Embletta PDS Service Manual Rev 1 May 2001

Contents 1

Introduction ... 3

2

General inspection... 4

3

4

General inspection form

4

General inspection procedures

5

Calibration Check

9

Troubleshooting Guide ... 11 Battery Problems

11

Problems connecting Embletta to the computer

12

Problems starting a recording

13

Problems downloading data

14

Problems analysing data

14

Data Loss

15

Warning lights

16

System Specifications... 17

Appendix A: Product problem report ... 18

---------------------------------- Contents

2

1 Introduction The Embletta PDS (Portable Diagnostic System) is a pocket-sized digital recording device designed to diagnose sleep-disordered breathing. This small and lightweight system is designed for ambulatory recordings. The patient wears the Embletta with a Velcro Strap or optional vest. The Embletta has nine channels and can record up to 12 hours of physiological data. The data is reviewed and analysed using the software Somnologica for Embletta. In addition to Embletta’s capacity in diagnosing sleep-disordered breathing, it can be directly connected to flow generators to measure their effectiveness. Note: All service repair work is performed by Flaga and any units that require repair beyond the scope of this guide should be returned to ResMed. Under no circumstances should an Embletta PDS unit be opened, or any repairs attempted beyond the scope of this guide.

---------------------------- Section 1: Introduction

3

2 General inspection Carry out the procedures on the following pages to confirm that the Embletta PDS is in good working condition: Record of Inspection . 1 External examination

Pass

2 Regional setting

Completed

3 Device connection

Completed

4 Battery test

Green

5 Sensor input test

8 Cleaning

Red

Problem resolved

Flow/pressure

On

Off

Oral Thermistor

On

Off

Snoring

On

Off

Thoracic Respiratory Effort

On

Off

Abdominal Respiratory Effort

On

Off

Oximeter

On

Off

Patient air flow via cannulae

Pass

Fail

Patient air flow via Thermistor

Pass

Fail

Snore

Pass

Fail

Abdominal movement

Pass

Fail

Chest wall movement

Pass

Fail

Oximetry

Pass

Fail

Body Position

Pass

Fail

6 Download test 7 Sensor Recording test

Fail

Completed

Completed

Inspection Details Name

Signature

Embletta Serial Number

Date

19805/1

4

Embletta PDS Service Manual ------------------------

1

External Examination Visually examine the Embletta recorder and sensor adapter for external damage such as: •

deformation or cracking of the casing.

•

damaged components such as the sensor inlets.

If the outside casing is fractured or sensor inlets are damaged, return the unit to your distributor for repair.

2

Regional Settings Working on the computer the Embletta will be connected to, click Start>Settings>Control Panel>Regional Settings. Check that the options for your location are correct.

3

Device connection 1

Open Somnologica for Embletta and use the Download Cable to connect the recorder to the computer.

2

New Device Wizard will automatically detect the new device

3

Click Next

4

Select the correct device and click Next

5

Enter a name for the device

6

Click Next>Finish

The new device should be displayed in the Devices manager to the left of the Operations sheet. Test study A short five minute test study will be conducted to further test the Embletta’s functions using a test patient and all six inputs in the Sensor Adaptor. With the Download Cable still attached enter the patient information. Proceed to the Prepare Recorder button and enter the relevant details. Allow yourself some time when entering the recording start time to set the sensors into the adaptor and to attatch them to the test patient.

------------------------- Section 2: General inspection

5

4

Battery test Remove the Download Cable from the Recorder and insert the Sensor Adaptor. If functioning correctly a beep should be heard and an amber light will flash on the signals panel. Press the Check ✔ button to illuminate the battery status light. If it is green, continue with the test. If it is red there is a problem with the batteries and you will need to refer to Battery problems on page 11 before proceeding with the general inspection.

Sensor Adaptor Pressure Luer Lock

6

Embletta PDS Service Manual ------------------------

5

Sensor input test With the Sensor Adaptor still connected, insert the sensors into the Adaptor and the Pressure Luer Lock. Press the Check  button to initiate the signal test. Check the corresponding sensor lights on the signal panel are illuminated.

Snoring sensor

Respiratory effort sensor

Respiratory effort sensor

Oral Thermistor

Oximeter

Nasal Cannula

During the test recording While the short test recording is taking place (indicated by the double-flashing green light) press the event ! button a few times and try some test snores. These functions will be checked once the data has been downloaded into Somnologica for Embletta.

