes to the medical system that must be evaluated include:

Changing the system configuration
Adding devices to or disconnecting devices from the system
Updating or upgrading equipment connected to the system
Issues resulting from user-initiated system changes may include corruption or loss of data.

NOTES:

When using the serial port to connect the device to other equipment, follow each device’s cleaning instructions.
Verify all equipment connected to the device is suitable for the patient’s environment.

Care and Maintenance

Wipe the device with a soft cloth dampened with a mild detergent or 10% bleach solution. Do not use undiluted bleach or any cleaning solution other than those recommended here, as permanent damage could result. Dry with a soft cloth or allow to air dry.