CapnoTrue AMP and ASP Technical Support Manual Rev 2.2 Released Jan 2013

Technical Support Manual CapnoTrue®AMP/ASP

REV 2.2

CAPNOTRUE®AMP/ASP Technical Support Manual REV: 2.2 Released: 01/2013

The information in this document is subject to change without notice.

Copyright © 2013 bluepoint MEDICAL GmbH & Co. KG. All Rights Reserved. This document contains proprietary information that is protected by copyright. All rights are reserved. No part of this document may be photocopied, reproduced or translated to another language without prior written consent of bluepoint MEDICAL GmbH & Co. KG.

Contact information bluepoint MEDICAL GmbH & Co. KG An der Trave 15 23923 Selmsdorf Deutschland Tel.: +49 (38823) 548 8000 Fax: +49 (38823) 548 8029 E-Mail: [email protected] www.bluepoint-medical.com

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Technical Support Manual CapnoTrue®AMP/ASP

REV 2.2

Table of Contents 1

Intended use of the service menu ... 5

2

PIN CODE ... 5

3

Accessing the SERVICE MENU ... 6

4

System information... 7

5

Start up settings ... 7

6

5.1

Adjustable DEFAULT SETTINGS and factory default values ... 8

5.2

Explanation of the adjustable start up parameters ... 9

5.2.1

Pulse tone ... 9

5.2.2

Volume... 9

5.2.3

O2 compensation ... 9

5.2.4

Mode ... 9

5.2.5

Adult and neonatal alarm limit defaults ... 9

5.2.6

High priority alarm on/off ... 10

5.2.7

Medium priority alarm on/off ... 10

5.2.8

Low priority alarm on/off ... 10

5.2.9

SpO2 averaging ... 10

5.2.10

Home care mode ... 10

5.2.11

Memory full warning ... 11

5.2.12

Auto-Off ... 12

5.2.13

Hide delete data... 12

5.3

FACTORY SETTINGS ... 12

5.4

Non-adjustable start parameters ... 12

Maintenance (only CAPNOTRUE®ASP) ... 13 6.1

Check gas accuracy ... 14

6.2

Pressure test... 15

6.3

Calibration... 16

7

Demo mode ... 17

8

Change pin code ... 17

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Technical Support Manual CapnoTrue®AMP/ASP

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Warnings Warnings are identified by the WARNING symbol shown above. Warnings alert the user to potential serious outcomes, such as death, injury, or adverse events to the patient or user. Changing the default start up settings of the device can seriously affect the functionality of the device and the alarms! Only suitably qualified personnel with the required technical and medical knowledge are allowed to change the default start up settings!

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Technical Support Manual CapnoTrue®AMP/ASP

REV 2.2

1 Intended use of the service menu The main focus of the SERVICE MENU is to provide option to adjust the default start up parameters of the CAPNOTRUE®AMP/ASP device. Every time the device is switched on, the Start up Default Settings will be active, no matter what has been set before the device was switched off. Under normal operating conditions the factory default settings don’t need to be changed. They are carefully chosen to provide secure alarms in the most usual operation conditions and to fulfil the requirements of the applied capnograph and pulse oximeter standards. Next to this SYSTEM INFORMATION can be viewed and the DEMO MODE can be activated on the device. Some sections are applicable only on the sidestream device CAPNOTRUE®ASP. If not stated otherwise, the sections are applicable to both versions.

2 PIN CODE Never give patients access to the service menu! The Access PIN code for the service menu has to be separated from the normal user manual!

By entering the Service PIN CODE you confirm that you have read and understood the service manual and take full responsibility for the consequences that might result from the changed alarm functionality.

PIN CODE : 1 9 8 1

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3 Accessing the SERVICE MENU 1. Press the menu button on the device, use the up/down buttons to select menu point SETUP 2. Confirm with the enter button 3. Use the up/down buttons to select menu point SERVICE 4. Confirm with the enter button 5. Enter the PIN Code, using the up/down buttons and the enter button 6. Confirm correct PIN with menu point ENTER 7. Within the SERVICE menu you can View SYSTEM INFORMATION (component serial numbers etc.) Change the default START UP SETTINGS (adjust start up settings and restore factory default settings) Perform MAINTENANCE tasks (only CAPNOTRUE®ASP) Activate the DEMO MODE (demonstration of device function) Change the service PIN CODE

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4 System information The service menu point SYSTEM INFORMATION is for factory internal use only; there are no adjustable parameters in this menu.

