Table of Contents

Advertisement

PV 10 Clinician's Manual

Table of Contents

1
Intended Use of the PV 10 .............................................................................................3
1.1
What is the PV 10?............................................................................................4
1.2
Indications for Use.............................................................................................4
1.3
Contraindications............................................................................................... 5
1.4
About this Manual..............................................................................................6
2
Important Safety Information ...........................................................................................7
2.1
General User Precautions .................................................................................7
2.2
Electrical Safety................................................................................................. 8
2.3
Environmental Conditions .................................................................................8
2.4
Usage of Patient Tube and Mask ....................................................................10
2.5
Usage of Filters ............................................................................................... 11
2.6
Cleaning and Maintenance.............................................................................. 11
2.7
Adverse Patient Symptoms .............................................................................12
2.8
Usage of a Humidifier ......................................................................................12
2.9
Usage of Oxygen............................................................................................. 13
3
Product Description .......................................................................................................14
3.1
Main Components ...........................................................................................14
3.2
Front and Setting Panel...................................................................................16
3.3
Rear Panel ......................................................................................................19
3.4
Equipment Designation and Safety Label .......................................................20
3.5
Output Connector for Data Transfer ................................................................ 21
4
Preparing the PV 10 for Use .........................................................................................23
4.1
Installing the PV 10 .........................................................................................23
4.2
Placing the PV 10 ............................................................................................23
4.3
Connecting the PV 10 to the Mains Supply ..................................................... 24
4.4
Connecting the Patient Tube and Mask ..........................................................24
4.5
Checking the PV 10 before Use ......................................................................26
5
Setting up the PV 10 .....................................................................................................27
5.1
Description of the CPAP and Ramp functions .................................................27
5.2
Setting the CPAP Pressure .............................................................................27
5.3
Setting the Ramp Time.................................................................................... 28
5.4
Locking/Unlocking the Setting Panel ...............................................................28
5.5
Setting the Default Display ..............................................................................29
5.6
Setting the Alarm Clock ...................................................................................30
5.7
Setting the Actual Time ...................................................................................31
6
Using the PV 10 ............................................................................................................32
6.1
Switching the PV 10 On and Off......................................................................32
6.2
Starting and Stopping a Ramp Period .............................................................33
6.3
Displaying the Operating Time ........................................................................34
6.4
Displaying the Internal Firmware Version ........................................................35
7
Cleaning the PV 10 and Replacing the Filters...............................................................36
7.1
Cleaning the PV 10 .........................................................................................36
7.2
Cleaning the Patient Tube and Mask .............................................................. 36
7.3
Cleaning and Replacing the Patient Air Filter..................................................37
Doc. No. 003379 En S-1
BREAS MEDICAL
Table of Contents
1

Advertisement

Table of Contents
loading
Need help?

Need help?

Do you have a question about the PV 10 and is the answer not in the manual?

Questions and answers

Summary of Contents for Breas Medical PV 10

  • Page 1: Table Of Contents

    Preparing the PV 10 for Use ..................23 Installing the PV 10 ..................23 Placing the PV 10 ....................23 Connecting the PV 10 to the Mains Supply ............. 24 Connecting the Patient Tube and Mask ............24 Checking the PV 10 before Use ..............26 Setting up the PV 10 .....................27...
  • Page 2 Technical Specifications ....................46 Accessories ........................48 12.1 BREAS Accessories List ................. 48 12.2 Using an External Battery with the PV 10 ............50 12.3 Using a Remote Control with the PV 10............52 BREAS MEDICAL Doc. No. 003379 En S-1...
  • Page 3: Intended Use Of The Pv 10

    Read this manual thoroughly before using the PV 10 so that you completely understand how the PV 10 is operated and maintained, to ensure correct usage, maximum performance and serviceability. WARNING! Do not use the PV 10 for any kind of life support treatment. Doc. No. 003379 En S-1 BREAS MEDICAL...
  • Page 4: What Is The Pv 10

    The internal memory of the PV 10 can be downloaded to a PC to allow you to view the patient compliance data in the BREAS PV 10 Calendar Soft- ware.
  • Page 5: Contraindications