------------------------- Section 2: General inspection

7

6

Download Test With the test recording completed, remove the Sensor Adaptor and hook up the Recorder to your computer via the Download Cable. Press the  Download Data button in Somnologica for Embletta. The downloading of information is indicated on the screen. Once completed, the recording appears as a folder in the Recordings manager under the patient’s name and can also be seen in the All traces screen.

7

Sensor Recording Test To determine the sensors are working and the information has been recorded correctly:

8

1

Click on the plus + button next to the patient folder.

2

Open the raw data folder and the recorded information will be displayed in a workpad.

3

Check all signals requested for the recording are present.

Cleaning the Embletta PDS The Embletta PDS recorder does not require cleaning after each use, but if required the Embletta PDS should be cleaned with ethanol for sterilization. Following sterilization use soap and a moist cloth to remove any dirt. Do not use acetone or other solvents. To clean difficult spots use medical octane or propyl alcohol, then clean with soap and water to remove the octane smell. Avoid liquid coming into contact with the connectors and inner parts Any reusable sensors that come into contact with the patient should be cleaned with ethanol before re-use. Do not autoclave, ethyl oxidize sterilize or immerse the sensors in liquid. The Velcro Straps should be washed regularly in a normal rinse cycle.

8

Embletta PDS Service Manual ------------------------

Calibration Check Equipment required • Calibrated Manometer (0 - 30cm H20 range) •

Embletta PDS

•

CPAP unit

•

Air tubing, modular mask frame and closed Bubble Cushion® A closed bubble cushion is available on order from ResMed. It is simply a bubble cushion with no hole cut in it which fits onto the modular mask frame. Any secure method of blocking the flow of air from the nasal cushion may be used. (The air outlets vents on the elbow of the mask frame must not be blocked.)

Equipment set up 1 Set up the CPAP unit with the air tubing and mask. 2

Fit the closed bubble cushion to the mask frame.

3

Set up the Embletta for a 5 - 10 minute test recording. In Recording Wizard select:

4

• CPAP in the Study Type screen • the Nasal/CPAP Pressure channel in the Adjusting channel configuration screen • Press Finish to initialise the recording Disconnect the Download Cable and insert the Sensor Adaptor

5

Connect a sensor tube to the Recorder on the Pressure Luer Lock and connect the other end of the tube to the access port on the mask frame.

6

Locate the second access port on the mask frame and connect it to the manometer.

7

Connect the CPAP unit to the mains power supply but do not turn it on.

The completed equipment set up

------------------------- Section 2: General inspection

9

Calibration test 1 With the Embletta now recording, turn on the CPAP unit.

10

2

Adjust the CPAP unit until the pressure on the manometer reaches 10 ± 0.2 cm H2O and wait 10 seconds for the pressure to stabilise.

3

Adjust the CPAP unit again until the pressure on the manometer reaches 20 ± 0.2 cm H2O

4

Wait for 10 seconds for the pressure to stabilise then turn off the CPAP machine.

5

When the Embletta recording has finished, pull out the Sensor Adaptor and insert the Download Cable.

6

Download the data into Somnologica for Embletta

7

Open the All traces sheet and check that the pressure recorded matches the pressure reading that was on the manometer. If they don’t match, the Embletta will need to be sent back to your distributor for re-calibration.

Embletta PDS Service Manual ------------------------

3 Troubleshooting Guide To diagnose a problem, follow this guide to find a possible cause from the symptoms being exhibited by the Embletta.

1

Battery Problems Begin by inserting the Sensor Adaptor into the recorder and pressing the Check 3 button. The condition of the batteries are indicated by the battery condition lights on the front panel of the Embletta PDS. The green light indicates the batteries are fully charged, while the red light indicates a low charge and requires immediate attention. Check the following: •

Ensure the batteries are the correct type (AA) and are correctly inserted. One battery should be placed in the upper slot with the positive (+) end towards the lid. The other battery should be in the lower slot with negative end (-) towards the lid.

