Embletta PDS User Manual May 2001

Introduction ○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

The Embletta® PDS (portable diagnostic system) records signals while you sleep. Your clinician will examine the recordings to determine if you have sleep-disordered breathing. This booklet describes how to use the Embletta PDS in 5 steps. It’s very important to follow the procedure exactly as described. Take your time, read each step carefully, and call your sleep lab or clinician if you have any problems.

Contact details: _______________________________________________________________________________________________________________ _______________________________________________________________________________________________________________ _______________________________________________________________________________________________________________ _______________________________________________________________________________________________________________ _______________________________________________________________________________________________________________ _______________________________________________________________________________________________________________

2 14879r2.p65

2

4/5/01, 12:41 PM

Warnings ○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

While the Embletta PDS is recording, we recommend you do not use a mobile phone in close proximity to the device. Do not remove the batteries from the Embletta PDS. Removal will discontinue the study, and the Embletta PDS will need to be reprogrammed by your clinician. Do not attempt to open the Embletta PDS case or adjust the unit yourself. If you have any problems with the device, contact your clinician. The Embletta PDS is not waterproof. Do not immerse the device or any of its accessories in water or any other liquid. The Embletta PDS is fully shockproof. However, the device will not withstand blows or collisions.

3 14879r2.p65

3

4/5/01, 12:41 PM

Embletta PDS Items ○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

The following items should be in the Embletta PDS carry case or already connected to your body.

Sensor adapter Belt Leather holster • Embletta PDS recorder in leather holster with Velcro® elastic strap • Embletta PDS soft pad to place on the back of the Embletta PDS leather holster • Sensor adapter (may already be connected to the Embletta PDS) with sensors connected • The sensors, including • Embletta PDS oximeter sensor with FlexiWrap • Nasal cannula • Snore sensor (optional) • Oral thermistor (optional) • Respiratory effort sensors attached to Velcro elastic straps (two) • Skin Fix • Medical tape • Pressure tubing for CPAP studies

4 14879r2.p65

4

4/5/01, 12:41 PM

○

Using the Embletta PDS ○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

Step 1. Attaching the Sensors Note:

If a step has been completed by your clinician, proceed to the next step.

The sensors should already be connected to the sensor adapter. If one of the sensors has disconnected, simply reconnect it using the color code. The sensor adapter has 5 color-coded inputs on its top end - connect blue to blue, yellow to yellow, etc.

Respiratory effort sensors 1. Place the respiratory effort sensor that is plugged into the yellow sensor adapter port on your stomach. Center it just above your waistline and wrap the strap around you. 2. With the Velcro facing away from your body, run the free end of the respiratory effort strap through the loop on the side of the respiratory effort sensor.

3. Fasten the Velcro so the strap is snug and secure.

5 14879r2.p65

5

4/5/01, 12:41 PM

4. Place the respiratory effort sensor that is plugged into the blue sensor adapter port on your chest at mid-line and tighten in the same manner. Note:

You may need to readjust the straps to keep them secure when you lie down.

Snore sensor (Optional) Note:

When in place, the side of the snore sensor with the small round bump should touch your skin.

1. Attach the snore sensor to your neck slightly off center.

2. Use adhesive tape to secure the sensor.

6 14879r2.p65

6

4/5/01, 12:41 PM

Nasal cannula 1. Peel the paper backing away from the circular part of the Skin Fix. 2. Place one Skin Fix on each of your cheekbones.

3. Place the nasal prongs in your nostrils so that they curve toward you. 4. Loop the tubing over your ears and then position it under your chin. 5. Tighten the cannula tubing, if necessary, by pushing the bolo slide (toggle) towards your chin.

bolo slide (toggle) 6. Peel the paper backing away from the strip of each Skin Fix. 7. Wrap the Skin Fix strip over the cannula tubing (and the oral thermistor wire if provided, see “Oral thermistor”) and press firmly to ensure the tubing is locked in place. 7 14879r2.p65

7

4/5/01, 12:42 PM

Oral thermistor (Optional) 1. Position the oral thermistor on your upper lip.

2. Loop the sensor wire over your ears (as you did with the nasal cannula tubing), and position it under your chin. 3. Tighten the sensor wire by pushing the bolo slide (toggle) towards your chin. 4. Secure both the oral flow thermistor wire and the nasal cannula tubing by taping them to your cheek using Skin Fix. 5. Bend the oral thermistor sensor gently so that the tip sits over your mouth. Note:

The sensor tip should not touch your lip/skin as this can affect signal quality.