    PV 10 Clinician’s Manual Intended Use of the PV 10 Contraindications Therapy with the PV 10 should not be prescribed when the following spe- cific diseases or conditions are present: • Bullous lung disease • Pathologically low blood pressure •...
  • Page 6: About This Manual

    Intended Use of the PV 10 PV 10 Clinician’s Manual About this Manual Always read this manual before setting up and using the PV 10 or per- forming maintenance on the machine, to ensure correct usage, maxi- mum performance and serviceability.
  • Page 7: Important Safety Information

    Do not use the PV 10 and contact the responsible care provider for an inspection in the event of suspected damage to the device, inexplicable or sudden pressure, performance or sound disturbances during opera- tion, or if the delivered air from the PV 10 is abnormally hot or emits an odour. •...
  • Page 8: Electrical Safety

    PV 10 Clinician’s Manual Electrical Safety • Do not operate the PV 10 if it has a damaged cord or plug, if it is not working properly or if any part of the PV 10 has been dropped, damaged, or submerged in water.
  • Page 9 “Electromagnetic compatibility”. Necessary measures must be taken in order to be certain that the specified limits are not exceeded as this may impair the safety of the PV 10. Such measures should include, but not be limited to: –...
  • Page 10: Usage Of Patient Tube And Mask

    Only use the PV 10 with a mask, patient tube and ventilation valve (if applicable) recommended by BREAS or your health care professional. • Do not use the connected mask unless the PV 10 is turned on and oper- ating properly. •...
  • Page 11: Usage Of Filters

    Only use filters that are specified in this manual. • Replace or clean the filters regularly to ensure correct function of the PV 10. Failure to replace or clean a dirty filter may cause the PV 10 to operate at higher temperatures than intended. •...
  • Page 12: Adverse Patient Symptoms

    • Moisture build-up in the PV 10 system can cause damage. Be careful to disconnect the tubing at the PV 10 air outlet first so that no water flows back into the PV 10. •...
  • Page 13: Usage Of Oxygen

    • When the PV 10 is not in operation and the oxygen flow is left on, oxygen delivered into the patient tubing may accumulate within the tube and device. Oxygen accumulated in the tube or device will create a risk of fire.
  • Page 14: Product Description

    Product Description PV 10 Clinician’s Manual Product Description Main Components The PV 10 and its packaging do not contain any natural rubber latex. The PV 10 standard package contains the following components: BREAS MEDICAL Doc. No. 003379 En S-1...
  • Page 15 PV 10 Clinician’s Manual Product Description DESCRIPTION PV 10 main unit Filter (grey, washable), installed Filter (white, disposable), 1 pc Patient tube Carrying bag Power cord • European, or • British. PV 10 User Manual Doc. No. 003379 En S-1...
  • Page 16: Front And Setting Panel

    Product Description PV 10 Clinician’s Manual Front and Setting Panel BREAS MEDICAL Doc. No. 003379 En S-1...
  • Page 17 PV 10 Clinician’s Manual Product Description Patient air outlet and control buttons COMPONENT DESCRIPTION Patient air outlet Used for connecting the PV 10 to the patient tube and mask. ∅ 22/15 mm (ISO 5356-1). Setting panel See details below. I/O button User control used for switching the PV 10 on or off.
  • Page 18 LED indicating whether the PV 10 is switched on or off: • Steady green light – PV 10 is switched on. • Flashing light – PV 10 is switched off, but still connected to the power source. Ramp LED LED indicating that the PV 10 is operating at a ramp period with the start pressure.
  • Page 19: Rear Panel

    4 3 2 1 9 8 7 6 SYMBOL COMPONENT DESCRIPTION Analogue/ Used for connecting the PV 10 to either a digital output remote control, a PC or sleep diagnostic equip- connector ment. Read the PV 10 Clinician’s Manual thoroughly before using the analogue/ digital connector.
  • Page 20: Equipment Designation And Safety Label

    Class II equipment; dual isolation Body floating (IEC 601-1 Type BF, Isolated Applied Part) Read the User Manual thoroughly before connecting the PV 10 to the patient. CE marking applies in accordance with the directive MDD 93/42/EEC. 0 1 2 3...
  • Page 21: Output Connector For Data Transfer