•

If using rechargeable batteries check that they have been charged by measuring the battery voltage. A fully charged battery sustains a voltage of 1.5V. Battery voltage can be read in Somnologica for Embletta by initiating a test recording in Recording Wizard under the Prepare Recorder option. Advance through to the Battery voltage screen

Note: New batteries should be used for each sleep study. Note: Rechargable batteries will not maintain their charge if not used for a long period of time.

----------------------- Section 3: Troubleshooting Guide

11

2

Problems connecting Embletta to the computer Somnologica for Embletta should automatically detect a new Embletta when it is connected to the serial port of a computer. If this does not work check the following: •

See if the Embletta has power when connected to the Download Cable. This is indicated by a beep and an amber flashing light on the device.

•

Make sure that the Detect new devices automatically option is checked in the Tools>Options>Advanced menu.

•

If the Embletta is still not automatically detected, it can be selected manually. Go to the Device manager. Click Devices and select Add device.

•

If the above options fail to work the serial port on the computer may be occupied by another process in the computer. Check the System tray on the desktop (located on the bottom right corner of the screen which has clock display etc,) as this will often indicate active processes. Try turning off these processes temporarily.

Note: Make sure the keyboard connector on the Download cable is plugged in to the computer (PC or laptop) as this provides power to the recorder during communication with the computer.

12

Embletta PDS Service Manual ------------------------

3

Problems starting a recording •

Check that your regional settings are correct in your control panel. The regional settings will also affect the measurement standards for height and weight readings.

•

If recording by external switch check the Use external switch to start and stop option has been selected in the Adjusting the recording interval screen in Recording Wizard.

Note: If you are using the external switch ensure that you start the recording by pressing firmly on the Start button for five seconds.

•

Check that all three connectors of the Download Cable are properly connected. The recording will not be initialised unless the Download Cable is connected. You should hear a beeping sound indicating that the Embletta has powered up normally.

Note: The Embletta is powered up only when either the Sensor Adaptor or the Download Cable are inserted into the socket. •

If you have more than one Embletta system, try exchanging either the Download Cable or the Embletta unit between systems and start a recording. If you are able to start the recording by exchanging either the cable or Embletta unit, return the faulty component to your nearest ResMed office for repair.

•

Ensure that the PC is correctly configured for use with the Embletta system. Most computers that run Windows 98 SE, Windows N.T 4.0 (SP6 or higher) or Windows 2000 can be used. For Windows 98 and Windows NT, Internet Explorer 5 must also be installed. Recently installed hardware devices using the same serial port may cause conflicts.

----------------------- Section 3: Troubleshooting Guide

13

•

Check the connection of the Download Cable to the serial port of the computer, and check that the port is configured correctly. Please note that Somnologica for Embletta can only be configured for use with COM1: there is no other configuration possible.

Contact your computer administrator if further assistance is required.

4

Problems downloading data The Embletta PDS stores data within internal memory, which is then downloaded via the Download Cable onto the hard disk of the PC and viewed in Somnologica for Embletta. Long downloading time Downloading time is dependant upon the number of recording channels used. If all the channels are used, the download time will be two to three minutes per hour of recording. No download If the data does not download observe if the Prepare Recorder button is checked in the Operations screen. If not, the program will not let you proceed to the next step, Download Data. You will need to do the following:

5

1

Go to Device manager on the bottom left hand corner of your screen.

2

Select the appropriate device and right click.

3

Select Download to initiate communication between the computer and the recorder.

Problems analysing data If you have problems analysing data, first open the traces sheet in Somnologica for Embletta and inspect the data. Look for obvious anomalies: • Are all the signals there? • Is the recording time and duration correct? • Do the signals look normal? Signals missing If you have lost one or more signals, the analysis may either not work correctly or give misleading results. In Somnologica for Embletta, select Settings in the Analysis menu and leave out the analysis that should be dismissed, for example, if the snore sensor came off during the night, you may wish to leave out the snoring analysis. Unsatisfactory analysis criteria If the analysis is complete, but you are not happy with the criteria on which the results are based, choose Settings from the Analysis menu and examine the criteria: you may wish to modify the analysis criteria that the software uses to detect certain events. Note: If you are still unable to complete the analysis notify your distributor for further assistance.

