PV102 Bilevel TIME Operating Manual Issue N-1

Manufacturer’s declaration of conformity

Name and address

BREAS Medical AB Företagsvägen 1, SE-435 33 Mölnlycke, Sweden Telephone No.: +46 31 86 88 00, Fax No.: +46 31 86 88 10

Equipment description

Electromedical therapy equipment

Brand name/trademark

BREAS PV102 Bilevel TIME

Type designation/model

PV102 Bilevel TIME

Harmonised European standards

The Harmonised European standards which have been used, are listed below. Number

Title

EN 60 601-1

Safety for Medical Electric Apparatus

EN 60 601-1-2 Electromagnetic Compatibility for Medical Apparatus

Mark of compliance 0123

Declaration

The equipment complies completely with the above-mentioned harmonised standards and with the Directive 93/42/ECC. The manufacturer or his authorised representative within the EU/EEA bear sole responsibility that the product to which this declaration relates, conforms to the essential requirements in the medical device directive.

Manufacturer’s signature

Date: 4 June, 1998 Ove Eklund

Operating Manual PV 102

1

INTRODUCTION

INTRODUCTION The Breas PV 102 is intended for treatment of obstructive and central sleep apnoea, hypopnea and other forms of sleep-related breathing problems. Besides the separate settings for inspiration and expiration pressures, a back-up rate can also be set. The adjustable rise time makes it possible to set the time for the pressure to change from EPAP to IPAP. This feature allows the speed for pressure to be set for each individual patient thus providing superior breathing comfort compared to similar products. Its small size and low weight makes the PV 102 ideal for use in the home and while travelling.

IMPORTANT! Read this Operating Manual thoroughly so that you completely understand how the PV 102 is operated and maintained before taking into use.

Warning! The PV 102 should not be used for any kind of life support treatment.

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SAFETY SYMBOLS

2

Operating Manual PV 102

SAFETY SYMBOLS The following safety symbols are shown on the Serial No. label underneath the PV 102. Read the Operating Manual thoroughly before connection to the patient.

Body floating.

Class II equipment; dual isolation.

CE marking applies according to MDD 93/42/EEC.

TÜV approved according to: IEC 601-1 and IEC 601-1-2.

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Operating Manual PV 102

3

IMPORTANT SAFETY NOTICES

IMPORTANT SAFETY NOTICES •

The PV 102 should not be used for any kind of life support treatment.

•

Clinic personnel and the patient must read this operating manual and understand how the PV 102 is used before setting up and using the machine.

•

Adjustment of settings may only be carried out by authorised clinic personnel.

•

Do not use the PV 102 in environments where there are explosive gases or other inflammable anaesthetic agents present.

•

The device complies with the requirements of IEC 601-1-2 with regards to ‘Electromagnetic compatibility’. Necessary measures must be taken in order to ascertain that the specified limits are not exceeded as this may impair the safety of the ventilator. Such measures should include, but are not limited to: - normal precautions with regard to relative humidity and conductive characteristics of clothing in order to minimize the build-up of electrostatic charges. - avoiding the use of radio emitting devices in close proximity to the equipment, such as high-frequency surgery apparatus or cordless (mobile) telephones, CB radios, microwave ovens, etc resulting in a field level exceeding 10 V/m (IEC 601-1-2) - do not use patient hoses or tubes made from static or electrically conductive material.

•

Do not use a steam autoclave to sterilise the PV 102.

•

The performance of the PV 102 may deteriorate at temperatures below 5°C and above 35°C.

•

If the internal temperature in the PV 102 rises too high, the blower motor will switch off. In this case, switch off the ventilator and allow it to cool. Then switch on again.

•

Do not place on soft surfaces as there is a risk of the air intake for internal cooling being blocked.

•

Use a new mask for each new patient.

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IMPORTANT SAFETY NOTICES

Operating Manual PV 102

•

Patient connected parts and filter must be replaced regularly to ensure correct function of the PV 102. All replaced parts must be disposed of according to local environmental regulations regarding the disposal of used equipment and parts.

•

If the PV 102 is used in a clinic by several patients, a bacteria filter must be fitted between the air outlet and the patient circuit to prevent contamination.

Caution! The use of a bacteria filter on the output of the unit may interfere with the operation of the patient disconnect alarm. Users should evaluate filters before use with a patient. Consult your local distributor for information on recommended filter types.

•

Contact your responsible clinic if any of the following symptoms appear: dryness of air passages or nose, skin sensitivity, runny nose, ear pain, sinus discomfort, daytime sleepiness, mood change, disorientation, irritability or memory lapse.

•

If oxygen has been prescribed, connect the oxygen tube to the mask.

