Nox SAS System Setup Instructions

a. 1x Nox A1s recorder The Nox A1s gathers information that is recorded from the applied sensors. Clips are attached to the Nox A1s for fastening the device to the Neck band.
b. Neck band The Nox A1s recorder is fastened with clips to the neck band for securing the placement of the device on the participant chest.
c. 1x Head cable The Head cable is plugged into the proxy of the Nox A1s recorder and will be attached to the electrodes placed on the forehead. The blue (R) and red (L) connector of the head cable connects to the blue and red body cables.
d. 1x Red body cable Connects to the red (L) part of the head cable and is attached to the electrodes placed on the left side of the body and leg to monitor \\activity from heart and leg movements.
e. 1x Blue body cable Connects to the blue (R) part of the head cable and is attached to the electrodes placed on the right side of the body and leg to monitor activity from heart and leg movements.
f. 1x Nox Abdomen Cable Connects to the Nox A1s recorder. The lower part attaches the abdomen RIP belt.
g. 1x Nasal Cannula The cannula is used to measure air flow pressure through the nose. It fits into the pressure connector on the Nox A1s.
h. 2x RIP belts (Respiratory inductance plethysmography) The RIP belts are made from super stretchable elastics and are used for measuring the effort of breathing. One belt is used for measuring thorax breathing movements and one belt is used for measuring abdomen breathing movements.
i. 1x Oximeter The Oximeter is an advanced wrist-worn pulse oximeter and provides pulse rate and blood oxygen saturation signals.
j. 3x Nox SAS Electrode Bag containing adhesive electrodes and adhesive strips Adhesive electrodes are attached to the body to record physiological signals from legs and heart. Adhesive stripes are used to secure cables and cannula.
k. 1x Cardboard backing sheet The Cardboard backing sheet is used to simplify the setup for the participant by hanging the Nox A1s sleep monitor with the disposable cardboard and all sensors around the neck.
l. Carry bag The Carrying bag is for storing the Nox SAS Kit
m. 1x white bandaid roll
n. 3x single use wristband
o. 2x Alcohol pads to clean skin. ONLY to be used the first night

Nox SAS System Setup Instructions

On the first night of the study please allocate extra 30 minutes before sleep to set up the equipment. The equipment should only be set up before going to bed. Please make sure to follow each step carefully to ensure a correct set-up of equipment. Incorrect setup may lead to exclusion of the data from the study.

Step by step video instructions are available: https://www.youtube.com/watch?v=zPnyxmfWPfA Things to consider before starting

Cleaning

• Skin needs to be clean and free of oils, creams, and cosmetics
• Remove artificial nails and nail polish from fingers if possible

Please consider

• Start the hook-up without a T-shirt but have one available for later steps
• It’s necessary to use a mirror during hook-up
• It’s ok to put on shorts or pyjama pants after the hook-up is complete
• Note that spare electrodes and tapes are included if needed

CAUTION:

• Electrodes should be applied only to intact, clean skin (e.g., not over open wounds, lesions, infected, or inflamed areas)
• Minor skin irritation can occur with electrode use. If skin irritation occurs, please contact your prescribing physician or health care professional

The carry case includes everything you need for the setup of the SAS sleep study Three Nox SAS electrode Bag with electrodes, and tape (Use one bag each night, follow instructions on the Bags) ♦ Blue and red body cables ♦ Nox A1s Sleep Monitor on a disposable carton with sensors for monitoring ♦ Oximeter for oxygen saturation and pulse detection ♦ Please refer to the list of components and verify that the carry case includes all the mentioned devices and cables.

STEP 1

Night 1: Use the Nox SAS Electrode Bag, labelled First Night for steps 1-3. See Image 0 (SAS sleep system) for reference.

* With an alcohol pad, firmly clean the skin, left and right side:

• Below the collarbones
• On the lower part of rib cage
  • Identify the area that has the least amount of hair.
  • Use the alcohol pad to clean the skin below each of the collarbones.

* Take four single electrodes

• Place single electrodes on the areas cleaned as shown in the figure:
  • Below the collarbones
  • On the lower part of rib cage

STEP 2

From the Nox SAS Electrode Bag find two double electrodes and use the same alcohol wipe as before. See image 2 for reference.