14

Embletta PDS Service Manual ------------------------

6

Data Loss Signals missing • If you do not see one or more of the signals in the traces sheet in Somnologica for Embletta, ie, there is no pane with the name of the signal, make sure that when initialising the recording you had indicated that this signal was to be recorded. •

The signal may have been deleted from the workpad you are working in. Make sure that the signal is seen in the Recording Organiser under the data folder as one of the signals being recorded. If it is not, then the signal was either not recorded or was deleted from the folder on the computer. If it is seen, use the Data/Add Trace command to get the signal back in the workpad.

Flat or empty panes 1 If you seem to have lost one or more signals, ie, there is a pane with the name of the signal, but no trace in the pane, go further back into the recording. Check to see if the signal seems lost during the entire study. 2

Try using the Scale to Fit option in Somnologica for Embletta: do this by rightclicking the mouse inside the pane.

3

If you still have no trace in the pane, either: • the sensor is faulty • the sensor was not connected or it fell off the patient before the study started.

Before starting another study, test the sensor by conducting a short test recording with the sensor connected to a test subject or repeat the Sensor input test described on page 7 of this manual. Partial recording If you have data for only a portion of the recording time, check the following •

Are the time settings for the study correct?

•

Are the regional settings found in the control panel correct?

•

Have the batteries expired during recording? Check the battery voltage trace: the Embletta will cease operation at 1.8V.

----------------------- Section 3: Troubleshooting Guide

15

No Data If you have no data from the Embletta, try repeating the download procedure. If you still get no data this would indicate that the preparation of the Embletta was incorrectly performed, that the recorder lost power, or that the batteries had insufficient voltage. Inaccurate readings and measurements The sensors may cause inaccurate measurement and readings in specific situations. When using oximeter sensors:

•

remove nail polish or false fingernails.

•

keep the sensor out of the presence of strong ambient light. If necessary, shield the sensor area. (Medical tape would suffice).

Respiratory bands

Noisy signals from the respiratory band sensors may indicate fractured wires or faulty piezo element. Note: Misuse or improper handling of the sensors can result in damage to the sensor or the cable. This may cause inaccurate measurements and readings.

7

Warning lights Red Status Light If there is a red status light on the Embletta, this means it is not working correctly. Try reprograming the unit and conducting a quick 5 min test study. After the recording disconnect the Sensor Adaptor, insert the Download cable and press the Check 3 button.

Further Help For further technical assistance see www.flaga.is/support. To report technical problems contact [email protected] and copy the report to [email protected]

16

Embletta PDS Service Manual ------------------------

4 System Specifications Embletta PDS DIMENSIONS (H x W x L) 20 x 65 x 124mm (0.8 x 2.5 x 4.9in) WEIGHT Embletta 110g (0.24lb) Batteries 46g (0.1lb) POWER SUPPLY 2 AA batteries (12 hours duration) HOUSING CONSTRUCTION Injection moulded plastic, covered with aluminium shields NUMBER OF CHANNELS 7 sensors, 14 derived signals RECORDING CAPACITY Up to 12 hours (16MB memory) MAXIMUM PATIENT LEAKAGE CURRENT 10µA, complying with EN60601-1 OPERATING TEMPERATURE +5°C to +50°C (40°F to 120°F) STORAGE TEMPERATURE -20°C to +50°C (0°F to 120°F) HUMIDITY 90% non-condensing IEC 601-1 CLASSIFICATIONS Class IIa, Type BF Note: The manufacturer reserves the right to change these specifications without notice.

----------------------- Section 4: System Specifications

17

Appendix A: Product problem report Instructions to originator:

1 Complete Section A 2 Indicate what repairs where done and/or response given to customer 3 Send to ResMed QA, Sydney, for review and logging

SECTION A - to be completed by originator Originated by... Office... Date of occurrence ... Date of this report... ...

Customer Name ... Address ... ... Contact ... Phone ...