5 Start up settings Within the service menu point START UP SETTINGS selective default start up parameters can be adjusted or the default start up parameters can be reset to the factory defaults. Changing the default start up settings of the device can seriously affect the functionality of the device and the alarms! Only suitably qualified personnel with the required technical and medical knowledge are allowed to change the default start up settings!

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Technical Support Manual CapnoTrue®AMP/ASP

5.1

REV 2.2

Adjustable DEFAULT SETTINGS and factory default values Parameter

Possible settings

Factory default

Pulse tone

On / Off

On

Volume

1-4

4

O2 compensation

0-30% / 30-70% / 70-100%

0-30%

Mode

adult / neonatal

adult

EtCO2 High

0.1 - 9.9 % / off

7.3

EtCO2 Low

off / 0.1 - 9.9 %

3.2

SpO2 High

1 - 99 % / off

off

SpO2 Low

off / 1 - 99 %

85

RR High

4 – 150 /min / off

off

Apnoea

off, 20, 40, 60 sec

20

PR High

1 - 250 /min / off

140

PR Low

off / 1 - 250 /min

45

FiCO2 High

0.1 - 9.9 % / off

1.2

EtCO2 High

0.1 - 9.9 % / off

7.3

EtCO2 Low

off / 0.1 - 9.9 %

3.2

SpO2 High

1 - 99 % / off

95

SpO2 Low

off / 1 - 99 %

85

RR High

4 – 150 /min / off

off

Apnoea

20, 40, 60 sec

20

PR High

1 - 250 /min / off

150

PR Low

off / 1 - 250 /min

30

FiCO2 High

0.1 - 9.9 % / off

1.2

High alarms

On / Off

On

Medium alarms

On / Off

On

Low alarms

On / Off

On

SpO2 averaging

Stb / Std / Sens

Std

Home care mode

On / Off

Off

Memory full

On / Off

On

Auto-off

On / Off

On

Hide delete data

On / Off

Off

Adult defaults

Neonatal defaults

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Technical Support Manual CapnoTrue®AMP/ASP

5.2

REV 2.2

Explanation of the adjustable start up parameters

The service menu is available only in English language. Device language settings have no effect on the service menu. All changes in the start settings are only activated if SAVE DEFAULT SETTINGS is selected at the end of the DEFAULT SETTINGS menu and after restarting the device!

5.2.1 Pulse tone Defines if the pulse tone is muted or not at start up (on / off). When muted, the corresponding symbol

is displayed at the top of measurement screen.

(During normal operation mode the pulse tone mute button toggles pulse tone on/off.)

5.2.2 Volume Defines which pulse tone loudness is used at device start up. Range: 1 – 4 NOTE: Alarm loudness is not affected.

5.2.3 O2 compensation The presence of oxygen can cause some interference in the CO2 measurement. These interferences are compensated by setting the range of O2 concentration under the menu point “Gas compensation” accordingly.

5.2.4 Mode Selection between adult and neonatal mode at start up is possible. When NEONATAL is selected, the neonatal symbol is displayed at the measurement screen top. In this mode the default alarm limits are adjusted to neonatal default settings (refer to Chapter 5.1). Please ensure that accessories appropriate for neonates are used!

5.2.5 Adult and neonatal alarm limit defaults Under normal operating conditions the factory alarm limit defaults don’t need to be changed. They are carefully chosen to provide secure alarms in the most usual operation conditions and to fulfil the requirements of the applied capnograph and pulse oximeter standards. Special operating conditions like sleep monitoring or dedicated use on small children might require to permanent change of the alarm limits to more appropriate values. Alarm limit defaults can be adjusted at the menu points ADULT DEFAULTS or NEONATAL DEFAULTS. -9-

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5.2.6 High priority alarm on/off When set to off, all high priority alarms (e.g. “Bad signal quality” or “Apnoea”) do not result in audible alarm. Optical indication is still active.

