Snap Diagnostics 9-10000 Patient Testing Instructions

: June 17, 2024
: Snap Diagnostics

Snap Diagnostics 9-10000 Patient Testing

Product Information

Specifications

Model: SAM Model 9-10000
Manufacturer: Snap Diagnostics
Address: 616 Atrium Drive, Ste 100, Vernon Hills, IL, 60061
Customer Support: 847-777-0000
Website: www.snapdiagnostics.com
FCC ID: 2BDPB910000
Temperature Range: -13 to 158 F (-25 to 70C)
Relative Humidity Range: 15% to 90% non-condensing

Product Usage Instructions

Warnings

Route sensor cables carefully to prevent entanglement, strangulation, or choking.
Inspect sensor application sites every 6 to 8 hours for correct alignment and skin integrity.
Discontinue use if allergic reaction occurs.
Avoid using damaged equipment or sensors.
Avoid connecting unauthorized external devices to the USB-C port.

Cautions

Use under the supervision of a licensed healthcare practitioner.
Use only Snap Diagnostics supplied sensors and cables.
Dispose of nasal cannula and belt strap after single patient use.
Do not open the device as the battery is not user-replaceable.
Avoid getting the device or sensors wet and keep away from foreign objects.

Indications for Use

This booklet provides instructions for taking the Snap Diagnostics home sleep test with the SAM Model 9-10000 device.

Introduction

The testing equipment should be applied as instructed prior to recording. For best results, wear the equipment for the entire recording duration. Reapply if removed during recording time.

Storage Instructions

Avoid storing the recording device and accessories in extreme heat or cold environments. Maintain temperature and humidity within specified ranges.

FAQ

Q: How often should I inspect the sensor application sites?

A: It is recommended to inspect the sensor application sites at least every 6 to 8 hours to ensure correct alignment and skin integrity.

Q: Can I replace the battery of the device?

A: No, the battery is not removable or replaceable by the user.
Do not attempt to open the device.

Snap Diagnostics
SAM Model 9‐10000 Patient Testing Instructions

Copyright ©2024 SNAP Diagnostics, LLC
All Rights Reserved. This booklet or any portion thereof may not be reproduced in any manner without the express written permission of the publisher.
Snap Diagnostics
616 Atrium Drive, Ste 100
Vernon Hills, IL, 60061
Customer Support 847‐777‐0000
www.snapdiagnostics.com

FCC ID: 2BDPB910000

WARNINGS

Carefully route the sensor cables to reduce the possibility of entanglement, strangulation or choking. Children, elderly, or any individual who could possibly become entangled in a cable or choke on parts should be continuously observed by an adult or monitored.
Inspect the sensor application sites at least every 6 to 8 hours to ensure correct sensor alignment and skin integrity. Sensitivity to sensors may vary due to medical status or skin condition. If you have poor peripheral blood circulation or sensitive skin, you should inspect the site more frequently. Prolonged continuous SPO2 monitoring may increase the risk of undesirable changes in skin characteristics, such as irritation, reddening, blistering, or burning.
Discontinue use if you exhibit an allergic reaction to any part of the device or sensors.
Do not use damaged equipment or sensors. If the equipment or any sensor appears to be damaged in any way, discontinue use immediately and replace.
Do not connect any unauthorized external devices to the device USB‐C port.

CAUTIONS

℞ only: U.S. Federal law restricts this recorder to sale by or on the order of a licensed healthcare practitioner. Use of this device must be under the direct supervision of a qualified adult (parent or guardian) or health care practitioner trained in the user of the SAM Model 9‐10000.
Use only Snap Diagnostics supplied sensors and cables with this device. Using other accessories may result in increased electromagnetic emission or decreased electromagnetic immunity of the equipment.
The nasal cannula and belt strap are intended for a single patient use only and should be disposed of after use.
The device should not be opened. The battery is not removable or replaceable by the user.
Do not allow the device or sensors to get wet.
Avoid placing food or liquid on any part of the system.
Do not introduce any foreign object into the device.
Avoid leaving the equipment unattended around pets.