Product code... Description ... Batch/Serial No... Date of Purchase.../.../... ... Equipment Supplier... If applicable: Pressure setting ... cm H2O. Hour Meter reading ... Nature of the Problem: Commercial, Service or Repair [ ] COMMERCIAL [ ] Order Error [ ] Shipping Error [ ] Customer does not want [ ] Other ... [ ] SERVICE/REPAIRS [ ] Repair [ ] Adjustment [ ] Replacement [ ] Other ... Nature of the Problem: Identity, Quality, Safety or Effectiveness [ ] IDENTITY [ ] Incorrect Labelling [ ] Missing Items [ ] Assembly Incorrect [ ] Other ... [ ] QUALITY [ ] Appearance [ ] Function [ ] Packaging [ ] Durability [ ] Other ... [ ] SAFETY [ ] EFFECTIVENESS Details of repairs made/response given to customer: (Give details of components, PCBs replaced if applicable)... Date returned to customer: .../.../... Service performed by: ... ... ... Service / repairs / Replacement [ ] Charged [ ] No Charge Authorized by: ... Goods returned for credit [ ] Credit allowed Authorized by: ... SECTION B - to be completed by QA, Sydney Designation

[ ] Problem Ref No... [ ] Complaint Problem Code ... Complaint, Investigation initiated: [ ] YES [ ] NO if No, Reason: ... ... Reviewed and authorized by: ...Date:...

18

Embletta PDS Service Manual ------------------------

Distributed by: ResMed Corp 14040 Danielson Street Poway CA 92064-6857 USA Tel:+1 (858) 746 2400 Fax:+1 (858) 746 2900

Manufactured by: ResMed Ltd 97 Waterloo Road North Ryde NSW 2113 Australia Tel:+61 (2) 9886 5000 or 1 800 658 189 Fax:+61 (2) 9889 1483

Distributed by: ResMed (UK) Limited 67B Milton Park Abingdon Oxon OX14 4RX UK Tel:+44 (1235) 862 997 Fax:+44 (1235) 831 336

Distributed by: ResMed GmbH & Co KG Rudolfstraße 10 D-41068 Möenchengladbach Germany Tel:+49 (021 61) 35 21 0 Fax:+49 (021 61) 35 21 299

Distributed by: ResMed SA Parc De la Bandonniére 2 rue Maurice Audibert 69800 Saint Priest France Tel:+33 (4) 3725 1251 Fax:+33 (4) 3725 1260

Distributed by: ResMed Singapore Pte Ltd 57 Ubi Ave 1 #07 - 09 Ubi Centre Singapore 408936 Tel:+65 284 7177 Fax:+65 284 7787

Distributed by: ResMed Malaysia SDN BDH Unit 4.04, Wisma BICMA Lot 2, Jalan 243/51A 46100 Pataling Jaya Selangor DE Malaysia Tel: + 60 (3) 7877 1068 Fax + 60 (3) 7877 6099

Distributed by: ResMed NZ Ltd PO Box 51-048 Pakuranga Auckland New Zealand Tel: +0800 737 633 (NZ toll free) Fax: +0800 737 634(NZ toll free)

Distributed by ResMed Sweden AB Industrigatan 2 461 37 Trollhättan Sweden Tel: +46 520 420 110 Fax: +46 520 397 15

Embletta and Somnologica are trademarks of Flaga hf. Medical Devices The ResMed Products described in this manual are protected by: AU 139765, AU 697652, EP(DE,FR,GB) 0088761, EP(DE,FR,GB) 0661071, JP 1697822, US 4944310, US 5199424, US 5522382. Other patents pending. Designs registered: AU 138187, AU 138188, DE 49905995, FR 558747-558759 . © 2001 ResMed Ltd. 19805/1 01 05

RESMED

PRINTED MATERIAL SPECIFICATION Rev

Date

Details

Drn

1

25/5/01

ORIGINAL ISSUE

CF

Elec

Mech

Mkt

Prod

DOC NO

19805

PAGE

1 OF 1

REV

1

RA

QA

GM

Embletta PDS Service Manual 1.

DETAILS Dimensions:

A4 (297 H x 210 W) ± 5 mm

Style:

Printed single-sided on A4 sized 115 gsm offset, collated and stapled to make A4 sized booklet

Cover:

2.

Color of printing:

Black.

Art Work:

As shown on following pages. If re-typeset, the same styles and sizes must be maintained.

SAMPLING, INSPECTION & TESTING Refer R04 P 003; Sampling Regimen A. Note: Revision number on the artwork to read, 19805/1 01 05 Defects to be inspected: a

Specification and revision number

b.

Incorrect text

c.

Text missing or crooked on page

d.

Pictures are of similar quality when compared to Objective copy

e.

Pages missing or out of order

f.

Dimensions out of tolerance (refer to details above)

g.

Dirt, grease, etc.