Caution! The following precautions must be taken when using oxygen as its presence can speed up the combustion of inflammable materials.

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•

Naked lights and other sources of ignition must be kept well away from the oxygen cylinder, a distance of at least 2 metres.

•

Do not smoke in a room where oxygen is being used.

•

The room must be well ventilated.

•

Do not use aerosols or solvents close to the oxygen supply, even when switched off.

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Operating Manual PV 102

4

INSTALLATION

4.1

Unpacking •

4.2

4.3

INSTALLATION

Check the machine for any damage and that all ordered accessories are included.

Placement •

Place the PV 102 on its feet, on a hard, flat surface. Make sure that nothing can block the patient air inlet at the rear of the machine.

•

Check that the PV 102 cannot be affected by any electromagnetic fields emitted by other equipment nearby.

Connecting the tube and mask •

Connect the patient circuit to the air outlet in the front panel, see illustration.

•

Connect the other end of the tube to the mask.

•

The leakage from the mask should be at least approx. 20 litres/min at 10 mbar pressure, e.g. achieved by a hole, min. 4.0 mm diameter, in the mask.

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INSTALLATION

4.4

Operating Manual PV 102

Mains power supply IMPORTANT! Make sure that the power cord is undamaged before it is connected to the machine. • Check that the voltage selector is set for the voltage the machine will be connected to. Different countries have different power supplies, the USA has, for example, 115 V and all European countries have 230 V. Voltage range 115 V covers 115 – 120 V Voltage range 230 V covers 230 – 240 V To change the voltage setting

• Make sure the power cord is not connected. • Change the voltage setting by turning the selector with a screwdriver. • Change to the correct fuse rating.

4.5

Replacing the fuse • Disconnect the mains power supply (1) before removing the fuse. • Check that the power supply fuse (2) has the correct rating for the set voltage. For 230 V, use a glass fuse TT 400 mA rated for 250 V. For 115 V, use a glass fuse TT 800 mA • Change the fuse by pulling the fuse holder straight out. There is a spare fuse in the holder.

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Operating Manual PV 102

PANEL DESCRIPTIONS

5

PANEL DESCRIPTIONS

5.1

Front panel

1.

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Patient air outlet, 22/15 mm ISO.

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PANEL DESCRIPTIONS

5.2

Operating Manual PV 102

Setting panel 1

2

3

PRESSURE

4 0

10

20

30 min

mbar/cm H2O

5 6

ON RAMP

IPAP

14

7

15

8 9 10 11

16 17

12 13

1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17. 18.

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EPAP

RISE TIME

RATE

sec

BPM

18

ALARM

ON/OFF

TIME

Green LED for set EPAP pressure. Also used when setting the trigger sensitivity. Current pressure, green LED Green LED for set IPAP pressure. Also used when setting the trigger sensitivity. Pressure gauge, 0-30 mbar Button, ramp start EPAP setting indicator, green Decrease setting value button Function selector button Rise time setting indicator, green Display, set rise time, 0.3-1.0 seconds Red LED, leakage alarm Green ON LED indicator ON / OFF switch IPAP setting indicator, green Increase setting value button Lock function indicator Back-up rate setting indicator, green Display, set back-up rate, 6-40 BPM

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Operating Manual PV 102

5.3

PANEL DESCRIPTIONS

Rear panel

1. 2. 3. 4. 5. 6.

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Air filter, washable (grey) and disposable (white). Mains power socket. Hour meter, shows total running time. Fuse holder with fuse, TT 800 mA for 115 V, TT 400 mA for 230 V. Voltage selector; 115 V or 230 V. Analog/Digital output connector, female.

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PANEL DESCRIPTIONS

5.4

Operating Manual PV 102

Underside 1. Patient air filter. 2. Model and serial number label. 3. Air intake for internal cooling. Do not block!

Explanation of symbols on equipment label:

1 2 115-120V/230-240V, 50-60Hz, 90 VA

3

1. 2. 3. 4. 5. 6. 7.

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4

5

6

7

Model number. Serial number. Class II equipment; dual isolation. Body floating. Read the Operating Manual thoroughly before use. CE marking applies according to MDD 93/42/EEC. TÜV approved according to: IEC 601-1, IEC 601-1-2.

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Operating Manual PV 102

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DETAILED FUNCTION DESCRIPTION

DETAILED FUNCTION DESCRIPTION At delivery, the PV 102 is set to EPAP = 5, IPAP = 10, Rate = 8 and Rise time = 0.5. These settings must be adjusted to suit each patient. The last set value is always stored in the PV 102's memory and is saved when switching off. When switching on, the PV 102 will use the current settings in the memory.