5.2.7 Medium priority alarm on/off When set to off, all high priority alarms (e.g. Alarm limit violation) do not result in audible alarm. Optical indication is still active.

5.2.8 Low priority alarm on/off When set to off, all high priority alarms (e.g. “SpO2 Sensor off”) do not result in audible alarm. Optical indication is still active.

5.2.9 SpO2 averaging Defines the SpO2 averaging mode at device start up: Stable: When this setting is selected any strong and sudden variations in data will not immediately affect the reading (data incorporated over time); minor irregularities have little or no effect on the displayed reading.

Standard: Averaging parameters used for this setting are between those of the stable and sensitive settings.

Sensitive: The reading is more sensitive to irregularities but reacts very quickly to any changes in measured parameters. Refer to Chapter "Technical Specifications" in the User Manual for further details on the influence of the SpO2 averaging settings on the SpO2 reaction time.

5.2.10 Home care mode

The function of the “Home Care Mode” is to prevent false alarms which are typical if a patient is monitored for a long time (movement and other artefacts). If the “Home Care Mode” is activated in the Service Menu all functions of the device will be the same as in “Standard Mode”, only the sensitivity of the Limit Alarms is changed. In Home Care Mode Limit Alarms are only activated, if the limit is violated for 15 seconds continuously. This is valid for limit alarms only. This is not valid for the alarm messages and especially not for the Apnoea message.

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Technical Support Manual CapnoTrue®AMP/ASP

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Find below all limit alarms listed: EtCO2 High and Low (expired CO2) FiCO2 High (inspired CO2) RR High (respiration rate) SpO2 High and Low (oxygen saturation) PR High and Low (pulse rate) For example: If SpO2 low is active for 9 seconds and then SpO2 is normal again = no alarm will sound, but values are displayed and stored. If SpO2 low is active for 16 seconds = SpO2 low limit alarm is activated (yellow flashing of number and medium priority audible alarm) as long as the alarm situation is present. After activating the mode the Home Care-Mode symbol is displayed in the measurement screen:

5.2.11 Memory full warning If the MEMORY FULL warning is set to off, there is no warning that the device’s memory for measurement data is nearly full. If the memory space is full, the oldest data is overwritten without warning or confirmation. The symbol for memory full is still displayed at the top of the measurement screen, but no message has to be confirmed by the user at start up.

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Technical Support Manual CapnoTrue®AMP/ASP

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5.2.12 Auto-Off When the parameter Auto-off is set to value “on”, the device switches off automatically after having no valid signal for 2 minutes. It doesn’t switch off when an alarm condition is present. When the parameter Auto-off is set to value “off” the device never switches off automatically. 5.2.13 Hide delete data An option is now available to deactivate the “delete data” button in the menu. This operation is reversible and can be set in the pin protected service menu. Default settings

Activate “Hide delete data”

If “Hide delete data” is set to back to “off”, the button to delete the data is visible again. 5.3

FACTORY SETTINGS

Factory reset sets all values which can be modified in service menu back to the factory default values (see Chapter 5.1 for the factory default values). 5.4

Non-adjustable start parameters

Some of the device parameters are not adjustable in the DEFAULT SETTINGS. Alarm volume

The volume of the alarms is always on fixed level

Brightness level

The last used brightness level is restored at start up. Brightness can be adjusted in the regular setup menu

Battery low warning

The warning sound can be suppressed, but the message is always shown

Time resolution of data records

The time between the record of two trend view data points is fixed to 8 seconds

Language

The last used language setting is restored after start up. Language can be set in the regular user setup menu.