• Locate the shin muscle on your leg by flexing the ankle.
• With the alcohol pad, firmly clean the skin, left and right side.
• Place the double electrodes where you have cleaned:
  • Outer side of the leg on the shin muscle
• Make sure the electrode is not placed on the bone

STEP 3

Find the red and blue cable from the carry case. Also have the tape ready from the Nox SAS Electrode Bag.

• Connect the red and blue body cables to the electrodes:
  • Blue cable on the right side
  • Red cable on the left side
  • The single connectors are attached to the single electrodes under the collarbone and rib cage.
  • The double connectors are attached to the double electrodes on the leg.
• Secure the connector on leg with a long tape from the Nox SAS Electrode Bag.

PRECAUTION: Self-adhesive electrodes should be replaced if they no longer stick firmly to the skin – use extra tape to secure them if loose.

STEP 4

• Next, put on a night shirt if you sleep in one.
• Bring out the end-connectors of the red and blue body cables by pulling them up through the nightshirt neckline.

PRECAUTION: The Nox A1s recorder and Nox RIP belts should be worn over clothing to prevent allergic reaction to the equipment materials.

STEP 5

The sleep monitor can be found in the carry case with a neck band and sensors attached on a disposable carton in four colour-coded pockets.

• Hang the Nox A1s sleep monitor around your neck, so that the display screen faces forward.
  • The A1s comes with the neck band attached via clamps on the device, you could also clamp them directly to the shirt.
• Adjust the position of the sleep monitor so it rests on top of the chest, by adjusting the neck band.
• Find the end-connectors of the red and blue body cables and connect to the designated connector from the Nox A1 Sleep Monitor.
  • The connectors are colour coded in such a way that the red cable connects to the red connector and the blue cable connects to blue connector.

STEP 6

• Take the elastic belt (RIP Belt) from the red triangle pocket.
• One end is snapped to the back of the Nox A1s device.
• Wrap the belt around the chest.
  • Make sure that the belt is not twisted.
  • Snap the other end of the belt to the back of the Nox A1s sleep monitor.
• It is important to position the belt just below the armpits on top of the chest.
  • The length can be adjusted so it fits comfortably.
• • Take the elastic belt (RIP Belt) from the yellow diamond pocket.
• • Verify that there is an Abdomen Cable connected to the Nox A1s device.
• • One end of the elastic belt should be fastened to the belt connector of the abdomen cable.
• • Wrap the belt around the abdomen.
  • Make sure that the belt is not twisted.
  • Snap the other end of the belt to the other belt connector of the abdomen cable.
• Position the belt just above the belly button.
  • The length can be adjusted so it fits comfortably.
• Make sure that you have two elastic belts now connected, one is wrapped around the thorax and one around the abdomen.

The Nox RIP belts should fit snugly without being uncomfortably tight to avoid discomfort.

STEP 7

Using a mirror is recommended for this step.

• First, clean the skin with water and then with a second alcohol wipe (alcohol wipes should only be used on first night).
  • Temple and forehead up to the hairline
• Place double electrodes where you have cleaned. Please make sure that no hair is caught under the electrodes:
  • Take one of the double electrodes and start by placing one electrode on the middle of the forehead
  • Place the next electrode on the right temple at eye level in a vertical position
  • Repeat the step for the electrode on the left side of the temple
  • Finally place the last two electrodes between the temple and middle of the forehead right below your hairline

CAUTION: Self-adhesive electrodes on the face should be secured with tape from the tape roll if they don’t stick firmly to the skin – use extra tape to secure them if they are loose. ONLY USE THE TAPE FROM THE TAPE ROLL ON THE FACE

STEP 8

The head cable in the green circle pocket for ensuring that the electrical activity of the brain is measured.

• Take the head cable from the green circle pocket
• Connect the cable to all the double electrodes on the forehead.
  • Start with the cable on your right and move to the left side
  • Make sure that each snap is securely fastened.
  • If needed, use extra tape from the band-aid roll provided in the bag to secure the fastening of the electrodes.