    PC or to sleep diagnostic equipment. A female connector is provided in the rear panel on the PV 10 for analogue and/or digital communication. The PV 10 must not be connected to a PC when the PV 10 is being used by a patient. •...
  • Page 22 Product Description PV 10 Clinician’s Manual Digital connection The digital connection may be used for connecting the PV 10 to a remote control, or to a PC for patient data analysis. PINS INPUT/OUTPUT Pin 1 +5 V power Pin 2...
  • Page 23: Preparing The Pv 10 For Use

    38. • A bacteria filter is recommended between the patient outlet and the patient tube if the PV 10 is to be used by different patients at a clinic. Placing the PV 10 •...
  • Page 24: Connecting The Pv 10 To The Mains Supply

    (if applicable) recommended by BREAS or the responsible health care professional. • Do not use the connected mask unless the PV 10 is switched on and operating properly. • Always use a new mask, tube and ventilation valve, if applicable, when the PV 10 is to be used by a new patient.
  • Page 25 PV 10 Clinician’s Manual Preparing the PV 10 for Use To connect the PV 10 to the patient tube and mask: Connect the patient tube to the air outlet, see figure below. Connect the other end of the patient tube to the mask and the ventilation valve, if applicable.
  • Page 26: Checking The Pv 10 Before Use

    Switch on the PV 10 and disconnect the power cord for more than 5 seconds. Check that the audible alarm for power failure sounds. If the power failure alarm is not heard, do not use the PV 10 and con- tact your service provider.
  • Page 27: Setting Up The Pv 10

    Ramp function When the PV 10’s ramp function is activated, it starts operating at a 4 mbar ramp pressure instead of the preset pressure. The PV 10 will then gradually increase the pressure during the entire ramp period until the set pressure is reached.
  • Page 28: Setting The Ramp Time

    Locking/Unlocking the Setting Panel The setting panel can be locked either from the setting panel on the PV 10, a remote control, or a PC (personal computer with the BREAS PV 10 Calen- dar Software installed) if connected to the PV 10.
  • Page 29: Setting The Default Display

    Setting up the PV 10 Setting the Default Display The default display is shown on the PV 10 setting panel when no other set- ting or displaying mode is active. You can set the default display to show one of the three alternatives below.
  • Page 30: Setting The Alarm Clock

    Press the Mode button once again. Press the button to adjust the alarm time. – The PV 10 will return to normal operation and show the default display after 2 minutes. To return to normal operation before the 2 minutes have expired: •...
  • Page 31: Setting The Actual Time

    If you set the actual time showed on the display, this will not change the PV 10’s internal clock used when registering the patient data. To change the internal clock, refer to the BREAS PV 10 Calendar Software.
  • Page 32: Using The Pv 10

    Steady green light – The PV 10 is switched on, running from a mains power supply or an external battery. • Flashing light – The PV 10 is switched off but still connected to a sup- ply of power. BREAS MEDICAL...
  • Page 33: Starting And Stopping A Ramp Period

    The ramp period stops automatically when the ramp time has expired. After the ramp period, the PV 10 will start operating at the preset CPAP pressure. To manually stop a ramp period: •...
  • Page 34: Displaying The Operating Time

    PV 10 Clinician’s Manual Displaying the Operating Time The PV 10 can display the machine operating time and the patient operating time. There is no total running time that includes all the time when the PV 10 is switched on.
  • Page 35: Displaying The Internal Firmware Version

    Using the PV 10 Monitoring patient compliance For a PV 10 where the patient operating time has been reset and the setting panel has been locked, the number of patient operating hours will be an indication of the patient operating time at the treatment pressure.
  • Page 36: Cleaning The Pv 10 And Replacing The Filters

    To clean the PV 10: Switch off the PV 10 and disconnect the electrical supply. Remove the patient tube and mask. Clean the outside of the PV 10 using a lint-free cloth and a mild deter- gent solution. Reconnect the patient tube and mask.
  • Page 37: Cleaning And Replacing The Patient Air Filter

    The patient air filter or filters are located in the filter holder in the rear panel of the PV 10. There are two types of filters: a washable filter and a disposa- ble filter. The PV 10 may be used with one or two filters installed.
  • Page 38 To wash the washable (grey) patient air filter: Pull the filter(s) out of the filter holder of the PV 10 (see figure). Wash the grey filter using warm water and a mild detergent. Rinse thor- oughly with water.
  • Page 39 PV 10 Clinician’s Manual Cleaning the PV 10 and Replacing the Filters 4 3 2 1 9 8 7 6 1742 Doc. No. 003379 En S-1 BREAS MEDICAL...
  • Page 40: Alarms

