PV 102+ Operating Manual Issue P-1

TABLE OF CONTENTS

7.4

Operating Manual PV 102+

Yearly maintenance service ... 27

8

TROUBLE-SHOOTING ... 28

9

TECHNICAL SPECIFICATION PV 102+ ... 29

10

SERVICE RECORDS... 31

11

ACCESSORIES ... 32

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Issue: P-1

Operating Manual PV 102+

1

INTRODUCTION

1.1

Intended use

INTRODUCTION

The Breas PV 102+ is intended for treatment of obstructive and central sleep apnoea, hypopnea and other forms of sleep-related breathing problems. It is a bi-level device, which means that the expiration pressure (EPAP) can be set lower than the inspiration pressure (IPAP). A back-up rate can also be set and an adjustable rise time makes it possible to set the time for the pressure to change from EPAP to IPAP. The PV 102+ is intended for use in homes, while travelling or in institutions.

1.2

Indications Obstructive pulmonary disease, Hypercapnia, Emphysema, Bronchitis, Restrictive pulmonary disease, Poliomyelitis, Multiple sclerosis.

1.3 Contraindications •

Bullous Lung Disease

•

Pathologically Low Blood Pressure

•

Severe Cardiac Arrhythmias

•

Coronary Artery Disease

•

Pneumothorax

•

Pneumomediastinum

•

Pneumocephalus has been reported in patients using nasal CPAP. Caution should be used when prescribing CPAP for susceptible patients such as those with cerebral spinal fluid (CSF) leaks, abnormalities of the cribriform plate, prior history of head trauma and/or pneumocephalus.

•

Massive epistaxis or previous history of massive epistaxis (risk of recurrence)

•

Existing respiratory failure or insufficiency

•

The use of positive airway pressure therapy may be temporarily contraindicated if the patient exhibits signs of a sinus or middle ear infection.

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INTRODUCTION

1.4

Operating Manual PV 102+

About this manual Read this manual before setting up and using the PV 102+ to ensure correct usage, maximum performance and serviceability. This manual is primarily intended for care providers, clinical personnel, physicians and others who require a working knowledge of the PV 102+. Service personnel may order the BREAS PV 102+ Service manual which contains detailed service and repair information. Icons In this manual, icons are used to alert you to specific information. The meaning of each icon is explained in the table below. Icon

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Type of information

Explanation

Warning

A “warning” is used when there is a risk of personal injury.

Caution

A “caution” is used when there is risk of equipment damage, when you may risk losing data, getting an unexpected result, or having to redo all or part of a procedure.

Note

A “note” provides information that is not of critical importance, but may nevertheless be valuable, such as tips and tricks.

Reference

A “reference” guides you to other manuals where you will find additional information on a specific topic.

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Operating Manual PV 102+

2

IMPORTANT SAFETY NOTICES

IMPORTANT SAFETY NOTICES This chapter lists all safety precautions for the PV 102+. Furthermore, the safety symbols on the equipment designation label are described. Warnings! •

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

•

The PV 102+ shall only be used by patients with spontaneous breathing.

•

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

•

The PV 102+ shall only be used after prescription by a physician.

•

Inadequate use of device/accessories may cause loss of treatment.

•

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 you suspect that the device does not work as intended and/or the device sounds odd, please contact the responsible health care personnel.

•

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

•

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

•

Use a new mask for each new patient.

•

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 is recommended between the air outlet and the patient circuit to prevent contamination. Reuse of mask and/or bacteria filter may expose patients to contagious agents.

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IMPORTANT SAFETY NOTICES

Operating Manual PV 102+

•

The use of a bacteria filter on the output of the device may interfere with the operation of the patient disconnect function. It may also interfere with the device trigger function. Users should evaluate filters before use with a patient. Consult your local distributor for information on recommended filter types.

•

Do not change the settings decided by health care personnel.

•

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

•

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

Cautions

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•

Clinical personnel must read and the patient is recommended to read this operating manual, and understand how the PV 102+ is used before setting up and using the device.