Indications for Use

The SNAP Diagnostics SAM Model 9‐10000 device is indicated for use in the diagnostic evaluation of patients for apnea and snoring and to provide quantitative and qualitative analysis of apnea and snoring.
The SNAP Diagnostics SAM Model 9‐10000 is not intended as a substitute for full polysomnography when additional parameters such as sleep stages or EEG activity are required.
The target population consists of patients who are suspected of apnea and/or complain about snoring. The majority of the test procedures will take place at the patient’s home, although some may take place in a sleep laboratory. Both pediatric and adult patients may be tested.
CAUTION: US Federal law restricts this device to sale by or on the order of a physician. Use of this device must be under the direct supervision of a qualified adult (parent or guardian) or health care practitioner trained in the use of the SNAP Model 9 device.

Introduction

This booklet provides instructions for taking your Snap Diagnostics home sleep test with the SAM Model 9‐10000 device. These instructions may refer to the SAM Model 9‐10000 as SAM.
The testing equipment will be applied as instructed below, prior to the start of recording.
For best results, the testing equipment should be worn for the entire recording. If you need to get up during the recording, the equipment can remain on. Re‐apply equipment if removed during the recording time.
An instructional video is available on our website, https://snapdiagnostics.com/snap‐instructional‐video/

Storage
The recording device and accessories should not be stored in extreme heat or cold environments.

Temperature Range: ‐13 to 158 F (‐25 to 70C)
Relative Humidity Range: 15% to 90% non‐condensing

Operating Conditions
If stored at temperature extremes, allow 15 minutes for device to reach room temperature prior to use.

Temperature: 41 to 104 F (+5 to +40 C)
Relative Humidity: 15% to 90% non‐condensing Atmospheric pressure range 700 hPa to 1060 hPa

Snap Testing Kit

To complete your sleep test, the following equipment will be used:

Snap-Diagnostics-9-10000-Patient-Testing-FIG-1

Ensure that the sensors are securely connected to the recorder before use.

Connection Locations

A – Oximeter Monitor Connection
B – Airflow Sensor (microphone) to SAM Connection
C – Airflow Sensor (microphone) to Cannula Connection
D – Elastic Band Connection (band not shown below)

Connect to the SAM + Belt

Step 1: Fasten the Belt around your upper chest, over your bed clothes, placing the Sleep Apnea Monitor (SAM) in front. The belt size can be adjusted. It should fit snug and not cause a restriction in breathing. The SAM should be placed on your chest with the airflow sensor connection facing down.
Tip: The SAM + Belt will be worn over your clothing. The length of the belt may be adjusted by releasing the Velcro® and pulling on the end of the belt. The fit should feel snug, but comfortable. Connect to the Airflow Sensor + Nasal Cannula
Step 2: Place the nasal cannula underneath your nose with the shorter pair of prongs resting under your nostrils and the longer pair of prongs pointing down toward your mouth. The elastic headband fits over the ears. You can pull on the ends of the band to adjust the cannula for a comfortable fit. Prior to the start of recording, when you speak or blow into the cannula the airflow sensor (microphone) LED will display in green.
Connect to the Oximetry Watch Monitor + Ring Sensor
Step 3: The Oximetry Watch Monitor is worn around the wrist. Strap the watch to your non‐dominant hand. Do not close the wrist strap too tightly. The fit should feel secure, and not too loose or too tight.
Step 4: Place the ring sensor on your thumb. If the thumb is too tight, you may use a different finger. The ring can be placed on the bony part of the finger between the knuckles and may be secured with medical tape as needed.
Tip: If it feels comfortable, we recommend using a different hand for each night of testing and wearing the ring sensor on your thumb. If you have any conditions that cause loss of feeling or poor circulation, or if you use medications that may cause you to be less alert, be sure to check the skin on your finger for irritation during and after use. If you experience any irritation, discontinue use and call Snap at (847) 777‐0000 for assistance.

Important: The testing equipment should feel secure yet comfortable. If any part feels too tight, be sure to adjust it before starting the recording. For further guidance, testing support is available at (847) 777‐0000.
Once you have comfortably applied the monitors and sensors, you can turn them on to begin recording. Rotate the SAM device up to better see the front of the device and the LED’s.