8 14879r2.p65

8

4/5/01, 12:42 PM

Oximeter sensor Notes:

You may wish to have the oximeter sensor wire run under your sleepwear from the Embletta to your finger. Simply feed the wire under your sleepwear before attaching the sensor to your finger. The oximeter sensor will not function properly if nail polish has been applied to your nail.

1. Peel the paper backing away from the FlexiWrap.

2. Firmly press the sensor against the adhesive side.

3. Carefully position any finger (not your thumb) on the adhesive side of the FlexiWrap, ensuring that the dotted line is at the tip of your finger. Wrap the flaps around your finger.

4. Carefully fold the FlexiWrap over the tip of your finger so that the two diodes are vertically aligned. Wrap the short flap around your finger. 9 14879r2.p65

9

4/5/01, 12:42 PM

5. Wrap the long flap around your finger to secure the sensor.

6. Secure the sensor wire to the base of your finger or wrist using medical tape.

Note:

If you are using an adult clip sensor or standard adult finger clip, simply insert your finger into the sensor. The sensor will clip onto your finger. Then tape the sensor wire to your wrist.

Body position sensor In addition to the 6 external sensors, the Embletta PDS also has a built-in body position sensor. This sensor records your sleeping position during the night and helps your clinician to diagnose your condition. When you start your sleep study, you will need to lie Event down in bed on your back and press the button on the Embletta recorder. The body position sensor will relate your movements during the night to this position.

10 14879r2.p65

10

4/5/01, 12:42 PM

Step 2. Connecting the Parts to the Recorder Note:

Your sleep clinician may have connected some parts for you. If one of the following steps has already been completed, proceed to the next step.

1. Plug the sensor adapter into the top of the Embletta PDS recorder. Be careful not to put pressure on the sensor wires or connectors. You will hear a beep and the device will power up. Belt Sensor adapter Sensor wires Luer lock 2. Connect the nasal cannula to the Luer lock on top of the Embletta PDS. Twist clockwise to tighten.

Note:

If a CPAP study is required, connect the pressure tubing to the Luer lock on top of the Embletta PDS. Twist clockwise to tighten.

11 14879r2.p65

11

4/5/01, 12:42 PM

3. Put the soft pad on the back of the Embletta PDS leather holster.

4. Collect the sensor wires together. Wrap the top end of the soft pad around them and fasten with the Velcro. The soft pad protects the wires and provides a cushion between you and the Embletta PDS.

12 14879r2.p65

12

4/5/01, 12:42 PM

Step 3. Testing Procedure Before going to sleep and beginning your study, check that the sensors are attached correctly and that there is enough battery power to complete the study. On button Test button Event button

Press the Test button and hold it until you hear a beep. The yellow lights on the front of the Embletta PDS will illuminate for 1 minute.

Status lights • Yellow means recording has not yet begun. • Green means recording has started. • Red means that an error has occurred and you should contact your sleep lab or clinician before continuing (contact details on page 2).

Battery light • Green means there is enough battery power to complete your study. • Red means battery power is low and you should contact your sleep lab or clinician before progressing any further (contact details on page 2).

13 14879r2.p65

13

4/5/01, 12:42 PM

Sensor lights The nasal cannula (flow/pressure), oral thermistor, snore, and respiratory effort [thorax (chest) and abdomen] sensors should flash as you inhale and exhale. During the signal test, the oximeter sensor light will also illuminate if a signal is detected.

If the sensor lights are not lighting up properly, do the following: 1. Check the placement of the sensors. 2. Check the sensors are firmly connected to the sensor adapter. 3. Check the sensor adapter is properly connected to the Embletta PDS recorder. 4. Contact your sleep lab or clinician if the Embletta PDS is still not detecting signals properly (contact details on page 2).

14 14879r2.p65

14

4/5/01, 12:42 PM

Step 4. Starting a Sleep Study Note:

Before starting your sleep study, turn off any mobile phones near your bed. Signals from a mobile phone may interfere with the Embletta PDS recording. If you are doing a study with your ResMed flow generator, please see “Performing a CPAP study”.