•

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

•

The performance of the PV 102+ may deteriorate at temperatures below 5ºC and above 40ºC.

•

Do not use the PV 102+ when placed in direct sunlight.

•

Do not place the device on a vibrating surface.

•

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

•

For PC connection, use only Breas communication cable, part no 001 530 or 001 980. For connection to the remote control, use only Breas cable, part no 001 248 or 001 249. Using cables other than these will damage the connector's printed circuit board.

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Operating Manual PV 102+

IMPORTANT SAFETY NOTICES

Environmental Conditions •

The device complies with the requirements of IEC 601-1-2 with regard 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 device. Such measures should include, but are not limited to: - normal precautions with regard to relative humidity and conductive characteristics of clothing in order to minimise 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 an electromagnetic field level exceeding 10 V/m. - do not use patient hoses or tubes made from static or electrically conducting material.

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IMPORTANT SAFETY NOTICES

2.1

Operating Manual PV 102+

Safety Symbols The safety symbols below are shown on the equipment designation label with serial number underneath the PV 102+. Explanation of symbols on equipment label: 1

2

3

4

5

6

This table describes the symbols shown on the equipment designation label. No

Symbol

1

–

Model designation

2

–

Serial number

3

Class II equipment; dual isolation

4

Body floating

5

Read the operating manual thoroughly before connecting the PV 102+ to the patient.

6 0123

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Explanation

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

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Operating Manual PV 102+

PANEL DESCRIPTIONS

3

PANEL DESCRIPTIONS

3.1

Front panel

1.

Patient air outlet, 22/15 mm ISO

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PANEL DESCRIPTIONS

3.2

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Operating Manual PV 102+

Setting panel

1.

Green LED for setting EPAP pressure or yellow LED when setting trigger sensitivity.

2.

Current pressure, green LED

3.

Green LED for setting IPAP pressure or yellow LED when setting trigger sensitivity.

4.

Bar graph used to show IPAP/EPAP pressure or trigger sensitivity.

5.

Button, ramp on/off

6.

EPAP setting indicator, green

7.

Decrease setting value button

8.

Function selector button

9.

Rise time setting indicator, green

10.

Display, set rise time, 0.3–1.0 seconds

11.

Red LED, leakage alarm

12.

Green ON LED indicator

13.

ON/OFF switch

14.

IPAP setting indicator, green

15.

Increase setting value button

16.

Lock function indicator

17.

Back-up rate setting indicator, green

18.

Display, set back-up rate, 6–40 BPM

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Operating Manual PV 102+

3.3

PANEL DESCRIPTIONS

Rear panel

1.

Air filter, washable (grey) and disposable (white), if used

2.

Mains power socket

3.

Hour meter, shows total running time

4.

Fuse holder with fuse, use 1 A TT rated for 250 V

5.

External DC socket

6.

Analog/Digital output connector, female

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PANEL DESCRIPTIONS

3.4

Operating Manual PV 102+

Underside 1. Patient air filter 2. Model and serial number label 3. Air intake for internal cooling

Do not block the air inlet for internal cooling.

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Operating Manual PV 102+

4

INSTALLING THE PV 102+ •

4.1

4.2

INSTALLING THE PV 102+

Check the device 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 device.

•

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

Connecting the tube and mask 1.

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

2.

Connect the other end of the tube to the mask.

The leakage from the mask should be at least approximately 20 litres/min. at 10 mbar pressure. This is achieved by a 4.0 mm diameter hole in the mask. Use of erratic mask without required leakage can cause inadequate treatment.

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INSTALLING THE PV 102+

4.3

Operating Manual PV 102+

Mains power supply • Voltage 100–240 V AC • Power consumption max. 1 A

Make sure that the power cord is undamaged before it is connected to the device.