    When the PV 10 is running from the mains power supply with no exter- nal back-up power source connected: – If the power failure lasts for 5 seconds or less, the PV 10 will go back to normal operation at the pressure delivered before the power fail- ure.
  • Page 41: Function Error Alarm

    A continuous audible alarm sounds. • The PV 10 is automatically switched off. If the fault persists, do not use the PV 10 and contact your responsible serv- ice provider or BREAS representative. Doc. No. 003379 En S-1 BREAS MEDICAL...
  • Page 42: Trouble-Shooting

    Trouble-shooting PV 10 Clinician’s Manual Trouble-shooting If the PV 10 does not work properly, try to identify the problem in the trou- ble-shooting table below. Check the possible causes and carry out the sug- gested remedial actions. If you do not find the problem or possible cause in the table below, or if...
  • Page 43 The patient air filter is Clean or replace the filter. blocked. Incorrect operation. Do not use the PV 10 and call for service. A continuous audible Function error • Disconnect and reconnect the alarm sounds and the power cord, and switch on the PV 10 is switched off.
  • Page 44: Maintenance

    • Do not under any circumstances attempt to service or repair the PV 10 yourself. If you do so, the manufacturer will no longer be responsible for the performance and safety of the PV 10.
  • Page 45: 10.2 Service And Repair

    Maintenance 10.2 Service and Repair The service and repair of the PV 10 must only be carried out by authorised service personnel in accordance with BREAS service instructions. Service inspections must always be carried out after any repair of the device.
  • Page 46: Technical Specifications

    4–20 mbar, in 0.5 mbar increments. Tolerance: ±0.5 mbar Ramp time 10, 20 or 30 minutes Set lock function • From the setting panel of the PV 10 • From connected remote control/PC Clock function • Time display • Alarm clock Mains supply 100–240 V AC, 50–60 Hz, 68 VA...
  • Page 47 W × H × D 160 × 115 × 235 mm (6.3 × 4.5 × 9.3 in) Weight 1.7 kg (3.7 pounds) The PV 10 and its packaging do not contain any natural rubber latex. Doc. No. 003379 En S-1 BREAS MEDICAL...
  • Page 48: Accessories

    Only use accessories recommended by BREAS or your licensed health care professional. BREAS cannot guarantee the performance and safety for the use of other accessories with the PV 10. The following BREAS accessories are currently available for the PV 10.
  • Page 49 PV 10 Clinician’s Manual Accessories DESCRIPTION BREAS PART NO. MASKS AND MASK ACCESSORIES Nasal CPAP mask: • with tube, 13 inches 003347 • with tube, 6 inches 003346 Headgear to nasal mask with 3-point strap: • small 002646 • medium 002647 •...
  • Page 50: Using An External Battery With The Pv 10

    PV 10 Clinician’s Manual 12.2 Using an External Battery with the PV 10 The PV 10 can be operated from a 12–24 V DC external battery or a battery in a vehicle. The BREAS EB 12 battery is recommended. With an external battery connected, the PV 10 will automatically switch over to the external battery source if the mains power cord is removed or if the mains power supply fails.
  • Page 51 Battery operation time The operation time is dependent on the battery condition, its capacity, the ambient air temperature and the PV 10 pressure setting. The operation time for a fully charged 60 Ah battery at 20°C (68°F) room temperature with the pressure set at 10 mbar will be approximately 30–40 hours.
  • Page 52: Using A Remote Control With The Pv 10

    12.3 Using a Remote Control with the PV 10 The remote control may be used as an optional accessory to the main unit of PV 10. Only use the BREAS PV 10 remote control together with the PV 10. 4 32 1 9 8 7 6...
  • Page 53 If the setting panel is locked by the remote control or PC, the lock function LED of the PV 10 shows a yellow light. If the PV 10 has been locked by using the remote control or PC, it must also be unlocked from the remote control.
  • Page 54 Accessories PV 10 Clinician’s Manual BREAS MEDICAL Doc. No. 003379 En S-1...

Table of Contents

Save PDF