Performing a sleep study 1. Your clinician has pre-programmed a start time for your sleep study. When the green light is flashing, you can start the sleep study. 2. Wrap the Embletta PDS strap around your abdomen or wherever it is most comfortable for you. Push the free end of the strap through the remaining loop on the Embletta PDS holster and adjust the strap so it is snug and secure.

3. Lie down on your back in bed. Press the Event button and hold it down for 2 seconds before you go to sleep. This will calibrate the body position sensor. It will also time-stamp the recording and indicate to the clinician when your sleep study started. While the Embletta PDS is recording data, the green status light will flash continuously. 15 14879r2.p65

15

4/5/01, 12:42 PM

If you need to get up during the night, press the Event button to time-stamp the recording. Press the Event button again when you return to bed. You can get out of bed as many times as necessary during the night, but remember to press the Event button every time.

Performing a CPAP study Pressure tubing

Air tubing

1. Your clinician has pre-programmed a start time for your CPAP study. When the green light is flashing, you can start the CPAP study.

16 14879r2.p65

16

4/5/01, 12:42 PM

2. Wrap the Embletta PDS strap around your abdomen or wherever it is most comfortable for you. Push the free end of the strap through the remaining loop on the Embletta PDS holster and adjust the strap so it is snug and secure.

3. Connect the free end of the pressure tubing to the port on your CPAP mask. Note:

The location of the port may vary depending upon which mask you are using.

4. Turn on your flow generator. 5. Place the mask on your face. 6. Lie down on your back in bed and press the Event button. Hold it down for 2 seconds before you go to sleep. This will calibrate the body position sensor and time-stamp the recording to indicate to the clinician when your CPAP study started. While the Embletta PDS is recording data, the green status light will flash continuously. If you need to get up during the night, press Event button to time-stamp the the recording. Press the Event button again when you return to bed. You can get out of bed as many times as necessary during the night, but remember to press the Event button every time. 17 14879r2.p65

17

4/5/01, 12:42 PM

Step 5. Stopping a Sleep Study 1. As soon as you wake in the morning, press the Event button (hold it for 2 seconds) to timestamp the end of the recording session. 2. Disconnect the sensor adapter from the Embletta PDS. This will turn off the device. 3. Remove the sensors from your body. You do not have to disconnect the sensors from the sensor adapter. 4. Take off the Embletta PDS strap. 5. Place all Embletta PDS components in the carry case. 6. Discard any used tape. 7. Return the Embletta PDS to your clinician, who will download the data for analysis and review.

18 14879r2.p65

18

4/5/01, 12:42 PM

Glossary ○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

Body position sensor - a built-in sensor that detects and records your sleep positions during the night. Event button - tells your clinician what time you started your study. It also lets the clinician know how often you got up during the night and the duration of your study. Lights - (light emitting diodes) are the small lights on the front panel of the Embletta PDS. The lights illuminate during the signal test to indicate whether the sensors are functioning properly, whether the battery power is sufficient to complete the study, and whether the recorder is set to record the study data. While the Embletta PDS is recording data, the green status light will flash continuously. Nasal cannula/prongs - measures both nasal airflow and snoring. Oral thermistor - measures breathing through your mouth or mouth leak. Oximeter sensor - measures the oxygen saturation level of your blood and detects your pulse rate. OSA (obstructive sleep apnea) - occurs when the muscles that control the tongue and soft palate relax too much, blocking your airway and preventing breathing. Pressure tubing - tubing used to measure the pressure at the CPAP mask. Respiratory effort sensor - detects chest and abdominal movements due to your breathing. Sensor adapter - connects the sensors to the Embletta PDS recorder. The sensors are color-coded with the unit: abdomen = yellow; thorax (chest) = blue; snore = white; oral thermistor = grey; oximeter = brown. 19 14879r2.p65

19

4/5/01, 12:42 PM

Sleep-disordered breathing - occurs when your normal breathing pattern is interrupted by apneas and hypopneas while you sleep. Snore sensor - records vibrations in your neck associated with snoring. Soft pad - a neoprene pad you place on the back of the Embletta PDS leather holster. It reduces abrasions that may be caused by the Velcro on the back of the case and wraps around the sensor adapter to hold the sensor wires together.

20 14879r2.p65

20

4/5/01, 12:42 PM