Date and time

Date and time can be set in the regular user setup menu, when the devices starts the actual time is taken from the internal Real Time Clock

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Technical Support Manual CapnoTrue®AMP/ASP

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6 Maintenance (only CAPNOTRUE®ASP) The menu point MAINTENANCE is only available for the sidestream device CAPNOTRUE®ASP. The CAPNOTRUE®AMP cannot be calibrated. However, please note that both the CAPNOTRUE®ASP and the CAPNOTRUE®AMP are permanently factory calibrated! The stable design of both the sidestream and the mainstream CO2 module results in no routine calibrations. However, to meet any local or specific customer requirements, a basic maintenance plan is nevertheless highly recommended. This section specifies a number of maintenance tasks in connection with the built in CO2 module that are recommended on an annual basis.

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Technical Support Manual CapnoTrue®AMP/ASP

6.1

REV 2.2

Check gas accuracy

Calibration and test gas: Gas accuracy check of the CAPNOTRUE®ASP built in CO2 module requires the use of a suitable test gas mixture. A cylinder containing such mixture may be acquired from the vendor of your choice, provided the following gas concentrations and accuracy are as follows: CO2: 4 to 11 % and O2: 45 to 100% at a accuracy of ±0.03 vol% or ±(0.02 vol% + 0.1% of reading), whichever is greatest.

Gas measurement check: 1.

Connect a new sampling line assembly (Nomo Adapter with sampling line and airway adapter) to the CAPNOTRUE®ASP

2.

Warm up for at least 1 min.

3.

Connect the calibration gas to the airway adapter

4.

Select Service > Maintenance > Check gas accuracy

5.

Check that the displayed gas concentration readings correspond to the calibration gas values.

6.

The gas reading shall be within the following range: ±(0.2 vol% + 2% of reading)

7.

If the readings are outside the specified range, perform a gas span calibration. If the test fails repeatedly, return the device to Bluepoint MEDICAL.

NOTE: The CAPNOTRUE® monitor is designed to display end tidal CO2 concentrations etCO2. For this reason the monitor will not display a measurement value, if test gas with a constant flow is applied during normal monitoring mode.

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Technical Support Manual CapnoTrue®AMP/ASP

REV 2.2

6.2

Pressure test

1.

Select CHECK PRESSURE in the maintenance menu

2.

Check that the barometric pressure value displayed corresponds to the actual barometric pressure value at the local site. The value is not allowed to differ more than ±5 kPa from the actual barometric pressure.

3.

If the value differs more than ±5 kPa from the actual barometric pressure, return the device to Bluepoint MEDICAL.

Cuvette pressure test: 1.

Connect a new sampling line assembly (Nomo Adapter with sampling line and airway adapter) to the CAPNOTRUE®ASP

2.

Select CHECK PRESSURE in the maintenance menu

3.

Check that the cuvette pressure value displayed is 1 to 5 kPa lower than the ambient pressure.

4.

If the value is outside the specified range, return the device to Bluepoint MEDICAL. - 15 -

Technical Support Manual CapnoTrue®AMP/ASP

6.3

REV 2.2

Calibration Measurement accuracy within specifications is no longer guaranteed in case a calibration gas which does not comply with the required specifications regarding gas concentrations and accuracy is used during Gas span calibration.

Gas span calibration: 1.

Warm up for at least 1 min.

2.

Select CALIBRATION in the maintenance menu

3.

Make sure that the surrounding gas is normal air (21% O2 and 0% CO2) then select YES

4.

Enter the correct concentration of the calibration gas into the CAPNOTRUE®ASP.

5.

Supply the calibration gas with gas accuracy concentration as specified under 6.1 to the airway adapter for at leased 30 seconds and select YES

6.

Wait until the gas span calibration is no longer in progress

7.

Verify the gas readings as described under 6.1. If the value is outside the specified range, return the device to Bluepoint MEDICAL - 16 -

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7 Demo mode For demonstration and promotion purposes it is possible to activate a DEMO MODE at the device. If activated the Demo symbol is displayed in orange at the header of the screen.

In this mode SpO2 and CO2 measurement values are continuously simulated and displayed. The demo data is also available at the USB port for Real Time Mode measurements.

8 Change pin code Only suitably qualified personnel with the required technical and medical knowledge are allowed to enter the SERVICE menu. To avoid unauthorised access to the menu the PIN CODE can be changed.

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