6.1

On/Off button

ON/OFF

The PV 102 is switched on and off by pressing the ON/OFF button for 2 seconds. The green LED is lit when running. See Chapter 4 for connection to the mains supply.

6.2

Decrease/Increase setting buttons Press to decrease (-) or increase (+) the value of the selected setting.

6.3

Pressure gauge A moving green LED (1) shows the current patient air pressure. It goes out 5 minutes after the last adjustment was made. The green LED (2) to the left shows the set EPAP pressure and the green LED (3) to the right shows the set IPAP pressure. They go out approx. 10 seconds after the last adjustment. The PV 102 delivers a maximum pressure of 30 mbar. All LED indicators, except the LED in the On/Off button, go out 5 minutes after the last adjustment was made. They are activated again once the function button is pressed.

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DETAILED FUNCTION DESCRIPTION

6.4

Operating Manual PV 102

Setting the EPAP pressure (expiration pressure)

Range: 4 - 30 mbar.

PRESSURE 0

10

20

30 min

mbar/cm H2O

1. Select the EPAP parameter using the function button. 2. Press the – or + button to set the required EPAP pressure.

EPAP

3. The green LED to the left shows the selected pressure. The EPAP pressure cannot be set higher than the IPAP pressure. If the EPAP pressure is set to the same value as the IPAP pressure, the PV 102 will deliver a continuous pressure (CPAP). The setting is saved in the memory after 5 seconds. The LED goes out approx. 10 seconds after the last adjustment was made.

6.5

Setting the IPAP pressure (inspiration pressure)

Range: 4 – 30 mbar. PRESSURE 0

10

mbar/cm H O

20

30 min

2

IPAP

1. Select the IPAP parameter using the function button. 2. Press the – or + button to set the required IPAP pressure. 3. The green LED to the right shows the selected pressure. The setting is saved in the memory after 5 seconds. The LED goes out approx. 10 seconds after the last adjustment was made.

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Operating Manual PV 102

6.6

DETAILED FUNCTION DESCRIPTION

Setting the rise time Range: 0.3 - 1.0 seconds. The adjustable rise time makes it possible to set the time for the pressure to change from EPAP to IPAP.

RISE TIME

• Select the rise parameter using the function button.

0.3 sec

• Press the – or + button to decrease or increase to the required ramp time. This setting decides how quickly the set IPAP pressure is reached. A setting of 0.3 seconds, which is the shortest time, will give a very rapid and sharp pressure increase. The longest setting of 1.0 second gives a softer pressure increase. Set to a value comfortable for the patient; 0.4 – 0.5 usually gives a comfortable initial setting. The numeric display window goes out 5 minutes after the last adjustment. It is activated again once the function button is pressed.

6.7

Setting the back-up rate Range: 6 - 40 breaths per minute. • Select the rate parameter using the function button. RATE

12 BPM

• Press the – or + button to decrease or increase the rate. The Rate LED will light for every breath delivered by the PV 102.

If the patient's own breathing rate (triggering) drops below the set rate, the PV 102 will always give the set number of EPAP/IPAP (alternating) breaths. Start the set-up at a low setting so as not to disturb the patient's own breathing rate. Set to a suitable rate before the patient uses the machine the first night. The numeric display will start to flash if the setting is above the number of breaths that the ventilator can deliver. (Total time: Inhalation + exhalation.) Reduce the setting until the display stops flashing. The numeric display window goes out 5 minutes after the last adjustment. It is activated again once the function button is pressed.

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DETAILED FUNCTION DESCRIPTION

6.8

Operating Manual PV 102

Setting the ramp time The ramp function is useful when you want to start at a lower IPAP pressure than the set value. When the ramp function is activated, the machine delivers the set EPAP pressure and gradually increases the IPAP pressure up to the set level. The Ramp function can be activated even if the setting panel is locked. However, when the ramp function is activated, no other settings can be adjusted. The ramp function can, at any time, be switched off by pressing and holding the Ramp button until the LED goes out.

Range: 5 – 30 minutes.

PRESSURE 0

10

20 mbar/cm H O 2

ON RAMP

30 min

1. Select the ramp parameter by pressing the Ramp button for 1 second. The green LED in the button lights. 2. A green LED lights at the 5 minute position as a time indication. 3. Press the + button to increase to the required time.

When the set time has expired, the function is switched off and the green LED in the button goes out. Note!

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It is not possible to change the time setting once the function has been activated. The ramp function must be switched off and then on again in order to adjust the Ramp time setting.

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6.9

DETAILED FUNCTION DESCRIPTION

Lock for setting panel When the setting panel is locked, only the ON/OFF button and the Ramp function are active. •

Hold both the – and +buttons for 5 seconds to lock or unlock the setting panel.