4.4

Replacing the fuse 1.Disconnect the mains power supply (1) before removing the fuse. 2.Check that the power supply fuse (2) has the correct rating for the set voltage. Use 1 A TT fuse rated for 250 V. 3.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+

5

FUNCTIONS AND SETTINGS

FUNCTIONS AND SETTINGS 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.

5.1

ON/OFF button • The PV 102+ is switched on and off by pressing the ON/OFF button for 2 seconds. • The green LED is lit when running.

5.2

Decrease/Increase setting buttons •

5.3

Press to decrease (–) or increase (+) the value of the selected setting.

Bar graph 2

1 3

• A moving green LED (1) shows the current patient air pressure. It goes off 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 off approximately 10 seconds after the last adjustment.

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•

The PV 102+ delivers a maximum pressure of 30 mbar.

•

All LED indicators on the bar graph go off 5 minutes after the last adjustment was made. They are activated again once the function button is pressed.

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FUNCTIONS AND SETTINGS

5.4

Operating Manual PV 102+

Setting the EPAP pressure (expiration pressure)

3

Range: 4– set IPAP pressure (max 30 mbar).

1

1. Select the EPAP parameter using the function button. The EPAP LED will be lit.

2

2. Press the – or + button to set the required EPAP pressure. 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 off approximately 10 seconds after the last adjustment was made.

5.5

Setting the IPAP pressure (inspiration pressure) 3

Range: 4–30 mbar. 1. Select the IPAP parameter using the function button.

1

2. Press the – or + button to set the required IPAP pressure.

2

3. The green LED to the right shows the selected pressure. • The setting is saved in the memory after 5 seconds. • The LED goes off approximately 10 seconds after the last adjustment was made.

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Operating Manual PV 102+

5.6

FUNCTIONS AND SETTINGS

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.

0.3

1. Select the rise parameter using the function button. 2. Press the – or + button to decrease or increase to the required rise 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 off 5 minutes after the last adjustment. It is activated again once the function button is pressed.

5.7

Setting the back-up rate Range: 6–40 breaths per minute. 1. Select the rate parameter using the function button.

12

2. 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 device the first night. The numeric display will start to flash if the setting is above the number of breaths that the device can deliver (total time: inhalation + exhalation). Reduce the setting until the display stops flashing. The numeric display window goes off 5 minutes after the last adjustment. It is activated again once the function button is pressed.

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FUNCTIONS AND SETTINGS

5.8

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 device 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 off.

Range: 5–30 minutes 2 1 3

1. Select the ramp parameter by pressing the ramp button for 1 second. The green LED indicating the ramp function is lit. 2. A green LED is lit at the 5-minute position as a time indication. 3. Set the desired ramp time using the – and + buttons.

When selecting the ramp parameter, a new value has to be set within 10 seconds or the function will be locked. When the set time has expired, the function is switched off and the green LED in the button goes off. 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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Operating Manual PV 102+

5.9

FUNCTIONS AND SETTINGS

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 as when locking i.e. the setting panel or the remote control or PC.

5.10

Alarms Power failure alarm

If the power supply should fail during operation, an audible alarm is given. 1.

Switch off the device.

2.

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

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 automatically reset. Function error alarm

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

5.11

Safety Should the control electronics fail, the PV 102+ cannot deliver a pressure higher than 40 mbar at single fault condition.

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FUNCTIONS AND SETTINGS

5.12

Operating Manual PV 102+

Analog/Digital connector For PC connection, use only Breas communication cable, part no 001 530 or 001 980. For connection to the remote control, use only Breas cable, part no 001 248 or 001 249. Using cables other than these will damage the connector's printed circuit board.

5 4 3 2 1

Analog/digital connector for PC communication/remote control.

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 = 12 V

Analog signal pressure

1 volt = 0 mbar, 2 volt = 10 mbar, 3 volt = 20 mbar, 4 volt = 30 mbar Analog signal flow

0,5 volt = 0 L/m, 1 volt = 20 L/m, 2 volt = 60 L/m, 3 volt = 100 L/m, 4 volt = 140 L/m

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