Start Recording

Step 5: Turn on the SAM Recorder
Press the power/record button to turn on the SAM recorder and start the recording. The light above the battery symbol will illuminate.
Step 6: Turn on the Oximetry Watch Monitor
Press the power button on the side of the watch to turn it on.
When powered on, the Oximetry Watch Monitor will automatically pair with the SAM recorder. Once successfully paired, a blue light will illuminate on the SAM recorder. Note: A blinking blue light indicates that the device is searching for connection. A solid blue light indicates that the device is connected.
After the device completes its self‐test a green REC light indicates all functions are operable and recording will start automatically. Once recording has started, only the REC light will display blinking green approximately every 5 seconds. The device will record for 6 hours and automatically turn off.
If LED’s display magenta or amber, refer to the table on page 14 for troubleshooting or contact Snap Customer Support at 847‐777‐0000.

Battery Life

The recorder will turn off automatically after 6 hours of use. If you need to turn off the device for any reason, press the power button twice.
A fully charged battery, indicated by a green light, can record 3 nights of sleep. A half full battery, indicated by an amber light, can record a full night of sleep. A magenta light indicates that the battery must be charged before use.

If you have insufficient battery, please call Snap Support (847) 777‐0000.

LED Communications

The LEDs on the SAM device will communicate the device status.
During the start‐up process a self‐test will run for approximately 40 seconds, the LED’s will automatically cycle through a color sequence for a short period of time, ending in blue or green before the recording starts. There is no need to monitor this process.
The Record/Power LED will remain green for the duration of the recording unless a sensor becomes disconnected, changing the LED to amber. All other LED’s will remain unlit while the recording is in progress unless the status is checked. Rotate the SAM device up to better see the front of the device and the LED’s.
To check the status of the SAM device during the recording, pressing the power button 1 time will illuminate the LED’s for 5 seconds. Do not double press the power button as this will stop the recording.
If the Battery or Record LED displays a constant magenta color, contact Snap Customer Support at 847‐777‐0000.

LED Communications (continued)

LED Color Meaning| Green (Working)| Amber (Alert)| Magenta (Fail)| Blue (BLE)
---|---|---|---|---
__

Battery

| Full Charge| 1‐night charge

available

| No Charge, Call

Snap

| N/A
REC

Record

Return the Test Kit

Once you have completed the test, return the test for analysis with all parts provided. Follow the instructions provided when you received it:

If the test kit was sent directly to you from Snap, return it to Snap following the shipping instructions provided in the box or on our website,
https://snapdiagnostics.com/return‐instructions/.
If you received the kit from your provider’s office, return it to them.

Results
Your sleep data is analyzed by our laboratory at Snap, and once ready, will be sent directly to your medical provider. Your medical provider will contact you to discuss the results of the test.
To inquire about the status of your test, you may call our support team at
(847) 777‐0000 or email us at [email protected].

Support

We offer 24‐hour patient support to answer testing‐related questions. For assistance, please call (847) 777‐0000
Answers to frequently asked questions (FAQ) are available on our website, https://snapdiagnostics.com/patient‐faq/
To view the IDTF performance standards on a smartphone, scan this QR code using your phone’s camera.
To read your privacy rights under the Health Insurance Portability and Accountability Act (HIPAA), please visit https://snapdiagnostics.com/privacy/
To view our privacy policy on a smartphone, scan this QR code using your phone’s camera.
Snap Diagnostics is approved as an Independent Diagnostic Testing Facility (IDTF). To read about Medicare’s IDTF Performance Standards, please visit https://snapdiagnostics.com/tbd
To view the IDTF performance standards on a smartphone, scan this QR code using your phone’s camera.

Symbol Table

Snap-Diagnostics-9-10000-Patient-Testing-FIG-15

Bluetooth Wireless Communications

This product implements Bluetooth wireless communication. Only manufacturer‐supplied Bluetooth accessories should be connected to the product. If you experience difficulty in making or maintaining a Bluetooth connection, please contact Snap Customer Support at (847)777‐0000.
Do not connect the product’s USB port to any computer, charger, or accessory other than those provided by the manufacturer.”

FCC Compliance Statement

FCC ID: 2BDPB910000
This device complies 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.
Any changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate this equipment.

Note: 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 radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in an installation. If this equipment does 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:

Reorient or relocate the receiving antenna.
Increase the separation between the equipment and receiver.
Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.
Consult the dealer or an experienced radio/TV technician for help.

Good Night!
Snap Diagnostics
616 Atrium Drive, Ste 100 Vernon Hills, IL, 60061 Customer Support 847‐777‐0000
www.snapdiagnostics.com

726‐784636 Rev Beta 01052024