STEP 9

• Take the nasal cannula from the blue square pocket.
• Identify the end with the prongs and make sure they face downwards.
• Place the prongs facing downwards into your nostrils.
• Pull the cannula tubing over your ears and then position it under your chin.
  • Make sure the cannula is not tangled in the head cable.
  • Slide the fastener under the chin to hold the cannula securely in place.
  • Place a piece of tape from a band aid roll provided in the case on the cannula to hold it securely. DO NOT use tape from Nox SAS Electrode Bag on your face.

STEP 10

• Remove the disposable carton from the device.
  • Pull it off by holding on to the device with one hand and pull at the same time the carton in a downward direction.
  • Dispose of the carton for paper recycling.
• Make sure that the black cable on the back of the sleep monitor has not snapped off from the device.

STEP 11

• Take the oximeter from the carry case and place it on the wrist of either hand.
• Secure the wristband strap around the wrist.
• Insert a finger into the probe. Choose the hand and finger that is most convenient and feels most comfortable.
• Make sure that the finger reaches the end of the probe.
• Do not push the finger out of the probe.
• Secure the finger probe with tape from Nox SAS Electrode Bag. Avoid tightening it too much.

CAUTION:

• Do not fasten the pulse oximeter too tightly around the patient’s wrist. Inaccurate readings and patient discomfort could result.
• When using the oximeter in the home, take care of where it is stored in between uses. Avoid exposing it to lint and dust by storing it in the carry case between nights.
• The pulse oximeter may not work when circulation is reduced. Warm or rub the finger or reposition the sensor.

STEP 12

• • You have successfully finished attaching the Self-Applied-Somnography (SAS) system.
• • It’s ok to put on shorts or pyjama pants at this point.
• • Recording type as directed by your site should be:
  • o A1s – Scheduled start: The recording will start automatically at a pre-scheduled time. You do not have to do anything to start or end the recording. This applies for all the nights.
• • Go to bed as you would usually do.
• • If you need to get up during the night for any reason (for example going to the bathroom), leave all the sensors and electrodes in place.
• • Take care that the oximeter on the wrist and the sensor on the finger do not get exposed to water.
• • The recording will stop automatically after a pre-determined number of hours of recording.

The morning after each sleep study, please:

• Remove all the tape, electrodes and cables carefully.
  • CAUTION:
    • Tape and electrodes may damage the skin if removed carelessly.
    • Electrodes should be properly disposed of after use.

If assistance is needed, please contact your study site (see information on cover).

Second and third night

Please follow the same instructions for the second and third nights but remember to only clean the skin with water and do NOT use alcohol pads to clean on the second and the third night.

Belts and nasal cannula are reused for second and third night.

The morning after the last sleep study please carefully pack everything back into the carry case before returning it to your sleep center.

Cautions and Precautions for Nox SAS Electrodes and Nox SAS Cable

Nox SAS Electrodes - CAUTION:

• Electrodes should only be used by or in consultation with a health care provider familiar with their proper placement and use
• Electrodes may damage the skin if removed carelessly
• For single use only. Reuse of the product may cause contamination, leading to infections.
• Electrodes should be applied only to intact, clean skin (e.g., not over open wounds, lesions, infected, or inflamed areas
• Electrodes should be properly disposed of after use
• Minor skin irritation can occur with electrode use. If skin irritation occurs, please contact your prescribing clinical site.

PRECAUTION:

• Self-adhesive electrodes should be replaced if they no longer stick firmly to the skin

Nox SAS Cables – WARNINGS:

• Do not use damaged equipment. Use of damaged equipment may result in patient harm, such as burn or electrical shock or lead to incorrect patient diagnosis.
• Carefully route cables and connections to reduce the possibility of entanglement or strangulation.
• Make sure the conductive parts of electrodes and associated connectors, including the neutral electrode, do not contact other conductive parts including earth to prevent potential serious harm to the operator/patient.
• Avoid accidental contact between connected but unused patient applied parts and other conductive parts including those connected to protective earth to prevent potential serious harm to the operator/patient.
• No modification of this equipment is allowed. Unauthorized modifications may result in patient harm, such as burn or electrical shock or lead to incorrect patient diagnosis