While the lock is activated, the LED in the lock symbol will show a green light if locked using the setting panel or a yellow light if locked by using the Remote Control or a PC. The PV 102 can only be unlocked by using the same method used when locking i.e. the setting panel or the remote control or PC.

6.10

Alarms Power failure alarm

If the power supply should fail during operation, an audible alarm is given. Switch off the machine. Once power is restored, switch on the PV 102 again.

The audible alarm can be muted by pressing and holding the On/Off button for 15 seconds. Leakage alarm

ALARM

ON/OFF

If the mask is removed or there is high leakage, the flow will increase and after 15 seconds a leakage alarm is given. When the flow returns to normal, the alarm is reset.

Function error alarm

If an internal fault occurs, the machine will automatically switch off and an audible alarm is given. Switch the machine on again. If the fault persists, do not use the machine and send it for service.

6.11

Safety Should the control electronics fail, the PV 102 cannot deliver a pressure higher than 40 mbar at SFC.

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DETAILED FUNCTION DESCRIPTION

6.12

Operating Manual PV 102

Analog/Digital connector Analog/digital connector for PC communication/Remote control. 5 4 32 1

Note! Use only Breas cable part no 001 530 or 001 980 (when using the Calendar Data Analysis software). Using other cables than these will damage the connector's printed circuit board.

9 8 7 6

Only equipment approved according to the relevant IEC standard, e.g. IEC 950 for data processing equipment and IEC 601-1 for medical equipment may be connected to the analog output connector. If in doubt, consult the technical service personnel or your local Breas representative. All connected equipment must be placed at least 1.5 metres from the patient. Pins used:

Analog connection

Digital connection for PC/Remote

Pin 5 = Ground

Pin 2 = RX

Pin 8 = Flow

Pin 3 = TX

Pin 9 = Pressure

Pin 5 = Ground Pin 6 = Remote On, max 5 V Pin 7 = 35 V WARNING!!!

Analog signal pressure 1 volt = 10 mbar, 2 volt = 30 mbar.

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Operating Manual PV 102

6.13

DETAILED FUNCTION DESCRIPTION

Trigger function The triggers are controlled by the increase and decrease in the flow caused by the patient's breathing. Often, there is a need to adjust the sensitivity of the inspiration and expiration triggers for different patients in order to achieve maximum comfort and flexibility. Factors that can affect the sensitivity are the patient’s breathing pattern, leakage etc. Even the choice of mask system can have an effect. Therefore, it is advisable to adjust the sensitivity after the patient has tested the mask system. All testing must be done with the patient in the normal sleeping position. When the PV 102 is switched on, the two LEDs in the pressure indicator for the trigger sensitivity setting will light for a few seconds.

6.13.1 Adjusting the sensitivity of the triggers 1. Press and hold the Ramp button. 2. Press and hold the On/Off button. 3. Keeping the Ramp button pressed, release the On/Off button when the LEDs light in the pressure indicator. 4. Release the Ramp button after 5 seconds. The blower will now not start and the display will show the current trigger sensitivity setting (between 15 - 30), and the IPAP indicator LED will light. Inspiration trigger

The adjusting range for inspiration trigger is between 15 - 30 on the Pressure scale where setting 15 gives the lowest sensitivity and 30 gives a very sensitive and fast inspiration trigger. Adjust the sensitivity with the – and + buttons, where pressing the – button will give lower sensitivity and pressing the + button will give higher sensitivity. Note!

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In the range between about 25 - 30 the trigger is very sensitive, which increases the risk for self-triggering. Always check the risk of self-triggering before handing over the ventilator to the patient.

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DETAILED FUNCTION DESCRIPTION

Operating Manual PV 102

Expiration trigger

To adjust the expiration trigger, press the function selection button. The EPAP indicator LED will light and the current expiration trigger will be shown in the pressure indicator, a setting value between 1 - 14. The adjusting range for the expiration trigger is between 1-14 on the pressure scale where setting 1 gives the lowest sensitivity and 14 gives a very fast and sensitive expiration trigger. Adjust the sensitivity using the – and + buttons, where pressing the – button will give lower sensitivity and pressing the + button will give higher sensitivity. Pressing the function selection button will switch between the inspiration and expiration trigger functions. When adjustment is completed, switch off the machine. The setting is stored at the same time. Then, start the machine in the normal way. The trigger sensitivity must always be checked when the EPAP and IPAP values are changed. It is important that the patient tests the new setting for a reasonable period and in the lying position. At delivery, the inspiration trigger setting is normally set at 22 and the expiration trigger at 8.

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